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

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



Case Details

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VAERS ID: 1015472 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021115666

Write-up: Death unexplained; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102031712185870, Safety Report Unique Identifier GB-MHRA-ADR 24694508. A 85-years-old female patient recevied bnt162b2 (BNT162B2) from Lot# EK4243 on 29Jan2021 at single dose for covid-19 immunization . The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial The patient experienced death on 31Jan2021. Clinical course reported as follows: patient found dead at home 2 days after having covid vaccine .An autopsy was not performed. Unsure of cause of death yet. No follow-up attempts are possible. No further information is expected. .; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1015556 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Feeding disorder, Hyperpyrexia, Sopor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DEPAKIN; QUETIAPINE; ACETYLSALICYLIC ACID; DUTASTERIDE; TRIATEC [RAMIPRIL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021097696

Write-up: Less than 24 hours after the administration of Comirnaty vaccine performed on 01Jan202, hyperpyrexia occured, followed by diarrheal discharges, difficulties with feeding and soporous state.; Less than 24 hours after the administration of Comirnaty vaccine performed on 01Jan202, hyperpyrexia occured, followed by diarrheal discharges, difficulties with feeding and soporous state.; Less than 24 hours after the administration of Comirnaty vaccine performed on 01Jan202, hyperpyrexia occured, followed by diarrheal discharges, difficulties with feeding and soporous state.; Less than 24 hours after the administration of Comirnaty vaccine performed on 01Jan202, hyperpyrexia occured, followed by diarrheal discharges, difficulties with feeding and soporous state.; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority- IT-MINISAL02-659296. A 91-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EL1484), intramuscularly, at right deltoid, on 01Jan2021, at 0.3 mL, single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included valproate sodium (DEPAKIN), quetiapine (QUETIAPINE), acetylsalicylic acid (ACETYLSALICYLIC ACID), dutasteride (DUTASTERIDE), ramipril (TRIATEC). The patient experienced less than 24 hours after (COMIRNATY vaccine administration 01Jan2021) hyperpyrexia, followed by diarrheal discharges, difficulties with feeding and soporous state (feeling sleepy). Admitted to hospital on 09Jan2021 (not have news of the hospital stay). Died on 13Jan2021. It was not reported if an autopsy was performed. Sender''s comments: Regional center of Pharmacovigilance : On 26Jan2021 a request was initiated for the FOLLOW UP procedure to request the clinical report and further information. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Less than 24 hours after the administration of Comirnaty vaccine performed on 01Jan202, hyperpyrexia occured, followed by diarrheal discharges, difficulties with feeding and soporous state.; Less than 24 hours after the administration of Comirnaty v


VAERS ID: 1015558 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse
SMQs:, Anaphylactic reaction (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), Hypersensitivity (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021109812

Write-up: Collapse verified by Social health workers staff on duty as a result of which she died; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-662896. A 100-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, Batch/lot # EL1484) intramuscular at single dose at left shoulder on 18Jan2021 10:00 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced collapse verified by social health workers staff on duty as a result of which she died on 26Jan2021. It was not reported if an autopsy was performed. Reporter''s comments: Resident subjected to the first dose of Comirnaty on 18Jan2021 without presenting symptoms or signs of any kind in the following days. In the night of 26Jan2021 collapse with sudden death. The outcome of event was fatal. Sender''s comments: Clinical report requested.; Reporter''s Comments: Resident subjected to the first dose of Comirnaty on 18Jan2021 without presenting symptoms or signs of any kind in the following days. In the night of 26Jan2021 collapse with sudden death.; Reported Cause(s) of Death: Circulatory collapse


VAERS ID: 1015563 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021104291

Write-up: Person died shortly after vaccination; This is a spontaneous report received from the regulatory authority without any regulatory authority number. A contactable consumer reported for an elderly (90 plus -years-old) patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at an unspecified dose for covid-19 immunisation. The patient medical history was not specified, but it was reported that the patient had underlying health problems. The patient''s concomitant medications were not reported. The patient died shortly after vaccination on an unspecified date. It was not reported if an autopsy was performed. The cause of death was still investigated. The Health Authority reported that there is no reason to assume that the death was related to vaccine administration. Information about Batch/Lot number has been requested.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1015564 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

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: FENTANYL SANDOZ; SINEMET
Current Illness: Dementia; Living in nursing home (Long-term resident from 11/Dec/2020.); Parkinson''s disease (For several years)
Preexisting Conditions: Medical History/Concurrent Conditions: Brain damage; Stroke (In the 1990s); Subarachnoid haemorrhage (Gave brain failure); Urinary tract infection (treated and "recovered slightly")
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021113665

Write-up: SWALLOWING DIFFICULT; DEMENTIA AGGRAVATED; BNT162B2 was given intramedullar; 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. Regulatory authority report number was NO-NOMAADVRE-FHI-2021-U1131 with Safety Report Unique Identifier of NO-NOMAADVRE-E2B_00014343. An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EJ6796), intramedullar on 07Jan2021 as a single dose for COVID-19 immunisation. Ongoing medical history included Parkinson''s disease from several years, living in nursing home from 11Dec2020, and dementia from 2015. Other relevant medical history included subarachnoid haemorrhage in Oct2020, global severe brain failure after subarachnoid haemorrhage in 2020 and unspecified if ongoing, and stroke on an unknown date in the 1990s. Concomitant medications included fentanyl (FENTANYL SANDOZ) taken for pain from 21Dec2020, carbidopa/levodopa (SINEMET) taken for Parkinson''s disease from an unknown date; both unknown if ongoing. On 16Jan2021, the patient experienced swallowing difficult and dementia aggravated; both reported as serious for being fatal. The clinical course was as follows: The patient was acutely admitted to a psychiatric ward in Dec2020 due to delirium and acting out. On 21Dec2020, the patient was considered a possible preterminal. On 23Dec2020, the state of health was recovering somewhat. On 30Dec2020, the patient was treated for urinary tract infection and "recovered slightly". The patient withstood little strain before getting worse and had fluctuating state of health. The patient was vaccinated on 07Jan2021. On 16Jan2021, the patient presented with aggravated dementia and difficulty swallowing nine days after vaccination. The patient died on 20Jan2021. The clinical outcomes of the aggravated dementia and difficulty swallowing were reported as fatal. It was not reported if an autopsy was performed. The physician assessment was severely frail patient that withstood little strain and vaccine may have tipped him into the death phase. The regulatory authority assessed the events were possibly related to the vaccination. Sender''s Comment: An 82-year-old man with worsening brain failure / dementia and difficulty swallowing nine days after vaccination with COVID-19 vaccine (COMIRNATY), and he dies four days after this. Severe frail patient. 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 random, 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 relationship 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 report is also classified as serious, even though a causal link between the vaccine and the death has not been established. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: difficulty swallowing; aggravated dementia


VAERS ID: 1015566 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, C-reactive protein, Diarrhoea, Enterococcus test, General physical health deterioration, Heart rate, Nausea, Respiratory rate, Urinary retention, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KALEORID; TOLVON; SOMAC; ALBYL-E; FOLSYRE NAF; PARACET [PARACETAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia, unspecified; Anxiety disorder; Aspiration pneumonia; Colon cancer; Colostomy; Dilatation of esophagus; Falling (Tendency to fall); Gastroduodenitis; Hip arthrosis; Hypertension; Hypoalbuminemia (No kidney failure); Iron deficiency anemia; Living in nursing home (Long-term stay); Lung embolism (Small non-occlusive peripheral, left lower lobe.); Lung embolism (postoperatively (colostomy/urostomy)); Malnutrition; Myocardial infarct (unspecified, type 2); Pneumonia; Sepsis (postoperatively (colostomy/urostomy)); Sepsis (Focus: urinary tract, Fever and hypotension); Stomach pain (During hospitalization for sepsis); Urinary tract infection; Urostomy; Vomiting (During hospitalization for sepsis)
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: C-reactive protein; Result Unstructured Data: Test Result:23; Comments: evening; Test Date: 20210109; Test Name: C-reactive protein; Result Unstructured Data: Test Result:52; Test Date: 20210110; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210111; Test Name: C-reactive protein; Result Unstructured Data: Test Result:72; Test Date: 20210115; Test Name: C-reactive protein; Result Unstructured Data: Test Result:25; Test Date: 20210111; Test Name: Enterococcus test; Test Result: Positive ; Test Date: 20210109; Test Name: Pulse rate; Result Unstructured Data: Test Result:110; Test Date: 20210111; Test Name: Pulse rate; Result Unstructured Data: Test Result:103; Test Date: 20210112; Test Name: Pulse rate; Result Unstructured Data: Test Result:104; Test Date: 20210108; Test Name: Respiratory rate; Result Unstructured Data: Test Result:25; Comments: evening; Test Date: 20210109; Test Name: Respiratory rate; Result Unstructured Data: Test Result:25; Test Date: 20210110; Test Name: Respiratory rate; Result Unstructured Data: Test Result:24; Test Date: 20210112; Test Name: Respiratory rate; Result Unstructured Data: Test Result:21
CDC Split Type: NOPFIZER INC2021103846

Write-up: VOMITING (OLD, BLOODY); URINARY RETENTION; DIARRHEA; STOMACH PAIN (LOWER PART OF ABDOMEN); NAUSEA; REDUCED GENERAL CONDITION (WITH INCREASED CRP, RESPIRATORY RATE AND PULSE RATE); This is a spontaneous report from a contactable other HCP (nurse) downloaded from the Medicines Agency (MA) Regulatory Authority-WEB regulatory authority NO-NOMAADVRE-FHI-2021-U5ejy. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014216. An 88-year-old multimorbid male patient received bnt162b2 (COMIRNATY, Lot#: EJ6795), intramuscular on 06Jan2021 at single dose for covid-19 immunization. Medical history included Colon cancer, sepsis and Lung embolism (postoperatively (colostomy/urostomy)) in 2011; Hip joint arthrosis, Malnutrition, Anxiety disorder, Tendency to fall, unspecified type 2 Myocardial infarct in 2018; unspecified Anemia, hypertension, Pneumonia in Jun2019; Dilatation of esophagus, Gastroduodenitis, Aspiration pneumonia, Iron deficiency anemia, Lung embolism (Small non-occlusive peripheral, left lower lobe), Urinary tract infection in Aug2019; sepsis in Jun2020 (Focus: urinary tract, fever and hypotension), Vomiting and Stomach pain in Jun2020 (During hospitalization for sepsis), Hypoalbuminemia in Jun2020 (No kidney failure), Long-term stay Living in nursing home from 25Sep2020. Concomitant medications included potassium chloride (KALEORID) from 03Jul2020, mianserin hydrochloride (TOLVON) for depression from 14Jul2020, pantoprazole sodium sesquihydrate (SOMAC) from 09Aug2019, acetylsalicylic acid, magnesium oxide (ALBYL-E) from 03Jul2020, folic acid (FOLSYRE NAF) from 27Nov2018, paracetamol (PARACET) from 19Oct2020. Patient with reduced general condition (with increased CRP, respiratory rate and pulse rate), stomach pain, nausea, vomiting (bloody), diarrhea and urinary retention in a period of 10 days after vaccination with covid-19 vaccine (Cominarty). Increased CRP, respiratory rate and pulse two days after vaccination, nausea and stomach pain after five days, diarrhea after nine days and vomiting, urinary retention and death after 10 days. The patient has a history of several serious illnesses, but still not considered frail. The death is thus experienced as abrupt and therefore desirable to report. Additional information: Fell 08Jan2021 - lay on the floor in the morning. Reduced general condition in the evening. Started treatment with trimethoprim 160 mg 09Jan2021, 1 tablet two times a day, for urinary tract infection. Started treatment with sulfamethoxazole 400 mg + trimethoprim 80 mg (Bactrim) 11/Jan/2021. 2 tablets two times a day. Relatives have been informed and have themselves asked whether the vaccine could be a contributing cause of the course of the disease. Throughout the process he sat up every day, ate every day, drank well, being afebril and had stools daily. Walked with a walker and one nurse assisting him. The patient underwent lab tests and procedures which included c-reactive protein: 23 on 08Jan2021 evening, 52 on 09Jan2021, 72 on 11Jan2021, 25 on 15Jan2021, enterococcus test positive on 11Jan2021, Pulse rate: 110 on 09Jan2021, 103 on 11Jan2021, 104 on 12Jan2021, respiratory rate: 25 on 08Jan2021 evening, 25 on 09Jan2021, 24 on 10Jan2021, 21 on 12Jan2021. Patient died on 16Jan2021. It was unknown if an autopsy done. Sender Comment: An 88-year-old multimorbid patient with reduced general condition (increased CRP, respiratory rate and heart rate), abdominal pain, nausea, vomiting, diarrhea and urinary retention 2-10 days after vaccination with covid-19 vaccine (Cominarty), followed by death 10 days after vaccination. The patient has a history of several serious illnesses, but was still not considered frail. Death is thus perceived as sudden and therefore desirable to report. 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) (~ 20%), respiratory and infectious diseases (including pneumonia and sepsis) (~ 15%), and cancer (~ 10%). The most common adverse reactions with Cominarty 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. Nausea after vaccination may occur in association with vasovagal reactions. A vasovagal reaction is caused by a reaction in the autonomic nervous system, which can be triggered by frightening or unpleasant sensory impressions. Such reactions are not specifically related to the content of the vaccine, but to conditions surrounding the injection procedure. In connection with fever and malaise that may occur in the first 1-2 days after vaccination, vomiting and vomiting may occur as accompanying symptoms. Gastrointestinal symptoms such as abdominal pain and / or diarrhea have been reported after vaccination. Such symptoms may occur in connection with fever, and nausea and abdominal cramps may occur in connection with vasovagal reactions, or have occurred for a completely different reason. In each case, it is difficult to assess whether the symptoms are caused by the vaccine, or had another cause. The patient in question develops nausea and abdominal pain only after five days, and vomiting only ten days after vaccination, which reduces the likelihood of a causal relationship between the vaccination and these symptoms. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It cannot be ruled out that the vaccine has contributed to the worsening of the patients 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 random, 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 relationship 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 report is also classified as serious, even though a causal link between the vaccine and the death has not been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: REDUCED GENERAL CONDITION (WITH INCREASED CRP, RESPIRATORY RATE AND PULSE RATE); NAUSEA; DIARRHEA; VOMITING (OLD, BLOODY); URINARY RETENTION; STOMACH PAIN (LOWER PART OF ABDOMEN)


VAERS ID: 1015567 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA156571 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Confusional state, Dizziness, Echocardiogram, Hallucination, Oedema peripheral, PO2, Physical examination
SMQs:, Cardiac failure (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; BURINEX; MORPHINE; TRAMADOL
Current Illness: Atrial fibrillation; Chronic respiratory failure; Claudication intermittent; End stage cardiac failure (End stage heart failure since admission to the nursing home); Hypertension; Living in nursing home; Non-smoker; Walker user (He has been mobilized with a walker in the department.)
Preexisting Conditions: Medical History/Concurrent Conditions: Dependence on oxygen therapy (The first time after he arrived at the nursing home, he had O2 on the nasal catheter, but since then he has not used it, except for the last 24 hours before he died.); DVT; Fall (Fell on the morning of 18/1. Afterwards complained of ribs, abrasions on the back, no pain in the head or elsewhere.); Implantable defibrillator insertion; Pleural effusion recurrent (Has underwent several pleural effusions); Polymyalgia rheumatica; Prostate cancer NOS
Allergies:
Diagnostic Lab Data: Test Date: 20201102; Test Name: Echocardiography; Result Unstructured Data: Test Result:Enlargement of left atria. Normally large heart sp; Comments: Enlargement of left atria. Normally large heart spaces.; Test Date: 20210118; Test Name: Physical examination; Result Unstructured Data: Test Result:no neurological outcomes or signs of infection. Th; Comments: no neurological outcomes or signs of infection. The situation was interpreted as an exacerbation of heart failure.; Test Date: 20210115; Test Name: SpO2; Test Result: 94 %
CDC Split Type: NOPFIZER INC2021103894

Write-up: EDEMA LEGS; HALLUCINATING; CONFUSION; DIZZINESS; Confusion, aggravation of heart failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, NO-NOMAADVRE-FHI-2021-U8p1p, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014245. A 91 Years old Male patient received first dose of bnt162b2 (COMIRNATY) (lot number: PAA156571), intramuscularly on 06Jan2021 for VACCINATION. Medical history included living in nursing home in Jun2020 and ongoing, ongoing end stage cardiac failure, ongoing walker user, pleural effusion recurrent, dependence on oxygen therapy from Jun2020 and not ongoing, ongoing claudication intermittent, polymyalgia rheumatica, ongoing hypertension, prostate cancer nos, Deep vein thrombosis (DVT) in 2013 and not ongoing, fall on 18Jan2021, ongoing chronic respiratory failure, ongoing atrial fibrillation, ongoing non-smoker, implantable defibrillator insertion in 2015. Concomitant medications included Tramadol for back pain from unknown date to 17Jan2021, Morphine Subcutaneous from 19Jan2021 02:00, bumetanide (BURINEX), apixaban (ELIQUIS). The patient developed Confusion, aggravation of heart failure (Cardiac failure aggravated) in Jan2021, edema legs on 18Jan2021, hallucinating on 17Jan2021, confusion on 17Jan2021, dizziness on 15Jan2021. The outcome of Cardiac failure aggravated was fatal, of other events was not recovered. The case was considered to be Serious. Relevant laboratory findings and investigations included physical examination on 18Jan2021, echocardiography on 02Nov2020 included Enlargement of left atria. Normally large heart spaces. Global hypokinesia with EF at level 25-30%. Normal width of aortic root, as well as normal width of ascending aorta. Pulmonlis is not visualized. The aortic valve is tricuspid and shows slight fibrosis. Maximum speed over the flap 1.4 m / sec. No aortic aneurysm. Mitralis shows slightly increased echogenicity and there is some lime in the mitral ring. Insignificant mistral insuffiency. Tricuspid morphological without remarks, minor to moderate tricuspid insufficiency, maximum HK / HF gradient 3.5 m / sec. corresponding to 48 mmHg. Inferior vena cava normal width. Conclusion: Pronounced impaired systolic left ventricular function in line with previous pulmonary hypertension in line with previous. An elderly man admitted to the nursing home in June 2020 with severe heart failure directly from the hospital. He had been hospitalized with heart failure in the end stages and had pleural effusion several times. We had the impression that this was a man who was going to die quickly from the information in the epicrisis, but he showed great progress. Initially after he arrived at the nursing home he had O2 on the nasal catheter, he has not used it afterward, with the exception of the last 24 hours before he died. He has been mobilized with a walker in the department. Ate well and put on weight. No swelling or wheezing. Apart from pain in his shoulder and back, he has not complained about anything. He has good effect of tramadol for the pain. He has been in good spirits, taken walks in corridors with a walker and eaten well. He was vaccinated against corona 6Jan and has been in good shape since then. From Friday 15Jan2021 he complained of some dizziness. In this connection, SpO2, 94% was controlled. From Sunday 17Jan2021 afternoon / evening he started to get confused and hallucinating. Fell on the morning of 18Jan2021, no one was present when he fell, but staff arrived quickly. Afterwards he complained of pain in ribs, abrasions on the back, no pain in the head or elsewhere. Still hallucinating. Little pain and therefore did not ask for tramadol, last intake of tramadol was in the evening 17Jan2021. From Monday morning on 18Jan2021, swelling/edema in his legs was noticed. Still no trouble breathing. The doctor on duty examined him on Monday afternoon, no neurological findings or signs of infection, the situation was interpreted as an exacerbation of heart failure, Burinex was increased and X-ray thorax was ordered to the next day, and new blood tests was scheduled. He ate breakfast and supper as usual in the living room with the other patients 18Jan2021, then went to his own room with a walker. He went to bed as usual in the evening, sleep well until he when woke up at 02:00 19Jan202, and had a bit gurgling breath. Morphine s.c was administred and he recovered a bit, drank water. Then his breath quickly deterioated and he died at. 02:45 19Jan2021. Epicrisis from control by cardiologist 02Nov2020: Echocardiogram: The picture appears unchanged and there are very few opportunities to change his situation. Conservative action with adjustment of the diuretic therapyis appropriate. More advanced therapy is not recommended considering that the patient is relatively fragile as a whole. In the case of Eliquis, it should be reduced from 5 mg x 2 to 2.5 mg x 2 as soon as possible with regard to age and renal function. Otherwise, unchanged medication. Further echocardiographic examination has no meaning for this patient. However, a renewed lung x-ray and if necessary pleural effusion on a symptom-relieving basis. All events assessment for Comirnaty/ Source of assessment Regional Pharmacovigilance Center / Result of Assessment Possible Reporter''s comments Reporter''s qualification: Physician. Sender''s Comments (TRANSLATION): 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 some else incidental, concurrent cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. 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 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: Reporter''s qualification: Physician.; Reported Cause(s) of Death: Confusion, aggravation of heart failure


VAERS ID: 1015568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRTAZAPINE; METFORMIN; OLANZAPINE TEVA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Aortic stenosis (moderate degree, considered inoperable); Depression; Diabetes mellitus (Good blood sugar control); Living in nursing home (Long-term resident since 2014 after developing depression and anxiety); Loss of personal independence in daily activities; Schizoaffective disorder (Since her twenties)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021095225

Write-up: SUDDEN DEATH; Suddenly she fell/dropped dead, in the bathroom; This is a spontaneous report from contactable physician downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U8p9q . Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014115. A 78-year-old female patient received bnt162b2 (COMIRNATY, lot number EJ6796), intramuscular on 07Jan2021 at single dose for vaccination. The medical history included Anxiety, Schizoaffective disorder since her twenties, Depression, Diabetes mellitus from 2014(Good blood sugar control), Aortic stenosis from 2014(moderate degree, considered inoperable), Living in nursing home since 2014 after developing depression and anxiety, Inability to take care of herself. The concomitant medications were mirtazapine (strength 30 mg, lot number N06AX11) oral from 2014, metformin (strength 500 mg, lot number A10BA02) oral from 23JUL2020 to 13JAN2021 for diabetes mellitus, olanzapine(OLANZAPINE TEVA, strength 10 mg, lot number N05AH03) oral for Schizoaffective disorder. On 13Jan2021 the patient suddenly died six days after vaccination with covid-19 vaccine (bnt162b2). Multimorbid patient. She seemed to be in normally stable shape all day (the day she died), and had eaten with others and was in a good mood until the evening meal. Suddenly she fell/dropped dead, in the bathroom, without warning signs. She was somatically stable form in recent years. The patient died on 13Jan2021. It''s unknown if an autopsy was performed. The cause of death was Sudden death. The outcome of the event was fatal. Sender''s comment: A 78-year-old woman died suddenly six days after vaccination with covid-19 vaccine (Cominarty). Multimorbid patient. Normal stable general condition the day she died. 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 other accidental, concurrent cause that has nothing to do with the vaccination in question. Based on 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 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 died, the report is classified as serious, even though no causality between the vaccine and the death has been established. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death; Suddenly she fell/dropped dead, in the bathroom


VAERS ID: 1015569 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation, 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: 2021-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FURIX [FUROSEMIDE]; SOMAC; SOBRIL; ATROVENT; METOPROLOL; LEVAXIN; VENTOLINE [SALBUTAMOL]; REMERON; PREDNISOLONE; CIPRALEX [ESCITALOPRAM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety (Troublesome. Anxiety in dementia); Chronic obstructive lung disease (Moderate. Stabilised with prednisolone.); Dementia; Heart failure; Hypertension; Hypothyroidism (Hypothyroidism after treatment of hyperthyroidism with radioactive iodine); Living in nursing home; Pulmonary failure
Allergies:
Diagnostic Lab Data: Test Name: SpO2; Result Unstructured Data: Test Result:62-80 %; Comments: without oxygen; Test Name: SpO2; Result Unstructured Data: Test Result:80-90 %; Comments: without oxygen
CDC Split Type: NOPFIZER INC2021103891

