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

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



Case Details

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VAERS ID: 1287179 (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: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Cardio-respiratory arrest, Dyspnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (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: STAGID; PERINDOPRIL/INDAPAMIDE; ATENOLOL; NIFEDIPINE; KARDEGIC; TAMSULOSIN; PERMIXON; BROMAZEPAM; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Benign prostatic hypertrophy; Gastroesophageal reflux disease; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021478254

Write-up: Cardio-respiratory arrest; Acute dyspnea; Acute oedema of lung; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number is FR-AFSSAPS-NC20211679. A 76-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 intramuscular on 13Apr2021 11:00 (Batch/Lot Number: EW2246) as single dose for COVID-19 immunisation. Medical history included type II diabetes mellitus, arterial hypertension, gastroesophageal reflux disease and benign prostatic hypertrophy Concomitant medications included metformin embonate (STAGID), indapamide, perindopril erbumine (PERINDOPRIL/INDAPAMIDE), atenolol, nifedipine, acetylsalicylate lysine (KARDEGIC), tamsulosin, serenoa repens extract (PERMIXON), bromazepam and pantoprazole, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (COMIRNATY, solution for injection), dose 1 on 19Mar2021 for COVID-19 immunisation. On 14Apr2021, during the night following the vaccination, the patient called the fire brigade at 5:42 am and explained "I can no longer breathe". Firefighters left immediately and arrived at the scene at 5:54 a.m. Upon arrival, the patient is in cardiopulmonary arrest. SMUR (mobile emergency and resuscitation service) request by firefighters. Information sent to the regulator: Patient "crumbles", acute lung edema. The patient lives alone, he has not seen anyone since his vaccination in the morning at 11am. The presence of other post-vaccination symptoms is therefore not known. Summary of management: Cardiopulmonary resuscitation, external cardiac massage and BVM (bag valve mask). Semi-automatic defibrillator installation: no shock. Evolution: Total absence of cardiac activity after a minimum of 45 minutes of resuscitation. The patient is declared deceased. Conclusion: Acute dyspnea, crumbling evoking a massive acute edema of the lung with cardiorespiratory arrest within 24 hours following a booster vaccination with Comirnaty in a 76-year-old diabetic, hypertensive patient. The pharmacovigilant notes: Accountability score established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. The patient died on 14Apr2021. It is unknown if autopsy was done. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; Acute dyspnea; Acute oedema of lung


VAERS ID: 1287184 (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: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood glucose decreased, Blood pressure increased, Blood pressure measurement, Cerebrovascular accident, Loss of consciousness, Oxygen saturation
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), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (narrow)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVOTHYROX; DOLIPRANE; OMEZELIS; KARDEGIC; KIPOS; LERCAPRESS [ENALAPRIL MALEATE;LERCANIDIPINE HYDROCHLORIDE]
Current Illness: Hypertension (with poor compliance); Suicide threat (black thoughts with threat of suicide by medication)
Preexisting Conditions: Medical History/Concurrent Conditions: Depressive disorder; Treatment noncompliance
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: capillary blood sugar; Result Unstructured Data: Test Result:1.82; Test Date: 20210410; Test Name: BP; Result Unstructured Data: Test Result:180/90; Test Date: 20210410; Test Name: SaO2; Test Result: 99 %
CDC Split Type: FRPFIZER INC2021478247

Write-up: CVA/suspicion of stroke; found unconscious on the ground; capillary blood sugar (Dextro) 1.82; BP 180/90; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-NY20210740. A 79-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: ET7205), intramuscular, administered in left arm on 31Mar2021 at a single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and suicide threat from Feb2021, both were reported as ongoing; poor compliance, and in a depressive context. Patient was placed in an institution in early Feb2021 following the fire in her house where she lost everything. History of hypertension and black thoughts since the fire. To note a poor compliance which was realized at the time of patient''s death because drugs were found in the belongings of the patient. The vaccine was administered to patient in a depressive context due to recent house fire requiring the institutionalization and death of a son 3 weeks earlier. Concomitant medications included levothyroxine sodium (LEVOTHYROX, 75 ug strength); paracetamol (DOLIPRANE, 500 mg strength); calcium lactate pentahydrate, crataegus spp., magnesium thiosulfate, melissa officinalis (OMEZELIS); acetylsalicylate lysine (KARDEGIC, 75 mg strength); cholecalciferol (KIPOS); and enalapril maleate, lercanidipine hydrochloride (LERCAPRESS). 10 days after the first injection, on 10Apr2021, at lunchtime, patient was found unconscious on the ground, with BP 180/90, SaO2 99% and capillary blood sugar (Dextro) 1.82. Emergency services was called and patient was administered one ampoule of VALIUM. Then, patient was transferred to the hospital center (patient hospitalized). Death the same day on 10Apr2021 with suspicion of stroke (CVA). The outcome of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: CVA/suspicion of stroke


VAERS ID: 1287185 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, C-reactive protein, C-reactive protein increased, Computerised tomogram thorax, Cough, Oxygen saturation, Oxygen saturation decreased, Pain, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral atrophy (Cortico-subcortical atrophy); COPD; Emphysema; Fibromyalgia; Leukoaraiosis (Grade 3)
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: CT with contrast; Result Unstructured Data: Test Result:no pulmonary embolism; Comments: no focus, normal injected thoracic CT; Test Date: 20210421; Test Name: CRP; Result Unstructured Data: Test Result:39 mg/l; Comments: Normal high range 5; Test Date: 20210420; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased; Test Date: 20210420; Test Name: Covid-19 antigen test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021478242

Write-up: Oxygen saturation decreased/desaturation; Cough; Sudden death unexplained; CRP 39 mg/l (normal high range: 5); asthenia; diffuse pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-NY20210818 with safety report unique identifier FR-AFSSAPS-2021042491. A 74-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number EW9127), intramuscular on 18Apr2021 at a single dose for covid-19 immunization. Medical history included COPD, emphysema, leukoaraiosis grade 3, fibromyalgia, and cerebral atrophy (cortico-subcortical atrophy). The patient was previously vaccinated with the first dose of BNT162B2 (COMIRNATY, lot number ET3620), intramuscular on 22Mar2021 at a single dose for covid-19 immunization. The patient''s concomitant medications were not reported. On 18Apr2021 cough increased with asthenia and diffuse pain. On 20Apr2021 oxygen saturation decreased/desaturation requiring 2 liters of oxygen (oxygenotherapy) - this required emergency consultation. The patient required hospitalization for events cough and oxygen saturation decreased in the medical sector and the patient was started on antibiotic therapy with Augmentin. CT with contrast on 20Apr2021: no pulmonary embolism, no focus, normal injected thoracic CT. Covid-19 antigen test on 20Apr2021 was negative. CRP on 21Apr2021 was 39 mg/l (normal high range: 5). On 21Apr2021 06:15 sudden death unexplained. The patient died on 21Apr2021. Autopsy reported as probable - no autopsy results were available. The outcome of events oxygen saturation decreased/desaturation and cough was not recovered. The outcome of events asthenia, diffuse pain and, CRP: 39 mg/l was unknown. Reporter comment: Conclusion: 74-year-old woman with a history of COPD, emphysema, cerebral atrophy, leukoaraiosis, fibromyalgia having received two injections of the COMIRNATY vaccine (batch ET3620 / EW9127). On the day of the 2nd injection, increased cough, then desaturation and unfavorable outcome despite hospitalization with sudden unexplained death 3 days later. NB: Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Therapy 1985; 40: 111-8. NB: Imputability without prejudice to the elements of investigation that could be carried out in the framework of legal or amicable compensation procedures. Therapy 1985; 40: 111-8. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Conclusion: 74-year-old woman with a history of COPD, emphysema, cerebral atrophy, leukoaraiosis, fibromyalgia having received two injections of the COMIRNATY vaccine (batch ET3620 / EW9127). On the day of the 2nd injection, increased cough, then desaturation and unfavorable outcome despite hospitalization with sudden unexplained death 3 days later. NB: Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Therapy 1985; 40: 111-8.; Reported Cause(s) of Death: sudden death unexplained


VAERS ID: 1287199 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-11
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: Carotid artery stenosis; Dyslipidaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021483977

Write-up: Haemorrhage cerebral; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number FR-AFSSAPS-RS20211016. A 75-years-old male patient received first dose of bnt162b2 (Pfizer vaccine, Formulation: Solution for injection), dose 1 intramuscular on Mar2021 as single dose for covid-19 immunisation. Medical history included dyslipidaemia, carotid artery stenosis (40% on last ultrasound of the supra-aortic arteries). No history of SARS-Cov2 infection or testing was reported. Current medication included atorvastatin calcium (tahor), 10mg daily. On 11Apr2021, around 10:15 am, the patient was found unconscious by his wife in his bed, non-responsive, with blood in his mouth and noisy breathing. The couple had a separate room exceptionally because his wife was a little feverish with a rhinorrhea the day before. Upon arrival of the emergency mobile service, the patient had a glasgow score at 3 with pupils in miosis, reactive and symmetrical. No facial paralysis was observed, but probable inhalation with intraoral red and brown blood. The patient was hypothermic at 35.2 degree celsius, without hypoglycemia. The patient presented with tonic crisis, without myoclonia with desaturation under 15L of oxygen with a high concentration mask and diffuse mottling. He receives a total of 2 mg of clonazepam (rivotril). Loss of urine and bite of the tongue were observed. The orotracheal intubation before hospitalization by rapid sequence induction with etomidate (unspecified trade name) 30mg and suxamethonium chloride (celocurine) 100mg was described as difficult with the use of a long mandrel, sedation was relayed by midazolam hydrochloride (hypnovel) 10mg per hour, sufentanil 10 gamma per hour and curarization with 50mg of atracurium besylate (tracrium). An intravascular volume replacement with 750 ml of crystalloids was performed. No pupillary movement was observed during transportation. The patient was referred directly to the Emergency Room scanner. The brain scan found a deep right intraparenchymal hematoma of 5.5 cm long axis with tetraventricular flooding, and hydrocephalus on background of marked vasculodegenerative leukopathy. The patient was transferred to an adapted care service. Upon admission the patient was sedated with midazolam 10mg and sufentanil 10mg. The pupils were in miosis, bilateral non-reactive. The patient was intubated. Intracerebral Hemorrhage (ICH) prognostic score was 4 (97% mortality) and functional outcome in patients with primary intracerebral hemorrhage (func) score was 5 (13% functional independence on day 90). Medical summary of the hospitalization, management and evolution included upon arrival, a specialist advice was requested no neurosurgical treatment was upheld (seriousness of the lesion and impossibility of therapeutic action as well as very poor short term prognosis). The sedation window demonstrated the absence of awakening with a glasgow score of 5. the pupils remained in miosis, bilateral non-reactive. Corneal reflexes were present. after a second discussion with the family on the next day and an expressed unwillingness of the patient (during his lifetime) to organ donation, it was decided to stop invasive care and continue the management by comfort care. The patient died on 12apr2021. The declarant indicated "no blood pressure measurement was performed before the facts". No reactions appearing in the following of the vaccine was reported. In total, fatal hemorrhagic stroke approximately 3 weeks after vaccination with comirnaty, without notion of arterial hypertension thereafter but with vascular leukopathy on scan. The patient died on 12Apr2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Haemorrhage cerebral


VAERS ID: 1287225 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute 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), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Respiratory insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Acute on chronic respiratory failure; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ACUTE RESPIRATORY FAILURE (Acute on chronic respiratory failure) in an 86-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3001413) for COVID-19 vaccination. Concurrent medical conditions included Respiratory insufficiency. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ACUTE RESPIRATORY FAILURE (Acute on chronic respiratory failure) (seriousness criterion death). The patient died on 03-Apr-2021. The reported cause of death. An autopsy was not performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death:


VAERS ID: 1287464 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Colitis, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
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: Negative
CDC Split Type: GBPFIZER INC2021474891

Write-up: Typhlitis; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104270922462150-UYYVJ. Safety Report Unique Identifier GB-MHRA-ADR 25202874. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Apr2021 (Batch/Lot Number: ER1749) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced typhlitis on an unspecified date. The patient died on 14Apr2021. It was not reported if an autopsy was performed. Lab data includes COVID-19 virus test: Negative on an unspecified date. The outcome of the event was fatal. Patient has not tested positive for COVID-19 since having the vaccine. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Typhlitis


VAERS ID: 1287465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Aortic aneurysm rupture, Hepatic haemorrhage, Illness, SARS-CoV-2 test, Thrombosis
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
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: Accident (was waiting for an operation on her ankle to have it fused.); Aortic embolus; Bone fragile (slight brittle bones); Curvature of spine (very slight); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021480112

Write-up: ruptured aortic aneurysm; Hepatic haemorrhage; Thrombosis; sickness; severe abdominal pains; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202104280557199860-CWFJP, Safety Report Unique Identifier GB-MHRA-ADR 25209134. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH, COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Feb2021 (Batch/Lot Number: EJ6790) as SINGLE DOSE for COVID-19 immunisation. Medical history included aortic embolus, osteoporosis (slight brittle bones) from an unknown date , suspected COVID-19 from 04Jan2021 to 16Jan2021, very slight spinal deformity, and an accident years ago for which the patient was waiting for an operation on her ankle to have it fused, both from an unknown date. Patient is not enrolled in clinical trial, is not pregnant, and is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced ruptured aortic aneurysm, severe abdominal pains, sickness, hepatic hemorrhage and thrombosis on an unspecified date. The seriousness criteria is death and medically significant. The patient underwent lab tests and procedures which included SARS-CoV-2 test: yes - positive COVID-19 test on an unspecified date. The patient died on 09Mar2021 around 03:50 am due to ruptured aortic aneurysm and hemorrhage to the liver apparently due to a small blood clot. It was not reported if an autopsy was performed. The outcome of the events sickness is recovering, and that of abdominal pain is unknown. Reportedly, the hospital and the coroner have the details for any relevant investigations or tests conducted. Patient has not tested positive for COVID-19 since having the vaccine. The clinical course is as follows: Severe abdominal pains, sickness led the patient to be taken to the Accident &Emergency. Ruptured aortic aneurysm. Normal and procedural tests were carried out but patient passed away the following morning at approximately 03:50 (09Mar21). Cause of death was ruptured aortic aneurysm and haemorrhage to the liver apparently due to a small blood clot in the liver which made it swollen and haemorrhage but due to an apparently weak aortic aneurysm it ruptured but nobody could explain why/how the small blood clot got there and patient was a fit, young (50) lady. It had been asked if it could be linked to the first vaccine and it had been told no She was physically fit and walked six miles a day even with the ankle. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Thrombosis; Aortic aneurysm rupture; Hepatic haemorrhage


VAERS ID: 1287477 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cholestasis, Haemolysis, Hepatorenal syndrome, Hyperbilirubinaemia, Jaundice
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemolytic disorders (narrow), Acute pancreatitis (narrow), Systemic lupus erythematosus (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INDERAL; ALDACTONE [SPIRONOLACTONE]; URSOFALK
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Liver cirrhosis; Non-Hodgkin''s lymphoma
Allergies:
Diagnostic Lab Data: Test Name: Hyperbilirubinaemia; Result Unstructured Data: Test Result:increased from 8 to 21 mg/dl
CDC Split Type: GRPFIZER INC2021491333

Write-up: Hepatorenal syndrome; Hemolysis; Cholestasis; Hyperbilirubinemia; Jaundice; This is a spontaneous report from a contactable physician downloaded from the regulatory authority (GR-GREOF-20212362). An 82-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly, on 05Mar2021 as a single dose for COVID-19 immunisation. Medical history included liver cirrhosis from 2018 and Non-Hodgkin''s lymphoma from 2004. Concomitant medications included propranolol hydrochloride (INDERAL), spironolactone (ALDACTONE), and ursodeoxycholic acid (URSOFALK) taken for cryptogenic cirrhosis from 24Apr2018. The patient experienced hepatorenal syndrome on 07Mar2021, which was reported as fatal. The patient also experienced hemolysis, cholestasis, hyperbilirubinemia, and jaundice on 07Mar2021. All of the events required hospitalization and were reported as medically significant. The patient underwent lab tests and procedures which included hyperbilirubinaemia: increased from 8 to 21 mg/dl on an unspecified date. The clinical outcome of hepatorenal syndrome was fatal and of hemolysis, cholestasis, hyperbilirubinemia, and jaundice was not recovered. The patient died in Apr2021 (reported as: about 1.5 months after vaccination). The cause of death was reported as hepatorenal syndrome. An autopsy was not performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Hepatorenal syndrome


VAERS ID: 1287485 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dyspnoea, Heart rate, Oxygen saturation, Pneumonia, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   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: Aortic aneurysm; Chronic ischemic heart disease, unspecified; Congestive heart failure; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/60 mmHg; Test Date: 20210320; Test Name: Body temperature; Result Unstructured Data: Test Result:35 degrees Centigrade; Test Date: 20210320; Test Name: Heart rate; Result Unstructured Data: Test Result:140; Comments: /min; Test Date: 20210320; Test Name: Oxygen saturation; Test Result: 81 %; Test Date: 20210320; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021464230

Write-up: dyspnoea/ dyspnea with oxygen saturation of 81%; tachycardia/ tachycardia with heart rate of 140/min; Pneumonia; This is a spontaneous report from a contactable physician, downloaded from the Regulatory Authority-WEB. The regulatory authority number is HU-OGYI-220121. A 73-year-old male patient received the first dose of bnt162b2 [COMIRNATY, Solution for injection; also reported as "COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran concentrate for dispersion for injection"], intramuscularly, administered in the right arm on 16Mar2021 (Batch/Lot Number: ET1831; Expiration Date: Jun2021) at 0.3 mL (also reported as 30 micrograms), single for COVID-19 immunization. Relevant medical history included hypertension; chronic ischemic heart disease, unspecified; aortic aneurysm; and congestive heart failure; all from an unknown date and not ongoing. The patient''s concomitant medications were not reported. On 20Mar2021, the patient experienced dyspnoea, tachycardia, and pneumonia, which all led to death. It was further reported that on 20Mar2021 at 1 p.m., dyspnea with oxygen saturation of 81% and tachycardia with heart rate of 140/min occurred at the patient unexpectedly; blood pressure was 130/60 mmHg and body temperature was 35 degrees Centigrade (?C). The patient was cooperating and clear-minded until then. Respiratory aspiration was ineffective and the patient received oxygen therapy until the ambulance arrived. The patient was trasported to the emergency department at 02:30 p.m., and the patient died in the hospital that evening. Pneumonia was confirmed as the cause of death. COVID-19 PCR test was negative on 20Mar2021. According to the reporter, the event was related to the patient''s underlying diseases. Therapeutic measures were taken as a result of dyspnoea and pneumonia. The patient died on 20Mar2021 due to dyspnoea, tachycardia, and pneumonia. It was not reported if an autopsy was performed. Sender Comment: The patient became tachycard and had dyspnea 4 days after Comirnaty vaccination, and died the same day. Pneumonia was confirmed as cause of death, the reporter considered the event related to the patient''s underlying diseases. The causal relationship between the reported death and Comirnaty is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: dyspnoea/ dyspnea with oxygen saturation of 81%; tachycardia/ tachycardia with heart rate of 140/min; Pneumonia


VAERS ID: 1287487 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-04-07
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Cardiomyopathy; Congestive heart failure; Dilated cardiomyopathy; Gallbladder removal; Hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021464241

Write-up: Oedema pulmonary; This is a spontaneous report from a contactable consumer (patient). This is a report received from the OGYIP with regulatory authority report number HU-OGYI-243221. A 63-year-old male patient received BNT162B2 (COMIRNATY, lot number and expiration date not reported), intramuscular on 12Mar2021 as 0.3 mL, single for COVID-19 immunisation. Medical history included Cardiomyopathy, Atherosclerosis, Obesity/ heavily obese, Gallbladder removal, dilatative cardiomyopathy and congestive heart failure due to hypertension. The patient''s concomitant medications were not reported. On 07Apr2021, the patient passed away. According to the autopsy, the cause of death was Oedema pulmonary. The patient was heavily obese, developed dilatative cardiomyopathy and congestive heart failure due to hypertension, which led to the fatal outcome. Sender Comment: The causal relationship is unlikely between the suspected drug and the adverse event, because according to the autopsy, the patient''s primary diseases led to the pulmonary edema causing death. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Autopsy-determined Cause(s) of Death: Oedema pulmonary


VAERS ID: 1287513 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Chest pain, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
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: Clot blood; Diabetes; Heart disease, unspecified; Vascular disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: IQPFIZER INC2021481142

Write-up: chest pain; sweating; stroke; This is a spontaneous report from a contactable physician received via colleague. A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 21Apr2021 as single dose for covid-19 immunization. Medical history included chronic heart disease, diabetes, blood clot, and "vessel diseases" all from an unknown date. No COVID-19 infection prior to vaccination. The patient''s concomitant medications were not reported. On an unspecified date, it was reported that the patient developed chest pain and sweating which caused hospitalization. On 25Apr2021, the patient died and the cause of death was stroke which started on an unspecified date. The patient didn''t take any medication for his chronic diseases and didn''t tell his family about his diseases before his death. It was also reported by the Pfizer colleague that she watched a tv interview with the patient family and his doctor who followed the case and they are both disagree that he died from the vaccination but the media is saying the opposite. The outcome of the event stroke was fatal while for the events developed chest pain and sweating was unknown. The patient died on 25Apr2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information available, the reported events chest pain, sweating, and stroke are likely intercurrent conditions that are unrelated to PFIZER-BIONTECH COVID-19 VACCINE. Events are more likely related to the patient''s medical history of chronic heart disease, diabetes, blood clot, and "vessel diseases".; Reported Cause(s) of Death: stroke


VAERS ID: 1287520 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / -

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? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aneurysm ruptured; Aphasia; Cerebral hemorrhage
Preexisting Conditions: Medical History/Concurrent Conditions: Dysphagia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death sudden; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SUDDEN DEATH (Death sudden) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Dysphagia in 2017. Concurrent medical conditions included Cerebral hemorrhage since 2017, Aneurysm ruptured since 2017 and Aphasia since 2017. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form in total. The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information included. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Translated Document added. NNI; Sender''s Comments: This case of death concerns an 87-year-old, female patient who experienced sudden death after the administration of mRNA-1273 (Lot number: unknown). Although a temporal association exist, very limited information regarding this event have been provided at this time. Patient''s medical history and autopsy report is lacking. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1287526 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-04-06
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725_65_008 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Cancer of lung; Schizophrenia
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: COVID-19 molecular test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC2021428838

Write-up: clinical vaccinal failure suspected as a positive patient in COVID-19 following molecular swab at a distance of second dose Pfizer. Asymptomatic patient; clinical vaccinal failure suspected as a positive patient in COVID-19 following molecular swab at a distance of second dose Pfizer. Asymptomatic patient; This is a spontaneous report from a contactable other HCP (healthcare professional) downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-715743. A 64-year-old female patient received the first dose of BNT162B2 (COMIRNATY; solution for injection; Lot Number: EJ679765003) via an unspecified route of administration on 21Jan2021 and the second dose of BNT162B2 (COMIRNATY; solution for injection; Lot Number: EL0725_65_008) intramuscularly in the left shoulder on 10Feb2021 at 09:15, both at 0.3mL, single dose for COVID-19 immunisation. Medical history included arthrosis, schizophrenia and malignant cancer of lung, all from unspecified dates and unspecified if ongoing. Concomitant medications were not reported; however, it was reported that the patient was in polytherapy with 6 drugs for malignant cancer of lung, arthrosis and schizophrenia. It was also reported that the patient had no adverse reactions with the first dose of BNT162B2. On 06Apr2021, the patient experienced "clinical vaccinal failure suspected as a positive patient in COVID-19 following molecular swab at a distance of second dose Pfizer. Asymptomatic patient." The event was fatal. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 06Apr2021. The patient died on 27Apr2021. It was not reported if an autopsy was performed and the cause of death was reported as asymptomatic COVID-19 and vaccination failure. Reporter''s comments: Intercosed time between first and second dose: 21Jan2021 10Feb2021. Time elapsed between the administration of the second dose and the detection of the infection 10Feb2021 - 06Apr2021. Lot and expiration physiological solution not available; vaccine reconstitution not available now; first dose vaccine batch EJ679765003 administered on 21Jan2021, no adverse reactions. Patient in polytherapy with 6 drugs for malignant cancer of lung, arthrosis, schizophrenia. Follow -up attempts are possible. No further information is expected.; Reporter''s Comments: Intercosed time between first and second dose: 21Jan2021 10Feb2021. Time elapsed between the administration of the second dose and the detection of the infection 10Feb2021 - 06Apr2021. Lot and expiration physiological solution not available; vaccine reconstitution not available now; first dose vaccine batch EJ679765003 administered on 21Jan2021, no adverse reactions. Patient in polytherapy with 6 drugs for malignant cancer of lung, arthrosis, schizophrenia.; Reported Cause(s) of Death: Vaccination failure; Asymptomatic COVID-19


VAERS ID: 1287571 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW224654060 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Epilepsy, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: VELPHORO; PANTORC; GARDENALE [PHENOBARBITAL SODIUM]; TENORMIN; AMLODIPINE; FRISIUM; LASIX [FUROSEMIDE SODIUM]; CARDIOASPIRIN
Current Illness: Dialysis
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pancreatitis; CVA; Epilepsy; Kidney transplant; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021473716

