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From the 9/17/2021 release of VAERS data:

Found 15,386 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 97 out of 154

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VAERS ID: 1226666 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET 7205 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Incorrect route of product administration, Malaise, Presyncope, Vertigo
SMQs:, Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)

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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021398772

Write-up: patient received second dose of BNT162B2 ,subcutaneous at right shoulder; from 10 days onset of asthenia and generalized malaise On April 2, a vertiginous and pre-syncopal episode; from 10 days onset of asthenia and generalized malaise On April 2, a vertiginous and pre-syncopal episode; from 10 days onset of asthenia and generalized malaise On April 2, a vertiginous and pre-syncopal episode; from 10 days onset of asthenia and generalized malaise On April 2, a vertiginous and pre-syncopal episode; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-712306. A 74-years-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: ET 7205) subcutaneous at right shoulder on 02Apr2021 12:00 as 0.3 mL, single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced from 10 days onset of asthenia and generalized malaise on april 2, a vertiginous and pre-syncopal episode (vertigo) (death) on 02Apr2021. Therapeutic measures were taken as a result of the events. The patient died on 03Apr2021. It was not reported if an autopsy was performed.


VAERS ID: 1226797 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery disease, Malaise
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Respiratory disorder ((not specified))
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021399196

Write-up: acute coronary event/considering the medical history of the patient; Not feeling well; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB with regulatory authority number NL-LRB-00443919 and Safety Report Unique Identifier is NL-LRB-00498609. An 85-year-old male patient received bnt162b2 (COMIRNATY reported as COVID-19 VACCINE NOT SPECIFIED INJVLST), via an unspecified route of administration on 11Feb2021 (Lot Number: EJ6788) as a single dose for covid-19 immunisation. Medical history included respiratory disorder (not specified) and heart failure. The patient''s concomitant medications were not reported. This serious spontaneous report from a physician concerns a male aged 85 years, with malaise (death) following administration of covid-19 vaccine not specified injvlst (action taken: not applicable) for covid 19 immunization. The patient was resuscitated. The reporter described that another cause of death (acute coronary event) could not be excluded, considering the medical history of the patient. It was reported that the patient was not feeling well and acute coronary event on 11Feb2021 (also reported as 1 day after vaccination). Following death, the physician have been in contact with the medical examiner, there will be a report via mental health care to a regulatory authority. Given the history, another cause of death cannot be completely ruled out (acute coronary event). The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter comment''s: -unknown- Past drug therapy I don''t know: No BSN available: Yes -confounding factors- confounding factors: underlying heart failure, lung problems -COVID-19- Previous COVID19 infection: No -Other- diagnostic procedures: Resuscitation remarks report from: Following death I have been in contact with the medical examiner, there will be a report via mental health care to a regulatory authority. Given the history, another cause of death cannot be completely ruled out (acute coronary event) No follow-up attempts possible. No further information expected.; Reporter''s Comments: -unknown- Past drug therapy I don''t know:No BSN available:Yes -confounding factors- confounding factors: underlying heart failure, lung problems -COVID-19- Previous COVID19 infection:No -Other- diagnostic procedures:Resuscitation remarks report from: Following death I have been in contact with the medical examiner, there will be a report via mental health care to a regulatory authority. Given the history, another cause of death cannot be completely ruled out (acute coronary event); Reported Cause(s) of Death: malaise; acute coronary event/considering the medical history of the patient


VAERS ID: 1226798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood pressure measurement, Chest X-ray, Chest scan, Dyspnoea, Hypotension, Laboratory test, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 27
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: VASELINE CETOMACROGOL CREAM; MOVICOLON; DURATEARS [DEXTRAN 70;HYPROMELLOSE]; LISINOPRIL; COLECALCIFEROL; PANTOPRAZOL [PANTOPRAZOLE]; FUROSEMIDE; LIXIANA; CLOPIDOGREL; METOPROLOL [METOPROLOL SUCCINATE]; AMLODIPINE
Current Illness: Cardiac pacemaker insertion (DDD pacemaker); Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Collapse cardiovascular (due to sick sinus syndrome); Ischaemic stroke; Non-Hodgkin''s lymphoma
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Date: 202102; Test Name: CT-thorax; Result Unstructured Data: Test Result:opacification; Comments: ground-glass opacification, no pulmonary embolism; Test Name: Lung photo; Result Unstructured Data: Test Result:Suggesting COVID-19; Test Name: Lab values; Result Unstructured Data: Test Result:Suggesting COVID-19; Test Name: antibody corona test; Test Result: Negative ; Test Date: 20210213; Test Name: coronatest; Test Result: Negative ; Test Date: 20210213; Test Name: coronatest; Test Result: Negative ; Test Date: 20210215; Test Name: coronatest; Test Result: Negative
CDC Split Type: NLPFIZER INC2021399139

Write-up: severe breathlessness, clinical picture of covid; Non STEMI; low blood pressure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00444364. A 93-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EJ6788) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing cardiac pacemaker insertion DDD pacemaker, ongoing dementia , non-hodgkin''s lymphoma from 2007, circulatory collapse from 2020 due to sick sinus syndrome, ischaemic stroke from 2013. Concomitant medications included cetomacrogol, paraffin, liquid, propylene glycol, white soft paraffin (VASELINE CETOMACROGOL CREAM); macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON); dextran 70, hypromellose (DURATEARS [DEXTRAN 70;HYPROMELLOSE]); lisinopril; colecalciferol; pantoprazol; furosemide; edoxaban tosilate (LIXIANA); clopidogrel; metoprolol succinate; amlodipine (AMLODIPINE). One day after vaccination, the patient experienced dyspnoea. Two days after vaccination, the patient was hospitalised with severe dyspnoea, corresponding clinical presentation of Covid. Laboratory results and X-ray also matched with covid. However, the patient was tested 3 times negative for SARS Cov 2 and once for antibodies. The patient had need for supplemental oxygen. The patient was treated with dexamethasone and antibiotics. Initially, some improvement, no clear due to which medication. After 4 days, the dexamethasone and antibiotics were withdrawn. Three days later low blood pressure (value unknown). In the following days increased need for oxygen and chest pressure. Appeared to be non stemi on 20Feb2021. On CT thorax ground-glass opacification was seen, no pulmonary embolism. 13 days after vaccination, palliative care was started and the patient deceased 17 days after vaccination. The event dyspnea was assessed as serious (life-threatening, hospitalization). The outcome of dyspnoea and low blood pressure is unknown. The patient underwent lab tests and procedures which included blood pressure measurement: low on 20Feb2021, chest scan: opacification on Feb2021 ground-glass opacification, no pulmonary embolism , chest x-ray: suggesting covid-19 on an unspecified date, laboratory test: suggesting covid-19 on an unspecified date, sars-cov-2 antibody test: negative on an unspecified date, sars-cov-2 test: negative on 13Feb2021, sars-cov-2 test: negative on 13Feb2021, sars-cov-2 test: negative on 15Feb2021. Therapeutic measures were taken as a result of non stemi (acute myocardial infarction), severe breathlessness, clinical picture of covid (dyspnoea), and low blood pressure. The patient died on 28Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Non STEMI


VAERS ID: 1226799 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Malaise, Nausea, Pneumonia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   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: PANTOPRAZOLE; ZOLPIDEM; CLOPIDOGREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210222; Test Name: covid test; Test Result: Negative
CDC Split Type: NLPFIZER INC2021399191

Write-up: developing a respiratory infection resulting in death/pneumonia; Fatigue/tired; varyingly stuffy/varyingly short of breath/dyspnoea; sick/became ill/feeling sick; Nausea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB regulatory authority number NL-LRB-00451954, Safety Report Unique Identifier NL-LRB-00499075. An elderly female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EJ6789) as single dose for covid-19 immunisation. The patient''s medical history was not reported. Concomitant medications included pantoprazole, zolpidem and clopidogrel. The patient experienced developing a respiratory infection resulting in death, fatigue, varyingly stuffy, sick and nausea with latency of 1 day after start of covid-19 vaccine injection (17Feb2021). The patient had respiratory tract infection, feeling sick, nausea, fatigue and dyspnoea following administration of covid-19 vaccine. A covid test was done on the day she died; the test was negative. Patient was in good shape and still lived on her own without any help in the household etc. The day after vaccination, she developed a pneumonia. She alerted her physician after one week of feeling sick. When the physician saw her, it was already too late, and antibiotics couldn''t cure/help her. Physician mentioned that the vaccination may have played a role in lowering her immune system and thus making her more susceptible for other infections, such as pneumonia. The reporter commented the patient was developing a respiratory infection resulting in death. The day after the side effect, patient became ill, nauseated, unwell, tired and varyingly short of breath, no fever, she did not call the reporter as a doctor because she did not want hospitalization anymore, when the reporter was consulted today it was too late and she died in-house a few hours after the reporter''s visit. The patient had no previous COVID-19 infection. The patient was actually extremely fit for her age, lived independently without any help from home care, there was no dementia, etc. The day after the vaccine she got sick, probably got pneumonia from another virus or bacteria. By calling the reporter as a doctor late (almost a week after becoming ill) it was too late to be able to save her, e.g. with antibiotics. The vaccine may have played a role in (temporarily) weakening her immune system and thus making it more susceptible to other infections. The patient died on 22Feb2021 due to the events. An autopsy was not performed. Reporter Comment: - I do not know Past drug therapy I don''t know: no - developing a respiratory infection resulting in death - Additional information ADR: the day after the side effect, patient became ill, nauseated, unwell, tired and varyingly short of breath, no fever, she did not call me as a doctor because she did not want hospitalization anymore, when I was consulted today it was too late and she died in-house a few hours after my visit - COVID-19 Previous COVID-19 infection: No. - Other diagnostic procedures: covid test, result unknown - Follow up 25Feb2021 Follow-up received: death on 22 Feb. covid test was negative, taken on date of death no autopsy The patient was actually extremely fit for her age, lived independently without any help from home care, there was no dementia, etc. The day after the vaccine she got sick, probably got pneumonia from another virus or bacteria. By calling me as a doctor late (almost a week after becoming ill) it was too late to be able to save her, e.g. with antibiotics. The vaccine may have played a role in (temporarily) weakening her immune system and thus making it more susceptible to other infections. Assessor Lareb: FU received. Date of death and autopsy data entered. COVID test added. Case narrative completed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of Reporter Comment: The day after the vaccine she got sick, probably got pneumonia from another virus or bacteria. By calling me as a doctor late (almost a week after becoming ill) it was too late to be able to save her, e.g. with antibiotics. The vaccine may have played a role in (temporarily) weakening her immune system and thus making it more susceptible to other infections.; Reported Cause(s) of Death: developing a respiratory infection resulting in death/pneumonia; Fatigue/tired; varyingly stuffy/varyingly short of breath/dyspnoea; sick/became ill/feeling sick; nausea


VAERS ID: 1226803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac failure, Echocardiogram, Electrocardiogram, Exercise electrocardiogram, Malaise, Myocardial infarction, Radial pulse
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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: LORAZEPAM; COLECALCIFEROL; FUROSEMIDE; CLOPIDOGREL; GABAPENTINE; METOPROLOL SUCCINATE; PANTOPRAZOL [PANTOPRAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal) (upset stomach); Acute renal insufficiency (in renal infarction, component of moderate intake); Asthma cardiac (triggered by Acute renal insufficiency); Carpal tunnel syndrome (right); Cataract; CVA (start in 2021); Hypertensive crisis (Ischemia in the right hemisphere, catchment area a cerebri media); Left anterior hemiblock (ECG: LAHB); Pneumonia; Renal artery stenosis; Renal infarction (Crisis indicated by renal infarction based on severe origostenosis); Shoulder dislocation (shoulder luxation); Supraventricular extrasystoles; Tear film insufficiency, unspecified; Thoracic pain; Total knee replacement (left knee hemiprosthesis, Total Knee Prosthesis right); Uterine ablation (uterine extirpation); Ventricular extrasystoles (2016 Palpitations in frequent premature atrial contraction (PACs))
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: blood pressure; Result Unstructured Data: Test Result:immeasurable; Comments: not measurable (lost due to infarction); Test Name: TTE; Result Unstructured Data: Test Result:normal left ventricular function; Comments: no valve vitium; Test Date: 20210321; Test Name: ECG; Result Unstructured Data: Test Result:myocard infarct; Comments: showed an infarction (unknown old or new); Test Name: ergometry; Result Unstructured Data: Test Result:normal; Test Date: 20210321; Test Name: pulse; Result Unstructured Data: Test Result:low
CDC Split Type: NLPFIZER INC2021399220

Write-up: myocardial infarction due to / with concomitant heart failure; Passing away. The patient turned 20Mar2021which persisted until afternoon 21Mar2021 when suddenly unresponsive, ECG showed myocardial infarction. died in the night; Malaise; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is NL-LRB-00483468, Safety report unique identifier NL-LRB-00485214. A 92-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Pfizer), first dose via an unspecified route of administration on 18Mar2021 (lot number: ER7812) as single dose for COVID-19 immunisation. Medical history included CVA (Cerebrovascular accident), hypertensive crisis start in 2021 (Ischemia in the right hemisphere, catchment area a cerebri media, due to hypotension after hypertensive crisis treatment), total knee replacement (left knee hemiprosthesis, Total Knee Prosthesis right), cataracts and afterwards in right eye insufficient tear film, carpal tunnel syndrome (right), shoulder dislocation, uterine ablation (uterine extirpation), acid reflux (esophageal) (upset stomach), left anterior hemiblock (ECG: LAHB), supraventricular extrasystoles from 2016, ventricular extrasystoles (2016 Palpitations in frequent premature atrial contraction (PACs) / Premature ventricular contractions(PVCs)), asthma cardiac (triggered by Acute renal insufficiency), Acute renal insufficiency (in renal infarction, component of moderate intake), renal infarction (Crisis indicated by renal infarction based on severe origostenosis a. Renalis left, dd embolization of walled plaque aorta descendens), renal artery stenosis, cardiac history in 2003 the patient had non-specific thoracic complaints, and pneumonia. The patient was not previous COVID-19 infected. Before the vaccination, the patient was admitted to a rehabilitation department in a nursing home. She was still living independently at home, but after a CVA (Cerebrovascular accident) / hypertensive crisis she came to rehabilitate. She was doing well on the ward clinically, but after the infarction, there was difficulty with mobilization and independence for which a Protected living with intensive care and nursing indication had been requested. patient was going to move to a somatic ward. The patient''s condition in the weeks / days before vaccination was good. No deteriorating health. No corona test was conducted around the time of vaccination. The patient previously (before vaccination) took TTE (transthoracic echocardiogram) showed normal left ventricular function, no valve vitium, ergometry showed normal. Concomitant medications included gabapentine (capsule strength: 100 mg), pantoprazol (tablet strength: 20 mg),lorazepam (tablet strength: 1 mg), clopidogrel (tablet strength: 75mg),furosemide (tablet strength: 40 mg), metoprolol succinate (tablet strength: 50 mg), colecalciferol (capsule strength: 800IU). There was no adjustment in the medication around the time of vaccination. Patient''s weight was 74.4 kg, height was 161 cm. On 18Mar2021, she had the vaccination at the GGD. On Saturday evening 20Mar2021 she got malaise complaints (feeling full, not well/not feeling well) which persisted until Sunday afternoon 21Mar2021. On Sunday afternoon she suddenly became unapproachable with immeasurable blood pressure (not measurable (lost due to infarction) ) and low pulse. The diagnostic procedures ECG was made. This showed a myocardial infarction. After that, the whole evening was difficult to approach and not tasty. This lasted until patient was found not to be approachable. Then deterioration and death. The patient died on 22Mar2021 (5:15 AM, also reported as ''Died in the night''). The recorded cause of death was myocardial infarction due to / with concomitant heart failure, malaise. An autopsy was not performed. Possibly react genic side effects of vaccination was malaise and feeling full / unwell in the evening. There was probably no relationship between events and BNT162B2, but the reporter still want to report these events. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Malaise; myocardial infarction due to / with concomitant heart failure; myocardial infarction due to / with concomitant heart failure


VAERS ID: 1226808 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Chest pain, Dyspnoea exertional, Myocardial infarction, Restlessness, Unresponsive to stimuli
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Pulmonary hypertension (broad), 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), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ISOSORBIDE MONONITE; PANTOPRAZOLE; MOVICOLON; CLOPIDOGREL; TILDIEM; SIMVASTATINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm repair; Aortic aneurysm (infrarenal); CABG (LIMA D1-LAD, graft CX, peripheral arterial disease); Ischaemia myocardial; Peripheral arterial disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021399173

Write-up: Dyspnoea/ Dyspnoea exertional; Chest pain; not approachable; cardiogenic shock after myocardial infarction; cardiogenic shock after myocardial infarction; Unrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority. The regulatory authority number is NL-LRB-00493652. A 91-year-old male patient received his first dose of BNT162B2 (COMIRNATY, lot number: ET3674) at the age of 91-years-old, via an unspecified route of administration on 01Apr2021 at 11:30 at single dose for COVID-19 immunisation. Medical history included aortic aneurysm (infrarenal, for which patient had an EVAR), ischaemia myocardial, and CABG (LIMA D1-LAD, graft CX, peripheral arterial disease). The patient has no previous COVID-19 infection. Concomitant medications included isosorbide mononitrate (ISOSORBIDE MONONITE) modified-release tablet; pantoprazole gastro-resistant coated tablet; macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON) powder for oral solution; clopidogrel tablet; diltiazem hydrochloride (TILDIEM) modified-release capsule, hard; and simvastatine film-coated tablet. The patient experienced unrest (also reported as agitation) on 01Apr2021; and dyspnoea/ dyspnoea exertional, chest pain, and not approachable on 02Apr2021. The course of events was as follows: In the night on the day of vaccination, the patient was unrest. The day after, he experienced dyspnoea exertional, chest pain and was unresponsive to verbal stimuli. He went to bed where he passed away suddenly. Cause of death was probably cardiogenic shock due to a myocardial infarction. The patient died on 02Apr2021. The causes of death were Unrest, Dyspnoea/ Dyspnoea exertional, Chest pain, not approachable, and cardiogenic shock after myocardial infarction. It was unknown if autopsy was performed. Reporter''s Comment: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): No. Agitation, chest pain, shortness of breath: Additional information on ADRs: the patient was very restless the night after vaccination (vaccinated around 11:30 am), spent a lot of time in/out of bed, the day after short of breath with exertion, chest pain, and not easily approachable. Eventually, shortly after lying down, sudden death was observed in a patient on a no-CPR policy. Death as of natural causes after consultation with the municipal coroner, presumably on the basis of cardiogenic shock after myocardial infarction. Confounding factors: Extensive cardiac history: EVAR associated with infrared aortic aneurysm, cardiac ischemia requiring CABG. Note: CABG: LIMA D1-LAD, graft CX, peripheral arterial disease. Previous COVID-19 infection: No. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): No. Agitation, chest pain, shortness of breath: Additional information on ADRs: the patient was very restless the night after vaccination (vaccinated around 11:30 am), spent a lot of time in/out of bed, the day after short of breath with exertion, chest pain, and not easily approachable. Eventually, shortly after lying down, sudden death was observed in a patient on a no-CPR policy.; Reported Cause(s) of Death: cardiogenic shock after myocardial infarction; cardiogenic shock after myocardial infarction; Unrest; Dyspnoea/ Dyspnoea exertional; Chest pain; not approachable


VAERS ID: 1226809 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: NLPFIZER INC2021399127

Write-up: Cerebral haemorrhage/Multiple brain hemorrhages; several strokes; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority is NL-LRB-00494657. An 84-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration, on 03Mar2021 17:15, as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no previous COVID-19 infection. On 04Mar2021 at 13:15 (20 hours after start), the patient experienced cerebral haemorrhage/multiple brain hemorrhages and several strokes. Laboratory test included scan on an unspecified date with unknown result. The outcome of the events was fatal. The patient died on an unspecified date. It was unknown if autopsy was performed. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage/Multiple brain hemorrhages; several strokes


VAERS ID: 1226811 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Echocardiogram, Ejection fraction, Electrocardiogram, Laboratory test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DESLORATADINE; AMLODIPINE; COLECALCIFEROL; EDOXABAN; TEMAZEPAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: echocardiogram; Result Unstructured Data: Test Result:unknown results; Test Date: 202011; Test Name: LVEF; Test Result: 70 %; Comments: normal; Test Date: 2021; Test Name: LVEF; Test Result: 15 %; Comments: poor; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: lab; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021399227

Write-up: Dyspnoea/shortness of breath; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB manufacturer report number NL-LRB-00496928. This is the first of two reports. An 83-years-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Lot number: ET3674) as single dose for covid-19 immunization. Medical history was not reported. Concomitant medications included desloratadine; amlodipine; colecalciferol; edoxaban; temazepam. The patient previously received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Feb2021 as single dose for covid-19 immunization and on 05Mar2021, she experienced malaise, general physical health deterioration and abdominal pain. The patient did not have previous COVID-19 infection. On 26Mar2021, 3 hours after the 2nd vaccination, the patient experienced dyspnoea that caused death, life threatening and caused or prolonged hospitalization. A few hours after 2nd vaccination increasing shortness of breath. The patient underwent lab tests and procedures which included in Nov2020, patient still completely normal left ventricular function (70%), and now in 2021 she had a very poor left ventricular function (15%). In 2021, patient had diagnostic procedures of ECG, lab, echocardiogram with unknown results. Treatment measures for dyspnoea was treated with Hartfalenmedicatie. The outcome of the event was fatal. It was not reported if an autopsy was performed. This report was assessed by the reporting physician was serious. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Dyspnoea/shortness of breath


VAERS ID: 1226812 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021398891

Write-up: found dead in bed 5-6 days after vaccination; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NL-LRB-00502142. A 79-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was found dead in bed by the police late afternoon on 06Apr2021 after reporting from neighbors that the curtains had been closed for several days. The doctor did not want to come for the autopsy. The last contact was on April 1 in the course of the afternoon. Then no complaints indicated. Given the state of decomposition of the body, he probably died 5-6 days ago in Apr2021. An examination in the house shows from the papers present that he had a Covid vaccination with the Pfizer vaccine on 31Mar2021 at the vaccination location in [PRIVACY]. The health statement contained all the answers to no. BSN available: yes. The patient died on an unspecified date in Apr2021. It was not reported if an autopsy was performed. Drugs and latency: covid-19 vaccin pfizer inj found dead: 1 day after start Case Summary and Reporters Comments Text: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no found dead in bed 5-6 days after vaccination No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no found dead in bed 5-6 days after vaccination; Reported Cause(s) of Death: Found dead


VAERS ID: 1226813 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021398893

Write-up: Sudden death 4 days after vaccination; This is a spontaneous report from a contactable physician downloaded from the regulatory authority NL-LRB-00502183. A 78-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Apr2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had sudden death on 07Apr2021, 4 days after vaccination. It was unknown if an autopsy was performed. Case Summary and Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no. Sudden death 4 days after vaccination - additional information on ADR: It is not clear whether this is due to the vaccine. BSN available: yes. Previous COVID-19 infection: No No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no Sudden death 4 days after vaccination- Additional information on ADR: It is not clear whether this is due to the vaccine. BSN available: yes Previous COVID-19 infection: No; Reported Cause(s) of Death: Sudden death