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority. Regulatory authority report number NO-NOMAADVRE-FHI-2021-U8pzp, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014226. An 87-years-old female patient received first dose of bnt162b2 (COMIRNATY, lot: EJ6796), intramuscular on 07Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included anxiety (Troublesome. Anxiety in dementia), hypertension, dementia, Heart failure, Living in nursing home, Pulmonary failure, chronic obstructive pulmonary disease (Moderate. Stabilised with prednisolone), hypothyroidism (Hypothyroidism after treatment of hyperthyroidism with radioactive iodine). Concomitant medication included furosemide (FURIX [FUROSEMIDE]) for heart failure, pantoprazole sodium sesquihydrate (SOMAC) for prophylaxis against gastrointestinal ulcer, oxazepam (SOBRIL) for anxiety, ipratropium bromide (ATROVENT) for chronic obstructive pulmonary disease, metoprolol (METOPROLOL) for hypertension, levothyroxine sodium (LEVAXIN) for hypothyroidism, salbutamol (VENTOLINE [SALBUTAMOL]) for chronic obstructive lung disease, mirtazapine (REMERON) for anxiety, prednisolone (PREDNISOLONE) for chronic obstructive lung disease, escitalopram (CIPRALEX [ESCITALOPRAM]) for anxiety. The patient experienced sudden death on 09Jan2021. Detail clinical course was provided the paetint died suddenly two days after vaccination with covid-19 vaccine (Cominraty). Exacerbation of chronic obstructive lung disease two weeks before the vaccination, treated with antibiotics for one week. She had very poor oxygen saturation afterwards, before the vaccine was administered. In good general condition at the time of the vaccination, and also the day she died. That day she was up, effortless, eating well and had visits from relatives. In the evening the same day her health condition suddenly got reduced, without any specific symptoms. She then died within one hour. The patient underwent lab tests and procedures which included oxygen saturation: 62-80 % on an unknown date without oxygen, oxygen saturation: 80-90 % on an unknown date without oxygen. The patient died on 09Jan2021. It was not reported if an autopsy was performed. Additional information: She had very poor oxygen saturation before the vaccine was administered. SpO2: 62-80% without oxygen. Before this, SpO2: 80-90%, without oxygen. The death was not reported before, due to her lung failure which indicated a poor prognosis. Reported by agreement with National Institute of Public Health (NIPH). Additional information on drug provided in product notes. Product notes: J07BX - Other virus vaccines. Sender''s Comments (TRANSLATION): 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, were cardio- and cerebrovascular diseases 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 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 another incidental, concurrent cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. 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 report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SUDDEN DEATH


VAERS ID: 1015570 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home
Allergies:
Diagnostic Lab Data: Test Name: assessment of frailty; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NOPFIZER INC2021103888

Write-up: died; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U93m3, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014203. A 83-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number unknown), intramuscular in left arm on 06Jan2021 at single dose for covid-19 immunisation. The patient was a nursing home resident, living in nursing home. Concomitant medications were not reported. The patient died on 17Jan2021. It was unknown if an autopsy was performed. The cause of death was unknown. There is no information about the course of event, any previous illnesses or drug use. The patient was vaccinated before an assessment of frailty became a routine before vaccination. The outcome of the event was fatal. Sender Comment: A woman in her 80s, a nursing home resident, is said to have died 11 days after vaccination. There is no information about the course of events, any previous illnesses or drug use. Melder states that the patient was vaccinated before an assessment of frailty became a general routine before vaccination. Comment: The notification does not contain sufficient information to be able to assess a possible causal connection with the vaccination. We therefore ask for more information in order to be able to assess the incident. On a general basis, we have the following comment: 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 is increased in the first four months after hospitalization, 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 cerebrovascular 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%). 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. 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. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1015571 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: Abdominal pain
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home; Prostate cancer; Stroke (Previous stroke with pronounced aphasia, who did not want life-prolonging treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210109; Test Name: Body temperature; Result Unstructured Data: Test Result:41.0 (rectal temperature); Test Date: 20210113; Test Name: C-reactive protein; Result Unstructured Data: Test Result:121; Test Date: 20210109; Test Name: Respiratory rate; Result Unstructured Data: Test Result:32/minute; Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: NOPFIZER INC2021103855

Write-up: pyelonephritis; vomit/diarrhea; vomit/diarrhea; FEVER (HIGH); Hard constipation; This is a spontaneous report from a contactable physician from the Medicines Agency (MA) Regulatory Authority -WEB NO-NOMAADVRE-FHI-2021-Uj1m8. A 91 years old male patient received 1st dose of BNT162B2 (COMINARTY; EJ6795) intramuscular at left arm on 05Jan2021 11:44 single dose for COVID-19 immunization. Medical history included Living in nursing home, prostate cancer and previous stroke with pronounced aphasia, who did not want life-prolonging treatment and ongoing lower abdominal pain in the bladder region since 04Jan2021. The patient got acutely ill on 09Jan2021, with high fever and died on 13Jan2021. The patient was still warm and clammy of fever when he died. He complained about lower abdominal pain in the bladder region from the day before the vaccination. After negative covid-19 test in Jan2021, the most suspected cause was pyelonephritis, after difficult catheterization. Vaccine reaction can not be completely ruled out, but the symptoms occurred four days after vaccination, somewhat later than expected. Additional information: - 09Jan: Found on the floor: naked, trembling and huddled in vomit/diarrhea, with increased respiratory frequency. Nothing indicated pneumonia, since the breath calmed down and there were no rattling, not even terminally. - No paracetamol in advance of measuring high fever four days after vaccination. - 07Jan: Hard constipation found, that was solved. On 05Jan: Patient meant he might have residual urine. Catheterized 07Jan, on the third attempt at very difficult access. Patient had known prostate cancer. Due to tight foreskin, he was catheterized blindly and without optimal cleaning. It is obvious to suspect pyelonephritis as the cause; he had increased pain in the bladder, so the catheter was discontinued 09Jan. The urine in the bag looked normal the day before. - His high fever may indicate both pyelonephritis or vaccine reaction. Body temperature 41.0 (rectal temperature) on 09Jan2021. C-reactive protein 121. A few hours before he died on 13Jan2021. Respiratory rate in the morning of 09Jan2021: 32/minute. Outcome of constipation was resolved on 07Jan2021. Outcome of fever and pyelonephritis was fatal, outcome of other events was unknown. Sender''s Comments (TRANSLATION): Nonspecific symptoms such as fever, feeling unwell, headache, dizziness and general malaise occur in the first days after vaccination. But in each case, it is difficult to know if they are due to the vaccination or another random, concurrent cause that has nothing to do with the vaccine in question. High fever and reduced general condition may be signs of a serious illness that is not due to the vaccination in question. Fever is among the most common side effects ($g 10%) in study participants, occurring within 1-2 days of vaccination. The most common side effects are usually mild or moderate in intensity and go away after a few days. The patient in question has abdominal pain (in the bladder area) before the vaccination and does not develop a fever until four days after the vaccination, which reduces the likelihood of a causal relationship. 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, were cardio- and cerebrovascular diseases 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 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 another random, concurrent cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. 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 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.; Reported Cause(s) of Death: fever; pyelonephritis


VAERS ID: 1015572 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: PARACET [PARACETAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Living in nursing home; Pneumonia recurrent
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: NOPFIZER INC2021095230

Write-up: SARS-CoV-2 infection/COVID-19 disease/reduced general condition; SARS-CoV-2 infection/COVID-19 disease/reduced general condition; This is a spontaneous report from contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Umm9d, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014345. An 87-years-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 05Jan2021 at single dose in right arm for COVID-19 immunisation. Medical history included living in residential institution, recurrent pneumonias, dementia. Concomitant medication included paracetamol (PARACET) (N02BE01 (unspecified number) reported for paracetamol) for fever. It reported that the patient experienced SARS-CoV-2 infection on 06Jan2021. The patient had vaccinated on 05Jan2021. He had reduced general condition on 06Jan2021. COVID-19 outbreak detected on 07Jan2021 due to positive test in fellow resident. Patient tested (COVID-19 test) positive on 08Jan2021, alongside several staff members. He developed COVID-19 disease and died due to COVID-19 on 19Jan2021. The outbreak is traced back to a staff member, and time of transmission is judged to be prior to vaccination. Reporting physician assumes no link between vaccination and COVID-19 disease with fatal outcome. Assessment of relatedness reported as no relationship by reporter. The patient died on 19Jan2021. It was not reported if an autopsy was performed. Sender''s Comment: It is stated in the report that the patient was infected with COVID-19 before the time of vaccination. The vaccine used is not live. It can therefore not cause diseases that are vaccinated against or any other infections. The incident is therefore considered to have no connection with the vaccine. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of COVID-19 infection with fatal outcome. The reported event likely represent intercurrent medical condition in this elderly 87 year old patient. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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: SARS-CoV-2 infection/COVID-19


VAERS ID: 1015573 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MORPHINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden (The last six months); Dementia; Heart failure; Living in nursing home; Palliative care (From before the vaccination); Reduced general condition (Gradually reduced the last six months)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021103850

Write-up: PNEUMONIA; This is a spontaneous report a contactable physician downloaded from the Regulatory Authority-WEB [regulatory authority NO-NOMAADVRE-FHI-2021-Un97a], Safety Report Unique Identifier [NO-NOMAADVRE-E2B_00014209]. An 88 years old male patient received his 1st dose of BNT162B2 (COMIRNATY, lot number EJ6795) at single dose intramuscular on 06Jan2021 for vaccination. Medical history included with heart failure and dementia, that had been in reduced general condition and bedridden the last six months as of 02Feb2021, and living in nursing home. Patient received palliative treatment/ care decided from before the vaccination. Patient had lived longer than expected. This was a multimorbid patient. Concomitant drug included morphine since Jun2020 for pain. Patient experienced pneumonia four days after vaccination with covid-19 vaccine (on 10Jan2021). Time interval between beginning of concomitant drug administration and start of reaction was 7 months. Symptoms of pneumonia started from 10Jan2021. Patient was treated with inhalations and morpine in pain pump. Nine days later he died (on 19Jan2021). Reporter was unsure about the connection with the vaccine, but it may be related. Sender''s Comments: 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, were cardio- and cerebrovascular diseases 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%). The vaccine used is not a live vaccine. It can therefore not cause diseases that one is vaccinated against or other infections, such as pneumonia. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or another random, concurrent cause that has nothing to do with the vaccination in question. Source of assessment from Regional Pharmacovigilance Center was possible. Reporter''s comment: 15Jan2021 NIPH: Received additional information (phone) - Death 19Jan2021, not 13Jan2021. No follow-up attempts possible. No further information expected.; Reporter''s Comments: 15Jan2021 NIPH: Received additional information (phone) - Death 19Jan2021, not 13Jan2021; Reported Cause(s) of Death: PNEUMONIA


VAERS ID: 1015574 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021095250

Write-up: THROMBOTIC STROKE (LARGE); This is a spontaneous report from a contactable physician from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Un9za. A 90-year-old male patient received first dose of bnt162b2 (COMIRNATY, Lot#: EJ6795), via unknown route of administration on 05Jan2021 13:30 on arm left at single dose for covid-19 immunisation. Medical history included prostate cancer from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient with a large thrombotic stroke three days after vaccination with covid-19 vaccine (Cominarty). Increasingly reduced consciousness and he died nine days after the stroke. Patient with prostate cancer, started radiation therapy two days before the stroke. Returned to a short-term place in the nursing home a few days after the stroke. The outcome of the event was fatal. It was unknown if autopsy was performed. Sender Comment: A 90-year-old man with a major thrombotic stroke three days after vaccination with covid-19 vaccine (Cominarty). Increasingly reduced consciousness, and he died nine days after the stroke. Patient with prostate cancer, started radiation therapy two days before the stroke. Returned to a short-term place in the nursing home a few days after the stroke. No information on concomitant medications reported. 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 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 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 classified as serious, even though a causal link between the vaccine and the death has not been established. Thrombotic stroke/ start date : 08Jan2021/ stop date 17Jan2021/ outcome: fatal/ duration of reaction: 10 days. Comirnaty/ Thrombotic stroke / Regional Pharmacovigilance Center / Possible. Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)/ 3 days. Additional information on drug: J07BX - Other virus vaccines, concentrate for solution for injection, dispersion. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: THROMBOTIC STROKE (LARGE)


VAERS ID: 1015575 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Decreased appetite, Heart rate, Nausea, Oxygen saturation, Oxygen saturation decreased, Pain
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in residential institution
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:no values were given; Test Name: heart rate; Result Unstructured Data: Test Result:no values were given; Test Date: 20210111; Test Name: Oxygen saturation; Test Result: 62 %
CDC Split Type: NOPFIZER INC2021103860

Write-up: oxygen saturation 62%; APPETITE ABSENT; PAIN; ALTERED STATE OF CONSCIOUSNESS; NAUSEA; PAIN; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Urm35, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014291. A 90-year-old female patient received her first single dose of bnt162b2 (COMIRNATY) intramuscularly 13:30 on 06Jan2021 for vaccination. The patient''s medical history included living in residential institution. Concomitant medications were not reported. On 06Jan2021, 1 hour after the vaccination, the patient developed pain and nausea. The next day she had recovered. On 10Jan2021, the patient developed altered state of consciousness (deep sleep, difficult to awaken), appetite absent (did not want to eat), pain. On 11Jan2021, the physician was asked if the patient''s deteriorating condition could be related to vaccination. The physician stated that there was no association. Relevant laboratory findings and investigations included in the report (oxygen saturation, 11Jan2021, 62%). The reporter also stated that heart rate and blood pressure was measured, but no values were given in the report. The patient received oxygen therapy from 11Jan2021. Outcome of the oxygen saturation was unknown. The patient''s condition continued to deteriorate over the following days, and the patient died on 15Jan2021. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. This case was received from an Other health professional. Sender''s Comments: The report concerns a patient in her 90s, who shortly after the first dose of the Covid-19 vaccine Comirnaty experienced pain and became nauseous and unwell. The patient recovered the next day, but a few days later the patient became uncontactable, would not accept nourishment, experienced new pain and gradually became weaker. The reporter states that the supervising doctor believed that the new symptoms were not related to the vaccination. The patient died 9 days after vaccination. The most common adverse reactions with Comirnaty 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 went away after a few days. On the other hand, we cannot rule out that such relatively mild side effects may lead to a more serious course in severely weak patients. The Norwegian Medicines Agency and the National Institute of Public Health have recently updated their advice on Covid-19 vaccination of elderly and frail patients. When vaccinating vulnerable/frail, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. In the individual case, however, it is difficult to know whether the symptoms are due to a vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and/or habitual condition. 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 eventually died, the report is also 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: unknown cause of death


VAERS ID: 1015576 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021104699

Write-up: death; This is a spontaneous case from non-contactable consumer or non-HCP received by phone. The Consumer reported four reports of death. This is report first of four. A patient of unspecified age and gender received bnt162b2 (COMIRNATY) via an unspecified route of administration on an unknown date at single dose for Covid-19 immunization. Patient''s medical history and concomitant medications were not reported. The patient died on an unknown date. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-2021108692 the same source document, different patient;PL-PFIZER INC-2021108693 the same source document, different patient;PL-PFIZER INC-2021108694 the same source document, different patient;PL-PFIZER INC-2021108694 the same source document, different patient; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1015577 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021108692

Write-up: death; This is a spontaneous case from non-contactable consumer or non-HCP received by phone. The Consumer reported four reports of death. This is report two out from four A patient of unspecified age and gender received bnt162b2 (COMIRNATY) vaccine , via an unspecified route of administration on an unknown date at single dose for Covid-19 immunization. Patient''s medical history and concomitant medications were not reported. The patient died on an unknown date. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-2021104699 the same source document, different patient; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1015578 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021108693

Write-up: death; This is a spontaneous case from non-contactable consumer or non-HCP received by phone. The Consumer reported four reports of death. This is report three out from four A patient of unspecified age and gender received bnt162b2 (COMIRNATY) vaccine , via an unspecified route of administration on an unknown date at single dose for Covid-19 immunization. Patient''s medical history and concomitant medications were not reported. The patient died on an unknown date. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-2021104699 the same source document, different patient; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1015579 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021108694

Write-up: death; This is a spontaneous case from non-contactable consumer or non-HCP received by phone. The Consumer reported four reports of death. This is report fourth of four. A patient of unspecified age and gender received bnt162b2 (COMIRNATY) via an unspecified route of administration on an unknown date at single dose for Covid-19 immunization. Patient''s medical history and concomitant medications were not reported. The patient died on an unknown date. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-2021104699 the same source document, different patient;PL-PFIZER INC-2021104699 the same source document, different patient; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1015584 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021109850

Write-up: occurrence of death on the day of administration of the first dose of Comirnaty; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [Regulatory Authority number PT-INFARMED-B202101-973] from a contactable other health professional. A 58-year-old male patient received the 1st dose of BNT162B2 (COMIRNATY, lot# EL1484) 0.3 ml, intramuscular, on 18Jan2021 at 12:30, at 0.3 ml single, for COVID-19 immunisation. The patient was under surveillance for 30 minutes after administration, between 12:37 and 13:07. During this period no adverse reaction appeared. The patient''s medical history included unspecified co-morbidities and concomitant medication included an unspecified drug. Patient has not been diagnosed with COVID-19 before vaccination. Approximately two hours later, at 14:45, the patient died. It was reported that an autopsy was performed, but no results were available. Reporter comment: Medication error occurred? No Other information- 12:30- Administration of the vaccine without observing any reaction within 30 minutes, fulfilling all the procedures inherent to the vaccination process. The patient was under surveillance from 12:37 to 13:07. 14:45 - Reported death. Observation: Given the superior indication for performing the autopsy. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Medication error occurred? No Other information- 12:30- Administration of the vaccine without observing any reaction within 30 minutes, fulfilling all the procedures inherent to the vaccination process. The patient was under surveillance from 12:37 to 13:07. 14:45 - Reported death. Observation: Given the superior indication for performing the autopsy.; Sender''s Comments: Event unknown cause of death is assessed as Related until sufficient information is available to confirm an unrelated cause of death. There is currently limited information to allow for meaningful medical assessment. Case will be reassessed when follow-up information is received. 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: occurrence of death on the day of administration of the first dose of Comirnaty


VAERS ID: 1015586 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: SULPIRIDE; BISOPROLOL; BETAHISTINE; VITODE; ALENDRONIC ACID; AMLODIPINE BESILATE;LOSARTAN POTASSIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Dyslipidaemia; Femur fracture; Hearing aid user; Hearing loss; Hip surgery; Hypoacusis; Vertigo
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021103827

Write-up: Dyspnea; This is a spontaneous report received from a contactable physician, downloaded from the Agency Regulatory Authority PT-INFARMED-F202101-1497. An 89-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number EL1484) , intramuscular on 19Jan2021 16:00 at single dose for covid-19 immunisation . Medical history included hypoacusis, arterial hypertension, hearing loss (bilateral hearing aids), dyslipidemia, vertigo syndrome, all of which were from an unspecified date and unknown if ongoing, fracture of the left femur (partial hip arthroplasia 2019). Concomitant medication included sulpiride, bisoprolol, betahistine, calcifediol (VITODE), alendronic acid, amlodipine besilate;losartan potassium. The patient experienced dyspnea and resulted in death on 21Jan2021. According to the Nursing Home doctor, the patient was not bedridden, had adequate nutritional status, without cachexia or obesity. No test was performed to detect the presence of SARS-Cov2 before the vaccine was administered. The adverse reaction (ADR) occurred approximately 38 hours after administration of the suspected drug, lasting approximately 2 hours. Life support maneuvers were carried out (unspecified, not specified by which entity). There was no reduction in dosage, suspension or reintroduction of the suspected drug, due to its single dose character. There is no suspicion of interaction between drugs. According to information from the Nursing Home doctor, the patient had no history of allergies or previous reactions to drugs. Uneventful vaccination within the recommended surveillance time (30 minutes). Conservation and preparation were carried out outside the institution, administered by PRIVACY (Approximate time of vaccine administration: Around 4 pm on 19Jan2021). The reporter reported that did not know the cause of death and an autopsy was requested by the patient''s son. There is no information on the autopsy report. The medication is for additional monitoring. Treatment was received for the event. Evolution of ADR: fatal. The patient died on 21Jan2021. An autopsy was performed and results were not provided. Result of Assessment : Possible.; Reporter''s Comments: additional information on the documents tab; Reported Cause(s) of Death: dyspnea


VAERS ID: 1015598 (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: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Oxygen saturation, Sepsis, X-ray
SMQs:, Sepsis (narrow), Opportunistic infections (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: DUROFERON; SIMVASTATIN; STILNOCT; MIRTAZAPINE; CANDESARTAN; JANUVIA [SITAGLIPTIN PHOSPHATE]; METOPROLOL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:high; Test Name: saturation; Result Unstructured Data: Test Result:declining; Test Name: X-rays; Result Unstructured Data: Test Result:signs of pneumonia
CDC Split Type: SEPFIZER INC2021096481

Write-up: Sepsis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-1611314396332. Safety Report Unique Identifier SE-MPA-2021-001149. A 91-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration in Jan2021 as single dose for covid-19 immunization. Medical history included hypertension and diabetes, each from an unknown date and unknown if ongoing. Concomitant medication included ferrous sulfate (DUROFERON), simvastatin (MANUFACTURER UNKNOWN), zolpidem tartrate (STILNOCT), mirtazapine (MANUFACTURER UNKNOWN), candesartan (MANUFACTURER UNKNOWN), sitagliptin phosphate (JANUVIA), metoprolol (MANUFACTURER UNKNOWN), paracetamol (MANUFACTURER UNKNOWN). The patient experienced sepsis in Jan2021, which was serious as it lead to death.; the patient was hospitalized on an unspecified date. The event was further detailed as follows: patient suffered from increasing fatigue after vaccination, anxious, confused, declining saturation and was hospitalized. X-rays showed signs of pneumonia, high CRP. Reported suspected side effect was noted as sepsis, seven days after vaccination. The patient died ten days after vaccination. Cause of death was acute respiratory failure due to suspected sepsis due to urinary tract infection. The reporter assessed the sepsis as serious, as it lead to death. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Sepsis; acute respiratory failure due to suspected sepsis due to urinary tract infection; acute respiratory failure due to suspected sepsis due to urinary tract infection


VAERS ID: 1015599 (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: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Decreased appetite, Dysphagia, Fatigue, General physical health deterioration, Pain
SMQs:, 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)

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: SPIRIVA RESPIMAT; AIROMIR [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive lung disease; Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021103898

Write-up: AFFECTED GENERAL CONDITION/health had started deteriorating before the vaccination; AFFECTED GENERAL CONDITION/health had started deteriorating before the vaccination; Cause of death is submitted as chronic obstructive pulmonary disease /Medical history included chronic obstructive pulmonary disease; increasing tiredness; general body pain; decreased appetite; Difficulty swallowing; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB SE-MPA-1611746035540, Safety Report Unique Identifier SE-MPA-2021-001787. An 83-year-old female patient received BNT162B2 (COMIRNATY, lot: EJ 6134), via intramuscular on an unknown date in Jan2021 at single dose for COVID-19 immunisation. Concomitant medications included tiotropium bromide (SPIRIVA RESPIMAT) daily and salbutamol sulfate (AIROMIR) as needed. Medical history included chronic obstructive pulmonary disease and dementia Alzheimer''s type. Historical vaccine reaction was general physical health deterioration after influenza immunisation. Reported term was general physical health deterioration. Four days after the vaccination with BNT162B2, debut of increasing tiredness, general body pain and decreased appetite. Debut of general physical health deterioration was three days later according to the submitted onset date (7 days later after vaccination). The woman died the same day, 7 days after the vaccination. The woman''s health had started deteriorating before the vaccination and she had reduced appetite. Difficulty swallowing debuted after the vaccination. The woman stopped taking her oral medication on an unknown date. According to the reporter, there was a correlation in time between the symptoms and the vaccination, but causality is deemed low. No autopsy will be performed. Outcome of general physical health deterioration was fatal. Outcome of increasing tiredness, general body pain, decreased appetite and difficulty swallowing was no resolved. This case was assessed as serious, death. Cause of death was submitted as chronic obstructive lung disease by SE-MPA. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Chronic obstructive lung disease; General physical health deterioration


VAERS ID: 1015601 (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: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, General physical health deterioration, Infection, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: METOPROLOL; ELIQUIS; SALURES; CANDEXETIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Hypertension; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095264

Write-up: Confusion; fever; affected breathing, suddenly impaired general condition; Infection NOS; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-000485. Other case identifier number SE-MPA-1610720146757. A 98-year-old female patient received bnt162b2 (COMIRNATY, Batch/lot number: EJ6795), intramuscular in Jan2021 at single dose for Covid-19 immunization. Medical history included vascular dementia, hypertension, cardiac failure and atrial fibrillation. Concomitant medication included metoprolol, apixaban (ELIQUIS), bendroflumethiazide (SALURES), candesartan cilexetil (CANDEXETIL). The patient experienced infection nos (serious criteria reported as death) on Jan2021. Reported suspected adverse event is infection nos in Jan2021, two days after vaccination. According to rapporteur: Confusion, fever, affected breathing, suddenly impaired general condition." The patient died five days after vaccination. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Infection NOS; Confusion; fever; affected breathing, suddenly impaired general condition


VAERS ID: 1015602 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Chronic obstructive pulmonary disease; Myocardial infarct (earlier myopcardial infarct)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021096049

Write-up: Chronic obstructive pulmonary disease; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB and received via Regulatory Authority SE-MPA-2021-000707. A 85-years-old female patient received BNT162B2 (COMIRNATY, lot# EJ6795), via an unspecified route of administration in Dec2020 at single dose for COVID-19 vaccination. Medical history included earlier myopcardial infarct, chronic obstructive pulmonary disease (COPD), cardiac failure, all from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient experienced died eight days after vaccination in Jan2021. According to the report the main cause of death is COPD. Heart failure and status after myocardial infarction are contributing causes. Furthermore, expected death in COPD with heart failure as a contributing factor. Reporter does not assess patients death as a drug side effect. The patient died in Jan2021. Report assessed as serious, Death. No autopsy performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Chronic obstructive pulmonary disease