Write-up: cardiocirculatory arrest at home; Prolonged seizure in a known epileptic in therapy; post-vaccine fever; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-719653. A 53-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13Apr2021 (Batch/Lot Number: EW224654060) as single dose for COVID-19 immunization. Medical history included epilepsy, kidney transplant, renal failure, acute pancreatitis, Cerebrovascular accident (CVA) and ongoing dialysis. Concomitant medication included sucroferric oxyhydroxide (VELPHORO), pantoprazole sodium sesquihydrate (PANTORC), phenobarbital sodium (GARDENALE [PHENOBARBITAL SODIUM]), atenolol (TENORMIN), amlodipine, clobazam (FRISIUM), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and acetylsalicylic acid (CARDIOASPIRIN), all taken for an unspecified indication, start and stop date were not reported. The patient experienced pyrexia, cardiac arrest and epilepsy, all on 13Apr2021 with fatal outcome. The events were reported as serious per fatal and described as cardiocirculatory arrest at home. prolonged seizure in a known epileptic in therapy, in the course of post-vaccine fever. The patient died on 13Apr2021. 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: Prolonged seizure in a known epileptic in therapy; post-vaccine fever; cardiocirculatory arrest at home


VAERS ID: 1287573 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, C-reactive protein, Cerebral haemorrhage, Computerised tomogram head, Electrocardiogram, Heart rate, Malaise, Oxygen saturation, Platelet count, SARS-CoV-2 test, Vital signs measurement, Vomiting, White blood cell count
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORVASC; OLPREZIDE
Current Illness: Bladder neoplasm (Not better specified. On therapy with intravesical instillations); Dyslipidemia; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of prostate
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: Glucose; Test Result: 123 mg/dl; Test Date: 20210423; Test Name: Blood pressure; Result Unstructured Data: Test Result:160/80; Test Date: 20210423; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/70; Test Date: 20210423; Test Name: Brain computerised tomography; Result Unstructured Data: Test Result:large acute right subdural hematoma; Comments: : large acute right subdural hematoma causing compressive effects on the surrounding parenchyma and a 1 cm superior midline shift; Test Date: 20210423; Test Name: C-reactive protein; Result Unstructured Data: Test Result:1.3 mg/L mg; Test Date: 20210423; Test Name: ECG; Result Unstructured Data: Test Result:no alterations; Test Date: 20210423; Test Name: Heart rate; Result Unstructured Data: Test Result:86; Test Date: 20210423; Test Name: Heart rate; Result Unstructured Data: Test Result:75; Test Date: 20210423; Test Name: O2 saturation; Test Result: 94 %; Test Date: 20210423; Test Name: O2 saturation; Test Result: 96 %; Test Date: 20210423; Test Name: Platelet count; Result Unstructured Data: Test Result:176 x10 9/l; Test Date: 20210423; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210423; Test Name: vital parameters; Result Unstructured Data: Test Result:normal; Test Date: 20210423; Test Name: White blood cells; Result Unstructured Data: Test Result:11.58 x10 9/l
CDC Split Type: ITPFIZER INC2021483975

Write-up: Cerebral hemorrhage; Malaise; Vomiting; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-720442. A 90-years-old male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EW2246; Expiration Date: Jul2021), via intramuscular, administered in right arm on 23Apr2021 11:31 at a single dose (0.3 mL, Freq {total}) for covid-19 immunization. Medical history included dyslipidaemia, bladder neoplasm, hypertension arterial and prostate adenocarcinoma. No history of allergy. Negative Covid-related medical history. Concomitant medication included amlodipine besilate (NORVASC) and hydrochlorothiazide, olmesartan medoxomil (OLPREZIDE). The patient previously took first dose of bnt162b2 (COMIRNATY,Formulation: Solution for injection, Lot Number: ER9470; Expiration Date: Jul2021) on the right arm 02Apr2021 at 11.25 am for covid-19 immunisation. On 23Apr2021, after about 20 minutes from suspect vaccine administration, patient experienced onset of malaise, vomiting and cerebral haemorrhage. Patient was pale and sweaty, but alert and well oriented in time and space. The patient was therefore positioned in a supine position. The patient underwent lab tests and procedures which vital signs included BP was 110/70 mmHg, HR was 86 bpm, SpO2 was 94 percent in ambient air, blood glucose was 123 mg/dL; BP was 160/80 mmHg, HR was 75 bpm, SpO2 was 96 percent. Within a few minutes, spontaneous improvement of general conditions. ECG monitoring was also started, which did not document significant changes in the trace. When the internal emergency service was alerted, the patient was transferred to the emergency room. Patient arrived in the emergency room on 23Apr at 13.31, sleepy, reawakened to stimuli, alert and oriented, vital parameters normal. Antigenic swab for SARS COV 2 negative. During hospitalization, rapid worsening of clinical conditions, alert patient, not oriented in time and space. Left side hypostenia. Computed tomography of head: large acute right subdural hematoma causing compressive effects on the surrounding parenchyma and a 1 cm superior midline shift. Coexistence of thin contralateral subdural flap associated with punctiform subarachnoid hemorrhage. Subsequent further worsening of the general clinical condition. Patient unable to wake up to verbal and pain stimuli. No neurosurgical indications were placed in consideration due to the very serious clinical and radiological picture. Large subdural hematoma in the right hemispheric site with a thickness of about 24mm was documented, which continued along the right tentorium and in turn continuously with a blood collection along the posterior portion of the sickle, maximum thickness 5mm. A thin subdural blood collection was also observed along the left hemisphere with a maximum thickness of 4mm. In the sub-tentorial area, a thin subdural extraxial blood collection was observed along the right petrous margin. Thin blood hyperdensity 4mm thick, likely to be of epidural relevance, was documented along the clivus, extending caudally beyond the foramen magnum up to the tooth of the axis. A millimeter subarachnoid blood spot was observed along the right sylvian fissure. Tiny subcortical hemorrhagic spot in the left parietal subcortical area. The overall mass effect with greater pressure vector from the right hemispheric collection demonstrated by obliteration of the CSF sulci along the right hemisphere, by the compression of the right lateral ventricle and above all by the shift of the midline to the left of about 17mm. No hydrocephalus. Patient had right uncal hernia and subfalcina hernia. Pantorc 1 vial and Plasil 1 vial were administered and an infusion of physiological solution was started as an treatment. On 24Apr2021, the patient died. An autopsy was not performed. The outcome of the events was resulted in fatal.; Reported Cause(s) of Death: Cerebral hemorrhage


VAERS ID: 1287754 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-04-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm, Back pain, Flank pain
SMQs:, Retroperitoneal fibrosis (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021478423

Write-up: abdominal aortic aneurysm; Pain in back and flank; Pain in back and flank; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00519688. A 73-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 mL) at the age of 73-year-old, via an unspecified route of administration on 24Apr2021 (Lot Number: Unknown) as 0.3 mL, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had pain in her back and flank on 24Apr2021 and died in the night on the day of vaccination. The patient also experienced abdominal aortic aneurysm on an unspecified date and was also reported as possible cause of death. The patient died on 24Apr2021. It was unknown if an autopsy was performed. Previously the patient experienced no COVID-19 infection. The outcome of the events was fatal. No follow-up attempts are possible; information about lot or batch number cannot be obtained.; Reported Cause(s) of Death: abdominal aortic aneurysm; Pain in back and flank; Pain in back and flank


VAERS ID: 1287755 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Condition aggravated, Haemoglobin, Haemoglobin decreased, Leukaemia, Magnetic resonance imaging, Malaise, Myelodysplastic syndrome
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Blood premalignant disorders (narrow), Myelodysplastic syndrome (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 13
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: OXYCODON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Leukemia; Myelodysplastic syndrome
Allergies:
Diagnostic Lab Data: Test Name: bloodtest; Result Unstructured Data: Test Result:Unknown; Test Date: 20210409; Test Name: HB; Result Unstructured Data: Test Result:3.4 mmol/L; Test Name: MRI; Result Unstructured Data: Test Result:Unknown
CDC Split Type: NLPFIZER INC2021478419

Write-up: A serious relapse in her illness/ HB of 3.4; myelodysplastic syndrome and leukemia / serious relapse in her illness; myelodysplastic syndrome and leukemia / serious relapse in her illness; myelodysplastic syndrome and leukemia / serious relapse in her illness; unwell; This is a spontaneous report from a contactable consumer (daughter) downloaded from the Medicines Agency (MA) -WEB, regulatory authority number NL-LRB-00520059. A 74-years-old female patient received bnt162b2 (Pfizer vaccine, Solution for injection), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: Unknown) (received at 74-years-old) as single dose for covid-19 immunization. Medical history included myelodysplastic syndrome and leukemia. Concomitant medication included oxycodone hydrochloride (OXYCODON, 5 mg) taken for an unspecified indication, start and stop date were not reported, the patient had other co-medications but the names are unknown. The patient experienced a myelodysplastic syndrome and leukemia / serious relapse in her illness on 06Apr2021. Her mother was unwell all day after the vaccination (malaise) (death, hospitalization) on 06Apr2021. The events "myelodysplastic syndrome and leukemia / serious relapse in her illness" and being "unwell" occurred 1 second after the vaccination. On Friday, 09Apr2021, reporter''s mother had an hb of 3.4 (death, hospitalization). Patient felt ill in the two days after vaccination. On the third day after vaccination, on 09Apr2021, she was hospitalized with hemoglobine level of 3,4. In the hospital patient was treated with blood transfusion and they did a MRI and blood test, of which the results are unknown. In the end her health was declined so far that they stopped the treatment. The patient was hospitalized for a serious relapse in her illness on 09Apr2021. As narrated by the reporter, her mother had leukemia. After the injection, she was sick at home for 2 days and on Friday 09Apr2021 she was admitted with an HB of 3.4. Her mother was unwell all day after the vaccination. Which ultimately resulted in a recording on Friday, 09Apr2021. Of course, her mother had underlying suffering, but the rate at which she declined after the vaccination was not like the normal disease process in recent years. In the hospital, her mother was so ill that even the treatment for her illness had to be stopped. The doctors deny that this has anything to do with the vaccination. However, the reporter stated they see it differently. Her mother passed away on 19Apr2021. Her mother used a lot of drugs of which she did not know the name and dosage. In the week that her mother was in hospital, another MRI took place. There were numerous blood tests. Blood transfusions were also given. She said she wants to emphasize that her mother was already seriously ill. But they (she and her father) are convinced that the vaccination worsened the patient''s clinical picture very quickly and drastically and that her mother died as a result. The therapeutic measures were taken as a result myelodysplastic syndrome and leukemia / serious relapse in her illness and HB of 3.4 (blood transfusions). The patient died on 19Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot or batch number cannot be obtained.; Reported Cause(s) of Death: myelodysplastic syndrome and leukemia / serious relapse in her illness; myelodysplastic syndrome and leukemia / serious relapse in her illness; myelodysplastic syndrome and leukemia / serious relapse in her illness; HB of 3.4; unwell


VAERS ID: 1287756 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Malaise
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021478416

Write-up: in the evening tomach discomfort; in the evening not feeling well; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00520170. A 70-year-old female patient received bnt162b2 (COMIRNATY) lot number and expiration date not provided, via an unspecified route of administration on 22Apr2021 as single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. In the evening of 24Apr2021, the patient experienced stomach discomfort and not feeling well. The patient died in his sleep on 25Apr2021. An autopsy was not performed. Previously the patient experienced no Covid-19 infection. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Stomach discomfort; Malaise


VAERS ID: 1287767 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arterial thrombosis, Asthenia, Blood pressure fluctuation, Blood pressure measurement, Cardiac arrest, Computerised tomogram, Dyspnoea, Dyspnoea exertional, Embolism arterial, Embolism venous, Erythema, General physical health deterioration, Heart rate, Heart rate increased, Incorrect route of product administration, Loss of consciousness, Malaise, Nausea, Oedema peripheral, Peripheral swelling, Pulmonary embolism, SARS-CoV-2 test, Seizure, Skin warm, Ultrasound Doppler
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210308; Test Name: blood pressure; Result Unstructured Data: Test Result:fluctutations; Test Date: 20210322; Test Name: CT scan; Result Unstructured Data: Test Result:pulmonary embolism; Test Date: 20210308; Test Name: pulse rate; Result Unstructured Data: Test Result:increased; Test Date: 20210320; Test Name: COVID-19 PCR; Test Result: Negative ; Test Date: 20210322; Test Name: COVID-19 PCR; Test Result: Negative ; Test Date: 202103; Test Name: standard Doppler examination; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: PLPFIZER INC2021478442

Write-up: Cardiac arrest; Seizures/convulsion; Malaise; Nausea; Loss of consciousness; Pulmonary embolism without mention of acute cor pulmonale; Stomach pain/severe abdominal pain; Exercise dyspnoea/shortness of breath always when she climbed the stairs; Change in blood pressure/Pressure fluctuations; venous thromboembolism; Oedema, redness of the leg, leg hot; Oedema, redness of the leg, leg hot; General physical health deterioration; Swelling of the leg; Weakness; Pulse rate increased/elevated heart rate; Oedema, redness of the leg, leg hot; Short of breath; received COMIRNATY via subcutaneous route; Arterial embolism and thrombosis; Arterial embolism and thrombosis; This is as spontaneous report received from a contactable pharmacist downloaded from a regulatory authority-WEB. The regulatory authority report number is PL-URPL-DML-MLP.4401.1.218.2021. An 89-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number and expiry date not reported), via subcutaneous route, on 03Mar2021 12:56, as single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 08Mar2021, the patient experienced general physical health deterioration; weakness; short of breath; change in blood pressure/pressure fluctuations; oedema, swelling, redness of the leg, leg hot; and pulse rate increased/elevated heart rate. These were reported to the primary care physician and the physician did not see a cause-and-effect relationship with the vaccination despite the knowledge about the vaccination date, a few days earlier. The physician''s recommendations were Vessel due and Biseptol, and referral for standard Doppler examination (unknown results). The patient was also given "calming advise" by an administrative employee. On 11Mar2021, the patient experienced exercise dyspnoea/shortness of breath always when she climbed the stairs. After reporting shortness of breath, the physician decided to issue a referral for a PCR test for COVID-19 and imposed quarantine. The patient underwent PCR test for COVID-19 on 20Mar2021 at home. On 22Mar2021, the patient''s well-being deteriorated significantly, she experienced nausea, stomach pain/severe abdominal pain, malaise, and a moment later, the patient had loss of consciousness and fell into seizures/convulsion. The patient''s son called an ambulance. It came after 20 minutes and took the patient to the hospital emergency. CT scan at the ER showed pulmonary embolism. The patient was diagnosed with pulmonary embolism. Despite the diagnosis, the general physician did not start treatment due to the prior quarantine of the patient. It was reported that "the patient came to the ER about 15, to the cardiology department about 19". It was unknown about which treatment (i.e. heparin) was implemented. The samples collected for the PCR test for COVID-19 on 20Mar2021 and on 22Mar2021 in the hospital gave a double negative COVID-19 result. On 24Mar2021, the unconsciousness incident repeated itself. On 24Mar2021 at 23:10, there was a sudden cardiac arrest. After resuscitation, at 23:40, death was pronounced. The causes of death were reported to be pulmonary embolism with no information about pulmonary acute heart and arterial embolism and thrombosis. It was reported that deterioration of health, weakness, significant deterioration in well-being, shortness of breath, increased heart rate, pressure changes, loss of consciousness with convulsions, sudden cardiac arrest could be related to a pulmonary embolism diagnosed in the hospital, and together with edema, redness and increased warming the legs indicate the occurrence of venous thromboembolism. The outcome of the events nausea; loss of consciousness; pulmonary embolism without mention of acute cor pulmonale; oedema, swelling, redness of the leg, leg hot; stomach pain/severe abdominal pain; short of breath; cardiac arrest; seizures/convulsion; weakness; pulse rate increased/elevated heart rate; exercise dyspnoea/shortness of breath always when she climbed the stairs; change in blood pressure/pressure fluctuations; malaise; general physical health deterioration; arterial embolism and thrombosis; venous thromboembolism was fatal (as reported). The patient died on 24Mar2021 23:40. No autopsy was performed. The health authority assessed the causality to all events as unlikely (Result of Assessment: Unlikely). Health Authority Comment: The adverse events mentioned in the report: deterioration of health, weakness, significant deterioration in well-being, shortness of breath, increased heart rate, pressure changes, loss of consciousness with convulsions, sudden cardiac arrest could be related to a pulmonary embolism diagnosed in the hospital, and together with edema, redness and increased warming the legs indicate the occurrence of venous thromboembolism, which is an unexpected adverse event of Comirnaty vaccine. Severe abdominal pain was also not included in Comirnaty, while nausea, although included in the publication, should be treated in the context of the overall clinical picture - as an unexpected adverse event - it is difficult to assess what these symptoms were related to, and thromboembolic changes cannot be excluded in other organs. Due to the current knowledge about thromboembolic complications with Comirnaty vaccine (no statistically significant increase in these events was observed compared to the general population), the relationship was assessed as unlikely. There is a time relationship between the administration of the vaccine and the appearance of symptoms. The reporting person classified them as severe. URPL also classified the application as severe. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism without mention of acute cor pulmonale; Arterial embolism and thrombosis; nausea; Loss of consciousness; Oedema, redness of the leg, leg hot; Oedema, redness of the leg, leg hot; Stomach pain/severe abdominal pain; Short of breath;


VAERS ID: 1287787 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Decreased appetite, Dizziness, Dyspnoea, Fatigue, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   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: Cancer of head of pancreas (The patient had surgery for a pancreatic head cancer in December 2016); Surgery (The patient had surgery for a pancreatic head cancer in December 2016)
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: SARS-CoV-2; Result Unstructured Data: Test Result:diagnosed with SARS-CoV-2 virus infection; Comments: diagnosed with SARS-CoV-2 virus infection confirmed by a test on March 16, 2021
CDC Split Type: ROPFIZER INC2021479727

Write-up: Dizziness; Fatigability; Appetite lost; Breathing difficult; diagnosed with SARS-CoV-2 virus infection confirmed by a test on March 16, 2021; This is a spontaneous report from a contactable consumer who is also the patient''s daughter downloaded from the regulatory authority-WEB, regulatory authority number RO-NMA-2021-SPCOV6833-FU1. A 63-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 07Mar2021 (Batch/Lot Number: EP2166) as SINGLE DOSE (1 DF) for covid-19 immunisation. Medical history included Cancer of head of pancreas (The patient had surgery for a pancreatic head cancer in December 2016). The patient''s concomitant medications were not reported. On 12Mar2021 the patient experienced fatigue/ Fatigability, dizziness, lack of appetite/ Appetite lost, difficult breathing/ Breathing difficult. The events were assessed as serious (hospitalization, fatal). The patient needed hospitalization where she was diagnosed with SARS-CoV-2 virus infection confirmed by a test on March 16, 2021. The patient underwent lab tests and procedures which included sars-cov-2 test: diagnosed with sars-cov-2 virus infection on 16Mar2021 (diagnosed with SARS-CoV-2 virus infection confirmed by a test on March 16, 2021). The patient died on 20Mar2021. It was not reported if an autopsy was performed. Sender Comment: Follow up information added on 26-Apr-2021: following investigation of the case, on 22-Apr-2021 it was concluded: it is denied that the death was caused by the post-vaccination reaction; the person was confirmed with COVID-19 infection on 16-Mar-2021 and died on 20-Mar-2021 at the Hospital. Routine follow-up is not conducted for HA-web reports. No follow-up attempts are needed. No further information is expected. The information about lot number was provided within the initial report. The case was closed for follow-up activities.; Reported Cause(s) of Death: Dizziness; Fatigability; Appetite lost; Breathing difficult


VAERS ID: 1287802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Hyperlipidaemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021473967

Write-up: Myocardial infarct; cardiac arrest; abundant bleeding from the airways or lungs; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority number is SE-MPA-2021-025650. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient''s medical history included ongoing hypertension and ongoing hyperlipidaemia. The patient''s concomitant medications were not reported. On an unspecified date in Mar2021, the patient had myocardial infarct. It was further mentioned that the man (patient) came in with cardiac arrest during ongoing CPR (cardiopulmonary resuscitation). Upon arrival, the man probably had abundant bleeding from the airways or lungs. The reporter states that there is a time connection, but it is highly uncertain whether there is a causal Connection. The outcome of the event myocardial infarct was fatal and unknown outcome for the other events. The patient died on an unknown date due to myocardial infarction. The reporter states that it was unclear about any ongoing medication. Autopsy was performed. The autopsy report: preliminary diagnosis and findings: Suspected acute myocardial infarction, blood-stained lungs, severe coronary atherosclerosis mainly in the left coronary artery but also right, moderate arteriosclerosis of the aorta and thoracic and lumbar vertebrae, fracture after LUCAS (cardiac massage device). Body cavities and serous cavities: The sternum has a transverse fracture and six rib fractures are seen on the left and four on the right, as well as a transverse fracture of the vertebral column at vertebra Th11, all in connection with LUCAS Circulatory system: The heart is normally configured. In the coronary arteries, abundant arteriosclerosis is seen, which is highly narrowing, mainly in the left coronary artery, where the exit from the aorta is completely narrowed. No fresh thrombosis. The septum and papillary muscles as well as the front wall of the left ventricle are seen patchy throughout. The aorta has a normal course and is seen as normal. Its major vascular departures are seen with mild arteriosclerosis. Respiratory organs: The bronchial tree contains a moderate amount of blood-mixed fluid, partly foamy both proximal and distal. The pulmonary parenchyma is dark and fluid-filled but without bleeding, infarctions or tumors. No wall accumulations or emboli are found. Central nervous system: No signs of infarction or other focal pathology. The cause of death was myocardial infarction.; Reported Cause(s) of Death: Myocardial infarct; Autopsy-determined Cause(s) of Death: Suspected acute myocardial infarction; severe coronary atherosclerosis; moderate arteriosclerosis of the aorta and thoracic and lumbar vertebrae; fracture after LUCAS (cardiac massage device)... sternum has a transverse fracture and six rib fractures


VAERS ID: 1287807 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Joint disorder (moderate arthropathy (mild joint problems))
Allergies:
Diagnostic Lab Data: Test Name: CT head; Result Unstructured Data: Test Result:massive expansive cerebral bleeding; Test Name: Thrombocytes; Result Unstructured Data: Test Result:349
CDC Split Type: SEPFIZER INC2021478452

Write-up: Massive cerebral bleeding; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-031340. A 77-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as a single dose for COVID-19 immunisation; ibuprofen (IPREN, Batch/Lot number was not reported), oral from an unspecified date to an unspecified date, at 400 mg, alternate day (400 mg 1 tablet every other day) for an unspecified indication. Medical history included moderate arthropathy (mild joint problems) from an unknown date and unknown if ongoing. The woman is described by the reporter as otherwise healthy. There were no concomitant medications. The patient experienced massive cerebral bleeding on Apr2021. Reported suspect adverse event was cerebral bleeding. Seven days after receiving the first dose of Comirnaty, the woman suffered from sudden dizziness, vomiting and headache, followed by decreased consciousness. CT head showed a massive expansive cerebral bleeding. Neurosurgical action was not possible. Thrombocytes 349. The woman died the next day (unspecified date). Report was assessed as serious, death. It has not yet been decided (unknown) whether an autopsy will be performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Massive cerebral bleeding


VAERS ID: 1288585 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: mogelijk overlijden; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (mogelijk overlijden) in an 88-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 01-Mar-2021. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) at an unspecified dose. Death occurred on 18-Mar-2021 The patient died on 18-Mar-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. No concomitant medication reported. No treatment information was provided. Conflictingly date of death also reported as 30 Mar 2021.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information can''t be requested.; Reported Cause(s) of Death: niet meer aanspreekbaar, somnolent en hierop overleden


VAERS ID: 1294958 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-04-08
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood urea, C-reactive protein, Dyspnoea, Fibrin D dimer, Nausea, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: Arthrosis (of big joints); Gastroesophageal reflux; Hypertension arterial; Hyperuricemia; Osteoporosis; Vasculitis (Renal and pulmonary involvement)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Creatinine; Test Result: Inconclusive ; Result Unstructured Data: 182 micromole per litre; Test Date: 20210412; Test Name: Potassium; Test Result: Inconclusive ; Result Unstructured Data: 2.9 millimole per liter; Test Date: 20210412; Test Name: Urea; Test Result: Inconclusive ; Result Unstructured Data: 7.9 millimole per liter; Test Date: 20210412; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 83 milligram per liter; Test Date: 20210412; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: 6.51 milligram per liter
CDC Split Type: CZMODERNATX, INC.MOD20211

Write-up: Pulmonary embolism; Breathlessness; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DYSPNOEA (Breathlessness) in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001531 and 3001531) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hyperuricemia, Gastroesophageal reflux, Vasculitis (Renal and pulmonary involvement), Hypertension arterial, Arthrosis (of big joints) and Osteoporosis. On 08-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DYSPNOEA (Breathlessness) (seriousness criterion medically significant) and NAUSEA. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 13-Apr-2021. The reported cause of death was Pulmonary embolism. An autopsy was not performed. At the time of death, DYSPNOEA (Breathlessness) and NAUSEA had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood creatinine: 182 (Inconclusive) 182 micromole per litre. On 12-Apr-2021, Blood potassium: 2.9 (Inconclusive) 2.9 millimole per liter. On 12-Apr-2021, Blood urea: 7.9 (Inconclusive) 7.9 millimole per liter. On 12-Apr-2021, C-reactive protein: 83 (Inconclusive) 83 milligram per liter. On 12-Apr-2021, Fibrin D dimer: 6.51 (Inconclusive) 6.51 milligram per liter. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1295004 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA XHBVC439AB / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: ISOSORBIDE MONONITRAAT RETARD RPH; RENVELA; FUROSEMIDE; NOVOMIX; ARANESP; BISOPROLOL [BISOPROLOL FUMARATE]; LOSARTAN; ADIRO AP; CARDURA; AKOSTOL; ALOPURINOL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20210

Write-up: Sudden death; Fever; General malaise; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. xhbvc439ab) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRAAT RETARD RPH) from 16-Mar-2019 to an unknown date for Cardiac ischaemia, INSULIN ASPART, INSULIN ASPART PROTAMINE (CRYSTALLINE) (NOVOMIX) from 05-Mar-2013 to an unknown date for Diabetes with renal manifestations, BISOPROLOL FUMARATE (BISOPROLOL [BISOPROLOL FUMARATE]) from 12-May-2017 to an unknown date for Dyspnea, LOSARTAN from 08-Aug-2018 to an unknown date for Hypertension arterial, SEVELAMER CARBONATE (RENVELA) from 21-Nov-2013 to an unknown date and FUROSEMIDE from 11-May-2013 to an unknown date for Nephropathy, ACETYLSALICYLIC ACID (ADIRO AP) from 09-Jun-2017 to an unknown date and ACOTIAMIDE HYDROCHLORIDE (AKOSTOL) from 15-May-2019 to an unknown date for Peripheral vascular disease, unspecified, DARBEPOETIN ALFA (ARANESP) from 10-Sep-2020 to an unknown date for Peritoneal dialysis, DOXAZOSIN MESILATE (CARDURA) from 15-Jan-2021 to an unknown date and ALOPURINOL from 15-Jun-2012 to an unknown date for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Fever) and MALAISE (General malaise). On 10-Apr-2021, PYREXIA (Fever) and MALAISE (General malaise) had not resolved. The patient died on 10-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. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1295028 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, Death, Hypotension, Influenza like illness
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Dehydration (broad), Hypokalaemia (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: End stage renal disease (ESRD); Renal dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: syndrome grippal; fibrillation; Hypotension; death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (fibrillation), HYPOTENSION (Hypotension) and INFLUENZA LIKE ILLNESS (syndrome grippal) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Renal dialysis since an unknown date. Concurrent medical conditions included End stage renal disease (ESRD). On 15-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In March 2021, the patient experienced ATRIAL FIBRILLATION (fibrillation) (seriousness criteria death, hospitalization and medically significant) and HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization). On 16-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced INFLUENZA LIKE ILLNESS (syndrome grippal) (seriousness criteria death and hospitalization). The patient died on 02-Apr-2021. The reported cause of death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. The action taken for mRNA-1273 was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: The date of death of and event hypotension was added.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not confirmed. Cause and dates of hospitalization not specified.


