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

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



Case Details

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VAERS ID: 1035437 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Metastases to peritoneum
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   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: ZOPIKLON
Current Illness: Peritoneal carcinomatosis (Primary tumor not discovered)
Preexisting Conditions: Medical History/Concurrent Conditions: Ascites; Insomnia; Living in nursing home; Palliative care; Reduced general condition
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021097469

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number: NO-NOMAADVRE-FHI-2021-U8p2z, Safety report unique identifier NO-NOMAADVRE-E2B_00014012. An 85-year-old female patient received BNT162b2 (COMIRNATY, batch number EJ6796), via intramuscular route of administration on 06Jan2021 at 12:39 as a single dose for COVID-19 immunisation. Medical history included ascites from Dec2020 to an unknown date, palliative care from an unknown date and unknown if ongoing, living in residential institution from an unknown date and unknown if ongoing, reduced general condition from an unknown date and unknown if ongoing, insomnia from an unknown date and unknown if ongoing, and newly discovered, widespread peritoneal carcinomatosis (primary tumor not discovered) from an unknown date and ongoing. Concomitant medication included zopiclone (ZOPIKLON) from an unspecified date for insomnia. The patient experienced tiredness on 07Jan2021 with outcome of recovered on 08Jan2021. The event was assessed as non-serious. The patient died eight days after the vaccination, on 14Jan2021. The death was perceived as related to the patient''s cancer. It is unknown if an autopsy was performed. Regulatory Authority''s comment: An 85-year-old woman with fatigue the day after vaccination with covid-19 vaccine (Comirnaty). No longer abnormally tired the next day. She died eight days after the vaccination. Newly discovered and widespread peritoneal carcinomatosis (primary tumor not discovered) and ascites. The death was perceived as related to the patient''s cancer. The most common adverse reactions in study participants were injection site pain ($g 80%), fatigue ($g 60%), headache ($g 50%), myalgia and chills ($g 30%), arthralgia ($g 20%), fever and swelling at the injection site ($g 10%). They occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and passed after a few days. On the basis of the information in the report and in accordance with international criteria, the causal relationship for the event tiredness and 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. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. 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 incidental, at the same time a cause that has nothing to do with the vaccination in question. Reporter''s comment: NIPH: Received additional information: Date of death, cause of death (in the death certificate), concomitant drug (zopiclone), Event (tiredness more correct than reduced general condition). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: peritoneal carcinomatosis


VAERS ID: 1035439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Bedridden, Dizziness, Dyspnoea, General physical health deterioration, Muscular weakness, Physical examination, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Heart failure; Living in nursing home; Multimorbidity; Treatment noncompliance
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: Physical examination; Result Unstructured Data: Test Result:Stable vital signs and no clinical findings of; Comments: note.
CDC Split Type: NOPFIZER INC2021146120

Write-up: Bedridden; Apnoea; Laboured breathing; Lower extremities weakness of; Dizziness; Syncope; Reduced general condition; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory authority-WEB [Regulatory Authority number NO-NOMAADVRE-FHI-2021-U8xwg] from a contactable physician. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014506. A 95-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) (lot# EJ6795), intramuscular, on 07Jan2021 in the morning, at single dose, for COVID-19 immunisation. Medical history included multimorbidity, dementia, treatment noncompliance (discontinued all regular medications (including antiepileptic/cardiac failure drugs) by herself, for a long period), living in residential institution, cardiac failure. Despite this, the patient was in good general condition, mobile, had no symptoms of physical/functional failure, but low dietary intake. Concomitant medications were not reported. The patient experienced syncope on 07Jan2021, reduced general condition on 07Jan2021, laboured breathing on 10Jan2021, lower extremities weakness of on 10Jan2021, dizziness on 10Jan2021, bedridden on 15Jan2021, apnoea on 15Jan2021. The patient underwent lab tests and procedures which included physical examination: stable vital signs and no clinical findings of note on 10Jan2021. The patient died due to all the reported events on 20Jan2021. It was not reported if an autopsy was performed. Clinical course: on 07Jan2021 the patient developed syncope following meal time, around 03:00 PM. After this, the patient had reduced general condition but the condition fluctuated during the day and from day to day. On 10Jan2021 the patient developed laboured breathing, dizziness, lower extremities weakness of. The patient underwent lab tests and procedures which included physical examination: stable vital signs and no clinical findings of note on 10Jan2021. On 15Jan2021 the patient became bedridden with apnoea. On 18Jan2021 palliative care was initiated and on 20Jan2021 the patient died. The reporter stated that the patient''s symptoms and subsequent death could be related to immunization, due to a reasonable time relation to administration of Comirnaty and lack of other plausible findings during the course of symptoms. However, the reporter did not exclude the possibility that the symptoms were a natural process in an older patient with multimorbidity or in association with recent self discontinuation of all other medications. Relatedness of suspect drug to AE was assessed by Regional Pharmacovigilance Center as possible. Regulatory Authority comment: the report concerns a patient in her 90s who developed syncope during a meal a few hours after the first dose of the Covid-19 vaccine Comirnaty. After this, the patient''s general condition deteriorated, and in the following days there was shortness of breath, dizziness and muscle weakness. The patient eventually became bedridden and palliation was started. The patient died 13 days after vaccination. Reporter considers that the matter in question may be related to vaccination, due to the temporal relationship. However, reporter does not rule out that the matter in question may be a natural process as a result of the patient being multimorbid and having recently auto-discontinued all chronic medications. The most common adverse reactions in study participants were injection site pain ($g 80%), fatigue ($g 60%), headache ($g 50%), myalgia and chills ($g 30%), arthralgia ($g 20%), fever and swelling at the injection site ($g 10%). They occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and resolved after a few days. The side effects occurred less frequently in the elderly ($g 55 years) than in younger adults. However, we cannot rule out that relatively mild side effects may become more pronounced and / or lead to a more serious course in severely debilitated patients. Data on use in frail patients with comorbidity (eg cardiovascular disease) are limited, and such missing information will be obtained in post-marketing studies. In the individual case, however, it is difficult to know whether the symptoms prior to the death are due to a vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. Normally, between 300 and 400 people die per week in nursing homes and similar institutions. In a study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. Some retrospective studies have similar findings and find, among other things, that the risk of death is increased in the first four months after nursing home admission, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebro-vascular diseases were accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (about 20%), respiratory and infectious diseases (including pneumonia and sepsis) (about 15%), and cancer (about 10%). Based on the information in the report, the causal connection with vaccination is considered as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship 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 report is also classified as serious, even though no causal link between the vaccine and the death has been established.; Reported Cause(s) of Death: Laboured breathing; Bedridden; Lower extremities weakness of; Syncope; Dizziness; Apnoea; Reduced general condition


VAERS ID: 1035440 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-19
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Heart rate, Heart rate decreased, Infection, Oxygen saturation, Oxygen saturation decreased, Productive cough, Respiration abnormal, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUPHALAC EASY; LAXOBERAL
Current Illness: Frailty; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Femoral neck fracture; Subdural haematoma (traumatic)
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: pulse rate; Result Unstructured Data: Test Result:low; Test Date: 20210119; Test Name: oxygen saturation; Result Unstructured Data: Test Result:low
CDC Split Type: NOPFIZER INC2021146123

Write-up: Oxygen saturation low; Phlegm; Pulse rate low; acute stroke; possible acute infectious disease; poorly contactable; sore in respiration; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA). Regulatory Authority Report Number: NO-NOMAADVRE-FHI-2021-U9xjw, Sender''s (Case) Safety Report Unique Identifier: NO-NOMAADVRE-E2B_00014632. A 92-year-old male patient received the bnt162b2 (COMIRNATY), intramuscularly in the left arm on 05Jan2021 at 14:00 at a single dose for COVID-19 immunization. Medical history included cerebral infarction from an unknown date and unknown if ongoing, ongoing living in nursing home from an unknown date, ongoing frailty from an unknown date, subdural haematoma from an unknown date and unknown if ongoing, femoral neck fracture from an unknown date and unknown if ongoing. Concomitant medications included lactulose (DUPHALAC EASY) taken for Constipation from 01Feb2019 to 21Jan2021, sodium picosulfate (LAXOBERAL) taken for Constipation from 01May2019 to 21Jan2021. On 19Jan2021, the patient experienced: oxygen saturation low (death), phlegm (death), pulse rate low (death), poorly contactable (medically significant), acute stroke (medically significant), sore in respiration (medically significant), possible acute infectious disease (medically significant). The clinical course was reported as follows: The patient was a very frail patient due to a traumatic subdural haemorrhage, cerebral infarction and femoral neck fracture. In need for care; the patient would need help with feeding and all kinds of care. The patient had days where he was very tired and slept a lot. On 19Jan2021, the patient experienced acute worsening with a very low heart rate and low saturation, poorly contactable and sore in respiration. There was a very uncertain relationship to the vaccine, as he was in a habitual state until 19Jan2021. There were no signs of vaccine-related side effects before he had the acute exacerbation on 19Jan2021, which may be caused by an acute stroke (but not focal neurological outcomes) or possible acute infectious disease. Additional information on drug: J07BX - Other virus vaccines. Reporter comments: Reporter qualifications: Physician. Sender Comments (translation): 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. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or another random simultaneous cause that has nothing to do with the vaccination in question. The report states that the patient was in his habitual state for 14 days after the vaccination before acute exacerbation, which makes a time relationship between the vaccine and the event uncertain. It is also stated that the patient had an underlying disease(s) before vaccination. Based on the event description, it is more likely that these diseases are behind the event. It is also conceivable that the event had a completely different cause that only happened by chance after the vaccination, as described in the report; acute stroke or acute infectious disease. Based on the information in the report, we consider the causal connection with vaccination to be unlikely. An improbable causal relationship is defined as a reaction, including pathological laboratory tests, that occurs in such a temporal relationship to the use of a drug that a causal relationship is unlikely (but not impossible), and where underlying disease, other drugs or chemicals can explain the reaction. We have registered that the reporter of the side effect considers the causal connection to be very uncertain. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. The clinical outcome of the events: oxygen saturation low, phlegm, pulse rate low, was fatal. The clinical outcome of the events: poorly contactable, acute stroke, sore in respiration, possible acute infectious disease, was unknown. The patient died on 21Jan2021 due to oxygen saturation low, phlegm, pulse rate low; as they had fatal outcomes. It was unknown if an autopsy was performed. Event assessment: Comirnaty/all events/Regional Pharmacovigilance Center: Unlikely Event assessment: Comirnaty/all events/Reporter: Uncertain The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Oxygen saturation low; Phlegm; Pulse rate low


VAERS ID: 1035441 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, Secretion discharge
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: Medical History/Concurrent Conditions: Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: body temperature; Result Unstructured Data: Test Result:almost normal; Test Date: 20210115; Test Name: CRP values; Result Unstructured Data: Test Result:increased
CDC Split Type: NOPFIZER INC2021135906

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014531, Worldwide unique case identification number NO-NOMAADVRE-FHI-2021-Udx9d. A 93-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jan2021 11:00 at single dose at right arm for Covid-19 vaccination. Medical history included living in nursing home from an unknown date and unknown if ongoing. Two days after being vaccinated with Comirnaty the patient developed increased CRP values (almost normal body temperature) and mucus discharge /gurgle on 15Jan2021, which lasted until she died eight days after the vaccination (the reporter stated that this was an unexpected/sudden death) on 21Jan2021. Outcome of events mucus discharge and increased CRP values was fatal (Stop date for event mucus discharge was reported as 15Jan2021 and for event C-reactive protein increased was reported as 21Jan2021). It was not reported if an autopsy was performed. Reporter comment: 05Feb2021 Medicines Information Centres: requested additional information. This is a preliminary report. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained. ; Reporter''s Comments: 05Feb2021 Medicines Information Centres: requested additional information. This is a preliminary report.; Reported Cause(s) of Death: MUCUS DISCHARGE; increased CRP values


VAERS ID: 1035442 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, Body temperature, C-reactive protein, Fatigue, General physical health deterioration, Oxygen saturation, Pneumonia aspiration, Productive cough, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Activities of daily living impaired; Dementia; Living in nursing home; Palliative care; Physical impairment; Pressure sore; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210116; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Test Date: 20210118; Test Name: C-reactive protein; Result Unstructured Data: Test Result:121 mg/l; Test Date: 20210120; Test Name: C-reactive protein; Result Unstructured Data: Test Result:61 mg/l; Test Date: 20210122; Test Name: C-reactive protein; Result Unstructured Data: Test Result:18 mg/l; Test Date: 20210116; Test Name: Oxygen saturation; Test Result: 93 %
CDC Split Type: NOPFIZER INC2021146135

Write-up: Reduced general condition; Phlegm; Vomiting; Aspiration pneumonia; Fever 37.9 deg C; Vomiting; tiredness; Bedridden; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA):- NO-NOMAADVRE-FHI-2021-Udxxd, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014555. An 88-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular at single dose in the right arm on 07Jan2021 for covid-19 immunisation. Medical history included living in nursing home, type 2 diabetes mellitus, pressure sore, dementia, palliative care from 22Jan2021, activities of daily living impaired, physical impairment. Concomitant medications were not reported. On 16Jan2021, the patient experienced fever 37.9 deg C (medically significant) and vomiting (medically significant), both with outcome of recovered with sequelae on 16Jan2021 (as reported). She developed tiredness on 11Jan2021, bedridden on 11Jan2021, reduced general condition on 21Jan2021, phlegm on 21Jan2021, aspiration pneumonia on 18Jan2021, vomiting on 21Jan2021, all with fatal outcome (as reported). The patient underwent lab tests and procedures which included body temperature: 37.9 centigrade on 16Jan2021; C-reactive protein: 121 mg/l on 18Jan202, 61 mg/l on 20Jan2021, 18 mg/l on 22Jan2021; oxygen saturation: 93% on 16Jan2021. The patient died on 27Jan2021. It was not reported if an autopsy was performed. Clinical course was described as follows: The patient was living in nursing home, and had experienced a deterioration in function (physical impairment, activities of daily living impaired) over the last year, according to the reporter. The patient had known dementia , type 2 diabetes mellitus and pressure sore. On 11Jan2021, the patient became bedridden and developed tiredness. On 16Jan2021 the patient was found after vomiting. The patient also developed fever in the evening (body temperature , 16Jan2021, 37.9 deg C) (Oxygen saturation , 16Jan2021, 93%). The patient''s condition stabilized during the night, and the patient showed no signs of infection. On 18Jan2021 the patient condition deteriorated and aspiration pneumonia was suspected (C-reactive protein, 18Jan2021, 121 mg/L ). The patient then experienced a minor improvement ( C-reactive protein , 20Jan2021, 61 mg/L ), before she on 21Jan2021 again experienced vomiting, phlegm and reduced general condition. On 22Jan2021 the physician decided to stop antibiotic treatment (C-reactive protein , 22Jan2021, 18 mg/L ) and initiated palliative care The patient died on 27Jan2021. The patient''s outcome was fatal, at the time of the report. The case was considered to be serious. Sender Comment: The message concerns a patient in her 80s, who experienced being bedridden and fatigued a few days after the first dose of the Covid-19 vaccine Comirnaty. The patient then developed vomiting and fever a few days later, which is suspected to have contributed to the patient developing aspiration pneumonia. The patient''s condition worsened, despite antibiotic treatment and the patient was switched to palliative care. The patient died 20 days after vaccination. The patient was a nursing home resident and had known dementia and diabetes and had had declining functional levels in the past year. The most common adverse reactions in study participants were injection site pain ($g 80%), fatigue ($g 60%), headache ($g 50%), myalgia and chills ($g 30%), arthralgia ($g 20%), fever and swelling. at the injection site ($g 10%). They occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and passed after a few days. Adverse reactions occurred less frequently in the elderly ($g 55 years) than in younger adults. However, we cannot rule out that relatively mild side effects may become more pronounced and / or lead to a more serious course in severely debilitated patients. Data from use in frail patients with comorbidity are limited, and such lack of information will be obtained in post-marketing studies, among other things. The vaccine is non-living and therefore cannot cause diseases it is vaccinated against or any other infections. Nursing home patients have an increased risk of contracting infections such as pneumonia (including aspiration pneumonia), and pneumonia is also a common cause of death in nursing home patients on long-term stays. In a Norwegian study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and find, among other things, that the risk of death is increased in the first four months after hospitalization, and that patients who have recently been admitted to hospital have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In the individual case, however, it is difficult to know whether the symptoms prior to the death are due to a vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. Based on the information in the report, the causal connection with vaccination is considered as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient''s death, the message is also classified as serious, even though no causal link between the vaccine and the death has been established. Reporter comment: 04Feb2021 Additional information received by phone from reporter. Additional information about patient''s medical history, the event and laboratory analysis. Event assessment: Comirnaty/all events/ Regional Pharmacovigilance Center: possible.; Reporter''s Comments: 04Feb2021, Additional information received by phone from reporter. Additional information about patient''s medical history, the event and laboratory analysis.; Reported Cause(s) of Death: Tiredness; Bedridden; Reduced general condition; Phlegm; Aspiration pneumonia; Vomiting


VAERS ID: 1035443 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, Blood pressure measurement, Dyspnoea, General physical health deterioration, Hypotension, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APOCILLIN; DIVIFARM; CEFOTAXIM VILLERTON; BURINEX; METOPROLOL SANDOZ [METOPROLOL SUCCINATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspnea; Frailty; Heart failure; Living in nursing home; Pneumonia; Sarcoidosis; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Date: 202101; Test Name: O2 saturation; Result Unstructured Data: Test Result:poor
CDC Split Type: NOPFIZER INC2021135962

Write-up: bedridden; General physical health deterioration; oxygen saturation decreased; increasing shortness of breath; blood pressure low; This is as spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) Regulatory authority-WEB. The regulatory authority report number is NO-NOMAADVRE-FHI-2021-Upqyq, Safety report unique identifier NO-NOMAADVRE-E2B_00014527. A 93 years old female patient received the first dose of BNT162B2 (COMIRNATY, lot number EJ6795) via intramuscular on 12Jan2021 at 11:36 at single dose for vaccination. The medical history included frailty, living in nursing home, sarcoidosis, heart failure, vitamin D deficiency, dyspnea and suspected pneumonia. The concomitant medication included colecalciferol (DIVIFARM) from 16Jun2020 to 20Jan2021 for unspecified vitamin D deficiency, bumetanide (BURINEX) from 11Jun2014 to 20Jan2021 for heart failure, metoprolol succinate (METOPROLOL SANDOZ) from 12Jun2014 to 20Jan2021 for heart failure, phenoxymethylpenicillin potassium (APOCILLIN) from 09Jan2021 to 18Jan2021 for dyspnea and suspected pneumonia, cefotaxime sodium (CEFOTAXIM VILLERTON) from 18Jan2021 to 20Jan2021 for dyspnea and suspected pneumonia. On Jan2021, the patient developed oxygen saturation decreased, increasing shortness of breath, and blood pressure low. On 19Jan2021, the patient developed general physical health deterioration and bedridden. The event was reported as uncertain, but increasing shortness of breath with poor O2 saturation and low blood pressure. The patient had known sarcoidosis and heart failure from before. The patient experienced much weaker and bedridden from 19Jan2021, a day before she died. The patient died on 20Jan2021. The case was considered to be serious. Reporter''s comment: The patient has been in poor, but stable, state for a long time. She had habitually shortness of breath which worsened with light exertion, but able to walk with a walker. The patient was considered as much weaker and bedridden on 19Jan2021, slept a lot. Became uncontactable on 20Jan2021 and died the same day. Sender Comment: Symptoms such as fever, headache and general malaise occur in the first days after vaccination with all vaccines. A large proportion of those vaccinated reported fatigue, joint and muscle pain, and a small proportion developed fever and chills after this vaccine. Fever and malaise occurred more often after the second dose. Such symptoms are short-lived and transient. It is stated in the report that the patient had underlying diseases before vaccination. As the incident is described, it is more likely that these diseases are behind the incident. The fact that the deterioration in the patient''s condition occurs more than a week after vaccination may indicate another cause, as the side effects typically occur after 1-2 days, but it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination. Based on the information in the report and according to given criteria, a causal connection has been 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 (1). Since the patient''s death, the message is classified as serious, even though no causal link between the vaccine and the death has been established. ; Reporter''s Comments: The patient has been in poor, but stable, state for a long time. She had habitually shortness of breath which worsened with light exertion, but able to walk with a walker. The patient was considered as much weaker and bedridden on 19Jan2021, slept a lot. Became uncontactable on 20Jan2021 and died the same day.; Reported Cause(s) of Death: General physical health deterioration; oxygen saturation decreased; increasing shortness of breath; bedridden; blood pressure low


VAERS ID: 1035444 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Loss of consciousness
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 (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NYCOPLUS MULTI; NORVASC; CALCIGRAN FORTE; TOLVON; APODORM; PARACET [PARACETAMOL]; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; TOILAX
Current Illness: Bedridden
Preexisting Conditions: Medical History/Concurrent Conditions: Consciousness fluctuating; Dyspnea; General physical condition decreased; Living in nursing home; Palliative care
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021135961