VAERS ID: 1015605 (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: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Dyspnoea, Investigation, Pneumonia aspiration, Pyrexia, Sepsis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: 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: Vascular dementia
Allergies:
Diagnostic Lab Data: Test Name: Examination; Result Unstructured Data: Test Result:shows he had got aspiration pneumonia and sepsis
CDC Split Type: SEPFIZER INC2021104164

Write-up: SEPSIS; PNEUMONI (ASPIRATIONS); breathing difficulties; fever; swallowing difficulties; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB SE-MPA-2021-000888, received from Regulatory Authority. A 76-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 ml, lot number: EL1484), intramuscular on an unknown date in Jan2021 at single dose for covid-19 immunisation. Medical history included vascular dementia, unknown if ongoing. The patient''s concomitant medications were not reported. Two days after the vaccination with Comirnaty, the man falls ill with breathing difficulties and fever and after two more days he is admitted to a hospital, infections clinic and he had then developed swallowing difficulties. Examination shows he had got aspiration pneumonia and sepsis and was treated with antibiotics (brand unknown). The man died one week after the vaccination with Comirnaty. The reporter states it is unlikely that Comirnaty is the cause of death. The outcome of the events aspiration pneumonia and sepsis was fatal. The patient died on an unspecified date. Autopsy will not be performed No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sepsis; PNEUMONI (ASPIRATIONS)


VAERS ID: 1015607 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Nasopharyngitis, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Senile dementia
Allergies:
Diagnostic Lab Data: Test Name: Covid-19 test; Test Result: Negative ; Test Date: 202101; Test Name: Covid-19 test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021103895

Write-up: vomited; Cold symptoms; reduced or no apetite; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (EMA) EudraVigilance-WEB, Regulatory Authority number SE-MPA-2021-000996. Other case identifier number SE-MPA-1611178240521. A 93-years-old female patient received bnt162b2 (COMIRNATY, lot number: EJ6796), via an unspecified route of administration, in Jan2021 at single dose for COVID-19 immunization. Medical history included Covid-19 in Jan2021 and senile dementia, unknown if ongoing. The patient''s concomitant medications were not reported. The patient developed cold symptoms and vomited in Jan2021. The woman had a special home care living, tested negative for Covid 19 one week before vaccination with Comirnaty. Same day as the vaccination she started vomiting and got cold symptoms, new performed Covid-19 test showed positive in Jan2021. The reporter stated that a nurse at the special home care living believes that she got the reactions from having been vaccinated with Comirnaty. Thereafter she had reduced or no appetite. A relative confirmed that the woman had no symptoms before the vaccination with Comirnaty. The reaction started less than 1 day after vaccination with Comirnaty. The woman died 11 days after the vaccination in 2021. No autopsy was performed. The outcome of the events cold symptoms and vomited was fatal. The outcome of the other event was unknown. The Swedish Medical Product Agency had requested more information from a physician, who stated it is more likely that the woman died from Covid-19 sequelae than of Comirnaty. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cold symptoms; vomited


VAERS ID: 1015608 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH LOT 1484 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Chronic obstructive pulmonary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095271

Write-up: Death; bnt162b2 via subcutaneous; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, Regulatory Authority number SE-MPA-2021-001170. Other case identifier number SE-MPA-1611322339511. A 74-year-old female patient received bnt162b2 (COMIRNATY, LOT 1484 and Expiration Date unknown) via subcutaneous on an unknown date in Jan2021 at 0.3 mL, single dose for COVID-19 immunisation. The patient''s medical history included chronic obstructive pulmonary disease and unknown if it was ongoing. The concomitant medications were not reported. The patient was found dead in her bed one morning two days after vaccination. Patient was unexpected death in Jan2021, but there are several other more likely causes of death than vaccine side effect. Autopsy was unknown right now, it will be performed, the reporter will send autopsy report when it is available. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1015609 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA156571-EJ679 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Pneumonia, Sepsis
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Cerebrovascular disorder; Claudication; Dementia; Enlarged prostate; Hypertension; Hypothyroidism; Venous insufficiency
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Name: body temperature; Result Unstructured Data: Test Result:high; Test Name: heart rate; Result Unstructured Data: Test Result:fast; Test Name: pulse oximetry; Result Unstructured Data: Test Result:poor POX
CDC Split Type: SEPFIZER INC2021095407

Write-up: IMAGE COMPATIBLE WITH SEPSIS; IMAGE COMPATIBLE WITH PNEUMONIA; This is a spontaneous report from a contactable physician downloaded from theRegulatory Authority-Web. The regulatory authority report number is SE-MPA-2021-001193. Other case identifier number is SE-MPA-1611325222540. A 92-year-old male patient received BNT162B2 (COMIRNATY Lot number PAA156571-EJ6795), intramuscular on 30Dec2020 as single dose for covid-19 immunization. Medical history included hypertension, dementia, venous insufficiency, enlarged prostate, hypothyroidism, claudication and cerebrovascular disorder, all from unknown dates and unknown if ongoing. No concomitant medications were noted. The patient experienced image compatible with sepsis and image compatible with pneumonia three weeks after vaccination in Jan2021, which were serious as they lead to death. The patient underwent lab tests and procedures on an unspecified date which included blood pressure: low, body temperature: high, heart rate: fast. Details were as follows: patient suddenly started to breath fast and coughed. Suspicion of aspiration pneumonia was aroused but, the patient got worse during one day and developed sepsis. Low blood pressure, fast heart rate, high temperature, blue lips, respiratory distress, poor pulse oximetry ("POX"). The patient died the day after. The cause of death was severe bacterial pneumonia. The patient was not autopsied. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pneumonia bacterial


VAERS ID: 1015610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cachexia, Dementia
SMQs:, Dementia (narrow), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021096174

Write-up: DEATH/Causes of death were cachexia - dementia; DEATH/Causes of death were cachexia - dementia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB Regulatory Authority number SE-MPA-2021-001507. An 89-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number EL1484) , intramuscular in Jan2021 at single dose for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing , ongoing dementia. The patient''s concomitant medications were none. The woman was vaccinated with the first dose of Comirnaty in Jan2021. Two days later, the woman died peacefully. Causes of death were cachexia - dementia. Report assessed as serious, death. The patient died on an unspecified date in Jan2021. It unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cachexia; Dementia


VAERS ID: 1015611 (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: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: FOTIL; LAKTULOS MEDA; MICROLAX [SODIUM CITRATE;SODIUM LAURYL SULFOACETATE]; MEMANTINE SANDOZ; LEVAXIN; OPTIMOL [TIMOLOL MALEATE]; CITALOPRAM SANDOZ; RISPERIDON ACTAVIS; OXASCAND; NATRIUMFLUORID; KLORHEXIDIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aggressiveness; Anxiety; Dementia Alzheimer''s type; Hallucinations; Hypothyroidism; Intraocular pressure high; Melanoma recurrent (malignant melanoma which recurred); Rash (nonspecific)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095402

Write-up: Death NOS; lost consciousness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, number is SE-MPA-2021-001606. Report from a physician regarding a 93-year-old female. A 93-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6796), intramuscularly in Jan2021 at 0.3 mL, single in left arm for COVID-19 immunization. Medical history included increased intraocular pressure, Alzheimer''s type dementia with late onset, hypothyroidism, malignant melanoma which recurred in November 2020 and a non-specific rash which was possibly due to malignant melanoma. Additionally, aggression, anxiety and hallucination, it''s unclear from the report whether this was due to the woman''s dementia. Concomitant medication included pilocarpine hydrochloride, timolol maleate (FOTIL), lactulose (LAKTULOS MEDA), sodium citrate, sodium lauryl sulfoacetate (MICROLAX) from 29Apr2020, memantine hydrochloride (MEMANTINE SANDOZ), levothyroxine sodium (LEVAXIN), timolol maleate (OPTIMOL), citalopram hydrobromide (CITALOPRAM SANDOZ), risperidone (RISPERIDON ACTAVIS), oxazepam (OXASCAND) from 29Apr2020. The patient took Natriumfluorid, and klorhexidin APL as a concomitant medication 0.3% + 0.2% Toothpaste. The patient died on an unspecified date in Jan2021. Reported suspect vaccine was COMIRNATY. Indication: COVID-19 epidemic. Reported term was Death NOS. The woman was vaccinated in early January, there is conflicting information in the report regarding the date. She died 5-6 days after the vaccination. The woman collapsed in the bathroom and lost consciousness. She never regained consciousness but died an hour later. Cause of death according to the reporter is probably Alzheimer''s disease and malignant melanoma. Report assessed as serious, death. The date of vaccination is unclear due to it being documented differently in different medical records, though it was probably administered 5 days prior to the woman''s death. According to the reporter, suspected correlation between the vaccination and death is very low, and there is no suspicion that the vaccination might have aggravated the woman''s concomitant illnesses. The report was made due to bnt162b2 being a new vaccine. No autopsy will be performed. The agency has requested further information. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: malignant melanoma; Dementia Alzheimer''s type


VAERS ID: 1015612 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Pulmonary oedema, Respiratory rate
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FURIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral vascular lesion; Dysphagia; Hypertension; Ischemic heart disease; Multimorbidity; Palliative care; Tiredness; Weakness left or right side; Wheeze (treated with furosemide injections ''''as needed'''' since Jul2020)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:90/35; Test Name: temperature; Result Unstructured Data: Test Result:36.6 degrees Celsius; Test Name: heart rate; Result Unstructured Data: Test Result:79/minute; Test Name: respiratory rate; Result Unstructured Data: Test Result:40/minute; Test Name: respiratory rate; Result Unstructured Data: Test Result:increased
CDC Split Type: SEPFIZER INC2021103993

Write-up: Pulmonary oedema; This is a spontaneous report a contactable physician downloaded from the regulatory authority-WEB , unique case identification number SE-MPA-2021-001762, Safety Report Unique Identifier SE-MPA-1611736250161. A 95-year-old female received BNT162B2 (COMIRNATY, lot number: EJ 6134) second dose intramuscularly on unspecified date in Jan2021 (Three to four weeks after first dose) at 0.3 ml single for Vaccination. Medical history included Cerebral vascular lesion with right side hemiparesis and dysphagia, hypertension, myocardial ischaemia, she could develop wheezing and had been treated with furosemide injections ''''as needed'''' since Jul2020, according to the reporter the woman was multimorbid and in palliative care, lately it had been noted that the woman had become more tired, all from unspecified date and unknown if ongoing. Concomitant medications included furosemide (FURIX). The patient previously received BNT162B2 (COMIRNATY, lot number: EJ 6796) first dose intramuscularly on 27Dec2020 at single dose for covid-19 immunization and it went well. The woman developed pulmonary oedema. According to the physician the woman received the first dose of BNT162B2 on 27Dec2020 and it went well. Three to four weeks later (Jan2021) she received her second dose of BNT162B2. The same day she had a slightly increased respiratory rate and the day after vaccination she gets worse with a respiratory rate of 40/minute, blood pressure 90/35, heart rate 79/minute and temperature 36.6 degrees Celsius. According to the reporter it was a suspected pulmonary oedema and the woman was treated with 3 litres of Oxygen and injection Furix (furosemide). The woman dies a few hours later. According to the reporter the Death of the woman could have been natural but because it is close in time to dose number 2 of BNT162B2 the reporter send a report to the regulatory authority. It was unknown if autopsy was done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pulmonary oedema


VAERS ID: 1015614 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021114260

Write-up: passed away after one dose; Received dose 1 and one week later tested positive for Covid-19; covid-19/positive SARS-CoV-2 test; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 19 patients and this is the 3 rd of the 19 reports. A patient of unspecified age and gender received first dose of bnt162b2 (COMIRNATY, lot/batch number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient passed away after one dose of bnt162b2 on an unspecified date in 2021. The patient received dose 1 and one week later, the patient was tested positive for Covid-19 on an unspecified date in 2021. The patient underwent lab tests and procedures which included a positive SARS-CoV-2 test in 2021. The outcome of events tested positive for Covid-19 was unknown. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Information on batch/lot number will be requested.; Sender''s Comments: The causal relationship between BNT162B2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported drug ineffective and COVID-19 cannot be ruled out. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : SE-PFIZER INC-2021114063 Same reporter, product and similar events; different patient; Reported Cause(s) of Death: passed away after one dose


VAERS ID: 1015615 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: SEPFIZER INC2021114261

Write-up: patient passed away after the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 19 patients and this is the report for the patient that died after dose 2. A patient of unspecified age and gender received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical vaccine included first dose of Comirnaty for COVID-19 immunization and one week later tested positive for Covid-19 on an unspecified date. It was reported that the patient passed away after the second dose on an unspecified date. The patient underwent lab tests and procedures which included a positive SARS-CoV-2 test in 2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. The batch/lot number was not provided and will be requested during follow up.; Sender''s Comments: The causal relationship between BNT162B2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: patient passed away after the second dose


VAERS ID: 1015617 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Positron emission tomogram, Pyrexia, SARS-CoV-2 test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (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: Atherosclerosis; Cardiac failure chronic; Catheter placement; Lung oedema; Phobia (Coronaphobia); Prostate cancer (without metastases); Splenomegaly
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:Negative; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:negative; Test Name: positron emission tomography scan; Result Unstructured Data: Test Result:unknown results
CDC Split Type: SKPFIZER INC2021109759

Write-up: Fever; Weakness; This is a spontaneous report a contactable physician downloaded from the Regulatory Authority-WEB [regulatory authority SK-SUKLSK-20210326]. A 79-year-old male patient received the 1st doe of bnt162b2 (COMIRNATY, batch/lot number requested) intramuscular at single dose on 19Jan2021 after lunch for covid-19 immunisation. Medical history included lung oedema, splenomegaly, prostate cancer without metastases, catheter placement, cardiac failure chronic, arteriosclerosis, suffered from ''''coronaphobia'''' (as reported by the daughter of the patient). A positron emission tomography scan was performed in the past (unknown result). COVID-19 antigen test and COVID-19 PCR test were negative on an unknown date. The patient''s concomitant medications were not reported. on 20Jan2021, one day after vaccination, the patient experienced weakness and fever (38.5?C). The patient underwent lab tests and procedures which included body temperature: 38.5 centigrade on 20Jan2021, Sars-cov-2 test on 2 different unknown dates: negative. The patient said that he felt very well, he dissimulated. On 22Jan2021 at 00:15 a.m. the patient died at home. Autopsy was done. The events were considered fatal. An autopsy was performed and results were not provided. Primary cause of death was reported as cardiac failure and atherosclerosis. Secondary cause of death was reported as condition after vaccination. Sender Comment: Causality was assessed as possible. No follow-up attempts are possible, information on batch number cannot be obtained; Reported Cause(s) of Death: cardiac failure; atherosclerosis; condition after vaccination


VAERS ID: 1016316 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prostate cancer metastatic
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery disease; Dementia; Diabetes mellitus; Multimorbidity; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021120681

Write-up: worsening of general condition; This is a spontaneous report from a contactable other HCP and physician received by Pfizer from local license party via local health authority. An 82-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot. no. EJ 6796), intramuscularly in left upper arm on 30Dec2020 at single dose for covid-19 immunisation. Medical history included glob. metastatic prostate NPL from 2015 and ongoing, diabetes mellitus type IIb, renal insufficiency, dementia, coronary artery disease, polymorbidity. The patient''s concomitant medications were not reported. The vaccines had not been administered before. The patient had diagnoses of glob. metastatic prostate NPL (since approx. 2015 ongoing), diabetes mellitus type IIb, coronary artery disease, dementia, renal insufficiency, polymorbidity. The diagnoses were confirmed, progression of disease with worsening of condition and without any relation to bnt162b2 vaccination. No evidence of vaccination reaction. The vaccine had not been administered again, the events did not recur without timely relation to the vaccination. Course and therapy of vaccination reaction: "no assured vaccination reaction", outpatient treatment was not considered necessary, hospitalization performed, reaction not assessed as life threatening. Outcome of vaccination reaction: "continuous worsening of general condition". The patient died on an unspecified date. A further continuous worsening of general condition without any relation to bnt162b2 had lead to a prophylactic hospitalization and treatment. A causal relation between course of disease and vaccination was not given. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Sender''s Comments: The reported " worsening of general condition" with fatal outcome is considered unrelated to the COVID-19 vaccine, BNT162B2 administration. This 82-year-old male patient with multiple severe medical conditions including metastatic prostate cancer, diabetes mellitus type IIb, coronary artery disease, dementia, renal insufficiency provided the most likely reason to be responsible for the reported " worsening of general condition" . 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.; Reported Cause(s) of Death: continuous worsening of general condition


VAERS ID: 1016445 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Haemoptysis, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Atrial fibrillation; Left ventricular dysfunction; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021115699

Write-up: Death/sudden death; SOB and coughing up blood; SOB and coughing up blood; This is a spontaneous report from a contactable physician. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102030913022400, Safety Report Unique Identifier GB-MHRA-ADR 24689327. An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jan2021 14:05 at single dose for COVID-19 immunization. Medical history included T2DM, LVSF, AF and aortic stenosis. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. concomitant medications were not reported. Pt vaccinated at PCN hub with Pfizer at 2.05pm on 29Jan2021. At 4.05pm on 29Jan2021 call to emergency services, SOB and coughing up blood. Passes away on 29Jan2021. Coroners office aware of case and post-mortem planned. Significant co-morbidities likely to be cause of sudden death, but in view of sudden death and time line form completed. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of SOB and coughing up blood was unknown. Patient died on 29Jan2021. The autopsy was not done yet. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: death/sudden death


VAERS ID: 1016446 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonitis, SARS-CoV-2 test negative
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN; DONEPEZIL; FEXOFENADINE; LOPERAMIDE; LORAZEPAM; PARACETAMOL; TRAZODONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021115626

Write-up: Pneumonitis; This is a spontaneous report from a contactable healthcare professional. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102031213563850, Safety Report Unique Identifier GB-MHRA-ADR 24691505. An 83-year-old male patient received bnt162b2 (BNT162B2) at single dose on 18Jan2021 for Covid-19 immunisation. The patient medical history was not reported. It was unsure if patient has had symptoms associated with COVID-19, or if patient is manufacturer unknown in clinical trial. Concomitant medication included amoxicillin (manufacturer unknown), donepezil (manufacturer unknown), fexofenadine (manufacturer unknown), loperamide (manufacturer unknown), lorazepam (manufacturer unknown), paracetamol (manufacturer unknown), trazodone (manufacturer unknown). The patient experienced pneumonitis on 20Jan2021. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative covid-19 test on 21Jan2021. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 21Jan2021. 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: Pneumonitis


VAERS ID: 1016447 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonitis
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (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: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; DIGOXIN; FRUSEMIDE [FUROSEMIDE]; LOSARTAN; PARACETAMOL; QUININE; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Hypertension; Keratoacanthoma (recent referral to haematology); Neutrophils increased; Thrombocytopenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021115771

Write-up: Pneumonitis; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202102031228189250, Safety Report Unique Identifier GB-MHRA-ADR 24691620. A 90-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history included Keratoacanthoma recent referral to haematology: chronically raised neutrophils and thrombocytopenia, atrial fibrillation (AF), hypertension (HTN). Concomitant medication included bisoprolol, digoxin, furosemide (FRUSEMIDE), losartan, paracetamol, quinine, warfarin. The patient experienced pneumonitis on 20Jan2021 with outcome of fatal. Patient was given amoxicillin 13Jan2021 (as reported) for a chest infection. The patient died on 26Jan2021. It was not reported if an autopsy was performed. The cause of death was pneumonitis. Patient had not tested positive for COVID-19 since having the vaccine. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonitis


VAERS ID: 1016465 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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: IDOTRIM; QUININE SULFATE; LEVAXIN; LEVAXIN; MIRTAZAPIN KRKA; KALEORID; CIRCADIN; PANODIL; CLOPIDOGREL ACTAVIS [CLOPIDOGREL BESYLATE]; FURIX [FUROSEMIDE]; MAGNESIA MEDIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Accident cerebrovascular; Constipation; Depression; Heart failure; Hemiplegia; Hypotension; Hypothyroidism; Illness (Five days prior to the vaccination); Kidney failure; Osteoporosis; Pneumonia; Vomited (the night and morning prior to the drug administration)
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: body temperature; Result Unstructured Data: Test Result:fever; Test Date: 20210122; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: ISPFIZER INC2021113993

Write-up: Respiratory failure; Fever; Oxygen saturation decreased; This is a spontaneous report downloaded from the Regulatory Authority-WEB IS-IMA-1677. The report was received from a contactable other healthcare professional (pending clarification, also reported as physician) via the Regulatory Authority. An 88-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Batch/lot number: EJ6796, Expiration Date: 30Apr2021) on 21Jan2021, via an unspecified route of administration at single dose for COVID-19 immunization. Medical history included accident cerebrovascular, osteoporosis, heart failure, hypothyroidism, kidney failure, pneumonia, hypotension, depression, hemiplegia, vomited (the night and morning prior to the drug administration), ill (five days prior to the vaccination) and constipation. Concomitant medication included trimethoprim (IDOTRIM, reported as: IDOTRIM 100 mg1x1), quinine sulfate (reported as: QUININE SULFATE 200 mg 1x1), levothyroxine sodium (tablet, reported as: LEVAXIN 0,05mg), levothyroxine sodium (reported as: LEVAXIN 0,10 mg), mirtazapine (reported as: MIRTAXZAPIN KRKA 30 mg 1x1), potassium chloride (reported as: KALEORID 750 mg 2x1), melatonin (reported as: CIRCADIN 2mg 2x1), paracetamol (reported as: PANODIL 1grx3), clopidogrel besylate (CLOPIDOGREL ACTAVIS, reported as: CLOPIDOGREL ACT 75 mg 1x1), furosemide (reported as: FURIX 40 mg 2x1), magnesium hydroxide (MAGNESIA MEDIC, reported as: MAGNESIA MED 1x1). Clinical course: Five days prior to the vaccination the patient had been ill and vomited the night and morning prior to the drug administration. It was considered that the event, vomiting, could be related to constipation. The patient did not have fever. On 22Jan2021, the morning after the vaccination, the patient experienced fever and decreased oxygen saturation. The patient was hospitalized where he passed away on 22Jan2021 due to respiratory failure. The patient died shortly after arriving to hospital. The patient died on 22Jan2021. It was not reported if an autopsy was performed. The outcome of event ''fever and decreased oxygen'' saturation was not recovered. Reporter''s comments: "The reporter does not have a reason to suspect that there is a direct link between the vaccination and the cause of death." Sender Comment: "Second vaccination with Comirnaty"; Reporter''s Comments: The reporter does not have a reason to suspect that there is a direct link between the vaccination and the cause of death.; Reported Cause(s) of Death: Respiratory failure


VAERS ID: 1016786 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   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: Chronic kidney disease; Diabetes; Epilepsy; Ischemic heart disease; Obesity (moderately obese)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021113660

Write-up: Sudden death; Nausea; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) BE-FAMHP-DHH-N2021-75620 and received via Regulatory Authority (FAMHP). An elderly patient of an unspecified gender received bnt162b2 (COMIRNATY), on 16Jan2021 at SINGLE DOSE for COVID-19 vaccination. Medical history diabetes, ischemic heart disease, epilepsy, chronic kidney failure, no frailty, moderately obese, all unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced nausea on an unspecified date in Jan2021, sudden death on 17Jan2021. The outcome of events was fatal. The patient died on 17Jan2021. An autopsy was not performed. Reporter Comment: The only argument for causality is the sudden unexpected death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: The only argument for causality is the sudden unexpected death.; Reported Cause(s) of Death: nausea; sudden unexpected death


VAERS ID: 1016796 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021113666

Write-up: Death; Hypertensive crisis; Pulmonary edema; This is a spontaneous report downloaded from the Medicines Agency (EMA) EudraVigilance-WEB DE-PEI-PEI2021001925. This is a report received from the Regulatory Authority. A non-contactable physician reported that a 71 years old male patient received the first dose of BNT162B2 (COMIRNATY) intramuscularly, at single dose, on 10Jan2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 10Jan2021, 30 minutes after the vaccination, the patient developed hypertensive crisis and pulmonary oedema. The patient died. Unknown cause of death was reported. It was unknown if autopsy was done. All events were reported with fatal clinical outcome. Relatedness of drug to all reaction(s)/event(s) was reported as D. Unclassifiable (by PEI). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death; Hypertensive crisis; Pulmonary edema


VAERS ID: 1016797 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac insufficiency; Cerebral infarction; Dementia; Fever; General physical health deterioration; Hemiparesis; Hypothyroidism; Pulmonary arterial hypertension; Tachyarrhythmia absoluta; Thrombosis; Unresponsive to verbal stimuli
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021113659

