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

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



Case Details

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VAERS ID: 1000403 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: CALOGEN [FATS NOS]; RENALIN; GALFER; FOLIC ACID; MEMANTINE; SENOKOT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Chronic kidney disease; Fainting (Faints while sitting out at commode but nil in recent months); Road traffic accident; Vascular dementia; Comments: 1) pacemaker 2013, 2) RTA June 2016, 3) vascular dementia 4) Chronic Kidney Disease 2018 5) history of faints while sitting out at commode but nil in recent months.
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021103092

Write-up: MYOCARDIAL INFARCTION; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (IE-HPRA-2021-063720). A 97-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EM0477) intramuscularly on 22Jan2021 at 0.3 ml single in left deltoid for COVID-19 immunization. The patient''s medical history included pacemaker from 2013, Road traffic accident (RTA) from Jun2016, vascular dementia, chronic kidney disease from 2018, history of faints while sitting out at commode but nil in recent months. It was reported that the patient was very unwell one year ago (2020) and had been receiving end of life care for a period but improved. In the three months prior to reporting (Oct2020), the patient tended to be in bed more often but this fluctuated. The patient had taken her meals in her bedroom in the past three months. It was outlined that the patient had been recently bright/alert and eating well. The patient''s concomitant medications included ferrous fumarate (GALFER); blumea balsamifera, curcuma longa, lagerstroemia speciosa, orthosiphon aristatus (RENALIN); fats nos (CALOGEN); sennoside A+B (SENOKOT); folic acid; and memantine for dementia. The patient previously received quadrivalent influenza vaccine (split virion, inactivated), suspension for injection in pre-filled syringe. The patient experienced myocardial infarction on 25Jan2021. On 22Jan2021, the patient was well post vaccination and no side effects to vaccination had been noted. On 25Jan2021 at 7.30 am, the patient was noted to be asleep in bed when checked. At 8.15 am, the patient was found dead. The patient was not for resuscitation. It was reported that the General Practitioner (GP) certified the cause of death as myocardial infarction. The patient died on 25Jan2021. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: MYOCARDIAL INFARCTION


VAERS ID: 1000473 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Fluid intake reduced, Hypophagia, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: BUSCOPAN; AFIPRAN; PARACET [PARACETAMOL]; PINEX; SELO-ZOK; FENTANYL SANDOZ; LANTUS; MORPHINE ORION; SOBRIL; COZAAR; HALDOL; MIDAZOLAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Cognitive impairment; Decreased appetite; Diabetes mellitus; Gastrointestinal spasm; Hypertension; Living in nursing home; Nausea; Unrest
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021089362

Write-up: DIARRHEA; VOMITING; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority with Regulatory authority report number NO-NOMAADVRE-FHI-2021-U4eqa, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014144. An 89-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number: EJ6795), intramuscularly on 06Jan2021 09:00 at single dose in Left arm for Covid-19 vaccination. Medical history included diabetes mellitus, angina pectoris, decreased appetite (Reduced food intake two weeks before vaccination) cognitive impairment, gastrointestinal spasm, nausea, hypertension, unrest, all from an unknown date and unknown if ongoing. The patient was Living in nursing home. Concomitant medication included hyoscine butylbromide (BUSCOPAN) from 12Jan2021 to 17Jan2021 for gastrointestinal spasm, metoclopramide hydrochloride (AFIPRAN) from 12Jan2021 to 17Jan2021 for nausea, paracetamol (PARACET) from an unknown date to 13Jan2021 for pain, paracetamol (PINEX) from an unknown date to 11Jan2021 for pain, metoprolol succinate (SELO-ZOK) from an unknown date to 12Jan2021 for hypertension, fentanyl (FENTANYL SANDOZ) from 11Jan2021 to 17Jan2021 for pain, insulin glargine (LANTUS) from an unknown date to 13Jan2021 for diabetes mellitus, morphine hydrochloride (MORPHINE ORION) from 12Jan2021 to 17Jan2021 for pain, oxazepam (SOBRIL) from an unknown date to 13Jan2021 for unrest, losartan potassium (COZAAR) from an unknown date to 12Jan2021 for hypertension, haloperidol (HALDOL) from 12Jan2021 to 17Jan2021 for unrest, midazolam from 12Jan2021 to 17Jan2021 for unrest. The patient experienced vomiting on 06Jan2021 and diarrhea on 08Jan2021, reported as serious with serious criteria death. The patient experienced vomiting once on the same day as vaccination on 06Jan2021. Two days after vaccination on 08Jan2021, he developed diarrhea, gradually continuous running stools, no food/fluid intake. Reporter states that it is not certain that the symptoms are due to a side effect of the vaccine as the man had reduced appetite a few weeks before vaccination, as well as comorbidity. In the time before vaccination, the man also did not want to take his medication, including long-acting insulin. The patient died on an unspecified date in Jan2021. It was not reported if an autopsy was performed. The outcome of events vomiting and diarrhea was fatal. Sender Comment: Nausea is reported as a side effect of the vaccine Comirnaty, while diarrhea is not listed as a known side effect. In some people, reactions such as short-term / transient nausea and loose stomach can be linked to being vaccinated, but then as a form of physiological stress response to the event / vaccination. In this case, there is a relatively close temporal relationship between vomiting, diarrhea and vaccination. It is stated that the patient had reduced food intake in the period before vaccination, and it can therefore not be ruled out that vomiting and diarrhea may have been symptoms of an underlying condition that was present in before vaccination. On the basis of the information in the report and in accordance with 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 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: Vomiting; diarrhea


