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

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



Case Details

This is page 117 out of 172

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VAERS ID: 1329812 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   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: Acute renal insufficiency; Coronary heart disease; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021539568

Write-up: Cerebral circulatory disorder (stroke); Lung embolism; This is a spontaneous report downloaded from a Non-contactable Consumer from the Regulatory Authority-WEB [DE-PEI-CADR2021060275], Safety Report Unique Identifier [DE-PEI-202100052193] A 72-years-old female patient received bnt162b2 (COMIRNATY), on 08Jan2021 as UNKNOWN, SINGLE for covid-19 immunisation. Medical history included ongoing coronary artery disease , ongoing acute kidney injury , ongoing type 2 diabetes mellitus. The patient''s concomitant medications were not reported. On 09Jan2021 the patient experienced Cerebral circulatory disorder (stroke), Lung embolism. The patient''s outcome was fatal for Accident cerebrovascular, fatal for Lung embolism. The patient died on 09Jan2021. An autopsy was performed and results were not provided. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular; Lung embolism


VAERS ID: 1329813 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-04-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac discomfort, Cerebrovascular accident, Cough, Death, Dizziness, Dyspnoea, Performance status decreased, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   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: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021544623

Write-up: stroke; Unknown cause of death; Fatigue, severe cough, shortness of breath, heart problems, dizziness, severe drop in performance; Fatigue, severe cough, shortness of breath, heart problems, dizziness, severe drop in performance; Fatigue, severe cough, shortness of breath, heart problems, dizziness, severe drop in performance; Fatigue, severe cough, shortness of breath, heart problems, dizziness, severe drop in performance; Fatigue, severe cough, shortness of breath, heart problems, dizziness, severe drop in performance; Fatigue, severe cough, shortness of breath, heart problems, dizziness, severe drop in performance; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021061996], Safety Report Unique Identifier [DE-PEI-202100054152]. A 92 years old female patient received the second dose of BNT162B2 (COMIRNATY, lot number ET3674) on 28Mar2021 at single dose for COVID-19 immunization. The patient medical history and concurrent conditions included: hypertension. The patient concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, lot ER2659) on 02Mar2021 at single dose for covid-19 immunization and experienced no adverse drug reaction. On 05Apr2021, the patient experienced groggy, coughing, dyspnea, cardiac discomfort, light headedness, performance status decreased. On 18Apr2021, the patient experienced unknown cause of death. The reporter stated after the 1st vaccination, the state of patient health is very good. After 2nd vaccination, rapid deterioration of the entire condition. Creeping onset from the 1st week after the 2nd vaccination increasing deterioration until the stroke, only 3 weeks after the 2nd vaccination. The outcome of unknown cause of death was fatal. Autopsy not performed. The outcome of the other events was unknown. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1329814 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-04-01
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Diabetes; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: COVID-19 PCR Test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021544636

Write-up: died on 13Apr2021; COVID-19-PCR-Test positiv; COVID-19-PCR-Test positiv; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021063465, Safety Report Unique Identifier DE-PEI-202100055527. An 83 Years old female patient received the second dose of Comirnaty (Lot No. EP9598) 0.3 ml at single dose for COVID-19 immunisation on 20Feb2021. The patient''s medical history included Hypertension, diabetes and post apoplexy. Relevant concomitant drug was unknown. The patient was not taking immunosuppressants. The patient previously received the first dose of Comirnaty at single dose for COVID-19 immunisation on 20Feb2021. On 01Apr2021, a Coronavirus disease-19 infection was detected by Polymerase chain reaction test (cycle threshold values 33-34). The affected person was asymptomatic. One sequencing was positive for N501Y and delH69/V70. The person concerned died on 13Apr2021. The patient was not recovered/not resolved from COVID-19. The death was not unexpected, even before the Corona infection she was prefinal. Source of assessment: Regulatory Authority Result of Assessment: C. Inconsistent causal association to immunization No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1329815 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Neurodegenerative disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021544629

Write-up: unclear death one day after the 1st vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number: DE-PEI-CADR2021063626. Safety Report Unique Identifier: DE-PEI-202100055452. A 57-year-old male patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 14Apr2021 (Batch/Lot Number was unknown) as 0.3ml single for covid-19 immunisation. Medical history included ongoing arterial hypertension, neurodegenerative disease. No known allergies. The patient''s concomitant medications were not reported. On 15Apr2021 the patient experienced unclear death one day after the 1st vaccination ((sitting on the sofa tilted to the side) /very early lay resuscitation afterwards paramedics and emergency doctor). The event outcome was fatal. Autopsy was recommended, it was not reported if an autopsy was performed. Relatedness of Comirnaty to event unknown cause of death was inconsistent causal association to immunization by Regulatory Authority. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1329816 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-04-18
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021544620

Write-up: Stroke/Accident cerebrovascular; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021064155 with Safety Report Unique Identifier DE-PEI-202100056238. An 86-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: ER7812), via an unspecified route of administration on 22Mar2021 at 0.3 ml single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) for COVID-19 immunisation. On 18Apr2021, the patient experienced accident cerebrovascular. Stroke after 27 days after the second vaccination. The patient died on 21Apr2021. An autopsy was not performed. Relatedness of drug to reaction(s)/event(s): Comirnaty/ Accident cerebrovascular / Regulatory Authority/ D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Stroke/Accident cerebrovascular


VAERS ID: 1329817 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Stroke (a stroke in January)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021544645

Write-up: My mother died four days after the second vaccination with Biontec. The day after the vaccination she could not get up and did not eat and only slept.; Tiredness; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021064418, Safety Report Unique Identifier DE-PEI-202100056763. A 74-year-old female patient received second dose of BNT162B2 (COMIRNATY) on 05May2021 at 0.3 ml single for COVID-19 immunisation. Medical history included ongoing stroke since Jan2021, but had been examined by the doctor and neurologist a week before the vaccination and the condition was determined to be stable. Physiotherapy was prescribed and performed. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on unknown date. During last visit the weekend before, she made a very healthy impression. On Wednesday, according to the nursing staff, she was "in a good mood" and ate in the dining room. Then in the afternoon there was the second vaccination. The next day (06May2021) she didn''t get up, just slept. The patient experienced Tiredness. Then she stopped eating. She was still drinking, but her condition worried the staff and they actually wanted (they informed the reporter on Sunday) to call the doctor on Monday morning. The patient passed away on Monday night (10May2021). The outcome of Tiredness was not resolved. Senders comments: Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses. Yes, my mother had a stroke in January, but had been examined by the doctor and neurologist a week before the vaccination and the condition was determined to be stable. Physiotherapy was prescribed and performed. / During my last visit the weekend before, she made a very healthy impression. On Wednesday, according to the nursing staff, she was "in a good mood" and ate in the dining room. Then in the afternoon there was the second vaccination. The next day she didn''t get up, just slept. Then she stopped eating. She was still drinking, but her condition worried the staff and they actually wanted (they informed me on Sunday) to call the doctor on Monday morning. My mother passed away on Monday night. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: passed away


VAERS ID: 1329818 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse chronic
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021544617

Write-up: Death occurred three days after vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority DE-PEI-CADR2021064465. Safety Report Unique Identifier DE-PEI-202100056809. A 27-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included alcohol abuse. The patient''s concomitant medications were not reported. The patient experienced death occurred three days after vaccination on 25Apr2021. Reporter comment included postmortem examination was performed brief report from the criminal investigation department: no external causes. Toxicology was pending. According to the roommates, patient had gone to sleep in an inebriated state on 23Apr2021, one day after the vaccination. Since the roommates were working, they did not check on him and it was not noticed further that no one saw him on 24Apr2021. On 25Apr2021 they found him dead in bed with headphones in his ears and smartphone on his chest. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1329819 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-30
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Influenza like illness, Neck pain, Pulmonary embolism, Right ventricular failure
SMQs:, Cardiac failure (narrow), Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021544641

Write-up: On 4May2021 Exitus letalis, a.e. Right heart failure, DD pulmonary artery embolism; Exitus letalis, a.e. Right heart failure, DD pulmonary artery embolism; The symptoms appeared 3 weeks after the second vaccination. Flu-like symptoms, then headache and neck pain.; The symptoms appeared 3 weeks after the second vaccination. Flu-like symptoms, then headache and neck pain.; The symptoms appeared 3 weeks after the second vaccination. Flu-like symptoms, then headache and neck pain.; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021064825], Safety Report Unique Identifier [DE-PEI-202100057245]. A 78-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 on 15Mar2021 for Covid-19 immunisation. The symptoms appeared 3 weeks after the second vaccination. On 30Apr2021, patient experienced flu-like symptoms, then headache and neck pain. On 04May2021, exitus letalis, a.e. right heart failure, DD (differential diagnoses) pulmonary artery embolism. Treatment was received for right heart failure. The patient died on 04May2021. An autopsy was not performed. Outcome of flu-like symptoms, then headache and neck pain was not resolved. Outcome of right heart failure, DD (differential diagnoses) pulmonary artery embolism was fatal. Sender Comment: Information on risk factors or previous illnesses: Anamnesis empty, FA unknown. No medication taking. Physically fit so far, climbing stairs without problems, long walking distances without problems. / The second vaccination took place on 05Apr2021. From "26Apr2021 (as reported)" Occurrence of flu-like symptoms, followed by neck pain / headache. No prodromes of an acute coronary syndrome, no angina pectoris or the like. On 04May2021 around 16:00 peracute unconsciousness, gasping, stagnation. Resuscitation attempts by the doctor (neighbor on site) until the ambulance arrives, here already signs of upper influence congestion / right heart failure. No restoration of circulatory function. Exitus letalis after 40 minutes. No autopsy. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pulmonary artery embolism; Cardiac failure right


VAERS ID: 1329820 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood uric acid, Blood uric acid increased, Death, Lipids, Lipids increased
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Tumour lysis syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol abuse chronic; Dementia (alcohol-related dementia); Hypertension; Intracerebral haemorrhage (post-intracerebral haemorrhage 2015 without residual)
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism; Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: uric acid; Result Unstructured Data: Test Result:slight increase; Test Date: 20210422; Test Name: blood lipids; Result Unstructured Data: Test Result:slight increase
CDC Split Type: DEPFIZER INC2021544638

Write-up: Sudden death/Unknown cause of death; slight increase in uric acid and blood lipids; slight increase in uric acid and blood lipids; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021065643 with Safety Report Unique Identifier DE-PEI-202100058279. This s report was received from Regulatory Authority. A 72 years old male patient received the first dose of BNT162B2 (COMIRNATY, mRNA TOZINAMERAN, lot EX3510), on 21Apr2021 at single dose for COVID-19 immunisation. The patient''s medical history and concurrent conditions included: alcohol abuse chronic, hypertension, dementia, cerebral haemorrhage; and allergies to Pollinose. Information on risk factors or previous illnesses: Alcoholism (none for several months), hypertension, alcohol-related dementia; post-intracerebral haemorrhage 2015 without residual. No concomitant medication reported. On 25Apr2021 the patient experienced unknown cause of death. This report is serious- death. Sender''s comments: Patient was found dead in front of his bed by his wife after having finished the morning wash and shower. Resuscitation was unsuccessful. A comprehensive laboratory examination on 22Apr2021 was completely unremarkable, apart from a slight increase in uric acid and blood lipids. The patient''s outcome was fatal for unknown cause of death, for others was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death/Unknown cause of death


VAERS ID: 1329930 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-19
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021545754

Write-up: Death after the second vaccination; This is a spontaneous report based on information received by Pfizer from BioNTech (manufacturer reference number: 54148), license party for COMIRNATY. The non-contactable consumer reported: "The mother of one of his friends was vaccinated with 1st and 2nd dose in nursing home. After the 1st dose everything was well tolerated, but 1 day after the 2nd dose the mother died. It is not certain whether this is related to the vaccination." No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1329947 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-05-09
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Polymerase chain reaction
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO; BISOPROLOL; ASS; DIGITOXIN; SPIRONOLACTON; TAVOR [LORAZEPAM]; PANTOZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (nein); Heart failure NYHA class III; Tachyarrhythmia absoluta; Ventricular assist device insertion (therapy)
Allergies:
Diagnostic Lab Data: Test Date: 20210509; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: DEPFIZER INC2021546994

Write-up: sinus venous thrombosis with ICB in the course under anticoagulatives in presence of LVAD (artificial heart); This is a spontaneous report from a non-contactable physician. A 66-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 14Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient received vaccination at the age of 65-year-old. Medical history included ventricular assist device insertion (LVAD) therapy, chronic obstructive pulmonary disease (COPD), NYHA III, tachyarrhythmia absoluta (TAA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rivaroxaban (XARELTO); bisoprolol; acetylsalicylic acid (ASS); digitoxin; spironolactone (SPIRONOLACTON); lorazepam (TAVOR); pantoprazole (PANTOZOLE). All received within 2 weeks of vaccination. The patient experienced sinus venous thrombosis with ICB in the course under anticoagulatives in presence of lvad (artificial heart) on 09May2021. Adverse event treated with craniectomy and EVD insertion. The patient underwent lab tests and procedures which included PCR: negative (nasal swab) on 09May2021. The patient died of sinus venous thrombosis with ICB on 14May2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sinus venous thrombosis with ICB


VAERS ID: 1329971 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (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: Artificial heart device user; Left ventricular assist device insertion
Preexisting Conditions: Medical History/Concurrent Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021553009

Write-up: Sinus vein thrombosis; This is a spontaneous report from a non-contactable physician reporting for a patient. A 63-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing LVAD (Left ventricular assist device insertion), ongoing artificial heart, chronic obstructive pulmonary disease (COPD) Gold IV. Concomitant medication included therapeutic anticoagulation. The patient developed sinus vein thrombosis 3 weeks after initial vaccination with Biontech vaccine on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event sinus vein thrombosis was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Considering a plausible drug event temporal association, the company cannot completely rule out a reasonable possibility that bnt162b2 (COMIRNATY) caused the sinus vein thrombosis leading to fatal outcome. The concurrent medical condition provides additional explanation for the onset of the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Sinus vein thrombosis


VAERS ID: 1329976 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-05-02
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Death, Eczema, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021553694

Write-up: heavy Eczema/it got worse; Breathing problems; condition worsened; death; This is a spontaneous report from a contactable consumer reporting for her mother. This is a report based on information received by Pfizer from BioNTech [manufacturer reference number: 54100], license party for COMIRNATY. An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After being vaccinated on 01Feb2021 the patient died on 02May2021, 6 weeks after the second dose her condition worsened, she developed a heavy eczema and breathing problems and it got worse. Even though she was 89 years old, she could have lived for some more years as she was physically fit before. The patient died on 02May2021. It was not reported if an autopsy was performed. The outcome of events heavy eczema, breathing problems and condition worsened was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: death


VAERS ID: 1331350 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Cardiac arrest, Generalised tonic-clonic seizure, Sudden death, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity (BMI $g,=30)
Preexisting Conditions: Medical History/Concurrent Conditions: Agoraphobia; Anxiodepressive syndrome; Insomnia
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:higher than or equal to 30
CDC Split Type: ESPFIZER INC2021544659

Write-up: Sudden death, cause unknown; generalized tonic contraction; cardiac arrest/asystole; ventricular fibrillation; This is a spontaneous report from contactable physician and Other Health Professional downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-855103. A 73-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm on 05May2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. Medical history included Anxiodepressive syndrome from 2008, ongoing obesity (BMI $g,=30), agoraphobia from 2002, insomnia from 2000. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 14Apr2021 in arm for COVID-19 immunisation. A case has been received from a 73-year-old patient, the same day that she receives the second dose of vaccination against Covid-19 with bnt162b2 05May2021, they report sudden death of unknown cause. The notification was received at the Privacy on 06May2021 and came from a physician from the Privacy. Textual information collected from the digital clinic story: Reason for consultation: Notice 061: 05May2021 15:59: It gets activated as 12:09 h because the alert referred that the patient did not respond. The family referred that they have been vaccinated today (05May2021) against COVID 19 with Pfizer. Refert to suffer only from "nerves" without another medical history. Registered exploration (05May2021 16:03): On arrival, the patient presents generalized tonic contraction. After placing the airway adjunct and the safety lateral position, they canalize the peripheral venous route. She entered in cardiac arrest, ventricular fibrillation. They immediately start advanced CPR (Cardiopulmonary resuscitation) applying defibrillation and entering sinusal rhythm with pulse and spontaneous breathing. They activated helicopter and started transfer in ambulance. At this moment she entered asystole so they return advanced CPR maneuvers and intubating the patient and making the transfer to the heliport. The helicopter team continues CPR. Clinical judgment was Death at 14:10 on 05May2021. Autopsy was done, results were not available. The outcome of events generalized tonic contraction, cardiac arrest/asystole, ventricular fibrillation was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1331354 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021545565

Write-up: Death; This is a spontaneous report from a contactable physician received through Regulatory Authority webpage. A 47 year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in right arm on 12May2021 12:15 AM(Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced death on 14May2021 15:30. The patient died on 14May2021 15:30. It was not reported if an autopsy was performed. It was unknown if the patient was diagnosed with COVID-19 Prior to vaccination or if the patient has been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information expected; Information about batch/lot number cannot be obtained.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history, concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1331377 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood potassium, Body temperature, Cardio-respiratory arrest, Headache, Influenza, International normalised ratio, Pyrexia, Right ventricular failure, Sudden death, Vertigo, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: INEXIUM [ESOMEPRAZOLE MAGNESIUM]; COUMADIN SODIUM; ATACAND; BISOPROLOL [BISOPROLOL FUMARATE]; CORTANCYL; IZALGI; DAFALGAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Arthrodesis (for rheumatoid arthritis); Knee fracture; Osteosynthesis; Paroxysmal atrial fibrillation; Partial gastrectomy; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: Potassium; Result Unstructured Data: Test Result:4.3 mmol/L; Test Date: 20210501; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210422; Test Name: INR; Result Unstructured Data: Test Result:2.85; Comments: normal renal function
CDC Split Type: FRPFIZER INC2021539370

Write-up: Sudden death unexplained; cardio respiratory arrest; right ventricular failure; vertigo; headaches; fever; abdominal pain; vomitting; Flu syndrome; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority FR-AFSSAPS-CN20211472, Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021048957. A 71-year-old female patient received second dose of BNT162B2 (COMIRNATY, Lot Number: ET6956), intramuscular, administered in arm left on 29Apr2021 at single dose for COVID-19 immunisation. Medical history included arterial hypertension from 2000, paroxysmal atrial fibrillation from 2013, partial gastrectomy from 2002, osteosynthesis left ankle from 2005, left knee fracture from 2002, rheumatoid arthritis from 1977, MP left hand arthrodesis from 1977 for rheumatoid arthritis. There was no history of COVID-19 and no PCR test history. Concomitant medications included esomeprazole magnesium (INEXIUM); warfarin sodium (COUMADIN SODIUM); candesartan cilexetil (ATACAND); bisoprolol fumarate (BISOPROLOL); prednisone (CORTANCYL); papaver somniferum, paracetamol (IZALGI); paracetamol (DAFALGAN). The patient previously took cordarone from Dec2016 and experienced pneumopathy medicated. The patient experienced sudden death unexplained on 02May2021. Flu syndrome after vaccination on 29Apr2021 and 30Apr2021 with abdominal pain and vomiting on 30Apr2021 in the morning. on 01May2021, fever at 38 deg. The 02May2021 morning, feeling of vertigo, headaches, taking paracetamol at 11am. Patient found by her husband in cardio respiratory arrest around 12-13h (on 02May2021). External cardiac massage performed by a neighbor then relayed by the firefighters with ventilation. Upon arrival of the emergency medial service at 1:15 p.m., installation of the DSA(semi-automatic defibrillator), no cardiac activity. Intermediate reactive pupils. Administration of adrenaline 4 * 2mg (right ventricular failure on 02May2021). Resumption with shocked TV then shocked FV again. The patient underwent lab tests included Potassium (3.6-4.8 mmol/l): 4.3 mmol/l on 22Apr2021, body temperature: 38 centigrade on 01May2021, international normalised ratio (INR): 2.85 on 22Apr2021 (normal renal function). The outcome of event Sudden death unexplained, cardio respiratory arrest and right ventricular failure was fatal and other event was unknown. The patient died on 02May2021 13: 36. An autopsy was not performed. No follow-up attempts are possible. No further information is expected. Information about batch number already obtained.; Reported Cause(s) of Death: cardio respiratory arrest; Sudden death unexplained; right ventricular failure


VAERS ID: 1331378 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood creatinine, Blood potassium, Blood pressure measurement, Blood thyroid stimulating hormone, Blood urea, Brain natriuretic peptide, Chest X-ray, Chills, Electrocardiogram, General physical health deterioration, Liver function test, Palpitations, Tachyarrhythmia, Troponin
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Asthma; Goitre nodular; Renal failure (moderate)
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Mitral valve incompetence; Nephrolithiasis; Ovarian neoplasia (bilateral ovarian neoplasia); Tuberculous pleurisy
Allergies:
Diagnostic Lab Data: Test Name: creatinine; Result Unstructured Data: Test Result:increased to 167 umol/l; Test Date: 20210311; Test Name: plasma potassium; Result Unstructured Data: Test Result:5.1 mEq/l; Comments: Acute renal failure with 5.1 meq/l hyperkalaemia; Test Name: blood pressure; Result Unstructured Data: Test Result:80/40 mmHg; Test Date: 20210311; Test Name: TSH; Result Unstructured Data: Test Result:normal; Test Name: Urea; Result Unstructured Data: Test Result:increase to 1.91 g/l; Test Date: 20210311; Test Name: brain natriuretic peptides; Result Unstructured Data: Test Result:increased to 1200; Test Date: 20210311; Test Name: chest X-ray; Result Unstructured Data: Test Result:shows some signs of overload; Test Date: 20210311; Test Name: electrocardiography; Result Unstructured Data: Test Result:tachyarrhythmia at 160 bpm.; Test Date: 20210311; Test Name: liver test; Result Unstructured Data: Test Result:hepatic cytolysis; Test Date: 20210311; Test Name: troponins; Result Unstructured Data: Test Result:slightly increased to 47 but stable in the cycle o; Comments: slightly increased to 47 but stable in the cycle of troponin.
CDC Split Type: FRPFIZER INC2021506237

