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From the 9/10/2021 release of VAERS data:

Found 14,925 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 947270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-15
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: 2021-01-10
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021027057

Write-up: patient died while there were no other complaints at that time; This is a spontaneous report received from a contactable consumer (Pfizer colleague). A 99-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient died 3 days after the vaccination while there were no other complaints at that time on 10Jan2021. The patient died on 10Jan2021. It was not reported if an autopsy was performed. The family assessed there was a causal relationship with the vaccine. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died 3 days after the vaccination while there were no other complaints


VAERS ID: 947332 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; ; ; ; FULTIUM D3; ; ; ; LOTRIDERM; ; MAROL; ; ; ; SENNA [SENNA SPP.]; FLUCELVAX TETRA
Current Illness: Bedridden (Patient bed bound following a craniotomy for an acute subdural haematoma in 2019)
Preexisting Conditions: Medical History/Concurrent Conditions: Acute subdural haematoma; Craniotomy; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021016371

Write-up: Died in sleep; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number was GB-MHRA-ADR 24556999 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-20210105122200. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1688), via an unspecified route of administration on 31Dec2020 as a single dose for COVID-19 vaccination. Medical history included craniotomy in 2019, acute subdural haematoma in 2019, and ongoing bedridden following a craniotomy for an acute subdural haematoma from 2019. The patient was not enrolled in clinical trial. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN), ferrous sulfate (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), flucloxacillin (MANUFACTURER UNKNOWN), colecalciferol (FULTIUM D3), gabapentin (MANUFACTURER UNKNOWN), hypromellose (MANUFACTURER UNKNOWN), levothyroxine sodium (MANUFACTURER UNKNOWN), betamethasone dipropionate/clotrimazole (LOTRIDERM) , macrogol (MANUFACTURER UNKNOWN), tramadol hydrochloride (MAROL), omeprazole (MANUFACTURER UNKNOWN), oxybutynin (MANUFACTURER UNKNOWN), paracetamol (MANUFACTURER UNKNOWN), senna spp. (MANUFACTURER UNKNOWN), and influenza vaccine inact sag 4v (FLUCELVAX TETRA). On 05Jan2021, the patient died in his sleep. The clinical course was as follows: The patient had not had symptoms associated with COVID-19. The patient received the vaccination on 31Dec2020. The patient had tested negative for COVID-19 since having the vaccine on an unknown date. There were no other reactions noted but the patient died in his sleep overnight on 05Jan2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Died in sleep


VAERS ID: 947357 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-19
Onset:2021-01-03
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Fall, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210103; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021019774

Write-up: tested Covid positive/suspected COVID-19; tested Covid positive/suspected COVID-19; Shortness of breath; Fall; This is a spontaneous report from a contactable physician from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210106123053. An 81-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection, shortness of breath on 03Jan2021. Reaction to vaccine is none. Patient was admitted with fall and on the floor for 5 hours on 03Jan2021. He was tested COVID positive on admission on 03Jan2021. So he tested positive about two weeks after first dose of Pfizer COVID-19 vaccine. Patient was suspected COVID-19 from 03Jan2021. The patient underwent lab test included COVID-19 virus test: Yes - Positive COVID-19 test (03Jan2021). Outcome of the events was fatal. The patient died on 03Jan2021. It was unknown if an autopsy was performed. Cause of death reported as SARS-CoV-2 infection/suspected COVID-19, shortness of breath and fall. No follow-up attempts possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection/suspected COVID-19; SARS-CoV-2 infection/suspected COVID-19; shortness of breath; Fall


VAERS ID: 947362 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia with Lewy bodies; Frailty; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: examination; Result Unstructured Data: Test Result:no signs of sepsis; Comments: she had no signs of sepsis, she had no fever, her chest was clear and she had no difficulty breathing
CDC Split Type: GBPFIZER INC2021019690

Write-up: Death; Unresponsive to stimuli; This is a spontaneous report received from a contactable physician by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210106141652 and GB-MHRA-ADR 24563112. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1688) via unspecified route of administration on 30Dec2020 at single dose for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. Medical history included ongoing asthenia, ongoing Parkinson''s disease and ongoing dementia with Lewy bodies. The patient experienced unresponsive to stimuli on 31Dec2020, death on 01Jan2021. The reporter described that this lady was extremely frail with a history of Parkinson''s and Lewy Body dementia. However, on the day that she received the injection she was not acutely unwell. The reporter visited her the following day (31Dec2020) and found her unresponsive and clearly dying. On examination she had no signs of sepsis, she had no fever, her chest was clear and she had no difficulty breathing. She died the next day 01Jan2021. This could simply be a coincidence of course but this was a sudden change after receiving the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 01Jan2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death; Unresponsive to stimuli


VAERS ID: 947363 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-22
Onset:2020-12-31
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0724-L456 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acidosis, Acute kidney injury, Blood creatine phosphokinase increased, Circulatory collapse, Death
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (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), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; ; ;
Current Illness: Chronic kidney disease stage 3; Diabetic (well controlled for 8 years)
Preexisting Conditions: Medical History/Concurrent Conditions: Gout
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: Creatine kinase; Result Unstructured Data: Test Result:significantly raised.; Test Date: 20201231; Test Name: Blood glucose; Result Unstructured Data: Test Result:43
CDC Split Type: GBPFIZER INC2021019684

Write-up: Death; Acidosis; Acute kidney injury; Blood creatine phosphokinase increased; Circulatory collapse; This is a spontaneous report from a contactable physician. This is a report received from the Pfizer from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-ADR 24563115. An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ0724-L456), via an unspecified route of administration on 22Dec2020, as single dose for covid-19 immunization. Medical history included ongoing chronic kidney disease, ongoing diabetes mellitus, well controlled for 8 year and gout from an unknown date. Concomitant medication included allopurinol (MANUFACTURER UNKNOWN) for gout, felodipine (MANUFACTURER UNKNOWN) for hypertension, metformin (MANUFACTURER UNKNOWN) for diabetes mellitus, ramipril (MANUFACTURER UNKNOWN) for hypertension, simvastatin (MANUFACTURER UNKNOWN) for diabetes mellitus. The patient experienced death on 31Dec2020 ( reported as diabetes mellitus inadequate control), acidosis on 31Dec2020, which was medically significant with outcome of not recovered; acute kidney injury on 31Dec2020, which was medically significant with outcome of not recovered; blood creatine phosphokinase increased on 31Dec2020, which was medically significant with outcome of not recovered; circulatory collapse on 31Dec2020, which was medically significant with outcome of not recovered. The events were acidosis, acute kidney injury, blood creatine phosphokinase increased and circulatory collapse were serious as they were medically significant. The patient underwent lab tests and procedures which included creatine kinase, which was significantly raised on 31Dec2020, and blood glucose was 43 on 31Dec2020. Details were as follows: Had vaccine on 22Dec2020. Attended A+E via ambulance after being found on floor 31Dec2020. The patient was found to have extremely high sugars (43) and was acidotic. Acute kidney injury and creatine kinase significantly raised were noted. The patient died on 31Dec2020. It was not reported if an autopsy was performed. Cause of death, was put down as diabetes, but the physician indicated concert as the patients diabetes had been well controlled for eight years. Obviously not an immediate reaction but concerned as to unexpected death. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in a clinical trial.; Reported Cause(s) of Death: Diabetes mellitus inadequate control; Diabetes mellitus


VAERS ID: 947365 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-21
Onset:2020-12-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRINE; ; ; ; ; ZOLADEX LA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Heart disease, unspecified
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021019671

Write-up: sudden death; This is a spontaneous report received from a contactable physician from the. The regulatory authority report number is GB-MHRA-WEBCOVID-20210106143746. A 90 years old male patient received BNT162B2 (Batch/lot number: EJ0553) on 21Dec2020 at single dose for COVID-19 immunization. Medical history was Chronic kidney disease, heart disease. Concomitant drug was acetylsalicylic acid (ASPIRINE) for Myocardial ischaemia, atorvastatin for Myocardial ischaemia, bisoprolol for Myocardial ischaemia, levothyroxine sodium for Hypothyroidism, ramipril for Hypertension, goserelin acetate (ZOLADEX LA) for Prostate cancer. No reaction noted but sudden death 3 days after vaccination (24Dec2020), although had history of heart disease. Cause of death not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Outcome of the event was fatal. Unknown whether autopsy done or not. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 947382 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2020-12-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553/V0001 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ; ; ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy; IHD
Allergies:
Diagnostic Lab Data: Test Date: 20201221; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021019867

Write-up: stroke; This is a spontaneous report from a contactable physician received by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 24566618 & GB-MHRA-WEBCOVID-20210107104558. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ0553/V0001), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. Relevant medical history included: ischemic heart disease (IHD) and arteriopathy. Patient has not had symptoms associated with COVID-19 and is not enrolled in clinical trial. Concomitant medications included: clopidogrel (MANUFACTURER UNKNOWN), taken for transient ischaemic attack (TIA) from Jul2012 to an unspecified date, furosemide (MANUFACTURER UNKNOWN) taken from Jul2012 to an unspecified date, lansoprazole (MANUFACTURER UNKNOWN), taken from Nov2012 to an unspecified date, nebivolol (MANUFACTURER UNKNOWN), taken for left ventricular dysfunction from 01Jul2014 to an unspecified date, ramipril (MANUFACTURER UNKNOWN), taken from 2012 to an unspecified date and simvastatin (MANUFACTURER UNKNOWN) taken for hypercholesteremia from Nov2012 to an unspecified date. The patient experienced stroke on 19Dec2020, which caused hospitalization. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 21Dec2020. The clinical outcome of stroke was fatal. The patient died of the stroke in the hospital on an unspecified date. An autopsy was not performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 947426 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-07
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart attack (at age 50)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021026804

Write-up: heart attack; This is a spontaneous report from a contactable consumer (relative). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included heart attack (at age 50) on an unspecified date. The patient''s concomitant medications were not reported. The patient experienced a heart attack on 07Jan2021, which was reported as fatal. The patient died of a heart attack about a week after the vaccine was given. The clinical outcome of heart attack was fatal. The patient died on 07Jan2021. The cause of death was reported as heart attack. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: heart attack


VAERS ID: 955204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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: calcium channel blocker
Current Illness:
Preexisting Conditions: Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Our friend passed away 6 days after receiving the first dose of the Pfizer vaccine. He experienced a general weakness on the evening prior to hid death.


VAERS ID: 952914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Discoloured vomit
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune encephalopathy (Especially autoimmune encephalopathy of paraneoplastic origin); Urothelial carcinoma bladder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021023705

Write-up: Death (death certificate: uncertain type of death); evening vomiting; This is a spontaneous report from a non-contactable physician the Regulatory Authority. This is a report received from the Regulatory Authority. Regulatory authority report number was DE-PEI-CADRPEI-2021011672. A 79-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EJ6796), intramuscular on 30Dec2020 as a single dose for COVID-19 immunization. Medical history included especially autoimmune encephalopathy of paraneoplastic origin and suspected urothelial carcinoma of the bladder. The patient''s concomitant medications were not reported. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) on 03Dec2020 for immunization and was tolerated. On 31Dec2020 (also reported as 30Dec2020), the patient developed evening vomiting which was dark in color and most likely food related. On 31Dec2020 at 04:35, the patient died. It was not reported if an autopsy was performed. The clinical outcome of vomiting was reported as fatal; however, the cause of death was reported as unknown cause of death. The vomiting and unknown cause of death were reported as medially significant and fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 953012 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Illness, Limb discomfort, Malaise, SARS-CoV-2 test negative, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   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: Claudication; Essential hypertension; Living in residential institution; Type 2 diabetes mellitus; Vascular dementia (Vascular dementia with frailty); Comments: Residential care home resident, Vascular dementia with frailty, 2006 Type 2 DM, 2006 Essentia hypertension, 2006 Claudication in legs Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021022839

Write-up: further sickness; vomited; felt unwell; Sudden death unexplained; slightly sore arm; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210108094947 & GB-MHRA-ADR 24571609. A 93-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included residential care home resident, vascular dementia with frailty, type 2 diabetes mellitus (DM) from 2006 to an unknown date, essential hypertension from 2006 to an unknown date, claudication in legs from 2006 to an unknown date. The patient''s concomitant medications were not reported. The patient had not had symptoms associated with COVID-19 and is not enrolled in a clinical trial. The patient experienced slightly sore arm on 05Jan2021, sudden death unexplained on 07Jan2021 and vomited and felt unwell on 07Jan2021 10:00 PM and further sickness on 07Jan2021 10:15 PM. The patient was entirely well after vaccine apart from a slightly sore arm that resolved. On 07Jan2021, 2 days after the vaccine administration, the patient vomited and felt unwell at 10:00 PM. Observation was stable, then further sickness at 10:15pm. Thereafter slumped to the side and died peacefully. There were no signs of other allergic reaction. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 06Jan2021. The outcome of sudden death unexplained was fatal, of slightly sore arm was recovered in Jan2021 and of vomited, felt unwell and further sickness was unknown. The patient died on 07Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 953036 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Consciousness decreased; Hypermobility syndrome; Pain NOS; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021004985

Write-up: Death; The initial case was missing the following minimum criteria: reporter with first-hand knowledge. Upon receipt of follow-up information on 14Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician downloaded from the regulatory authority. This is a report received from the regulatory authority. Regulatory authority report number was IS-IMA-1518. A 75-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EJ6796), via an unspecified route of administration on 29Dec2020 as a single dose for COVID-19 immunization. Medical history included hypermobility syndrome, consciousness decreased, pain, and Parkinson''s disease. The patient''s concomitant medications were not reported. On 01Jan2021, the patient died. The clinical course was as follows: The patient had impaired consciousness for a few days. On 29Dec2020 the patient was vaccinated with BNT162B2. On 31Dec2020 end-of-life care was initiated. The patient''s condition was worsening with hypermobility, dementia and pain (not otherwise specified). The patient had impaired consciousness for the past 6 days. The patient passed away on 01Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The physician did not consider that there was a reason to suspect a causal association between the death and the vaccination; however, in the light of the circumstances it was reported.; Sender''s Comments: The association between the event death with BNT162b2 can not be fully excluded based on the temporal relationship and the limited information 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: 953037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: ; VIT D; ; ; RISPERIDON KRKA; ACIDOPHILUS BIFIDUS; ; ; BETMIGA; SOBRIL; ; BETOLVEX [CYANOCOBALAMIN]; ; AMLODIPIN [AMLODIPINE]; VAGIFEM;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dementia; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021005061

Write-up: Death; The initial case was missing the following minimum criteria: (no first-hand knowledge). Upon receipt of follow-up information on (14Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician and healthcare professional. This is a report downloaded from the regulatory authority. The regulatory authority report number IS-IMA-1491. An 88-year-old female patient received BNT162B2 (COMIRNATY; Lot number EJ6796, Expiration date 30Apr2021), via an unspecified route of administration on 30Dec2020 as single dose for covid-19 immunization. Medical history included pneumonia, chronic obstructive pulmonary disease and dementia from an unknown date, and not ongoing. Concomitant medication included vitamin b complex (MANUFACTURER UNKNOWN), ergocalciferol (VIT D), enalapril (MANUFACTURER UNKNOWN), ciprofloxacin (MANUFACTURER UNKNOWN), risperidone (RISPERIDON KRKA) , bifidobacterium animalis, lactobacillus acidophilus (ACIDOPHILUS BIFIDUS), escitalopram (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), mirabegron (BETMIGA), oxazepam (SOBRIL) , quetiapine (MANUFACTURER UNKNOWN), cyanocobalamin (BETOLVEX [CYANOCOBALAMIN]), folic acid (MANUFACTURER UNKNOWN), amlodipine (AMLODIPIN), estradiol (VAGIFEM), vitamins nos (also reported as Vitaplus), Magical mouthwash, B-kombin, Progastro. The patient experienced worsening of condition on 31Dec2020, which was serious as it was life-threatening and had fatal outcome; the patient experienced death on 01Jan2021. The patient died on 01Jan2021. Details were as follows: patient was diagnosed with pneumonia 1.5 weeks prior to immunization with BNT162B2. The patients condition had deteriorated for the past days and weeks. The patient was vaccinated on 30Dec2020, and on 30Dec2020 . The patient condition continued to worsen. On 01Jan2021, the patient passed away. It was not reported if an autopsy was performed. Reporter''s comments: There is not an obvious causal association between the death and immunisation with Comirnaty due to worsening of the patients condition prior to immunisation.; Sender''s Comments: Based on the close temporal relationship, the association between the event death with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 953450 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2020-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021023631

Write-up: Exitus letalis; Influenza like illness; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) WEB (DE-PEI-CADRPEI-2020011585). A 93-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly, on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension arterial. The patient''s concomitant medications were not reported. The patient experienced influenza like illness and exitus letalis on 29Dec2020, which were reported as medically significant and fatal. It was reported that two days after vaccination, the patient developed influenza like illness (previously asymptomatic) and then found lifeless the following day (as reported). The clinical outcome of influenza like illness and exitus letalis was fatal. The patient died on 29Dec2020. The cause of death was influenza like illness (reported as unknown cause of death). It was unknown if an autopsy was performed. The causality assessment to both of the events was reported as unclassifiable by Regulatory Authority. No follow-up attempts possible; information about batch number cannot be obtained.; Reporter''s Comments: Previously asymptomatic, then found lifeless the following day.; Reported Cause(s) of Death: Influenza like illness


VAERS ID: 953452 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, Pulmonary embolism
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021023752

Write-up: Letal death; Asystolia; Pulmonary embolism; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) WEB (DE-PEI-PEI2021000071). An 82-year-old female patient received BNT162B2 (COMIRNATY; Lot number: EJ6797), intramuscularly from 30Dec2020 at 0.3 mL, single for COVID-19 immunization. Medical history included diabetes and hypertension. The patient''s concomitant medications were not reported. At the time of vaccination there was no evidence of decompensation of the underlying disease. The patient experienced letal death, asystolia and pulmonary embolism on 31Dec2020, which were reported as life-threatening and fatal. The outcome of letal death, asystolia and pulmonary embolism was fatal. The patient died on 31Dec2020. An autopsy was not performed. The causality assessment for the events, death, asystolia and pulmonary embolism to the suspect product was reported as inconsistent causal association.; Reported Cause(s) of Death: Asystolia; Pulmonary embolism; Letal death


VAERS ID: 953468 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2020-12-01
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-01
   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: Atrial fibrillation; Cataract extraction; Intraocular lens implant; Left inguinal hernia; Osteoarthritis knee (right knee); Polymyalgia rheumatica; Postoperative care (Postop wound management gen secondary care done by practice); Pressure sore; Prostate cancer; Radiofrequency ablation (Radiofrequency ablation of varicose vein of leg); Retention urine; Total hip replacement (Total prosthetic replacement of hip joint using cement - left.); Total knee replacement (Total prosthetic replacement of knee joint using cement - left.); Total knee replacement (Primary total knee replacement NEC); Transurethral prostatectomy (Bladder outlet and prostate operations); Ventricular tachycardia; Wound dressing
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021022507

Write-up: patient passed away 4 days after receiving vaccination, not known if related but patient was seen 2 days before at the surgery and was fit and well at that time. Death was unexpected.; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority, RA. Regulatory authority report number was GB-MHRA-ADR 24546873 with Safety Report Unique Identifier of GB-MHRA-EYC 00236252. A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ0553), intramuscular on 17Dec2020 as 0.3 ml single dose for COVID-19 immunisation. Medical history included cataract operation on 23Oct2020, intraocular lens implant on 23Oct2020, atrial fibrillation from 10May2018 and unknown if ongoing, ventricular tachycardia from 11Sep2003 and unknown if ongoing, polymyalgia rheumatica from 31Mar2008 and unknown if ongoing, total prosthetic replacement of left hip joint using cement on 24Feb2011, total prosthetic replacement of left knee joint using cement on 28Nov2011, osteoarthritis of right knee from 02Jul2012 and unknown if ongoing, prostate cancer from 28Feb2017 and unknown if ongoing, pressure sore from 01Sep2017 and unknown if ongoing, postoperative care from 10Jan2018 and unknown if ongoing, left inguinal hernia from 07Jun2017 and unknown if ongoing, urine retention from 11Nov2016 to 04Feb2017, transurethral prostatectomy from 17Feb2017 to 13May2017, total knee replacement on 26Oct2018 to 18Jan2019 (as reported), high frequency ablation from 03Jul2019 to 25Sep2019, and wound dressing from 03Jan2019 and unknown if ongoing. Concomitant medications included apixaban (MANUFACTURER UNKNOWN), paracetamol (MANUFACTURER UNKNOWN), propafenone (MANUFACTURER UNKNOWN), and zopiclone (MANUFACTURER UNKNOWN). The patient previously took codeine (MANUFACTURER UNKNOWN) from 29Oct2018 to an unknown date for an unknown indication and experienced adverse reaction. In Dec2020 (reported as 4 days after the vaccination), the patient passed away. It was not known if it was related to the vaccine but the patient was seen 2 days before at the surgery and was fit and well at that time. The death was unexpected. An autopsy was performed, and the results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 953471 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-20
Onset:2020-12-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Hypotension, Livedo reticularis, Loss of consciousness, Peripheral coldness, Respiratory rate increased
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; ; ; ; CO-CODAMOL; ; ; ; ; GLYCERYL TRIACETATE; ; LAXIDO; ; MICRALAX MACROGOL; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal abscess (Chronic); Aortic stenosis; Cervical myelopathy; Chronic kidney disease stage 3; Clammy (Started 2 days prior to vaccine); Dyspnoea (Started 2 days prior to vaccine); Essential hypertension; Feeling cold (Started 2 days prior to vaccine); Fracture of humerus (Closed fracture distal right humerus); Heart failure; Ischaemic foot (Critical left foot ischamia); Ischaemic heart disease; Lethargy (Started 2 days prior to vaccine); Lipodermatosclerosis; Mitral incompetence; Non STEMI (Acute); Peripheral vascular disease; Postmenopausal bleeding (Unidentified cause); Sweaty (Started 2 days prior to vaccine); Unwell (Started 2 days prior to vaccine); Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20201221; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1; Test Date: 20201221; Test Name: low blood pressure; Result Unstructured Data: Test Result:low; Test Date: 20201221; Test Name: respiratory rate; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC2021022784