Write-up: Pneumonia; Respiratory infection; This is a spontaneous report from a non-contactable Physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021001943. This is a report received from the Regulatory Authority. A 83-year-old female patient received the first dose of BNT162B2 (COMIRNATY), Intramuscular on 13Jan2021 at single dose for COVID-19 immunisation. Medical history included Cardiac insufficiency, Pulmonary arterial hypertension, Hemiparesis, Hypothyroidism, Thrombosis, Atrial fibrillation, Tachyarrhythmia absoluta, Dementia, Cerebral infarction, Unresponsive to verbal stimuli, General physical health deterioration, Fever. Concomitant medication was not reported. After vaccination on unknown date the patient developed Pneumonia and Respiratory tract infection. The patient is died on 16Jan2021. Autopsy was not done. Death cause was reported as Pneumonia. The outcome of Respiratory infection was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1016798 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-01-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Atrial fibrillation; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021113669

Write-up: found lifeless at 2.30 p.m/developed Sudden death, cause unknown/patient was dead; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB regulatory authority DE-PEI-PEI2021001950. An 88-year-old male patient received first dose of bnt162b2 (COMIRNATY, Lot number EK9788), intramuscularly on 31Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included Dementia, Apoplexy, Atrial fibrillation. Concomitant medications were not reported. The patient was found lifeless at 2.30 pm. 3 hours after vaccination the patient developed Sudden death, cause unknown. The patient was dead on 31Jan2021. The patient was treated with unsuccessful reanimation. Death cause was reported as Sudden death, cause unknown. It was unknown if autopsy was done. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1016800 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical condition abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 22
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 INC2021113664

Write-up: Death; Deterioration of the general condition; This is a spontaneous report from a consumer downloaded from the Medicines Agency (MA) Regulatory Authority-WEB Regulatory Authority number DE-PEI-PEI2021001954. A 99-year-old female patient received bnt162b2 (COMIRNATY, lot number not provided), via an unspecified route of administration on 06Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On the same day after vaccination the patient developed General physical condition abnormal and Death, lasting for unknown. The patient is died on 28Jan2021. Death cause was reported as Sudden death, cause unknown. General physical condition abnormal stop date 28Jan2021. The outcome of event General physical condition abnormal was unknown. The patient died on 28Jan2021. It was not reported if an autopsy was performed. Comirnaty/ Death,General physical condition abnormal/ Regulatory Authority/ D. Unclassifiable No follow-up attempts are possible. Batch/Lot# and expiry date not provided and not possible to obtain.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1016802 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   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: Medical History/Concurrent Conditions: Brain damage; Hypertension arterial; Mental disability (from early childhood brain damage); Quincke''s edema (History of Quincke edema as an allergic reaction); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021113661

Write-up: Suddenly died; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB DE-PEI-PEI2021001977. A 50 years old male patient received BNT162B2 (COMIRNATY, lot number EL1491), via an unspecified route of administration on 20Jan2021 at the 50 years old at single dose for COVID-19 immunization. The medical history included Type II diabetes mellitus, Hypertension arterial, Mental disability (from early childhood brain damage), Quincke edema(History of Quincke edema as an allergic reaction) . The concomitant medications were not reported. On 27Jan2021 8 days after vaccination the patient developed Sudden death, cause unknown. The patient had Dental treatment with general anesthesia on 27Jan2021. The patient died on 27Jan2021. It''s unknown if an autopsy was performed. The cause of death was reported as Sudden death, cause unknown. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1016804 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bloody stool; Coronary insufficiency; Dementia; Diabetes mellitus; Gastroenteritis; Renal insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positiv/positive
CDC Split Type: DEPFIZER INC2021113670

Write-up: lack of efficacy; corona infection; This is a spontaneous report from a non-contactable Physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021002000. This is a report received from the Regulatory Authority. An 87-year-old female patient received the first dose of BNT162B2 (COMIRNATY, batch/lot number: EM0477), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunisation. Medical history included coronary insufficiency, renal insufficiency, diabetes mellitus, dementia, gastroenteritis, bloody stool. The patient''s concomitant medications were not reported. Unknown date in Jan2021 after vaccination the patient developed COVID-19, lasting for unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positiv/positive on 19Jan2021, diagnosis was confirmed by COVID-19 PCR test. The patient died on 19Jan2021. Death cause was reported as COVID-19. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1016809 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Coronary heart disease ((3 vessel disease)); Immobile; Nephropathy; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021120572

Write-up: COVID-19 test positive; COVID-19 test positive; upper respiratory infection; This is a spontaneous report from a contactable other health professional and physician received via local (Federal State) health authority. A 98-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number EJ6796) , intramuscular on 30Dec2020 at single dose on left arm for covid-19 immunisation. Medical history included coronary artery disease (3 vessel disease) , Alzheimer disease, type II diabetes mellitus with nephropathy, immobility in the presence of palliative situation. The patient''s concomitant medications were not reported. The patient experienced covid-19 test positive on 07Jan2021, upper respiratory infection on 05Jan2021. On 05Jan2021 the patient incurred infection of the upper respiratory tract. The diagnosis was made based on clinical signs. The symptoms were typical and did not give evidence of vaccination reaction. The patient required outpatient treatment and was hospitalized due to the event. On 06Jan2021 she was diagnosed with infection of the upper airways. She was tested for Covid which gave a positive result for COVID on 07Jan2021. She was hospitalized out of caution given her polymorbid status. The patient underwent lab tests and procedures which included COVID-19 test: positive on 07Jan2021. Therapeutic measures were taken as a result of events. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective,COVID-19, and Upper respiratory infection cannot be totally excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: COVID-19 test positive; COVID-19 test positive; upper respiratory infection


VAERS ID: 1016810 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Upper gastrointestinal haemorrhage
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Hemiparesis; Immobile
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: COVID-19 testing; Test Result: Positive
CDC Split Type: DEPFIZER INC2021120633

Write-up: suspicion of upper intestinal bleeding/gastrointestinal bleeding; COVID-19 testing on 06Jan2021 showed positive; COVID-19 testing on 06Jan2021 showed positive; This is a spontaneous report from State Office for Health and Social Affairs via BioNTech. A contactable consumer and physician reported that an 83-year-old male patient received first dose of bnt162b2 (COMIRNATY) Lot # EJ6796, intramuscular in the left upper arm on 30Dec2020 at single dose for covid-19 prophylaxis. Medical history included apoplexy cerebral with hemiparesis from 2018, immobility and ongoing hypertension. The patient''s concomitant medications were not reported. It was reported that on 06Jan2021 home visit for urgent suspicion of upper intestinal bleeding/gastrointestinal bleeding, emergency admission to hospital and the patient was hospitalized on 06Jan2021. Precautionary COVID-19 testing on 06Jan2021 showed positive. Diagnosis: Purely clinical diagnosis for hematine vomiting. Comirnaty was not administered again. The patient did not experience any adverse events. No outpatient treatment was required. The vaccination reaction was not life threatening.The outcome of the event COVID-19 testing showed positive was unknown. The patient died on an unspecified date in 2021.It was unknown if an autopsy was performed.; Sender''s Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset. The upper gastrointestinal haemorrhage with fatal outcome is most likely due to the patient''s underlying conditions, unrelated to BNT162B2 vaccination. 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: suspicion of upper intestinal bleeding/gastrointestinal bleeding


VAERS ID: 1016816 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2021-01-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchospasm, Death, Physical examination, Pneumonia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SALBUTAMOL; TIOTROPIUM BROMIDE; PREDNISONE; RISPERIDONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (BODE 6 (Stage III, SEVERE) under home oxygen therapy,); Depressive disorder; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Name: BODE; Result Unstructured Data: Test Result:6 (Stage III, SEVERE)
CDC Split Type: ESPFIZER INC2021069714

Write-up: Bronchospasm; bilateral pneumonia; passed away; A 74-years-old female patient started to receive bnt162b2 (COMIRNATY) , intramuscular from 27Dec2020 to an unspecified date at 0.3 mL, single for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced passed away (death) (death) on 09Jan2021 , bronchospasm (bronchospasm) (hospitalization) on 02Jan2021 with outcome of unknown , bilateral pneumonia (pneumonia) (hospitalization, medically significant) on Jan2021 with outcome of unknown. The patient was hospitalized for bronchospasm (bronchospasm) from Jan2021 to an unknown date. The patient was hospitalized for bilateral pneumonia (pneumonia) from Jan2021 to an unknown date. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of bilateral pneumonia (pneumonia). The patient died on 09Jan2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: passed away


VAERS ID: 1016828 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Dysphonia, Dyspnoea, Fatigue, Pneumonia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Urinary tract infection (for several years)
Preexisting Conditions: Medical History/Concurrent Conditions: Apathy; Eating disorder
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Test Date: 202101; Test Name: body temperature; Result Unstructured Data: Test Result:gradually rose to 39.1 Centigrade
CDC Split Type: FIPFIZER INC2021114349

Write-up: Pneumonia; breathing turned hoarse; shortness of breath; exceptionally tired; temperature 37.4 Centigrade, gradually rose to 39.1 Centigrade; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (FI-FIMEA-20210307). A 95-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 19Jan2021 at single dose (also reported as 1DF, x1) for COVID-19 immunization. Medical history included apathetic, eating and drinking became difficult, and ongoing chronic urinary tract infection for several years. The patient''s concomitant medications were not reported. Clinical course: From the autumn onwards, the patient''s condition in the nursing home gradually faded, becoming more apathetic. Eating and drinking became difficult. Hospital transportation and fluid therapies were previously excluded, from the convalescence treatment was under consideration. Chronic urinary tract infection ongoing for several years. On 19Jan2021, the patient received the COVID vaccine. On 23Jan2021, patient started shortness of breath, has been exceptionally tired. Temperature 37.4 Centigrade. The temperature gradually rose to 39.1 Centigrade, breathing turned hoarse on the morning of death. The patient died on due to pneumonia symptoms on 25Jan2021. It was not reported if an autopsy was performed. There is no clear link to the vaccine, but it was reported as a possible side effect. The outcome of events ''shortness of breath, exceptionally tired, temperature 37.4 Centigrade, gradually rose to 39.1 Centigrade and breathing turned hoarse'' was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1016830 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiac failure, Dyspnoea, Renal failure, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: NORSPAN [BUPRENORPHINE]; PRIMASPAN; FURESIS; PANADOL FORTE [CAFFEINE;PARACETAMOL]; CALCICHEW D3 EXTRA APPELSIINI; ATORVASTATIN ORION; BISOPROLOL ACTAVIS; MELATONIN ORION; ORMOX; ELIQUIS
Current Illness: Coronary heart disease; Heart failure (ward periods due to heart failure.); Renal insufficiency (Treatment was complicated by severe renal impairment.)
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Hypertension; Memory impairment; Myocardial infarction (During the last year of life, the latter treated conservatively.)
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: blood tests; Result Unstructured Data: Test Result:End-stage renal disease
CDC Split Type: FIPFIZER INC2021114193

Write-up: severe lower body swelling; increased shortness of breath; Cardiac failure/heart failure; Renal failure/end-stage renal disease; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, FI-FIMEA-20210328. An 80-year-old female patient received bnt162b2 (COMIRNATY, lot number unknown), via intramuscular on 19Jan2021 at single dose (reported as "1,DF,x1") for COVID-19 vaccination. The patient medical history included ongoing severe coronary heart disease, atrial fibrillation, hypertension, memory impairment caused by vascular issue, and ongoing severe renal insufficiency. During the last year of life, two myocardial infarctions, the latter treated conservatively, ward periods due to heart failure (ongoing). Treatment was complicated by severe renal impairment. Concomitant medications included buprenorphine (NORSPAN) from 01Jan2020 to 26Jan2021, acetylsalicylic acid (PRIMASPAN) from 01Jan2020 to 26Jan2021, furosemide (FURESIS) from 01Jan2020 to 26Jan2021, caffeine, paracetamol (PANADOL FORTE) from 01Jan2020 to 26Jan2021, calcium carbonate, colecalciferol (CALCICHEW D3 EXTRA APPELSIINI) from 01Jan2020 to 26Jan2021, atorvastatin calcium (ATORVASTATIN ORION) from 01Jan2020 to 26Jan2021, bisoprolol fumarate (BISOPROLOL ACTAVIS) from 01Jan2020 to 26Jan2021, melatonin (MELATONIN ORION) from 01Jan2020 to 26Jan2021, isosorbide mononitrate (ORMOX) from 01Jan2020 to 26Jan2021, apixaban (ELIQUIS) from 01Jan2020 to 26Jan2021. Information for the doctor on 26Jan2021 about severe lower body swelling and increased shortness of breath. End-stage renal disease in blood tests. Feeling relieved with dehydrating and analgesics. The patient died in nursing home on 26Jan2021. As the root cause of death on the death certificate was chronic coronary heart disease and the immediate cause of death was heart failure, a contributing factor among others end-stage renal disease. The infectious doctor instructed to make an adverse reaction report. Temporal connection to the vaccine, in reporter''s opinion no cause-and-effect relationship. The outcome of the events cardiac failure, renal failure were fatal, of the events severe lower body swelling and increased shortness of breath was unknown. The patient died on 26Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the clinical course, the fatal cardiac failure and renal failure are more likely the progression of ongoing heart failure, myocardial infarctions, severe coronary heart disease, atrial fibrillation, hypertension, and renal insufficiency, unrelated to suspect vaccine BNT162B2.; Reported Cause(s) of Death: Coronary artery disease; Cardiac insufficiency; heart failure; Renal failure/end-stage renal disease


VAERS ID: 1016832 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Hypoglycaemia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Hypoglycaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cachexia; Cognitive disorders; Fall; Operation NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021109872

Write-up: severe hypoglycemia; death, no identified cause of death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-LL20210198. This is a report received from the Regulatory Authority. A 94-year-old female patient received BNT162B2 (COMIRNATY, lot number EJ6796), via intramuscular on Tuesday 12Jan2021 at single dose in left arm for COVID-19 vaccination. The patient medical history included cachexic, cognitive disorders, falls and implantation from Dec2020. The patient concomitant medications were not provided. The patient was vaccinated on 12Jan2021 because clinically stable but 100 percent fragile who received her family in her room (vaccine equal to protect them). The patient had no symptoms in the following days (no fever, no vomiting, sweating, no diarrhea). This cachexic patient with cognitive disorders repeated fall and worsening since her implantation in mid-Dec2020. The patient died on Monday 18Jan2021 after hospitalization on Sunday 17Jan2021 for severe hypoglycemia. No link retained by the doctor, death expected. It was reported no identified cause of death. The outcome of severe hypoglycemia was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1016835 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Blood potassium, Body temperature, C-reactive protein, Cyanosis, Dyspnoea, Electrocardiogram, Hypokalaemia, Inflammation, Laboratory test, Livedo reticularis, Oxygen saturation, Pneumonia aspiration, Pulmonary embolism, Pyrexia, Rales, Respiratory distress, SARS-CoV-2 test, Suspected COVID-19, Tachycardia, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
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: DUROGESIC; LYSANXIA; ORAMORPH [MORPHINE SULFATE]; SEROPLEX
Current Illness: Deglutition disorder; Frontotemporal dementia; Primary progressive aphasia
Preexisting Conditions: Medical History/Concurrent Conditions: Aspiration; Hospitalization; Pain; Weight loss (1 kg)
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: Serum potassium; Test Result: 2.94 mmol; Test Date: 20210122; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210122; Test Name: CRP; Result Unstructured Data: Test Result:294 mg/l; Test Date: 20210122; Test Name: ECG; Result Unstructured Data: Test Result:diffuse elevations; Test Date: 20210122; Test Name: capillary refill time; Result Unstructured Data: Test Result:$g3 seconds; Test Date: 20210122; Test Name: SaO2; Test Result: 65 %; Test Date: 20210122; Test Name: SaO2; Test Result: 85 %; Test Date: 20210122; Test Name: COVID PCR test; Test Result: Negative ; Test Date: 20210122; Test Name: COVID PCR test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021109889

Write-up: laboured breathing; Distress respiratory; hyperthermia of 38?C; blood test results indicative of inflammation with CRP of 294 mg/l; Hypokalaemia of 2.94 mM; Tachycardia; Suspicion of aspiration pneumonia; Suspicion of pulmonary embolism; Suspicion of Acute coronary syndrome; Suspected COVID-19; bibasal crackles; cyanosis of the extremities; mottling on the knees; polypnoea; This is a spontaneous report from a contactable Physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The Regulatory Authority number is FR-AFSSAPS-NY20210155. A 54-year-old female patient received bnt162b2 (COMINARTY, Lot/BATCH Number EJ6795 and Expiration Date unknown) via Intramuscular on 19Jan2021 at single dose for COVID-19 vaccination.Medical history included ongoing primary progressive aphasia (PPA) with progression to frontotemporal dementia (FTD) and ongoing deglutition disorder. From 30Dec2019 to 05Jun2020: Hospitalization at a cognitive behavioural therapy unit because of difficulties in home care related to the progression of frontal progressive aphasia (PPA). Initiation of SEROPLEX to allow for an improvement in behavioural aspects. During the stay, care by a speech therapist and an occupational therapist. Nutritional care with mixed diet. Weight loss of 1 kg between hospital admission (58 kg) and discharge (57 kg). From 06Jun2020 to 23Jan2021: hospitalisation of the patient in a geriatric follow-up care and rehabilitation facility for further management of PPA.From the cognitive and behavioural perspective, evolution from progressive aphasia (PPA) to frontotemporal dementia (FTD) with progressive and total grabatisation, onset of right-sided diffuse grasping stiffness and pyramidal syndrome. Progressive loss of the ability to walk, need for wheelchair restraint due to the risk of falling. Stiffness refractory to baclofen or antiparkinsonian drugs. Progressive increase in anxiety with episodes of crying, leading to SEROPLEX dose increase (end of 2020). Nutritionally, progressive loss of autonomy, with complete nutritional support. Extremely slow swallowing and retention of food in the mouth. Associated intermittent bruxism. Progressive loss of weight (47 kg in January 2021). 02Sep2020: request for specialist consultation due to the manifestation of pain (tense facial muscles, stiffness when sitting in the chair, grabatisation with the need to use patient lift). On physical examination, the patient conscious but uncommunicative. Interaction with gaze and smile. No pain or objective anxiety. The patient calm, smiling, relaxed. No swallowing problems reported, but retention of food in the mouth was observed. Mentioned doubt about possible aspiration. Summary of the opinion: Neurological recovery not possible, progressive worsening of neurological symptoms in this context, artificial parenteral or enteral nutrition does not seem indicated in light of the absence of possible clinical recovery. Benefit/risk ratio to the disadvantage of artificial nutrition, need for an invasive procedure, daily biological monitoring at introduction. Risk of poor digestive tolerance. Orientation towards comfort feeding. Flu vaccination was given on 16Nov2020. 17Dec2020: request for a specialist consultation due to clinical deterioration over the past week, involving fatigue, feeding difficulties and pain during mobilisation, which encouraged the prescription of midazolam for anxiolytic purposes and ORAMORPH for analgesic purposes. On physical examination, the patient was uncommunicative, staring, manifesting pyramidal stiffness of the right side of the body and tension at the time of mobilisations. Abdomen soft, depressible and sensitive to palpation. Last liquid stools 3 days earlier. Mentioned difficult mouth care because the patient would not open her mouth. Absence of bronchial congestion and signs of respiratory distress. Summary of the opinion: continuation of midazolam, addition of DUROGESIC and additional doses of ORAMORPH as needed, no PEG in light of advanced dementia, continuation of comfort feeding and comfort mouthwashes. From the end of December to mid-January: no specific pulmonary symptoms. Eupneic, uncongested patient. The concomitant drug included fentanyl (DUROGESIC), prazepam (LYSANXIA), morphine sulfate (ORAMORPH), escitalopram oxalate (SEROPLEX).During the night of 22/23Jan2021, onset of respiratory distress (SaO2 65%), signs of laboured breathing, mottling, hyperthermia of 38 centigrade and blood test results indicative of inflammation with CRP of 294 mg/l. Hypokalaemia of 2.94 mM. ECG: diffuse elevations. Tachycardia. Suspicion of aspiration pneumonia, pulmonary embolism, Acute coronary syndrome (ACS) or COVID infection. Finally, COVID PCR test result negative. Adaptation of treatment with midazolam and morphine, then transfer to a palliative care unit. On admission: patient awake, eyes wide open, shaking hands, but not communicating verbally. Patient was calm, oxygenated (SaO2 85percent despite 15 l/min), polypnoeic (60 cycles/min), no bronchial congestion but with bibasal crackles, cyanosis of the extremities, capillary refill time $g3 seconds, mottling on the knees, soft, depressive and painless abdomen. No vomiting. Administration of midazolam and morphine bolus, which did not result in respiratory improvement. Decision to establish deep and continuous sedation. Persistence of polypnoea (40 cycles/min), spontaneous awakenings, the patient wincing. Increased dosing of midazolam and morphine (bolus and continuous infusion). 24Jan2021: patient calm, comfortable throughout the day. Death reported on 24Jan2021 at 7:14 p.m. Furthermore, the second COVID PCR test result negative. Unknown if autopsy was done. The outcome of events were fatal with treatment given. Conclusion: A 54-year-old patient with a history of primary progressive aphasia (PPA) with progression to frontotemporal dementia (FTD), complete grabatisation with total loss of autonomy, particularly with regard to eating with probable swallowing disorders, who died due to respiratory distress on Day 3 following COVID-19 vaccination with COMIRNATY (batch EJ6795). Suspected aspiration pneumonia, pulmonary embolism, acute coronary syndrome or COVID infection. Two COVID PCR test results negative. No reports of vomiting after vaccination. Comment by the Regional Pharmacovigilance Centre (CRPV): Recorded report for information backup. Unable to establish a causal relationship for the vaccine. Therefore, the fields have been deliberately left blank.; Reported Cause(s) of Death: laboured breathing; Distress respiratory; hyperthermia of 38?C; Inflammation; Hypokalaemia; Tachycardia; Suspicion of aspiration pneumonia; Suspicion of pulmonary embolism; Suspicion of Acute coronary syndrome (ACS); Suspicion of COVID infection; bib


VAERS ID: 1016837 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Neoplasm malignant
SMQs:, Non-haematological malignant tumours (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: Cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021119849

Write-up: death due to generalized cancer; This is a spontaneous report from a contactable physician received via a sales representative and a contactable consumer. An elderly male patient of unknown age received bnt162b2 (COMIRNATY) on unknown date at single dose for COVID-19 immunization. Medical history included ongoing generalized cancer. Concomitant medication was not reported. The patient died more than 7 days after receiving the vaccine. The patient was not stable; one day he was fine, another day he was much worse. The medical team and the patient''s family considered the death was due to generalized cancer and not to the vaccination at all. It was unknown if the autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on available information, the death was due to generalized cancer and not to the Bnt162b2 vaccination.; Reported Cause(s) of Death: death due to generalized cancer


VAERS ID: 1016850 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE HYDROCHLORIDE; BENDROFLUMETHIAZIDE; LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021115589

Write-up: Unexpected death/Sudden death; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-TPP6830445C3201090YC1611838428741, Safety Report Unique Identifier GB-MHRA-ADR 24684468. A 84-year-old male patient received bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included amitriptyline hydrochloride from 06Jan2020, bendroflumethiazide and lisinopril both from 31Mar2020. Unexpected death a day after the vaccine. History hypertension otherwise well and fit man. Sudden death on the morning after the vaccine. The outcome of the event was fatal. Possibly unrelated to vaccine. The patient died on 29Jan2021. An autopsy was not performed yet (Awaiting post-mortem). 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 event sudden death cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Unexpected death/Sudden death


VAERS ID: 1016981 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Off label use, Product use issue, SARS-CoV-2 test, Virologic failure
SMQs:, Lack of efficacy/effect (narrow), Medication errors (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: 23
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: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021115689

Write-up: Virologic failure; SARS-CoV-2 infection; SARS-CoV-2 infection; Taking regular medicines for rheumatoid arthritis, received BNT162B2; Taking regular medicines for rheumatoid arthritis, received BNT162B2; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202102021534304120, Safety Report Unique Identifier GB-MHRA-ADR 24686672 A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr..). Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced SARS-CoV-2 infection on 24Jan2021 (also reported as suspected COVID-19 from 24Jan2021 to 01Feb2021),Virologic failure, serious criteria reported as death. Not a vaccine reaction as such but unexpected COVID related death in patient who was vaccinated 2 weeks prior to positive test dies a week later after positive test. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive covid-19 test on 24Jan2021. The patient died on 01Feb2021. The outcome of rest events was unknown. 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: SARS-CoV-2 infection; Virologic failure; SARS-CoV-2 infection


VAERS ID: 1016987 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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:
Current Illness: Nerve pain (ongoing for 6+ months)
Preexisting Conditions: Comments: Only medical issue was nerve pain in leg, ongoing for 6+ months Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021115177

Write-up: Death; This is a spontaneous report received from a contactable consumer by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202102031718302370 and Safety Report Unique Identifier GB-MHRA-ADR 24694433. A 91-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing nerve pain in leg, ongoing for 6+ months. Patient had not had symptoms associated with COVID-19. He did not have a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. The patient experienced death on 24Jan2021. The cause of death was unknown. The patient died on 24Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1016989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-21
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Pneumonitis, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCAL D3; AMLODIPINE; ATORVASTATIN; EDOXABAN; LANSOPRAZOLE; LOSARTAN; PARACETAMOL; SALBUTAMOL; TRIMIPRAMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021115665