Write-up: Atrial fibrillation; chills with a deterioration in general condition; chills with a deterioration in general condition; complained of palpitations.; tachyarrhythmia; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-DJ20210951 with Safety Report Unique Identifier FR-AFSSAPS-2021041655. A 90-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 11Mar2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. Medical history included Nephrolithiasis, Ovarian neoplasia, ongoing Renal failure, ongoing asthma , Tuberculous pleurisy, ongoing Arterial hypertension, Mitral valve incompetence, ongoing Goitre nodular, appendicectomy. The patient''s concomitant medications were not reported. The patient experienced atrial fibrillation on 17Mar2021 with outcome of recovering, chills with a deterioration in general condition on an unspecified date with outcome of unknown, chills with a deterioration in general condition on an unspecified date with outcome of unknown, complained of palpitations on an unspecified date with outcome of unknown, tachyarrhythmia on an unspecified date with outcome of unknown. Female patient received a first dose of the vaccine (batch no. unknown) on 11Mar2021.Subsequently, she presented with chills with a deterioration in general condition and complained of palpitations.She was referred to the ER after the discovery of a tachyarrhythmia.In the Emergency Unit, the tachyarrhythmia is confirmed on the electrocardiography at 160 bpm. Acute renal failure with 5.1 meq/l hyperkalaemia and hepatic cytolysis was noted on the laboratory assessment. BNPs (brain natriuretic peptides) are increased to 1200 and the troponins slightly increased to 47 but stable in the cycle of troponin. The TSH (Thyroid Stimulating Hormone) is normal.The chest X-ray shows some signs of overload.After cardiological advice, the patient is put on Bisoprolol and she is hospitalized. The hospital report mentions that the patient initially remained very tachycardic and that there were some signs of overload for which treatment with LASILIX was started at small doses.24 hours later, her creatinine increased to 167 ?mol/l with an increase in her urea to 1.91 g/l. Serum potassium is corrected following administration of KAYEXALATE. There is no inflammatory syndrome.In the indication of atrial fibrillation, treatment with ELIQUIS is started on 19Mar2021 at a dosage of 2.5 mg 2 x per day.The patient underwent lab tests and procedures which included blood creatinine: increased to 167 umol/l, blood potassium: 5.1 meq/l on 11Mar2021 Acute renal failure with 5.1 meq/l hyperkalaemia , blood pressure measurement: 80/40 mmhg, blood thyroid stimulating hormone: normal on 11Mar2021, blood urea: increase to 1.91 g/l, brain natriuretic peptide: increased to 1200 on 11Mar2021, chest x-ray: shows some signs of overload on 11Mar2021, electrocardiogram: tachyarrhythmia at 160 bpm. on 11Mar2021, liver function test: hepatic cytolysis on 11Mar2021, troponin: slightly increased to 47 but stable in the cycle o on 11Mar2021 slightly increased to 47 but stable in the cycle of troponin. Therapeutic measures were taken as a result of atrial fibrillation. The patient died on 21Mar2021.Overall, a tachyarrhythmia occurred in a 90-year-old patient with hypertension within one week of receiving a first dose of COMIRNATY vaccine. Treatment with ELIQUIS and onset of rectal bleeding with initial drop in Blood Pressure then stabilized and death observed the next day. Case Summary and Reporter''s Comments Text : Collection following a declaration from a pharmacist received by letter concerning the related case DJ20210952 (digestive haemorrhage under ELIQUIS (apixaban)).; Sender''s Comments: Linked Report(s) : FR-AFSSAPS-DJ20210952 AFSSAPS; Reported Cause(s) of Death: Bleeding rectal


VAERS ID: 1331563 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ischaemic heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Sudden death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001650) for COVID-19 vaccination. Concurrent medical conditions included Ischaemic heart disease. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 20-Apr-2021. The reported cause of death was mort subite. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The action taken with mRNA-1273 was not applicable. Company Comment: This is a case of death in a 90-year-old male subject with a medical history of Ischaemic heart disease, who died 10 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 90-year-old male subject with a medical history of Ischaemic heart disease, who died 10 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Mort subite


VAERS ID: 1331879 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Asthma; Hypercholesterolemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: vital signs; Result Unstructured Data: Test Result:No vital signs
CDC Split Type: GRPFIZER INC2021560852

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB (GR-GREOF-20213263). A 68-year-old female patient received BNT162B2 (COMIRNATY), intramuscularly, on 16Apr2021 as a single dose for COVID-19 immunisation. Medical history included hypercholesterolemia, hypertension, arrhythmia, and asthma. Concomitant medications included unspecified medications (reported as: used to well-regulate medical history). The patient experienced acute myocardial infarction on 18Apr2021, which was reported as medically significant and fatal. The clinical course was reported as follows: Two days after the vaccination, the patient was found dead at home and was admitted to the hospital where cardiopulmonary resuscitation was performed with no vital signs and she was diagnosed with acute myocardial infraction on 18Apr2021. The patient''s relatives did not want an autopsy. The patient died on 18Apr2021. The cause of death was acute myocardial infarction. An autopsy was not performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1331888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Death, Hepatic function abnormal, Neoplasm progression, Portal vein thrombosis
SMQs:, Liver related investigations, signs and symptoms (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related conditions (narrow), 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: Medical History/Concurrent Conditions: Hepatic metastases (Stable; based on CT scan.)
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:hepatic metastases stable
CDC Split Type: GRPFIZER INC2021565573

Write-up: unknown cause of death; portal vein thrombosis; Hepatic metastases; hepatic function aggravated; This is a spontaneous report from a contactable physician via a sales representative. A 56-year-old female patient received the first dose of BNT162B2 (COMIRNATY; solution for injection) intramuscularly on an unspecified date at 0.3 mL, single dose for COVID-19 immunisation, palbociclib (IBRANCE; capsule) orally from an unspecified date to an unspecified date at an unspecified dose and frequency for breast cancer (hormone positive) and fulvestrant via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose and frequency for breast cancer (hormone positive). Medical history included stable hepatic metastases (based on CT scan) from an unspecified date and unspecified if ongoing. Concomitant medications were not reported. The patient had received multiple treatments for her condition in the past that were not otherwise specified. The patient experienced portal vein thrombosis on an unspecified date (5-8 days after vaccination) that had been successfully treated. Then, she experienced hepatic metastases and hepatic function aggravated, both on unspecified dates. Then, the patient died on an unspecified date. The action taken in response to the events for palbociclib and fulvestrant were both unknown. The clinical outcome of the event portal vein thrombosis was recovered/resolved on an unspecified date while the clinical outcomes of the events hepatic metastases and hepatic function aggravated were both unknown. The patient died on an unspecified date. The cause of death was not reported, and it was not reported if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information currently available the event Death (unknown cause) and Portal vein thrombosis are attributed to underlaying medical conditions including breast cancer, hepatic metastases and considered unrelated to suspect products BNT162B2 (COMIRNATY) vaccine and palbociclib (IBRANCE). The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1331967 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Fatigue, Oxygen saturation, Oxygen saturation decreased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SODIUM CHLORIDE; NORVASC; HALDOL; LASIX [FUROSEMIDE]; PARACETAMOL; KANRENOL; INHIXA; LANSOX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Delirium; Dementia; Dyslipidaemia; Exposure to COVID-19; Hypertensive heart disease; Pneumonitis; Subdural haematoma (traumatic)
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: Oxygen saturation low; Test Result: 95 %
CDC Split Type: ITPFIZER INC2021544647

Write-up: fatigue; disoriented; mild desaturation (95%); This is a spontaneous report from a contactable physician downloaded from the regulatory authority [IT-MINISAL02-725878]. A 100-year-old female patient received second dose of BNT162B2 (COMIRNATY) Lot number EX7389, expiration date 31Aug2021, Intramuscular in right arm on 05May2021 14:00 at 0.3 ml single for COVID-19 immunisation. Medical history included Dyslipidaemia, Delirium, Pneumonitis, Exposure to COVID-19, Subdural haematoma (traumatic), Dementia, Hypertensive heart disease. Concomitant medications included sodium chloride, amlodipine besilate (NORVASC), haloperidol (HALDOL), furosemide (LASIX), paracetamol, potassium canrenoate (KANRENOL), enoxaparin sodium (INHIXA), and lansoprazole (LANSOX). The patient received first dose of BNT162B2 Lot number EX0893, on 14Apr2021 16:51, and had heart failure following respiratory failure from pneumonia, Urinary tract infection (from 22Apr2021 to 03May2021) from Klebsiella pneumoniae. On 05May2021, the patient appeared disoriented in the evening, with mild desaturation (95%) and fatigue (still reported contact with positive sars-covid-19 during hospital stay with isolation). The patient died on 06May2021 due to disoriented, mild desaturation (95%) and fatigue. Autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: fatigue; disoriented; mild desaturation (95%)


VAERS ID: 1331968 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apallic syndrome, Atrial fibrillation, Cerebrovascular accident, Ischaemia
SMQs:, Supraventricular tachyarrhythmias (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: 2021-05-07
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANTACAL; ATENOLOL; VOLTAREN [DICLOFENAC]; MUSCORIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021544643

Write-up: Atrial fibrillation and multiple ischaemias resulting in a semi-vegetative state.; Atrial fibrillation and multiple ischaemias resulting in a semi-vegetative state.; Atrial fibrillation and multiple ischaemias resulting in a semi-vegetative state; strokes; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-725916. This Physician reported different events for both doses of Comirnaty for the same patient. This is the first of two reports. Only this report is serious. A 94-year-old female patient received 2nd dose of bnt162b2 (COMIRNATY, Lot Number: EX0893), intramuscular on 23Apr2021 as single dose for covid-19 immunization. Medical history included hypertension arterial from an unknown date and unknown if ongoing. Patient was lucid and independent. Concomitant medications included amlodipine besilate (ANTACAL) for hypertension; atenolol for hypertension, diclofenac (VOLTAREN) for aches & pains in legs/ swelling and pain in one lower leg from an unknown date in 2021, thiocolchicoside (MUSCORIL) syringes for aches & pains in legs/ swelling and pain in one lower leg from an unknown date in 2021. Historical vaccine included 1st dose of bnt162b2 (COMIRNATY, Lot Number: ET7205) intramuscular on 27Mar2021 for SARS-CoV-2 vaccination and experienced leg swelling. The patient had been simultaneously taking VOLTAREN and MUSCORIL syringes for swelling and pain in one lower leg which occurred one week after the first dose of the vaccine, but discontinued from the day before to the day after the vaccine. In addition, the reporter reported that the patient was ''''currently (as of 07May2021) hospitalized. '''' On the morning of 26Apr2021, patient experienced atrial fibrillation and multiple ischaemias resulting in a semi-vegetative state. Patient passed away on 07May2021 after 12 days in a semi-vegetative state. It was unknown if autopsy was done. Doctors said that a correlation with the vaccine was unlikely, that "strokes are the order of the day in elderly people." Outcome of the events was fatal. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-2021547893 same patient, different event after 1st dose of Comirnaty vaccine; Reported Cause(s) of Death: Atrial fibrillation and multiple ischaemias resulting in a semi-vegetative state.; Atrial fibrillation and multiple ischaemias resulting in a semi-vegetative state.; Atrial fibrillation and multiple ischaemias resulting in a semi-vegetative state.; s


VAERS ID: 1331971 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   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 INC2021544654

Write-up: cardiac arrest/cardiorespiratory arrest; cardiorespiratory arrest; persistence of non-shockable rhythm; remained unconscious; renal diseases; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority-WEB. The regulatory authority report number is [IT-MINISAL02-726800]. A 91-year-old female patient received second dose of BNT162B2 (COMIRNATY) Lot number FA5831, expiration date 31Aug2021, Intramuscular in left Deltoid on 08May2021 10:13 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unknown date and had no reaction. The patient experienced cardiac arrest one hour after the vaccination in the car on 08May2021. The patient experienced death in the emergency room due to cardiorespiratory arrest and persistence of non-shockable rhythm. The patient suffered from cardiovascular and renal diseases. She had been stretched out, her pulse undetectable, no breathing. Operators with the Automated External Defibrillator were alerted and was called, cardiopulmonary resuscitation with automatic external defibrillator, cannula needle started. Put peripheral venous catheter, never defibrillated, she remained unconscious. Response arrived after 10 ''and took charge of the patient. An autopsy will be performed. Reporter Comment: Inoculation site: left deltoid Other information: the unconscious patient? She has been stretched out, her pulse undetectable, no breathing. Operators with the Automated External Defibrillator were alerted and was called, cardiopulmonary resuscitation started. Put peripheral venous catheter, never defibrillated, she remains unconscious. Response arrives after 10 ''and takes charge of the patient. Sender Comment: 10May2021 Local Center contacted reporting updated card. Requested clinical report, Emergency Room report and autopsy report, when available. On hold. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Inoculation site: left deltoid Other information: the unconscious patient? She has been stretched out, her pulse undetectable, no breathing. Operators with the Automated External Defibrillator were alerted and was called, cardiopulmonary resuscitation started. Put peripheral venous catheter, never defibrillated, she remains unconscious. Response arrives after 10 ''and takes charge of the patient.; Reported Cause(s) of Death: cardiac arrest; persistence of non-shockable rhythm; cardiorespiratory arrest; remained unconscious; renal diseases


VAERS ID: 1331979 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ELO725 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021555471

Write-up: hemorrhagic stroke; This is a spontaneous report from a contactable physician (patient''s wife). An 85-year-old male patient received BNT162B2 (COMIRNATY), 1st dose via an unspecified route of administration on 13Feb2021 12:20 at the age of 85-year-old male (Batch/Lot Number: ELO725; Expiration Date: Mar2021) as single dose for COVID-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. The patient experienced hemorrhagic stroke on 15Feb2021 13:15, he was hospitalized. The patient died on 17Feb2021 17:30. Cause of death was hemorrhagic stroke. It was not reported if an autopsy was performed.; Sender''s Comments: Based on the information currently available,The casual association between the reported event "Haemorrhagic stroke " and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: hemorrhagic stroke


VAERS ID: 1332080 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   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:
Allergies:
Diagnostic Lab Data: Test Name: Autopsy CT imaging; Result Unstructured Data: Test Result:no findings; Comments: post-mortem
CDC Split Type: JPPFIZER INC2021551187

Write-up: Sudden cardiac death; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 92-year-old female patient received BNT162B2 (COMIRNATY) (Batch/Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration on 11May2021 (at the age of 92-years-old) as UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15May2021 at 03:00, the patient died of sudden cardiac death. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included computerised tomogram (CT): no findings (post-mortem). The reporting physician assessed the causal relationship between the event and BNT162b2 as unknown.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of sudden cardiac death. The reported event may likely be associated with intercurrent medical condition in this elderly 92 year old patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including autopsy results, EKG , cardiac enzymes and echocardiogram, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1332085 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain stem haemorrhage, Decreased appetite, Depressed level of consciousness, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: IRINOTECAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Small cell lung cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: COVID-19 PCR test with nasal swab; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC2021553573

Write-up: Brain stem haemorrhage; Consciousness level depressed; Inappetence; This is a spontaneous report from a contactable physician. A 69-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) intramuscularly (at the age of 69 years) as a single dose on 10May2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitantly, the patient received chemotherapy with irinotecan within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included small cell lung cancer and diabetes mellitus, both from an unknown date. On 10May2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) intramuscularly for COVID-19 immunization. The patient experienced inappetence on 10May2021 (the day of vaccination). The patient hospitalized on 14May2021. The patient experienced depressed level of consciousness on 15May2021 (5 days after the vaccination), and brain stem haemorrhage on 16May2021 (6 days after the vaccination). It was predicted that the patient would die in a few days. The patient did not receive any treatment for the events. Since the vaccination, the patient was tested for COVID-19 PCR with nasal swab, which showed negative result. The event brain stem haemorrhage was reported as serious due to being fatal/ life-threatening, hospitalization, and disability. The patient required an emergency room/department visit or urgent care for the events. Cause of death was brain stem haemorrhage. The patient died on an unspecified date. The outcome of the inappetence and depressed level of consciousness was unknown. It was unknown whether autopsy was performed or not.; Sender''s Comments: The events considered intercurrent conditions and unlikely related to the product BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown). The comorbidities of being elderly, small cell lung cancer and diabetes mellitus, may have contributed to the development of the events.; Reported Cause(s) of Death: Brain stem haemorrhage


VAERS ID: 1332086 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 2021-05-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021556802

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from A Medical Agency (MDA). The regulatory authority report number is V21106687. An 89-year and 8-month-old female received the 1st dose of BNT162B2 (Pfizer vaccine, Solution for injection, lot number and expiration date not provided) via an unspecified route of administration on 15May2021 15:30 at age of 89-year and 8-month-old as a single dose for COVID-19 immunization. The patient''s family history and medical history were not provided. The patient''s concomitant medications were not reported. Body temperature before vaccination was not provided. On 15May2021 at 19:24 (3 hours and 54 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 15May2021 20:28(the day of the vaccination), the patient died due to cardio-respiratory arrest. It was not reported if an autopsy was performed. The course of the event was as follows: On 15May2021 (the day of vaccination), at approximately 15:30 the patient received the first dose of BNT162B2 vaccination at the institution. After vaccination, no particular acute reaction was observed and the patient ate supper. At 18:30 (3 hours after vaccination), the patient went back to the bed. At approximately 19:20 (3 hours and 50 minutes after vaccination), when a staff visit the patient bed and she was found in cardio-respiratory arrest. An ambulance was called. At 20:09 (4 hours and 39 minutes after vaccination), the patient arrived to the reporter''s hospital. The intension of the patient''s family members was confirmed, and they did not wish to have cardiopulmonary resuscitation for the patient. Thus, at 20:28 (4 hours and 58 minutes after vaccination), the patient was confirmed to be dead. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162B2 as unassessable . There was other possible cause of the event such as any other diseases (detail was not provided). The reporting physician commented as follows: The causality between the event and BNT162B2 was considered less likely. However, this case was death case on the day of the vaccination, and thus, this case was reported. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1332088 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood pressure measurement, Blood pressure systolic, Blood urea, C-reactive protein, Cardio-respiratory arrest, Depressed level of consciousness, Protein total, Vomiting, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAGMITT; DICLOFENAC NA; LANSOPRAZOLE; ROZEREM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure decreased; Fall; Hypertension; Hypoproteinaemia; Micturition disorder; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:decreased to 60; Comments: at 22:30; Test Date: 20210319; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:decreased to 54-69; Test Date: 20210322; Test Name: BUN; Result Unstructured Data: Test Result:64.4; Test Date: 20210322; Test Name: CRP; Result Unstructured Data: Test Result:33.6; Test Date: 20210322; Test Name: T.P; Result Unstructured Data: Test Result:5.0 g/dl; Test Date: 20210322; Test Name: White blood cell count; Result Unstructured Data: Test Result:16800; Test Date: 20210322; Test Name: Creatinine; Result Unstructured Data: Test Result:1.44
CDC Split Type: JPPFIZER INC2021556837

Write-up: cardio-respiratory arrest; Vomiting twice; Depressed level of consciousness; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21106684. An 89-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly, on 13May2021 at 13:10 (Lot Number: ER7449; Expiration Date: 30Jun2021) (at the age of 89-years-old) as 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension, renal failure chronic, hypoproteinaemia, fall on 18Mar2021, blood pressure decreased from 19Mar2021 to 19Mar2021, and micturition disorder from 19Mar2021 to 11Apr2021. The patient had no allergy. Concomitant medications included magnesium oxide (MAGMITT), diclofenac sodium (DICLOFENAC NA), lansoprazole (MANUFACTURER UNKNOWN), and ramelteon (ROZEREM). The patient previously received the first dose of BNT162B2 (COMIRNATY; Lot number: ER7449; Expiration date: 30Jun2021), intramuscularly, on 22Apr2021 at 0.3 mL, single for COVID-19 immunisation. The patient experienced vomiting twice and depressed level of consciousness on 13May2021 at 19:30 (6 hours 20 minutes after the vaccination), which were reported as fatal. The patient also experienced cardio-respiratory arrest on 14May2021 at 04:00. The clinical course was reported as follows: On 18Mar2021, the patient experienced fall but had no fracture. On 19Mar2021, blood pressure systolic decreased to 54-69. The patient was anuric and urinated via catheter. The patient received glucose/potassium chloride/sodium chloride/sodium lactate (KN NO. 3) 500 mL. On 20Mar2021, balloon catheter was placed. Thereafter, glucose/potassium chloride/sodium chloride/sodium lactate 500 mL twice was continued. On 22Mar2021, blood test was conducted, which showed white blood cell count of 16800, C-reactive protein (CRP) of 33.6, blood urea nitrogen (BUN) of 64.4, creatinine of 1.44, and protein total (T.P.) of 5.0 g/dL. Piperacillin hydrate (TAZOPIPE) 4.5 grams, twice was continued until 29Mar2021. The patient was fasted until 25Mar2021. From 25Mar2021, the patient started to eat little by little with continued infusion. On 04May2021, infusion solution was discontinued. From 08May2021, the patient had reduced dietary intake. The patient was unable to urinate on her own and catheterized. On 09May2021, the condition was similar. On 13May2021, the patient vomited. At 19:30, depressed level of consciousness was reported; however, the patient soon returned to the usual condition and placed under observation. At 22:30, the patient vomited with blood pressure measurement decreased to 60 on 13May2021. On 14May2021 at 04:00, the patient was visited and was found to have cardio-respiratory arrest. The reporting physician commented as follows: From 19Mar2021 to 11Apr2021, the patient was unable to eat food and received unspecified infusion solution 1000 mL/day. Subsequently, the patient started to eat food. The patient was vaccinated twice; however, cause of death was not considered due to adverse reaction of the vaccine. It was considered due to renal failure chronic, hypoproteinaemia, and geromarasmus. The clinical outcome of all of the events was fatal. The patient died on 14May2021. The causes of death were reported as renal failure chronic, hypoproteinaemia, and geromarasmus. It was not reported if an autopsy was performed. The reporting physician assessed the events were unrelated to BNT162B2. Other possible causes of the event, such as any other diseases, were decreased physical strength and renal function aggravated.; Sender''s Comments: Reported events are considered intercurrent and unrelated to suspect BNT162B2.; Reported Cause(s) of Death: Renal failure chronic; Hypoproteinaemia; Geromarasmus


VAERS ID: 1332089 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-27
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac failure, Oxygen saturation
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: Cardiac failure
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: blood pressure; Result Unstructured Data: Test Result:decrease; Test Date: 20210416; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210427; Test Name: oxygen concentration; Result Unstructured Data: Test Result:decrease
CDC Split Type: JPPFIZER INC2021556891

Write-up: Cardiac failure aggravated; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21106612. A 92 year old female patient received?the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ET3674, Expiration date 31Jul2021) on 16Apr2021 at 14:00 (at the age of 92-years-old) via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history was not provided. Concomitant medications were not provided. Body temperature before vaccination was 36.5 degrees Centigrade. Family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 27Apr2021 in the morning (11 days after the vaccination), the patient experienced cardiac failure aggravated. On 27Apr2021 (11 days after the vaccination), the patient was admitted to the hospital. On 03May2021 (17 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: From the beginning of March 2021, the patient had increased oedema due to cardiac failure. On 16Apr2021, the patient received the vaccine and there was no particular change in symptom. On 27Apr2021 in the morning, the patient developed blood pressure decrease and oxygen concentration decrease, for which the patient was hospitalized in another hospital. On 03May2021, the patient died of aggravation of cardiac failure. Causality between COMIRNATY vaccination and death were considered unrelated.The reporting physician classified the event as non-serious and assessed that the event was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases.; Sender''s Comments: Based on the information provided, the reported fatal cardiac failure is an intercurrent medical condition and unrelated to BNT162B2.; Reported Cause(s) of Death: Cardiac failure aggravated


VAERS ID: 1332090 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-04-03
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Body temperature, C-reactive protein, Infective spondylitis, Magnetic resonance imaging, Pyrexia, SARS-CoV-2 test, 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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 10
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 (haemodialysis was introduced for renal failure chronic); Renal failure chronic; Shunt occlusion
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: Blood culture; Test Result: Positive ; Comments: Sepsis; Test Date: 20210403; Test Name: Body temperature; Result Unstructured Data: Test Result:38.0 Centigrade; Comments: in the evening; Test Date: 20210405; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210405; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Comments: on the evening; Test Date: 20210406; Test Name: CRP; Test Result: 28.3 mg/dl; Comments: increased; Test Date: 20210406; Test Name: CRP; Test Result: 28.26 mg/dl; Test Date: 20210409; Test Name: MRI; Result Unstructured Data: Test Result:Pyogenic spondylitis (L2/3) noted; Comments: L2 and L3 Discitis Inflammatory spread in front of L2 and L3 vertebral bodies; Test Date: 20210406; Test Name: New coronavirus nucleic acid PCR method; Test Result: Negative ; Test Date: 20210406; Test Name: White blood cells; Result Unstructured Data: Test Result:22100 /mm3; Comments: increased
CDC Split Type: JPPFIZER INC2021557781

