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

Found 17,128 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 126 out of 172

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VAERS ID: 1399657 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-23
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Pneumonia, Pulmonary embolism, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 16
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: Aortic valve stenosis (moderate aortic stenosis); Ischaemic cardiomyopathy
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma urinary bladder (recurrent carcinoma of the bladder); TIA (after Transient ischaemic attack)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021653583

Write-up: Cardiorespiratory insufficiency in the context of pneumonia; Cardiorespiratory insufficiency in the context of pneumonia; Central pulmonary artery embolism on both sides with accompanying pneumonia on the left side; Central pulmonary artery embolism on both sides with accompanying pneumonia on the left side; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-27861. An 81-years-old male patient received bnt162b2 (COMIRNATY), via intramuscular on 11Mar2021 (Lot Number: ET1831) as single dose for COVID-19 immunisation. The patient''s medical history and concurrent conditions included: Ischaemic cardiomyopathy (continuing), Aortic valve stenosis (continuing), carcinoma urinary bladder (recurrent carcinoma of the bladder) from an unknown date to an unknown date and TIA (after Transient ischaemic attack) from an unknown date to an unknown date. The patient''s concomitant medications were not reported. The patient''s weight was not reported, and height was not reported. The patient experienced central pulmonary artery embolism on both sides with accompanying pneumonia on the left side on 23Mar2021 and cardiorespiratory insufficiency in the context of pneumonia on 08Apr2021. The event details reported as follows: On 23Mar2021 the patient experienced pulmonary embolism, pneumonia (hospitalization). On 08Apr2021 the patient experienced cardiac insufficiency, respiratory insufficiency (death, hospitalization). Treatment of the side effects included: Antikogulation with LMWH, then edoxaban. Antibiotic: Unasyn, Resumption 2 days after discharge due to bilateral pneumonia. Exitus letalis on 08Apr2021 in the case of cardiorespiratory insufficiency in the context of pneumonia (multiple organ failure, multimorbidity). The patient was not recovered for Pulmonary embolism and Pneumonia, fatal for Cardiac insufficiency and Respiratory insufficiency. The patient died on 08Apr2021 from Cardiac insufficiency, Respiratory insufficiency, Multiorgan failure, Multimorbidity. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Respiratory insufficiency; Multiorgan failure; Multimorbidity; Cardiac insufficiency


VAERS ID: 1399711 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021666654

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 560741. A 43-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 43-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced adverse event following immunisation (death) on an unspecified date. The patient died on an unspecified date. Outcome of the event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1399712 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation, Fall
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669724

Write-up: Adverse event following immunisation; Fall; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 561179. An 89-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 89-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced adverse event following immunisation (death) on an unspecified date, fall (death) on an unspecified date. The patient died on an unspecified date. Outcome event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation; Fall


VAERS ID: 1399713 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669725

Write-up: Dyspnoea; Unresponsive to stimuli; This is a spontaneous report from a contactable other health professional. This is a line listing report received from the Regulatory Authority. Regulatory authority report number is 561188. A 92-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dyspnoea, unresponsive to stimuli with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Dyspnoea; Unresponsive to stimuli


VAERS ID: 1399714 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fibrin D dimer increased, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669726

Write-up: Fibrin D dimer increased; Thrombocytopenia; This is a spontaneous report from a contactable other health professional via the Regulatory authority (RA). Regulatory authority report number is 561318. A 73-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fibrin d dimer increased (fibrin d dimer increased) (death) and thrombocytopenia (thrombocytopenia) (death) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Fibrin D dimer increased; Thrombocytopenia


VAERS ID: 1399715 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-29
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669727

Write-up: Fall; This is a spontaneous report from a contactable healthcare professional received via the Regulatory authority (RA). Regulatory authority number 562649. An 86 years old male patient received BNT162B2 (COMIRNATY) on an unknown date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 29May2021 the patient experienced fall. The event was reported with a fatal outcome. The patient died on an unspecified date in 2021. 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: Fall


VAERS ID: 1399716 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-22
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669728

Write-up: Depressed level of consciousness; Hypotension; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority. Regulatory authority report number is 562988. A 94-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 22May2021, the patient experienced depressed level of consciousness and hypotension. The events were serious, fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Depressed level of consciousness; Hypotension


VAERS ID: 1399717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669730

Write-up: Thrombocytopenia; Thrombosis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 563009. A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at an unspecified age (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thrombocytopenia (death) and thrombosis (death) on an unspecified date. The patient died on an unspecified date. Outcome of events was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Thrombocytopenia; Thrombosis


VAERS ID: 1399718 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-20
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Arthralgia, Chest pain, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669731

Write-up: Arteriosclerosis coronary artery; Arthralgia; Chest pain; Malaise; Vomiting; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority. Regulatory authority report number is 563022. An 86-year-old male patient received BNT162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 20May2021, the patient experienced arteriosclerosis coronary artery, arthralgia, chest pain, malaise and vomiting. All the events were serious, fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Arteriosclerosis coronary artery; Arthralgia; Chest pain; Malaise; Vomiting


VAERS ID: 1399719 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669733

Write-up: Multiple organ dysfunction syndrome; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority. Regulatory authority report number is 563058. A 92-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 24May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced multiple organ dysfunction syndrome on 26May2021. The event was serious, fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Multiple organ dysfunction syndrome


VAERS ID: 1399720 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Faecal vomiting, 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669734

Write-up: Faecal vomiting; Unresponsive to stimuli; This is a spontaneous report from a contactable other healthcare professional via the Regulatory authority (RA). Regulatory authority report number is 563267. A 71-year-old male patient received BNT162b2 (COMIRNATY), on an unspecified date at unknown, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced faecal vomiting and unresponsive to stimuli. The patient died due to the events on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Faecal vomiting; Unresponsive to stimuli


VAERS ID: 1399721 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Delirium, Pulmonary embolism, Urinary tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669735

Write-up: Confusional state; Delirium; Pulmonary embolism; Urinary tract infection; This is a spontaneous report from a contactable other health professional. This is a line listing report received from the Regulatory Authority (RA). Regulatory authority report number is 563420. A 70-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. O an unspecified date, the patient experienced confusional state, delirium, pulmonary embolism, urinary tract infection with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Confusional state; Delirium; Pulmonary embolism; Urinary tract infection


VAERS ID: 1399722 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669736

Write-up: Hypotension; Hypothermia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 563500. As per source A 93-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hypotension (hypotension) (death) and hypothermia (hypothermia) (death) on 21May2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Hypotension; Hypothermia


VAERS ID: 1399723 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-10
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669737

Write-up: Pneumonia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 563514. A 91-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 91-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pneumonia (death) on 10May2021. The patient died on an unspecified date. Outcome of event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1399724 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-16
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669738

Write-up: Adverse event following immunisation; Cerebrovascular accident; This is a spontaneous report from a contactable healthcare professional received via the Regulatory Authority. Regulatory authority number 563665. An 82 years old female patient received BNT162B2 (COMIRNATY) on an unknown date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 16Apr2021 the patient experienced adverse event following immunization and cerebrovascular accident. Both the events were reported with fatal outcome. The patient died on an unspecified date in 2021. 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: Adverse event following immunisation; Cerebrovascular accident


VAERS ID: 1399761 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction (2 years ago: keeps a small decompensation and CRI 2 ortho operations in the year)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021653526

Write-up: Flu-like symptoms; Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-94078. A 77-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26May2021 (Batch/Lot Number: FA7812) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included myocardial infarction. Patient who had a myocardial infarction 2 years ago: keeps a small decompensation and CRI 2 ortho operations in the year. The patient''s concomitant medications were not reported. No new element since the 1st dose of Pfizer in Apr2021. The patient experienced flu-like symptoms and sudden death on 26May2021. Flu syndrome on the evening of the 26May2021: went to bed earlier. Death during the night following conclusion of the emergency medical and resuscitation service: sudden death (already deceased when the doctor arrived). The patient did not receive any treatment for the events. The patient died on 26May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death; Flu-like symptoms


VAERS ID: 1399762 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: ATORSTATINEG; LISINOPRIL; METFORMAX; VENLAFAXINE; ZYLORIC; LIXIANA; DOMINAL FORTE; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asymptomatic COVID-19 (PCR positive); Comments: Myocardial infarction in 2012, PTCA (percutaneous transluminal coronary angioplasty) in 2012, type 2 diabetes diagnosed in 2017, Arterial hypertension, secondary depression end of 2017, atrial fibrillation anticoagulated, PCR COVID positive in JAN-2021 but asymptomatic, not had problems with angina since 2012, no major dyspnea lately, no complaint.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210619047

Write-up: SUDDEN DEATH ON 1/06; PATIENT DISCOVERED DEAD, FALLEN AGAINST FURNITURE; This spontaneous report received from a physician via a Regulatory Authority [BE-FAMHP-DHH-N2021-94580] concerned a 73 year old of unspecified race and ethnicity male. The patient''s weight was 108 kilograms, and height was 178 centimeters. The patient''s past conditions included, myocardial infarction in 2012, PTCA (percutaneous transluminal coronary angioplasty) in 2012, not had problems with angina since 2012, type 2 diabetes diagnosed in 2017, arterial hypertension, secondary depression end of 2017, atrial fibrillation anticoagulated, PCR (Polymerase chain reaction) COVID positive in JAN-2021 but asymptomatic Covid-19 and had no major dyspnea. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: xd955 expiry: unknown) dose was not reported, 1 total dose was administered on 28-MAY-2021 for Covid-19 immunisation. Concomitant medications included allopurinol (zyloric), atorvastatin calcium (atorstatineg), bisoprolol, edoxaban tosilate (lixiana), lisinopril, metformin hydrochloride (metformax), prothipendyl hydrochloride (dominal forte), and venlafaxine for unknown indication. On 01-JUN-2021, the patient was discovered dead, fallen against furniture (sudden death). It was unknown if an autopsy was performed. There was no evolution of the ADR (Adverse drug reaction) and there was no complaint. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of sudden death on 1/06 and patient discovered dead, fallen against furniture on 01-JUN-2021. This report was serious (Death).; Reporter''s Comments: Treatment - No Evolution of the ADR - Death ADR description - sudden death on 1/06. Patient discovered dead, fallen against furniture. No complaint the preceding days; Sender''s Comments: V0: 20210619047-COVID-19 VACCINE AD26.COV2.S-Sudden Death, Fall. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SUDDEN DEATH; PATIENT DISCOVERED DEAD, FALLEN AGAINST FURNITURE


VAERS ID: 1400433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Investigation, 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: 2021-05-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE EG; LYRICA; DAFALGAN; VALSARTAN; CLEXANE; SEDISTRESS SLEEP; PARACODINE; OXYNORM; TEMESTA [LORAZEPAM]; STEOVIT D3; NOBITEN [NEBIVOLOL HYDROCHLORIDE]; LIPITOR [ATORVASTATIN]; AMLOR; DUROGESIC; D-CURE; MOVICOL APELSIN; DUOVENT; SIPR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (controlled with medication); Chronic renal insufficiency; COVID-19 (paucisymptomatic: positive tested); Dyslipidaemia; Hip replacement; Knee replacement; Lumbar spinal stenosis; Obesity
Allergies:
Diagnostic Lab Data: Test Name: ADL; Result Unstructured Data: Test Result:9/24; Comments: reasonable degree of autonomy; Test Name: Lawton scale (I-ADL); Result Unstructured Data: Test Result:4/8; Comments: moderate dependence for instrumental tasks; Test Name: covid-19 test; Test Result: Positive
CDC Split Type: BEPFIZER INC2021653531

Write-up: Sudden death 4h30 27/5, found dead in bed without complaints. Roommate also heard nothing; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-93879. A 74-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 26May2021 11:00 (Lot Number: EW6126) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included covid-19 from 24Mar2021 to an unknown date paucisymptomatic: positive tested, knee replacement from 02Dec2020, right hip replacement from 19Mar2021, morbid obesity, chronic renal insufficiency, arterial hypertension (under controlled with medication), dyslipidemia, narrow lumbar canal. No known allergy. No alcohol consumption, no active tabagism. Concomitant medications included omeprazole (OMEPRAZOLE EG); pregabalin (LYRICA); paracetamol (DAFALGAN); valsartan; enoxaparin sodium (CLEXANE); valeriana officinalis (SEDISTRESS SLEEP); dihydrocodeine bitartrate (PARACODINE); oxycodone hydrochloride (OXYNORM); lorazepam (TEMESTA); calcium carbonate, colecalciferol (STEOVIT D3); nebivolol hydrochloride (NOBITEN); atorvastatin (LIPITOR); amlodipine besilate (AMLOR); fentanyl (DUROGESIC); colecalciferol (D-CURE); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL APELSIN); fenoterol hydrobromide, ipratropium bromide (DUOVENT); escitalopram oxalate (SIPRALEXA). The patient previously received first dose of COMIRNATY on 05May2021 (Lot Number: EW6126) for covid-19 immunisation. The patient experienced sudden death 4h30 27May2021, found dead in bed without complaints. roommate also heard nothing on 27May2021. No treatment was received. ADL: 9/24, reasonable degree of autonomy. Lawton scale (I-ADL) 4/8: moderate dependence for instrumental tasks. No cognitive problems. The patient died on 27May2021. It was not reported if an autopsy was performed. In view of the important body size of the patient and history of AHT, ischemic corfailure may also be possible, but pulmonary embolism cannot be ruled out despite preventive dose of LMWH. There may therefore be a causal connection, but without an autopsy (no idea for the time being whether this is foreseen) this cannot be said with certainty. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1400457 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia viral, Viral myocarditis
SMQs:, Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis rheumatoid; Bechterew''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEDCGMA21188165

Write-up: Death; Viral myocarditis; Pneumonia viral; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), VIRAL MYOCARDITIS (Viral myocarditis) and PNEUMONIA VIRAL (Pneumonia viral) in a 58-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Previously administered products included for an unreported indication: COVID-19 VACCINE ASTRAZENECA on 18-Jan-2021. Past adverse reactions to the above products included Drug intolerance NOS with COVID-19 VACCINE ASTRAZENECA. Concurrent medical conditions included Bechterew''s disease and Arthritis rheumatoid. On 15-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) Unknown. On 17-Feb-2021, the patient experienced VIRAL MYOCARDITIS (Viral myocarditis) (seriousness criteria death and medically significant) and PNEUMONIA VIRAL (Pneumonia viral) (seriousness criteria death and medically significant). An autopsy was performed. The autopsy-determined cause of death was Viral myocarditis and Pneumonia viral. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product details not provided Treatment details was not provided Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the serious events, a causal relationship cannot be excluded. The event death was consistent with the reported cause of death in the case.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the serious events, a causal relationship cannot be excluded. The event death was consistent with the reported cause of death in the case.; Autopsy-determined Cause(s) of Death: Viral myocarditis; Pneumonia viral


VAERS ID: 1400469 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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: COVID-19 (with severe (Acute respiratory distress syndrome) ARDS.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100079088

Write-up: Brain death; Arrest cardiac; This regulatory authority case was reported by a physician and describes the occurrence of BRAIN DEATH (Brain death) and CARDIAC ARREST (Arrest cardiac) in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 (with severe (Acute respiratory distress syndrome) ARDS.) in January 2021. On 20-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant). The patient died on 23-May-2021. The reported cause of death was Heart arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided No treatment product information was provided. For medical history COVID-19, the patient was treated with extracorporeal membrane oxygenation (ECMO) following ?Reha'' (rehabilitation). Company Comment: Very limited information regarding these events has been provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Translation uploaded as initial_additional SD1: updated with medical history.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Heart arrest


VAERS ID: 1400471 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Angiocardiogram, Cardiac arrest, Generalised tonic-clonic seizure, Loss of consciousness, Resuscitation, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (At the beginning of /Mar2020, a COVID-19 was probably experienced.); Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: Coronary angiography; Result Unstructured Data: Test Result:Ramus interventricularis anterior occluded; Comments: Ramus interventricularis anterior occluded proximally
CDC Split Type: DEPFIZER INC2021653467

Write-up: Acute myocardial infarction, of anterior wall; Unconsciousness; Resuscitation; Asystolia; Generalised tonic-clonic seizure; slight pain at the injection site; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-202100086140. A 56-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: EX3510), vaccinated at the age of 56 years old, as single dose for covid-19 immunisation. Medical history included non-tobacco user, covid-19 from Mar2020 to an unknown date. The patient''s concomitant medications were not reported. On 01Jan2021 (PENDING CLASSIFICATION) the patient experienced Acute myocardial infarction, of anterior wall, Unconsciousness, Generalised tonic-clonic seizure, Asystolia, Resuscitation. Diagnosis confirmed by Coronary angiography: Ramus interventricularis anterior occluded proximally. The patients outcome was: fatal for Acute myocardial infarction, of anterior wall, fatal for Unconsciousness, fatal for Generalised tonic-clonic seizure, fatal for Asystolia, fatal for Resuscitation. Patient who deceased on 27Apr2021 was continuously cared for by me as a GP since the beginning of the nineties. Patient was of normal weight, sporty (decades of sailing), took no medication, no hypertension, no diabetes, no vascular diseases, never smoker, no risk factors for cardiac diseases. At the beginning of /Mar2020, a corona disease was probably experienced. Typical symptoms (taste disturbances, odour disturbances, poor AZ). PCR test as proof is not available at this time. exitus letalis on 27Apr2021 under the picture of a heart attack (see epicrisis). It should be noted that the seven-day pectanginous complaints described in the epicrisis are not accurately represented. Patient was completely symptom-free until the night before his death, apart from slight pain at the injection site. There is a clear temporal connection between the described vaccination and patient death. The sequence of events from the vaccination to the death of the man with a healthy heart suggests an embolic event, possibly caused by the vaccination. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. The patient died on 27Apr2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Acute myocardial infarction, of anterior wall


VAERS ID: 1400679 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-05-12
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Autoimmune haemolytic anaemia, Coombs direct test
SMQs:, Haemolytic disorders (narrow), Systemic lupus erythematosus (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 20
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: ATORVASTATINA ABEX; ADVAGRAF; SINTROM; FUROSEMIDA KERN PHARMA; OLMETEC; REVOLADE; ZYLORIC; CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; AMOXICILINA/ACIDO CLAVULANICO ARDINECLAV
Current Illness: Atrial fibrillation; Autoimmune thrombocytopenia; Hypercholesteremia; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Cardiac transplant
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: Coombs direct test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Autoimmune hemolytic anemia; This regulatory authority case was reported by a physician and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) in a 47-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001532) for COVID-19 vaccination. Co-suspect product included non-company product AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILINA/ACIDO CLAVULANICO ARDINECLAV) for Tooth infection. The patient''s past medical history included Acute myocardial infarction in 2001 and Cardiac transplant in December 2011. Concurrent medical conditions included Hypercholesteremia, Atrial fibrillation, Autoimmune thrombocytopenia and Hypertension arterial. Concomitant products included ELTROMBOPAG OLAMINE (REVOLADE) for Autoimmune thrombocytopenia, ATORVASTATIN CALCIUM (ATORVASTATINA ABEX) from 18-Jun-2012 to an unknown date, TACROLIMUS (ADVAGRAF) from 04-Jun-2012 to an unknown date, ACENOCOUMAROL (SINTROM) from 06-Jun-2012 to an unknown date, FUROSEMIDE (FUROSEMIDA KERN PHARMA) from 03-Jun-2012 to an unknown date, OLMESARTAN MEDOXOMIL (OLMETEC) from 06-Oct-2015 to an unknown date, ALLOPURINOL (ZYLORIC) from 27-Jul-2012 to an unknown date and MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) from 17-Apr-2019 to an unknown date for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 21-Apr-2021, the patient started AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILINA/ACIDO CLAVULANICO ARDINECLAV) (Oral) 750 milligram every eight hours. On 08-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 12-May-2021, the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia) (seriousness criteria death, hospitalization and medically significant). The patient died on 01-Jun-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Coombs direct test: positive (Positive) Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Outcome of the Event reported as Fatal , Death date updated .; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the serious event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1400741 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-04-06
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Fatigue, Neuralgia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood cholesterol abnormal; Hypercholesterolemia (treated); Hypertension (treated); Uric acid increased (treated)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021653436

Write-up: Slight fatigue; felt discomfort described as vagal; discomfort below the sternum "on the stomach side"; deceased/Sudden death; This is a spontaneous report from a contactable consumer (patient''s wife) downloaded from the Regulatory Authority-WEB regulatory authority FR-AFSSAPS-2021062256. A 67-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Left arm on 21Feb2021 (Lot Number: ER0641) as 2nd dose, single dose for covid-19 immunisation. Medical history included uric acid increased (treated), hypercholesterolaemia (treated), hypertension (treated), cholesterol. The patient''s concomitant medications were not reported. Slight fatigue that occurred after the second injection. Not disabling but "unusual" and improving. On 06Apr2021, felt discomfort described as vagal (he was with a resuscitator), with discomfort below the sternum "on the stomach side" not painful, no anxiety. Was found deceased 1 hour later. No autopsy. Sudden death on D45 post-vaccination in a 67-year-old patient with mild hypertension (treated), and traces of cholesterol. Cause of death unknown. The outcome of the event Sudden death was fatal, event slight fatigue was recovering, others was unknown. The patient died on 06Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: deceased/Sudden death


VAERS ID: 1400742 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-05-06
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure systolic, C-reactive protein, COVID-19, Electrocardiogram, Heart rate, Oxygen saturation, Procalcitonin, Respiratory rate, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Arteriopathic disease; Diabetes mellitus; Dyslipidaemia; Korsakoff''s syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction; Phlebitis lower limb; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Name: systolic blood pressure; Result Unstructured Data: Test Result:120/10 mmHg; Test Date: 20210516; Test Name: C-reactive protein; Result Unstructured Data: Test Result:106 mg/l; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:sinus tachycardia; Comments: sinus tachycardia and left axis deviation, a right ventricular hypertrophy and sequelae of myocardial infarction; Test Name: heart rate; Result Unstructured Data: Test Result:108; Test Date: 20210516; Test Name: oxygen saturation; Test Result: 85 %; Test Date: 20210516; Test Name: procalcitonin; Result Unstructured Data: Test Result:0.26; Test Name: Respiratory rate; Result Unstructured Data: Test Result:28; Test Date: 20210506; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021645233