Write-up: Pneumonitis; Drug ineffective; Covid-19; This is a spontaneous report from a contactable healthcare professional, received from the Regulatory authority report number GB-MHRA-WEBCOVID-202102031728405430, Safety Report Unique Identifier GB-MHRA-ADR 24694509. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Jan2021 at single dose for COVID-19 immunization, via an unspecified route of administration. Medical history included suspected covid-19 on 17Jan2021. Concomitant medication included calcium carbonate, colecalciferol (ADCAL D3), amlodipine, atorvastatin, edoxaban, lansoprazole, losartan, paracetamol, salbutamol, trimipramine. The patient experienced pneumonitis on 21Jan2021 and the sars-cov-2 test was positive on 21Jan2021. The patient died on 23Jan2021. It was not reported if an autopsy was performed. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonitis


VAERS ID: 1017010 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Loss of consciousness, Sudden death
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: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Smoker; Vitiligo
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021123254

Write-up: passing of brother-in-law (husband''s brother) for an unknown reason/ died suddenly; short of breath; lost consciousness; This is a spontaneous report from a contactable consumer (patient''s brother-in-law) via Pfizer colleague. A 54-year-old male patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. Medical history included vitiligo, asthma, smoking. The patient''s concomitant medications were not reported. The reporter reported the passing of brother-in-law (husband''s brother) for an unknown reason, 5 days after receiving the Corona vaccine. The patient received a vaccine last Thursday 28Jan2021, and on Tuesday 02Feb2021 died suddenly. Felt well, suddenly felt short of breath and after a few minutes lost consciousness (02Feb2021). His neighbor, a cardiologist, performed resuscitation operations on him and he said there was no cardiac arrest or arrhythmia. The family refused to perform an autopsy and also did not currently claim a connection to the vaccine. The patient died on 02Feb2021. An autopsy was not performed. The outcome of the events "short of breath" and "lost consciousness" was unknown, of the other event was fatal. Information about the lot/batch number has been requested.; Reported Cause(s) of Death: passing of brother-in-law (husband''s brother) for an unknown reason


VAERS ID: 1017058 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood test, Computerised tomogram head, Computerised tomogram thorax, General physical health deterioration, Restlessness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: Cardiac failure; Renal failure
Preexisting Conditions: Medical History/Concurrent Conditions: Arm fracture (Right arm. Occurred 10 days before the patient was hospitalised.); Cerebral infarction; Hemiparesis; Living in residential facility; Walking aid user
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: Blood test; Result Unstructured Data: Test Result:Relatively normal findings, no signs of infection.; Test Date: 20210119; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:No pathology.; Test Date: 20210119; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:Bilateral pleural effusion.
CDC Split Type: NOPFIZER INC2021113662

Write-up: UNREST; REDUCED GENERAL CONDITION; ALTERED STATE OF CONSCIOUSNESS; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority-WEB. Regulatory authority or other manufacturer number NO-NOMAADVRE-FHI-2021-U3xjy. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY) , intramuscular on 14Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included ongoing cardiac failure , cerebral infarction, hemiparesis, arm fracture in Jan2021 (Right arm. Occurred 10 days before the patient was hospitalized), living in residential facility, walking aid user, ongoing renal failure. The patient''s concomitant medications were not reported. On 19Jan2021, the patient developed was hospitalised due to unrest, reduced general condition and subsequently altered state of consciousness. The patient''s outcome was Fatal, at the time of the report. The patient underwent lab tests and procedures on 19Jan2021 which included blood test : relatively normal findings, no signs of infection, computerised tomogram head: no pathology, computerised tomogram thorax: bilateral pleural effusion. The patient died on 20Jan2021. An autopsy was performed and results were not provided. Sender Comment: The patient had several underlying diseases and a recent arm fracture. Reporter states that no pathology was found that could explain the patient''s symptoms and that the cause of death was unclear. Preliminary autopsy report gives no clear findings for cause of death, but results from further investigations are awaited. As informed by telephone, it is possible to send information from the final autopsy report when this is available. Further dialogue about this can be done via the reporting portal. Forwarding of information will be useful for further follow-up of both this report and the further work with reports of deaths after vaccination in general. When vaccinating vulnerable, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. In the individual case, however, it is difficult to know whether the symptoms are due to a vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and or habitual condition. On the basis of the information in the report and in accordance with international criteria, the causal relationship 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 report is also classified as serious, even though a causal link between the vaccine and the death has not been established. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain.; Reported Cause(s) of Death: unrest; reduced general condition; altered state of consciousness


VAERS ID: 1017062 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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: MIDAZOLAM; SOBRIL; OXYCODONE; SAROTEX; ZOPICLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Chronic renal failure; Idiopathic pulmonary fibrosis (Late stage); Insomnia; Living in nursing home; Neuropathic pain; Pain; Palliative care
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Body temperature; Result Unstructured Data: Test Result:38.6 Centigrade
CDC Split Type: NOPFIZER INC2021113668

Write-up: RESPIRATORY FAILURE AGGRAVATED; PATCHY RASH; FEVER; This is a spontaneous report from a contactable healthcare professional downloaded from the regulatory authority (NO-NOMAADVRE-FHI-2021-Ux47n and NO-NOMAADVRE-E2B_00014380). An 85-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6795), intramuscularly, in the left arm, on 05Jan2021 at 12:40 at a single dose for COVID-19 immunisation. Medical history included idiopathic pulmonary fibrosis (late stage), palliative care, chronic renal failure, living in nursing home, anxiety, insomnia, pain, and neuropathic pain. Concomitant medications included midazolam hydrochloride taken for anxiety from 17Dec2020 to 11Jan2021, oxazepam (SOBRIL) taken for feeling anxious from 26Nov2020 to 09Jan2021, oxycodone hydrochloride taken for pain from 17Dec2020 to 11Jan2021, amitriptyline hydrochloride (SAROTEX) taken for neuropathic pain from 28Dec2020 to 09Jan2021, and zopiclone taken for insomnia from 26Nov2020 to 09Jan2021. The patient experienced respiratory failure aggravated on 06Jan2021, which was reported as fatal. The patient also experienced patchy rash and fever on 06Jan2021. It was reported that the rash and fever were transient, but the general condition gradually deteriorated. The patient stopped intake of food and fluids and his consciousness decreased. The patient gradually got worse and died a few days later. The patient underwent lab tests and procedures which included body temperature: 38.6 Centigrade in Jan2021. The clinical outcome of respiratory failure aggravated was fatal and of patchy rash and fever was recovering (also reported to have recovered on 08Jan2021). The patient died on 11Jan2021. The cause of death was assessed as respiratory failure aggravated. It was not reported if an autopsy was performed. The causality for the suspect product to all of the events was reported as possible by the Regional Pharmacovigilance Center. Sender''s Comment: The vaccine is non-living and therefore cannot cause diseases it is vaccinated against for or any other infections. Non-specific disease symptoms may nevertheless occur in the first days after vaccination with all vaccines. A large proportion of those vaccinated in the Comirnaty studies reported fatigue, joint and muscle pain, and a small proportion developed fever and chills after this vaccine. Such symptoms are usually short-lived and transient. However, we cannot rule out that such relatively mild side effects as mentioned above may become more pronounced and / or lead to a more serious course in severely debilitated patients. In each case, it is difficult to know whether the symptoms are due to a vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. On the basis of the information in the report and in accordance with international criteria, the causal relationship 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 report is also classified as serious, even though a causal link between the vaccine and the death has not been established.; Reported Cause(s) of Death: RESPIRATORY FAILURE AGGRAVATED


VAERS ID: 1017063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

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:
Current Illness: Cognitive impairment; Living in nursing home; Multimorbidity; Supraventricular tachycardia (SVT-AVRT)
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Atrial fibrillation; AV block; Frailty (Fragile patient, but was mobilized using a pulpit and support.); Tumor (Lung tumor of some size ( unknown if primary tumor or metastasis? Cancer orio incerta?).)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021113657

Write-up: DEATH; This is a spontaneous report a contactable physician downloaded from the Regulatory Authority-WEB [regulatory authority NO-NOMAADVRE-FHI-2021-Uy5gx], Safety Report Unique Identifier [NO-NOMAADVRE-E2B_00014308] A 88-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot# EM0477) via Intramuscular in left arm on 19Jan2021 at single dose for COVID-19 immunisation. The medical history included living in nursing home, multimorbidity, abdominal aortic aneurysm, atrial fibrillation, supraventricular tachycardia, tumor, frailty, AV block, cognitive impairment. On 21Jan2021, the patient developed death. It''s unknown if autopsy was performed. The case was considered to be Serious. It was also reported that "J07BX - Other virus vaccines". Reporter''s comment: Mulitmobid patient. Concomitant diseases: AAA (ABDOMINAL AORTIC ANEURYSM), stroke, atrial fibrillation, SVT-AVRT, AV block, cognitive impairment, lung tumor (primary or metastasis? Cancer orio incerta?). Fragile patient, but was mobilized using a pulpit and support. Additional information obtained by regional pharmacovigilance center (by phone) 29Jan2021: Telephone conversation 29Jan2021 with both the notifier (shift doctor) and the supervising doctor at the nursing home: The patient was admitted to the nursing home in 2019. She was a reduced patient with heart failure and dementia. Tumor in the lungs of some size, unknown whether metastasis or primary tumor. It was considered not to investigate the tumor further, but to treat her symptomatically. Before vaccination, she had a short life expectancy, estimated at a few months, but it was not expected that she would die now. She did not have terminal care until the vaccine was administered. The day after the vaccine was given, she became worse in the evening, and she was examined by the doctor on duty and morphine was prescribed. The course was unexpectedly sudden and she died the next day, ie two days after the vaccine was administered. She died peacefully. The cause of death was reported as a side effect of drug in therapeutic dose. This was based on the fact that it went unexpectedly fast, and there was no warning that she was going to die. She had no infections or other proven causes for her death , and she was up and walking before the vaccine was administered. Based on this and closeness in time, the local doctors considered that there was a clear / probable connection with the vaccine. Sender''s comment: additional information on drug provided in product notes. Sender Comment: 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 random, 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 relationship 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 report is also classified as serious, even though a causal link between the vaccine and the death has not been established. Drug-reaction / Event Matrix: possible per Regional Pharmacovigilance Center No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1018310 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30042698 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SCIPPA; SEVENAL; QUAMATEL; MEFORAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular block first degree; Bladder cancer; Chronic gastritis; Coronary sclerosis; Depression; Emphysema pulmonary; Strangulation ileus; Type 2 diabetes mellitus; Urinary bladder excision
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: Death; A regulatory authority report was received from a physician, concerning a 78 year-old male patient, who received Moderna''s COVID-19 Vaccine and patient died. The patient''s medical history included strangulation ileus, depression, atrioventricular block first degree, coronary sclerosis, emphysema pulmonary, type 2 diabetes mellitus, urinary bladder excision, chronic gastritis, and bladder cancer. Products known to have been used by the patient, within two weeks prior to the event, included escitalopram oxalate, phenobarbital, famotidine, and metformin hydrochloride. On 16 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number 30042698) for COVID-19 infection prophylaxis. The patient died on the day of vaccination. The reporter stated that the patient had several chronic concurrent diseases at the time of the vaccination, however, the patient was in a fair general condition for the vaccination. It was reported that the patient was well-oriented and after the vaccination, no abnormalities were detected during the observation period. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 16 Jan 2021. The autopsy was performed and the causes of death were reported as bronchitis, cardiac failure and arteriosclerosis. The reporter assessed the causality as unlikely related between the event and mRNA-1273. Follow-up received on 01 Feb 2021 included NNI.; Reporter''s Comments: An 78 year old vaccinated patient died on the day of vaccination. He had several chronic concurrent diseases at the time of the vaccination. However, The patient was in a fair general condition for the vaccination, he was well-oriented. After the vaccination, no abnormalities were detected during the observation period. The autopsy was performed and the causes of death were reported as bronchitis, cardiac failure and arteriosclerosis. Based on above there is an unlikely the causal relationship between the suspect vaccine and the death of the patient. The case is serious due to the patient''s death as reported. Further information is expected. The autopsy was performed and the causes of death were reported as bronchitis, cardiac failure and arteriosclerosis.; Reported Cause(s) of Death: bronchitis; cardiac failure; arteriosclerosis


VAERS ID: 1021345 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2021-01-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210103; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Test Result:Positive
CDC Split Type: DEPFIZER INC2021120231

Write-up: COVID-19 confirmed by positive COVID-19 rapid POC test; COVID-19 confirmed by positive COVID-19 rapid POC test; This is a spontaneous report downloaded from the Regulatory Authority WEB, Regulatory Authority number: DE-PEI-PEI2021002013. A non-contactable physician reported that a 94-years-old male patient received the first dose of BNT162B2 (COMIRNATY) at single dose, on 27Dec2020, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 03Jan2021, the patient developed COVID-19, confirmed by positive COVID-19 rapid POC test. The patient died on an unspecified date, in 2021 due to COVID-19. Autopsy was done but autopsy results were not available at time of this report. Relatedness of drug to reactions/events: Source of assessment: PEI Result of Assessment: D. Unclassifiable. The information on the lot number has been requested.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 rapid POC test; COVID-19 confirmed by positive COVID-19 rapid POC test


VAERS ID: 1021688 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-01-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer (right tonsillar cancer (didn''t respond to radical RT); progressed to wrapping round carotid artery); Carotid artery disease (at risk of carotid blow out); Loss of consciousness; Tonsil cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021121500

Write-up: Bleeding; cough; This is a spontaneous report received from a contactable pharmacist by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202102040951453770 and GB-MHRA-ADR 24696970. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0739), via an unspecified route of administration, on 30Jan2021 at a single dose for COVID-19 immunization. Medical history included loss of consciousness, neoplasm malignant (patient had large right tonsillar cancer which didn''t respond to radical RT which he completed end of last year and within a couple of months of completing his treatment progressed significantly locally with his disease wrapping round his carotid artery), large right tonsillar cancer, and disease wrapping round his carotid artery (at risk of carotid blow out). The patient did not have any symptoms associated with COVID-19 and did not have a COVID-19 test. The patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received radical radiotherapy (RT) for large right tonsillar cancer, which didn''t respond to treatment. The patient experienced bleeding on 31Jan2021, which was reported as medically significant and fatal. The patient also experienced cough on 30Jan2021, which was reported as medically significant. The clinical course was reported as follows: The patient developed a cough and then following day after vaccination, he had a claustrophobic bleed at home that was fatal. The bleed was reported to be related to cancer. The clinical outcome of bleeding was fatal and of cough was unknown. The patient died on 31Jan2021. The cause of death was assessed as bleeding (no cause reported). It was not reported if an autopsy was performed. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: bleeding


VAERS ID: 1021727 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical health deterioration, Pain
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: ILPFIZER INC2021138413

Write-up: death; his condition has been deteriorating recently; pain all over his body; This is a spontaneous report from a contactable physician. A 92-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death on unknown date, his condition has been deteriorating recently on an unspecified date with outcome of unknown, pain all over his body on an unspecified date with outcome of unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the limited information available the event death is attributed to patient''s advanced age and the deterioration of his general physical health and assessed unrelated to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1021897 (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: 2021-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL 1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Fatigue, General physical health deterioration, Heart rate, Heart rate increased, Illness, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Respiratory rate increased, SARS-CoV-2 test, Vascular dementia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (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: 2021-01-01
   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: MIDAZOLAM; ALVEDON; HALDOL; CILAXORAL; ROBINUL; FURIX [FUROSEMIDE]; XYLOCAIN [LIDOCAINE HYDROCHLORIDE]; ELOCON; MORFIN [MORPHINE]; MINIFOM; OXASCAND; MINIDERM [GLYCEROL]; FLUTIFORM; AIROMIR [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Illness; Multi-infarct dementia
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: body temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Test Date: 202101; Test Name: heart rate; Result Unstructured Data: Test Result:increased; Test Date: 202101; Test Name: oxygen saturation; Test Result: 90 %; Test Date: 202101; Test Name: increased respiratory rate; Result Unstructured Data: Test Result:increased; Test Date: 202101; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021118804

Write-up: Death; Multi-infarct dementia; ill; fever (38.8 degrees); wheezing; decreased saturation (90%); increased respiratory rate; increased heart rate; reduced general condition; tired and exhausted; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, Regulatory Authority number SE-MPA-1611931338628. Other case identifier number SE-MPA-2021-002100. A 94-year-old female patient received bnt162b2 (COMIRNATY, Batch/lot number: EL 1484), via intramuscular on an unspecified date in Jan2021 at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history included multi-infarct dementia from an unspecified date, seriously ill from an unspecified date to Nov2020. The patient''s concomitant medications included midazolam, paracetamol (ALVEDON), haloperidol (HALDOL), sodium picosulfate (CILAXORAL), glycopyrronium bromide (ROBINUL), furosemide (FURIX), lidocaine hydrochloride (XYLOCAIN), mometasone furoate (ELOCON), morphine (MORFIN), simethicone (MINIFOM), oxazepam (OXASCAND), glycerol (MINIDERM), fluticasone propionate/formoterol fumarate (FLUTIFORM), salbutamol sulfate (AIROMIR). Reported adverse event term was death. According to the reporter, four days after the vaccination with bnt162b2 (Jan2021), the woman became ill with fever (38.8 degrees), wheezing, decreased saturation (90%), increased respiratory rate and heart rate, reduced general condition, tired and exhausted. The woman died within 16 hours. COVID- test was negative. As the cause of death, the reporter stated the high age and multi-infarct dementia-vaccine impact. According to the reporter, the woman was seriously ill, unclear diagnosis, at the end of Nov2020 but recovered. It was unknown if an autopsy was performed. Report assessed as serious, death.; Reported Cause(s) of Death: fever (38.8 degrees); wheezing; decreased saturation (90%); increased respiratory rate; increased heart rate; reduced general condition; tired and exhausted; ill; Multi-infarct dementia; Death


VAERS ID: 1023334 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMINE B COMPLEX; METFORMIN; PARACETAMOL; LEVODOPA/CARBIDOPA; LACTULOSE; VALERIAN ROOT EXTRACT; VIDISIC CARBOGEL; ZOPICLON; OXAZEPAM; SINEMET
Current Illness: Parkinson''s disease; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021126257

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from the Regulatory Authority. LAREB. Regulatory authority report number was NL-LRB-00437379. An 85-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EM0477), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunisation. Ongoing medical history included type 2 diabetes mellitus and Parkinson''s disease. Concomitant medications included vitamin b complex (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), paracetamol (MANUFACTURER UNKNOWN), carbidopa/levodopa (MANUFACTURER UNKNOWN), lactulose (MANUFACTURER UNKNOWN), valeriana officinalis root/valeriana officinalis root extract (VALERIAN ROOT EXTRACT), carbomer (VIDISIC CARBOGEL), zopiclone (MANUFACTURER UNKNOWN), oxazepam (MANUFACTURER UNKNOWN), and carbidopa/levodopa (SINEMET); all taken for unknown indications from unknown dates and unknown if ongoing. On 29Jan2021, the patient died. The clinical course was as follows: The patient had no complaints on the day of vaccination and the day after vaccination. The day after vaccination, the patient even practiced with the physiotherapist on the theravital (exercise bicycle). The morning of the 2nd day after the vaccination, the patient was found dead in bed due to care. It was not reported if an autopsy was performed. The cause of death was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1024954 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood gases, Blood lactic acid, Blood pressure measurement, Body temperature, Brain natriuretic peptide, C-reactive protein, Cardiac failure, Cardiovascular examination, Chest X-ray, Chronic obstructive pulmonary disease, Culture urine, Electrocardiogram, Emergency care examination, Gastrointestinal examination, Haemoglobin, Heart rate, Neutrophil count, Oxygen saturation, PCO2, PO2, Pulmonary function test, Respiratory rate, SARS-CoV-2 test, White blood cell count, pH body fluid
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: RIVAROXABAN; ACEBUTOLOL; ATORVASTATIN; RAMIPRIL; FUROSEMIDE; DIFFU K; RISPERIDONE; PARACETAMOL; LEVOTHYROXINE; INSULIN GLARGINE; NOVORAPID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse event NOS; Angina of effort; Delusional disorder, unspecified type; Dyslipidemia; Hypothyroidism; Intracerebral hemorrhage; Ischemic heart disease; Obesity hypoventilation syndrome (ventilation under oxygen therapy 2L / minute. Patient refusing the NIV); Pulmonary embolism; Stent placement; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: HCO3; Result Unstructured Data: Test Result:46.5 mM; Test Date: 20210123; Test Name: HCO3; Result Unstructured Data: Test Result:44mM; Test Date: 20210123; Test Name: Blood gas; Result Unstructured Data: Test Result:Respiratory acidosis with hyperoxaemia with metabo; Comments: Respiratory acidosis with hyperoxaemia with metabolic compensation attempt; Test Date: 20210123; Test Name: Blood gas reading after 1.5 hrs. of NIV; Result Unstructured Data: Test Result:Improvement in hypercapnic acidosis; Test Date: 20210123; Test Name: lactic acid; Result Unstructured Data: Test Result:0.5 mM K+ 4.3mM; Comments: non-invasive ventilation (NIV) administered; Test Date: 20210123; Test Name: BP left arm; Result Unstructured Data: Test Result:180/84 mmHg; Test Date: 20210123; Test Name: BP right arm; Result Unstructured Data: Test Result:125/72 mmHg; Test Date: 20210122; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210123; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210123; Test Name: BNP; Result Unstructured Data: Test Result:125; Test Date: 20210123; Test Name: Cardiovascular examination; Result Unstructured Data: Test Result:increased left cardiac signs with bruits at mid-fi; Comments: increased left cardiac signs with bruits at mid-field and lower limb oedema; Test Date: 20210124; Test Name: Cardiovascular examination; Result Unstructured Data: Test Result:Bruits to 2/3 field. No other signs of heart failu; Comments: Bruits to 2/3 field. No other signs of heart failure; Test Date: 20210123; Test Name: heart exam; Result Unstructured Data: Test Result:Regular heartbeat with no audible murmur, Bruits i; Comments: Regular heartbeat with no audible murmur, Bruits in mid-field, JT and LLO ++, Soft, painless calf, No chest pain, Perceptible peripheral pulse, No sign of shock: no skin mottling, re-coloration time less than 3 seconds; Test Date: 20210123; Test Name: Lung X-ray; Result Unstructured Data: Test Result:diffuse alveolar-interstitial syndrome with no cle; Comments: diffuse alveolar-interstitial syndrome with no clear sign of acute lung oedema, no frothing in pleural sacs; Test Date: 20210123; Test Name: CRP; Result Unstructured Data: Test Result:278 mg/l; Test Date: 20210123; Test Name: Urine culture; Test Result: Negative ; Test Date: 20210123; Test Name: Dextro; Result Unstructured Data: Test Result:1.19; Test Date: 20210123; Test Name: emergency examination; Result Unstructured Data: Test Result:patient was somnolent with profuse sweating; asthe; Comments: patient was somnolent with profuse sweating; asthenia ++; Test Date: 20210123; Test Name: abdomen examination; Result Unstructured Data: Test Result:Soft, painless, large BHA +, no palpated masses; Comments: Soft, painless, large BHA +, no palpated masses; Test Date: 20210123; Test Name: Hb; Result Unstructured Data: Test Result:10.4 g/dl; Test Date: 20210123; Test Name: pulse rate; Result Unstructured Data: Test Result:79 beats per minute; Test Date: 20210123; Test Name: neutrophils; Result Unstructured Data: Test Result:predominant; Test Date: 20210123; Test Name: Oxygen saturation; Test Result: 94 %; Comments: at 04:00; Test Date: 20210123; Test Name: Oxygen saturation; Test Result: 91 %; Comments: at midnight; Test Date: 20210123; Test Name: Oxygen saturation; Test Result: 90 %; Comments: at 09:12 with 3L; Test Date: 20210123; Test Name: Oxygen saturation; Test Result: 98 %; Comments: with 4 L O2; Test Date: 20210123; Test Name: Oxygen saturation; Test Result: 97 %; Comments: with 4 L O2; Test Date: 20210123; Test Name: pCO2; Result Unstructured Data: Test Result:14 kpa; Test Date: 20210123; Test Name: pCO2; Result Unstructured Data: Test Result:9.76 kpa; Test Date: 20210123; Test Name: pH; Result Unstructured Data: Test Result:7.25; Test Date: 20210123; Test Name: pH; Result Unstructured Data: Test Result:7.39; Test Date: 20210123; Test Name: pO2; Result Unstructured Data: Test Result:14.5 kpa; Test Date: 20210123; Test Name: pO2; Result Unstructured Data: Test Result:12.4 kpa; Test Date: 20210123; Test Name: lung exam; Result Unstructured Data: Test Result:dyspnea with sub-clavicular draw and chest-abdomen; Comments: dyspnea with sub-clavicular draw and chest-abdomen balancing, no cyanosis, bruits in mid-field, no cough or phlegm; Test Date: 20210123; Test Name: Breathing rate (BR); Result Unstructured Data: Test Result:33 with slight draw; Test Date: 20210123; Test Name: COVID-19 PCR; Test Result: Negative ; Test Date: 20210123; Test Name: leukocyte count; Result Unstructured Data: Test Result:14.99 g/l; Comments: Inflammatory syndrome with hyperleukocytosis
CDC Split Type: FRPFIZER INC2021126206