Write-up: Death within 24 hours of vaccine; Livedo reticularis; Hypotension; Respiratory rate increased; Peripheral coldness; Loss of consciousness; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-EYC 00236256. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), subcutaneous on 20Dec2020 at first single dose for covid-19 immunization. Medical history included malaise from Dec2020, Started 2 days prior to vaccine; cold sweat from Dec2020, started 2 days prior to vaccine; dyspnoea from Dec2020, started 2 days prior to vaccine; feeling cold from Dec2020, started 2 days prior to vaccine; lethargy from Dec2020, started 2 days prior to vaccine; hyperhidrosis from Dec2020, started 2 days prior to vaccine, peripheral vascular disorder from 1982, peripheral ischaemia from 1982, Critical left foot ischemia; essential hypertension from 2003; myocardial ischaemia from 2005; Chronic kidney disease from 2006; myelopathy from 2007; Acute myocardial infarction in 2012; Mitral valve incompetence in 2012; Cardiac failure in 2013; Post thrombotic syndrome in 2015; Vascular dementia in 2017; Aortic stenosis in 2017; humerus fracture in 2019, Closed fracture distal right humerus; Postmenopausal haemorrhage 2019, unidentified cause; abdominal abscess in Jul2020, chronic, . Concomitant medication included acetylsalicylic acid (ASPIRIN), atorvastatin (MANUFACTURER UNKNOWN), bisoprolol fumarate (MANUFACTURER UNKNOWN), bumetanide (MANUFACTURER UNKNOWN), codeine phosphate, paracetamol (CO-CODAMOL) , colecalciferol (MANUFACTURER UNKNOWN), dimeticone (MANUFACTURER UNKNOWN), docusate sodium (MANUFACTURER UNKNOWN), doxycycline hyclate (MANUFACTURER UNKNOWN), glyceryl triacetate (MANUFACTURER UNKNOWN), isosorbide mononitrate (MANUFACTURER UNKNOWN), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO), melatonin (MANUFACTURER UNKNOWN), macrogol (MICRALAX MACROGOL), paracetamol (MANUFACTURER UNKNOWN), senna spp. (SENNA SPP.), tramadol hydrochloride (MANUFACTURER UNKNOWN). The patient previously took trimethoprim, penicillin and ace inhibitors and angiotensin ii receptor blockers and experienced adverse drug reaction, not specified. On 21Dec2020, the patient experienced death within 24 hours of vaccine, livedo reticularis, hypotension, respiratory rate increased, peripheral coldness, loss of consciousness. The events were serious as it lead to death. The patient underwent lab tests and procedures which included body temperature of 38.1 on 21Dec2020. The patient died on 21Dec2020. It was not reported if an autopsy was performed. Details were as follows: Death within 24 hours of first vaccination dose occured. Patient had been unwell two days prior to the vaccination. New onset dyspnoea at rest and lethargy were noted. No fever at that time was noted. Noted to be cold, clammy and sweaty and this persisted for the following two or three days. No doctor notified of these developments. Over the following two days patient remained in a similar condition. She remained cold, clammy and dyspnoeic. Few observations appear to have been taken over this time; I do not know if she was fevered at any point due to lack of data. She was administered her first Covid-19 vaccine dose on 20Dec2020. On the morning of 21Dec2020, she was found unrousable in bed. Paramedics were called. She was noted to be cold and mottled, temperature was 38.1, low blood pressure (BP) and high respiratory rate. She died a couple of hours later. The case was reported to the procurator fiscal (PF) as cause of death was unknown, and death happened within 24 hours of a new vaccine, also with some concerns over patient care after she became unwell, not notifying general practitioner (GP) of deterioration in health. Post mortem was agreed by PF, but date not known. The other outcome for death within 24 hours of first vaccination dose was not known (NK) if death caused by vaccine. The patient was unwell prior to the dose. Cause of death was reported as unknown. The reporter did not know if the Pfizer COVID-19 vaccine caused or accelerated or contributed to this patient''s death. The patient''s deterioration was not informed until after her death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 953488 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021023785

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number was GB-MHRA-ADR 24569457 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-20210107171332. An 80-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1688), via an unspecified route of administration on 06Jan2021 as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown if the patient had had symptoms associated with COVID-19. The patient was not enrolled in the clinical trial. Concomitant medications included edoxaban (MANUFACTURER UNKNOWN) taken for blood caffeine (as reported) from 06Dec2019 and unknown if ongoing. The patient previously received the first dose of BNT162B2 on an unknown date for COVID-19 immunization and had no known adverse effects. On 07Jan2021, the patient died due to an unknown cause of death. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 953501 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-16
Onset:2020-12-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, Fall
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), Accidents and injuries (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ISTIN; ; ;
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021023371

Write-up: cardiac arrest; suddenly went funny colour, odd noise, and fell back in chair; suddenly went funny colour, odd noise, and fell back in chair; Death; This is a spontaneous report received from a contactable physician from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210109135858 and GB-MHRA-ADR 24575544. An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ0553), via an unspecified route of administration, on 16Dec2020 at a single dose for COVID-19 vaccination. The patient''s medical history was not reported. Concomitant medications included amlodipine besilate (ISTIN), propranolol (MANUFACTURER UNKNOWN) taken for anxiety from 17Dec2020, levothyroxine (MANUFACTURER UNKNOWN), and ramipril (MANUFACTURER UNKNOWN). The patient previously received the influenza vaccine (reported as flu vaccine; MANUFACTURER UNKNOWN) for immunization on 07Oct2020. The patient suddenly went funny colour, odd noise, and fell back in chair and experienced cardiac arrest on an unspecified date. The patient experienced death on 21Dec2020, which was reported as fatal. The clinical course was reported as follows: The patient was well and suddenly went funny colour, odd noise, and fell back in chair. The emergency services were called and taken in cardiac arrest. The patient died in the emergency department. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The clinical outcome of suddenly went funny colour, odd noise, and fell back in chair was unknown and of cardiac arrest and death was fatal. The patient died on 21Dec2020. The cause of death was reported as cardiac arrest. It was unknown if an autopsy was performed. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 953522 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ELO141/V1009 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; FERROUS SULPHATE [FERROUS SULFATE]; HUMAN INSULATARD; ; ; NOVORAPID; ; ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Amputation; Chronic obstructive pulmonary disease; Chronic osteomyelitis involving lower leg; Diabetic neuropathy; Living in nursing home; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021024072

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 24584912. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ELO141/V1009), via an unspecified route of administration on 08Jan2021 as single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, chronic osteomyelitis, diabetic neuropathy, amputation, alcohol misuse, chronic obstructive pulmonary disease, patient cared for in nursing home- self neglect, all from an unknown date. Concomitant medication included duloxetine (MANUFACTURER UNKNOWN) from 10Oct2019 for diabetic neuropathy, ferrous sulphate (MANUFACTURER UNKNOWN) from 24Jun2020 for Iron deficiency anemia, insulin human injection, isophane (HUMAN INSULATARD) from 16Mar2020 for type II diabetes mellitus, lansoprazole (MANUFACTURER UNKNOWN) from 16Oct2013 for dyspepsia, macrogol (MANUFACTURER UNKNOWN) from 01Jul2020 to 22Oct2020 for constipation, insulin aspart (NOVORAPID) from 16Oct2020 for type II diabetes mellitus, paracetamol (MANUFACTURER UNKNOWN) for chronic osteomyelitis (involving lower leg) from 11Sep2013, pregabalin (MANUFACTURER UNKNOWN) from 24Jun2020 for chronic osteomyelitis, tadalafil (MANUFACTURER UNKNOWN) from 19Nov2013 to 20Jul2020 for erectile dysfunction, thiamine (MANUFACTURER UNKNOWN) from 26Sep2019 for alcohol problem, tramadol (MANUFACTURER UNKNOWN) from 22Jul2011 for chronic osteomyelitis (involving lower leg). The patient died on 12Jan2021. Patient died of unknown causes about 84hrs after 1st Covid-19 vaccination. Nil to suggest that this was directly related to vaccine but as it was unknown cause of death and not expected, then it is considered significant adverse event. Patient had not tested positive for COVID-19 since he received the vaccine. Post-Mortem details were pending. The patient underwent lab tests which included COVID-19 virus test that was negative on 10Jan2021. The patient died on 12Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 953527 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-22
Onset:2021-01-12
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0724 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute cardiac event, Death, Electrocardiogram, Electrocardiogram ST segment abnormal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; ; ; ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm repair; Coronary artery bypass graft; Depression (under mental health secondary care/consultant led service); Micturition urgency; Myocardial ischaemia; Comments: under mental health secondary care/consultant led service Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210112; Test Name: ECG; Result Unstructured Data: Test Result:significant ST changes in keeping with acute; Comments: significant ST changes in keeping with acute cardiac event
CDC Split Type: GBPFIZER INC2021024582

Write-up: Death NOS; significant ST changes in keeping with acute cardiac event; Sudden collapse; significant ST changes in keeping with acute cardiac event; This is a spontaneous report received from a contactable physician by Pfizer from the Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210112181704. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ0724), via an unspeciifed route of administration on 22Dec2020 at sigle dose for COVID-19 immunisation. Medical history included myocardial ischaemia, coronary artery bypass graft (CABG), abdominal aortic aneurysm (AAA) repair, micturition urgency and depression (under mental health secondary care/consultant led service). Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included acetylsalicylic acid for myocardial ischaemia, lansoprazole for unknown indication, mirabegron for micturition urgency, olanzapine for depression, pregabalin for depression, INFLUENZA VACCINE on 23Sep2020 for immunisation, simvastatin for myocardial ischaemia, tamsulosin for micturition urgency and venlafaxine for depression. The patient experienced death NOS on 12Jan2021. It was reported: patient has past history of ischaemia heart disease (IHD) - previous CABG and AAA repair. Also has significant psychiatric history and remains under consultant led service (previously was detained Agency S3). Sudden collapse this evening (12Jan2021) and Ambulance led resuscitation unsuccessful. During resuscitation regained cardiac output briefly and ECG at that time (12Jan2021) by ambulance crew showed significant ST changes in keeping with acute cardiac event. Patient has been breathless for last 1w. Received Pfizer covid vaccine 22Dec2020 so reported due to proximity of this novel treatment to event rather than definite causation or effect. the reporter noted that they were the OOH GP who has dealt with this patient and Ambulance on the evening and had no other involvement. More information will be available from patient''s registered GP. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events sudden collapse and significant ST changes in keeping with acute cardiac event was unknown. The patient died on 12Jan2021. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 953532 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 2021-01-10
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021027103

Write-up: cardiac arrest; This is a spontaneous report from a contactable consumer. An about 45 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 evening, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was without background illnesses. On 10Jan2021 the patient experienced cardiac arrest and deceased. The patient died in the night of 10-11Jan2021. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 955741 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Depressed level of consciousness, Diarrhoea, Dyspnoea, Gene mutation identification test, Influenza like illness, Malaise, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   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: EMCONCOR CHF; ELIQUIS; SPIRIX; TRIATEC [RAMIPRIL]; SOMAC; BURINEX; SELEXID [PIVMECILLINAM HYDROCHLORIDE]; DOLCONTIN [MORPHINE SULFATE]; PARACET [PARACETAMOL]; ZYPREXA; XALATAN; BETULAC;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antidiuretic hormone increased; Anxiety; Aortic stenosis; Atelectasis; Atrial fibrillation; Cardiac pacemaker insertion; Cerebral ischemia; Cognitive impairment; Dementia; Dilated cardiomyopathy; Gastric acid increased; Glaucoma secondary; Heart attack; Heart failure; Obstipation; Oedema; Osteopetrosis; Pain; Pain back; Palliative care; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Name: Gene mutation identification test; Result Unstructured Data: Test Result:Heterozygot: R 33 Q in LMNA
CDC Split Type: NOPFIZER INC2021006702

Write-up: Vomiting; Increased shortness of breath; Short episodes of decreased consciousness after toilet visits; Diarrhea; felt unwell, the patient herself says that it feels like the flu; felt unwell, the patient herself says that it feels like the flu; The initial case was missing the following minimum criteria: reporter had no first hand knowledge. Upon receipt of follow-up information on 14Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report downloaded from the Regulatory Authority WEB NO-NOMAADVRE-FHI-2021-U427R, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013732. A contactable other health professional reported that an 81-year-old female patient received her first dose of bnt162b2 (COMIRNATY, batch/lot number: EJ6796), via intramuscular route on 29Dec2020, at single dose administered into left arm for covid-19 immunisation. Medical history included heart attack, cerebral ischaemia from 2017, aortic stenosis, atelectasis, osteopetrosis, antidiuretic hormone increased, urinary tract infection from 26Dec2020, dilated cardiomyopathy, palliative care, atrial fibrillation, heart failure, gastric acid increased, oedema, pain, pain back, anxiety, glaucoma secondary, obstipation, pacemaker in 2017, increased cognitive impairment and possibly dementia. Concomitant medication included bisoprolol fumarate (EMCONCOR CHF) for an unspecified indication, apixaban (ELIQUIS) for atrial fibrilation, spironolactone (SPIRIX) for heart failure, ramipril (TRIATEC) for heart failure, pantoprazole sodium sesquihydrate (SOMAC) for gastric acid increased, bumetanide (BURINEX) for heart failure and oedema, pivmecillinam hydrochloride (SELEXID) for urinary tract infection, morphine sulfate (DOLCONTIN) for pain, paracetamol (PARACET) for pain back, olanzapine (ZYPREXA) for anxiety, latanoprost (XALATAN) for glaucoma secondary, lactulose (BETULAC) for obstipation and selenium oxide (SELENIUM OXIDE) for urinary tract infection. The patient experienced vomiting, increased shortness of breath, short episodes of decreased consciousness after toilet visits, diarrhea and felt unwell, the patient herself says that it feels like the flu; all on 02Jan2021 and died on the same day. The patient underwent lab tests and procedures which included gene mutation identification test: positive - heterozygot: R 33 Q in LMNA on an unspecified date. It was not reported if an autopsy was performed. The Center assessed the causality between bnt162b2 and all events as Possible. Outcome of the events was fatal. Reporter Comment: Regulatory Authority has requested additional information. This is a preliminary report. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: NIPH has requested additional information. This is a preliminary report.; Reported Cause(s) of Death: Increased shortness of breath; Short episodes of decreased consciousness after toilet visits; Diarrhea; felt unwell, the patient herself says that it feels like the flu; felt unwell, the patient herself says that it feels like the flu; Vomiting


VAERS ID: 955746 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2020-12-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood albumin, Blood creatinine, Blood potassium, Blood pressure diastolic decreased, Blood pressure measurement, Body temperature, Body temperature decreased, Brain natriuretic peptide, C-reactive protein, Confusional state, General physical health deterioration, Glomerular filtration rate, Heart rate, Oxygen saturation, Physical examination, SARS-CoV-2 test, Urine analysis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BURINEX; LOSARTAN KRKA [LOSARTAN]; BETULAC; NYCOPLUS B TOTAL; ; ATROVENT; ZOPIKLON MYLAN; METOPROLOL SANDOZ [METOPROLOL SUCCINATE]; PARALGIN FORTE [CODEINE PHOSPHATE;PARACETAMOL]; CIRCADIN; SOBRIL; VENTOLIN; SOMAC
Current Illness: Atrial fibrillation; Dyspnoea; Hypertension; Mitral valve insufficiency; Polymyalgia rheumatica
Preexisting Conditions: Medical History/Concurrent Conditions: Agitation; Decompensated heart failure; Obstipation; Oedema; Pneumonia; Sleep disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210101; Test Name: Serum albumin; Result Unstructured Data: Test Result:34 g/l; Test Date: 20210101; Test Name: Serum creatinine; Result Unstructured Data: Test Result:303 umol/l; Test Date: 20210101; Test Name: Serum potassium; Result Unstructured Data: Test Result:5.1 mmol/L; Test Date: 20210101; Test Name: Blood pressure; Result Unstructured Data: Test Result:96/55 mmHg; Test Date: 20210101; Test Name: Body temperature; Result Unstructured Data: Test Result:33.1 Centigrade; Test Date: 20210101; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:30345 ng/L; Test Date: 20210101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30 mg/l; Test Date: 20210101; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:11 ml/min; Comments: additional information provided for unit: {1.73_m2} (mL/min/{1.73_m2}); Test Date: 20210101; Test Name: Pulse rate; Result Unstructured Data: Test Result:irregular; 64 bpm; Test Date: 20210101; Test Name: Oxygen saturation; Test Result: 90 %; Test Date: 20210101; Test Name: Physical examination; Result Unstructured Data: Test Result:oedema; Comments: Pitting oedema legs; pulmonary sound reduced; reduced general condition; afebrile; Test Date: 20210101; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210101; Test Name: Urine analysis; Result Unstructured Data: Test Result:No findings; Test Date: 20210101; Test Name: Leukocyte count; Result Unstructured Data: Test Result:7.8 x10 9/l
CDC Split Type: NOPFIZER INC2021006701

Write-up: ACUTE RENAL FAILURE; body temperature: 33.1 centigrade; blood pressure: 96/55 mmhg; CONFUSION; REDUCED GENERAL CONDITION; The initial case was missing the following minimum criteria: reporter had no first-hand knowledge. Upon receipt of follow-up information on 15Jan2021, this case now contains all required information to be considered valid. This is a spontaneous follow up report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-UGYJ2 Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013718. A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number and expiration date unknown), intramuscular on 28Dec2020, at single dose for covid-19 immunisation. The patient also received salbutamol (VENTOLINE) at 5 mg (x 4 as needed) for dyspnea and pantoprazole sodium sesquihydrate (SOMAC, 20 mg) at 20 mg, once per day for gastric ulcer prophylaxis. Medical history included ongoing mitral valve insufficiency, pneumonia from Feb2020 to an unknown date, ongoing polymyalgia rheumatica, decompensated heart failure from Jan2019 to an unknown date, ongoing hypertension, ongoing atrial fibrillation, and oedema, obstipation, ongoing dyspnea, sleep disorder and agitation. Concomitant medication included bumetanide (BURINEX) for oedema, losartan (LOSARTAN KRKA) for hypertension, lactulose (BETULAC) for obstipation, calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (NYCOPLUS B-TOTAL), reported as "Biotin 30 ug, Folic acid 200 ug, Niacin 20 mg, Pantotensyre 5 mg, Riboflavin 1.7 mg, Tiamin 1.5 mg, Vitamin B6 1.6 mg, Vitamin B12 2 ug (Nycoplus B-kompleks)" for Vitamin supplementation, paracetamol for pain relief, ipratropium bromide (ATROVENT) for dyspnoea, zopiclone (ZOPIKLON MYLAN) for sleep disorder, metoprolol succinate (METOPROLOL SANDOZ) for atrial fibrillation, codeine phosphate, paracetamol (PARALGIN FORTE) for pain relief, melatonin (CIRCADIN) for sleep disorder, oxazepam (SOBRIL) for agitation. The patient experienced acute renal failure on 30Dec2020 and required hospitalization on an unspecified date. The patient experienced confusion and reduced general condition on 30Dec2020. The patient died on 02Jan2021 due to acute renal failure, confusion and reduced general condition. The patient underwent lab tests and procedures on 01Jan2021 which included serum albumin: 34 g/l, blood creatinine: 303 umol/l, serum potassium: 5.1 mmol/l, blood pressure: 96/55 mmHg, body temperature: 33.1 centigrade, brain natriuretic peptide: 30345 ng/l, C-reactive protein: 30 mg/l, estimated glomerular filtration rate: 11 ml/min, additional information provided for unit: {1.73_m2} (mL/min/{1.73_m2}), heart rate: irregular; 64 bpm, oxygen saturation: 90 %, physical examination: Pitting oedema legs; pulmonary sound reduced; reduced general condition; afebrile, COVID-19 virus test: negative, urine analysis: no findings, leukocyte count: 7.8 x10 9/l. The patient died on 02Jan2021 due to acute renal failure, confusion and reduced general condition. An autopsy was not performed. The outcome of the rest events was unknown. Event assessment for COMIRNATY, VENTOLINE and SOMAC to Confusion, Acute renal failure, and Reduced general condition: possible (Regional Pharmacovigilance Center). Reported case narrative from Regional Pharmacovigilance Center: 95 year old female with numerous co-morbidities. Post-vaccination reduced general condition. Hospitalized 4 days after immunisation with Comirnaty with acute renal failure, serum creatinine levels $g 300. History of low-grade renal impairment, with habitual creatinine approx 70. No signs of infection. General condition deteriorated quickly, died the following day, 5 days after immunisation. Sender comment: The patient was a female in her 90''s with comorbidity in the form of amongst other hypertension, atrial fibrillation and heart failure. From previously, known reduced kidney function (creatinine around 70). Was admitted to the hospital with acute kidney failure, 4 days after vaccination with Comirnaty. No sign of infection. Rapid deterioation of the condition and the patient died the day after admittance to the hospital. The patient is assessed as having a high risk of developing kidney failure in the first place. When vaccinating marginal, older patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccination could have contributed to worsening of the patients underlying disease. In the individual case it is hard to know if the death was caused by the vaccination, the patient''s underlying disease or some other, coincidential, concurrent cause which does not have any relationship to the vaccination. The causality is assessed as possible - due to the concurrence in timing, and a causal relationship to the vaccination cannot be ruled out. No follow-up attempts are possible, information about batch number cannot be obtained.; Reporter''s Comments: 08Jan2021: Agency: this is a preliminary report; Reported Cause(s) of Death: Acute renal failure; confusion; reduced general condition


VAERS ID: 955787 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2020-12-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-30
   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: Medical History/Concurrent Conditions: Chronic disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021028577