Write-up: Sepsis; pyogenic spondylitis due to long-term placed catheter infection; pyrexia; This is a spontaneous report from a contactable physician received from the regulatory authority (PMDA). Regulatory authority report number v21101813. A 73-year-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EP9605; Expiration Date: 30Jun2021) via intramuscular around 14:00 on 15Mar2021 as a single dose for COVID-19 immunisation. The patient was 73-year-old at the time of vaccination. The patient had a medical history of renal failure chronic, haemodialysis from 20Oct2020, shunt occlusion from 18Jan2021, and insertion of long term catheter from 18Jan2021. On 20Oct2020, haemodialysis was introduced for renal failure chronic at another hospital. However, shunt occlusion occurred subsequently, for which insertion of long term catheter was performed on 18Jan2021. The patient''s concomitant medications were not reported. The patient experienced pyrexia, sepsis and pyogenic spondylitis due to long-term placed catheter infection on 03Apr2021. The patient underwent lab tests and procedures which included C-reactive protein: 28.3 mg/dl on 06Apr2021; magnetic resonance imaging (MRI): pyogenic spondylitis (l2/3) noted, L2 and L3 discitis (there was inflammatory spread in front of L2 and L3 vertebral bodies) on 09Apr2021; New coronavirus nucleic acid PCR method: negative 06Apr2021; CRP (reference range 0 to 0.3): 28.26 mg/dl on 06Apr2021, blood culture: positive (Sepsis) on 06Apr2021. The course of the event was as follows: On the evening of 03Apr2021, pyrexia of 38.0 degrees Centigrade and low back pain developed. As fever had gone by 05Apr2021, the patient visited the hospital to receive the second dose of BNT162b2. Since the pyrexia on 03Apr2021 was neither described on the vaccine screening questionnaire nor reported to the physician and primary physician''s consent to vaccination was confirmed, BNT162b2 was vaccinated as usual. However, the patient presented with pyrexia of 38.4 degrees Centigrade on the evening of 05Apr2021 (the day of the vaccination). On 06Apr2021 (1 day after the vaccination), the patient visited fever outpatient of the hospital. At his visit, blood test showed WBC and CRP increased to 22100/mm3 and 28.3 mg/dL, and the patient was admitted to the hospital for further evaluation. Catheter infection was found and MRI revealed pyogenic spondylitis at L2/3. Although receiving conservative treatment with antibiotics, the patient experienced sepsis and died on 8th day of hospital admission. The reporter classified the events pyrexia (occurred after second dose of vaccination), pyogenic spondylitis due to long-term placed catheter infection, and sepsis as death. Therapeutic measures were taken as a result of the events (administration of antibiotic for the events sepsis and pyogenic spondylitis due to long-term placed catheter infection, and administration of antifebrile for the event pyrexia (occurred after second dose of vaccine)). No autopsy was performed because the family did not hope. It was unknown whether the patient had allergy history, adverse reaction history, vaccination history (excluding reported vaccination) and side reaction history. The patient lived at home (living together). There was no level of care needed. Activities of daily living (ADL) degree was independent. The swallowing function, ingestion intake was possible. The body temperature before vaccination was 36.4 degrees centigrade. No abnormality was noted before and after the vaccination. Pyrexia was noted at 18:30 on 05Apr2021 and the patient visited an outpatient department the next day. There was no emergency call. It was confirmed that the patient died at 08:06 on 13Apr2021. No diagnostic imaging at the time of death or autopsy was performed. The outcome of the event pyrexia (under first dose of BNT162b2) was recovered on 05Apr2021. The outcome of the events pyogenic spondylitis due to long-term placed catheter infection, and sepsis was fatal. The reporter assessed the event pyrexia as possibly related to BNT162b2 and the events pyogenic spondylitis due to long-term placed catheter infection and sepsis as unrelated to BNT162b2. The reporter considered sepsis as the cause of the death.; Sender''s Comments: Based on the available information, the company assessed there was not a reasonable possibility that the reported events Sepsis and Pyogenic spondylitis (both with fatal outcome) were related to the suspect product BNT162b2 (COMIRNATY). The events are more likely intercurrent conditions.; Reported Cause(s) of Death: sepsis; pyogenic spondylitis due to long-term placed catheter infection; pyrexia (occurred after second dose of vaccination)


VAERS ID: 1332092 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Investigation, Myocardial ischaemia, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 11
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: OLMESARTAN; BAYASPIRIN; TENELIA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Lung cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: Body temperature; Result Unstructured Data: Test Result:35.2 Centigrade; Comments: Before vaccination; Test Date: 20210430; Test Name: Examination; Result Unstructured Data: Test Result:triple vessel disease
CDC Split Type: JPPFIZER INC2021558983

Write-up: cardiac failure; Ischaemic heart disease; ventricular fibrillation; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21106879. A 84-years-old male patient received BNT162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 28Apr2021 13:20 (Batch/Lot Number: ET3674; Expiration Date: 31Jul2021) as single dose (at the age of 84 years old) for COVID-19 immunisation. Medical history included hypertension, diabetes mellitus and lung cancer. Concomitant medications included olmesartan medoxomil (OLMESARTAN 40) 1 tablet/day, acetylsalicylic acid (BAYASPIRIN 100) 1 tablet 1x, and teneligliptin hydrobromide hydrate (TENELIA 20) 1 tablet 1x. No information on family history was provided. The patient was an 84-year and 5-month-old male. Body temperature before vaccination was 35.2 degrees Centigrade. On 28Apr2021 at 13:20 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# ET3674, Expiration date 31Jul2021) via an unspecified route of administration as 1st dose, single for COVID-19 immunization. On 30Apr2021 at around 03:00 (2 days after the vaccination), the patient experienced the reported event of ischaemic heart disease. On 11May2021 (13 days after the vaccination), the patient died of cardiac failure. It was not reported if an autopsy was performed. The course of the event was as follows: On 30Apr2021 at around 03:00, the patient complained of breathing difficulty. On 30Apr2021 at 06:30, the patient was transferred to a hospital on emergency. Cardiac catheterization was performed for the treatment, and examinations were conducted (triple vessel disease). During hospitalization, ventricular fibrillation occurred concurrently. Therefore, after cardioversion was performed, cardiac catheterization was done again. On 11May2021, the patient developed cardiac failure, and died without recovering. The reporting physician classified the event (reported as Ischaemic heart disease) as serious (fatal outcome (life-threatening was reported by the reporter)) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician commented as follows: The physician in charge told that the relationship with BNT162b2 was unclear as the arteriosclerosis was severe (it could not be said for certain). The possibility of his underlying being the cause could be suspected.; Reported Cause(s) of Death: cardiac failure; ischaemic heart disease


VAERS ID: 1332093 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021558984

Write-up: thoracic aneurysm, ruptured; This is a spontaneous report from a contactable physician received from the regulatory authority. The Regulatory Authority report number is v21106977. A 92-year-old female patient received BNT162B2 (COMIRNATY) (Batch/Lot Number: EX3617; Expiration Date: 31Aug2021), dose 2, via an unspecified route of administration on 14May2021 at 16:00 (at the age of 92-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medication were not reported. The patient had no particular family history. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY) (Lot number: unknown, Expiration date: unknown), dose #1, via an unspecified route of administration on an unspecified date in 2021 as 1st DOSE, SINGLE for COVID-19 immunization with no adverse effects experienced. On 14May2021 (the day of vaccination), no abnormal findings were observed after the patient received the second dose of BNT162B2 vaccination. On 15May2021, no abnormalities were observed with round at 02:00 (9 hours after vaccination). At 05:13 (13 hours and 13 minutes after vaccination), the healthcare professional was aware that the patient had respiratory arrest and contacted. The patient died on 15May2021. Since the cause of death was unknown, autopsy imaging (AI) was asked, which showed haemorrhage from the thoracic aorta into the thoracic cavity. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: AI showed thoracic aneurysm, ruptured. The patient had medical history of thoracic aneurysm, ruptured as an underlying disease. The patient underwent lab tests and procedures which included body temperature (14May2021): 36.8 degrees centigrade (before vaccination).; Autopsy-determined Cause(s) of Death: thoracic aneurysm, ruptured


VAERS ID: 1332094 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Body temperature, Investigation, Loss of consciousness, Sudden cardiac death
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 (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: Ai; Result Unstructured Data: Test Result:revealed marked coronary artery calcification; Test Date: 20210512; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210515; Test Name: External examination; Result Unstructured Data: Test Result:results led to a suspicion of sudden cardiac death
CDC Split Type: JPPFIZER INC2021559002

Write-up: Suspicion of sudden cardiac death; Unconscious; This is a spontaneous report from a contactable physician received from. Regulatory authority report number is v21106776. A 66 year-old male patient received the first dose of BNT162B2 (COMIRNATY; solution for injection; Lot Number: EX3617; Expiration Date: 31Aug2021) via an unspecified route of administration on 12May2021 at 10:44 (the day of vaccination, at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing hypertension from an unspecified date. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Family history was not confirmed. Concomitant medications were not reported. On 15May2021 around 10:55 (3 days after the vaccination), the patient experienced suspicion of sudden cardiac death. The course of the events was as follows: Body temperature before vaccination was 36.3 degrees centigrade. The patient was regularly visiting a local hospital for hypertension. On 12May2021, the patient received a coronavirus vaccine, after which he was living his life as usual. On 15May2021 at 09:00, the patient returned home from work. Until 10:00, he remained unchanged. On 15May2021, just before 11:00, his wife found him unconscious on the sofa in the living room. The patient was transported and received resuscitative maneuvers but was unresponsive; he was confirmed dead at 12:14. Autopsy imaging (Ai) revealed marked coronary artery calcification. External examination led to a suspicion of sudden cardiac death. On 15May2021 (3 days after the vaccination), the patient died, and the outcome of the event was fatal. The cause of death was reported as suspicion of sudden cardiac death. An autopsy was performed and revealed marked coronary artery calcification. The reporting physician classified the event sudden cardiac death as serious (death) and assessed the causality between the event and BNT162B2 as unassessable. Other possible cause(s) of the event such as any other diseases included myocardial infarction and marked coronary artery calcification. The reporting physician commented as follows: The finding of marked coronary artery calcification was suggestive of the patient''s underlying high coronary risk, but the causal relationship between the death and vaccination was unknown.; Reporter''s Comments: The finding of marked coronary artery calcification was suggestive of the patient''s underlying high coronary risk, but the causal relationship between the death and vaccination was unknown.; Reported Cause(s) of Death: suspicion of sudden cardiac death; Autopsy-determined Cause(s) of Death: Marked coronary artery calcification


VAERS ID: 1332096 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-18
   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: VALACICLOVIR; ACETAMINOPHEN; LANSOPRAZOLE; SALAZOSULFAPYRIDINE; CETIRIZINE; FOLIC ACID; MAGNESIUM OXIDE; RINGER''S SOLUTION [CALCIUM CHLORIDE;POTASSIUM CHLORIDE;SODIUM CHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Diabetes mellitus; Inappropriate antidiuretic hormone secretion; Late effects of cerebral infarction; Symptomatic epilepsy; Tako-Tsubo cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021563909

Write-up: Marasmus; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A non-pregnant 94-years-old female patient received bnt162b2 (COMIRNATY), dose 1, intramuscular, administered in right arm on 15May2021 at 15:00 (Lot Number: EY2173; Expiration Date: 31Aug2021) at the age of 94 years, as single dose, for COVID-19 immunisation. Medical history included diabetes mellitus, syndrome of inappropriate secretion of antidiuretic hormone (SIADH), Tako-Tsubo cardiomyopathy, cardiac failure chronic, late effects of cerebral infarction, symptomatic epilepsy suspected. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included valaciclovir, acetaminophen, lansoprazole, salazosulfapyridine, cetirizine, folic acid, magnesium oxide, calcium chloride/potassium chloride/sodium chloride (RINGER''S SOLUTION). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 18May2021 at 06:00 the patient experienced death. It was reported that on 15May2021 at 15:00 (the day of vaccination), the patient received?the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscular in the right arm for COVID-19 immunization. On 18May2021 (3 days after the vaccination), the patient died. Clinical course was reported as follows: Three days after the vaccination, at 06:00, the patient was found in rigor state with foaming at the mouth. The patient was transferred to a hospital with cardiopulmonary resuscitation. In the hospital, the patient died. The outcome of the event was fatal with treatment including cardiopulmonary resuscitation (chest compression and bag valve mask ventilation). The cause of the death was reported as marasmus. Autopsy was not performed.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of marasmus. The reported event likely represent intercurrent medical condition in this elderly patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Marasmus


VAERS ID: 1332103 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Altered state of consciousness, Blood chloride, Blood creatinine, Blood osmolarity, Blood sodium, Blood urea, C-reactive protein, COVID-19, Cardiac failure, Cardiac failure congestive, Chest X-ray, Drug ineffective, Dyspnoea, Eosinophil count, Haemoglobin, Hypoxia, Lethargy, Lymphocyte count, Mean cell haemoglobin concentration, Mean cell volume, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Oxygen saturation, Platelet count, Red blood cells urine, Red cell distribution width, Renal failure, Respiratory failure, SARS-CoV-2 test, Sepsis, Tachypnoea, Thrombocytopenia, Urinary tract infection, Urine output, White blood cell count, White blood cells urine positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE; COMBODART; ASPIRIN BAYER; SIMVASTATIN; GTN; SALMETEROL; BUDESONIDE; ATROVENT; VITAMIN B12 [VITAMIN B12 NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asbestosis; Benign prostatic hyperplasia; Congestive heart failure; COPD; Ex-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: chloride; Result Unstructured Data: Test Result:107.9 mmol/L; Test Date: 20210430; Test Name: chloride; Result Unstructured Data: Test Result:111.8 mmol/L; Test Name: creatinine; Result Unstructured Data: Test Result:70 umol/l; Test Date: 20210428; Test Name: creatinine; Result Unstructured Data: Test Result:125 umol/l; Test Date: 20210430; Test Name: creatinine; Result Unstructured Data: Test Result:140 umol/l; Test Date: 20210419; Test Name: osmolality; Result Unstructured Data: Test Result:323 mosm/kg; Test Date: 20210419; Test Name: sodium serum; Result Unstructured Data: Test Result:149 mmol/L; Test Date: 20210420; Test Name: sodium serum; Result Unstructured Data: Test Result:146 mmol/L; Test Date: 20210426; Test Name: sodium serum; Result Unstructured Data: Test Result:149 mmol/L; Test Date: 20210428; Test Name: sodium serum; Result Unstructured Data: Test Result:152 mmol/L; Test Date: 20210430; Test Name: sodium serum; Result Unstructured Data: Test Result:161 mmol/L; Test Date: 20210419; Test Name: urea serum; Result Unstructured Data: Test Result:8.8 mmol/L; Test Date: 20210420; Test Name: urea serum; Result Unstructured Data: Test Result:10.2 mmol/L; Test Date: 20210422; Test Name: urea serum; Result Unstructured Data: Test Result:11.9 mmol/L; Test Date: 20210426; Test Name: urea serum; Result Unstructured Data: Test Result:15.5 mmol/L; Test Date: 20210428; Test Name: urea serum; Result Unstructured Data: Test Result:23.3 mmol/L; Test Date: 20210430; Test Name: urea serum; Result Unstructured Data: Test Result:21.8 mmol/L; Test Date: 20210419; Test Name: chest X-Ray; Result Unstructured Data: Test Result:bilateral increased interstitial lung markings; Comments: bilateral increased interstitial lung markings, upper lobe venous diversion and bilateral pleural effusions. Findings are in keeping with congestive heart failure. Increased airspace shadowing in the lower lung zones bilaterally; Test Date: 20210427; Test Name: chest X-Ray; Result Unstructured Data: Test Result:there is likely cardiomegaly, COAD changes, bilate; Comments: there is likely cardiomegaly, COAD changes, bilateral calcified pleural plaques, small R pleural effusion but no obvious consolidations are seen. Likely old rib fractures present on the R side.; Test Date: 20210419; Test Name: CRP; Result Unstructured Data: Test Result:35.8 mg/l; Test Date: 20210420; Test Name: CRP; Result Unstructured Data: Test Result:31.2 mg/l; Test Date: 20210422; Test Name: CRP; Result Unstructured Data: Test Result:30 mg/l; Test Date: 20210426; Test Name: CRP; Result Unstructured Data: Test Result:72.8 mg/l; Test Date: 20210428; Test Name: CRP; Result Unstructured Data: Test Result:186.6 mg/l; Test Date: 20210430; Test Name: CRP; Result Unstructured Data: Test Result:196.9 mg/l; Test Date: 20210419; Test Name: eosinophils; Result Unstructured Data: Test Result:0.01 x10 9/l; Test Date: 20210420; Test Name: eosinophils; Result Unstructured Data: Test Result:0.04 x10 9/l; Test Date: 20210422; Test Name: eosinophils; Result Unstructured Data: Test Result:0.06 x10 9/l; Test Date: 20210426; Test Name: eosinophils; Result Unstructured Data: Test Result:0.03 x10 9/l; Test Date: 20210428; Test Name: eosinophils; Result Unstructured Data: Test Result:0.02 x10 9/l; Test Date: 20210430; Test Name: eosinophils; Result Unstructured Data: Test Result:0.01 x10 9/l; Test Date: 20210419; Test Name: haemoglobin; Result Unstructured Data: Test Result:13.5 g/dl; Test Date: 20210420; Test Name: haemoglobin; Result Unstructured Data: Test Result:13.2 g/dl; Test Date: 20210422; Test Name: haemoglobin; Result Unstructured Data: Test Result:13.5 g/dl; Test Date: 20210430; Test Name: haemoglobin; Result Unstructured Data: Test Result:13.8 g/dl; Test Date: 20210419; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.85 x10 9/l; Test Date: 20210420; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.91 x10 9/l; Test Date: 20210422; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.78 x10 9/l; Test Date: 20210426; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.01 x10 9/l; Test Date: 20210428; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.52 x10 9/l; Test Date: 20210430; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.88 x10 9/l; Test Date: 20210419; Test Name: mean cell haemoglobin concentration; Result Unstructured Data: Test Result:32.4 g/dl; Test Date: 20210420; Test Name: mean cell haemoglobin concentration; Result Unstructured Data: Test Result:32 g/dl; Test Date: 20210422; Test Name: mean cell haemoglobin concentration; Result Unstructured Data: Test Result:32.1 g/dl; Test Date: 20210426; Test Name: mean cell haemoglobin concentration; Result Unstructured Data: Test Result:31.6 g/dl; Test Date: 20210428; Test Name: mean cell haemoglobin concentration; Result Unstructured Data: Test Result:29.9 g/dl; Test Date: 20210430; Test Name: mean cell haemoglobin concentration; Result Unstructured Data: Test Result:30.5 g/dl; Test Date: 20210428; Test Name: mean cell volume; Result Unstructured Data: Test Result:93.7 fL; Test Name: neutrophils; Result Unstructured Data: Test Result:increasing; Test Date: 20210426; Test Name: neutrophils; Result Unstructured Data: Test Result:8.40; Test Date: 20210428; Test Name: neutrophils; Result Unstructured Data: Test Result:7.90; Test Date: 20210430; Test Name: neutrophils; Result Unstructured Data: Test Result:9.25; Test Name: NT-ProBNP; Result Unstructured Data: Test Result:29000 pg/mL; Comments: raised; Test Date: 20210419; Test Name: NT-ProBNP; Result Unstructured Data: Test Result:29920 pg/mL; Test Date: 20210422; Test Name: NT-ProBNP; Result Unstructured Data: Test Result:14876 pg/mL; Test Date: 20210426; Test Name: NT-ProBNP; Result Unstructured Data: Test Result:12323 pg/mL; Test Date: 20210428; Test Name: NT-ProBNP; Result Unstructured Data: Test Result:6044 pg/mL; Test Name: SpO2; Test Result: 74 %; Comments: room air; Test Date: 20210428; Test Name: platelets; Result Unstructured Data: Test Result:143; Test Date: 20210430; Test Name: platelets; Result Unstructured Data: Test Result:120; Test Date: 20210427; Test Name: RBC; Result Unstructured Data: Test Result:250; Test Date: 20210419; Test Name: red cell distribution width; Test Result: 15.5 %; Test Date: 20210420; Test Name: red cell distribution width; Test Result: 15.4 %; Test Date: 20210422; Test Name: red cell distribution width; Test Result: 15 %; Test Date: 20210426; Test Name: red cell distribution width; Test Result: 15 %; Test Date: 20210428; Test Name: red cell distribution width; Test Result: 16 %; Test Date: 20210430; Test Name: red cell distribution width; Test Result: 15.8 %; Test Date: 20210419; Test Name: Sars-Cov-2 RT-PCR; Result Unstructured Data: Test Result:not detected; Test Date: 20210420; Test Name: Sars-Cov-2 RT-PCR; Result Unstructured Data: Test Result:positive, CT 32; Comments: Nasal swab (RT-PCR); Test Name: Urine output; Result Unstructured Data: Test Result:decreased; Test Date: 20210430; Test Name: WBC; Result Unstructured Data: Test Result:10.98; Test Date: 20210427; Test Name: WBC; Result Unstructured Data: Test Result:500
CDC Split Type: MTPFIZER INC2021523178