VAERS ID: 1226814 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-29
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Chest X-ray, Pneumonia
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; GLUCIENT SR; METOPROLOL SUCCINATE; SIMVASTATINE; ACETYLSALICYLZUUR; AMIODARON [AMIODARONE]; PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]
Current Illness: Cardiomyopathy (Known cardiac pump dysfunction)
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic cardiomyopathy (Confounding factors: ischemic cardiomyopathy)
Allergies:
Diagnostic Lab Data: Test Name: X thorax; Result Unstructured Data: Test Result:Enlarged heart; Comments: Enlarged heart. Central some busy blurred lung vasculature. Also some kerley-B lines, progressive, suspecting some overfilling. New consolidation in midfield left, suspected of infection. Some pleural fluid, especially on the right.
CDC Split Type: NLPFIZER INC2021398894

Write-up: acute heart failure with known poor pumping function; possibly also pneumonia; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00502413. A 87-years-old male patient received second dose of bnt162b2 (COMIRNATY; Batch/Lot Number: Unknown), via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. Medical history included ongoing cardiomyopathy (Known cardiac pump dysfunction), ischemic cardiomyopathy (Confounding factor). BSN available was reported as yes. There was no previous COVID-19 infection. Concomitant medications included furosemide; metformin hydrochloride (GLUCIENT SR); metoprolol succinate; simvastatine; acetylsalicylzuur; amiodarone (AMIODARON); pantoprazole sodium sesquihydrate (PANTOZOL). The patient previously took first dose of bnt162b2 (COMIRNATY), for COVID-19 immunization and experienced no adverse reaction. On 29Mar2021 (4 days after start), the patient experienced acute heart failure with known poor pumping function (cardiac failure acute) (death, hospitalization) and possibly also pneumonia (death, hospitalization). The patient was treated with diuretics and antibiotics. The patient underwent lab tests and procedures which included x-thorax: Enlarged heart. Central some busy blurred lung vasculature. Also some kerley-B lines, progressive, suspecting some overfilling. New consolidation in midfield left, suspected of infection. Some pleural fluid, especially on the right. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter comment: acute heart failure with known poor pump function, possibly also pneumonia No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Reporter comment: acute heart failure with known poor pump function, possibly also pneumonia; Reported Cause(s) of Death: acute heart failure with known poor pumping function; possibly also pneumonia


VAERS ID: 1226815 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   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: Artificial cardiac pacemaker user; Coronary atherosclerosis; Heart failure; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: Autopsy; Result Unstructured Data: Test Result:Preliminary results; Comments: Preliminary results shows slightly enlarged heart with scarring after previous myocardial infarctions and severe coronary atherosclerosis (with stenosis). The lungs are heavy and rich in pleural fluid. The spleen''s consistency is somewhat diffluent. Kidneys with decreased cortical thickness. CRP post-mortem 86 mg/L.
CDC Split Type: NOPFIZER INC2021398932

Write-up: FOUND DEAD; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uyj7r8. A 78-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: ET3674), intramuscular on 24Mar2021 as SINGLE DOSE for COVID-19 immunisation. Medical history included artificial cardiac pacemaker user, heart failure, coronary atherosclerosis, and renal failure. The patient''s concomitant medications were not reported. The patient was found dead on 27Mar2021. The last time anyone had been in contact with the patient was on the evening of 26Mar2021. No information was available for the reporter, as to whether the patient had any symptoms after vaccination and before he was found dead. The police has asked for an autopsy. An autopsy was performed on 29Mar2021 that revealed: preliminary results shows slightly enlarged heart with scarring after previous myocardial infarctions and severe coronary atherosclerosis (with stenosis). The lungs are heavy and rich in pleural fluid. The spleen''s consistency is somewhat diffluent. Kidneys with decreased cortical thickness. CRP post-mortem 86 mg/L. The reporter stated by phone that microscopy and toxicology was yet to be performed, but at the time it was not established any clear cause of death. The reporter stated that it was uncertain whether there was a relationship between the vaccination and the patient being found dead, but chose to report it due to close temporal relationship. The patient outcome was fatal at the time of the report. Additional information received from reporter by phone on 07Apr2021 which confirmed date of death and exact date of autopsy. Reporter also gave information about the patient having a cardiac pacemaker and that the last time anyone had been in contact with the patient was on the evening of 26Mar2021. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported event as Possible. Sender Comment: The report concerns a patient in his 70s, who was found dead three days after the first dose of the Covid-19 vaccine Comirnaty. The reporter states that it is uncertain whether there is a connection between the vaccination and the death, but reports due to a close time relationship. Preliminary autopsy results show no clear cause of death, but the patient had several underlying diseases that can predispose to sudden death. When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including deaths, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. In Norway, we have received and processed more than 100 reports of deaths after vaccination of elderly people in need of care, most of whom were nursing home patients. For several of the deaths, reporters have stated that they do not suspect a connection with vaccination and that the incident is due to a serious underlying disease in the patient. The Norwegian Medicines Agency has established an expert group that will review the deaths of frail elderly people after vaccination. The expert group will, among other things, assess whether there are any common features in these patients, which may have contributed to a fatal outcome. In each case, it is difficult to know whether the death is due to the vaccine, the patient underlying disease or something else accidental, at the same time a cause that has nothing to do with the vaccination in question. Based on the information in the report and in accordance with international criteria, we assess the causal link between the vaccination and the death as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the message is also classified as serious, although a causal relationship with vaccination has not been established. No follow-up attempts are possible. No information is expected.; Autopsy-determined Cause(s) of Death: Preliminary results shows slightly enlarged heart with scarring after previous myocardial infarctions and severe coronary atherosclerosis (with stenosis). The lungs are heavy and rich in pleural fluid. The spleen''s consistency is somewhat diffluent.


VAERS ID: 1226816 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: NOPFIZER INC2021400170

Write-up: patient was fully vaccinated and more than 7 days had passed between dose 2 and when the patient got COVID-19; patient was fully vaccinated and more than 7 days had passed between dose 2 and when the patient got COVID-19; This is a spontaneous report from a contactable consumer at the Institute of Public Health. An elderly patient of an unspecified gender received the first and second dose of bnt162b2 (vaccine, Batch/Lot numbers were not reported), via an unspecified route of administration on Jan2021 both as single doses, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. There has been an outbreak of infection among six fully vaccinated residents of a nursing home. They had received the Pfizer vaccine. There are five infected and one who died, among elderly nursing home residents who were all fully vaccinated in January. The National Institute of Public Health has received 1 fatal report for the patient. No other reports were received. The patient was fully vaccinated, and more than 7 days had passed between dose 2 when the patient got COVID-19. No other information was available at the moment. The outcome of the events was fatal. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: The patient was fully vaccinated and more than 7 days had passed since dose 2 and when the patient got COVID-19; The patient was fully vaccinated and more than 7 days had passed since dose 2 and when the patient got COVID-19


VAERS ID: 1226817 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-12
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021399015

Write-up: Death from natural causes; This is a spontaneous report from a contactable physician downloaded from the regulatory authority PT-INFARMED-B202103-2360. A 97-year-old male patient received (COVID-19 mRNA vaccine (with modified nucleoside) (Comirnaty), concentrate for dispersion for injection, 30 mcg/0.3 ml, batch EP2166, CAUL: 09621, dose of 0.3 ml) intramuscular as a single dose for COVID-19 immunization. Medical history included cardiac heart insufficiency; 1.5 L / min long duration supplementary oxygen for unknown respiratory condition with pulmonary hypertension. Concomitant medications were unknown. The patient died 15 days after the administration of the suspected vaccine. The reported cause of death was "death by natural causes". The patient had emergency medical care and was hospitalized. Oxygen therapy (1.5 L / min) was required due to unknown respiratory disease with pulmonary hypertension. There is also reference to previous heart failure. The Reporter is unaware of the usual medication of the patient. Outcome of ADR: Death. Relatedness of drug to reaction(s)/event(s): Source of assessment: Reporter Method of assessment: unknown, Result of Assessment: improbable. No follow-up attempts possible. No information expected.; Reporter''s Comments: Concomitant Medication-Unknown Did a Medication Error occur? -No Other information-Previous cardiac heart insufficiency; 1.5 L / min long duration supplementary oxygen for unknown respiratory condition with pulmonary hypertension; Reported Cause(s) of Death: Death from natural causes


VAERS ID: 1226830 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Blood pressure measurement, Brain natriuretic peptide, Bundle branch block left, C-reactive protein, Cardiac arrest, Cardiac failure, Cough, Dyspnoea, Echocardiogram, Glomerular filtration rate, Glomerular filtration rate decreased, Heart rate, Investigation, Oedema peripheral, Oxygen saturation, Polymerase chain reaction, Radioisotope scan, Respiratory failure, Respiratory rate, Troponin, Wheezing, White blood cell count increased, White blood cell disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METOPROLOL SANDOZ [METOPROLOL SUCCINATE]; CANDESARTAN SANDOZ; JANUVIA [SITAGLIPTIN PHOSPHATE]; SIMVASTATIN BLUEFISH; ALLOPURINOL NORDIC DRUGS; CARBOCAIN; NITROGLYCERIN; SERTRALIN HEXAL; IOMERON; LANTUS; BETOLVEX [CYANOCOBALAMIN]; TEGRETOL R
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis (moderate); Cardiac failure; Gout; Hemiparesis (right); Hypertension; Insulin-requiring type 2 diabetes mellitus; Living in nursing home; Meningioma; Oedema peripheral (uses a supporting stockings during the day); Pulmonary oedema; Surgery (2007 and 2015); Weakness left or right side; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: blood pressure; Result Unstructured Data: Test Result:144/90; Test Date: 202103; Test Name: brain natriuretic peptide; Result Unstructured Data: Test Result:4913 ng/L; Test Date: 202103; Test Name: CRP; Result Unstructured Data: Test Result:58; Test Date: 202103; Test Name: echocardiogram; Result Unstructured Data: Test Result:severe reduced mobility in the heart; Comments: interpreted by a cardiologist as terminal heart failure; Test Date: 202103; Test Name: GFR; Result Unstructured Data: Test Result:too low; Test Date: 202103; Test Name: heart rate; Result Unstructured Data: Test Result:87; Test Date: 202103; Test Name: Examination; Result Unstructured Data: Test Result:well-oriented, left bundle branch block; Comments: has aggravated leg swelling, pitting oedema bilaterally, left leg more swollen than right, had so earlier in 2015, have supporting stockings during the day. Has no fever, heart pain or palpitations, systolic wheezing I2 right; Test Date: 202103; Test Name: saturation; Test Result: 70 %; Test Date: 202103; Test Name: saturation; Test Result: 88 %; Comments: on room air; Test Date: 202103; Test Name: saturation; Test Result: 95 %; Comments: with oxygen; Test Date: 202103; Test Name: saturation; Test Result: 95 %; Comments: on 1 L of oxygen; Test Date: 202103; Test Name: PCR; Test Result: Negative ; Test Date: 202103; Test Name: Pulmonary scintigraphy; Result Unstructured Data: Test Result:no pulmonary embolism; Comments: no pulmonary embolism; Test Date: 202103; Test Name: respiratory rate; Result Unstructured Data: Test Result:16; Test Date: 202103; Test Name: TnT; Result Unstructured Data: Test Result:32 ng/L; Test Date: 202103; Test Name: leukocytes; Result Unstructured Data: Test Result:11.4 x10 9/l
CDC Split Type: SEPFIZER INC2021399146

Write-up: heart failure (terminal); respiratory insufficiency; cardiac arrest; aspiration; increasing difficulty breathing; dry cough/ coughing from time to time; left bundle branch block; aggravated leg swelling, pitting oedema bilaterally, left leg more swollen than right; leukocytes 11.4 x 10^9/L (Reference value: 3.5-8.8); too low GFR; has a high respiratory rate and wheezing breathing sounds; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is SE-MPA-2021-020845 and the other case number is SE-MPA-1615987881383. An 83-year-old female patient received her second dose of BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on Mar2021 at single dose for COVID-19 immunisation. Medical history included cardiac failure, insulin-requiring type 2 diabetes mellitus, hypertension, gout, meningioma in 2007 and had surgery on 2007 and 2015, thereafter she developed right sided hemiparesis. She also had weakness on the left or right side. In addition, the patient has moderate aortic valve stenosis, pulmonary oedema, and pitting oedema bilaterally in legs which she uses a supporting stockings during the day, all in 2015. She lived in a special nursing home and was a wheelchair user. Concomitant medications included metoprolol succinate (METOPROLOL SANDOZ) prolonged-release tablet; candesartan cilexetil (CANDESARTAN SANDOZ) tablet; sitagliptin phosphate (JANUVIA) film-coated tablet; simvastatin (SIMVASTATIN BLUEFISH) film-coated tablet; allopurinol (ALLOPURINOL NORDIC DRUGS) tablet; mepivacaine hydrochloride (CARBOCAIN) solution for injection/infusion; nitroglycerin solution for injection/infusion; sertraline hydrochloride (SERTRALIN HEXAL) film-coated tablet; iomeprol (IOMERON) solution for injection/infusion; insulin glargine (LANTUS) solution for injection/infusion; cyanocobalamin (BETOLVEX) film-coated tablet; carbamazepine (TEGRETOL RETARD) prolonged-release tablet; furosemide (FURIX) tablet; sodium chloride (NATRIUMKLORID BAXTER) solution for injection/infusion; acetylsalicylic acid (TROMBYL) tablet; and heparin sodium (HEPARIN LEO) solution for injection/infusion. The patient received her first dose of BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on Feb2021 at single dose for COVID-19 immunisation. The patient experienced heart failure (terminal) on Mar2021. The course of events was as follows: She arrived at the emergency room on Mar2021 due to dyspnoea (conversational). About a week earlier, she received the second dose of COMIRNATY. The patient has had increasing difficulty breathing and dry cough last week (Mar2021). Examination on Mar2021 included PCR negative, well-oriented, left bundle branch block, heart rate 87, blood pressure 144/90, respiratory rate 16, saturation 88% on room air, 95% with oxygen, has aggravated leg swelling, pitting oedema bilaterally, left leg more swollen than right, had so earlier in 2015 which she uses a supporting stockings during the day. Has no fever, heart pain or palpitations, systolic wheezing I2 right. Lab samples: ProBNP (brain natriuretic peptide) 4913ng/L (increasing), TnT 32ng/L, CRP (C-reactive protein) 58, leukocytes 11.4 x 10^9/L (Reference value: 3.5-8.8). Suspicion of heart insufficiency in the first place, received 40 mg of furosemide(FURIX) in the emergency room, the patient was hospitalized and has been stable overnight, saturation 95% on 1 L of oxygen, received food and drink, insulin (LANTUS) received later than usual. The next morning, the patient was clear-minded, adequate, and has eaten. She has a high respiratory rate and wheezing breathing sounds, also coughing from time to time. Before the examination, she has normal breathing, pulse and blood pressure, possibly mild tachycardia, latent hypo-hypertension. The next day, the patient will have a pulmonary scintigraphy, because CT of the thorax cannot be performed due to too low GFR (glomerular filtration rate). Prior to this, the patient received 3 L of oxygen and laid flat on the couch, which she has not been used to as she has had a more sitting-sleeping position for the past 6 years. She then experienced a decrease in POX, which has led to an increased supply of oxygen, later alarm about cardiac arrest. First asystole, then PEA (pulseless electrical activity), no defibrillation. She experienced aspiration because of CPR. Unclear genesis to this. Hypoxia? Bradycardia? The patient was resuscitated but failed respiratory and circulatory. Taken to intensive care and on arrival, the patient was intubated and required 100% oxygen in the ventilator, saturated around 70% despite intubation. Probable aspiration because of cardiac arrest. Pulmonary scintigraphy showed no pulmonary embolism. Bedside echocardiogram was performed and showed severe reduced mobility in the heart, interpreted by a cardiologist as terminal heart failure. Palliative care was started. The patient was sedated with intermittent doses of fentanyl and midazolam. She was unstable in blood pressure and was given norepinephrine and dobutamine as inotropic and vasopressor support. She oscillates between sinus bradycardia 40-50 and sinus tachycardia and received 2 doses (injection) of atropine. The patient moved her arms on a few occasions, CAD was planned to be inserted, but the patient died a few hours later. She had a cardiac arrest about a week after receiving the second dose of COMIRNATY. Probably not caused by COVID-19 vaccine. However, deterioration in cardiopulmonary status after vaccination cannot be ruled out. Autopsy was not performed. It was assessed as a natural death due to terminal heart failure. Cause of death was also reported as respiratory insufficiency. The patient died on Mar2021. The causes of death were cardiac failure/terminal heart failure and respiratory insufficiency. The outcome of other events was unknown. Autopsy was not performed. No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac failure/ terminal heart failure; Respiratory insufficiency


VAERS ID: 1226834 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Fall, Head injury
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FURIX [FUROSEMIDE]; ATORVASTATIN; TROMBYL; SPIRONOLACTONE; SERTRALINE; ENALAPRIL; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021399131

Write-up: Death; found dead in bed; Fallen and hit his head; Fallen and hit his head; This is a spontaneous report downloaded from the regulatory authority (Regulatory Authority Report Number: SE-MPA-2021-023862). A contactable physician reported that a 77-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EP2166) at the age of 77 years, intramuscular, in Mar2021, at a single dose, for COVID-19 immunization. The patient''s medical history included heart failure. The patient''s concomitant medications included furosemide (FURIX), atorvastatin, acetylsalicylic acid (TROMBYL), spironolactone, sertraline, enalapril, and metoprolol. The reported suspected adverse reaction was death. In Mar2021, the patient had fallen some day before he died and had hit his head. In Mar2021 the patient was found dead in bed 3 days after the vaccination (Mar2021). In conversations with the physician, he informs that an autopsy will not be performed. The outcome of event reported as "Death; found dead in bed", fatal, the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death; found dead in bed


VAERS ID: 1226835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-03-01
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amino acid level increased, C-reactive protein increased, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL SANDOZ; INSUMAN BASAL; ESOMEPRAZOL KRKA; ATORBIR; ONDANSETRON; BETAMETASON ALTERNOVA; FURIX [CEFUROXIME]; STESOLID; ALLOPURINOL NORDIC DRUGS; ACETYLSALICYLSYRA TEVA; SERTRALIN HEXAL; GEMCITABINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Coronary artery surgery; Diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: TPK; Result Unstructured Data: Test Result:133; Test Date: 20210208; Test Name: TPK; Result Unstructured Data: Test Result:114; Test Date: 20210209; Test Name: TPK; Result Unstructured Data: Test Result:109; Test Date: 20210210; Test Name: TPK; Result Unstructured Data: Test Result:56; Test Date: 20210211; Test Name: TPK; Result Unstructured Data: Test Result:57; Test Date: 20210215; Test Name: TPK; Result Unstructured Data: Test Result:109; Test Date: 20210308; Test Name: TPK; Result Unstructured Data: Test Result:149; Test Date: 20210316; Test Name: TPK; Result Unstructured Data: Test Result:7; Test Date: 20210209; Test Name: CRP; Result Unstructured Data: Test Result:293; Test Date: 20210210; Test Name: CRP; Result Unstructured Data: Test Result:247; Test Date: 20210211; Test Name: CRP; Result Unstructured Data: Test Result:decreasing CRP; Test Date: 20210215; Test Name: CRP; Result Unstructured Data: Test Result:77; Test Date: 20210316; Test Name: CRP; Result Unstructured Data: Test Result:247
CDC Split Type: SEPFIZER INC2021398895

Write-up: THROMBOCYTOPENIA; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number SE-MPA-2021-025116. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; gemcitabine, intravenous from 03Mar2021 (Batch/Lot number was not reported) to 03Mar2021, at 1824 mg, 1000 mg/m2 for an unspecified indication; gemcitabine, intravenous from 10Mar2021 (Batch/Lot Number: Unknown) to 10Mar2021, at 1824 mg, 1000 mg/m2 for pancreatic carcinoma metastatic; gemcitabine, intravenous from 03Feb2021 (Batch/Lot number was not reported) to 03Feb2021, at 1824 mg, 1000 mg/m2 for an unspecified indication. Medical history included cardiac failure, diabetes mellitus, coronary artery surgery. Concomitant medications included bisoprolol fumarate (BISOPROLOL SANDOZ) from 13Mar2020; insulin human injection, isophane (INSUMAN BASAL) from 06May2020 to an unspecified stop date; esomeprazole magnesium (ESOMEPRAZOL KRKA) taken for an unspecified indication from 20May2020 to an unspecified stop date; atorvastatin calcium (ATORBIR) taken for an unspecified indication from 22May2020; ondansetron from 27Jan2021 to an unspecified stop date; betamethasone sodium phosphate (BETAMETASON ALTERNOVA) from 27Jan2021 to an unspecified stop date; cefuroxime (FURIX [CEFUROXIME]) from 22May2020 to an unspecified stop date; diazepam (STESOLID) taken for an unspecified indication from 27Jan2021 to an unspecified stop date; allopurinol (ALLOPURINOL NORDIC DRUGS) taken for an unspecified indication from 06May2020 to an unspecified stop date; acetylsalicylic acid (ACETYLSALICYLSYRA TEVA) taken for an unspecified indication from 22May2020 to an unspecified stop date; sertraline hydrochloride (SERTRALIN HEXAL) taken for an unspecified indication from 22May2020 to an unspecified stop date. In Mar2021, the patient experienced thrombocytopenia. The patient underwent lab tests and procedures which included amino acid level increased: 133 on 21Jan2021, amino acid level increased: 114 on 08Feb2021, amino acid level increased: 109 on 09Feb2021, amino acid level increased: 56 on 10Feb2021, amino acid level increased: 57 on 11Feb2021, amino acid level increased: 109 on 15Feb2021, amino acid level increased: 149 on 08Mar2021, amino acid level increased: 7 on 16Mar2021, c-reactive protein increased: 293 on 09Feb2021, c-reactive protein increased: 247 on 10Feb2021 , c-reactive protein increased: decreasing crp on 11Feb2021, c-reactive protein increased: 77 on 15Feb2021, c-reactive protein increased: 247 on 16Mar2021. The action taken in response to the event, for gemcitabine was unknown , for gemcitabine was unknown, for gemcitabine was unknown. The patient died on an unspecified date due to the event thrombocytopenia. It was not reported if an autopsy was performed. The agency has requested the medical records and the autopsy protocol. No follow-up attempts possible. No further information expected. Batch/lot number was not provided and cannot be obtained.; Reported Cause(s) of Death: THROMBOCYTOPENIA


VAERS ID: 1227497 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-03-09
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / 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: 2021-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021398605

Write-up: cerebral haemorrhage; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) -WEB, regulatory authority number AT-BASGAGES-2021-21256. An 87-year-old female patient received bnt162b2 (vaccine, Batch/Lot number was not reported), intramuscular on 21Feb2021 as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 09Mar2021, the patient experienced death from cerebral haemorrhage. The patient died on 09Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death from cerebral haemorrhage


VAERS ID: 1227505 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   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: ELIQUIS; ZYLORIC; DUODART; OGASTORO; TOREM [TORASEMIDE SODIUM]; SPIRIVA; SERETIDE; TRAJENTA; DAFALGAN; BELOC ZOK; FRESUBIN [CAFFEINE;CARBOHYDRATES NOS;FATS NOS;FIBRE, DIETARY;MINERALS NOS;PROTEINS NOS;VITAMINS NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal insufficiency (unknown severity); Diabetes mellitus; Heart insufficiency (unknown severity); Respiratory insufficiency (unknown severity)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021403593