Write-up: Decompensation cardiac; Exacerbation of chronic obstructive pulmonary disease; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from the Regulatory Authority (AFSSAPS). The regulatory authority report number is FR-AFSSAPS-CN20210133. An 83-year-old female patient received the bnt162b2 (COMIRNATY; Lot Number: EM0477), intramuscularly on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included Stented ischemic heart disease from 2002 to an unknown date, Angor of effort from an unknown date and unknown if ongoing, pulmonary embolism from 2019 to an unknown date, Diabetes type 2 from an unknown date and unknown if ongoing, dyslipidemia from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, Intracerebral hemorrhage in 2012, chronic delusional disorders from an unknown date and unknown if ongoing , obesity syndrome from an unknown date and unknown if ongoing (ventilation under oxygen therapy 2L / minute. Patient refusing the NIV), SAOS paired from an unknown date and unknown if ongoing. Concomitant medications included rivaroxaban (MANUFACTURER UNKNOWN), acebutolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), ramipril (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN) , potassium chloride (DIFFU K), risperidone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), insulin glargine (MANUFACTURER UNKNOWN) , insulin aspart (NOVORAPID), all taken for an unspecified indication from an unspecified date to an unspecified date; paracetamol (MANUFACTURER UNKNOWN) all taken for pain from an unspecified date to an unspecified date. On 23Jan2021, the patient experienced: decompensation cardiac, which required hospitalization and was medically significant; and resulted in death; and exacerbation of chronic obstructive pulmonary disease which required hospitalization. The patient was hospitalized for decompensation cardiac and exacerbation of chronic obstructive pulmonary disease from 23Jan2021 to an unknown date. The clinical course was reported as follows: Pre-vaccination monitoring had been put in place by the patient''s residential establishment. All constants were good. The patient''s temperature 37 Centigrade on vaccination day (on 22Jan2021). The patient had a rapid assessment during immediate monitoring for 30 to 45 minutes. The patient was usually on O2, but the patient did not have it when she was moved to her room. During overnight monitoring: Oxygen saturation (Sat) 91% at midnight on 23Jan2021, 94 % at 04:00. In the morning, 90% at 09:12 with 3L. Breathing rate (BR) was 33 with slight draw. The treating physician was called, and the furosemide dosage was increased. The patient was sleepy since the morning. (The patient was normally communicative.) Given the lack of improvement, the patient was hospitalised on 23Jan2021 for heart failure. Clinically, the patient showed: "increased left cardiac signs with bruits at mid-field and lower limb oedema" At the emergency room (ER), the patient was somnolent with profuse sweating; asthenia ++; Pulse: 79 beats per minute (bpm); blood pressure (BP left arm): 180/84 mmHg, BP right arm: 125/72 mmHg, Oxygen saturation (SAO2): 98% with 4L O2, body temperature (T): 36.5 Centigrade, Dextro (Electrocardiogram): 1.19; Heart exam: Regular heartbeat with no audible murmur, Bruits in mid-field, JT and LLO ++, Soft, painless calf, No chest pain, Perceptible peripheral pulse, No sign of shock: no skin mottling, re-coloration time less than 3 seconds. Lung exam: dyspnea with sub-clavicular draw and chest-abdomen balancing, no cyanosis, bruits in mid-field, no cough or phlegm. Abdomen: Soft, painless, large BHA +, no palpated masses. Development-Blood gas: Respiratory acidosis with hyperoxaemia with metabolic compensation attempt, pH 7.25, pCO2 14 kpa, PO2 14.5 kpa, Oxygen saturation: 97%, HCO3- 46.5mM, haemoglobin (Hb) 10.4 g/dl, lactic acid 0.5 mM K+ 4.3mM- non-invasive ventilation (NIV) administered; Lung X-ray: diffuse alveolar-interstitial syndrome with no clear sign of acute lung oedema, no frothing in pleural sacs; Urine culture-negative. Blood culture not performed; COVID-19 PCR: Negative; Blood gas reading after 1.5 hrs. of NIV: Improvement in hypercapnic acidosis: pH 7.39, pCo2 9.76 kpa, pO2 12.4 kpa, Oxygen saturation:98%, HCO3- 44mM; leukocyte count: Inflammatory syndrome with hyperleukocytosis (14.99 g/l), predominant on neutrophils and CRP at 278 mg/l, Brain natriuretic peptide (BNP) 125; all on 23Jan2021. Treatment included: amoxicillin sodium, clavulanate potassium (AUGMENTIN) intravenous (IV), 1g morning, noon and night, for 7 days; isosorbide dinitrate (RISORDAN); IV; 0.5mg via intravenous (IVD) drip; isosorbide dinitrate (RISORDAN) IV 1mg/hr. "up to QSP PAS 140 mmHg"; salbutamol (VENTOLIN) 4 per day for 48 hrs., "on 02 for 20 minutes", ipratropium (ATROVENT) 1 per day; "on air 20 minutes. " Medical Conclusion: Exacerbation of chronic obstructive pulmonary disease (COPD) requiring NIV with probable infectious trigger. On 24Jan2021, the patient was uncomfortable. The patient was "damp to the touch." Bruits to 2/3 field. No other signs of heart failure. The patient was prescribed 60 mg furosemide (LASILIX) IV, morphine 0.2 mg/hour. On 25Jan2021, the patient was less vigilant with moaning. The morphine was increased to 1 mg/hour. On 26Jan2021 at 08:20, the patient passed. The clinical outcome of the event, exacerbation of chronic obstructive pulmonary disease, was unknown. The clinical outcome of the event, decompensation cardiac, was fatal. The patient died on 26Jan2021 due to decompensation cardiac. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1024956 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-31
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / 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: AVLOCARDYL [PROPRANOLOL]; FENOFIBRATE; KARDEGIC; METFORMIN; SERESTA; SEROPLEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol addiction; Hebephrenic schizophrenia; Hypertriglyceridemia; Suicide attempt
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021127173

Write-up: Death unexplained; 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 (AFSSAPS). The regulatory authority report number is FR-AFSSAPS-MA20210241. A 51-year-old male patient received the bnt162b2 (COMIRNATY; Lot Number: EM0477), intramuscularly on 21Jan2021 at 51-years-old at a single dose for COVID-19 immunization. Medical history included hebephrenic schizophrenia from an unknown date and unknown if ongoing, "addictological comorbidity (alcohol)" from an unknown date and unknown if ongoing, major hypertriglyceridemia from an unknown date and unknown if ongoing, suicide attempts from an unknown date and unknown if ongoing. No known medical history of drug allergy. Concomitant medications included propranolol (AVLOCARDYL), fenofibrate (MANUFACTURER UNKNOWN), acetylsalicylate lysine (KARDEGIC), metformin (MANUFACTURER UNKNOWN), oxazepam (SERESTA), escitalopram oxalate (SEROPLEX); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient experienced death unexplained (death, medically significant) on 31Jan2021. The clinical course was reported as follows: The patient was vaccinated on 21Jan2021. There was no event noted by the doctor who carried out the vaccination. The patient was monitored for 24 hours. On 31Jan2021, the patient was found deceased at his home; unexplained death. The clinical outcome of the event was fatal. The patient died on 31Jan2021 due to death unexplained. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1024990 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Altered state of consciousness, Blood creatinine, Blood culture, Blood pressure diastolic, Blood pressure systolic, Blood sodium, Body temperature, C-reactive protein, Computerised tomogram thorax, Glomerular filtration rate, Heart rate, Hypernatraemia, Hyperthermia, Lung disorder, Neutrophil count, SARS-CoV-2 test, Sepsis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLAVIT; NOBITEN [NEBIVOLOL HYDROCHLORIDE]; SEROQUEL; FORXIGA; LANTUS; SIPRALEXA; TRAJENTA; ZYLORIC; AMLOR; MOXON; FLUDEX [BROMHEXINE HYDROCHLORIDE;DEXTROMETHORPHAN HYDROBROMIDE]; ASAFLOW; COVERSYL [PERINDOPRIL ARGININE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Dementia; Hypertension arterial; Renal insufficiency; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210109; Test Name: Blood creatinine; Result Unstructured Data: Test Result:6,05 (no unit provided); Test Date: 20210115; Test Name: Blood creatinine; Result Unstructured Data: Test Result:3,57 (no unit provided); Test Date: 202101; Test Name: Blood culture; Result Unstructured Data: Test Result:Steriles; Test Date: 20210109; Test Name: Diastolic blood pressure; Result Unstructured Data: Test Result:60 mmHg; Test Date: 20210109; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:130 mmHg; Test Date: 20210109; Test Name: Blood sodium; Result Unstructured Data: Test Result:167 mmol/L; Test Date: 20210115; Test Name: Blood sodium; Result Unstructured Data: Test Result:155 mmol/L; Test Date: 20210109; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 202101; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:parenchymal abnormality; Comments: (left postero-basal pneumopathy in favour of a bacterial infection); Test Date: 20210109; Test Name: C-reactive protein; Result Unstructured Data: Test Result:252 mg/l; Test Date: 20210115; Test Name: C-reactive protein; Result Unstructured Data: Test Result:126 mg/l; Test Date: 20210109; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:9.1 ml/min; Comments: MDRD Formula; Test Date: 20210109; Test Name: Heart rate; Result Unstructured Data: Test Result:80 Units/min; Test Date: 20210109; Test Name: Neutrophil count; Result Unstructured Data: Test Result:24400 /mm3; Test Date: 202101; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210109; Test Name: White blood cell count; Result Unstructured Data: Test Result:27260 /mm3
CDC Split Type: LUPFIZER INC2021126652

Write-up: Acute renal failure; Hypernatremia; Pneumopathy; hyperthermia; consciousness disorders; Sepsis; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (LU-ALMPS-202100131). A 77-year-old male patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, on 06Jan2021 (at the age of 77-years-old) at a single dose for COVID-19 vaccination; insulin aspart (NOVORAPID), via an unspecified route of administration, from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication; and ceftriaxone (MANUFACTURER UNKNOWN), intravenously, from Jan2021 to an unspecified date 2 grams, once a day for pneumopathy. Medical history included renal insufficiency, type II diabetes mellitus, dementia, hypertension arterial, and Alzheimer''s disease. Concomitant medications included folic acid (FOLAVIT), nebivolol hydrochloride (NOBITEN), quetiapine fumarate (SEROQUEL), dapagliflozin propanediol monohydrate (FORXIGA), insulin glargine (LANTUS), escitalopram oxalate (SIPRALEXA), linagliptin (TRAJENTA), allopurinol (ZYLORIC), amlodipine besilate (AMLOR), moxonidine (MOXON), bromhexine hydrochloride, dextromethorphan hydrobromide (FLUDEX), acetylsalicylic acid (ASAFLOW), and perindopril arginine (COVERSYL). The patient experienced acute renal failure on an unspecified date, sepsis in Jan2021, and hypernatremia and pneumopathy on 09Jan2021. All of the events were reported as fatal. The patient also experienced hyperthermia and consciousness disorders on 09Jan2021. The patient was hospitalized on 09Jan2021 due to pneumopathy, hyperthermia, and consciousness disorders. The clinical course was reported as follows: Three days after vaccination, the patient was hospitalized for pneumopathy with dyspnea, hyperthermia, and consciousness disorders. Antibiotherapy was started (unspecified date during hospital stay) with ceftriaxone (MANUFACTURER UNKNOWN) IV (2 grams/day) and IV hydration. Parenteral nutrition was set due to the impossibility to implement a nasogastric tube. During hospitalization, there was a slight biological improvement, but the level of consciousness was fluctuating and a poor response to antibiotic therapy. On 18Jan2021, the patient died in a context of renal insufficiency on dehydration, severe sepsis, left postero-basal pneumopathy, and severe hypernatremia. The patient underwent lab tests and procedures which included blood creatinine: 6,05 (no unit provided) on 09Jan2021 and 3,57 (no unit provided) on 15Jan2021; blood culture: steriles in Jan2021; diastolic blood pressure: 60 mmHg on 09Jan2021; systolic blood pressure: 130 mmHg on 09Jan2021; blood sodium: 167 mmol/L on 09Jan2021 and 155 mmol/L on 15Jan2021; body temperature: 36.5 centigrade on 09Jan2021; computerised tomogram thorax: parenchymal abnormality (left postero-basal pneumopathy in favour of a bacterial infection) in Jan2021; C-reactive protein: 252 mg/L on 09Jan2021 and 126 mg/l on 15Jan2021; glomerular filtration rate: 9.1 ml/min (MDRD Formula) on 09Jan2021; heart rate: 80 units/min on 09Jan2021; neutrophil count: 24400/mm3 on 09Jan2021; SARS-CoV-2 test: negative in Jan2021; and white blood cell count: 27260/mm3 on 09Jan2021. The action taken in response to the events for insulin aspart was unknown and for ceftriaxone was dose not changed. The clinical outcome of acute renal failure, sepsis, hypernatremia and pneumopathy was fatal and of hyperthermia and consciousness disorders was unknown. The patient died on 18Jan2021. The cause of death was reported as acute renal failure, sepsis, hypernatremia, and pneumopathy. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot number cannot be obtained.; Reported Cause(s) of Death: Hypernatremia; Acute renal failure; Pneumopathy; Sepsis


VAERS ID: 1025738 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-12
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, Alanine aminotransferase, Alanine aminotransferase increased, Blood lactate dehydrogenase, Blood pressure measurement, C-reactive protein, Cardiogenic shock, Chest X-ray, Chills, Dyspnoea, Echocardiogram, Ejection fraction, Hypotension, Malaise, Pleural effusion, Troponin I
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic stenosis; Diabetes mellitus; Hemodialysis; Intestinal ischemia (with resection); Leg amputation; Retinopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:98 IU/l; Test Date: 20210123; Test Name: LDH; Result Unstructured Data: Test Result:387 IU/l; Test Date: 20210121; Test Name: hypotension; Result Unstructured Data: Test Result:hypotension; Test Date: 20210123; Test Name: Lying rtg thorax; Result Unstructured Data: Test Result:bilateral pleural fluid; Test Date: 20210123; Test Name: C-reactive protein; Result Unstructured Data: Test Result:23 mg/l; Test Date: 20210123; Test Name: EKKO; Result Unstructured Data: Test Result:Hypokinesia LAD''s supply area; Test Date: 20210123; Test Name: EF; Result Unstructured Data: Test Result:35-40 (severe aortic stenosis) %; Test Date: 20210123; Test Name: Troponin I; Result Unstructured Data: Test Result:from 4479 to 6482 ng/L
CDC Split Type: DKPFIZER INC2021126155

Write-up: ST segment elevation myocardial infarction; Cardiogenic shock; Dyspnoea; Shivering; Hypotension; Unwell; bilateral pleural fluid; Alanine aminotransferase (ALAT): 98 IU/L; This is a spontaneous report from contactable physician downloaded from the regulatory authority-WEB regulatory authority or other manufacturer number DK-DKMA-WBS-0030939, Safety Report Unique Identifier DK-DKMA-ADR 24664705. A 61-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, batch/lot number: EJ6134, expiration date: 30Apr2021), intramuscularly on 20Jan2021 at single dose (1 dose form) for COVID-19 immunisation. The patient''s medical history included severe comorbiditet with diabetes mellitus with multiple complications, in hemodialysis/Haemodialysed, leg amputation, intestinal ischemia with resection, aortic stenosis and retinopathy, all were ongoing. The patient''s concomitant medications were not reported. The day after, on 21Jan2021, the patient felt unwell was shivering and developed hypotension. After 3 days (23Jan2021) the patient was hospitalized with dyspnoea, ST segment elevation myocardial infarction and cardiogenic shock. The adverse events were by the reporter reported as Fatal (24Jan2021) and causing hospitalization. The patient was conservatively treated. Test results on 23Jan2021 included Troponin I: from 4479 ng/L to 6482 ng/L; Blood lactate dehydrogenase (LDH): 387 IU/L; Alanine aminotransferase (ALAT): 98 IU/L; CRP: 23 mg/L; Lying rtg thorax (Chest X-ray): bilateral pleural fluid; Echocardiography (EKKO): Hypokinesi at LADs supply area; Ejection fraction (EF): 35-40%, severe aortastenose. The patient died on 24Jan2021. No Autopsy was performed. Reported cause(es) of death: ST segment elevation myocardial infarction and cardiogenic shock (pending clarification). Reporters causality: The causal relationship between vaccine and ADRs was quite uncertain, but significance cannot be ruled out. The outcome of the events Alanine aminotransferase (ALAT): 98 IU/L and bilateral pleural fluid was unknown, of the other events was fatal (reported as not recovered for Hypotension, shivering, unwell and dyspnea, pending clarification).; Reported Cause(s) of Death: Cardiogenic shock; ST segment elevation myocardial infarction


VAERS ID: 1025748 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Body temperature, C-reactive protein, C-reactive protein increased, Dyspnoea, Increased upper airway secretion, Investigation, Pain, Physical examination, Pulmonary oedema, Pyrexia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: OXYNORM; DIGOXIN ORION; NITROGLYCERIN ORION; VENTOLINE [SALBUTAMOL SULFATE]; SIBICORT; LEVOLAC; PANADOL FORTE [PARACETAMOL]; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; BISOPROLOL ORION; OFTAGEL; HISTEC; M
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (diagnosed 2016, then MMSE 13 / 30p); Atrial fibrillation ((Marevan)); Hypercholesterolemia; Hypertension; Living in nursing home; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: Body temperature; Result Unstructured Data: Test Result:high fever; Test Date: 20210127; Test Name: rapid CRP; Result Unstructured Data: Test Result:6; Test Date: 20210128; Test Name: rapid CRP; Result Unstructured Data: Test Result:46; Test Date: 202007; Test Name: Heart auscultation; Result Unstructured Data: Test Result:Heart auscultation smooth rhythm, no murmurs.; Test Date: 202007; Test Name: Pulmonary auscultation neat and symmetrical.; Result Unstructured Data: Test Result:Pulmonary auscultation neat and symmetrical.; Test Date: 202007; Test Name: functional capacity; Result Unstructured Data: Test Result:a bed-ridden and tired lady; Comments: a bed-ridden and tired lady. Able to walk short distances assisted by a nurse. Saucy food and often needs help with meals. Needs total help with washing. Rarely answers anymore verbally. Occasionally spits out medicines. At that time she was examined in bed. She lies on her side and keeps her eyes mostly closed. Does not communicate verbally.; Test Date: 202007; Test Name: Physical examination; Result Unstructured Data: Test Result:Breathing calm; Comments: Breathing calm. Abdomen palpated, does not appear to be tender. No swelling in the feet, warm periphery. Dorsalis pedis artery and Tibialis posterior artery ++ / +. Skin intact, no wounds to treat.; Test Date: 20210127; Test Name: Physical examination; Result Unstructured Data: Test Result:STEMI and pulmonary edema; Test Date: 20210128; Test Name: Physical examination; Result Unstructured Data: Test Result:the patient was very slimy, no fever; Comments: the patient was very slimy, no fever, does not intake through mouth.
CDC Split Type: FIPFIZER INC2021126103

Write-up: C-reactive protein increased; ST segment elevation myocardial infarction; Pyrexia; Pulmonary oedema; Increased upper airway secretion/slimy; pain; shortness of breath; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority. The Authority Number is FI-FIMEA-20210391. An 89-year-old female patient received first dose of bnt162b2 (COMIRNATY, Lot Number and Expiration Date unknown) via Intramuscular on 25Jan2021 at single dose for COVID-19 vaccination. The patient''s medical history included living in a nursing home since Aug2016. The underlying conditions were severe Alzheimer''s disease (diagnosed 2016, then MMSE 13 / 30p), tablet-treated type II diabetes, atrial fibrillation (Marevan), hypertension, and hypercholesterolemia. Previously Sertralin 50mg for mood, discontinued in summer 2020. Colleague''s annual check Jul2020, when the functional capacity was described as follows: according to the nurse''s description, a bed-ridden and tired lady. Able to walk short distances assisted by a nurse. Saucy food and often needs help with meals. Needs total help with washing. Rarely answers anymore verbally. Occasionally spits out medicines. At that time she was examined in bed. She lies on her side and keeps her eyes mostly closed. Does not communicate verbally. Heart auscultation smooth rhythm, no murmurs. Pulmonary auscultation neat and symmetrical. Breathing calm. Abdomen palpated, does not appear to be tender. No swelling in the feet, warm periphery. Dorsalis pedis artery and Tibialis posterior artery ++ / +. Skin intact, no wounds to treat. On duty doctor''s record: "89-year-old woman. In-bed treatment, no hospital transfers, symptomatic treatment of internal and neurological diseases to be carried out in a nursing home. The concomitant medications were reported as oxycodone hydrochloride (OXYNORM), digoxin (DIGOXIN ORION), glyceryl trinitrate (NITROGLYCERIN ORION), salbutamol sulfate (VENTOLINE), chlorhexidine gluconate, hydrocortisone (SIBICORT), lactulose (LEVOLAC), paracetamol (PANADOL FORTE), macrogol 3350;potassium chloride;sodium bicarbonate;sodium chloride (MOVICOL), bisoprolol fumarate (BISOPROLOL ORION), carbomer (OFTAGEL), cetirizine hydrochloride (HISTEC), warfarin sodium (MAREVAN) for Atrial fibrillation, donepezil hydrochloride (DONEPEZIL ORION), bromhexine hydrochloride (MUCOVIN), linagliptin (TRAJENTA).On 27Jan 2021 rose high fever, the ambulance found out on the spot STEMI and pulmonary edema, rapid CRP 6. The doctor on duty was consulted, considering the symptomatic line of treatment, morphine was given to treat the symptoms. The next day, rapid CRP 46, the patient was very slimy, no fever, does not intake through mouth. Considering the whole, in agreement with the relative, she was transferred to hospice care. Received morphine in a home hospital for pain and shortness of breath. Peaceful death in the presence of a nurse on 30Jan2021 at 00:51. Unknown if autopsy has been done. The outcome of pain and shortness of breath, was unknown and the outcome of all other events were fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: high fever; spot STEMI; pulmonary edema; rapid CRP 6; slimy


VAERS ID: 1025749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIFFU K; ESCITALOPRAM; FORLAX; LANSOYL; LOXAPAC [LOXAPINE]; SERESTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stricture; Dementia; Unspecified hypertensive heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021120425

Write-up: Sudden death, cause unknown; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB, FR-AFSSAPS-AN20210168. This is a report received from the Regulatory Authority. Health professional declaration from the Agency portal. A contactable physician reported that a 95-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot. EJ6795) at single dose, intramuscularly, in the muscle of the left arm, on 28Jan2021 between 3 and 4 p.m., for COVID-19 immunisation. Relevant medical history included an unspecified hypertensive heart disease, aortic stricture and advanced dementia, all from an unspecified date and unknown if ongoing. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included the following long-term treatment without recent changes: potassium chloride (DIFFU K), escitalopram, macrogol 4000 (FORLAX), paraffin, liquid (LANSOYL), loxapine (LOXAPAC) and oxazepam (SERESTA). On 29Jan2021, at 5.30 p.m. the patient was found lying crosswise on her bed with the door open. It was reported sudden death without warning signs. It should be noted that the patient did not present any particular signs the previous days. She had fallen on 21Jan2021 without complications. To the doctor''s knowledge, no autopsy request was in progress (no autopsy done). The patient has not been tested for COVID-19. On 08Feb2021, reported she did not show any signs of anoxia when the death was discovered, nor had she had covid syndrome prior to the death. Conclusion: sudden death between 26 and 27 hours following vaccination with COMIRNATY. Summary: sudden death occurred between 26 and 27 hours after administration of COMIRNATY vaccine. No follow-up attempts possible. No further information expected. Follow-up (08Feb2021): New information downloaded from the Agency Regulatory Authority-WEB, FR-AFSSAPS-AN20210168. This is a report received from the Regulatory Authority. Included: patient clinical details.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1025960 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA; MACROGOL; LEVOTHYROXINE SODIUM; AMIODARONE; FUROSEMIDE
Current Illness: Atrial fibrillation; Cardiac failure; Renal impairment
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:<80 %; Test Date: 20210129; Test Name: pyrexia; Result Unstructured Data: Test Result:38 to 40.5 Centigrade
CDC Split Type: NLPFIZER INC2021126259