Write-up: The patient died on 30Dec2020 with multiple, serious, chronic illnesses. Suspected reaction to Covid vaccination on 27Dec2020 cannot be ruled out.; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority WEB DE-PEI-CADRPEI-2021011745. An 89-year-old male patient received bnt162b2 (COMIRNATY, batch/lot number: EJ6796, exp. date unknown), intramuscularly on 27Dec2020 at single dose for prophylaxis. The patient''s medical history included several multiple chronic diseases. The patient''s concomitant medications were not reported. The patient died on 30Dec2020 with multiple serious chronic illnesses, suspected reaction to COVID vaccination on 27Dec2020 cannot be ruled out. The patient died on 30Dec2020. It was not reported if an autopsy was performed. The patient suffered of several multiple chronic diseases. 4 days after vaccination the patient developed unknown cause of death. Death cause was reported as unknown cause of death. Reporters comment: After the vaccination on 27Dec2020, the patient''s condition deteriorated increasingly until he died on 30Dec2020. It cannot be ruled out with certainty that the previous vaccination had a negative effect on the patient''s condition. Senders comment: Multiple serious, chronic diseases No follow-up attempts possible. No further information expected.; Reporter''s Comments: After the vaccination on 27Dec2020, the patient''s condition deteriorated increasingly until he died on 30Dec2020. It cannot be ruled out with certainty that the previous vaccination had a negative effect on the patient''s condition.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 955789 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-13
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial; Atrial fibrillation; Carcinoma colon; Hypertension; Iron deficiency anaemia; Osteoporosis; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039284

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority report number DE-PEI-PEI2021000724. A 99-year-old female patient started to receive bnt162b2 (COMIRNATY, batch/lot number EM0477, expiration date unknown) via an unspecified route of administration on "14Jan2021" at single dose for COVID-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, iron deficiency anaemia from an unknown date and unknown if ongoing, asthma bronchial from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, type 2 diabetes mellitus from an unknown date and unknown if ongoing, Carcinoma colon from an unknown date and unknown if ongoing, osteoporosis from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 13Jan2021 after vaccination the patient developed Unknown cause of death. Vaccinated in the morning, died in the afternoon. No complaints immediately after the vaccination. It was not reported if an autopsy was performed. Event Assessment: Agency / D. Unclassifiable.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 955790 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
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: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021032465

Write-up: died apprioximately one hour later; This is a spontaneous report from a non-contactable other healthcare professional (HCP) from a lay media. An 89-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jan2021 at 12:00 at single dose for Covid-19 immunisation. The relevant medical history and concomitant medications were not reported. Afterwards she was for 15 minutes under medical observation. At that time there were no visible allergy-typical symptoms. The patient was generally fit and at the timepoint of the vaccination well oriented. At 12:45 a situation took place that the patient must be resuscitated. However, she died apprioximately one hour later on 13Jan2021. Autopsy was ordered. The outcome of the event was fatal. Information on the lot/ batch number has been requested.; Sender''s Comments: Current information is very limited for full assessment. The advanced old patient died one hour following the vaccine use; further information such as complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation. 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: 955791 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2020-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Culture, Cytology abnormal, Echocardiogram, Investigation, Magnetic resonance imaging, Pulmonary function test, SARS-CoV-2 test, Sleep study, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]; COLCHIMAX [COLCHICINE;DICYCLOVERINE HYDROCHLORIDE]; ABASAGLAR; ; ; SPIRIVA RESPIMAT
Current Illness: Atrial fibrillation; Chronic myelomonocytic leukaemia (chronic myelomonocytic leukemia diagnosed in May 2019 under regular treatment with EPO); Dyslipidaemia; Hypertension (HTN); Morbid obesity; Obstructive sleep apnoea syndrome; Pericardial effusion (Recent admission 11Nov2020 to 23Nov2020, signs of tamponade that requires pericardiocentesis.); Sleep apnoea syndrome (in treatment with CPAP (Continuous positive airway pressure therapy)); Type 2 diabetes mellitus (insulin-dependent diabetes mellitus/grade II diabetic retinopathy)
Preexisting Conditions: Medical History/Concurrent Conditions: Activities of daily living impaired; Anticoagulant therapy; Arrhythmia (due to atrial fibrillation); Arthralgia (on 24Dec2020, paracetamol was prescribed); Arthralgia (MRI shows complete supraspinatus and partial subscapularis rupture); Chronic bronchitis; Depression (Long-term depression, chronic depressive syndrome); Diarrhea (compatible with ulcerative colitis due to diarrheal syndrome without specific treatment or follow-up); Drug allergy; Hospitalization (for severe pericardial effusion with signs of tamponade that requires pericardiocentesis.); Mild mental retardation; Polymyalgia rheumatica (intermediate dose corticosteroid therapy was started with partial response.); Restrictive pulmonary disease; Ulcerative colitis (compatible with ulcerative colitis due to diarrheal syndrome without specific treatment or follow-up)
Allergies:
Diagnostic Lab Data: Test Name: Thoracoabdominal CT; Result Unstructured Data: Test Result:without significant alterations, nonspecific tumor; Comments: without significant alterations, nonspecific tumor markers, autoimmunity and pending serologies.; Test Name: culture; Test Result: Negative ; Test Name: cytology for malignant cells; Test Result: Negative ; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Echocardiogram to control mild residual pericardia; Comments: Echocardiogram to control mild residual pericardial effusion.; Test Date: 2019; Test Name: Autoimmune study; Test Result: Negative ; Comments: negative in 2019 in treatment with colchicine.; Test Date: 2012; Test Name: MRI; Result Unstructured Data: Test Result:complete supraspinatus and partial subsc; Comments: MRI shows complete supraspinatus and partial subscapularis rupture; Test Name: bronchodilator test; Test Result: Negative ; Test Date: 202011; Test Name: PCR COVID19; Test Result: Negative ; Test Date: 201909; Test Name: respiratory polygraphy; Result Unstructured Data: Test Result:respiratory polygraphy in September 2019 with an A; Comments: respiratory polygraphy in September 2019 with an AHI (apnea-hypopnea index) 47. CT90 (sleep time with saturation lower than 90%) 59%, SpO2m 89% and compatible pulse oximetry recording.
CDC Split Type: ESPFIZER INC2021028328

Write-up: sudden death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority EB, ES-AEMPS-710884. A 71-year-old female patient received her first dose of bnt162b2 (COMIRNATY, lot number: EJ6796), via intramuscular on 27Dec2020 at single dose in deltoids for covid-19 vaccination. Medical history included obstructive sleep apnoea syndrome from 2019 and ongoing, hypertension from 2004 and ongoing, type 2 diabetes mellitus from 2004 and ongoing, ongoing dyslipidaemia, pericardial effusion from 2014 and ongoing, atrial fibrillation from 2019 and ongoing, morbid obesity from 2013 and ongoing, chronic myelomonocytic leukaemia from May2019 and ongoing. Pathological history included NSAID allergy, mild mental retardation, moderate functional dependence. In 2003 diagnosis compatible with ulcerative colitis due to diarrheal syndrome without specific treatment or follow-up. Right subacromial syndrome 2012 (MRI shows complete supraspinatus and partial subscapularis rupture), insulin-dependent diabetes mellitus, grade II diabetic retinopathy, HTN, Long-term depression, chronic depressive syndrome, chronic bronchitis, chronic myelomonocytic leukemia diagnosed in May2019 under regular treatment with EPO (Erythropoietin). Previous Complete arrhythmia due to atrial fibrillation, anticoagulated with acenocoumarol. Restrictive lung disease since 2018. Negative bronchodilator test. Severe OSAHS (sleep apnea-hypopnea syndrome in treatment with CPAP (Continuous positive airway pressure therapy): respiratory polygraphy in Sep2019 with an AHI (apnea-hypopnea index) 47, CT90 (sleep time with saturation lower than 90%) 59%, SpO2m 89% and compatible pulse oximetry recording. Labeled polymyalgia rheumatica 2018 without meeting criteria and intermediate dose corticosteroid therapy was started with partial response in outpatient follow-up. Chronic pericardial effusion known since 2014. Autoimmune study negative in 2019 in treatment with colchicine. Recent admission 11Nov2020 to 23Nov2020 for severe pericardial effusion with signs of tamponade that requires pericardiocentesis. Negative cytology for malignant cells, negative culture. Colchicine is introduced. Favorable subsequent evolution. Thoracoabdominal CT without significant alterations, nonspecific tumor markers, autoimmunity and pending serologies. Echocardiogram to control mild residual pericardial effusion. Outpatient monitoring. During admission, a COVID19 PCR was performed with a negative result (Nov2020). The patient previously received regular chronic treatment included folic acid (ACFOL), spironolactone (ALDACTONE), bisoprolol, furosemide (SEGURIL), ipratropium bromide (ATROVENT), tiotropium bromide (SPIRIVA), apixaban (ELIQUIS), metformin, pravastatin, quetiapine, venlafaxine, lorazepam. Concomitant medication included beclometasone dipropionate, formoterol fumarate (FOSTER) for bronchitis chronic from 2018, colchicine, dicycloverine hydrochloride (COLCHIMAX) for pericardial effusion from Nov2020, insulin glargine (ABASAGLAR) from 2018 for Type 2 diabetes mellitus, quetiapine from 2016 for major depression, venlafaxine from 2016 for Major depression, tiotropium bromide (SPIRIVA RESPIMAT) from 2018 for Bronchitis chronic. This patient with multiple pathologies admitted to a senior residence and experienced sudden death less than 24 hours after receiving COVID19 vaccine. According to the clinical course of the residence, on 24Dec2020 she was seen by the physician of the residence for left subacromial syndrome and paracetamol was prescribed. On 26Dec2020 in the morning she experienced nausea and malaise resolved and later reappeared again the next day in the morning (27Dec2020), so she did not eat breakfast. She remained afebrile the whole time. They explain that on 27Dec2020 in the afternoon she presented a better general condition and that she was walking around the residence, in the afternoon she was vaccinated. She didn''t want to have dinner. On 28Dec2020 in the morning the patient was found without signs of life in the bed of her room at the residence. Given that the causes of death are not obvious, it was decided to perform a clinical autopsy (performed 29Dec2020) to rule out a relationship with COVID19 vaccination. The patient died on 28Dec2020. Results of the clinical autopsy performed on 29Dec2020 are pending. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 955792 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-22
Onset:2020-12-01
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Angioedema, Blood culture, Coma scale abnormal, Depressed level of consciousness, Dyspnoea, Hypotension, Hypothermia, Malaise, Multiple organ dysfunction syndrome, Oxygen saturation decreased, Pruritus, Rash, Rash maculo-papular, Skin exfoliation, Stevens-Johnson syndrome, Swelling face, Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-29
   Days after onset: 28
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: Eczema; Fruit allergy
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Test Result: Negative
CDC Split Type: GBPFIZER INC2021028075

Write-up: Angioedema; Depressed level of consciousness; Toxic epidermal necrolysis; Oxygen saturation decreased; Hypotension; Skin exfoliation; Coma scale abnormal; Rash maculo-papular; Hypothermia; Pruritus; Rash; Swelling face; shortness of breath; felt a bit unwell; Possible anaphylaxis; Multi-organ failure; Steven Johnson syndrome; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB GB-MHRA-ADR 24566668. An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unknown route on 22Dec2020 at single dose for covid-19 vaccination. Medical history included food allergy: pineapple from an unknown date and unknown if ongoing, and eczema. The patient''s concomitant medications were not reported. The patient experienced swelling face on 25Dec2020, angioedema, depressed level of consciousness, rash maculo-papular, hypotension, hypothermia, pruritus, oxygen saturation decreased, rash, skin exfoliation, coma scale abnormal, toxic epidermal necrolysis on 28Dec2020. All these events were reported as serous per death and hospitalization. Outcome was reported as fatal. The patient also experienced Multi-organ failure, possible anaphylaxis, Steven Johnson syndrome on an unspecified date in Dec2020, felt a bit unwell on 25Dec2020, shortness of breath on 27Dec2020. Seriousness for these events was not provided. Outcome of these events was not provided. The patient died on 29Dec2020. An autopsy was not performed. Medical cause of death was reported as toxic epidermal necrolysis and multi-organ failure. Event details: Family noted on Christmas day he had dinner with them all and noticed his face was swollen and he felt a bit unwell. Possible anaphylaxis, Steven Johnson syndrome as a result of covid-19 vaccination. Patient presented 5 days post COVID-19 vaccine with shortness of breath. On Examination: peeling skin and widespread macula-papular rash and brown scaling over scalp, angiodema, itchy, reduced conciousness, desaturating, hypothermia and hypotensive. Multi-organ failure. Administered hydrocortisone IV (intravenous) and 2 x 0.5mL of adrenaline + fluids - some improvement in GCS (Glasgow coma scale) but not fully rousable onward - decision was made to place on ICP (integrated care pathway). Blood cultures negative. No follow-up attempts are possible, information on batch numbers cannot be obtained.; Reported Cause(s) of Death: multi-organ failure; Toxic epidermal necrolysis


VAERS ID: 955793 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0379 / 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: 2021-01-14
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021033850

Write-up: Cardiac arrest; This is a spontaneous report received from a contactable other HCP by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 24593178. A 53-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0379, Expiry date: Apr2021, use by 16Jan2021, 09:50), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. The patient had no known previous medical history. Concomitant medications were not reported. On 14Jan2021, the patient experienced cardiac arrest. It was reported patient who was a social worker, attended a medical practice this morning at 09:32 and received 1st Pfizer vaccination. This was the 3rd dose of the batch. She was apyrexial, and no issues in the immediate 15 minutes observation. It had been notified that this patient collapsed this afternoon with a cardiac arrest and had died. Outcome of event was fatal. The patient died on 14Jan2021. It was not reported if an autopsy was performed. The cause of death was cardiac arrest. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 955794 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: 20201227; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021038747

Write-up: Death within 28 days of vaccination; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-ADR 24595279. A 94 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EJ1688), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. On 01Jan2021 the patient experienced death within 28 days of vaccination. The patient died on 01Jan2021. The cause of death was not reported. It was unknown if an autopsy was performed. The patient underwent lab tests and procedures which included COVID-19 virus test on 27Dec2020: no - negative covid-19 test. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 955796 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Cardiac arrest, Cough, Electrocardiogram, Heart rate, Monofilament pressure perception test, Syncope, Ultrasound scan, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

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: Age-related macular degeneration (Also reported on 03Dec2020 and 08Dec2020); Chronic kidney disease stage 3 (Also reported on 03Dec2020.); Chronic kidney disease stage 4; Diabetes mellitus (In remission.); Diabetic foot (Left and right. At low risk. Also on 11Sep2020); Ex-smoker (10-19/day); Hypertension (Also reported on 03Dec2020.); Medical observation (Weight and height. Also on 11Sep2020.); Social alcohol drinker (Trivial drinker - <1u/day)
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspnoea
Allergies:
Diagnostic Lab Data: Test Date: 20200214; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:unknown results; Comments: ongoing; Test Date: 20200629; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:unknown results; Test Date: 20200715; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:unknown results; Test Date: 20200911; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:unknown results; Test Date: 20201203; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:unknown results; Test Date: 20200214; Test Name: Blood test; Result Unstructured Data: Test Result:All component measured and reported.; Comments: ongoing; Test Date: 20200710; Test Name: Blood test; Result Unstructured Data: Test Result:All component measured and reported; Test Date: 20200911; Test Name: Blood test; Result Unstructured Data: Test Result:All component measured and reported.; Test Date: 20200703; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:unknown results; Comments: ongoing; Test Date: 20200214; Test Name: HEART RATE; Result Unstructured Data: Test Result:normal; Comments: Left and right posterior tibial pulse and dorsalis pedis palpable, ongoing; Test Date: 20200911; Test Name: HEART RATE; Result Unstructured Data: Test Result:normal; Comments: Left and right posterior tibial pulse and dorsalis pedis palpable; Test Date: 20200214; Test Name: monofilament pressure perception test; Result Unstructured Data: Test Result:Left foot normal.; Comments: ongoing; Test Date: 20200911; Test Name: monofilament pressure perception test; Result Unstructured Data: Test Result:Left foot normal.; Test Date: 20200803; Test Name: Ultrasound scan of heart; Result Unstructured Data: Test Result:unknown results; Comments: ongoing; Test Date: 20200911; Test Name: Urine analysis; Result Unstructured Data: Test Result:All components measured and reported; Comments: ongoing
CDC Split Type: GBPFIZER INC2021033407

Write-up: Cardiac arrest; Cough; Syncope; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is: GB-MHRA-ADR 24588335. An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EK1768, Concentrate for suspension for injection multi, expiry date: 11Jan2021) via intramuscular route of administration on 08Jan2021 at 0.3 mL, single for COVID-19 vaccination. Ongoing medical history included hypertension from 08Oct2020 (patient medical comments: also reported on 03Dec2020), chronic kidney disease stage 3 from 08Oct2020 (patient medical comments: also reported on 03Dec2020), age-related macular degeneration from 08Oct2020 (patient medical comments: also reported on 03Dec2020 and 08Dec2020), chronic kidney disease stage 4 from 18Sep2020, diabetes mellitus from 18Sep2020 (In remission), ex-tobacco user from 11Sep2020 (10-19/day), social alcohol drinker from 11Sep2020 (Trivial drinker - <1u/day), diabetic foot from 14Feb2020 (Left and right, at low risk, also on 11Sep2020), medical observation from 14Feb2020 and ongoing (Weight and height, also on 11Sep2020). Other medical history included dyspnoea. Concomitant medication included fluticasone furoate 110ug once daily (27.5micrograms/dose, two sprays to be used in each nostril) via nasal route of administration from 26Nov2020 for dyspnoea. The patient previously took influenza virus on 23Sep2020 for flu immunization, pneumococcal polysaccharide vaccine for pneumococcal immunization, angiotensin receptor blockers from 27Feb2020 and experienced drug intolerance and ace inhibitor from 27Feb2020 and experienced drug intolerance. On 09Jan2021, the patient experienced cardiac arrest, cough and syncope. Patient had COVID-19 vaccination, during the following night at about 3:00 am patient had a cough attack, collapsed, had a cardiac arrest and died, 999 was called, cardiopulmonary resuscitation (CPR) was started, adrenaline was given. The patient had ongoing (as reported) Blood pressure measurement from 14Feb2020 (Patient Medical comments: Also on 29Jun2020, 15Jul2020, 11Sep2020 and 03Dec2020), ongoing blood test from 14Feb2020 (Patient Medical comments: All component measured and reported. Also reported on 11Sep2020 and 10Jul2020), ongoing Electrocardiogram from 03Jul2020, ongoing monofilament pressure perception test from 11Sep2020 (Left foot normal, patient medical comments: also on 14Feb2020), ongoing heart rate normal from 11Sep2020 (Left and right posterior tibial pulse and dorsalis pedis palpable, also on 14Feb2020), ongoing urine analysis from 11Sep2020 (All components measured and reported), ongoing ultrasound scan of heart from 03Aug2020. The outcome of cardiac arrest was fatal. The outcome of cough and syncope and the time of death was unknown. The patient died on 09Jan2021. It was not reported if an autopsy was performed. it was reported that the coroner was assessing/investigating, unclear if events are related to the vaccination or not. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 955799 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-16
Onset:2020-12-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Bundle branch block right, Cardiac arrest, Circulatory collapse, Cyanosis, Electrocardiogram, Heart rate, Hypothermia, Malaise, Pulseless electrical activity, Respiratory arrest, Respiratory rate, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-16
   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: ; ; ANORO; ; ; ; CO-CODAMOL; ; ; HUMULIN I; ; MONOMIL XL; ; ; ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Analgesic therapy; Angina pectoris; Benign prostatic hyperplasia; Chronic kidney disease stage 3; Constipation; COPD; Diabetes; Diabetic neuropathy; Dry eye; Dyspepsia; Gout; Heart failure; Hypercholesteremia; Hypercholesterolaemia; Ischemic heart disease; Neuropathy peripheral; Osteoarthritis; Pulmonary embolism; Comments: Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20201216; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:showed bradycardia, right bundle branch block; Test Date: 20201216; Test Name: Heart rate; Result Unstructured Data: Test Result:40; Comments: beats per minute; Test Date: 20201216; Test Name: respiration; Result Unstructured Data: Test Result:8; Comments: dropped to 8 per minute
CDC Split Type: GBPFIZER INC2021031242