Write-up: Vaccination failure; COVID-19 respiratory infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021062307. A 90-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly on 22Jan2021 at single dose (0.3 mL, single), and the second dose intramuscularly on 11Feb2021 (lot number: EJ6789) at single dose (0.3 mL, single) for COVID-19 immunisation. Medical history included ongoing arteriopathic disease, ongoing korsakoff''s syndrome, myocardial infarction, ongoing dyslipidaemia, ongoing diabetes mellitus, phlebitis lower limb, pulmonary embolism, and ongoing arterial hypertension. The patient''s concomitant medications were not reported. In May2021, SARS COV 2 cluster in the patient''s residence was reported. On 06May2021, SARS COV 2 polymerase chain reaction (PCR) was positive (N501Y mutation). The patient presented clinical symptoms with progressive cardiorespiratory deterioration. Patient experienced vaccination failure and COVID-19 respiratory infection. On 16May2021, the patient was hospitalized for respiratory tract infection with oxygen saturation at 85% under 15 L of oxygen and laboratory signs of inflammation (C-reactive protein at 106 mg/L, procalcitonin (PCT) 0.26), and probable aspiration pneumonia evolving for several days. The patient received piperacillin sodium/tazobactam sodium (TAZOCILLINE) and metronidazole (FLAGYL). The patient was agitated and refused care (removed the mask at high concentration), requiring clonazepam (RIVOTRIL) administration. Respiratory rate was 28, systolic blood pressure was 120/10 mmHg and heart rate 108. The patient was bedridden with consciousness disorder. The decision to limit active care was made. Electrocardiogram showed sinus tachycardia and left axis deviation, a right ventricular hypertrophy and sequelae of myocardial infarction. No chest computerized tomography (CT) scan was reported. On 19May2021, the patient died due to cardio-respiratory decompensation aggravated by a COVID-19 infection. Conclusion: Vaccine failure with SARS Cov 2 infection N501Y mutation in a 90-year-old patient living in a community having been vaccinated by BNT162B2 with a complete vaccination schedule. Death was due to aggravation of cardio-respiratory decompensation by a COVID-19 infection in the context of a serious cardiac co-morbidities. An autopsy was not performed.; Reported Cause(s) of Death: COVID-19 respiratory infection; Vaccination failure


VAERS ID: 1400744 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Discomfort, Nausea, Pyrexia, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DILTIAZEM HCL
Current Illness: Alzheimer''s disease (early-onset); Hypertension arterial (well-balanced)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210214; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20210125; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021653361

Write-up: Sudden death; nausea; fever of 38 degrees celcius/fever (temperature 37.8 C); unusual asthenia; feeling of discomfort; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB regulatory authority FR-AFSSAPS-2021062609. An 85-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly, administered in arm left on 10Feb2021 (Batch/Lot Number: EJ6795) at age of 85 years old at 0.3 ml single for covid-19 immunisation. Medical history included ongoing early-onset alzheimer''s disease, ongoing well-balanced high blood pressure. Concomitant medications included diltiazem hcl 60 mg twice daily. The patient previously took 1st dose of bnt162b2 (COMIRNATY) for covid-19 immunisation. The patient was stable without decompensated pathology. On 11Feb2021, the patient presented with a fever of 38 degrees celcius. She presented with unusual asthenia and described "a feeling of discomfort". On 12Feb2021, the fever disappeared. On 14Feb2021, reappearance of a fever (temperature 37.8 C) for 1 day. On 16Feb2021, the patient presented with nausea (administration of a single tablet of Metopimazine (VOGALENE)). On 21Feb2021, the patient was found dead in her chair in the morning at 8:45 a.m. She had been seen by the healthcare team shortly before (breakfast service). In total, sudden death in an 85-year-old patient without pathology in the process of decompensation and vaccinated 12 days previously by COMIRNATY (D2) The patient died on 21Feb2021. An autopsy was not performed. The patient had SARS-CoV-2 test with negative result on 25Jan2021. The outcome of events fever, unusual asthenia, discomfort, nausea was unknown. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Sudden death


VAERS ID: 1400763 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   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: COUMADINE; INSULIN; PREGABALIN; STAGID; PERINDOPRIL; FUROSEMIDE; NEBIVOLOL; CRESTOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery disease; Diabetes with unspecified complication; Endometriosis; Hypertension; Obesity; Sleep apnea syndrome; Transient ischemic attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021682028

Write-up: patient was found dead; This is a spontaneous report downloaded from the regulatory authority-FR-AFSSAPS-MA20212178 (Safety Report Unique Identifier: FR-AFSSAPS-2021067663). A contactable pharmacist reported a 53-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch Number: FA8016), intramuscular on 01Jun2021 (at an age of 53-years-old) as 2nd dose, single dose for covid-19 immunisation. Medical history of the patient included hypertension, sleep apnoea syndrome, diabetes with multiple complications, coronary artery disease from an unspecified date in 2018 to an unknown date, transient ischaemic attack from an unspecified date in 2015 to an unknown date, obesity, endometriosis. Concomitant medications included warfarin sodium (COUMADINE) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; insulin (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; pregabalin (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; metformin embonate (STAGID) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; perindopril (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; furosemide (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; nebivolol (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; rosuvastatin calcium (CRESTOR) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took isomeride, mediator, first dose of comirnaty for covid-19 immunisation. The patient was found dead in the night from 2Jun2021 to 3Jun2021. It was not reported if an autopsy was performed. The clinical outcome of the event was fatal.; Reported Cause(s) of Death: Death


VAERS ID: 1400771 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001945 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Foetal death
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Fetal death; This regulatory authority case was reported by a physician and describes the occurrence of FOETAL DEATH (Fetal death) in a 22-week-old male infant exposed to mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001945) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): Concurrent medical conditions included Vaccine exposure during pregnancy. No Medical History information was reported. On 09-May-2021, the mother received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-May-2021, the infant was diagnosed with FOETAL DEATH (Fetal death) (seriousness criteria death and medically significant). The infant died on 20-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intra-uterine), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 (COVID 19 Vaccine Moderna) in response to the event was not applicable. Company Comment : Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. No further information is available for this case Sender''s (Case) Safety Report Unique Identifier : FR-AFSSAPS-2021061999; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. No further information is available for this case; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1400779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Creutzfeldt-Jakob disease, Electroencephalogram, Lumbar puncture, Magnetic resonance imaging head
SMQs:, Dementia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
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: ONGLYZA; ZANIDIP; CRESTOR; PARIET; CORTANCYL; DIFFU-K; OROCAL VITAMINE D3 [CALCIUM CARBONATE;COLECALCIFEROL]; DACRYOSERUM [BORIC ACID;PHENYLMERCURIC BORATE;SODIUM BORATE]; L-THYROXINE [LEVOTHYROXINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Cholecystectomy; Cognitive disorders; Hypercholesterolaemia; Hypertension arterial; Rhizomelic pseudopolyarthritis; Thyroid nodule; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:rock water liquid, 1 element, 2 red blood cells, a; Comments: rock water liquid, 1 element, 2 red blood cells, absence of germ on direct examination, culture in progress, proteinorachia at 0.32 g / L, glycorachia at 5.6mmol / L for blood glucose at 12.9 mmol / L, chlorurorachia at 150 mmol / L. Isofocusing in progress. Protein 14.3.3 in progress.; Test Date: 20210507; Test Name: brain MRI; Result Unstructured Data: Test Result:cortical hypersignal on the left hemispherical dif; Comments: cortical hypersignal on the left hemispherical diffusion sequence, no central gray nuclei hypersignal.; Test Date: 20210506; Test Name: Electroencephalogram; Result Unstructured Data: Test Result:very altered, a little asymmetrical (probably more; Comments: very altered, a little asymmetrical (probably more altered on the right) with periodic activity suggesting Creutzfeldt-Jakob disease. No crisis recorded.
CDC Split Type: FRPFIZER INC2021653387

Write-up: Creutzfeldt-Jakob disease; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority report number FR-AFSSAPS-PS20211178, Safety Report Unique Identifier FR-AFSSAPS-2021063339. An 83-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: ET3620) intramuscularly in left arm on 17Mar2021 at single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension arterial, hypercholesterolaemia, arthritis, cholecystectomy, pseudo-rhizomelic arthritis, thyroid nodule and early cognitive disorders. No history of COVID. Concomitant medications included saxagliptin hydrochloride (ONGLYZA), lercanidipine hydrochloride (ZANIDIP), rosuvastatin calcium (CRESTOR), rabeprazole sodium (PARIET), prednisone (CORTANCYL), potassium chloride (DIFFU-K), calcium carbonate, colecalciferol (OROCAL VITAMINE D3), boric acid, phenylmercuric borate, sodium borate (DACRYOSERUM) and levothyroxine(L-THYROXINE), all taken for an unspecified indication from an unspecified date. On 27Mar2021: hospitalization for about a week for the management of a pulmonary embolism (corresponding detailed information captured in AER#2021653376). Subsequently, the patient presented signs of mental confusion and paranoia (no longer recognizes her relatives, loss of speech and coordination of movements) =$g consultation in neurology on 05May2021, then hospitalization (May2021). Electroencephalogram of 06May2021: very altered, a little asymmetrical (probably more altered on the right) with periodic activity suggesting Creutzfeldt-Jakob disease. No crisis recorded. Brain MRI with injection on 07May2021: cortical hypersignal on the left hemispherical diffusion sequence, no central gray nuclei hypersignal. Lumbar puncture of 11May2021: rock water liquid, 1 element, 2 red blood cells, absence of germ on direct examination, culture in progress, proteinorachia at 0.32 g/L, glycorachia at 5.6mmol / L for blood glucose at 12.9 mmol/L, chlorurorachia at 150 mmol/L. Isofocusing in progress. Protein 14.3.3 in progress. In total: diagnosis of probable Creutzfeldt-Jakob disease in its sporadic form in an 83-year-old patient, presenting a dementia syndrome of rapid evolution in 1 month with typical abnormalities on the EEG as well as on the brain MRI. Evolution: rapid worsening with akinetic mutism. Transfer to palliative care for continuation of care on 20May2021. The patient died on 30May2021. It was not reported if an autopsy was performed. In total, occurrence of Creutzfeldt-Jakob disease diagnosed approximately 1.5 months after the second injection of the Comirnaty vaccine. The role of the vaccine in the onset of this disease is unlikely even if we cannot formally exclude it (onset of the first signs after vaccination). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Creutzfeldt-Jakob disease


VAERS ID: 1400790 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   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: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Dyspnea; Asthenia; This regulatory authority case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Dyspnea) in an 84-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes. On 13-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (Dyspnea) (seriousness criteria death and life threatening) and ASTHENIA (Asthenia). The patient died on 15-Apr-2021. The reported cause of death was d?compensation respiratoire aigue. It is unknown if an autopsy was performed. At the time of death, ASTHENIA (Asthenia) had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable. This is a case of sudden death in a 84-year-old male patient with a history of diabetes, who died of dyspnea 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. Senders case reference number is FR-AFSSAPS-2021062650.; Sender''s Comments: This is a case of sudden death in a 84-year-old male patient with a history of diabetes, who died of dyspnea 2 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: D?compensation respiratoire aigue


VAERS ID: 1400977 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death) in a 34-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002188) for COVID-19 vaccination. The patient''s past medical history included Depression. On 11-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on 17-May-2021 The patient died on 17-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Death is not expected adverse event of COVID-19 VACCINE MODERNA. Time to onset was 6 days. Based on the above, lacking detailed information, causality is not assessable. The case is serious because the patient died. Further information is expected. Death is not expected adverse event of COVID-19 VACCINE MODERNA. Time to onset was 6 days. Based on the above, lacking detailed information, causality is not assessable. The case is serious because the patient died. Further information is expected.; Sender''s Comments: This is a case of sudden death in a 34-year-old Male with a history of depression, who died 6 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1400978 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Colonoscopy, Death, Polymerase chain reaction, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; COVEREX AS KOMB; MILURIT; TALLITON; FUROSEMIDE; COVEREX AS; DOXAZOSIN
Current Illness: Aortic stenosis; Chronic renal insufficiency; Heart failure with reduced ejection fraction; Ischemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Colitis (NOS); Colonoscopy (Results: Diverticulosis, possibly ongoing for a longer period of time causing intestinal inflammatory.); Diverticula of colon
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Colonoscopy; Result Unstructured Data: Diverticulosis, possibly ongoing for a longer period of time causing intestinal inflammatory.; Test Date: 2021; Test Name: PCR; Test Result: Negative ; Result Unstructured Data: Negative for COVID-19; Test Date: 2021; Test Name: Antigen Test; Test Result: Negative ; Result Unstructured Data: Negative for COVID-19
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: hal?l; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (hal?l) in an 88-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Colitis (NOS), Diverticula of colon and Colonoscopy (Results: Diverticulosis, possibly ongoing for a longer period of time causing intestinal inflammatory.). Concurrent medical conditions included Heart failure with reduced ejection fraction, Ischemic heart disease, Chronic renal insufficiency and Aortic stenosis. Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), INDAPAMIDE, PERINDOPRIL ARGININE (COVEREX AS KOMB), ALLOPURINOL (MILURIT), CARVEDILOL (TALLITON), FUROSEMIDE, PERINDOPRIL ARGININE (COVEREX AS) and DOXAZOSIN for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 28-Apr-2021 The patient died on 28-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: diverticulosis (abnormal) Diverticulosis, possibly ongoing for a longer period of time causing intestinal inflammatory.. In 2021, Polymerase chain reaction: negative (Negative) Negative for COVID-19. In 2021, SARS-CoV-2 test: negative (Negative) Negative for COVID-19. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (hal?l) to be unlikely related. Treatment information was not provided. The health professional assessed the causal relationship was unlikely between the suspected drug- Moderna COVID-19 vaccine and the adverse event. This is a case of death in a 88-year-old female subject with a history of Heart failure, Ischemic heart disease, Chronic renal insufficiency and Aortic stenosis who died 28 days after receiving first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273.; Sender''s Comments: This is a case of death in a 88-year-old female subject with a history of Heart failure, Ischemic heart disease, Chronic renal insufficiency and Aortic stenosis who died 28 days after receiving first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1400979 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram thorax, Echocardiogram, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colon cancer; Stoma creation
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: Chest CT; Result Unstructured Data: Test Result:covid pneumonia; Test Date: 20210509; Test Name: Echocardiography; Result Unstructured Data: Test Result:pumonary embolism; Test Date: 20210426; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021654375

Write-up: implied a massive pulmonary embolism; COVID-19 pneumonia/symptoms of decreased appetite, throat dryness, fever and feeling unwell; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB HU-OGYI-361921. A contactable physician reported that a 66 years old male patient received first dose BNT162B2 (COMIRNATY, lot number EW9127), intramuscular at Arm Left on 16Apr2021 at 0.3 ml single dose for COVID-19 immunisation. Medical history included colon cancer for which the patient received radio-chemotherapy. He also had a stoma. Concomitant drugs were not reported. On 16Apr2021 the 66-years-old male patient received the first dose of 0.3 ml COMIRNATY concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: EW9127, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) intramuscularly in the left arm to prevent Covid-19. The patient was hospitalized on 26Apr2021 with symptoms of decreased appetite, throat dryness, fever and feeling unwell, Covid-19 antigen test was positive on 26Apr2021. The chest CT on 26-APR-2021 showed Covid-19 pneumonia and Echocardiography 09-MAY-2021 implied a massive pulmonary embolism. The patient received covid therapy, but his respiratory parameters worsened and after an unsuccessful reanimation, passed away on 10May2021 at 00:15. The patient underwent lab tests and procedures, which included Chest CT : covid pneumonia on 26-APR-2021; Echocardiography on 09-MAY-2021: pumonary embolism; COVID-19 antigen test: Positive on 26-APR-2021.The patient died on 10-MAY-2021. The autopsy was performed, and the autopsy result was not available. The cause of death was COVID-19 pneumonia, COVID-19 antigen test positive and Pulmonary embolism. The outcome of events was fatal. Sender Comment: According to the SmPC of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient got infected with the virus after the first dose, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on available information and temporal relationship, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Pulmonary embolism. 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 pneumonia; COVID-19 antigen test positive; massive pulmonary embolism


VAERS ID: 1400980 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-08
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   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: Living in residential institution; Mental deterioration
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral atherosclerosis; Coronary artery calcification; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021661665

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (HU-OGYI-362121). A 76-year-old male patient received the second dose of BNT162B2 (COMIRNATY) intramuscular, in left arm, on 24Feb2021 (lot number: EP 2163), at 0.3 ml single, for COVID-19 immunisation. First dose was given on 03Feb2021 (lot/batch number: E76136). Medical history included hypertension (not ongoing), cerebral atherosclerosis (not ongoing) and coronary artery calcification (not ongoing). The patient was suffering from gradual somato-mental degeneration and required full care in a social care institute. Concomitant medication was not reported. On 08Mar2021 the patient died. According to the reporter, the patient death was a consequence of his underlying disease, the possibility of sudden or unexpected death was not considered during examination. The association of death with vaccination was not suspected. Autopsy was not performed. Sender Comment: The 76-year-old patient died 12 days after the second dose of Comirnaty. According to the reporter, the patient death was a consequence of his underlying disease, autopsy was not done. The causal relationship between the reported death and Comirnaty was considered unlikely. The case was serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: underlying disease


VAERS ID: 1400996 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cough, Loss of consciousness, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Lung cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210507; Test Name: Blood test; Result Unstructured Data: Test Result:Results showed thrombocytopenia; Test Date: 20210509; Test Name: oxygen saturation; Result Unstructured Data: Test Result:drop
CDC Split Type: ISPFIZER INC2021653754

Write-up: decrease in platelets; cough; fell into oxygen saturation; lost consciousness; pneumonia; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB IS-IMA-2692. A 61-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 04May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient''s medical history included ongoing lung cancer which was diagnosed in Dec2019. Concomitant medications were not reported. It was reported that the patient used several medications due to his disease (lung cancer), the last treatment cycle was in /Jan2021. Historical vaccine included first dose of bnt162b2 on 13Apr2021 (Batch/Lot number was not reported) for covid-19 immunisation. On 04May2021, the patient experienced cough (caused hospitalization and death). On 07May2021, the patient experienced decrease in platelets (caused hospitalization and death). On 09May2021, the patient experienced fell into oxygen saturation, lost consciousness, and pneumonia (prolonged hospitalization and caused death). Additional clinical details was as follows. After consultation with his treating oncologist the patient was vaccinated with Comirnaty. After the second administration he experienced cough. A blood sample was taken which revelated thrombocytopenia. Consequently the patient was admitted to the hospital. The patient felt well in the morning of 08May2021, however, the following morning (09May2021) he presented with drop in oxygen saturation and soon lost consciousness. Patient died in the morning on 10May2021. It was unknown if an autopsy was performed. The reporter assessed the events as serious due to hospitalization and patient death and considered the events possibly related to the drug. Sender Comment: This case is being investigated locally. Follow-up information will be provided once available. Batch/lot number: unknown. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: cough; fell into oxygen saturation; decrease in platelets; lost consciousness; pneumonia


VAERS ID: 1401023 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-12
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   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: TRITTICO; OLMESARTAN; XADAGO; AMLODIPINA ALTER; NEUPRO; DITROPAN; MADOPAR; CARDIOASPIRIN
Current Illness: Blindness (Blindness in the right eye.); Essential hypertension, unspecified; Incontinence of urine; Osteoarthrosis, generalized, involving unspecified site; Paralysis agitans
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis C (Hepatitis C carrier.); Lumbosacral disc herniation (Lumbar intervertebral disc hernia with no myelopathy.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: myocardial infarction; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (myocardial infarction) in a 79-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042698) for COVID-19 vaccination. The patient''s past medical history included Lumbosacral disc herniation (Lumbar intervertebral disc hernia with no myelopathy.) and Hepatitis C (Hepatitis C carrier.). Concurrent medical conditions included Incontinence of urine, Osteoarthrosis, generalized, involving unspecified site, Essential hypertension, unspecified, Paralysis agitans and Blindness (Blindness in the right eye.). Concomitant products included TRAZODONE HYDROCHLORIDE (TRITTICO), OLMESARTAN, SAFINAMIDE MESILATE (XADAGO), AMLODIPINE (AMLODIPINA ALTER), ROTIGOTINE (NEUPRO), OXYBUTYNIN HYDROCHLORIDE (DITROPAN), BENSERAZIDE HYDROCHLORIDE, LEVODOPA (MADOPAR) and ACETYLSALICYLIC ACID (CARDIOASPIRIN) for an unknown indication. On 18-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 12-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MYOCARDIAL INFARCTION (myocardial infarction) (seriousness criteria death and medically significant). The patient died on 13-Mar-2021. The reported cause of death was Infarct myocardial. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication was reported. Very limited information regarding this event has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Translation source received on 04-Jun-2021 contain non-significant information: Relevant Medical history comments were updated. Formulation details for concomitant medications was updated. On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains no new information.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1401154 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-28
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Platelet count, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Carcinoma of mouth (Severe oncological disability.); Neoplasm NOS (Severe Oncological Disability.)
Preexisting Conditions: Medical History/Concurrent Conditions: Disability; Hepatic infection (hepatic infection by virus C)
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Platelet count; Result Unstructured Data: Test Result:129
CDC Split Type: ITPFIZER INC2021653452