Write-up: DYSPNEA; LOSS OF CONSCIOUSNESS; This is as spontaneous report received from a contactable other health care professional downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is NO-NOMAADVRE-FHI-2021-Uwrme, Safety report unique identifier NO-NOMAADVRE-E2B_00014735. A 92 years old male patient received the second dose of BNT162B2 (COMIRNATY, lot number EM0477) via intramuscular on 27Jan2021 at 14:08 at single dose in left arm for vaccination. The medical history included palliative care, dyspnea, consciousness fluctuating, general physical condition decreased, living in nursing home and ongoing bedridden. Concomitant medications included nitrazepam (APODORM) from 06Jan2020 to 2021 for insomnia, calcium carbonate, colecalciferol (CALCIGRAN FORTE) from 06Aug2018 to 2021 for calcium supplementation, esomeprazole magnesium (NEXIUM) from 18Feb2019 to 2021 for reflux esophagitis, amlodipine besilate (NORVASC) from 30Jul2018 to 2021 for hypertension, vitamins NOS (NYCOPLUS MULTI) from 11Feb2019 to 2021 for vitamin supplementation, paracetamol (PARACET) from 06Jan2020 to 2021 for pain, bisacodyl (TOILAX) from 10Jul2015 to 2021 for obstipation, mianserin hydrochloride (TOLVON) from 18Mar2019 to 2021 for insomnia. The patient previously received the first dose of BNT162B2 (COMIRNATY) on an unspecified date at unspecified dosage for COVID-19 immunization. The patient general condition was deteriorating at the time at second vaccination but he was awake when dose was given. On 27Jan2021, the patient developed dyspnea, loss of consciousness. The patient received furosemide (FURIX) via oral at 40 mg, as needed from 29Jan2021 to 31Jan2021 for dyspnea. The reporter stated that death was expected before vaccination. On 31Jan2021, the patient died. The case was considered to be serious and was received from an other health professional. Sender comment: Causality assessment: On the basis of the information in the report and in accordance with international criteria, the causal link between dyspnoea and loss of consciousness with the 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. In the relevant case, it is stated that the patient''s health was declining at the time of the second vaccine dose, a cause other than the vaccine is therefore more likely. When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without necessarily being related to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and shortened the time to death. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something other coincidental event that has nothing to do with the vaccination in question. Since the patient died, the message is classified as serious, although the causal link between the vaccine and the death is classified as possible. Background information on deaths in nursing home patients: Normally between 300 and 400 people die per week in nursing homes and similar institutions. In a study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and find, among other things, that the risk of death has increased in the first four months after hospitalization, and that patients who have recently been admitted to hospital have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebro-vascular disease accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (20%), respiratory and infectious diseases (including pneumonia and sepsis) (15%), and cancer (10%). Reported Cause(s) of Death: Dyspnoea; LOSS OF CONSCIOUSNESS


VAERS ID: 1035446 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021142608

Write-up: severe sepsis; the patient died; This is a spontaneous report from a contactable physician forwarded by Medical Information Team. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The physician reported one serious complication, the patient died on 02Feb2021, he was vaccinated 2 days earlier (31Jan2021), he had severe sepsis, and it was reported on 05Feb2021. It was not reported if an autopsy was performed. The severe sepsis outcome was not reported. The information on the batch number has been requested.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. Event sepsis is more likely represents an intercurrent medical condition and unrelated to bnt162b2 . The case will be re-assessed when relevant information, medical history, concomitant drug, particularly the cause of death, 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: the patient died


VAERS ID: 1035447 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021146119

Write-up: Ascending aortic aneurysm rupture; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB (PL-URPL-3-114-2021). An 82-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY; Lot number: EJ6136; Expiration date reported as: 30Jan2021), via an unspecified route of administration, on 26Jan2021 at 09:57 (at the age of 82-years-old) at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced ascending aortic aneurysm rupture on 27Jan2021, which was reported as fatal. The patient died on 27Jan2021. The cause of death was reported as ascending aortic aneurysm rupture. An autopsy was performed that revealed rupture of an ascending aortic aneurysm. The causality assessment was reported as unlikely for the event from Authorities. Sender''s Comment: Aortic aneurysm rupture is an unexpected side effect of the vaccine Comirnaty. The regulatory authority database has not reported aortic rupture in relation to administration Comirnaty. There is a time relationship between the administration of the vaccine and the occurrence of the reaction. However, according to the physician''s opinion, the rupture of the ascending aortic aneurysm, which was the cause of death, had no causal relationship with vaccination. The reporting person classified them as severe. Regulatory authority also classified the application as heavy. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Ascending aortic aneurysm rupture; Autopsy-determined Cause(s) of Death: Rupture of an ascending aortic aneurysm


VAERS ID: 1035448 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haematoma, Haemorrhagic stroke, Headache, Loss of consciousness, Product use issue
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021146137

Write-up: Loss of consciousness; Hemorrhagic stroke (intracerebral hematoma); Hemorrhagic stroke (intracerebral hematoma); Headache; Patient received Comirnaty whyle on anticoagulant Xarelto; This is a spontaneous report downloaded from the Medicines Agency (MA) -WEB [Regulatory Authority number PL-URPL-DML-MLP.4401.2.14.2021] from a contactable consumer. An 80-year-old female patient received bnt162b2 (COMIRNATY) (lot# EJ6136), intramuscular, on 19Jan2021 at 13:02, at 0.3 ml single, for COVID-19 immunisation and rivaroxaban (XARELTO), via an unspecified route of administration, from/to an unspecified date, at 10 mg daily, for an unspecified indication. The patient''s medical history and concomitant medications were not reported. On 19Jan2021 around 05:00 PM the patient experienced loss of consciousness, hemorrhagic stroke (cerebral haematoma) and headache. The events were considered serious as caused patient''s hospitalization on 19Jan2021 and as fatal on 22Jan2021. The action taken in response to the events for rivaroxaban was unknown. It was unknown if an autopsy was performed. Clinical course: on 19Jan2021 at around 05:00 PM patient experienced severe headache, the medical rescue team was called, loss of consciousness after the paramedics arrived. Patient was transported to hospital where a hemorrhagic stroke (intracerebral hematoma) was diagnosed. She remained in a critical condition and died on 22Jan2021. Regulatory Authority comment: headache and loss of consciousness (syncope) are the side effects expected and described in the SmPC for a given Comirnaty vaccine and for the taking Xarelto. A relationship cannot be ruled out for either of them. A hemorrhagic stroke is an unexpected side effect for Comirnaty. However, Comirnaty''s SmPC warns that the vaccine should be administered with special care to people taking anticoagulants. Haemorrhage into an important organ (e.g. the brain) is an expected side effect described in the SmPC for patients taking Xarelto (group: other anticoagulants). The indication for its use is prophylaxis of venous thromboembolism. The temporal relationship speaks for a cause-and-effect relationship. URPL assessed the application as heavy. Relatedness of both drugs to all reaction(s)/event(s) by NCA (Method of assessment :): possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hemorrhagic stroke (intracerebral hematoma); Loss of consciousness; Hemorrhagic stroke (intracerebral hematoma); Hemorrhagic stroke (intracerebral hematoma); Headache


VAERS ID: 1035478 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2021-01-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021135963

Write-up: Death NOS; This is a spontaneous report from a contactable nurse downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-000860. Other case identifier number is SE-MPA-1611214823529. A 99-year-old female patient received BNT162B2 (COMIRNATY, lot number: EJ6795), via intramuscular in Dec2020 at single dose (reported as "1 DF") for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The woman died, reported as death NOS. The woman died 6 days after the vaccination with BNT162B2. Report assessed as serious, death. The patient died in Jan2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1035480 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Breath sounds abnormal, Cardiac failure, Dyspnoea, Fatigue, Nail discolouration, Oxygen saturation, Pyrexia, Wheezing
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PREGABALIN; FENTANYL; ALVEDON; NEUPRO; INOLAXOL [STERCULIA URENS GUM]; CILAXORAL; SERTRALINE; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; MADOPARK QUICK
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure (heart insufficiency); Parkinson''s disease; Scoliosis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Oxygen saturation; Test Result: 68 %; Comments: in close proximity her death
CDC Split Type: SEPFIZER INC2021134660

Write-up: Fever of 39 degrees; Breathing difficult; wheezing breathing and lung sounds; wheezing breathing and lung sounds; blue finger nails; tired; heart failure; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number SE-MPA-2021-001720. Other case identifier number SE-MPA-1611676367041. A 75-year-old female patient received bnt162b2 (COMIRNATY Batch/lot number: EL1484) , via an unspecified route of administration on Jan2021 at single dose for covid-19 immunisation . Medical history included severe scoliosis, cardiac failure(heart insufficiency), parkinson''s disease, all from an unknown date and unknown if ongoing. The patient was described as multimorbid, stable but in poor health. The woman had been very ill in November and December, but after that made a partial recovery. In connection to that, the woman had been thoroughly medically examined at the hospital. Concomitant medication included pregabalin, fentanyl, paracetamol (ALVEDON), rotigotine (NEUPRO), sterculia urens gum (INOLAXOL) , sodium picosulfate (CILAXORAL), sertraline, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), benserazide hydrochloride, levodopa (MADOPARK QUICK). Reported terms were fever and difficulty breathing. The patient experienced heart failure with fatal outcome in 2021 , fever of 39 degrees, breathing difficult, wheezing breathing and lung sounds, blue finger nails, and tired, all on Jan2021 with outcome of unknown, and considered as medically significant. It was reported that two days after the vaccination, the woman developed a fever and breathing difficulties. She had a temperature of 39 degrees, wheezing breathing and lung sounds, blue finger nails. The woman was tired but responded after stimuli. No COVID-test was taken. Rapid deterioration, the woman died the day after the symptoms debuted, reported cause of death was heart failure. Oxygen saturation was 68 % in close proximity her death. The patient died in 2021. An autopsy was not performed. According to the reporter, it''s hard to assess a correlation to Comirnaty due to the woman already being stable but in poor health. Case was assessed as serious, death.; Reported Cause(s) of Death: heart failure


VAERS ID: 1035481 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood pressure measurement, Body temperature, Body temperature increased, Bronchitis, Circulatory collapse, Depressed level of consciousness, Heart rate, Heart rate irregular, Hypotension, Investigation, Oxygen saturation, Oxygen saturation decreased, Respiratory rate
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

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: BETOLVEX [CYANOCOBALAMIN]; WARFARIN; SELOKEN [METOPROLOL SUCCINATE]; FURIX [FUROSEMIDE]; SINEMET; SIMVASTATIN; DIGOXIN; LEVOCAR [CARBIDOPA;LEVODOPA]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal insufficiency; Angiopathy; Heart disease, unspecified; Parkinson''s disease; Penicillin allergy; Respiratory arrest; Sleep excessive; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: blood pressure; Result Unstructured Data: Test Result:91/33; Test Date: 202101; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 degrees Celcius, elevated to 38.5 Centigrade; Test Date: 202101; Test Name: pulse; Result Unstructured Data: Test Result:Irregular, around 70; Test Name: Pk (INR); Result Unstructured Data: Test Result:Stable; Test Date: 202101; Test Name: saturation; Result Unstructured Data: Test Result:73; Test Date: 202101; Test Name: respiratory rate; Result Unstructured Data: Test Result:24
CDC Split Type: SEPFIZER INC2021120222

Write-up: circulatory collapse; Depressed level of consciousness; Oxygen saturation decreased; Atrial fibrillation; Hypotension; Wheezy bronchitis; pulse irregular, around 70; bodytemperature 37,7 degrees Celcius, elevated to 38,5; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB and received via Regulatory Authority, SE-MPA-2021-001856. A 92-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot. EJ6134), intramuscularly in arm right in Jan2021 at 0.3 mL, single for COVID-19 immunization. Medical history included angiopathy, heart disease, unspecified, parkinson''s disease, type 2 diabetes mellitus, and hypersensitivity towards penicillins. The patient had a special home care living and was reported in Nov2020 to have been more tired sleeping a lot in the middle of the day, respiratory arrest and earlier adrenal insufficiency, probably iatrogenic because of high dose cortisone. Concomitant medications included cyanocobalamin (BETOLVEX), warfarin, metoprolol succinate (SELOKEN), furosemide (FURIX), carbidopa/levodopa (SINEMET), simvastatin, digoxin, and carbidopa/levodopa (LEVOCAR). The patient developed atrial fibrillation, wheezy bronchitis, hypotension, oxygen saturation decreased and depressed level of consciousness. The patient''s Pk (INR) was checked before the vaccination with BNT162B2 and it was stable. During the night, day 2 after the vaccination, the patient started to be ill with wheezy bronchitis, blood pressure, 91/33, pulse irregular, around 70, body temperature 37.7 degrees Celcius, elevated to 38.5, respiratory rate 24, saturation 73 and he became depressed level of consciousness. The patient got oxygen and was given palliative care. It could be an adverse reaction and the immune system was working against the vaccination. Reactions started 2 days after the vaccination with BNT162B2. The patient died 4 days after the vaccination with BNT162B2. Cause of death was circulatory collapse. The patient died on an unspecified date, in 2021. Outcome of events circulatory collapse, depressed level of consciousness, oxygen saturation decreased, atrial fibrillation, hypotension, and wheezy bronchitis was fatal, and of events pulse irregular, around 70, and body temperature 37.7 degrees Celcius, elevated to 38.5 was unknown. No autopsy was performed. Follow-up (11Feb2021): New information received from a contactable physician from the Agency Regulatory Authority-WEB includes: information on autopsy. Follow-up attempts completed. No further information expected.; Reported Cause(s) of Death: Circulatory collapse; depressed level of consciousness; oxygen saturation decreased; atrial fibrillation; hypotension; wheezy bronchitis


VAERS ID: 1035483 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Depressed level of consciousness, Dysphagia, Infection, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Diabetes; Hypertension; Stroke
Allergies:
Diagnostic Lab Data: Test Name: p-glucos; Result Unstructured Data: Test Result:12 mmol/L
CDC Split Type: SEPFIZER INC2021135657

Write-up: infection; difficult swallowing food; Depressed level of consciousness; Fever; This is a spontaneous report from a contactable nurse downloaded from the regulatory authority-WEB, Regulatory Authority number SE-MPA-2021-002207. Other case identifier number SE-MPA-1612110177217. A 74-years-old male patient received bnt162b2 (COMIRNATY, lot number: EJ 6796), intramuscular in Jan2021 at 0.3 mL, single dose for covid-19 immunisation. Medical history included diabetes, hypertension and earlier stroke, unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced depressed level of consciousness and fever in Jan2021. Reported as "The man experienced fever and was uncontactable four days after vaccination. The day after, he had difficult swallowing food and therefore no insulin was given, p-glucos 12 mmol/l. The patient also had yellow like color on face. Ambulance was contacted. Patient died eleven days thereafter. Reporter writes cause of death "infection?". The patient underwent lab tests and procedures which included blood glucose: 12 mmol/l on an unknown date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Depressed level of consciousness; Fever; infection


VAERS ID: 1035484 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIGOXIN; FINASTERIDE; ATACAND; LASIX [FUROSEMIDE]; ALVEDON; ELIQUIS; BICALUSTAD; ZOPICLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Breathlessness; Cardiac failure; Heart insufficiency; Myocardial infarction; Reduced general condition; Vascular disorder; Weakness worsened
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021135821

Write-up: cardiac failure; myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB, Regulatory Authority number is SE-MPA-2021-002323. Other case identifier number is SE-MPA-1612191351983. A 94-year-old male patient received BNT162B2 (COMIRNATY; lot number: EJ6134) intramuscularly on an unspecified date in 2021 at 0.3 ml, single for COVID-19 immunisation. Medical history included cardiac failure, myocardial infarction, atrial fibrillation, heart insufficiency, vascular disorder, reduced general condition with more symptoms from his cardiac failure, breathlessness and worsened weakness. Concomitant medications included digoxin, finasteride, candesartan cilexetil (ATACAND), furosemide (LASIX RETARD), paracetamol (ALVEDON), bicalutamide (BICALUSTAD), apixaban (ELIQUIS) and zopiclone. The reported suspect adverse reaction was death. According to the reporter the patient received BNT162B2 and died four Days later he was found dead in his bed, propably he died in his sleep. Suspected time for Death was three day after the vaccination, on an unspecified date in Feb2021. According to the reporter the patient was feeling well the evening after the vaccination, he had contact with his relatives. The death of the patient was suspected to be caused of his Medical histroy (cardiac failure/ myocardial infarction). According to the reporter no direct suspicion of adverse reaction on BNT162B2. Report assessed as serious due to death. The outcome of events was fatal. It was unknown if an autopsy was performed. The Swedish MPA will request further information. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Myocardial infarct; Cardiac failure


VAERS ID: 1035485 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Alzheimer''s disease; Palliative care
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021135314

Write-up: Fever; Affected breathing; This is a spontaneous report from a contactable nurse downloaded from the Medicines Agency (MA) -WEB, Regulatory Authority number SE-MPA-2021-002418. Other case identifier number SE-MPA-1612270812279. A 93-year-old male patient received BNT162B2 (COMIRNATY) (batch/lot number EJ6134, expiry date unknown) intramuscularly on an unspecified date in Jan2021 at 0.3 mL single dose for COVID-19 immunisation. Medical history included palliative care, Alzheimer''s disease. No earlier known drug reactions. The patient''s concomitant medications were not reported. The patient developed fever and respiratory distress two days after the vaccination (onset date provided as an unspecified date in Jan2021) and died on an unspecified date in 2021. It''s unknown if an autopsy was performed.; Reported Cause(s) of Death: fever; respiratory distress


VAERS ID: 1035486 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRTAZAPIN ACTAVIS; INDERAL; CITALOPRAM SANDOZ; OXASCAND; EPIPEN; LAKTULOS MEDA; ENALAPRIL SANDOZ; GABAPENTIN ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to wasp sting; Alzheimer''s disease; Epilepsy; Hypertension; Liver cirrhosis; Subarachnoid bleeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021134710

Write-up: Death (suspected correlation); decreased general condition; This is a spontaneous report from a contactable nurse downloaded from the Medicines Agency (MA) -WEB, Regulatory Authority number is SE-MPA-2021-002450. Other case identifier number is SE-MPA-1612337967460. A 76-year-old female patient received BNT162B2 (COMIRNATY; lot number: EJ6796) intramuscularly on an unspecified date in Jan2021 at 0.3 ml, single for COVID-19 immunization. Medical history included Alzheimer''s disease, epilepsy, liver cirrhosis, hypertension, subarachnoid bleeding, and allergic reaction to wasp sting. Concomitant medications included mirtazapine (MIRTAZAPIN ACTAVIS) from 05May2020, propranolol hydrochloride (INDERAL) from 17Sep2020, citalopram hydrobromide (CITALOPRAM SANDOZ) from 17Sep2020, oxazepam (OXASCAND) from 19Nov2020, epinephrine (EPIPEN) if allergic reaction to arthropod sting, lactulose (LAKTULOS MEDA) from 22Oct2020, enalapril maleate (ENALAPRIL SANDOZ) from 15Sep2020, and gabapentin (GABAPENTIN ACTAVIS) from 12Jan2021. The suspect adverse reaction was death (suspect connection) on an unspecified date in Jan2021. The patient died nine days after the vaccination. According to the reporter the patient developed decreased general condition nine days after the vaccination and died hastily the same day. The report assessed as serious due to death. The cause of death was unknown. The outcome of death (suspect connection) was fatal and of decreased general condition was unknown. It was unknown if an autopsy was performed. The Swedish MPA will request further information. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death (suspected correlation)


VAERS ID: 1035488 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ3166 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Erythema, Heart rate, Oxygen saturation, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic diarrhoea; Epilepsy; Hemiparesis; Hypertension; Ischemic heart disease; Nausea; Osteoporosis; Pain; Pulse rate increased; Stroke
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:normal; Test Name: heart rate; Result Unstructured Data: Test Result:normal; Test Name: oxygen saturation; Result Unstructured Data: Test Result:normal; Test Name: respiratory rate; Result Unstructured Data: Test Result:normal
CDC Split Type: SEPFIZER INC2021136082

Write-up: Death; a slight redness on the cheek; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-002456. Other case identifier number SE-MPA-1612343887078. A 74-year-old female patient received the first dose of BNT162B2 (COMIRNATY) (batch/lot number: EJ3166) via intramuscular in Feb2021 at single dose for covid-19 immunisation. Medical history included hypertension, pulse rate increased, osteoporosis, pain, nausea, stroke from 2015, ischemic heart disease, hemiparesis, chronic diarrhea, epilepsy, all unknown if ongoing. The patient''s concomitant medications were not reported. Previous drug reactions included high pulse, nausea, pain by furosemide (LASIX), valsartan (DIOVANE) and amiloride (NORMORIX). Blood pressure, heart rate, respiratory rate, oxygen saturation was normal. Felt well according to relatives. After vaccination the patient developed a slight redness on the cheek in Feb2021, was treated with 2 desloratadine 10 mg and 15 tablets betamethasone (BETAPRED). Reported adverse event also included death in Feb2021 one day after vaccination. The outcome of the event (a slight redness on the cheek) was unknown. The patient died in her sleep on Feb2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1035489 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Myalgia, Myocardial ischaemia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRENESSA; VITAMIN D3; VITAMIN K2 [MENAQUINONE]; ZINC; VITAMIN C ACID
Current Illness: Back pain (spinal deformities); Knee pain; Pain ankle; Rheumatism
Preexisting Conditions: Medical History/Concurrent Conditions: Loss of consciousness
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:150/90 mmHg
CDC Split Type: SKPFIZER INC2021146683