Write-up: Cardiac arrest; Respiratory arrest; Unresponsive to stimuli; did not feel well; cyanosed; right bundle branch block; collapsed; Pulseless electrical activity; Hypothermic; Bradycardia; This is a spontaneous report received from a contactable pharmacist by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-ADR 24547306 and GB-MHRA-WEBCOVID-20201224141239. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EJ0553), via an unspecified route of administration on 16Dec2020 17:22 at single dose for COVID-19 vaccination. Medical history included chronic kidney disease, myocardial ischaemia, neuropathy peripheral, osteoarthritis, angina pectoris, cardiac failure, chronic obstructive pulmonary disease, diabetes mellitus and benign prostatic hyperplasia, all from an unspecified date and unknown if ongoing; gout, dyspepsia, constipation, hypercholesteremia, dry eye, pulmonary embolism, analgesic therapy, diabetic neuropathy and hypercholesterolaemia. Patient had not had symptoms associated with COVID-19. Patient had not been tested/or has had an inconclusive test for COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included allopurinol for gout, amoxicillin for chronic obstructive pulmonary disease, umeclidinium bromide, vilanterol trifenatate (ANORO) for chronic obstructive pulmonary disease, apixaban for pulmonary embolism, bisoprolol for cardiac failure, carbocisteine for chronic obstructive pulmonary disease, codeine phosphate, paracetamol (CO-CODAMOL) for analgesic therapy, duloxetine for diabetic neuropathy, furosemide for cardiac failure, insulin human injection, isophane (HUMULIN I) for diabetes mellitus, lansoprazole for dyspepsia, isosorbide mononitrate (MONOMIL XL) for angina pectoris, prednisolone for chronic obstructive pulmonary disease, salbutamol for chronic obstructive pulmonary disease, senna alexandrina for constipation, simvastatin for hypercholesterolaemia, guaraprolose (Systane eye drops) for dry eye and tamsulosin for benign prostatic hyperplasia. It was reported: Patient was vaccinated on 16Dec2020 at 17:22, he remained in the vaccination hub for 15 minutes to rule out any anaphylaxis or side effects. He felt fine after 15 minutes so went home. Within 30 minutes of going home he didn''t feel well and collapsed in the garden. An ambulance was called at 18:21 and arrived on the scene at 18:27. The ambulance documented in their notes the reason for the call was patient did not feel well 30 minutes after having the vaccine and collapsed. Patient did not complain of chest pain prior to collapse. Patient became unresponsive to stimuli at 18:50, low respiratory effort after collapse, patient went into respiratory arrest at 18:55 and went into cardiac arrest at 18:57. Advanced life support was given to the patient. Patient was pronounced dead at hospital emergency department at 20:14 on 16Dec2020. Cause of death was noted as cardiac arrest. Patient had not tested positive for COVID-19 since having the vaccine. Patient initially breathing independently with 5 liters nasal specs. Patient stated he couldn''t breathe before collapse so administered 6 liters via mask, respirations dropped to 8 per minute before respiratory arrest. Patient appeared cyanosed, assisted ventilation throughout, good rise and fall of chest, good equal air entry bilaterally. Circulation, initial radial pulse felt thread and slow HR (heart rate) 40 bpm (beats per minute), 12 lead ECG (electrocardiogram) showed bradycardia, right bundle branch block. Patient went into cardiac arrest at 18:57, witnessed by crew so immediate compressions commenced. Patient in PEA (pulseless electrical activity) rhythm throughout. Initially alert and orientated but appeared distressed. Became unresponsive at 18:50. Patient was hypothermic, so dose interval for adrenaline was doubled. Full ALS (advanced life support) protocol followed throughout. Patient died at the hospital on 16Dec2020 at 20:14. The cause of death was reported to be cardiac arrest. It was not reported if an autopsy had been performed. At the time death the outcome of the following events was reported to be not recovered: collapsed, respiratory arrest, unresponsive to stimuli, did not feel well. The outcome of the following events was unknown: pulseless electrical activity, hypothermic, right bundle branch block, cyanosed, bradycardia. No seriousness criteria were provided for the non-fatal events. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 955800 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2020-12-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EI0553 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   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: ; ; MONOMIL XL; ; ORAMORPH; PREDNISON;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphocytic leukaemia; IHD; Lung cancer metastatic (FROM CA LUNG); NIDDM
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021034127

Write-up: Vomiting; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-20201230095817, Sender''s Safety Report Unique Identifier GB-MHRA-ADR 24548721. A 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot/Batch number EI0553), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. Medical history included metastatic neoplasm (from CA lung), myocardial ischaemia (IHD) and type 2 diabetes mellitus (NIDDM) from unknown dates and unknown if ongoing and chronic lymphocytic leukaemia from 2019. Concomitant medication included amlodipine for IHD, atorvastatin for IHD, isosorbide mononitrate (MONOMIL XL) for IHD, omeprazole for hyperacidity, morphine sulfate pentahydrate (ORAMORPH) for palliative care, prednisone for palliative care, influenza vaccine (INFLUENZA VACCINE SEQIRUS) on 10Oct2020 for immunization, ticagrelor for IHD and steroids at 65 mg. The patient experienced vomiting on 18Dec2020, which was fatal. This man was terminally ill but commenced vomiting approximately 12 hours after vaccine administration. This vomiting continued for three days until his death. The patient died on 21Dec2020 due to vomiting. It was not reported if an autopsy was performed. Patient has not tested positive for Coronavirus disease 2019 since having the vaccine. Patient has not had symptoms associated with Coronavirus disease 2019. Patient has not been tested/or has had an inconclusive test for Coronavirus disease 2019. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vomiting


VAERS ID: 955803 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Pain; UTI (urinary tract infection few months prior to report); Comments: relatively fit and well. greatly managed hypertension and bits of aches and pains. and some eye drops. last contact was few months ago with UTI Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021032504

Write-up: Death; This is a spontaneous report received from a contactable physician by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 24573305 and GB-MHRA-WEBCOVID-20210108150224. A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK1768), on 07Jan2021 at single dose for COVID-19 immunisation. Medical history included relatively fit and well; greatly managed hypertension and bits of aches and pains and some eye drops. Last contact was few months ago with urinary tract infection. Patient had not had symptoms associated with COVID-19. Patient had not been tested/or had an inconclusive test for COVID-19. Unsure if patient was enrolled in clinical trial. Concomitant medications included acetylsalicylic acid, paracetamol, pregabalin, all for unknown indication and ramipril for hypertension. On 07Jan20201 the patient died. It was reported: patient died at home few hours after receiving the vaccine at home. Coroner called to see if there was any possible cause based on her medical history but was not sure. REDACTED coroner office was going to do post mortem and toxicology. It was unknown if autopsy was done or not at the time of the report. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 955806 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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: Diverticular disease; Hypertension; Idiopathic pulmonary fibrosis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021027923

Write-up: short of breath; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210108221409, Safety Report Unique Identifier: GB-MHRA-ADR 24575002. An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0739), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. Medical history included atypical idiopathic pulmonary fibrosis, hypertension and diverticular disease. Concomitant medications included alendronic acid, calcium carbonate;colecalciferol, ezetimibe, omeprazole, prednisolone for Idiopathic pulmonary fibrosis and ramipril, all from unknown date. Reporter stated that they do not know the vaccine was related to this death (it probably was not) but as it occurred within 24 hours of the vaccine, it was being reported. The patient became short of breath on the morning of the 08Jan2021. Paramedics attended the home and performed CPR (cardiopulmonary resuscitation) which was unsuccessful. Patient had not tested positive for COVID-19 since having the vaccine. Unsure if patient has had symptoms associated with COVID-19. Unsure if patient is enrolled in clinical trial. The patient died on 08Jan2021. It was not reported if an autopsy was performed. Outcome of short of breath was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: short of breath


VAERS ID: 955814 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-12
Onset:2021-01-01
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210101; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021031721

Write-up: COVID-19 virus test and revealed yes - positive COVID-19 test/SARS-CoV-2 infection; COVID-19 virus test and revealed yes - positive COVID-19 test/sars-cov-2 infection; This is a spontaneous report downloaded from the Regulatory Authority. Regulatory authority number: GB-MHRA-ADR 24581491. A contactable physician reported that an elderly male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Dec2020 at single dose for COVID-19 immunisation. Medical history was not reported. The patient''s concomitant medications were not reported. Patient is not enrolled in clinical trial. The patient was suspected COVID-19 but unsure when symptoms started. She underwent COVID-19 virus test and revealed yes - positive COVID-19 test on 01Jan2021. She experienced sars-cov-2 infection on 01Jan2021 with outcome of fatal. The patient died on 08Jan2021, cause of death was COVID-19 virus test and revealed yes - positive COVID-19 test/sars-cov-2 infection. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The association between the event lack of effect (fatal SARS CoV2 infection) with BNT162b2 can not be fully 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: COVID-19 virus test and revealed yes - positive COVID-19 test/sars-cov-2 infection; COVID-19 virus test and revealed yes - positive COVID-19 test/sars-cov-2 infection


VAERS ID: 955823 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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: 2021-01-08
   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: Comments: Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021029514

Write-up: Sudden death unexplained/Presumed cause cardiac arrest; This is a spontaneous report received from a contactable physician by Pfizer from the agency and Healthcare products Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-ADR 24587484 and GB-MHRA-WEBCOVID-20210113100039. A 79 years old female patient received to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1688) on 07Jan2021 17:08 at single dose for covid-19 vaccination. The patient medical history included: Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. It was reported: the patient had vaccination at 17:08 07Jan2021. No problems identified during 15min waiting period. Patient went home, had supper with son who left her at 22:00. She was found the next day by her son, and pronounced dead at 13:30 08Jan2021. Presumed cause cardiac arrest. Death referred to coroner 11Jan2021. No significant history or risk of cardiovascular disease apart from age no clear link to vaccine, but yellow card recommended by colleagues for completeness. Patient has not tested positive for COVID-19 since having the vaccine. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained/Presumed cause cardiac arrest


VAERS ID: 955824 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / 2 - / -

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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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: ; ; ; CLENIL MODULITE; VENTOLIN [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Atrial fibrillation; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021032745

Write-up: Passed away overnight on 10Jan2021. Assumed cardio-respiratory arrest; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 24590954 and GB-MHRA-WEBCOVID-20210113174906. An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0141) via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history included asthma, atrial fibrillation and hypertension. Concomitant medications included amlodipine for hypertension, apixaban for atrial fibrillation, atorvastatin for primary prevention, beclometasone dipropionate (CLENIL MODULATE) for asthma and salbutamol sulfate (VENTOLIN) for asthma. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was reported: Patient attended for 2nd Covid vaccination on 09Jan2021. No significant preceding symptoms. Passed away overnight on 10Jan2021. Assumed cardio-respiratory arrest. For post-mortem. Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. The reporter considered the event life-threatening and therefore serious. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Assumed cardio-respiratory arrest


VAERS ID: 955825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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: LAXIDO; ; SERETIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Breast cancer (recent diagnosis); Constipation; Hypertension; Comments: Hypertension, mild asthma, recent diagnosis of breast cancer Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: tested; Result Unstructured Data: Test Result:has not tested positive for COVID-19
CDC Split Type: GBPFIZER INC2021029884

Write-up: Haemorrhage brain; Haemorrhagic stroke; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210113180138, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 24591328. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EJ1688) on 06Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension, mild asthma, recent diagnosis of breast cancer and constipation. The patient has not had symptoms associated with COVID-19. The patient is not enrolled in clinical trial. The patient has not tested positive for COVID-19 in Jan2021 since having the vaccine. Concomitant medication included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO) from 13Dec2020 for constipation, ramipril from 14Jul2014 for hypertension and fluticasone propionate, salmeterol xinafoate (SERETIDE) from 11Feb2020 for asthma. The patient had haemorrhage brain and haemorrhagic stroke on 09Jan2021, seriousness reported as death. The patient died on 11Jan2021. It was unknown if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke; Haemorrhage brain


VAERS ID: 955826 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Malaise, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-30
   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: MATRIFEN;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20201210; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021033570

Write-up: Death; Malaise; Diarrhoea; Vomiting; Pyrexia; This is a spontaneous report received by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210113180506 and Safety Report Unique Identifier GB-MHRA-ADR 24591279. A contactable physician reported that an 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1688), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included dementia, and vitamin b12 deficiency. Patient had not had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. Concomitant medications included fentanyl (MATRIFEN) from 2016 at 25 mcg/hr, paracetamol from 2015 and non-medicinal product (no details reported). Patient previously received influenza vaccine inact sag 3v (FLUAD) on 20Oct2020 for influenza immunization. The patient experienced death, malaise, diarrhoea, vomiting, and pyrexia; all on 30Dec2020. It was stated that the patient had the vaccine then the following day she became unwell with diarrhoea and vomiting and a fever. The patient became quickly unwell and passed away on 30Dec2020. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No-negative COVID-19 test on 10Dec2020. Outcome of event death was fatal, and of other events was unknown. The patient died on 30Dec2020. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 955828 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fall, Pneumonia aspiration, SARS-CoV-2 test, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; ; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: IHD; Indigestion; Iron low; Prostatism; Vitamin deficiency; Comments: Patien quite frail. Had vaccine on 31/12/20 then had a fall on 05/02/21 became very drowsy ? Aspiration pneumonia and died on the 6th January Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20201220; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021033283

Write-up: accidental fall; aspiration pneumonia; quite frail; drowsy off legs; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 24594577. A 93 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number:EJ1688), at single dose for COVID-19 immunization on 31Dec2020. Medical history included IHD (myocardial ischaemia), vitamin deficiency , iron low, prostatism and indigestion. Concomitant medication included acetylsalicylic acid from 15Oct2001 for myocardial ischaemia, calcium and colecalciferol from 24Dec2020 for vitamin deficiency, ferrous fumarate from 24Dec2020 for iron low, finasteride from 09Apr2010 for prostatism, omeprazole from 20Jan2012 for Dyspepsia, pravastatin from 05Nov2012 for myocardial ischaemia and tamsulosin from 16Jul2017 for Prostatism. The patient had vaccine on 31Dec2020. He had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 05Jan2021, the patient experienced accidental fall. He was quite frail, became drowsy off legs, and experienced aspiration pneumonia. The outcome of accidental fall was fatal. The patient died on 06Jan2021. It was not reported if an autopsy was performed. The outcome of events quite frail, drowsy off legs, aspiration pneumonia was unknown. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test (20Dec2020): no - negative covid-19 test. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: accidental fall


VAERS ID: 955829 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-10
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021039434

Write-up: Death within 28 days of vaccination; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202101141348291580, safety Report Unique Identifier GB-MHRA-ADR 24595288. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EJ1688, expiration date unknown), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient''s medical history was reported as patient had not had symptoms associated with COVID-19, patient was not enrolled in clinical trial. COVID-19 virus test on 26Dec2020 was "No - Negative COVID-19 test". Concomitant medications were not reported. On 10Jan2021, the patient experienced death within 28 days of vaccination. The patient died on 10Jan2021. It was not reported if an autopsy was performed. The cause of death was not reported. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death within 28 days of vaccination


VAERS ID: 955830 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lower respiratory tract infection, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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: Heart rate abnormal
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response); Comments: short course of fludrocortisone for postural hypotension, approx 1-2w stopped before vaccination Unsure if patient has had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210109; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021033613

Write-up: Chest infection; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority report number GB-Regulatory Authority-WEBCOVID-202101141450098130, and Sender''s (Case) Safety Report Unique Identifier GB-Regulatory Authority-ADR 24595672. A 92-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. Medical history included immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response) from an unknown date and unknown if ongoing and ongoing heart rate abnormal. Concomitant medication included bisoprolol from 10Dec2020 for heart rate abnormal. The patient previously took a short course of fludrocortisone for postural hypotension, stopped approximately 1-2 weeks before vaccination. It was unsure if patient has had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced chest infection on 08Jan2021. The patient was very frail, bedbound. Given COVID vaccine due to wishes of family. The patient had previous MRTI likely unrelated to vaccine but death within days of being vaccinated. The patient underwent lab test which included COVID-19 virus test: negative on 09Jan2021. The patient died on 10Jan2021. It was not reported if an autopsy was performed. The outcome of the event chest infection was fatal. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Chest infection


VAERS ID: 955837 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Gastrointestinal haemorrhage, Glomerular filtration rate, Haemoglobin, Platelet count, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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: CALCIGRAN FORTE; ZOPICLONE ACTAVIS; ENALAPRIL KRKA; FURIX [FUROSEMIDE]; PARACET [PARACETAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthropathy psoriatic; Atherosclerosis; Bladder cancer; Coxarthrosis; Dementia; Heart failure; Hypertension; Renal failure; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20201123; Test Name: Creatinine; Result Unstructured Data: Test Result:135 IU/l; Comments: Units:U/L (enzyme unit per litre); Test Date: 20201123; Test Name: Estimated GFR; Result Unstructured Data: Test Result:42 ml/min; Comments: Units: mL/min/{1.73_m2}; Test Date: 20201123; Test Name: Hemoglobin; Result Unstructured Data: Test Result:13.7 g/dl; Test Date: 20201123; Test Name: Platelets; Result Unstructured Data: Test Result:138 x10 9/l; Test Date: 20201231; Test Name: Platelets; Result Unstructured Data: Test Result:132 x10 9/l; Test Date: 20201123; Test Name: White blood cells; Result Unstructured Data: Test Result:7.6 x10 9/l
CDC Split Type: NOPFIZER INC2021027029

Write-up: BLEEDING GASTROINTESTINAL; The initial case was missing the following minimum criteria: reporter had no firsthand knowledge. After receiving Follow up information on 15Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report downloaded from the Regulatory Authority NO-NOMAADVRE-FHI-2021-U9ngz, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013839. A contactable physician reported that an 83-year-old male patient had received bnt162b2 vaccine (COMIRNATY, batch/lot number EJ6795), via intramuscular route on 06Jan2021, at single unspecified dose (first dose) for Covid-19 immunisation. Medical history included hypertension, arteriosclerosis, osteoarthritis, renal failure, bladder cancer, dementia, cardiac failure, type 2 diabetes mellitus and psoriatic arthropathy, all from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate, colecalciferol (CALCIGRAN FORTE, 500 mg/400 iU), zopiclone (ZOPICLONE ACTAVIS, 5 mg), enalapril maleate (ENALAPRIL KRKA, 10 mg) at a dose of 10 mg once daily, furosemide (FURIX 20 mg) and paracetamol (PARACET 500 mg) at a dose of 1 g up to 3 times per day. No information that the patient was taking blood thinners or had known GI pathology. The patient experienced bleeding gastrointestinal on 08Jan2021. The patient underwent lab tests and procedures which included blood creatinine: 135 iu/l on 23Nov2020 Units:U/L (enzyme unit per litre), glomerular filtration rate: 42 ml/min on 23Nov2020 Units: mL/min/1.73_m2, haemoglobin: 13.7 g/dl on 23Nov2020, platelet count: 138 x10 9/l on 23Nov2020, and 132 x10 9/l on 31Dec2020, and white blood cell count: 7.6 x10 9/l on 23Nov2020. The patient died on 08Jan2021 after been flown to the hospital as a result of the event. It was not reported if an autopsy was performed. The Center has assessed the causal relationship between the suspect product and the reported event as Possible. Reported as an uncertain, possible new, unexpected and serious side effect to the vaccine Comirnaty. Additional information from Sender''s comments (Health Authority comments): "According to the approved Summary of Product Characteristics (SPC) for Comirnaty, gastrointestinal bleeding is not a known side effect of the vaccine. It is stated in the report that the patient had several underlying diseases before the vaccination. Based on the event description, it is more likely that something other than the vaccine is the cause of the event in question. However, it cannot be ruled out that the vaccine may have contributed to the deterioration of the patient''s general condition. We have considered it to be a possible causal link between the vaccination and GI bleeding. The report is classified as serious according to current criteria". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: BLEEDING GASTROINTESTINAL


VAERS ID: 955838 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   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: Dementia; Multimorbidity; Pneumonia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021027016

Write-up: Sudden death; This is a spontaneous report from two contactable physicians downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-UDMAY, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013809. An 83-year-old female patient received the first dose of bnt162b2 (COMIRNATY, batch/lot number EJ6795) intramuscular in the right arm on 06Jan2021 10:57 at single for covid-19 immunisation. Medical history included dementia, pneumonia, multimorbidity, all ongoing. The patient''s concomitant medications included treatment for pneumonia. The patient experienced sudden death on 06Jan2021. It was not reported if an autopsy was performed. The causality between the suspect product(s) and the event(s) were assessed as possible by the Regional Pharmacovigilance Center. Case narrative: According to reporter, it is doubtful that there is a causal link between vaccination and death, but it cannot be ruled out that vaccination may have helped to speed up death for other reasons. The patient was an elderly demented multi-morbid female who was considered terminal shortly before death. Was at the time undergoing treatment for a suspected pneumonia. Treatment was apparently successful and it was considered that the patient should receive the vaccine. Vaccination was administered approximately 6 hours before the patient was found dead in her own bed. She was observed, without any remarks, by nursing staff 1 hour before she was found dead. Sender''s comments (Health Authority comments): Thank you for reporting a suspected side effect after vaccination. The information is registered in the national adverse reaction register (the Norwegian Medicines Agency), and then forwarded to international adverse reaction databases. In this way, your message becomes part of an important international collaboration that is continuously ongoing to monitor and maintain safe vaccination worldwide. It is stated in the report that the patient had underlying diseases before vaccination. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. As the incident is described, it is more likely that these diseases are behind the incident. However, it cannot be ruled out that the vaccine has contributed to any of the symptoms. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 955839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Diarrhoea, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrest; Cerebral infarction; Chronic kidney disease; Cognitive impairment; Pulmonary sarcoidosis
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: blood pressure; Result Unstructured Data: Test Result:fall
CDC Split Type: NOPFIZER INC2021033035

Write-up: NAUSEA; ACUTE DIARRHEA; FALL IN BLOOD PRESSURE; This is a spontaneous report downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB NO-NOMAADVRE-FHI-2021-Ugyxy, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013811. A contactable other hcp reported that a 79-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number: EJ6795), via intramuscular route at left arm on 06Jan2021 12:44 at single dose for COVID-19 vaccination. Medical history included cerebral infarction, chronic kidney disease, ongoing diabetes, mild cognitive impairment, pulmonary sarcoidosis, and cardiac arrest. The patient''s concomitant medications were not reported. The patient experienced nausea, acute diarrhea and fall in blood pressure, all on 07Jan2021. The seriousness criteria of all events was death. It was reported that "Nursing home patient with diabetes, previous history of cardiac arrest, kidney disease, pulmonary sarcoidosis and cognitive impairment. Patient died the day after vaccination with Comirnaty". The patient died on 07Jan2021. It was not reported if an autopsy was performed. The Regional Pharmacovigilance Center assessed the causal relationship between the suspect product and the reported events as possible. Reporter comment: 14-JAN-2021, NIPH: requested additional information. This is a preliminary report. Sender''s comments (Health Authority comments): "Thanks for the report of suspected adverse reaction after vaccination. It is stated in the report that the patient had underlying diseases before vaccination. When vaccinating marginal patients who are ill with many underlying diseases, some serious incidents, including deaths, may occur occur shortly after vaccination without having a connection with the vaccination. Based on the description of the incident, it is more likely that these diseases have caused the incident. However, it cannot be ruled out that the vaccine has contributed to any of the symptoms. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination". No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 14-JAN-2021, NIPH: requested additional information. This is a preliminary report.; Reported Cause(s) of Death: NAUSEA; ACUTE DIARRHEA; FALL IN BLOOD PRESSURE