Write-up: Thrombocytopenia on 28May2021.; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-737533. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 07May2021 (Lot Number: FA5831) as single dose for COVID-19 immunisation. Medical history included ongoing Neoplasm NOS (Severe Oncological Disability), hepatic infection from an unknown date and unknown if ongoing (hepatic infection by virus C), ongoing Carcinoma of mouth (Severe oncological disability), Severe Oncological Disability. The patient''s concomitant medications were not reported. The patient experienced thrombocytopenia (death, medically significant) on 28May2021, the patient died this morning due to evolution of the main oncological disease locally advanced oral cavity squamous carcinoma cause of death (death, medically significant) in 2021. The clinical course was reported as follows: "The patient died this morning due to evolution of the main oncological disease locally advanced oral cavity squamous carcinoma cause of death.. As a result of further investigations had already emerged Thrombocytopenia to 129 ..and hepatic infection by virus C, undated (research and viral confirmation not performed because of death)."The patient underwent lab tests and procedures which included platelet count: 129 on 28May2021. The patient died on 04Jun2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Thrombocytopenia; The patient died this morning due to evolution of the main oncological disease locally advanced oral cavity squamous carcinoma cause of death


VAERS ID: 1401167 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2229 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   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: AFib; COPD; Hypertension; Obesity; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210530; Test Name: body temperature; Result Unstructured Data: Test Result:max 38 Centigrade
CDC Split Type: ITPFIZER INC2021668468

Write-up: death; Second dose administration of the Comirnaty vaccine on 29May2021. In the following two days, fever (max 38 ? C) with asthenia; Second dose administration of the Comirnaty vaccine on 29May2021. In the following two days, fever (max 38 ? C) with asthenia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-738215 received via regulatory authority. A 71-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FC2229 and expiry date: 30Sep2021), via an intramuscularly, in Arm Left (left shoulder) on 29May2021 at 16:07, as single dose for COVID-19 immunisation. The patient''s medical history included smoker, hypertension, COPD, Obesity, and AFib and it was unknown if medical history was ongoing. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FA5831 and expiry date was not reported), via an unspecified route of administration, 08May2021 at 16:03, as single dose for COVID-19 immunisation and no ADRs (adverse reactions) after first dose. Second dose administration of the COMIRNATY vaccine on 29May2021. In the following two days, on 30May2021, the patient experienced fever (max 38 degree C) with asthenia. On 31May2021 at 21:40, the patient died due to unknown cause. Outcome of the events was fatal. Sender Comment: Attached is the certificate of death made by doctor. The doctor who ascertained the death has been contacted for more information. Reporter comment: Second dose administration of the COMIRNATY vaccine on 29May2021. In the following two days, fever (max 38 degree C) with asthenia. Death of unknown cause on 31May2021 at 21:40. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Second dose administration of the Comirnaty vaccine on 29May2021. In the following two days, fever (max 38 ? C) with asthenia. Death of unknown cause on 31May2021 at 21:40.; Reported Cause(s) of Death: Death


VAERS ID: 1401341 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Chills, Computerised tomogram, Constipation, Culture, Cyanosis, Dehydration, Flushing, Heart rate, Oxygen saturation, Oxygen saturation decreased, Pallor, Pyrexia, Sepsis, Urinary tract infection, Urine analysis, Vomiting, X-ray
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bedridden; Gastrostomy
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular disorder (orally taking Anti-thrombotic medications)
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: Test Result:96/49; Test Date: 20210602; Test Name: Blood pressure; Result Unstructured Data: Test Result:78/54; Test Date: 20210607; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:39.2 (high fever) Centigrade; Test Date: 20210602; Test Name: CT; Result Unstructured Data: Test Result:Stool mass in the CT; Test Date: 20210604; Test Name: Culture of urine and saliva; Result Unstructured Data: Test Result:CRE (K. Pneumoniae); Test Date: 20210601; Test Name: pulse; Result Unstructured Data: Test Result:85; Comments: 18:50; Test Date: 20210602; Test Name: pulse; Result Unstructured Data: Test Result:61; Test Date: 20210601; Test Name: SAT; Test Result: 95 %; Comments: 18:50; Test Date: 20210602; Test Name: Urine analysis; Result Unstructured Data: Test Result:Urinary tract infection; Test Date: 20210602; Test Name: X-ray; Result Unstructured Data: Test Result:No pneumonia
CDC Split Type: JPPFIZER INC2021656043

Write-up: Sepsis due to uriinary tract infection; Sepsis due to uriinary tract infection; cyanosis; constipation; dehydration; Body temperature 38.4; vomiting; flushed face; blood pressure 96/49 decreased than usual; pallor facial; shivering; SAT decreased; This is a spontaneous report from a contactable other HCP (inoculator) and contactable physician received from the Regulatory Authority. The regulatory authority report numbers are v21111699, v21112518, v21112630, v21112668 and v21113048. The patient was an 88-year and 6-month-old female. Body temperature before vaccination was 36.4 degrees Centigrade. There were points to be considered on the vaccine screening questionnaire; receiving Anti-thrombotic medications due to Cerebrovascular disorder. Medical history included bedridden due to cerebrovascular disorder and percutaneous endoscopic gastrostomy (PEG).Family history was not reported. On 01Jun2021 at 11:05 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5715, Expiration date 31Aug2021) at the age of 88-year-old via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 18:50(7 hours 45 min after the vaccination), the patient experience vomiting, body temperature 38.4, flushed face, blood pressure 96/49 decreased than usual, pallor facial, shivering, SAT decreased. On 02Jun2021 (1 day after the vaccination), the patient was admitted to the hospital. On 02Jun2021 (1 day after the vaccination), the outcome of the event was not recovered/not resolved. The course of the event was as follows: On 01June after 11:00, vaccination was carried out, and the condition was reported to the family in the evening without any vital problems. At 18:50, vomiting, flushed face, body temperature 38.4 SAT95% P=85, breathing was peaceful. No antipyresis even after 22:00, so cooling, acetaminophen was used, intravenous drip was started. The next day, no decrease in body temperature was observed, and CALONAL was administered, antibiotics were initiated. Vomiting present, suction of injectable food by suction, shivering, pallor facial, SAT decreased, and cyanosis appeared. Blood pressure 78/54 Body temperature 39.2 p = 61, started oxygen. The patient was transported to the cooperating medical equipment by ambulance. The reporting other HCP classified the event as serious (Hospitalization on 02Jun2021), the causality between the event and BNT162B2 as unassessable. Other possible causes of the event such as any other diseases was/were as follows: Bedridden due to Cerebrovascular disorder, no speech, vomiting due to constipation of stool mass at the later examination, fear of pneumonia aspiration, less urination even after the intravenous drip treatment , dehydration, pyrexia due to urinary tract infection was also considered. The reporting other HCP commented as follows: Examinations were performed at the hospital. Stool mass in the CT=$g the cause of vomiting? No pneumonia on the X-ray. A balloon (catheter) was inserted during transportation. As a result of urine analysis, urinary tract infection may be the cause of pyrexia. The explanation was given to the family at the hospital but whether it was the vaccine or not was unclear. The diagnosis has been told as sepsis. Currently hospitalized for treatment. On 02Jun2021 around 15:00, the patient was transported to the cooperating medical equipment by ambulance. On 02Jun2021, the patient experienced sepsis. The reporting physician classified the event as serious (death), the causality between the event and BNT162B2 as unassessable. Other possible causes of the event such as any other diseases were geromarasmus (bedridden, gastrostomy tube) and urinary tract infection (repeated). The course of the event was as follows: On 01Jun2021, the patient received vaccination. It had been passed without acute reactions, however, in the evening pyrexia occurred, for which the patient was emergently transported to the hospital on the same day. When an ambulance was requested, the patient had a high fever and in a shock status. On 02Jun2021, the patient was admitted. Sepsis due to urinary tract infection was diagnosed. Treatment with cefmetazole (CZE) was started. On 04Jun2021, based on the result of the culture of urine and saliva, C. Pneumoniae (CRE) was identified. Inflammatory reaction was resolving. On 07Jun2021, in the middle of the night, the condition aggravated (blood pressure decreased). On 08Jun2021 at 3:38, the patient died. The reporter comment was updated/added as follows: On 08Jun2021, the hospital called and reported that the patient died a little past 03:00. It was not reported whether an autopsy was performed. The cause of death was not reported. The physician commented as follows: The direct effect of the vaccine may have resulted in a weakened immune system. Vaccination of bedridden elderly people may increase the number of cases like this, so it was necessary to remove bedridden people for priority vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis due to uriinary tract infection; Sepsis due to uriinary tract infection


VAERS ID: 1401343 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, C-reactive protein increased, Computerised tomogram, Platelet count decreased, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210523; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Comments: Before vaccination; Test Date: 20210601; Test Name: CRP; Test Result: 0.94 mg/dl; Test Date: 20210601; Test Name: platelets decreased; Result Unstructured Data: Test Result:40000; Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210603; Test Name: CT; Result Unstructured Data: Test Result:thrombosis in the cerebral sinus; Test Date: 20210602; Test Name: CT; Result Unstructured Data: Test Result:showed findings for which thrombosis in the cerebr; Comments: showed findings for which thrombosis in the cerebral sinus was suspected
CDC Split Type: JPPFIZER INC2021656244

Write-up: Platelets decreased; Thrombus; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21111831. The patient was a 72-year and 3-month-old male. Body temperature before vaccination was 37.0 degrees Centigrade. The family history was not reported. The patient was receiving dialysis. The patient had no allergy, and he had not received vaccination within 2 months. On 23May2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 28May2021 at 00:00 (4 days and 9 hours after the vaccination), the patient experienced platelets decreased and Thrombus. On 01Jun2021 (9 days after the vaccination), the patient was admitted to the hospital. On 03Jun2021 (11 days after the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 28May2021 (5 days after vaccination), the patient experienced persistent queasy and vomiting. On 01Jun2021 (9 days after vaccination), the patient was examined. The patient experienced mild depressed level of consciousness, platelets decreased (to 40000), and increased inflammatory reaction (CRP 0.94 mg/dL), and he was admitted to the reporting hospital for follow up. On 03Jun2021, at around 02:00 (10 days and 11 hours after vaccination), the patient experienced depressed level of consciousness and decreased blood pressure. At 05:38 (10 days, 14 hours, and 38 minutes after vaccination), the patient was confirmed to have cardiac arrest and respiratory arrest. Cardiopulmonary resuscitation was not desired, and the patient was confirmed to die. CT after the death showed thrombosis in the cerebral sinus. Retrospectively, CT which was performed on the previous day (02Jun2021) also showed findings for which thrombosis in the cerebral sinus was suspected. No other obvious causes were observed. It was considered that thrombosis and platelets decreased due to autoimmunologic mechanism associated with the vaccination might occur which was reported in NEJM 2021:342:2124-2130. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. ; Reported Cause(s) of Death: Thrombus; Platelets decreased


VAERS ID: 1401344 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Cardiac arrest, Cyanosis, Marasmus, Pulse abnormal, Pupil fixed, Respiration abnormal, Respiratory rate, Slow response to stimuli, Tachypnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Communication disorder; Dementia Alzheimer''s type; Marasmus
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Blood pressure; Result Unstructured Data: Test Result:84/50 mmHg; Test Date: 20210603; Test Name: Respiratory rate; Result Unstructured Data: Test Result:16; Comments: /minute
CDC Split Type: JPPFIZER INC2021656288

Write-up: respiration suddenly turned to irregular; blood pressure 84/50 mmhg; Radial artery palpable was weak; Pupils (left 3, right 2); tachypnoea; Geromarasmus; cyanosis; response apparently decreased; Cardiac arrest; This is a spontaneous report from a contactable physician received via the Agency. The patient was a non-pregnant 98-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was not provided if the patient received other medications within 2 weeks of vaccination. The patient''s concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included dementia Alzheimer''s type and cardiac failure, no communication was available, marasmus. On 27May2021 at 14:30 (the day of vaccination) (at the age of 98 years old), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420; Expiration Date: 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 03Jun2021 at 12:15 (6 days after the vaccination), the patient experienced respiration suddenly turned to irregular (tachypnoea 16/minute) blood pressure 84/50 mmhg. Radial artery palpable was weak. Pupils (left 3, right 2). The patient had marasmus originated to being elderly, no communication was available. However, response apparently decreased, and cyanosis developed. 20 minutes after, Cardiac arrest was noted and the death of the patient was confirmed. The patient died on 03Jun2021. Autopsy was not performed. The outcome of the event Geromarasmus was fatal without treatment. The outcome of the other events was unknown without treatment. The reporting physician assessed the event Geromarasmus as serious (Death). Cause of death was Geromarasmus. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: The advanced old patient''s death is more likely related to the underlying serious disease geromarasmus unrelated to vaccine use; 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: Geromarasmus


VAERS ID: 1401345 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Malaise, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic regurgitation; Growth hormone overproduction
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021656294

Write-up: pain in both limb; General malaise; This is a spontaneous report from a contactable physician received from. Regulatory authority report number is v21111830. The patient was a 61-year and 11-month-old female. Body temperature before vaccination was 36.2 degrees Centigrade. The family history was not reported. The patient had medical histories of aortic regurgitation and pituitary growth hormone hypersecretion. On 21May2021 at 14:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via an unspecified route of administration at age of 61 years old as a single dose for COVID-19 immunization. On 28May2021 (7 days after the vaccination), the patient experienced general malaise. On 04Jun2021 (14 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 21May2021 (the day of vaccination), at 14:15, the patient received the first dose of BNT162b2 vaccination. On 28May2021 (7 days after vaccination), the patient complained of general malaise. On 03Jun2021 (13 days after vaccination), at around 16:00, the patient complained of pain in both limb, and the general malaise persisted. At 17:30, the patient went home from her place of work. On 04Jun2021, at 00:15, the patient''s family contacted her colleague that the patient felt ill, and she was transferred to the emergency hospital. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Since there were no evidences for which other factors were suspected as of the time of report, it was considered that the event was caused by a side effect.; Reported Cause(s) of Death: General malaise


VAERS ID: 1401347 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fall
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bilateral hydronephrosis (After ureteral stent placement for bilateral hydronephrosis); Breast cancer; Metastases to bone; Metastases to lung; Peritoneal dissemination; Renal impairment
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021658527

Write-up: Loss of posture; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21111918, then from a contactable nurse received via a Pfizer sales representative. The patient was a 79-year and 1-month-old female. Body temperature before vaccination was 36.6 degrees Centigrade on 29May2021. The family history was not reported. The patient had medical histories of breast cancer, metastases to lung, metastases to bone, retroperitoneal dissemination, renal impairment, and after ureteral stent placement for bilateral hydronephrosis. On 28May2021 at 14:10 (the day of vaccination, at the age of 79-year and 1-month-old), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 29May2021 at 23:30 (one day, 9 hours, and 20 minutes after the vaccination), the patient experienced loss of posture. On 30May2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27May2021, the bilateral ureteral stents were placed for urine volume decreased, aggravation of renal function, and hydronephrosis. However, the general condition was favorable, and the patient had no pyrexia, thus, the vaccination was performed on 28May2021. On 28May2021, the patient visited the reporting hospital for receiving the first dose of BNT162b2 vaccination. The patient originally had multiple metastases of breast cancer. On 29May2021, no changes were observed in the daytime; however, at 23:30 (one day, 9 hours, and 20 minutes after vaccination), the family member found the patient collapsed, and the patient was emergently transferred to the hospital. On 30May2021, at 00:31 (one day, 10 hours, and 21 minutes after vaccination), cardiopulmonary resuscitation (CPR) could not be performed, and the patient''s death was confirmed. The cause of death was loss of posture. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were multiple metastases of breast cancer and renal impairment. The reporting physician commented as follows: It was considered unlikely that the event was caused by only the BNT162b vaccination, and it was considered that aggravation due to the underlying diseases might strongly involve in the event. However, it was considered that it was hard to be said that the event was unrelated to the vaccination because the event occurred the following day of the vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: loss of posture


VAERS ID: 1401348 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-29
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram thorax, Interstitial lung disease
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Body temperature; Result Unstructured Data: Test Result:unknown results; Comments: before vaccination; Test Date: 20210530; Test Name: chest CT; Result Unstructured Data: Test Result:showed grand-glass opacities on the both lung; Comments: showed grand-glass opacities on the both lung fields and right pleural effusion
CDC Split Type: JPPFIZER INC2021658532

Write-up: Interstitial pneumonia; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21111899. An 85-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration at the age of 85-year-old (as reported ''85-year and 7-month-old'') on 25May2021 (Lot Number: EY2173; Expiration Date: 31Aug2021) as single dose for COVID-19 immunisation. Medical history included none. There were no concomitant medications. The patient was an 85-year and 7-month-old male. Body temperature before vaccination on 25May2021 was not provided. The family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 29May2021 at 10:00 (4 days and 10 hours after the vaccination), the patient experienced interstitial pneumonia. On 04Jun2021 (10 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 30May2021 (4 days after vaccination), the patient visited the reporting hospital with a chief complaint of dyspnoea. The patient had progressive hypoxaemia, and chest CT showed grand-glass opacities on the both lung fields and right pleural effusion. The patient was diagnosed with acute interstitial pneumonia. On 04Jun2021 (10 days after vaccination), the patient died although a steroid pulse therapy was performed.The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The patient underwent lab tests and procedures which included computerised tomogram thorax: showed grand-glass opacities on the both lung fields and right pleural effusion on 30May2021, body temperature: unknown results on 25May2021. The patient died on 04Jun2021. It was not reported if an autopsy was performed. The outcome of event was fatal.; Reported Cause(s) of Death: Interstitial pneumonia


VAERS ID: 1401349 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac monitoring, Heart rate, Oxygen saturation, Pneumonia, SARS-CoV-2 test
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   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: 20210512; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination; Test Date: 20210517; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: at 00:00; Test Date: 20210517; Test Name: body temperature; Result Unstructured Data: Test Result:38.0 Centigrade; Comments: at 02:00; Test Date: 20210517; Test Name: cardiac monitor; Result Unstructured Data: Test Result:showed cardiac arrest; Comments: At 16:40; Test Date: 20210517; Test Name: pulse; Result Unstructured Data: Test Result:decreased; Comments: At 16:00; Test Date: 20210517; Test Name: SpO2; Test Result: 80 %; Comments: at 02:00; Test Date: 20210517; Test Name: COVID-19 antigen; Test Result: Negative ; Test Date: 20210517; Test Name: loop-mediated isothermal amplification (LAMP); Test Result: Negative ; Comments: loop-mediated isothermal amplification (LAMP)
CDC Split Type: JPPFIZER INC2021658643

Write-up: Pneumonia; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21111808. The patient was an 87-years and 10-month-old female. Body temperature before vaccination was 36.0 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 12May2021 at 13:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) at the age of 87-years-old via an unspecified route of administration as a single dose for COVID-19 immunization. On 17May2021 at 00:00 (4 days, 10 hours, and 30 minutes after the vaccination), the patient experienced pneumonia. On 17May2021 (5 days after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: On 12May2021 (the day of vaccination), at 13:30, the patient received the first dose of BNT162b2 vaccination. On 17May2021, at 00:00 (4 days, 10 hours, and 30 minutes after vaccination), the body temperature was 37.0 degrees Celsius. At 02:00 (4 days, 12 hours, and 30 minutes after vaccination), the body temperature was 38.0 degrees Celsius, and the SpO2 was 80%. At around 09:00 (4 days, 19 hours, and 30 minutes after vaccination), the patient visited the reporting hospital. The patient was diagnosed with pneumonia, and she was admitted to the hospital. The COVID-19 antigen was negative, and the loop-mediated isothermal amplification (LAMP) was negative. At 16:00 (5 days, 2 hours, and 30 minutes after vaccination), the pulse rate decreased. At 16:40 (5 days, 3 hours, and 10 minutes after vaccination) the cardiac monitor showed cardiac arrest. At 17:46 (5 days, 4 hours, and 16 minutes after vaccination), the patient was confirmed to die. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was pneumonia. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1401350 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ROXATIDINE ACETATE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastric ulcer
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021658725

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority number v21111934. A 90-year and 8-month-old female patient received the first single dose of BNT162B2 (COMIRNATY; lot FA5715, expiry date 31Aug2021) on 04Jun2021 at 11:08, for COVID-19 immunisation. Body temperature before vaccination was 36.7 degrees Centigrade. Medical history included gastric ulcer. Concomitant medications included roxatidine acetate hydrochloride (75 mg tablet) orally, at 75 mg once daily, for gastric ulcer. On 04Jun2021 at 11:08 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5715, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 05Jun2021 at 17:08 (1 day after the vaccination), the patient developed cardio-respiratory arrest. On 05Jun2021 at 17:51 (1 day after the vaccination), the patient died of cardio-respiratory arrest. It was not reported if an autopsy was performed. The course of the event was as follows: on 05Jun2021 at 13:00, home-visit bathing service was not provided. The patient was talking to a care giver. In the afternoon (16:00), when a home caregiver visited the patient, the patient was found lying down in the right spine position. She was taken to a hospital by an ambulance. At 17:05, when an emergency service arrived, she was in cardio-respiratory arrest. At 17:26, an ambulance arrived at a hospital, and at 17:51, cardio-respiratory arrest was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1401351 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Gait disturbance, Hypoaesthesia, Pneumonia, Polymerase chain reaction
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR test; Result Unstructured Data: Test Result:negative; Comments: after hospital admission
CDC Split Type: JPPFIZER INC2021660068

Write-up: Gait disturbance due to numbness in hands and feet; Pneumonia; Gait disturbance due to numbness in hands and feet; This is a spontaneous report from a contactable physician received via a Company sales representative. A female (in her 70s) patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 28May2021 (Lot number and expiration date were not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was not reported. On 28May2021 (on the same day of the vaccination), the patient experienced gait disturbance due to numbness in hands and feet with outcome of unknown. On 31May2021 (3 days after the vaccination), the patient was admitted to the hospital. On unknown date, the patient experienced pneumonia. On 04Jun2021 (7 days after the vaccination), the patient died due to pneumonia. The course of the event was as follows: On 28May2021, the patient received the first dose and subsequently developed gait disturbance due to numbness in hands and feet. On 31May2021, the patient could not walk and was taken to another hospital by ambulance. PCR test conducted after the hospital admission was negative. On 04Jun2021, the patient died of pneumonia. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was probably related to BNT162b2. The information on the Lot / Batch number has been requested.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Pneumonia and Gait disturbance cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1401353 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral ventricular rupture, Dyslalia, Hemiplegia, Magnetic resonance imaging, Thalamus haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: MRI; Result Unstructured Data: Test Result:right sided thalamus haemorrhage and cerebral vent; Comments: right sided thalamus haemorrhage and cerebral ventricular rupture
CDC Split Type: JPPFIZER INC2021665666