Write-up: COVID 19 infection; COVID 19 infection; dyspnea; tachypnea; hypoxemia; Respiratory failure; Heart failure; Acute kidney injury; Renal failure; urinary tract infection; Altered consciousness; Thrombocytopenia; Evidence of sepsis; lethargic; Congestive Heart Failure worsened; This is a spontaneous report from a contactable physician. A 91-year-old male patient received bnt162b2 (COMIRNATY), intramuscular first dose on 26Jan2021 (Lot Number: EM0477), second dose on 16Feb2021 (Lot Number: EJ6789), both at single dose for COVID-19 immunisation. Relevant Medical history included cardiac failure congestive, chronic obstructive pulmonary disease (COPD), asbestos plaques, benign prostatic hyperplasia, former smoker. Concomitant medication(s) included omeprazole taken for an unspecified indication, start and stop date were not reported at 20mg BD; dutasteride, tamsulosin hydrochloride (COMBODART) taken for an unspecified indication, start and stop date were not reported 0.5mg dly; acetylsalicylic acid (ASPIRIN BAYER) taken for an unspecified indication, start and stop date were not reported at 75mg dly; simvastatin taken for an unspecified indication, start and stop date were not reported 20mg nocte; GTN taken for an unspecified indication, start and stop date were not reported at patch 5mg dly; salmeterol taken for an unspecified indication, start and stop date were not reported at Inhaler 25mcg 2 puffs BD; budesonide taken for an unspecified indication, start and stop date were not reported inhaler 250mg 2 puffs BD; ipratropium bromide (ATROVENT) taken for an unspecified indication, start and stop date were not reported 2 puffs TDS; vitamin b12 nos (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported every 3 months. The patient experienced COVID 19 infection, dyspnea, tachypnea, hypoxemia, respiratory failure, heart failure, acute kidney injury, renal failure, urinary tract infection, altered consciousness, thrombocytopenia, evidence of sepsis, lethargic, congestive heart failure worsened, all on an unknown date. The patient was hospitalized from 19Apr2021 to an unknown date for 12 days. Patient admitted on the 19Apr2021 and died in hospital on the 01May2021 (hospitalised for 12 days). Patient was not admitted to the ICU. Patient Required controlled oxygen via Venturi mask 28% (92% on oxygen Venturi mask 28%). Known case of heart failure - admitted with elevated NT-ProBNP. During his admission Creatinine uptrended from baseline 70 to 140, in keeping with AKI. Urine output decreased. Evidence of a urinary tract infection (Urinalysis WBC 500; RBC 250). Patient became increasingly lethargic during the admission, minimally communicative. Evidence of sepsis. Inflammatory markers (CRP eleveated to 196.9) with increasing neutrophils. New thrombocytopaenia (mild) during admission. Patient received therapies for Covid-19 that was Augmentin at 1.2g TDS IV from 26Apr2021 to 01May2021. The events required the initiation of new medication or other treatment or procedure: Bumetanide 1mg BD IV, then decreased to 1mg daily. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient underwent lab tests and procedures which included: On 19Apr2021: blood chloride: 107.9 mmol/l, blood osmolarity: 323 mosm/kg,blood urea: 8.8 mmol/l, chest x-ray: bilateral increased interstitial lung markings, upper lobe venous diversion and bilateral pleural effusions. Findings are in keeping with congestive heart failure. Increased airspace shadowing in the lower lung zones bilaterally, blood sodium: 149 mmol/l, c-reactive protein: 35.8 mg/l, eosinophil count: 0.01 x10 9/l, haemoglobin: 13.5 g/dl, lymphocyte count: 0.85 x10 9/l, mean cell haemoglobin concentration: 32.4 g/dl, red cell distribution width: 15.5 %, NT-proBNP (COBAS): 29920 pg/mL, Sars-Cov2-RT-PCR (Nasal swab (RT-PCR)): not detected.On 20Apr2021: lymphocyte count: 0.91x10 9/l, eosinophil count: 0.04 x10 9/l, haemoglobin: 13.2 g/dl, mean cell haemoglobin concentration: 32 g/dl, red cell distribution width: 15.4 %, c-reactive protein: 31.2 mg/L, urea (serum): 10.2 mmol/L, sodium (serum) 146 mmol/L. On 22Apr2021: lymphocyte count: 0.78x10 9/l, eosinophil count: 0.06 x10 9/l, haemoglobin: 13.5 g/dl, mean cell haemoglobin concentration: 32.1 g/dl, red cell distribution width: 15.0 %, urea (serum): 11.9 mmol/L, c-reactive protein: 30.0 mg/L, NT-proBNP (COBAS): 14876 pg/mL. On 26Apr2021: Neutrophils: 8.40x10 9/l, lymphocyte count: 1.01x10 9/l, eosinophil count: 0.03 x10 9/l, mean cell haemoglobin concentration: 31.6 g/dl, red cell distribution width: 15.0 %, urea (serum): 15 mmol/L, sodium (serum) 149 mmol/L, c-reactive protein: 72.8 mg/L, NT-proBNP (COBAS): 12323 pg/mL. On 27Apr2021: Chest X-ray: there is likely cardiomegaly, COAD changes, bilateral calcified pleural plaques, small R pleural effusion but no obvious consolidations are seen. Likely old rib fractures present on the R side. On 28Apr2021: Neutrophils: 7.90x10 9/l, lymphocyte count: 0.52x10 9/l, eosinophil count: 0.02 x10 9/l, Mean cell volume: 93.7 fL, mean cell haemoglobin concentration: 29.9 g/dl, red cell distribution width: 16.0 %, Platelets: 143 x10 9/l, urea (serum): 23.3 mmol/L, sodium (serum) 152 mmol/L, creatinine 125umol/L, c-reactive protein: 186.6 mg/L, NT-proBNP (COBAS): 6044 pg/mL. On 30Apr2021: Neutrophils: 9.25x10 9/l, lymphocyte count: 0.88x10 9/l, eosinophil count: 0.01 x10 9/l, haemoglobin: 13.8 g/dl, mean cell haemoglobin concentration: 30.5 g/dl, red cell distribution width: 15.8 %, Platelets: 120 x10 9/l, urea (serum): 21.8 mmol/L, sodium (serum) 161 mmol/L , blood chloride: 111.8 mmol/l, creatinine 140 umol/L, c-reactive protein: 196.9 mg/l. The patient died on 11May2021. An autopsy was not performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. However, the patient underlying conditions cardiac failure congestive, chronic obstructive pulmonary disease (COPD), asbestos plaques, and former smoker may provide alternative explanations for the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: COVID 19 infection; dyspnea; tachypnea; hypoxemia; respiratory failure; heart failure; acute kidney injury; renal failure; urinary tract infection; altered consciousness; thrombocytopenia; evidence of sepsis; lethargic; congestive heart failure worse


VAERS ID: 1332139 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cerebral infarction, Chronic obstructive pulmonary disease, Depressed level of consciousness, Dysphagia, Dyspnoea, Heart rate, Hemiparesis, Malaise, Pupillary reflex impaired, Pyrexia, Respiratory rate, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATIMOS; OMEPRAZOL; ACETYLSALICYLZUUR; ALENDRONIC ACID/COLECALCIFEROL; EUTHYROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: blood pressure; Result Unstructured Data: Test Result:128/70 mmHg; Test Date: 20210407; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Date: 20210407; Test Name: heartbeat; Result Unstructured Data: Test Result:97; Comments: bpm; Test Date: 20210407; Test Name: breathing; Result Unstructured Data: Test Result:32; Comments: /min
CDC Split Type: NLPFIZER INC2021544669

Write-up: couldn''t swallow anymore; Hemiparesis (right); no pupil reflex; work diagnosis cerebral infarction Arteria cerebri media; does not respond to addressing, Lowered consciousness; Fever/Temperature 38.3C; Unwell; very drowsy, wants to sleep; increasing shortness of breath (COPD); dyspnoea; barely responds to being addressed; Fever; very drowsy, wants to sleep; Unwell; 01/02Apr21 vomit. +/- restored; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB NL-LRB-00531993. A 95-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. Medical history included COVID-19 from Jan2021 (survived COVID infection in Jan2021), pneumonia from Jan2021. Concomitant medications included formoterol fumarate (ATIMOS); omeprazole; acetylsalicylzuur; alendronic acid, colecalciferol; levothyroxine sodium (EUTHYROX), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 26Feb2021 for COVID-19 immunisation with no adverse reaction. Patient had fever, feeling unwell, somnolence/ very drowsy, wants to sleep, vomiting and decreased consciousness a day after vaccination on 01Apr2021. The patient barely responds to being addressed on 01Apr2021. On 01/02Apr2021 the patient experienced vomit. +/- restored. She recovered from these complaints. On 07Apr2021 she again had all these complaints, without vomiting, and she also had dyspnoea. The patient did not respond to addressing, lowered consciousness, had very drowsy, wants to sleep, increasing shortness of breath (COPD), unwell, fever/temperature 38.3C on 07Apr2021. Her fever decreased so she could move out of her bed into her wheelchair. On 10Apr2021, patient''s consciousness decreased, no pupil reflex. On 10Apr2021, the patient experienced couldn''t swallow anymore. Patient went to the emergency room where they found: hemiparalysis right, no bleeding, work diagnosis cerebral infarction Arteria cerebri media. Patient''s swallowing was also impaired, so patient was sent back home with palliative care. The patient underwent lab tests and procedures which included blood pressure measurement: 128/70 mmhg, body temperature: 38.3 centigrade, heart rate: 97 bpm, respiratory rate: 32/min on 07Apr2021. The patient died on 15Apr2021. It was not reported if an autopsy was performed. The patient recovered from consciousness decreased, fever, somnolence, unwell, vomiting with onset date 01Apr2021. The outcome of the second episode of consciousness decreased, fever, somnolence, unwell was fatal, the outcome of dyspnoea, hemiparesis (right), pupillary reflex absent, swallowing impaired was fatal. The outcome of event work diagnosis cerebral infarction Arteria cerebri media was unknown. Cause of death was provided as "see details of side effects after 2nd vaccination on 31Mar2021. NB: no side effects after the 1st vaccination on 26Feb2021. After survived COVID infection in Jan2021, was the 2nd vaccination unnecessary?" No follow-up attempts are possible; Information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: couldn''t swallow anymore; does not respond to addressing, Lowered consciousness?; very drowsy, wants to sleep; increasing shortness of breath (COPD); Hemiparesis (right); Unwell; no pupil reflex; Fever; dyspnoea


VAERS ID: 1332140 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-25
Onset:2021-04-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021539556

Write-up: patient died 2 days later of a brain haemorrhage; became unwell/ patient became unwell on the toilet during the night. No further reason; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00533185. An 83-years-old female patient received first dose of bnt162b2 (COMIRNATY), on 25Apr2021 as 1st dose, single for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient experienced cerebral haemorrhage, unwell following 2 days after administration of covid-19 vaccine. The outcome of cerebral haemorrhage is fatal and the outcome of unwell is fatal. The patient died on 27Apr2021. It was not reported if an autopsy was performed. Case Summary and Reporter''s Comments Text : BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no patient died 2 days later from a brain haemorrhage Additional information ADR: Patient became unwell on the toilet during the night. No further reason. Patient was not ill, had no change of medication. BSN available: yes COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: no No follow-up attempts are possible. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no patient died 2 days later from a brain haemorrhage Additional information ADR: Patient became unwell on the toilet during the night. No further reason. Patient was not ill, had no change of medication. BSN available: yes COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: no; Reported Cause(s) of Death: Brain hemorrhage; became unwell/ patient became unwell on the toilet during the night. No further reason


VAERS ID: 1332141 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 2021-05-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021539499

Write-up: Died barely half an hour - 45 min erns; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB [NL-LRB-00533467]. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06May2021 as 1st dose, single for covid-19 immunisation. The patient''s medical history not reported. No Previous COVID-19 infection. Concomitant medication includes non-specified cholesterol lowering agent. The patient experienced died barely half an hour - 45 min ERNS (emergency response notification system) on 06May2021. 30 minutes after start, cardiac arrest (death) following administration of covid-19 vaccine injectable solution for Covid-19 immunisation. The outcome of cardiac arrest is fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Died barely half an hour - 45 minutes erns (emergency response notification system) Additional information ADR: Died BSN available: yes COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: No because would then be investigated as a crime Comment reporter: only wanted to indicate that I, as a daughter, want to indicate that my father died shortly after vaccination.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1332142 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-05-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210501; Test Name: fever; Result Unstructured Data: Test Result:high fever
CDC Split Type: NLPFIZER INC2021544994

Write-up: Died after a high fever; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number NL-LRB-00535915. A 92 years old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no previous COVID-19 infection. On 01May2021, the patient experienced fever (death) following administration of covid-19 vaccine Pfizer solution for injection. Drugs and latency for fever was 7 days after start. The patient died after a high fever after vaccination. The patient died/ Passed away on 01May2021. It was unknown if an autopsy was performed. The outcome of the event fever was fatal. No follow-up attempts are possible, information on batch/lot number cannot be obtained. ; Reported Cause(s) of Death: Died after a high fever


VAERS ID: 1332143 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-04-08
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Diagnostic procedure, SARS-CoV-2 test
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: 2021-04-10
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Name: Diagnostic procedures; Result Unstructured Data: Test Result:result no chances of survival; Test Name: pcr test; Test Result: Negative
CDC Split Type: NLPFIZER INC2021544665

Write-up: Brain hemorrhage; This is a spontaneous report from a contactable consumer reporting for the father downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00536050. An 84-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21Mar2021 (Batch/Lot Number: Unknown) as 2nd dose, single for COVID-19 immunisation. Medical history included disease risk factor from 13Feb2021. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) for COVID-19 immunisation on 13Feb2021 and experienced Bleeding in the eye. There was no Previous COVID-19 infection. The patient experienced Brain hemorrhage following administration of covid-19 vaccine pfizer solution for injection on 08Apr2021. Cerebral haemorrhage occured 18 days after start. The reporter''s father died of this brain haemorrhage. The patient underwent lab tests and procedures which included polymarase chain reaction test: negative on unknown date. Diagnostic procedures were done, result no chances of survival, further result not known to the reporter, signals COVID but polymarase chain reaction test was negative. The patient died on 10Apr2021. The outcome of cerebral haemorrhage was fatal. It was not reported if an autopsy was performed. Reporter''s Comments: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: Bleeding in the eye Date: 13Feb2021 Additional information ADR: My father died of this brain haemorrhage BSN available: yes Previous COVID-19 infection: No. Other: diagnostic procedures: Yes, result no chances of survival further result not known to me, signals covid but pcr test was negative No follow-up attempts are possible; information on batch/lot number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: Bleeding in the eye Date: 13Feb2021 Additional information ADR: My father died of this brain haemorrhage BSN available: yes Previous COVID-19 infection: No. Other: diagnostic procedures: Yes, result no chances of survival further result not known to me, signals covid but pcr test was negative; Reported Cause(s) of Death: Brain hemorrhage


VAERS ID: 1332144 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-21
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021544906

Write-up: Cerebral infarction; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00536458. A 76-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: EW2243) via an unspecified route of administration on 13Apr2021 (13 days before patient''s death date 26Apr2021) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. No previous COVID-19 infection. No past drug therapy. The patient experienced cerebral infarction on 21Apr2021 (8 days after vaccination date 13Apr2021). Cerebral infarction was treated with patient had been admitted to hospital and comatose given poor prognosis treatment had been discontinued. The patient died on 26Apr2021 due to cerebral infarction. It was unknown if an autopsy was performed. Additional information ADR: Report made only for statistics; chance is small that relationship is with vaccine, still reported as GP in case it should occur more often. Other: no diagnostic procedures, likely death is independent of vaccine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cerebral infarction


VAERS ID: 1332145 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-07
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amyloidosis, Blood test, Magnetic resonance imaging, Organ failure
SMQs:, 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), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:unknown results; Test Name: MRI; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021544926

Write-up: Amyloidosis; Organ failure; This is a spontaneous report from a contactable other health professional downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00536763. An 86-year-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced amyloidosis and organ failure both on 07Apr2021 with serious criteria of death and hospitalization. The patient died on 15Apr2021. It was unknown if autopsy was done. Lab data included MRI and blood tests on unspecified dates. The outcome of the events were fatal. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: organ failure; amyloidosis


VAERS ID: 1332155 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-13
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6132 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021545014

Write-up: Got a couple of episodes of TIA (small blood clots usually cause), 10-12 days after 2 doses of the vaccine, then she got a more fulminant stroke, unconscious and quick death; Got a couple of episodes of TIA (small blood clots usually cause), 10-12 days after 2 doses of the vaccine, then she got a more fulminant stroke, unconscious and quick death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uapgzx. A 98-year-old female patient (also reported as in her late 90s) received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 03Feb2021 (Lot Number: EJ6132) as single dose for covid-19 immunization. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# EJ6795) on 13Jan2021 for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got a couple of episodes of TIA (small blood clots usually cause), 10-12 days after 2 doses of the vaccine from 13Feb2021, then she got a more fulminant stroke on 22Feb2021, unconscious and quick death. Verbatim provided as: 10-12 days after vaccination with dose 2, a couple of episodes of TIA occur. About a week after this, she suffered a massive stroke on 22Feb2021 with a fatal outcome after a short time. The patient died on Feb2021. It was not reported if an autopsy was performed. The outcome of TIA was not recovered. Regional Pharmacist considered that the causality between the suspect drug and events was possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1332160 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cardiac arrest, Cough, Device function test, Echocardiogram, Electrocardiogram, Endotracheal intubation, Pleural effusion, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIOLTO RESPIMAT; ENTRESTO; ALBYL-E; XARELTO; EMCONCOR CHF; ROSUVASTATIN SANDOZ; SOMAC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac arrest (Twice.); Cardiac failure; COPD; Coronary artery disease; Implantable defibrillator evaluation (showed stable conditions.); Implantable defibrillator user; Myocardial infarction; Reflux oesophagitis
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Autopsy; Result Unstructured Data: Test Result:possibly pleural effusion; Comments: showed no macroscopic findings of acute, severe pathology in parenchymal organs, except possibly pleural effusion. No signs of a new cardiac failure; Test Date: 202103; Test Name: Implantable defibrillator evaluation; Result Unstructured Data: Test Result:Stable conditions.; Test Date: 20210501; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:Showed almost total stillness of heart.; Test Date: 20210501; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:First rhythm after cardiac arrest was asystole. Sh; Comments: First rhythm after cardiac arrest was asystole. Showed pulseless electrical activity (PEA) upon admission to hospital.; Test Date: 20210501; Test Name: endotracheal intubation; Result Unstructured Data: Test Result:They found blood infused exudate
CDC Split Type: NOPFIZER INC2021545016

Write-up: CARDIAC ARREST; pleural effusion; SUBJECTIVE FEVER; COUGH; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uwzpxa, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00028417. A 79-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 28Apr2021 as 2ND DOSE, SINGLE for covid-19 immunisation . The patient previously took the first dose bnt162b2 on unknown date for covid-19 immunization and no adverse event occurred. Medical history included coronary artery disease, Reflux oesophagitis, myocardial infarction, Implantable defibrillator user, cardiac failure, atrial fibrillation, cardiac arrest, chronic obstructive pulmonary disease, implantable defibrillator evaluation from Mar2021 showed stable conditions. Concomitant medications included olodaterol hydrochloride, tiotropium bromide monohydrate (SPIOLTO RESPIMAT) taken for chronic obstructive pulmonary disease; sacubitril valsartan sodium hydrate (ENTRESTO) taken for cardiac failure; acetylsalicylic acid, magnesium oxide (ALBYL-E) taken for myocardial infarction; rivaroxaban (XARELTO) taken for atrial fibrillation; bisoprolol fumarate (EMCONCOR CHF) taken for cardiac failure; rosuvastatin calcium (ROSUVASTATIN SANDOZ) taken for myocardial infarction; pantoprazole sodium sesquihydrate (SOMAC) taken for gastrooesophageal reflux disease. The patient initially developed subjective fever, cough after vaccination on 28Apr2021, but was otherwise in good general condition. On 01May2021, the patient developed cardiac arrest, described by the reporter as a rapid and dramatically development of dyspnoea and chills. No chest pain, respiratory failure, then observed cardiac arrest. The first rhythm after cardiac arrest was asystole. The patient was given three shocks against presumed ventricular tachycardia. Showed pulseless electrical activity (PEA) upon admission to hospital. Cardiac ultrasound showed almost total stillness of heart. They found blood infused exudate from endotracheal intubation. Resuscitation was stopped after 55 minutes of advanced life support/resuscitation. The patient died on 01May2021. Autopsy done in May2021, showed no macroscopic findings of acute, severe pathology in parenchymal organs, except possibly pleural effusion. No signs of a new cardiac failure. Final autopsy report will not be completed for several months. Outcome of events cardiac arrest and pleural effusion was fatal. Outcome of other events was unknown. The reporter stated that the association between vaccination and the death of the patient is uncertain, but due to close temporal relationship and no other pathology to explain the death, the event is reported as a possible serious adverse event of vaccination. The case was considered to be serious by reporter. Sender Comment: The report concerns a patient in his 70s, who a few days after the second dose of the Covid-19 vaccine Comirnaty had a fatal cardiac arrest. 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 serious underlying diseases and previous episodes of cardiac arrest. In current country, we have received and processed more than 150 reports of deaths after vaccination, most of which were nursing home patients or elderly people in need of care. 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. A regulatory authority has established an expert group that has reviewed deaths in frail elderly people after vaccination, among other things to assess whether there are any common features in these patients, which may have contributed to fatal outcomes. The report from the expert group is expected to be published shortly. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something else accidental, at the same time a cause that has nothing to do with the vaccination in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. 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''s death, the message is also classified as serious, although a causal relationship with vaccination has not been established. Since the message is about a death and an autopsy is planned, we would like you to send us an update when the results are available. This will provide useful additional information to the message and its assessment. In case of suspected side effect after vaccination, we also want to know the batch number of the relevant vaccines, and request that this be forwarded. If you do not know the batch number, we ask for contact information for the place where vaccination has been performed, if known, so that we can obtain a batch number. Reports after coronary vaccination in the Adverse Reaction Register are processed by a regulatory authority in collaboration with another regulatory authority. Reporter Comment: 11May2021: The reporter will be asked in the feedback to update the report with batch number of vaccine and the final autopsy results when/if available. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reporter''s Comments: 11May2021 : The reporter will be asked in the feedback to update the report with batch number of vaccine and the final autopsy results when/if available.; Reported Cause(s) of Death: cardiac arrest; Autopsy-determined Cause(s) of Death: Hospital autopsy: No macroscopic findings of acute, severe pathology in parenchymal organs, except possibly pleural effusion. No signs of a new cardiac failure. Final autopsy report will not be completed for several months.