VAERS ID: 1000474 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Death, Dyspnoea, Fluid intake reduced, General physical health deterioration, Hypophagia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MORFIN [MORPHINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Confused; Disorientated; Drowsiness; Dyspnea; Pain (Started morfine (subcutanous) 01Jan2021 for generalised pain); Reduced general condition; Respiratory arrest; Urinary tract infection (Per oral antibiotics 30Dec2020 - 06Jan2021 for possible urinary tract infection); Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: C-reactive protein; Result Unstructured Data: Test Result:20; Test Date: 20210115; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30
CDC Split Type: NOPFIZER INC2021089310

Write-up: RESPIRATORY ARREST; REDUCED GENERAL CONDITION; DYSPNEA; health condition was already reduced (reduced general condition and possible dyspnea) from before, and it got worse the same day as the vaccination; This is a spontaneous report from a contactable Other Health Professional downloaded from the Agency Agency-WEB NO-NOMAADVRE-FHI-2021-Uedw5, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014102. A 94-years-old male patient received his first dose bnt162b2 (COMIRNATY), lot number: EM0477, intramuscular on left arm on 14Jan2021 12:25 at single dose for covid-19 immunisation. Medical history included wheelchair user, respiratory arrest, reduced general condition, possible dyspnea, generalised pain and started morfine (subcutanous) 01Jan2021 for generalised pain, he was not completely clear and oriented afterwards and was more drowsy/confused; urinary tract infection (Per oral antibiotics 30Dec2020 to 06Jan2021 for possible urinary tract infection), all from an unknown date. Concomitant medication included morfin [morphine] subcutaneous from 01Jan2021 for generalised aching. The patient experienced dyspnea and reduced general condition the same day as vaccination with covid-19 vaccine bnt162b2 on 14Jan2021, and experienced respiratory arrest and death the day after on 15Jan2021. His health condition was already reduced (reduced general condition and possible dyspnea) from before, and it got worse the same day as the vaccination on 14Jan2021. He could not either eat/drink or take his medicines and was bedridden to the day after the vaccination when he died (15Jan2021). It was reported "Start-up with oxygen 0.5-1 L on spectacle catheters after clearly reduced breathing pattern." He was independent in meal situations from an unspecified date. The patient underwent lab tests and procedures which included c-reactive protein: 20 on 07Jan2021, c-reactive protein: 30 on 15Jan2021. The patient died on 15Jan2021. It was not reported if an autopsy was performed. Sender Comment: A 94-year-old man with dyspnoea and reduced general condition same day as vaccination with covid-19 vaccine (Comirnaty). Respiratory arrest and death the next day. His health was already reduced from before the vaccination, but the situation worsened after the vaccination. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or some other random incident, happening at the same time but 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 died, the message is classified as serious, even though no causal link between the vaccine and the death has been established. Reporter''s comment: 21Jan2021: Received additional information from reporter (phone call): date of death, date of adverse events, other details. No follow-up attempts possible. No further information expected.; Reporter''s Comments: 21Jan2021: Received additional information from reporter (phonecall): date of death, date of adverse events, other details; Reported Cause(s) of Death: reduced general condition; RESPIRATORY ARREST; His health condition was already reduced (reduced general condition and possible dyspnea) from before, and it got worse the same day as the vaccination; dyspnea