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable healthcare professional via regulatory authority with regulatory authority report number is CH-SM-2021-13652. An 80-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Mar2021 (Lot Number: EP9605) as a single dose for covid-19 immunisation. Medical history included heart insufficiency (unknown severity), respiratory insufficiency (unknown severity), chronic renal insufficiency (unknown severity) and diabetes mellitus. The patient received the first dose of Comirnaty first dose via intramuscular route of administration on Feb2021 (Lot number: EP9605 [also reported as unknown]) for Covid-19 immunisation but no suspected adverse reactions were reported. It is not known if the patient had allergies. Concomitant medication(s) included apixaban (ELIQUIS); allopurinol (ZYLORIC); dutasteride, tamsulosin hydrochloride (DUODART); lansoprazole (OGASTORO); torasemide sodium (TOREM); tiotropium bromide (SPIRIVA); fluticasone propionate, salmeterol xinafoate (SERETIDE); linagliptin (TRAJENTA); paracetamol (DAFALGAN); metoprolol succinate (BELOC ZOK); and caffeine, carbohydrates nos, fats nos, fibre, dietary, minerals nos, proteins nos, vitamins nos (FRESUBIN), all indication, start and stop date were not reported. The day after the second dose (24Mar2021), in a context of extreme vulnerability (the patient no longer left home), his wife called emergency services at 07:00 am for cardio-respiratory arrest. Death occurred on 24Mar2021. The outcome of the event was fatal. The patient died on 24Mar2021. It was not reported if an autopsy was performed. This case was reported as serious with seriousness criterion results in death. A causality between death and Comirnaty was reported as being unlikely by regulatory authority. Reporter''s comment: Death occurring 24 hours after the 2nd dose Pfizer injection in the context of extreme vulnerability, the patient no longer left his home. His wife called emergency services at 07 a.m. for cardio-respiratory arrest. SENDER''s COMMENT: Death occurred the day after administration of the second dose of Comirnaty vaccine in a very vulnerable 80-year-old male patient. Sudden deaths following Covid-19 mRNA vaccines are not reported neither in this country''s monograph nor in the foreign ones. Even in the literature there are no documented cases of death in causal correlation with these vaccines. The patient was extremely vulnerable in the presence of severe comorbidities and already did not leave home anymore, in particular heart insufficiency, respiratory insufficiency and renal insufficiency. Therefore, in view of the advanced age and the very compromised health status of the patient, given that no adverse reactions of any kind occurred after the first dose, and given that the treating physician hypothesizes a cardiovascular arrest as the cause of death, at the current state of knowledge, despite the temporal correlation of <24h, we assess the causal correlation as unlikely between the vaccine and death.; Reporter''s Comments: Death occurring 24 hours after the 2nd dose Pfizer injection in the context of extreme vulnerability, the patient no longer left his home. His wife called emergency services at 07 a.m. for cardio-respiratory arrest.; Sender''s Comments: Based on the available information, the Company considered there was not a reasonable possibility that the reported event Cardio-respiratory arrest (with fatal outcome) was related to the suspect product Comirnaty (BNT162B2), this 80-year-old patient with severe comorbidities, including heart failure, respiratory and renal insufficiency. The event is more likely related to patient''s undelying conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1227511 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 40
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: 20210202; Test Name: Covid-19 virus test; Result Unstructured Data: Test Result:yes-positive
CDC Split Type: DEPFIZER INC2021398821

Write-up: Unknown cause of death; COVID-19 virus test: yes-positive; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority. The regulatory authority number is DE-PEI-202100032177. A 90-year-old female patient received BNT162B2 (COMIRNATY, lot number and expiration date were unknown) at the age of 90-years-old, via an unspecified route of administration on 27Jan2021 at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. The patient died on 15Mar2021 due to an unknown cause. The patient underwent lab test and procedure which included COVID-19 virus test: yes-positive on 02Feb2021. The outcome of the event COVID-19 was unknown. The patient died on 15Mar2021. The cause of death was unknown. An autopsy was not performed. Relatedness of the drug to unknown cause of death was reported as unclassifiable. No follow-up attempts are possible; information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1227514 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 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: Allergy to antibiotic (such as Doxyfloxacin, Doxycyclin und Novaminsulfon); CABG; Coronary heart disease; Gout; Hypertension; Hypothyreosis; Parkinson''s disease; Renal failure NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021404017

Write-up: died of cerebral haemorrhage 6 days after the 2nd vaccination; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 35043], license party for vaccine. A contactable consumer (relative) reported that a male patient of an unspecified age (reporter''s father in law) received the second dose of bnt162b2 (vaccine), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included Parkinson''s disease, hypertension, coronary heart disease, coronary artery bypass graft (CABG), hypothyreosis, gout, renal failure grade 3, and allergy to several antibiotics such as Doxyfloxacin, Doxycyclin and Novaminsulfon. The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (vaccine) on an unspecified date for COVID-19 immunisation. The patient died of cerebral haemorrhage 6 days after the 2nd vaccination on an unspecified date. It was not reported if an autopsy was performed. Information about the lot/batch number has been requested.; Reported Cause(s) of Death: died of cerebral haemorrhage 6 days after the 2nd vaccination


VAERS ID: 1227701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ROPINIROLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021404941

Write-up: Death; This is a spontaneous report from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104130004534830; Safety Report Unique Identifier: GB-MHRA-ADR 25129126. A contactable consumer reported that a 71-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 04Feb2021 (lot number and expiry date: unknown) at a single dose for COVID-19 immunisation. The patient''s medical history included Parkinson''s disease. Concomitant medications included ropinirole taken for Parkinson''s disease. The patient previously received first dose BNT162B2 of COVID-19 immunisation. The patient underwent lab tests and procedures which included COVID: no - negative on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The consumer reported patient''s death which occurred less than 24 hours post vaccination. The patient died on 04Feb2021 due to an unknown cause. Postmortem was ongoing. Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1227707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Brain death, Cardiac arrest, Cardiac failure, Heart rate, Oxygen saturation, Physical examination, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORIZAL PLUS; VESOMNI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210327; Test Name: blood pressure; Result Unstructured Data: Test Result:160/80; Test Date: 20210327; Test Name: Pulse; Result Unstructured Data: Test Result:62; Test Date: 20210327; Test Name: oxygen saturation; Test Result: 98 %; Test Date: 20210327; Test Name: examination; Result Unstructured Data: Test Result:hemodynamically stable; Comments: without fever, in a good mood; Test Name: rapid COVID-19 test; Test Result: Negative
CDC Split Type: GRPFIZER INC2021409488

Write-up: Lack of cardiac function; Absence of brainstem reflexes; cardiac asystole; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency -WEB (GR-GREOF-20212005). A 63-year-old male patient received the second dose of BNT162B2 (vaccine), intramuscularly, on 27Mar2021 at 12:30 as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine besilate, hydrochlorothiazide, olmesartan medoxomil (ORIZAL PLUS) from 30Oct2017 to 27Mar2021 and solifenacin succinate, tamsulosin hydrochloride (VESOMNI) from 01Nov2019 to 27Mar2021. The patient previously received the first dose of BNT162B2 (vaccine) on 06Mar2021 for COVID-19 immunisation and experienced no side effects. The patient did not receive any other vaccines within 15 days prior to the vaccination. The patient experienced lack of cardiac function, absence of brainstem reflexes, and cardiac asystole on an unspecified date, which were reported as fatal and medically significant. The clinical course was reported as follows: From the examination after vaccination on 27Mar2021, the patient was hemodynamically stable with oxygen saturation: 98% and pulse: 62, without fever, in a good mood, with blood pressure: 160/80 at the time before vaccination. He had not received acetylsalicylic acid (ASPIRIN) or anticoagulants in the past. It was also mentioned that he had never presented any anaphylactic episode in the past and neither injectable drugs had been needed to treat severe allergies. The patient remained in the health center for 15-20 minutes approximately, after the vaccination (following the protocol) and he left with his wife at 13:15. It was confirmed that the patient was transferred to the health center in the emergency department at 19:30 on an unspecified date with cardiac asystole and absence of cerebral reflexes. Cardiopulmonary resuscitation was performed according to the protocol, after repeated defibrillations and intravenous administration of 3 amp of adrenaline (MANUFACTURER UNKNOWN), there was no recovery or any electrocardiographic activity. A rapid COVID-19 test was performed on an unspecified date, which was negative. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on an unspecified date. The cause of death was reported as cardiac failure, brain death, and cardiac asystole. 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: cardiac failure; brain death; cardiac asystole


VAERS ID: 1227708 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, General physical health deterioration, Respiratory tract infection, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   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: Medical History/Concurrent Conditions: AFib; COPD; NIDDM
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Covid 19 Positive via PCR nasal / pharyngeal swab.; Comments: Covid 19 Positive via PCR nasal / pharyngeal swab.; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:did not have any COVID-19 symptoms prior to vaccin
CDC Split Type: IEPFIZER INC2021409428

Write-up: COVID-19/ COVID INFECTION; CONDITION DETERIORATED; RTI; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, IE-HPRA-2021-066081. This is a report received from the regulatory authority. A 90 -year- old male patient received first dose of bnt162b2 (COMIRNATY, Lot Number: EJ6134), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation . Medical history included type 2 diabetes mellitus, atrial fibrillation and chronic obstructive pulmonary disease. There were no concomitant medications. The patient did not have any COVID-19 symptoms prior to vaccination. On 21Jan2021, the patient was vaccinated and It was reported that no adverse reactions were noted post vaccination. On 28Jan2021, the patient tested positive for COVID-19 following a PCR nasal/pharyngeal swab. It was reported that the patient''s condition deteriorated in the days prior to death. The patient was seen by a General Practitioner (GP). The patient was treated for a respiratory tract infection (RTI) with antibiotics, intramuscular Rocephin and oxygen (O2) therapy. However, there were no significant improvements. A palliative care pathway was commenced. On 10Feb2021, at 12.10pm, the patient died. The reported fatal events were Covid-19/COVID infection, condition deteriorated and respiratory tract infection (RTI). On 11Feb2021 a Coroner reported that the patient ''s death occurred as a result of COVID-19 following vaccination with COVID-19 vaccine. Follow-up information was received by the regulatory authority from a healthcare professional on 16Mar2021: It was reported that the patient''s death certificate had been completed as ''''COVID, vaccine related''''. Follow-up attempts are completed. No further information is expected; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-066080 regulatory authority; Reported Cause(s) of Death: COVID-19


VAERS ID: 1227731 (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: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021411383

Write-up: thrombosis/a huge thrombus that they were not able to break and unfortunately obstructed the entrance to the lung; This is a spontaneous report from a contactable consumer received via email. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), on an unspecified date in Mar2021 as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced thrombosis on an unspecified date in Mar2021, which led to death. The patient died on 31Mar2021 and had between 2 1/2 weeks from being vaccinated and the physician commented it was all symptoms from vaccine, he was detected a huge thrombus that they were not able to break and unfortunately obstructed the entrance to the lung he did not suffer from any disease. It was not reported if an autopsy was performed. Information on lot/batch number has been requested.; Reported Cause(s) of Death: big thrombo which obstructed lung entrance


VAERS ID: 1227735 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial flutter, C-reactive protein, Cardiac asthma, Computerised tomogram, Condition aggravated, Left ventricular failure, Pneumonia, Respiratory failure, SARS-CoV-2 test, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   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: BROMFENAC; NITROGLYCERINE; CLOPIDOGREL; DEXAMETHASON [DEXAMETHASONE]; FLUOXETINE; AMLODIPINE; METOPROLOL [METOPROLOL SUCCINATE]; FRAXIPARINE (NADROPARIN CALCIUM); PANTOPRAZOL [PANTOPRAZOLE]; EPLERENONE
Current Illness: Fatigue; Hypertension; Parkinsonism
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac asthma; Chest pain; Fall (possibly with parkinsonism or foot lift paresis with an the emergency room visit after fall); Heart failure; Leg paresis (with an the emergency room visit after fall); Myocardial infarction; Percutaneous transluminal coronary angioplasty
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: CT; Result Unstructured Data: Test Result:extended bilateral infiltrative abnormalities righ; Comments: extended bilateral infiltrative abnormalities right, CORADS 4; Test Date: 20210227; Test Name: CRP; Result Unstructured Data: Test Result:75; Test Date: 20210227; Test Name: Covid test pcr; Test Result: Negative ; Test Date: 20210227; Test Name: leukocyte; Result Unstructured Data: Test Result:11.5
CDC Split Type: NLPFIZER INC2021399040

Write-up: Cardiac asthma; Pneumonia; Atrial flutter; asthma cardiac recurrence with underlying left ventricular function impairment and a pulmonary infection (pneumonia) and atrial flutter with clinical deterioration and respiratory insufficiency; left ventricular function impairment; respiratory insufficiency; This is a spontaneous report from a contactable healthcare professional downloaded from the regulatory authority [Regulatory authority number NL-LRB-00461716]. An 84-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Feb2021 (Batch/Lot Number: EJ6790) as 0.3 mL, single for COVID-19 immunization. Medical history included percutaneous transluminal coronary angioplasty (PTCA) procedure of the left anterior descending coronary artery (LAD) in Jan1992, ongoing hypertension, cardiac asthma, ongoing parkinsonism, ongoing fatigue, infero-lateral infarction in 1992, cardiac failure, and fall possibly with parkinsonism or foot lift paresis (02Feb2021) with an the emergency room visit after fall. Concomitant medications included glyceryl trinitrate (NITROGLYCERINE) taken for chest pain from unknown dates; bromfenac (BROMFENAC), clopidogrel (CLOPIDOGREL), dexamethasone (DEXAMETHASON), fluoxetine (FLUOXETINE), amlodipine (AMLODIPINE), metoprolol succinate (METOPROLOL), nadroparin calcium (FRAXIPARINE); pantoprazol (PANTOPRAZOL) and eplerenone (EPLERENONE) all taken for an unspecified indications and therapy dates. It was reported that the patient was self-reliant before vaccination. Five days after vaccination (27Feb2021), the patient was hospitalized due to cardiac asthma, pneumonia and atrial flutter. During hospitalization, the patient had high infection parameters with C-reactive protein (CRP) of 75 and leukocyte (L) of 11.5 (unit of measure and normal range not provided). The patient had COVID-19 suspected but negative PCR on that same date. Extensive bilateral infiltrative abnormalities on the right side, but CORADS 4 on the CT was noted in Feb2021. The patient''s health deteriorated. The patient deceased 8 days after vaccination (02Mar2021). The cause of death was asthma cardiac recurrence with underlying left ventricular function impairment and a pulmonary infection (pneumonia) and atrial flutter with clinical deterioration and respiratory insufficiency. An autopsy was not performed. The reporter considers the vaccination may have resulted in bilateral pneumonia and the family thinks about the possibility of developing pneumonia. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: asthma cardiac recurrence with underlying left ventricular function impairment and a pulmonary infection (pneumonia) and atrial flutter with clinical deterioration and respiratory insufficiency; clinical deterioration and respiratory insufficiency; a


VAERS ID: 1227737 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-14
Onset:2021-02-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Magnetic resonance imaging
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:
Allergies:
Diagnostic Lab Data: Test Name: MRI scan; Result Unstructured Data: Test Result:unknown
CDC Split Type: NLPFIZER INC2021399129

Write-up: Cerebral hemorrhage; This is as spontaneous report received from a contactable consumer or other non-health professional downloaded from the Medicine Agency (MA) -WEB. The regulatory authority report number is NL-LRB-00479926, Safety report unique identifier NL-LRB-00501383. A 93-year-old male patient received bnt162b2 (vaccine), via an unspecified route of administration on 14Feb2021 (Batch/Lot Number: EJ6789) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebral hemorrhage on 19Feb2021, 5 days after vaccination. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown on an unspecified date. The patient died on an unspecified date due to cerebral hemorrhage. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible. No further information expected. Information on lot# obtained.; Reported Cause(s) of Death: cerebral haemorrhage


VAERS ID: 1227748 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 0
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: Alzheimer''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021398920

Write-up: Fulminant pneumonia; Multiple cardiac arrests; This is a spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) Database-WEB. The regulatory authority report number is PL-URPL-3-470-2021. An 88-year-old male patient received the second dose BNT162B2 (vaccine; lot number: ER2659; expiration date: 06Mar2021) intramuscular, administered on the left arm on 03Mar2021 09:49 at a single dose for COVID-19 immunisation. Medical history included ongoing Alzheimer''s disease. The patient''s concomitant medications were not reported. Date of the reaction on 04Mar2021, at 11:55. In the submitted report of an adverse reaction after vaccination, the following symptoms were listed: Patient admitted to the emergency room in critical condition after multiple sudden cardiac arrests; cardiovascular system supported by norepinephrine infusion, mechanically assisted breathing - respirator. The patient was on day 0 after receiving the 2nd dose of vaccine vaccine against SARS-CoV-2. Postmortem autopsy revealed severe fulminant pneumonia which became the direct cause of the patient''s death. A relationship between the intake of a dose of the vaccine and death seems likely. Relatedness of drug to reactions/events: Pneumonia and cardiac arrest per NCA was considered possible. The patient died on 04Mar2021 due to fulminant pneumonia and multiple sudden cardiac arrests. An autopsy was performed that revealed postmortem autopsy revealed severe fulminant pneumonia, which was the direct cause of the patient''s death. (pneumonia). Reporter comment: A relationship between the intake of a dose of the vaccine and death seems probable. Sender comment: Name of the vaccine vaccine- COVID-19 vaccine (mRNA). Sudden cardiac arrest and severe fulminant pneumonia were unexpected symptoms for vaccine. There was a time relationship between the intake of the second dose of the vaccine and the occurrence of side effects. Cases of cardiac arrest and pneumonia have been reported in the EVDAS database until 06Apr2021. Although the occurrence of severe pneumonia after vaccination, which was the cause of the patient death, raises doubts, the assessment took into account the doctor''s opinion that pneumonia was likely to be associated with the vaccine. The person reporting adverse reaction following immunisation qualified it as serious. ARMP assessed the adverse events as heavy. No follow-up attempts possible. No further information expected.; Reporter''s Comments: A relationship between the intake of a dose of the vaccine and death seems probable.; Reported Cause(s) of Death: Direct cause of the patient''s death - fulminant pneumonia; multiple sudden cardiac arrests; Autopsy-determined Cause(s) of Death: Postmortem autopsy revealed severe fulminant pneumonia, which was the direct cause of the patient''s death.


VAERS ID: 1228050 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bradycardia, Chest pain
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; METOPROLOL; PERINDOPRIL; SOLIFENACINE [SOLIFENACIN]; CLOPIDOGREL; BECLOMETASONE;FORMOTEROL; COLECALCIFEROL; GLICLAZIDE; PRAVASTATIN
Current Illness: Diabetes mellitus; Hypercholesteraemia
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; Coronary bypass
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Bradycardia; Acute chest pain; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (Bradycardia) and CHEST PAIN (Acute chest pain) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. The patient''s past medical history included Cerebrovascular accident and Coronary bypass. Concurrent medical conditions included Hypercholesteraemia and Diabetes mellitus. Concomitant products included PANTOPRAZOLE, METOPROLOL, PERINDOPRIL, SOLIFENACINE [SOLIFENACIN], CLOPIDOGREL, BECLOMETASONE;FORMOTEROL, COLECALCIFEROL, GLICLAZIDE and PRAVASTATIN for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced BRADYCARDIA (Bradycardia) (seriousness criterion death) and CHEST PAIN (Acute chest pain) (seriousness criterion death). The patient died on 25-Mar-2021. The reported cause of death was Cardiac death. 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 reported. Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1228055 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Breast cancer; Chronic obstructive pulmonary disease; Hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1616764386368

Write-up: D?DSFALL; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (D?DSFALL) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3000493 and 3000493) for COVID-19 vaccination. The patient''s past medical history included Asthma, Breast cancer in 2009, Chronic obstructive pulmonary disease and Obesity. Concurrent medical conditions included Diabetes and Hypertension. In February 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. In March 2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. Death occurred in March 2021 The patient died in March 2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant product use was not provided by the reporter. No treatment information was provided. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231470 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Dizziness, Loss of consciousness, Somnolence
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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: MORPHINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No information on risk factors or previous illnesses.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Death; Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.; Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.; Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.), SOMNOLENCE (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.) and DIZZINESS (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No information on risk factors or previous illnesses.). Concomitant products included MORPHINE for an unknown indication. On 24-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.) (seriousness criterion death), SOMNOLENCE (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.) (seriousness criterion death) and DIZZINESS (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.) (seriousness criterion death). The patient died on 24-Jan-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. Within two hours of the vaccination, the patient was no longer normal and was delirious. He kept losing consciousness and gradually became colder and colder until he no longer woke up. No treatment information was provided. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 81-year-old male subject with unknown medical history, who died on the same day after receiving the Moderna COVID-19 vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231481 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   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: SARS-CoV-2 PCR test positive
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20210

Write-up: Malignant ischaemic stroke; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ISCHAEMIC STROKE (Malignant ischaemic stroke) in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 vaccination. The patient''s past medical history included SARS-CoV-2 PCR test positive on 11-Aug-2020. On 26-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 26-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ISCHAEMIC STROKE (Malignant ischaemic stroke) (seriousness criterion death). The patient died on 27-Mar-2021. The reported cause of death was ictus isqu?mico. It is unknown if an autopsy was performed. 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 reported. This is a case of death in a 82-year-old male subject with unknown medical history and history of SARS-CoV-2 PCR test positive on 11-Aug-2020, who died one day after receiving the mRNA-1273 Moderna vaccine. Very limited information has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 82-year-old male subject with unknown medical history and history of SARS-CoV-2 PCR test positive on 11-Aug-2020, who died one day after receiving the mRNA-1273 Moderna vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: ischemic stroke.