Write-up: ischaemic heart disease; muscle pain; Joint pain; vaccination site pain; This is a spontaneous report from a contactable consumer. A 84-years-old female patient received the first dose of bnt162b2 (COMIRNATY) vaccine , intramuscular on 08Feb2021 09:00 at single dose for covid-19 immunisation . Medical history included ongoing rheumatic disorder , ongoing back pain spinal deformities , ongoing knee and ankle pain, loss of consciousness . Concomitant medication included perindopril erbumine (PRENESSA), vitamin d3 (VITAMIN D3), vitamin k2 [menaquinone] (VITAMIN K2 [MENAQUINONE]), zinc (ZINC), ascorbic acid (VITAMIN C ACID). The patient experienced ischaemic heart disease on 09Feb2021 causing patient death on 09Feb20221, muscle pain on 09Feb2021 with outcome of unknown , joint pain on 09Feb2021 with outcome of unknown , vaccination site pain on 08Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 150/90 mmhg. The patient was vaccinated with 1st dose on 08Feb2021 at 9:00 am. On the same day the patient was complaining from pain in vaccination site, on next day (09Feb2021) the patient was complaining on muscle pain, joint pain, she referred that she has measured her body temperature but not provided the measured value, when the thermometer was found there was 36,8 Celsius grades. The patient took half tablet of 500 mg paracetamol on 08Feb2021. Later on 10Feb2021 the family did get information about patients death at home on 09Feb2021, the obduction physician did state the time of death on 10:00 pm, cause of death ischaemic heart disease. The reporter was not able to confirm if vaccine COMIRNATY was applied, was not able to provide the lot number. An autopsy was not performed.; Reported Cause(s) of Death: ischaemic heart disease


VAERS ID: 1035753 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-22
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood lactic acid, Computerised tomogram thorax, Sepsis, White blood cell count
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: Lactate; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210124; Test Name: CT thorax; Result Unstructured Data: Revealed abundant thickening in both lungs, no pulmonary embolism, small amount of pericardial fluid.; Test Date: 20210124; Test Name: Leucocyte count; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: Death due to sepsis; A regulatory authority report was received from a physician, concerning an 80-year-old female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273), experienced death due to sepsis (death, sepsis). The patient''s historical condition was not reported. No concomitant medications were reported. On an unknown date in Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient developed sepsis. On 24 Jan 2021, the patient had laboratory tests reported for computerised tomography (CT) thorax which revealed abundant thickening in both lungs, no pulmonary embolism, small amount of pericardial fluid, leucocyte count was 46 (unknown units), and lactate was 3-7. On the same day, the patient died due to sepsis. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 24 Jan 2021. The cause of death was reported as sepsis. Plans for an autopsy were not provided.; Reporter''s Comments: Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Sepsis


VAERS ID: 1037307 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Mini mental status examination, Pulmonary oedema, Pyrexia, Rales, Respiratory failure, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: PANTOMED [DEXPANTHENOL]; HALDOL; MEDROL [METHYLPREDNISOLONE]; BROMAZEPAM SANDOZ; D-CURE; ASAFLOW; DAFALGAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bleeding gastrointestinal; Coronavirus infection (to midDec2020-Covid pos-recov after days of upper airway symptoms +malaise,ClinFrailtySc7); Dementia (2014 MMSE 24/30, 2017 MMSE 21/27, 2019 MMSE 18/28 +behavioral disturbances); Dyspnoea exertional (week before coronavirus infection, urinary infect and more than usual shortness of breath exertional); Fall (Falls and loss of autonomy that will eventually require nursing home admission in2019); General physical health deterioration (week before coronavirus infection: slow-progressive deterioration of general condition); Living in nursing home (Falls and loss of autonomy that will eventually require nursing home admission in 2019); Loss of personal independence in daily activities (Falls and loss of autonomy that will eventually require nursing home admission in 2019); Oesophagitis; Para (Para 1); Urinary infection (week before coronavirus: infection, urinary infect, more than usual shortness of breath exertional); Vision abnormal (Severe vision problems due to AMD)
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 2014; Test Name: MMSE; Result Unstructured Data: Test Result:24/30; Test Date: 2017; Test Name: MMSE; Result Unstructured Data: Test Result:21/27; Test Date: 2019; Test Name: MMSE; Result Unstructured Data: Test Result:18/28; Test Date: 202012; Test Name: Covid positive (RT-qPRC +)-; Result Unstructured Data: Test Result:negative; Comments: rapid test; Test Date: 202012; Test Name: Covid positive (RT-qPRC +)-; Result Unstructured Data: Test Result:positive; Comments: PCR test
CDC Split Type: BEPFIZER INC2021150390

Write-up: Respiratory failure; Lung edema; Moist rales; Fever; Dyspnea; This is a spontaneous report from PHYSICIAN downloaded from the Agency Regulatory Authority-WEB BE-FAMHP-DHH-N2021-76025. A 98-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) at single dose on 14Jan2021 at 98 years for covid-19 immunisation. Medical history included: Para 1, coronavirus infection (Covid positive (RT- qPRC +)) from Dec2020 to an unknown date mid Dec2020 (smooth recovery after a few days of upper airway symptoms and malaise - Clinical Frailty Score 7), week before coronavirus infection, there was a slow-progressive deterioration of the general condition, with documented urinary infection and more than usual shortness of breath exertional; severe vision problems due to AMD, oesophagitis, gastrointestinal haemorrhages in 2017 and in 2019, dementia (2014 MMSE 24/30, 2017 MMSE 21/27, 2019 MMSE 18/28) + behavioral disturbances (calling behavior)), living in residential institution from 2019, falls and loss of autonomy that will eventually require nursing home admission in 2019, severe senile pruritus with xeroderma for which 2 mg methylprednisolone 2 mg/day will start in Oct2020.. No medical or surgical history. No allergy. Concomitant medication included dexpanthenol (PANTOMED) at 1 DF, 1x/day from 10Dec2020 to 11Jan2021, haloperidol (HALDOL) at 0.5 DF, daily from 10Dec2020 to 11Jan2021, methylprednisolone (MEDROL) at 0.5 DF, daily from 10Dec2020 to 11Jan2021, bromazepam (BROMAZEPAM SANDOZ) at 1 DF, daily from 10Dec2020 to 11Jan2021, colecalciferol (D-CURE) at 1 DF every 2 weeks from 10Dec2020 to 11Jan2021, acetylsalicylic acid (ASAFLOW) at 1 DF, alternate day from 10Dec2020 to 11Jan2021, paracetamol (DAFALGAN) at 1 DF, as needed from 10Dec2020 to 11Jan2021. The patient previously took methylprednisolone for senile pruritus. On 15Jan2021 the patient experienced fever, dyspnea, respiratory failure, lung edema, moist rales, described as fever syndrome 39 degrees with dyspnea and wet ronchi. Progressive cor and respiratory failure. Acute fever syndrome, which in itself was a likely (co-) cause of the terminal corruption. All events were considered fatal. The patient underwent lab tests and procedures which included body temperature: 39 centigrade on 15Jan2021, mini mental status examination: 24/30 in 2014, mini mental status examination: 21/27 in 2017, mini mental status examination: 18/28 in 2019. On 16Jan2021 the patient died, fever-free, from circulatory insufficiency and pulmonary edema. It was not reported if an autopsy was performed. Reporter''s comment: -history: Para 1. No medical or surgical history. No allergy. Severe vision problems due to AMD. Esophagitis, GI bleeding 2017 and 2019. Dementia (2014 MMSE 24/30, 2017 MMSE 21/27, 2019 MMSE 18/28 + behavioral disturbances (calling behavior)), Falls and loss of autonomy for which eventually nursing home admission in 2019. Severe senile pruritus with xeroderma for which start-up 2mg methylprednisolone 2mg/day in Oct2020. -mid December: Covid positive (RT-qPRC +)- smooth recovery after a few days of upper airway symptoms and malaise- Clinical Frailty Score 7.- week before, there was a slow-progressive deterioration of the general condition, with documented urinary infection and more than usual shortness of breath exertional. -15Jan: Fever syndrome 39 degrees with dyspnea and wet ronchi. Progressive cor and respiratory failure. Acute fever syndrome, which in itself was a likely (co-) cause of the terminal corruption. - 16Jan: death, fever-free. The patient died on 16Jan from circulatory insufficiency and pulmonary edema - I wish to report this without commenting on any causal relationship. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Para1.NOmed/surg hist.NOaller.Vis probl due AMD.Esoph,GIbleed2017+2019.Demen+behav disturb,Falls+auton loss+nurs home adm2019.Sen prurit+xerod+start methylpredn2mg/dayOct2020.-midDec:Covid+ -recov after upp airway symp+mal-CFS7.-week bef,slow-progr gen cond deter,urin inf+ $gusual shortn breath exert.-15Jan:Fev39?C+dyspn+wet ronchi.Progr cor+resp fail.Acu fev synd,likely(co-)cause of corrupt.-16Jan:death.Pt died16Jan circul ins+pulm edema-Wish to report w/o comment on causal relationship.; Reported Cause(s) of Death: circulatory insufficiency; pulmonary edema


VAERS ID: 1037308 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-26
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: Arterial hypertension; Cognitive impairment; Frailty (Dependence on Daily Living Assistance in toilet, dressing , walking); Gait disturbance
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021150391

Write-up: Cardio-respiratory arrest; Cardiovascular disorder; This is a spontaneous report from a contactable physician downloaded from the regulatory authority -WEB BE-FAMHP-DHH-N2021-76127. An 84-year-old female patient received the first dose of bnt162b2 (COMIRNATY) (lot number EM0477), via an unspecified route of administration at single dose on 07Jan2021 for Covid-19 immunisation. Medical history included hypertension, cognitive impairment, walking disorders, recurrent falls - frailty: dependence on daily living assistance in toilet, dressing , walking. Concomitant medications were not reported. On 26Jan2021, the patient experienced cardio-respiratory arrest, cardiovascular disorder with fatal outcome. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Reporter''s comment: Treatment: no Evolution of the ADR - Death Situations - Other: Probably not related to the vaccine The person did not have any particular reaction to the vaccination. Death occurred unexpectedly 19 days after the first dose of Pfizer BioNtech vaccine. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - No Evolution of the ADR - Death Situations - Other: Probably not related to the vaccine The person did not have any particular reaction to the vaccination. Death occurred unexpectedly 19 days after the first dose of Pfizer BioNtech vaccine.; Reported Cause(s) of Death: Cardiovascular disorder; Cardio-respiratory arrest


VAERS ID: 1037309 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: Cognitive disorder; Palliative care (11Dec2020 : pallitative record)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021150389

Write-up: resident fell on 25Jan2021 and died the day after. Not entirely clear whether there is a connection with the administration of the vaccine.; This is a spontaneous report from a contactable other healthcare professional via agency for medicines and health products downloaded from the Medicines Agency (MA) WEB BE-FAMHP-DHH-N2021-76184. A 92-years-old female patient received the first dose of bnt162b2 (COMIRNATY, lot EJ6134), via an unspecified route of administration on 22Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing palliative setting (11Dec2020: pallitative record) and ongoing cognitive problem. The patient''s concomitant medications were not reported. The patient experienced fall on 25Jan2021 with fatal outcome on 26Jan2021. It was reported that the resident fell on 25Jan2021 and died the day after. Not entirely clear whether there is a connection with the administration of the vaccine. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Reporter''s comments: Treatment - Yes neurological follow-up resident after fall (palliative setting). Evolution of the ADR - Deceased. 92 year old woman - in palliative setting (11Dec2020: pallitative record). frailty score 9: poor physical condition. Mrs also had cognitive problems. 2/1 Ms weighed 57.3 and 23Jan 54.1, again a rapid decline given her poor physical condition. Mrs had not shown fever or other signs of inflammation after administration of the vaccine. Fall on 25Jan, during which time she required neurological monitoring. More likely, however, that resident died of a cause other than the vaccine. Relatedness of drug to reaction/event fall was unclassifiable with Method. Source of assessment: No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of Reporter Comment: Treatment Yes neurological follow-up resident after fall (palliative setting). Evolution of the ADR Deceased. Frailty score 9:poor physical condition. Mrs also had cognitive problems.Rapid decline given her poor physical condition.Mrs had not shown fever or other signs of inflammation after admin of the vaccine.Fall on 25Jan,during which time she required neurological monitoring.More likely,however,that resident died of a cause other than the vaccine.; Reported Cause(s) of Death: fall


VAERS ID: 1037310 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021160947

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the first of thirteen reports. A patient of unspecified age and gender started to receive bnt162b2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Jan2021, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on 22Jan2021 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.; Sender''s Comments: The association between the event lack of effect (fatal COVID19) with COMIRNATY use can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : BE-PFIZER INC-2021166347 Same reporter/product/event, different patient;BE-PFIZER INC-2021166343 Same reporter/product/event, different patient;BE-PFIZER INC-2021166348 Same reporter/product/event, different patient;BE-PFIZER INC-2021166349 Same reporter/product/event, different patient;BE-PFIZER INC-2021166346 Same reporter/product/event, different patient;BE-PFIZER INC-2021166352 Same reporter/product/event, different patient;BE-PFIZER INC-2021166345 Same reporter/product/event, different patient;BE-PFIZER INC-2021166342 Same reporter/product/event, different patient;BE-PFIZER INC-2021166344 Same reporter/product/event, different patient;BE-PFIZER INC-2021166353 Same reporter/product/event, different patient;BE-PFIZER INC-2021166351 Same reporter/product/event, different patient; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome


VAERS ID: 1037311 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021166342

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the second of thirteen reports. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medical history were not reported. On 22Jan2021, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on an unspecified date with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. Follow-up attempts are not possible. No further information is expected. Information on lot number cannot be obtained.; Sender''s Comments: The association between the event lack of effect (COVID-19) with COMIRNATY use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : BE-PFIZER INC-2021160947 Same reporter/product/event, different patient; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome


VAERS ID: 1037312 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021166343

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the third of thirteen reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Patient medical history and concomitant medical history were not reported. An outbreak of covid-19 infection in the retirement home where the physician was working, was reported on 22Jan2021. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on unspecified date with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. Follow-up attempts are not possible. No further information is expected. Information on lot number cannot be obtained.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : BE-PFIZER INC-2021160947 same reporter, product and event; different patient; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome


VAERS ID: 1037313 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021166344

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the fourth of thirteen reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Jan2021, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on an unspecified date 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.; Sender''s Comments: The association between the event lack of effect (COVID-19) with COMIRNATY use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : BE-PFIZER INC-2021160947 Same reporter/product/event, different patient; Reported Cause(s) of Death: COVID-19


VAERS ID: 1037314 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021166345

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned; Contamination spread to 34 residents and 13 deaths to be mourned; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the fifth of thirteen reports. A patient of unspecified age and gender started to received BNT162B2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 22Jan20211, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on 22Jan2021 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.; Sender''s Comments: Linked Report(s) : BE-PFIZER INC-2021160947 Same reporter/product/event, different patient; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned; Contamination spread to 34 residents and 13 deaths to be mourned


VAERS ID: 1037315 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021166346

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned/patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned/patient had COVID-19 with fatal outcome; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the sixth of thirteen reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22Jan2021, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on unspecified date with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. Follow-up attempts are not possible. Information on the batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective at the time of onset of COVID 19 infection, based on the information provided. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : BE-PFIZER INC-2021160947 same reporter, product and event; different patient; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned/patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned/patient had COVID-19 with fatal outcome


VAERS ID: 1037316 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021166347

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the seventh of thirteen reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at a single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 22Jan2021, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on 22Jan2021 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.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : BE-PFIZER INC-2021160947 Same reporter/product/event, different patient; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome


VAERS ID: 1037317 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021166348

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the 8th of thirteen reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Jan2021, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on an unspecified date 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.; Sender''s Comments: The association between the event lack of effect (fatal COVID-19) with COMIRNATY use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : BE-PFIZER INC-2021160947 Same reporter/product/event, different patient; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome


VAERS ID: 1037318 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021166349

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the ninth of thirteen reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 22Jan2021, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient had COVID-19 on an unspecified date 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.; Sender''s Comments: The association between the event lack of effect (fatal COVID-19) with COMIRNATY use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : BE-PFIZER INC-2021160947 same reporter, product and event; different patient.; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome


VAERS ID: 1037319 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021166350

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the tenth of thirteen reports. A patient of unspecified age and gender started to receive bnt162b2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Jan2021, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on an unspecified date 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.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : BE-PFIZER INC-2021160947 Same reporter/product/event, different patient; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome


VAERS ID: 1037320 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021166351

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the eleventh of thirteen reports. A patient of unspecified age and gender received BNT162B2 (COMIRNATY; lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Jan2021, the physician reported an outbreak of COVID-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on 22Jan2021 with a 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.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 based on the known safety profile. However the short duration of 11 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. 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 RA, IEC, as appropriate.,Linked Report(s) : BE-PFIZER INC-2021160947 Same reporter/product/event, different patient; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome


VAERS ID: 1037321 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021166352

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the 12th of thirteen reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Jan2021, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on 22Jan2021 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.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 based on the known safety profile. However the short duration of 11 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. 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 RA, IEC, as appropriate.,Linked Report(s) : BE-PFIZER INC-2021160947 Same reporter, product and event; different patient.; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome; Contamination spread to 34 residents and 13 deaths to be mourned / patient had COVID-19 with fatal outcome


VAERS ID: 1037322 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: BEPFIZER INC2021166353

Write-up: Contamination spread to 34 residents and 13 deaths to be mourned; This is a spontaneous report from a contactable physician. This physician reported similar events for thirteen patients. This is the thirteenth of thirteen reports. A patient of unspecified age and gender started to received BNT162B2 (COMIRNATY, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Jan20211, the physician reported an outbreak of covid-19 infection in the retirement home where the physician was working. It was further reported that the contamination spread to 34 residents and 13 deaths to be mourned. The patient experienced COVID-19 on 22Jan2021 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.; Sender''s Comments: Based on the current available information, the event COVID-19 is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : BE-PFIZER INC-2021160947 Same reporter/product/event, different patient; Reported Cause(s) of Death: Contamination spread to 34 residents and 13 deaths to be mourned; Contamination spread to 34 residents and 13 deaths to be mourned


VAERS ID: 1037330 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-05
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021151607

Write-up: Somnolence; General physical condition decreased; This is a spontaneous report form a physician via the Drug Commission of the Medical Association downloaded from the Agency Regulatory Authority-WEB DE-DCGMA-21187842. An 84-years-old female patient received bnt162b2 (COMIRNATY, lot/batch no.: EJ6796), via an unspecified route of administration on an unspecified date at 0.3 mL, single for covid-19 immunisation. Medical history included ongoing dementia. The patient''s concomitant medications included palliative care. The patient experienced somnolence and general physical condition decreased on 05Jan2021. The events were fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter Comment: ADR (Adverse Drug Reaction): somnolence worsened 5 days after vaccination, a connection to the vaccination not seen, as there was a time lag. The patient already enrolled in palliative care as part of advanced dementia. No follow-up attempts possible. No further information expected.; Reporter''s Comments: ADR (Adverse Drug Reaction): somnolence worsened 5 days after vaccination , a connection to the vaccination not seen, as there was a time lag. The patient already enrolled in palliative care as part of advanced dementia.; Reported Cause(s) of Death: Somnolence; General physical condition decreased


VAERS ID: 1037342 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-28
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Diet refusal, Disturbance in attention, Hyporesponsive to stimuli, Hypotension, Stupor
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021146131

Write-up: Refusal to eat; Hyporesponsive to stimuli; Final decompensation/Decompensation cardiac; Generalized hypotension/Iatrogenic hypotension; Stupor; Vigilance reduction; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB DE-PEI-PEI2021002332. A 92-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EL1491), via an unspecified route of administration on 17Jan2021 at single dose for COVID-19 immunisation. Medical history included dementia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 28Jan2021, after vaccination, the patient developed refusal to eat, hyporesponsive to stimuli, final decompensation/decompensation cardiac, generalized hypotension/iatrogenic hypotension, stupor and vigilance reduction, lasting for unknown and caused death of patient. The patient died on 04Feb2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: refusal to eat; hyporesponsive to stimuli; final decompensation/decompensation cardiac; generalized hypotension/iatrogenic hypotension; stupor; vigilance reduction


VAERS ID: 1037343 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021146136

Write-up: Respiratory failure; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB (DE-PEI-PEI2021002333). A 61-year-old male patient received the first dose BNT162B2 (COMIRNATY; Lot number: EJ6796), via an unspecified route of administration, on 30Dec2020 (at the age of 61-years-old) at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced respiratory failure on an unspecified date, which was reported as fatal. The patient died on an unspecified date. The cause of death was assessed as respiratory failure. It was not reported if an autopsy was performed. The causality assessment to the event was reported as unclassifiable by Regulatory Authority. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Respiratory failure