VAERS ID: 1000476 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose decreased, Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: BISOPROLOL; DUROFERON; PANTOLOC [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; CLOPIDOGREL; AMLODIPINE; CANDEXETIL; ATORVASTATIN; METFORMIN; TRAJENTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021089170

Write-up: Dead; FEVER; Blood sugar decreased; This is a spontaneous report from a contactable nurse received from Regulatory Authority, downloaded from the Regulatory Authority-WEB (SE-MPA-2021-000794, other case identifier: SE-MPA-1611147230356). An 88-year-old female patient received BNT162B2 (COMIRNATY; Lot number EL1484) intramuscular in Jan2021 at 0.3 mL single for COVID-19 immunisation. Relevant medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included candesartan cilexetil (CANDEXETIL) from 08Sep2020, ferrous sulfate (DUROFERON) from 10Mar2020, pantoprazole sodium sesquihydrate (PANTOLOC) from 10Mar2020, linagliptin (TRAJENTA) from 01Dec2020, amlodipine from 08Sep2020, atorvastatin from 10Mar2020, bisoprolol from 21Nov2020, clopidogrel from 10Mar2020 and metformin from 21Nov2020. In Jan2021, the patient experienced fever, decreased blood sugar and died. According to the rapporteur, the female developed fever in the afternoon the same day as she got vaccinated with BNT162B2, during the night her blood sugar decreased. She was sent to hospital and died two days after vaccination with BNT162B2. The patient died in Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1000477 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Death, Depressed level of consciousness, Hemiplegia, SARS-CoV-2 test positive
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (during Christmas weekend 2020 and tested positive for Covid); Hypertension; Infection; Progression of Alzheimer''s disease; Tiredness (more tired than usual after the covid infection)
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021089283

Write-up: STROKE/decreased consciousness and right-side paresis; This is a spontaneous report from a contactable physician downloaded from the Agency (EMA) Agency-WEB SE-MPA-2021-000972, other case identifier: SE-MPA-1611224017780, received from Regulatory Authority. A 72-year-old female patient received bnt162b2 (COMIRNATY, Batch/lot number: EL1484), via an unspecified route of administration on Jan2021 at unknown age at single dose for covid-19 immunisation. Medical history included progression of Alzheimer''s disease and hypertension. The female was living in a special care home and got infected with Covid during Christmas weekend 2020 and a few days later on 30Dec2020 she tested positive for Covid. The female had sparse infection symptoms, no fever, but felt more tired than usual after the covid infection. The patient''s concomitant medications were not reported. The female experienced a stroke on Jan2021. The reporter stated that according to guidelines the female was vaccinated with Comirnaty in mid-Jan2021 and fell ill 5 days later, decreased consciousness and right-side paresis. The reporter stated it was similar to a clinical picture in the event of a stroke, unknown if it was an ischemic stroke or caused by a bleeding. The female calmly died shortly thereafter. The patient underwent lab tests and procedures which included COVID19 test: positive on 30Dec2020. The patient died on Jan2021. Outcome of the event stroke was fatal. An autopsy was not performed. The reporter stated that the probability of death caused by Comirnaty is low. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: stroke


VAERS ID: 1000478 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Cough, Death, Pneumonia, Pyrexia, SARS-CoV-2 test negative, White blood cell disorder
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: MEMANTINE; MIRTAZAPINE; LASIX [FUROSEMIDE] RETARD; TROMBYL; APROVEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder catheterisation; Cerebellar stroke; Polymyalgia rheumatica; Polyneuropathy; Reduced general condition; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: CRP; Result Unstructured Data: Test Result:42; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative; Test Date: 202101; Test Name: leukocytes in the urine; Result Unstructured Data: Test Result:leukocytes in the urine
CDC Split Type: SEPFIZER INC2021089014