VAERS ID: 1332172 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRONOL; ACARD; NEBILET; XARELTO; KARBIS; TORSEMIDE; IPP [OMEPRAZOLE]; SUVARDIO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty; Arterial hypertension; Cholelithiasis; Chronic ischemic heart disease, unspecified (Chronic ischemic heart disease); Chronic respiratory failure (Chronic respiratory failure - COPD (Chronic Obstructive Pulmonary Disease)); Congestive heart failure; Coronary arterial stent insertion; Cyst of kidney (Left kidney cyst); Gallbladder stones; Hyperuricemia; Lipid metabolism disorder; Obesity; Osteoarthritis; Paroxysmal atrial fibrillation; Percutaneous coronary intervention
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021545018

Write-up: Haemorrhagic stroke; Petechiae; This is a spontaneous report from a contactable physician and consumer (daughter-in-law of patient) downloaded from the Regulatory Authority. A 70-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 16Apr2021 09:41 (Lot Number: EW9127; Expiration Date: 01Jul2021) as 1st dose, single for covid-19 immunisation. Medical history included chronic respiratory failure - COPD (Chronic Obstructive Pulmonary Disease), congestive heart failure, chronic ischemic heart disease, arterial hypertension, paroxysmal atrial fibrillation, status after: PCI (percutaneous coronary interventions), LAD (Left Anterior Descendens), RCA (Right Coronary Artery) with DES (Drug-Eluting Stent) implantation, gallbladder stones, left kidney cyst, hyperuricemia, osteoarthritis, obesity, Cholelithiasis, Lipid metabolism disorder, Angioplasty. Concomitant medications included spironolactone (SPIRONOL); acetylsalicylic acid (ACARD); nebivolol hydrochloride (NEBILET); rivaroxaban (XARELTO); candesartan cilexetil (KARBIS); torsemide; omeprazole (IPP); rosuvastatin calcium (SUVARDIO), and unspecified medications (Valvlsco and Nazatox). The patient experienced haemorrhagic stroke, petechiae on 16Apr2021 18:00. Skin petechiae limited to the extremities, on the day of vaccination there was a hemorrhagic stroke, the patient was taken to the hospital where he died. On 26Apr2021, the reporting person sent a statement that, in their opinion, only a vaccine was a suspect drug. The outcome of the events was fatal. The patient died on 17Apr2021 due to events. It was not reported if an autopsy was performed. Sender comment: Petechiae and hemorrhagic stroke are unexpected adverse drug reactions for the vaccine. Patient with multiple concurrent diseases, taking multiple medications that may have contributed to the occurrence of a hemorrhagic stroke. Haemorrhage is an adverse reaction expected for Xarelto. Cerebral haemorrhage is an expected effect for Acard. In the SmPC (Summary of Product Characteristics) of Torsemid, the side effect is thromboembolic complications. It is possible that the medication and the patient''s illness may have contributed to the side effects. A association to vaccination was considered possible due to the close temporal relationship. The reporting person qualified NOP as heavy. URPL assessed the NOP as severe (death). Relatedness of drug to reactions/events (for every event): Source of assessment:Regulatory Authority. Result of Assessment: Possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke; Petechiae


VAERS ID: 1332173 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Dysphonia, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: Coronary artery disease; Diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: body temperature; Result Unstructured Data: Test Result:increased
CDC Split Type: PLPFIZER INC2021545023

Write-up: Hoarseness; Body temperature increased; Malaise; This is a spontaneous report from a contactable consumer (patient''s family) downloaded from the regulatory authority-WEB PL-URPL-DML-MLP.4401.2.299.2021. A 78-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular at the age of 78-year-old on 13Apr2021 (Lot Number: EW2243) as single dose for COVID-19 immunisation. Medical history included coronary artery disease, diabetes. The patient''s concomitant medications were not reported. The patient experienced hoarseness (fatal) on 20Apr2021, body temperature increased (death) on 20Apr2021, malaise (death) on 20Apr2021. The patient underwent lab tests and procedures which included body temperature: increased on 20Apr2021. The patient died on 28Apr2021. An autopsy was not performed. The outcome of events was fatal. Sender comments: Fever, malaise are expected adverse side reactions of the vaccine. Hoarseness is an unexpected adverse drug reaction.The elderly patient was chronically ill, which could have been the cause of death, but it can not be ruled out that the vaccine contributed to side effects and, consequently, death. The temporal relationship speaks for a cause-and-effect relationship. HA assessed the application as severe (death). Relatedness of drug to reactions/events (for every event): Source of assessment: NCA; Method of assessment: Result of Assessment: Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hoarseness; Body temperature increased; Malaise


VAERS ID: 1332195 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-19
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: SAPFIZER INC2021534340

Write-up: He took the Pfizer vaccine 10 days before his death he had a tough symptoms; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as unknown dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer informed his/her brother (the patient) death. The patient he took the pfizer vaccine 10 days before his death. He had a tough symptoms. The consumer can send the hospital report if needed. Event occurred in a country different from that of the consumer. 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: He took the Pfizer vaccine 10 days before his death he had a tough symptoms


VAERS ID: 1332221 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Myocardial infarction, Prostatic specific antigen, Renal failure, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Prostate cancer (since over 20 years ago)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PSA; Result Unstructured Data: Test Result:increased
CDC Split Type: SEPFIZER INC2021539438

Write-up: myocardial infarction; breathing difficulties; Urinary tract infection; kidney failure; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is SE-MPA-2021-036135. An 84-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing prostate cancer since over 20 years ago. The patient''s concomitant medications were not reported. The patient experienced myocardial infarction (death, hospitalization) on Apr2021 , breathing difficulties (death, hospitalization) on Apr2021, urinary tract infection (death, hospitalization) on Apr2021, kidney failure (death, hospitalization) on Apr2021. The patient underwent lab tests and procedures which included prostatic specific antigen: increased. Therapeutic measures were taken as a result of breathing difficulties, urinary tract infection. The patient died on an unspecified date. It was not reported if an autopsy was performed. The clinical course was reported as follows: Report from a consumer regarding a 84-year-old male. Medical history included prostate cancer. Reported suspect vaccine was Comirnaty (covid-19 vaccines). Reported suspect adverse events were renal failure, urinary tract infection, breathing difficult and myocardial infarct. The man suffered from kidney failure in one kidney 16 days after his first dose of Comirnaty. After 2 days of hospitalization, drainage is inserted into one kidney and four days later for the other.The man is said to have demanded to be anesthetized, although the doctors advised against it. Upon awakening, the man was given oxygen due to severe breathing difficulties. The man also suffered from a urinary tract infection which is treated with antibiotics and he also had a heart attack. The reporter states that the man had anticoagulant treatment, but which was removed before the procedure. After 5 days, palliative care was started, and the man died 29 days after the vaccination with Comirnaty. The reporter reports suspicion of side effects of the vaccine, but states that the doctors had said that it was because the man''s prostate cancer had pressed on the ureters because it had grown, (PSA had increased) or alternatively that the lymph nodes had grown. The reporter states that the man had had prostate cancer for over 20 years, but in less than 3 weeks after the vaccination with Comirnaty, the man gets kidney failure. Outcome: Fatal. Report assessed as serious, death. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: kidney failure; Urinary tract infection; breathing difficulties; myocardial infarction


VAERS ID: 1332294 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001530 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   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: CRESTASTATIN; NEBIVOLOL STREULI
Current Illness: Arterial hypertension; Hypercholesteraemia; Hypertonia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Death; unconsciousness; malaise; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), MALAISE (malaise) and LOSS OF CONSCIOUSNESS (unconsciousness) in a 76-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3001530) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension, Hypercholesteraemia and Hypertonia. Concomitant products included ROSUVASTATIN CALCIUM (CRESTASTATIN) from 09-Feb-2021 to 11-Apr-2021 and NEBIVOLOL HYDROCHLORIDE (NEBIVOLOL STREULI) from an unknown date to 11-Apr-2021 for an unknown indication. On 08-Apr-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 08-Apr-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced MALAISE (malaise) (seriousness criterion medically significant). On 11-Apr-2021, the patient experienced DEATH (Death) (seriousness criterion death) and LOSS OF CONSCIOUSNESS (unconsciousness) (seriousness criterion medically significant). The patient died on 11-Apr-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, MALAISE (malaise) outcome was unknown and LOSS OF CONSCIOUSNESS (unconsciousness) had not resolved. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death) and MALAISE (malaise) to be unlikely related and LOSS OF CONSCIOUSNESS (unconsciousness) to be not related. On 08 Apr 2021, the patient received moderna vaccine and experienced malaise alone after 3 hours. On 11 Apr 2021,while the patient went to the fridge experienced unconsciousness and unsuccessful resuscitation. The death was reported as completely unexpected by the treating physician No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of death in a 76-year-old male subject with a medical history of hypertension, Hypercholesteraemia and Hypertonia, who died 3 days after receiving the vaccine. Autopsy was not performed, based on the reporters acute cardiovascular event could have led to the patient''s death the causality to the vaccine is assessed as unlikely. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up received on 13 May 2021.Translation uploaded.Added medical history.; Sender''s Comments: This is a case of death in a 76-year-old male subject with a medical history of hypertension, Hypercholesteraemia and Hypertonia, who died 3 days after receiving the vaccine. Autopsy was not performed, based on the reporters acute cardiovascular event could have led to the patient''s death the causality to the vaccine is assessed as unlikely.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1332307 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-20
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: 2021-03-25
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Insulin-requiring type 2 diabetes mellitus; Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Death NOS; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death NOS) in a 75-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Insulin-requiring type 2 diabetes mellitus and Ischaemic heart disease. On 15-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 25-Mar-2021 The patient died on 25-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021044924 Limited information regarding the death, including the cause of death, has been provided at this time and a causal relationship cannot be excluded. The patient''s underlying conditions may have contributed to their death; Sender''s Comments: Limited information regarding the death, including the cause of death, has been provided at this time and a causal relationship cannot be excluded. The patient''s underlying conditions may have contributed to their death; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1333061 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aneurysm ruptured, Blood pressure measurement, C-reactive protein, Fatigue, Glomerular filtration rate, Headache, Nausea, Procalcitonin, Pyrexia, Subarachnoid haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATACAND; ASPIRIN CARDIO; CALCIMAGON; ZANIDIP; TORASEMID; NEPHROTRANS
Current Illness: Arterial hypertension; Chronic renal insufficiency; Ischaemic heart disease; Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210408; Test Name: Blood pressure; Result Unstructured Data: 197/68; Test Date: 20210403; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 7.43 mmol/L; Test Date: 20210406; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 167 mg/L; Test Date: 20210406; Test Name: Estimated glomerular filtration rate; Test Result: Inconclusive ; Result Unstructured Data: 7 ml/min/1.73m2; Test Date: 20210406; Test Name: Procalcitonin; Test Result: Inconclusive ; Result Unstructured Data: 2.26 microgram per litre
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: aneurysm rupture; headache; fever; Fatigue; Nausea; This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SUBARACHNOID HAEMORRHAGE, ANEURYSM RUPTURED (aneurysm rupture), HEADACHE (headache), PYREXIA (fever), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 78-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 30042460) for COVID-19 vaccination. The patient''s past medical history included Acute myocardial infarction and Stroke. Concurrent medical conditions included Arterial hypertension, Ischaemic heart disease, Chronic renal insufficiency and Penicillin allergy. Concomitant products included CANDESARTAN CILEXETIL (ATACAND), ACETYLSALICYLIC ACID (ASPIRIN CARDIO) from 03-Apr-2021 to an unknown date, CALCIUM (CALCIMAGON [CALCIUM]), LERCANIDIPINE HYDROCHLORIDE (ZANIDIP), TORASEMIDE (TORASEMID) and SODIUM BICARBONATE (NEPHROTRANS) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (headache) (seriousness criteria medically significant and life threatening), PYREXIA (fever) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 03-Apr-2021, the patient experienced SUBARACHNOID HAEMORRHAGE (seriousness criteria death and medically significant) and ANEURYSM RUPTURED (aneurysm rupture) (seriousness criteria death and medically significant). On 17-Apr-2021, PYREXIA (fever) and FATIGUE (Fatigue) outcome was unknown. The patient died on 17-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, C-reactive protein: 7.43 mmol/l (Inconclusive) 7.43 mmol/L. On 06-Apr-2021, C-reactive protein: 167 mg/l (Inconclusive) 167 mg/L. On 06-Apr-2021, Glomerular filtration rate: 7 ml/min/1.73m2 (Inconclusive) 7 ml/min/1.73m2. On 06-Apr-2021, Procalcitonin: 2.26 (Inconclusive) 2.26 microgram per litre. On 08-Apr-2021, Blood pressure measurement: 197/68 (High) 197/68. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered HEADACHE (headache), PYREXIA (fever), FATIGUE (Fatigue) and NAUSEA (Nausea) to be probably related and SUBARACHNOID HAEMORRHAGE and ANEURYSM RUPTURED (aneurysm rupture) to be unlikely related. No treatment medications were reported. This is a case of death in a 78-year-old female subject with a medical history of Ischaemic heart disease, Chronic renal insufficiency and Penicillin allergy, who died 17 days after receiving the first dose of vaccine. Although a temporal association exists, based on the current available information, that the aneurysm rupture leading to subarachnoid hemorrhage and death, the events are assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: MAH causality and narrative updated according to the company comment. Serious criteria for some events changed.; Sender''s Comments: This is a case of death in a 78-year-old female subject with a medical history of Ischaemic heart disease, Chronic renal insufficiency and Penicillin allergy, who died 17 days after receiving the first dose of vaccine. Although a temporal association exists, based on the current available information, that the aneurysm rupture leading to subarachnoid hemorrhage and death, the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1333063 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-03-09
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Apraxia, Death, General physical health deterioration, Hypokinesia, Seizure
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Reported no significant symptoms, no complications and with favorable progress.); Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Inability to swallow; Inability to move spontaneously; Gradual decline in her general conditions; Death; multiple epileptic Seizure; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), SEIZURE (multiple epileptic Seizure), APRAXIA (Inability to swallow), HYPOKINESIA (Inability to move spontaneously) and GENERAL PHYSICAL HEALTH DETERIORATION (Gradual decline in her general conditions) in an 87-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Dementia in 2020 and COVID-19 (Reported no significant symptoms, no complications and with favorable progress.) in 2020. On 29-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced SEIZURE (multiple epileptic Seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced APRAXIA (Inability to swallow) (seriousness criterion medically significant), HYPOKINESIA (Inability to move spontaneously) (seriousness criterion medically significant) and GENERAL PHYSICAL HEALTH DETERIORATION (Gradual decline in her general conditions) (seriousness criterion medically significant). The patient died on 10-Apr-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, SEIZURE (multiple epileptic Seizure) had not resolved and APRAXIA (Inability to swallow), HYPOKINESIA (Inability to move spontaneously) and GENERAL PHYSICAL HEALTH DETERIORATION (Gradual decline in her general conditions) outcome was unknown. Patient experienced multiple epileptic seizures within a 24-hour period an event that to a gradual decline in her general conditions, including inability to swallow and inability to move spontaneously (from that moment, she could only move in a wheelchair). Swallowing was compromised to the point that would not eat anything other than blended food. Following the gradual decline, palliative care was set up. No investigations of any kind were carried out by the medical staff. Concomitant product use was not provided by the reporter. This case concerns an 87-year-old woman, residing in a care home for elderly people, known to have dementia and previous COVID-19 disease in 2020, with no significant symptoms, no complications and with favourable progress. Usual pharmacotherapy unknown. No known allergies. On 29-Jan-2021, the woman was vaccinated with the first dose of the Moderna Covid-19 vaccine. No adverse reactions were reported. Approximately one month later, on 05-Mar-2021, the woman was vaccinated with the second dose of the Moderna Covid-19 vaccine. On 09-Mar-2021, the woman experienced multiple epileptic seizures within a 24-hour period, an event that to a gradual decline in here general conditions, including inability to swallow and inability to move spontaneously (from that moment, she could only move in a wheelchair). Swallowing was compromised to the point that would not eat anything other than blended food. Following the gradual decline, palliative care was set up. The patient was confirmed deceased on 10-Apr-2021. No investigations of any kind were carried out by the medical staff. Action taken with m-RNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Translation received. Narrative updated.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1333066 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-03
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain lower, Cardiac death, Chills, Fatigue, 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), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; XARELTO; PERINDOPRIL; ATORVASTAX; XENALON
Current Illness: Atrial fibrillation; Drug allergy (Allergy to Acemetacin); Heart failure; Hypercholesterolemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: found unconscious; cardiac death; considerable exhaustion; severe pain in the lower abdomen; chills; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC DEATH (cardiac death) and LOSS OF CONSCIOUSNESS (found unconscious) in a 79-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Atrial fibrillation, Hypertension, Hypercholesterolemia, Heart failure and Drug allergy (Allergy to Acemetacin). Concomitant products included BISOPROLOL from 29-Sep-2020 to an unknown date, RIVAROXABAN (XARELTO) from 26-Mar-2015 to an unknown date, PERINDOPRIL from 26-Mar-2014 to an unknown date, ATORVASTATIN CALCIUM (ATORVASTAX) from 29-Apr-2014 to an unknown date and SPIRONOLACTONE (XENALON) from 25-Jan-2019 to an unknown date for an unknown indication. In March 2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHILLS (chills). On 04-Apr-2021, the patient experienced ABDOMINAL PAIN LOWER (severe pain in the lower abdomen). On 05-Apr-2021, the patient experienced CARDIAC DEATH (cardiac death) (seriousness criterion death) and FATIGUE (considerable exhaustion). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (found unconscious) (seriousness criterion medically significant). On 05-Apr-2021, LOSS OF CONSCIOUSNESS (found unconscious) outcome was unknown. The patient died on 05-Apr-2021. The reported cause of death was suspected sudden cardiac death. It is unknown if an autopsy was performed. At the time of death, ABDOMINAL PAIN LOWER (severe pain in the lower abdomen), CHILLS (chills) and FATIGUE (considerable exhaustion) outcome was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC DEATH (cardiac death) to be unlikely related. No further causality assessments were provided for LOSS OF CONSCIOUSNESS (found unconscious), ABDOMINAL PAIN LOWER (severe pain in the lower abdomen), CHILLS (chills) and FATIGUE (considerable exhaustion). Follow-up received on 13-May-2021 was significant and included the appended translation document and additional information based on the narrative was updated. On an unspecified date, it was reported that the patient developed severe pain in the lower abdomen two days after the second dose of covid-19 vaccine and made an emergency medical visit. No treatment information was provided, but it was reported that "nothing in particular" was found. It was reported that the pain improved, but the patient experienced considerable exhaustion. On an unspecified date, three days after the vaccination, it was reported that the patient was found unconscious and resuscitation was unsuccessful. Based on the current available information and temporal association between the use of the product and the death, a causal relationship cannot be excluded, although the patient''s concurrent conditions were likely related to their death. Awaiting translation for additional information. Sender''s Comment: Sudden cardiac death in a 79-year-old patient known to have heart disease 3 days after the second injection of the Moderna covid-19 vaccine. The countries monograph for the Moderna covid-19 vaccine does not list cases of death under the side effects (1). The database, in the Moderna covid-19 vaccine monograph (2), out of 49,811 reports, lists 1441 cases of death. In light of the literature data and information available to us, considering the cardiological comorbidities of the patient, despite the close temporal link, we consider a link between the sudden cardiac death and the Moderna covid-19 vaccine as unlikely. This view on causality cannot, however, entirely rule out the role/contribution of the vaccine. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not provided, although the patient''s concurrent conditions were possibly related to their death. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Translated document received on 13 MAY 2021 with no new information; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not provided, although the patient''s concurrent conditions were possibly related to their death. .; Reported Cause(s) of Death: Suspected sudden cardiac death


VAERS ID: 1333071 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, COVID-19 pneumonia, Heart rate, Influenza like illness, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension (for 30 years); Benign prostatic hyperplasia; Ischemic heart disease (for 30 years); Large intestine carcinoma; Parkinson''s syndrome; Type II diabetes mellitus (for 30 years)
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Skin malignant melanoma excision (on the back)
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: normal; Test Date: 202104; Test Name: Heart rate; Result Unstructured Data: normal
CDC Split Type: CZMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 PNEUMONIA (oboustrann? covid-19 pneumonie) in a 96-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Skin malignant melanoma excision (on the back) and Cholecystectomy. Concurrent medical conditions included Parkinson''s syndrome, Benign prostatic hyperplasia, Large intestine carcinoma since 2019, Arterial hypertension (for 30 years), Type II diabetes mellitus (for 30 years) and Ischemic heart disease (for 30 years). On 02-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced INFLUENZA LIKE ILLNESS. On 15-Apr-2021, the patient experienced COVID-19 PNEUMONIA (seriousness criteria death, hospitalization, medically significant and life threatening). On an unknown date, the patient experienced PYREXIA. The patient died on 21-Apr-2021. The reported cause of death was COVID-19 pneumonia. An autopsy was not performed. At the time of death, INFLUENZA LIKE ILLNESS and PYREXIA outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: positive Positive. In April 2021, Blood pressure measurement: normal normal. In April 2021, Heart rate: normal normal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. Treatment for the events were not provided. No Concomitant medications were provided Company comment: The event of COVID 19 PNEUMONIA is assessed as unlikely related to mRNA-1273 while based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. This case was linked to CZ-CZSUKL-21004569 (E2B Linked Report).; Sender''s Comments: The event of COVID 19 PNEUMONIA is assessed as unlikely related to mRNA-1273 while based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. CZ-CZSUKL-21004569:; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1333099 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEDROL; APO-FAMOTIDIN; XETER; SALAZOPYRIN
Current Illness: Rheumatoid arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: GERD; Hypercholesteraemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of FATIGUE and ASTHENIA in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. The patient''s past medical history included GERD and Hypercholesteraemia. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included FAMOTIDINE (APO-FAMOTIDIN) for GERD, ROSUVASTATIN CALCIUM (XETER) from 02-Feb-2021 to an unknown date for Hypercholesteraemia, methylprednisolone (MEDROL) and SULFASALAZINE (SALAZOPYRIN) for Rheumatoid arthritis. On 02-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 03-Apr-2021, the patient experienced FATIGUE (seriousness criterion death) and ASTHENIA (seriousness criterion death). The patient died on 12-Apr-2021. The reported cause of death was Fatigue and Weakness. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered FATIGUE and ASTHENIA to be possibly related. No treatment information was provided. This is a case of death in a 56-year-old female subject with a medical history of GERD, Hypercholesteraemia and Rheumatoid arthritis, who died 10 days after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 56-year-old female subject with a medical history of GERD, Hypercholesteraemia and Rheumatoid arthritis, who died 10 days after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Fatigue; weakness


VAERS ID: 1333104 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Oxygen saturation, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad)

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: Medical History/Concurrent Conditions: Disease Parkinson''s; Hypercholesterolaemia; Hypertension; Lung neoplasm surgery; Radiotherapy
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: Oxygen saturation
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a pharmacist and describes the occurrence of TACHYCARDIA in a 91-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Hypercholesterolaemia, Disease Parkinson''s, Hypertension, Lung neoplasm surgery and Radiotherapy. Previously administered products included for an unreported indication: ATORVASTATINA EG, NITROGLICERINA ZENTIVA, AXAGON [ESOMEPRAZOLE MAGNESIUM], LEXOTAN, DIURESIX [TORASEMIDE], TARGIN, ESKIM and PLAVIX. On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TACHYCARDIA (seriousness criterion death) and VOMITING. The patient died on 02-Apr-2021. The reported cause of death was Vomiting, Oxygen saturation low and Tachycardia. It is unknown if an autopsy was performed. At the time of death, VOMITING, outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Oxygen saturation: low. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Concomitant product use was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: FU added On 10-May-2021: Vaccine Dose number added; Reported Cause(s) of Death: Vomiting; Oxygen saturation low; Tachycardia


VAERS ID: 1333110 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   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: APROVEL; DOXAZOSIN; CATAPRESAN TTS-2; CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; PROGRAF; DIDROGYL; EUTIROX; PANTOPRAZOLE; ACARBOSE; METFORMIN; MEDROL [METHYLPREDNISOLONE]; ROCALTROL
Current Illness: Diabetes; Hypertension arterial; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Renal transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: (8 APRILE 2021 1^ DOSE) (8 APRILE 2021 1^ DOSE); This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN ((8 APRILE 2021 1^ DOSE)) and MYALGIA ((8 APRILE 2021 1^ DOSE) ) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Renal transplant. Concurrent medical conditions included Diabetes, Hypertension arterial and Hypothyroidism. Concomitant products included ACARBOSE and METFORMIN for Diabetes, IRBESARTAN (APROVEL), DOXAZOSIN and CLONIDINE (CATAPRESAN TTS-2) for Hypertension arterial, LEVOTHYROXINE SODIUM (EUTIROX) for Hypothyroidism, MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), TACROLIMUS (PROGRAF) and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Renal transplant, CALCIFEDIOL (DIDROGYL), PANTOPRAZOLE and CALCITRIOL (ROCALTROL) for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced CHEST PAIN ((8 APRILE 2021 1^ DOSE)) (seriousness criterion death) and MYALGIA ((8 APRILE 2021 1^ DOSE)) (seriousness criterion death). The patient died on 17-Apr-2021. The reported cause of death was Pain retrosternal and Pain muscle. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 with respect to the events was not applicable. This is a case of death in a 63-year-old female subject with a medical history of Renal transplant, Diabetes, Hypertension arterial and Hypothyroidism, who died 9 days after receiving the first dose of vaccine. Very limited information has been provided at this time. Death report is not available. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Narrative updated.; Sender''s Comments: This is a case of death in a 63-year-old female subject with a medical history of Renal transplant, Diabetes, Hypertension arterial and Hypothyroidism, who died 9 days after receiving the first dose of vaccine. Very limited information has been provided at this time. Death report is not available. No follow up is possible.; Reported Cause(s) of Death: pain retrosternal; pain muscle