VAERS ID: 1037344 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021151605

Write-up: Heart failure; Media infarct; This is a spontaneous report from a physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021002364. A 79-years-old female patient received the second dose of bnt162b2 (COMIRNATY; Lot # EJ6788) vaccine , intramuscular on 03Feb2021 at single dose for covid-19 immunisation . The patient medical history was not reported. The patient received the first dose of BNT162B2 on 04Jan2021. The patient''s concomitant medications were not reported. The patient experienced heart failure and media infarct on 03Feb2021. The patient died from the above mentioned events on 05Feb2021. An autopsy was not performed. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Cardiac failure; Myocardial infarction


VAERS ID: 1037345 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021151553

Write-up: Death; This is a spontaneous report from a physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021002377. An 88-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY, batch/Lot # EJ6796) at single dose on 19Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (COMIRNATY, batch/Lot # E0411) at single dose on 28Dec2020 for covid-19 immunisation. The patient died on an unspecified date in 2021. The cause of death was unknown. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) assessed as D. Unclassifiable by PEI. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1037346 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2021-01-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse chronic; Dementia Alzheimer''s type; Hepatic steatosis; Hypertension arterial; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021150317

Write-up: Cardiac arrest; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB [DE-PEI-PEI2021002391]. A 81-year-old male patient started received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EJ6796) , intramuscular on 27Dec2020 at single dose for covid-19 immunisation . Medical history included dementia Alzheimer''s type from, hepatic steatosis, chronic alcohol abuse, hypertension and osteoporosis. The patient''s concomitant medications were not reported. Six days after vaccination the patient had cardiac arrest and died on 01Jan2021. Death cause was reported as Cardiac failure. An autopsy was not performed. Comirnaty/ cardiac arrest/ Regulatory Authority/ C. Inconsistent causal association No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1037356 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; PARACETAMOL/CODEINE; NORVASC; PREDNISOLONE
Current Illness: Hypertension; Seropositive rheumatoid arthritis; Skin malignant neoplasm NOS
Preexisting Conditions: Medical History/Concurrent Conditions: Benign neoplasm of colon; Cholelithiasis; Digestion impaired; Diverticulum intestinal
Allergies:
Diagnostic Lab Data: Test Date: 202006; Test Name: blood pressure; Result Unstructured Data: Test Result:165 mmHg; Test Date: 202010; Test Name: blood pressure; Result Unstructured Data: Test Result:135 mmHg
CDC Split Type: EEPFIZER INC2021146415

Write-up: intracerebral haemorrhage; stroke; bad feeling after vaccination; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB EE-SAM-53621020523. An 86-year-old female patient received second dose of bnt162b2 (COMIRNATY; batch/lot number and expiry date were unknown), intramuscular on 01Feb2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included benign tumors of the colon, ongoing skin malignancy, cholelithiasis, ongoing hypertension, ongoing seropositive rheumatoid arthritis, diverticulosis, and digestive problems. She has no other allergies. Concomitant medications included pantoprazole; codeine phosphate, paracetamol for rheumatoid arthritis; amlodipine besilate (NORVASC) for hypertension; and prednisolone for rheumatoid arthritis (seropos). The patient previously received first dose of bnt162b2 (COMIRNATY) on 11Jan2021 at a single dose for COVID-19 immunization and developed malaise, fatigue, muscle pain, and asthenia. On 01Feb2021, the second dose of Comirnaty vaccine was administered. The patient complained about bad feeling after vaccination. On 04Feb2021, stroke occurred (rupture of a blood vessel in the brain) and the patient died in the evening (about at 9 p.m.). The patient has been in a nursing home for almost half a year since 30Apr2020, therefore cannot describe all the side effects exactly. According to the nursing home, the patient did not feel unwell after both vaccinations, there were no symptoms of side effects. The patient walked outside for 1 hour every day using a rollator, also on the day of the illness. She was adequate and physically active, aware of her medicines. The treatment did not change during the stay. According to the family doctor, the patient''s blood pressures have been 165 mmHg in Jun2020 and 135 mmHg in Oct2020. The patient was hospitalized and died. The original cause of death was noted to be intracerebral haemorrhage. The outcome of the event intracerebral haemorrhage was fatal, while for the other events was unknown. According to the family doctor, death and haemorrhage are not related to the vaccine, but rather as a coincidence. It was not reported if an autopsy was performed. Sender''s comments: Serious report from a patient''s close relative. There was a history of other risk factors (age, hypertension, rheumatoid arthritis) that may have contributed to the development of haemorrhage. According to the nursing home, there were no complaints after receiving the vaccine. The causality is considered not related. No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: intracerebral haemorrhage


VAERS ID: 1037370 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Blood creatinine, Blood potassium, Blood pressure measurement, Blood urea, Body temperature, C-reactive protein, Echocardiogram, Electrocardiogram, Gamma-glutamyltransferase, Haemoglobin, Heart rate, Hypotension, Myocardial infarction, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Physical examination, Platelet count, Pulmonary oedema, SARS-CoV-2 test, Syncope, Troponin, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALPRAZOLAM; CANDESARTAN; FINASTERIDE; LASILIX [FUROSEMIDE]; MOVICOL [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; PANTOPRAZOLE; TAMSULOSIN; TERCIAN [CYAMEMAZINE]
Current Illness: Cognitive disorder; Communication disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of prostate; Fall; Fever; Hypertension arterial; Nausea; Prostate transurethral resection; Syncope vasovagal; Vomiting
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: ALT; Result Unstructured Data: Test Result:74 IU/l; Test Date: 20210202; Test Name: AST; Result Unstructured Data: Test Result:76 IU/l; Test Date: 20210202; Test Name: ALP; Result Unstructured Data: Test Result:73 IU/l; Test Date: 20210202; Test Name: bilirubin; Result Unstructured Data: Test Result:13 umol/l; Test Date: 20210202; Test Name: creatinine; Result Unstructured Data: Test Result:111 umol/l; Test Date: 20210202; Test Name: K; Result Unstructured Data: Test Result:4.6 mmol/L; Test Date: 20210130; Test Name: blood pressure; Result Unstructured Data: Test Result:80/50 mmHg; Test Date: 20210130; Test Name: blood pressure; Result Unstructured Data: Test Result:12/8 mmHg; Test Date: 20210201; Test Name: blood pressure; Result Unstructured Data: Test Result:120/80 mmHg; Test Date: 20210202; Test Name: blood pressure; Result Unstructured Data: Test Result:90/69 mmHg; Test Date: 20210202; Test Name: blood pressure; Result Unstructured Data: Test Result:131/85 mmHg; Test Date: 20210202; Test Name: blood pressure; Result Unstructured Data: Test Result:12/70 mmHg; Test Date: 20210202; Test Name: urea; Result Unstructured Data: Test Result:18.7 mmol/L; Test Date: 20210131; Test Name: body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Test Date: 20210202; Test Name: CRP; Result Unstructured Data: Test Result:125 mg/l; Test Date: 20210202; Test Name: TTE; Result Unstructured Data: Test Result:Estimated left ventricular ejection fraction (LVEF; Comments: Estimated left ventricular ejection fraction (LVEF) between 15 and 20%, lower akinesia and severe hypokinesia with septal sparing. Ascending aorta undilated, left ventricle (LV) undilated, no left ventricular hypertrophy (LVH), grade 2-3 mitral insufficiency probably owing to ruptured chordae tendineae, no retraction of the aortic valve, increased left ventricle (LV) filling pressures, inferior vena cava (IVC) of 27 mm, empty pericardial sac.; Test Date: 20210202; Test Name: ECG; Result Unstructured Data: Test Result:abnormality in the lower leads; Test Date: 20210202; Test Name: ECG; Result Unstructured Data: Test Result:inferolateral shift which regressed with formed Q; Comments: inferolateral shift which regressed with formed Q wave and T wave inversion regular sinus rhythm of 107 bpm; Test Date: 20210202; Test Name: GGT; Result Unstructured Data: Test Result:65 IU/l; Test Date: 20210202; Test Name: Hb; Result Unstructured Data: Test Result:11.7 g/dl; Test Date: 20210130; Test Name: heart rate; Result Unstructured Data: Test Result:55; Comments: 55 bpm; Test Date: 20210130; Test Name: heart rate; Result Unstructured Data: Test Result:80; Comments: 80 bpm; Test Date: 20210201; Test Name: heart rate; Result Unstructured Data: Test Result:111; Comments: 111 bpm; Test Date: 20210202; Test Name: heart rate; Result Unstructured Data: Test Result:103; Test Date: 20210202; Test Name: heart rate; Result Unstructured Data: Test Result:111; Comments: 111 bpm; Test Date: 20210202; Test Name: NT-proBNP; Result Unstructured Data: Test Result:35.048 ng/L; Test Date: 20210130; Test Name: saturation; Test Result: 95 %; Test Date: 20210202; Test Name: saturation; Result Unstructured Data: Test Result:normal %; Test Date: 20210202; Test Name: physical examination; Result Unstructured Data: Test Result:cognitive disorders, temporospatial disorientation; Comments: cognitive disorders, temporospatial disorientation, altered general condition, murmur in the mitral valve area, resting dyspnoea with whimpering, left auscultation area, no pain during the examination, Lower limb pitting oedema; Test Date: 20210202; Test Name: platelets; Result Unstructured Data: Test Result:240 10*6/mL; Test Date: 20210203; Test Name: COVID-19 test; Result Unstructured Data: Test Result:negative; Test Date: 20210202; Test Name: troponin; Result Unstructured Data: Test Result:1297 ng/L; Test Date: 20210202; Test Name: WBC; Result Unstructured Data: Test Result:13.9 g/l
CDC Split Type: FRPFIZER INC2021151654

Write-up: Vasovagal syncope with hypotension; Vasovagal syncope with hypotension; pulmonary oedema; acute coronary syndrome; Infarct myocardial; This is a spontaneous report from a contactable pharmacist via Agency downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-AN20210218. An 85-years-old male patient received the second dose of bnt162b2 (COMIRNATY, lot/Batch number: EJ6788), intramuscular in the left arm on 02Feb2021 at single dose for covid-19 immunisation. Medical history included prostate transurethral resection, hypertension arterial, prostate cancer all unknown if ongoing, underlying cognitive disorders and communication problems. The patient received the first dose of bnt162b2 (COMIRNATY, batch EM0477), on 12Jan2021 at single dose for covid-19 immunisation and experienced band-like epigastric pain with dyspnoea. The patient had no history of COVID-19. COVID-19 test: PCR/serologic was negative.Concomitant medication included alprazolam (unknown manufacturer), candesartan (unknown manufacturer), finasteride unknown manufacturer), furosemide (LASILIX), macrogol 4000, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), pantoprazole (unknown manufacturer), tamsulosin (unknown manufacturer), cyamemazine (TERCIAN). The patient experienced infarct myocardial on 02Feb2021. The event was fatal. The patient died on 04Feb2021. It was not reported if an autopsy was performed. Clinical course was as follows. On 02Feb2021 at around 6 a.m., band-like epigastric pain with dyspnoea, a few hours later, in the morning, the patient was vaccinated (2nd dose). Around 1 p.m., vasovagal syncope with hypotension, the patient reported not feeling well, and complained about his stomach. At that moment, no pyrexia, normal saturation, blood pressure (BP) 90/69 mmHg, persisting lower limb oedema. Crackles in 2/3 of the left lung and the base of the right lung. Patient did not tolerate back decubitus alleging diffuse pain, abdomen unexaminable.ECG performed at 2:45 p.m. revealed an abnormality in the lower leads. Patient seemed to improve clinically in the afternoon. At 7 p.m., blood pressure (BP) 131/85, heart rate (HR) 103. Patient transferred to the emergency department on 02Feb2021 in the evening after ECG had been read by the doctor, which was followed by hospitalisation at ICU. It should be noted that on the preceding days, the patient complained of stomach pains with nausea and vomiting. Vasovagal syncope on 30Jan2021 resulting in a fall, blood pressure (BP) 80/50, heart rate (HR) 55 bpm and 95 percent oxygen saturation in ambient air, pallor and sweating, followed by blood pressure (BP) 12/8, heart rate (HR) 80 bpm. On 31Jan2021, another syncope resulting in a fall from standing at 2 p.m. Vomiting and hyperthermia of 38.2 Celsius degrees in the evening. On 01Feb2021: no pyrexia, blood pressure (BP) 120/80, heart rate (HR) 111 bpm. On 02Feb2021 at 1 a.m., the patient reported not feeling well with "rapid and laboured breathing", complained of stomach pain. In the morning, blood pressure (BP) 12/70, heart rate (HR) 111 bpm. Physical examination at intensive care unit (ICU) revealed cognitive disorders, temporospatial disorientation, altered general condition, murmur in the mitral valve area, resting dyspnoea with whimpering, left auscultation area, no pain during the examination, Lower limb pitting oedema. An ECG performed on admission to intensive care unit revealed an inferolateral shift which regressed with formed Q wave and T wave inversion regular sinus rhythm of 107 bpm. Transthoracic echocardiogram (TTE) at intensive care unit: Estimated left ventricular ejection fraction (LVEF) between 15 and 20%, lower akinesia and severe hypokinesia with septal sparing. Ascending aorta undilated, left ventricle (LV) undilated, no left ventricular hypertrophy (LVH), grade 2-3 mitral insufficiency probably owing to ruptured chordae tendineae, no retraction of the aortic valve, increased left ventricle (LV) filling pressures, inferior vena cava (IVC) of 27 mm, empty pericardial sac. Covid PCR test result negative on 03Feb2021 at 2:25 a.m. Blood test of 02Feb2021 at 11 p.m.: WBC 13.9 G/l, Hb 11.7 g/dl, platelets 240 G/l, urea 18.7 mmol/l, creatinine 111 umol/l, K 4.6 mmol/l; CRP 125 mg/l; HS troponin T 1297 ng/l , NT-proBNP 35.048 ng/l, AST 76 IU/l; ALT 74 IU/l, ALP 73 IU/l, GGT 65 IU/l, bilirubin 13 umol/l. At 6 a.m. on 03Feb: Killip class III pulmonary oedema. Pharmacological treatment with intravenous diuretics, Risordan. Death of the patient at 1 a.m. during the night of 03/04Feb. According to the cardiologist at intensive care unit: "Patient admitted at 3 p.m. due to development of necrosis. ECG found an inferolateral shift that regressed with formed Q wave and T wave inversion. It can be considered that the patient''s condition was due to recanalisation with antithrombotic treatment administered by the ambulance staff; another interpretation is that necrosis actually started earlier in this patient with cognitive disorders and communication problems, residing in a nursing facility. ECG corresponds to an image fully indicative of necrosis." Moreover, the nursing facility doctor a posteriori suspected myocardial infarction on 30Jan. Conclusions were as follows. Pulmonary oedema due to acute coronary syndrome with delayed treatment initiation; on the basis of additional examinations and the clinical history, it seems that necrosis may have started before the vaccination. Summary: acute coronary syndrome and pulmonary oedema in a man vaccinated against covid-19 the same day. however, symptoms may have begun 4 days before. A drug is coded as an active ingredient where the brand name is unknown. Please Note: Imputability "without prejudice to further investigations that could be carried out as part of legal or amicable compensation procedures. " No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1037372 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Chronic respiratory failure; Oxygen supplementation (oxygen dependence)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021151098

Write-up: Death / found dead; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB (Regulatory Authority number FR-AFSSAPS-BX20210488). A 97 years old female patient received the first single dose of BNT162B2 (COMIRNATY; lot EJ6795) intramuscular, in right arm, on 26Jan2021, for COVID-19 vaccination. Medical history included chronic respiratory failure, cardiac failure and oxygen supplementation (oxygen dependence), all from an unknown date and unknown if ongoing. The patient was living in nursing home. Concomitant medication included rivaroxaban (XARELTO). The patient did not have Covid-19 before vaccination, had not been tested. The vaccination was done without immediate adverse effects, no noticeable event in the following days (no fever, no symptoms of an infectious process, no respiratory symptoms, no decompensation of the underlying diseases). The patient was found dead in the morning on 31Jan2021, 5 days after vaccination. Cause of death was unknown. It was unknown if an autopsy was done. NB: imputation made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1037375 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
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: 2021-02-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Embolism; Gastrooesophageal reflux; Hypertension arterial; Infarct myocardial; Malnutrition (severe (+++)); Osteoporosis; Stent placement; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: Covid- 19 PCR; Result Unstructured Data: Test Result:positive; Comments: 02Feb2021, performance of the Nasal PCR test in this patient who is COVID-19 positive at 5 p.m.
CDC Split Type: FRPFIZER INC2021150325

Write-up: COVID-19; COVID-19; This is a spontaneous report from a contactable physician from the Medicines Agency (MA) -WEB FR-AFSSAPS-MA20210291 . A 93 year-old female patient received the first dose of bnt162b2 (COMIRNATY; Lot # EJ6788) vaccine , intramuscular on 19Jan2021 at single dose for covid-19 immunisation . Medical history included cerebrovascular accident from , osteoporosis , hypertension, gastrooesophageal reflux disease , embolism , asthma , stent placement , myocardial infarction and undernutrizion (+++) The patient''s concomitant medications were not reported. The patient was tested positive to Covid-19 Nasal PCR test on 02Feb2021. The patient died on 03Feb2021 from Covid-19 It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: Covid-19


VAERS ID: 1037378 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: OXAZEPAM; MIRTAZAPINE; PERMIXON; PARACETAMOL; DUPHALAC [LACTULOSE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cervical vertebral fracture; Mixed dementia
Allergies:
Diagnostic Lab Data: Test Date: 20201209; Test Name: Covid-19 test; Result Unstructured Data: Test Result:unknown
CDC Split Type: FRPFIZER INC2021150322

Write-up: Sudden death; This is a spontaneous report from a contactable PHYSICIAN downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-PO20210225 A 100-years-old male patient received first dose of bnt162b2 (COMIRNATY) , intramuscular in arm left on 19Jan2021 at single dose (reported as 0.3 mL, single ) from Lot#EJ6795 for covid-19 immunisation . Medical history included cervical vertebral fracture unknown if ongoing , mixed dementia unknown if ongoing. Concomitant medication included oxazepam (OXAZEPAM) 1 DF, 1x/day, in the evening, mirtazapine (MIRTAZAPINE), serenoa repens extract (PERMIXON), paracetamol (PARACETAMOL), lactulose (DUPHALAC )The patient experienced sudden death without warning sign, without any signs. No symptoms, no cause found on 21Jan2021. Lab data included sars-cov-2 test (09Dec2020): unknown . It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1037381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Cardio-respiratory arrest, Heart rate, Investigation, Myalgia, Nausea, Oxygen saturation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   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: APROVEL; LERCAN; TOVIAZ; ESOMEPRAZOLE; NOCTAMIDE; LAROXYL
Current Illness: Hypertension arterial (well-balanced)
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: BP; Result Unstructured Data: Test Result:120/60; Test Date: 20210202; Test Name: Heart rate; Result Unstructured Data: Test Result:70; Test Date: 20210202; Test Name: clinical examination; Result Unstructured Data: Test Result:normal; Test Date: 20210202; Test Name: oxygen saturation; Test Result: 99 %
CDC Split Type: FRPFIZER INC2021150314

Write-up: Sudden death; cardiopulmonary arrest; Myalgia; Nausea; asthenia; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB (FR-AFSSAPS-TS20210171). A 95-year-old female patient received BNT162B2 (COMIRNATY), intramuscularly, on 01Feb2021 at 19:30 a single dose for COVID-19 vaccination. Medical history included ongoing hypertension arterial (well-balanced) and stroke in 1999. The patient had no history of cardiovascular disease, no history of venous thrombosis, and no history of COVID-19. Concomitant medications included irbesartan (APROVEL), lercanidipine hydrochloride (LERCAN), fesoterodine fumarate (TOVIAZ), esomeprazole (MANUFACTURER UNKNOWN), lormetazepam (NOCTAMIDE), and amitriptyline hydrochloride (LAROXYL). The patient experienced myalgia and nausea on 02Feb2021 and sudden death on 03Feb2021 at 15:30, which were reported as fatal. The patient also experienced asthenia on 02Feb2021 and cardiopulmonary arrest on 03Feb2021. The clinical course was reported as follows: Despite her age, the patient was still very active and in great shape according to the family and the attending physician. The patient had no problem during the vaccination. In the evening, about 2 hours later (as reported), the patient complained of nausea then muscle aches and pains. On 02Feb2021, the patient still complained of muscle pain, asthenia, and nausea. The attending physician visited, who noted absence of fever, blood pressure (BP) at 120/60, heart rate at 70, and oxygen saturation at 99% with normal clinical examination, all on 02Feb2021. The doctor concluded reactogenic manifestations in connection with the vaccine and prescribed paracetamol (MANUFACTURER UNKNOWN) and algeldrate sodium alginate (GAVISCON) and recommended rest. On 03Feb2021, the patient had increased asthenia, stayed in bed (which is really unusual according to her family), complained of nausea and myalgia especially of the upper body, no other complaints, no trouble of consciousness, and no other pain, but did not eat breakfast. The daughter of the patient came to the room 1 hour later and discovered her in cardiopulmonary arrest. Cardiac massage was started by the family, paramedics were called, and intervention of Emergency Medical Service was started. The resuscitation maneuvers were ineffective, and death observed at 15:30 (44 hours after vaccination). In conclusion, there was sudden death in an elderly patient, but in good general condition and without major comorbidity or associated acute pathology, having early systemic reactogenic effects. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of all of the events was fatal. The patient died on 03Feb2021. The cause of death was reported as sudden death and assessed as cardiopulmonary arrest. An autopsy was not performed. No follow-up attempts are possible; information on lot number cannot be obtained.; Reported Cause(s) of Death: cardiopulmonary arrest; Sudden death