VAERS ID: 1295064 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-03-22
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Cardiac failure, Cardiopulmonary failure, Diarrhoea, Fluid overload, General physical health deterioration, Hyperthermia, Hypotension, Ischaemic stroke, Oxygen saturation decreased, Pseudomonal bacteraemia, Respiratory distress, SARS-CoV-2 antibody test, SARS-CoV-2 test, SARS-CoV-2 test positive, Scan brain, Septic shock, Vaccination failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: Medical History/Concurrent Conditions: Arrhythmia NOS; Chronic anemia; Congenital hip dislocation; Erysipelas (of the left lower limb); Hip surgery; Hypertension; Hypertensive cardiomyopathy; Hypertrophic heart disease; Lupus-like syndrome (Trandate Alpress induced lupus); Lymphocytic colitis; Morbid obesity; Myelodysplastic syndrome; Obesity hypoventilation syndrome (probably in the context of psychiatric pathology with heavy treatment); Parkinson''s syndrome (induced by neuroleptics); Psychotic disorder
Allergies:
Diagnostic Lab Data: Test Name: blood cultures; Result Unstructured Data: Test Result:positive for Pseudomonas aeruginosa; Comments: positive for Pseudomonas aeruginosa; Test Name: Covid serology; Test Result: Positive ; Comments: positive with an anti-SARS-COV-2 antibody titration $g 250 units/ml showing vaccine protection; Test Date: 20210322; Test Name: PCR Covid; Test Result: Positive ; Test Date: 20210324; Test Name: PCR Covid; Test Result: Negative ; Comments: controlled negative; Test Name: brain scan; Result Unstructured Data: Test Result:semi-recent ischemic stroke highlighted; Comments: semi-recent ischemic stroke highlighted
CDC Split Type: FRPFIZER INC2021446977

Write-up: altered general condition with respiratory distress, hyperthermia and glaireous diarrhea.; altered general condition with respiratory distress, hyperthermia and glaireous diarrhea.; altered general condition with respiratory distress, hyperthermia and glaireous diarrhea.; altered general condition with respiratory distress, hyperthermia and glaireous diarrhea.; hypotension with a partial effectiveness of the vascular filling; Vaccination failure; COVID-19 PCR test positive/suspicion of vaccine failure with respiratory symptoms and weakly positive Covid19 PCR; abrupt desaturation to 66%; blood cultures came back positive for Pseudomonas aeruginosa; semi-recent ischemic stroke highlighted on the brain scan; Sign of cardiac decompensation; cardiorespiratory decompensation in a context of rhythmic, hypertrophic and valvular heart disease, on probable obesity hypoventilation syndrome; septic shock; signs of overload; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) -WEB, regulatory authority number FR-AFSSAPS-DJ20210924. Additional case identifier: FR-AFSSAPS-2021039688. A 72-year-old female patient received bnt162b2 (Pfizer vaccine), dose 2 intramuscular on 15Feb2021 (Batch/Lot Number: EJ6789) as single dose and dose 1 intramuscular on 25Jan2021 (Batch/Lot Number: EJ6789) as a single dose for COVID-19 immunisation. Medical history included obesity hypoventilation syndrome probably in the context of psychiatric pathology with heavy treatment, Arrhythmia (rhythmic) and hypertrophic heart disease on severe hypertension, chronic anemia on myelodysplastic syndrome, psychotic terrain with post-neuroleptic parkinsonian syndrome, morbid obesity, erysipelas of the left lower limb in 2019, lymphocytic colitis, Lupus-like syndrome (Trandate Alpress induced lupus), congenital dislocation of the hip operated, and hypertensive cardiomyopathy. The patient''s concomitant medications were not reported. The patient experienced vaccination failure on 22Mar2021 with outcome of recovered. Futher ADR description stated that the patient was taken in by the French EMS on 22Mar2021 for abrupt desaturation to 66% without chest pain. Hospitalized in this context. The clinical course was slowly favorable. The patient was treated with rocephine antibiotics from 24Mar2021 to 07Apr2021 and with corticosteroids which were stopped on 08Apr2021. Diuretics were increased in response to signs of overload in early April. Favorable outcome with 40 mg of furosemide and the introduction of trinitrin. The thoracic-abdominal-pelvic scan did not reveal any sign of pulmonary embolism. Sign of cardiac decompensation. PCR Covid19 of 22Mar2021 weakly positive controlled negative on 24Mar2021. No screening performed. COVID-19 serology came back positive with an anti-SARS-COV-2 antibody titration $g 250 units/ml showing vaccine protection. The conclusion of this hospitalization is a cardiorespiratory decompensation in a context of rhythmic, hypertrophic and valvular heart disease, on probable obesity hypoventilation syndrome. It seemed that the diagnosis of Covid19 disease is not fully confirmed by the PCR results. The patient left the hospital on 09Apr2021 but was re-hospitalized on 12Apr2021 in a new altered general condition with respiratory distress, hyperthermia and glaireous diarrhea. Rapidly, the patient presents a brutal hypotension with a partial effectiveness of the vascular filling. Presence of signs of respiratory struggle. Rapidly unfavorable outcome in a few hours with death of the patient on 12Apr2021. The report of this stay mentioned a septic shock of unknown origin, possibly pulmonary, associated with a semi-recent ischemic stroke highlighted on the brain scan. No new COVID-19 samples were taken. Subsequently, blood cultures came back positive for Pseudomonas aeruginosa. In total, suspicion of vaccine failure with respiratory symptoms and weakly positive Covid19 PCR in a patient who had received a complete vaccine regimen. However, Covid19 disease does not seem to be fully confirmed since the clinical signs have also been linked to cardiac decompensation. The patient also died in the aftermath in a state of septic shock. History of Covid not reported. The patient died on 12Apr2021. An autopsy was not performed. The outcome of septic shock was fatal, while vaccination failure and COVID-19 PCR test positive/suspicion of vaccine failure with respiratory symptoms and weakly positive Covid19 PCR are recovered on 12Apr2021. The outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Septic shock


VAERS ID: 1296827 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-15
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: COPD; Coronary heart disease; Dialysis; Peripheral arterial occlusive disease; Renal insufficiency
Preexisting Conditions: Comments: lfd. NINS, COPD, KHK, pAVK
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021491316

Write-up: covid 19 pneumonia 2 months after the second vaccination; covid 19 pneumonia 2 months after the second vaccination; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB local regulatory authority number AT-BASGAGES-2021-24374. A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Feb2021 (Batch/Lot Number: EL1491; Expiration Date: 30Apr2021) as a single dose and dose 1 via an unspecified route of administration on an unspecified date (batch/lot number unknown) as a single dose for COVID-19 immunization. Medical history included ongoing dialysis in renal insufficiency, ongoing chronic obstructive pulmonary disease, ongoing coronary heart disease, and ongoing peripheral arterial occlusive disease. The patient''s concomitant medications were not reported. The patient experienced COVID-19 pneumonia (fatal) 2 months after the second vaccination on 15Apr2021. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1296828 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-04-01
   Days after vaccination:9
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: COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021491293

Write-up: suspected Vaccination failure; COVID-19; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB local regulatory authority number AT-BASGAGES-2021-24408. A contactable health care professional reported that a 90-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 29Jan2021 for COVID-19 immunization. The patient experienced suspected vaccination failure and COVID-19 on Apr2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Causality assessment by the reporter was unassessable/unclassifiable for both events. No follow-up attempts needed. No further information is expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1296829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-04-01
   Days after vaccination:57
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: COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021491306

Write-up: Vaccination failure; COVID-19; a regulatory authority-WEB local regulatory authority number AT-BASGAGES-2021-24415. This is a report from a contactable other HCP. A 93-year-old male patient received second dose of BNT162b2(COMIRNATY, solution for injection, Lot number was unknown and expiration date was not reported) via unspecified route of administration on 03Feb2021 as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 11Feb2021, the patient experienced unspecified respiratory symptoms (e.g: cough with or without fever). On 31Mar2021, the patient was hospitalized. On 04.2021 the patient experienced Vaccination failure, other, COVID-19. On 06Apr2021, the patient was diagnosed with respiratory symptoms (e.g: cough with or without fever). On an unspecified date, the patient expired due to COVID-19 and the date of death was unknown. No information was provided on autopsy details. The outcome of the event Vaccination failure was unknown. The outcome the event COVID-19 was Fatal. Causality between Comirnaty and both events by the reporter: Unassessable/Unclassifiable. No follow-up attempts needed, batch/lot. no. will be followed-up by RA and automatically provided as soon as available. No further information is expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1296830 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
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 - / 2 - / -

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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021491286

Write-up: suspect of breakthrough infection; Onset of illness 28Mar2021; This is a spontaneous report from a contactable Other health professional downloaded from a regulatory authority-WEB local regulatory authority number AT-BASGAGES-2021-24416.A 90 -years-old male patient receive first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number and expiration date were not reported) via unspecified route on 03Apr2021 at single dose for COVID-19 immunization. The patient medical history concomitant medications were not reported. Previously patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number and expiration date were not reported) via unspecified route on 13Mar2021 at single dose for covid-19 immunization. Date of the illness on 28Mar2021. Date of the diagnosis 11Apr. On an unknown date in Apr2021, the patient experienced Vaccination failure, other, COVID-19. Reporter causality assessment: Unassessable/Unclassifiable for Comirnaty for vaccination failure and COVID 19. The outcome of the event vaccination failure was unknown and fatal for COVID-19. No follow-up attempts needed, batch/lot. no. will be followed-up by RA and automatically provided as soon as available. No further information is expected. ; Reported Cause(s) of Death: COVID-19


VAERS ID: 1296831 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-25
   Days after vaccination:12
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: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Variant; Result Unstructured Data: Test Result:Variant: (unlisted)
CDC Split Type: ATPFIZER INC2021496510

Write-up: COVID-19; suspected vaccination failure; This is a spontaneous report from a contactable other hcp downloaded from a regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-24417. A 79-years-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 13Mar2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s weight and height were not reported. No relevant medical history reported. The patient''s concomitant medications were not reported. On 25Mar2021 the patient experienced COVID-19 death, Vaccination failure. It was reported that 1st dose was on 04Feb2021, 2nd dose was on 13Mar2021, date of illness on 25Mar2021, diagnosis date was 29Mar2021. The patient had respiratory symptoms (e.g. cough with or without fever), no hospital, Variant: (unlisted). Patient hospitalization was reported as no but it was also reported that "Stat. [PRIVACY, hospital] from 01Apr to 06Apr2021. Deceased on 06Apr2021 in the [PRIVACY, hospital]". The patient''s outcome was fatal for COVID-19, unknown for Vaccination failure. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: patient experienced COVID-19 death, Vaccination failure; patient experienced COVID-19 death, Vaccination failure


VAERS ID: 1296832 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-23
   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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Confusional state, Eyelid oedema, Fall, Influenza like illness, Lip oedema, Pulmonary embolism, Pulmonary infarction, Pyrexia, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HALCION; CANDESARTAN; TAMSULOSIN; AMLODIPINE; EUTHYROX
Current Illness: Adenoma adrenal; Aortic valve stenosis (Grade 2); Atherosclerosis generalised; Coronary artery sclerosis (Grade 3); Coronary artery stenosis (Grade 2); Hypertension arterial; Left ventricular dilatation; Left ventricular hypertrophy
Preexisting Conditions: Medical History/Concurrent Conditions: Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: Covid-Test; Result Unstructured Data: Test Result:negative; Comments: negative
CDC Split Type: ATPFIZER INC2021491301

Write-up: Pulmonary infarction of the right lower lobe; fulminant central and recurrent pulmonary artery embolism; flu symptoms such as chills, headaches and body aches; Due to the deterioration in general condition, a fall happened; int the night hours there was an increase in fever; increasing confusion; a few hours later lip edema; a few hours later left eyelid edema; increasing physical weakness; This is a spontaneous report from a contactable physician or a Regulatory Authority. This report is downloaded from the Agency Regulatory Authority-WEB local regulatory authority number AT-BASGAGES-2021-24696. A 99 Years-old-male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 23Jan2021 (at the age of 99 years) as single dose for Covid-19 immunisation. The patient medical history and concurrent conditions which included pulmonary embolism, left ventricular hypertrophy (continuing), left ventricular dilatation (continuing), coronary artery sclerosis (continuing), hypertension arterial (continuing), coronary artery stenosis (continuing), aortic valve stenosis (continuing), atherosclerosis generalised (continuing), adenoma adrenal (continuing). The patient concomitant medications included triazolam (HALCION), candesartan (CANDESARTAN), tamsulosin (TAMSULOSIN), amlodipine (AMLODIPINE), levothyroxine sodium (EUTHYROX). On 23Jan2021 the patient had experienced a few hours later lip edema, left eyelid edema, increasing physical weakness, increasing confusion. On 24Jan2021 the patient experienced in the night hours there was an increase in fever, flu symptoms such as chills, headaches and body aches (influenza like illness), due to the deterioration in general condition, a fall happened. On 25Jan2021 the patient experienced pulmonary infarction of the right lower lobe and fulminant central and recurrent pulmonary artery embolism. The patient underwent lab tests and procedures which included SARS-CoV-2 test negative on 25Jan2021. The outcome of the event recurrent pulmonary embolism and pulmonary infarction was fatal and rest all events was not recovered and the patient died on 25Jan2021 from recurrent pulmonary embolism. The autopsy determined cause of death was reported to be recurrent pulmonary embolism. No follow-up attempts needed, batch/lot. no. will be followed-up by Regulatory Authority and automatically provided as soon as available. No further information is expected.; Reported Cause(s) of Death: Recurrent pulmonary embolism; Autopsy-determined Cause(s) of Death: Recurrent pulmonary embolism


VAERS ID: 1296834 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   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 ER7449 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASAFLOW; COVERSYL [PERINDOPRIL ARGININE]; PARACETAMOL; BURINEX; SIPRALEXA; SIMVASTATIN; XARELTO; BISOPROLOL; MONTELUKAST; RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]; ZYLORIC; ALDACTONE [SPIRONOLACTONE]; ZOLPIDEM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm of aorta (Left untreated because of the age and the co-morbidities of the patient.); Atrial fibrillation; Bradycardia; COPD; COVID-19; Emphysema; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021483940

Write-up: Sudden death; This is a spontaneous report received from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB regulatory authority. Regulatory authority number BE-FAMHP-DHH-N2021-88427. An 84-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot number ER7449), via an unknown route, on 08Apr2021 at single dose for COVID-19 immunisation. Relevant medica history included chronic obstructive pulmonary disease (COPD), hypertension arterial, atrial fibrillation, bradycardia, emphysema, aneurysm of aorta (left untreated because of the age and the co-morbidities of the patient) and COVID-19 from 05Nov2020, all unknown if still ongoing. Relevant concomitant medications included acetylsalicylic acid (ASAFLOW), perindopril arginine (COVERSYL), paracetamol, bumetanide (BURINEX), escitalopram oxalate (SIPRALEXA), simvastatin, rivaroxaban (XARELTO), bisoprolol, montelukast, fluticasone furoate;vilanterol trifenatate (RELVAR ELLIPTA), allopurinol (ZYLORIC), spironolactone (ALDACTONE) and zolpidem. On 09Apr2021, the patient experienced sudden death. The cause of death was not provided. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1296836 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-04-13
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coagulopathy, Pulmonary embolism
SMQs:, Haemorrhage laboratory terms (broad), Embolic and thrombotic events, venous (narrow)

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: TRAZODONE [TRAZODONE HYDROCHLORIDE]; QUETIAPINE EG; AUREOMYCINE; PHYSIODOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction (death of the sister in 2015 at age of 41 (myocardial infarction?)); Tobacco user
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021491354

Write-up: Pulmonary embolism; Coagulation disorder; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB. The regulatory authority number is BE-FAMHP-DHH-N2021-88777. A 45-year-old female patient received BNT162B2 (COMIRNATY), second dose via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: EJ6789) as single dose for COVID-19 immunisation. Medical history included tobacco (user). Concomitant medications included trazodone hydrochloride from Sep2017 to an unspecified stop date; QUETIAPINE EG from Apr2018 to an unspecified stop date; and AUREOMYCINE from 10Apr2021 to an unspecified stop date; all lot numbers were unknown. The patient also took physiological serum of PHYSIODOSE since 10Apr2021. The patient was vaccinated with the first dose of COMIRNATY on 22Jan2021 (lot number: EJ6134) for Covid-19 immunisation. On 13Apr2021, the patient had a pulmonary embolism and a coagulation disorder. The patient died on 13Apr2021. It was unknown if an autopsy was performed. The regulatory authority assessed the events coagulation disorder and pulmonary embolism as unclassifiable to COMIRNATY. Reporter Comment: Evolution of the ADR - Death Situations - Other: family history: her sister died in 2015 at the age of 41 (myocardial infarction?) No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Evolution of the ADR - Death Situations - Other: family history: her sister died in 2015 at the age of 41 (myocardial infarction?); Reported Cause(s) of Death: Coagulation disorder; Pulmonary Embolism


VAERS ID: 1296837 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-12
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood creatinine, Blood fibrinogen, Blood potassium, Blood pressure measurement, Blood sodium, Body temperature, Coagulopathy, Coma scale, Computerised tomogram, Computerised tomogram head, Death, Electrocardiogram, Fibrin D dimer, Haemoglobin, Haemorrhagic transformation stroke, Heart rate, Hemiplegia, International normalised ratio, Ischaemic stroke, Nerve compression, Nervous system disorder, Oxygen saturation, Platelet count, Prothrombin time, SARS-CoV-2 test, Thrombocytopenia, Thrombosis, Troponin
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   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: RIVOTRIL; L-THYROXINE [LEVOTHYROXINE]; ZINC; ALDACTONE [SPIRONOLACTONE]; FEROGRAD; PANTOPRAZOL SANDOZ; PROLIA; STEOVIT D3; DOMPERIDON [DOMPERIDONE]; LERCANIDIPINE TEVA; LIPANTHYLNANO; TRADONAL; ZOLPIDEM MYLAN; GABAPENTINE EG
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Arthroscopy; Back surgery; Chronic renal failure; Colposcopy (Colposcopy anty/positive,); Hip arthroscopy; Hormone replacement therapy; Hypercholesterolaemia; Hypothyroidism; Intestinal resection; Nephrectomy; Shoulder discomfort; Small bowel resection (perforation by foreign object); Total hip replacement (right); Umbilical hernia; Ureterectomy; Varicose vein; Vulval operation
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result:32; Test Name: creatinine; Test Result: 3.06 mg/dl; Test Date: 20210416; Test Name: fibrinogen; Result Unstructured Data: Test Result:108; Test Name: K+; Result Unstructured Data: Test Result:5.4 mmol/L; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/82 mmHg; Test Name: Na+; Result Unstructured Data: Test Result:139 mmol/L; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:drowsy but easily aroused E: 3/4; Comments: drowsy but easily aroused E: 3/4, M: hemi image left, right 6/6, V: 4/5, small pupil isocore.; Test Date: 20210413; Test Name: Control CT; Result Unstructured Data: Test Result:large parenchymal hemorrhage with swelling on the; Comments: large parenchymal hemorrhage with swelling on the right cerebral; accompanying edematous cerebral swelling with mild midline shift, right lateral ventricular obliteration and hemorrhagic sediment in the major transtentoral herniation.; Test Date: 20210415; Test Name: Control CT; Result Unstructured Data: Test Result:known major hemorrhagic right parenchymal hemorrha; Comments: known major hemorrhagic right parenchymal hemorrhage with mesh action involving obliteration of the right lateral ventricle and increase of midline shift to notralateral; mass action with diffuse obliteration of the peripheral sulci over the right hemisphere with diffuse loss of gray-white matter differentiation; Slight increase in volume left side ventricle, cava developed hydrocephalus. Urinary tract infection with E. faecium and E. coli; R / Rocephin IV.; Test Name: CT scan brain; Result Unstructured Data: Test Result:without contrast: Thrombus M2 segment of the right; Comments: without contrast: Thrombus M2 segment of the right cerebral artery media. Referred for urgent thromboectomy.; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm; Test Name: D-dimers; Result Unstructured Data: Test Result:35546; Test Date: 20210416; Test Name: D-dimers; Result Unstructured Data: Test Result:38,393; Comments: Diffuse intravascular coagulopathy?; Test Name: Haemoglobin; Result Unstructured Data: Test Result:9.2 g/dl; Test Name: heart rate; Result Unstructured Data: Test Result:81; Comments: /min; Test Name: INR; Result Unstructured Data: Test Result:1.9; Test Date: 20210416; Test Name: INR; Result Unstructured Data: Test Result:1.4; Test Name: Oxygen saturation; Test Result: 98 %; Test Name: platelets; Result Unstructured Data: Test Result:124000; Test Date: 20210416; Test Name: Prothrombin time; Result Unstructured Data: Test Result:58; Test Name: COVID PCR; Test Result: Negative ; Test Date: 20210416; Test Name: thrombocytopenia; Result Unstructured Data: Test Result:50,000; Test Name: troponin; Result Unstructured Data: Test Result:200
CDC Split Type: BEPFIZER INC2021491345