VAERS ID: 955840 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   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: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; NOVORAPID; OXYNORM; FLUCONAZOL KRKA; ALBYL-E; INSULATARD [INSULIN HUMAN INJECTION, ISOPHANE];
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Diabetes mellitus; Infection; Pain; Reduced general condition
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: C-reactive protein; Result Unstructured Data: Test Result:177 mg/l; Test Date: 20210106; Test Name: C-reactive protein; Result Unstructured Data: Test Result:127 mg/l
CDC Split Type: NOPFIZER INC2021033068

Write-up: infection without known focus; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory authority -WEB NO-NOMAADVRE-FHI-2021-Uq8mm, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013862. A contactable physician reported that a 93-year-old female patient received bnt162b2 (COMIRNATY, batch/lot number EJ6795, expiry date: not reported) via intramuscular route on 05Jan2021, at a single dose (first dose, administered into left arm) for covid-19 immunization. Medical history included dementia, diabetes mellitus and pain. In addition patient had impaired general condition the day before vaccination and the same day as vaccination Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) from 28May2020, at a dose of 1 sachet 4 days per week, insulin aspart (NOVORAPID FLEXPEN, 100 iU) from 03Feb2020 to , oxycodone hydrochloride (OXYNORM, 5 mg) from 25Nov2019, at a dose of 5 mg as needed (up to 2 times per day) for pain, fluconazole (FLUCONAZOL KRKA, 100 mg) from 17Jul2020, at a dose of 100 mg weekly, acetylsalicylic acid, magnesium oxide (ALBYL-E, 75 mg) from 27Apr2020, at a dose of 75 mg once daily, insulin human injection, isophane (INSULATARD FLEXPEN, 100 iU) from 11Jun2020, at a dose of 30 IU in the morning, and paracetamol (PARACETAMOL, 500 mg) from 21Nov2020, at a dose of 1 g, 3 times per day. Insulin NOVORAPID FLEXPEN and INSULATARD FLEXPEN, macrogol (MOVICOL), acetylsalicylic acid (ALBYL-E), Fluconazole, oxycodone (OXYNORM) were discontinued at the same time as initiating palliative care. Patient was afebrile and no respiratory symptoms, but CRP was 177 mg/l at night (05Jan2021) on the same day as vaccination. The day after the gradual deterioration of the general condition and finally not contactable. CRP 127 mg/l (06Jan2021), afebrile and was treated with paracetamol 1 gram x 3. Palliative care was initiated with morphine and midazolam. The patient died two days after vaccination. Reporter (physician) has assessed that the woman had an infection that started before she received the vaccine COMINARTY. The patient experienced infection without known focus on 05Jan2021. The patient died on 07Jan2021. It was not reported if an autopsy was performed. The regional pharmacovigilance center has assessed the causality between concomitant drug OXYNORM and the event as possible. Additional information in Sender''s comments (Health authority comments): "It is stated in the report that the patient had underlying diseases before vaccination, and based on his report, an infection that started before the vaccination. It cannot be completely ruled out that the vaccine may have contributed to the deterioration of the patient''s basic condition and the presumed already established infection. We have considered it to be a possible causal link between the fatal outcome and the vaccination with Cominarty. The report is classified as serious according to current criteria". No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reporter qualification: Physician.; Reported Cause(s) of Death: infection without known focus


VAERS ID: 955841 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Confusional state, Coordination abnormal, Decreased appetite, Vaccination site inflammation, Vaccination site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   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: NITROGLYCERIN; SOBRIL; AFIPRAN; IMOVANE; ISOPTIN [VERAPAMIL HYDROCHLORIDE]; CALCIGRAN FORTE; PLAVIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (cognitive impairement); Fracture (with falling tendency); Heart attack; Hypertension; Hypertrophic obstructive cardiomyopathy; Malnutrition; Non STEMI; Orthostatic hypotension; Osteoporosis; TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021033075

Write-up: Local reaction with swelling and redness; VOMITING; Coordination difficulties; Local reaction with swelling; Confusion; Poor appetite; Loss of initiative; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB NO-NOMAADVRE-FHI-2021-Uy9gq, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013840. A 90-year-old female patient received bnt162b2 (COMIRNATY, batch/lot number EJ6795, expiration date Apr2021) via intramuscular route in the left arm on 07Jan2021, at a single dose for covid-19 immunisation. The patient''s medical history included hypertension, orthostatic hypotension, osteoporosis, heart attack, malnutrition, hypertrophic obstructive cardiomyopathy, transient ischemic attack (TIA),and dementia (cognitive disorder), Non-ST-elevation myocardial infarction (NSTEMI) and fractures (falling tendency) all from an unknown date and unknown if ongoing. Concomitant medications included nitroglycerin (NITROGLYCERIN TAKEDA, 0.5 mg), oxazepam (SOBRIL, 10 mg), metoclopramide hydrochloride (AFIPRAN, 10 mg) as needed, zopiclone (IMOVANE, 7.5 mg), verapamil (ISOPTIN [VERAPAMIL HYDROCHLORIDE], 40 mg), calcium carbonate, colecalciferol (CALCIGRAN FORTE, 1000 mg/800 iU), and clopidogrel bisulfate (PLAVIX, 75 mg). On 07Jan2021, the patient experienced loss of initiative. On 08Jan2021, patient experienced confusion had poor appetite, coordination difficulties and a local reaction with swelling. On 09Jan2021, the patient had local reaction with swelling and redness, and experienced vomiting. The patient died on 09Jan2021 due the events loss of initiative, confusion, poor appetite, coordination difficulties, local reaction with swelling, local reaction with swelling and redness, and vomiting. It was not reported if an autopsy was performed. It was further reported that the patient gradually decreased general condition over time, unable to eat by herself, increasing confusion and coordination difficulties. Vomited twice a few hours before the patient was found dead in bed. The Regional Pharmacovigilance Center has assessed the causality between the suspect product and the events of confusional state, apathy, decreased appetite, vomiting and coordination abnormal as possible, and between the suspect product and the events of vaccination site redness and vaccination site swelling as probable. Senders Comment: It is stated in the report that the patient had several underlying diseases before the vaccination. Based on the event description, it is more likely that these diseases are behind the event in question. However, it cannot be ruled out that the vaccine may have contributed to the deterioration of the patient''s general condition. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination. We have considered it to be a possible causal relationship between the vaccination and the overall symptom picture described, but specifically local reaction with swelling and redness is considered to have a probable causal relationship with the vaccination. The report is classified as serious according to current criteria". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Loss of initiative; Poor appetite; Local reaction with swelling and redness; VOMITING; Coordination difficulties; Local reaction with swelling; Confusion


VAERS ID: 955842 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Disease recurrence, Dyspnoea, General physical health deterioration, Pyrexia, Rales, Respiratory rate increased, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   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: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; LEVAXIN; DUROGESIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Asthma; Constipation; Dementia; Frailty; Hallucination NOS; Hypothyreosis; Malnutrition; Memory impaired; Pain NOS; Rales; Terminal state; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: COVID-19 virus test negative; Test Result: Negative
CDC Split Type: NOPFIZER INC2021027026

Write-up: REDUCED GENERAL CONDITION; RALES; RALES; DYSPNEA; Fever, decreased general condition, dyspnoea, rales, cough, increased respiration; COUGH; BREATHING RATE INCREASED; This is a spontaneous report from downloaded from the Medicines Agency (MA) EudraVigilance-WEB NO-NOMAADVRE-FHI-2021-UZDZE, Safety Report Unique Identifier NO NOMAADVRE-E2B_00013778. A contactable other Health Professional and a contactable physician reported that a 75-years-old female patient received the first dose of bnt162b2 (COMIRNATY, Batch/lot number: EJ6796), intramuscular at right arm on 30Dec2020 11:25 at single dose for COVID-19 immunization. Medical history included terminal state, frailty, memory impaired, rales, hallucination NOS, dementia, asthma, type 2 diabetes mellitus, malnutrition, anxiety, constipation, hypothyreosis, pain NOS. Patient with a permanent place in an institution. Bedridden, often experienced hallucinations, was outspoken and had uncritical behavior. Concomitant medication included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for constipation, levothyroxine sodium (LEVAXIN) taken for hypothyreosis, fentanyl (DUROGESIC) taken for pain NOS. No other medication had been given in connection with vaccination, except the listed treatments. The patient experienced reduced general condition, rales, dyspnea, fever, cough, increased respiration on 30Dec2020. According to reporter the patient was calm on the day of vaccination, which was different from the patient''s habitual condition. After vaccination the patients develops symptoms as mentioned. No vital measurement was performed on the patient, as it was known that the patient would have opposed this. The patient has been gradually reduced over time, but had not been considered to be in the terminal phase. The events outcome was fatal. The patient underwent lab test included sars-cov-2 test negative on 31Dec2020. The patient died on 02Jan2021. It was not reported if an autopsy was performed Health authority''s comments: Thank you for reporting a suspected side effect after vaccination. The information is registered in the national adverse reaction register (the Medicines Agency), and then forwarded to international adverse reaction databases. In this way, your message becomes part of an important international collaboration that is continuously ongoing to monitor and maintain safe vaccination worldwide. It is stated in the report that the patient has underlying diseases before vaccination. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. As the incident is described, it is more likely that these diseases are behind the incident. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Reduced general condition; Rales; Dyspnea; Fever; Cough; Breathing rate increased


VAERS ID: 958809 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-16
Onset:2020-12-01
Submitted: 0000-00-00
Entered: 2021-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Chills, Computerised tomogram head normal, Confusional state, Death, Echocardiogram abnormal, Fall, Headache, Hypoglycaemia, Hypophagia, Hypotension, Hypothermia, Hypoxia, Malaise, Oedema peripheral, Oxygen saturation, Skin ulcer, Somnolence, Tachypnoea, Unresponsive to stimuli, White blood cell count normal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-29
   Days after onset: 28
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: Aortic stenosis (moderate); Atrial fibrillation; Cardiac valve fibroelastoma; Lethargy; Pulmonary hypertension
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: blood sugar; Result Unstructured Data: Test Result:improved; Test Date: 20201228; Test Name: blood sugar; Result Unstructured Data: Test Result:hypoglycaemia/ hypoglycaemic; Test Date: 20201229; Test Name: Blood pressure; Result Unstructured Data: Test Result:hypotension/ hypotensive; Test Date: 20201226; Test Name: Body temperature; Result Unstructured Data: Test Result:hypothermia/ hypothermic; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:no bleed; Test Name: C-reactive protein; Result Unstructured Data: Test Result:37; Test Date: 201906; Test Name: Echocardiogram; Result Unstructured Data: Test Result:possible papillary fibroelastoma- not investigated; Test Date: 20201229; Test Name: Heart rate; Result Unstructured Data: Test Result:tachypnoea/ tachypnoeic; Test Date: 20201229; Test Name: National Early Warning Score; Result Unstructured Data: Test Result:14; Comments: hypotensive, hypoxic, tachypnoeic, unresponsive; Test Date: 202012; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased/ low; Test Name: White blood cell count; Result Unstructured Data: Test Result:Normal
CDC Split Type: GBPFIZER INC2021028062

Write-up: Hypotension/ hypotensive; Hypoxia/ hypoxic; Tachypnoea/ tachypnoeic; Unresponsive to stimuli/ unresponsive; Death; Somnolence/ Drowsy; Hypoglycaemia/ hypoglycaemic; Hypothermia/ hypothermic; Hypophagia/ reduced oral intake; Fall; Confusional state/ confused; Headache; Chills; Skin ulcer/ Leg ulcers; Oedema peripheral/ bilateral leg oedema; Oxygen saturation decreased/ low saturations; feel unwell; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency, manufacturer report number GB-MHRA-ADR 24566650. A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, moderate aortic stenosis from an unknown date and unknown if ongoing, pulmonary hypertension from an unknown date and unknown if ongoing, possible papillary fibroelastoma from Jun2019 and unknown if ongoing, non-specifically lethargic from Dec2020 and unknown if ongoing. The patient had been non-specifically lethargic for 1-2 weeks in early Dec2020. The patient''s concomitant medications were not reported. In the 24-48 hours following vaccine, developed headache and chills. Daughter thought it was all post-vaccination inflammatory response and that it would settle. Continued to feel unwell, reduced oral intake, 2x falls and became confused on 25Dec2020. The patient was admitted on 26Dec2020, hypothermic. Consultant review 27Dec2020 and no diagnosis documented. Leg ulcers and bilateral leg oedema noted, supplemental oxygen commenced due to low saturations in Dec2020. Plan was for chest x-ray, infection screen, COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to 29Dec2020, given intravenous treatment and blood sugars improved. National Early Warning Score (NEWS) of 14 (hypotensive, hypoxic, tachypnoeic, unresponsive) on 29Dec2020 and Medical Emergency Team (MET) call put out at 06:50. By the time MET team arrived the patient had died. The patient experienced headache on Dec2020 , chills on Dec2020, hypophagia on 25Dec2020, fall on 25Dec2020, confusional state on 25Dec2020 , hypothermia on 26Dec2020, skin ulcer on Dec2020, oedema peripheral on Dec2020, oxygen saturation decreased on Dec2020, somnolence on 28Dec2020, hypoglycaemia on 28Dec2020, hypotension on 29Dec2020, hypoxia on 29Dec2020, tachypnoea on 29Dec2020, unresponsive to stimuli on 29Dec2020, death on 29Dec2020 , feel unwell on 25Dec2020. All the events except feel unwell were reported as serious as hospitalization and death. The patient underwent lab tests and procedures which included computerised tomogram head: no bleed, C-reactive protein: 37, echocardiogram: possible papillary fibroelastoma- not investigated in Jun2019, white blood cell count: normal. The patient died on 29Dec2020. An autopsy was not performed. The outcome of the event feel unwell was unknown, while other remain events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Headache; Chills; Fall; Hypophagia/ reduced oral intake; Confusional state/ confused; Skin ulcer/ Leg ulcers; Oedema peripheral/ bilateral leg oedema; Oxygen saturation decreased/ low saturations; Somnolence/ Drowsy; Death; Hypoglycaemia/ hypoglycaem


VAERS ID: 960052 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-01-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bedridden, Condition aggravated, Death, Dyspnoea, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (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 (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (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: 2021-01-04
   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: Arthrosis multiple; Cardiac disorder; Chronic anaemia; Chronic pain; Dyspnoea; Exsiccosis; Reduced general condition; Renal insufficiency (grade 4); Weakness
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma cervix; Leukoencephalopathy; Maxillary sinusitis; Renal failure; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210102; Test Name: O2 saturation; Test Result: 97 %; Test Date: 20210102; Test Name: lungs; Result Unstructured Data: Test Result:clear; Test Name: apid antigen test; Test Result: Negative
CDC Split Type: DEPFIZER INC2021039336

Write-up: Die 50 hours after vaccination; Especially kidney failure; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory authority report number DE-PEI-PEI2021000192. A female patient of 88 years old received bnt162b2 (COMIRNATY, batch/lot number EJ6797, expiration date unknown) , via an unspecified route of administration on 02Jan2021 at single dose for covid-19 immunisation. Medical history included renal failure from Dec2018 to an unknown date , Maxillary sinusitis from 2018 and unknown if ongoing , ongoing reduced general condition , leukoencephalopathy from 2018 and unknown if ongoing , ongoing Weakness, Exsiccosis from 2018 and ongoing , ongoing Dyspnoea, ongoing Chronic anaemia, ongoing renal insufficiency(grade 4), ongoing arthrosis multiple, Ongoing Cardiac disorder, Carcinoma cervix from an unknown date and unknown if ongoing, ongoing Chronic pain, wheelchair dependent. The patient''s concomitant medications were not reported. On 04Jan2021, the patient developed die 50 hours after vaccination and especially kidney failure, lasting for unknown. The patient was dead on 04Jan2021. Death cause was reported as die (unknown cause of death). Injection site showed no abnormalities. Patient had Renal insufficiency grade 4. No suspicion of vaccination complication due to disease course and clinical course. General condition deterioration already before vaccination since Christmas, bedridden since 1st day before vaccination, on the day of vaccination lungs were clear, O2 saturation at 97%. Symptoms shortly before death: Dyspnea, weakness, injection site unremarkable. A rapid antigen test was done before vaccination (result: negative). There will be no autopsy, the family decided against it. The patient died on 04Jan2021. Outcome of especially kidney failure was unknown. An autopsy was not performed. Event Assessment was unclassifiable.; Reported Cause(s) of Death: die 50 hours after vaccination.


VAERS ID: 960053 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dementia of the Alzheimer's type, with delirium
SMQs:, Dementia (narrow), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039328

Write-up: Dementia of the Alzheimer''s type, with delirium; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021000428. This is a report received from the Regulatory Authority. An 85-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6795), via intramuscular on 30Dec2020 at single dose for prophylactic vaccination. The relevant medical history included Dementia Alzheimer''s type from an unspecified date and unknown if ongoing. The patient''s concomitant medications were not reported. On 01Jan2021 after vaccination the patient developed Dementia of the Alzheimer''s type, with delirium, lasting for unknown. The patient died on 01Jan2021. Death cause was reported as Dementia of the Alzheimer''s type, with delirium. An autopsy was not performed. The outcome of the event was fatal.; Reported Cause(s) of Death: Dementia of the Alzheimer''s type, with delirium


VAERS ID: 960054 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

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:
Preexisting Conditions: Medical History/Concurrent Conditions: Demented; Exsiccosis; Markedly reduced food intake
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039270

Write-up: Exitus letalis/died; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority report number DE-PEI-PEI2021000474. A 94-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot/batch number and expiry date were not provided), intramuscular in upper arm on 07Jan2021 at single dose for COVID-19 immunisation. Medical history included Demented, Exsiccosis, Markedly reduced food intake. The patient''s concomitant medications were not reported. The patient experienced exitus letalis (death, medically significant) on 09Jan2021. 2 day(s) after vaccination the patient died. Death cause was reported as unknown cause of death. The patient died on 09Jan2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Reporter Comment: Exitus letalis the morning after the vaccination, probably only temporal connection, no causality, 94-year-old demented patient, incipient desiccosis with insufficient food intake. No symptoms developed after vaccination. Information on the lot/batch number has been requested.; Reporter''s Comments: Exitus letalis the morning after the vaccination, probably only temporal connection, no causality, 94-year-old demented patient, incipient desiccosis with insufficient food intake. No symptoms developed after vaccination.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 960055 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Fall, Head injury, Peripheral vascular disorder
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Artificial cardiac pacemaker user; Cerebellar infarction; Duodenal ulcer; Myocardial infarction; Stent insertion NOS; Ulcus ventriculi; Vagotomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039320

Write-up: Heart attack; Head injury; Circulatory problems; Fall; This is a spontaneous report from a non-contactable Consumer or other non-HCP downloaded from the Regulatory Authority WEB DE-PEI-PEI2021000493. This is a report received from the Regulatory Authority. A 91-year-old male patient received his first dose of bnt162b2 (COMIRNATY, batch number not reported) via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included duodenal ulcer, vagotomy in 1988, ulcus ventriculi, myocardial infarction, cerebellar infarction, angina pectoris, stent insertion NOS, artificial cardiac pacemaker user from 2019. Patient had previous illnesses. The patient''s concomitant medications were not reported. Two hours after vaccination, the patient developed circulatory problems/ circulatory disorder peripheral, fall, head injury. The patient experienced acute myocardial infarction. The patient was dead on 04Jan2021 and death cause was reported as Acute myocardial infarction. It was not reported if an autopsy was performed. Relatedness of drug to all reactions/events: (Source of assessment: Regulatory Authority) C. Inconsistent causal association.; Reported Cause(s) of Death: circulatory problems; Acute myocardial infarction; fall; head injury


VAERS ID: 960056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-03
Onset:2021-01-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adipositas; Angina pectoris CCS class II; Coronary artery disease (Severe 3-vessel disease); Defibrillation; Ex-smoker; Hypertension arterial; Triple vessel disease (Condition after recanalization and stending); Type II diabetes mellitus; Ventricular fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039296

Write-up: Cardiac arrest; Suspected myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-Regulatory Authority-2021000509. A 59-year-old male patient was vaccinated with the first dose of BNT162B2 (COMIRNATY, lot/batch number: EM0477) on 03Jan2021 at single dose for COVID-19 immunization, route of administration was not reported. Medical history included: coronary artery disease from 2019 (Severe 3-vessel disease), angina pectoris CCS class II from 2019, triple vessel disease from 2019 (Condition after recanalization and stending), hypertension arterial, adipositas, type II diabetes mellitus, ex-smoker, ventricular fibrillation from 19Aug2019, defibrillation from 19Aug2019, all unknown if ongoing. Concomitant medication was not reported. 3 days after vaccination the patient developed death and suspected myocardial infarction and cardiac arrest (failure circulatory) and frustrating resuscitation, lasting for unknown. The patient was dead on 06Jan2021 and was hospitalized and condition was life threatening. Death cause was reported as arrest cardiac. It was unknown if Autopsy was performed. Follow-up information has been requested.; Reported Cause(s) of Death: Frustrating resuscitation; Suspected myocardial infarction; Arrest cardiac


VAERS ID: 960057 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Apoplexy; Chronic renal insufficiency (Stat. 2); Dementia; Hip prosthesis user; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039317

Write-up: Acute kidney failure; Emesis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021000557. A 80-year-old female patient received first dose bnt162b2 (COMIRNATY) (Batch/lot number: EJ6796), intramuscular on 07Jan2021 at single dose for covid-19 immunisation. Medical history included Chronic renal insufficiency(Stat. 2), Hypertension, Dementia, Alcohol abuse, Hip prosthesis user, all from an unknown date and unknown if ongoing, and Apoplexy(stop). The patient''s concomitant medications were not reported. 24 hours after vaccination(08Jan2021) the patient developed Emesis and Acute renal failure, lasting for unknown. The patient was dead in Jan2021. Death cause was reported as Acute renal failure. Outcome of Emesis was unknown, of acute renal failure was fatal. It was not reported if an autopsy was performed. Event Assessment was unclassifiable.; Reported Cause(s) of Death: Acute renal failure