VAERS ID: 1231833 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-25
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Respiratory failure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), 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 INC2021418775

Write-up: Dyspnoea; Respiratory failure; Vomiting; This is a spontaneous report from a contactable other health professional via the Medical Agency . Regulatory authority report number is 531342. An 84-year-old male patient received BNT162B2 (vaccine, solution for injection, lot number not provided), via an unspecified route of administration, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 25Mar2021, the patient developed dyspnea, respiratory failure, and vomiting for which he died on unknown 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: Dyspnoea; Respiratory failure; Vomiting


VAERS ID: 1231834 (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: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Areflexia, Drooling, Dysarthria, Lethargy
SMQs:, Peripheral neuropathy (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), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418792

Write-up: Areflexia; Drooling; Dysarthria; Lethargy; This is a spontaneous report from a contactable HCP. This is a report received from Medical Agency. Regulatory authority report number 531686. A 91-year-old patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 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. On 01Apr2021 the patient experienced areflexia, drooling, dysarthria and lethargy. The patient died on an unspecified date in Apr2021. 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: Areflexia; Drooling; Dysarthria; Lethargy


VAERS ID: 1231835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-02
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021418793

Write-up: Depressed level of consciousness; This is a spontaneous report from a contactable other health professional via the Medical Agency. Regulatory authority report number is 531705. A 73-year-old male patient received BNT162b2 (vaccine, Lot # unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced a depressed level of consciousness on 02Apr2021. The event was serious as fatal. It was unknown whether 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


VAERS ID: 1231836 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418794

Write-up: Vomiting; This is a spontaneous report from a contactable other health professional via the Medical Agency. Regulatory authority report number is 532021. A 89-years-old female patient received bnt162b2 (vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fatal vomiting 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. No further information is expected.; Reported Cause(s) of Death: Vomiting


VAERS ID: 1231837 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
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 INC2021418795

Write-up: death; This is a spontaneous report from a contactable other hcp. received from the Medical Agency. Regulatory authority report number 534761. A 100-years- old female patient received BNT162B2 (vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient 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


VAERS ID: 1231838 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021418796

Write-up: Loss of consciousness; This is a spontaneous report from a contactable other health professional via the Medical Agency, Regulatory authority report number: 532790. An 82 years old male patient received BNT162B2 (vaccine, solution for injection) on an unspecified date at single dose, via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient experienced loss of consciousness on an unspecified date which let to patient''s death on an unknown date. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information on batch cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Loss of consciousness


VAERS ID: 1231839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-03
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021418797

Write-up: Concomitant disease aggravated; Pyrexia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 533124. A 69 year-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via an unspecified route of administration on an unspecified date (reported as "3 days") (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 03Apr2021 the patient experienced pyrexia and the aggravation of an unspecified concomitant disease, both reported as fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Concomitant disease aggravated; Pyrexia


VAERS ID: 1231840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-07
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Dyspnoea, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418798

Write-up: Cyanosis; Dyspnoea; Respiratory distress; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 533147. An 82-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route of administration, at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 07Apr2021, the patient died due to cyanosis, dyspnoea and respiratory distress. 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: Cyanosis; Dyspnoea; Respiratory distress


VAERS ID: 1231841 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021418799

Write-up: Depressed level of consciousness; This is a spontaneous report from a contactable other healthcare professional via the Medical Agency. Regulatory authority report number is 533668. A 90-year-old female patient received BNT162b2 (vaccine), via an unspecified route of administration, on 01Apr2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Apr2021, three days after vaccination, the patient experienced depressed level of consciousness resulting in death on 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: Depressed level of consciousness


VAERS ID: 1231868 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Axillary abscess; Chronic kidney disease stage 3; Diabetes mellitus; Dysphagia; Hypertensive cardiomyopathy; Metabolic syndrome; Peripheral arterial disease; Polyneuropathy; Spinal cord injury; Stroke
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Septic shock; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021. This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SEPTIC SHOCK (Septic shock) in a 69-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000496) for COVID-19 vaccination. Concurrent medical conditions included Spinal cord injury, Polyneuropathy, Diabetes mellitus, Dysphagia, Stroke, Hypertensive cardiomyopathy, Atrial fibrillation, Peripheral arterial disease, Metabolic syndrome, Chronic kidney disease stage 3 and Axillary abscess since February 2021. On 09-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) at an unspecified dose. On 14-Mar-2021, the patient experienced SEPTIC SHOCK (Septic shock) (seriousness criterion death). The patient died on 14-Mar-2021. The reported cause of death was Septic shock. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered SEPTIC SHOCK (Septic shock) to be unlikely related. Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.; Reported Cause(s) of Death: Septic shock


VAERS ID: 1231874 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute pulmonary oedema, Atrial fibrillation, Cardiac failure acute, Delirium, Dyspnoea, Hypotension, Pneumonia, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   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: ELIQUIS; ASPIRIN CARDIO; TOREM [TORASEMIDE]; QUETIAPIN MEPHA; METOPROLOL MEPHA ZOK
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Anemia normochromic (Date of diagnosis unknown.); Cardiomyopathy (Date of diagnosis unknown. Severe valvular and rhythmogenic cardiomyopathy with highly restricted left ventricular ejection fraction.); Chronic renal impairment (Status G4 (KDIGO)); Dementia (Date of diagnosis unknown.); Heart insufficiency (Date of diagnosis unknown. Severe valvular and rhythmogenic cardiomyopathy with highly restricted left ventricular ejection fraction.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021416450

Write-up: Acute AKI II on chronic renal failure (aetiology acute: prerenal IR chornic severe heart failure).; acute biventricular decompensation with pulmonary edema in hypertensive decompensation and tachycardic atrial fibrillation; bilateral pneumonia; acute biventricular decompensation with pulmonary edema in hypertensive decompensation and tachycardic atrial fibrillation; Dyspnea, hypotension, tachycardia; Dyspnea, hypotension, tachycardia; Dyspnea, hypotension, tachycardia; acute biventricular decompensation with pulmonary edema in hypertensive decompensation and tachycardic atrial fibrillation; hyperactive delir since 26Mar2021; This is a spontaneous report received from a contactable other HCP via the regulatory authority. Regulatory authority report number CH-SM-2021-14218. A 85-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Mar2021 (Batch/Lot Number: Unknown) as single for Covid-19 immunisation . Medical history included renal impairment (Status G4 KDIGO) , cardiomyopathy (Date of diagnosis unknown). Severe valvular and rhythmogenic cardiomyopathy with highly restricted left ventricular ejection fraction , cardiac failure (Date of diagnosis unknown). Normochromic anaemia (Date of diagnosis unknown) , dementia (Date of diagnosis unknown) , hypersensitivity. On 23Feb2021 the patient received the first dose of BNT162B2 without adverse effects. Concomitant medication(s) included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN CARDIO) taken for an unspecified indication, start and stop date were not reported; torasemide (TOREM) taken for an unspecified indication, start and stop date were not reported; quetiapine fumarate (QUETIAPIN MEPHA) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (METOPROLOL MEPHA ZOK) taken for an unspecified indication, start and stop date were not reported. Five days later, on 29Mar2021, dyspnea, tachycardia, hypotension and acute on chronic renal failure (AKI II) of prerenal etiology (severe chronic heart failure) were detected on admission to the hospital. Bilateral pneumonia was also observed and treated with antibiotics during hospitalization. During her stay in hospital, she suffered from hyperactive delirium on pre-existing dementia and acute biventricular decompensation with pulmonary edema with hypertensive peak and tachycardic atrial fibrillation. The patient died on 02Apr2021; no autopsy was performed. Acute renal failure, cardiac failure, pneumonia and acute pulmonary edema were considered cause of death. A causal relationship between Comirnaty and Death, Hypotension, Acute renale failure, Tachycardia, Dyspnoea, Acute heart failure, Hyperactive delirium, Bilateral pneumonia, Atrial fibrillation and Acute pulmonary oedema was assessed as being unlikely. No symptoms found in this patient are reported among the side effects in the RA of Comirnaty. The database, of 198,115 reports to the Comirnaty monograph, reports, 1,682 cases of death, 5,762 cases of dyspnea, 1,141 cases of hypotension, 3584 cases of tachycardia, 30 cases of pneumonia, 115 cases of acute renal failure, 2 cases of acute heart failure, 408 of atrial fibrillation, 3 of hyperactive delirium, 36 cases of acute pulmonary edema. In the light of these data and the available information, considering the age and comorbidities of the patient, we believe that all the acute symptoms reported may be related to complications in relation to bilateral pneumonia and pre-existing cardiac and renal failure. For this reason, despite the excellent temporal correlation, we believe that a direct correlation between the symptomatology developed by the patient and her subsequent death with Comirnaty is unlikely. However, this judgment of causality does not completely exclude the role of the vaccine.; Reporter''s Comments: Death on 02Apr2021 of 85 years old patient, second dose of Comirnaty 23Mar2021 and 5 days after hospitalization with dyspnea, tachycardia, hypotension and acute on chronic renal failure (AKI II) of pre-existing etiology (chronic heart failure). During hospitalization bilateral pneumonia, hyperactive delirium on pre-existing dementia, acute biventricular decompensation with pulmonary edema and hypertensive peak, tachycardic atrial fibrillation. Autopsy not performed.; Reported Cause(s) of Death: Acute pulmonary oedema; Pneumonia; Cardiac failure; Renal failure


VAERS ID: 1231917 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-17
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-04-20
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: 2021-02-17
   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: DEPFIZER INC2021398837

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-202100032182. An 89-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration on 22Jan2021 (at the age of 89years) as 0.3 mL, single for Covid-19 immunization. The patient received the first dose of Comirnaty on 31Dec2020 for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 17Feb2021, the patient experienced unknown cause of death. The patient died on 17Feb2021. An autopsy was not performed. Relatedness of drug to reaction(s)/event(s) (Source of assessment: PEI); Result of Assessment: D (Unclassifiable). No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231918 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409258

Write-up: Apoplexy; This is a spontaneous report received from a non-contactable physician downloaded from the Medicine Agency (MA) -WEB. The regulatory authority report number is DE-PEI-202100032667. An 81-year-old female patient received bnt162b2 (vaccine), via an unspecified route of administration on 20Mar2021 (Lot Number: ER7812) at age of 81 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced apoplexy (death, hospitalization, life threatening) on 27Mar2021. The patient''s outcome was fatal for Apoplexy. The patient died on 07Apr2021. It was not reported if an autopsy was performed. The causality assessment for suspect drug to event was reported as follows: Source of assessment was PEI, Result of Assessment was D. Unclassifiable. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: ischaemischer Apoplex


VAERS ID: 1231921 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adipositas (Grad 3); Diabetes mellitus; Diabetic polyneuropathy (Grad 3); Gammopathy; Plasmacytoma; Renal insufficiency (Grade 3)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409242

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority. The regulatory authority report number is DE-PEI-202100032675. An 85-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 27Mar2021 (Lot Number: ER7812) at age of 85 years old as single dose for covid-19 immunisation. Medical history included ongoing diabetic polyneuropathy grad 3, ongoing plasmacytoma, ongoing diabetes mellitus, ongoing adipositas grad 3, ongoing gammopathy, ongoing renal insufficiency grade 3. The patient''s concomitant medications were not reported. On 31Mar2021 the patient experienced unknown cause of death. The patient died on 31Mar2021. An autopsy was not performed. The causality assessment for suspect drug to event was reported as follows: Source of assessment was regulatory authority, Result of Assessment was D. Unclassifiable. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231922 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409226

Write-up: Death; Vaccination reaction; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-202100032678. An 83-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 25Mar2021 (Lot Number: ER7812) at age of 83 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Mar2021 at age of 83 years old as single dose for covid-19 immunisation. On 25Mar2021 the patient experienced vaccination reaction. On 26Mar2021 the patient experienced unknown cause of death. The patient''s outcome was not recovered for impfreaktion, fatal for unknown cause of death. The patient died on 26Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231928 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Coronary heart disease; Diabetes mellitus; Hyperparathyroidism; Kidney failure; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409164

Write-up: Unknown cause of death; asystole; Occurrence of shortness of breath/Difficulty breathing; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority WEB, regulatory authority number DE-PEI-CADR2021044735, Safety Report Unique Identifier DE-PEI-202100032434. A 76-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 07Apr2021 12: 30 (Lot Number: EW8904) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing Coronary heart disease, ongoing Renal insufficiency, ongoing Arterial hypertension, ongoing Hyperparathyroidism, ongoing Diabetes mellitus, ongoing preterminal kidney failure. The patient''s concomitant medications were not reported. On 08Apr2021, the patient experienced occurrence of shortness of breath/ Difficulty breathing, asystole (medical significant), Unknown cause of death (death). The patient died on 08Apr2021. It was unknown if an autopsy was performed. It was reported that Information on risk factors or previous illnesses CHD, diabetes mellitus, preterminal kidney failure, arterial hypertension, secondary HPT / normal course with no symptoms after administration of the vaccine at 12:30 p.m. 07Apr2021 until late. Afternoon (until the son is present), Between 2 and 3 o''clock in the morning, those affected call their son with rattling breathing, asystole when the PRIVACY arrives, foamy, whitish sputum. No concerned known of any allergies. The outcome of cause of death unknown was fatal, of the other events was not recovered. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231929 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Influenza, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   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: Schizophrenia; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021409168

Write-up: COVID-19 PCR test positive; 06Mar21 died of virus flu with proven Covid-19 infection; Influenza A virus infection from Mar2021; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority, regulatory authority number is DE-PEI-CADR2021044761. Safety report unique identifier DE-PEI-202100032456. A 71-year-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 24Feb2021 (Lot Number: EP9598) as 0.3 mL, single for COVID-19 immunisation. Medical history included schizophrenia; type 2 diabetes mellitus and all unknown if ongoing. The patient''s weight was 70 kg, and height was 167 cm. Concomitant medications were not reported. The patient died of virus flu with proven covid-19 infection (unknown cause of death) on 06Mar2021. He had Influenza A virus infection from Mar2021. And he had cough on 04Mar2021 (2 days before death). Pulmonological clinically normal. The patient underwent lab tests and procedures which included COVID-19 PCR test with result of positive. The patient died on 06Mar2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Influenza A virus infection; Unknown cause of death; COVID-19 PCR test positive


VAERS ID: 1231930 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-09
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: Apoplexy; Arterial hypertension; Dementia; Depression; Hemiparesis; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409214

Write-up: Despite Covid-19 vaccination on 24Feb2021, the patient died according to the death certificate on 21Mar2021 of viral pneumonia with proven COVID-19 infection.; proven COVID-19 infection; vaccination on 24Feb2021, Covid-19 on 09Mar2021; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Agency-WEB DE-PEI-CADR2021044771, Safety Report Unique Identifier DE-PEI-202100032478. An 88-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly on 24Feb2021 (Lot Number: EP9598) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing arterial hypertension, ongoing depression, ongoing osteoporosis, ongoing apoplexy, ongoing dementia, ongoing hemiparesis. The patient''s concomitant medications were not reported. On 09Mar2021 the patient experienced pneumonia viral NOS, COVID-19. Despite Covid-19 vaccination on 24Feb2021, the patient died according to the death certificate on 21Mar2021 of viral pneumonia with proven COVID-19 infection. The patient''s outcome was fatal for Pneumonia viral NOS, not recovered for COVID-19. The patient died on 21Mar2021. An autopsy was not performed. Sender''s comments: "Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses: known dementia, depression, condition after apoplexy with hemiparesis, arterial hypertension, osteoporosis / 09Mar21 cough, pulmonary increased vesicular breathing, weakness". The PEI assessed Pneumonia viral NOS and COVID-19 were D. Unclassifiable. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Pneumonia viral NOS


VAERS ID: 1231931 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-08
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Circulatory collapse, Drug ineffective, Respiratory tract infection viral, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   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: Arterial hypertension; Chronic renal insufficiency; Coronary heart disease; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409172

Write-up: cardiovascular failure/Sudden cardiac death; cardiovascular failure/Sudden cardiac death; COVID-19; COVID-19; Viral infection of the respiratory tract; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) -WEB, regulatory authority number DE-PEI-CADR2021044779, Safety Report Unique Identifier DE-PEI-202100032482. A 74-year-old female patient received bnt162b2 (Pfizer vaccine, Solution for injection), intramuscular on 24Feb2021 (Lot Number: EP9598) as single dose for covid-19 immunisation. Medical history included ongoing Chronic renal insufficiency, ongoing Coronary heart disease, ongoing Arterial hypertension, ongoing Type 2 diabetes mellitus. The patient''s concomitant medications were not reported. The patient''s weight was 72 kg, and height was 156 cm. On 08Mar2021, the patient experienced Viral infection of the respiratory tract, COVID-19. On 09Mar2021, the patient experienced cardiovascular failure/Sudden cardiac death. The patient died on 09Mar2021. No autopsy was performed. It was reported that Information on risk factors or previous illnesses arterial hypertension, coronary heart disease, Diabetes mellitus type 2, chronic renal insufficiency / one day before death in general. physical weakness, Pulmo exacerbated vesicular breathing. No concerned have any allergies. Relatedness of drug to reactions was assessed as D. Unclassifiable by PEI. The outcome of the events cardiovascular failure/Sudden cardiac death was fatal, of the other events was not recovered. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: cardiovascular failure; Sudden cardiac death


VAERS ID: 1231936 (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: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Covid-19 test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021404402

Write-up: patient died approximately 1 week after first vaccination; Covid-19 test positive; This is a spontaneous report based on information received by Pfizer from a company [manufacturer control number: 38084], license party for Comirnaty. A non-contactable physician reported that a female patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date in Apr2021 at SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. The patient has been vaccinated with bnt162b2 during Easter holidays. A few days later the COVID-19 test was positive in Apr2021. The patient died approximately 1 week after first vaccination according to the daughter in Apr2021. It was not reported if an autopsy was performed. The outcome of the event COVID-19 test was positive was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. COVID-19 is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: patient died approximately 1 week after first vaccination


VAERS ID: 1231937 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-09
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409750

Write-up: infection; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 38624], license party for vaccine. This case referred to the female patient. A female patient of an unspecified age received bnt162b2 (vaccine), via an unspecified route of administration on 17Mar2021 08:00 (Batch/Lot Number: ER7812) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced infection (death) on 09Apr2021. The patient died on 09Apr2021. It was not reported if an autopsy was performed. Following was reported by a contactable physician: "My parents were vaccinated with COMIRNATY Ch.-B.: ER7812 on March, 17 th 2021 at 8:00 am. Neither of them had any acute illness. Both died on April, 09 th as a consequence of an infection (similar symptoms )."; Sender''s Comments: Based on limited data given, the event "infection" is assessed as possibly related to vaccine. 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) : DE-PFIZER INC-2021409762 same Reporter, other patient, same event; Reported Cause(s) of Death: infection


VAERS ID: 1231938 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409762

Write-up: infection; This is a spontaneous report based on information received by Pfizer from a company [manufacturer control number: 38404], license party for Comirnaty. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Mar2021 08:00 (Lot Number: ER7812) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced infection on an unspecified date. The patient died on 09Apr2021. It was not reported if an autopsy was performed. The outcome of event infection was fatal.; Sender''s Comments: The Company considered there was not a reasonable possibility that the reported event Infection (with fatal outcome) was related to the suspect product BNT162B2 (COMIRNATY).,Linked Report(s) : DE-PFIZER INC-2021409750 same Reporter, other patient, same event; Reported Cause(s) of Death: infection


VAERS ID: 1231939 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021416607

Write-up: sudden death; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 40262], license party for Pfizer vaccine. A male patient of an unspecified age received bnt162b2 (Pfizer vaccine), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient suddenly died on 13Apr2021. It was not reported if an autopsy was performed. The information on the batch number has been requested; Sender''s Comments: Based on the limited information provided, temporal association and per company relatedness guidance the event "sudden death" is considered related to suspect product bnt162b2 (Pfizer vaccine), at this time in this patient. This case will be reassessed should additional information become available especially the cause of death. 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: Sudden death


VAERS ID: 1231944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-04-01
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMOXICILLIN TRIHYDRATE
Current Illness: Lung disorder (FEV 45% and FVC 47%, test results from 2019)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: FEV; Test Result: 45 %; Test Date: 2019; Test Name: FVC; Test Result: 47 %
CDC Split Type: DKPFIZER INC2021409079

Write-up: Difficulty breathing; Hypoxic arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number DK-DKMA-WBS-0061121. A 54-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EP9605; Expiration Date: Jun2021) as single dose for covid-19 immunisation. Medical history included ongoing lung disorder FEV 45% and FVC 47%, test results from 2019. Concomitant medication(s) included amoxicillin trihydrate for pneumonia from 27Mar2021 to 01Apr2021. There is no information regarding past medication. The patient experienced hypoxic arrest on 01Apr2021, the event was reported as being Fatal; difficulty breathing on 2021 and was hospitalised. No treatment or medical procedure due to the ADRs were reported. Hypoxic arrest was fatal and the outcome of Difficulty breathing was unknown. The patient died on 01Apr2021. Reported cause of death was Hypoxic arrest. An autopsy was not performed. Causality: The reporter stated that the death has been reported to the police, but the police do not wish to proceed with an inquest. The physician reported this case due to the correlation in time between vaccine and fatale outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hypoxic arrest


VAERS ID: 1231946 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-03-21
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Respiratory failure, 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), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm aortic; Cardiac insufficiency; Chronic obstructive pulmonary disease; Hemodialysis; Hypertension not adequately controlled; Permanent atrial fibrillation; Terminal renal insufficiency (has been receiving hemodialysis for many years)
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: EEPFIZER INC2021398140

Write-up: Death; Respiratory failure; COVID-19/ SARS-CoV-2 PCR test was positive; Vaccination failure/ SARS-CoV-2 PCR test was positive; This is as spontaneous report received from a contactable Physician downloaded from the regulatory authority. The Regulatory Authority report number is EE-SAM-29862103261. A 72-year-old male patient received BNT126B2 (COMIRNATY), first dose intramuscular on 15Jan2021 (Batch/Lot number was not reported) as 0.3 mL, single and second dose intramuscular on 05Feb2021 (Batch/Lot number was not reported) as 0.3 mL, single for COVID-19 immunisation. Medical history included Aneurysm aortic, Cardiac insufficiency, Hypertension not adequately controlled, Permanent atrial fibrillation, Terminal renal insufficiency (has been receiving hemodialysis for many years), chronic obstructive pulmonary disease (COPD). The patient''s concomitant medications were not reported. The patient was vaccinated with the two doses of Comirnaty vaccine (on January 15th and February 5th). SARS-CoV-2 PCR test was positive on 21Mar2021. The patient is in the hospital since 21Mar2021, with severe respiratory failure. Exitus letalis 25 March 2021. Serious side effects, as a result of the ineffectiveness of the vaccine, the patient became ill with COVID-19. The patient died on 25Mar2021. It was not reported if an autopsy was performed. The causal link is considered possible. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death; Respiratory failure; COVID-19/ SARS-CoV-2 PCR test was positive; Vaccination failure/ SARS-CoV-2 PCR test was positive


VAERS ID: 1234324 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-11-01
Onset:2021-03-24
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Aspartate aminotransferase, Blood creatinine, Blood glucose, Blood potassium, Blood sodium, Blood urea, Cerebral haemorrhage, Computerised tomogram head, Electrocardiogram, Haematocrit, Haemoglobin, International normalised ratio, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Platelet count, Plateletcrit, Prothrombin time, Red blood cell count, Red cell distribution width, SARS-CoV-2 test, Thrombin time, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VALSARTAN/HIDROCLOROTIAZIDA KERN PHARMA; LYRICA; MEMANTINE HYDROCHLORIDE; ARICEPT; SINTROM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (treated with Aricept 10mg/d and Memantine 10mg/d); Chronic renal insufficiency; Cognitive impairment; Deep venous thrombosis femoral (for which she is anticoagulated with Sintrom); Hypertension (treated with valsartan/hdcltz Kern 160/25mg); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: aPTT; Result Unstructured Data: Test Result:1.01; Comments: RATIO; Test Date: 20210324; Test Name: ALT (GPT); Result Unstructured Data: Test Result:17 uiU/L; Test Date: 20210324; Test Name: AST (GOT); Result Unstructured Data: Test Result:20 uiU/L; Test Date: 20210324; Test Name: creatinine; Result Unstructured Data: Test Result:119 umol/l; Comments: 1.35 mg/100mL; Test Date: 20210324; Test Name: glucose; Result Unstructured Data: Test Result:6.8 mmol/L; Comments: 123.12 mg/100mL; Test Date: 20210324; Test Name: potassium; Result Unstructured Data: Test Result:4.5 mmol/L; Test Date: 20210324; Test Name: sodium; Result Unstructured Data: Test Result:140 mmol/L; Test Date: 20210324; Test Name: Urea; Result Unstructured Data: Test Result:10.3 mmol/L; Comments: 62 mg/100mL; Test Date: 20210324; Test Name: cranial CT; Result Unstructured Data: Test Result:extensive left frontoparietal lobar hematoma; Comments: showed extensive left frontoparietal lobar hematoma, very heterogeneous and with multiple satellite bleedings accompanied by perihemorrhagic edema and subarachnoid hemorrhage content, it causes a subfalcial herniation to the right of 1 cm without ventricular involvement; Test Date: 20210324; Test Name: ECG; Result Unstructured Data: Test Result:Sinus rhythm at 60 bpm; Comments: QRS greater than 120ms with complete right bundle branch block morphology and associated repolarization alterations; Test Date: 20210324; Test Name: Hematocrit; Result Unstructured Data: Test Result:0.39 L/L; Test Date: 20210324; Test Name: hemoglobin; Result Unstructured Data: Test Result:128 g/l; Test Date: 20210324; Test Name: INR; Result Unstructured Data: Test Result:unknown; Test Date: 20210324; Test Name: MCH; Test Result: 30.8 pg; Test Date: 20210324; Test Name: MCHC; Result Unstructured Data: Test Result:329 g/l; Test Date: 20210324; Test Name: MCV; Result Unstructured Data: Test Result:93.7 fL; Test Date: 20210324; Test Name: MPV; Result Unstructured Data: Test Result:9.3 fL; Test Date: 20210324; Test Name: Platelets; Result Unstructured Data: Test Result:218 x10 9/l; Test Date: 20210324; Test Name: Plateletcrit; Test Result: 0.30 %; Test Date: 20210324; Test Name: Prothrombin time; Result Unstructured Data: Test Result:1.87; Test Date: 20210324; Test Name: Red cells; Result Unstructured Data: Test Result:4.15 x10 12/l; Test Date: 20210324; Test Name: RDW; Test Result: 13.3 %; Test Date: 20210128; Test Name: SARS-CoV-2 test negative; Result Unstructured Data: Test Result:negative; Test Date: 20210324; Test Name: SARS-CoV-2 test negative; Result Unstructured Data: Test Result:negative; Test Date: 20210324; Test Name: Thrombin time; Test Result: 25.50 s; Test Date: 20210324; Test Name: Leukocytes; Result Unstructured Data: Test Result:9.62 x10 9/l
CDC Split Type: ESPFIZER INC2021409283