Write-up: Pneumonia; cough; fever; CRP 42; had leukocytes in the urine; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB SE-MPA-1611238512515 Safety Report Unique Identifier SE-MPA-2021-001019 and received via Regulatory Authority. An 85-years-old male patient received the first dose of BNT162B2 (COMIRNATY) (lot: EJ6795) intramuscular on Jan2021 at single dose for COVID-19 immunisation. Medical history included polyneuropathy from an unknown date and unknown if ongoing, cerebellar stroke from 2006 and unknown if ongoing, reduced general condition from an unknown date and unknown if ongoing, bladder catheterisation from an unknown date and unknown if ongoing, vascular dementia from an unknown date and unknown if ongoing, polymyalgia rheumatica from an unknown date and unknown if ongoing. Concomitant medication included memantine from 2017 to 21Jan2021, mirtazapine from 2017 to 21Jan2021, furosemide (LASIX RETARD) from 2006 to 21Jan2021, acetylsalicylic acid (TROMBYL) from 2006 to 21Jan2021, irbesartan (APROVEL) from 2006 to 21Jan2021. The patient experienced pneumonia on Jan2021. The patient lived in a service home and was vaccinated with Comirnaty in early Jan2021, 12 days after the vaccination with Comirnaty he got a cough and one day later he got fever, CRP 42 and got treated with ciprofloxacin. He had a negative COVID test. Next day he was out of fever and he ate breakfast, but dies later that day (Jan2021). No reaction close to vaccine 2, before death the patient had periods of a reduced general condition and at the time of death the patient had leukocytes in the urine, but he also carried a catheter. The reporter states that the pneumonia is the cause of death and that the probability of death caused by Comirnaty is low. The reaction started 13 days after the vaccination with Comirnaty. It is unknown if the man has had any previous drug reactions. Event outcome for pneumonia was fatal, for fever was recovered on Jan2021, while for others was unknown. The patient died on Jan2021. An autopsy will not be performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1000479 (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: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Condition aggravated, Continuous positive airway pressure, Death, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021097900

Write-up: Cardiac failure aggravated; breathing difficulties; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-001654 and other case identifier number SE-MPA-1611657205772. An 89-year-old female patient received BNT162B2 (COMIRNATY; Lot number EL1484), intramuscular in Jan2021 as single dose for covid-19 immunization. Medical history included cardiac failure from an unknown date and unknown if ongoing and atrial fibrillation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced cardiac failure aggravated in Jan2021, which was serious as it lead to death. The patient also experienced breathing difficulties in Jan2021, with unknown outcome. Details were as follows: patient had palliative care prescriptions since Apr2020, but was sent to hospital with breathing difficulties three days after the vaccination and died the same day. The patient was treated with CPAP (continuous positive airway pressure) and intravenous diuretic at the hospital. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac failure aggravated


VAERS ID: 1003806 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Glomerular filtration rate, Haemoglobin, 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: 2021-01-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; MIANSERIN; ALPRAZOLAM; ZYMAD; SOTALOL; TERCIAN [CYAMEMAZINE]; DIFFU-K; NACL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Anemia (need to be transfused for anemia at 7.6g/l with no cause found); Bedridden; Dyslipidaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: potassium; Result Unstructured Data: Test Result:4.52 mmol/L; Test Date: 20210108; Test Name: GFR; Result Unstructured Data: Test Result:96.6 ml/min; Test Date: 20210108; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9.2 g/dl
CDC Split Type: FRPFIZER INC2021088235

Write-up: sudden death; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20210082. A 87-years-old female patient received first dose of bnt162b2 (COMIRNATY, Lot number: EM0477), via intramuscular on 20Jan2021 15:00 at single dose on the left arm for COVID-19 vaccination. Medical history included Alzheimer''s disease, bedridden, dyslipidaemia and altered state for a few weeks in December, needed to be transfused for anemia at 7.6g/l with no cause found. Concomitant medication included paracetamol, mianserin, alprazolam, colecalciferol (ZYMAD), sotalol, cyamemazine (TERCIAN), potassium chloride (DIFFU-K) and nacl. The patient experienced sudden death on 20Jan2021 23:00. Last assessment carried out on this patient 08Jan2021: Hemoglobin 9.2 g/dl, potassium 4.52 mmol/l, GFR 96 .9 ml/min. Regarding the follow-up after vaccination at the center: Evolution: refused the snack and at 7:00 p.m. took half a dessert. Patient found dead 8 hours after the vaccination on 20Jan2021 at 11 pm. It was unknown if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1004188 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2021-01-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA156571-EJ679 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray abnormal, Death, Pneumonia, Sepsis
SMQs:, Cardiomyopathy (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Osteoporosis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Name: temperature; Result Unstructured Data: Test Result:elevated; Test Name: heart rate; Result Unstructured Data: Test Result:fast; Test Name: X-ray; Result Unstructured Data: Test Result:bilateral pneumonia
CDC Split Type: SEPFIZER INC2021095267