VAERS ID: 1333116 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-25
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Chest pain, Confusional state, Death
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease (Chronic renal insufficiency)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COVID-19; Dyslipidemia; End ileostomy (under palliative care); Gastritis chronic; Hysterectomy; Ileocecal resection; Microvascular angina; Sigmoid diverticulitis; Syncope; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; Aggravated chronic kidney disease; Thoracic pain; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), ACUTE KIDNEY INJURY (Aggravated chronic kidney disease), CONFUSIONAL STATE and CHEST PAIN (Thoracic pain) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Dyslipidemia, Arterial hypertension, Syncope, Type II diabetes mellitus, Microvascular angina, Gastritis chronic, COVID-19, Ileocecal resection, Sigmoid diverticulitis, End ileostomy (under palliative care) on 25-Mar-2021 and Hysterectomy. Concurrent medical conditions included Chronic kidney disease (Chronic renal insufficiency). On 25-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) at an unspecified dose. On 25-Mar-2021, received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 ml in total. On 25-Mar-2021, the patient experienced ACUTE KIDNEY INJURY (Aggravated chronic kidney disease) (seriousness criterion medically significant), CONFUSIONAL STATE (seriousness criterion medically significant) and CHEST PAIN (Thoracic pain) (seriousness criterion medically significant). The patient died on 06-Apr-2021. The reported cause of death was Chronic renal insufficiency. It is unknown if an autopsy was performed. At the time of death, ACUTE KIDNEY INJURY (Aggravated chronic kidney disease) and CONFUSIONAL STATE outcome was unknown and CHEST PAIN (Thoracic pain) had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. It was reported that patient was already under palliative care due to kidney disease and having rejected dialysis. Per MR - End ileostomy removed from events and added to medical history. This is a case of death in a 87-year-old female subject with a medical history of ileostomy (under palliative care) and Chronic kidney disease, who died 12 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Company Comment: This is a case of death in a 87-year-old female subject with a medical history of HTN, DM, CKD, Syncope, Angina, Gastritis, Sigmoid diverticulitis with resection, Covid-19 and Hysterectomy, who died 12 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Translated document received on 04 May 2021 has no new information. On 11-May-2021: Follow-up provide medical history and an additional event.; Reported Cause(s) of Death: Chronic renal insufficiency


VAERS ID: 1333122 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-04-13
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

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

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: HYDROXYCARBAMIDE CAPSULE 500MG / Brand name not specified; PANTOPRAZOL TABLET MSR 20MG / Brand name not specified; ACETYLSALICYLZUUR TABLET 80MG / Brand name not specified
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: Unknown cause of death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-May-2021 and was forwarded to Moderna on 12-May-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Unknown cause of death) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. Concomitant products included HYDROXYCARBAMIDE CAPSULE 500MG / Brand name not specified from 04-Mar-2021 to an unknown date, PANTOPRAZOL TABLET MSR 20MG / Brand name not specified and ACETYLSALICYLZUUR TABLET 80MG / Brand name not specified for an unknown indication. On 28-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 13-Apr-2021 The patient died on 13-Apr-2021. The cause of death was not reported. An autopsy was not performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. This is a case of death in a 70-year-old male subject with a possible medical history of chronic myelogenous leukemia (because of concomitant HYDROXYCARBAMIDE), who died 16 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: A follow up received on 13 May 2021 has no new information; Sender''s Comments: This is a case of death in a 70-year-old male subject with a possible medical history of chronic myelogenous leukemia (because of concomitant HYDROXYCARBAMIDE), who died 16 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1336219 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Fatigue
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20211

Write-up: Cerebral bleeding; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral bleeding) and FATIGUE (Tiredness) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. unknown and unknown) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced FATIGUE (Tiredness) (seriousness criteria death and hospitalization). In April 2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral bleeding) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Cerebral bleeding. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. This is a case of death in a 92-year-old female subject with unknown medical history of HTN, PVD, CHF, A fib, MI, DM, COPD, OA and insomnia, who died approximately within a month after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 92-year-old female subject with unknown medical history of HTN, PVD, CHF, A fib, MI, DM, COPD, OA and insomnia, who died approximately within a month after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Cerebral bleeding


VAERS ID: 1336355 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-10
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Respiratory failure, SARS-CoV-2 test positive, 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? 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: Weakness generalised (General weakness)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: COVID-19 virus test positive; Result Unstructured Data: Test Result:positive
CDC Split Type: ATPFIZER INC2021553627

Write-up: Vaccination breakthrough after second vaccination, second vaccinator died of respiratory insufficiency with positive SARS-COV-2 testing despite completed vaccination; Vaccination failure after the second vaccination on 29Jan2021; Vaccination breakthrough after second vaccination, second vaccinator died of respiratory insufficiency with positive SARS-COV-2 testing despite completed vaccination; This is a spontaneous report from a contactable physician downloaded from the regulatory authority EudraVigilance-WEB AT-BASGAGES-2021-26930. A 90-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration, dose 1 as 1st dose, single on an unspecified date, dose 2 intramuscular on 29Jan2021 as 2nd dose, single for covid-19 immunisation. The patient''s medical history included continuing weakness generalized. Concomitant medication not reported. The patient''s concomitant medications were not reported. Vaccination failure after second vaccination carried out on 29Jan2021, died of respiratory insufficiency with positive SARS-COV-2 testing despite completed vaccination. On 10Mar2021 the patient experienced Vaccination failure, Respiratory insufficiency, COVID-19 virus test positive. The outcome was: unknown for Vaccination failure, fatal for Respiratory insufficiency, unknown for COVID-19 virus test positive. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Vaccination breakthrough after second vaccination, second vaccinator died of respiratory insufficiency with positive SARS-COV-2 testing despite completed vaccination


VAERS ID: 1336363 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Dyspnoea, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (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 INC2021562785

Write-up: Agitation; Dyspnoea; Myocardial infarction; This is a spontaneous report from a contactable other health professional via a regulatory authority. Regulatory authority report number is 553078. An 83-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number), 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 unknown date, the patient developed agitation, dyspnoea and myocardial infarction. The events caused patient''s death 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: Agitation; Dyspnoea; Myocardial infarction


VAERS ID: 1336364 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (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 INC2021562787

Write-up: Vision blurred; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 550666. An 89-year-old female patient received BNT162b2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient was not pregnant at the time of vaccine. On unknown date, the patient died due to vision blurred (as reported). It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Vision blurred


VAERS ID: 1336365 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia aspiration
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 INC2021562788

Write-up: Pneumonia aspiration; This is a spontaneous report from a contactable other healthcare professional received from the Therapeutic Goods Administration (TGA). The regulatory authority report number is 551017. A 99-year-old female patient received bnt162b2 (COMIRNATY) on 18Apr2021 at unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pneumonia aspiration on 20Apr2021. The patient died in 2021 due to the event. The outcome of the event was fatal. 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: Pneumonia aspiration


VAERS ID: 1336375 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a pharmacist and describes the occurrence of ARRHYTHMIA in a 35-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (seriousness criteria death and medically significant). The patient died on 16-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator. Treatment of this event was not reported. This is a case of death in a 35-year-old female subject with unknown medical history, who died one day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 35-year-old female subject with unknown medical history, who died one day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1336380 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA CNK: 4301081 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in an 80-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. CNK: 4301081) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 30-Apr-2021 The patient died on 30-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with the mRNA-1273 in response to the event is not applicable. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Cause of death and patient''s history and concurrent conditions not provided confounded assessment; Reporter''s Comments: Treatment. Evolution of the ADR; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Cause of death and patient''s history and concurrent conditions not provided confounded assessment; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1336381 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021553628

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number BE-FAMHP-DHH-N2021-91435. An adult male patient received first dose of bnt162b2 (COMIRNATY), on 08May2021 as 1st dose, single for covid-19 immunisation. Medical history included lymphoma. The patient''s concomitant medications were not reported. The patient experienced sudden death on 08May2021. No treatment received. The patient died on 08May2021. An autopsy was not performed. Reporter Comment: The patient died suddenly on this date. I happened to note when filling out the death certificates that he was prioritized for vaccination the same day with the first dose of Comirnaty. According to the family, the patient was recovering from lymphoma, with no active treatment at this time. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: The patient died suddenly on this date. I happened to note when filling out the death certificates that he was prioritized for vaccination the same day with the first dose of Comirnaty. According to the family, the patient was recovering from lymphoma, with no active treatment at this time.; Sender''s Comments: Information provided was so limited to prevent a meaningful or definite medical assessment for this demise. A causal relationship cannot be completely excluded between BNT162B2 injection and sudden death, due to the close chronological sequence. This case will be reassessed should 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: Sudden death


VAERS ID: 1336411 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Cardiogenic shock, SARS-CoV-2 test, Septic shock, Superinfection bacterial, Vaccination failure
SMQs:, Cardiac failure (narrow), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure (Stage I); Aneurysm of ascending aorta; Atrial fibrillation paroxysmal; Dementia of the Alzheimer''s type NOS; Ischemia cerebrovascular; Lumbar pain syndrome
Allergies:
Diagnostic Lab Data: Test Name: Sars-CoV2; Test Result: Positive
CDC Split Type: CHPFIZER INC2021558877

Write-up: Exitus letalis, septic shock during COVID-19 pneumonia; suspected septic and cardiogenic shock in the setting of bacterial superinfected Covid-19 pneumonia; suspected septic and cardiogenic shock in the setting of bacterial superinfected Covid-19 pneumonia; suspected septic and cardiogenic shock in the setting of bacterial superinfected Covid-19 pneumonia; Exitus letalis, septic shock during COVID-19 pneumonia; This is a spontaneous report received from a contactable pharmacist via a regulatory authority. Regulatory authority report number CH-SM-2021-15010. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included Dementia of the Alzheimer''s type NOS, Atrial fibrillation paroxysmal from 2018 to an unknown date , Aneurysm of ascending aorta, Ischemia cerebrovascularfrom 21Dec2018 to an unknown date , Lumbar pain syndrome , Acute renal failure with stage1. The patient''s concomitant medications were not reported. The patient experienced exitus letalis, septic shock during covid-19 pneumonia on an unspecified date, exitus letalis, septic shock during covid-19 pneumonia on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The patient died on an unspecified date. It was not reported if an autopsy was performed. outcome of events was fatal.The 94-year-old male patient received his second vaccination dose of Comirnaty (Tozinameran; lot no. unknown) on 31Mar2021 for immunisation against COVID-19. On 19Apr2021, the patient was hospitalised and tested positive for Sars-CoV2. During the course, the patient became increasingly haemodynamically and respiratory unstable with suspected septic and cardiogenic shock in the setting of bacterial superinfected Covid-19 pneumonia. Therapy with Dexamethasone, Remdesivir, Piperacillin/Tazobactam, Amoxicillin/Clavulanic acid and Klacid (Clarithromycin) was initiated. In addition, acute renal failure stage I according to KDIGO was diagnosed. According to the presumed will of the patient, intensive medical measures such as intubation were waived and, in view of the poor prognosis, palliative therapy was initiated, under which the patient died. In addition, paroxysmal atrial fibrillation since 2018, cerebrovascular ischaemic insult in the mediastinal area on the right in a "wake-up" constellation on 21Dec2018, ectasia of the ascending aorta, dementia and lumbospondylogenic pain syndrome were known as relevant previous diseases. We have no further information on this case.A causal relationship between Comirnaty and COVID-19 Pneumonia and Vaccination Failure was assessed as being possible.This case was reported as serious (fatal outcome). Sender''s comment: a regulatory authority prescribing information for Comirnaty (tozinameran) states under Warnings/Precautions that vaccination with Comirnaty may not protect everyone who is vaccinated. There is a temporal relationship between the use of Comirnaty and COVID-19 infection (vaccine failure). In summary, we formally assess the causality between the use of Comirnaty and COVID-19 infection (vaccination failure) as possible on the basis of the temporal relationship and the documentation in the drug information. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1336453 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-25
Onset:2021-05-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021553648

Write-up: Unknown cause of death; This is a spontaneous report received from a non- contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number is DE-PEI-202100063186. A72-year-old female patient received BNT162B2 (COMIRNATY) at 0.3 ml single dose via an unknown route on 25Apr2021 for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 04May2021 the patient experienced unknown cause of death. Autopsy was performed and result was pending. Assessment: Source of assessment: Agency; Result of Assessment: D. Unclassifiable. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1336454 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-09
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage, Haematoma, Intracardiac thrombus, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   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: Alcohol abuse; Anemia; Arterial hypertension; Diabetes mellitus; Hepatic cirrhosis; Mitral valve stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021553641

Write-up: Petechiae; Bleeding gastrointestinal; Intracardiac thrombus; Haematoma; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100064228. A 61-year-old female patient received bnt162b2 (COMIRNATY), via unspecified route of administration on 27Apr2021 (lot number: unknown) at single dose for COVID-19 immunisation. The relevant medical history included ongoing alcohol abuse, ongoing mitral valve stenosis, ongoing arterial hypertension, ongoing hepatic cirrhosis, ongoing diabetes mellitus and ongoing anemia. Concomitant medications were not reported. On 09May2021 the patient experienced intracardiac thrombus, petechiae, haematoma, bleeding gastrointestinal. The events were reported as serious due to death. The patient died on 09May2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. Relatedness of drug to reaction/event (for all events), Source of assessment: regulatory authority, Result of Assessment reported as D. Unclassifiable. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Petechiae; Bleeding gastrointestinal; Haematoma; Intracardiac thrombus


VAERS ID: 1336455 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Circulatory collapse, Intestinal infarction, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (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, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   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; Coronary sclerosis; Gastritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021553647

Write-up: Cardiovascular failure due to small bowel infarction in Bridenileus; Cardiovascular failure due to small bowel infarction in Bridenileus; General debility; Vomiting; This is a spontaneous report downloaded from the Regulatory Authority. A non-contactable physician reported that a 76-year-old female patient received second dose of (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration at the age of 76-year-old on 12Feb2021 at 0.3ml single dose for COVID-19 immunisation. Medical history included ongoing arterial hypertension, ongoing coronary sclerosis, ongoing gastritis. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on 22Jan2021 at 0.3ml single dose for COVID-19 immunisation. The patient experienced general debility and vomiting on 22Feb2021, cardiovascular failure due to small bowel infarction in Bridenileus on unspecified date. The outcome of events was fatal. The patient died on 23Feb2021. An autopsy was performed that revealed cardiovascular failure due to small bowel infarction in bridenileus. This report was reported as serious report. The drug related to all events. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: Vomiting; General debility; Autopsy-determined Cause(s) of Death: Cardiovascular failure due to small bowel infarction in Bridenileus; Cardiovascular failure due to small bowel infarction in Bridenileus


VAERS ID: 1336456 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-04
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Cough, Drug ineffective, Dyspnoea, Pulmonary embolism, SARS-CoV-2 test, Somnolence
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   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: Arterial hypertension; Pancreatic insufficiency; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021553643

Write-up: Drug Ineffective/COVID-19 pneumonia; Drug Ineffective/COVID-19 pneumonia; Groggy; Pulmonary embolus; Coughing; Dyspnoea; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority [DE-PEI-202100064242]. An 84-year-old male patient received BNT162B2 (COMIRNATY) at single dose on 30Mar2021 for COVID-19 immunisation. Ongoing medical history included pancreatic insufficiency; type II diabetes mellitus; arterial hypertension. Concomitant medications were not reported. On 04Apr2021, the patient experienced groggy, pulmonary embolus, coughing and dyspnoea; that resulted in death on 15Apr2021. Patient also experienced drug ineffective, cause of death reported as COVID-19 pneumonia. COVID-19 PCR test was positive on an unspecified date. It was unknown if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Drug Ineffective; Groggy; Pulmonary embolus; Coughing; Dyspnoea; COVID-19 pneumonia


VAERS ID: 1336457 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021553640

Write-up: Myocardial infarct; This is a spontaneous report downloaded from the Medicines Agency (MA) -WEB, regulatory authority number DE-PEI-202100064301, from a non-contactable consumer. An 81-year-old male patient received BNT162B2 (Pfizer vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocardial infarct on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s): Myocardial infarct; Source of assessment: PEI; Result of Assessment: D. Unclassifiable. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarct


VAERS ID: 1336458 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH RE9480 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Echocardiogram, Intracardiac thrombus, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT Abdomen; Result Unstructured Data: Test Result:no results available; Test Name: Echocardiography; Result Unstructured Data: Test Result:no results available
CDC Split Type: DEPFIZER INC2021553632

Write-up: Death sudden; Cardiac thrombosis; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100064302. An 84-years-old female patient received bnt162b2 (COMIRNATY), on 16Apr2021 (Lot Number: RE9480) as UNKNOWN, 0.3 mL, single for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. On 21Apr2021 the patient experienced Cardiac thrombosis. On 05May2021 the patient experienced Death sudden. The patient''s outcome was fatal for Cardiac thrombosis, fatal for Death sudden. The patient died on 05May2021. It was not reported if an autopsy was performed. Lab data included CT Abdomen and Echocardiography, both with no results available. Relatedness of drug to all events by regulatory authority was D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac thrombosis; Death sudden


VAERS ID: 1336464 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021553637

Write-up: Pulmonary embolism; This is a spontaneous report downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100064303. This spontaneous report was received from a non-contactable Physician and concerns a patient. A 57-year-old male patient received bnt162b2 (COMIRNATY) on 14Apr2021 (lot: unknown) as single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. On 15Apr2021 the patient experienced Pulmonary embolism, reported as serious due to death. No Autopsy has bee Done. The patient''s weight and height were not reported. The outcome of the event was fatal. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1336472 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-21
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: Cardiopulmonary insufficiency (Pre-existing cardiopulmonary disease)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021561150

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB [regulatory authority or other manufacturer number C.1.8.1], Safety Report Unique Identifier DE-PEI-202100065752. A 76-years-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 ML), at the age of 76-years-old, via an unspecified route of administration on 03May2021 as single dose for covid-19 immunisation. Medical history included ongoing Cardiopulmonary insufficiency (Pre-existing cardiopulmonary disease). The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Event outcome was fatal. The Regional Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and the reported event as D No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1336481 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory failure, Cardiac failure, Condition aggravated, Syncope, Tachypnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (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), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic atrial fibrillation; Hypertension; Type II diabetes mellitus; Varicose vein
Preexisting Conditions: Medical History/Concurrent Conditions: Acute kidney failure; Acute respiratory failure; Decompensation cardiac; Syncope; Tachypnoea
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021561156

Write-up: Acute kidney failure; Syncope; Tachypnoea; Acute respiratory failure; Decompensation cardiac; the patient experienced Syncope, Acute respiratory failure, Acute kidney failure, Decompensation cardiac, Tachypnoea. Events outcome was fatal. The patient died on 13Apr2021.; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, Authority Number DE-PEI-202100066141. A 81-years-old female patient received bnt162b2 (COMIRNATY), at the age of 81-years-old, via an unspecified route of administration on 07Apr2021 (Lot Number: EW8904) as 0.3 mL, SINGLE for covid-19 immunisation. Medical history included Hypertension, Type II diabetes mellitus, Varicose vein, Chronic atrial fibrillation, all ongoing. On 14Mar2021 the patient had Syncope, Acute respiratory failure, Acute kidney failure, Decompensation cardiac, Tachypnoea. The patient''s weight was not reported, and height was not reported. The patient''s concomitant medications were not reported. On unknown date the patient experienced Syncope, Acute respiratory failure, Acute kidney failure, Decompensation cardiac, Tachypnoea all with outcome fatal. The patient died on 13Apr2021. Decompensation cardiac was reported as cause of death. An autopsy was not performed. Relatedness of drug to reaction(s)/event(s): all events. Source of assessment: HA. Result of Assessment: C. Inconsistent causal association to immunization No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1336565 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death, Fatigue, Headache, Vaccination site pain
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021561147

Write-up: heart failure; Unknown cause of death; Fatigue; Injection site pain; Headache; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority-WEB DE-PEI-CADR2021060896, Safety Report Unique Identifier DE-PEI-202100053139. This case was split to capture events after first dose. The consumer reported different events for two doses. This is the first of two reports and it refers to the 2nd dose. Second report AER: 2021566626. This report is serious (death). An 82-years-old female patient received BNT162B2 (COMIRNATY, mRNA TOZINAMERAN), second dose via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: ET3045) as 2nd dose, single for covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. Patient received first dose of Comirnaty on unspecified date for covid-19 immunisation and experienced fatigue, headaches and pain in the vaccinated arm. On 27Mar2021 the patient experienced Fatigue, Headache, Injection site pain. On 31Mar2021 the patient experienced Unknown cause of death. Patient experienced heart failure on unspecified date. The patient died on 31Mar2021. An autopsy was not performed. Patient had symptoms of fatigue and headaches and pain in the vaccinated arm after the first vaccination. After the second vaccination, the same side effects were much more pronounced. 9 days after the second vaccination, she sagged and died of heart failure. The event outcome for fatigue, headache and infection site pain was not recovered, for heart failure was unknown, for unknown cause was fatal. A regulatory authority assessed the causal relationship between BNT162B2 (COMIRNATY) and all the reported events as D. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1336572 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 19
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: Bullous pemphigoid
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to lanolin; Immune system disorder; Nickel sensitivity
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: COVID test; Test Result: Positive ; Test Date: 202103; Test Name: antibodies; Result Unstructured Data: Test Result:had almost no antibodies
CDC Split Type: DEPFIZER INC2021544621

Write-up: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; deceased; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, Number is DE-PEI-CADR2021062383, with Safety Report Unique Identifier DE-PEI-202100054571. A 74-year-old female patient (reporter''s mother) received BNT162B2 (COMIRNATY) 1st dose at 0.3 ml on an unknown date, 2nd dose on 04Mar2021, both at single dose via an unknown route for COVID-19 immunisation. The patient''s medical history and concurrent conditions included the autoimmune disease bullous pemphigoid and had a very weak immune system, contact allergy to nickel and lanolin. Concomitant drug was not provided. On 21Mar2021 the patient experienced unknown cause of death. Patient deceased on 21Mar2021. No autopsy was performed. Patient experienced mild cough and cold 5 days after second vaccination. Corona infection detected by test. After 4 days with oxygen bottle and nasal tube in the retirement home, patient was admitted to hospital in the intensive care unit, then very quickly less and less oxygen content in the blood. After 13 days she passed away. Ventilation was done through the mask. For the ventilator with intubation patient was considered too weak by the doctors, they advised against it. The doctors in the intensive care unit found that patient had almost no antibodies the second vaccination. It was reported that assessment between Comirnaty and event unknown cause of death / regulatory authority/ D was unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: deceased


VAERS ID: 1336599 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021561219

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority, DE-PEI-CADR2021067200, Safety Report Unique Identifier DE-PEI-202100059873. A 55-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unknown route, on 15Apr2021 (at the age of 55-year-old) at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 16Apr2021 the patient experienced unknown cause of death. No autopsy was performed. 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: 1336607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-05-14
   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: Cardiac arrhythmia; Pacemaker insertion (cardiac)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021561204

Write-up: Heart attack, cardiac arrest, restored vital functions with resuscitation resulting in broken ribs; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB DE-PEI-CADR2021068279, Safety Report Unique Identifier DE-PEI-202100060854. The consumer reported different events for the same patient, for two vaccine doses. This case refers to second dose. A 91-year-old female patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unknown route, on 13May2021 at single dose for COVID-19 immunisation. Relevant medical history included cardiac arrhythmia with pacemaker ongoing from an unknown date. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number not provided) on unknown date for COVID-19 immunisation and on 14Apr2021 she developed infarct myocardial, renal failure and lung embolism. No relevant concomitant medications were provided. On 14May2021, the patient had heart attack, cardiac arrest, restored vital functions with resuscitation resulting in broken ribs. The patient deceased in intensive care unit on 14May2021, cardiovascular support discontinued according to patients'' instructions and will. Additional cause of death was infarct myocardial. No autopsy was performed. The HA assessed the causal relationship between BNT162B2 (COMIRNATY) and all the reported events as D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021572369 Same reporter, same patient, different doses (first dose), different events.; Reported Cause(s) of Death: Infarct myocardial; Arrest cardiac