Write-up: Death; Thrombocytopenia; hemorrhagic remodeling with clamping; Ischemic stroke; Hemiplegia left; Blood clotting problem; hemorrhagic remodeling with clamping; Neurological problem; thrombus arteria cerebri media right; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number BE-FAMHP-DHH-N2021-88881. A 76-years-old female patient received bnt162b2 (COMIRNATY, lot number and expiration date not provided), via an unspecified route of administration on 10Apr2021 at single dose for covid-19 immunisation. The patient''s medical history included arterial hypertension, hypercholesterolaemia, chronic renal failure, nephrectomy in Sep2020, ureterectomy right in Sep2020, Colposcopy (Colposcopy anty/positive,), Intestinal resection, umbilical hernia, hip arthroscopy, total hip replacement (right), hypothyroidism, multiple back procedures, shoulder decompression (2x), Vulvoplasty, small bowel resection (perforation by foreign object), finger, hip arthroscopy, hormonal replacement therapy, and varices. The patient''s concomitant medications included clonazepam (RIVOTRIL), l-thyroxine [levothyroxine], zinc, spironolactone (ALDACTONE [SPIRONOLACTONE]), ascorbic acid, ferrous sulfate (FEROGRAD), pantoprazole sodium sesquihydrate (PANTOPRAZOL SANDOZ), denosumab (PROLIA), calcium carbonate, colecalciferol (STEOVIT D3), domperidone (DOMPERIDON [DOMPERIDONE]), lercanidipine hydrochloride (LERCANIDIPINE TEVA), fenofibrate (LIPANTHYLNANO), tramadol hydrochloride (TRADONAL), zolpidem tartrate (ZOLPIDEM MYLAN), and gabapentin (GABAPENTINE EG). The patient previously took Paracetamol and experienced drug allergy. On 12Apr2021, the patient experienced thrombocytopenia, hemorrhagic remodeling with clamping, ischemic stroke, hemiplegia left, blood clotting problem, hemorrhagic remodeling with clamping, neurological problem, and thrombus arteria cerebri media right. On 17Apr2021, the patient died (death). The patient died on 17Apr2021. It was not reported if an autopsy was performed. Reporter''s comments: Treatment - Unknown. Evolution of the ADR -Died .Examinations -Heparin induced thrombocytopenia negative Anamnesis: Admitted to the emergency department on 12Apr2021. Fell next to her bed at 3:30 am. Clinical examination: drooping corner of the mouth on the left, no movement in the left arm and leg, limited strength of the right arm. Oxygen staturing 98%, heart rate 81/min, blood pressure 110/82 mmHg, temp. 36.2C. CT (computed tomogram) brain without contrast: Thrombus M2 segment of the right cerebral artery media. Referred for urgent thromboectomy. Glasgow coma scale: drowsy but easily aroused E: 3/4, M: hemi image left, right 6/6, V: 4/5, small pupil isocore. Additional studies: Hb(hemoglobin) 9.2 g/dl - platelets 124000 - International Normalized Ratio 1.9 - D-dimers 35546 - Na+ (sodium)139 mmol/l - K(potassium) + 5.4 mmol/l, troponin 200 - creatinine 3.06 mg / dl - COVID PCR negative - ECG ( electrocardiogram) sinus rhythm. Hospitalization progress: -12Apr: Stop sedation after procedure and attempt extubation. Anemia before transfusion. Hyperkalaemia for which Glucose + AR once. Trandate IV(intravenous) a few times and then start ebrantil drip because of Arterial Hypertension. 5:00 pm: tries to open eyes, executes right command on demand, switch pressure regulated, volume controlled ventilation to Continuous Positive Airway Pressure. -13Apr: tries to open eyes and squeezes right on command: squeezing and also letting go on demand, moves right leg spontaneously, minimal reaction to pain left hand, left leg withdraws to pain. Ebrantil was tapered overnight, at around 140 mmHg. Control CT: large parenchymal hemorrhage with swelling on the right cerebral; accompanying edematous cerebral swelling with mild midline shift, right lateral ventricular obliteration and hemorrhagic sediment in the major transtentoral herniation. Echo cardio; good function. Duplex neck vessels: bilaterally limited atheromatosis. 14Apr: neurological Sequence. Afternoon: midazolam IV due to clonies. Negative living will for life-prolonging therapy issued by family. 15Apr: neurologically possibly slightly less responsive. Control CT skull: known major hemorrhagic right parenchymal hemorrhage with mesh action involving obliteration of the right lateral ventricle and increase of midline shift to notralateral; mass action with diffuse obliteration of the peripheral sulci over the right hemisphere with diffuse loss of gray-white matter differentiation; Slight increase in volume left side ventricle, cava developed hydrocephalus. Urinary tract infection with E. faecium and E. coli; R / Rocephin IV. 16Apr: disordered coagulation (thrombocytopenia 50,000, Prothrombin time 58, International Normalized Ratio. 1.4, activated partial thromboplastin time 32, fibrinogen 108, D-dimers 38,393 (Diffuse intravascular coagulopathy?); Determine Heparin-induced thrombopenia As: but also clearly less awake. Received Temesta for possible convulsions. Extubation and start palliative sedation. Decision: Left hemi-picture cerebrovascular disease requiring urgent thromboectomy; secondary hemorrhagic remodeling with cerebral edema and transtentorial herniation. Infaust prognosis. Acute on chronic renal failure. Urinary tract infection with E. faecium and E. coli. Thrombocytopenia, low fibrinogen and elevated d-dimeric (Diffuse intravascular coagulopathy, had Pfizer vaccine on Saturday 10Apr); etiology of diffuse intravascular coagulation? No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Treatment - Unknown Evolution of the ADR - Died Examinations - Heparin induced thrombocytopenia negative Anamnesis: Admitted to the emergency department on 12Apr2021. Fell next to her bed at 3:30 am Clinical examination: drooping corner of the mouth on the left, no movement in the left arm and leg, limited strength of the right arm. Oxygen staturing 98%, heart rate 81/min, blood pressure 110/82 mmHg, temp. 36.2C CT brain without contrast: Thrombus M2 segment of the right cerebral artery media. Referred for urgent thromboectomy. Glasgow coma scale: drowsy but easily aroused E: 3/4, M: hemi image left, right 6/6, V: 4/5, small pupil isocore. Additional studies: Hb 9.2 g/dl - platelets 124000 - International Normalized Ratio 1.9 - D-dimers 35546 - Na + 139 mmol/l - K + 5.4 mmol/l, troponin 200 - creatinine 3.06 mg / dl - COVID PCR negative - ECG sinus rhythm. Hospitalization progress: -12Apr: Stop sedation after procedure and attempt extubation. Anemia before transfusion. Hyperkalaemia for which Glucose + AR once. Trandate IV a few times and then start ebrantil drip because of Arterial Hypertension 5:00 pm: tries to open eyes, executes right command on demand, switch pressure regulated, volume controlled ventilation to Continuous Positive Airway Pressure. -13Apr: tries to open eyes and squeezes right on command: squeezing and also letting go on demand, moves right leg spontaneously, minimal reaction to pain left hand, left leg withdraws to pain. Ebrantil was tapered overnight, at around 140 mmHg. Control CT: large parenchymal hemorrhage with swelling on the right cerebral; accompanying edematous cerebral swelling with mild midline shift, right lateral ventricular obliteration and hemorrhagic sediment in the major transtentoral herniation. Echo cardio; good function. Duplex neck vessels: bilaterally limited atheromatosis. 14Apr: neurological Sequence. Afternoon: midazolam IV due to clonies. Negative living will for life-prolonging therapy issued by family. 15Apr: neurologically possibly slightly less responsive. Control CT skull: known major hemorrhagic right parenchymal hemorrhage with mesh action involving obliteration of the right lateral ventricle and increase of midline shift to notralateral; mass action with diffuse obliteration of the peripheral sulci over the right hemisphere with diffuse loss of gray-white matter differentiation; Slight increase in volume left side ventricle, cava developed hydrocephalus. Urinary tract infection with E. faecium and E. coli; R / Rocephin IV. 16Apr: disordered coagulation (thrombocytopenia 50,000, Prothrombin time 58, International Normalized Ratio. 1.4, activated partial thromboplastin time 32, fibrinogen 108, D-dimers 38,393 (Diffuse intravascular coagulopathy?); Determine Heparin-induced thrombopenia As: but also clearly less awake. Received Temesta for possible convulsions. Extubation and start palliative sedation. Decision: Left hemi-picture cerebrovascular disease requiring urgent thromboectomy; secondary hemorrhagic remodeling with cerebral edema and transtentorial herniation. Infaust prognosis. Acute on chronic renal failure. Urinary tract infection with E. faecium and E. coli. Thrombocytopenia, low fibrinogen and elevated d-dimeric (Diffuse intravascular coagulopathy, had Pfizer vaccine on Saturday 10Apr); etiology of diffuse intravascular coagulation?; Reported Cause(s) of Death: Death; Thrombocytopenia; hemorrhagic remodeling with clamping; Ischemic stroke; Hemiplegia left; Blood clotting problem; hemorrhagic remodeling with clamping; Neurological problem; thrombus arteria cerebri media right


VAERS ID: 1296838 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-11
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Aphasia, Blood alcohol, C-reactive protein, C-reactive protein increased, Carotid artery occlusion, Cerebral thrombosis, Coagulation time, Coagulopathy, Computerised tomogram, Computerised tomogram head, Echocardiogram, Electrocardiogram, Electroencephalogram, Haemoglobin, Haemophagocytic lymphohistiocytosis, Hemiparesis, International normalised ratio, Ischaemic stroke, Leukocytosis, Magnetic resonance imaging, Perfusion brain scan, Platelet count, Platelet count decreased, Pneumonia aspiration, Respiratory failure, Thrombocytopenia, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (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), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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: ALDACTONE [SPIRONOLACTONE]; ASAFLOW; BISOPROLOL EG; BURINEX; ELIQUIS; GLUCOPHAGE [METFORMIN]; LANTUS; NOVORAPID; SERETIDE; STILNOCT; TOTALIP; TRAZOLAN; BURINEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Arterial stenosis limb; Atrial fibrillation with rapid ventricular response; Breast carcinoma; CABG; Cardiac pacemaker malfunction; Cardiac pacemaker revision; Catheterization arterial; Chemotherapy; Chronic obstructive pulmonary disease; Chronic renal failure; Continuous positive airway pressure; Coronary artery occlusion; DC shock; Diabetes mellitus (Resultant/age (1995), Prescription/Insulin (2001).); Dyspnoea exacerbated; Hospitalisation; Hypercholesterolaemia; Hypoperfusion; Implantable cardioverter defibrillator insertion; Ischemic cardiomyopathy; Left anterior descending coronary artery stenosis; Left ventricular dysfunction; Mastectomy; Mitral insufficiency; Obstructive sleep apnea syndrome; Percutaneous transluminal angioplasty (of the Right Subclavian Artery); Peripheral arteriosclerosis; Peripheral artery angioplasty; Peripheral artery stent insertion; Posteroinferior myocardial infarction; Radiotherapy; Tachycardia; Vascular stenosis
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Blood alcohol content; Result Unstructured Data: Test Result:unknown; Comments: at 15:50; Test Date: 20210212; Test Name: activated cloth time; Result Unstructured Data: Test Result:236; Test Date: 20210411; Test Name: activated cloth time; Result Unstructured Data: Test Result:32; Test Date: 20210413; Test Name: activated cloth time; Result Unstructured Data: Test Result:196; Test Name: CT scan; Result Unstructured Data: Test Result:unknown; Test Name: Brain CT; Result Unstructured Data: Test Result:No intracranial bleeding. Atrophy. Small meningiom; Comments: No intracranial bleeding. Atrophy. Small meningioma li fr.; Test Date: 20210411; Test Name: C-reactive protein; Result Unstructured Data: Test Result:3.8; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:known ischemic cardiomyopathy without arguments; Comments: for overfilling.; Test Name: EKG; Result Unstructured Data: Test Result:sinusoidal; Test Name: Electroencephalogram; Result Unstructured Data: Test Result:trace with a base rhythm of 9.3 Hz, slow hearth; Comments: left hemisphere; Test Date: 20210411; Test Name: hemoglobin; Result Unstructured Data: Test Result:17.3; Test Date: 20210411; Test Name: INR; Result Unstructured Data: Test Result:<1.0; Test Date: 20210415; Test Name: INR; Result Unstructured Data: Test Result:1.0; Test Name: Angio; Result Unstructured Data: Test Result:stop picture li autologous chondrocyte; Comments: implantation.; Test Name: perfusion study; Result Unstructured Data: Test Result:The perfusion study shows pronounced artifacts in; Comments: in the context of movement.; Test Date: 20210411; Test Name: platelet count; Result Unstructured Data: Test Result:169,000; Test Date: 20210415; Test Name: platelet count; Result Unstructured Data: Test Result:120,000; Test Name: lung X-ray; Result Unstructured Data: Test Result:unknown
CDC Split Type: BEPFIZER INC2021491319

Write-up: hemophagocytic lymphohistiocytosis; platelet count: 120,000 (N: 154-327,000); strong thrombus at left cerebri media. Significantly reduced blood flow to the left cerebri media region; CRP increased; Acute renal insufficiency; Right-sided dropout; rather elongated occlusion in the distal part of the carotid interna; Aphasia/mixed aphasia; Blood clotting problem; Leukocytosis; Pneumonia aspiration; Ischemic stroke; Thrombocytopenia; Respiratory insufficiency; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. Regulatory authority report number BE-FAMHP-DHH-N2021-88999. An 80-year-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, arterial hypertension, ischemic cardiomyopathy, chronic renal failure, diabetes type 2 from 1995 to unknown date (insulin prescription from 2001), and hypercholesterolemia. Other medical history includes: On 01Jan1985, the patient had breast carcinoma (resection/radiotherapy/chemotherapy). On 01Jan1995, the patient had obstructive sleep apnea syndrome (9 months nasal continuous positive airway pressure). On 01Jun2006, the patient underwent Percutaneous Transluminal Angioplasty of the Right Subclavian Artery. On 12Sep2006, catheterization showed moderately decreased left ventricular function. Moderate ostial mainstream stenosis (Fractional Flow Reserve 0.72). Significant stenosis in the mid to distal Left Anterior Descending (coronary). Occlusion of the mid Right Coronary Artery with collaterals. Slight mitral valve insufficiency. Indication for Coronary Artery Bypass Grafting with mitral valve plastic (if needed). On 12Dec2006, Coronary Artery Bypass Grafting with ligation of the Left Internal Artery Mammary - Left Anterior Descending, free Right Internal Artery Mammary-M1 and pond- Right Coronary Artery (as reported). Subclavian stenosis for which conservative management was warranted for the time being. On 04May2012, Coronarography showed chronic total occlusion of proximal right coronary artery and moderate stenosis at last menstrual period, functionally very significant (Fractional Flow Reserve 0.71). Occlusion VB-RVA. Patent Left Internal Arteria Mammaria-D1, occlusion jump graft to mid Left Anterior Descending. Free Right Internal Arteria Mammaria Y graft Left Internal Arteria Mammaria to M1 is patent (as reported). Schedule percutaneous coronary intervention last menstrual period and Chronic Total Occlusion Right Coronary Artery in 2nd and 3rd time. On 09May2012, Coronarography with Fractional Flow Reserve measurement in distal Left Anterior Descending 0.85 despite collaterals giving Left Anterior Descending to Right Coronary Artery, main strain not responsible for ischemia, drug management (as reported). On 11May2012, Electrophysiological examination showed persistently inducible sustained monomorphic chamber tachycardia in patient with ischemic cardiomyopathy and old inferior posterior infarction, indicative of implantable cardioverter defibrillator implantation. On 16May2012, the patient had implantable cardioverter defibrillator. On 30May2012, Cardiology recording due to pacemaker lead dysfunction. On 01Jun2012, the patient had pacemaker lead revision and replacement. On 04Jun2012, CT angiography lower limbs confirmed diffuse atheromatous with multiple stenosis between 30 and 50%, but good flow to distal. Conservative policy. On 17Jan2013, the patient had Implantable Cardioverter Defibrillator. Control due to imminent perforation of the implantable cardioverter defibrillator, the implantable cardioverter defibrillator was placed sub-pectoral. On 01Sep2014, Admission in connection with increasing dyspnoea. This appeared to be due to hypoperfusion based on an idioventricular rhythm in combination with chronic obstructive pulmonary disease. On 16Sep2014, the patient underwent Left Percutaneous Transluminal Angioplasty Superficial Femoral Artery. On 16Sep2014, Coronarography showed occlusion Right Coronary Artery, Left Anterior Descending moderate atheromatosis with mid segment major stenosis, left circumflex artery stenosis proximal to distal transition, occlusion vein, patent Left Internal Arteria Mammaria-D1 and free Right Internal Arteria Mammaria-OM1. On 13Jun2016, the patient underwent Percutaneous Transluminal Angioplasty and Stenting External Iliac Artery. Percutaneous Transluminal Angioplasty and Stenting Superficial Femoral Artery (1as). On 18Nov2019, admission with the new atrial fibrillation with rapid ventricular response requiring DC shock and start-up Eliquis. Concomitant medications included spironolactone (ALDACTONE); acetylsalicylic acid (ASAFLOW); bisoprolol fumarate (BISOPROLOL EG); bumetanide (BURINEX); apixaban (ELIQUIS); metformin (GLUCOPHAGE); insulin glargine (LANTUS) taken for diabetes mellitus type 2; insulin aspart (NOVORAPID) taken for diabetes mellitus type 2; fluticasone propionate, salmeterol xinafoate (SERETIDE); zolpidem tartrate (STILNOCT); atorvastatin calcium (TOTALIP); trazodone hydrochloride (TRAZOLAN); and bumetanide (BURINEX). The patient experienced CRP increased, significantly reduced blood flow to the left cerebral media region, acute renal insufficiency, right-sided dropout, rather elongated occlusion in the distal part of the carotid interna, aphasia, strong thrombus at left cerebral media, blood clotting problem, and leukocytosis on 11Apr2021 at 13:00. The patient also experienced ischemic stroke, thrombocytopenia, respiratory insufficiency, and pneumonia aspiration on 11Apr2021. The patient underwent lab tests and procedures which included CT scan: unknown and lung X-ray: unknown, both on unspecified dates; activated cloth time: 236 on 12Feb2021; Blood alcohol content: unknown (at 15:50), activated cloth time: 32, C-reactive protein: 3.8, hemoglobin: 17.3, INR: <1.0, platelet count: 169,000 on 11Apr2021; activated cloth time: 196 on 13Apr2021; INR: 1.0 and platelet count: 120,000 (N: 154-327,000)on 15Apr2021. Outcome of hemophagocytic lymphohistiocytosis was unknown. The patient died due to the rest of the events on 19Apr2021. It was unknown if an autopsy was performed. The events were unclassifiable per FAMHP. Reporter''s comments: Examinations - CT (computed tomogram) scan, lung X-ray. Lab: platelet count 169,000 on 11Apr21, 120,000 on 15Apr21 (N: 154-327,000); activated cloth time: 236 (on 12Feb21), 196 (on 13Apr21), 32 on 11Apr21 (N: <36); INR (international normalized ratio) <1.0 on 11Apr21, 1 on 15Apr21; hemoglobin 17.3 on 11Apr21; CRP 3.8 on 11Apr21. Anamnesis: At noon still had dinner with family, since 13:00 left arm and leg, aphasia. Clinical examination on 11Apr2021 at 15:50: Blood alcohol content. VII judge (as reported). Right impression hemophagocytic lymphohistiocytosis. Performs commands with li hemisoma (F4 / 5), right no movement. Technical investigations: Brain CT: No intracranial bleeding. Atrophy. Small meningioma li fr. (as reported) Angio: stop picture li autologous chondrocyte implantation (as reported). EKG (electrocardiogram) sinusoidal. Brain CT and Perfusion Study: Clinical Information: Right Hemiparesis and Aphasia. The centerline of the brain has been preserved. Widened ventricles and deepened cortical sulci. Periventricular white matter hypodensity. No bleeding detected. Angio CT neck vessels: Calcified plaques in the aortic arch. Also calcified patches in the origin of the carotid bilaterally. Prominent atheromatous calcified plaque at the bifurcation on both left and right with indications of high-grade stenosis in the origin of the internal carotid and on the left also a pronounced calcified plaque in the origin of the internal carotid with a sharp decrease in blood flow to the internal carotid. Lumen with slowly decreasing diameter towards the distal and in my opinion absent flow in the petrous and cavernous part up to and including the cerebri media but also a clear thrombus is shown on the left side. Further distal there is also markedly reduced blood flow to the sylvic branches and peripheral. The perfusion study shows pronounced artifacts in the context of movement. Decision: Admission of this 80-year-old patient in the context of ischemic cerebrovascular disease with mixed aphasia and right hemiplegia, based on occlusion in the distal part of the carotis interna as well as substantial thrombus at the level of the cerebri media on the left, for which IV thrombolysis and thrombectomy. Known cardiovascular risk factors citing Arterial Hypertension, hypercholesterolemia, Diabetes mellitus, Atrial Fibrillation, for which Eliquis. Unfavorable clinic, not clearing (as reported). Complication of aspiration pneumonia, for which Augmentin, with deterioration respiratory and oxygen deprivation, for which switch Tazocin. Stroke elaboration: Nuclear Magnetic Resonance brain not possible given pacemaker. Transthoracic echocardiography known ischemic cardiomyopathy without arguments for overfilling. Electroencephalogram trace with a base rhythm of 9.3 Hz, slow hearth left hemisphere. During admission developing respiratory insufficiency, high oxygen deprivation, cognitive behavioral therapy 2 had already been discussed with family. Switch from Augmentin to Tazocin no improvement. Increased inflammatory blood count, acute renal insufficiency. Comfort care started in consultation with family. Patient died on 19Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ischemic stroke; CRP increased; Thrombocytopenia; Significantly reduced blood flow to the left cerebri media region; Acute renal insufficiency; Right-sided dropout; rather elongated occlusion in the distal part of the carotid interna; Aphasia/mixed a


VAERS ID: 1296839 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-01
   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 ER7449 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Bedridden, Cerebrovascular accident, Death, Loss of consciousness, Motor dysfunction, Nervous system disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021491351

Write-up: passing away; Neurological disorder NOS; Consciousness loss; loss of motor function; Speech loss; bedridden for more than 7 days; strong suspicion of stroke; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-89160. An 87-year-old female patient received her first dose of BNT162B2 (COMIRNATY, lot number: ER7449), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Apr2021, the patient experienced neurological disorder NOS, consciousness loss, loss of motor function, speech loss, and was bedridden for more than 7 days. It was reported that there was strong suspicion of stroke on an unspecified date in 2021. There was no treatment given in response to the events. Examinations were reported as none. The patient passed away on 11Apr2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. Reporter''s comments: Treatment - No. Evolution of the ADR - passing away. Examinations - none. Strong suspicion of stroke No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - No. Evolution of the ADR - passing away. Examinations - none. Strong suspicion of stroke.; Reported Cause(s) of Death: passing away; Neurological disorder NOS; Consciousness loss; loss of motor function; Speech loss; bedridden for more than 7 days; strong suspicion of stroke


VAERS ID: 1296840 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-04-18
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute kidney injury, Angiogram, C-reactive protein, Death, Dyspnoea, Fibrin D dimer, Haemoglobin, Hemiplegia, International normalised ratio, International normalised ratio increased, Ischaemic stroke, Oxygen saturation, Platelet count, Pulmonary embolism, Thrombocytopenia, Troponin I
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COZAAR; SEROQUEL; KREDEX; SINTROM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Name: PTT; Test Result: 29 %; Test Name: thoracic and cerebral angioCT; Result Unstructured Data: Test Result:confirming thrombotic damage; Test Name: C-reactive protein; Result Unstructured Data: Test Result:164 mg/l; Test Name: D-dimers; Result Unstructured Data: Test Result:7650 ng/ml; Test Name: hemoglobin; Result Unstructured Data: Test Result:14.9 g/dl; Test Date: 20210418; Test Name: INR; Result Unstructured Data: Test Result:2.45; Test Date: 20210419; Test Name: saturation; Test Result: 50 %; Test Name: thrombocytopenia; Result Unstructured Data: Test Result:80,000 /mm3; Test Name: troponin I; Result Unstructured Data: Test Result:438 ng/L
CDC Split Type: BEPFIZER INC2021491336