Write-up: Dyspnea with decrease in saturation <80% and cardiac decompensation, passed away shortly afterwards; Dyspnea with decrease in saturation <80% and cardiac decompensation, passed away shortly afterwards; Dyspnea with decrease in saturation <80% and cardiac decompensation, passed away shortly afterwards; Fever: 38 to 40.5 degrees Celsius; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00437398. A 90-year-old male patient received a dose of BNT162B2 (COMIRNATY) from lot#EM0477 at 0,3ml single dose for COVID-19 immunization on 28Jan2021. Concomitant medication included edoxaban tosilate (LIXIANA) tablet 30mg, macrogol powder via oral solution 1g, levothyroxine sodium tablet 62ug, amiodarone tablet 200mg, furosemide tablet 20mg. Medical history included cardiac failure, atrial fibrillation and renal impairment, all ongoing. On 29Jan2021 the patient experienced Dyspnea with decrease in saturation <80%, cardiac decompensation and fever: 38 to 40.5 degrees Celsius. The patient passed away shortly afterwards. It was unknown if an authopsy was performed. The patient was treated for the events with paracetamol and oxygen administration. Reporter''s comments: Pfizer vaccine (Comirnaty). Past drug therapy Pfizer vaccine (Comirnaty): no. dyspnoea. Additional information ADR: started with fever T$g 39 degrees, a few hours later severe dyspnoea with saturation drop <80% and cardiac decompensation, died soon after. confounding factors: familiar with decompensation cardiac, atrial fibrillation and renal dysfunction. COVID19: Previous COVID-19 infection: No. Date and time of start of drug and date and time of last administration: asked but unknown for edoxaban, macrogol, levothyroxine, amiodaron, furosemide.Time Interval between Beginning of Drug Administration and Start of Reaction / Event: 30 h for pyrexia. No follow-up attempts are possible. No further information is expected.; Reporter''s comments: Pfizer vaccine (Comirnaty). Past drug therapy Pfizer vaccine (Comirnaty): no. dyspnoea. Additional information ADR: started with fever T$g 39 degrees, a few hours later severe dyspnoea with saturation drop <80% and cardiac decompensation, died soon after. confounding factors: familiar with decompensation cardiac, atrial fibrillation and renal dysfunction. COVID19: Previous COVID-19 infection: No. Date and time of start of drug and date and time of last administration: asked but unknown for edoxaban, macrogol, levothyroxine, amiodaron, furosemide.Time Interval between Beginning of Drug Administration and Start of Reaction / Event: 30 h for pyrexia.; Reported Cause(s) of Death: cardiac failure; oxygen saturation decreased; dyspnoea; pyrexia


VAERS ID: 1025961 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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: OMNIC OCAS; ACENOCOUMAROL; BUMETANIDE; D-CURA; ATROVENT; HYDROCOBAMINE; AIRFLUSAL
Current Illness: COPD; Dyspnoea; Heart failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021126262

Write-up: that patient passed away today in the end, probably due to acute heart failure; This is a spontaneous report received from a contactable physician, downloaded from the regulatory authority NL-LRB-00437557. A 93-years-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Feb2021 at single dose for covid-19 immunisation. Medical history included dyspnoea, chronic obstructive pulmonary disease, cardiac failure, all ongoing. Concomitant medication included tamsulosin hydrochloride (OMNIC OCAS), acenocoumarol (ACENOCOUMAROL), bumetanide (BUMETANIDE), colecalciferol (D-CURA), ipratropium bromide (ATROVENT), hydroxocobalamin hydrochloride (HYDROCOBAMINE), fluticasone propionate, salmeterol xinafoate (AIRFLUSAL). The patient passed away the next day on 02Feb2021 (approximately 20 hours after vaccination). Patient had suffered from worsening dyspnea several days prior to the vaccination. It is reported that patient passed away today in the end, probably due to acute heart failure. The outcome of the event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed away today in the end, probably due to acute heart failure


VAERS ID: 1025980 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CALCIMED D3; SERTRALINE; OLMESARTAN MEDOXOMIL; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Iodine allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 PCR test nasal swab; Test Result: Positive
CDC Split Type: PTPFIZER INC2021129027

Write-up: death 9 days after vaccination, asymptomatic until vaccination date, positive test 3 days following vaccination; death 9 days after vaccination, asymptomatic until vaccination date, positive test 3 days following vaccination; This is a spontaneous report from a contactable physician (patient''s son). An 84-year-old male patient received the first dose of the bnt162b2 (COMIRNATY), intramuscularly in the left arm on 21Jan2021 at 84-years-old at 0.3 mL, single for COVID-19 immunization; administered at a nursing home/senior living facility. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included hypertension from an unknown date and unknown if ongoing, allergy to iodine from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate, colecalciferol (CALCIMED D3), sertraline (MANUFACTURER UNKNOWN), olmesartan medoxomil (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021, the patient experienced death 9 days after vaccination, asymptomatic until vaccination date, positive test 3 days following vaccination (Drug Ineffective, Covid-19); which required hospitalization, and resulted in death. No treatment was received for the adverse events. The patient was hospitalized for the events for 4 days. The patient underwent lab tests and procedures which included COVID-19 PCR test nasal swab: positive on 25Jan2021. The clinical outcome of the events: drug ineffective and COVID-19, was fatal. The patient died on 30Jan2021 due to COVID-19 disease. An autopsy was not performed. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Sender''s Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 (COMIRNATY) cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag (3 days in this case) between the first vaccine dose and the event onset. Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use. Further information is needed for full medical assessment; Reported Cause(s) of Death: COVID-19 disease


VAERS ID: 1029855 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Cardiopulmonary failure, Dyspnoea, Pneumonia aspiration, Pyrexia, Respiratory failure, SARS-CoV-2 test
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), Cardiomyopathy (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? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 24
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: Delusional disorder, paranoid type; Dementia; Intelligence reduced; Paranoid state (behavioral delusional disorder); Secondary parkinsonism (in neuroleptic therapy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210118; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021127729

Write-up: Aspiration pneumonia; Respiratory insufficiency; COVID-19 pneumonia; Fever; Dyspnoea; Cardiopulmonary insufficiency; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from the Austrian Regulatory Authority. The regulatory authority report number is AT-BASGAGES-2021-00970. A 68-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EJ6796 Expiration Date: 30Apr2021), via an unspecified route of administration on 13Jan2021 at 68-years-old at a single dose for COVID-19 immunization. The patient''s medical history included ongoing Secondary parkinsonism (neuroleptic therapy) from an unknown date, ongoing intelligence reduced from an unknown date, ongoing dementia from an unknown date, ongoing paranoid state (behavioral delusional disorder), ongoing behavioral delusional disorder from an unknown date. Concomitant medications were not reported. On 01Jan2021, the patient experienced cardiopulmonary insufficiency; which required hospitalization, and was assessed as medically significant and finally resulted in death. On 18Jan2021, the patient experienced COVID-19 pneumonia, fever, dyspnoea and respiratory insufficiency; which required hospitalization and was assessed as medically significant. On 25Jan2021, the patient experienced aspiration pneumonia which required hospitalization, and was assessed as medically significant and finally resulted in death. The patient was hospitalized for the events from 18Jan2021 to an unknown date. The clinical course was reported as follows: The patient was vaccinated with COMIRNATY on 13Jan2021 (first dose). The patient was admitted on 18Jan2021 with fever and dyspnea, post a Sars-CoV-2 test on 18Jan2021, which was positive for COVID-19 with pneumonia and increasing respiratory insufficiency. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 18Jan2021. The clinical outcome of the event, fever, was unknown. The clinical outcome of the events: COVID-19 pneumonia, respiratory insufficiency, dyspnoea was not recovered. The clinical outcome of the events: cardiopulmonary insufficiency and aspiration pneumonia, was fatal. The patient died on 25Jan2021 due to cardiopulmonary insufficiency and aspiration pneumonia. An autopsy was performed, and results were not provided. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Cardiopulmonary insufficiency; Aspiration pneumonia


VAERS ID: 1029856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-15
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Blood lactic acid increased, Chest X-ray, Depressed level of consciousness, Investigation, Livedo reticularis, Liver function test, Liver function test abnormal, Pleural effusion, Renal failure, Respiration abnormal, Somnolence, Troponin, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: CABG; Dementia; Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: Lactate; Result Unstructured Data: Test Result:high; Test Date: 20210115; Test Name: chest X-ray; Result Unstructured Data: Test Result:pleural fluid left; Test Date: 20210115; Test Name: studies lab; Result Unstructured Data: Test Result:kidney failure; Test Date: 20210115; Test Name: vital parameters; Result Unstructured Data: Test Result:acceptable; Comments: vital parameters; Test Date: 20210115; Test Name: liver function; Result Unstructured Data: Test Result:disorders; Test Date: 20210115; Test Name: troponins; Result Unstructured Data: Test Result:strongly increased
CDC Split Type: BEPFIZER INC2021126821

Write-up: Pleural effusion; drowsy, not very reactive; Lactate high; reduced reactivity; greatly increased troponins; Renal insufficiency; Respiration abnormal; Liver function test abnormal; Marbled skin; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-75675. An 86-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 Vaccination. Medical history included ischemic heart disease, Coronary artery bypass graft (CABG), dementia. The patient''s concomitant medications were not reported. On 15Jan2021, the patient experienced pleural effusion, ''drowsy, not very reactive'', lactate high, reduced reactivity, greatly increased troponins, renal insufficiency, respiration abnormal, liver function test abnormal, marbled skin, all events were assessed as serious due to death. The patient underwent lab tests and procedures which included chest x-ray: pleural fluid left on 15Jan2021, troponin: strongly increased on 15Jan2021, liver function: disorders on 15Jan2021, lactate: high on 15Jan2021, studies lab: kidney failure on 15Jan2021, vital parameters: acceptable on 15Jan2021. Patient died on 20Jan2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. Health authority comment: Date of vaccination unknown, date of death: probably 20Jan2021. 15Jan: consultation with family doctor. At that time was already kidney failure and liver disease, so all symptoms were present in advance. A few days later the patient was vaccinated. No causal relationship with vaccine according to doctors (but according to family). Additional studies lab: liver function disorders, kidney failure, strongly increased troponins, chest X-ray: pleural fluid left, vital parameters are otherwise acceptable. No follow-up attempts are possible, information on lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pleural effusion; drowsy, not very reactive; Lactate high; reduced reactivity; greatly increased troponins; Renal insufficiency; Respiration abnormal; Liver function test abnormal; Marbled skin


VAERS ID: 1029857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, SARS-CoV-2 test positive, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: Cardiovascular disorder; Pulmonary disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021125990

Write-up: Unexpected death; patient tests positive for Covid on day 6 (19/1), no symptoms; patient tests positive for Covid on day 6 (19/1), no symptoms; This is a spontaneous report from a contactable physician downloaded from the regulatory authority (BE-FAMHP-DHH-N2021-75732). Spontaneous COVID-19 report received by the authorities on 21Jan2021. A 76-year-old female patient received the first dose of BNT162B2 (COMIRNATY; lot number: EJ6796) via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunisation. Medical history included cardiovascular and pulmonary patient. Recent cardiology admission report (recent admission can still be requested). Concomitant medications were not reported. The patient experienced COVID-19 virus test positive/tested positive for Covid on day 6 (19Jan2021), no symptoms and sudden death on 20Jan2021. The cause of death was reported as unknown cause of death. Death on 20Jan2021, etiology unclear. The patient was in a room after admission from hospital, test for d6 positive. No symptoms. Unexpected death one day after Covid-19 diagnosis (cardiac?). Not likely to be related to vaccination. Cardiovascular and pulmonary patient, admission to hospital after stay on cardiology. No treatment received for events. The outcome of events was fatal. Relatedness of drug to reactions (all the events) assessed as unclassifiable by the agency with the WHO method of assessment. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1029858 (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: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EMO477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, 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: ASAFLOW; ANORO; PARACETAMOL; EXELON [RIVASTIGMINE]; LORAMET; EMCONCOR; QUETIAPINE; VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Cataract operation; COPD; Cytopenia; Dementia; Depression; Fall; Fracture of neck of femur; Infection bacterial (Started AB (augmentin 875 mg 3x1 / day).); Neck surgery; Nicotine abuse; Pneumonia; Postoperative delirium; Tumor (possibly tumorous, but for which a conservative / wait-and-see policy was pursued); Comments: estimated weight 55-60 kg - Medical history: appendectomy, depression, cystopexy, nicotine busus, cataract surgery, COPD, 2015: fall with left femoral neck fracture, total hip replacement and postoperative delirium. 2015: left pneumonia with limited delirium, 2016: vascular dementia + Lewy body dementia ?, 01/2018: pneumonia and COPD flare-up * She still had an active nicotine abuse and had COPD. , possibly tumorous, but for which a conservative / wait-and-see policy was pursued. 20/1: erysipilas at the bottom of her leg after a leg wound. Started AB (augmentin 875 mg 3x1 / day). The course of the disease was mild: no fever, no subjective complaints and the patient did not seem to have any further problems.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021125987

Write-up: On Sunday 24Jan2021, her condition apparently deteriorated suddenly and she died within half an hour.; On Sunday 24Jan2021, her condition apparently deteriorated suddenly and she died within half an hour.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-75878. An 84-year-old female patient received BNT162B2 (COMIRNATY; Lot number EMO477 ), via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunization. Medical history included appendicectomy in 2015, depression from 2015, cytopexy from 2015 to, nicotine abuse from 2015, cataract surgery in 2015, chronic obstructive pulmonary disease (COPD) from 2015 to an unknown date, fall with left femoral neck fracture, total hip replacement and postoperative delirium from 2015, dementia from 2016 to, pneumonia and COPD flare-up from Jan2018, erysipilas at the bottom of her leg after a leg wound from Jan2020 (reported as started AB (AUGMENTIN) 875 mg 3x1 / day), "possibly tumorous, but for which a conservative / wait-and-see policy was pursued." Concomitant medication included acetylsalicylic acid (ASAFLOW), umeclidinium bromide, vilanterol trifenatate (ANORO), paracetamol (PARACETAMOL), rivastigmine (EXELON), lormetazepam (LORAMET), bisoprolol fumarate (EMCONCOR), quetiapine (QUETIAPINE), venlafaxine (VENLAFAXINE). The patient experienced general physical health deterioration, that was elaborated as sudden death on Sunday 24Jan2021, her condition apparently deteriorated suddenly and she died within half an hour. Reporter commented that overall, the patient still showed a good (physical) general condition, given her medical history there was of course a certain "frailty" and need for supervision (closed ward). The patient died on 24Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Overall, this lady still showed a good (physical) general condition, given her medical history there is of course a certain "frailty" and need for supervision (closed ward); Reported Cause(s) of Death: Sudden death


VAERS ID: 1029859 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIUM CARBONATE; ZOLPIDEM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (Moderate dementia); Femur fracture (Femur fracture 2015 (in wheelchair))
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021126599

Write-up: Unexpected sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority BE-FAMHP-DHH-N2021-75933, BE-FAMHP-DHH-N2021-75971. A 82-year-old male patient received first dose of bnt162b2 (COMIRNATY, batch number: EM0477), via an unspecified route of administration on 17Jan2021 at single dose for covid-19 immunization, trazodone hcl, via an unspecified route of administration from 2017 to an unspecified date at unknown dose for an unspecified indication, risperidone, via an unspecified route of administration from Feb2020 to an unspecified date at dose increased from 1 mg to 1.5 mg per day for an unspecified indication, olanzapine, via an unspecified route of administration from 2017 to an unspecified date at unknown dose for an unspecified indication. Medical history included femur fracture from 2015 to an unknown date (in wheelchair), moderate dementia from an unknown date and unknown if ongoing. Concomitant medication included calcium carbonate, zolpidem. The patient experienced unexpected sudden death on 25Jan2021. The action taken in response to the event for trazodone hcl and olanzapine was unknown, for risperidone was dose increased. The patient died on 25Jan2021. An autopsy was not performed. Reporter comment: No cardiovascular history, stable parameters - 8 days after vaccination: sudden death (According to GP there was no immediate death expected in the next 3 months) - none disease signs up to minutes before death - QT prolongation by olanzapine, trazodone and risperidone: not excluded, but no recent cardiac examination - according to the GP there a connection with the vaccine cannot be ruled out, but it may be a coincidence- according to CRA doctor no connection with vaccination- Treatment - No Evolution of the ADR - Passed away. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: No cardiovascular history, stable parameters - 8 days after vaccination: sudden death (According to GP there was no immediate death expected in the next 3 months) - none disease signs up to minutes before death - QT prolongation by olanzapine, trazodone and risperidone: not excluded, but no recent cardiac examination; Sender''s Comments: Information provided was limited and did not allow a thorough medical assessment of this fatal case. Causality cannot be completely excluded for COVID-19 immunization or suspect drug TRAZODONE, according to Company internal procedure, as cautionary measure and for reporting purpose. The impact of this report on the benefit/risk profile of the Pfizer drugs 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: Unexpected sudden death


VAERS ID: 1029870 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021126919

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable consumer downloaded from the -WEB. The regulatory authority report number DE-PEI-CADRPEI-2021013220. A 90-year-old female patient received BNT162B2 (COMIRNATY; Lot number EL1491), intramuscular on 22Jan2021 single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included apixaban (ELIQUIS). The patient experienced exitus letalis on 23Jan2021. Reporter commented that unproblematic: according to the care report does not seem to have any side effects from the corona vaccination(12:16 pm), calm and relaxed (19:15), found no signs of life (3:37). The patient died on 23Jan2021. It was not reported if an autopsy was performed. PEI/ Unclassifiable. Death cause was reported as unknown cause of death. Senders comment: regularly eliquis, antihypertensive drugs, analgesics, sedatives. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: unproblematic: according to the care report "does not seem to have any side effects from the corona vaccination" (12:16 pm), "calm and relaxed" (19:15), "found no signs of life" (3:37); Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1029874 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Toxicity to various agents
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), 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), Drug abuse and dependence (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   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: Atrial fibrillation; Hypertension arterial; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021125997

Write-up: Sotaloline toxicity; Acute renal failure; This is a spontaneous report from a non-contactable other hcp, it was downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021002045. A 80-year-old male patient received second dose of bnt162b2 (COMIRNATY) (lot/batch number EJ6797), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, type 2 diabetes mellitus from an unknown date and unknown if ongoing, hypertension arterial from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 27Jan2021 after vaccination the patient developed Cardiopulmonary resuscitation and Sotalolin toxication and Acute renal failure, lasting for unknown. The patient had not recovered at the date of reporting. The patient died on 28Jan2021. An autopsy was not performed. Death cause was reported as Cardiac arrhythmia. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrhythmia


VAERS ID: 1029875 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / -

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

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021126704

Write-up: Vaccination complication resulting in death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB regulatory authority DE-PEI-PEI2021002101. A 69-year-old female patient received second dose of bnt162b2 (COMIRNATY, Lot/ batch number: EJ6788), via an unspecified route of administration on 03Feb2021 at single dose (reported as 1 DF, single) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (batch no.: EJ6796) for covid-19 immunization on 03Jan2021 (reported had been tolerated). On the same day after the 2nd vaccination, the patient developed Vaccination adverse reaction and death, lasting for unknown. The patient was dead. Autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination complication resulting in death


VAERS ID: 1029876 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021126702

Write-up: Sudden onset of death without fever; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB Regulatory Authority number DE-PEI-PEI2021002102. A 86-year-old male patient received bnt162b2 (COMIRNATY) (lot number unknown), intramuscular on 30Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sudden onset of death without fever on an unspecified date in 2021. The patient died in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Sudden onset of death without fever


VAERS ID: 1029877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Test Date: 20210125; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021134977

Write-up: bothsided pneumonia in the presence of COVID-19 infection/positive PCR test on COVID-19; bothsided pneumonia in the presence of COVID-19 infection/positive PCR test on COVID-19; This is a spontaneous report from a contactable physician by Pfizer from BIONTECH. An 82-year-old female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient was vaccinated with 1 first dose on 05Jan2021. The vaccines have not been administered before. The patient had positive PCR test on COVID-19 on 07Jan2021. On 19Jan2021, the patient had progressive worsening of general condition, bedridden, very weak, nutrition (food and drink) has to be supported and served, no cough, no fever. On 25Jan2021, hospitalization with further worsening of general condition and in soporous state. Positive PCR Test on COVID-19 on 25Jan2019. Treatment in hospital from 25Jan2021 to 27Jan2021, Diagnosis: bothsided pneumonia, epicrisis available. On 28Jan2021, the patient had further worsening of general condition, very week, sopor, as per relatives'' wish palliative care initiation. The patient experienced bothsided pneumonia in the presence of COVID-19 infection, firstly diagnosed on 25Jan2021. The diagnoses are confirmed as per hospital epicrisis. The vaccine has not been administered again. The patient died on 01Feb2021. It was not reported if an autopsy was performed. Without any relation to COMINARTY has lead to a prophylactic hospitalization and treatment. A causal relation between course of disease and vaccination is not given. Information about lot/batch number has been requested.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported positive PCR test on COVID-19 based on the known safety profile. However the short duration of 2 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.; Reported Cause(s) of Death: bothsided pneumonia in the presence of COVID-19 infection/positive PCR test on COVID-19; bothsided pneumonia in the presence of COVID-19 infection/positive PCR test on COVID-19


VAERS ID: 1029878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-20
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, COVID-19, Confusional state, Cyanosis, Drug ineffective, Nasopharyngitis, Oxygen saturation, Oxygen saturation decreased, Respiratory failure, Respiratory tract infection, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: body temperature; Result Unstructured Data: Test Result:38.0 Centigrade; Test Date: 20210126; Test Name: oxygen saturation; Test Result: 81 %; Test Date: 20210125; Test Name: COVID PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: DEPFIZER INC2021135047

Write-up: oxygen saturation 81%; cold; livid discoloration of acra; respiratory infection with respiratory insufficiency; respiratory infection with respiratory insufficiency; slightly confused; very weak; COVID-19 PCR test positive; COVID-19 PCR test positive; This is a spontaneous report from a contactable physician via local license partner. A 85-year-old male patient received first dose of BNT162B2 (COMIRNATY) on 05Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had respiratory infection with respiratory insufficiency on 20Jan2021. On 20Jan2021 patient was in reduced general condition, slightly confused, very weak, no cough, no fever. On 25Jan2021 positive PCR test (throat swab). On 26Jan2021 very bad general condition, confused, cold and livid discoloration of acra, oxygen saturation 81%. Palliative therapy with alleviation of symptoms after consultation of his daughter. On 27Jan2021 further deterioration of general condition, temperature 38 degrees Celsius, "Exitus letalis" at 5:10 p.m. All events except COVID-19 PCR test positive required outpatient treatment, hospitalization and was life-threatening. The patient died on 27Jan2021 at 5:10 p.m due to all events except COVID-19 PCR test positive. The outcome of COVID-19 PCR test positive was unknown. Information on the lot/batch number has been requested.; 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, due to the number of days passed since the vaccine is given and due to only the first dose was administered. Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and autopsy results, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: respiratory infection with respiratory insufficiency; respiratory infection with respiratory insufficiency; slightly confused; very weak; oxygen saturation 81%; cold; livid discoloration of acra


VAERS ID: 1029882 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Blood pH, 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: 2021-01-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Secondary dementia; Spinocerebellar ataxia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: lactate; Result Unstructured Data: Test Result:unknown results; Test Name: blood pH; Result Unstructured Data: Test Result:unknown results
CDC Split Type: DKPFIZER INC2021126365

Write-up: Sudden death - was found dead in the morning; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [DK-DKMA-WBS-0030175, DK-DKMA-ADR 24648381]. The case was received from a contactable physician via Medicines Agency (MA). A 60-years-old female patient received second dose of bnt162b2 (COMIRNATY, lot number: EJ6136, Expiration Date 30Apr2021), intramuscular on 23Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing spinocerebellar ataxia and ongoing secondary dementia. The patient previously received first dose of bnt162b2 on 31Dec2020 (lot number: EJ6797). The patient''s concomitant medications were not reported. The patient experienced sudden death - was found dead in the morning on 25Jan2021.An autopsy was not performed. Causality: The patient had been observed awake in habitual state earlier in the morning. Has not been ill. The physician has ordered a forensic autopsy. Sender Comment: Test: Both blood pH and lactate have been measured by performing an arterial blood gas analysis No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: Sudden death


VAERS ID: 1029883 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, C-reactive protein, Delirium, Gastrointestinal examination, Malaise, Pneumonia, Pyrexia, X-ray
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: LANSOPRAM; MIRTAZAPIN KRKA; PANODIL; TOLTERODINE TARTRATE TEVA; SIMVASTATIN STADA; IPREN
Current Illness: Depression; Fall (Admitted after fall and uspecified pain); Hypercholesterolemia; Pain NOS (Admitted after fall and uspecified pain); Urinary frequency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Blood test; Result Unstructured Data: Test Result:No result specified; Test Date: 20210123; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Increasing; Test Date: 20210123; Test Name: Gastrointestinal examination; Result Unstructured Data: Test Result:No finding of acute problems in the stomach; Test Date: 202101; Test Name: X-ray; Result Unstructured Data: Test Result:No result specified
CDC Split Type: DKPFIZER INC2021126339