VAERS ID: 1037603 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-19
Onset:2020-12-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ5503 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Confusional state, Illness, Migraine, Muscle fatigue, Pneumonia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCAL D3; APIXABAN; LORAZEPAM; OLANZAPINE; TAPENTADOL; VITAMIN D SUPPORT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Emphysema; Heart failure; Mental disorder; Mental status changes; Osteoporosis; Pain in extremity; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20201223; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021147298

Write-up: SARS-CoV-2 infection/COVID-19; Pneumonia; Mental confusion; Muscle fatigue; Migraine headache; Sickness; This is a spontaneous report from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202102082254371900 and Safety Report Unique Identifier GB-MHRA-ADR 24725750. A contactable consumer reported that a 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: Ej5503, expiry: unknown), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 vaccination. Medical history included pulmonary embolism, cardiac failure, emphysema, chronic obstructive pulmonary disease, osteoporosis, mental disorder, mental status changes and pain in extremity. Patient has not had symptoms associated with COVID-19 and is not enrolled in clinical trial. Concomitant medications included calcium carbonate, colecalciferol (ADCAL D3) from 03Jan2019 for osteoporosis, apixaban from 24Apr2020 for pulmonary embolism, influenza vaccine (INFLUENZA VIRUS) from 13Nov2020, lorazepam from 06Apr2017 for mental disorder, olanzapine from 05Jun2017 for mental status changes, tapentadol from 05Aug2020 for pain in extremity and colecalciferol (VITAMIN D SUPPORT) from 04Jan2019 for osteoporosis. The patient experienced sars-cov-2 infection on 24Dec2020, migraine headache on 20Dec2020, sickness on 20Dec2020, mental confusion on 22Dec2020, muscle fatigue on 20Dec2020, pneumonia on 23Dec2020. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive covid-19 test on 23Dec2020. Therapeutic measures were taken as a result of sars-cov-2 infection, migraine headache, sickness, mental confusion, muscle fatigue and pneumonia. The patient was put on BiPAP (Bilevel Positive Airway Pressure) for 48 hrs and antibiotic steroids. For 8 days, the patient did not respond to them. The outcome of the events migraine headache, sickness, mental confusion, muscle fatigue and pneumonia were unknown. The patient died on 09Jan2021 due to COVID-19 (SARS-CoV-2 infection). It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: COVID-19/SARS-CoV-2 infection


VAERS ID: 1037604 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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: ALCOHOL; ALLOPURINOL; APIXABAN; DIGOXIN; OMEPRAZOLE; QUININE SULFATE; THIAMINE; VITAMIN B COMPLEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Atrial fibrillation (high stroke risk); Hypertension; Liver cirrhosis (stable); Muscle spasms
Allergies:
Diagnostic Lab Data: Test Name: Hasbled bleeding risk score; Result Unstructured Data: Test Result:4/9; Test Name: liver function blood tests; Result Unstructured Data: Test Result:Normal
CDC Split Type: GBPFIZER INC2021147463

Write-up: Intracerebral bleed; This is a spontaneous report received by Pfizer from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202102092000180230 with Safety Report Unique Identifier of GB-MHRA-ADR 24731012. A contactable physician reported that an 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1688), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (high stroke risk), hepatic cirrhosis (stable, normal liver function blood tests), minimal alcohol intake, hypertension, and muscle spasms. Concomitant medications included alcohol, allopurinol, apixaban anticoagulant for high stroke risk in atrial fibrillation, digoxin, omeprazole, quinine sulfate for muscle spasms, thiamine, and vitamin b complex. The patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. She was not enrolled in a clinical trial. This patient had multiple other risk factors for intracerebral bleed including taking apixaban anticoagulant, hypertension, age history of liver cirrhosis (stable, minimal alcohol intake, normal liver function blood tests), Hasbled bleeding risk score of 4/9. The patient was logged for monitoring. The intracerebral bleed that caused death in hospital happened 4 days after her first vaccination on 11Jan2021. The patient has not tested positive for COVID-19 since having the vaccine. The patient died on 11Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Intracerebral bleed


VAERS ID: 1037605 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN1185 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ASPIRIN (E.C.); ATORVASTATIN; BENDROFLUMETHIAZIDE; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Ischaemic heart disease; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021147377

Write-up: Sudden death/unexpected death; This is a spontaneous report received by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202102101224527310 and Safety Report Unique Identifier GB-MHRA-ADR 24734149. A 78-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EN1185), via an unspecified route of administration, first dose on 03Feb2021 at single dose, for COVID-19 immunisation. Medical history included myocardial infarction from 1998, ischaemic heart disease/myocardial ischaemia from 2001 and hypertension from an unknown date. Unsure if patient has had symptoms associated with COVID-19. Patient had not had a COVID-19 test and is not enrolled in clinical trial. Concomitant medication included amlodipine, acetylsalicylic acid (ASPIRIN (E.C.), atorvastatin and bisoprolol for myocardial ischaemia from unspecified dates; and bendroflumethiazide for hypertension from unspecified date. Patient has been found dead at home 10Feb2021- sudden death/unexpected death. Reporter understand that they should report any serious events within 2 weeks of having the vaccine, even though reporter was unsure the two things are related. Patient has not tested positive for COVID-19 since having the vaccine. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death/unexpected death


VAERS ID: 1037606 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic stenosis, Cardiac failure, Diabetes mellitus, Myocardial ischaemia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (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: 2021-02-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALFACALCIDOL; ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; CARVEDILOL; CLOPIDOGREL; ERYTHROPOIETIN; FLUOXETINE; GTN; LANSOPRAZOLE; LANTHANUM CARBONATE; NICORANDIL; NOVORAPID; ONDANSETRON; PROCHLORPERAZINE; RENAVIT; SENNA [SENNA ALEXANDRINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure aggravated; Diabetic nephropathy; Dialysis; Ischaemic heart disease; Palpitations; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021153190

Write-up: renal failure; aortic stenosis; heart failure; diabetes mellitus; ischemic heart disease; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102101816473700, Safety Report Unique Identifier GB-MHRA-ADR 24737684. A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0739), via an unspecified route of administration single dose on 03Feb2021 for covid-19 immunisation. Medical history included myocardial ischaemia, diabetic nephropathy, palpitations, renal failure, dialysis, cardiac failure. Concomitant medications included alfacalcidol for renal failure, acetylsalicylic acid (ASPIRIN) for ischaemic heart disease, atorvastatin for myocardial ischaemia, carvedilol for myocardial ischaemia, clopidogrel for myocardial ischaemia, erythropoietin for renal failure, fluoxetine for depression, GTN for myocardial ischaemia, lansoprazole for indigestion, lanthanum carbonate for renal failure, nicorandil for myocardial ischaemia, insulin aspart (NOVORAPID) for diabetes, ondansetron for nausea, prochlorperazine for nausea, ascorbic acid, biotin, calcium pantothenate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (RENAVIT) for renal failure, senna alexandrina leaf (SENNA) for constipation, zopiclone for insomnia. The patient had renal failure and aortic stenosis both on an unspecified date and died in the sleep on 08Feb2021. It was not reported if an autopsy was performed. Cause of death was heart failure secondary to ischemic heart disease, with renal failure, diabetes mellitus and aortic stenosis as contributing factors. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: IHD; renal failure; DM; aortic stenosis; heart failure sec to IHD


VAERS ID: 1037608 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141/V1010 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: physical examination; Result Unstructured Data: Test Result:Unknown results; Test Name: scans; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC2021152875

Write-up: Death; Stroke confirmed; felt unwell; This is a spontaneous report from a contactable consumer from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202102102139105660, Safety Report Unique Identifier GB-MHRA-ADR 24738813. An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0141/V1010), via an unspecified route of administration on 09Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient felt unwell and ambulance was called. Paramedics confirmed and patient taken to hospital. Stroke confirmed and patient died 24 hours later. The cause of death was unknown. On an unspecified date, the patient underwent lab tests and procedures which included physical examination and scan: for both the results were unknown. It was not reported if an autopsy was performed. The patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1037609 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Blood pressure high; Chest infection (this time of year, as reported); Heart failure (monitored every 6 months); Kidney failure (monitored every 6 months); Pneumonia (this time of year, as reported)
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:small amount of Covid; Test Name: chest x Ray; Result Unstructured Data: Test Result:white tabs; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: for 4 times
CDC Split Type: GBPFIZER INC2021153010

Write-up: chest X-ray showed white tabs; Breathing difficult; This is a spontaneous report from a contactable consumer received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102102216178790, Safety Report Unique Identifier GB-MHRA-ADR 24738935. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 17Jan2021 at a single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19 and she is not enrolled in clinical trial. Relevant medical history included blood pressure high, asthma, kidney failure and heart failure (both monitored every 6 months), pneumonia and chest infection (both this time of year, as reported). No relevant concomitant medications were provided. On 19Jan2021, the patient the patient developed breathing difficult, considered a life-threating condition. The patient underwent COVID-19 virus test four times and resulted negative, but chest X-ray showed white tabs and blood test revealed a small amount of COVID. The patient was shielding since March 2020 and avoided contact only attended medical appointments. On 02Feb2021, the patient died due to breathing difficult. 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: Breathing difficult


VAERS ID: 1037613 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK 4243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCAL D3; ATORVASTATIN; OMEPRAZOLE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspepsia; Hypercholesterolaemia; Hypertension; Osteopenia
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: Body temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC2021153244

Write-up: Death; shortness of breath; high temperature; This is a spontaneous report received from a contactable physician via the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102111748038680. Safety Report Unique Identifier GB-MHRA-ADR 24745219. A 73-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK 4243), via an unspecified route of administration, on 23Jan2021, at single dose, for COVID-19 immunisation. The patient''s medical history included hypertension, dyspepsia, hypercholesterolaemia, osteopenia. Patient did not have symptoms associated with COVID-19, did not have a COVID-19 test and was not enrolled in clinical trial. Concomitant medications included calcium carbonate, colecalciferol (ADCAL D3) for osteopenia, atorvastatin (unknown manufacturer) for hypercholesterolaemia, omeprazole (unknown manufacturer) for dyspepsia, ramipril (unknown manufacturer) for hypertension. The patient experienced death on 26Jan2021. It was not reported if an autopsy was performed. Clinical course reported as: high temperature and shortness of breath from 24Jan2021, found collapsed on 26Jan2021. Patient did not test positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1037617 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 31
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: Food allergy; Heart disorder (something to do with the valves.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021043788

Write-up: Contracted Covid-19 with breathing difficulties; Contracted Covid-19 with breathing difficulties; This is a spontaneous report from contactable consumer (patient) and daughter via a company representative. Patient''s daughter was a Health Care Professional. A 95-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jan2021, at single dose, for COVID-19 immunization. Medical history included underlying heath issues with his heart (something to do with the valves) and was allergic to mustard. The patient''s concomitant medications were not reported. The patient contracted COVID-19 on an unspecified date, in Jan2021 and was in hospital on Friday 15Jan2021 with breathing difficulties. It was reported that he contracted COVID after the vaccine had be given. However, the patient had been self-isolating and only going to his allotment in the mornings. He did however have Christmas dinner with his family Christmas day, with his daughter and son in law who are both active paramedic. They both now also have Covid and yesterday his daughter moved in with him to take care of him and she only has mild symptoms. It could be he contracted it at Christmas but the symptoms didn''t show until this week. According to the patient''s daughter, the patient went before to have the Pfizer vaccine and was asked if he had any allergies, he said he did, he was allergic to mustard. It was reported that the patient was one of the first people to be asked to get the vaccine he even cycled to the place and when he got there, they didn''t allow him because of his allergy to mustard. Accordingly, due to that the patient was not given the vaccine at that time was told that he would be contacted when the AstaZenca one was available. He had to wait for the Astrazeneca vaccine but ended up having the Pfizer one and contracted COVID. Reporter stated that if he had it 3 weeks earlier when he was supposed to would still be alive now. The patient died on an unspecified date, in Feb2021 due to COVID-19. It was unknown if autopsy was done. Information on batch number has been request. Follow-up (25Jan2021): New information reported from a consumer (daughter) via a company representative includes: medical history (allergic to mustard and additional reporter (daughter). No follow-up attempts are possible, information about batch number cannot be obtained. Follow up (11Feb2021): New information received includes: details regarding patient''s death and event''s updated.; Reported Cause(s) of Death: COVID-19; Breathing difficult


VAERS ID: 1037658 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021151269

Write-up: Fever; Dyspnea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, IT-MINISAL02-673008. A 75 years old male patient received the second dose of BNT162B2 (COMIRNATY, Lot. EK9788, expiration date: 31May2021) intramuscularly, at 0.3 mL, single dose, on 03Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 04Feb2021, the patient experienced fever and dyspnea. The patient died on 04Feb2021. It was unknown if autopsy was done. Clinical outcome of the events was reported as fatal. Reporter comment: Fever and dyspnea from the morning; the day before reported administration of the second SARS CoV2 vaccine dose.; Reporter''s Comments: Fever and dyspnea from the morning; the day before reported administration of the second SARS CoV2 vaccine dose.; Reported Cause(s) of Death: Dyspnea; Fever


VAERS ID: 1037663 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage, SARS-CoV-2 test positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   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: EUTHYROX
Current Illness: Abdominal discomfort (no further investigation was done)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201221; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021151164

Write-up: Gastrointestinal haemorrhage; This is a spontaneuous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [NL-LRB-00441009]. A 95-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown) , via an unspecified route of administration on 03Feb2021 at 0.3 mL, single for covid-19 immunisation . Medical history included abdominal complaints, for which no further investigation was done and covid 19 with hardly any symptoms on 21Dec2020. Concomitant medication included levothyroxine sodium (EUTHYROX, 25ug) tablet . Two days after vaccination, the patient had a gastrointestinal haemorrhage without invasive treatment. The patient deceased 24 hours later due to the gastrotinestinal haemorrhage on 06Feb2021. It was not reported if an autopsy was performed. Reporter''s comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. gastrointestinal bleeding has occurred 2 days after vaccination. Additional information ADR: The patient had been aware of abdominal complaints for some time, which he did not want to have examined. 2 days after vaccination gastrointestinal haemorrhage occurred, on which a cautious policy has been agreed. Patient died after 24 hours. It is unclear whether this could be a side effect of the vaccination, but it is necessary to report it given the short period in between. COVID19. Previous COVID-19 infection: disease symptoms: none Other diagnostic procedures: No.; Reported Cause(s) of Death: gastrointestinal bleeding


VAERS ID: 1037664 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Death, Hemiplegia, Weight, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Emphysema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: weight; Test Result: 25 kg
CDC Split Type: NLPFIZER INC2021152703

Write-up: within a week she died; cerebral infarction; the left side of her body was paralyzed; tremendous weight loss; This is a spontaneous report from a contactable consumer who reported similar events for 3 patients. This is the first of three reports. A 94-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included ongoing emphysema. The patient''s concomitant medications were not reported. The patient experienced cerebral infarction, the left side of her body was paralyzed and tremendous weight loss, all on an unspecified date. The patient died within a week on an unspecified date. The cause of death was unknown. The patient underwent lab tests and procedures which included weight: 25 kg. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: unknown


VAERS ID: 1037665 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Corona virus infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021159174

Write-up: within a week she died; lungs filled with fluid; This is a spontaneous report from a contactable consumer or other non hcp who reported similar events for 3 patients. This is the second of three reports. An 84-years-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included corona. The patient''s concomitant medications were not reported. The patient had lungs filled with fluid on unspecified date with outcome of unknown. The patient died within a week on an unspecified date. The cause of death was unknown. It was not reported if an autopsy was performed. Information on the batch number has been requested.; Reported Cause(s) of Death: death


VAERS ID: 1037668 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA156571 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Auscultation, Blood sodium, Body temperature, C-reactive protein, Cardiogenic shock, Echocardiogram, Ejection fraction, Electrocardiogram, Glomerular filtration rate, Haemoglobin, Myocardial infarction, N-terminal prohormone brain natriuretic peptide, White blood cell count
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HALDOL; DIVISUN; BEHEPAN [CYANOCOBALAMIN]; FOLSYRE NAF; ZOPIKLON MYLAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Auditory hallucinations; Frailty (CLINICAL FRAILTY SCALE: 7); Living in nursing home; Malnutrition; Muscular dystrophy (facioscapulohumeral muscular dystrophy); Performance status decreased (Barthel Index of Activities of Daily Living, score 9.); Visual hallucinations
Allergies:
Diagnostic Lab Data: Test Date: 20210201; Test Name: Angiography; Result Unstructured Data: Test Result:Stenosis in LAD, CX, RCA.; Comments: Stenosis in LAD, CX, RCA. (PCI x 3 LAD, x2 CX).; Test Date: 20210201; Test Name: Auscultation; Result Unstructured Data: Test Result:Systolic murmur grade 3-4, most pronounced 2nd rig; Comments: Systolic murmur grade 3-4, most pronounced 2nd right intercostal space and at the apex.; Test Date: 20210201; Test Name: Serum sodium; Result Unstructured Data: Test Result:146 mmol/L; Test Date: 20210201; Test Name: Body temperature; Result Unstructured Data: Test Result:Afebrile.; Test Date: 20210201; Test Name: C-reactive protein; Result Unstructured Data: Test Result:7 mg/l; Test Date: 20210201; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:Pronounced B-lines (as in pleural effusion), espec; Comments: Pronounced B-lines (as in pleural effusion), especially on the left side.; Test Date: 20210201; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:Very small left ventricle, almost akinetic septum/; Comments: Very small left ventricle, almost akinetic septum/anterior wall. EF 30-35 %.; Test Date: 20210201; Test Name: Ejection fraction; Result Unstructured Data: Test Result:30 -35 %; Test Date: 20210201; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ST depression in I, II, aVL, and V4-V6, QS anteros; Comments: ST depression in I, II, aVL, and V4-V6, QS anteroseptally.; Test Date: 20210201; Test Name: GFR; Result Unstructured Data: Test Result:82; Comments: Units:mL/min/{1.73_m2}; Test Date: 20210201; Test Name: Hemoglobin; Result Unstructured Data: Test Result:12.3 g/dl; Test Date: 20210201; Test Name: NT-proBNP; Result Unstructured Data: Test Result:5200 ng/L; Test Date: 20210201; Test Name: White blood cells; Result Unstructured Data: Test Result:6.3 x10 9/l
CDC Split Type: NOPFIZER INC2021150316

Write-up: Heart attack; Cardiogenic shock; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB regulatory authority number NO-NOMAADVRE-FHI-2021-Umdg7, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014827. An 82-year-old female patient (a nursing home resident) received the first dose of BNT162B2 (COMIRNATY, lot paa156571), on 28Jan2021 13:20 at single dose for COVID-19 immunization, via intramuscular route in the left arm. Concomitant medications were HALOPERIDOL (HALDOL), COLECALCIFEROL (DIVISUN), BEHEPAN [CYANOCOBALAMIN], FOLIC ACID (FOLSYRE NAF), ZOPICLONE (ZOPIKLON MYLAN). Relevant medical history included malnourished, frail, with facioscapulohumeral muscular dystrophy, reduced level of function that has escalated in the last 2 weeks, visual and auditory hallucinations over the last six months. No signs of acute infection, normal CRP. Not known heart disease from the past. On 01Feb2021 the patient experienced Cardiogenic shock and Heart attack. The clinical course was reported as following; No side effects were reported after vaccination. On day four after vaccination, acute retrosternal chest pain, diagnosed with acute heart attack (stenoses in LAD, CX and RCA), heart failure with pulmonary edema and ejection fraction 30 - 35%. Exacerbation of the condition, the patient died the same day. Sender Comment: Background: Abnormal ECG as in myocardial infarction, angiography showed stenoses in LAD, CX and RCA. Echocardiography with signs of constipation and pleural fluid, transthoracic echocardiography showed very small left ventricle with almost akinetic septum / anterior wall. EF 30 - 35%. nt-PRObnp 5200. Comment: The reporter states that in principle there is no suspected causal connection between the vaccine and the acute myocardial infarction and triple disease, but that it is reported as a routine due to death, and since the patient had received the covid-19 vaccine. Based on what we know about side effects of the vaccine at present, we also consider it more likely that the underlying disease / risk factors for cardiovascular disease are the cause of the current event. Due to a temporal connection between vaccination and incident, one can nevertheless, purely categorically, assess the causal connection 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. When vaccinating marginal patients with underlying diseases and risk factors for disease, some serious events, including acute disease deaths, may occur relatively soon after vaccination, unrelated to vaccination. No follow-up attempts possible. No further information expected; Sender''s Comments: Based on the information available the reported events are considered not related to suspect drug BNT162B2 COMIRNATY.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1037669 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Epileptic seizure (verbal restlessness, He is "gone" for 5-10 minutes (rolles eyes).)
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Cognitive impairment; Hypertension; Living in nursing home; TIA; Wheelchair user
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021150321