Write-up: Death; Massive pulmonary embolism identified on 19Apr; left hemiplegia linked to ischemic stroke on 19Apr; left hemiplegia linked to ischemic stroke on 19Apr; normalised ratio 2.45; onset of dyspnea on 18Apr; Acute renal failure; Thrombocytopenia; This is a spontaneous report from a contactable physician, downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is BE-FAMHP-DHH-N2021-89423. This is a spontaneous COVID-19 report received by the authorities on 23Apr2021. An 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 23Mar2021 (batch/lot number and expiration date were not reported) at a single dose for COVID-19 immunization. Relevant medical history included arterial hypertension and atrial fibrillation; both from an unknown date. Concomitant medications included losartan potassium (COZAAR); quetiapine fumarate (SEROQUEL); and carvedilol (KREDEX), all taken for an unspecified indication, start and stop date were not reported; and acenocoumarol (SINTROM) taken for atrial fibrillation (FA), start and stop date were not reported. The patient experienced acute renal failure, normalised ratio (INR) 2.45, thrombocytopenia, and onset of dyspnea on 18Apr2021; left hemiplegia linked to ischemic stroke on 19Apr2021; massive pulmonary embolism identified on 19Apr2021; and death on 20Apr2021. It was further reported that on 18Apr2021, there was an appearance of dyspnea with objectified hypoxemia. On 19Apr2021, saturation was 50% with sudden change in consciousness and left hemiplegia on three floors. Also on 19Apr2021, the patient was intubated at home and identified massive pulmonary embolism and left hemiplegia linked to a right sylvian ischemic stroke. The patient underwent further lab tests and procedures, which included thoracic and cerebral angio Computed Tomography (CT) confirming thrombotic damage on an unspecified date, INR of 2.45 on 18Apr2021; thrombocytopenia of 80,000 /mm3 on an unspecified date; D-dimers of 7650 ng/ml on an unspecified date; partial thromboplastin time (PTT) of 29% on an unspecified date; hemoglobin 14.9 g/dl on an unspecified date; C-reactive protein of 164 mg/l on an unspecified date; and troponin I of 438 ng/l on an unspecified date. Therapeutic measures were taken as a result of massive pulmonary embolism identified on 19Apr2021, acute renal failure, normalised ratio 2.45, thrombocytopenia, and left hemiplegia linked to ischemic stroke on 19Apr2021, which included fibrinolysis by alteplase in view of hemodynamic instability - mechanical thrombectomy on 19Apr2021. The patient died on 20Apr2021. An autopsy was not performed. Reporters comments: Treatment - fibrinolysis by alteplase in view of hemodynamic instability - mechanical thrombectomy on 19Apr. Examinations - thoracic and cerebral angioCT confirming thrombotic damage, INR 2.45; thrombocytopenia 80,000 / mm3; D-dimers 7650 Ng / ml; PTT 29%; hemoglobin 14.9 g / dl; C-reactive protein 164 mg / l; troponin I 438 Ng / l . 18Apr: appearance of dyspnea with objectified hypoxemia. 19Apr: saturation 50% + Sudden change in consciousness and left hemiplegia on three floors. 19Apr: intubated at home + identified massive pulmonary embolism, left hemiplegia linked to a right sylvian ischemic stroke. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Reporter''s Comments: Summary of Reporter Comment: Treatment - fibrinolysis by alteplase in view of hemodynamic instability - mechanical thrombectomy on 19Apr. 18Apr: appearance of dyspnea with objectified hypoxemia. 19Apr: saturation 50% + Sudden change in consciousness and left hemiplegia on three floors. 19Apr: intubated at home + identified massive pulmonary embolism, left hemiplegia linked to a right sylvian ischemic stroke.; Reported Cause(s) of Death: Death; left hemiplegia linked to ischemic stroke on 19Apr; onset of dyspnea; Massive pulmonary embolism identified on 19Apr; Acute renal failure; normalised ratio 2.45; Thrombocytopenia; left hemiplegia linked to ischemic stroke on 19Ap


VAERS ID: 1296859 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-04
Onset:2021-04-11
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Conjunctivitis, Dysphagia, Fatigue, Hypersomnia, Hypophagia, Pyrexia
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Depression (excl suicide and self injury) (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Comments: in the evening; Test Date: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Comments: 22:30; Test Date: 20210418; Test Name: Body temperature; Result Unstructured Data: Test Result:38-39 Centigrade; Comments: in the evening; Test Date: 20210418; Test Name: Body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Comments: 02:00; Test Date: 20210418; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Comments: 07:00
CDC Split Type: CZPFIZER INC2021484684

Write-up: conjunctivitis; fever 39?C; limited swallowing; fatigue; slept more; food in little amount soft at first, then spoons of water only; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number CZ-CZSUKL-21004446. A 96-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04Apr2021 (Batch/Lot Number: EW2239) as first dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was informed that from 11Apr2021 patient was more tired and slept more. Food was taken in lesser amount and soft only. On the evening of 17Apr2021 temperature began rising up to 38.9 centigrade. At 21 o''clock the temperature was dealt by cold poultice on hands and legs. At 22:30 the temperature was decreased to 38.1 centigrade. At 2:00 a.m. of 18Apr2021 temperature was 37.4 centigrade. She was sleeping calmly and breathing through the nose. At 7:00 the temperature was 37.3 centigrade, conjunctivitis was treated by carbethopendecinii bromide/boric acid/sodium tetraborate decahydrate (OPHTALMO-SEPTONEX) drops and guaiazulene (OPHTALMO-AZULEN) ointment. In the evening of 18Apr2021 the temperature was the same, between 38 and 39 centigrade. We use cold poultice. She takes only spoons of water. Swallowing was very limited. The patient died during sleep at night on 19Apr2021. It was not reported if an autopsy was performed. At time of death outcome of conjiuntivitis was unknown, while patient had not yet recovered from other reported events. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: fever 39?C; Death


VAERS ID: 1296863 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-29
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood creatinine, Computerised tomogram, Dialysis, Laboratory test, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (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), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   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: Rheumatism; Rhinitis allergic
Allergies:
Diagnostic Lab Data: Test Name: Creatinine value; Result Unstructured Data: Test Result:739 umol/l; Test Name: CT abdomen; Result Unstructured Data: Test Result:NA; Test Name: dialysis; Result Unstructured Data: Test Result:NA; Test Name: laboratory parameters; Result Unstructured Data: Test Result:NA; Test Name: X-ray findings; Result Unstructured Data: Test Result:NA
CDC Split Type: DEPFIZER INC2021491369

Write-up: Acute kidney failure; This is a spontaneous report downloaded from a regulatory authority-WEB [E2B Authority number: DE-PEI-202100047996. An 87-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: ER7812), via an unspecified route of administration on 14Mar2021 as SINGLE DOSE for covid-19 immunization (Age at vaccination: 87 years). Medical history included Rheumatism and rhinitis allergic. The patient''s concomitant medications were not reported. The patient received the first dose of bnt162b2 (COMIRNATY) on 21Feb2021 for covid-19 immunisation. The patient experienced acute kidney failure on 29Mar2021. The patient was hospitalized on an unspecified date and the reporter assessed the event as life-threatening for the event. The patient underwent lab tests and procedures which included creatinine value: 739 umol/l, CT abdomen, dialysis, laboratory parameters and x-ray findings: NA on an unspecified date. Outcome of the event was fatal. The patient died on 29Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Acute kidney failure


VAERS ID: 1296865 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-06
   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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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 INC2021491342

Write-up: Tiredness; Inappetence; Groggy; Diarrhea; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, company number DE-PEI-202100049400. An 81-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took comirnaty on 11Mar2021 and for covid-19 prophylaxis. On 06Apr2021 the patient experienced Diarrhea. On 08Apr2021 the patient experienced Inappetence, Groggy, Tiredness. It was reported that the patient died on 19Apr2021. It was not reported if an autopsy was performed. The outcome of the event diarrhea was unknown, while fatal for the events inappetence, groggy, and tiredness. Causality has been assessed as "Unclassifiable " for all events by the Regulatory Authority. No follow-up attempts are needed, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Tiredness; Inappetence; Groggy


VAERS ID: 1296866 (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: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021491329

Write-up: Diarrhoea; Vomiting; Ache stomach; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100049402. A 78-year-old female patient received bnt162b2 (COMIRNATY, 0.3 mL), via an unspecified route of administration on 08Apr2021 (Lot Number: EW8904) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Apr2021 the patient experienced Diarrhoea, Vomiting, Ache stomach. The outcome for the events was fatal. The patient died on 17Apr2021. It was not reported if an autopsy was performed. This report is serious - death. "English summary (full translation available upon request)". Causality assessment reported as D.. Unclassifiable by Regulatory Authority. No follow-up attempts are needed, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: vomiting; ache stomach; diarrhoea


VAERS ID: 1296867 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-19
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic arteriosclerosis, Arrhythmia, Brain oedema, Cardiac hypertrophy, Myocardial infarction, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021491346

Write-up: Brain oedema; Lung edema; Arrhythmia; Cardiac hypertrophy; massive upper influx congestion one would presume a cardiac pump failure; Aortic arteriosclerosis; Infarct myocardial; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority Report Number: DE-PEI-202100049406). A non-contactable physician reported that a 64-year-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 17Feb2021, at a single dose, for COVID-19 immunization. The patient''s medical history included ongoing hypertension. The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY) on 25Jan2021 at the age of 64 years for COVID-19 immunization. On 19Feb2021, the patient experienced infarct myocardial that resulted to death. On an unspecified date, the patient had cardiac hypertrophy, brain oedema, aortic arteriosclerosis, and lung edema. According to the reporter, no pathological morphological cause of death could be found in the autopsy. Due to massive upper influx congestion one would presume a cardiac pump failure. This can be explained most probably by arrhythmia in the context of cardiac hypertrophy. Further heart conditions (unspecified) could also be causes of death in terms of differential diagnosis. The outcome of "Infarct myocardial" was fatal while the outcome of the other events was unknown. The patient died on 19Feb2021. An autopsy was performed that revealed cardiac hypertrophy, brain oedema, aortic arteriosclerosis, and lung edema. The reported cause of death was infarct myocardial. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial; Autopsy-determined Cause(s) of Death: Cardiac hypertrophy; Brain oedema; Aortic arteriosclerosis; Lung edema


VAERS ID: 1296868 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-19
   Days after vaccination:4
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: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021491324

Write-up: Unknown cause of death; This is a spontaneous report downloaded from a regulatory authority-WEB [E2B Authority number: DE-PEI-202100049407]. An 85-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took comirnaty for COVID-19 immunization. On 19Apr2021, the patient experienced unknown cause of death. The patient died on 19Apr2021. An autopsy was not performed. Causality for Comirnaty and Unknown cause of death was reported as: D. Unclassifiable (Source of assessment: PEI). 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: 1296869 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-17
   Days after vaccination:4
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: 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), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   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: Amyotrophic lateral sclerosis; Cachexia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021491309

Write-up: Respiration failure; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB with regulatory authority number DE-PEI-202100050351. A 79-years-old male patient received BNT162B2 (COMIRNATY, mRNA TOZINAMERAN, formulation; solution for injection) via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: ET3045) with unknown dosage as a single dose for covid-19 immunisation.The patient medical history and concurrent conditions included as Amyotrophic lateral sclerosis (10002026), Cachexia (10006895). Concomitant medications were not reported. On 17Apr2021, the patient experienced Respiration failure. The patient outcome was fatal for Respiration failure. The patient died on 17Apr2021 and this report was considered as serious which caused death. It was not reported if an autopsy was performed. The causality was assessed as Unclassifiable by Regulatory Authority. English summary full translation available upon request. No follow-up attempts needed; follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Ventilatory failure


VAERS ID: 1296870 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-23
   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 - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   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: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021491311

Write-up: Sudden death; Fever; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100050352. A 90-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Apr2021 (batch/lot number and expiration date not reported) as single dose for COVID-19 immunisation. Medical history included ongoing dementia. The patient''s concomitant medications were not reported. The patient experienced fever on 23Apr2021, and sudden death on 27Apr2021. The patient died on 27Apr2021. It was not reported if an autopsy was performed. Causality assessment reported as unclassifiable by Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sudden death; Fever


VAERS ID: 1296871 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
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 EL8723 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure
Preexisting Conditions: Medical History/Concurrent Conditions: Acute decompensated heart failure; General physical condition decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021491350

Write-up: Congestive cardiac failure aggravated; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB regulatory authority number DE-PEI-202100050355. An 89-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EL8723), via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. Medical history included general physical condition decreased from 23Feb2021 to an unknown date, acute decompensated heart failure from 23Mar2021 to an unknown date and ongoing cardiac failure. The patient''s concomitant medications were not reported. The patient experienced congestive cardiac failure aggravated on an unspecified date. The patient died on 05Mar2021. It was unknown if an autopsy was performed. Causality reported as inconsistent causal association to immunization by PEI. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Congestive cardiac failure aggravated


VAERS ID: 1296872 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   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 ER9480 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021491318

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100050465. A 78-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Apr2021 (Lot Number: ER9480) as SINGLE DOSE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 06Apr2021. The patient died on 06Apr2021. An autopsy was not performed. Causality for Comirnaty and Unknown cause of death was reported as: D. Unclassifiable. No follow-up attempts needed, follow-up automatically provided.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1296873 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-29
   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 ER7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure immeasurable, Blood pressure measurement, Dyspnoea, Restlessness
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: blood pressure; Result Unstructured Data: Test Result:immeasurable; Test Date: 20210329; Test Name: blood pressure; Result Unstructured Data: Test Result:drop of blood pressure
CDC Split Type: DEPFIZER INC2021491353

Write-up: Dyspnoea; Unrest; Blood pressure immeasurable; Drop of blood pressure; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100050466. An 87-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot number: ER7812), via an unspecified route of administration on 28Mar2021 as 0.3 mL, single for covid-19 immunisation. The patient medical history included ongoing hypertension and diabetes mellitus. The patient previously received the first dose of bnt162b2 (COMIRNATY, lot number was not reported) on 07Mar2021 for covid-19 immunization. The patient''s concomitant medications were not reported. On 29Mar2021, the patient experienced dyspnoea, unrest, blood pressure immeasurable and drop of blood pressure. The outcome of the events was fatal. The patient died on 01Apr2021. Cause of death were dyspnoea, unrest, blood pressure immeasurable and drop of blood pressure. An autopsy was not performed. PEI causality assessment for COMIRNATY and all 3 events: Unclassifiable. No follow-up attempts needed, follow-up automatically provided by EMA.; Reported Cause(s) of Death: Drop of blood pressure; Blood pressure immeasurable; unrest; Dyspnoea


VAERS ID: 1296874 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Nausea, Ventricular fibrillation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: Flu-like illness; Vomiting; Nausea; Ventricular fibrillation; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 03-May-2021. This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VENTRICULAR FIBRILLATION (Ventricular fibrillation) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criterion death). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like illness), VOMITING (Vomiting) and NAUSEA (Nausea). The patient died on 17-Apr-2021. The reported cause of death was Ventricular fibrillation. It is unknown if an autopsy was performed. At the time of death, INFLUENZA LIKE ILLNESS (Flu-like illness), VOMITING (Vomiting) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator. No treatment medications provided by the reporter. Company Comment: This is a case of death in a 50-year-old female subject with unknown medical history, who died 2 days after receiving the first 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 50-year-old female subject with unknown medical history, who died 2 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Ventricular fibrillation


VAERS ID: 1296875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-29
   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 ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   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: ADVAGRAF; CERTICAN; ALFACALCIDOL; COLECALCIFEROL; RESTEX; BISOPROLOL; TORASEMID; PANTOPRAZOLE; AMLODIPINE
Current Illness: Aortic valve incompetence (Grade 1); Atrial fibrillation; Mitral valve disease mixed; Mitral valve stenosis (Grade I); Polyneuropathy; Psoriatic arthropathy; Renal transplant; Truncus coeliacus thrombosis (Truncus brachiocephalicus occulsion); Vascular shunt (Shunt-Arm)
Preexisting Conditions: Medical History/Concurrent Conditions: Atypical haemolytic uraemic syndrome; Drug allergy (Iode, acetylsalicylic acid, ACE inhibitors, cibrofloxacin)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021491291

Write-up: Cerebral haemorrhage; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional via the regulatory authority. Regulatory authority number is DE-PEI-CADR2021057709. A 59-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: ER7812), via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. Medical history included Renal transplant, Vascular shunt (Shunt arm), Atypical haemolytic uraemic syndrome (1987 to 1991), Polyneuropathy, Mitral valve disease mixed (degenerative origin with grade II mitral valve insufficiency), Mitral valve stenosis (Grade I), Aortic valve incompetence (Grade I), Truncus coeliacus thrombosis (Truncus brachiocephalicus occlusion), Psoriatic arthropathy, Atrial fibrillation (from August 2018). Patient was allergic to Iode, acetylsalicylic acid, ACE inhibitors and cibrofloxacin. Concomitant medications included Advagraf, Certican, Alfacalcidol, Colecalciferol 20000, Restex, Bisoprolol, Torasemid, Pantoprazole and Amlopidine. On 29Mar2021, the patient experienced cerebral haemorrhage. On 30Mar2021, the patient died due to cerebral haemorrhage. It was not reported if an autopsy was performed. Outcome of the event was fatal. Health Authority Comment Comment: Patient was allergic to Iode, acetylsalicylic acid, ACE inhibitors and cibrofloxacin. Information on risk factors or previous illnesses: Kidney transplant, Shunt arm, atypical HUS (1987/1991), Polyneuropathy, Combined mitral valve disease of degenerative origin with grade II mitral valve insufficiency, Grade I mitral valve stenosis, Grade I aortic regurgitation, Brachiocephalic trunk Occulsion, Arthropathic psoriasis and Atrial fibrillation from August 2018. Infusion: "Soliris 1200 mg every 2 weeks / Sudden confusion, paralyzed right side of body, fall, loss of consciousness in ambulance." Causality assessment was D. Unclassifiable No follow-up attempts needed, follow-up automatically provided.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1296876 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-21
   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 ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   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: DEPFIZER INC2021491284

Write-up: death with unknown cause; Strong pressure in the front of the rib cage/Dyspnoea; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number: DE-PEI-CADR2021058004 and DE-PEI-202100048973. A 93-years-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: ER7812), via an unspecified route of administration on 18Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 21Mar2021, the patient experienced Strong pressure in the front of the rib cage/Dyspnoea. On 24Mar2021, the patient experienced Unknown cause of death (death with unknown cause). The patient''s outcome was not recovered for Dyspnoea and fatal for death with unknown cause. The patient died on 24Mar2021. An autopsy was not performed. Causality assessment reported as D. Unclassifiable by PEI. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: death with unknown cause


VAERS ID: 1296890 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   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 ET3674 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Ear, nose and throat examination, T-cell lymphoma
SMQs:, Hearing impairment (broad), Malignant lymphomas (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LOSARTAN; CARVEDILOL STADA; KALIUMKLORID SANDOZ
Current Illness: T-cell lymphoma
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Ear, nose and throat examination; Result Unstructured Data: Test Result:unknown results; Comments: No results available
CDC Split Type: DKPFIZER INC2021473798

Write-up: Bell''s palsy: Unilateral fascialis paresis involving "the entire" left side of the face. No other neurological symptoms.; T-cell Lymphoma; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0061569. Safety Report Unique Identifier DK-DKMA-ADR 25094958. This is a spontaneous case, received on 07Apr2021 from a physician, which describes the occurrence of Bell''s palsy (Bell''s palsy: Unilateral fascialis paresis involving ''the entire'' left side of the face. No other neurological symptoms) in a 42 years old male patient, vaccinated with Comirnaty (tozinameran). Concomitant medication included: Kaliumklorid ''Sandoz'' (POTASSIUM CHLORIDE), Carvedilol ''STADA'' and Losartan ''Medical Valley''. There is no information regarding past medication. There is no information regarding patient medical history. Patient concurrent conditions included Cardiac insufficiency and T-cell lymphoma. On 11Mar2021 the patient was vaccinated with first dose of Comirnaty (Batch number: EP9605). On 06Apr2021 the patient was vaccinated with second dose of Comirnaty (Batch number: ET3674) for COVID-19 immunisation. On 06Apr2021, the patient developed Bell''s palsy. The adverse drug reaction, Bell''s palsy, was by the physician reported as resulting in hospitalisation on an unknown date. No treatment or medical procedure due to the adverse drug reaction was reported. Action taken with Comirnaty was not applicable. The adverse drug reaction, Bell''s palsy, was not recovered at the time of reporting. Patient died 15Apr2021 and reported cause of death: T-cell lymphoma. Test results: Apr2021, Ear, nose and throat examination: No results available. Causality: The physician stated that the patient death from T-cell Lymphoma and the death was not deemed to be related to the vaccine. It is unknown if autopsy was done. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on information provided, the event death from T-cell Lymphoma is related to underlying disease but unrelated to Comirnaty (tozinameran).; Reported Cause(s) of Death: T-cell Lymphoma


VAERS ID: 1296891 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-06
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 EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anencephaly, Cleft palate, Congenital absence of cranial vault, Maternal exposure during pregnancy, Ultrasound foetal
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Ultrasound fetal; Result Unstructured Data: Test Result:1 trimesterscan: acrania; Test Date: 202104; Test Name: Ultrasound fetal; Result Unstructured Data: Test Result:acrania confirmed by repeated ultrasound
CDC Split Type: DKPFIZER INC2021483968

Write-up: Maternal exposure during pregnancy, first trimester/Foetal exposure during pregnancy; Anencephalia; Acrania in fetus; Cleft palate; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0061921, safety report unique identifier DK-DKMA-ADR 25110977. Report received from a regulatory authority. Two cases were created from the same source document (mother and fetus). This is the fetus case. A fetus patient of unspecified age and gender received bnt162b2 (COMIRNATY), transplacental on 06Jan2021 (Batch/Lot Number: EM0477; Expiration Date: 30Apr2021) as SINGLE DOSE, transplacental on 31Jan2021 (Batch/Lot Number: EK9788; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. a physician which describes the occurrence of Absence of cranial vault congenital (Acrania in fetus), Cleft palate (Cleft palate), Anencephalia (Anencephalia) and Foetal exposure during pregnancy (Foetal exposure during pregnancy) in a foetus which mother was vaccinated with Comirnaty (tozinameran). There is no information regarding concomitant medication. There is no information regarding past medication. There is no information regarding patient medical history or concurrent conditions. On 06jan2021 and 31jan2021 the mother was vaccinated with COMIRNATY (Batch number: EM0477;EK9788) for COVID-19 immunisation. In Apr2021, at the first trimester ultrasound (12 weeks of pregnancy), the foetus was diagnosed with Absence of cranial vault congenital, Anencephalia and Cleft palate. The ADRs, Absence of cranial vault congenital and Anencephalia, were by the reporter reported as: congenital anomaly and Fatal, as the mother got an induced abortion due to the congenital anomaly. The patient underwent lab tests and procedures which included ultrasound foetal: 1 trimesterscan: acrania on Apr2021, ultrasound foetal: acrania confirmed by repeated ultrasound on Apr2021. The outcome of the event Cleft palate was not recovered, while unknown for the other events. Causality: The reporter states that a connection with the Pfizer vaccine is very unlikely but cannot rule it out completely." Follow-up not possible, no further information expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : DK-PFIZER INC-2021491687 mother case


VAERS ID: 1296892 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   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: DIGOXIN DAK; ELIQUIS; PANODIL; ATORVASTATIN TEVA
Current Illness: Artificial cardiac pacemaker user; Heart rate irregular; Hypercholesterolaemia; Pain; Tooth infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021483972

Write-up: Sudden severe nosebleed without precedent; This is a spontaneous report downloaded from the regulatory authority (Regulatory Authority Report Number: DK-DKMA-WBS-0063096). A contactable physician reported that a 91-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: ER2659, Expiration Date: 30Jun2021), via an unspecified route of administration, on 16Mar2021, at a single dose, for COVID-19 immunization. The patient''s medical history included hypercholesterolaemia, heart rate irregular, pain, tooth infection and a cardiac assistance device user (pacemaker); all were ongoing. The patient''s concomitant medications included digoxin (DIGOXIN DAK) from 14May2020 for heart rate irregular, apixaban (ELIQUIS) from 28May2020 as thrombosis prophylaxis, paracetamol (PANODIL) from 13May2020 for pain, and atorvastatin calcium (ATORVASTATIN TEVA) from 14May2020 for hypercholesterolaemia. On 16Mar2021, the patient was vaccinated with first dose of BNT162B2. On 25Mar2021, the patient developed sudden severe nosebleed without precedent. The adverse drug reaction (ADR) was reported as fatal. No treatment or medical procedures due to the ADR was reported. Only normal confirmation of death was performed. No findings reported. There is no information regarding test results. For the causality, the physician states that there is a correlation of time. The physician believes that the patient''s death was due to the severe nosebleed bleed out and that the nosebleed could be difficult to stop due to the concurrent thrombosis prophylaxis. The physician had been in contact with the patient by phone and the patient seemed in good spirit. The physician had also been in contact with a relative (also a physician) to the patient which described no cuts or any other signs that could explain the nosebleed. They further described that there was blood everywhere in the apartment. The police were contacted, but reject inquest, because they said it was an expected death. The patient is now buried. The reported cause of death was nosebleed. The patient died on 31Mar2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden severe nosebleed without precedent


VAERS ID: 1296898 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-04
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEBILET; AMARYL [GLIMEPIRIDE]; MICARDISPLUS; TRAJENTA; JARDIANCE
Current Illness: Dysplasia of cervix (uteri); Hypertension; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Superficial femoral vein thrombosis
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: platelet count; Result Unstructured Data: Test Result:213 x10 9/l
CDC Split Type: EEPFIZER INC2021478284