Write-up: Cerebral ventricular rupture; left sided paralysis; dyslalia; vomiting; right sided thalamus haemorrhage; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21112071. A 74-year and 4-month-old male received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number and Expiration date were reported as unknown) via an unspecified route of administration as a single dose on 19May2021 (at the age of 74-year-old) for COVID-19 immunization. Body temperature before vaccination was not reported. No information on medical history, concomitant medications or family history was provided. On 20May2021 at around 17:30 (1 day after the vaccination), vomiting appeared with outcome of unknown. On 20May2021 at around 18:00 (1 day after the vaccination), left sided paralysis and dyslalia appeared with outcome of unknown. On that day, right sided thalamus haemorrhage was found as well with outcome of unknown. On 20May2021 at around 17:30 (1 day after the vaccination), the patient experienced cerebral ventricular rupture. The patient was hospitalized. On 29May2021 (10 day after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the event was as follows: On 20May2021 at around 17:30, the patient vomited. On 20May2021 at around 18:00, left sided paralysis and dyslalia appeared, therefore, an emergency service was requested. MRI showed right sided thalamus haemorrhage and cerebral ventricular rupture. The patient was hospitalized to receive conservative medical treatment. On 28May2021, his condition worsened. On 29May2021, the patient died and left the hospital mortality. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. The reporter considered that there was possible cause of the event such as any other diseases. The reporting physician commented as follows: The causal relationship with BNT162b2 was uncertain. The information on the Lot / Batch number has been requested.; Reported Cause(s) of Death: Cerebral ventricular rupture


VAERS ID: 1401354 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-06-01
   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: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021666484

Write-up: Sudden death; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21112180. A 90-year and 3-month-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose on 02Jun2021 at 14:00 (the day of vaccination) (at 90 years old) for COVID-19 immunization. Relevant patient history and concomitant medications were not reported. Body temperature before vaccination was 36.3 degrees centigrade. Family history was unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On an unspecified date in Jun2021, the patient experienced sudden death. The course of the event was as follows: On 07Jun2021 in the morning, the police contacted the reporter to tell that the patient was found dead. The patient''s condition after the vaccination, outcome, date of death were unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. The reporting physician commented as follows: It was sudden death and unassessable.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1401355 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021666500

Write-up: Cerebellar infarction right; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21112148. This 76-year and 7-month-old male patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unknown route, on 12May2021 at 12:40 (at the age 76-year-old) at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 13May2021 at 06:00 (17 hours and 20 minutes after the vaccination), the patient experienced cerebellar infarction right. The course of the event was as follows: on 13May2021 (one day after the vaccination), the patient was found to have disturbed consciousness during sleeping, and he was transferred to the reporting hospital. The patient was diagnosed with cerebellar infarction right, and he was emergently admitted to the hospital. However, the patient had respiratory disorder due to brainstem compression, and he was managed with an artificial ventilator. On 16May2021 at 17:09 (4 days after vaccination), the patient was confirmed dead. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented that the causality between the event and BNT162b2 vaccination was unknown. No follow-up are attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cerebellar infarction right


VAERS ID: 1401356 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Blood pressure decreased, Body temperature, Breath sounds abnormal, Cardiac arrest, Cardiac hypertrophy, Circulatory collapse, Depressed level of consciousness, Echocardiogram, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210607; Test Name: Echocardiography; Result Unstructured Data: Test Result:a finding that looked like aortic dissection
CDC Split Type: JPPFIZER INC2021667969

Write-up: Depressed level of consciousness; Blood pressure decreased; Weak breathing; cardiac hypertrophy; Acute circulatory failure; aortic dissection; cardiac arrest; felt unwell/poorly; This is a spontaneous report from two contactable physicians received from the Regulatory Authority Agency and from a Company representative. Regulatory authority number v21112240. A 93-year and 6-month-old female patient received the first dose of BNT162B2 (COMIRNATY; lot EY5423, expiry date 31Aug2021) intramuscular, on 07Jun2021 at around 13:37 (at 93 years of age), at 0.3 ml single, for COVID-19 immunisation. Medical history included arrhythmia and hypertension. The patient was taking unspecified blood-thinning medication. Body temperature before vaccination was 36.8 degrees centigrade. Family history was not reported. On 07Jun2021 at 13:54 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) intramuscular, as the first single dose, for COVID-19 immunization. On 07Jun2021 at 15:12 (1 hour 18 minutes after the vaccination), the patient experienced depressed level of consciousness and blood pressure decreased. On 07Jun2021 she also experienced weak breathing. On 07Jun2021 (on the same day of the vaccination), the outcome of these events was fatal. The course of the event was as follows: on 07Jun2021 at around 13:37 the patient received COMIRNATY intramuscularly at 0.3 ml and 15 minutes later, the patient was confirmed to have no problem and returned home by taxi. Before the patient got home, she made a stop at a supermarket. While shopping, the patient felt unwell, poorly with depressed level of consciousness and returned to the hospital at around 15:10. Echocardiography was performed for suspected heart disorder. Although diagnosis was not made, there was a finding that looked like aortic dissection. At an emergency outpatient unit, the patient was intubated and placed on ventilator. Cardiac massage was performed and adrenaline (BOSMIN) was intravenously injected. Cardiopulmonary resuscitation was conducted. The patient eventually had cardiac arrest and died. Causality between the events and COMIRNATY was unlikely but it was difficult to say for certain that there was no causality. CT and autopsy were suggested but family member (the patient''s younger brother) refused. Acute circulatory failure was added as cause of death. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was cardiac hypertrophy. The reporting physician commented as follows: approximately 1 hour after the vaccination, the patient''s condition took a sudden turn. It was highly likely that the vaccination exerted some kind of influence. The 2nd physician classified blood pressure decreased and weak breathing as serious (death) and assessed that the causality between the events and BNT162b2 as unknown.; Reported Cause(s) of Death: Acute circulatory failure; Weak breathing; Depressed level of consciousness; Blood pressure decreased; Cardiac hypertrophy


VAERS ID: 1401357 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-06-06
   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: Cardiac failure congestive (under hospital treatment); Pneumonia aspiration (under hospital treatment); Upper gastrointestinal haemorrhage (under hospital treatment)
Preexisting Conditions: Medical History/Concurrent Conditions: Late effects of cerebral infarction; Late effects of head trauma; Symptomatic epilepsy (required the treatment with oral medicine)
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: Body temperature; Result Unstructured Data: Test Result:35.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021667998

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21112283. The patient was a 79-year and 2-month-old female. Body temperature before vaccination was 35.1 degrees Centigrade. Medical history included chronic aspiration pneumonia, cardiac failure congestive, upper gastrointestinal haemorrhage (under hospital treatment), late effects of cerebral infarction, late effects of head trauma and symptomatic epilepsy. The patient was receiving oral medication for symptomatic epilepsy. Family history was not provided. On 05Jun2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5829, Expiration date 31Aug2021) at 79 years old via an unspecified route of administration as a single dose for COVID-19 immunization. On 06Jun2021 at 21:10 (1 day after the vaccination), the patient died of cardiac arrest. It was not reported if an autopsy was performed. The course of the events was as follows: The patient had symptomatic epilepsy caused by late effects of cerebral infarction and late effects of head trauma. She had persistent disturbance of consciousness and she was bedridden. She was receiving hospital treatment for chronic aspiration pneumonia, cardiac failure congestive, and upper gastrointestinal haemorrhage. However, as she was in a lull and she had no fever (before vaccination), on 05Jun2021, she received the vaccination. After the vaccination, no change was noted in her vital signs and there were no findings suggesting allergy symptoms or adverse reactions. Around 30 hours after the vaccination, she was found in cardiac arrest. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Aggravated underlying diseases were considered as possible causes of the event. The reporting physician commented as follows: Given her progressive weakness status, even if she had not received the vaccination, sudden change of her condition could have happened. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1401358 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Mesenteric arterial occlusion
SMQs:, Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, arterial (narrow), Ischaemic colitis (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: Bedridden; Dementia; Intestinal diverticular bleeding (Past); Permanent atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Blood pressure; Result Unstructured Data: Test Result:increased; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021668074

Write-up: Superior mesenteric arterial occlusion/Superior mesenteric arterial embolism; Blood pressure increased; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21112239. A 92-year and 2-month-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) intramuscularly on 04Jun2021 at 15:30 at a single dose for COVID-19 immunisation. Medical history included dementia (severe), permanent atrial fibrillation, past diverticular bleeding from 28May2021, and bedridden. The patient previously received apixaban (ELIQUIS) for atrial fibrillation, which was suspended when diverticular bleeding developed on 28May2021. Body temperature before vaccination, family history, and concomitant medications were not reported. On 04Jun2021 around 17:00 (1 hour and 30 minutes), the patient experienced blood pressure increased. On 05Jun2021 at 14:00 (1 day after the vaccination), the patient experienced superior mesenteric arterial occlusion/superior mesenteric arterial embolism. On 05Jun2021 (1 day after the vaccination), the outcome of the event superior mesenteric arterial occlusion/superior mesenteric arterial embolism was fatal, while the outcome of blood pressure increased was unknown. It was not reported whether autopsy was done. The course of the events was as follows. The patient originally had severe dementia and was bedridden. He was an elderly patient who had difficulty in communication. The patient was taking an anticoagulant drug (ELIQUIS) for atrial fibrillation, but the drug was suspended when diverticular bleeding developed on 28May2021. The risk for embolism became higher. On 04Jun2021 at 15:30 (the day of vaccination), BNT162b2 was administered intramuscularly. Around 17:00 (1 hour and 30 minutes), the blood pressure increased (anaphylaxis was absent). On 05Jun2021 at 02:00 (1 day after the vaccination), the patient was transported by ambulance. Superior mesenteric arterial embolism was diagnosed. On 05Jun2021 at 12:00 (1 day after the vaccination), the patient died. The reporting physician classified the event superior mesenteric arterial occlusion/superior mesenteric arterial embolism as serious (death) and assessed that the causality between the same event and BNT162b2 as unassessable. The seriousness and causality of the event blood pressure increased were not reported. Other possible cause(s) of the events such as any other diseases was atrial fibrillation. The reporting physician commented as follows: It was conceivable that the underlying disease and the withdrawal of the anticoagulant drug had increased the risk for superior mesenteric thrombosis.; Reported Cause(s) of Death: Superior mesenteric arterial occlusion/Superior mesenteric arterial embolism


VAERS ID: 1401359 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 85-YEAR-OLD / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021668155

Write-up: Respiratory failure; This is a spontaneous report from a contactable nurse received from the Agency Regulatory Authority. Regulatory authority report number is v21112207. The patient was an 85-year-old male. Body temperature before vaccination was 36.2 degrees centigrade. Family history, medical history, and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 21May2021 at 13:30 (the day of vaccination) at the age of 85-year-old, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 25May2021 at 12:58 (4 days after the vaccination), the patient experienced respiratory failure. On an unknown date, the outcome of the event was fatal. It was unknown whether autopsy was done. The course of the event was as follows: On 25May2021 at 12:58 (4 days after the vaccination), the patient experienced respiratory failure. The reporting nurse classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was unknown.; Reported Cause(s) of Death: Respiratory failure


VAERS ID: 1401360 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   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: Medical History/Concurrent Conditions: Physical deconditioning; Pyrexia
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade
CDC Split Type: JPPFIZER INC2021668437

Write-up: Vomiting; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21112186. A 94-year-old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Jun2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Body temperature before vaccination was 36.5 degrees centigrade. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown). Medical history: There had been repetitive episodes of pyrexia in 38s (degrees centigrade) since about a month before with physical deconditioning. Family history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 03Jun2021 at 14:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 06Jun2021 at 22:00 (3 days after the vaccination), the patient experienced vomiting. On 07Jun2021 (4 days after the vaccination), the outcome of the event was fatal. Autopsy was done. The course of the event was as follows: The patient was an elderly person. No increased body temperature was noted before the second vaccination, but it was said that there had been repetitive episodes of pyrexia in 38s (degrees centigrade) since about a month before with physical deconditioning. Although the detailed situation after the second vaccination was unknown, 2 hours after the patient was last confirmed alive, she was found dead with her vomit. In the respiratory tract, autopsy revealed a slightly large volume of mushy substance with properties similar to the stomach contents. No increased lung weight was noted, and it was a sudden death with few findings of left heart failure. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases: It was said that there had been repetitive episodes of pyrexia in 38s (degrees centigrade) since about a month before, but the details were unknown. The reporting physician commented as follows: It was unknown whether vomiting was a side effect, and considering that cardiopulmonary resuscitation was performed, the effect of it could not be ruled out for the entry into the respiratory tract. Information on the lot/batch number has been requested; Reported Cause(s) of Death: Vomiting; Autopsy-determined Cause(s) of Death: In the respiratory tract, autopsy revealed a slightly large volume of mushy substance with properties similar to the stomach contents


VAERS ID: 1401361 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autoimmune haemolytic anaemia, Blood bilirubin unconjugated, Blood lactate dehydrogenase, Blood test, Body temperature, Coombs test, Crossmatch, Haptoglobin, Malaise, Mean cell volume, Pyrexia
SMQs:, Haemolytic disorders (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: indirect bilirubin; Result Unstructured Data: Test Result:increased; Test Date: 20210531; Test Name: LDH; Result Unstructured Data: Test Result:increased; Test Date: 20210213; Test Name: blood examination; Result Unstructured Data: Test Result:no anaemia; Test Date: 20210524; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210531; Test Name: body temperature; Result Unstructured Data: Test Result:fever (unknown value) Centigrade; Test Date: 20210603; Test Name: Coombs test; Result Unstructured Data: Test Result:positive; Test Date: 20210531; Test Name: cross-matching analyses; Result Unstructured Data: Test Result:positive; Test Date: 20210603; Test Name: haptoglobin; Result Unstructured Data: Test Result:decreased; Test Date: 20210531; Test Name: MCV; Result Unstructured Data: Test Result:120fL or higher
CDC Split Type: JPPFIZER INC2021668710

Write-up: Autoimmune haemolytic anaemia; general malaise; slight fever; This is a spontaneous report from a contactable physician received from the regulatory Authority (RA). Regulatory authority report number is v21112187. A 90-year and 1-month-old male patient received first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 24May2021 at 15:00 (Lot Number: EX3617; Expiration Date: 31Aug2021) (at the age of 90-year-old) as single dose for COVID-19 immunisation. Medical history included cerebral infarction from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (BAYASPIRIN) oral taken for an unspecified indication from an unspecified start date and ongoing. Body temperature before vaccination was 36.7 Centigrade. On 24May2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On 31May2021 at 08:00 (6 days and 17 hours after the vaccination), the patient experienced autoimmune general malaise, slight fever and haemolytic anaemia. On 06Jun2021 (13 days after the vaccination), the outcome of haemolytic anaemia was fatal, the outcome of the other events was unknown. The course of the event was as follows: on 31May2021 at 08:00 (6 days and 17 hours after the vaccination), in the morning, the patient had general malaise and slight fever, and he visited the reporting hospital. The patient had macrocytic anaemia of MCV 120fL or higher and haemolysis findings (increased indirect bilirubin and LDH). A blood transfusion of red cell concentrate was prepared on stanby basis. However, cross-matching analyses was positive, and the patient was suspected to have haemolytic anaemia. On 02Jun2021 (9 days after the vaccination), corticosteroid was introduced; however, the disease could not be controlled. On 03Jun2021 (10 days after the vaccination), it was reported that the haptoglobin decreased, and Coombs test was positive, and thus, haemolytic anaemia was definitely diagnosed. The periodic blood examination on 13Feb2021 showed no anaemia. During 3 and a half months until the onset of the event, there were no administration of new drugs or affection of infection, and thus, secondary haemolytic anaemia due to other causes was deniable. The event was considered as a side reaction caused by BNT162 vaccination considering the last vaccination. On 06Jun2021 (13 days after the vaccination), at night, the patient died. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: in this case, the causality between the death and BNT162 vaccination could not be ruled out.; Reported Cause(s) of Death: Autoimmune haemolytic anaemia


VAERS ID: 1401362 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Ileus, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021668854

Write-up: asphyxia due to vomit caused by ileus; asphyxia due to vomit caused by ileus; asphyxia due to vomit caused by ileus; This is a spontaneous case from a contactable pharmacist received via a Pfizer sales representative. A male patient in his 70s received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as single dose on unknown date in 2021 (the day of vaccination) for COVID-19 immunization. Relevant medical history, family history and concomitant medications were not reported. Body temperature before vaccination was not provided. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced asphyxia due to vomit caused by ileus. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal. Unknown if an autopsy was performed. The course of the event was as follows: The patient was emergently transferred to the reporting hospital from another hospital. On unknown date in 2021, the following day after the patient received the second dose of BNT162b2 vaccination, he was emergently transferred to the reporting hospital. The patient had asphyxia due to vomit caused by ileus. The patient had no bowel movement since 4 days ago. He visited the practitioner and had and enema; however, he could not have bowel movement. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unknown. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The attending physician considered that the causality between the event and BNT162b2 vaccination was unknown.; Sender''s Comments: Based on the minimal available information there is not a reasonable possibility that the drug contributed to occurrence of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate ?data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: asphyxia due to vomit caused by ileus; asphyxia due to vomit caused by ileus; asphyxia due to vomit caused by ileus


VAERS ID: 1401363 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAGNESIUM OXIDE; MIYA-BM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ALS; Bedridden; Bronchitis; Dyslalia; Dysphagia; Gavage; Pyrexia; Tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021669388

Write-up: Bradycardia; Cardiac arrest; Tachycardia; This is a spontaneous report from a contactable pharmacist received via the Agency and from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21112426. The patient was a non-pregnant 83-year-old and 11-month-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Body temperature before vaccination was 36.9 degrees Centigrade. The patient previously received ampicillin sulbactam (ABPC/SBT) 6 g daily for bronchitis from 18May2021 to 24May2021, and there was no allergy. The patient received magnesium oxide (MAGNESIUM OXIDE) and clostridium butyricum (MIYA-BM) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. If the patient had allergies was unknown as information was not provided. Other medical history included amyotrophic lateral sclerosis (ALS) from Nov2019. On 01Jun2021 at 14:53 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) at 83 years old intramuscular in the left arm for COVID-19 immunization. After the vaccination, the patient experienced tachycardia. On 02Jun2021 at 19:20 (the day after the vaccination), the patient experienced bradycardia and cardiac arrest. The patient died on 02Jun2021 at 20:07. The course of the events was provided as follows: The patient was diagnosed with ALS in Nov2019. Decrease in strength of four extremities and dyslalia became remarkable, and she was admitted to a hospital for a purpose of long term rehabilitation on 20Apr2020. At the time of admission, the patient showed her unwillingness to be placed on life-prolonging treatment. From around Dec2020, dysphagia became remarkable, so her meals were modified to be easily eaten. However, swallowing status was further aggravated from around Apr2021. Pyrexia developed on 18May2021. A diagnosis of bronchitis was made and treatment was started. Oral intake of food was discontinued and tubal feeding was started from 31May2021. The patient sometimes experienced temporal tachycardia after tubal feeding. As communication with the patient was difficult due to remarkable decrease in strength of four extremities and dyslalia, BNT162b2 was given based on presumed consent. Thereafter, tachycardia was noted, but it was considered post status of tubal feeding. From around 02Jun2021 at 19:20, bradycardia started and her heart soon arrested. Contact with her family was made and chest pressing was started. Resuscitation was stopped based on the patient''s will after arrival of the family. Death was confirmed. Since the vaccination, the patient has not been tested for COVID-19. The events resulted in prolongation of hospitalization (The patient was vaccinated while in hospital) and death. The outcome of the events was fatal with treatment including chest pressing. Cause of death was ALS. An autopsy was not performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was ALS. The reporting physician commented as follows: The patient was bedridden due to the progression of ALS, and also had bronchitis. The patient''s general condition was considered to be poor. It was concluded that the cause of death was ALS. However, the causal relationship could not be denied since the death occurred after vaccination.; Reported Cause(s) of Death: tachycardia; bradycardia; cardiac arrest; ALS


VAERS ID: 1401364 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Pulmonary tuberculosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021669472

Write-up: Cardiac failure; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. The patient was a 93-year-old female. Body temperature before vaccination was not provided. The patient family history was not provided. The patient had medical histories of hypertension and pulmonary tuberculosis. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 03Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) intramuscular at single dose for COVID-19 immunization. On 05Jun2021 (2 days after the vaccination), the patient experienced cardiac failure. On unknow date in May2021 (unknown days after the vaccination, as reported), the patient was admitted to the hospital. On 05Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 05Jun2021 (2 days after the vaccination), the patient died due to cardiac failure. The causality between the event and BNT162b2 was not provided.; Sender''s Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical 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: Cardiac failure


VAERS ID: 1401376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-04-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Atrial fibrillation, Bed rest, Cardiac failure chronic, Decreased appetite, End stage renal disease, General physical health deterioration, Herpes zoster, Hyperaesthesia, Hypertension, N-terminal prohormone brain natriuretic peptide, Pain, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; ESOMEPRAZOLE; STILNOX; DIGOXINE; FUROSEMIDE; ELIQUIS; COVERSYL [PERINDOPRIL ERBUMINE]; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib (for 10 years); Coagulation disorder; End stage cardiac failure (for 2 years); Gout; Hypertension arterial (for 20 years); Terminal renal insufficiency
Allergies:
Diagnostic Lab Data: Test Name: NT-proBNP; Result Unstructured Data: Test Result:4000 ng/L; Comments: stabilised at around 4000 ng/L.; Test Date: 202104; Test Name: NT-proBNP; Result Unstructured Data: Test Result:12000 ng/L; Comments: increased to 12000 ng/L
CDC Split Type: LUPFIZER INC2021653365