Write-up: Pneumonia (one-sided pneumonia); Malaise - Became very bad quickly; High fever which results in delirium; High fever which results in delirium; This is a spontaneous report from contactable physician via Regulatory Authority-WEB DK-DKMA-WBS-0030397, Safety Report Unique Identifier DK-DKMA-ADR 24648818. A 77-years-old male patient received the second dose of bnt162b2 (COMIRNATY, lot/Batch number: EJ6134), intramuscular on 21Jan2021 at single dose for covid-19 immunisation. Medical history included fall and unspecified pain from 23Jan2021 due to which the patient was admitted, depression, hypercholesterolemia and urinary frequency all ongoing. The patient previously received the first dose of bnt162b2 (COMIRNATY, Batch number: EJ6797) intramuscular on 31Dec2020 at single dose for covid-19 immunisation. Concomitant medication included lansoprazole (LANSOPRAM), mirtazapine (MIRTAZAPIN KRKA), paracetamol (PANODIL), tolterodine tartrate (TOLTERODINE TARTRATE TEVA), simvastatin (SIMVASTATIN STADA), ibuprofen (IPREN). On 23Jan2021 the patient experienced malaise - became very bad quickly, pneumonia (one-sided pneumonia) and high fever which results in delirium. The patient underwent lab tests and procedures on 23Jan2021 which included Gastrointestinal examination: No findings of acute problems in the stomach, c-reactive protein: increasing. In Jan2021 also blood test and x-ray were performed with no result specified. The patient was treated with two kinds of unknown antibiotics, but it did not help. The patient died on 26Jan2021 due to pneumonia. It was not reported if an autopsy was performed. The outcome of the other events was unknown. a forensic autopsy has been requested. If the Regulatory Authority receives supplemental significant information regarding this case the case will be re-submitted. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1029890 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Congestive cardiomyopathy, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: MEMANTIN ORION; DIVISUN; LINATIL; PANADOL FORTE [PARACETAMOL]; TOLVON; BISOPROLOL ACCORD; MELATONIN ORION; RISPERIDON ORION; ORMOX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Dilated cardiomyopathy; Living in nursing home; Pain; Sleep disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021126062

Write-up: Sudden death; dilated heart disease/Dilated cardiomyopathy; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) WEB FI-FIMEA-20210428. An 80-year-old walking and largely independent female patient received BNT162B2 (COMIRNATY), intramuscularly on 01Feb2021 at single dose for covid-19 vaccination. Medical history included nursing house, dilated heart disease/Dilated cardiomyopathy, pain, alzheimer''s disease, sleep disorder. Concomitant medication included memantine hydrochloride (MEMANTIN ORION) from 19Nov2015 for Alzheimer''s disease; colecalciferol (DIVISUN) from 19Nov2015, enalapril maleate (LINATIL) from 11Oct2016 for dilated cardiomyopathy; paracetamol (PANADOL FORTE) from 15Nov2016 form pain;, mianserin hydrochloride (TOLVON) from 04Oct2018 for sleep disorder; bisoprolol fumarate (BISOPROLOL ACCORD) from 02Jan2020 for dilated cardiomyopathy; melatonin (MELATONIN ORION) from 19Apr2016 for sleep disorder; risperidone (RISPERIDON ORION) from 29Aug2016 for sleep disorder, isosorbide mononitrate (ORMOX) from 18Nov2011 for dilated cardiomyopathy. The patient received vaccine on 01Feb2021 in a nursing house. No noticeable side effects locally, no fever, etc. The patient died unexpectedly sitting in the living room of the nursing house on 03Feb2021 at 9.50. According to the forensic doctor, this is a death associated with dilated heart disease/ Dilated cardiomyopathy and no autopsy is necessary, but recommended that an adverse reaction report should be made. The patient died on 03Feb2021. 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: dilated heart disease/Dilated cardiomyopathy; Sudden death


VAERS ID: 1029891 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Alanine aminotransferase, Altered state of consciousness, Aspartate aminotransferase, Benign breast neoplasm, Bilirubin conjugated, Blood bilirubin, Blood creatinine, Blood pressure measurement, Body temperature, Breast swelling, Cardiac failure, Cardiac output, Coma, Haemoglobin, Hallucinations, mixed, Heart rate, Hepatic function abnormal, Hypotension, Melaena, Metastases to peritoneum, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Peau d'orange, Physical examination, SARS-CoV-2 test, Somnolence, Swelling, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; NEOMERCAZOLE; DIGOXINE; FLUOXETINE; FUROSEMIDE; SOTALOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety reaction; Attempted suicide; Decompensation cardiac (hospitalization in Nov2020); Hypertension arterial; Hyperthyroidism; Monoclonal gammopathy of unknown significance; Paroxysmal atrial fibrillation (treated with amiodarone (replaced by sotalol since 2011 following hyperthyroidism))
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: Bilirubine conjugated; Result Unstructured Data: Test Result:34 umol/l; Test Date: 20210125; Test Name: Bilirubine total; Result Unstructured Data: Test Result:44 umol/l; Test Date: 20201123; Test Name: Creatinine; Result Unstructured Data: Test Result:52 umol/l; Test Date: 20210125; Test Name: Creatinine; Result Unstructured Data: Test Result:119 umol/l; Test Date: 20210127; Test Name: Creatinine; Result Unstructured Data: Test Result:212 umol/l; Test Date: 20210125; Test Name: Blood pressure; Result Unstructured Data: Test Result:impregnable mmHg; Test Date: 20210125; Test Name: Blood pressure; Result Unstructured Data: Test Result:80/40 mmHg; Test Date: 20210128; Test Name: Blood pressure; Result Unstructured Data: Test Result:80/50 mmHg; Test Date: 20210125; Test Name: Temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210125; Test Name: Cardiac output; Result Unstructured Data: Test Result:148; Test Date: 20210125; Test Name: Haemoglobin; Result Unstructured Data: Test Result:12.4 g/dl; Test Date: 20210127; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.8 g/dl; Test Date: 20210125; Test Name: Heart rate; Result Unstructured Data: Test Result:24; Comments: 24 bpm; Test Date: 20210125; Test Name: Heart rate; Result Unstructured Data: Test Result:118; Comments: 118 bpm; Test Date: 20210128; Test Name: Heart rate; Result Unstructured Data: Test Result:107; Comments: 107 bpm; Test Date: 20210125; Test Name: NT-ProBNP; Result Unstructured Data: Test Result:14756 ng/L; Test Date: 20210127; Test Name: NT-ProBNP; Result Unstructured Data: Test Result:21581 ng/L; Test Date: 20210125; Test Name: Oxygen saturation; Test Result: 48 %; Test Date: 20210125; Test Name: physical examination; Result Unstructured Data: Test Result:drowsy, reaction to pain, heart rate 24, saturatio; Comments: drowsy, reaction to pain, impregnable blood pressure, no radial pulse, cold extremities; Test Date: 20210125; Test Name: physical examination; Result Unstructured Data: Test Result:marbled appearance, cold extremities. muted heartb; Comments: marbled appearance,cold extr.muted heartbeat,no pulse,soft calves w/out odema of the low limbs.Low-pitched wheezing sounds (rhonchis); Test Date: 20210125; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210125; Test Name: Leucocytes; Result Unstructured Data: Test Result:18.4 g/l; Test Date: 20210127; Test Name: Leucocytes; Result Unstructured Data: Test Result:19.4 g/l; Test Date: 20210125; Test Name: AlAT; Result Unstructured Data: Test Result:277; Test Date: 20210125; Test Name: ASPAT; Result Unstructured Data: Test Result:775
CDC Split Type: FRPFIZER INC2021127076

Write-up: Melaena; swelling with skin change (orange peel) left breast, left flank swelling with skin infiltration; swelling with skin change (orange peel) left breast, left flank swelling with skin infiltration; swelling with skin change (orange peel) left breast, left flank swelling with skin infiltration; drowsiness; blood pressure 80/40 mmHg; Decompensation cardiac; altered either consciousness or coma; altered either consciousness or coma; auditory and visual hallucinations; Probable neoplasia of the left breast and/or left colon with peritoneal carcinomatosis and other locations; Acute renal failure and associated hepatic function; Probable neoplasia of the left breast and/or left colon with peritoneal carcinomatosis and other locations; Acute renal failure and associated hepatic function; This is a spontaneous report from a contactable physician via Regulatory Authority downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-AN20210183. An 89-years-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot EJ6795), intramuscular in the left arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history included hypergammaglobulinaemia benign monoclonal, hypertension, anxiety, paroxysmal atrial fibrillation from 2002 with cardiac decompensation treated with amiodarone (replaced by sotalol since 2011 following hyperthyroidism), suicide attempt. The patient was hospitalized in Nov2020 for cardiac decompensation. The patient was living in a nursery home. The patient was at risk of developing a severe form of COVID-19 disease: yes (heart failure, age, unstable general condition). The patient did not have previous COVID-19 and PCR/serology COVID-19 test was not taken. Concomitant habitual treatment included apixaban (ELIQUIS), carbimazole (NEOMERCAZOLE), digoxin, fluoxetine, furosemide and sotalol since 2011. The patient experienced decompensation cardiac on 25Jan2021. The patient died on 31Jan2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included alanine aminotransferase (0-35 UI/l): 277 on 25Jan2021, aspartate aminotransferase (0-35 UI/l): 775 on 25Jan2021, blood creatinine: 52 umol/l on 23Nov2020, 119 umol/l on 25Jan2021, 212 umol/l on 27Jan2021, blood pressure measurement: 80/50 mmhg on 28Jan2021, body temperature: 36. 4 centigrade on 25Jan2021, cardiac output: 148 on 25Jan2021, haemoglobin: 12. 4 g/dl on 25Jan2021, 11. 8 g/dl on 27Jan2021, heart rate: 24 then 118 bpm on 25Jan2021 marbled appearance, cold extremities, muted heartbeat, no pulse, soft calves without oedema of the lower limbs; low-pitched wheezing sounds (rhonchis), heart rate: 107 bpm on 28Jan2021, bilirubine conjugated (0-5 umol/l): 34 umol/l on 25Jan2021, bilirubine total (0-15 umol/l): 44 on 25Jan2021, n-terminal prohormone brain natriuretic peptide: 14756 ng/l on 25Jan2021, 21581 on 27Jan2021. Leucocytes: 18,4 g/l on 25Jan2021, 19,4 g/l on 27Jan2021. Clinical course was as follows. On 25Jan2021 drowsiness without initial hemodynamic disorder or desaturation, altered either consciousness or coma, auditory and visual hallucinations for a few days. No signs of cranial trauma or fever. No case of COVID-19 in this patients nursery home. COVID-19 PCR test - negative on 25Jan2021. When taken in charge of firefighters on 25Jan2021 physical examination showed drowsy, reaction to pain, heart rate 24, saturation 48%, cardiac output 148, impregnable blood pressure, no radial pulse, cold extremities, temperature 36,4C. On arrival Glasgow 10 (Y3V2M5), Heart rate 118, blood pressure 80/40 mmHg, marbled appearance, cold extremities, muted heartbeat, no pulse, soft calves without oedema of the lower limbs. Low-pitched wheezing sounds (rhonchis). On 28Jan2021 blood pressure 80/50 mmHg, heart rate 107/min, significant swelling with skin change (orange peel) left breast, left flank swelling with skin infiltration. Melaena. Additional examinations: Treatment and progression: Limitation of active therapeutics raised on 25Jan2021, initiation of antibiotic therapy with ceftriaxone 1g/day and intravenously metronidazole. Morphine if pain or dyspnea, Midazolam if anxiety, Scopolamine if congestion. Probable neoplasia of the left breast and/or left colon with peritoneal carcinomatosis and other locations. On 28Jan2021 start of treatment with morphine + midazolam. On 31Jan2021: patient''s death noted at 14:21. Conclusion: Global cardiac decompensation in a patient with a significant cardiac history 4 days after a first injection of Comirnaty, probable discovery of associated neoplasia, and hallucinations. Acute renal failure and associated hepatic function. Death of the patient following this episode. Accountability made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Ministry of Health n 84/50, January 24, 1984; published in Therapy 1985: 40: 111-8. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1029893 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, C-reactive protein, C-reactive protein increased, Dehydration, Pneumonia aspiration, Pneumonia bacterial, Respiratory distress, Seizure, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (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), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; COVID-19; COVID-19 respiratory infection; Epilepsy; Hypoxemia; Sebaceous cyst; Tibia fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: C-reactive protein; Result Unstructured Data: Test Result:329
CDC Split Type: FRPFIZER INC2021126231

Write-up: INCREASED CRP at 329; transient ischemic (TI) shock; aspiration pneumonia; convulsive crisis; ACUTE RENAL FAILURE; BACTERIAL PNEUMONIA; DEHYDRATION; RESPIRATORY DISTRESS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-LL20210270 This is a report received from the Regulatory Authority. An elderly male patient received bnt162b2 (COMIRNATY, Lot#: EJ6796), via Intramuscular on 14Jan2021 at single dose for covid-19 immunization. Medical history included covid-19 infections from Oct2020, Deficiency encephalopathy on epilepsy in childhood and unknown if ongoing, Hypoxemic lung disease from 2013, covid-19 from Oct2020, Sebaceous cyst abscess in the back and unknown if ongoing , cholecystectomy from 1989, Tibial and mandibular fracture and unknown if ongoing. The profile was that of a person with cerebral palsy care home resident patient. The patient''s concomitant medications were not reported. Onset of unresponsive respiratory distress O2 high concentration mask (oxygen therapy mask) (14Jan2021). On 18Jan2021 he presents clinically observed bacterial pneumonia, dehydration, acute end-stage renal failure. Death by transient ischemic (TI) shock with a C-reactive protein at 329 on 19Jan2021 in connection with aspiration pneumonia in the context of a convulsive crisis. The outcome of the events was fatal. It was unknown if autopsy was performed.; Reported Cause(s) of Death: transient ischemic (TI) shock; aspiration pneumonia; convulsive crisis; INCREASED CRP


VAERS ID: 1029898 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adult failure to thrive, Investigation, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 21
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: Arnold neuralgia; Arterial hypertension; Dementia; Malnutrition; Osteoarthritis of neck; Palliative care; Pneumonia aspiration; Rectal bleeding; Sigmoid diverticulitis; Starvation; Transient ischaemic attack; Ulcer
Allergies:
Diagnostic Lab Data: Test Date: 2020; Test Name: examinations; Result Unstructured Data: Test Result:suspected colonic lesions consistent with a tumor; Test Date: 20200727; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20200820; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20201109; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20201116; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20201123; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20201207; Test Name: COVID-19 test; Test Result: Negative ; Test Date: 20201214; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021127177

Write-up: Adult failure to thrive; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. This is a report received from the Regulatory Authority. Regulatory Authority report number was FR-AFSSAPS-NT20210140. An 81-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477), intramuscular in the arm on 15Jan2021 as a single dose for COVID-19 vaccination. Medical history included rectal bleeding, sigmoid diverticulitis, dementia, osteoarthritis of neck, aspiration pneumonia, Arnold''s neuralgia, undernutrition, starvation, arterial hypertension, transient ischaemic attack, and ulcer; all from unknown dates and unknown if ongoing. The patient''s concomitant medications included unspecified nutritional supplements. In Jan2021, the patient experienced adult failure to thrive; which was serious for being fatal. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had COVID-19 tests on 27Jul2020, 20Aug2020, 09Nov2020, 16Nov2020, 23Nov2020, 07Dec2020, and 14Dec2020; all of which were negative. The clinical course was as follows: He lived at home but with a substantial plan of assistance. He was hospitalized last summer for a deterioration in his general condition. The examinations performed suspected colonic lesions consistent with a tumor. The patient presented with nausea and vomiting. It was decided, given the comorbidities, not to perform a biopsy in search of cancer and no surgical management. He was therefore hospitalized for palliative care with nutritional supplements mainly during the last month of life. The patient was vaccinated on 15Jan2021 with family agreement and no adverse effects described after vaccination. On 22Jan2021 at 05:00, the patient died due to slip syndrome (as reported). The clinical outcome of adult failure to thrive was fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: adult failure to thrive


VAERS ID: 1029899 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pneumonia aspiration, 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: 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: DUROGESIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fracture of clavicle; Hyperalgesia; Osteoporosis; Weakness of arms
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: febrile
CDC Split Type: FRPFIZER INC2021127175

Write-up: Pyrexia; Distress respiratory; aspiration pneumonia; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NT20210141. This is a report received from the Regulatory Authority. A 92-year-old female patient received the first dose of bnt162b2 (COMIRNATY) Batch/lot number: EJ6795, intramuscularly on 21Jan2021 at single dose in right arm for covid-19 vaccination. Medical history included osteoporosis, clavicular fracture in 2014, impotence of the left arm post-traumatic and hyperalgesic. The patient''s concomitant medications included fentanyl (DUROGESIC) 12ug / hour for hyperalgesic. The patient showed no signs of ongoing infection on the day of vaccination, 21Jan2021 (normal constants, RAS clinical examinations). The monitoring of the constants at 15 min, 30 min then every 3 hours for 24 hours then once / d (anti-Covid post-vaccination surveillance protocol within the care home where the vaccination took place), was normal. Day 0 to Day 6. On 26Jan2021, the patient was febrile (38.5 Celsius degrees, Pyrexia), and presented with respiratory distress. The patient did not want hospitalization or relentlessness, palliative care was supervised by the doctor on 15 (in the absence of a doctor who could travel), who prescribed SC morphine. In the absence of auscultation by a doctor, knowing that the patient was on the wrong track, it can be assumed that she had aspiration pneumonia. The death was declared on 27Jan2021. It was not reported if an autopsy was performed. The outcome of the events was fatal.; Reported Cause(s) of Death: Pyrexia; Distress respiratory; aspiration pneumonia


VAERS ID: 1029901 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Nausea
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021126105

Write-up: Infarct myocardial; nausea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-PO20210157. This is a report received from the Regulatory Authority. An 85-year-old female patient received first injection of bnt162b2 (COMIRNATY, unknown lot number), intramuscularly on 25Jan2021 at 0.3 ml, single at unknown injection arm for COVID-19 vaccination. The patient medical history was not reported. There were no concomitant medications. The patient experienced infarct myocardial on 30Jan2021, which led to death. The patient does not present, according to her husband, of notable antecedents (medical history), in particular cardiac. On 30Jan2021 in the morning, she declared a feeling of chest tightness to her husband. The husband reported that the patient presented retro-sternal pain radiating between the shoulder blades accompanied by nausea for 45 minutes. She wanted to go to the bathroom to throw up. The husband heard a crashing noise in the toilet and found his wife unconscious on the floor. The death was quickly noted at 11:00 am. The cause mentioned by the doctor on the spot is the occurrence of a heart attack. She did not have a priori COVID 19, no information on a possible COVID-19 test. The patient had no usual treatment. The action taken in response to the event for bnt162b2 was not applicable. The patient died on 30Jan2021. It was not reported if an autopsy was performed. The outcome of nausea was known. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1029904 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Creatinine renal clearance, Death, Echocardiogram, SARS-CoV-2 test, Ultrasound Doppler
SMQs:, 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: AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; RAMIPRIL; LOXAPAC [LOXAPINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome (without a clearly established diagnosis of bipolarity; usual normalization in a few days or weeks, rapidly improved by transient increases in Urbanyl.); Behavior disorder (Moderate behavioral disorders, progressively increasing over the years, attributed to an dementia disease); Carcinoma excision (infiltrating epidermoid carcinoma, cutaneous, at temporal level, having benefited from a resection); Corneal lesion (Corneal lesions, corneal transplant refusal 2011.); Deep vein thrombosis (Right femoropopliteal DVT in 2010, left popliteal iliofemoral in May2017); Dementia (no objective tests, validated by daily observation; managed best by behavioral method and sometimes a small dose of benzodiaepines); Hallux Valgus correction (Hallux valgus operated in 1996); Hypertension arterial; Mood altered (Alternation of anxiodepressive / euphoric periods without a clearly established diagnosis of bipolarity, usual normalization in a few days or weeks, rapidly improved by transient increases in Urbanyl.); Renal insufficiency (Moderate; Clearance 50 ml/min in Feb2020); Squamous cell carcinoma of skin (infiltrating epidermoid carcinoma, cutaneous, at temporal level, having benefited from a resection); TIA (brutal lack of word isolated in Jan2012, brain CT Supra-aortic trunks echodoppler cardio echo Normal)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Brain CT; Result Unstructured Data: Test Result:normal; Test Date: 202002; Test Name: clearance; Result Unstructured Data: Test Result:50 ml/min; Test Date: 202101; Test Name: cardio echo; Result Unstructured Data: Test Result:normal; Test Date: 20210121; Test Name: PCR SARScov-2; Test Result: Negative ; Test Date: 202101; Test Name: Supra-aortic trunks echodoppler; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021125894

Write-up: Death unexplained; This is as spontaneous report received from a contactable physician, downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-RS20210112. A 100-year-old female patient received BNT162B2 (COMIRNATY) (lot number EM0477, expiry date unknown) on 19Jan2021 16:00 at a single dose intramuscularly in the right arm for sars-cov2-vaccination. The patient''s medical history included transient Ischeamic attack (TIA) (brutal lack of word isolated in Jan2012, brain CT, Supra-aortic trunks echodoppler, cardio echo were normal); moderate renal failure (clearance 50 ml/min in Feb2020); arterial hypertension; right femoropopliteal deep vein thrombosis (DVT) in 2010, left popliteal iliofemoral in May2017; alternation of anxiodepressive / euphoric periods without a clearly established diagnosis of bipolarity, usual normalization in a few days or weeks, rapidly improved by transient increases in Urbanyl; moderate behavioral disorders, progressively increasing over the years, attributed to an demential disease (no objective tests) validated by daily observation, and which the healthcare team managed best by behavioral method and sometimes a small dose of benzodiaepines; infiltrating epidermoid carcinoma, cutaneous, at temporal level, having benefited from a resection; Hallux valgus operated in 1996; corneal lesions, corneal transplant refusal 2011. Concomitant medications included amlodipine, acetylsalicylic acid/ascorbic acid (ASPIRIN), ramipril, loxapine hydrochloride (LOXAPAC). No particular health event in recent weeks (general condition fragile but stable). No loxapine (LOXAPAC) given in the week before death. Vaccination against COVID-19 on 01Jan2021 at 4 p.m. by BNT162B2 in the right arm. No adverse effects during post-vaccination monitoring, or subsequently (nothing noticeable at the injection site, no sign of discomfort observed afterwards). The patient was found deceased on the morning of Thursday 21Jan2021, without any sign of orientation towards a particular cause of death. Postmortem nasopharyngeal swab PCR SarsCov2 negative. The event was reported as death unexplained. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1029905 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: ECG; Result Unstructured Data: Test Result:extensive anterior transmural; Comments: extensive anterior transmural myocardial infarction. Thrombolysis
CDC Split Type: FRPFIZER INC2021126232

Write-up: Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB regulatory authority FR-AFSSAPS-TS20210136. An 86-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscularly on 19Jan2021 at single dose for covid-19 vaccination. The patient''s medical history and concomitant medications were not reported. There was no information on cardiovascular history or current treatments. Declaration made by the establishment that received the patient for chest pain. On 23Jan2021 at night, onset of lasting intense chest pain. On ECG: extensive anterior transmural myocardial infarction. The patient had thrombolysis. The patient had death during transfer from hospital to hospital. In total, death complicating an extensive transmural infarction in a patient vaccinated 4 days previously with Comirnaty. The patient died on 23Jan2021. An autopsy was not performed. The outcome of the event was fatal. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1029906 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021136012

Write-up: death; This is a spontaneous report from a contactable physician. This report was received via a sales representative. This physician reported similar events for 16 patients. This is the first of 16 reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. It was not reported if an autopsy was performed. According physician event was not related to vaccine. Patient should have been ill before vaccination. The information on the batch number has been requested.; Sender''s Comments: The causal association cannot be excluded between the reported event of death and BNT162B2 vaccine. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. 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) : FR-PFIZER INC-2021136132 same reporter, drug, different event;FR-PFIZER INC-2021136128 same reporter, drug, different event;FR-PFIZER INC-2021136133 same reporter, drug, different event;FR-PFIZER INC-2021136124 same reporter, drug, different event;FR-PFIZER INC-2021136131 same reporter, drug, different event;FR-PFIZER INC-2021136125 same reporter, drug, different event;FR-PFIZER INC-2021136126 same reporter, drug, different event;FR-PFIZER INC-2021136127 same reporter, drug, different event;FR-PFIZER INC-2021136130 same reporter, drug, different event;FR-PFIZER INC-2021136129 same reporter, drug, different event;FR-PFIZER INC-2021136123 same reporter, drug, different event;FR-PFIZER INC-2021136122 same reporter, drug, different event;FR-PFIZER INC-2021136121 same reporter, drug, different event;FR-PFIZER INC-2021136120 same reporter, drug, different event;FR-PFIZER INC-2021136119 same reporter, drug, same event, different patient; Reported Cause(s) of Death: death


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