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable physician. This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB with regulatory authority number:EE-SAM-34672104194. A 74-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 24Mar2021 (Batch/Lot Number: ER9470) as 0.3 mL, single for covid-19 immunization. Medical history included superficial femoral vein thrombosis, ongoing type II diabetes mellitus, hypertension and dysplasia of cervix (uteri). The patient does not have thrombocytopenia. Concomitant medications included nebivolol hydrochloride (NEBILET); glimepiride (AMARYL); hydrochlorothiazide, telmisartan (MICARDISPLUS); linagliptin (TRAJENTA) and empagliflozin (JARDIANCE) all taken for an unspecified indication, start and stop date were not reported. On 04Apr2021, the patient had difficulty breathing, with a tendency to worsen. On 18Apr2021, an ambulance was called. The patient had severe hypoxaemia and developed clinical death in the presence of an ambulance. The patient was resuscitated for 15 min. Upon arrival at the emergency department, the condition destabilized within half an hour. The death was recorded on April 18th at 01:25. Massive pulmonary embolism was found at necropsy. In addition, the left leg veins thrombi - rather old. The patient underwent lab tests and procedures which included platelet count: 213 x10 9/l on 18Apr2021. The patient died on 18Apr2021 due to pulmonary embolism. An autopsy was performed, and results were not available. Sender Comment: Serious, unlisted side effect, the temporal relationship exists. The causal link is considered doubtful. Reporter comment: it is difficult to say about the causal link. Certainly, other factors may have been the cause of pulmonary embolism. However, the patient was first diagnosed with deep vein thrombosis in 2008, but massive pulmonary embolism did not develop until 2021, 2 weeks after the first vaccine dose. No follow-up attempts are possible. No further information is expected. Lot/Batch provided.; Reporter''s Comments: It is difficult to say about the causal link. Certainly, other factors may have been the cause of pulmonary embolism. However, the patient was first diagnosed with deep vein thrombosis in 2008, but massive pulmonary embolism did not develop until 2021, 2 weeks after the first vaccine dose.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1296899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-02
   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 EP2163 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Auscultation, Bacteriuria, Blood bicarbonate, Blood creatine phosphokinase, Blood creatinine, Blood urea, C-reactive protein, Capillary fragility, Chest X-ray, Coagulation test, Confusional state, Constipation, Decreased appetite, Disorientation, Dyspnoea, Electrocardiogram, Faecal vomiting, Fatigue, Gait disturbance, General physical health deterioration, Haemoglobin, Hallucination, visual, Heart rate, High density lipoprotein, Ileus paralytic, Ischaemia, Lung infiltration, Oxygen saturation, Oxygen saturation decreased, PCO2, PO2, Pneumonia aspiration, Psychomotor hyperactivity, Rhonchi, SARS-CoV-2 test, Skin lesion, Slow response to stimuli, Tachypnoea, Urinary incontinence, Urine analysis, Vomiting, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Parkinson-like events (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Psychosis and psychotic 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), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 14
Permanent Disability? Yes
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: Cataracts; Hearing aid user; Hearing loss; Hypercholesteremia; Hypertension arterial; Hypothyroidism; Ischaemic heart disease; Lacunar infarction; Type II diabetes mellitus; Visual acuity reduced
Allergies:
Diagnostic Lab Data: Test Name: Auscultation; Result Unstructured Data: Test Result:rhythmic; Comments: rhythmic with HR(Heart rate) around 115; Test Name: bicarbonate; Result Unstructured Data: Test Result:20.6; Test Name: CK; Result Unstructured Data: Test Result:916; Test Name: creatinine; Result Unstructured Data: Test Result:1.38; Test Name: urea; Result Unstructured Data: Test Result:105; Test Name: Thorax X-ray/AP; Result Unstructured Data: Test Result:scattered rhonchi in both pulmonary cambers; Test Date: 20210316; Test Name: Thorax X-ray/AP; Result Unstructured Data: Test Result:doubtful infiltrate in the left hemithorax; Test Name: Coagulation; Result Unstructured Data: Test Result:Normal; Test Name: CRP; Result Unstructured Data: Test Result:42.8; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: Hemoglobin; Result Unstructured Data: Test Result:12.2 gr; Test Name: heart rate; Result Unstructured Data: Test Result:around 115; Test Name: HDL; Result Unstructured Data: Test Result:370; Test Name: Oxygen saturation; Test Result: 75 %; Test Name: pCO2; Result Unstructured Data: Test Result:32.2; Test Name: pH; Result Unstructured Data: Test Result:7.39; Test Name: pO2; Result Unstructured Data: Test Result:55.5; Test Date: 20210416; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Negative; Test Name: basic urine: sediment; Result Unstructured Data: Test Result:bacteriuria; Test Name: leucocytes; Result Unstructured Data: Test Result:25
CDC Split Type: ESPFIZER INC2021491313

Write-up: Oxygen saturation 75%; Paralytic ileus; Probable left pneumonia due to aspiration; Tachypneic and with fecaloid vomiting; Bacteriuria; Tachypneic and with fecaloid vomiting; Chest X-ray: doubtful infiltrate in the left hemithorax; Acute confusional syndrome; Hallucination, visual; Disorientation; Psychomotor agitation; Hyporexia; Dyspnea; Walking difficulty; Deterioration in general condition; Prostration; Constipation; Vomiting; Dyspnea; No collaboration or response to stimuli; Scattered rhonchi; Generalized abdominal pain; Multiple skin lesions; Capillary fragility; Distal ischemia in MID (cyanosis, absence of foot pulse); Occasional urinary incontinence; This is a spontaneous report from a contactable pharmacist downloaded from-WEB, regulatory authority number ES-AEMPS-783154. A 93-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EP2163), via an unspecified route of administration, administered in arm on 02Mar2021 as single dose for covid-19 immunization. Medical history included Hypertension arterial, Ischaemic heart disease, Hypercholesteremia, lacunar infarction from 2014 to an unknown date, Type II diabetes mellitus, hypothyroidism, hearing loss with prosthesis, and decreased visual acuity due to non-operated cataracts from an unknown date. Concomitant medications were not reported. The patient previously took linagliptin, metformin hydrochloride, atorvastatin, bisoprolol, amlodipine, furosemide (SEGURIL), lorazepam, acetylsalicylic acid, and rabeprazole sodium (PARIET). On 02Mar2021, the patient experienced hallucination, visual, disorientation, psychomotor agitation, hyporexia, dyspnea, and walking difficulty. The patient was admitted from the emergency room, according to an emergency report, due to deterioration in general condition with prostration, disorientation and psychomotor agitation that has not improved in recent days. It was associated with a tendency to constipation with vomiting and subsequent dyspnea progressively. Vomiting was reported three times. The caregiver reported that she has not observed fever or respiratory distress. Upon arrival at the ward, the patient with a very poor general condition presents agitation, with no collaboration or response to stimuli. Dyspnea with work of breathing, rhythmic AC (Arrhythmogenic cardiomyopathy), difficult to assess murmurs due to respiratory sounds, AP MVC with scattered rhonchi. Soft abdomen, with data of generalized abdominal pain, the caregiver did not palpate masses or visceromegaly, very diminished noises. Auscultation of abdominal murmur, lower extremities without edema, multiple skin lesions secondary to capillary fragility, with data of distal ischemia in MID (cyanosis, absence of foot pulse). Geriatric Assessment included Functional: Dependent for ABVD (Adriamycin Bleomycin Vinblastine Dacarbazine), eats alone, independent for the toilet, autonomous ambulation at home, climbs stairs. occasional urinary incontinence, hearing loss with prosthesis and decreased visual acuity due to non-operated cataracts. Nutritional: edentulous with prosthesis but with chewing problems, no dysphagia, bland diet, no weight loss. Mental: No cognitive impairment. Social: she lives at home with her husband, two caregivers and two children; with good family support. Hemogram: Hb (Hemoglobin) 12.2 gr, Coagulation: normal; Gasometry: pH 7.39, pCO2 32.2, pO2 55.5, bicarbonate 20.6; Biochemistry: urea 105, creatinine 1.38, HDL (high-density lipoproteins) 370, CK (Creatine kinase) 916, CRP (C-Reactive protein) 42.8. COVID-19 PCR: negative. Basic urine: leucocytes 25, and basic urine: sediment: bacteriuria. Chest X-ray: doubtful infiltrate in the left hemithorax. ECG (electrocardiogram): unknown results, Acute confusional syndrome, and probable left pneumonia due to aspiration. Bad general condition. Tachypneic and with fecaloid vomiting. Oxygen saturation 75%. Lightness in both legs and arms at the distal level. The events hallucination, visual; disorientation, psychomotor agitation, hyporexia, dyspnea, and walking difficulty were assessed to have caused disability and death on 17Mar2021 to the patient. The outcome of other events was unknown. The patient died on 17Mar2021. 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: Hyporexia; Psychomotor agitation; Dyspnea; Disorientation; Walking difficulty; Hallucination, visual


VAERS ID: 1296902 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-17
   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 EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Anamnestic reaction, Cardiac index, Chest pain, Death, Electrocardiogram, Loss of consciousness, Neurological examination, Pain in extremity, Paraesthesia, Physical examination
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: CAPENON HCT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colon cancer (Patient treated in 2017 for colon cancer, of which he operated and treated until its total referral.); Hypertension
Allergies:
Diagnostic Lab Data: Test Name: Cardiac auscultation; Test Result: Negative ; Comments: 0 .QSOFA scale result: Negative; Test Date: 20210420; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:10:09:00; Asystole rhythm.; Test Name: Neurological evaluation:; Result Unstructured Data: Test Result:non-reactive right pupil; non-reactive left pupil.; Test Name: Primary Assessment: Airway; Result Unstructured Data: Test Result:Non-permeable; Test Name: Primary Assessment: Ventilation; Result Unstructured Data: Test Result:Apnea
CDC Split Type: ESPFIZER INC2021491302

Write-up: found deceased that morning upon awakening; found unconscious without response to stimuli; Anamnesis; Acute myocardial infarction; Chest pain; tingling in left arm; Pain in left arm; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-841106.A 76-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW4815, via intramuscular route, in left arm on 15Apr2021 as single dose for COVID-19 immunisation. The patient medical history included that the patient was treated in 2017 for colon cancer, of which he was operated and treated until its total referral and hypertension (hypertension arterial). No allergies were reported. The patient concomitant medications included CAPENON HCT 40 MG / 5 MG / 12.5 MG 1 tablet daily. The patient had experienced pain in left arm and tingling in left arm on Saturday afternoon, 17Apr2021, the symptoms did not cease until early morning of Monday 19 to Tuesday 20, when he suffered and acute myocardial infarction that caused his death on 20Apr2021. The patient Found unconscious without response to stimuli after not seeing him since last night when he went to bed with mild chest pain on 18Apr2021 lasting 2 days. The patient also experienced anamnesis and reason for consultation was unconscious. In primary assessment: Airway: Non-permeable. Ventilation: Apnea. Circulation: Capillary filling 2 sec; pulse without pulse. Neurological evaluation: non-reactive right pupil; non-reactive left pupil. Level of Consciousness. Secondary Assessment: Cardiocirculatory System: Cardiac auscultation: 0. QSOFA scale result: Negative. Comments on evaluation: Absence of vital signs. Lightness in the left lateral area, lying on that side. Electrocardiogram number 1: Time: 20Apr2021 10:09:00; Asystole rhythm. A 76-year-old patient was found deceased that morning upon awakening. Death is possible AMI (acute myocardial infarction) due to the clinic. Covid 19 vaccination 1 week ago to be evaluated by Regulatory Authority. It is unknown if autopsy was done. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected. Information about batch number already obtained.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1296903 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   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 EW2243 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Malaise, Myalgia, Persistent depressive disorder, Polymerase chain reaction, Sudden death, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: Dyslipidaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Nasopharyngeal smear PCR; Result Unstructured Data: Test Result:negative
CDC Split Type: ESPFIZER INC2021483974

Write-up: Death sudden; dysthermic sensation; woke up with discomfort, went to the bathroom, and when she returned she fainted; woke up with discomfort, went to the bathroom, and when she returned she fainted; Myalgia; Malaise; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-842111. An 80-year-old female patient received BNT162B2 (COMIRNATY solution for injection), intramuscular on 08Apr2021 (Batch/Lot Number: EW2243) as 0.3 mL, single for covid-19 immunisation . Medical history included dyslipidaemia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced myalgia and malaise on 09Apr2021 and death sudden on 10Apr2021. Furthermore, as reported, on 09Apr2021, she presented myalgia and dysthermic sensation (no fever). In a follow-up call made on 12Apr2021, the husband reports that she died at home on 10Apr2021. They say that she woke up with discomfort, went to the bathroom, and when she returned she fainted. Upon the arrival of the emergency, she had already died. The patient underwent lab test included nasopharyngeal smear PCR: negative on 11Apr2021. The patient died on 10Apr2021. It was not reported if an autopsy was performed. Outcome of the event "dysthermic sensation" and "woke up with discomfort, went to the bathroom, and when she returned she fainted" were unknown while others were fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death; malaise; myalgia


VAERS ID: 1296906 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-23
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL RATIO; OMNIC OCAS; LISINOPRIL RATIOPHARM [LISINOPRIL]; PREDNISONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ESPFIZER INC2021491310

Write-up: Medication lack of drug effect/COVID-19 confirmed by positive COVID-19 test; COVID-19/COVID-19 confirmed by positive COVID-19 test; This is as spontaneous report received from a contactable pharmacist downloaded from a regulatory authority-WEB. The regulatory authority report number is ES-AEMPS-843980. An 86-year-old male patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, on 12Mar2021, (lot number: ET1831); and the first dose via an unspecified route of administration, on 19Feb2021 (lot number: EM6950), both as single dose, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (PARACETAMOL RATIO Tablet 1 g); tamsulosin hydrochloride (OMNIC OCAS Prolonged-release tablet 0.4 mg); lisinopril (LISINOPRIL RATIOPHARM Tablet 20 mg); and prednisone tablet 5 mg, all taken for unspecified indications, therapy dates not reported. On 19Feb2021, the patient received the first dose of COMIRNATY. On 12Mar2021, the patient received the second dose of COMIRNATY. On 23Mar2021, the patient tested positive for COVID-19 via COVID-19 PCR test. It was reported that medication lack of drug effect occurred. The events resulted to hospitalization on an unspecified date. The patient died on an unspecified date. Cause of death was reported to be COVID-19. The outcome of the events was fatal. It was unknown if autopsy was performed. The health authority assessed the events as serious (death, hospitalization). No follow-up attempts are possible. No further information expected. Information about batch number already obtained.; Reported Cause(s) of Death: COVID-19/COVID-19 confirmed by positive COVID-19 test; Medication lack of drug effect/COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1296908 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-21
   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 EW2104 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021491358

Write-up: Unknown cause of death; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority report number is ES-AEMPS-845165. A 90-year-old patient male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EW2104 and expiry date was not provided), via intramuscular injection, on 21Apr2021 (at the age of 90-years-old) as a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had previously received first dose of vaccine on 30Mar2021.As reported patient was independent for ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine). On 21Apr2021, patient died of an unknown cause (sudden death and no signs of violent death were reported). Due to the patient''s age, no autopsy was requested. No follow-up attempts are possible. No further information is expected. Information about batch number already obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1296913 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   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 EW2239 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Fatigue, General physical health deterioration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRONOLACTONE ORION; PARA-TABS; PREDNISOLON [PREDNISOLONE]; CANESTEN; OXANEST; KALISOL; CIPRALEX [ESCITALOPRAM OXALATE]; MELATONIN; PEGORION; VENTOLINE [SALBUTAMOL SULFATE]; OPAMOX; ROSUVASTATIN ACTAVIS; FURESIS; FUROSEMID HAMELN; NITROSID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary heart disease; Heart failure; Paroxysmal atrial fibrillation; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021496497

Write-up: Death; General physical health deterioration; Pyrexia; Asthenia; Fatigue; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13Apr2021 (Batch/Lot Number: EW2239) as single dose at the age of 82-year-old for COVID-19 immunisation. Medical history included coronary artery disease, atrial fibrillation, cardiac failure, vascular dementia. Concomitant medication(s) included spironolactone (SPIRONOLACTONE ORION) taken for cardiac failure; paracetamol (PARA-TABS) taken for an unspecified indication; prednisolon [prednisolone] (manufacturer unknown) taken for asthma; clotrimazole (CANESTEN) taken for an unspecified indication; oxycodone hydrochloride (OXANEST) taken for an unspecified indication; potassium chloride (KALISOL) taken for an unspecified indication; escitalopram oxalate (CIPRALEX [ESCITALOPRAM OXALATE]) taken for an unspecified indication; melatonin (manufacturer unknown) taken for an unspecified indication; macrogol 4000 (PEGORION) taken for an unspecified indication; salbutamol sulfate (VENTOLINE [SALBUTAMOL SULFATE]) taken for asthma; oxazepam (OPAMOX) taken for an unspecified indication; rosuvastatin calcium (ROSUVASTATIN ACTAVIS) taken for an unspecified indication; furosemide (FURESIS) taken for cardiac failure; furosemide sodium (FUROSEMID HAMELN) taken for an unspecified indication; isosorbide dinitrate (NITROSID) taken for an unspecified indication; isosorbide dinitrate (DINIT [ISOSORBIDE DINITRATE]) taken for an unspecified indication; levothyroxine sodium (THYROXIN) taken for an unspecified indication; apixaban (ELIQUIS) taken for arrhythmia prophylaxis; amoxicillin trihydrate (AMORION) taken for prophylaxis; carbomer (OFTAGEL) taken for an unspecified indication. For all concomitant medications start and stop date were not reported. The patient received the 1st dose of bnt162b2 (COMIRNATY) on an unknow date for COVID-19 immunisation. The patient experienced general physical health deterioration, pyrexia, asthenia and fatigue on 14Apr2021. Therapeutic measures were taken as a result of pyrexia, asthenia, fatigue with symptomatic treatment. The patient died on 21Apr2021. The events were described as: 27Apr2021 initial nurse: Fatigue, fever, asthenia, symptomatic treatment. Resident powerless, fever, decreased functional capacity and fatigue. In the end death. The events were considered fatal. 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: General physical health deterioration; Pyrexia; Asthenia; Fatigue


VAERS ID: 1296916 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-07-01
Onset:2021-04-12
   Days after vaccination:285
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood pressure measurement, Coma scale, Computerised tomogram head, Glycosylated haemoglobin, Haemorrhagic transformation stroke, Hypertension, Investigation, Ischaemic stroke, PO2, Ultrasound Doppler
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: RESITUNE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Bipolar disorder; Carotid endarterectomy
Allergies:
Diagnostic Lab Data: Test Name: CT angiography of Supra-Aortic-Trunk; Result Unstructured Data: Test Result:multiple left carotid cortical sequelae of semi-re; Comments: multiple left carotid cortical sequelae of semi-recent appearance with spontaneous hyperdensity enhancing suggestive of laminar necrosis. There was no arterial occlusion; especially left carotid.; Test Date: 20210414; Test Name: CT angiography of Supra-Aortic-Trunk; Result Unstructured Data: Test Result:ulcerated non-stenosing plaque of the left common; Comments: ulcerated non-stenosing plaque of the left common carotid artery probably at the origin of the strokes; Test Date: 20210415; Test Name: Blood pressure; Result Unstructured Data: Test Result:240/120 mmHg; Test Date: 20210415; Test Name: Blood pressure; Result Unstructured Data: Test Result:200/110 mmHg; Test Name: glasgow; Result Unstructured Data: Test Result:15; Test Date: 20210415; Test Name: glasgow; Result Unstructured Data: Test Result:4/15; Test Date: 20210415; Test Name: Cerebral CT scan; Result Unstructured Data: Test Result:Significant haemorrhagic transformation with large; Comments: Significant haemorrhagic transformation with large left parietal frontal intraprenchymal hematoma, associated with tetraventricular flooding, sub-falcic, left internal temporal and diencephalic involvement, dilation of the right lateral ventricle.; Test Name: glycated hemoglobin; Test Result: 5.3 %; Test Name: NIHSS; Result Unstructured Data: Test Result:11; Test Date: 20210414; Test Name: NIHSS; Result Unstructured Data: Test Result:clinical improvement with NIHSS from 16 to 8; Test Date: 20210415; Test Name: PO2 in ambient air; Test Result: 92 %; Test Name: Cervico-cephalic echo-doppler; Result Unstructured Data: Test Result:iso-hypoechoic plaque on the appearance of very lo; Comments: iso-hypoechoic plaque on the appearance of very localized dissection of the left common carotid artery upstream of the endarterectomy area having no significant impact on the hemodynamic plan. Hyperechoic, regular plaque of the right internal carotid, estimated at 30-40%
CDC Split Type: FRPFIZER INC2021483947

Write-up: Haemorrhagic transformation stroke; Arterial hypertension; Ischemic stroke; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-AN20211393. A 68-year-old male patient received BNT162B2 (COMIRNATY), first dose intramuscular, administered in the left arm on 12Apr2021 (batch/lot number: EW9127) as a single dose for COVID-19 immunisation; olanzapine, oral from Jul2020 (batch/lot number: unknown) to an unspecified date, at unspecified dose for bipolar disorder. Medical history included bipolar disorder, carotid endarterectomy and aortic stenosis. Concomitant medication included acetylsalicylic acid (RESITUNE) taken for an unspecified indication, start and stop date were not reported. The patient was at risk of developing a severe form of COVID-19 disease. The patient experienced ischemic stroke on 12Apr2021, haemorrhagic transformation stroke on 15Apr2021 and arterial hypertension on 15Apr2021. The events were assessed as fatal. It was further reported that on 12Apr2021, the patient had called 15 for headache for 48 hours, around 10 p.m., he presented with clonies of the right arm. When SMUR arrived, he was Glasgow 15, he presented a new crisis, treated by Rivotril. Note that this was a 68-year-old patient at D7 with a left endarterectomy with 95% asymptomatic stenosis. Clinical examination on arrival in the emergency room: No sign of struggle or bankruptcy, no cough, no dyspnea, no expectoration, no chest pain, no congestive sign, no headache, fall of the barred on the right, fall of the Mingazzini on the right, doubt about dysarthria, intact cranial pairs, no clear cerebellar or vestibular syndrome. NIHH at 11. Additional tests: Scope: sinus rhythm and regular. Cervico-cephalic echo-doppler: iso-hypoechoic plaque on the appearance of very localized dissection of the left common carotid artery upstream of the endarterectomy area having no significant impact on the hemodynamic plan. Hyperechoic, regular plaque of the right internal carotid, estimated at 30-40%. Biology: 5.3% glycated hemoglobin. Cerebral CT scan of 15Apr2021: Significant haemorrhagic transformation with large left parietal frontal intraprenchymal hematoma, associated with tetraventricular flooding, sub-falcic, left internal temporal and diencephalic involvement, dilation of the right lateral ventricle. At the time of endarterectomy, CT angiography of ASDs found multiple left carotid cortical sequelae of semi-recent appearance with spontaneous hyperdensity enhancing suggestive of laminar necrosis. There was no arterial occlusion; especially left carotid. Treatment and evolution: The patient presumably presented with partial seizures, sometimes secondarily generalized, symptomatic of a left carotid ischemic stroke. He received a bolus of 1 g of levetiracetam then was relayed by levetiracetam 500 mg morning and evening. A bi-antiplatelet aggregation (Kardegic and Plavix) was started on 14Apr2021. On 14Apr2021, clinical improvement with NIHSS from 16 to 8 on clear improvement in phasic disorders and right hemiparesis. At the etiological level, the hypothesis of a thromboembolic origin in ulcerated plaque was favored. Doppler ultrasound of the supra-aortic trunks found an ulcerated non-stenosing plaque of the left common carotid artery probably at the origin of the strokes. Scoped monitoring did not find any embologenic rhythm disorder. In terms of cardiovascular risk factors, introduction of perindopril 2 mg with a blood pressure target of less than 140/90 mmHg, introduction of atorvastatin 40 mg with an LDL target of less than 0.7 g / l. On 15Apr2021, at 2 p.m., the patient was put back to bed by the caregiver and was seen well. At 2:10 p.m., the IDE was called in by a 240/120 mmHg hypertension: she then found the patient inanimate in the room. Clinical examination found arterial hypertension at 200/110 mmHg, 92% spO2 in ambient air with stertorous breathing without indrawing. The Glasgow score is 4/15 (Y1V1M2), the pupils were in areactive mydriasis. He was then transferred to intensive care: he was intubated in rapid sequence (propofol, esmeron), Cormack 1 with maintenance by propofol. On 16Apr2021, faced with a contraindication to multi-organ harvesting, the procedure was stopped and the patient was extubated. Conclusion: Patient who presented an ischemic stroke (secondarily with hemorrhagic transformation with hypertensive surge leading to a sudden coma then death) a few hours after a first dose of BNT162B2 vaccine. Summary: Patient who presented an ischemic stroke (secondarily with hemorrhagic transformation with hypertensive surge leading to a sudden coma then death) a few hours after a first dose of COMIRNATY vaccine. The action taken in response to the events for olanzapine was dose not changed. The patient died on 16Apr2021. An autopsy was not performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Ischemic stroke; Haemorrhagic transformation stroke; Arterial hypertension


VAERS ID: 1296917 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-15
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREVISCAN [FLUINDIONE]
Current Illness: Auricular fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: PCR test for COVID-19; Test Result: Positive
CDC Split Type: FRPFIZER INC2021491349

Write-up: received both doses of bnt162b2 and on 15Mar2021, the patient ''s PCR test for COVID-19 was positive reported as vaccination failure; received both doses of bnt162b2 and on 15Mar2021, the patient ''s PCR test for COVID-19 was positive reported as vaccination failure; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number FR-AFSSAPS-BS20210631. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 20Jan2021 (lot number: EJ6788) as SINGLE DOSE and dose 2 intramuscular on 10Feb2021 (lot number: EJ6788) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing auricular fibrillation. Concomitant medication included fluindione (PREVISCAN [FLUINDIONE]). The patient received both doses of bnt162b2 and on 15Mar2021, the patient ''s PCR test for COVID-19 was positive reported as vaccination failure. The patient was hospitalized for the events from 15Mar2021 to an unknown date. The patient died on 30Mar2021 due to the events. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: received both doses of bnt162b2 and on 15Mar2021, the patient ''s PCR test for COVID-19 was positive reported as vaccination failure; received both doses of bnt162b2 and on 15Mar2021, the patient ''s PCR test for COVID-19 was positive reported as vacci