Write-up: pneumonia (unrest, gradually decreased appetite, lethargy, tachypnoea, fever); This is a spontaneous report from contactable physician downloaded from the Medicines Agency (MA) -WEB NO-NOMAADVRE-FHI-2021-Unypd, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014606. A 91-year-old male patient received BNT162B2 (COMIRNATY, lot number: EJ6795), intramuscular on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included episode with an epileptic-like seizure and verbal restlessness on 12Jan2021, wheelchair user, cognitive impairment, transient ischaemic attack (TIA), living in nursing home, angina pectoris and hypertension, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced pneumonia (unrest, gradually decreased appetite, lethargy, tachypnoea, fever) on 14Jan2021 with fatal outcome. The patient died on 24Jan2021. Reporter stated that it was not certain that the vaccine has led to pneumonia. It was not reported if an autopsy was performed. No COVID-19 test performed (No covid-19 positive tests in the nursing home). Sender''s comment: A 91-year-old multimorbid man with clinical symptoms of pneumonia, such as agitation and rales, eight days after vaccination with COVID-19 vaccine (COMINARTY). Eventually, decreased appetite, lethargy, typhoid fever and fever developed. He dies 10 days after the first symptoms of pneumonia, ie 18 days after vaccination. Reporter indicates that it is not certain that the vaccine led to pneumonia. Prior to that, the patient was frail with significant cognitive impairment, and a wheelchair user. Pneumonia is not a known side effect of the vaccine. None of the vaccine components are live and therefore the vaccine cannot cause covid-19 infection. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio and cerebrovascular disease accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (about 20%), respiratory and infectious diseases (including pneumonia and sepsis) (about 15%) and cancer (about 10%). When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the 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 some other random, incidental cause that has nothing to do with the vaccination in question. On the basis of the information in the notification and in accordance with international criteria, the causal connection with the 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 possible. No further information expected.; Reported Cause(s) of Death: pneumonia


VAERS ID: 1037672 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Food refusal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIGRAN FORTE; EMCONCOR CHF; SOMAC; XALATAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aphasia; Apraxia; Cerebral bleeding (with aphasia, apraxia and rapidly developing dementia.); Dementia Alzheimer''s type (Known, mixed dementia (vascular and Alzheimer''s)); Living in nursing home (For five years); Markedly reduced food intake (small change from end Dec2020, with episodes with vomiting and reduced food intake after that); Vascular dementia (Known, mixed dementia (vascular and Alzheimer''s)); Vomiting (small change from end Dec2020, with episodes with vomiting and reduced food intake after that)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021146121

Write-up: food refusal. did not eat.; This is a spontaneous report from a contactable physician from the Medicines Agency (MA) WEB NO-NOMAADVRE-FHI-2021-Uy79w with additional case identifier NO-NOMAADVRE-E2B_00014509. An 84-year-old female patient received bnt162b2 (COMIRNATY, lot number: EJ6795), intramuscular on 06Jan2021 at a single dose (at 84-years-old) for COVID-19 immunisation. Product notes included "J07BX - Other virus vaccines". Medical history included living in nursing home: for five years; vascular dementia and dementia alzheimer''s type: Known, mixed dementia (vascular and Alzheimer''s), cerebral bleeding from 2015: with aphasia, apraxia and rapidly developing dementia. Concomitant medication included calcium carbonate, colecalciferol (CALCIGRAN FORTE) (A12AX - Calcium, combinations with vitamin D and/or other agents) from an unspecified date to 13Jan2021 for osteoporosis, bisoprolol fumarate (EMCONCOR CHF) (C07AB07 - Bisoprolol) from an unspecified date to 13Jan2021 for hypertension, pantoprazole sodium sesquihydrate (SOMAC) (A02BC02 - Pantoprazol) from an unspecified date to 13Jan2021 and latanoprost (XALATAN) (S01EE01 - Latanoprost) from an unspecified date to 13Jan2021 for glaucoma. On 05Jan2021 (as reported), the patient had food refusal. Did not eat. The event was described as follows: An 84 year old female with food refusal (did not eat) from the day before vaccination with covid-19 vaccine (Comirnaty), and the food refusal continued after the vaccination. She died eight days after the vaccination. The death was expected due to her underlying diseases, like dementia. Reported as a possible side effect due to short time from vaccine to death and since it cannot be ruled out that a side effect of the vaccine has contributed to the food refusal. Additional information: Clinical frailty scale 7 and completely in need of care, but stable health condition. A small change from end Dec2020, with episodes with vomiting and reduced food intake after that. The patient died on 14Jan2021. It was not reported if an autopsy was performed. Sender Comment: An 84-year-old woman with nutritional refusal (did not eat) from the day before vaccination with covid-19 vaccine (Comirnaty). The refusal to eat continued after the vaccination, and she died eight days after the vaccination. Deaths are assessed as expected on the basis of basic illness. Reported as a possible side effect due to the short time from vaccine to death, and since it cannot be ruled out that a side effect of the vaccine has contributed to the refusal to eat. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. 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 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. The causality for the event food refusal per the regional pharmacovigilance center was possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: food refusal


VAERS ID: 1037673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDNISOLONE
Current Illness: End stage COPD; Frailty (Clinical Frailty Scale 6-7); Living in nursing home; Multimorbidity; Osteoporosis; Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021146126

Write-up: Pneumonia; Reduced general condition/declining general condition; Felt unwell; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB NO-NOMAADVRE-FHI-2021-Uzr1q, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014627. A 75-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EM0477), intramuscular in right arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included living in nursing home, multimorbidity, end stage copd, osteoporosis, rheumatoid arthritis, frailty with clinical scale 6-7; all ongoing. Concomitant medication included prednisolone. The patient previously took forsteo for osteoporosis. On 15Jan2021, the patient developed reduce general condition and pneumonia and reported as cause of patient''s death. Felt unwell within 48 hours of first dose of Comirnaty vaccination in Jan2021. Admitted 19Jan2021, initially BIPAP, treated for pneumonia with biochemical response. Moved from surveillance, but gradually declining general condition. The patient''s outcome was fatal, at the time of the report. The outcome of the event felt unwell was unknown. The case was considered to be serious. The patient died on 28Jan2021. It was not reported if an autopsy was performed. The assessment of relatedness for prednisolone: possible for both events/Regional Pharmacovigilance Center and assessment of relatedness for Comirnaty: possible for both events. Reporter''s comment: A multimorbid patient at care center, known COPD gold 4, osteoporosis, RA. Clinical Frailty Scale 6-7 which does not contraindicate vaccination against COVID-19 (limit 8). Felt unwell within 48 hours of first dose of Comirnaty vaccination. Admitted 19Jan2021, initially BIPAP, treated for pneumonia with biochemical response. Moved from surveillance, but gradually declining general condition. Terminal course from 27/01/13/Jan/2021:13:002021. Died 28Jan2021 at 01:35. ADDITIONAL INFORMATION ON DRUG PROVIDED IN PRODUCT NOTES: J07BX - Other virus vaccines Reporter''s comment: 05Feb2021 RELIS: requested additional information. This is a preliminary report. Sender''s Comments: Since the report describes a suspected side effect that is serious, we would like to receive a copy of the epicrisis from the hospital. This is important in order to be able to assess the event as best as possible. Our assessment is thus based on information available in the report, and we have so far assessed the causal link as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. It is stated in the report that the patient had underlying diseases before vaccination. Based on the event description in the report, it is more likely that these diseases are behind the event. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. It is also conceivable that the event had a completely different cause that only happened by chance after the vaccination. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts possible. No further information expected.; Reporter''s Comments: A multimorbid patient at care center, known COPD gold 4, osteoporosis, RA. Clinical Frailty Scale 6-7 which does not contraindicate vaccination against COVID-19 (limit 8). Felt unwell within 48 hours of first dose of Comirnaty vaccination. Admitted 19Jan2021, initially BIPAP, treated for pneumonia with biochemical response. Moved from surveillance, but gradually declining general condition. Terminal course from 27/01/13/Jan/2021:13:002021. Died 28Jan2021 at 01:35.; Reported Cause(s) of Death: Reduced general condition/declining general condition; pneumonia


VAERS ID: 1037676 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021146139

Write-up: Sudden cardiac arrest in the mechanism PEA; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB PL-URPL-3-113-2021. This is a report received from the Regulatory Authority. The application PL-URPL-3-113-2021 was sent to URPL on 03Feb2021. An 82-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EK9788 and expiry date May2021), intramuscular on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. A description of the reaction was included on the pre-report of a post-vaccination adverse reaction. The patient developed a sudden cardiac arrest by PEA (pulseless electrical activity) approximately 20 minutes after receiving the vaccine. Cardiopulmonary resuscitation was started, ALS (advanced life support) was applied - the patient was intubated, 3 ampoules of adrenaline were administered. After carrying out rescue operations, the patient was taken over by an ambulance. The patient was reanimated, he was taken to the hospital. Admitted to the intensive care unit (ICU) at 12:20. Disconnected from resuscitation device due to failure to resume heart beat. Death was confirmed at 12:50. The patient was treated with cardiology and undergoing chronic lung disease. The data contained in the electronic report is all at the disposal of URPL - in the case of obtaining additional information, another version will be sent. The patient died on an unspecified date due to sudden cardiac arrest by PEA (pulseless electrical activity). It was not reported if an autopsy was performed. Sender Comment: Sudden cardiac arrest by pulseless electrical activity is an unexpected side effect for the vaccine. It cannot be ruled out that it occurred as a result of an anaphylactic shock. The report concerns an elderly patient under cardiac treatment and for chronic lung disease.The EVDAS database has so far reported 68 sudden death cases after vaccination Comirnaty and 27 circulatory collapse cases. There is a time relationship between vaccination and the occurrence of side effects. The person reporting the adverse reaction after vaccination classified it as severe. The URPL rated the adverse reaction after vaccination as severe. Relatedness of drug to reaction(s)/event(s) by NCA (Method of assessment : WHO-UMC) : Possible No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac arrest in the mechanism PEA


VAERS ID: 1037704 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: ROPFIZER INC2021146528

Write-up: death; This is a spontaneous report from a contactable physician. A 55-year-old female patient received the second dose of bnt162b2 (COMIRNATY) lot number and expiration date not reported, via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were reported as psychotropic substances. The patient experienced death in Feb2021. Death occurred approximately one week after administration of Dose 2 of Comirnaty. The event took place a week ago at the time of reporting. The cause of death is unknown and the forensic report is awaited. According to the physician, they don''t suspect a connection between death and the Comirnaty vaccine and they take into consideration a potential toxicological cause.The It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot number and expiration date cannot be obtained. No further information is expected.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The unknown cause of death is assessed as related to suspect vaccine BNT162B2 per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history, concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1037709 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021151703

Write-up: Death; This is a spontaneous report from a contactable nurse downloaded from the Agency Regulatory Authority-WEB SE-MPA-2021-002445. Other case identifier number SE-MPA-1612334621639. A 72-year-old female patient received BNT162B2 (COMIRNATY, lot number: EJ6795), intramuscular in Jan2021 at 0.3 mL single dose for COVID-19 immunization. The patient medical history included Alzheimer''s disease from an unknown date to an unknown date. The patient''s concomitant medications were not reported. The occurred in death in Jan2021, cause of death was unclear but believed to be airway obstruction, it looked as if she had something in her throat, no cough, was very calm throughout the process, a small piece of meatball came up, in the mean time she had difficulty breathing. Attempts to make mouth to mouth was made, but it was not easy. Cardiopulmonary resuscitation was not continued on the basis that a decision has been made about zero-CPR. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Airways obstruction


VAERS ID: 1037712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BATCH NUMBER HA / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dizziness, Dyspnoea, Restless legs syndrome
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENTOCORT; KALCIPOS; ALENDRONIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Celiac disease; Crohn''s
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021151996

Write-up: Death; restless legs; dizziness; heavy breathing; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB. Regulatory Authority number SE-MPA-2021-002736, other case identifier number SE-MPA-1612183759070. A 66-year-old female patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on unknown date in Jan2021 as a single dose (1 DF) for covid-19 immunisation, lot number: unknown (batch number has been requested, as reported). Medical history included Celiac disease and Crohn''s, both unknown if ongoing. Concomitant medications included budesonide (ENTOCORT), calcium carbonate (KALCIPOS) and alendronic acid. On unknown date in Jan2021 patient experienced Death, restless legs, dizziness and heavy breathing. All events assessed serious due to death. It was reported that patient developed restless legs, dizziness and heavy breathing, two days after dose 2 of Comirnaty. Ambulance was called but the patient died before she was admitted to hospital. Autopsy is planned. The Medical Products Agency will request for autopsy report. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Death; restless legs; dizziness; heavy breathing


VAERS ID: 1037891 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anuria, Asthenia, Fatigue, Muscular weakness, Oxygen saturation, Respiratory tract infection, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVODOPA/CARBIDOPA; CLOZAPINE; DOMPERIDONE; FOLIUMZUUR; MIRABEGRON
Current Illness: Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: saturation; Result Unstructured Data: normal level; Test Date: 20210129; Test Name: saturation; Test Result: 90 %; Test Date: 20210131; Test Name: saturation; Test Result: 80 %; Test Date: 20210129; Test Name: corona culture; Test Result: Negative
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Fatigue; Asthenia; Muscle weakness lower limb; Respiratory tract infection; Anuria; A regulatory authority report was received from a healthcare professional concerning an 89-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced respiratory tract infection, anuria, muscle weakness lower limb, asthenia, and fatigue. The patient''s medical history included Parkinson''s disease. Concomitant medications included carbidopa 50/12.5 mg, clozapine, carbidopa 100/25 mg, domperidone, folic acid, and mirabegron. On 25 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273, for the prophylaxis of COVID-19 infection. On 28 Jan 2021, reported as four days after the vaccine, the patient experienced muscle weakness lower limb, asthenia, respiratory tract infection, and anuria. Diagnostic lab test revealed the patient''s O2 saturation rate was normal level. On 29 Jan 2021, the patient experienced fatigue. Additional diagnostic lab tests revealed the patient''s O2 saturation was 90 percent. The patient tested negative for SARS-COV-2 test. On 31 January 2021, diagnostic lab test revealed the patient''s O2 saturation was 80 percent. The patient died on 31 Jan 2021. The cause of death was reported as fatigue, respiratory tract infection and anuria. Plans for an autopsy were unknown. Action taken with second dose of mRNA-1273 in response to the events was not applicable.; Reporter''s Comments: This case concerns a 89-year-old male with medical history of Parkinson''s, who experienced serious unexpected fatal events of respiratory tract infection, fatigue, and anuria, and nonserious unexpected events of asthenia and muscular weakness. Events began 4 days after first dose mRNA-1273. SARS-COV-2 test negative. Treatment unknown. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1038914 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary sepsis
SMQs:, Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal insufficiency; Dementia Alzheimer''s type; Glaucoma; Hay fever; Hyperthyroidism; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021151552

Write-up: Pulmonary sepsis; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB with Regulatory authority report number [DE-PEI-PEI2021002384]. An 86 years old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, batch/lot number: EJ6796), intramuscularly on 27Dec2020 at single dose for covid-19 immunization. Medical history included Dementia Alzheimer''s type, Chronic renal insufficiency, Hyperthyroidism, Hay fever, Type II diabetes mellitus, Glaucoma, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced Pulmonary sepsis on an unspecified date after vaccination, reported as serious with serious criteria death. Death cause was reported as Pulmonary sepsis. The patient died on 06Jan2021. An autopsy was not performed. The outcome of event pulmonary sepsis was fatal. Relatedness of drug to reaction(s)/event(s) assessed as Inconsistent causal association by Regulatory Authority. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary sepsis


VAERS ID: 1038915 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2020-12-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Fracture multiple; Hypertension arterial; Myocardial infarction; Osteomyelitis; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021151550

Write-up: COVID-19 infection; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB. This is a report received from the regulatory authority. The regulatory authority report number is DE-PEI-PEI2021002389. A 93-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EJ6796), intramuscularly on 27Dec2020 at 93-years-old at a single dose for COVID-19 immunization. The patient''s medical history included fracture multiple from an unknown date and unknown if ongoing, osteomyelitis from an unknown date and unknown if ongoing, myocardial infarction from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing, Parkinson''s disease from an unknown date and unknown if ongoing, hypertension arterial from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 31Dec2020, the patient experienced COVID-19 infection; which resulted in death. The patient developed COVID-19 five days (as reported) after the vaccination, lasting for 7 days. The clinical outcome of the event, COVID-19 infection, was fatal. The patient died on 06Jan2021 due to COVID-19 respiratory infection. An autopsy was not performed. The causality assessment between the suspect vaccine and the event, COVID-19 infection, was assessed as inconsistent causal association by the regulatory authority. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1038920 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Asthenia, Blood pressure measurement, Coma scale, Depressed level of consciousness, Echocardiogram, Electrocardiogram, Fatigue, Heart rate, Malaise, Oxygen saturation, Respiratory rate, Respiratory rate decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), 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), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: Multimorbidity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Blood pressure; Result Unstructured Data: Test Result:116/72; Test Date: 202101; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:4; Test Date: 202101; Test Name: Echocardiography; Result Unstructured Data: Test Result:Bedside; Test Date: 20210116; Test Name: EKG; Result Unstructured Data: Test Result:Possible Non STEMI with increased coronary marker.; Test Date: 202101; Test Name: Pulse rate; Result Unstructured Data: Test Result:72; Test Date: 202101; Test Name: Oxygen saturation; Test Result: 99 %; Test Date: 202101; Test Name: Respiratory rate; Result Unstructured Data: Test Result:35-40.; Comments: fast, Unit not specified
CDC Split Type: DKPFIZER INC2021141219

Write-up: Non STEMI; Consciousness decreased. Increasingly unreachable according to wife. Homecare also finds the patient unreachable; Weakened. Has hardly been able to eat; Tiredness; Exposed respiration according to physicians; Difficult to assess, fragile 91 year old increasingly unwell after vaccination according to relative. Gotten worse since summer according to wife.; This is a spontaneous report downloaded from the Medicines Agency (MA) -WEB DK-DKMA-WBS-0029175. The case was received from a contactable physician via The Medicines Agency (MA). A 91-years-old male patient received the first dose of BNT162B2 (COMIRNATY) (Batch number: EJ6134, expiration date: 30Apr2021) intramuscular on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing multimorbidity. The patient''s concomitant medications were not reported. On 15Jan2021 the patient developed Consciousness decreased, Respiration rate decreased, Tiredness, Unwell and Weakness. The reporter describes the occurrence of consciousness decreased. Increasingly unreachable according to wife. Homecare also finds the patient unreachable. Respiration rate decreased (Exposed respiration according to physicians), Tiredness, Unwell (Difficult to assess, fragile 91 year old increasingly unwell after vaccination according to relative. Gotten worse since summer according to wife.) and Weakness (Weakened. Has hardly been able to eat according to wife). The patient was treated with isotonic saline, Adrenalin (EPINEPHRINE), Lanexat FLUMAZENIL and Narcanti (NALOXONE) and hospitalised after an ambulance was called. The ADR consciousness decreased, respiration rate decreased, tiredness, unwell and weakness was not recovered. The patient died 16Jan2021. Reported cause of death: Non STEMI. Test results coma scale on Jan2021: 4. Oxygen saturation on Jan2021: 99%. Respiratory rate on Jan2021: 35-40, fast, unit not specified. Blood pressure on Jan2021: 116/72, Unit not specified. Pulse rate on Jan2021: 72. EKG on 16Jan2021: Possible Non STEMI with increased coronary marker. Echocardiography on Jan2021: Bedside. Causality reported as that the reporter was certain that the ADRs are not causes of death. The ADRs were by the Medicines Agency assessed medically significant due to Depressed level of consciousness being on the IME list and the patient was treated with intravenous isotonic saline, Adrenalin (EPINEPHRINE), Lanexat FLUMAZENIL and Narcanti (NALOXONE).; Reported Cause(s) of Death: Non STEMI


VAERS ID: 1038940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2021-01-11
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J6796 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Body temperature, COVID-19 pneumonia, Chest X-ray, Drug ineffective, Oxygen saturation, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ORFIDAL; AZILECT; MOLAXOLE; RISPERIDONE; SECALIP SUPRA; SINEMET DEPOT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment (advanced); COVID-19; Dyslipidemia; Hypertension (HTA); Parkinson''s disease; Type 2 diabetes mellitus (Type II diabetes)
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: Blood cultures; Test Result: Negative ; Test Date: 20210112; Test Name: low-grade fever; Result Unstructured Data: Test Result:37.5 Centigrade; Test Date: 20210114; Test Name: chest X-Ray; Result Unstructured Data: Test Result:alveolar opacities; Comments: Bilateral interstitial alveolar opacities predominantly peripherally in the middle-upper third of both fields pulmonary; Test Date: 20210118; Test Name: chest X-Ray; Result Unstructured Data: Test Result:stability of the alveolar opacities; Comments: Compared with the 14Jan, stability of the bilateral interstitial alveolar opacities of peripheral predominance in the middle-upper third of both lung fields. No significant changes observed with respect to previous control 14Jan2021.; Test Date: 20210121; Test Name: chest X-Ray; Result Unstructured Data: Test Result:without changes; Comments: Without significant changes with respect to previous control from 18Jan; Test Date: 20210201; Test Name: chest X-Ray; Result Unstructured Data: Test Result:slight improvement; Comments: slight improvement of the right infiltrators; Test Date: 20210112; Test Name: desaturation; Result Unstructured Data: Test Result:up to 85 %; Test Date: 20210111; Test Name: SARS-CoV-2 antibody test; Test Result: Positive ; Comments: Detected total antibodies (IgG+ IgM); Test Date: 20210112; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210120; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210129; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ESPFIZER INC2021152095