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number ES-AEMPS-819699. A 85-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 24Mar2021 (Batch/Lot Number: ET7205) as 0.3 mL, single for covid-19 immunisation; acenocoumarol (SINTROM), oral from Nov2020 to an unspecified date, at 4 mg, 1x/day for deep vein thrombosis. Medical history included hypertension treated with valsartan/hdcltz Kern 160/25mg, type 2 diabetes mellitus, Alzheimer''s disease treated with Aricept 10mg/d and Memantine 10mg/d, chronic kidney disease, femoropopliteal Thrombosis deep vein from Nov2020 to an unknown date for which she is anticoagulated with Sintrom, moderate-severe cognitive impairment reported as on a socio-functional level, she lives at home with her husband, has a caregiver, is dependent for basic activities of daily life and has moderate-severe cognitive impairment. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN/HIDROCLOROTIAZIDA KERN PHARMA) taken for hypertension from 30Jul2020 to an unspecified stop date; pregabalin (LYRICA); memantine hydrochloride (MEMANTINE HYDROCHLORIDE) taken for dementia alzheimer''s type; donepezil hydrochloride (ARICEPT). The patient previously took the first dose of comirnaty (lot number: ET1831) on 03Mar2021 for covid-19 immunisation. The patient experienced cerebral haemorrhage (hemorrhage of the brain) on 24Mar2021. On 24Mar2021, after waking up well and having been vaccinated with the second dose of the Pfizer vaccine, she suddenly presented around 10:30 am with the onset of right hemiparesis and speech impairment. Event reported as serious with hospitalization and fatal outcome. The patient was hospitalized for cerebral haemorrhage from 24Mar2021 to an unknown date. In the emergency room, vitamin K and prothrombinic complex were administered. Admission to Neurology was decided. On arrival at the Neurology ward: low level of consciousness, with Glasgow Coma Scale of 5 (O2, V1, M2), forced oculocephalic deviation to the right, no speech or commands, right hemiplegia. Given the seriousness of the situation and the probable poor short-term vital prognosis, palliative medication was started. The patient underwent lab tests and procedures which included all on 24Mar2021: on arrival at the emergency room: Drowsy; disoriented. She is 3/3 and understands simple but not complex commands. Ocular preference to the left - Right homonymous hemianopsia by threat - right facial asymmetry - Brachial (0/5) - crural (2/5) right hemiparesis. Blood test: activated partial thromboplastin time (aPTT): 1.01 RATIO (0.75-1.30), alanine aminotransferase (GPT): 17 uiU/L (0-31), aspartate aminotransferase (GOT): 20 uiU/L (0-31), blood creatinine: 119 umol/l (1.35 mg/100mL) (50-98), blood glucose: 6.8 mmol/l (123.12 mg/100mL) (3.0-6.0), blood potassium: 4.5 mmol/l (3.50-5.10), blood sodium: 140 mmol/l (136-145), blood urea: 10.3 mmol/l (62 mg/100mL) (2.9-8.2), haematocrit: 0.39 L/L (0.35-0.45), haemoglobin: 128 g/l (120-150), Red cells: 4.15 x10E12/L (3.90-5.00), MCV: 93.7 fL (80.0-98.0), MCHC: 329 g/L (320 -360), MCH: 30.8 pg (27.0-32.0), RDW: 13.3% (12.0-15.0), Platelets: 218 x10E9/L (140-350), MPV: 9.3 fL (7.0-10.5), Plateletcrit: 0.30%, Leukocytes: 9.62 x10E9/L (3.80-11.00), Prothrombin time: 1.87, INR: unknown (0.75-1.20), Thrombin time: 25.50 s (17.00-24.00), SARS-CoV-2 test negative (PCR): negative (previous on 28Jan2021 negative). Cranial CT scan (computerised tomogram head): showed extensive left frontoparietal lobar hematoma, very heterogeneous and with multiple satellite bleedings accompanied by perihemorrhagic edema and subarachnoid hemorrhage content, it causes a subfalcial herniation to the right of 1 cm without ventricular involvement. ECG (electrocardiogram): sinus rhythm at 60 bpm, QRS greater than 120ms with complete right bundle branch block morphology and associated repolarization alterations. The action taken in response to the event for acenocoumarol was not applicable. The patient died on 28Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hemorrhage of the brain


VAERS ID: 1234326 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal X-ray, Abdominal discomfort, Activated partial thromboplastin time, Alanine aminotransferase, Amylase, Blood creatinine, Blood gases, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Chest X-ray, Computerised tomogram, Dyspnoea, Electrocardiogram, Fibrin D dimer, Haemoglobin, Heart rate, PCO2, PO2, Platelet count, Prothrombin time, Pulmonary embolism, Pyrexia, SARS-CoV-2 test, Urine analysis, Vomiting, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIMVASTATINA NORMON; DISTRANEURINE [CLOMETHIAZOLE]; BUSCAPINA; CARVEDILOL; VIPDOMET; ADIRO; NABILA [MEMANTINE HYDROCHLORIDE]; OPTOVITE B12; PARACETAMOL; DELTIUS; ASTUDAL; PARIZAC [OMEPRAZOLE]; UNIKET; PREDNISONA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute coronary syndrome (Acute coronary syndrome without ST elevation); Alcohol use (drinks a glass of wine a day); Appendectomy; Arterial stenosis (Mild carotid stenosis); B12 deficiency anemia; Chondropathy (Patellar chondropathy I.); Clostridium difficile infection (Admission in 2015 to facility for Clostridium difficile disease.); Dyslipidemia; Essential tremor; Ex-smoker (Former smoker of 20 c/day, for more than 30 years); Gait disorder; Myelopathy cervical (with pyramidal syndrome in the lower limbs and a probable component of neuropathy and steroid myopathy in the lower limbs.); Polymyalgia rheumatica; Rheumatoid arthritis; Rib fracture; Triple vessel disease (previous mean, Stable, partially revascularized three-vessel coronary disease having performed angioplasty with Zotarolimus STENT on Descending anterior proximal. performing descending STENT.); Type II diabetes mellitus (Oral anti-diabetics); Unstable angina
Allergies:
Diagnostic Lab Data: Test Name: abdomen x-ray; Result Unstructured Data: Test Result:no levels, distended loops of large I; Comments: no levels, distended loops of large I; Test Name: Activated partial thromboplastin time; Result Unstructured Data: Test Result:0.78; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:18; Test Name: urine; Result Unstructured Data: Test Result:28.0; Comments: ISOLATED URINE AMYLASE 28.0; Test Name: creatinine; Result Unstructured Data: Test Result:1.5; Test Name: blood gas; Result Unstructured Data: Test Result:pH 7.433, pCO2 33.2, pO2 69.1; Comments: Arterial blood gas: pH 7.433, pCO2 33.2, pO2 69.1; Test Name: glu; Result Unstructured Data: Test Result:186; Test Name: Lactatodehydrogenase; Result Unstructured Data: Test Result:223; Test Name: potassium; Result Unstructured Data: Test Result:4; Test Name: blood pressure; Result Unstructured Data: Test Result:123/80 mmHg; Test Name: sodium; Result Unstructured Data: Test Result:140; Test Name: urea; Result Unstructured Data: Test Result:71; Test Date: 20210311; Test Name: body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Test Name: chest x-ray; Result Unstructured Data: Test Result:No acute pleuropulmonary alterations.; Comments: No acute pleuropulmonary alterations. Fracture callus in the left sixth costal arch.; Test Date: 20210313; Test Name: Computerized axial tomography; Result Unstructured Data: Test Result:No parenchymal condensations suggestive of COVID i; Comments: Repletion effects in segmental artery subsegmental anterior segment Right upper lobe in relation to acute pulmonary embolism thrombus, I do not see filling defects in main pulmonary arteries or in left hemithorax arteries, calcified plaques in coronary arteries. No parenchymal condensations suggestive of COVID infection.; Test Name: C-reactive protein; Result Unstructured Data: Test Result:24; Test Name: ecg; Result Unstructured Data: Test Result:Sinus ECG with Q in III; Test Name: ddimer; Result Unstructured Data: Test Result:10000; Test Name: hb; Result Unstructured Data: Test Result:15.8; Test Name: heart rate; Result Unstructured Data: Test Result:91; Comments: bpm; Test Name: pCO2; Result Unstructured Data: Test Result:33.2; Comments: Arterial blood gas: pH 7.433, pCO2 33.2, pO2 69.1; Test Name: pH; Result Unstructured Data: Test Result:7.433; Comments: Arterial blood gas: pH 7.433, pCO2 33.2, pO2 69.1; Test Name: platelets; Result Unstructured Data: Test Result:171000; Test Name: pO2; Result Unstructured Data: Test Result:69.1; Comments: Arterial blood gas: pH 7.433, pCO2 33.2, pO2 69.1; Test Name: Prothrombin time; Result Unstructured Data: Test Result:1.16; Test Name: Sars antigen; Test Result: Negative ; Comments: SARS Antigen test: Negative; Test Name: SARS-cov-2 PCR; Result Unstructured Data: Test Result:Pending; Test Name: urine; Result Unstructured Data: Test Result:118.0; Comments: URINE COCENT AMYL/CREA URINE 118.0 U/g (58.0 - 283.0); Test Name: white blood cells; Result Unstructured Data: Test Result:12100
CDC Split Type: ESPFIZER INC2021409370

Write-up: Vomited; Lung embolism; Sudden dyspnea; FEVER 37.6?C; DYSNEA WITH ABDOMINAL WORK; Abdominal distress; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA). The regulatory authority report number is ES-AEMPS-821095. An 87-years-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 10Mar2021 (Lot Number: ET1831) as single dose for covid-19 immunisation. Medical history included Former smoker of 20 c / day, for more than 30 years. He drinks a glass of wine a day. type 2 diabetes mellitus (Oral anti-diabetics). Dyslipidemia. Admission in 2015 to facility for Clostridium difficile disease. Acute coronary syndrome without ST elevation (2008). Previous mean. Stable, partially revascularized three-vessel coronary disease (2016). 3-vessel coronary disease having performed angioplasty with Zotarolimus STENT on Descending. Severe 3-vessel coronary disease performing descending STENT. anterior proximal. Unstable angina (2009). Rib fracture (2005). Rheumatoid arthritis.Polymyalgia rheumatica in Internal Medicine Consultation with B12 deficiency. Mild carotid stenosis. Essential tremor. Known from the Neurology consultation due to multifactorial gait disorder, cervicoarthrosic myelopathy with pyramidal syndrome in the lower limbs and a probable component of neuropathy and steroid myopathy in the lower limbs. Cognitive impairment Surgery: Appendectomy. Patellar chondropathy I. Concomitant medications included simvastatin (SIMVASTATINA NORMON); clomethiazole (DISTRANEURINE); hyoscine butylbromide (BUSCAPINA); carvedilol; alogliptin benzoate, metformin hydrochloride (VIPDOMET); acetylsalicylic acid (ADIRO); memantine hydrochloride (NABILA); cyanocobalamin (OPTOVITE B12); paracetamol; colecalciferol (DELTIUS); amlodipine besilate (ASTUDAL); omeprazole (PARIZAC); isosorbide mononitrate (UNIKET); prednisona. The patient previously took meloxicam and experienced allergy. The patient was admitted for dyspnea and fever with pulmonary embolism on CT. Clostridium studies were requested, anticoagulation was started in the emergency room. A week ago he started with diarrheal stools (he has them frequently). 24 hours ago he received the first dose of the SARS vaccine. It begins with fever, nausea and diarrhea on 11Mar2021 assessed by his Primary Care Physician who initiates buscopan. Today increased dyspnea persisting with fever. Diagnosis was pulmonary embolism, acute fever. Physical examination: Blood pressure 123/80, Heart rate 91 / m, Saturation 93% without O2. I see the patient after CT Angiography, he received agitation sedation. Sleepy, eye opening to the call. Tachypneic, not clear Jugular engorgement, noise of upper respiratory secretions Rhythmic coronary artery Pulmonary artery I do not hear added sounds. Distended abdomen does not seem painful, with abdominal breathing. No edema or sign of deep vein thrombosis in the lower extremities. Glu 186, Urea 71, Creatinine 1,5, EFG 42, Na 140, K 4 , Alanine aminotransferase (or TGP) 18, blood-retinal barrier 1,3, Lactatodehydrogenase 223, TpIUS 108, C-reactive protein 24, Hemoglobin 15,8, Leucocytes 12100, Platelets 171000. COAGULATION: RATE OF THE C.P. 79.0% FIBR 560. Activated partial thromboplastin time 0.78, Prothrombin time 1.16 DDIMER 10000. Arterial blood gas: pH 7.433, pCO2 33.2, pO2 69.1. URINE COCENT AMYL/URINE CREA 118.0 U/g (58.0 - 283.0), URINE ISOLATED AMYLASE 28.0 SEDIMENT 10-15 leukocytes/field. Sinus ECG with Q in III. Chest X-ray: No acute pleuropulmonary alterations. Fracture callus in the left sixth costal arch. Abdominal X-ray, no levels, distended loops of large I. AngioCT: Repletion effects in segmental artery subsegmental anterior segment Right upper lobe in relation to acute pulmonary embolism thrombus, I do not see filling defects in main pulmonary arteries or in left hemithorax arteries, calcified plaques in coronary arteries. No parenchymal condensations suggestive of COVID infection. SARS Antigen test was Negative. SARS-CoV2 PCR pending. Events outcome was fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vomited; Lung embolism; Dyspnea; Febricula; Dyspnea; Abdominal distress


VAERS ID: 1234329 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood creatine phosphokinase, Blood creatinine, Blood pressure measurement, C-reactive protein, Cardio-respiratory arrest, Computerised tomogram, Haemoglobin, Haemorrhagic stroke, International normalised ratio, PCO2, Pneumonia, Pneumonia aspiration, Procalcitonin, Pulmonary sepsis, Red blood cell count, SARS-CoV-2 test, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; COPD; Fibrillation atrial; Hypertension arterial; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210403; Test Name: CT; Result Unstructured Data: Test Result:descriptive; Comments: an acute intraparenchymal hematoma located at the level of the right thalamus and posterior arm of the right internal capsule, with approximate dimensions of 2.8 cm (LL) x 2.3 cm (AP) x 3 , 2 cm (CC). It is accompanied by minimal perilesional edema. It exerts a slight mass effect, with a deviation of the midline about 7 mm to the right; Test Name: CRP; Result Unstructured Data: Test Result:101.8 mg/l; Test Date: 20210403; Test Name: CRP; Result Unstructured Data: Test Result:73.1 mg/l; Test Name: Hb; Result Unstructured Data: Test Result:12.8 g/dl; Test Date: 20210403; Test Name: Hb; Result Unstructured Data: Test Result:12.8 g/dl; Test Name: INR; Result Unstructured Data: Test Result:2.01; Test Date: 20210403; Test Name: INR; Result Unstructured Data: Test Result:2.24; Test Date: 20210403; Test Name: pCO2; Result Unstructured Data: Test Result:33.3; Test Date: 20210403; Test Name: pH; Result Unstructured Data: Test Result:7.45; Test Date: 20210403; Test Name: PCT; Result Unstructured Data: Test Result:0.13; Test Date: 20210403; Test Name: platelets; Result Unstructured Data: Test Result:374000; Test Date: 20210403; Test Name: PCR SARS COV test; Test Result: Negative ; Test Date: 20210403; Test Name: leukocytes; Result Unstructured Data: Test Result:18480; Comments: with shift to the left; Test Date: 20210403; Test Name: hCO3; Result Unstructured Data: Test Result:23; Test Date: 20210403; Test Name: CK; Result Unstructured Data: Test Result:252; Test Name: creatinine; Test Result: 0.84 mg/dl; Test Date: 20210403; Test Name: blood pressure; Result Unstructured Data: Test Result:<180 mmHg; Comments: systolic; Test Name: CT; Result Unstructured Data: Test Result:descriptive; Comments: Gentle increase in size of the acute intraparenchymal hematoma of the right thalamus and posterior arm of the internal capsule, with current dimensions of 3.4 ( CC) x 2.4 (AP) x 3.1 cm (LL) (previously 3.2 x 2.3 x 2.8 cm), with minimal perilesional edema and a similar mass effect on the midline (deviation of approx. 7 mm towards the contralateral side). It also presents an opening to the ventricular system with ventricular hemorrhage in both greater occipital horns on the right side, without hydrocephalus.
CDC Split Type: ESPFIZER INC2021409280

Write-up: Haemorrhagic stroke; Cardiorespiratory arrest; Respiratory sepsis; nosocomial pneumonia; bronchial aspiration; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number is ES-AEMPS-822426. An 80-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Apr2021 (Lot Number: EW2239) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), asthma, hypothyroidism, atrial fibrillation, and hypertension arterial. The patient''s concomitant medications were not reported. The patient was found by his son lying on the floor next to the bed on 02Apr2021, he did not report fever, vomiting. On 03Apr2021: Control cranial CT: Patient with right thalamic hemorrhagic stroke with onset of symptoms the day before yesterday (as reported), a neurosurgery was consulted who rejected treatment for his part, yesterday a control CT scan was performed with a slight increase in bleeding with perilesional edema. Since its passage to observation of a patient with Glasgow Coma Scale: 15/15 persistence of the left hemiparesis, no headache. Hb 12.8 g/dl, platelets 374,000, leukocytes: 18,480 with shift to the left. INR: 2.24. CRP: 73.1, PCT: 0.13, CK: 252; Normal liver profile. Normal kidney profile. pH: 7.45, pCO2: 33.3, HCo3-: 23. Control AS: Hemoglobin 12.8 g/dL Creatinine 0.84 mg/dL 2.01 INR C-reactive protein 101.8 mg/L - First emergency CT. The study carried out showed an acute intraparenchymal hematoma located at the level of the right thalamus and posterior arm of the right internal capsule, with approximate dimensions of 2.8 cm (LL) x 2.3 cm (AP) x 3, 2 cm (CC). It is accompanied by minimal perilesional edema. It exerts a slight mass effect, with a deviation of the midline about 7 mm to the right. Second CT control. Gentle increase in size of the acute intraparenchymal hematoma of the right thalamus and posterior arm of the internal capsule, with current dimensions of 3.4 (CC) x 2.4 (AP) x 3.1 cm (LL) (previously 3.2 x 2.3 x 2.8 cm), with minimal perilesional edema and a similar mass effect on the midline (deviation of approx. 7 mm towards the contralateral side). It also presents an opening to the ventricular system with ventricular hemorrhage in both greater occipital horns on the right side, without hydrocephalus. Urgent PCR SARSCOV2 yesterday (unknown date) negative. Clinical Judgment: Spontaneous right thalamic hemorrhagic stroke with ventricular hemorrhage, probable of hypertensive origin. Acute confusional syndrome. Treatment: Start of corticosteroid therapy with dexamethasone 4mg/8h and control of Blood pressure not lowering <180 mmHg systolic. It was decided to keep anticoagulation suspended given the current risk/benefit of the patient. On 08Apr2021. Respiratory sepsis (SOFA score 6 points) in the context of nosocomial pneumonia Level II, possible bronchial aspiration origin. Extremely serious situation with probable bad evolution. Cause of the death: Cardiorespiratory arrest; Intermediate cause: Respiratory sepsis in response to nosocomial pneumonia Level II (probable bronchoaspiration origin); Main cause: Right thalamic hemorrhagic stroke. The patient died on 08Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Respiratory sepsis in response to nosocomial pneumonia Level II (probable bronchoaspiration origin); Hemorrhagic stroke


VAERS ID: 1234330 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type I diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021400115

Write-up: Unknown cause of death; Hypotension; This is a spontaneous report from a contactable reporter (patient''s daughter) received through Agency Regulatory Authority. An 87-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on Mar2021 (also reported as administered 5 weeks ago) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Type I Diabetes, with good health and controlled, from an unspecified date. The patient''s concomitant medications were not reported. The patient experienced hypotension on an unspecified date in 2021. She passed away the day after receiving the COMIRNATY vaccine (Mar2021). The patient died on Mar2021. An autopsy was not performed as the family did not want to do the autopsy. The cause of death was unknown. The outcome of hypotension was unknown. No follow-up attempts are possible. Information about the batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1234350 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-03-16
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EJ6795-EJ6789 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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: Anxiodepressive syndrome; Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Peripheral arterial occlusive disease; Senile macular degeneration
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: COVID-19 pneumonitis; Vaccination failure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonitis) in a 93-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. EJ6795-EJ6789 and EJ6795-EJ6789) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Senile macular degeneration and Peripheral arterial occlusive disease. Concurrent medical conditions included Type 2 diabetes mellitus, Anxiodepressive syndrome and Hypertension arterial. On 22-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form every three weeks. On 12-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VACCINATION FAILURE (Vaccination failure). On 26-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonitis) (seriousness criterion death). The patient died on 26-Mar-2021. The reported cause of death was COVID-19 pneumonitis. It is unknown if an autopsy was performed. At the time of death, VACCINATION FAILURE (Vaccination failure) outcome was unknown. 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 event, therefore, action taken with the drug in response to the event was not applicable. Based on information received, death was due COVID-19 pneumonitis, the event is assessed as unlikely related to mRNA-1273. Reporter did not allow further contact; Sender''s Comments: Based on information received, death was due COVID-19 pneumonitis, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19 pneumonitis


VAERS ID: 1234363 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-15
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   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: Abdominal pain (Notion of abdominal pain a few days before vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021409335

Write-up: coronary occlusion; malaise; Arrest cardiac; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-BX20212886, Safety report unique identifier FR-AFSSAPS-2021035855. A 75-years-old male patient received bnt162b2 (COMIRNATY), first dose, unknown on 03Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history included Notion of abdominal pain a few days before vaccination. Concomitant medications were not reported. The patient experienced arrest cardiac on 15Feb2021 09:30. Reported as: The patient was with very good general condition, no particular history, who presented with malaise while gardening in the morning at 9:30 am, at D13 of vaccination. Found on the ground about 20 minutes later by a relative who undertook resuscitation maneuvers. No flow estimated at 20 minutes, patient in asystole on arrival of the firemen. Resuscitation measures undertaken, sedation, intubation, asystole despite the use of adrenaline (10 mg over 40 minutes) and intraosseous bicarbonate, death after 1h20 of cardiac massage. Evoked cause was reported as coronary occlusion. No medico-legal obstacle. "Notabene: Imputation made "without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable procedures of compensation". The patient died on 15Feb2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Arrest cardiac; Coronary occlusion; malaise