Write-up: Sepsis; Pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. Regulatory Authority report number is SE-MPA-2021-001251. Other case identifier number SE-MPA-1611326316846. An 87-year-old male patient received BNT162B2 (COMIRNATY; Lot number Lot number: PAA156571-EJ6795), intramuscular in Dec2020 as single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, osteoporosis and dementia from unknown dates and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced sepsis and pneumonia in Jan2021, which were serious as it lead to death; patient was admitted to the hospital on an unspecified date. Details were as follows: The man had a scenario compatible with pneumonia and sepsis. 16 days after the vaccination with BNT162B2 the patient was wheezy in the morning and there was a suspicion of aspiration. He suddenly got worse with elevated temperature, low blood pressure and fast heart rate. The patient was admitted to a hospital on an unspecified date, and a chest X-ray was performed where they saw bilateral pneumonia. The patient died a few days later. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pneumonia; Sepsis


VAERS ID: 1010236 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Fatigue, Hypertension, Pain, Rales, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: Aortic aneurysm; Dementia vascular; Marasmus; Ulcus cruris
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemia cerebral
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021097455

Write-up: death; somnolence; Pain; rale; hypertensive emergency; fatigue aggravated; This is a spontaneous report received from a contactable physician by Pfizer from the database. The regulatory authority report number is AT-BASGAGES-2021-00487. An 83-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing ulcus cruris, ongoing marasmus, ongoing dementia vascular, Ischemia cerebral from an unknown date and unknown if ongoing, ongoing aortic aneurysm. The patient''s concomitant medications were not reported. On 13Jan2021 the patient experienced fatigue aggravated. On 14Jan2021 the patient experienced hypertensive emergency. On 18Jan2021 the patient experienced somnolence, hypertensive emergency, pain, rale. On 19Jan2021 the patient experienced death. It was not reported if an autopsy was performed. Medication from 14Jan2021: Ringer''s solution 500 ml sc because of decreased fluid absorption on 14Jan; nitrospray on 14. and 18Jan because of RR$g200; 0.5 Vendal ampoules on 18. and 19Jan because of pain; 0.5 Buscopan ampoules on 18. and 19Jan because of mucus rattling. The outcome of events Pain, Hypertensive emergency and rale was unknown, while the outcome of the other events was fatal. Sender Comment: Confounding factors: elderly age, underlying weakness. Temporal relationship: 7 days between vaccination and death. The causal relationship between the product/substance COMIRNATY / TOZINAMERAN and fatigue aggravated and somnolence is assessed as unclassifiable. The information provided in this individual case does not warrant a change in the product information or other measures. The case will be closed at this time. The topic will be monitored closely. Follow-up information has been requested. No follow-up attempts possible. No further information expected.


VAERS ID: 1010237 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension (arterial hypertension); Atrial fibrillation (tachicardia, atrial fibrillation); Cerebral atrophy (cortical atrophy); Diabetes mellitus (diabetes mellitus); Extrasystoles (SVES and VES (triples and couplets)); Lumbago (lumbago by the spine); Normal pressure hydrocephalus (Normal pressure cephalus- condition after lumbar puncture 2011); Steatosis hepatic (Inhomogeneous Steatosis hepatis); Vitamin D deficiency (Vit D deficiency)
Preexisting Conditions: Medical History/Concurrent Conditions: Acute appendicitis (acute appendicitis with localized peritonitis, open appendectomy); Appendectomy (open appendectomy); Atrial tachycardia (unstable atrial tachycardia due to exsiccosis); Commotio cerebri (condition after a fall with commotio cerebri); Coxarthrosis (Left hip joint, increased sclerosis in acetabular roof with bony extensions, narrowing hip joint gap); Diastolic dysfunction (severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction); Ejection fraction low (severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction); Electrical cardioversion (condition after electric cardioversion); Electrocardiogram QTc interval prolonged (severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction); Exsiccosis; Generalised convulsion (SEC generalized cerebral seizure, DD TIA with resulting epileptic seizure); Haematuria microscopic (microhematuria); Hypergammaglobulinaemia; Hypoproteinaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021097977