Write-up: COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB ES-AEMPS-743325. A 92-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot# J6796) via intramuscular in right arm on 28Dec2020 at single dose for COVID-19 vaccination. Medical history included type 2 diabetes mellitus, hypertension arterial, COVID-19 in May2020, dyslipidaemia, Parkinson''s disease, advanced cognitive impairment. Functional situation was dependent for basic activities of daily living. She walked with the help of device and supervision. Concomitant medication included lorazepam (ORFIDAL), rasagiline mesylate (AZILECT), macrogol 3350/potassium chloride/sodium bicarbonate/sodium chloride (MOLAXOLE), risperidone (RISPERIDONE), fenofibrate (SECALIP SUPRA), carbidopa/levodopa (SINEMET DEPOT). After 14 days of the administration of the first dose of vaccine on 11Jan2021 the patient started experiencing desaturation and for this reason rapid antigen testing for coronavirus was performed and realized with positive result. The patient went to the emergency room on 12Jan2021 derived from residence due to episode of desaturation of up to 85% the same morning together with a low-grade fever 37.5?C that started on 11Jan2021. She was referred to the hospital where they diagnosed bilateral pneumonia due to COVID with PCR+. PCR for SARS-CoV-2 in pharyngeal exudate 12Jan2021 was detection positive. Chest X-Ray 14Jan2021 showed that bilateral interstitial alveopacities of peripheral predominance in the middle-upper third of both lung fields, suggestive of process infectious disease of probable viral nature in current epidemiological context. Probable cardiomegaly. Pleural calcification based on left lung. Blood cultures 14Jan2021 was negatives. Chest X-Ray 18Jan2021 showed compared with the 14Jan2021, stability of the bilateral interstitial alveolar opacities of peripheral predominance in the middle-upper third of both lung fields. No significant changes observed with respect to previous control 14Jan2021. PCR SARS-CoV-2 20Jan2021 was positive. Chest X-ray 21Jan2021showed without significant changes with respect to previous control from 18Jan2021. Pharyngeal exudate Coronavirus PCR SARS-CoV-2 29Jan2021 was positive, detection by RT-PCR technique; Chest X-Ray 01Feb2021 showed slight improvement of the right infiltrators. Serological study SARS-COV-2, Total Ab (IgG/IgM) SARS COV-2 Positive, IgG SARS COV-2 Positive, IgM SARS COV-2 Positive, SARS COV-2 coronavirus serology comment was Detected total antibodies (IgG+ IgM). Conclusion was bilateral interstitial alveolate infiltrates compatible with infectious process of a viral nature by COVID 19. The patient received antibiotic treatment, dexamethasone and enoxaparin with good clinical evolution. After stabilization, she presents very low intakes. Nasogastric tube was not placed and oral intake is still attempted, even if it was scarce. After stabilization they decided to discharge her to the residence with IgG+ and PCR+ and without other specification presents IgG COVID positive. Since her arrival there was worsening of her baseline situation with refusal to ingestion, dyspnea, desaturation, agitation, tachycardia and retraction; finally the patient passed away on 08Feb2021. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 pneumonia


VAERS ID: 1038951 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-24
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Blood creatinine, Blood culture, Blood urea, Body temperature, Electrocardiogram, Haemoglobin, Livedo reticularis, Lymphocyte count, Malaise, Muscle rigidity, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Oxygen saturation, Physical examination, Platelet count, Red blood cell count, SARS-CoV-2 test, Septic shock, Skin discolouration, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Toxic-septic shock conditions (narrow), Parkinson-like events (narrow), Hypotonic-hyporesponsive episode (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: Medical History/Concurrent Conditions: Bladder catheter permanent (carrying an indwelling urinary catheter with history of urinary tract infections); Disease Parkinson''s; Hypoacusis; Hypothyroidism; Transient ischemic attack; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Name: Cytobacteriological examination of the urine; Result Unstructured Data: Test Result:leukocyturia between 100,000 and 1,000,000 cells /; Comments: leukocyturia between 100,000 and 1,000,000 cells / mm3; Test Name: Serum creatinine; Result Unstructured Data: Test Result:181 umol/l; Test Date: 20201204; Test Name: Serum creatinine; Result Unstructured Data: Test Result:101 umol/l; Test Name: blood cultures; Test Result: Negative ; Test Name: Urea; Result Unstructured Data: Test Result:11.5 mmol/L; Test Date: 20210124; Test Name: temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Name: ECG; Result Unstructured Data: Test Result:tachycardia, bundle branch block; Test Date: 20210124; Test Name: Hb; Result Unstructured Data: Test Result:14.9 g/dl; Test Date: 20210124; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.5 x10 9/l; Test Date: 20210124; Test Name: polynuclear neutrophils; Result Unstructured Data: Test Result:6.72 x10 9/l; Test Name: NTProBNP; Result Unstructured Data: Test Result:1170 ng/L; Test Date: 20210124; Test Name: saturation; Test Result: 91 %; Comments: no dyspnea; Test Date: 20210124; Test Name: PHYSICAL EXAMINATION; Result Unstructured Data: Test Result:Scanty concentrated urine, foul-smelling purulent; Comments: Scanty concentrated urine, foul-smelling purulent discharge from the penis No pulmonary focus, flexible non-painful abdomen No deficit sign Soft calves T ? 38.1 ? C; Test Date: 20210124; Test Name: platelets; Result Unstructured Data: Test Result:248 x10 9/l; Test Name: Red blood cells; Result Unstructured Data: Test Result:between 100,000 and 1,000,000 cells / mm3; Test Date: 202012; Test Name: Covid-19 test; Test Result: Negative ; Comments: negative several times in December 2020; Test Date: 20210125; Test Name: Covid-19 test; Test Result: Negative ; Test Date: 20210124; Test Name: White globules; Result Unstructured Data: Test Result:7.5 x10 9/l
CDC Split Type: FRPFIZER INC2021151653

Write-up: Septic shock; malaise; hyper rigidity; marbling; marbling; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-AN20210225. A 72-year-old male patient received bnt162b2 (COMIRNATY, Lot number: EJ6795), intramuscularly on left arm on 06Jan2021 at single dose for COVID-19 vaccination. Medical history included hypoacusis, bladder catheter permanent (carrying an indwelling urinary catheter with history of urinary tract infections), end-stage parkinson''s disease, hypothyroidism and transient ischaemic attack. The patient was reported as a person at risk of developing a severe form of COVID-19 disease. The patient''s concomitant medications were not reported. The patient was not previously diagnosed Covid-19. The patient experienced septic shock on 24Jan2021 serious criteria reported as death; malaise on 24Jan2021, 24Jan2021 malaise with hyper rigidity, marbling, grayish complexion, seriousness reported as non-serious. The patient underwent Covid-19 test: PCR: negative several times in Dec2020. Physical examination on 24Jan2021, no dyspnea saturation 91% in AA, Scanty concentrated urine, foul-smelling purulent discharge from the penis. No pulmonary focus, flexible non-painful abdomen. No deficit sign; Soft calves T ? 38.1 ? C. Additional tests on unknown date: ECG (Electrocardiogram): tachycardia, bundle branch block, PCR covid negative on 25Jan2021. Biology on 24Jan2021: White globules 7.5 G / L, polynuclear neutrophils 6.72 G / L, lymphocytes 0.5 G / l; platelets 248 G / L, Hb (Haemoglobin) 14.9 g / dl. On unknown date, negative blood cultures. Cytobacteriological examination of the urine leukocyturia between 100,000 and 1,000,000 cells / mm3, Red blood cells between 100,000 and 1,000,000 cells / mm3. More than 2 germs found in quantities greater than 105 / ml. Serum creatinine 181 ?mol / l on unknown date against 101 on 04Dec2020. Urea 11.5 mmol / l, NTProBNP (N-terminal prohormone brain natriuretic peptide) 1170 ng/l on unknown date. Treatment and evolution: Antibiotic therapy, Comfortable care in view of the patient''s comorbidities. Comatose and congested patient on 25Jan2021, death on 30Jan2021. CONCLUSION: Shock of probably infectious origin in a patient who had been vaccinated by comirnaty 18 days earlier. SUMMARY septic shock in a man vaccinated against covid-19 18 days ago. The patient died on 30Jan2021 due to septic shock. The outcome of rest events was unknown. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Septic shock


VAERS ID: 1038962 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-02-04
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood thyroid stimulating hormone, Electromyogram, Headache, 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: 2021-02-05
   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: INEXIUM [ESOMEPRAZOLE MAGNESIUM]; LYSANXIA; APRANAX [NAPROXEN]; VOLTARENE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Arthralgia
Allergies:
Diagnostic Lab Data: Test Name: TSH; Result Unstructured Data: Test Result:normal; Test Name: EMG; Result Unstructured Data: Test Result:rejected suspicion of carpal tunnel syndrome; Test Date: 202101; Test Name: biological assessment; Result Unstructured Data: Test Result:normal; Test Date: 20210203; Test Name: COVID-19 test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021150323

Write-up: Sudden death; Occipital headache; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-LM20210121 This is a report received from the Regulatory Authority. A 52-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot# EJ6795) via intramuscular in right deltoid on 04Feb2021 at single dose for COVID-19 vaccination, naproxen (APRANAX) orally from 25Jan2021 at 550 mg twice a day (Freq:1 min) 1 tablet in the morning and evening for arthralgia, diclofenac sodium (VOLTARENE) cutaneous from 25Jan2021 at unknown dose for arthralgia. Medical history included anxiodepressive syndrome and arthralgia of both wrists. No other notable history. She was a caregiver working in care home. Concomitant medication included esomeprazole magnesium (INEXIUM) and prazepam (LYSANXIA). The patient had normal biological assessment in early Jan2021, following the onset of menopause, assessment TSH was also normal. On sick leave for 15 days for arthralgia of both wrists, usually relieved with splints, suspicion of carpal tunnel syndrome by the attending physician, which was explored and rejected (EMG negative). An infiltration was scheduled for 15Feb2021. Pre-vaccination consultation included diffuse painful complaint, intermittent headache, not worrying. The patient took COVID test on 03Feb2021. Anticovid vaccination on 04Feb2021 (also reported as 03Feb2021, pending clarification) with no effect to report after the injection. The patient had occipital headache complaint in the evening of 04Feb2021. She had sex the same evening. She suddenly died at home on 05Feb2021 at 3:00 a.m. Intervention of the Emergency medical services but patient with asystole. Scientific autopsy was to be performed on 05Feb2021 and no autopsy results was available. The action taken in response to the events for naproxen and diclofenac sodium was unknown. The outcome of occipital headache was fatal (also reported as unknown, pending clarification).; Reported Cause(s) of Death: Occipital headache; Sudden death, cause unknown


VAERS ID: 1038989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aerococcus urinae infection, Body temperature, Death, Hyperthermia, Pyrexia, Urological examination, Urosepsis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral amyloid angiopathy; Hypertension arterial; NIDDM
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: body temperature; Result Unstructured Data: Test Result:38 degrees; Test Date: 20210128; Test Name: cytobacteriological examination of the urine; Result Unstructured Data: Test Result:positive for Aerococcus Urinae
CDC Split Type: FRPFIZER INC2021151099

Write-up: Death unexplained; Aerococcus Urinae in urine; Fever (38 degrees); hyperthermia; possible context of sepsis with urinary origin; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB (FR-AFSSAPS-RS20210133). A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6788), intramuscularly in the left arm, on 21Jan2021 at a single dose for SARS-CoV-2 vaccination. Medical history included hypertension arterial, non-insulin-dependent diabetes mellitus (NIDDM), and cerebral amyloid angiopathy. The patient was not previously diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient experienced fever (38 degrees) on 24Jan2021 and death unexplained on 30Jan2021, which were reported as fatal. The patient also experienced hyperthermia on 24Jan2021, Aerococcus Urinae in urine on 28Jan2021, and possible context of sepsis with urinary origin in Jan2021. The clinical course was reported as follows: The patient had an onset of fever (body temperature of 38 degrees on 24Jan2021) and hyperthermia. On 26Jan2021, there was alteration of the general condition and the patient therefore remained in bed. On 28Jan2021, the cytobacteriological examination of the urine collected was positive for Aerococcus Urinae; hence, the patient was treated with ceftriaxone sodium (ROCEPHIN). On 30Jan2021, the patient was found dead (as reported: it is concluded that she died in a possible context of sepsis with urinary origin). Therapeutic measures were taken as a result of fever (38 degrees), hyperthermia, Aerococcus Urinae in urine, and possible context of sepsis with urinary origin, which included unspecified antipyretics and ceftriaxone sodium as aforementioned. The patient died on 30Jan2021. The cause of death was assessed as possible context of sepsis with urinary origin (reported as death unexplained). It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: possible context of sepsis with urinary origin


VAERS ID: 1038993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Dehydration, Depressed level of consciousness, Diarrhoea, Dyspnoea, Erythema, Haematochezia, Respiratory distress, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   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: Atrial fibrillation; Behavior disorder; COVID-19; CVA (Sylvian left stroke and post stroke comitiality); Disorder personality; Hypertension; Non-insulin-dependent diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021151655

Write-up: Respiratory distress; Obtundation; Erythema; Emesis; Dehydration; mucous diarrhea appeared with traces of blood/diarrhea; mucous diarrhea appeared with traces of blood/diarrhea; Dyspnoea; disturbance of consciousness; This is a spontaneous report from a contactable Physician downloaded from the Medicines Agency (MA) -WEB with Regulatory authority report number FR-AFSSAPS-TO20210399. A 90-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EJ6788), intramuscularly on 26Jan2021 at single dose in right arm for COVID-19 vaccination. Medical history included COVID-19 from an unknown date and not ongoing; Cerebrovascular accident (CVA, Sylvian left stroke and post stroke comitiality) from an unknown date and unknown if ongoing, Hypertension from an unknown date and unknown if ongoing, Atrial fibrillation from an unknown date and unknown if ongoing; Non-insulin-dependent diabetes mellitus from an unknown date and unknown if ongoing; Behavioral and personality disorders from an unknown date and unknown if ongoing. The patient''s concomitant medication included anticoagulant for Atrial Fibrillation. The patient experienced respiratory distress, obtundation, erythema, emesis, dehydration, diarrhoea, all on 03Feb2021. On the morning of 03Feb2021, mucous diarrhea appeared with traces of blood. Then very profuse vomiting (several liters) and repeated very quickly evolving into dehydration. Then respiratory distress without hindrance. Dyspnoea and significant desaturation poorly compensated (72 percent to 80 percent) by O2 therapy at 8L/minute. Finally, disturbance of consciousness with opposition to treatment. Then death. After the death an erythema extended to the level of the upper right limb was noted. The patient died on 03Feb2021. 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: mucous diarrhea appeared with traces of blood; Dyspnoea; disturbance of consciousness; Respiratory distress; Obtundation; Erythema; Vomiting; Dehydration; Diarrhoea


VAERS ID: 1038995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-22
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Heart rate, Oxygen saturation, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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: ALPRAZOLAM; METFORMIN; MACROGOL; ZOPICLONE; MIRTAZAPINE; HALDOL; PARACETAMOL; NORMACOL [CALENDULA OFFICINALIS;RHAMNUS FRANGULA]; EXACYL; LANSOPRAZOLE; TERCIAN [CYAMEMAZINE TARTRATE]
Current Illness: Alzheimer''s disease (marked cognitive disorders/which are increasing; cognitive deterioration.); Anxiety depression
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (without treatment (date unspecified).); Constipation
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: blood pressure; Result Unstructured Data: Test Result:13/5 mmHg; Test Date: 20210114; Test Name: heart rate; Result Unstructured Data: Test Result:72/min; Test Date: 20210114; Test Name: oxygen saturation; Test Result: 94 %; Comments: in ambient air
CDC Split Type: FRPFIZER INC2021150318

Write-up: vomiting; Death unexplained; This is a spontaneous report from a contactable other health professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number is FR-AFSSAPS-TS20210173. A 92-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EM0477), intramuscular on 18Jan2021 at single dose (reported as "1 DF") for COVID-19 vaccination. Co-suspect medication included cyamemazine tartrate (TERCIAN), via an unspecified route of administration from 20Jan2021 at 25 mg, 2x/day (25 mg x 2 / d) for an unspecified indication. Medical history included constipation, ongoing long-standing anxiety-depressive background, marked cognitive disorders (Alzheimer''s disease). Cancer of the left breast, without treatment (date unspecified). Patient had been living in a geriatric long-stay ward since Mar2019. Patient with no history of swallowing disorders. Food composed of a chopped texture. For several weeks, cognitive disorders which are increasing, refusal of food more and more frequent in this context of cognitive deterioration. No cardiovascular or respiratory disorders. The patient''s concomitant medications included usual treatment with alprazolam, metformin, macrogol, zopiclone, mirtazapine, haloperidol (HALDOL) from an unspecified date to 20Jan2021 in the morning and replaced this on 20Jan2021 by cyamemazine tartrate (TERCIAN), paracetamol, calendula officinalis, rhamnus frangula (NORMACOL) if constipation, tranexamic acid (EXACYL) and lansoprazole. Pre-vaccination consultation on 14Jan2021, the patient underwent lab test included: BP "13/5" mmHg (as reported), heart rate 72 / min, oxygen saturation 94% in ambient air. First injection of BNT162B2 vaccine on 18Jan2021. Good tolerance. No modification the following days, in particular no digestive disorder. However, an anxious patient, modification of the treatment by replacing HALDOL by TERCIAN on 20Jan2021. On 22Jan2021, around 3 p.m., i.e. 2 hours after the end of the meal, the patient was found in her room in her marbled chair, deceased, with traces of vomiting on the floor of the room. Unclear if it was post-vomiting (reported as "post-vomiting?"). In total, unexplained death in a context of vomiting in an elderly patient, 4 days after a 1st injection of BNT162B2 vaccine and 2 days after the replacement of HALDOL by TERCIAN. The action taken in response to the event for cyamemazine tartrate was not applicable. The patient died on 22Jan2021 for unexplained death in a context of vomiting. An autopsy was not performed.; Reported Cause(s) of Death: vomiting; Death unexplained


VAERS ID: 1038996 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Death, Diarrhoea, Fatigue, General physical health deterioration, Heart rate, Hypotension, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: Blood stool (for several weeks (unsure if it was tumor)); Blood urine (for several weeks (unsure if it was tumor))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: BP; Result Unstructured Data: Test Result:90/50 mmHg; Comments: During the night: RAS, calls for a drink, constant measurements: BP at 120/90; Test Date: 20210125; Test Name: BP; Result Unstructured Data: Test Result:120/90 mmHg; Test Date: 20210125; Test Name: pulse rate; Result Unstructured Data: Test Result:74 /min; Test Date: 20210125; Test Name: oxygen saturation; Test Result: 94 %
CDC Split Type: FRPFIZER INC2021151652

Write-up: deterioration of the contemporary general state; Hypotension with blood pressure (BP) at 90/50 mm Hg; tired ++; increase in asthenia; episode of diarrhea; Death unexplained; This is a spontaneous report from a contactable other Health Professional downloaded from the Medicines Agency (MA) -WEB, regulatory authority number is FR-AFSSAPS-TS20210174. A 100-year-old female patient received BNT162B2 (COMIRNATY, lot number EM0477), via intramuscular on 19Jan2021 at single dose for Covid-19 vaccination. The patient medical history included resident in nursing home. The caregivers have observed blood in the stool and urine for several weeks (unsure if it was tumor (reported as "tumor?")). But no investigation carried out in agreement with the patient and the family due to the terrain and the absence of reported pain. The patient concomitant medications were not reported. No information on chronic treatment (no access to software after death). Alteration of general condition for several weeks, clinical condition deteriorating. The patient vaccinated on 19Jan2021 by BNT162B2 in the establishment. No particular event in the course. On 25Jan2021, (Day 6 of vaccination), the patient experienced increase in asthenia which had been present for several weeks, episode of diarrhea, wishes to remain lying down and did not go to the chair. Taking of constants: Hypotension with blood pressure (BP) at 90/50 mm Hg and saturation at 94 percent. During the night: RAS, calls for a drink, constant measurements: BP at 120/90 and pulse at 74/min. Review at 1:30 am: coherent remarks, says she was tired ++, no other symptomatology. On 26Jan2021, toilet in the morning: RAS. Discovery dead in her chair at 9 a.m. In total, death on Day 7 from the vaccine in a very old patient, with deterioration of the contemporary general state of digestive and urinary hemorrhagic manifestations evolving for several weeks. A priori, there is no argument allowing to question the role of the vaccine in this death. The outcome of the event hypotension was recovering; of the events tired ++, increase in asthenia, episode of diarrhea was unknown. The patient died on 26Jan2021 for unexplained death and reduced general condition. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained; Reduced general condition