Write-up: end-stage renal failure; acute pulmonary oedema; end-stage heart failure; continuous atrial fibrillation; hypertension arterial; Zona/ophthalmic and facial shingles; Pain/persistence of pain; Bed rest; Weight loss; General physical health deterioration/altered general condition; hyperalgesic leading to loss of appetite; hyperalgesic leading to loss of appetite; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number LU-ALMPS-202102420. A 92-year-old female patient received second dose of BNT162B2 (COMIRNATY), via intramuscular on 02Mar2021 (batch/lot number: EP2163) as single dose for covid-19 immunisation; fentanyl (DUROGESIC, strength: 25ug), via an unspecified route of administration from 16Apr2021 at 25 ug, frequency: 1h for pain. Medical history included terminal renal insufficiency from 2001, end stage cardiac failure from 2019 (for 2 years), coagulation disorder, gout from 2001, atrial fibrillation (AFib) from 2011 (for 10 years), hypertension arterial from 2001 (for 20 years). Concomitant medications included allopurinol; esomeprazole; zolpidem tartrate (STILNOX); digoxine; furosemide; apixaban (ELIQUIS); perindopril erbumine (COVERSYL); bisoprolol. The patient previously took first dose of BNT162B2 (COMIRNATY), via intramuscular on 02Feb2021 (batch/lot number: EJ6796) as single dose for covid-19 immunization. On 12Apr2021, patient experienced zona and pain. Around 12Apr2021 or 13Apr2021, occurrence of ophthalmic and facial shingles, hyperalgesic leading to loss of appetite, altered general condition and bed rest. On 16Apr2021, medical consultation: initiation of treatment with ZELITREX. Due to the persistence of pain, introduction of morphine (DUROGESIC 25). Improvement of the cutaneous symptomatology but persistence of the pain. On 04May2021, the patient died of acute pulmonary oedema in a context of end-stage heart failure, continuous atrial fibrillation (ACFA), hypertension arterial (HTA) and end-stage renal failure. NT-proBNP stabilised at around 4,000 ng/L. At the end of Apr2021, NT-pro BNP increased to 12,000 ng/L. The action taken for fentanyl was not applicable. The outcome of the events "hyperalgesic leading to loss of appetite" was unknown, for other events was fatal. The patient died on 04May2021. An autopsy was not performed. The casual relationship of DUROGESIC and all events assessed as C1 S1 (I1 dubious) B1 by NCA via regulatory authority. The casual relationship of Comirnaty and Zona assessed as C2 S1 (I1 dubious) B2 by NCA via regulatory authority. The casual relationship of Comirnaty and General physical health deterioration, Bed rest and Weight loss assessed as C1 S1 (I1 dubious) B1 by NCA via regulatory authority. The casual relationship of Comirnaty and Pain assessed as C2 S1 (I1 dubious) B3 by NCA via regulatory authority. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: end-stage renal failure; General physical health deterioration; Pain; Bed rest; Weight loss; End stage cardiac failure; AFib; Zona; Acute pulmonary edema; Hypertension arterial


VAERS ID: 1401419 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-17
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: General physical condition decreased; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Death; General physical health deterioration; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 75-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included General physical condition decreased. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 14-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 ml. On 17-Apr-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration). The patient died on 17-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) outcome was unknown. Company Comment: This case concerns a 75-year-old male patient who received mRNA-1273 and experienced general physical condition decreased shortly after taking the vaccine and died 3 days later, Although, there exist a very strong tempal association. there is still not enough information to assess the causal relationship to product use without the exact cause of death. However, causal relationship between the product administration and general health deterioration cannot be excluded.; Sender''s Comments: This case concerns a 75-year-old male patient who received mRNA-1273 and experienced general physical condition decreased shortly after taking the vaccine and died 3 days later, Although, there exist a very strong tempal association. there is still not enough information to assess the causal relationship to product use without the exact cause of death. However, causal relationship between the product administration and general health deterioration cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1401422 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Bone pain, Epistaxis, Fatigue, Malaise, Myalgia, Myeloid leukaemia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: Body temperature; Result Unstructured Data: Koorts: 37.5 tot 38 graden Celsius
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Myeloid leukaemia; Myalgia; Generalized joint pain; Fatigue; Bone pain; Malaise; Nose bleed; This regulatory authority case was reported by an other and describes the occurrence of BONE PAIN (Bone pain), MALAISE (Malaise), EPISTAXIS (Nose bleed), MYELOID LEUKAEMIA (Myeloid leukaemia), MYALGIA (Myalgia), ARTHRALGIA (Generalized joint pain) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced BONE PAIN (Bone pain) (seriousness criterion death), MALAISE (Malaise) (seriousness criterion death), EPISTAXIS (Nose bleed) (seriousness criterion death), MYALGIA (Myalgia) (seriousness criterion death), ARTHRALGIA (Generalized joint pain) (seriousness criterion death) and FATIGUE (Fatigue) (seriousness criterion death). On an unknown date, the patient experienced MYELOID LEUKAEMIA (Myeloid leukaemia) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was meyeloide leukemie. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: increased Koorts: 37.5 tot 38 graden Celsius. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant information was not provided. Treatment information of the patient was not provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Meyeloide leukemie


VAERS ID: 1401424 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Chills, Computerised tomogram, Dyspnoea, Fatigue, Headache, Malaise, Multiple organ dysfunction syndrome, Oxygen saturation decreased, Pneumonia, Pyrexia, Septic shock
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; ROSUVASTATINE [ROSUVASTATIN]; BENZBROMARON; ISOSORBIDE DINITRATE; BECLOMETASONE;FORMOTEROL; TIOTROPIUM; METOPROLOL; OMEPRAZOL; CALCIUM CARBONATE; AMLODIPINE; LISINOPRIL; COLCHICINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:no results; Test Date: 20210424; Test Name: pyrexia; Result Unstructured Data: Test Result:38 - 40.5 Centigrade; Test Name: CT scan; Result Unstructured Data: Test Result:no results
CDC Split Type: NLPFIZER INC2021668428

Write-up: Pneumonia with septic shock. From 4 days after vaccine progressive dyspnoea and 5 days after combined with low oxygen saturation; Dyspnoea; Low oxygen saturation; multiorgan failure; Pneumonia with septic shock. From 4 days after vaccine progressive dyspnoea and 5 days thereafter combined with low oxygen saturation; Cold shivers; Fever: 38 to 40.5 degrees Celcius; Not feeling well; Fatigue; Headache; This is as spontaneous report received from a contactable Physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00566180. A 68-years-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: Unknown) as 1st dose, single dose for covid-19 immunization. The patient''s medical history was not reported. The patient did not had previous COVID-19 infection. Concomitant medication(s) included acetylsalicylic acid (ACETYLSALICYLIC ACID) 80mg, rosuvastatine [rosuvastatin] (ROSUVASTATINE [ROSUVASTATIN]) 10mg, benzbromarone (BENZBROMARON) 100mg, isosorbide dinitrate (ISOSORBIDE DINITRATE) 5mg, beclometasone; formoterol (BECLOMETASONE;FORMOTEROL) 100/6ug/do, tiotropium (TIOTROPIUM) 13ug, metoprolol (METOPROLOL) 200mg, omeprazole (OMEPRAZOL) 40mg, calcium carbonate (CALCIUM CARBONATE) 1.25g, amlodipine (AMLODIPINE) 5mg, lisinopril (LISINOPRIL) 10mg, colchicine (COLCHICINE) 0.5mg.On 24Apr2021 (1 day after vaccination), the patient experienced cold shivers, fever: 38 to 40.5 degrees Celsius, not feeling well, fatigue and headache. On 27Apr2021, (four days after vaccination) pneumonia with septic shock, patient got progressive dyspnea and later combined with a low oxygen saturation, for which he was admitted to hospital and five days after combined with low oxygen saturation after which sent to emergencies and admission to intensive care. On an unknown date, the patient underwent lab tests which included blood test :no results reported, computerized tomogram(CT scan): No results reported and body temperature: 38 - 40.5 centigrade on 24Apr2021.The events cold shivers, headache, fever: 38 to 40.5 degrees Celsius was treated with paracetamol, pneumonia with septic shock were treated with antibiotics, invasive ventilator, vasopression, inotropie and corticosteroids. The patient was treated with unspecified medication for the event not feeling well. On 30Apr2021, patient died of pneumonia and septic shock due to Streptococcus pneumoniae with multi-organ failure. It was not reported if an autopsy was performed. The outcome of the events pneumonia with septic shock, cold shivers, fever: 38 to 40.5 degrees Celsius, multi-organ failure was fatal. The outcome for the events dyspnea, low oxygen saturation, not feeling well, fatigue and headache outcome was unknown. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Sender''s Comments: The reported event hyperpyrexia was confirmed with temperature value below 41.5?C (or 106.7?F, choose the appropriate value), a value which, from a medical point of view is not consistent with ?hyperpyrexia''. The Company therefore coded this event as ?pyrexia.; Reported Cause(s) of Death: Cold shivers; pneumonia and septic shock due to streptococcus pneumoniae (blood cultures); Fever: 38 to 40.5 degrees Celcius; with accompanying multiorgan failure; pneumonia and septic shock due to streptococcus pneumoniae (blood cultures)


VAERS ID: 1401431 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 2 - / 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: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure (Admitted to hospital 05May2021 to 10May2021); Alcohol abuse; Atherosclerotic cardiovascular disease (Admitted to hospital 05May2021 to 10May2021); Chronic obstructive pulmonary disease exacerbation (Admitted to hospital 05May2021 to 10May2021); Cigarette smoker (smoked 20-30 cigarettes daily. Have smoked for 70 years.); Dehydration (Admitted to hospital 05May2021 to 10May2021); Living in care (was admitted to a care center for rehabilitation); Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021645303

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-00362. A 76-years-old male patient received bnt162b2 (COMIRNATY), via intramuscular on 19May2021 at 12:00 (Batch/Lot Number: FA7812) as single dose for covid-19 immunisation. Medical history included acute renal failure from an unknown date (Admitted to hospital 05May2021 to 10May2021), Parkinson''s disease from an unknown date, dehydration from an unknown date (Admitted to hospital 05May2021 to 10May2021), cigarette smoker from an unknown date (smoked 20-30 cigarettes daily. Have smoked for 70 years), atherosclerotic cardiovascular disease from an unknown date (Admitted to hospital 05May2021 to 10May2021), living in care from an unknown date (was admitted to a care center for rehabilitation), chronic obstructive pulmonary disease exacerbation from an unknown date (Admitted to hospital 05May2021 to 10May2021), alcohol abuse from an unknown date. The patient''s concomitant medications were not reported. The patient had previously received the first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 vaccination. The patient experienced sudden death on 20May2021 at 01:25. The event was reported as serious due to death and medically significant. It was not reported if an autopsy was performed. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and the reported event as Possible. The outcome of the event was fatal. Sender''s comments: When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including deaths, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something else accidental, at the same time a cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the message is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SUDDEN DEATH


VAERS ID: 1401524 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-27
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NICOTINE; ETHYL LOFLAZEPATE; LOSARTAN; ALENDRONIC ACID; PENTOXIFILLINE; EUTIROX; BISOPROLOL; ACETYLSALICYLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021653318

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PT-INFARMED-M202105-3256. A 72-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 16May2021 (Lot number EW6126) as 2nd dose, 0.3 ml single dose for covid-19 immunisation. The patient''s medical history was not reported. Concomitant medications included nicotine; ethyl loflazepate; losartan; alendronic acid; pentoxifylline (PENTOXIFILLINE); levothyroxine sodium (EUTIROX); bisoprolol; acetylsalicylic acid. The patient previously received bnt162b2 (COMIRNATY), dose 1 intramuscular on 18Apr2021 (Batch/Lot Number unknown) as 1st dose, 0.3 ml single dose for Covid-19 immunisation. The patient experienced acute myocardial infarction (death, Medically Significant and Life-threatening) on 27May2021. The patient died on 27May2021. It was unknown if an autopsy was performed. No Medication error occurred. The outcome of the event was fatal. The reporter considered that the event was possibly related to bnt162b2 (COMIRNATY). No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1401552 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, C-reactive protein, COVID-19, Chest scan, Computerised tomogram aorta, Cough, Dyspnoea, Electrocardiogram, Fibrin D dimer, Heart rate, Hypoxia, Myocardial infarction, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Pneumonia, Pyruvate kinase, SARS-CoV-2 test, Troponin, Ventilation/perfusion scan, pH body fluid
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Mitral insufficiency; Myalgia
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; COVID-19; Macular degeneration
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:13.7; Test Date: 202103; Test Name: lactate; Result Unstructured Data: Test Result:6.2; Test Date: 20210314; Test Name: Potassium; Result Unstructured Data: Test Result:3.1; Comments: NOMALIZES; Test Date: 202103; Test Name: blood pressure; Result Unstructured Data: Test Result:162/93; Test Date: 202103; Test Name: Sodium; Result Unstructured Data: Test Result:132; Comments: on income; Test Date: 20210318; Test Name: Sodium; Result Unstructured Data: Test Result:134; Test Date: 202101; Test Name: DT thorax; Result Unstructured Data: Test Result:negative for pulmonary embolism,; Comments: but showed groundglass changes, which supported the suspicion that she had had Covid for several days before arriving at the hospital; Test Date: 202103; Test Name: DT aortic angio; Result Unstructured Data: Test Result:showed no pulmonary embolism,; Comments: but widespread densifications in both lungs of the ground-glass nature.; Test Date: 20210312; Test Name: c-reactive protein; Result Unstructured Data: Test Result:66; Test Date: 20210314; Test Name: c-reactive protein; Result Unstructured Data: Test Result:163; Test Date: 202103; Test Name: c-reactive protein; Result Unstructured Data: Test Result:$g 200; Comments: 254; Test Date: 202103; Test Name: c-reactive protein; Result Unstructured Data: Test Result:322; Test Date: 20210318; Test Name: c-reactive protein; Result Unstructured Data: Test Result:66; Test Date: 202103; Test Name: ecg; Result Unstructured Data: Test Result:with widespread t-wave negativities,; Comments: however, she had had it before; Test Date: 202103; Test Name: ecg; Result Unstructured Data: Test Result:dynamics and chest pain may; Comments: well be secondary to hypoxia; Test Date: 202101; Test Name: D-dimer; Test Result: Positive ; Test Date: 202103; Test Name: pulse; Result Unstructured Data: Test Result:80; Test Date: 202103; Test Name: proBNP; Result Unstructured Data: Test Result:9519; Test Date: 202101; Test Name: oxygen saturation; Test Result: 80 %; Test Date: 202101; Test Name: oxygen saturation; Result Unstructured Data: Test Result:97-100 %; Comments: get 5 liters of oxygen and saturation rose to 97-100%.; Test Date: 202103; Test Name: oxygen saturation; Test Result: 75 %; Test Date: 202103; Test Name: oxygen saturation; Test Result: 65 %; Comments: dropped rapidly during transfer; Test Date: 202103; Test Name: ph; Result Unstructured Data: Test Result:7.245; Test Date: 202103; Test Name: lpk; Result Unstructured Data: Test Result:15.5; Comments: 15-8-19-17,8-20; Test Date: 202102; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 202103; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20210308; Test Name: New troponin; Result Unstructured Data: Test Result:249-205; Test Date: 202103; Test Name: New troponin; Result Unstructured Data: Test Result:increase; Test Date: 202103; Test Name: Lung X-ray; Result Unstructured Data: Test Result:reduced air content, severe failure.; Comments: six days after admission to the hospital
CDC Split Type: SEPFIZER INC2021627847

Write-up: dyspnoea; dry cough; COVID positive / fluctuating saturation after COVID-19; Lung complication, suspected pneumonia; Type 2 infarction due to hypoxia; Type 2 infarction due to hypoxia; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number SE-MPA-2021-037898. Additional reference number includes SE-VISMA-1620722650778. An 83-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on Mar2021 (Lot Number: EP2166) as second dose, single dose for COVID-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration on Mar2021 (Lot number was not reported), at unspecified dose for an unspecified indication. Medical history included COVID-19 from Feb2021 to an unknown date, ongoing myalgia, ongoing mitral insufficiency, angina pectoris from an unknown date and unknown if ongoing and macular degeneration from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient received dose 1 of VAXZEVRIA (pending clarification) at the end of January 2021. The next day, the patient had a debut of pain between the shoulder blades that radiated between, against the sternum, started when she was resting and it lasted for a week, the medical record lists costosternal-type chest pain, suspected angiogenesis, she also states that she was very tired and went straight in to deep sleep. Arrived at hospital 12 days after vaccination. The patient stated that she had been heavy-breathing and had a fever in recent days. The form states that the dyspnoea started the day after the vaccination, the medical record states that the dyspnoea began 4 days later when the patient developed increasing dyspnoea. Saturated at 80%, get 5 liters of oxygen and saturation rose to 97-100%. Positive D-dimer, PCR positive. The patient thought the complications were due to the vaccine, she had not had it like this before, she stated. Initially, tinzaparin (INNOHEP) was given 14,000 units, DT thorax was negative for pulmonary embolism, but showed groundglass changes, which supported the suspicion that she had had COVID for several days before arriving at the hospital, she received treatment with dexamethasone, oxygen (mask and OPTIFLOW) and INNOHEP 4,500 units as thrombosis prophylaxis. Substantially complication-free care time, the patient was clear and oriented and could be discharged after 11 days of hospital care with a saturation of $g 95% on air. The patient was prescribed apixaban (ELIQUIS) 2.5 mg x2 to take to the follow-up visit. In the journal entry, the assessment is stated as an oxygen-demanding COVID-19 infection. The patient received dose 2 of VAXZEVRIA (pending clarification) was given in early March, 37 days after dose 1. The day after onset of effort dyspnoea with minimal exertion and discomfort / pain in the center of the chest without radiance, not aggravated by activity, she took nitro puffs which helped temporarily, but quickly needed to take more, the patient stated that she has not taken that much in several years, she also had a dry cough, but no fever / chills. The patient arrived at the health center 3 days later and then had saturation 75%, ECG (electrocardiogram)with widespread t-wave negativities, however, she had had it before, CRP M (C-reactive protein)$g 200, the patient was sent to hospital by ambulance. Patient was affected by breathing, but completely clear in the head and alert at rest with oxygen and afebrile. Saturation dropped rapidly during transfer to 65% without oxygen. Quick test showed COVID positive. Got 9 L oxygen and 2 g cefotaxime. Regular thin pulse, frequency 80, blood pressure 162/93, lactate 6.2, pH 7.245, LPK 15.5 ECG dynamics and chest pain may well be secondary to hypoxia. The patient was loaded with acetylsalicylic acid (BAMYL), transition to acetylsalicylic acid (THROMBYL). Cefotaxime 1gx3, ipratropium / salbutamol (COMBIVENT), sodium chloride inhalations and Nasal high flow oxygen (OPTIFLOW) were given as needed, thrombosis prophylaxis 4,500 units tinzaparin (INNOHEP). DT aortic angio showed no pulmonary embolism, but widespread densifications in both lungs of the ground-glass nature. Mediastinal lymphadenopathy, Cefotaxime were switched to piperacillin / tazobactam and moxifloxacin (AVELOX), methylprednisolone (SOLU-MEDROL) 500 mg to try to reduce inflammation. Palliative drugs were added the next day. Change to prednisolone after 4 days. New troponin increase and heart failure, received furosemide (FURIX) intravenously and KAD (catheter a demeur), 0 CPR, was admitted to IVA, hypoxic and insufficiency probably part of type 2 infarction. Lung X-rays six days after admission to the hospital generally showed reduced air content, severe failure. Type 2 infarction due to hypoxia. Got rising infection parameters and fever, they switched from piperacillin / tazobactam (TAZOCIN) to meropenem (MERONEM) + Anidulafungin (ECALTA). The patient deteriorated sharply, OPTIFLOW was withdrawn and the patient died shortly afterwards, 14 days after receiving dose 2 of VAXZEVRIA. The medical record states Lung complication, suspected pneumonia, fluctuating saturation after COVID-19. Type 2 infarction due to hypoxia. CRP 254 on income, 322 the day after, then down to 66 210312. 210314 CRP 163, drops to 66 210318. LPK 15-8-19-17,8-20. Sodium 132 on income, rises nicely to normal value, 134 210318. Potassium 3.1 210314, normalizes. LD 13.7. Trop 210308 249-205. ProBNP 9519 (as reported). The patient died on 2021. It was not reported if an autopsy was performed. Outcome was reported as Fatal. Report assessed as serious, death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: dyspnoea; dry cough; COVID positive / fluctuating saturation after COVID-19; Lung complication, suspected pneumonia; Type 2 infarction due to hypoxia; Type 2 infarction due to hypoxia


VAERS ID: 1403095 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-04-22
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Angina pectoris; Arterial hypertension; Chronic obstructive pulmonary disease (COPD stage 2); Coronary artery atherosclerosis
Preexisting Conditions: Medical History/Concurrent Conditions: Sepsis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Covid-19 virus / virus variant: UK (B.1.1.7)
CDC Split Type: ATPFIZER INC2021662838

Write-up: Vaccination failure/Covid-19 virus / virus variant: UK (B.1.1.7)/COVID-19 PCR test positive; Vaccination failure/Covid-19 virus / virus variant: UK (B.1.1.7)/COVID-19 PCR test positive; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-30017. A 70-year-old female patient received BNT162B2 (COMIRNATY), intramuscularly on 28Mar2021 (lot number and expiration date not provided) as a single dose for covid-19 immunisation. Medical history included Angina pectoris, Coronary artery atherosclerosis, Chronic obstructive pulmonary disease (stage 2), Arterial hypertension, all ongoing, Sepsis. The patient''s concomitant medications were not reported. The patient experienced Vaccination failure/Covid-19 virus / virus variant: (B.1.1.7)/COVID-19 PCR test positive on 22Apr2021 with the fatal outcome. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Covid-19 virus / virus variant: (B.1.1.7)) in 2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Clinical course: This serious spontaneous report was received from a Pharmacist and concerns a Female patient of 70 Year. The patient''s medical history and concurrent conditions included: Angina pectoris (continuing), Coronary artery atherosclerosis (continuing), Chronic obstructive pulmonary disease (continuing), Arterial hypertension (continuing), Sepsis. The patient''s weight was not reported, and height was not reported. The patient received the following suspect/interacting medications: Comirnaty, with unknown dosage, from 28Mar2021 to an unknown date for the indication(s). On 22Apr2021 the patient experienced Vaccination failure, other, COVID-19. On 2021 the patient experienced COVID-19 PCR test positive. The patient''s outcome was: unknown for Vaccination failure, fatal for COVID-19, unknown for COVID-19 PCR test positive. No concomitant medication reported. No follow-up attempts possible. No further information expected. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Vaccination failure/Covid-19 virus / virus variant: UK (B.1.1.7)/COVID-19 PCR test positive; Vaccination failure/Covid-19 virus / virus variant: UK (B.1.1.7)/COVID-19 PCR test positive