VAERS ID: 1296918 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-12
   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 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: Polymyalgia rheumatica
Allergies:
Diagnostic Lab Data: Test Name: biological work-up; Result Unstructured Data: Test Result:Result not provided
CDC Split Type: FRPFIZER INC2021491303

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-BX20213357. An 82-year-old female patient received the second dose of BNT162b2 (COMIRNATY, solution for injection; Lot number and expiration date unknown) via intramuscular route on 12Apr2021 as 1 DF at a single dose for COVID-19 immunisation. The patient''s medical history included polymyalgia rheumatica. The patient''s concomitant medications were not reported. On an unknown date, the patient received first dose of BNT162B2 for COVID-19 immunisation and reaction to first dose was not informed. The patient did not have COVID-19 and not tested. Before the realization of the 2nd vaccine injection, context of back pain and feeling of discomfort evolving for 72 hours, unusual, having motivated the realization of a biological work-up and consultation planned with the general physician finally during the day. The entourage had encouraged the patient to report it to the vaccinating doctor, but it was not sure that she did so, the patient wishing to be vaccinated. On 12Apr2021, 06 hours after the 2nd injection of vaccination, the patient experienced cardio-respiratory arrest, urgent medical intervention, result of the biological work-up not recovered at the time of treatment, progression to death. Medico-legal obstacle posed. Lab test included biological work-up Result not provided. The outcome of the event was fatal. ; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1296924 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   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 EX0893 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death, Heart rate, Oxygen saturation
SMQs:

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: FLUINDIONE; FUROSEMIDE; PERINDOPRIL; ATORVASTATINE [ATORVASTATIN CALCIUM]; GLICLAZIDE; OXAZEPAM; FINASTERIDE; MACROGOL; POTASSIUM CHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (No PCR test); Heart disorder (under anticoagulant drugs); Heart failure; Idiopathic pulmonary fibrosis; Insulin dependent diabetic; Malnutrition
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: blood pressure; Result Unstructured Data: Test Result:111/82 mmHg; Test Date: 20210422; Test Name: blood pressure; Result Unstructured Data: Test Result:98/61 mmHg; Test Date: 20210401; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Date: 20210422; Test Name: Pulse rate; Result Unstructured Data: Test Result:70 BPM; Test Date: 20210401; Test Name: Oxygen Saturation; Result Unstructured Data: Test Result:94; Test Date: 20210422; Test Name: Oxygen Saturation; Result Unstructured Data: Test Result:84
CDC Split Type: FRPFIZER INC2021491347

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-CN20211345. A 90-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration first dose on 01Apr2021 (Lot Number: ET7205) and intramuscular, administered on the left arm second dose on 22Apr2021 (Lot Number: EX0893) at a single dose for COVID-19 immunisation. Medical history included idiopathic pulmonary fibrosis, valvular and rhythmic cardiopathy (under anticoagulant drugs), heart failure, insulino-dependent diabetes, moderate undernutrition and COVID-19 (No PCR test). Concomitant medications included fluindione; furosemide; perindopril; atorvastatin calcium (ATORVASTATINE [ATORVASTATIN CALCIUM]); gliclazide; oxazepam; finasteride; macrogol and potassium chloride. The patient living in establishment for old persons had presented asthenia for 3 weeks before his death, and respiratory discomfort identical to the usual. Following Dose 1 on 01Apr2021: normal constants with tension at 111/82 mmHg, saturation at 94% and temperature at 36.3?C, no immediate adverse effects. Then he received the 2nd injection on 22Apr2021; lot EX0893. Following Dose 2: constant normal with blood pressure at 98/61 mmHg, pulse at 70 bpm and saturation at 84%, no immediate adverse effects. The patient experienced unknown cause of death on 23Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1296925 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-03-25
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Bilirubin conjugated, Blood alkaline phosphatase, Blood bilirubin, Blood immunoglobulin G, Coagulation factor V level, Gamma-glutamyltransferase, Hepatitis C antibody, Hepatitis acute, Liver function test, Prothrombin level
SMQs:, Hepatitis, non-infectious (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACTONEL; PARIET; DESLORATADINE; FOLIC ACID; CHOLURSO; ALPRAZOLAM; UVEDOSE; DAFALGAN; FLECTOR [DICLOFENAC SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (untreated); Autoimmune hepatitis (treated with budesonide (MIKICORT) and azathioprine (IMUREL) (considered recovered in July 2016)); Bladder cancer (treated with BCG therapy with a recurrence 6 month later); Hypercholesterolaemia (untreated, (simvastatin (ZOCOR) withdrawn because it was probably the cause of AIH in 2015))
Allergies:
Diagnostic Lab Data: Test Date: 20210404; Test Name: SGPT; Result Unstructured Data: Test Result:668; Test Date: 20210406; Test Name: SGPT; Result Unstructured Data: Test Result:733; Test Date: 20210413; Test Name: SGPT; Result Unstructured Data: Test Result:367; Test Date: 20210404; Test Name: SGOT; Result Unstructured Data: Test Result:1719; Test Date: 20210406; Test Name: SGOT; Result Unstructured Data: Test Result:1762; Test Date: 20210413; Test Name: SGOT; Result Unstructured Data: Test Result:401; Test Date: 20210404; Test Name: Direct bilirubin; Result Unstructured Data: Test Result:82; Test Date: 20210406; Test Name: Direct bilirubin; Result Unstructured Data: Test Result:98; Test Date: 20210413; Test Name: Direct bilirubin; Result Unstructured Data: Test Result:171; Test Date: 20210404; Test Name: Phosphatase alkaline; Result Unstructured Data: Test Result:215; Test Date: 20210406; Test Name: Phosphatase alkaline; Result Unstructured Data: Test Result:179; Test Date: 20210413; Test Name: Phosphatase alkaline; Result Unstructured Data: Test Result:218; Test Date: 20210404; Test Name: Total bilirubin; Result Unstructured Data: Test Result:114; Test Date: 20210406; Test Name: Total bilirubin; Result Unstructured Data: Test Result:131; Test Date: 20210413; Test Name: Total bilirubin; Result Unstructured Data: Test Result:240; Test Date: 20210404; Test Name: Immunoglobulin G; Result Unstructured Data: Test Result:increased; Test Date: 20210413; Test Name: Factor V; Result Unstructured Data: Test Result:39; Test Date: 20210404; Test Name: GGT; Result Unstructured Data: Test Result:224; Test Date: 20210406; Test Name: GGT; Result Unstructured Data: Test Result:211; Test Date: 20210413; Test Name: GGT; Result Unstructured Data: Test Result:266; Test Date: 20210212; Test Name: GGT; Result Unstructured Data: Test Result:11 IU/l; Test Date: 20210404; Test Name: Hepatitis C serology; Result Unstructured Data: Test Result:negative; Test Date: 20210404; Test Name: Liver function test; Result Unstructured Data: Test Result:abnormal; Test Date: 20210404; Test Name: Prothrombin; Result Unstructured Data: Test Result:34; Test Date: 20210413; Test Name: Prothrombin; Result Unstructured Data: Test Result:30
CDC Split Type: FRPFIZER INC2021483937

Write-up: Hepatitis acute; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LL20212165. A 75-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), first dose on 22Jan2021, then second dose on 19Feb2021, both intramuscular as a single dose for COVID-19 immunisation. Medical history included arrhythmia (untreated) and hypercholesterolaemia [untreated, (simvastatin (ZOCOR) withdrawn because it was probably the cause of AIH in 2015)] from an unknown date and unknown if ongoing, autoimmune hepatitis from 2015 to Jul2016 [treated with budesonide (MIKICORT) and azathioprine (IMUREL) (considered recovered in July 2016)], bladder cancer (treated with BCG therapy with a recurrence 6 month later) from 2004 to an unknown date. Concomitant medications included risedronate sodium (ACTONEL), desloratadine, folic acid and alprazolam from an unspecified start date and ongoing; rabeprazole sodium (PARIET) and colecalciferol (UVEDOSE), start and stop dates not reported; ursodeoxycholic acid (CHOLURSO) from 2015 to an unspecified stop date; paracetamol (DAFALGAN) and diclofenac sodium (FLECTOR) from 26Jan2021 to an unspecified stop date. The patient previously took mikicort for autoimmune hepatitis, imurel [azathioprine sodium] for autoimmune hepatitis and zocor for hypercholesterolaemia. The patient experienced hepatitis acute on 25Mar2021. The patient was hospitalized for hepatitis acute from 04Apr2021 to an unknown date. Clinical course was as follows: A few days after the second injection, the patient presented with asthenia. On 25Mar2021, the patient experienced lack of appetite, somnolence followed by progressive general deterioration. On 04Apr2021, the patient was admitted to hospital for general deterioration with anorexia, nausea and postprandial vomiting, asthenia and jaundice. Severe acute hepatitis was diagnosed. Laboratory tests showed an abnormal liver function tests, negative hepatitis C serology, immunoglobulins G increased. On 14Apr2021, auto-immune test screen for anti-nuclear antibodies EDIT was received. Paracetamol intoxication was excluded (Acetylcysteine (HIDONAC) protocol started upon admission as a precaution, the patient had a very exceptional PARACETAMOL intake, maximum 1 g a day). The patient had no alcohol consumption. A viral infection other than hepatitis C was suspected but no viral syndrome nor fever was recently observed. Immunosuppression was unlikely. Patient management and evolution while hospitalization included methylprednisolone (unspecified trade name) 120 mg, daily, 1 mg/kg/d started on 08Apr2021 and was increased to 200 mg, daily on 13Apr2021 and still ongoing. On 12Feb2021, Gamma GT was at 11 IU/L. On 04Apr2021, prothrombin was at 34 (unspecified unit), total bilirubin was at 114 (unspecified unit), direct bilirubinemia was at 82 (unspecified unit), aspartate transaminase was at 1719 (unspecified unit), alanine transaminase was at 668 (unspecified unit), Gamma GT was at 224 (unspecified unit) and alkaline phosphatase was at 215 (unspecified unit). On 06Apr2021, total bilirubin was at 131 (unspecified unit), direct bilirubinemia was at 98 (unspecified unit), aspartate transaminase was at 1762 (unspecified unit), alanine transaminase was at 733 (unspecified unit), Gamma GT was at 211 (unspecified unit) and alkaline phosphatase was at 179 (unspecified unit). On 13Apr2021, prothrombin was at 30 (unspecified unit), total bilirubin was at 240, direct bilirubinemia was at 171 (unspecified unit), aspartate transaminase was at 401 (unspecified unit), alanine transaminase was at 367 (unspecified unit), Gamma GT was at 266 (unspecified unit), alkaline phosphatase was at 218 (unspecified unit) and factor V was at 39 (unspecified unit). The patient died in the night of 20Apr2021. A hypothesis of AIH recurrence was assumed. Therapeutic measures were taken as a result of hepatitis acute. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute hepatitis


VAERS ID: 1296927 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-05
   Days after vaccination:15
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, Confusional state, Fall, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypoglycaemia (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: COVID-19 RT-PCR; Result Unstructured Data: Test Result:COVID-19 infection; Comments: vaccinal inefficiency, no information on the variant
CDC Split Type: FRPFIZER INC2021491307

Write-up: fall; confusion; Drug ineffective/COVID-19 infection, vaccinal inefficiency; Drug ineffective/COVID-19 infection, vaccinal inefficiency; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LL20212239. Additional case identifier: FR-AFSSAPS-2021042720. A 95-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 28Jan2021 (Batch/Lot Number: Unknown) as single dose and dose 2 intramuscular on 18Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced drug ineffective on 05Mar2021. Appearance of fall and confusion requiring hospitalization. On 05Mar2021, COVID-19 RT-PCR test was performed and disclosed COVID-19 infection, vaccinal inefficiency, no information on the variant. The events caused hospitalization. The patient was deceased. The outcome of the events fall and confusion was unknown. The patient died on an unspecified date due to vaccination failure and covid-19. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Drug ineffective/COVID-19 infection, vaccinal inefficiency; Drug ineffective/COVID-19 infection, vaccinal inefficiency


VAERS ID: 1296928 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-08
   Days after vaccination:18
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: Asthenia, COVID-19, Polymerase chain reaction, Pyrexia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210308; Test Name: PCR test for covid 19; Result Unstructured Data: Test Result:positive (variant not specified)
CDC Split Type: FRPFIZER INC2021491299

Write-up: Asthenia; Pyrexia; Vaccination failure; PCR Test was positive for COVID-19 disease; This is a spontaneous report from a contactable other HCP reporting for a patient downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number FR-AFSSAPS-LL20212240. A 97-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 28Jan2021 (Batch/Lot Number: Unknown) as single; and dose 2 intramuscular on 18Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. The patient experienced asthenia and pyrexia on an unspecified date; and vaccination failure on 08Mar2021. Disease history was reported as follows: Occurrence of cough, asthenia, fever, congestion. On 08Mar2021 PCR Test was positive for COVID-19 disease (variant not specified). The patient died due to the events on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot number cannot be obtained.; Reported Cause(s) of Death: asthenia; pyrexia; vaccination failure; PCR Test was positive for COVID-19 disease


VAERS ID: 1296930 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-24
   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 EW4815 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Heart failure
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021491288

Write-up: unexplained death; nausea; Vomiting; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-LY20213543. A 96-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Apr2021 (Lot Number: EW4815) as single dose for covid-19 immunisation. The patient previously received bnt162b2 (COMIRNATY), dose 1 intramuscular on 23Mar2021 for covid-19 immunisation. Medical history included ongoing diabetes mellitus, covid-19 from Oct2020 to an unknown date, and ongoing heart failure. The patient''s concomitant medications were not reported. On 24Apr2021, the patient experienced vomiting around 03:00 PM for 3 hours, no fever. On 25Apr2021, vomiting at the end of the day and on 26Apr2021, some nausea. The patient experienced unexplained death when dispensing medication on 26Apr2021, around 9AM. Outcome of the event vomiting was recovered, and outcome of the event nausea was unknown. It was not reported if an autopsy was performed. No follow-up attempt are possible. No further information is expected.; Reported Cause(s) of Death: unexplained death


VAERS ID: 1296931 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
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 EW2239 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Atrial fibrillation, Cough, Peripheral ischaemia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; COVID-19 (date of test unknown)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: FRPFIZER INC2021491327

Write-up: AFib; slight ischemia of the right leg/ persistent complete ischemia of the left leg from the knee; intense asthenia; cough; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is FR-AFSSAPS-LY20213545. A 91-year-old female patient received her second dose of BNT162B2 (COMIRNATY, lot number: EW2239), intramuscular on 07Apr2021 at single dose for COVID-19 immunisation. Medical history included cholecystectomy and COVID-19 (date of test was unknown). The patient''s concomitant medications were not reported. The patient experienced atrial fibrillation (AFib) on 13Apr2021. It was also reported that within an unspecified time after vaccination, on Apr2021, cough occurred. On 09Apr2021, 48 hours after vaccination, the patient experienced intense asthenia. On 13Apr2021, the patient experienced complete arrhythmia with atrial fibrillation, with rapid ventricle response, and slight ischemia of the right leg which regressed then occurrence of persistent complete ischemia of the left leg from the knee. The patient died on 17Apr2021. The cause of death was AFib. It was unknown if an autopsy was performed. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: AFib


VAERS ID: 1296943 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness, 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: 2021-04-13
   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: Cataract bilateral NOS; Cataract operation; Diverticulosis (moderate); Hypercholesterolaemia; Lipoma; Polyp removal (20 cm from the anal margin); Retinal detachment; Vitrectomy (right eye for retinal detachment)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021484762

Write-up: Sudden death unexplained; Influenza like illness; This is a spontaneous report from a contactable physician reporting for a patient downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NY20210742 Local Reference #FR-AFSSAPS-2021038105. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 01Apr2021 (Batch/Lot Number: ER9470) as single dose for covid-19 immunisation, age at vaccination unknown. Medical history included retinal detachment from Aug2017, bilateral corticosteroid-nuclear cataract from Jan2013, Diverticulosis (moderate) from May2011, vitrectomy of the right eye for retinal detachment from Aug2017, lipoma from May1979, hypercholesterolaemia from Dec1997, polypectomy (20 cm from the anal margin) from Dec2008, left cataract surgery from an unspecified date. The patient''s concomitant medications were not reported. On 08Apr2021, 7 days after the injection (also reported as 8 days after administration), onset of an influenza-like syndrome with improvement then relapse on 11Apr2021 with headache. On 13Apr2021, 13 Day after the beginning of drug administration, 12 Day after the last drug administration (also reported as 12 days), on the night of 12 to 13Apr2021 the patient developed sudden death unexplained. Conclusion: sudden unexplained death of a 79-year-old patient, occurring 12 days after an injection of the COMIRNATY vaccine (batch ER9470). The patient died on 13Apr2021 (also reported as 10Apr2021). It was not reported if an autopsy was performed. The event influenza-like illness was reported as serious, medically significant.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1296945 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-21
   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 EX0893 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Critical limb ischemia; Obstructive arteriosclerosis of lower extremities
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: LVEF; Test Result: 20 %
CDC Split Type: FRPFIZER INC2021491281

Write-up: Decompensation cardiac; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NY20210838. A 88-year-old female patient received 1st dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EX0893) via intramuscular route of administration in arm right on 20Apr2021 as 1 DF, single for covid-19 immunisation. The patient''s medical history included peripheral arterial occlusive disease (Critical limb ischemia), arterial hypertension and peripheral arterial occlusive disease (obstructive arteriosclerosis of lower extremities). The patient''s concomitant medications were not reported. The patient experienced decompensation cardiac on 21Apr2021. On 21Apr2021, sudden dyspnea and desaturation in connection with global cardiac decompensation predominantly left, left ventricular ejection fraction (LVEF) at 20%. Unfavorable evolution leading to the death of the patient. The patient underwent lab tests and procedures which included ejection fraction: 20 % on 21Apr2021. The patient died on 26Apr2021. It was not reported if an autopsy was performed. Conclusion: Cardiac decompensation leading to the death of an 88-year-old patient, occurring the day after a first injection of the COMIRNATY (batch EX0893). The outcome of event was fatal. No FU attempts possible. No further information expected.; Reported Cause(s) of Death: predominantly left cardiac decompensation


VAERS ID: 1297082 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   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 ET6956 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Myocardial necrosis marker, Toxicologic test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Cardiac enzymes; Result Unstructured Data: Test Result:were not increase; Test Name: Toxicological analysis; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021483980

Write-up: Arrest cardiac; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PO20211924. A 63-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 22Apr2021 (Batch/Lot Number: ET6956) as 0.3mL, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced arrest cardiac leading to death on 23Apr2021. At laboratory analysis, cardiac enzymes did not increase. The patient did not do unusual physical effort before the symptoms. On 26Apr2021, an autopsy was performed and result was as follow: no cause of death found, absence of thrombus, at dissection of injection site no reaction was observed. Toxicological analysis was normal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1297083 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-03-25
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Antibody test, Bronchitis, COVID-19, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis rheumatoid (Treated by tocilizumab (ROACTEMRA) and methotrexate(NOVATREX)); Chronic bronchitis; Depression; Heart failure; Hypertension arterial; Inflammation (Inflammatory syndrome since Jul2019); Lung nodule (2 pulmonary tissue nodules of 10mm)
Allergies:
Diagnostic Lab Data: Test Date: 20210327; Test Name: total antibodies; Test Result: Negative ; Test Date: 20210405; Test Name: OXYGEN SATURATION; Test Result: 78 %; Comments: desaturation; Test Date: 20210405; Test Name: OXYGEN SATURATION; Test Result: 85 %; Comments: Saturation rises 85% in 1 hour; Test Date: 20210325; Test Name: Antigenic test; Test Result: Positive ; Test Date: 20210326; Test Name: PCR test; Test Result: Positive ; Comments: variant not communicated
CDC Split Type: FRPFIZER INC2021491320

Write-up: Acute respiratory decompensation; bronchitis without fever; Vaccination failure/antigentic test positive/PCR test positive; antigentic test positive/PCR test positive; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PO20211949. A 90-year-old male patient received bnt162b2 (COMIRNATY), second dose on 16Feb2021 (Lot Number: EK9788) at 0.3 mL, single dose in the left arm and first dose on 26Jan2021 (Lot Number: EJ6795) as single dose, both intramuscular for COVID-19 immunization. Medical history included chronic bronchitis, depression, rheumatoid arthritis (treated by tocilizumab (ROACTEMRA) and methotrexate(NOVATREX)), lung nodule (2 pulmonary tissue nodules of 10mm), heart failure, and arterial hypertension all from an unknown date. Inflammation (Inflammatory syndrome) from Jul2019. The patient''s concomitant medications were not reported. On 25Mar2021, the patient tested positive for COVID-19 antigenic test and on 26Mar2021, tested positive for COVID-19 PCR test (variant not communicated). On 27Mar2021 had a negative antibody test result. On 02Apr2021, bronchitis without fever was reported and start of treatment with amoxicillin. On 05Apr2021, the patient had acute respiratory decompensation. Oxygen desaturation at 78%. Put under 9L of O2 in high concentration. Saturation raised to 85% in 1 hour. Death of the patient occurred on 05Apr2021 around 6 pm and the cause was considered to be acute respiratory decompensation and vaccination failure due to COVID-19. The outcome of the event bronchitis without fever was unknown while for the acute respiratory decompensation and vaccination failure due to COVID-19 was fatal. The patient died on 05Apr2021. An autopsy was not performed. No follow up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute respiratory decompensation; Vaccination failure/antigentic test positive/PCR test positive; antigentic test positive/PCR test positive


VAERS ID: 1297087 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / OT

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

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: Arterial hypertension; Chronic respiratory failure; Drug intoxication; Insulin-requiring type 2 diabetes mellitus; Knee prosthesis insertion; Morbid obesity; Obesity hypoventilation syndrome; Osteoarthritis; Pneumopathy; Psychosis manic-depressive; Sleep apnea syndrome; Smoker; Systolic heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021483978

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RS20211012. A 68-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 06Apr2021 (Lot Number: ET7205) as a single dose for COVID-19 immunisation. Medical history included Knee prosthesis insertion, Drug intoxication, Morbid obesity, Osteoarthritis, Psychosis manic-depressive, Pneumopathy, Obesity hypoventilation syndrome, Arterial hypertension, Systolic heart failure, Insulin-requiring type 2 diabetes mellitus, Chronic respiratory failure, Sleep apnea syndrome, Smoker. Concomitant medications were not reported. The patient experienced death unexplained on 15Apr2021. The patient died on 15Apr2021. 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 unexplained


VAERS ID: 1297103 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UEW2239 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm ruptured, Arrhythmia, Blood test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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: TAHOR; spironolactone; metformin HCL; COVERAM; KARDEGIC; sitagliptin; ESIDREX
Current Illness: Arterial hypertension; Tabaquism; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Lumbodynia; Ruptured cerebral aneurysm
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: blood test; Result Unstructured Data: Test Result:satisfactory
CDC Split Type: FRPFIZER INC2021491366

Write-up: ruptured aneurysm; paroxysmal rhythm disorder; Sudden death, cause unknown; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-ST20211696. A 61-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in the left arm on 09Apr2021 (batch/lot number: UEW2239) as 0.3 mL, single for COVID-19 immunisation; atorvastatin calcium (TAHOR), oral from an unspecified date (batch/lot number: unknown) to an unspecified date, at 10 mg, 1x/day for cardiovascular risk; spironolactone (manufacturer unknown), oral from an unspecified date (batch/lot number: unknown) to an unspecified date, at 25 mg, daily for an unspecified indication; metformin hcl (manufacturer unknown), oral from an unspecified date (batch/lot number: unknown) to an unspecified date, at 1000 mg, 3x/day for type 2 diabetes mellitus; amlodipine besilate, perindopril arginine (COVERAM), oral from an unspecified date (batch/lot number: unknown) to an unspecified date, at 1 DF, 1x/day for hypertension arterial; acetylsalicylate lysine (KARDEGIC), oral from an unspecified date (batch/lot number: unknown) to an unspecified date, at 75 mg, 1x/day for cardiovascular risk; sitagliptin (manufacturer unknown), oral from an unspecified date (batch/lot number: unknown) to an unspecified date, at 100 mg, 1x/day for type 2 diabetes mellitus; hydrochlorothiazide (ESIDREX), oral from an unspecified date (batch/lot number: unknown) to an unspecified date, at 25 mg, 1x/day for hypertension arterial. Medical history included lumbodynia from an unknown date and unknown if ongoing, ongoing arterial hypertension, ongoing tabaquism, and ongoing type 2 diabetes mellitus. Family history included the patient''s mother died of a ruptured cerebral aneurysm. The patient''s concomitant medications were not reported. The patient experienced sudden death, cause unknown on 20Apr2021. It was further reported that the attending physician reported that the patient had presented hypertension peaks 3 months previously which had required an increase in antihypertensive therapy. Satisfactory blood pressure self-checks, did not show any in the days following vaccination. The patient''s wife reported that a blood test was performed on 06Apr2021 and was satisfactory. Patient found dead in bed by his wife on the morning of 20Apr2021. The doctor of the mobile emergency and intensive cares services said it may be a ruptured aneurysm or a paroxysmal rhythm disorder. He asked the patient if she requested an autopsy, the wife refused. The action taken in response to the events for atorvastatin calcium, spironolactone, metformin hcl, amlodipine besilate, perindopril arginine, acetylsalicylate lysine, sitagliptin and hydrochlorothiazide was unknown. The patient died on 20Apr2021. An autopsy was not performed.; Reported Cause(s) of Death: ruptured aneurysm; paroxysmal rhythm disorder; Sudden death unexplained