VAERS ID: 1336620 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-24
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ascites, Chills, Death, Fatigue, Hot flush, Lymphoedema, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Metastasis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021561166

Write-up: Fever, chills, fatigue, hot flashes, Lymphoedema in the legs, ascites,; Ascites; Lymphoedema in the legs; Chills; Hot flush; Pyrexia; Fatigue; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB [DE-PEI-CADR2021070505], Safety Report Unique Identifier [DE-PEI-202100063539]. An 88-years-old female patient received first dose of bnt162b2 (COMIRNATY), on 07Mar2021 as 1st dose, single for covid-19 immunisation. Medical history included ongoing metastasis. The patient''s concomitant medications were not reported. On 24Mar2021 the patient experienced Pyrexia, Chills, Fatigue, Hot flush, Lymphoedema, Ascites. On 01May2021 the patient experienced Unknown cause of death. The patient died on 01May2021. An autopsy was not performed. The outcome was not recovered/not resolved for pyrexia, Chills, Fatigue, Hot flush, Lymphoedema, Ascites, fatal for Unknown cause of death. Sender Comment: Information on risk factors or previous illnesses: Lymph node swellings on the neck were previously known, which indicated metastases. Primary tumor should be clarified in hospital on 24Mar2021. However, she arrived there with a fever and chills and was in such bad condition that no further diagnostics could be made. She became increasingly weaker, loss of appetite, / from 11Mar2021 just tired, just lying down, from 24Mar2021 she got a fever and chills, died on 01May2021. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as 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: 1336629 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Incorrect route of product administration
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021561168

Write-up: Died on the 3rd day after the 2nd vaccination; received BNT162B2 (COMIRNATY) dose 2 intravenous; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority. An 89-year-old female patient received BNT162B2 (PFIZER) dose 2 intravenous on 19Mar2021 (Lot Number: ER7812) as 2nd dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of COMIRNATY on 26Feb2021 strength 0.3 ml. The patient died on the 3rd day after the 2nd vaccination on 22Mar2021. The outcome of event died was fatal and another event was unknown.. The patient died on 22Mar2021. An autopsy was not performed.Sender Comment: No Information on risk factors or previous illnesses. The PEI assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: died


VAERS ID: 1336637 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-22
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021561162

Write-up: Cerebral haemorrhage; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, DE-PEI-CADR2021071363, Safety Report Unique Identifier DE-PEI-202100064649. A 79-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Apr2021 (Lot Number: ER9480) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cerebral haemorrhage on 22Apr2021 with outcome of fatal. The patient died on an unspecified date. An autopsy was not performed. Relatedness of drug to event was unclassifiable. Senders comments: Are you or the person affected aware of any allergies? If yes, which ones? no Information on risk factors or previous illnesses none / brain haemorrhage; operation/removal of blood clot; death after two and a half weeks. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1337975 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-01
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity; Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021561160

Write-up: Malaise immediately after vaccination; My father died at the age of 58, 10 days after he received the first vaccination with Biontech. The emergency doctor assumed a pulmonary embolism. No autopsy is carried out at the mother''s request.; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority-WEB [DE-PEI-CADR2021070032], Safety Report Unique Identifier [DE-PEI-202100062641]. A 58-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing Penicilin allergy, rheumatism, ongoing obesity. The patient''s concomitant medications were not reported. The patient died at the age of 58, 10 days after on 01May2021 he received the first vaccination with biontech. The emergency doctor assumed a pulmonary embolism. No autopsy is carried out at the mother''s request. The patient experienced malaise immediately after vaccination; Ten days later he collapsed in the bathroom in the morning and dies a few minutes later. The patient died on 01May2021. An autopsy was not performed. Outcome was fatal for pulmonary embolism and unknown for other events. This report is serious - death. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? Penicilin. Information on risk factors or previous illnesses, Rheumatism, obesity / malaise immediately after vaccination; Ten days later my father collapses in the bathroom in the morning and dies a few minutes later. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. Batch/lot number: Unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Are you or the person concerned known of any allergies? If yes, which? Penicilin. Information on risk factors or previous illnesses, Rheumatism, obesity / malaise immediately after vaccination; Ten days later my father collapses in the bathroom in the morning and dies a few minutes later. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. Batch/lot number: Unknown.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1338001 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Death, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021552351

Write-up: He passed away 4 days later; chills; Sore throat; This is a spontaneous report from a non-contactable consumer. This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 54258, license party for Comirnaty. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration in Apr2021 as 1st dose, single for covid-19 immunisation. Medical history included asthma. The patient''s concomitant medications were not reported. The patient passed away 4 days later in Apr2021. The consumer reported that her grandpa (the patient) died after the first vaccination. He was vaccinated in mid-April (Apr2021). A few hours after (Apr2021) the vaccination he had chills and a sore throat. 4 days after (Apr2021) that he died. He also had severe asthma. The consumer asked what about people with asthma, should they be vaccinated at all? Outcome information was Death. The patient died on an unspecified date in Apr2021. It was not reported if an autopsy was performed. The outcome of the event chills and sore throat was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: He passed away 4 days later


VAERS ID: 1338020 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise
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: DKPFIZER INC2021559008

Write-up: felt unwell the day after vaccination; This is a spontaneous report from a contactable consumer received via Pfizer colleague. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. It was reported that the patient felt unwell the day after vaccination and was died two days after vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information of batch/lot number has been requested.; Reported Cause(s) of Death: felt unwell the day after vaccination


VAERS ID: 1338063 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Apallic syndrome, Aspiration, Blood culture, Body temperature, Cardio-respiratory arrest, Chest X-ray, Culture, Culture urine, Hypotension, Oxygen saturation, Presyncope, Skin ulcer, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aspiration; Chronic anemia; Dementia with Lewy bodies (due to Lewy bodies in advanced stage); Hiatal hernia; Hypertension; Peripheral arterial disease; Prostatic disorder; Transient ischemic attack (TIA, recovered.); Type 2 diabetes mellitus; Ulcer
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood culture; Result Unstructured Data: Test Result:pending results; Test Date: 2021; Test Name: body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Test Date: 2021; Test Name: chest X-ray; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: Culture; Result Unstructured Data: Test Result:negative results; Test Date: 2021; Test Name: Uroculture; Result Unstructured Data: Test Result:pending results; Test Date: 2021; Test Name: Saturation; Result Unstructured Data: Test Result:desaturations
CDC Split Type: ESPFIZER INC2021527810

Write-up: Hypotension; Somnolence; vegetative symptoms; vasovagal syndrome; Interdigital ulcers on both lower extremities, Significant pain, with agitation; Interdigital ulcers on both lower extremities, Significant pain, with agitation; Cardio-respiratory arrest; bronchoaspiration; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB ES-AEMPS-855163. An 80-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 23Mar2021 (Lot Number: ET3620) as 1st dose, 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension, Type 2 diabetes mellitus with peripheral arterial disease with chronic ulcers in lower esophageal sphincter (LES), hiatal hernia, ischemic cerebrovascular accident (TIA) in 2011 which was recovered on an unspecified date, prostate syndrome, chronic anemia, dementia due to Lewy bodies in advanced stage, totally dependent on basic personal and instrumental activities of daily living:, with episodes of broncho aspiration. The patient''s concomitant medications were not reported. The patient received the first dose of Comirnaty on 23Mar2021. On 26Mar2021, he presented a picture of disconnection from the environment accompanied by vegetative symptoms, somnolence and hypotension. Assessed by neurology on 26Mar2021, which indicates vasovagal syndrome related to multiple medications and admission was decided. The patient was hospitalized on Mar2021. During hospitalization, he presented a fever peak of 37.6 C with desaturations, which was why bronchoaspiration was suspected and empirical antibiotic treatment with amoxicillin / clavulanic acid was started pending uroculture and blood culture results on an unspecified date in 2021. A chest X-ray (unknown results) was performed without observing condensation together with negative results of the cultures on an unspecified date in 2021. In later days, the patient remains afebrile, presenting good clinical evolution, for which he was discharged home on 01Apr2021. The first days at home, on 01Apr2021, he presented a torpid evolution of interdigital ulcers in the lower extremities and a decision was made to hospitalize her at home. Interdigital ulcers on both lower extremities, with a center with scant fibrin, no purulent discharge, edges with granulation. It does not impress signs of over infection. Significant pain, with agitation. Analgesic medication is adjusted. On 11Apr2021, the family communicated the death of the patient at home on an unspecified date in Apr2021. The family comments that the day before they observed a significant worsening, prostration, more respiratory secretions (which, according to what they reported earlier, mobilized), little oral intake with secondary cough. After breakfast he started coughing with abundant respiratory secretions and subsequent cardio-respiratory arrest on Apr2021. Exitus due to evolution of underlying pathology. The patient died on an unspecified date in Apr2021 due to cardio-respiratory arrest. It was unknown if an autopsy was performed. The outcome of the event cardio-respiratory arrest was fatal; interdigital ulcers on both lower extremities, significant pain, with agitation was unknown; and recovering for the rest of the events. No follow-up attempts are possible. No information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1338068 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Aspiration, Blood bilirubin, Blood pressure measurement, Body temperature, Coagulation test, Coma, Coma scale, Computerised tomogram, Delayed ischaemic neurological deficit, Electroencephalogram, Full blood count, Headache, SARS-CoV-2 test, Serratia infection, Status epilepticus, Subarachnoid haemorrhage, Vomiting, X-ray
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 26
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: TRAMADOL; TRIPTIZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Finger traumatic amputation; Gastric ulcer; Post herpetic neuralgia
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Angiogram; Result Unstructured Data: Test Result:venous angioma was reported, as a possible cause o; Comments: venous angioma was reported, as a possible cause of bleeding.; Test Date: 20210414; Test Name: Total Bilirubin; Test Result: 1.84 mg/dl; Test Date: 20210414; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:165 mmHg; Test Date: 20210414; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210414; Test Name: Coagulation; Result Unstructured Data: Test Result:normal; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:7/15; Test Date: 20210414; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:13/15; Test Date: 20210414; Test Name: computerized tomography cranial scan; Result Unstructured Data: Test Result:bilateral subarachnoid hemorrhage; Comments: bilateral subarachnoid hemorrhage without being able to rule out a certain intraparenchymal component in the right base ganglia; Test Date: 20210419; Test Name: computerized tomography cranial scan; Result Unstructured Data: Test Result:Acute cortico-subcortical frontal-parieto-temporal; Comments: Acute cortico-subcortical frontal-parieto-temporal and right occipital ischemic infarcts, as well as in right base ganglia; Test Date: 20210419; Test Name: Electroencephalogram; Result Unstructured Data: Test Result:non-convulsive status epilepticus; Test Date: 20210414; Test Name: Hemogram; Result Unstructured Data: Test Result:normal; Test Date: 20210414; Test Name: Covid-19 polymerase chain reaction; Test Result: Negative ; Test Date: 20210415; Test Name: Diagnostic arteriography; Result Unstructured Data: Test Result:perforating branch
CDC Split Type: ESPFIZER INC2021553652

Write-up: delayed cerebral ischemia; Serratia tracheobronchitis; Status epilepticus not convulsive; Bronchoaspiration; Hemorrhage subarachnoid/bilateral subarachnoid hemorrhage; Headache; Vomited; Coma; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB ES-AEMPS-860774. An 81 years old male patient received 1st dose of BNT162B2 (Pfizer vaccine, lot/batch: EW2243) Intramuscular on 07Apr2021 at single dose for COVID-19 immunisation. Previous illnesses included Traumatic amputation 3rd finger right hand, Post-herpetic neuralgia. Neonatal, obstetric and surgical history was Appendectomy, Gastric ulcer. Mental condition: No cognitive impairment Independent for all the basic and instrumental activities of daily life. Active life, goes outside. Concomitant drugs included Tramadol, amitriptyline hydrochloride (TRIPTIZOL). He was transferred from another hospital on 14Apr2021 due to subarachnoid hemorrhage. The patient is taken to the emergency department by family members. They indicate 7 days of evolution consisting of headache, and progressive deterioration of his general condition, with several episodes of vomiting, initially associated with 1st dose of Pfizer C19 Vaccine (07Apr2021). Today they find the patient more hypo-reactive, aphasic, with fluid leakage from the corner of the mouth. A computerized tomography cranial scan was performed on an emergency basis in which bilateral subarachnoid hemorrhage was observed without being able to rule out a certain intraparenchymal component in the right base ganglia. This is decided upon after a comment from Neurosurgery to transfer to our hospital. Upon arrival, the patient is found to be inclined toward high blood pressure with systolic blood pressure 165 mmHg. With Glasgow Coma Scale 13/15 (eye response 4 verbal response 3 motor response 6), opens eyes when called, directs gaze crossing the midline to both sides, expresses short sentences and answers questions, obeys simple commands. The patient also indicates to being nauseous. 12.5 mg of urapidil are administered. Psychomotor agitation, fever of 37.7 centigrades with abundant rhonchi in both lung fields, obtaining a first pair of peripheral blood cultures. It was decided to perform a new computerized tomography brain scan and CT angiogram, in which an image of venous angioma was reported, as a possible cause of bleeding. Agitated during the entire procedure requiring the administration of 20 mg of propofol, with which control is gained, keeping the patient reactive, calm. He is moved up to the intensive care unit, and the radial artery is channeled and we removed the 2nd pair of blood cultures, in addition to selective bronchoaspiration and urine culture. Progressive deterioration of the level of consciousness, with Glasgow Coma Scale 7/15 (eye response 1 verbal response 1 motor response 5), without obtaining a response to stimulus, localized pain with both sides of the body. Poor management of secretions, orotracheal intubation was decided upon (rapid induction with 75 mcg fentanyl, 50 mg etomidate, 75 mg rocuronium; no ventilation problems, Cormack I with anterior glottis, without incidents, endotracheal tube 8.5). We inform his relatives of the situation and prognosis, as well as the indication for arteriography, which they understand and accept. Summary of additional tests: ANALYSIS 14Apr2021: Hemogram: Normal. Coagulation Normal. Biochemistry Total Bilirubin Noted: 1.84 mg/dL (0.30 - 1.20); Image: Computerized Tomography 14Apr2021. Conclusion: Bilateral subarachnoid hemorrhage without being able to rule out a certain degree of intraparenchymal component in right base ganglia. Covid-19 polymerase chain reaction 14Apr2021: negative. The patient dies on 27Apr2021 under optimal conditions of comfort, having previously been accompanied by the family. Main diagnosis: Subarachnoid hemorrhage; Other diagnoses: Coma, Bronchoaspiration, Status epilepticus. Evolution and comments: evolution during stay in intensive care unit. 81 year old patient admitted to the intensive care unit on 14Apr2021 for aneurysmal Fisher III subarachnoid hemorrhage. During his admission the patient presented with the following problems. Subarachnoid hemorrhage: A few hours after admission to the intensive care unit, the patient began to have neurological deterioration, going from a Glasgow Coma Scale 13/15 to a Glasgow Coma Scale 7/15, which is why orotracheal intubation was decided upon (Cormack I). A diagnostic arteriography was performed on 15Apr2021, where a perforating branch was observed that seems to be the origin of the bleeding but with a high ischemic risk if it were to embolize. With these findings, a joint decision was made with the interventional vascular radiology and neurosurgery team, due to risk/benefit (81 year old patient with high ischemic risk in the event of embolization with risk of significant functional and neurological comorbidities) to not embolize and monitor. Treatment with nipodipine is initiated. After that, an attempt to make neurological progress with him, but after several rounds of sedation, it was not possible to connect with the patient, he only moves the right side of the body spontaneously. A monitoring computerized tomography brain scan and angiogram were performed 19Apr2021 where the main finding was Acute cortico-subcortical frontal-parieto-temporal and right occipital ischemic infarcts, as well as in right base ganglia, suggestive of delayed cerebral ischemia. In view of the poor neurological evolution, an electroencephalogram was performed on 19Apr2021, diagnosing non-convulsive status epilepticus. Non-convulsive status epilepticus: This is diagnosed on 19Apr2021 with electroencephalogram in view of the poor neurological evolution. Treatment with phenytoin is initiated, which caused complete atrioventricular block, requiring treatment with atropine + isoprotenerol with subsequent resolution after suspension of phenytoin. This is replaced with levetiracetam, in addition to sedoanalgesia with propofol + remifentanil, attempting to make progress by lowering sedation the patient falls back into status epilepticus, so a 2nd fatty acid synthase (valproic acid) is added, despite this the patient remains in status epilepticus. The family is told about the poor prognosis of the situation, and the most probable functional prognosis is a situation of dependency, taking into account age, type of hemorrhage, established ischemic areas and evolution toward a super-refractory condition. For this reason, they are in favor of carrying out an adaptation of therapeutic measures since they consider that we may be in a futile therapeutic situation, on 27Apr2021 terminal extubation is decided upon, to ensure the patient optimal comfort. Serratia tracheobronchitis: The patient has a feverish peak that is pancultured on 18Apr2021. From the beginning he had been empirically and prophylactically covered with amoxicillin-clavulanate through orotracheal intubation with a low level of consciousness. In the selective bronchoaspiration on 18Apr2021, Serratia Marcescens was isolated, initiating treatment with targeted Ciprofloxacin, which was changed to piperacillin-tazobactam since quinolones lower the epileptogenic threshold. Good evolution of the infection, without consolidations or infiltrates on the x-ray, and without respiratory repercussions at any time. Subsequent selective bronchoaspiration neutralized. He has not shown dysfunction of other organs, he has required vasoactive support with norepinephrine for sedation. Good renal function with good diuretic rhythm. Being fully nourished with enteral nutrition and good tolerance. The patient dies on 27Apr2021 under optimal conditions of comfort, having previously been accompanied by the family. Observations: According to the Spanish Pharmacovigilance System algorithm, causality is unrelated, especially if taking into account the fact of finding venous angioma close to the source of the bleeding and observing the perforating vessel responsible for it, so there is a good alternative cause to the medication. This case will be reported to provide information on possible risk factors, or any information that is of value for post-marketing monitoring of the vaccines. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hemorrhage subarachnoid; headache; Vomited; Coma; Bronchoaspiration; delayed cerebral ischemia; Serratia tracheobronchitis


VAERS ID: 1338069 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-10
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021553656

Write-up: Sudden death; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority, ES-AEMPS-861158. A 64-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm on 27Apr2021 as 1st dose single for COVID-19 immunization. Patient medical history included that the patient had no known pathologies and was a non-smoker, athlete and concomitant medications were not reported. A family member reported that the patient had not been infected by COVID-19. On 10May2021 (as reported) Death occurred at night, two weeks after vaccination. It was classified as cardiorespiratory arrest. The judge has denied the autopsy request, despite the fact that the family doctor requested it, on suspicion that vaccination may have played some role in the outcome. The outcome of the event was fatal. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1338072 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-04-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Cough, Musculoskeletal pain, Pneumonia, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive, Sneezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 12
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: Celiac disease; Chronic kidney disease; Dyslipidaemia; Gastrooesophageal reflux; Hypertension arterial; Hypoacusis; Ischaemic heart disease; Obesity (BMI 33); Sleep apnea
Allergies:
Diagnostic Lab Data: Test Date: 20210503; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210503; Test Name: body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Test Date: 20210506; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ESPFIZER INC2021559947

Write-up: bilateral pneumonia; covid-positive pcr; 38,5?C, 38,7?C; Shivering; Cough; Sneezing; Arthromyalgia; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB ES-AEMPS-863640. A 83-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 30Apr2021 (Lot Number: EY3014) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension arterial, sleep apnea, obesity, chronic kidney disease, celiac disease, hypoacusis, gastrooesophageal reflux, ischaemic heart disease, dyslipidaemia. The patient''s concomitant medications were not reported. The patient experienced cough (death, hospitalization, medically significant) on 30Apr2021, sneezing (death, hospitalization, medically significant) on 30Apr2021, arthromyalgia (death, hospitalization, medically significant) on 30Apr2021, shivering (death, hospitalization, medically significant) on 01May2021, 38,5?c, 38,7?c (death, hospitalization, medically significant) on 03May2021, bilateral pneumonia (death, hospitalization, medically significant) on 06May2021, covid-positive pcr (death, hospitalization, medically significant) on 06May2021. The patient died on 12May2021. It was not reported if an autopsy was performed. Treatment included solumoderin + nolotil 575mg + paracetamol 1000mg + pectoxlisine + oxygen + dexamethasone + ethylprednisolone + ceftriaxone + hbpm. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: bilateral pneumonia; covid-positive pcr; Shivering; Cough; Sneezing; Arthromyalgia; 38,5?C, 38,7?C


VAERS ID: 1338074 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Dizziness, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 120
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angiopathy; Chronic kidney disease
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:180/80
CDC Split Type: ESPFIZER INC2021559964

Write-up: unknown cause of death; Hypertension; Dizziness; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority ES-AEMPS-864516. A 90-year-old male patient received bnt162b2 (COMIRNATY) intramuscular on 10Jan2021 (Batch/Lot Number: EM0477) as 0.3ml single for COVID-19 immunisation. Medical history included chronic kidney disease and peripheral angiopathy. The patient''s concomitant medications were not reported. The patient experienced hypertension (death) on 10Jan2021, dizziness (death) on 10Jan2021, unknown cause of death on 11May2021. The patient underwent lab tests and procedures which included blood pressure: 180/80 on an unknown date. The patient died on 11May2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: Exitus a few hours after receiving the vaccine. It started with dizziness and blood pressure elevation. Additional information obtained: Urgent assistance report on 11Jan2021 at 19:51. Patient of bad general state, hypertension 180/80 without vegetatism. Treatment: sublingual amlodipine. History of chronic kidney disease and peripheral angiopathy. It was impossible to obtain data of the exitus. Outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hypertension; Dizziness; unknown cause of death


VAERS ID: 1338075 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Asthenia, Diarrhoea, General physical health deterioration, Presyncope, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aspiration pneumonia (From the 18 to 24Jan2021 admission for bronchoaspiration pneumonia); Chronic kidney disease; Chronic obstructive pulmonary disease; Diabetes mellitus; Dyslipidemia; Hypertension; Hypothyroidism; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021560627

Write-up: Vomiting; low-grade fever; weakness; sudden worsening of the general condition; bronchoaspiration/Aspiration into bronchus; Diarrhoea; a self-limiting vagal reaction; This is a spontaneous report downloaded from the Regulatory Authority (RA)-WEB [ES-AEMPS-864584]. This contactable other HCP reported events for both doses of Comirnaty for this patient. This is the first of two reports for the second dose. A 79-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 19Feb2021 (Lot Number: EM6950) as 2nd dose, 0.3ml single for covid-19 immunisation. Medical history included hypertension, diabetes mellitus, dyslipidemia, vascular dementia, chronic kidney disease, chronic obstructive pulmonary disease, hypothyroidism; From the 18 to 24Jan2021 admission for bronchoaspiration pneumonia. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), intramuscular on 28Jan2021 (Lot Number: EJ6796) as 1st dose single for covid-19 immunization and experienced the fever that was not measured, from 03Feb2021 to 18Feb2021 new admission with acute respiratory failure with aspiration. Received a second dose of vaccine on 19Feb2021 and 2 hours later presented with diarrhea with a self-limiting vagal reaction. On 21Feb2021 started to have low-grade fever, weakness, a sudden worsening of the general condition, vomiting, diarrhea, and died. It is oriented as probable bronchoaspiration/Aspiration into bronchus. The outcome of the events was fatal. The patient died on 21Feb2021 due to events. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : ES-PFIZER INC-2021573951 the same patient different dose of product; Reported Cause(s) of Death: Diarrhoea; a self-limiting vagal reaction; Vomiting; low-grade fever; weakness; sudden worsening of the general condition; Aspiration into bronchus