VAERS ID: 960058 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bedridden, Fatigue, Hypotonia, Irregular breathing, Rhonchi
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   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: ASS; AZATHIOPRIN; CALCIMAGON [CALCIUM]; DULCOLAX [BISACODYL]; FOLSAURE SANAVITA; FUROSEMID; HYLO-VISION; MIRTAZAPIN; MELPERON; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; RISPERIDON; TIANEURAX; TOLTERODIN;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039370

Write-up: Decreased muscle tone; Pauses for breath; Rattling noises; Fatigue; Increasing weakness; Powerlessness; Bedridden; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021000644. A 78-year-old female patient received 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 prophylaxis. Medical history included cardiac insufficiency from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (ASS), azathioprine (AZATHIOPRIN), calcium (CALCIMAGON), bisacodyl (DULCOLAX), folic acid (FOLSAURE SANAVITA), furosemide (FUROSEMID), hyaluronate sodium (HYLO-VISION), mirtazapine (MIRTAZAPIN), melperone hydrochloride (MELPERON), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), risperidone (RISPERIDON), tianeptine sodium (TIANEURAX), tolterodine l-tartrate (TOLTERODIN), and acetylcysteine (TURANT), all taken from an unknown date to an unknown date for an unknown indication. The patient experienced increasing weakness (death), fatigue (death), powerlessness (death) and bedridden (death) on 09Jan2021, rattling noises (death), decreased muscle tone (death), pauses for breath (death) on 12Jan2021. The outcome of events was fatal. The patient died on 12Jan2021. It was not reported if an autopsy was performed. Relatedness of drug to all reactions/events: (Source of assessment: Regulatory Authority) D. Unclassifiable Clinical course: 2 day(s) after vaccination the patient developed Weakness and Tiredness and Strength loss of and Bedridden and Irregular breathing and Rhonchus and Hypotonia, lasting for unknown. The patient was dead. Follow-up information has been requested.; Reported Cause(s) of Death: Increasing weakness; Rattling noises; Fatigue; Decreased muscle tone; Pauses for breath; Powerlessness; Bedridden


VAERS ID: 960059 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 011035926710001 / UNK - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   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: Test Name: PCR; Test Result: Positive
CDC Split Type: DEPFIZER INC2021039253

Write-up: Unknown cause of death; COVID-19; COVID-19; Apoplexy; This is a spontaneous report from a non-contactable physician. This is a report received from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority or other manufacturer number DE-PEI-PEI2021000691. An 87-year-old male patient received BNT162B2 (COMIRNATY, lot/batch number 0110359267100013) intramuscularly at a single dose on 29Dec2020 for COVID-19 prophylaxis. The patient''s medical history and concomitant medications were not reported. On 01Jan2021, the patient developed Apoplexy, on 02Jan2021, patient developed COVID-19 and on 04Jan2021, patient experienced unknown cause of death. The patient was dead and condition was life threatening. Lab tests included PCR positive on an unspecified date. Follow-up information has been requested.; Reported Cause(s) of Death: Covid-19; Covid-19; Apoplexy; Unknown cause of death


VAERS ID: 960060 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039247

Write-up: Death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority WEB DE-PEI-PEI2021000692. This is a report received from the Regulatory Authority. An 89-year-old female patient received first dose of bnt162b2 (COMIRNATY, batch number: not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 prophylaxis. The patient''s medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. The patient died on an unspecified date. An autopsy was performed, and results were not provided. 1 hour after vaccination the patient developed unknown cause of death, lasting for unknown. The patient was dead, and condition was life threatening. Death cause was reported as unknown cause of death. Relatedness of drug to reaction(s)/event: (Source of assessment: Regulatory Authority) D. Unclassifiable. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 960061 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Cardiac insufficiency; Food refusal; Pneumonia hypostatic; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039278

Write-up: Lethal death less than 24 hours after vaccination; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority number DE-PEI-PEI2021000698. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 prophylaxis. Medical history included cardiac insufficiency, renal insufficiency, pneumonia hypostatic, food refusal. The patient''s concomitant medications were not reported. Less than 24 hours after vaccination the patient developed death. The patient was dead in Jan2021. It was not reported if an autopsy was performed. Source of assessment PEI, Result of Assessment was unclassifiable.; Reported Cause(s) of Death: Lethal death less than 24 hours after vaccination


VAERS ID: 960062 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia; Depression; Gastritis; Hepatic cirrhosis; Hypertension; Incontinence; Renal insufficiency (Grade 3)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039276

Write-up: Died in a palliative situation; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-PEI-PEI2021000719]. A female 93-year-old patient, was vaccinated with the first dose of Comirnaty, (lot/batch no.: EM0477) for COVID-19 prophylaxis on 13Jan2021. Medical history included: Hepatic cirrhosis, Renal insufficiency, Dementia, Depression, Hypertension, Atrial fibrillation, Incontinence, Gastritis, all from an unknown date and unknown if ongoing, General condition fluctuating in the last few months. Concomitant medication was not reported. 6 hours after vaccination(on 13Jan2021) the patient died in the afternoon, died in a palliative situation. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 960063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Huntington's disease, Seizure
SMQs:, Systemic lupus erythematosus (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   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: Medical History/Concurrent Conditions: Huntington''s chorea
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039295

Write-up: Death on 14Jan2021, mainly convulsions in Huntington''s disease; Death on 14Jan2021, mainly convulsions in Huntington''s disease; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA)Regulatory authority-WEB [DE-PEI-PEI2021000739]. A 56-year-old female patient received bnt162b2 (COMIRNATY, Batch/lot number: EJ6797), intramuscular on 01Jan2021 at single dose for COVID-19 immunization (covid-19 prophylaxis). Medical history included Huntington''s chorea. The patient''s concomitant medications were not reported. The patient was died on 14Jan2021 due to mainly convulsions in Huntington''s disease on 14Jan2021. It was not reported if an autopsy was performed. Additional information included: The following differential diagnoses were excluded: no clarifying examination. No outpatient treatment necessary. Outcome of the events was fatal.; Reported Cause(s) of Death: Death on 14Jan2021, mainly convulsions in Huntington''s disease; Death on 14Jan2021, mainly convulsions in Huntington''s disease


VAERS ID: 960064 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039301

Write-up: Vd. a. delayed allergic reaction; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) WEB. Regulatory authority report number DE-PEI-PEI2021000779. A female patient of 66 years old received the first dose of BNT162B2 (COMIRNATY, batch/lot number unknown, expiration date unknown), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. 2 days after vaccination on 11Jan2021 the patient developed vd. a. delayed allergic reaction, lasting for 4 days. The patient was dead on 14Jan2021 and condition was life threatening. It was not reported if an autopsy was performed. Event Assessment: PEI / D. Unclassifiable.; Reported Cause(s) of Death: vd. a. delayed allergic reaction


VAERS ID: 960065 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective, Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: 202101; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 202101; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021039308

Write-up: COVID-19 pneumonia/ Covid-19 disease; Acute dyspnea; COVID-19 pneumonia/ Covid-19 disease/ COVID-19 PCR test: positive, SARS-CoV-2 test: positive; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-PEI-PEI2021000799]. An 87-year-old male patient received the first dose of bnt162b2 (COMIRNATY, batch/lot number: EJ6797), via an unspecified route of administration on 04Jan2021 at single dose (1 dose form) for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 07Jan2021 (pending clarification), 4 days after vaccination the patient developed Acute dyspnea and COVID-19 pneumonia/ Covid-19 disease, lasting for 6 days. The patient was dead in Jan2021 and condition was life-threatening. In Jan2021, COVID-19 PCR test: positive, SARS-CoV-2 test: positive. Death cause was reported as COVID-19 pneumonia and acute dyspnea. It was unknown if an autopsy was performed. The outcome of the events was fatal.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 pneumonia/ Covid-19 disease/ COVID-19 PCR test: positive, SARS-CoV-2 test: positive; acute dyspnea


VAERS ID: 960066 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021033073

Write-up: exitus letalisin temporary association with vaccination; This is a spontaneous report from a contactable other healthcare professional received via local supervisory health authority. An 86-year-old female patient received her first dose of bnt162b2 (COMIRNATY, lot number EJ6796), via an unspecified route of administration on left arm on 11Jan2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was vaccinated with Comirnaty on 11Jan2021, after about 36 hours she died (exitus letalisin temporary association with vaccination). The patient died in Jan2021. It was not reported if an autopsy was performed. Autopsy for clarification of cause of death will be carried out.; Sender''s Comments: The event death is assessed as related to BNT162b2 vaccine and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. 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: died


VAERS ID: 960067 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021038935

Write-up: death after vaccination; This is a spontaneous report from a contactable consumer via newspaper. This report was received via a sales representative. This reporter reported the same event for two patients. This is the 1st of the two reports. A patient of unspecified age and gender received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced death on the day of vaccination in a retirement home. It was unknown if autopsy was performed. Outcome of the event was fatal. Information on the Batch/Lot number has been requested.; Reported Cause(s) of Death: death after vaccination


VAERS ID: 960068 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039425

Write-up: deaths on the day of vaccination; This is a spontaneous report from a contactable consumer via newspaper via a sales representative. This consumer reported same event for two patients. This is the second of two reports. A patient of unspecified age and gender started to receive bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The consumer reported of 2 deaths on the day of vaccination in a retirement home. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021038935 Same reporter/drug/event, different patient; Reported Cause(s) of Death: deaths on the day of vaccination


VAERS ID: 960071 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021039083

Write-up: died; This is a spontaneous report received from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date to at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had this vaccine died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: DEATH


VAERS ID: 960081 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-18
Onset:2020-12-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553/V0003 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Vaccination site discomfort
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-20
   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: ; ; ; ; ; FENBID; ; ; HYLO-FORTE
Current Illness: Disease risk factor (High risk of heart disease and diabetes mellitus (DM))
Preexisting Conditions: Medical History/Concurrent Conditions: Epiretinal membrane; Gout; Hypertension; Lumbar spondylosis; Osteoarthritis; Sciatica; Swelling of legs
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021031446

Write-up: heavy sensation in arm following jab; Death; This is a spontaneous report from a contactable physician. Report downloaded from the Agency Regulatory Authority-WEBGB-MHRA-EYC 00236211 with Safety Report Unique Identifier of GB-MHRA-ADR 24546700. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch: EJ0553/V0003), intramuscular in arm on 18Dec2020 at 30 ug single (30micrograms/0.3ml dose) for COVID-19 immunization. Medical history included gout, hypertension, Lumbar spondylosis, Epiretinal membrane, Swelling of legs, Sciatica, Osteoarthritis (all unknown if ongoing), had ongoing high risk of heart disease and diabetes mellitus (DM). Concomitant medication included allopurinol, acetylsalicylic acid, simvastatin, amitriptyline, tramadol hydrochloride, ibuprofen (FENBID) gel, buspirone, atenolol, hyaluronate sodium (HYLO-FORTE) eye drops. Patient died of unknown cause 2 days later (on 20Dec2020). Daughter has confirmed he had heavy sensation in arm following jab, but no other symptoms, he was found dead in bed. The outcome of heavy sensation in arm was not recovered. Awaiting coroners post-mortem (PM) for medical certificate cause of death (MCCD). The reporting physician did not think that the death is likely to be related to the administration of the vaccine. It was unknown if an autopsy was performed. No follow-up attempts needed. No further information expected.; Sender''s Comments: The 85-year-old male patient had medical history included gout, hypertension, lumbar spondylosis, epiretinal membrane, swelling of legs, sciatica, osteoarthritis, ongoing high risk of heart disease and diabetes mellitus (DM), and was on multiple concomitant medications. He received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020, and died of unknown cause 2 days later. He had heavy sensation in arm following jab, but no other symptoms, and he was found dead in bed. The company concurs with the reporting physician that the death is not likely to be causally related to the administration of the vaccine.; Reported Cause(s) of Death: Death


VAERS ID: 960085 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   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: Comments: Age: 89 Years on 14/01/2021.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021041290

Write-up: Death; This is a spontaneous report from a contactable pharmacist from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-MIDB-24bf16e9-34d0-4256-9367-73d873ad0e9a and GB-MHRA-ADR 24596015. An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0141), intramuscularly in the right arm, on 13Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 14Jan2021, which was reported as fatal. The clinical course was reported as follows: On 13Jan2021, the patient received the first dose of the vaccine at approximately 14:00-15:00 and died during the night. The pharmacist reported that the exact cause of death was unknown but think likely to be due to natural causes but unable to rule out. The patient had reported feeling generally well immediately following administration of the vaccine dose and before going to bed but didn''t wake up. The patient died on 14Jan2021 (as reported). The cause of death was reported as unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 960093 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-19
Onset:2020-12-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Haematemesis, Loss of consciousness, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-12-21
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201116; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021031481

Write-up: Loss of consciousness; Dizziness; High temperature; Vomiting blood; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority WEB (Regulatory Authority number GB-MHRA-WEBCOVID-20201223182431, Safety Report Unique Identifier GB-MHRA-ADR 24546960). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020, at single dose, for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. The patient underwent a COVID-19 virus test on 16Nov2020 with negative result. The patient experienced vomiting blood on 21Dec2020. On an unspecified date he experienced also loss of consciousness, dizziness and high temperature. All the events were reported as serious as fatal, per hospitalization, disability, medically significant, life threatening. They were reported as serious also per congenital anomaly (no further information provided). Therapeutic measures were taken as a result of all the reported events. The patient died on 21Dec2020. It was not reported if an autopsy was performed. Verbatim EMA narrative: Vomiting blood, vomiting, dizziness, loss of consciousness, fainting, high temperature very often. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: loss of consciousness; Dizziness; High temperature; Vomiting blood


VAERS ID: 960101 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553-L449 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
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: Urinary tract infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021027969

Write-up: drug ineffective; COVID-19; Sepsis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB manufacturer report number GB-Regulatory Authority-WEBCOVID-20210107092914. An 82-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EJ0553-L449), via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunisation. The patient medical history included urinary tract infection. Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications included antibiotics for urinary tract infection. The patient died on 31Dec2020. Probably unrelated to vaccine but patient died of covid. The patient had a minor urinary tract infection and was on antibiotics. Clinically well and no sepsis. However admitted to hospital soon after with sepsis and died. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts possible. No further information expected. Lot/batch number was provided.; Reported Cause(s) of Death: COVID-19; Sepsis


VAERS ID: 960111 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acidosis, Blood lactic acid, Blood lactic acid increased, Confusional state, Death, Echocardiogram, Electrocardiogram ST segment elevation, Hemiparesis, Right ventricular enlargement
SMQs:, Cardiac failure (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Pulmonary hypertension (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tumour lysis syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypercholesterolaemia; Hypertension; Comments: Unsure if patient has had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: blood lactic acid; Result Unstructured Data: Test Result:increased; Test Date: 20210107; Test Name: Echocardiography; Result Unstructured Data: Test Result:normal left ventricle but large right ventricle; Test Date: 20210107; Test Name: Electrocardiogram ST segment elevation; Result Unstructured Data: Test Result:widespread and then inferolateral ST elevation
CDC Split Type: GBPFIZER INC2021031416

Write-up: Death unexplained; Electrocardiogram ST segment elevation; Hemiparesis/right-sided facial weakness; Confusional state; Acidosis/acidemia; high lactate/blood lactic acid increased; Right ventricular enlargement; This is a spontaneous report from a contactable physician. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-20210107154410, Safety Report Unique Identifier GB-MHRA-ADR 24568917. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not known) via an unspecified route of administration on 05Jan2021 at a single dose for covid-19 immunization. Medical history included hypercholesterolaemia, hypertension and diabetes mellitus from unknown dates and unknown if ongoing, however fully active and mobile. Unsure if patient has had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Two days following vaccination she presented with widespread and then inferolateral ST elevation on ECG, hemiparesis and right-sided facial weakness, confusion state, high lactate/blood lactic acid increased and acidosis/acidemia. Echocardiography showed a normal left ventricle but large right ventricle. The differential was pulmonary embolism, intracranial haemorrhage/thrombosis and/or myocardial infarction. Unfortunately, she rapidly deteriorated and died. She has been referred to the coroner, so cause of death will hopefully be clarified. We are not referring as a definite side-effect, however, the temporal association and clinical findings, and after discussion with our lead pharmacist (and in my role as a medical examiner) we felt we should complete this as a possible reaction/complication. The patient died on 07Jan2021. The outcome of the events inferolateral ST elevation on ECG, hemiparesis and right-sided facial weakness, confusion state, high lactate/blood lactic acid increased and acidosis/acidemia was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 960117 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-05
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Haematemesis, Illness, Mobility decreased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Frailty; Comments: Frailty and alzheimer''s dementia Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021032294

Write-up: looked ill; feeling tired; not mobilising as normal; single large vomit of coffee grounds; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-Regulatory Authority-WEBCOVID-20210108074254, Safety Report Unique Identifier GB-Regulatory Authority-ADR 24571133. An 84 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number not known) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. Patient very frail and end stage dementia. Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 05Jan2021, the patient experienced haematemesis. The patient was unwell post vaccine which was given 5 days prior to reaction occurring - looked ill, feeling tired, not mobilising as normal, off food, no fevers, not vomited until 5th January - single large vomit of coffee grounds. Ambulance called but died in the community. The post-mortem was not being done. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 05Jan2021. An autopsy was not performed. The outcome of haematemesis was fatal and the outcome of the events looked ill, feeling tired, not mobilising as normal was unknown. No follow-up attempts possible; information regarding batch/lot cannot be obtained.; Reported Cause(s) of Death: single large vomit of coffee grounds


VAERS ID: 960122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-19
Onset:2021-01-06
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BNT162B2 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   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: Comments: Patient has not had symptoms associated with COVID-19 Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021031502

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-20210108135934, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 24573149. An 80-year-old male patient received dCOVID-19 MRNA VACCINE BIONTECH (BNT162B2) on 19Dec2020 at single dose for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. It is unsure if patient is enrolled in clinical trial. The patient experienced death on 06Jan2021. No reports of any reaction after having the vaccine. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on an unspecified date. Patient likely died from Coronary event. Death was reported to the Coroner. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 960173 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac arrest, Cardiac failure congestive, Condition aggravated, General physical health deterioration, Myocardial ischaemia, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-30
   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: ; ; ; ; ; ; COSMOCOL; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Congestive cardiac failure; Constipation; Epilepsy; Frailty; Indigestion; Ischaemic heart disease; LVH; Pain; TIA
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: o2 sats; Result Unstructured Data: Test Result:falling; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No
CDC Split Type: GBPFIZER INC2021024664

Write-up: Cause of death was unknown but was probably due to frailty/known IHD/CCF; Cause of death was unknown but was probably due to frailty/known IHD/CCF; Cause of death was unknown but was probably due to frailty/known IHD/CCF; Cause of death was unknown but was probably due to frailty/known IHD/CCF; General physical health deterioration; falling 02 sats; subsequent arrest; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number: GB-MHRA-WEBCOVID-20210112154920, and safety report unique identifier: GB-MHRA-ADR 24584672. A 90-year-old female patient received single dose of BNT162B2 (Solution for injection), via an unspecified route of administration on 29Dec2020 for COVID-19 immunization. Medical history included frailty of old age, congestive cardiac failure, atrial fibrillation (AF), left ventricular hypertrophy (LVH), transient ischaemic attack (TIA), ischaemic heart disease, epilepsy, indigestion, pain, and constipation. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included apixaban from 31Oct2019 for persistent atrial fibrillation, atorvastatin from 10Sep2019 for ischaemic heart disease, bisoprolol from 05Dec2017 for ischaemic heart disease, carbamazepine from 21Jan2002 for epilepsy, cimetidine from 03Apr2020 for indigestion, codeine from 22May2015 for pain, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (COSMOCOL) from 16Dec2019 for constipation, digoxin from 31Oct2019 for atrial fibrillation, furosemide from 05Mar2020 for heart failure, congestive; and perindopril from 11Jul2020 for heart failure, congestive. The patient experienced general physical health deterioration on 30Dec2020 next day after vaccination. Rapid deterioration in health: falling 02 sats and subsequent arrest. The events were considered serious: medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The outcome of general physical health deterioration, falling O2 sats, and subsequent arrest was unknown.The patient died on 30Dec2020. Cause of death was unknown but was probably due to frailty/known IHD/CCF. Cannot say if vaccination was causer of this but patient died within 24 hrs of the vaccination. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 960200 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lower respiratory tract infection, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-02
   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: Dementia; Frailty; Comments: Known frailty and advanced dementia in care home. Had vaccine on 31/12/20 developed chest infection on 02/01/2021. Rapidly deteriorated and passed away on 02/01/2021 Unsure if patient has had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20201127; Test Name: COVID-19 test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021033456

Write-up: Chest infection; This is a spontaneous report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101141121469160 and Safety Report Unique Identifier GB-MHRA-ADR 24594625. A contactable physician reported a 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1688) via an unspecified route on 31Dec2020 single dose for COVID-19 vaccination. The patient medical history included known frailty and advanced dementia in care home. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced chest infection on 02Jan2021. The patient had rapidly deterioration 48 hours after vaccine, developed chest infection and died. Patient had not tested positive for COVID-19 since having the vaccine. Reporter was unsure if patient had had symptoms associated with COVID-19. The patient underwent lab tests and procedures which included ''no - negative'' COVID-19 test on 27Nov2020. The patient died on 02Jan2021. It was unknown if an autopsy was performed. The cause of death was reported as chest infection. The action taken in response to the event(s) for BNT162B2 was not applicable. Outcome of the event was fatal. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Chest infection


VAERS ID: 960201 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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: ; ; ASPIRIN [ACETYLSALICYLIC ACID]; ; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment (mild); CVA; Myocardial infarction; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021040949

Write-up: Death; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101141345001560. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0141, via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included cerebrovascular accident from 2018 to an unknown date, myocardial infarction from 2018 to an unknown date and cognitive disorder (mild). Concomitant medication included atorvastatin (MANUFACTURER UNKNOWN), bisoprolol (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), tamsulosin (MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN) and esomeprazole (MANUFACTURER UNKNOWN). The patient has not had symptoms associated with COVID-19 and is not enrolled in a clinical trial. On 10Jan2021, the patient experienced death. It was reported that the patient was found dead at home 2 days after vaccination. It was discussed by the coroner that they felt it was likely due to myocardial infarction (MI) and likely unrelated to vaccination. The patient died on 10Jan2021. The cause of death was myocardial infarction. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 960202 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Steroid therapy (For exacerbation of COPD, not taking at time of vaccination); Comments: For exacerbation of COPD, not taking at time of vaccination. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021040991