VAERS ID: 1234378 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cardiovascular disorder, Drug ineffective, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (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: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Auricular fibrillation; Breast cancer; Cognitive disorder (neurocognitive disorders); Renal failure; Starvation; Thyroid nodule
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: unmeasurable fever; Result Unstructured Data: Test Result:unmeasurable fever; Test Date: 20210202; Test Name: PCR covid 19 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021409393

Write-up: drug ineffective; COVID-19 aggravated; unmeasurable fever; cardiovascular decompensation; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MA20211228, Safety report unique identifier FR-AFSSAPS-2021035332. A 93-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 19Jan2021 (Lot Number: EM0477) as SINGLE DOSE for covid-19 immunisation. Medical history included cognitive disorder/neurocognitive disorders, renal failure, breast cancer, atrial fibrillation, starvation, thyroid nodule. The patient''s concomitant medications were not reported. The patient experienced drug ineffective (death) on 02Feb2021, covid-19 aggravated (death) on 02Feb2021, unmeasurable fever (death) on 02Feb2021, cardiovascular decompensation(death) on 02Feb2021. On 02Feb2021, a unmeasurable fever, a cardiovascular decompensation. PCR Covid 19 test performed and result was positive on 02Feb2021. The patient died on 02Feb2021. It was not reported if an autopsy was performed. Time Interval between Beginning of Drug Administration and Start of Reaction / Event was 15 days. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: drug ineffective; COVID-19 aggravated; unmeasurable fever; cardiovascular decompensation


VAERS ID: 1234385 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-28
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Coma, Ischaemic stroke
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Dyslipidaemia; Mitral incompetence
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021409397

Write-up: coma; Ischemic stroke; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-PA20210451. A 92-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 11Feb2021 (Lot Number: EJ6789) at single dose (0.3ml) for covid-19 immunisation. Medical history included ongoing dyslipidaemia , ongoing Arterial hypertension, ongoing Mitral incompetence. The patient previously administrated the first dose of BNT162B2 for covid-19 immunisation on unknown date. The patient''s concomitant medications were not reported. The patient experienced ischemic stroke on 28Feb2021, coma on 28Feb2021 lead to hospitalization on an unspecified date with outcome of unknown. The patient died of Ischemic stroke on 03Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1234389 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Dyspnoea, Fatigue, Oxygen saturation, Oxygen saturation decreased, Progressive supranuclear palsy, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 5
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: Progressive supranuclear palsy
Preexisting Conditions: Medical History/Concurrent Conditions: Embolism pulmonary; Fractured neck of femur; Septicaemia; Thrombosis
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: Arterial oxygen saturation; Test Result: 75 %; Test Date: 20210331; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021409466

Write-up: worsening of symptoms of an already existing pathology; worsening of symptoms of an already existing pathology; oxygen saturation: 75 % on 31Mar2021; She experienced worsening of her symptoms 4 days after vaccination, associated with fever, difficulty breathing and fatigue.; She experienced worsening of her symptoms 4 days after vaccination, associated with fever, difficulty breathing and fatigue.; She experienced worsening of her symptoms 4 days after vaccination, associated with fever, difficulty breathing and fatigue.; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-PB20211982. Safety report unique identifier FR-AFSSAPS-2021035447. A 83-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 23Mar2021 (Lot Number: ER9470) as single dose for covid-19 immunisation. Medical history included pulmonary embolism from 2017 to an unknown date, septicaemia from 2017 to an unknown date, fractured neck of femur from 2019 to an unknown date, progressive supranuclear palsy from 2016 and ongoing, thrombosis from 2017 to an unknown date. The patient''s concomitant medications were not reported. The patient previously took modopar, scopoderm [hyoscine], ELIQUIS. The patient experienced worsening of symptoms of an already existing pathology (progressive supranuclear palsy) associated with fever, difficulty breathing and fatigue, all on 27Mar2021, oxygen saturation: 75 % on 31Mar2021. For event worsening of symptoms of an already existing pathology (progressive supranuclear palsy), the patient was taken into emergency care unit and hospitalized from 31Mar2021 to an unknown date. The patient underwent lab tests and procedures which included oxygen saturation: 75 % on 31Mar2021, COVID-19 PCR test: negative on 31Mar2021. The patient died on 01Apr2021 (1 a.m.). It was not reported if an autopsy was performed. The outcome of the event worsening of symptoms of an already existing pathology (progressive supranuclear palsy) was fatal, the outcome of the other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: worsening of symptoms of an already existing pathology (progressive supranuclear palsy); worsening of symptoms of an already existing pathology (progressive supranuclear palsy)


VAERS ID: 1234396 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Dyspnoea, Hypoxia, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia NOS; Colorectal adenocarcinoma (Lieberkuhnien carcinoma); Permanent cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021409446

Write-up: Embolism pulmonary; severe hypoxia; Alteration of the general condition with dyspnea and anorexia; Alteration of the general condition with dyspnea and anorexia; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-RE20211026, Safety report unique identifier FR-AFSSAPS-2021036225. A 94-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included arrhythmia NOS, rhythmic heart disease with pacemaker, colorectal adenocarcinoma (lieberkuhnien carcinoma). The patient''s concomitant medications were not reported. The patient experienced embolism pulmonary (death, hospitalization) on 01Apr2021, severe hypoxia (death, hospitalization) on 01Apr2021, alteration of the general condition with dyspnea and anorexia (non-serious) on 25Mar2021 with outcome of unknown. On 25Mar2021, patient experienced alteration of the general condition with dyspnea and anorexia. 01Apr2021, she was hospitalization with an assessment of a left pulmonary embolism without cardiac repercussions, with oxygen dependence in front of a severe hypoxia. Implementation of an anti-coagulant treatment at an effective dose. Unfavorable evolution, increase in oxygen dependence. The patient died on 07Apr2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: severe hypoxia; Embolism pulmonary


VAERS ID: 1234402 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-19
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure measurement, Body temperature, COVID-19, Heart rate, Oxygen saturation, Physical examination, 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: 2021-03-26
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MODOPAR; DEROXAT; LEVOTHYROX; KARDEGIC; RAMIPRIL; SERESTA; FUROSEMIDE; TAMSULOSIN
Current Illness: Heart failure (1st outbreak of heart failure with secondary bronchial infection in Dec2016)
Preexisting Conditions: Medical History/Concurrent Conditions: Blindness, one eye (Left eye blindness due to tumor enucleation); Bronchial infection (1st outbreak of heart failure with secondary bronchial infection in Dec2016); Decompensation cardiac (Left ventricular decompensation in Jan2018, then Feb2018, then May2019); Depression NOS; Enucleation of eyeball (tumor enucleation); Extrapyramidal syndrome (Extra pyramidal syndrome without proper Parkinson''s disease); Eye prosthesis user (left eye prosthesis); Hashimoto''s thyroiditis (Hypothyroidism due to Hashimoto''s thyroiditis); Hypothyroidism (Hypothyroidism due to Hashimoto''s thyroiditis); Stroke (without sequelae)
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:crackles; Comments: Pulmonary auscultation in which crackles were found mid-field of ICG.; Test Date: 20210225; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:increased crackles; Test Date: 20210226; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:intercostal indrawing; Test Date: 20210227; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:severe crackles; Test Date: 20210303; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:reduction of crackles; Test Date: 20210305; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:no polypnea; Test Date: 20210323; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:polypnea, crackles; Comments: dry bi-basal, symmetrical crackles, wet cough; Test Date: 20210324; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:slight polypnea; Test Date: 20210324; Test Name: blood pressure; Result Unstructured Data: Test Result:70/60 mmHg; Comments: hypotension; Test Date: 20210219; Test Name: body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Test Date: 20210222; Test Name: body temperature; Result Unstructured Data: Test Result:apyrexia Centigrade; Test Date: 20210224; Test Name: body temperature; Result Unstructured Data: Test Result:39.1 Centigrade; Test Date: 20210225; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210227; Test Name: body temperature; Result Unstructured Data: Test Result:apyrexia Centigrade; Test Date: 20210305; Test Name: body temperature; Result Unstructured Data: Test Result:apyrexia Centigrade; Test Date: 20210323; Test Name: heart rate; Result Unstructured Data: Test Result:tachycardia; Test Date: 20210324; Test Name: heart rate; Result Unstructured Data: Test Result:tachycardia; Test Date: 20210219; Test Name: saturation; Test Result: 97 %; Comments: Oxygen requirement (saturation 97/3L).; Test Date: 20210303; Test Name: saturation; Test Result: 95 %; Comments: Saturation 95 / 5L.; Test Date: 20210323; Test Name: saturation; Test Result: 79 %; Comments: at 11 pm. hemodynamic and respiratory failure with desaturation to 79% under 15L; Test Date: 20210323; Test Name: saturation; Test Result: 84 %; Comments: at 5.30 pm saturation 84 / 2L; Test Date: 20210323; Test Name: saturation; Test Result: 93 %; Comments: Oxygen saturation increased to 93% under 10L.; Test Date: 20210324; Test Name: saturation; Test Result: 89 %; Test Date: 20210226; Test Name: physical examination; Result Unstructured Data: Test Result:cyanosis; Comments: cyanosis of the hands; Test Date: 20210227; Test Name: physical examination; Result Unstructured Data: Test Result:Oedema; Comments: very mild Oedema of the Lower Extremities; Test Date: 20210305; Test Name: physical examination; Result Unstructured Data: Test Result:no cyanosis; Test Date: 20210320; Test Name: physical examination; Result Unstructured Data: Test Result:very anxious; Comments: it was noted that the patient was very anxious; Test Date: 20210322; Test Name: physical examination; Result Unstructured Data: Test Result:very thirsty; Comments: the patient was very thirsty and a wrong route was observed during her hydration; Test Date: 20210323; Test Name: physical examination; Result Unstructured Data: Test Result:Cyanosis; Comments: the patient was still very anxious and dehydrated. Cyanosis. Wrong routes. Aspiration brings back milk-white mucous fluid.; Test Date: 20210219; Test Name: SARS-CoV2 PCR test; Test Result: Positive ; Comments: PCR V1 profile - initial strain
CDC Split Type: FRPFIZER INC2021409440

Write-up: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report received from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-RS20210728, Safety report unique identifier FR-AFSSAPS-2021036243. A 98-year-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly administered in Arm on 13Jan2021 (Batch/Lot Number: unknown) and the second dose of BNT162B2 intramuscularly administered in Arm on 03Feb2021 (Batch/Lot Number: Unknown), both as single dose for COVID-19 immunisation. Medical history included cardiac failure from Dec2016 and ongoing, bronchial infection from Dec2016 to an unknown date, decompensation cardiac from Jan2018 to May2019 (Left ventricular decompensation in Jan2018, then Feb2018, then May2019), Stroke in 2017 without sequelae, depression, Hypothyroidism due to Hashimoto''s thyroiditis, Extra pyramidal syndrome without proper Parkinson''s disease, Left eye blindness due to tumor enucleation, left eye prosthesis. Concomitant medications included benserazide hydrochloride, levodopa (MODOPAR); paroxetine hydrochloride (DEROXAT); levothyroxine sodium (LEVOTHYROX); acetylsalicylate lysine (KARDEGIC); ramipril; oxazepam (SERESTA); furosemide; and tamsulosin. The patient has no history of COVID-19. On 19Feb2021, 16 days after the second dose of BNT162B2 injection, symptoms appeared. The patient complained of body aches. Pulmonary auscultation in which crackles were found mid-field of ICG. Hyperthermia at 38.6 T. Oxygen requirement (saturation 97/3L). SARS-CoV2 PCR positive the same day (PCR V1 profile- initial strain). On 22Feb2021, patient apyretic, reports feeling tired. On 24Feb2021, hyperthermia at 39.1T, headache. On 25Feb2021, hyperthermia at 39 T and increased crackles. On 26Feb2021, intercostal indrawing, cyanosis of the hands. On 27Feb2021, patient apyretic, severe crackles, very mild Oedema of the Lower Extremities.On 03Mar2021, reduction of crackles. Saturation 95/5L. On 05Mar2021, good clinical course with persistence of apyrexia, no polypnea or cyanosis. Subsequently, on 20Mar2021, it was noted that the patient was very anxious. On 22Mar2021, the patient was very thirsty and a wrong route was observed during her hydration. On 23Mar2021, at 5.30 p.m., the patient was still very anxious and dehydrated. Cyanosis, saturation 84/2L, polypnea, wet cough and wrong routes, dry bi-basal, symmetrical crackles. Oxygen saturation increased to 93% under 10L. The patient''s physician declares aspiration brings back milk-white mucous fluid. On 23Mar2021, at 11 p.m., hemodynamic and respiratory failure with desaturation to 79% under 15L. Patient in tachycardia. The patient''s physician declared Doubtful about pulmonary oedema in spite of dehydration and due to rapid installation, auscultation and history. On 24Mar2021, hypotension at 70/60, tachycardia with saturation at 89%, slight polypnea. The patient''s physician suggests cardiorespiratory failure due to hypovolemia. On 24Mar2021, collegial decision to stop the treatment, death of the patient on 26Mar2021 Overall, vaccine failure with a positive PCR 16 days after the second injection of the Comirnaty vaccine, improvement in symptoms of COVID infection on 05Mar2021. Subsequently, deterioration of the general condition with the onset of hemodynamic and respiratory failure on 23Mar2021 in a context of dehydration and possible aspiration. Death of the patient. Therapeutic measures were taken as a result of positive COVID-19 test with symptoms. The patient died on 26Mar2021. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: positive COVID-19 test with symptoms; Vaccination failure


VAERS ID: 1234831 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Aphasia, Confusional state, Disorientation, Encephalitis, Headache, Hemiplegia, Illness, Investigation, SARS-CoV-2 test, Seizure, Tumefactive multiple sclerosis
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 84
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: Depression; Umbilical cord abnormality
Allergies:
Diagnostic Lab Data: Test Name: investigations; Result Unstructured Data: Test Result:infection and inflammation of the brain; Comments: infection and inflammation of the brain was diagnosed; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021405174

Write-up: became ill; infection and inflammation of the brain; Acute disseminated encephalomyelitis; Tumefactive multiple sclerosis; uncontrollable seizures; movement down one side; quickly lost her speech; disoriented; extremely confused; Frequent headaches; This is a spontaneous report from a contactable other healthcare professional received from a Regulatory Agency (RA); the Regulatory Authority report number is GB-MHRA-WEBCOVID-202104080817517910. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE); Dose 2 via an unspecified route of administration on 07Jan2021 (batch/lot number: EL0141) as a SINGLE DOSE for COVID-19 vaccination. The patient''s medical history included umbilical cord abnormality and depression, both from an unknown date. Patient had no medical history of MS or Encephalitis and had no health issues (as reported). The patient was not enrolled in clinical trial. Patient was not pregnant. Patient has not had symptoms associated with COVID-19. At the start of 2021, patient was a wife and mum of two young boys with everything to live for: working as a dedicated nurse in care homes for over a decade; she worked tirelessly throughout the pandemic. Concomitant medications included anti depression tablet from an unspecified date in 2021 for 3 months.The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 15Dec2020 (batch/lot number: EJ055) as single dose for COVID-19 vaccination.The patient has not tested positive for COVID-19 since having the vaccine; patient tested no - negative for COVID-19 virus test on an unspecified date. The patient experienced frequent headaches on 08Jan2021; tumefactive multiple sclerosis on 16Feb2021 (described as "very, very, very rare aggressive form of MS"); acute disseminated encephalomyelitis on 17Feb2021; and became ill (Illness) on Feb2021. On an unspecified date, the patient also experienced infection and inflammation of the brain (Encephalitis infection), quickly lost her speech (speech loss), movement down one side (paralysis one side of body), disoriented (disorientated), extremely confused (confused), and uncontrollable seizures (seizures). The patient was hospitalized for 46 days due to tumefactive multiple sclerosis, acute disseminated encephalomyelitis, and infection and inflammation of the brain. Event "became ill" caused hospitalization. Therapeutic measures were taken as a result of tumefactive multiple sclerosis, acute disseminated encephalomyelitis, became ill, infection and inflammation of the brain, and uncontrollable seizures. It was reported that in mid Feb2021, the patient suddenly became ill and was taken into hospital 1 with symptoms of a stroke. After lots of investigations and tests, a stroke was ruled out and an infection and inflammation of the brain was diagnosed on an unspecified date. Unsure of the cause, doctors treated her with steroid medications, none of which seemed to help. After a long wait at hospital 1 she was transferred to hospital 2 where she was assessed by specialists. The family was told that the patient had developed acute disseminated encephalomyelitis (ADEM) on 17Feb2021. ADEM is a rare inflammatory condition that affects the brain and spinal cord. This is the result of the immune system becoming mis-programmed and activating immune cells to attack the healthy myelin cells covering the nerves. Patient quickly lost her speech, movement down one side, and was disoriented, and extremely confused. She was given Plasmapheresis, a plasma exchange treatment to replace her white blood cells and give her immune system a chance to fight back. After weeks of being all alone in the hospital and unable to have her family by her side, she took a turn for the worse. The plasma exchange had not been successful. Her condition was still deteriorating, and she began having uncontrollable seizures. The patient was put into a medically induced coma and was started on a new treatment for Multiple Sclerosis (MS). She spent 2 weeks in Intensive Care on a ventilator. On Wednesday 24Mar2021, the family were told that the patient had developed a very, very, very rare aggressive form of MS and that nothing more could be done to help her. The patient spent a total of 46 days in hospital. On 03Apr2021, the patient passed away peacefully with her husband and her mum by her side. The patient died of tumefactive multiple sclerosis. It was not reported if an autopsy was performed. This report does not relate to possible blood clots or low platelet counts. Follow-up attempts are completed. No further information is expected; Reported Cause(s) of Death: Tumefactive multiple sclerosis


VAERS ID: 1234846 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma scale, Haemorrhage intracranial, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:decreased; Test Name: COVID-19 virus test; Test Result: Inconclusive ; Comments: Inconclusive test
CDC Split Type: GBPFIZER INC2021411152

Write-up: hemorrhage; Intracranial hemorrhage; first dose BNT162B2 on 14Jan2021/ second dose on 25Mar2021; first dose BNT162B2 on 14Jan2021/ second dose on 25Mar2021; This is a spontaneous report from a contactable pharmacist received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104120936221340. An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified route of administration on 25Mar2021 (lot number was not known) as a single dose for COVID-19 immunisation. Medical history included hypertension and chronic kidney disease, both from an unknown date and unknown if ongoing. It was unsure if the patient has had symptoms associated with COVID-19 and unsure if the patient was enrolled in clinical trial. Concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE ) on 14Jan2021 for COVID-19 immunisation. The patient was admitted to intensive treatment unit on Apr2021- subarrachnoid haemorrhage (hemorrhage) on 11Apr2021 in which was fatal. It was also noted that intracranial hemorrhage on Apr2021 with decreased Glasgow coma scale suddenly 2 weeks after 2nd dose; this event was reported as not recovered. Additional lab data included COVID-19 virus test: inconclusive test on unspecified date. The patient died on 11Apr2021 due to subarrachnoid haemorrhage. It was unknown if an autopsy was performed. It was unclear if related to vaccine. No follow-up attempts are possible; information about the lot/batch number cannot be obtained.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1234856 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time prolonged, Antibody test, Cardiac arrest, Circulatory collapse, Computerised tomogram, Epistaxis, Fibrin D dimer, Hypertension, Loss of consciousness, Platelet count, Prothrombin time, Pulmonary embolism, SARS-CoV-2 test, Scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coagulopathy; DVT (left leg); DVT; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: activated partial thromboplastin clotting time; Result Unstructured Data: Test Result:180; Test Date: 20210411; Test Name: anti-PF4 antibodies; Result Unstructured Data: Test Result:not identified; Test Date: 20210411; Test Name: CTPA scan; Result Unstructured Data: Test Result:extensive hilar and peripheral PEs; Comments: thromboembolic event was PE; diagnosed; Test Date: 20210411; Test Name: D-dimer; Result Unstructured Data: Test Result:not higher than 4000; Test Date: 20210411; Test Name: platelet count; Result Unstructured Data: Test Result:not less than 150/L to 109/L; Test Date: 20200709; Test Name: Platelet count; Result Unstructured Data: Test Result:248; Test Date: 20210411; Test Name: Platelet count; Result Unstructured Data: Test Result:120; Test Name: PT; Result Unstructured Data: Test Result:64.5; Test Date: 20210411; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: scans; Result Unstructured Data: Test Result:did not detect a problem
CDC Split Type: GBPFIZER INC2021411038

Write-up: collapsed; unconscious; activated partial thromboplastin clotting time (aPTT) was 180; pulmonary embolus; cardiac arrest; nose bleed; high BP; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202104121335362920. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 22Mar2021 (batch/lot number ER1749 and expiry date not reported) as single dose for covid-19 immunization. Medical history included coagulopathy, deep vein thrombosis (left leg, 3 m DOAC) from Mar2020. The reporter informed that further investigations with hematology team and no problems with coagulation. The patient''s persistent problem with swelling of leg but all scans did not detect a problem. The hematology concluded risk of further DVT very slightly higher due to DVT in Mar2020 and on balance and on discussion not for further prophylactic anticoagulation. The patient additional medical history included DVT from Mar2021 that was related to previous venous or arterial thromboses also experienced. The patient had not had any previous reactions to medications (especially heparin or anticoagulants). The patient did not have confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The patient did not have history of, or current, malignancy. The patient did not currently smoke. The patient has no haemorrhage identified. The patient has no history of, or concurrent, intracranial malignancy. The patient did not have concurrent or recent intracranial infections. The patient had not had recent surgical or medical interventions to the central nervous system (including lumbar puncture). The patient had not had a recent trauma/head injury. The patient has not had symptoms associated with COVID-19 and the physician was unsure if patient was enrolled in clinical trial. The patient''s concomitant medications were not reported. The physician informed that on 24Mar2021, the patient experienced spontaneous nose bleed, high BP and was sent home from work, patient saw GP. On 31Mar2021, the patient went back at work and seemed to be fine. On 09Apr2021, the patient at work seemed to be fine. On 11Apr2021, the patient collapsed suddenly in garden at home; the patient was transferred to hospital in ambulance unconscious. At 09:23 to 11:05, the patient experienced cardiac arrest at hospital (cardiac arrest intermittent but prolonged cycles of CPR). The patient recovered after CPR and thrombolysis but prolonged cardiac arrest. The patient was transferred to intensive care sedated, intubated and mechanical ventilated, kidney machine, medicines to support blood pressure and heart. The patient died 18:55 despite full support. The patient underwent lab tests and procedures which included CTPA scan: showed extensive hilar and peripheral PEs (pulmonary embolus). The physician informed that the thromboembolic event was PE (pulmonary embolus) on 11Apr2021 diagnosed with CTPA scan on 11Apr2021. The platelet count was not less than 150/L to 109/L on 11Apr2021. The D-dimer was not higher than 4000. The anti-PF4 antibodies was not identified. The physician informed that the lowest platelet count after vaccine (usual normal range 150 to 450) was 120 on 11Apr2021 14:36. The last platelet count before vaccine (usual normal range 150 to 450) was 248 on 09Jul2020. The patient''s PT (prothrombin time) was 64.5 (unspecified date). The activated partial thromboplastin clotting time (aPTT) was 180. The physician informed that the events was related to possible blood clots or low platelet counts. The patient also underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 11Apr2021. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events cardiac arrest, activated partial thromboplastin clotting time (aPTT) was 180 was not recovered, collapsed, unconscious was unknown, nose bleed, high BP was recovering, pulmonary embolus was fatal. The patient died on 11Apr2021 18:55, it was unknown if an autopsy was performed. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolus


VAERS ID: 1234877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0724 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Enuresis, Fibrin D dimer, Investigation, Platelet count, Pulmonary embolism, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from recreational drugs; Alcohol use (Wine drinker); Basal cell carcinoma; Blepharoplasty; Breast implant user; Contraception; D & C; Eyelid operation NOS; Lipoma; Liposuction; Smoker (20 cigarettes'' a day)
Allergies:
Diagnostic Lab Data: Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown; Test Name: anti-PF4 antibodies; Result Unstructured Data: Test Result:Unknown; Test Name: Platelet count; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC2021410797

Write-up: Sudden death; acute pulmonary embolism; bed cold; DVT; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202104131438452890, Safety Report Unique Identifier GB-MHRA-ADR 25132819. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ0724, expiration date were not reported), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunisation. Medical history included other repair of eyelid in 13Jan2014, liposuction of subcutaneous tissue NEC in 04Apr2013, lipoma of other specified sites in 10Feb2013, blepharoplasty of upper eyelid in 24Sep2012, breast augmentation in 24Sep2012, basal cell carcinoma in 20Feb2012, contraception in 2005, dilation of cervix uteri and curettage of uterus in 1983, smoker (20 cigarettes'' a day), drinker (wine drinker). Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Unsure if patient is enrolled in clinical trial. Concomitant medication included citalopram. The patient experienced bed cold, acute pulmonary embolism and sudden death on an unspecified date. The events were reported as serious (Life-threatening and Fatal). It was reported that patient was found in bed cold and unresponsive on an unspecified date. Ambulance were called and attended and deemed CPR to be futile. No medical conditions that family are aware of. She smoked around 20 cigarettes per day. She drank wine but amount was unknown. No recreational drugs that family are aware of. It was reported that the report relate to possible blood clots or low platelet counts. The patient was diagnosed with acute pulmonary embolism due to DVT during post mortem examination. Platelet count, D-dimer and anti-PF4 anitbodies were unknown. The patient died on 14Jan2021. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Sudden death; Bed cold; Autopsy-determined Cause(s) of Death: Acute Pulmonary Embolism due to DVT; DVT


VAERS ID: 1234885 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN3924 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Death, Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-smoker (from teens heavy smoker when younger, stopped 20+ years ago.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021410987

Write-up: hip pain; dvt; chest pains; Death; This is a spontaneous report from a contactable healthcare professional received from the Agency Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202104131451180500, Safety Report Unique Identifier is GB-MHRA-ADR 25132875. An 81-year-old male patient received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH), via unspecified route of administration on 28Jan2021 (lot number: EN3924, expiration date not reported), as single dose for COVID-19 immunization. Medical history included ex-tobacco user (from teens heavy smoker when younger, stopped 20+ years ago) and occasional drank whiskey. Concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced death. On an unspecified date, the patient experienced hip pain, dvt (deep vein thrombosis) and chest pains, all with outcome of unknown. The events hip pain, dvt and chest pains were reported as life-threatening. The patient died on an unspecified date in Feb2021. The clinical course was reported as follows: The patient had been complaining of chest pains over the last couple of days but wasn''t one to bother anyone or go to doctors. On 13Feb2021, he visited his daughter''s address as it was her birthday and seemed fine at that time. At approximately 17:00 hours that day, he was back home and spoke to his son and said he was having chest pains. At 1806 hours, he texted his daughter and it didn''t make sense but this wasn''t unusual. On 14Feb2021 at 10:30 am, a neighbour rang daughter to say that the downstairs blinds were still shut. Family attended home address and found him deceased sat in a chair in the living room. Family confirmed that the patient was mobile on his own using a stick, he would sometimes complain of hip pain if he''d been sat for a while. Patient was an ex-smoker - from teens heavy smoker when younger, stopped 20+ years ago. Alcohol - occasional whiskey. No recreational drug use. No industrial diseases/claims. It was unsure if patient has had symptoms associated with COVID-19. Patient had not had a COVID-19 test. It was unsure if patient was enrolled in clinical trial No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information provided is limited for reasonable medical assessment. There was no information provided regarding cause of death, autopsy results and diagnostic studies. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and re-assessed based on additional data. Queries are in place for the missing information. Other reported events are probably due to an underlying medical condition. This case will be updated once additional information is available.; Reported Cause(s) of Death: Death


VAERS ID: 1234894 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021411189

Write-up: Death; 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-202104131610048480, Safety Report Unique Identifier: GB-MHRA-ADR 25133023. A patient of unspecified age and gender received BNT162B2, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Known) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19 Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications were not reported. The patient died on 01Apr2021. Cause of death was not reported. 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: Death


VAERS ID: 1234914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-18
Onset:2020-12-28
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJO55J / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ATORVASTATIN; CLOPIDOGREL; LANSOPRAZOLE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021416439

Write-up: Haemorrhagic stroke; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104141137596280. Safety Report Unique Identifier GB-MHRA-ADR 25139081. A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJO55J), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included amlodipine, atorvastatin, clopidogrel and lansoprazole all for an unspecified indication. On 28Dec2020 the patient had haemorrhagic stroke, the event was reported as fatal. On 28Dec2020 the patient had a negative covid-19 test. The date of death was not reported. An autopsy was not performed.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1234958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-03-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA-156571 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cellulitis, Drug ineffective, Erysipelas, Respiratory failure, Thrombophlebitis
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), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021421597

Write-up: drug ineffective; COVID-19 induced respiratory insufficiency; respiratory insufficiency; thrombophlebitis; erysipelas; phlegmon; This is a spontaneous report from a contactable physician downloaded from the regulatory authority HU-OGYI-196821. Case narrative: This spontaneous, serious report received on 27Mar2021 from a physician describes the occurrence of adverse events after vaccination with COMIRNATY (tozinameran). On 13Feb2021 at 8:20 a.m., the 77 years old male patient received COMIRNATY (concentrate for dispersion injection; active substance: tozinameran - 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine; batch number: PAA156571, expiry date: Mar2021, MAH: BioNTech Manufacturing GmbH) applied intramuscularly to the left upper arm for COVID-19 immunisation. Following vaccination, in Mar2021, the patient reported to have erysipelas, thrombophlebitis and phlegmon. The patient was hospitalised, the symptoms were resolving, but in the hospital, the patient had acquired COVID-19 and developed respiratory insufficiency, and died. Discharge summary is not available. The patient general condition, medical history and concomitant medicines were not reported. Sender comment: Erysipelas, thrombophlebitis and phlegmon are not expected adverse events of COMIRNATY. Alternatively, they might have been in relation with the patient underlying diseases, but there is no detailed information about them. Time to onset might have been several weeks, it is not correctly known either. Causality between the adverse events and COMIRNATY is unlikely. The patient acquired COVID-19 infection in hospital several weeks after the presumably first dose of vaccine. Immunity might have not developed within this time frame. The case is serious because the patient died. Further information is expected.; Reported Cause(s) of Death: COVID-19 respiratory insufficiency; COVID-19 respiratory insufficiency; drug ineffective


VAERS ID: 1234962 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021403430

Write-up: died; cough; Chills; subfebrility; This is a spontaneous report received from a contactable consumer (wife of the patient).A 65-year-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot No: ET7205, expiration date: unknown) via an unspecified route of administration in left arm on 26-MAR-2021 at at single dose for COVID-19 immunization.Patient medical history included non-smoker, had known algopyrin allergy.on 26Mar2021 (Friday), patient experienced chills, subfebrility, little cough by Saturday, and dies on Sunday at dawn. She has not yet have information about the cause of death and the result of autopsy. The patient wife enquired about the presence of algopyrin in vaccine.The outcome of events was fatal.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1234964 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, General physical health deterioration, Oxygen saturation decreased, Respiratory rate decreased, Respiratory tract infection, SARS-CoV-2 test
SMQs:, Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aspiration; Lower respiratory tract infection (Secondary to aspirations); Oral cancer stage unspecified; Rectal cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: Oxygen saturation decreased; Result Unstructured Data: Test Result:Reduced O2; Test Date: 20210203; Test Name: Respiratory rate decreased; Result Unstructured Data: Test Result:Reduced respiratory rate; Test Date: 20210128; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive via PCR nasal / pharyngeal swab; Comments: Positive via PCR nasal / pharyngeal swab
CDC Split Type: IEPFIZER INC2021409448

Write-up: Respiratory tract infection; REDUCED RESPIRATION RATE, O2; REDUCED RESPIRATION RATE, O2; WEAK; PHYSICAL DETERIORATION; COVID-19; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-066080. An 88-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 21Jan2021 (Lot Number: EJ6134) as Single Dose for COVID-19 immunisation. Medical history included lower respiratory tract infection secondary to aspirations, rectal cancer from 2013, oral cancer stage unspecified from 2010. The patient''s concomitant medications were not reported. The reporter outlined that no adverse reactions were noted post vaccination. On 28Jan2021, the patient tested positive for COVID-19 via PCR nasal/pharyngeal swab. It was reported that the patient''s condition deteriorated in the days prior to his death (onset date: Feb2021). On 03Feb2021, the patient was last seen by his General Practitioner (GP). The patient''s condition was comfortable but weak and the patent experienced a reduced respiration rate and O2. The patient''s GP was contacted. Therapeutic measures were taken as a result of reduced respiration rate and O2. The patient was treated for a respiratory tract infection (RTI) (onset date not reported) with antibiotics, intramuscular Rocephin and oxygen (O2) therapy. The patient also experienced physical deterioration on Feb2021. On 04Feb2021, at 11:40 am, the patient died. It was reported that the patient did not have any COVID-19 symptoms prior to vaccination, however, his death occurred as a result of COVID-19 seven days later. Other causes of death reported included weak, reduced respiration rate and O2, and physical deterioration. It was unknown if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-066081 HPRA; Reported Cause(s) of Death: REDUCED RESPIRATION RATE, O2; REDUCED RESPIRATION RATE, O2; PHYSICAL DETERIORATION; WEAK; COVID-19


VAERS ID: 1234965 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   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: ATORVASTATIN [ATORVASTATIN CALCIUM]; CLODEL [CLOPIDOGREL HYDROCHLORIDE]; OMESAR PLUS; PANTUP; NUPRIN [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antiplatelet therapy; Carotid artery stenosis; Hypertension; Non-Hodgkin''s lymphoma (PAST HISTORY OF NON HODGKINS LYMPHOMA)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021370917

Write-up: DEATH; ARRESTED; CHEST PAIN; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (regulatory authority number IE-HPRA-2021-070180). An 80-year-old male patient received BNT162B2 (COMIRNATY) dose 1 via an unspecified route of administration on 13Mar2021 (lot number EP9605) at 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension, non-hodgkin''s lymphoma (past history of non hodgkins lymphoma), carotid artery stenosis, and on anti-platelet. Concomitant medications included atorvastatin calcium from 01Jan2020 to 17Mar2021 for an unspecified indication; clopidogrel hydrochloride (CLODEL) from 01Jan2020 to 17Mar2021 as anti-platelet; hydrochlorothiazide/olmesartan medoxomil (OMESAR PLUS) from 01Jan2020 to 17Mar2021 for hypertension; pantoprazole sodium sesquihydrate (PANTUP) from 01Dec2019 to 17Mar2021 for an unspecified indication; acetylsalicylic acid (NUPRIN) from 01Jan2020 to 17Mar2021 as anti-platelet. The patient experienced death, arrested, and chest pain on 17Mar2021 which were reported as fatal. On 17Mar2021, the patient passed away. It was reported that the patient had been taken to the Accident and Emergency (A+E) department with chest pain, then transferred to the catherterisation (cath) lab in a different hospital, where he arrested. It was reported that the patient was managed by the cardiology team and the duration of the reaction was a few hours. It was noted that time to onset was no reaction, but he died on 17Mar2021, "?cause". It was unknown if an autopsy was performed. The reporter did not know whether the patient''s vaccination with BNT162B2 was linked to his death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: DEATH; ARRESTED; Chest pain


VAERS ID: 1234966 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hip replacement (18 months previously); Living in residential institution; Renal disorder (Treatment in (Redacted name) Clinic)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021409452

Write-up: DEVELOPED COVID 19; This is a spontaneous report from a contactable consumer or other non healthcare profesional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-070505. A 88-years-old female patient received BNT162B2 (COMIRNATY, BioNTech Covid-19 mRNA vaccine), via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included living in residential institution, renal disorder receiving treatment in clinic; and hip arthroplasty from 2019 (18 months previously). Patient was recovering in nursing home after treatment in Clinic for kidney issues. The patient was not taking any concomitant medication. On 15Jan2021, the patient developed COVID-19. It was reported that the patient had been doing well in residential care but then crashed very quickly and it was decided not to send her to hospital as it was felt the patient would not have wanted that. The patient received palliative care for three days before she died. The patient died on 23Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1234967 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pH, Blood pH decreased, Carbon dioxide increased, Cardiac arrest, Nervous system disorder, Respiratory failure, Tidal volume, Tidal volume decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lactic acidosis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOLPIDEM; MAGNESIUM VERLA; CHLORHEXIDINE MOUTHWASH; MYCOSTATIN MOUTHWASH; OXYNORM LIQUID; LANSOPRAZOLE; FLUDROCORTISONE; ENOXAPARIN; PARACETAMOL; LEVETIRACETAM; NICOTINE PATCH; MELATONIN; SENNA; FERROUS FUMARATE; SODIUM CHLORIDE; SANDOS K;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asystole (Experiencing frequent episodes of asystole. 10/Mar/2021 or 11/Mar/2021- last episode of asystole); Bacterial endocarditis; Dependence on ventilator; Hospitalization (had been an in-patient for four months); Paralysed (quadriplegic secondary to septic embolus to high cervical cord, secondary to bacterial endocarditis); Respiratory disorder (Ventilation issues had occurred the previous weekend i.e. 14/Mar/2021.); Septic embolus
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: pH; Result Unstructured Data: Test Result:Decreased; Test Date: 20210320; Test Name: Carbon dioxide increased; Result Unstructured Data: Test Result:raised; Test Date: 20210320; Test Name: Tidal volume; Result Unstructured Data: Test Result:Periods of very low
CDC Split Type: IEPFIZER INC2021409436

Write-up: PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; EPISODES OF ASYSTOLE; respiratory failure; respiratory failure secondary to severe neurological disease; This is a spontaneous from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. This is a report received from Regulatory authority report number IE-HPRA-2021-070650 with Safety Report Unique Identifier IE-HPRA-2021-070650. A 47-year-old male patient received bnt162b2 (COMIRNATY, Lot/Batch number: ER7812), dose 1 via an unspecified route of administration on 19Mar2021 15:45 as SINGLE DOSE for covid-19 immunisation. Medical history included septic embolus, experiencing frequent episodes of asystole with the last episode occurring on 10Mar2021 or 11Mar2021, dependence on ventilator, bacterial endocarditis, and paralysed. It was reported that the patient had been an in-patient for four months. The patient was ventilator dependent and quadriplegic secondary to septic embolus to high cervical cord, secondary to bacterial endocarditis. It was reported that the patient''s condition was extremely precarious and it was not considered likely that the patient would be discharged from hospital so a ceiling of care had been agreed upon. It was noted that the previous weekend, on 14Mar2021, these ventilation issues had also occurred. Concomitant medications included zolpidem from 23Feb2021 to 20Mar2021; magnesium aspartate (MAGNESIUM VERLA) from 17Mar2021 to 19Mar2021; chlorhexidine (CHLORHEXIDINE MOUTHWASH) and nystatin (MYCOSTATIN MOUTHWASH), both taken for mouthcare from 23Feb2021 to 20Mar2021; oxycodone hydrochloride (OXYNORM LIQUID) from 18Mar2021 to 18Mar2021; lansoprazole taken for gastroprotection from 23Feb2021 to 20Mar2021; fludrocortisone from 01Mar2021 to 20Mar2021; enoxaparin taken for venous thromboembolism (VTE) prophylaxis from 23Feb2021 to 20Mar2021; paracetamol from 18Mar2021 to 18Mar2021; levetiracetam from 23Feb2021 to 20Mar2021; nicotine (NICOTINE PATCH) from 04Mar2021 to 20Mar2021; melatonin from 23Feb2021 to 20Mar2021; sennoside a+b (SENNA) from 09Mar2021 to 20Mar2021; ferrous fumarate from 19Mar2021 to 20Mar2021; sodium chloride from 23Feb2021 to 20Mar2021; potassium bicarbonate, sodium bicarbonate, sodium phosphate monobasic (anhydrous) (SANDOS K) from 17Mar2021 to 19Mar2021; and midodrine from 12Mar2021 to 20Mar2021. The patient experienced problems with ventilation i.e. periods of very low tidal volumes with raised carbon dioxide (CO2) and decreased pH and episodes of asystole, all on 20Mar2021. The patient died on 20Mar2021 at 16:15. It was not reported if an autopsy was performed. It was outlined that the patient''s cause of death was captured in the notes as respiratory failure secondary to severe neurological disease. The patient''s death notification form recorded medical cause of death as "septic emboli to brain and spinal cord due to (or as a consequence of) bacterial endocarditis." The report outlined there was an interval of months between onset of this cause and death. The report outlined that the only link between the patient''s death and the vaccine was timing; there was no clinical suspicion of causation. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the limited information, a causal relationship between bnt162b2 and the reported events cannot be excluded based on temporal association. 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: PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW


VAERS ID: 1235025 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Oxygen saturation, Pyrexia, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), 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), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonectomy (From a previous malignancy the deceased had been subjected to the removal of a lung)
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210305; Test Name: body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Test Date: 20210305; Test Name: saturation; Result Unstructured Data: Test Result:76-80; Test Date: 20210316; Test Name: molecular swab for SARS CoV 2; Test Result: Positive
CDC Split Type: ITPFIZER INC2021408982

Write-up: After vaccine fever and respiratory crisis/fever 39 C/fever at 39.5; After vaccine fever and respiratory crisis; diarrhea; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB [IT-MINISAL02-711588]. An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular at 0.3 mL single in right shoulder on 05Mar2021 for COVID-19 immunisation. Medical history included from a previous malignancy the deceased had been subjected to the removal of a lung. Concomitant medication was not reported. Patient experienced after vaccine fever and respiratory crisis on 05Mar2021. Patient also experienced diarrhea the same day. About one hour after the administration of the vaccine, patient had fever 39 C and respiratory crisis (the ambulance was called 3 times) and oxygen was administered. Then with the fourth ambulance he was transferred to the hospital where he died. It was unknown if an autopsy was performed. Actions taken included oxygen, hospital transport. Impact on quality of life was 10/10. The outcome of events was fatal. Reporter comments: From a previous malignancy the deceased had been subjected to the removal of a lung. A control visit was carried out in December and the patient was in good condition. He used to go for walks and take care of the garden, the day of the vaccination he was fine and after the administration he only reported a weight in the stomach. A few hours later he began to feel ill with a fever at 39.5 controlled by tachipirina, then diarrhea. On day 8 only tenths and wheezing, saturation 76-80 on 05Mar2021. Sender comments: 08Apr2021 Contact with the reporter: patient positive with molecular swab for SARS CoV 2 performed on March 16; all family members were positive except the niece with a positive serologic for IgG Regional PV Center: a request for a clinical report is sent to the PRIVACY. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reporter comments: From a previous malignancy the deceased had been subjected to the removal of a lung. A control visit was carried out in December and the patient was in good condition. He used to go for walks and take care of the garden, the day of the vaccination he was fine and after the administration he only reported a weight in the stomach. A few hours later he began to feel ill with a fever at 39.5 controlled by tachipirina, then diarrhea. On day 8 only tenths and wheezing, saturation 76-80 on 05Mar2021.; Reported Cause(s) of Death: Fever; respiratory crisis; diarrhea


VAERS ID: 1235026 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINTROM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021409006

Write-up: Cardiocirculatory arrest at home. Rescued by the Emergency 112 with helicopter, Cardiopulmonary resuscitation with return of spontaneous circulation (ROSC). Later received in the intensive care unit and died.; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-711663. An 86-years-old female patient received bnt162b2 (COMIRNATY; COVID 19 COMIRNATY VACCINE (PFIZER)), dose 1 intramuscular on 29Mar2021 (Batch/Lot Number: ER9470; Expiration Date: 31Jul2021) as 0.3 mL, single for covid-19 immunisation. Medical history included atrial fibrillation and dementia, both from an unknown date and unknown if ongoing. Concomitant medication included acenocoumarol (SINTROM) taken for atrial fibrillation and anticoagulant therapy, start and stop date were not reported. The patient experienced cardiocirculatory arrest at home. rescued by the emergency 112 with helicopter, cardiopulmonary resuscitation with return of spontaneous circulation (rosc). later received in the intensive care unit and died on 05Apr2021. Therapeutic measures were taken as a result of event included: Cardiopulmonary resuscitation [CPR] Orotracheal intubation infusion of Adrenaline. The patient died on 05Apr2021. An autopsy was not performed. Reporter''s comments: Irreversible cardiac arrest occurred on 05Apr2021 in a patient aged 86 with a history of dementia and atrial fibrillation, anticoagulated with Sintrom. The Patient was a subject to vaccination with Comirnaty on 29Mar2021 (the 1 dose) Sender''s comments: Regional Pharmacist: autopsy not performed (not requested). No follow-up attempts possible. No information expected.; Reporter''s Comments: Irreversible cardiac arrest occurred on 05Apr2021 in a patient aged 86 with a history of dementia and atrial fibrillation, anticoagulated with Sintrom. The Patient was a subject to vaccination with Comirnaty on 29Mar2021 (the 1 dose); Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1235028 (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: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Echocardiogram, Pulmonary embolism, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: METFORAL; PLAVIX; BISOPROLOL FUMARATE
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: Echocardiogram; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC2021409246

Write-up: pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number IT-MINISAL02-712070. An 82-year-old male patient received the second dose of bnt162b2 (COMIRNATY) intramuscularly administered in left arm on 16Mar2021 (Lot Number: ET1831; Expiration Date: 30Jun2021) at single dose for COVID-19 immunisation. Medical history included diabetes from 01Jan2010 to 20Mar2021. Concomitant medications included metformin hydrochloride (METFORAL) taken for diabetes mellitus; clopidogrel bisulfate (PLAVIX) taken for secondary prevention; bisoprolol fumarate taken for cardiac failure chronic. The patient previously received the first dose of bnt162b2 on 23Feb2021 for COVID-19 immunisation. The patient experienced pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea (death) on 20Mar2021. Clinical course: Indicative of massive pulmonary embolism. The patient underwent lab tests and procedures which included Echocardiogram with unknown results on 21Mar2021. Therapeutic measures were taken as a result of pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea which included treatment with resuscitation and thrombolysis. The patient died on 21Mar2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. Reporters comments: Administered first dose on 23Feb and second dose on 16Mar2021 Health Authority Comment: no autopsy examination was required.; Reporter''s Comments: Administered first dose on 23Feb and second dose on 16Mar2021; Reported Cause(s) of Death: pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea


VAERS ID: 1235030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Dizziness, Dysphagia, Muscular weakness, Nervous system disorder, Pleural effusion, Speech disorder, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021398779

Write-up: autoimmune neurological syndrome; pulmonary effusions; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow/weakness; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. The regulatory authority number is IT-MINISAL02-712445. A 91-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: EJ6790), via an unspecified route of administration, on 16Mar2021, as single dose, for COVID-19 immunisation. Medical history included mild hypertension. The patient''s concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY, lot number: EJ6790), via an unspecified route of administration, on an unspecified date, for COVID-19 immunisation. It was reported that on 17Mar2021 "from the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow". It was also reported that the patient was admitted (unspecified date) where the doctors suspected an autoimmune neurological syndrome (onset date unspecified) and was treated with cortisone and immunosuppressant therapy. On an unspecified date, pulmonary effusions followed and then death. The reporter had no information about the hospitalization and death. The outcome of "from the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow" was fatal; and the outcome of the remaining events was unknown. The patient died on an unspecified date. It was unknown if an autopsy was performed. The health authority assessed the event "from the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow" as serious (fatal). Health authority Comment: On 07Apr2021 additional information is requested from the reporter: Lot number; clinical report on it or other available documentation; concomitant therapies, possibility of contacting a healthcare professional. No follow-up attempts possible. No further information expected.; Reporter''s Comments: mild hypertension; Reported Cause(s) of Death: From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vi


VAERS ID: 1235033 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-02
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021408960

Write-up: died from natural causes; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB manufacturer report number IT-MINISAL02-712914. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: ET7205) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient died from natural causes on 02Apr2021. The patient arrived in cardio-respiratory arrest, cardiopulmonary resuscitation maneuvers were performed without success (death) on 02Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death from natural causes


VAERS ID: 1235034 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021409121

Write-up: access to the emergency room for dyspnea, died to suspect pulmonary embolism; access to the emergency room for dyspnea, died to suspect pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-713004. A 94-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 07Apr2021 14:45 (Lot Number: ET7205; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced dyspnea and pulmonary embolism both on 07Apr2021, with outcome fatal. It is reported vaccination 1st dose with COMIRNATY mRNA vaccine against covid-19 on 07Apr2021 care of the home at 2:45 pm, in the evening, access to the emergency room for dyspnea, died to suspect pulmonary embolism. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender Comment: On 08Apr2021 request clinical report and if an autopsy examination was performed.; Reported Cause(s) of Death: died to suspect pulmonary embolism; dyspnea


VAERS ID: 1235037 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021409141

Write-up: Patient arrived in the emergency room at 15:55 and died at 16:40 from cardiovascular arrest. Absence of signs and symptoms attributable to anaphylactic shock.; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-713425. An 88-years-old male patient received BNT162B2 (COMIRNATY), intramuscular on 08Apr2021 15:36 (Lot Number: ET7205; Expiration Date: 31Jul2021) as 0.5 mL, single for covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. Patient arrived in the emergency room at 15:55 and died at 16:40 from cardiovascular arrest on 08Apr2021. Absence of signs and symptoms attributable to anaphylactic shock. The patient died on 08Apr2021. It was not reported if an autopsy was performed. Event outcome was fatal.; Reported Cause(s) of Death: cardiovascular arrest


VAERS ID: 1235038 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   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: Benign prostatic hypertrophy; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021409130

Write-up: sudden death; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB with regulatory authority report number IT-MINISAL02-713690. A 74-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: ET7205) intramuscularly in right deltoid on 06Apr2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension and benign prostatic hypertrophy. The patient''s concomitant medications were not reported. The patient experienced sudden death on 07Apr2021. It was not reported if an autopsy was performed. Reporter Comment: Request for death report and additional information to the reporting doctor, waiting for answer. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Request for death report and additional information to the reporting doctor, waiting for answer; Reported Cause(s) of Death: sudden death


VAERS ID: 1235039 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-07
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   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: Solid tumour
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021414221

Write-up: sudden death; This is a spontaneous report received from a contactable pysician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-713945. A 57-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left shoulder on 29Mar2021 08:46 (Batch/Lot Number: ET7205; Expiration Date: 31Jul2021) as 30 ug, single (at the age of 57-year-old) for covid-19 immunisation. Medical history included solid tumour. The patient''s concomitant medications were not reported. The patient experienced sudden death on 07Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1235098 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2020-04-05
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Infective spondylitis, Magnetic resonance imaging, Pyrexia, Sepsis, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 373
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Catheter placement; Haemodialysis; Renal failure chronic; Shunt occlusion
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: CRP; Test Result: 28.3 mg/dl; Test Date: 202104; Test Name: MRI; Result Unstructured Data: Test Result:Pyogenic spondylitis (L2/3) noted; Test Date: 20210403; Test Name: Pyrexia; Result Unstructured Data: Test Result:38.0 Centigrade; Comments: In the evening; Test Date: 20210405; Test Name: Pyrexia; Result Unstructured Data: Test Result:38.4 Centigrade; Comments: In the evening; Test Date: 20210406; Test Name: White blood cells; Result Unstructured Data: Test Result:22100 /mm3
CDC Split Type: JPPFIZER INC2021417806

Write-up: Pyrexia; pyogenic spondylitis due to long-term placed catheter infection; Sepsis; This is an initial spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number v21101813. A 73-year-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number-ER2659; Expiration Date: 30Jun2021) via an unspecified route of administration on 05Apr2021 at 15:00 as a single dose and was previously administered the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization. The patient was 73-years-old at the time of vaccination. The patient had a medical history of renal failure chronic, haemodialysis (from 20Oct2020), shunt occlusion, and insertion of long term catheter (on 18Jan2021). The patient''s concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection). It was reported that, on an unspecified date, the patient experienced pyogenic spondylitis due to long-term placed catheter infection, on 05Apr2021 (the day of the vaccination), the patient experienced pyrexia and on an unspecified date in Apr2021 sepsis. The patient underwent lab tests and procedures which included c-reactive protein: 28.3 mg/dl on 06Apr2021, magnetic resonance imaging: pyogenic spondylitis (l2/3) noted on Apr2021. On 03Apr2021 in the evening, pyrexia: 38.4 centigrade on 05Apr2021 in the evening 38.0 centigrade. On 06Apr2021 (1 day after the vaccination), the patient visited fever outpatient of the hospital. At the visit, white blood cell count: 22100 /mm3 on 06Apr2021. On 06Apr2021 (1 day after the vaccination), the patient was admitted to the hospital. Patient was receiving conservative treatment with antibiotics. On 13Apr2021 (8 days after the vaccination), the patient died and was discharged. It was not reported if an autopsy was performed. The reporting physician classified the event, pyrexia as serious (hospitalized, medically significant). The reporting physician commented as follows; It was unknown as to whether the event was related to BNT162b2. Regarding other possible cause of the event such as any other diseases, the reporting physician commented as follows: The patient was being in haemodialysis due to renal failure chronic and experienced pyogenic spondylitis due to long-term placed catheter infection. The outcome of the events sepsis and pyogenic spondilytis was fatal and for pyrexia was unknown.; Reported Cause(s) of Death: Sepsis; pyogenic spondylitis due to long-term placed catheter infection


VAERS ID: 1235105 (history)  
Form: Version 2.0  
Age: 102.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Blood pressure measurement, Body temperature, Computerised tomogram, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MINEBASE; THEOLONG; AMLODIPINE; TELMISARTAN
Current Illness: Pneumonia aspiration (Treatment with clarithromycin)
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve incompetence; Aortic valve stenosis; Cardiac failure chronic; Hospitalization NOS; Tricuspid valve incompetence
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210402; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Comments: pyrexia; Test Date: 20210412; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210402; Test Name: CT; Result Unstructured Data: Test Result:Pneumonia aspiration; Test Date: 20210414; Test Name: SpO2; Test Result: 75 %
CDC Split Type: JPPFIZER INC2021425503

Write-up: Asthmatic attack; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21102060. A 102-year and 4-month-old female patient received the first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Lot number ER9480, Expiration date 31Jul2021), via an unspecified route of administration on 12Apr2021 14:40 (at the age of 102-years and 4-months) as a single dose for COVID-19 immunization. Medical history included: ongoing pneumonia aspiration from 02Apr2021, cardiac failure chronic (aortic valve stenosis, aortic valve incompetence, tricuspid valve incompetence). On 24Mar2021, the patient was admitted to the hospital (hospitalization reason not specified). On 02Apr2021, the patient had pyrexia of 37.3 degrees Centigrade. Pneumonia aspiration was diagnosed based on the image of computed tomography (CT). Treatment with antibacterial drug of clarithromycin was started. The patient''s body temperature was 37.3 Centigrade on 02Apr2021, and before vaccination was 36.6 degree Centigrade on 12Apr2021. Concomitant medications included: clarithromycin (MINEBASE) from 02Apr2021, theophylline (THEOLONG), amlodipine, and telmisartan for an unspecified indication. On 12Apr2021 at 14:40 (the day of vaccination), the patient received the first dose of COMIRNATY. On 13Ap2021 around 21:00 (1 day after the vaccination), the patient experienced asthmatic attack. On 16Apr2021 (4 days after the vaccination) at 6:51, the patient died. The course of the event was as follows: On 13Apr2021 around 21:00 (1 day after the vaccination), intraoral sputum accumulation developed, and large volume of sputum was vacuumed. Moaning was noted but no wheezing was seen. On 14Apr2021 (2 days after the vaccination), the patient made reaction to verbal contact. At 18:40, labored respiration, moaning, and wheezing were noted. SpO2 decreased to 75%. Drugs including bronchodilator, steroid, and catecholamine were administered, but they were ineffective. Until 14Apr2021, the patient had no pyrexia. On 15Apr2021 (3 days after the vaccination), blood pressure decreased, and bradycardia developed. On 16Apr2021 at 6:51, the patient''s death was confirmed, and the patient left hospital mortality. The outcome of the event asthmatic attack was fatal. The reporting physician classified the event as serious (Death) and the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were bronchial asthma and cardiac failure.; Reported Cause(s) of Death: Asthmatic attack


VAERS ID: 1235238 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract; Eczema; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021409092

Write-up: The patient died suddenly the day after the injection. I don''t know if it was a side effect, patient probably died of a myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00483548, Safety Reportu Unique Identifier NL-LRB-00485690. A 79-years-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 11Mar2021 (Lot Number: EP9605) as single dose for Covid-19 immunisation. Medical history included cataract, smoker, eczema. The patient''s concomitant medications were not reported. The patient died suddenly the day after the injection on 12Mar2021. The reporter did not know if it was a side effect, patient probably died of a myocardial infarction. The death is unlikely to be due to the vaccination. only report because it was close to the vaccination and it was an unexpected death. Patient lived independently, single. Not a clear picture of health, but went for a weekly walk with a group of friends. No medication. No home care. The reporter did not know if it is a side effect. Myocardial infarction is the most likely cause of death. No previous COVID-19 infection. No diagnostic procedures. The patient died on 12Mar2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: I don''t know if it was a side effect, patient probably died of a myocardial infarction


VAERS ID: 1235253 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-13
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chromaturia, Confusional state, Fatigue, Heart rate, Hypophagia, Malaise, Oxygen saturation, Renal failure, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVODOPA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: blood pressure; Test Result: Inconclusive; Result Unstructured Data: 155/135 mmhg; Test Date: 20210321; Test Name: body temperature; Test Result: Inconclusive; Result Unstructured Data: 36.3/min; Test Date: 20210321; Test Name: heartbeat; Test Result: Inconclusive; Result Unstructured Data: 68-90/min; Test Date: 20210322; Test Name: pulse; Test Result: Inconclusive; Result Unstructured Data: 90/min; Test Date: 20210321; Test Name: Saturation; Test Result: Inconclusive; Result Unstructured Data: variable 60-90%,; Test Date: 20210321; Test Name: urine stick; Test Result: Inconclusive; Result Unstructured Data: no increased leukocytes
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of RENAL FAILURE (not tested but looks like kidney failure), MALAISE (not feeling well), CHROMATURIA (dark urine), CONFUSIONAL STATE (some confusion), HYPOPHAGIA (drank with difficulty or not, 3 bites of bread) and FATIGUE (fatigue) in a 98-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). Concomitant products included LEVODOPA for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MALAISE (not feeling well) (seriousness criterion death), CONFUSIONAL STATE (some confusion) (seriousness criterion death) and FATIGUE (fatigue) (seriousness criterion death). On 20-Mar-2021, the patient experienced RENAL FAILURE (not tested but looks like kidney failure) (seriousness criterion death) and CHROMATURIA (dark urine) (seriousness criterion death). On 21-Mar-2021, the patient experienced HYPOPHAGIA (drank with difficulty or not, 3 bites of bread) (seriousness criterion death). The patient died on 22-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood pressure measurement: 155/135 mmhg (Inconclusive) 155/135 mmhg. On 21-Mar-2021, Body temperature: 36.3/min (Inconclusive) 36.3/min. On 21-Mar-2021, Heart rate: 68-90/min (Inconclusive) 68-90/min. On 21-Mar-2021, Oxygen saturation: 60-90% (Inconclusive) wisselend 60-90%. On 21-Mar-2021, Urine analysis: no increases leukocytes (Inconclusive) no increased leucocytes. On 22-Mar-2021, Heart rate: 90 (Inconclusive) 90/min. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications also included non specified anticoagulants. Treatment of these events were not reported. Reporter did not allow further contact; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1235260 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-09-01
Onset:2021-03-11
   Days after vaccination:2748
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Magnetic resonance imaging, Myelopathy, Quadriplegia, Spinal cord compression, Spinal epidural haemorrhage, Spinal meningeal cyst
SMQs:, Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: MOVICOLON; PANTOPRAZOL [PANTOPRAZOLE]; FERROUS FUMARATE; MADOPAR; METOPROLOL SUCCINATE; ATORVASTATINE [ATORVASTATIN]; LEVODOPA/CARBIDOPA; APROVEL; RIVAROXABAN; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Non STEMI
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:meningeal cyst at the level of vertebrae C5 and C6; Comments: Conclusion: meningeal cyst at the level of vertebrae C5 and C6 right dorsolateral with myelum compression and myelopathy herd over vertebrae C4-C7 (during surgery they found it was due to haemorrhage)
CDC Split Type: NLPFIZER INC2021399184

Write-up: epidural bleeding at C4-C6 with spinal cord injury/quadriplegia; epidural bleeding at C4-C6 with spinal cord injury; meningeal cyst at the level of vertebrae C5 and C6 right dorsolateral; myelum compression; myelopathy herd over vertebrae C4-C7; This is a spontaneous report from a contactable physician downloaded from the regulatory authority Regulatory Authority number NL-LRB-00493370. An 81-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation; rivaroxaban, via an unspecified route of administration from Sep2013 (Batch/Lot Number: Unknown) to 12Mar2021, at 15 mg, once daily for atrial fibrillation; and clopidogrel, via an unspecified route of administration from Jun2020 (Batch/Lot Number: Unknown) to 12Mar2021, at 75 mg, once daily for non STEMI. Medical history included non STEMI and atrial fibrillation. The patient has no previous COVID-19 infection. Concomitant medications included macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON), pantoprazol [pantoprazole], ferrous fumarate, benserazide hydrochloride, levodopa (MADOPAR), metoprolol succinate, atorvastatine [atorvastatin], carbidopa, levodopa (LEVODOPA/CARBIDOPA) and irbesartan (APROVEL). The patient experienced epidural bleeding at c4-c6 with spinal cord injury on 11Mar2021. The events were assessed as medically significant and require hospitalization. The patient had spinal epidural bleeding and quadriplegia following administration of Pfizer covid-19 vaccine. Spinal epidural bleeding and quadriplegia are treated with hospital admission and operation which had no effect. The spinal epidural bleeding was at C4-C6 and led to spinal cord injury: quadriplegia. The operation was not effective, and patient died 3 weeks later. Latency of events spinal epidural bleeding and quadriplegia was 5 days after of Pfizer Covid-19 vaccine, within 8 years after start of rivaroxaban tablet 15 mg and within 9 months after start of clopidogrel tablet 75mg. MRI showed a meningeal cyst at the level of vertebrae C5 and C6 right dorsolateral with myelum compression and myelopathy herd over vertebrae C4-C7 (during surgery they found it was due to haemorrhage). The action taken in response to the events for rivaroxaban and clopidogrel was permanently withdrawn on 12Mar2021. The outcome of the events "meningeal cyst at the level of vertebrae C5 and C6 right dorsolateral", "myelum compression" and "myelopathy herd over vertebrae C4-C7" were unknown. The patient died on an unspecified date due to epidural bleeding at C4-C6 with spinal cord injury/quadriplegia. It was unknown if an autopsy was performed. Reporter Comment: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Epidural haemorrhage at C4-C6 with spinal cord injury. Information council other or disabling information: deterioration in general condition with completely dependent and bedbound. High aspiration risk. Hospitalization information: Spinal cord injury and surgery,. Additional information ADR: Admission and operation in hospital, no improvement on spinal cord injury. Death 3 weeks later. BSN available: yes. COVID19 Previous COVID-19 infection: No. Other diagnostic procedures: MRI - Conclusion: Meningeal cyst at the level of vertebral body C5 and C6 right dorsolateral with myelum compression and myelopathy over a longer range of vertebral body C4-C7. (appears to be due to bleeding during surgery). No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reporter''s Comments: Summary of Reporter Comment: Information council other or disabling information: deterioration in general condition with completely dependent and bedbound. High aspiration risk. Admission and operation in hospital, no improvement on spinal cord injury. Death 3 weeks later. MRI - Conclusion: Meningeal cyst at the level of vertebral body C5 and C6 right dorsolateral with myelum compression and myelopathy over a longer range of vertebral body C4-C7. (appears to be due to bleeding during surgery).; Reported Cause(s) of Death: epidural bleeding at C4-C6 with spinal cord injury/quadriplegia; epidural bleeding at C4-C6 with spinal cord injury


VAERS ID: 1235263 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Epistaxis, Malaise
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; NITRAZEPAM; NORTRIPTYLINE; CALCIUM + D3 [CALCIUM CARBONATE;CHOLECALCIFEROL]; BUSPIRONUM; IBANDRONINEZUUR ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Inguinal hernia repair; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021398902

Write-up: nosebleed; Malaise; Abdominal pain; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB manufacturer report number NL-LRB-00501806. A 93-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Feb2021, single dose for covid-19 immunisation. Medical history included suspected covid-19 from 08Feb2021, inguinal hernia repair from Feb2021 to an unknown date. Concomitant medications included pantoprazolum; nitrazepam; nortriptyline; calcium carbonate, colecalciferol (CALCIUM + D3); buspironum; ibandronate sodium (IBANDRONINEZUUR ACTAVIS). The patient experienced nosebleed, malaise, abdominal pain, all on 08Feb2021, all outcome was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: nosebleed; Malaise; Abdominal pain


VAERS ID: 1235264 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-16
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021409108

Write-up: Fatigue; Nausea; Not feeling well; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number NL-LRB-00502722. An 87-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Mar2021, the patient experienced fatigue (death), nausea (death) and not feeling well (death). The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. No Past drug therapy Comirnaty. "BSN" was available. No Previous COVID-19 infection and no Other diagnostic procedures. The outcome of the events was fatal. Information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: fatigue; nausea; not feeling well


VAERS ID: 1235265 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACTRAPID; ATORVASTATIN; METOPROLOL
Current Illness: Coronary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Name: lab; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021409162

Write-up: Myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number NL-LRB-00502948. A 74-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing Coronary disease. Concomitant medications included insulin (ACTRAPID), atorvastatin and metoprolol. The patient experienced myocardial infarction on 07Apr2021. The event was reported as serious with serious criteria death. The patient underwent lab tests and procedures which included electrocardiogram (ECG): unknown results on unknown date, laboratory test: unknown results on unknown date. Therapeutic measures were taken as a result of myocardial infarction included treated with medications according to a protocol. The patient died on Apr2021. It was not reported if an autopsy was performed. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty), Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. BSN available: yes. Confounding factors: Coronary suffering. Previous COVID-19 infection: No. Other diagnostic procedures: ECG, lab. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty), Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. BSN available: yes. Confounding factors: Coronary suffering. Previous COVID-19 infection: No. Other diagnostic procedures: ECG, lab.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1235266 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Ecchymosis, Fatigue, Headache, Magnetic resonance imaging, Magnetic resonance imaging head, Malaise, Myalgia, Nausea, Pneumonia, Ventilation/perfusion scan
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OXAZEPAM; COTRIMOXAZOL; ACENOCOUMAROL
Current Illness: Bladder infection; Cardiac failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI scan abdomen; Result Unstructured Data: Test Result:full or faeces; Test Name: MRI head; Result Unstructured Data: Test Result:MRI because of suspected meningitis: negative; Test Name: lung scan; Result Unstructured Data: Test Result:Pneumonia
CDC Split Type: NLPFIZER INC2021409178

Write-up: pneumonia, which was fatal; extensive hematomas; Headache; Pain in the joints; Fatigue; Nausea; Not feeling well, became deathly ill; Muscle pain; This is a spontaneous report from a contactable other HCP downloaded from a regulatory authority-WEB manufacturer report number NL-LRB-00503249. This is the first case of two reports for the second dose. An 83-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 02Apr2021 (Lot Number: ET3674) at age of 83 years old as single dose for covid-19 immunisation. Medical history included ongoing cardiac failure, ongoing bladder infection. Concomitant medications included oxazepam; sulfamethoxazole, trimethoprim (COTRIMOXAZOL); acenocoumarol. The patient previously took bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 25Feb2021 at single dose for covid-19 immunisation and experienced malaise, sudden deafness, and nausea. On 02Apr2021, the patient experienced malaise, myalgia, fatigue, nausea, pneumonia, generalized joint pain. On 03Apr2021, the patient experienced headache. On an unknown date, the patient experienced ecchymosis. All events were fatal and life threatening. Nausea was treated with acetylcysteine (FLUIMICIL). The outcome of all events was fatal. The patient died in Apr2021. It was not reported if an autopsy was performed. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: Nausea and sudden deafness, and just not feeling well Date: 25Feb2021. Incredible deafness after first Pfizer vaccine. Additional information ADR: Mothers has become critically ill. Her complaints were only heart failure, but for the rest still up to date. Already a deterioration in hearing after the first vaccination. Last week cystitis, she asked the doctor if she could have a vaccination. No problem. Admitted to hospital with pneumonia on Saturday 03April which was fatal. Thanks vaccination. COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: MRI scan abdomen - full of faeces - MRI head due to meningitis (was not) - Lung photo - Pneumonia. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: Nausea and sudden deafness, and just not feeling well Date: 25Feb2021 Incredible deafness after first Pfizer vaccine ; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021415031 same patient, different vaccine dose and events; Reported Cause(s) of Death: Malaise; myalgia; ecchymosis; fatigue; nausea; generalized joint pain; headache; pneumonia


VAERS ID: 1235268 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021403560

Write-up: Collapsed and was reanimated/Man died shortly after administration Pfizer vaccine; This is a spontaneous report from a non-contactable consumer. A 77-years-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 (at 77-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After the vaccination the patient waited for 15 minutes under supervision, before he went outside. Outside the patient collapsed and was reanimated before the emergency services came, the man was brought to the hospital by ambulance and died shortly after administration of Pfizer vaccine on the same day in the hospital on 12Apr2021. 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: Collapsed and was reanimated/Man died shortly after administration Pfizer vaccine


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