VAERS ID: 1403100 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Myocardial ischaemia, Pain in extremity
SMQs:, Other ischaemic heart disease (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021669732

Write-up: Malaise; Myocardial ischaemia; Pain in extremity; This is a spontaneous report from a contactable Healthcare professional via the Regulatory Authority. Regulatory authority report number is 563055. A 69-years-old male patient received COVID-19 VACCINE - Manufacturer unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date the patient experienced malaise, myocardial ischaemia and pain in extremity, all assessed being fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Malaise; Myocardial ischaemia; Pain in extremity


VAERS ID: 1403127 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PANTOMED; BISOPROLOL; FLUOXETINE; FORZATEN/HCT
Current Illness:
Preexisting Conditions: Comments: Hypertension arterial,pyrosis,depression.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210626138

Write-up: SUDDEN DEATH AT DAY 4 POST VACCINATION; This spontaneous report received from a physician via a Regulatory Authority [Regulatory Authority BE-FAMHP-DHH-N2021-93663] concerned an 83 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included hypertension arterial, pyrosis, depression. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD955 expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for covid-19 immunisation. Concomitant medications included fluoxetine for depression, amlodipine besilate/hydrochlorothiazide/olmesartan medoxomil for hypertension arterial, bisoprolol for hypertension arterial, and dexpanthenol for pyrosis. On an unspecified date, the patient experienced sudden death at day 4 post vaccination. On an unspecified date, the patient died from sudden death at day 4 post vaccination. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reporter''s Comments: Treatment - Evolution of the ADR - ADR description - Sudden death at day 4 post vaccination; Sender''s Comments: V0-20210626138 -Covid-19 vaccine ad26.cov2.s - SUDDEN DEATH AT DAY 4 POST VACCINATION . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SUDDEN DEATH AT DAY 4 POST VACCINATION


VAERS ID: 1403189 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-28
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100077669

Write-up: Pulmonary embolism; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was Pulmonary embolism. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment information was not provided. Company comment: Very limited information regarding this event has been provided at this time. Further information is not expected; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1403806 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   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: DESCOVY; TIVICAY; ATORVASTATIN +PHARMA
Current Illness: COPD (COPD); Nicotine abuse (chron. Nikotinkonsum); Osteoporosis (Osteoporose)
Preexisting Conditions: Medical History/Concurrent Conditions: Prostatic carcinoma (Prostata Ca in Remission)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20212

Write-up: Patient 2 Tage nach Moderna Impfung pl?tzlich verstorben; This regulatory authority case was reported by a pharmacist and describes the occurrence of SUDDEN DEATH (Patient 2 Tage nach Moderna Impfung pl?tzlich verstorben) in a 62-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Prostatic carcinoma (Prostata Ca in Remission), COPD (COPD), Nicotine abuse (chron. Nikotinkonsum) and Osteoporosis (Osteoporose). Concomitant products included EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY), DOLUTEGRAVIR SODIUM (TIVICAY) and ATORVASTATIN CALCIUM (ATORVASTATIN +PHARMA) for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 28-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SUDDEN DEATH (Patient 2 Tage nach Moderna Impfung pl?tzlich verstorben) to be possibly related. No treatment information was reported The action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding the event of death has been provided at this time. No follow up is possible.; Sender''s Comments: Very limited information regarding the event of death has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1403807 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   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: PLAVIX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021674328

Write-up: found dead in bed 7 days after 1st vaccination; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-30697. A 54-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26May2021 (Lot Number: FC0681) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included clopidogrel bisulfate (PLAVIX) taken for an unspecified indication, start and stop date were not reported. On 02Jun2021, the patient found dead in bed 7 days after 1st vaccination. The patient died on 02Jun2021. It was not reported if an autopsy was performed. Sender Comment: Regulatory Authority comment: Follow-up information has been requested. Relatedness of Comirnaty to reaction(s)/event(s) Source of assessment Reporter Result of Assessment Unclassified No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1403917 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002330 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Laryngeal oedema; Cardio-respiratory arrest; This regulatory authority case was reported by a pharmacist and describes the occurrence of LARYNGEAL OEDEMA (Laryngeal oedema) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 51-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002330) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 24-May-2021, the patient experienced LARYNGEAL OEDEMA (Laryngeal oedema) (seriousness criteria death, hospitalization and medically significant) and CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death, hospitalization and medically significant). The patient died on 25-May-2021. The reported cause of death was Cardio-respiratory arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment information provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1403920 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-13
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Heart disease congenital, Maternal exposure during pregnancy, Ultrasound abdomen
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210526; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result:CRL of 75 mm, corresponds to 13+4 SG.; Comments: CRL of 75 mm, corresponds to 13+4 SG. HN: +; TN 3.9 IPDV: reverse At the heart level, situs solitus is visualized. Four cavities were visualized with a single ventricular atrium valve that has significant valvular reflux. At the vasos-exits level, we can only visualize a single vessel in relation to possible truncus arteriosus, although it could also be a hypoplastic vessel that we cannot press (aorta). DV reverse flow.
CDC Split Type: ESPFIZER INC2021674030

Write-up: Maternal exposure during pregnancy, first trimester; Heart malformation/complex congenital heart disease; This is a spontaneous report from a contactable other health professional downloaded from the regulatory authority regulatory authority number ES-AEMPS-892685. This other hcp reported information for both mother and fetus. This is the fetus report. A 38-year-old female mother received bnt162b2 (COMIRNATY), first dose on an unspecified date (Batch/Lot Number: EL0725), second dose on 12Mar2021 (Batch/Lot Number: ET1831); both as single dose for covid-19 immunisation. The mother had received both doses of the bnt162b2 vaccine during pregnancy. The fetus received the both doses of vaccine via transplacental. The mother had medical history of migraine. The mother''s concomitant medications were not reported. The fetus experienced heart malformation/complex congenital heart disease on 13May2021. Event details: The 38-year-old woman admitted for legal interruption of pregnancy for fetus (14 weeks) with complex congenital heart disease. Diagnosis of heart disease: possible AV septum defect with single trunk arteriosus as first option (as 2nd AV septum defect with mitroaortic hypoplasia). The fetus underwent lab tests and procedures which included ultrasound abdomen on 26May2021: CRL of 75 mm, corresponds to 13+4 SG. HN: +; TN 3.9 IPDV: reverse. At the heart level, situs solitus is visualized. Four cavities were visualized with a single ventricular atrium valve that has significant valvular reflux. At the vasos-exits level, we can only visualize a single vessel in relation to possible truncus arteriosus, although it could also be a hypoplastic vessel that we cannot press (aorta). DV reverse flow. The outcome of event heart malformation/complex congenital heart disease was fatal. The fetus died on 26May2021 due to therapeutic abortion. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : ES-PFIZER INC-2021681271 mother case; Reported Cause(s) of Death: Therapeutic abortion (10043406); Heart malformation/complex congenital heart disease; Maternal exposure during pregnancy, first trimester


VAERS ID: 1404103 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-21
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood creatine, Blood pressure measurement, Blood sodium, Blood urea, Brain natriuretic peptide, C-reactive protein, Coma scale, Death, Electrocardiogram, Fibrin D dimer, Haemoglobin, Heart rate, Investigation, Oxygen saturation, Platelet count, Troponin, White blood cell count, X-ray
SMQs:, Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KARDEGIC; BISOPROLOL; ATORVASTATINE [ATORVASTATIN]; ESOMEPRAZOLE; METHOTREXATE; CORTANCYL; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma lung; Ex-tobacco user; Hypercholesterolaemia; Hypertension arterial; Interstitial lung disease; Lung disease; Lung neoplasm; Lung upper lobectomy; Pneumonia aspiration; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:bilateral dry crackles, decreased breath sounds at; Comments: the left base, no right sign.; Test Date: 20210410; Test Name: Creatine; Result Unstructured Data: Test Result:105; Comments: ?mol/L; Test Name: Blood pressure; Result Unstructured Data: Test Result:200/110 mmHg; Comments: Symmetrical; Test Name: Blood sodium; Result Unstructured Data: Test Result:132 mmol/L; Test Date: 20210410; Test Name: Urea; Result Unstructured Data: Test Result:Normal; Test Name: BNP; Result Unstructured Data: Test Result:220; Test Name: Glasgow; Result Unstructured Data: Test Result:15; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30 mg/l; Test Date: 20210410; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30 mg/l; Comments: stable; Test Name: ECG; Result Unstructured Data: Test Result:Left branch block; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:RS, QS aspect in anterior already known.; Comments: ETT performed; Test Name: D-dimer; Result Unstructured Data: Test Result:625; Test Name: Hemoglobin; Result Unstructured Data: Test Result:16.1 g/dl; Test Name: Heart rate; Result Unstructured Data: Test Result:75; Comments: beats per minutes Regular heart beats; Test Name: angio TDM; Result Unstructured Data: Test Result:found a thrombus in the left upper lobar branch.; Comments: Increased fibrosing parenchymatous impairment, particularly of the entire right pulmonary hemifield, requiring a specialized pneumological opinion. Increased cardiomegaly and appearance of multiple mediastinal and right hilar adenomegaly.; Test Name: examination; Result Unstructured Data: Test Result:Soft calves. No lower limbs edema. Peripheral; Comments: pulses perceived. Auscultation crackles until mid-field. Polypnea. Apyretic. Soft and painless abdomen; Test Name: Oxygen saturation; Test Result: 60 %; Test Name: Platelet count; Result Unstructured Data: Test Result:236 x10 9/l; Test Name: Troponin; Result Unstructured Data: Test Result:18 ng/ml; Test Name: Leukocyte count; Result Unstructured Data: Test Result:10.5 x10 9/l; Comments: No hyperleukocytosis; Test Name: X-ray; Result Unstructured Data: Test Result:white left lung on pneumonectomy; Comments: bilateral overload
CDC Split Type: FRPFIZER INC2021689317

Write-up: death unexplained; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RS20211598. An 85-year-old male patient received second dose of BNT162B2(COMIRNATY, Batch/Lot Number: Unknown), intramuscular on 08Apr2021 at single dose for covid-19 immunisation. Medical history included left upper lobectomy for pulmonary neoplasia in 2015, inhalation lung disease in 2019, diffuse interstitial lung disease on rheumatoid arthritis background, hypertension arterial, hypercholesterolemia and weaned smoking/recovered smoker in 1997, adenocarcinoma lung in 2015, pneumonia aspiration in 2019. Historical vaccine included 1st dose of BNT162B2 intramuscular on 12Mar2021 for covid-19 immunisation. In the following 3 weeks of 1st dose of BNT162B2, the patient felt much more tired and breathless than usual. The patient experienced left upper lobar branch pulmonary embolism and anticoagulation by rivaroxaban (XARELTO). The patient was hospitalized (from 16Mar2021) 27 days after BNT162B2 vaccination (first injection), for pulmonary embolism (in Mar2021). Following of the medical care: The patient remained hemodynamically stable at bed rest. Oxygenation at 2L/min. Pulmonary opinion: doubt about a real pulmonary embolism, continuation of anticoagulation with double dose of anticoagulant oral drug rivaroxaban. An echo-doppler of the lower limbs was requested but not performed. On 12Apr2021, the patient was discharged from the hospital. The patient underwent lab tests included clinical examination on unknown date: Blood pressure was at 200/110 symmetric. Heart rate was at 75 beats per minute. Regular heart sounds. Soft calves. No lower limbs edema. Peripheral pulses perceived. Auscultation crackles until mid-field. Polypnea. Apyretic. Soft and painless abdomen. Glasgow 15. X-ray: white left lung on pneumonectomy, bilateral overload. Biological examinations: hemoglobin 16.1 g/dL, platelets 236 x10 9/l, leukocytes 10.5 G/L, no hyperleukocytosis, C-reactive protein 30 mg/L, troponin 18 ng/mL, BNP 220, normal iono except blood sodium 132 mmol/L. Oxygen saturation: 60%. D-dimer at 625. ECG of the left branch block. Pulmonary auscultation: bilateral dry crackles, decreased breath sounds at the left base, no right sign. Electrocardiogram: RS, QS aspect in anterior already known. ETT performed. No argument for a cardiac origin to this dyspnea, rather of pulmonary origin. An angio TDM was performed and found a thrombus in the left upper lobar branch. Increased fibrosing parenchymatous impairment, particularly of the entire right pulmonary hemifield, requiring a specialized pneumological opinion. Increased cardiomegaly and appearance of multiple mediastinal and right hilar adenomegaly. Concomitant medications included acetylsalicylate lysine (KARDEGIC), bisoprolol, atorvastatine, esomeprazole, methotrexate; prednisone (CORTANCYL), folic acid, all from unknown date for unknown indication. The patient''s daughter reported her father''s death on 21Apr2021 (no details regarding the cause of death.) Biology on 10Apr2021: creatinine 105 ?mol/L, normal urea, CRP stable 30 mg/L. Patient died on 21Apr2021 for unknown cause. It was unknown if autopsy was done or not. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1404530 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-21
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Computerised tomogram head, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   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: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperplasia of prostate; Nephrosclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: Brain CT; Result Unstructured Data: Vascular encephalopathy; Test Date: 20210421; Test Name: Brain CT; Result Unstructured Data: Multi-focal, extensive bleeding left side; Test Date: 20210421; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: agyv?rz?s; This regulatory authority case was reported by a physician and describes the occurrence of CEREBRAL HAEMORRHAGE (agyv?rz?s) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. The patient''s past medical history included Nephrosclerosis and Hyperplasia of prostate. Concurrent medical conditions included Hypertension. On 03-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 millimetre. On 21-Apr-2021, the patient experienced CEREBRAL HAEMORRHAGE (agyv?rz?s) (seriousness criteria death and medically significant). The patient died on 23-Apr-2021. The reported cause of death was Cerebral hemorrhage. An autopsy was performed. The autopsy-determined cause of death was Cerebral hemorrhage. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Computerised tomogram head: abnormal (abnormal) Vascular encephalopathy and abnormal (abnormal) Multi-focal, extensive bleeding left side. On 21-Apr-2021, SARS-CoV-2 test: negative (Negative) negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CEREBRAL HAEMORRHAGE (agyv?rz?s) to be unlikely related. No concomitant medication was reported. Company comment: Very limited information regarding the event has been provided. This a report of dead 19 days after receiving the product, in a 85-old hypertensive patient, whose concomitant medication was not provided. Autopsy showed cerebral haemorrage. Very limited information regarding the event has been provided for inferring causality. Regulatory authority determined causality was unlikely.; Reporter''s Comments: Cerebral hemorrhage is not expected after vaccination with COVID-19 Vaccine Moderna. TTO was 18 days. The causal relationship between the event and the vaccine is considered unlikely. The case is serious due to fatal outcome.; Sender''s Comments: Very limited information regarding the event has been provided. This a report of dead 19 days after receiving the product, in a 85-old hypertensive patient, whose concomitant medication was not provided. Autopsy showed cerebral haemorrage. Very limited information regarding the event has been provided for inferring causality. Regulatory authority determined causality was unlikely.; Reported Cause(s) of Death: Cerebral hemorrhage; Autopsy-determined Cause(s) of Death: Cerebral hemorrhage


VAERS ID: 1404541 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 20-May-2021 The patient died on 20-May-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medications and treatment information was not provided. Company Comment : Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting.; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1404560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-02-28
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210228; Test Name: COVID-19 molecular test positive/molecular swab test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021332081

Write-up: The patient underwent molecular swab (positive) after the 2nd dose of comirnaty vaccine. Patient was diagnosed as covid-19 on 28th Feb on the same day of death.; The patient underwent molecular swab (positive) after the 2nd dose of comirnaty vaccine. Patient was diagnosed as covid-19 on 28th Feb on the same day of death.; The patient underwent molecular swab (positive) after the 2nd dose of comirnaty vaccine. Patient was diagnosed as covid-19 on 28th Feb on the same day of death.; The patient underwent molecular swab (positive) after the 2nd dose of comirnaty vaccine. Patient was diagnosed as covid-19 on 28th Feb on the same day of death.; This is a spontaneous report from a contactable Other Health Care Professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-704236. A 97-years-old female patient received BNT162B2 (COMIRNATY; Solution for injection), dose 2 intramuscular on 20Feb2021 (Batch/Lot Number: EP9598) as 2nd dose, single and dose 1 intramuscular on 30Jan2021 (Batch/Lot Number: EK9788) as 1st dose, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient underwent molecular swab (positive) after the 2nd dose of comirnaty vaccine. Patient was diagnosed as covid-19 on 28th Feb on the same day of death (on an unspecified date in 2021). The patient underwent lab tests on 28Feb2021 includes COVID-19 molecular test positive/molecular swab test, result: Positive and sars- cov-2- test positive. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The outcome of event unknown cause of death was Fatal, outcome of event sars cov-2 test positive was recovered, and vaccination failure was unknown, and outcome of events vaccination failure ad COVID-19 was unknown. ; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1404612 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-05-04
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia, Urinary tract infection
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: 2021-05-10
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB; ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB; This regulatory authority case was reported by a physician and describes the occurrence of PNEUMONIA (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) and URINARY TRACT INFECTION (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 04-May-2021, the patient experienced PNEUMONIA (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) (seriousness criteria death and medically significant) and URINARY TRACT INFECTION (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) (seriousness criterion death). The patient died on 10-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was unknown. Company Comment : Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events.; Reported Cause(s) of Death: Unknown


VAERS ID: 1404726 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-05-04
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia, Urinary tract infection
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: 2021-05-10
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB; ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB; This regulatory authority case was reported by a physician and describes the occurrence of PNEUMONIA (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) and URINARY TRACT INFECTION (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PNEUMONIA (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) (seriousness criteria death, hospitalization and medically significant) and URINARY TRACT INFECTION (ESEGUITO VACCINO MODERNA IL 15-04-2021. RICOVERATO IN OSPEDALE DESIO MB IL 04-05-2021 PER SOSPETTA BPN E IVU. DECEDUTO IL 10-05-2021 IN OSPEDALE DESIO MB) (seriousness criteria death and hospitalization). The patient was hospitalized on 05-May-2021 due to PNEUMONIA and URINARY TRACT INFECTION. The patient died on 10-May-2021. The reported cause of death was Bronchial pneumonia and Urinary tract infection. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was unknown. Very limited information regarding this event/s has been provided at this time. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Translation received. Added start date of hospitalization.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information is not expected.; Reported Cause(s) of Death: bronchial pneumonia; urinary tract infection


VAERS ID: 1404926 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-03
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Acute respiratory failure, Blood creatinine, Blood lactate dehydrogenase, Blood pressure measurement, Body temperature, C-reactive protein, Cardio-respiratory arrest, Computerised tomogram thorax, Glomerular filtration rate, Heart rate, Interstitial lung disease, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Interstitial lung disease (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDONINE [PREDNISOLONE]; ACTEMRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adult onset Still''s disease; Cardiac failure chronic; Diverticulitis (required hospital treatment from Apr2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Cr; Result Unstructured Data: Test Result:1.8; Comments: normally at 1.2-1.3; Test Date: 20210603; Test Name: LDH; Result Unstructured Data: Test Result:700; Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:140/80 mmHg; Test Date: 20210520; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Test Date: 20210603; Test Name: Chest CT; Result Unstructured Data: Test Result:bilateral pleural effusion; Test Date: 20210603; Test Name: CRP; Result Unstructured Data: Test Result:3; Test Date: 20210603; Test Name: eGFR; Result Unstructured Data: Test Result:20; Test Date: 20210603; Test Name: HR; Result Unstructured Data: Test Result:80; Test Date: 20210603; Test Name: Nt-proBNP; Result Unstructured Data: Test Result:800; Test Date: 20210603; Test Name: SpO2; Result Unstructured Data: Test Result:within the normal range %; Test Date: 20210603; Test Name: SpO2; Test Result: 56 %; Test Date: 20210603; Test Name: WBC; Result Unstructured Data: Test Result:40000
CDC Split Type: JPPFIZER INC2021658512