VAERS ID: 1039006 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Ischaemic heart disease; Comments: Heart disease, diabetes Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021155260

Write-up: Multiple organ failure; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the RA. Regulatory authority report number GB-MHRA-APPCOVID-202102131221504710, Safety Report Unique Identifier GB-MHRA-ADR 24756997. A 76-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. Medical history included myocardial ischaemia, diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced multiple organ failure on 01Feb2021 with outcome of fatal. The patient underwent lab tests included covid-19 virus test: negative on 04Feb2021. The patient died on 06Feb2021. It was not reported if an autopsy was performed. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts possible; information regarding batch/lot cannot be obtained.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1039718 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, 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), Other ischaemic heart disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   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: Anaemia (treated with ferrous sulphate); Chest pain (awaiting diagnostic angiogram)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021152883

Write-up: Cardiac arrest; cardiac cause; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102111011108460, Safety Report Unique Identifier GB-MHRA-ADR 24740421. A 49-year-old female patient received the 1st does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot # unknown) at single dose on 06Feb2021 for covid-19 immunisation. Medical history included anaemia, chest pain awaiting diagnostic angiogram. Unsure if patient has had symptoms associated with COVID-19. Patient had not a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medication were unknown. The patient previously took ferrous sulphate (manufacturer unknown, tablets) for anaemia. The patient experienced cardiac arrest and cardiac cause on 06Feb2021. Therapeutic measures were taken as a result of events. The patient died on 06Feb2021. Outcome of events was fatal. It was not reported if an autopsy was performed. Course of events: Patient had COVID vaccine approximately 10-15 mins prior to presenting with cardiac arrest in the Emergency Department. She was brought in by her husband who noted she put her hands to her chest and grasped prior to collapse in the car after the vaccine. She was then brought round to A&E where cardiopulmonary resuscitation (CPR) was started. She was noted to be in PEA arrest and doses of adrenaline (1:10 000), with IV Fluids. Cardiac Arrest Team decided to thrombolyse her given possible cardiac cause given recent history. She was subsequently thrombolysed with tenecteplase. However she did not regain output and CPR was stopped approximately 70 mins after she presented. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1039720 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4176 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUMETHIAZIDE; CARMELLOSE; DOXYCYCLINE; EUMOVATE; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease stage 3; Dry eyes; Eczema; Glaucoma; Hypertension; Prostatism; Rosacea
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021155648

Write-up: Loose stools; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102121322200950, Safety Report Unique Identifier GB-MHRA-ADR 24749491. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. The relevant medical history included CKD (Chronic kidney disease) stage 3, hypertension, eczema, glaucoma, dry eyes, rosacea and prostatism, all from an unspecified date. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medications included bendroflumethiazide from 13Jan2011 for hypertension, carmellose from 20Nov2013 for dry eye, doxycycline from 10Jun2013 for rosacea, clobetasone butyrate (EUMOVATE) from 11Jul1991 for eczema, tamsulosin from 13Jun2018 for prostatism. The patient experienced loose stools on an unspecified date. The seriousness criteria was reported as death. The patient died on 12Feb2021. Case narrative: Patient found deceased at home address, loose stool around his person. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of the event was fatal. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: loose stools


VAERS ID: 1039724 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021155158

Write-up: Found dead; This is a spontaneous report from a contactable consumer. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102130938244340, Safety Report Unique Identifier GB-MHRA-ADR 24753885. A 33-year-old patient of an unspecified gender received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 10Feb2021 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient died (found dead) on 10Feb2021. It was not reported if an autopsy was performed. Patient had not tested positive for COVID-19 since having the vaccine. Serious criteria was reported as death, hospitalization, life threatening. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Found dead


VAERS ID: 1039833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Melaena
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARBASALAATCALCIUM; FUROSEMIDE; PANTOPRAZOL [PANTOPRAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis (recently diagnosed as severe and symptomatic with life expectancy between 0.5 - 1 year); Decompensation cardiac
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021158434

Write-up: Death; melaena; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB (NL-LRB-00439484). A 92-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 03Feb2021 at a single dose for COVID-19 immunisation. Medical history included decompensation cardiac and aortic valve stenosis (recently diagnosed as severe and symptomatic with life expectancy between 0.5 - 1 year). Concomitant medications included carbasalate calcium (CARBASALAATCALCIUM), furosemide (MANUFACTURER UNKNOWN), and pantoprazole (PANTOPRAZOL). The patient experienced melaena on 03Feb2021. The patient also experienced death on 05Feb2021, which was reported as fatal. The clinical course was reported as: The reporter described that the patient was recently diagnosed with a severe symptomatic aortic valve stenosis, with a life expectancy between 0.5 - 1 year. At time of vaccination, melaena was suspected. The patient deceased 44 hours after vaccination. The clinical outcome of melaena was unknown. The cause of death was reported as unknown. 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: Unknown cause of death


VAERS ID: 1039867 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: BUPRENORPHINE; MIDAZOLAM; HEMINEVRIN [CLOMETHIAZOLE EDISILATE]; ZOPICLONE; HIPREX [METHENAMINE HIPPURATE]; FURIX [FUROSEMIDE]; ROBINUL; MIRTAZAPINE; DUROFERON; HALDOL; MORPHINE; FOLIC ACID; MEMANTINE; METOPROLOL; ALVEDON; MINIDERM [GLYCEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Aortic valve insufficiency; Dementia; Hypertension; Late effects of cerebral stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021151995

Write-up: breathing difficulties; wheezy breathing; Death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-002698. Other case identifier number SE-MPA-1612445101419. A 77-year-old male patient received second dose of bnt162b2 (COMIRNATY, lot/batch number unknown), intramuscular in Feb2021 at 0.3 mL, single for covid-19 immunisation. Medical history included alzheimers disease, dementia, hypertension, aortic valve insufficiency, late effects of cerebral stroke. Patient received first dose of bnt162b2 (COMIRNATY) on 12Jan2021 for covid-19 immunisation. Concomitant medications were Alvedon, Duroferon, Furix, Haldol, Heminevrin, Hiprex, Miniderm, Robinul, acetylsalicylic acid, buprenorphine, folic acid, memantine, metoprolol, midazolam, mirtazapine, morphine, zopiclone. The reporter wrote "Patient had breathing difficulties with wheezy breathing...". The patient died within 24 hours after vaccination in Feb2021. Event reported as serious due to death. No autopsy performed. The outcome of events was fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death; breathing difficulties; wheezy breathing


VAERS ID: 1040506 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood culture, Blood culture positive, Cholecystitis, Pyrexia, Sepsis, Ultrasound abdomen
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Living in nursing home; Polyneuropathy; Prostatic cancer; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Blood culture; Result Unstructured Data: Positive for e.coli; Test Date: 20210120; Test Name: Ultrasound abdomen; Result Unstructured Data: Findings compatible with cholecystitis.
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: SEPSIS; cholecystitis; FEVER; Blood cultures positive for E. Coli; A regulatory authority report was received from a physician concerning a 95-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced sepsis and fever. The patient''s medical history, as provided by the reporter, included polyneuropathy, prostatic cancer, atrial fibrillation, urinary tract infection, and living in a nursing home. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for the prophylaxis of COVID-19 infection. On 20 Jan 2021, a blood culture showed positive for E. coli and an abdominal ultrasound showed findings compatible with cholecystitis. Action taken with mRNA-1273 was not applicable as the patient deceased. The patient died on 22 Jan 2021. The cause of death was reported as sepsis, fever, and cholecystitis. Plans for an autopsy were not provided.; Reporter''s Comments: This case concerns a 95-year-old male, who experienced a serious unexpected fatal events of sepsis and pyrexia, with blood culture positive for E. coli and ultrasound with cholecystitis. Events began the same day as the first dose of mRNA-1273. Autopsy not provided. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: sepsis; fever; cholecystitis


VAERS ID: 1042049 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Pneumonia, Respiratory failure, SARS-CoV-2 test
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), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: covid-19 virus test; Result Unstructured Data: Test Result:covid-19
CDC Split Type: DEPFIZER INC2021113667

Write-up: Respiratory failure; Pneumonia; covid-19; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-PEI2021001974. An 86-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 16Jan2021 at single dose for covid-19 immunization. Medical history included dementia, stroke, and atrial fibrillation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced covid-19 on 19Jan2021; the patient also experienced respiratory failure and pneumonia on an unspecified date, which were serious as they were life threatening, and lead to death. Details were as follows: covid-19 on 19Jan2021 was noted. Also reported unknown after vaccination, the patient developed respiratory failure and pneumonia, reported as lasting until 29Jan2021. The patient was dead and condition was reported as life threatening. Death cause was reported as respiratory failure and pneumonia. The patient died on 29Jan2021. It was not reported if an autopsy was performed. The patient under lab test include covid-19 virus test: covid-19 on 19Jan2021. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up. Follow-up (15Feb2021): This follow-up is being submitted to notify that the batch number is not available, follow-up activities not applicable, information about lot/batch number cannot be obtained. Further follow-up information will be provided automatically upon availability via MA.; Reported Cause(s) of Death: pneumonia; respiratory failure


VAERS ID: 1044939 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; BETAHISTINE; CITALOPRAM; SPIRONOLACTONE; ESCITALOPRAM; AMIODARONE; OMEPRAZOLE; VISTA CAL D
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (requiring anticoagulants)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021158450

Write-up: Sudden death without known cause on 24/01/2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (BE-FAMHP-DHH-N2021-76192). A 95-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6134), via an unspecified route of administration, on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (requiring anticoagulants). Concomitant medications included apixaban (ELIQUIS), betahistine (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), amiodarone (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), and calcium, colecalciferol (VISTA CAL D) taken as nutritional supplement. The patient experienced sudden death without known cause on 24/01/2021 (on 24Jan2021). It was reported that the patient was previously in good health. The patient died on 24Jan2021. The cause of death was reported as sudden death without known cause. It was not reported if an autopsy was performed. The causality assessment to the event was reported as unclassified by the Agency. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - Evolution of the ADR - Died Previously in good health, history of atrial fibrillation requiring anticoagulants; Reported Cause(s) of Death: Sudden death without known cause


VAERS ID: 1044940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EVISTA; SIPRALEXA; LIPITOR [ATORVASTATIN]; ASAFLOW; L-THYROXIN [LEVOTHYROXINE]; OMEPRAZOLE; MOVICOL NEUTRAL; DAFALGAN FORTE; TARDYFERON; BURINEX; LORMETAZEPAM; RAMIPRIL; BRILIQUE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain lesion; Dementia; Gamma nail fixation (the right hip after a fall on 29Dec2020); Non ST segment elevation myocardial infarction; STEMI
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021158453

Write-up: Cardiovascular problem; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB BE-FAMHP-DHH-N2021-76210. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 Vaccination. Medical history included non-STEMI, STEMI, a gamma nail on the right hip after a fall (the right hip after a fall on 29Dec2020), extensive vascular ischemic cerebral lesions and dementia. Concomitant medication included raloxifene hydrochloride (EVISTA), escitalopram oxalate (SIPRALEXA), atorvastatin (LIPITOR), acetylsalicylic acid (ASAFLOW), levothyroxine (L-THYROXIN) , omeprazole, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL NEUTRAL), paracetamol (DAFALGAN FORTE), ferrous sulfate (TARDYFERON), bumetanide (BURINEX), lormetazepam, ramipril and ticagrelor (BRILIQUE). The patient experienced cardiovascular problem (death) on 30Jan2021. The patient died of cardiovascular problem on 30Jan2021. It was not reported if an autopsy was performed. Comirnaty/ Sudden death/ Agency (WHO)/ unclassifiable. Reporter''s comments: Treatment - No. Evolution of the ADR - Died. Situations - Other: administration - no direct causation suspected at present. The patient received the first vaccination on 21Jan2021. On 30Jan2021, she was found dead in bed by the nursing staff of the rest home where she was staying during the week round. No complaints were registered between the administration of the vaccination and the date of death. No follow-up attempts possible. No further information expected, information about lot/batch number cannot be obtained.; Reporter''s Comments: Treatment - No. Evolution of the ADR - Died. Situations - Other: administration - no direct causation suspected at present. The patient received the first vaccination on 21Jan2021. On 30Jan2021, she was found dead in bed by the nursing staff of the rest home where she was staying during the week round. No complaints were registered between the administration of the vaccination and the date of death.; Reported Cause(s) of Death: Cardiovascular problem


VAERS ID: 1044950 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021160519

Write-up: Decompensation cardiac; Failure heart left; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021002453. A male patient of an unspecified age received bnt162b2 (COMIRNATY) batch no.: EL1491, subcutaneous on 04Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY) for covid-19 immunisation on 14Jan2021. On the same day after vaccination (04Feb2021) the patient developed Failure heart left and Decompensation cardiac, lasting for 3 day(s). The patient is dead. The patient died in Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Failure heart left; Decompensation cardiac


VAERS ID: 1044951 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-19
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal insufficiency; Dementia Alzheimer''s type; Eye prosthesis user
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021160520

Write-up: Acute respiratory failure; Covid-19 pneumonia; Covid-19 pneumonia; Superinfection bacterial; Aortic aneurysm; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is DE-PEI-PEI2021002456. A 77 years old male patient received the first dose of bnt162b2 (COMIRNATY, batch/Lot number: EM0477 and Expiration Date unknown) via an unspecified route of administration on 01Jan2021 at single dose for COVID-19 immunization.Medical history included Chronic renal insufficiency, Eye prosthesis user, Dementia Alzheimer''s type, all unknown if it was ongoing. Concomitant medication was not reported. On 19Jan2021 after vaccination the patient developed acute respiratory failure, COVID-19 pneumonia, superinfection bacterial, aortic aneurysm, lasting for unknown. The patient is dead on 19Jan2021. Death cause was reported as COVID-19 pneumonia. Diagnosis was confirmed by positive COVID-19 PCR test in 2021. Unknown if autopsy had been done. Outcome of events was fatal. Events were assessed by the regulator as "C. Inconsistent causal association ". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute respiratory failure; Superinfection bacterial; Aortic aneurysm; COVID-19 pneumonia


VAERS ID: 1044952 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: Carcinoma prostate; Coronary heart disease; Dementia Alzheimer''s type; Diabetes mellitus; Hyperthyroidism; Left bundle branch block; Lumbalgia; Melanoma; Struma nodosa
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021160523

Write-up: Covid-19 Pneumonia; Covid-19 Pneumonia; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB with regulatory authority number DE-PEI-PEI2021002458. An 84 years old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, lot/batch number: EM0477), via an unspecified route of administration on 01Jan2021 at single dose for covid-19 immunization. Medical history included diabetes mellitus, Dementia Alzheimer''s type, Hyperthyroidism, Struma nodosa, Coronary heart disease, Melanoma, Carcinoma prostate, Lumbalgia, Left bundle branch block, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced covid-19 pneumonia after vaccination on 26Jan2021. Death cause was reported as COVID-19 pneumonia. The patient died on 26Jan2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1044957 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Malaise
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   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: Medical History/Concurrent Conditions: Cardiac disorder; Disorder renal
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021160561

Write-up: Weakness; malaise; chills; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB DE-PEI-PEI2021002504. An elderly male patient was vaccinated with the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. Medical history included disorder renal and cardiac disorder, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 01Jan2021 after vaccination the patient developed Malaise and Weakness and Chills and Exitus letalis, lasting for unknown. The patient died on 07Jan2021. It was not reported if an autopsy was performed. The outcome of events Malaise, Weakness and Chills was fatal. The cause of death was Malaise, Weakness and Chills. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Weakness; malaise; chills


VAERS ID: 1044958 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021160562

Write-up: Vomiting; Lethal death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021002513. An 81-year-old patient of an unspecified gender received the first dose of bnt162b2 (COMIRNATY, lot# EM0477), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On the same day after vaccination (14Jan2021), the patient developed vomiting with fatal outcome; lethal death, lasting for unknown. The patient died on 14Jan2021. It was not reported if an autopsy was performed. Causal relationship between the events and the administration of bnt162b2 was assessed as "unclassifiable " by the Agency. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lethal death; Vomiting


VAERS ID: 1044959 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, General physical condition abnormal, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (only minor symptoms); COVID-19 virus test positive
Allergies:
Diagnostic Lab Data: Test Date: 20201223; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021160564

Write-up: Exitus letalis; Deterioration in general condition; Weakness; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB DE-PEI-PEI2021002518 and received via Regulatory Authority. A 90-years-old male patient received his first dose of bnt162b2 (COMIRNATY), lot number: EK9788, intramuscular on 25Jan2021 at single dose for covid-19 immunisation. Medical history included covid-19 from 13Jan2021 and unknown if ongoing with only minor symptoms, COVID-19 virus test positive on 23Dec2020. The patient''s concomitant medications were not reported. On 26Jan2021 after vaccination the patient developed Deterioration in general condition and Weakness and experienced exitus letalis (as reported) on 27Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 23Dec2020. The patient died on 27Jan2021. The outcome of events Deterioration in general condition and Weakness was fatal. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Exitus letalis; Deterioration in general condition; Weakness


VAERS ID: 1044966 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
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: 20210107; Test Name: Covid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021164985

Write-up: Coronavirus infection; This is a spontaneous report from a contactable consumer or other non hcp based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. An elderly patient (79-year-old) of an unspecified gender received bnt162b2 (COMIRNATY, Lot EM0477), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced coronavirus infection (death) on an unspecified date. Symptoms included dizziness, pain in groin, nausea, vomiting, loss of consciousness. The patient underwent lab tests and procedures which included Covid test: positive on 07Jan2021. The patient died on 18Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Coronavirus infection


VAERS ID: 1044967 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: COVId-19 rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021164988

Write-up: Died/ cause of death was not reported; Corona disease/ COVId-19 rapid test positive; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech Manufacturer control number: 15873, license party for Comirnaty. This reporter reported similar events for 39 patients. This is the 18th of 39 reports. An approximately 90 years old patient of unspecified gender received bnt162b2 (COMIRNATY, lot number: EM0477), via unspecified route of administration on 31Dec2020 at single dose for COVID-19 vaccination. The Patient experienced Corona disease. A COVID rapid test was positive on 05Jan2021. Patient died on 08Jan2021. The patient had no symptoms. The cause of death was not reported. It was unknown if autopsy was done. The outcome of the event corona disease/ COVId-19 rapid test positive was unknown, while the other event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/product, similar event, different patient; Reported Cause(s) of Death: Died/ cause of death was not reported


VAERS ID: 1044968 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Necrosis, Pain in extremity, SARS-CoV-2 test positive, Wound
SMQs:, Accidents and injuries (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   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: Test Date: 20210106; Test Name: COVID PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165010

Write-up: Coronavirus infection; several wounds and necroses; several wounds and necroses; limb pain; positive PCR test; This is a spontaneous report from a contactable consumer. This is a report based on information received by Pfizer from Biontech, license party for Comirnaty (Biontech ticket reference number 15873). An 83-year-old patient of an unspecified gender received the first dose of BNT162B2 (COMIRNATY, lot EM0477), via an unspecified route of administration at the age of 82-year-old on 31Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced coronavirus infection on an unspecified date, positive PCR test on 06Jan2021, several wounds and necroses, limb pain on an unspecified date. The patient died on 12Jan2021 due to coronavirus infection. It was unknown if an autopsy was performed. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: coronavirus infection


VAERS ID: 1044969 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 15
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: 20210107; Test Name: Rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165016

Write-up: had a positive rapid test for COVID-19/ reported to have had COVID-19 disease; This is a spontaneous report received from a contactable consumer employee of a nursing home based on information received by Pfizer from Biontech [manufacturer control number: 15873], license party for Comirnaty. This reporter reported similar events for 39 patients. This is the 25th of 39 reports. An 87-year-old patient of unspecified gender received bnt162b2 (COMIRNATY, lot number: EM0477), via unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient was reported to have had a positive rapid test for COVID-19 on 07Jan2021. She was reported to have had COVID-19 disease. Symptoms included body temperature over 39 degrees Celsius and diarrhea. The patient died on 22Jan2021. It was not reported if the autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021164939 same reporter/product, similar event, different patient; Reported Cause(s) of Death: had a positive rapid test for COVID-19/ reported to have had COVID-19 disease


VAERS ID: 1044970 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: Coronavirus rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021165112

Write-up: Coronavirus infection identified via quick test; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number:15873] from a non-contactable consumer, license party for Comirnaty. A patient about 91-year-old of an unspecified gender received 1st dose of bnt162b2 (COMIRNATY, lot: EM0477), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had a positive COVID 19 quick test on 05Jan2021. The patient died on 15Jan2021. It was unknown if autopsy was done or not. Outcome of positive COVID 19 quick test was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021165108 PFIZER INC; Reported Cause(s) of Death: Coronavirus infection identified via quick test


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