Write-up: Death; This is a spontaneous report received from a contactable consumer by Pfizer from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-ADR 24600276. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK1768), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included steroid therapy from an unknown date and unknown if ongoing (For exacerbation of COPD, not taking at time of vaccination), chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced death on 13Jan2021; within 24 hours of receiving the vaccination. The patient had not had symptoms associated with COVID-19; and did not have a COVID-19 test. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in a clinical trial. The clinical outcome of the event was fatal. The patient died on 13Jan2021 due to unknown cause of death. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 960203 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021041094

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 24600508 and Safety Report Unique Identifier of GB-MHRA-WEBCOVID-202101151324539460. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1688), via an unspecified route of administration on 06Jan2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 15Jan2021; this was reported as an unexpected death. The patient died on 15Jan2021. It was not reported if an autopsy was performed. The cause of death was not reported. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 960204 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-15
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Death, Pallor
SMQs:, Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (Been in care since 201 (as reported)); Frailty; Comments: Severe Alzheimers Dementia Been in care since 201 Died suddenly on 15th November unexpected Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021040992

Write-up: Death; clammy and pale; clammy and pale; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-ADR 24601997. A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history included Severe Alzheimer''s disease from an unknown date and unknown if ongoing (Been in care since 201 (as reported)), frail from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced death (medically significant) on 15Jan2021, and clammy and pale (medically significant). The clinical course was reported as follows: the patient died suddenly on 15th November unexpected (as reported). The patient had been frail as normal; and became clammy and pale in the morning and then just died. The patient had not had symptoms associated with COVID-19; and did not have a COVID-19 test. The patient was not enrolled in a clinical trial. The patient had not tested positive for COVID-19 since having the vaccine. There was no relevant investigations or tests conducted. The clinical outcome of the event, death, was fatal. The clinical outcome of the events, clammy and pale, was unknown. The patient died on 15Jan2021 due to unknown cause of death. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 960207 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty; Anticoagulant therapy; Bone marrow transplant; Cardiac disorder NOS; Hepatic disorder NOS (caused by the anticoagulants he was receiving); Leukemia (unknown whether currently being treated); Myocardial infarction (second); Myocardial infarction (first); Osteonecrosis; Stent insertion NOS (2 of 2 stents that they were worn out); Stent insertion NOS (1 of 2 stents that they were worn out)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021045879

Write-up: cardiac arrest; felt dizzy; falling down; acute myocardial infarction; This is a spontaneous report from two contactable physicians (one was the hospital director and the other was the coordinator of the hospital vaccination program). A 63-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), intramuscular on 09Jan2021 as a single dose for COVID-19 vaccination. Medical history included leukemia (unknown whether currently being treated), bone marrow transplant on an unknown date, cardiac disorder, two myocardial infarctions on an unknown dates, 2 stent placements on unknown dates (that they were worn out), heart balloon insertion on an unknown date, hepatic problems caused by the anticoagulants, and aseptic hip necrosis. The patient''s concomitant medications were not reported. On 18Jan2021, the patient experienced acute myocardial infarction, felt dizzy, falling down, and cardiac arrest. The clinical course was as follows: On 18Jan2021, the patient went for a walk, he felt dizzy and fell down to the ground. The patient suffered a cardiac arrest. He was admitted to the hospital where an attempt was made to resuscitate him, but the patient died on 18Jan2021. The reason of death was recorded as an acute myocardial infarction. An autopsy was not performed and would not be performed. The clinical outcomes of felt dizzy, fall, and cardiac arrest were unknown at the time of death. One of the reporting physicians (coordinator of the hospital vaccination program who vaccinated the patient) mentioned that there was no possibility the adverse events and the death could be attributed to the vaccine and they were unrelated. No follow-up attempts are possible; information about lot number cannot be obtained.; Sender''s Comments: Based on the information available and on the pathophysiology of the event company does not reasonably attribute the reported event sas related to study vaccine, concomitant drugs, or clinical trial procedure. The event was likely due to subject underlying contributory factors. Case will be reevaluated based on further information during follow-up; Reported Cause(s) of Death: acute myocardial infarction


VAERS ID: 960208 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
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: 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: Illness
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021035780

Write-up: cardiac arrest; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included a background illness. The patient''s concomitant medications were not reported. The patient passed away from a cardiac arrest on an unspecified date, less than 24 hours after the second vaccination. The patient has a background illness but in good condition and functioning. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 960210 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021031629

Write-up: Death; This is a spontaneous report from a contactable physician via a sales representative. A 64-years-old male patient who was a physician received bnt162b2 (COMIRNATY, Lot number: EL1484, Expiration Date: Apr2021), via an unspecified route of administration on 13Jan2021 13:58 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was reported as multipathological subject. The reporter learned the news from the local press, front page of the newspaper. The patient experienced died following vaccination on an unspecified date in Jan2021. The patient was found death at home from his son on 14Jan2021. An autopsy would be performed.; Sender''s Comments: The event death is assessed as related to BNT162b2 vaccine and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. 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: 960215 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease aggravated, Feeling hot
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   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: ; BRONKYL; SPIRONOLACTONE ORION; HALDOL; PARACET [PARACETAMOL]; KALEORID; FURIX [FUROSEMIDE]; ATROVENT; PRADAXA; ZOPICLONE ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; COPD; Cor pulmonale; Dementia (Due to hyponatremia); Heart failure; Hypertension; Hypertonia; Hypokalemia; Hyponatremia (Due to medication use); Oedema; Pain NOS; Sleep disorder NOS; Terminal state; Unrest
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021035345

Write-up: CONCOMITANT DISEASE AGGRAVATED; Sensation of warmth; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U33d1, with Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013799. A 94-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, batch/lot number not provided), intramuscularly in left arm on 05Jan2021 at 11:00 at single dose (1st dose in left arm) for Covid-19 vaccination. The patient''s medical history included terminal state, hyponatremia (due to medication use), dementia (due to hyponatremia), cor pulmonale, chronic obstructive pulmonary disease (COPD), heart failure, hypertonia, hypertension, oedema, unrest, pain NOS, hypokalemia, atrial fibrillation, and sleep disorder NOS. The patient''s concomitant medications were metoprolol (strength: 50 mg) for hypertension, acetylcysteine (BRONKYL, strength: 200 mg), for COPD, spironolactone (SPIRONOLACTONE ORION, strength: 25 mg), for oedema and cardiac failure, haloperidol (HALDOL, strength: 1 mg) for unrest, paracetamol (PARACET, strength: 500 mg) for pain NOS, potassium chloride (KALEORID, strength: 750 mg) for hypokalemia, furosemide (FURIX, strength: 40 mg) for heart failure, ipratropium bromide (ATROVENT, strength: 0.25 mg) for COPD, dabigatran etexilate mesilate (PRADAXA, strength: 110 mg) for atrial fibrillation, and zopiclone (ZOPICLONE ACTAVIS, strength: 5 mg) for sleep disorder NOS. The patient experienced sensation of warmth on 05Jan2021, and concomitant disease aggravated on 06Jan2021. The patient died on 07Jan2021. It was not reported if an autopsy was performed but with unknown results. The Regional Pharmacovigilance Center assessed the causality between BNT162B2 and the events Sensation of warmth and Concomitant disease aggravated as Possible. According to reporter, death was caused by known concomitant disease (as reported). There is no clinical suspicion of a link between the vaccine and death. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Sensation of warmth; CONCOMITANT DISEASE AGGRAVATED


VAERS ID: 960216 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, General physical health deterioration, Weight
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia (gradual deterioration since start of year 2020.); Reduced general condition; Underweight
Preexisting Conditions: Medical History/Concurrent Conditions: Fall; UTI
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: Weight; Test Result: 38.6 kg; Comments: with clothes and shoes
CDC Split Type: NOPFIZER INC2021035332

Write-up: REDUCED GENERAL CONDITION; REDUCED GENERAL CONDITION; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB NO-NOMAADVRE-FHI-2021-Ugy5d, Sender Safety Report Unique Identifier: NO-NOMAADVRE-E2B_00013860. An 89-years-old female patient received bnt162b2 (COMIRNATY) batch EJ6795, first dose intramuscular in left arm at single dose on 06Jan2021 at 17:30 for covid-19 vaccination. Medical history included fall from 05Jan2021, ongoing underweight, urinary tract infection from 31Dec2020, ongoing dementia since an unknown date, and gradual deterioration since start of year 2020; ongoing signs of reduced general condition since 05Jan2021. The patient''s concomitant medication was not reported. The past drug included pivmecillinam (SELEXID, 400mg) at 400mg taken 3x/day for urinary tract infection from 31Dec2020 to 06Jan2021. The patient experienced reduced general condition since 07Jan2021. The patient underwent lab tests and procedures which included weight: 38.6 kg on 07Jan2021 with clothes and shoes. The patient died on 11Jan2021 at 09:10. It was not reported if an autopsy was performed. The Center assessed the causality between bnt162b2 and the event death as Possible. Narrative verbatim: The patient has dementia, gradually declined from the beginning of the year 2020. First cognitive impact after the measures that came in connection with COVID-19. The patient has shown less interest, isolated himself and had reduced appetite. Weight loss despite measures to prevent malnutrition. Last weight check taken 07Jan2021 - 38.6kg (with clothes and shoes). The last 14 days before her death, the patient has had a urinary tract infection. Selexid 400mg 1x3 was started 31Dec2020 in consultation with the emergency ward, and stopped 06Jan2021. The patient received Comirnaty on 06Jan2021 at 17:30, and the last Selexid tablet was given around that time. According to the medical record, the patient had signs of reduced general condition 24 hours before the vaccine was given. On 05Jan2021 the patient fell after visit. After the vaccine was given, the patient has been conscious and was active despite reduced general condition (called the staff for help, move with a walker, among other things). On 07Jan2021 the patient was confused, did not remember where she was and what time of day it was. This persisted until her death. Her general condition progressed last 24 hours and the patient was considered as a terminal. The patient died 11Jan2021 at 09:10. A 89 Years old Female patient received Comirnaty 06Jan2021 for VACCINATION. The medical history included DEMENTIA, FALL (05Jan2021), UTI (31Dec2020), UNDERWEIGHT. The patient was treated in the past with Selexid. On 07Jan2021, the patient developed GENERAL PHYSICAL CONDITION DECREASED. Relevant laboratory findings and investigations included in the report (WEIGHT, 07Jan2021, 38.6kg (with clothes and shoes)). Action taken was: Not Applicable. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. This case was received from a Physician. Sender''s comment as reported: Background: An 89-year-old woman with known dementia, who has gradually declined since the beginning of 2020, decreased appetite and weight loss, was vaccinated with Comirnaty 06Jan2021 at 17:30. Urinary tract infection in the last 14 days, treated with Selexid (pivmecillinam) which was terminated on 06Jan2021. The patient had had signs of impaired general condition (AT) in the last 24 hours before vaccination. Further reduction in general condition until the patient died 11Jan2021. Comment: It was reported that the patient had several underlying diseases before the vaccination. Based on the information in the report it is likely that the underlying diseases is the cause of the death. However, there is a temporal correlation and it cannot be entirely ruled out that the vaccine could have contributed to the worsening of the patient''s underlying diseases. It can also be that the event had a completely different cause which coincidentally developed after the vaccination. Based on the criteria from WHO we assess the causal relationship between Comirnaty and death as Possible. Meaning, a reaction, including pathological lab samples, that happens in a temporal correlation to the use of a pharmaceutical but which could also be caused by underlying disease, other pharmaceuticals or chemicals. Based on the given criteria the report is assessed as serious.; Reporter''s Comments: Reporter''s qualification: physician; Reported Cause(s) of Death: REDUCED GENERAL CONDITION; REDUCED GENERAL CONDITION


VAERS ID: 960217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Heart rate, Heart rate increased, Loss of consciousness, Pallor, Pupil fixed, Pupillary light reflex tests, Pyrexia, Respiratory rate, Respiratory rate increased, Somnolence, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; ; NORSPAN [BUPRENORPHINE]; PARACET [PARACETAMOL]
Current Illness: Aphasia (Lost the ability to verbally communicate. Care givers have to evaluate the patient''s condition...); Dementia (Do not resuscitate order in agreement with relatives/next of kin.); Living in nursing home; Polymyalgia rheumatica
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis (Twice.); Pain; Pulmonary embolism; Recurrent UTI (Since admission to nursing home.)
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: Body temperature; Result Unstructured Data: Test Result:Subfebrile; Test Date: 20210110; Test Name: Pulse rate; Result Unstructured Data: Test Result:140; Comments: Units:{beats}/min; Test Date: 20210110; Test Name: Light reflex tests pupillary; Result Unstructured Data: Test Result:Fixed pupils, 2 mm, not reactive to light; Test Date: 20210110; Test Name: Respiratory rate; Result Unstructured Data: Test Result:40; Comments: Units:/min
CDC Split Type: NOPFIZER INC2021035333

Write-up: fixed pupils; Lost consciousness, elevated respiratory rate and pulse, resulting in death; Lost consciousness, elevated respiratory rate and pulse, resulting in death; Lost consciousness, elevated respiratory rate and pulse, resulting in death; subfebrile; tired; pallor skin; sleeps heavily; tremors; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority -WEB NO-NOMAADVRE-FHI-2021-Uj4x1, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013871. A contactable other hcp reported that an 86-year-old female patient had received bnt162b2 (COMIRNATY, batch/lot number ej6795), via intramuscular route on 05Jan2021 at single dose (first dose, administered into left arm) for covid-19 immunisation. Medical history included ongoing aphasia (lost the ability to verbally communicate, care givers have to evaluate the patient''s condition from her facial expression), pulmonary embolism, ongoing dementia (do not resuscitate order in agreement with relatives/next of kin), deep vein thrombosis (twice), urinary tract infection from 2019 (since admission to nursing home), ongoing polymyalgia rheumatica, living in residential institution from 2019 and ongoing, and pain. Concomitant medications included apixaban (ELIQUIS, 2.5 mg) taken orally as anticoagulant therapy from 14Dec2017 at a dose of 2.5 mg every 12 hours, prednisolone (PREDNISOLONE, 5 mg) taken orally for polymyalgia rheumatica from 25Mar2015 at a dose of 10 mg every 24 hours, buprenorphine (NORSPAN [BUPRENORPHINE]) via transdermal route (patch), first started on an unspecified date in 2018, then from 13Mar2020 at a dose of 15 microgram/hour for pain, and paracetamol (PARACET [PARACETAMOL], 1 g) taken for pain from 25Mar2015 at a dose of 1 g every 8 hours. The patient lost consciousness, got elevated respiratory rate and pulse, all on 09Jan2021, eventually resulting in death. The patient died on 10Jan2021. On 09Jan2021, the patient experienced subfebrile, tired, pallor skin, slept heavily, tremors; and on 10Jan2021, Fixed pupils, outcome was these events were unknown. The patient underwent lab tests and procedures which included body temperature on 10Jan2021 with the subfebrile result, heart rate: 140 {beats}/min on 10Jan2021, pupillary light reflex tests on 10Jan2021 - fixed pupils, 2 mm, not reactive to light, and respiratory rate: 40/min on 10Jan2021. It was not reported if an autopsy was performed. The Regional Pharmacovigilance Center has assessed the causal relationship between the suspect product and the reported events as possible. Case narrative (from the Health Authority) including clinical course, therapeutic measures, outcome and additional relevant information: "A 86 Years old Female patient received Comirnaty on 05/Jan/2021 for VACCINATION. As concomitant medication the patient was given Eliquis, Prednisolone, Paracet, Norspan. The medical history included DEEP VEIN THROMBOSIS (twice), PULMONARY EMBOLISM, POLYMYALGIA RHEUMATICA, DEMENTIA with APHASIA, RECURRENT UTI (2019). Due to her dementia and aphasia she has had a pronounced need for assistance, and in agreement with her relatives/next of kin, she has a standing do not resuscitate (DNR) order. The patient has been a long-term resident at a nursing home since 2019, and has had a stable condition except for recurrent UTI. Her life expectancy was above 3 months at the time of the vaccination. On 09Jan2021, the patient was in her habitual state until the afternoon, when she became subfebrile, tired, and with pallor skin. She would not eat or drink the rest of the day and sleeps heavily, but reacts and awakens upon light shaking. On the morning of 10Jan2021 she seemed tired, would not open her eyes. When being rolled over for a change of diaper, the patient experienced sudden tremors, and developed LOSS OF CONSCIOUSNESS. Upon examination, she also has RESPIRATORY RATE INCREASED, HEART RATE INCREASED. Relevant laboratory findings and investigations included in the report (RESPIRATORY RATE, 10Jan2021, 40/min)( PULSE RATE, 10Jan2021, 140 bpm)( LIGHT REFLEX TESTS PUPILLARY, 10Jan2021, Fixed pupils, 2 mm, not reactive to light.)( BODY TEMPERATURE, 10Jan2021, Subfebrile). A palliative regime was started and the patient died the same day. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. This case was received from a Other health professional. Sender''s comments (Health Authority comments): "The report concerns loss of consciousness, increased respiratory rate and heart rate, which resulted in the death of a nursing home patient in her 80s, a few days after receiving the first dose of the Covid-19 vaccine Comirnaty. Reporter states that the patient is a resident of a long-term ward, does not speak, and otherwise had a great need for assistance, due to dementia. The patient also had polymyalgia rheumatica and recurrent urinary tract infections, but has otherwise been stable during her stay in the ward. Life expectancy was estimated to be over 3 months, when the vaccine was administered. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or other accidental, concurrent cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lost consciousness, elevated respiratory rate and pulse, resulting in death; Lost consciousness, elevated respiratory rate and pulse, resulting in death; Lost consciousness, elevated respiratory rate and pulse, resulting in death


VAERS ID: 960218 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Reduced general condition
Preexisting Conditions: Medical History/Concurrent Conditions: Fall (A few month ago); Femoral neck fracture (A few month ago); Living in nursing home
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021038913

Write-up: gradually lost himself to falling asleep quietly; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, the regulatory authority report number is NO-NOMAADVRE-FHI-2021-Unrn7. A 87-year-old male patient received bnt162b2 (COMIRNATY, lot number: EJ6795), intramuscular in Left Arm on 07Jan2021 10:20 at single dose for covid-19 immunisation. Medical history included living in nursing home, fall with femoral neck fracture a few months ago in 2020, ongoing reduced general condition, and ongoing dementia. The patient''s concomitant medications were not reported. The patient had advanced dementia and with gradual deterioration recently. Had, among other things, had a fall with a fracture of the femoral neck a few months ago and had in that connection had a place in the nursing home. Lately in the vaccine he had no signs of infection but he had gradually lost weight. Ate and drank less. This gradual reduction in "AT" and "ET" continued after vaccination was given. He did not get any allergic reactions, did not fail but gradually lost himself to falling asleep quietly in 13Jan2021. Clinically, this appears more like a natural last time and not a side effect of the vaccine, but as it was completely new, this case was reported. With the strengthened recommendations according to the elderly who came after the vaccination, the patient should not have had the vaccine when he had a short time left in the beginning and physician did not think that the vaccine made the difference here and the patient had expected a short lifespan but as physician said it was a death so it was reported. The patient died on 13Jan2021. It was unknown if an autopsy was performed. Reporter''s assessment of relatedness of the events to the suspect drug: possible. Case comment: The information is registered in the national adverse reaction register (the Medicines Agency), and then forwarded to international adverse reaction databases. In this way, your message becomes part of an important international collaboration that is continuously ongoing to monitor and maintain safe vaccination worldwide. Based on the information in the report, it is likely that the underlying diseases are the cause of death. However, there is a temporal connection, and it cannot be completely ruled out that the vaccine may have contributed to the aggravation of the patient''s underlying disease. Based on WHO criteria, we consider the causal link between Comirnaty and death to be possible. That is, reaction, including pathological laboratory tests, which occurs in temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Based on given criteria, the report is considered serious.; Reported Cause(s) of Death: gradually lost himself to falling asleep quietly


VAERS ID: 960219 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Blood pressure measurement, Intracardiac thrombus, Nausea, Oxygen saturation, Respiratory rate increased, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   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: ALBYL-E; LEVAXIN; LITHIONIT; CIPRAMIL [CITALOPRAM HYDROBROMIDE]; TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE]; SIMVASTATIN SANDOZ
Current Illness: Hypercholesteremia; Living in nursing home; Psychiatric disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: Blood pressure; Result Unstructured Data: Test Result:drop in blood pressure; Test Date: 20210106; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:drop in oxygen saturation
CDC Split Type: NOPFIZER INC2021038848