Write-up: cardio-respiratory arrest; Acute respiratory failure (interstitial pneumonia); Acute respiratory failure (interstitial pneumonia); acute respiratory distress syndrome; This is a spontaneous report from a contactable physician. An 88-year and 9-month-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EY0779; Expiration Date: 31Aug2021), via an unspecified route of administration, on 20May2021 at 14:00 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included adult still''s disease, cardiac failure chronic, and diverticulitis (required hospital treatment from Apr2021). Concomitant medications included prednisolone (PREDONINE) from 2018 and tocilizumab (ACTEMRA) from 2019. The patient experienced acute respiratory failure (interstitial pneumonia) on 03Jun2021 at 14:30 (14 days after the vaccination), which was reported as fatal. The patient also experienced acute respiratory distress syndrome on 03Jun2021 at 14:30 and cardio-respiratory arrest on 04Jun2021 at 18:00. The clinical course was reported as follows: The body temperature before vaccination was 36.5 degrees Centigrade on 20May2021. The patient required hospitalization treatment from Apr2021 for diverticulitis and at the time of discharge on 08May2021, the general condition was good and respiratory status was also good without generalized swelling. At the time of the vaccination, the patient stayed in a good condition, which was seen at the time of discharge from the hospital. On 20May2021, shortly after the vaccination, no abnormalities were noted soon after the vaccination. As the patient was admitted to an elder care facility with home-care services, she was observed by nurses, caregivers, and care managers every day. From 25May2021, the patient started to be aware of slight change of her physical condition. On 03Jun2021, in the morning, severe malaise and inappetence appeared and she could not eat meals. Afterwards, according to the nurse who observed the patient, no pyrexia was noted, oxygen saturation percutaneous (SpO2) was within the normal range on 03Jun2021, and a sign of respiratory failure was not seen. Thereafter, the patient was sleeping in her room. At 14:30, the physician in charge examined her. Afterwards, significant cyanosis and wheezing were noted. Swelling of the whole body acutely worsened. On 03Jun2021, the body temperature was 36.7 degrees Centigrade, SpO2 was 56%, blood pressure was 140/80 mmHg, and heart rate (HR) was 80. Oxygen administration was started. The patient visited the hospital where her attending physician was working. Blood test results on 03Jun2021 showed: white blood cell (WBC): 40000, C-reactive protein (CRP): 3, creatinine (Cr): 1.8 (estimated glomerular filtration rate (eGFR): 20), lactate dehydrogenase (LDH): 700, and N-terminal prohormone brain natriuretic peptide (Nt-proBNP): 800. Chest CT scan on 03Jun2021 showed bilateral pleural effusion. Acute aggravation of cardiac failure chronic and renal failure chronic (Cr was around 1.2-1.3 at normal level) and recurrence of adult still''s disease were suspected. However, her symptoms acutely progressed and cardiac failure chronic could have been controlled for several years, a marked sign of aggravation could not have been seen until the previous day. Since marked inflammatory reaction and increased LDH were concurrently occurred even though the patient was receiving prednisolone plus tocilizumab. Given those facts, progression of respiratory failure was considered, also, because of presence of pleural effusion, acute respiratory distress syndrome (ARDS) was suspected. Although continuous oxygen administration, administration of unspecified diuretic, nitrous acid medicine, and additional administration of betamethasone sodium phosphate (RINDERON) 6 mg were performed, her respiratory status was aggravated. On 04Jun2021 at 18:00, the patient was in cardio-respiratory arrest. The patient had Do Not Attempt Resuscitation (DNAR) order and artificial respiratory therapy management or transfer to a high level emergency medical service agency was not conducted. Therapeutic measures were taken as a result of acute respiratory failure (interstitial pneumonia) and acute respiratory distress syndrome as aforementioned and no treatment was given for cardio-respiratory arrest. The clinical outcome of all of the events was assessed as fatal. The patient died on 04Jun2021 at 18:00 (15 days after the vaccination). The cause of death was reported as acute respiratory failure and additionally assessed as interstitial pneumonia, acute respiratory distress syndrome, and cardio-respiratory arrest. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the event and BNT162B2 as unassessable. Other possible cause of the event was reported as follows: There was a possibility that adult still''s disease accidentally recurred which resulted in ARDS or cardiac failure chronic acutely aggravated. The reporting physician commented as follows: If aggravated respiratory status was due to ARDS, it was assumed that her underlying disease, adult still''s disease triggered systemic inflammatory response syndrome (SIRS) to occur. Recurrence of adult still''s disease was considered to be triggered with following factors: accidental recurrence, diverticulitis which was treated from Apr2021 to the beginning of May2021, or BNT162B2 which the patient received on 20May2021. Considering that the patient had noticed her poor condition from 25May2021, it was possible that from around the time adult still''s disease had already recurred. The reporter''s hospital mainly conducted facility management and home visit medical treatment, therefore, compared to a group of persons who could receive the vaccination at a public vaccination site, many patients who received at this hospital tended to have severe underlying diseases or have weakened physical conditions. In several cases of patients here, even though an adverse reaction seemed to be mild shortly after the vaccination, there was a complaint of vomiting or inappetence from 5 to 7 days after vaccination and hospital treatment was given. There were also other fatal case(s) which had been already reported. The reporter''s hospital had not allowed to give vaccination to the patients with terminal cancer or the patients who might expect to have serious outcome due to pyrexia as much as possible. In this case the patient''s condition became aggravated. The patient might have up to a year to live but it was not expected that she die within several days. The causal relationship with BNT162b2 was uncertain, but it could be considered.; Reported Cause(s) of Death: interstitial pneumonia; acute respiratory distress syndrome; cardio-respiratory arrest; Acute respiratory failure


VAERS ID: 1404927 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Marasmus
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: Medical History/Concurrent Conditions: Living in nursing home
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:not provided
CDC Split Type: JPPFIZER INC2021665738

Write-up: Geromarasmus; This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A 100-year-old male patient received the first dose of the bnt162b2 (COMIRNATY), via an unspecified route of administration in May2021 at a single dose for covid-19 immunisation. Medical history included resident of a special nursing home for the aged. The patient''s concomitant medications were not reported. Body temperature before vaccination was not provided. On an unspecified date, the patient experienced geromarasmus, which was serious for death. The clinical course was as follows: on an unknown date in late May2021 (the day of vaccination), the patient received the first dose of BNT162b2. On an unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient died. The patient died on an unspecified date in 2021 due to geromarasmus. It was not reported if an autopsy was performed. The causality between the event and BNT162b2 was not provided. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: The event geromarasmus considered intercurrent condition and unrelated to suspect product bnt162b2 (COMIRNATY). This case will be reassessed if follow-up information is received.; Reported Cause(s) of Death: Geromarasmus


VAERS ID: 1404928 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest pain, Respiratory arrest, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol allergy; Duodenal ulcer; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021667130

Write-up: Wheezing; Chest pain; Respiratory arrest; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician. The patient was a non-pregnant 79-year-old female. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. The patient had allergy to alcohol cotton. Other medical history included hypertension, dyslipidaemia, and duodenal ulcer. The patient had no history of asthma. On 10May2021, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot No. EX3617, Expiration date 31Aug2021) via an unspecified route of administration for COVID-19 immunization. On 31May2021 (the day of the vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot No. FA2453, Expiration date 31Aug2021) via an unspecified route of administration for COVID-19 immunization. Clinical course of the event was as follows: On 31May2021 from the night (the day of the vaccination), the patient experienced wheezing and chest pain. The symptoms persisted, thereafter. On 04Jun2021 (4 days after the vaccination), the patient visited a hospital A and was admitted. Wheezing and chest pain were resolving. On 06Jun2021 (6 days after the vaccination), respiratory arrest and cardio-respiratory arrest suddenly developed. The patient died without responding to cardiopulmonary resuscitation. The patient received treatments for events. The outcome of the events respiratory arrest and cardio-respiratory arrest was fatal with treatment including cardiopulmonary resuscitation. The outcome of wheezing was recovering, outcome of chest pain was reported as recovered. Autopsy was not performed. The death cause was myocardial infarction and respiratory arrest. The reporting physician assessed the events as serious (Death/Hospitalization). It was unknow if the patient has not been tested for COVID-19 since the vaccination.; Sender''s Comments: Based on the available information, the Company considered there was not a reasonable possibility that the reported events were related to the Covid-19 Vaccine (BNT162b2). Reportedly, the cause of patient''s demise was myocardial infarction and respiratory arrest. 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: Myocardial infarction; Respiratory arrest


VAERS ID: 1404929 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Depressed level of consciousness, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease (required dialysis); Dialysis
Allergies:
Diagnostic Lab Data: Test Date: 20210526; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021668060

Write-up: unknown cause of death; Vomiting; Consciousness decreased; This is a spontaneous report from a contactable physician. A 84-years-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 26May2021 10:30 (Batch/Lot Number: EY4834; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. Medical history included chronic kidney disease from an unknown date and unknown if ongoing (required dialysis), dialysis from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 30May2021 at around 07:00 (4 days after the vaccination), the patient experienced vomiting, and after that, also experienced consciousness decreased. The patient was hospitalized on same day. Body temperature before vaccination was 36.8 degrees Centigrade. On an unspecified date, the patient died. It was not reported if an autopsy was performed. The cause of death was unknown. Outcome of the events vomiting and consciousness decreased at the time of death was unknown. The course of the events was as follows: On 30May2021 at around 07:00, after breakfast the patient vomited frequent times. The reporting physician was consulted by a staff member of the serviced housing for the elderly. At 16:00, the reporting physician visited the serviced housing. Her consciousness level was JCS I-1to2. The physician was searched for a hospital where she could be transferred. During the observation, her consciousness level decreased to JCS III-100. At around 19:00, she was transferred to the hospital. The reporting physician classified the events as serious (death, hospitalized) and assessed the causality between the event and BNT162b2 as unassessable. Hypertension was considered as a possible cause of the event. The reporting physician commented as follows: At the reporter''s hospital, a final cause of death was uncertain.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1404930 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-08
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   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: Hypertension; Myocardial infarction old; Obstructive arteriosclerosis of lower extremities; Stent placement; Surgery; Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210524; Test Name: CT; Result Unstructured Data: Test Result:aortic dissection of the ascending aorta base; Comments: aortic dissection of the ascending aorta base
CDC Split Type: JPPFIZER INC2021672882

Write-up: Depressed level of consciousness; aortic dissection of the ascending aorta base; This is a spontaneous report from a contactable physician. An 87-year and 11-month-old female patient received first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 24May2021 at 13:00 (Batch/Lot Number: FA2453; Expiration Date: 31Aug2021) (at the age of 87-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension, surgery for thoracic aortic aneurysm, bilateral obstructive arteriosclerosis of lower extremities, myocardial infarction old, all from an unknown date and unknown if ongoing and stent placement in 2012. Body temperature before vaccination was 36.3 degrees Centigrade. The patient''s concomitant medications were not reported. On 24May2021 at 13:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On 08Jun2021 at 11:45 (15 days after the vaccination), the patient developed aortic dissection of the ascending aorta base. On 08Jun2021 at 13:40 (15 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the event was as follows: after the first dose of the vaccination, the patient was making good progress without pyrexia or allergic symptoms. On 08Jun2021, 15 days after the vaccination, the patient went to the care center as usual, and suddenly her consciousness level decreased. AED (automated external defibrillator) was set up at the care center, and an electric shock was given once. When an emergency service team arrived, she was in PEA (pulseless electrical activity). Thereafter, the patient was transferred to a hospital where CT showed aortic dissection of the ascending aorta base. Resuscitation was impossible to be done. On 08Jun2021 at 13:40, the patient''s death was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Thoracic aortic dissection was a possible cause of the event. The reporting physician commented as follows: the patient was at very advanced age and the presence of thoracic aortic dissection had been pointed out from before. In 2012, the patient underwent placement of stent-graft. It was found that the aneurysm was expanding over time, and in Aug2020, the aneurysm was confirmed to have expanded to 60 mm. Therefore, it was considered that she had a high risk of developing aortic dissection even without receiving the vaccination.; Reported Cause(s) of Death: Depressed level of consciousness; Ascending aortic dissection


VAERS ID: 1404932 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Amylase, Amylase increased, Aspartate aminotransferase abnormal, Blood creatine phosphokinase, Blood creatinine, Blood pressure measurement, Blood urea, Body temperature, Brain natriuretic peptide, Cardiac failure acute, Computerised tomogram, Electrocardiogram, Heart rate, Low density lipoprotein, Myocardial ischaemia, Oxygen saturation, Troponin, White blood cell count
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: URSO [URSODEOXYCHOLIC ACID]; DONEPEZIL HYDROCHLORIDE; IRBESARTAN; KALLIDINOGENASE; ASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hepatitis C; Hypertension; TIA
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: GPT; Result Unstructured Data: Test Result:31; Test Date: 20210603; Test Name: amylase; Result Unstructured Data: Test Result:764; Test Date: 20210603; Test Name: GOT; Result Unstructured Data: Test Result:72; Test Date: 20210603; Test Name: CK; Result Unstructured Data: Test Result:363; Test Date: 20210603; Test Name: Cr; Result Unstructured Data: Test Result:1.30; Test Date: 20210603; Test Name: blood pressure; Result Unstructured Data: Test Result:129/87 mmHg; Test Date: 20210603; Test Name: BUN; Result Unstructured Data: Test Result:22.7; Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Test Date: 20210603; Test Name: BNP; Result Unstructured Data: Test Result:496; Test Date: 20210603; Test Name: CT; Result Unstructured Data: Test Result:slight pleural effusion in the left chest and; Comments: slight pleural effusion in the left chest and; Test Date: 20210603; Test Name: ECG; Result Unstructured Data: Test Result:CRBBB and no increase in ST; Test Date: 20210603; Test Name: pulse rate; Result Unstructured Data: Test Result:120; Comments: beats/minute; Test Date: 20210603; Test Name: LDL; Result Unstructured Data: Test Result:378; Test Date: 20210603; Test Name: SpO2; Test Result: 91 %; Comments: room air; Test Date: 20210603; Test Name: cardiac troponin; Result Unstructured Data: Test Result:339; Test Date: 20210603; Test Name: WBC; Result Unstructured Data: Test Result:3000
CDC Split Type: JPPFIZER INC2021673194

Write-up: Cardiac failure acute; myocardial ischaemia; amylase increased; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21112472. The patient was a 96-year and 3-month-old female. Body temperature before vaccination was 36.7 degrees Centigrade. The family history was not provided. The patient had medical histories of hepatitis C, dementia, hypertension, and TIA (transient ischemic attack). The concomitant medications included ursodeoxycholic acid (URSO 100 tablet) at 400 mg (4 tablets) for hepatitis C, donepezil hydrochloride (manufacture name not reported, tablet 5 mg) at 5 mg (1 tablet) for dementia, irbesartan (manufacture name not reported, tablet 100 mg) at 100 mg (1 tablet) for hypertension, kallidinogenase (manufacture name not reported, tablet 50 mg) at 100 mg (2 tablets) for hypertension, and aspirin (manufacture name not reported, tablet 100 mg) at 100 mg (1 tablet) for TIA. On 02Jun2021 at 10:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) when 96 years old via an unspecified route of administration as the first single dose for COVID-19 immunization. On unknown date the patient experienced myocardial ischaemia and amylase increased with outcome of unknown. On 03Jun2021 at 09:00 (23 hours after the vaccination), the patient experienced cardiac failure acute. The outcome of the event was fatal. The course of the event was as follows: The patient experienced chills (the body temperature was 37.5 degrees Celsius), respiratory discomfort, and hypoxaemia. SpO2 was 91% (room air), blood pressure was 129/87 mmHg, and pulse rate was 120 beats/minute. ECG showed no complete right bundle branch block (CRBBB) and no increase in ST. Oxygen inhalation and fluid replacement were performed. The patient had respiratory arrest. The patient was confirmed to die. It was unknown whether an autopsy was performed. CK was 363, GOT was 72, GPT was 31, LDL was 378, cardiac troponin was 339, BNP was 496, Cr was 1.30, BUN was 22.7, amylase was 764, and WBC was 3000. CT showed slight pleural effusion in the left chest and slight ascites. The reporting physician classified the event as serious (death and hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was acute ischaemic heart disease. The reporting physician commented as follows: After the vaccination, the patient showed symptoms of cardiac failure, myocardial ischaemia, and amylase increased.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1404934 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NIFEDIPINE; SPIRONOLACTONE; SENNOSIDE A+B
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: real time PCR; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC2021674259

Write-up: Pneumonia aspiration; This is a spontaneous report from a contactable pharmacist. The patient was a non-pregnant 98-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received nifedipine; spironolactone; sennoside a+b within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history included hypertension. The patient had no allergies to medications, food, or other products. On 01Jun2021 (the day of vaccination), the patient received?the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) intramuscular at the age of 98-year-old for COVID-19 immunization. On 02Jun2021 at 12:00 (1 day after the vaccination), the patient experienced pneumonia aspiration. The patient received treatment with SBT/ABPC (Sulbactam / Ampicillin). The patient has been tested negative for COVID-19 with PCR (nasal swab). On 03Jun2021 (2 days after the vaccination), the patient died. Cause of death was pneumonia aspiration. An autopsy was not performed. The reporting pharmacist assessed the event as serious (death).; Sender''s Comments: Based on the information currently available the event pneumonia aspiration is attributed to an underlying medical condition and patient''s advanced age and assessed unlikely related to BNT162b2 (COMIRNATY) vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia aspiration


VAERS ID: 1404935 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   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: Cardiac failure chronic; Myocardial infarction old
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021674625

Write-up: Death; This is a spontaneous report from a contactable physician. An 88-year-old male received BNT162B2 (COMIRNATY) intramuscular, on 08Jun2021 (at the age of 88 years old), as first single dose, for COVID-19 immunisation. Medical history included myocardial infarction old and cardiac failure chronic. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of the vaccination. On 08Jun2021 (the same day as the vaccination), the patient died. The cause of death was unknown. It was unknown whether a treatment was attempted. It was unknown whether autopsy was performed. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between BNT162B2 and the reported death for case unknown cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1404937 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-05
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: Cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: blood pressure; Result Unstructured Data: Test Result:124/67 mmHg; Test Date: 20210604; Test Name: blood pressure; Result Unstructured Data: Test Result:130/64 mmHg; Test Date: 20210605; Test Name: blood pressure; Result Unstructured Data: Test Result:64/50 mmHg; Test Date: 20210527; Test Name: body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Comments: Before vaccination; Test Date: 20210528; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210604; Test Name: body temperature; Result Unstructured Data: Test Result:37s Centigrade; Test Date: 20210605; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210528; Test Name: pulse rate; Result Unstructured Data: Test Result:76; Comments: beats/minute; Test Date: 20210604; Test Name: pulse rate; Result Unstructured Data: Test Result:80; Comments: beats/minute; Test Date: 20210605; Test Name: pulse rate; Result Unstructured Data: Test Result:54; Comments: beats/minute; Test Date: 20210528; Test Name: SpO2; Test Result: 98 %; Comments: room air; Test Date: 20210605; Test Name: SpO2; Test Result: 74 %
CDC Split Type: JPPFIZER INC2021674734

Write-up: Death; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21112523. An 83-year-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose on 27May2021 at 11:00 (the day of vaccination) at 83 years old for COVID-19 immunization. Relevant medical history included cerebral infarction left. The family history was not provided. Concomitant medications were not reported. Body temperature before vaccination was 37.3 degrees Centigrade. On 05Jun2021 at 15:00 (9 days and 4 hours after the vaccination), the patient experienced death. On 05Jun2021 (9 days after the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 28May2021 (one day after vaccination), the vital signs were stable as follows: the blood pressure was 124/67 mmHg, the pulse rate was 76 beats/minute, the body temperature was 36.8 degrees Celsius, and the SpO2 was 98% (room air). On 04Jun2021 (Day 9 after vaccination), the blood pressure was 130/64 mmHg and the pulse rate was 80 beats/minute. Although the patient had slight fever of 37s degrees Celsius daily, other general conditions were stable. On 05Jun2021 (Day 10 after vaccination), the blood pressure was 64/50 mmHg, the pulse rate was 54 beats/minute, the body temperature was 36.6 degrees Celsius, and the SpO2 was 74%. An infusion solution was administered in addition to oxygen administration; however, the patient did not recover, and he died. The reporting pharmacist classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were aspiration pneumonia and urinary tract infection. The reporting pharmacist commented as follows: Since the patient was being admitted to the hospital, he repeatedly had aspiration pneumonia and urinary tract infection. Although the direct causality between the event and the vaccination was unknown, the patient died, and thus, this case was reported.; Reported Cause(s) of Death: Death


VAERS ID: 1404938 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Hypertension; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: K; Result Unstructured Data: Test Result:9.1; Test Date: 20210608; Test Name: Blood test; Result Unstructured Data: Test Result:hemolysis; Test Date: 20210605; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210608; Test Name: liver function; Result Unstructured Data: Test Result:increased; Test Date: 20210608; Test Name: platelet; Result Unstructured Data: Test Result:4.9
CDC Split Type: JPPFIZER INC2021674735

Write-up: Cardio-respiratory arrest; cardiac failure acute; This is a spontaneous report from a contactable physician. The patient was a 77-year-old male. Body temperature before vaccination was 36.4 degrees centigrade. Medical history included rheumatoid arthritis, hypertension, and dyslipidaemia. The patient was taking unspecified medications for the diseases. It was uncertain if the patient had family history. The patient had not been sick or had a fever in the past month. The patient had never had severe allergic reactions (such as anaphylaxis) to a medication or food, or convulsions (seizures). The patient had never been sick after receiving vaccination. The patient had not received any other vaccines in the past two weeks. On 05Jun2021 at 15:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5765, Expiration date 30Sep2021) at 77 years old via an unspecified route of administration at 0.3 mL, single for COVID-19 immunization. On 08Jun2021 at 00:00, it was confirmed that the patient was alive. On 08Jun2021 at around 05:00 (3 days after the vaccination), the patient experienced cardio-respiratory arrest. His family member found the patient in cardio-respiratory arrest. On 08Jun2021 at 05:30, the patient was transferred to an emergency hospital. CPR (cardiopulmonary resuscitation) was started. On 08Jun2021 at 06:04, the patient''s death was confirmed. The cause of death was cardiac failure acute (for about 6 hours). It was not reported if an autopsy was performed. Blood test showed the presence of hemolysis, K (potassium) 9.1, platelet 4.9, and increased liver function. All procedures were performed at another hospital. The reporting physician was informed of the above-mentioned information by another hospital on the phone. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported if there was other possible cause of the event such as any other diseases. The reporting physician commented as follows: At the time of the vaccination, no problems were noted. The causal relationship with BNT162b2 was uncertain.; Reported Cause(s) of Death: Cardio-respiratory arrest; cardiac failure acute


VAERS ID: 1404939 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Investigation, Malaise, Wheezing
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   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: S-1
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Advanced gastric carcinoma (required chemotherapy); Asphyxia; Cardiac arrest (for th)
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210608; Test Name: waveform monitor; Result Unstructured Data: Test Result:cardiac arrest; Comments: 14:40
CDC Split Type: JPPFIZER INC2021674755