VAERS ID: 1338084 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-18
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: AST/ALT ratio abnormal, Auscultation, Base excess, Blood bicarbonate, Blood calcium, Blood creatinine, Blood creatinine decreased, Blood fibrinogen, Blood fibrinogen increased, Blood glucose, Blood glucose increased, Blood lactic acid, Blood lactic acid increased, Blood potassium, Blood pressure diastolic, Blood pressure increased, Blood pressure systolic, Blood sodium, Blood urea, Blood urea increased, Body temperature, Body temperature decreased, Cardio-respiratory arrest, Chest X-ray, Electrocardiogram, Haematocrit, Haematocrit decreased, Haemoglobin, Heart rate, International normalised ratio, International normalised ratio increased, Lymphocyte count, Lymphocyte count decreased, Mean cell volume, Neutrophil count, Oxygen saturation, PCO2, PCO2 increased, Percussion test, Platelet count, Platelet count decreased, Protein total, Respiratory rate, SARS-CoV-2 test, Transaminases, White blood cell count, White blood cell count increased, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Hypertension (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (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: 2021-04-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; PARACETAMOL; SINEMET; TAMSULOSIN; XARELTO; MEMANTINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia; Ex-smoker; Hematuria; Parkinson''s disease (Predominant motor clinical picture, significant walking limitation); Tumor; Type 2 diabetes mellitus; Walking difficulty
Allergies:
Diagnostic Lab Data: Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:without audible murmurs; Comments: arrhythmic heart tones without audible murmurs, pitting bi-malleolar edema; Test Name: Respiratory auscultation; Result Unstructured Data: Test Result:wheezing; Comments: wheezing and rhonchi disseminated with bi-basal crackles; Test Name: excess base; Result Unstructured Data: Test Result:4.8; Test Name: bicarbonate; Result Unstructured Data: Test Result:-30.3; Test Name: calcium; Test Result: 9.4 mg/dl; Test Name: creatinine; Test Result: 0.57 mg/dl; Test Name: fibrinogen; Result Unstructured Data: Test Result:4.79; Test Name: glucose; Test Result: 162 mg/dl; Test Name: lactates; Result Unstructured Data: Test Result:2.2; Test Name: potassium; Result Unstructured Data: Test Result:3.79 mmol/L; Test Name: Diastolic blood pressure; Result Unstructured Data: Test Result:80 mmHg; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:152 mmHg; Test Name: sodium; Result Unstructured Data: Test Result:143.5 mmol/L; Test Name: urea; Test Result: 56 mg/dl; Test Name: Axillary temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: decreased; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Signs of vascular redistribution; Comments: Signs of vascular redistribution, without clear condensations; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:without acute alterations in repolarization; Comments: Atrial fibrillation at 60 beats/minute, axis at 30?, narrow QRS, without acute alterations in repolarization; Test Name: Hematocrit; Test Result: 38.6 %; Test Name: Hemoglobin; Result Unstructured Data: Test Result:12.1 g/dl; Test Name: heart rate; Result Unstructured Data: Test Result:102 beats per minute; Test Name: international normalized ratio; Result Unstructured Data: Test Result:3.32; Test Name: lymphocyte count; Result Unstructured Data: Test Result:600; Test Name: mean corpuscular volume; Result Unstructured Data: Test Result:95.8 fL; Test Name: neutrophil count; Result Unstructured Data: Test Result:9800; Test Name: Oxygen saturation; Test Result: 100 %; Comments: 100.00% (with ventimask oxygen requirement)), after 69% in ambient air; Test Name: partial pressure of carbon dioxide; Result Unstructured Data: Test Result:50; Test Name: fist percussion test; Test Result: Negative ; Test Name: pH; Result Unstructured Data: Test Result:7.39; Test Name: platelets; Result Unstructured Data: Test Result:115000; Test Name: protein; Result Unstructured Data: Test Result:7.2; Test Name: respiration rate; Result Unstructured Data: Test Result:20 per minute; Test Date: 20210318; Test Name: SARS-CoV-2 polymerase chain reaction; Test Result: Negative ; Test Name: aspartate transaminase/alanine aminotransferase; Result Unstructured Data: Test Result:23/8 IU/l; Test Name: leukocytes; Result Unstructured Data: Test Result:11630
CDC Split Type: ESPFIZER INC2021566934

Write-up: Hematocrit 38.6%; leukocytes: 11630; lymphocyte count: 600; platelets 115000; international normalized ratio 3.32; fibrinogen 4.79; glucose 162 mg/dL; Urea 56 mg/dL; aspartate transaminase/alanine aminotransferase 23/8 IU/L; creatinine 0.57 mg/dL; partial pressure of carbon dioxide 50; lactates 2.2; Axillary temperature: 35.8 Centigrade; Systolic blood pressure 152 mmHg,Diastolic blood pressure 80 mmHg; Cardiorespiratory arrest; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority. An 85-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: ET3620), intramuscular on 17Mar2021 (at unknown age) as 0.3ml single for COVID-19 immunisation. Medical history included Ex-smoker, Type 2 diabetes mellitus, Atrial fibrillation, Vesical tumor, episodes of gross hematuria, Parkinson (Predominant motor clinical picture, significant walking limitation), Moderate-severe dementia, walking difficulty. Concomitant medications included metformin; paracetamol; carbidopa, levodopa (SINEMET); tamsulosin; rivaroxaban (XARELTO); memantine. The patient previously took first dose of BNT162B2 (COMIRNATY, batch/lot number: EP9598) on 22Feb2021, intramuscular at single dose for COVID-19 immunisation and had Respiratory failure. The patient underwent lab tests and procedures which included on unknown date: Cardiac auscultation: arrhythmic heart tones without audible murmurs, pitting bi-malleolar edema, Respiratory auscultation: wheezing and rhonchi disseminated with bi-basal crackles, excess base: 4.8, bicarbonate: -30.3, calcium: 9.4 mg/dl, creatinine: 0.57 mg/dl, fibrinogen: 4.79, glucose: 162mg/dl, lactates:2.2, potassium: 3.79mmol/l, Diastolic blood pressure: 80 mmHg, Systolic blood pressure: 152 mmHg, sodium: 143.5, urea: 56 mg/dl, Axillary temperature: 35.8 Centigrade, Chest X-ray: Signs of vascular redistribution, without clear condensations, Electrocardiogram: without acute alterations in repolarization Atrial fibrillation at 60 beats/minute, axis at 30?, narrow QRS, without acute alterations in repolarization, Hematocrit: 38.6%, Hemoglobin: 12.1 g/dl, heart rate: 102 beats per minute, international normalized ratio: 3.32, lymphocyte count: 600, mean corpuscular volume: 95.8 fL, neutrophil count: 9800, Oxygen saturation: 100.00% (with ventimask oxygen requirement)), after 69% in ambient air, partial pressure of carbon dioxide: 50, fist percussion test: negative, pH: 7.39, platelets: 115000, protein: 7.2, respiration rate: 20 per minute, aspartate transaminase/alanine aminotransferase: 23/8 iu/l, leukocytes: 11630; on 18Mar2021, SARS-CoV-2 polymerase chain reaction: negative. The patient had Cardio-respiratory arrest on 18Apr2021, and passed away on 18Apr2021. It was unknown if an autopsy was performed. The outcome of Cardiorespiratory arrest was fatal, for other events was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : ES-PFIZER INC-2021553698 same patient, different vaccine doses; Reported Cause(s) of Death: Cardiorespiratory arrest


VAERS ID: 1338179 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   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: MIRTAZAPINE; ASTECON; PANADOL FORTE; MATRIFEN; VISCOTEARS; FURESIS; KALCIPOS-D; BISOPROLOL FUMARATE; PEGORION; KETIPINOR; VENTOLINE; ELIQUIS; SERETIDE DISKUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (G30.1 Late-onset); Asthma, unspecified (J45.9); Atherosclerotic cardiovascular disease (I25.1); Constipation; Depression; Dry eye; Heart disease, unspecified (a pre-existing heart disease); Hypercholesterolemia (E78.0); Ischaemia (I25.9); Oedema peripheral; Osteoporosis; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021553658

Write-up: Apnoea; Dyspnoea; This is a spontaneous report from a contactable nurse, from the regulatory authority, downloaded from the regulatory authority-WEB. The regulatory authority report number is FI-FIMEA-20212456. An 86-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EK9788) via intramuscular on 27Jan2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient''s medical history included (G30.1 Late-onset) Alzheimer''s disease, (I25.1) atherosclerotic essential RR disease, (J45.9) unspecified asthma, (E78.0) hypercholesterolemia, (I25.9) unspecified ischaemia, a pre-existing heart disease, depression, pain, dry eye, oedema peripheral, osteoporosis, and constipation. Concomitant medications included mirtazapine taken for depression; montelukast sodium (ASTECON) taken for asthma; paracetamol (PANADOL FORTE); fentanyl (MATRIFEN) taken for pain; carbomer (VISCOTEARS) taken for dry eye; furosemide (FURESIS) taken for oedema peripheral; calcium carbonate/colecalciferol (KALCIPOS-D) taken for osteoporosis; bisoprolol fumarate; macrogol 4000 (PEGORION) taken for constipation; quetiapine fumarate (KETIPINOR); salbutamol (VENTOLINE) taken for asthma; apixaban (ELIQUIS); fluticasone propionate/salmeterol xinafoate (SERETIDE DISKUS) taken for asthma. The patient experienced apnoea and dyspnoea on 29Jan2021 (2 days after vaccination). 07May2021, nurse reported: "The patient was in a long-term care home for Alzheimer''s disease. Two days after receiving the vaccine, shortness of breath while resting and shortness of breath started. The patient died on 03Feb2021. I made this announcement together with other close relatives, based on information from the place of care." The outcome of the events apnoea and dyspnoea was fatal. It was unknown whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Apnoea; Dyspnoea


VAERS ID: 1338187 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   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: PAMOL; RISPERDAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Dementia NOS; Osteoarthritis
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: body temperature; Result Unstructured Data: Test Result:over 38.0 Centigrade; Comments: 17-19Apr2021 fever over 38.0 degrees; Test Date: 202104; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 - 37.4 Centigrade; Comments: 20-26Apr2021 mild warming (37.2 - 37.4. Degrees)
CDC Split Type: FIPFIZER INC2021560871

Write-up: Exitus; recent fading of the well-being; fever; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20212573. A 92-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 15Apr2021 (Batch/Lot Number: EW2246) as single dose for covid-19 immunisation. Medical history included asthma, osteoarthritis, unspecified dementia. No known allergies. Concomitant medications included paracetamol (PAMOL) taken for an unspecified indication, start and stop date were not reported; risperidone (RISPERDAL) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 for covid-19 immunization with no side effects. 17-19Apr2021 fever over 38.0 degrees without changes in inflammatory values or other symptoms of infection. No detectable infection focus. 20-26Apr2021 mild warming (37.2 - 37.4 Degrees) and recent fading of the well-being. Hospice decision 26Apr2021. Exitus 27Apr2021. Prolonged fever after COVID 19 vaccine without evidence of infection. The outcome of the events fever and ''fading of the well-being'' was unknown. The patient died on 27Apr2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Exitus


VAERS ID: 1338191 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-04-01
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19; Fibrosis pulmonary
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: tested positive for the specific countries variant
CDC Split Type: FRPFIZER INC2021553671

Write-up: dyspnoea; fever; Vaccination failure/tested positive for the specific countries variant; COVID-19/tested positive for the specific countries variant; This is a spontaneous report from a contactable other health professional downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-2021050910. A 95-year-old female patient received BNT162B2 (COMIRNATY), 1st dose intramuscularly, administered in arm left on 26Jan2021 (Lot Number: EM0477) as a single dose, 2nd dose intramuscularly, administered in arm left on 16Feb2021 (Lot Number: ER0641) as a single dose for COVID-19 immunisation. Medical history included ongoing COVID-19 (as reported), ongoing fibrosis pulmonary. The patient''s concomitant medications were not reported. The patient experienced vaccination failure/tested positive for the specific countries variant, COVID-19/tested positive for the specific countries variant, both on 01Apr2021 and the events were reported as death, dyspnoea and fever, both on 11Apr2021, and the events were reported as being hospitalization and death. The patient was tested positive for the specific countries variant on 01Apr2021, hospitalized on 11Apr2021 for fever and dyspnoea, death on 14Apr2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive (tested positive for the specific countries variant) on 01Apr2021. The patient died on 14Apr2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure/tested positive for the specific countries variant; dyspnoea; fever; COVID-19/tested positive for the specific countries variant


VAERS ID: 1338194 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-05-06
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiogram, Blood gases, Blood pressure measurement, Blood test, Body temperature, Coma scale, Echocardiogram, Fraction of inspired oxygen, Glomerular filtration rate, Heart rate, Ischaemic stroke, Neurological examination, Oxygen saturation, Platelet count, Prothrombin time, Pulmonary embolism, Respiratory rate, Visual analogue scale, White blood cell count
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: ESOMEPRAZOLE; DILTIAZEM; BISOPROLOL; HYDROCHLOROTHIAZIDE; RAMIPRIL; METFORMIN; TRAMADOL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disorder; Hypertension arterial; Iron deficiency anaemia (Regenerative iron deficiency anaemia); Reflux esophagitis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result:0.8; Test Date: 20210506; Test Name: computed tomography angiography; Result Unstructured Data: Test Result:pulmonary embolism; Comments: multiple endovascular lacunar images compatible with right middle and lower lobar pulmonary embolism.; Test Date: 20210507; Test Name: computed tomography angiography; Result Unstructured Data: Test Result:ischemic stroke; Comments: large right parietal-occipital hypodensity indicating an ischemic stroke. No cerebral haemorrhage. No mass effect or parenchymal expansive process. Ventricular system, cortical sulci and basal cisterns are unremarkable. Vasculodegenerative leukopathy.; Test Date: 20210506; Test Name: gazometry; Result Unstructured Data: Test Result:hypoxia-hypocapnia; Comments: suggesting a pulmonary embolism, although the calves are supple and not painful; Test Date: 20210507; Test Name: gazometry; Result Unstructured Data: Test Result:acidosis; Comments: catastrophic with significant acidosis.; Test Date: 20210506; Test Name: blood pressure; Result Unstructured Data: Test Result:133/77 mmHg; Test Date: 20210507; Test Name: blood pressure; Result Unstructured Data: Test Result:60/40 mmHg; Test Date: 20210506; Test Name: blood panel; Result Unstructured Data: Test Result:anaemia; Comments: probably related to the oesophageal pathology; Test Date: 20210506; Test Name: body temperature; Result Unstructured Data: Test Result:35,7 Centigrade; Test Date: 20210507; Test Name: body temperature; Result Unstructured Data: Test Result:35,7 Centigrade; Test Date: 20210506; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:15; Comments: 15 despite spatial-temporal disorientation; Test Date: 20210507; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:3; Test Date: 20210507; Test Name: cardiac echocardiogram; Result Unstructured Data: Test Result:no right or left myocardial failure; Test Date: 20210507; Test Name: fio2; Test Result: 84 %; Test Date: 20210506; Test Name: mdrd gfr; Test Result: 56 mL; Comments: moderate renal insufficiency; Test Date: 20210506; Test Name: heart rate; Result Unstructured Data: Test Result:128; Comments: /minute; Test Date: 20210506; Test Name: heart rate; Result Unstructured Data: Test Result:90; Comments: /minute; Test Date: 20210507; Test Name: heart rate; Result Unstructured Data: Test Result:94; Test Date: 20210506; Test Name: neurological examination; Result Unstructured Data: Test Result:no signs of localisation; Test Date: 20210506; Test Name: oxygen saturation; Test Result: 99 %; Comments: saturated oxygen 99% in ambient air; Test Date: 20210507; Test Name: oxygen saturation; Test Result: 85 %; Test Date: 20210507; Test Name: oxygen saturation; Test Result: 80 %; Comments: the respiratory insufficiency worsens at 80% in ambient air; Test Date: 20210506; Test Name: platelets; Result Unstructured Data: Test Result:387 g/l; Comments: normal; Test Date: 20210507; Test Name: platelets; Result Unstructured Data: Test Result:386 g/l; Test Date: 20210506; Test Name: prothrombin time; Test Result: 70 %; Test Date: 20210506; Test Name: respiration rate; Result Unstructured Data: Test Result:28; Comments: 28/minute; Test Date: 20210507; Test Name: respiration rate; Result Unstructured Data: Test Result:28; Comments: /minute; Test Date: 20210507; Test Name: Visual Analogue Scale; Result Unstructured Data: Test Result:15; Test Date: 20210506; Test Name: leukocytes; Result Unstructured Data: Test Result:19.8 g/l
CDC Split Type: FRPFIZER INC2021553629

Write-up: Ischemic stroke; Embolism pulmonary; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-2021052029. A 78-years-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 19Apr2021 (Lot Number: EW2246) as 2nd dose, single for covid-19 immunisation. Medical history included Early cognitive disorders, Type 2 diabetes mellitus, Hypertension arterial, Reflux esophagitis, Regenerative iron deficiency anaemia. No COVID HISTORY. Concomitant medications included esomeprazole, diltiazem, bisoprolol, hydrochlorothiazide, ramipril, metformin, tramadol, paracetamol. The patient previously received first dose of bnt162b2, on 23Mar2021 (Lot Number: ER9470) as 1st dose, single for covid-19 immunisation. 17 days after Dose 2, on 06May2021, the patient was sent to the Emergency Room by their general practitioner due to a change in their general state with dyspnoea, date of onset not provided. The clinical examination was without any significant particularity (35.7?C; 133/77mmHg; Heart rate 128/minute; saturated oxygen 99% in ambient air; respiration rate 28/minute; Glasgow Coma Scale 15 despite spatial-temporal disorientation; Glc cap. 3g/l; symmetrical vesicular murmur with no rattle, neurological examination with no signs of localisation). Heart rate slowed spontaneously to sinus rhythm at 90/minute. The blood panel revealed anaemia (probably related to the oesophageal pathology), hyperleucocytosis (19.8g/l), moderate renal insufficiency (MDRD 56ml/minute) and, above all, hypoxia-hypocapnia, suggesting a pulmonary embolism, although the calves are supple and not painful. The platelets are normal at 387g/l. Prothrombin time 70%, activated partial thromboplastin time 0.8. This hypothesis is confirmed by computed tomography angiography: multiple endovascular lacunar images compatible with right middle and lower lobar pulmonary embolism. The patient is placed on Apixaban, and admitted to hospital. The patient had a slightly agitated night (got up, fell, incoherent remarks). In the afternoon of 07May2021, (Day 18 from Dose 2), while starting an erythrocyte transfusion, the respiratory insufficiency worsens with saturated oxygen at 80% in ambient air, appearance of crepitants at mid-field (Furosemide, high concentration oxygen), increase of cognitive disorders with agitation, no hemodynamic alteration. Platelets on 07May2021: 386g/l. Upon being taken into care around 16:45: 35.7?c; 60/40mmHg ; heart rate 94/minute; saturated o2 85% on FiO2 84% ; Respiratory rate 28/minute; Glasgow Coma Scale 3; Visual Analogue Scale 15; Glc cap. 5.09g/l Conduct: non-invasive ventilation (NIV) with face mask; Noradrenalin; cardiac echocardiogram done: no right or left myocardial failure. Sudden neurological deterioration with Glasgow Coma 3, the appearance of a left mydriasis while an anticoagulant treatment had just been started: a cerebral computed tomography scan is requested. Progression:The gazometry on non-invasive ventilation is catastrophic with significant acidosis. The computed tomography scan showed a large right parietal-occipital hypodensity indicating an ischemic stroke. No cerebral haemorrhage. No mass effect or parenchymal expansive process. Ventricular system, cortical sulci and basal cisterns are unremarkable. Vasculodegenerative leukopathy. Death is recorded at 18:25 at the end of carrying out the computed tomography scan. The declarant concludes a thrombotic storm with severe pulmonary embolism then ischemic stroke despite the prescription since the day before of Apixaban in a hypertensive, type II diabetic man who had received the second injection of Comirnaty vaccine 17 days earlier. Regenerative iron deficiency anaemia which could not be investigated but probably related to oesophageal pathology on hiatus hernia (history of oesophagitis). Moderate renal insufficiency. Coma then asystole leading to death. According to the declaring resucitator, the clinical signs seemed very unusual. He suggested a hypothesis of a paradoxical embolism linked to a permeable oval foramen, but the localisation of the cerebral vascular accident does not favour this hypothesis. Further, the pulmonary embolism was not massive. Awaiting information on a possible blood sample for a thrombophilia test and anti-PF4 antibody level test (but unlikely to have been carried out in this very rapidly unfavourable context). In summary: pulmonary embolism followed by a massive ischemic stroke 17 days after the 2nd dose of COMIRNATY in a 78-year old patient, leading to his death; normal platelets, no dose of anti-PF4 antibodies." The patient died on 07May2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Embolism pulmonary; Ischemic stroke


VAERS ID: 1338202 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 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: 2021-04-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve disease mixed; Colon cancer; Nephrectomy; Renal carcinoma (renal carcinoma in 2002 with nephrectomy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021553644

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is [FR-AFSSAPS-BX20214353] and Safety Report Unique Identifier [FR-AFSSAPS-2021052758]. An 85-year-old male patient received BNT162B2 (COMIRNATY) (Batch/Lot Number: EW2246) via intramuscular, administered in arm left on 09Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included moderate aortic valve disease; renal carcinoma in 2002 with nephrectomy; colon cancer in 2017. The patient''s concomitant medications were not reported. Patient previously received first dose of BNT162B2 for covid-19 immunisation. On Day 9 of Dose 2 (18Apr2021), patient was found dead in the shower, although he was asymptomatic a few minutes before. The sudden death without triggering factor or cause found. Patient did not have Covid-19; he had not been tested. The patient died on 18Apr2021. It was not reported if an autopsy was performed. The reported cause of death was sudden death without triggering factor. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death without triggering factor


VAERS ID: 1338206 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-12
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210312; Test Name: COVID-19; Test Result: Positive
CDC Split Type: FRPFIZER INC2021527943

Write-up: SARS-CoV-2 infection; Vaccination failure; death; This is a spontaneous report from a contactable pharmacist reporting for a patient downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-GR20211204, Safety Report Unique Identifier FR-AFSSAPS-2021037815. An 83-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 10Feb2021 (Batch/Lot Number: EJ6788) as 2ND DOSE, SINGLE; and dose 1 intramuscular on 20Jan2021 (Batch/Lot Number: EJ6788) as 1ST DOSE, SINGLE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. Patient was a symptomatic COVID-19-positive case (12Mar2021). She was a female resident of a residential care home having had the complete vaccine round with COMIRNATY (2 injections, one on 20Jan2021 and one on 10Feb2021, lot EJ6788). Onset of symptoms was on 12Mar2021. Differential diagnosis was a non-identified strain. Patient was admitted to hospital on 15Mar2021 with oxygen treatment. Outcome of the event SARS-CoV-2 infection and Vaccination failure was not recovered. The resident died, from a different primary cause, on 05Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Lot number has been received.; Reported Cause(s) of Death: died of different primary cause


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