Write-up: RESPIRATORY RATE HIGH; VOMITING; NAUSEA; ACUTE CORONARY SYNDROME; Cardiac thrombosis; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uq8ag, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013788. A contactable physician reported that an 82-year-old female patient received bnt162b2 (COMIRNATY, lot number: EJ6795), via intramuscular route on 05Jan2021 at a single dose (first dose, administered into left arm) for covid-19 immunisation. Medical history included ongoing mental disorder, ongoing living in residential institution and ongoing hypercholesteremia. Concomitant medications included acetylsalicylic acid, magnesium oxide (ALBYL-E, 75 mg) administered via oral route, levothyroxine sodium (LEVAXIN, 100 ug), lithium sulfate (LITHIONIT, 83 mg) administered via oral route, citalopram hydrobromide (CIPRAMIL [CITALOPRAM HYDROBROMIDE], 10 mg) administered via oral route, cyanocobalamin, folic acid, pyridoxine (TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE], 0.5 mg/0.8 mg/3 mg), and simvastatin (SIMVASTATIN SANDOZ, 40 mg), all from an unspecified date in 2019 to an unspecified date in 2021 for unknown indication. The patient experienced respiratory rate high, vomiting, nausea and acute coronary syndrome (ACS), all on 06Jan2021 with fatal outcome. The patient underwent lab tests on 06Jan2021 which included blood pressure measurement: drop in blood pressure and oxygen saturation: drop in oxygen saturation. The patient died on 06Jan2021. An autopsy was performed that revealed cardiac thrombosis (intracardiac thrombus) as the cause of death. The Regional Pharmacovigilance Center has assessed the causal relationship between the suspect product and respiratory rate high, vomiting and nausea as Possible, and causal relationship between the suspect product and acute coronary syndrome as Unlikely. Reporter''s comment: The patient developed nausea and vomiting 24 hours later. Subsequent frequent superficial respiration with BT (blood pressure) and SAT (oxygen saturation) fall. Clinical suspicion of "ACS syndrome (reported as AKS)". 15-Jan-2021 RELIS: additional information received by telephone: Patient with comorbidity psychiatric disorder, hypercholestrolemia, reduced functional level. No known heart failure at time of vaccination. Residence at nursing home not considered as terminal, hard to say but expected lifetime about 1.5 years. Preliminary autopsy report concludes: CARDIAC THROMBOSIS cause of death. Sender''s comments (Health Authority comments): "The report concerns a nursing home resident with several underlying diseases who, within 24 hours after vaccination, developed nausea, vomiting and hyperventilation, interpreted as a possible ACS. Information has been obtained from a temporary autopsy report where a blood clot in the heart has been detected. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It is difficult to imagine how the vaccine can cause a blood clot in the heart within a day. The patient had several underlying risk factors for ischemic heart disease, and it is considered that these are more likely to have caused the reported symptoms. However, it cannot be ruled out that the vaccine has contributed to some of the symptoms, as nausea and vomiting are known side effects of the vaccine. Nor can it be ruled out that side effects of the vaccine have led to a worsening of the patient''s underlying diseases". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: respiratory rate high; vomiting; nausea; acute coronary syndrome; CARDIAC THROMBOSIS; Autopsy-determined Cause(s) of Death: CARDIAC THROMBOSIS


VAERS ID: 960220 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021038893

Write-up: PNEUMONIA; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority NO-NOMAADVRE-FHI-2021-Uwje5. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013917. A 74-year-old male patient received first dose bnt162b2 (COMIRNATY) (Add info: J07BX - Other virus vaccines), intramuscular on 05Jan2021 at single dose (Dose no. in series: 1 ) for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced pneumonia on 08Jan2021, which les to death, with fatal outcome. The patient died in Jan2021. It was not reported if an autopsy was performed. Relatedness of suspect drug to AE assessed by Regional Pharmacovigilance Center as Possible. Sender''s comments : A man in his 70s, a nursing home resident, received the Covid-19 vaccine Comirnaty. He was evaluated at the hospital three days after vaccination to have clinical, biochemical, radiologically safe pneumonia with fatal outcome. There is no information in the report about any comorbidity, drugs in use or the status of the Covid-19 test. Uncertain causal relationship. The current incident is currently no known side effect of this vaccine. The incident most likely had another cause that occurred with a random coincidence in time, close to the time of vaccination. However, it cannot be ruled out that the vaccine may have contributed to some of the symptoms at the beginning of the course of the disease, or may have contributed to the worsening of any relevant underlying disease in the patient. Your message is important to increase knowledge about side effects that have not been discovered in the studies so far. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: PNEUMONIA


VAERS ID: 960221 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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: ALBYL-E; IMOVANE; PINEX FORTE; LEVAXIN; LISINOPRIL/HYDROKLORTIAZID; TRESIBA; AMLODIPIN ACCORD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Palliative care; Terminal state
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021035341

Write-up: DEATH; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory authority WEB. Regulatory authority report number is NO-NOMAADVRE-FHI-2021-Uzd7p, safety report unique identifier: NO-NOMAADVRE-E2B_00013904. A contactable physician reported that a 90-year-old female patient received first dose BNT162B2 (COMIRNATY, Solution for injection; lot number: EJ6795; expiry date: not known), intramuscular in the left arm on 05Jan2021 12:00 at single dose for Covid-19 vaccination. Medical history included terminal state and palliative care. Concomitant medications included acetylsalicylic acid, magnesium oxide (ALBYL-E), zopiclone (IMOVANE), codeine phosphate, paracetamol (PINEX FORTE), levothyroxine sodium (LEVAXIN), hydrochlorothiazide, lisinopril (LISINOPRIL/HYDROKLORTIAZID), insulin degludec (TRESIBA), and amlodipine besilate (AMLODIPIN ACCORD). The patient experienced death on 08Jan2021 (three days after the vaccination). It was unknown if an autopsy was performed. The Regional Pharmacovigilance Center assessed the causality between BNT162B2 and the event death as "possible". Sender''s comment: In the report it was stated that it clinically didn''t appear to be a connection between the vaccination and death. When vaccinating marginal patients who have underlying diseases, some serious events may arise shortly after vaccination without there being a correlation to the vaccination. However, it cannot be completely ruled out that the vaccination has contributed to the worsening of the patient''s underlying diseases. In the individual case, it is hard to know whether the event was caused by the vaccine, the patient''s underlying disease or some other random, coinciding cause which does not have anything to do with the current vaccination.; Reported Cause(s) of Death: Death


VAERS ID: 960225 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
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: 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: PTPFIZER INC2021034241

Write-up: Death; This is a spontaneous report from a contactable healthcare professional (HCP). This is a report received from the agency, I.P., National Authority of Medicine and Health Products, I.P. The Regulatory authority report number was not provided. An 81-year-old male patient received one dose of the BNT162B2 (COMIRNATY) via unspecified route 0.3 mL single for COVID-19 immunisation on an unspecified date. The patient medical history and concomitant medications were not reported. The patient death was reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. The reported cause of death was unknown. The action taken in response to the event for BNT162B2 was not applicable. Outcome of the event was fatal. No follow-up attempts are possible. Information on batch number cannot be obtained. No further Information is expected.; Reported Cause(s) of Death: death


VAERS ID: 961897 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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: ELIQUIS; ENTRESTO; OXYCODON; ; MCP; ; DIGIMERCK; NOVAMINSULFON;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Breast cancer metastatic (With bone and liver metastases); Carcinoma of rectum; Cardiomyopathy; Coronary heart disease; Mitral valve insufficiency; Pulmonary embolism; Renal insufficiency; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: negative rapid test
CDC Split Type: DEPFIZER INC2021039352

Write-up: Sudden death, cause unknown; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021000426. A 80-year-old female patient received first dose of bnt162b2 (COMIRNATY) (lot/batch number EJ6796), intramuscular on 08Jan2021 at single dose for covid-19 immunization. Medical history included renal failure from an unknown date and unknown if ongoing, breast cancer female from an unknown date and unknown if ongoing, with bone and liver metastases, coronary artery disease from an unknown date and unknown if ongoing, mitral valve incompetence from an unknown date and unknown if ongoing, type 2 diabetes mellitus from an unknown date and unknown if ongoing, rectal cancer from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing, pulmonary embolism from an unknown date and unknown if ongoing, cardiomyopathy from an unknown date and unknown if ongoing. Concomitant medication included apixaban (ELIQUIS), sacubitril valsartan sodium hydrate (ENTRESTO), oxycodone hydrochloride (OXYCODON), metoprolol, metoclopramide (MCP), citalopram, digitoxin (DIGIMERCK), novaminsulfon, tamoxifen. 155 minutes after vaccination (08Jan2021) the patient developed death sudden, lasting for unknown. The patient was in satisfactory condition prior to vaccination. The vaccination was expressly requested. The patient is dead. Death cause was reported as Sudden death, cause unknown. COVID-Test rapid test post mortem negative in Jan2021. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 961898 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure measurement, Body temperature, Cardiac fibrillation, Heart rate, Malaise, Oxygen saturation, Syncope, Ventricular fibrillation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tachyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypotension; COPD; Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:100/55 mmHg; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Test Name: Heart rate; Result Unstructured Data: Test Result:60; Comments: BPM; Test Name: O2 saturation; Test Result: 90 %
CDC Split Type: DEPFIZER INC2021039286

Write-up: Syncope; Malaise; Vomiting; Cardiac fibrillation NOS; ventricular fibrillation; malignant arrhythmia/rhythmic disturbance; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB regulatory authority DE-PEI-PEI2021000508. A 91-year-old male patient was vaccinated with the first dose of bnt162b2 (COMIRNATY, batch/lot no.: EJ6796), via an unspecified route of administration on 07Jan2021 at single dose for prophylactic vaccination. Medical history included ongoing COPD (chronic obstructive pulmonary disease), ongoing arterial hypotension and ongoing diabetes mellitus. Concomitant medication was not reported. After vaccination, on 08Jan2021, the patient developed malaise, syncope, vomiting and cardiac fibrillation NOS. The patient was dead. Patient had rhythmic disturbance and ventricular fibrillation after resuscitation (defibrillation). The patient was intubated and ventilated 4 ml of suprarenin, 300 mg of amiodarone and 1000 ml of sterofundin were administered. The patient underwent lab tests and procedures which included blood pressure: 100/55 mmHg; body temperature: 36 Centigrade; heart rate: 60 BPM; O2 saturation: 90 %, all on unspecified date. The patient died on 08Jan2021 at 12:33. The death of the patient was caused by malignant arrhythmia and ventricular fibrillation. It was not reported if an autopsy had been performed. Outcome of events were fatal. Result of Assessment C was inconsistent causal association for Cardiac fibrillation NOS and Result of Assessment was unclassifiable for syncope / malaise / vomiting. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: malaise; syncope; vomiting; cardiac fibrillation NOS; malignant arrhythmia/rhythmic disturbance; ventricular fibrillation


VAERS ID: 961900 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, 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: 2021-01-13
   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: LANTUS; ACTRAPID; SPIRONOLACTON; ; ; NEUROTRAT [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;THIAMINE MONONITRATE]; FOLSAN; ;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute allergic urticaria; Allergic contact dermatitis; Cerebral artery stenosis; Cerebral infarction; Consciousness clouding; Diabetes mellitus; Epilepsy; Hip prosthesis user; Korsakov''s syndrome; Psoriasis; Stroke; Traumatic brain injury
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021039353

Write-up: Sudden death, cause unknown; Malaise; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021000638 and received via Regulatory Authority. A 79-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot/batch number: EJ6796), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 prophylaxis. The patient medical history included Stroke, Cerebral artery stenosis, Diabetes mellitus from 05Nov2012, Allergic contact dermatitis, Consciousness clouding from 04Mar2014, Psoriasis, Epilepsy from 04Mar2014, Traumatic brain injury, Korsakov''s syndrome from 05Nov2012, Cerebral infarction from 04Mar2014, Acute allergic urticaria from 04Nov2019, Hip prosthesis user, all unknown if ongoing. Concomitant medications included Bisoprolol; folic acid (FOLSAN); Levetiracetam; cyanocobalamin, pyridoxine hydrochloride, thiamine mononitrate (NEUROTRAT); Oxazepam; rupatadine (reported as Rupatadin); spironolactone (SPIRONOLACTON); insulin glargine (LANTUS, reported as Lantus Insulinpen); insulin (ACTRAPID). The patient experienced on the same day after vaccination (13Jan2021) the patient developed Sudden death, cause unknown and Malaise, lasting for unknown. The patient was dead on 13Jan2021. Death cause was reported as sudden death, cause unknown and Malaise. The outcome of the events 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: Malaise; Sudden death, cause unknown


VAERS ID: 961901 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: 202101; Test Name: Covid tested; Test Result: Positive
CDC Split Type: DEPFIZER INC2021039029

Write-up: sick with Covid 19 and died after the vaccination. Covid positive after the first vaccination; sick with Covid 19 and died after the vaccination. Covid positive after the first vaccination; This is a spontaneous report from a contactable physician, based on information received by Pfizer from Biontech (manufacturer control number: not provided), license party for BNT162B2. The physician reported similar events for 2 patients. This is the case for the first of 2 patients. An elderly patient of an unspecified gender received the first dose of BNT162b2 (COMIRNATY,Lot/Batch Number and Expiration Date unknown), via an unspecified route of administration on 06Jan2021 at 1 dose form (DF) single dose for covid-19 prophylaxis. The patient''s medical history and concomitant medications were not reported. It was reported that the physician was a vaccinator of a vaccination center and on 06Jan2021, 07Jan2021 and 08Jan2021 he had vaccinated 3 elderly residents in a nursing home with the vaccine Corminaty. It turned out that 2 of the elderly residents were sick with Covid 19 and died after the vaccination in Jan2021. Covid tested positive after the first vaccination in Jan2021. This patient was vaccinated on 06Jan2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : DE-PFIZER INC-2021043240 same Reporter, same events, different patient; Reported Cause(s) of Death: Covid-19; Covid-19


VAERS ID: 961902 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID; Result Unstructured Data: Test Result:positive after the first vaccination
CDC Split Type: DEPFIZER INC2021043240

Write-up: sick with Covid 19 and died after the vaccination. Covid positive after the first vaccination; sick with Covid 19 and died after the vaccination. Covid positive after the first vaccination; This is a spontaneous report from a contactable physician, based on information received by Pfizer from Biontech (manufacturer control number: not provided), license party for BNT162B2. The physician reported similar events for 2 patients. This is the case for the 2nd of 2 patients. An elderly patient of an unspecified gender received the first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 prophylaxis. The patient''s medical history and concomitant medications were not reported. It was reported that the physician was a vaccinator of a vaccination center and on 06Jan2021, 07Jan2021 and 08Jan2021 he had vaccinated 3 elderly residents in a nursing home with the vaccine Corminaty. It turned out that 2 of the elderly residents were sick with Covid 19 and died after the vaccination. Covid tested positive after the first vaccination. This patient was vaccinated on 06Jan2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : DE-PFIZER INC-2021039029 same Reporter, same events, different patient; Reported Cause(s) of Death: Covid-19; Covid-19


VAERS ID: 961905 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-01-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Blood creatinine, Blood pressure systolic, Blood pressure systolic increased, Blood sodium, C-reactive protein, Chest X-ray, Coma, Coma scale, Computerised tomogram, Depressed level of consciousness, Fatigue, Flushing, Hemiparesis, Magnetic resonance imaging brain, Mobility decreased, Respiratory arrest, Vomiting, White blood cell count
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-05
   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: ; VOLTAREN [DICLOFENAC]; ELTROXIN; ; VITAMIN D [COLECALCIFEROL]; PANODIL; MAREVAN; SOLU-CORTEF; KALIUMKLORID; MAGNESIA [MAGNESIUM HYDROXIDE]
Current Illness: Cardiac pacemaker insertion (Due to bifascular block,); Constipation (concurrent conditions); Deep vein thrombosis (Multiple DVT); Gastric ulcer (concurrent conditions); Hypothyroidism; Monoclonal gammopathy; Pain (concurrent conditions); Panhypopituitarism; Pneumonia aspiration (OBS); Renal cell carcinoma (sequelae after cerebral radiation therapy due to metastases from renal cell carcinoma); Secondary adrenal insufficiency; Vitamin D deficiency (concurrent conditions)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Bacteria urine; Test Result: Positive ; Test Date: 202101; Test Name: Creatinine; Result Unstructured Data: Test Result:31.6; Comments: Unit not specified; Test Date: 20210103; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:persistently high systolic blood pressure; Test Date: 202101; Test Name: Sodium; Result Unstructured Data: Test Result:131; Comments: unit not specified; Test Date: 202101; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:nothing abnormal; Test Date: 20210102; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:11; Test Date: 202101; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:descends gradually under admission; Test Date: 202101; Test Name: CT scan; Result Unstructured Data: Test Result:without acute bleeding or ischemia; Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:195; Comments: unit not specified; Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:103; Comments: unit not specified; Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:15; Comments: unit not specified; Test Date: 202010; Test Name: MRI brain; Result Unstructured Data: Test Result:Of pituitary gland; Test Date: 202101; Test Name: Leukocyte count; Result Unstructured Data: Test Result:13.6; Comments: unit not specified
CDC Split Type: DKPFIZER INC2021043434

Write-up: Respiratory arrest; Coma. newly emerged level of consciousness. At arrival weak in contact. Gradual deterioration in level of consciousness under admission; had persistently high systolic blood pressure; Mobility decreased on the right site; Hemiparesis (right) with hanging mouth; flushing; vomiting; Newly emerged level of consciousness. At arrival weak in contact. Gradual deterioration in level of consciousness under admission; Aggravated tiredness; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority -WEB DK-DKMA-WBS-0028419. The report was received from a contactable physician via the Medicines Agency. An 80-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6797, expiration date: 30Apr2021), via intramuscular on 02Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing monoclonal gammopathy, ongoing cardiac pacemaker insertion (Due to bifascular block), ongoing deep vein thrombosis (Multiple DVT), ongoing pneumonia aspiration (OBS), ongoing hypothyroidism, ongoing secondary adrenocortical insufficiency, ongoing renal cell carcinoma (sequelae after cerebral radiation therapy due to metastases from renal cell carcinoma), ongoing panhypopituitarism, ongoing constipation (concurrent conditions), ongoing pain (concurrent conditions), ongoing gastric ulcer (concurrent conditions), ongoing vitamin D deficiency (concurrent conditions). Concomitant medication included lactulose from 11Mar2020 for constipation, diclofenac (VOLTAREN) from 08Jun2020 for pain localised, levothyroxine sodium (ELTROXIN) from 26May2017 for hypothyroidism, pantoprazole from 02Feb2016 for gastric ulcer, colecalciferol (VITAMIN D) from 19Jan2017 for vitamin D deficiency, paracetamol (PANODIL) from 28Jun2019 for pain, warfarin sodium (MAREVAN) from 02Feb2016 for anticoagulant therapy, hydrocortisone sodium succinate (SOLU-CORTEF) from 09Nov2020 for adrenal insufficiency, kaliumklorid from 20Apr2018 for potassium supplementation, magnesium hydroxide (MAGNESIA) from 27Nov2019 for constipation, and nutritional preparation. The patient experienced flushing on 02Jan2021, vomiting on 02Jan2021, newly emerged level of consciousness at arrival weak in contact gradual deterioration in level of consciousness under admission on 02Jan2021, aggravated tiredness on 02Jan2021, coma newly emerged level of consciousness at arrival weak in contact gradual deterioration in level of consciousness under admission on 03Jan2021, respiratory arrest on 04Jan2021, mobility decreased on the right site on 02Jan2021, hemiparesis (right) with hanging mouth on 02Jan2021. On 02Jan2021, the same days as the vaccination, the patient developed tiredness, flushing, mobility decreased, vomiting, decreased level of consciousness and hemiparesis (right). He was already weak in contact when he arrived to the hospital on 03Jan2021. Gradually aggravation in his consciousness under admission (Coma). On 04Jan201 the patient developed respiratory arrest and died on 05Jan2021 at 13:57. The patient was treated with oxygen demanding at high flow apparatus. Not a candidate for intensive care or heart-lung rescue. On 04Jan2021 the patient received a safety box. Conversation with relatives several times during the course, on the 05Jan2021 morning final decision to stop all treatment. On 03Jan2021, due to the patient''s pacemaker status, it was not possible to have an acute MRI scan to clarify the patient cerebral status and possibly cerebral stem infarction, which could also be explained in the situation where the patient had persistently high systolic blood pressure. The reported cause of death was respiratory arrest. The patient underwent lab tests and procedures which included bacteria urine: positive on Jan2021; creatinine: 31.6 unit not specified on Jan2021; sodium: 131 unit not specified on Jan2021; Thorax x-ray: nothing abnormal on Jan2021; Glasgow coma scale: showed 11 on 02Jan2021 and descends gradually under admission on Jan2021; computerised tomogram (CT scan): without acute bleeding or ischemia on Jan2021; c-reactive protein: 195 unit not specified on Jan2021, 103 unit not specified on Jan2021, 15 unit not specified on Jan2021; magnetic resonance imaging brain (MRI brain): of pituitary gland on Oct2020, Leukocyte count: 13.6 unit not specified on Jan2021; systolic blood pressure: persistently high systolic blood pressure on 03Jan2021. The patient died on 05Jan2021. An autopsy was not performed. The outcome of the event respiratory arrest was fatal, while other events was unknown. Causality reported as Consciousness is suspected to be due to normal pressure hydrocephalus, exacerbation of radiation sequelae in the brain due to infection or addison. However, it cannot be ruled out that the covid vaccine has had an impact on the course of the disease.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 961906 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2020-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Dyspnoea, Hypersensitivity, Oxygen saturation, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Angioedema (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), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Chronic kidney disease; Psychiatric disorder NOS
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: Arterial oxygen saturation; Test Result: 64 %
CDC Split Type: ESPFIZER INC2021043530

Write-up: Acute dyspnea; respiratory distress; acute respiratory insufficiency; suspected severe allergic reaction; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB (ES-AEMPS-711273). A 75-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6796), intramuscularly, on 31Dec2020 at a single dose for COVID-19 vaccination. Medical history included chronic kidney disease, arterial hypertension, and neuropsychiatric disorders. The patient had no allergy history. The patient''s concomitant medications were not reported. The patient experienced acute dyspnea, respiratory distress, acute respiratory insufficiency, and suspected severe allergic reaction on 31Dec2021, which were all reported as fatal. The clinical course was reported as: The patient had acute dyspnea and respiratory distress with arterial oxygen saturation of 64% two hours after vaccination, on 31Dec2020, and died three hours after vaccination. The emergency coordinating physician suspected severe allergic reaction. The clinical outcome of all of the events was fatal. The patient died on 31Dec2020 (reported as three hours after vaccination). The cause of death was reported as acute dyspnea, respiratory distress, acute respiratory insufficiency, and suspected severe allergic reaction. An autopsy was not performed. No follow-up attempts are possible. No information is expected.; Reported Cause(s) of Death: suspected severe allergic reaction; respiratory distress; acute dyspnea; Acute respiratory insufficiency


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