VAERS ID: 1297109 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Coma scale, Heart rate, Imaging procedure, Ischaemic stroke, Oxygen saturation, Respiratory rate
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS; SOTALOL
Current Illness: Artificial cardiac pacemaker user; Fibrillation atrial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Blood pressure; Result Unstructured Data: Test Result:93/77 mmHg; Test Date: 20210415; Test Name: Glasgow; Result Unstructured Data: Test Result:14; Test Date: 20210415; Test Name: heart rate; Result Unstructured Data: Test Result:82 bpm; Test Date: 20210415; Test Name: Imaging; Result Unstructured Data: Test Result:left M1 occlusion and ischemia in total left super; Comments: left M1 occlusion and ischemia in total left superficial Sylvian territory, without hemorrhagic change. Severe disturbances in vigilance and swallowing; Test Date: 20210415; Test Name: Oxygen saturation in ambient air; Test Result: 98 %; Test Date: 20210415; Test Name: Respiratory rate; Result Unstructured Data: Test Result:16/mn
CDC Split Type: FRPFIZER INC2021491317

Write-up: Ischemic stroke; This is a spontaneous report downloaded from the Regulatory Authority (RA)-WEB [Regulatory authority number FR-AFSSAPS-TO20212724. A contactable physician reported a 99-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular administered on arm right on 01Apr2021 (Batch/Lot Number: ET3620) as single dose for COVID-19 immunization. Medical history included ongoing atrial fibrillation and cardiac pacemaker user. Concomitant medications included apixaban (ELIQUIS) and sotalol (SOTALOL) both taken for unspecified indications and therapy dates. In the morning of 15Apr2021, the patient was found by her home help on the ground near her bed and making incomprehensible words. She had difficult standing position, mouth deviation and unreactive right hand. In admission on the emergency room, heart rate at 82 bpm, blood pressure at 93/77 mmHg, respiratory rate at 16/min, saturation 98% in ambient air, afebrile and Glasgow 14. Imaging on 15Apr2021 showed left M1 occlusion and ischemia in total left superficial Sylvian territory, without hemorrhagic change. She also had severe disturbances in vigilance and swallowing. It was stated that the patient had ischemic stroke. The patient was on transfer on 15Apr2021 with rapidly unfavorable outcome. On 16Apr2021, right hemiplegia noted complete with Babinsky sign on the right. On 22Apr2021, patient almost stopped and no longer speaking with comfort care only. The patient died on 25Apr2021 in the morning due to the ischemic stroke. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1297134 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypotension, Pneumonia aspiration, Respiratory failure
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021495924

Write-up: hypotension; pneumonia aspiration; respiratory failure; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. The regulatory authority report number is 543225. A 73-year-old male patient received BNT162B2 (COMIRNATY, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 30Mar2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 05Apr2021, the patient experienced hypotension, pneumonia aspiration, and respiratory failure, all with fatal outcome; reported "Medicine (Onset Time in Days): COMIRNATY COVID-19 Vaccine (BNT162b2 (mRNA)) - Suspect (6 days)". The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: hypotension; Pneumonia aspiration; respiratory failure


VAERS ID: 1297135 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
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 - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021495972

Write-up: Adverse event following immunisation/Outcome: Fatal; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 543311. A female patient of unspecified age (100 unit unknown) received BNT162B2 via an unspecified route of administration, in Apr2021, at single dose, for COVID-19 immunisation. The patient experienced Adverse event following immunization on 18Apr2021. Onset Time in 2 Days. The patient died on an unspecified date as an outcome of Adverse event following immunization. The patient died on an unspecified date. It was not reported if an autopsy was performed. Unknown if autopsy done. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation/Outcome: Fatal


VAERS ID: 1297136 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-19
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: Depressed level of consciousness, Disseminated intravascular coagulation, Sepsis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021495973

Write-up: Depressed level of consciousness; Disseminated intravascular coagulation; Sepsis; This is a spontaneous report from a contactable other healthcare professional via the Regulatory Authority. Regulatory authority report number is 543347. An 82-year-old female patient received the first and second dose of BNT162B2 (COMIRNATY lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 19Apr2021 the patient experienced depressed level of consciousness, disseminated intravascular coagulation and sepsis. The patient died on an unspecified date due to the events. 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: Depressed level of consciousness; Disseminated intravascular coagulation; Sepsis


VAERS ID: 1297137 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-01
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Sepsis, Urinary tract infection
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021495974

Write-up: Sepsis; Urinary tract infection; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 543358. A 69-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. On 01Apr2021, the patient experienced sepsis and urinary tract infection. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Sepsis; Urinary tract infection


VAERS ID: 1297138 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-17
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Fall
SMQs:, Accidents and injuries (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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 INC2021495975

Write-up: Arrhythmia; fall; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 543359. An 87-year-old 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. 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 arrhythmia and fall on 17Apr2021. The outcome of events was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Arrhythmia; Fall


VAERS ID: 1297139 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-05
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Subdural haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (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 INC2021495976

Write-up: fall; Subdural haemorrhage; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 543362. An 82-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fall and subdural haemorrhage on 05Apr2021 which resulted in death. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: fall; Subdural haemorrhage


VAERS ID: 1297140 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Terminal state
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021495977

Write-up: terminal state; This is a spontaneous report from a contactable other health professional reporting for a patient via the Regulatory Authority. Regulatory authority report number is 546508. A 96-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. It was unknown if patient was pregnant at time of vaccination. The patient experienced terminal state on 17Apr2021 with fatal outcome. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: terminal state


VAERS ID: 1297141 (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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, 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: 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 INC2021495978

Write-up: death; Loss of consciousness; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 543461. A 92-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced loss of consciousness and death on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: death; Loss of consciousness


VAERS ID: 1297142 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021495980

Write-up: cerebrovascular accident; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 545654. An 84-year-old 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 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cerebrovascular accident. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: cerebrovascular accident


VAERS ID: 1297143 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-13
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Terminal state
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021495981

Write-up: terminal state; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. The regulatory authority report number is 546503. An 82-year-old male patient received BNT162B2 (COMIRNATY, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced terminal state (as reported) on 13Apr2021. The outcome of the event was fatal. The patient died on an unspecified date. It was unknown if autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: terminal state


VAERS ID: 1297144 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-27
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Terminal state
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021495982

Write-up: Terminal state; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 546506. An 85-year-old female patient received bnt162b2 (COMIRNATY, Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced terminal state on 27Apr2021. The outcome was fatal. The patient died on an unspecified date. Cause of death was terminal state. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Terminal state


VAERS ID: 1297145 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-17
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Pneumothorax
SMQs:, Accidents and injuries (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 INC2021495983

Write-up: fall; pneumothorax; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 543370. An 88-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fall, pneumothorax, all on 17Mar2021. The outcome of the events was fatal. It was unknown if an autopsy was done. Patient died on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: fall; pneumothorax


VAERS ID: 1297167 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-03-13
   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 - / 1 - / -

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021493258

Write-up: pulmonary embolism; This is a spontaneous report from a contactable consumer. A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 19Feb2021 as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pulmonary embolism on 13Mar2021. The patient was hospitalized for the event on an unspecified date. Clinical course was as follows: Reporter''s 91-year-old mother was vaccinated on 19Feb2021 with her first dose of the Pfizer-Biontech vaccine with no other issues. Twenty-one (21) days later, on 13Mar2021, the first symptoms that something was not right appeared. After being seen by nurses and a doctor, she was admitted to hospital and was treated for a pulmonary embolism with heparin. She was not saying that the vaccine caused the embolism, but the chronology of events left them questioning. Therapeutic measures were taken as a result of pulmonary embolism. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: pulmonary embolism


VAERS ID: 1297169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-01
   Days after vaccination:4
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: Death, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021497242

Write-up: Suffered some kind of serious adverse reaction; 2-year-old baby dies during Pfizer''s COVID-19 vaccine experiments on children.; This is a spontaneous report from a Pfizer-sponsored program (Social Media Communication) from a non-contactable consumer. A 2-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as an unspecified dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. 2-year-old baby dies during Pfizer''s COVID-19 vaccine experiments on children. On 01Mar2021, the patient experienced suffered some kind of serious adverse reaction. The VAERS report does indicate that the child had been hospitalized since February 14, which suggests she may have gotten sick from first shot. Despite this, someone administered a second shot to the already sick and suffering child, which caused her die. The patient was hospitalized for the event from 14Feb2021. The patient died on 03Mar2021. It was not reported if an autopsy was performed. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. New reports indicate the ongoing trails include more than 10000 children aging in range from five to 11 in one of the group, and another 10000 children as young as six months old in the other. theses trails have been taking place since mid-march with the soon expectation that the jab will be authorized for use in children and babies.; Reported Cause(s) of Death: Suffered some kind of serious adverse reaction


VAERS ID: 1297170 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm, Blood test, Cerebral haemorrhage, Coma, Death, Vascular anastomosis
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), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: bloodwork; Result Unstructured Data: Test Result:Nothing specific
CDC Split Type: CAPFIZER INC2021498390

Write-up: Potential aneurism; AV anastomosis; passed away unexpectedly; comatose; intracerebral bleed; This is a spontaneous report from a contactable consumer (reporting for husband). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 23Apr2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that the reporter''s husband (patient) passed away unexpectedly on 30Apr2021. The patient had a catastrophic intracerebral bleed the morning of 29Apr2021. The patient was comatosed then lost all vital functions on 30Ap2021. There were no prodromes. The patient had no history of hypertension (HTN). There was no explanation. Not a thrombotic event though. There was nothing specific in the bloodwork on Apr2021. The reporter stated potential aneurism, AV anastomosis or something third (AS REPORTED). The outcome of the events was unknown. The patient died on 30Apr2021. 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: passed away unexpectedly


VAERS ID: 1297171 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-16
   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 EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, C-reactive protein, Chest X-ray, Death, Dyspnoea, Fibrin D dimer, Glomerular filtration rate, N-terminal prohormone brain natriuretic peptide, PCO2, PO2, Pulmonary oedema, pH body fluid
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   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: PROPRANOLOL; METO ZEROK; SYMBICORT; KCL-RETARD; CEFTRIAXONUM [CEFTRIAXONE]; LASIX [FUROSEMIDE]; NITRODERM; TRITTICO; AMLODIPINE; IRBESARTANUM; TORASEMIDUM; LIXIANA; PANTOPRAZOLUM; LERCANIDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (SARS-covid-19 disease diagnosed on 13Jan2021, no details known); Multimorbidity (Polymorbid patient (no list of comorbidities, but pharmacotherapy is extensive).); Polymedication (Polymorbid patient (no list of comorbidities, but pharmacotherapy is extensive).); Renal insufficiency (diagnosis date unknown, renal disease present (creatinine 90 micromol/L on unknown date))
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Blood creatinine; Result Unstructured Data: Test Result:90 umol/l; Test Date: 202102; Test Name: Blood potassium; Result Unstructured Data: Test Result:3.3 mmol/L; Test Date: 20210218; Test Name: Chest X-ray; Result Unstructured Data: Test Result:diffuse "shadowings" (infiltrate-like); Comments: which are interpreted as pulmonary oedema of unclear etiology; Test Name: C-reactive protein; Result Unstructured Data: Test Result:172 mg/l; Test Date: 202102; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:3960 ng/ml; Test Date: 202102; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:48; Comments: ml/min/1.73m2; Test Date: 202102; Test Name: NTpro-BNP; Result Unstructured Data: Test Result:10687 pg/ml pg/mL; Test Date: 202102; Test Name: pCO2; Result Unstructured Data: Test Result:31 mmHg; Comments: arterial blood gas analysis with 9L oxygen; Test Date: 202102; Test Name: pH; Result Unstructured Data: Test Result:7.459; Test Date: 202102; Test Name: pO2; Result Unstructured Data: Test Result:50 mmHg; Comments: arterial blood gas analysis with 9L oxygen
CDC Split Type: CHPFIZER INC2021497126

Write-up: Pulmonary oedema; Dyspnea; Death; This is a spontaneous report received from a contactable physician via a regulatory authority. Regulatory authority report number CH-SM-2021-14562. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY) intramuscular on 16Feb2021 (Lot Number: EM0477) as single dose for COVID-19 immunisation. Medical history included renal insufficiency and not ongoing (diagnosis date unknown, renal disease present (creatinine 90 micromol/L on unknown date)); COVID-19 from 13Jan2021 and not ongoing (SARS-covid-19 disease diagnosed on 13Jan2021, no details known); polymorbid patient (no list of comorbidities, but pharmacotherapy is extensive); alcohol and cigarette consumption unclear, allergies not known, liver disease unclear if present. Concomitant medications included propranolol from an unspecified start date to 18Feb2021; metoprolol succinate (METO ZEROK) from an unspecified start date to 17Feb2021; budesonide, formoterol fumarate (SYMBICORT) from an unspecified start date to 18Feb2021; potassium chloride (KCL-RETARD) from 18Feb2020 to Feb2021; ceftriaxone (CEFTRIAXONUM) from 18Feb2021 to Feb2021; furosemide (LASIX) from 18Feb2021 to Feb2021; glyceryl trinitrate (NITRODERM) from an unspecified start date to 18Feb2021; trazodone hydrochloride (TRITTICO) from an unspecified start date to 17Feb2021; amlodipine from an unspecified start date to 18Feb2021; irbesartan (IRBESARTANUM) from an unspecified start date to 18Feb2021; torasemide (TORASEMIDUM) from an unspecified start date to 18Feb2021; edoxaban tosilate (LIXIANA) from an unspecified start date to 17Feb2021; pantoprazole (PANTOPRAZOLUM) from an unspecified start date to 18Feb2021; lercanidipine from an unspecified start date to 17Feb2021. The patient experienced death on 19Feb2021 02:45, dyspnea (death, hospitalization) on 16Feb2021, pulmonary oedema (death, hospitalization) on 18Feb2021. Clinical course: Received on 16Feb2021 Comirnaty (first dose) and since then increasing worsening with mainly dyspnea and deterioration of general condition. Increasingly worse saturation at home. Prior to that time, patient was doing well based on her age. Admitted on 18Feb2021: clinical examination with pulmonary "rattling sounds". On chest X-ray (18Feb2021), diffuse "shadowings" (infiltrate-like) are evident, which are interpreted as pulmonary oedema of unclear etiology. Cardiomegaly. Suspected right pleural effusion. Labor (exact date unknown): NTpro-BNP:10687 pg/ml (Feb2021), CRP: 172 mg/L, Potassium: 3.3 mmol/L (Feb2021), Fibrin D dimer: 3960 ng/ml (Feb2021), Creatinine: 90 micromol/L (Feb2021), GFR (Glomerular filtration rate): 48 ml/min/1.73m2 (Feb2021). Arterial blood gas analysis with patient taking 9L of oxygen: pO2 50 mmHg (arterial blood gas analysis with 9L oxygen) (Feb2021), pCO2: 31 mmgHg (arterial blood gas analysis with 9L oxygen) (Feb2021), pH= 7.459 (Feb2021). The data is interpreted in the context of a pulmonary oedema of unclear etiology, with differential diagnosis: left heart failure or ARDS (acute respiratory distress syndrome), or reaction to Covid-19 vaccination. In the hospital a therapy with Lasix, oxygen, ceftriaxone and morphine was started. In the ward worsening with death on 19Feb2021, 02:45 am. It is not known if an autopsy was performed (very elderly female patient). Outcome of the events was fatal. A causality between Cormirnaty and all reported events (death, dyspnea and pulmonary oedema) was assessed as unlikely. This case was reported as serious with seriousness criteria caused/prolonged hospitalization and results in death. Health Authority Comment (a regulatory authority): Death of a 91-year-old polymorbid patient with previous covid-19 disease (Jan2021), 3 days after Comirnaty. The death was interpreted by the treating physicians as caused by pulmonary oedema of unclear etiology, with differential diagnosis: left heart failure or ARDS (acute respiratory distress syndrome), or reaction to Covid-19 vaccination. The monograph of Comirnaty does not report deaths, pulmonary edema, dyspnea among side effects. A database, out of 212,504 reports, reports to the Comirnaty monograph 6,262 cases of dyspnea and 80 of pulmonary oedema. In light of this data, knowing that the patient is very old, polymorbid according to the long list of drug therapy taken at home, and has already experienced covid-19 in Jan2021, despite the good temporal correlation we judge unlikely the correlation between the symptoms that then led to death (dyspnea, pulmonary oedema) and the death itself and the administration of Comirnaty. However, this judgment of causality does not totally exclude a role of the administered vaccine.; Sender''s Comments: Consider possible contributory effects from patient''s medical history and concomitant medications, the events death, pulmonary edema, dyspnea assessed as not related to vaccine BNT162B2.; Reported Cause(s) of Death: Death; Dyspnea; Pulmonary oedema


VAERS ID: 1297172 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-18
   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 EP9605 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   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: SINTROM; LOSARTANUM; BELOC ZOK; ALDACTONE [SPIRONOLACTONE]; ALLOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Auricular fibrillation (Chronic, anticoagulated with Sintrom); Carpal tunnel syndrome (right); Cataract bilateral NOS; Coronary atheroma (With non-sig lesion of the proximal Intra Ventricular Artery (anterior interventricular branch)); Diastolic dysfunction; Gouty tophi; Hypertension (treated); Left heart failure; Macroscopic haematuria
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021497082

Write-up: Death occurred on 18Apr2021 without any precursory signs in his sleep; This is a spontaneous report received from a contactable physician via a regulatory authority. Regulatory authority report number CH-SM-2021-14756. A 91-year-old male patient received BNT162b2 (COMIRNATY, Lot #EP9605) intramuscularly on 15Apr2021 (at the age of 91-year-old) at single dose for COVID-19 immunisation. Relevant medical history included left heart failure from 2005, auricular fibrillation from 2008 (chronic, anticoagulated with Sintrom), gouty tophi, hypertension (treated), macroscopic haematuria from 2015, right carpal tunnel syndrome, coronary atheroma with non-significant lesion of the proximal intraventricular artery (anterior interventricular branch), diastolic dysfunction and cataract bilateral from 2019. The patient had no known allergies. Concomitant medications included oral acenocoumarol (SINTROM) at 1DF 1x/day, oral losartan (LOSARTANUM) at 100mg 1x/day, oral metoprolol succinate (BELOC ZOK) at 25mg 1x/day, oral spironolactone (ALDACTONE) at 25mg 1x/day and oral allopurinol at 300mg 1x/day. The patient died in his sleep on 18Apr2021 without any precursory symptoms. The reporter assumed that death was not a result of the vaccination. It was unknown whether an autopsy was performed. A causality between Comirnaty and death was reported as being unlikely. This case was assessed as serious with seriousness criterion ''results in death''. Reporter''s Comment: Death in sleep and without precursory symptoms of 91-year-old polymorbid patient 3 days after vaccination with Comirnaty. Comirnaty, presumed cause of the side effect: No according to reporter. Sender''s comment (a regulatory authority): Death in sleep and without warning symptoms of 91-year-old polymorbid male patient 3 days after vaccination with Comirnaty. A monograph of Comirnaty does not report deaths among the side effects, and this database, at the Comirnaty monograph, reports 1858 deaths out of 212 504 reports. In light of the literature data, despite the good temporal correlation, but considering the polymorbidities and age of this elderly patient who died without reporting any symptoms, we consider the correlation between the death and the administration of Comirnaty unlikely. However, this judgment of causality cannot completely exclude the role of the vaccine.; Reporter''s Comments: Death in sleep and without precursory symptoms of 91-year-old polymorbid patient 3 days after vaccination with Comirnaty. Comirnaty, presumed cause of the side effect: No according to reporter.; Sender''s Comments: The event of sudden death is assessed as possibly not related to the suspect vaccine BNT162B2. Consider also possible contributory effects from patient''s medical history left heart failure, auricular fibrillation, hypertension and coronary atheroma. The impact of this report on the benefit/risk profile of the Pfizer drug 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: Died in his sleep


VAERS ID: 1297173 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-19
   Days after vaccination:4
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: Angiocardiogram, Death, Echocardiogram
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation; Coronary artery bypass (4x, Vein to posterolateral branch of circumflexa with jump to diagonal branch); Coronary disease (3-vessel disease); Coronary stent placement (Coro: subtotal main stem stenosis, stenting); Coronary stent placement (Coro: proximal RCA stenosis, stenting); Dyslipidemia; Embolism; Ex-smoker (30 pack years); Pulmonary embolism (chronic recurrent, under subtherapeutic anticoagulation apixaban); Renal failure (KDIGO G2/3a); Upper gastrointestinal haemorrhage (recurrent (different episodes in 1980, in 1998, in 2007)); Upper gastrointestinal haemorrhage (recurrent (different episodes in 1980, in 1998, in 2007)); Upper gastrointestinal haemorrhage (recurrent (different episodes in 1980, in 1998, in 2007))
Allergies:
Diagnostic Lab Data: Test Date: 200904; Test Name: Coro; Result Unstructured Data: Test Result:subtotal main stem stenosis, stenting; Test Date: 201111; Test Name: Coro; Result Unstructured Data: Test Result:proximal RCA stenosis, stenting; Test Date: 202004; Test Name: TTE; Result Unstructured Data: Test Result:cor pulmonale with right heart strain signs
CDC Split Type: CHPFIZER INC2021498217

Write-up: Death after Covid vaccination, causality questionable with polymorbidity; This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory Authority report number CH-SM-2021-14772. A 93-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via intramuscular, on 15Apr2021 at 0.3 mL single for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via intramuscular, on 11Mar2021 for COVID-19 immunisation and developed fatigue and became adynamic. Relevant medical history included thromboembolic disease first diagnosed in Jun2017, chronic recurrent pulmonary embolism from Apr2020 (under subtherapeutic anticoagulation apixaban), coronary 3-vessel disease (Nov2011 Coro: proximal RCA stenosis, stenting, Apr2009 Coro: subtotal main stem stenosis, stenting), recurrent upper gastrointestinal bleeding (different episodes in in 1980, in 1998, in 2007), renal failure (KDIGO G2/3a), dyslipidemia, arterial hypertension, atrial fibrillation and aorto-coronary bypass (ACBP) with vein to posterolateral branch of circumflexa with jump to diagonal branch. The patient was an ex-smoker (30 pack years). Relevant concomitant medications included apixaban (ELIQUIS) from 2017. The patient was found dead in bed by the nursing staff on 19Apr2021. Already about 4 weeks before, the patient was tired and a-dynamic, but not in the process of dying. Due to anamnesis recurrent pulmonary embolism, partly also under (subtherapeutic) anticoagulation as well as coronary 3-vessel disease with status after quadruple aorto coronary artery bypass surgery (ACBP) as well as repeated stenting, it is possible that the patient had a new pulmonary embolism or acute coronary Syndrome (ACS). A correlation with COVID 19 vaccination is theoretically conceivable but not certain in the elderly polymorbid patient. Autopsy was not performed in the absence of evidence of non-natural death. A causal relationship between COMIRNATY and Death was assessed as being unlikely. This case was reported as serious (fatal outcome). Sender''s comment: Death 4 days after the second administration of COMIRNATY in a very old patient (93 years old) with known risk factors for cardiovascular events (recurrent pulmonary embolism, coronary artery disease, atrial fibrillation). As the doctor also writes, in view of the different risk factors, a cause of death due to a new pulmonary embolism or acute coronary syndrome is more likely. Unfortunately, an autopsy was not performed, which could have given important indications. At the current state of knowledge despite the temporal correlation with the vaccine in an elderly patient and polymorbid we judged as unlikely the causal correlation with death. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: The causal association between the reported event and vaccine administered which led to a fatal outcome cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death after Covid vaccination, causality questionable with polymorbidity


VAERS ID: 1297187 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
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 ER9480 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD; Renal insufficiency; Stroke; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021491321

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100050464. An 84-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: ER9480), via an unspecified route of administration on 08Apr2021 (at 84 years old) as single dose for covid-19 immunization. Medical history included ongoing stroke, ongoing chronic obstructive pulmonary disease (COPD), ongoing Type II diabetes mellitus, ongoing renal insufficiency. Concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY) on 18Mar2021, for covid-19 immunization. The patient died on an unspecified date. The cause of death was not reported. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1297188 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021496557

Write-up: Respiratory insufficiency; Acute renal failure; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-202100050708. An 85-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Apr2021 (Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunisation. Medical history included ongoing dementia, ongoing type 2 diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced respiratory insufficiency, acute renal failure on an unspecified date. Time Interval between Beginning of Drug Administration and Start of Reaction / Event 8 days. Serious criteria reported as death. The patient died on an unspecified date. It was not reported if an autopsy was performed. Source of assessment: Regulatory Authority; Result of Assessment: Unclassifiable. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Acute renal failure; respiratory insufficiency


VAERS ID: 1297189 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
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 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021496568

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB DE-PEI-202100050713. A 79-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 10Apr2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. The cause of death was unknown. It was not reported if an autopsy was performed. Time interval between beginning of drug administration and start of reaction / event was 2 days. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


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