Write-up: Cardiac failure acute; malaise; wheezing; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21112519. The patient was a 90-year and 6-month-old male. Body temperature before vaccination was 36.8 degrees Centigrade. Medical history was reported as follows: The patient was diagnosed with advanced gastric carcinoma in Nov2020. The patient was at very advanced age and received chemotherapy. He had no allergy history. He was receiving oral gimeracil/oteracil potassium (S-1). In Oct2020, the patient developed cardiac arrest caused by asphyxia. Family history was not reported. On 07Jun2021 at 17:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot # EX3617, Expiration date 31Aug2021) an unspecified route of administration as a single dose at the age of 90-year and 6-month-old for COVID-19 immunization. On 08Jun2021 in the morning, malaise and wheezing were noted. On 08Jun2021 at around 14:00 (1 day after the vaccination), the patient experienced acute cardiac failure. On 08Jun2021 at 16:01 (1 day after the vaccination), the patient died of acute cardiac failure. The course of the events was as follows: On 07Jun2021, the patient received the vaccination. In the morning of 08Jun2021, the patient developed generalized malaise and wheezing. His breakfast intake was decreased. He could not consume lunch. At around 14:00, the patient''s wife saw the patient collapsed when he was about to go to the bathroom. At 14:27, an emergency service was requested. At 14:40, when an emergency team treated the patient, a waveform monitor showed cardiac arrest. While transporting him to a hospital by an ambulance, an esophageal obturator tube was inserted. At 15:11, the ambulance arrived at the hospital and IV route was secured, and administered adrenaline. Tracheal intubation was performed. During the course, pulseless electrical activity was recognized and spontaneous circulation was not returned. At 16:01, the patient''s death was confirmed. Bilateral pulmonary oedema, cardiomegaly and right atrial enlargement were recognized by AI (autopsy imaging). There were not any other fatal findings, and the cause of death was determined to be acute cardiac failure. The reporting physician classified the event, acute cardiac failure, as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event (acute cardiac failure) such as any other diseases. The reporting physician commented as follows: The patient was regularly visiting the surgery department of the reporter''s hospital for the treatment of gastric carcinoma and received chemotherapy. During his clinical course, the cancer showed tendency to shrink and it was unlikely to consider that there was direct causal relationship. When he received the vaccination, he did not complain of any obvious poor condition. The reporter confirmed with the physician who gave the vaccination to him that there were no complicating physical factors not to have the vaccination. In the morning of the vaccination day, he had wheezing. He previously experienced wheezing, which almost led to asphyxia. Wheezing has been seen occasionally since then. Malaise was noted after the vaccination, therefore, it was considered to be related to BNT162b2.; Reported Cause(s) of Death: Cardiac failure acute; Autopsy-determined Cause(s) of Death: Bilateral pulmonary oedema; cardiomegaly; right atrial enlargement


VAERS ID: 1404940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardiac tamponade, Computerised tomogram thorax
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   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: Arteriosclerosis; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:uncertain; Comments: before vaccination; Test Date: 20210608; Test Name: Chest CT; Result Unstructured Data: Test Result:cor biloculare, pericardial effusion; Comments: cor biloculare from the ascending aorta to the distal aortic arch and marked pericardial effusion
CDC Split Type: JPPFIZER INC2021674758

Write-up: cardiac tamponade due to acute ascending aortic dissection; cardiac tamponade due to acute ascending aortic dissection; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority number v21112525. A 90-year-old female patient received BNT162B2 (COMIRNATY; lot EY4834, expiry date 31Aug2021) on 07Jun2021 at 14:00, as second single dose, for COVID-19 immunisation. The first dose of Comirnaty was given on an unknown date. Medical history included arteriosclerosis and hypertension. Concomitant medications were not reported. Body temperature before vaccination was uncertain. On 07Jun2021 at around 14:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY4834, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 08Jun2021 at around 11:00 (1 day after the vaccination), the patient died. The cause of death was cardiac tamponade due to acute ascending aortic dissection. It was not reported if an autopsy was performed. The course of the events was as follows: according to the patient''s oldest son, when the patient received the second dose of BNT162b2 in a group at the vaccination site (07Jun2021 at around 14:00), she was in normal condition. On 08Jun2021 at 05:00 (1 day after the vaccination), when the patient''s oldest son was going to work, he confirmed that no change was noted in her walking status and consciousness status and she did not complain of any condition in particular. At 14:00, when he returned home, he found the patient dead in her bedroom. Judging from the surrounding situation and the dead body, the time of death was assumed to be around 11:00 on 08Jun2021. At 17:00, the patient was carried to the hospital. Chest CT scan showed cor biloculare from the ascending aorta to the distal aortic arch and marked pericardial effusion. It was diagnosed that the patient died of cardiac tamponade due to acute ascending aortic dissection. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Arteriosclerosis and hypertension were considered as other possible causes of the event. The reporting physician commented as follows: The patient died of acute aortic dissection on the next day of the vaccination. The causal relationship with BNT162b2 was uncertain.; Reported Cause(s) of Death: cardiac tamponade due to acute ascending aortic dissection; cardiac tamponade due to acute ascending aortic dissection


VAERS ID: 1404941 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-06-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   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: MENESIT; ATENEGINE; CABERGOLINE; YOKUKANSAN; BAYASPIRIN; ABILIFY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral thrombosis; Dementia with Lewy bodies; Schizophrenia; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210606; Test Name: body temperature; Result Unstructured Data: Test Result:pyrexia (unkown values) Centigrade
CDC Split Type: JPPFIZER INC2021675308

Write-up: Pneumonia aspiration; pyrexia; respiratory failure; This is a spontaneous report from a contactable physician received from the agency. Regulatory authority report number is v21112832. An 86-year and one-month-old male patient received first dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm left on 21May2021 at 14:00 (Lot Number: EY2173; Expiration Date: 31Aug2021) (at the age of 86-year-old) as single dose for COVID-19 immunisation. Medical history included dementia with Lewy bodies, schizophrenia, wheelchair user and cerebral thrombosis, all from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The body temperature before vaccination was 36.3 degrees Celsius. Concomitant medications included carbidopa/levodopa (MENESIT); amantadine hydrochloride (ATENEGINE); cabergoline; angelica acutiloba root/atractylodes lancea rhizome/bupleurum falcatum root/ cnidium officinale rhizome/glycyrrhiza spp. Root/poria cocos sclerotium/uncaria spp. hook (YOKUKANSAN); acetylsalicylic acid (BAYASPIRIN) and aripiprazole (ABILIFY), all concomitants were taken for an unspecified indication, start and stop date were not reported. On 21May2021 at 14:00 (the day of the vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY). On 06Jun2021 at 13:00 (15 days and 23 hours after the vaccination), the patient experienced pneumonia aspiration. The patient received treatment for the event. On 08Jun2021 (18 days after the vaccination), the outcome of the event was fatal. The cause of death was respiratory failure. An autopsy was not performed. The course of the event was as follows: since the patient had dementia with Lewy bodies and others, he was confined to a wheelchair, and the symptoms were gradually aggravated. On 06Jun2021, the patient had respiratory disorder which was considered as aspiration, and thereafter, he had pyrexia. On 08Jun2021, the patient died due to respiratory failure (since the physician was not his attending physician, the details were unknown). The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: it was considered that the event was caused by aggravation of the underlying diseases.; Sender''s Comments: Based on available information, the reported events are considered unrelated to BNT162B2 administration; these are intercurrent conditions in this elderly patient with underlying dementia, schizophrenia, cerebral thrombosis, wheelchair user. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia aspiration; pyrexia; Respiratory failure


VAERS ID: 1404942 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-06-03
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Decreased appetite, General physical health deterioration, Myocardial ischaemia, Pain in extremity, Vaccination site pain
SMQs:, Other ischaemic heart disease (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021675462

Write-up: pain on the left foot; inappetence; chills; vaccination site pain on the arm; patient was in bad heath; Ischaemic cardiac failure; This is a spontaneous report from a contactable physician received from regulatory authority and from the Agency with regulatory authority report number is v21112827. This is the 1st of 2 reports, for the second dose. The patient was a 75-year and 10-month-old female at the vaccination. Body temperature before vaccination was 36.6 degrees centigrade. The patient had medical history of hypertension. Patient was not pregnant. Concomitant medications included an antihypertensive drug and others. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot# ET3674, Expiration date 31Jul2021) intramuscular at age of 75-years, for COVID-19 immunization. After the vaccination, she had vaccination site pain on the arm, and it resolved in 2 days. On 22May2021 (the day of the vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) intramuscular at age of 75-years, for COVID-19 immunization. After the second dose, the patient complained of pain on the left foot, inappetence, and chills in addition to the vaccination site pain on the arm (the body temperature was not measured). Since the patient was in bad heath, she was to visit her attending physician on 04Jun2021. On 03Jun2021 (12 days after the vaccination), the patient experienced ischaemic cardiac failure. The patient usually went to the room of her older sister''s couple; however, she did not appear. Thus, her older sister came to check on her, and found the patient dead between the interspace of her bed. An autopsy was performed by the police at another hospital. Autopsy results revealed ischaemic cardiac failure. The reporting physician classified the event as serious (death). The reporting physician assessed that the causality between the event and BNT162b2 as un-assessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: since the patient had not visited physician''s office including her attending physician from the vaccination through date of death, details of symptoms leading to death were unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-2021686475 same patient/drug, different event/dose; Reported Cause(s) of Death: Ischaemic cardiac failure; Autopsy-determined Cause(s) of Death: ischemic cardiac failure


VAERS ID: 1404943 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Radiotherapy (Past radiotherapy to soft part sarcoma on the back); Sarcoma (Past radiotherapy to soft part sarcoma on the back)
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021678200

Write-up: Death; The patient suddenly fell; This is a spontaneous report from a contactable physician received from the Regulatory Authority Agency. Regulatory authority report number is v21112648. The patient was a 91-year-old male. Body temperature before vaccination was 36.4 degrees centigrade. Medical history included past radiotherapy to soft part sarcoma on the back. Family history and concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown). On 08Jun2021 at 10:08 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose at the age of 91-year-old for COVID-19 immunisation. On 08Jun2021 at 13:10 (3 hours and 2 minutes after the vaccination), the patient suddenly fell and experienced death. On 08Jun2021 (the day of vaccination), the outcome of the events was fatal. It was not reported whether autopsy was performed. The course of the events was as follows: On 08Jun2021 (after the vaccination), the patient had lunch and went to the neighbor to pass the circular notice. When going back home, the patient suddenly fell. The person nearby who was doing work at the factory immediately performed cardiac massage and called an ambulance. An automated external defibrillator (AED) was used, but the patient was confirmed dead at the destination other Medical Center. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases was unknown.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1404944 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Sudden death, Vital signs measurement
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: 2021-06-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ELDECALCITOL; MAGNESIUM OXIDE; CELECOXIB; REBAMIPIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aphonia psychogenic; Ataxia (possibly late effects of CO poisoning); Carbon monoxide poisoning; Conjunctivitis allergic; Constipation; Divorced; Mental retardation; Mutism (but was able to understand words and write); Post-traumatic stress disorder; Rehabilitation therapy; Suicide attempt (4 times with drugs and 2 times with charcoal briquettes); Thoracic spine compression fracture; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 202106; Test Name: AI/CT; Result Unstructured Data: Test Result:revealed no abnormality in the brain; Test Name: Vital signs; Result Unstructured Data: Test Result:stable
CDC Split Type: JPPFIZER INC2021678272

Write-up: Sudden death unexplained; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21112631. A 70-year and 1-month-old female patient received BNT162B2 (COMIRNATY; lot FA2453, expiry date 31Aug2021) on 31May2021 at 10:30, as first single dose, for COVID-19 immunisation. Body temperature before vaccination was 36.3 degrees centigrade. The patient was on treatment at the reporting clinic since Jan2021. Medical history included post-traumatic stress disorder (PTSD), mental retardation, aphonia psychogenic, ataxia of the limbs and trunk (possibly late effects of carbon monoxide (CO) poisoning), constipation, thoracic spine compression fracture (Feb2021), and conjunctivitis allergic. On 08Apr2021, the patient received a pneumococcal vaccine for the first time for immunisation. Concomitant medications included eldecalcitol (0.75) orally, 1 capsule, once a day, after breakfast, magnesium oxide (330 mg) 2 tablets, in 2 divided doses, after breakfast and dinner, celecoxib tablet (100 mg) as needed when having pain and rebamipide tablet 100 mg. Detailed patient''s history before vaccination was as follows: The patient was taking the prescribed drugs as described above, and there had been no change in the prescriptions recently. The patient had a complicated family, had been divorced twice, ran away from home once, and had suicide attempts (4 times with drugs and 2 times with charcoal briquettes). The patient had repeated suspending her treatment but was put on treatment at the reporting clinic since Jan2021. She could not talk but was able to understand words and write. She moved with a wheelchair and was vigorous enough to voluntarily do standing training while holding handrails and other activities. She ate and slept well and had stable vital signs. On 31May2021 at 10:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 06Jun2021 at 07:05 (6 days after the vaccination), the patient experienced sudden death unexplained. On 07Jun2021 (1 day after the vaccination), the outcome of the events was fatal (as reported, pending clarification). Autopsy would be performed by the police. The course of the events was as follows: the following information was from the other facility as no medical examination was done by the reporting clinic since 31May2021. On 31May2021 (after the vaccination), the patient spent her day without particular changes. On 06Jun2021 just after 07:00 (Sunday) (6 days after the vaccination), the patient was found debilitated on the wheelchair in front of the toilet, and an ambulance was called immediately. It was said that cardio-respiratory arrest had been confirmed inside the ambulance. The patient was urgently transported to Hospital. Autopsy imaging (AI) was performed, and computerised tomography (CT) revealed no abnormality in the brain. Because it was an unexpected sudden death, an autopsy would be performed by the police. The reporting physician classified the events as serious (hospitalization from 06Jun2021/death) and assessed the causality between the events and BNT162b2 as unassessable. The reporting physician commented about other possible cause(s) of the events such as any other diseases as follows: Although details were unknown, it was plausible to think that there were some causes other than the vaccine considering that the death occurred after a week of no changes following the vaccination.; Reported Cause(s) of Death: Cardio-respiratory arrest; Sudden death unexplained


VAERS ID: 1404945 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Respiratory arrest
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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   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: Disuse syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021678581

Write-up: Loss of consciousness; respiratory arrest; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. An 85-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration 31Aug2021) via an unspecified route of administration as single dose on 05Jun2021 (the day of vaccination), at 85 years old) for COVID-19 immunization. Relevant medical history included disuse syndrome. Relevant family history and concomitant medications were not provided. On 07Jun2021 (2 days after the vaccination), the patient experienced loss of consciousness and respiratory arrest. On 07Jun2021 (2 days after the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: The patient was an 85-year-old female patient. She was a bedridden (for disuse syndrome) patient who was being admitted to the institution. On 15May2021, although the patient was to receive the first dose of BNT162b2 vaccination, it was postponed because of pyrexia. On 05Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination at the institution. No significant changes were observed. On 07Jun2021 (2 days after vaccination), after breakfast, the patient experienced sudden loss of consciousness and respiratory arrest (according to the nursing staff). Although the patient was emergently transferred to the hospital, in the afternoon on the same day, the patient died. The causality between the event and BNT162b2 was not provided.; Sender''s Comments: Based on chronological connection to the vaccine a causal relationship between events loss of consciousness and respiratory arrest and BNT162b2 (COMIRNATY) vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Loss of consciousness; respiratory arrest


VAERS ID: 1404946 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021678726

Write-up: unknown cause of death; This is a spontaneous case from a contactable pharmacist received via a Pfizer sales representative. The patient was a 74-year-old male. Relevant family history, medical history, and concomitant medications were not provided. On 17May2021 at (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a unknown, single at the age of 74-year-old for COVID-19 immunization. On unknown date in May2021 (unknown days/hours/minutes after the vaccination), the patient experienced unknown cause of death. On unknown date in May2021 (unknown days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: A newspaper article on 31May2021 (14 days after vaccination) revealed that a 74-year-old male patient who received the first dose of BNT162b2 vaccination in the reporting hospital on 17May2021 (the day of vaccination) died. The date of death was on 29May2021 or 30May2021. The patient was transferred to another hospital, where he died. The cause of death was unknown. The causality between the event and BNT162b2 was not provided.; Sender''s Comments: Based on the information currently available a causal relationship between event death (unknown cause) and BNT162b2 (COMIRNATY) vaccine cannot be completely excluded. The case will be reevaluated should additional information including the cause of death become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1404947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-04
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   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: MAGNESIUM OXIDE; SIGMART; SEDIEL; RISPERDAL; LANSOPRAZOLE; DEPAKENE [VALPROATE SODIUM]; LODOPINE; SILECE; EURODIN [ESTAZOLAM]; ALDACTONE A; WARFARIN; TSUMURA YOKUKANSAN EXTRACT GRANULES FOR ETHICAL USE
Current Illness: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021684611

Write-up: Cardiac failure; This is a spontaneous report from contactable consumer (pharmaceutical wholesaler staff) and physician received via a Pfizer sales representative. An 84 years old female patient received BNT162B2 (COMIRNATY) on 24May2021, at single dose, for COVID-19 immunisation. Medical history included cerebral infarction and schizophrenia. Concomitant medications included magnesium oxide (fine granules 83% KENEI) 2 DF twice daily after breakfast and supper (2.4 g), nicorandil (SIGMART tablet 5 mg) 1 DF three times daily after meals (1.5 tablets), tandospirone citrate (SEDIEL tablet 10 mg) 1 DF twice daily after breakfast and lunch, risperidone (RISPERDAL Orodispersible tablet 0.5 mg) 1 DF twice daily after breakfast and lunch, lansoprazole (orodispersible tablet 15 mg DK) 1 DF once daily after supper, valproate sodium (DEPAKENE fine granules 40%) 1 DF once daily after supper (0.4 g), zotepine (LODOPINE fine granules 10%) 1 DF once daily after supper (0.3 g), flunitrazepam (SILECE tablet 1 mg) 1 DF once daily after supper, estazolam (EURODIN 2 mg tablet) 1 DF once daily after supper, spironolactone (ALDACTONE A fine granules 10%) 1 DF once daily after breakfast (0.25 g), warfarin (WARFARIN tablet 1 mg) 1 DF once daily between meals in the afternoon and angelica acutiloba root, atractylodes lancea rhizome, bupleurum falcatum root, cnidium officinale rhizome, glycyrrhiza spp. root, poria cocos sclerotium, uncaria spp. hook (TSUMURA YOKUKANSAN EXTRACT GRANULES FOR ETHICAL USE) 1 DF twice daily after breakfast and supper (5 g), all reported as ongoing. On an unspecified date (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, lot number and expiration date were not reported) via an unspecified route of administration, at single dose, for COVID-19 immunization. On 04Jun2021 (11 days after the vaccination), the patient experienced cardiac failure and died. The outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: the patient who lived in a nursing home received COMIRNATY. The patient''s response was good and on the day of death in the morning she was able to eat meal. 11 days after the vaccination the patient died. Event onset/death date was 04Jun2021. Event/cause of death was cardiac failure. Causality assessment was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the temporal relationship, the association between the event fatal cardiac failure with COMIRNATY use can not be fully exclude. 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: Cardiac failure


VAERS ID: 1405010 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Antineutrophil cytoplasmic antibody, Antinuclear antibody, Blood culture, Capillary leak syndrome, Hereditary angioedema with C1 esterase inhibitor deficiency, Malaria antigen test, Protein total, SARS-CoV-2 test positive
SMQs:, Angioedema (narrow), Congenital, familial and genetic disorders (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   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: FOLIC ACID; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Blood culture; Result Unstructured Data: Negative; Test Date: 20210603; Test Name: C1 esterase deficiency; Result Unstructured Data: Negative; Test Date: 20210603; Test Name: Antineutrophil cytoplasmic antibody; Result Unstructured Data: Negative; Test Date: 20210603; Test Name: Malaria antigen test; Result Unstructured Data: Negative; Test Date: 20210603; Test Name: Antinuclear antibody; Result Unstructured Data: Negative; Test Date: 20210603; Test Name: Protein; Result Unstructured Data: M protein negative; Test Name: SARS-CoV-2 test positive; Result Unstructured Data: Positive
CDC Split Type: NLJNJFOC20210626376

Write-up: CLARKSON SYNDROME WITH FATAL PROGRESSION; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00570304] concerned a 53 year old male, race and ethnicity not reported. The patient''s weight was 84 kilograms, and height was 180 centimeters. The patient''s past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 in total administered on 01-JUN-2021 for covid-19 immunisation. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. Concomitant medications included folic acid, and omeprazole. On 02-JUN-2021, the patient experienced clarkson syndrome with fatal progression. On 03-JUN-2021, Laboratory data included: Antineutrophil cytoplasmic antibody (NR: not provided) Negative, Antinuclear antibody (NR: not provided) Negative, Blood culture (NR: not provided) Negative, C1 esterase deficiency (NR: not provided) Negative, Malaria antigen test (NR: not provided) Negative, and Protein (NR: not provided) M protein negative. Laboratory data (dates unspecified) included: SARS-CoV-2 test positive (NR: not provided) Positive. On 06-JUN-2021, the patient died from capillary leak syndrome. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00570304] concerned a 53-year-old male (ethnicity not reported) who experienced Clarkson syndrome with fatal progression (capillary leak syndrome) one day after vaccine. Past medical history included COVID-19 on an unknown date. Concomitant medications included folic acid and omeprazole. One day after vaccine, the patient experienced Clarkson syndrome with fatal progression. On day 2: laboratory results returned negative for antineutrophil cytoplasmic antibody, antinuclear antibody, blood culture, C1 esterase deficiency, malaria antigen test, and M protein. SARS-CoV-2 test was positive on an unknown date, and the specific type of COVID test was not reported. On day 5, the patient died from capillary leak syndrome. It was unknown if an autopsy was performed. The subject''s positive COVID-19 test and history of COVID-19 infection (dates unknown) may have increased the risk for the event to occur. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate. Additional information has been requested.; Reported Cause(s) of Death: CAPILLARY LEAK SYNDROME


VAERS ID: 1405013 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced CEREBRAL HAEMORRHAGE (Fatale hersenbloeding) (seriousness criteria death and medically significant). The patient died on 17-May-2021. The reported cause of death was Cerebral bleeding. It is unknown if an autopsy was performed. Concomitant medications were not reported. Treatment information was not provided. Very limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cerebral bleeding


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