Write-up: Pre-collapse symptoms; left ventricular failure; This is a spontaneous report from a contactable physician downloaded from the database [AT-BASGAGES-2021-00632] received via Regulatory Authority. An 86-year-old male patient received the first dose of BNT162B2 (COMIRNATY) (Lot number EJ6796, expiration date unknown), intramuscular on 18Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concurrent conditions included: Acute appendicitis (from 12Aug2014, unknown if ongoing, acute appendicitis with localized peritonitis, open appendectomy), Appendectomy (from 15Jul2014, not ongoing, open appendectomy), Commotio cerebri (not ongoing, condition after a fall with commotio cerebri), Extrasystoles (continuing, SVES and VES (triples and couplets)), Arterial hypertension (continuing), Diabetes mellitus (continuing), Normal pressure hydrocephalus (continuing, Normal pressure cephalus- condition after lumbar puncture 2011), Cerebral atrophy (continuing, cortical atrophy), Haematuria microscopic (unknown if ongoing, microhematuria), Hypergammaglobulinaemia (unknown if ongoing), Lumbago (continuing, lumbago by the spine), Hypoproteinaemia, Vitamin D deficiency (continuing), Steatosis hepatic (continuing, Inhomogeneous Steatosis hepatis), Coxarthrosis (unknown if ongoing, Left hip joint, increased sclerosis in the acetabular roof with bony extensions, narrowing of the hip joint gap, this almost completely eliminated, bony extensions on the femoral head), Atrial fibrillation (continuing, tachicardia, atrial fibrillation), Electrical cardioversion (not ongoing, condition after electric cardioversion), Generalised convulsion (unknown if ongoing, SEC generalized cerebral seizure, DD TIA with resulting epileptic seizure), Atrial tachycardia (unknown if ongoing, unstable atrial tachycardia due to exsiccosis), Exsiccosis (unknown if ongoing), Electrocardiogram QTc interval prolonged (unknown if ongoing, severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction), Ejection fraction low (unknown if ongoing, severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction), Diastolic dysfunction (unknown if ongoing, severely impaired QTc prolongation, severely impaired LVEF, severely diastolic dysfunction). The patient''s weight and height was not reported. There''s no known allergies. Concomitant medications were not reported. On 19Jan2021 19:00, the patient experienced pre-collapse symptoms which was reported as serious due to required hospitalization. On 23Jan2021, the patient experienced left ventricular failure which resulting in death. The outcome of the event pre-collapse symptoms was unknown, for the event left ventricular failure was fatal. The patient died in Jan2021. Autopsy was performed. The cause of death was left heart failure according to autopsy findings from 25Jan2021, findings are not transmitted to BASG. No evidence of adverse drug reaction from vaccination. Causality assessment by BASGAGES: the causality of the event left heart failure with COMIRNATY was unlikely, for the event pre-collapse symptoms with COMIRNATY was possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: left ventricular failure


VAERS ID: 1010238 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Death, Malaise, Oxygen saturation decreased, Pneumonia, Respiratory disorder, Sedation, White blood cell count
SMQs:, Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (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: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOPROLOL EG; PANTOMED [DEXPANTHENOL]; QUETIAPINE EG; ELIQUIS; BEFACT [CYANOCOBALAMIN;PYRIDOXINE;THIAMINE]; PARACETAMOL EG; AMIODARONE; ALDACTONE [SPIRONOLACTONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Overactive bladder
Allergies:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result:180; Test Name: Leukocyte count; Result Unstructured Data: Test Result:15.000; Test Name: investigation; Result Unstructured Data: Test Result:yeasts from HC
CDC Split Type: BEPFIZER INC2021098152

Write-up: Respiratory disorder; Unwell; Bilateral pneumonia; Dopiness; Oxygen saturation decreased; This is a spontaneous report from a contactable consumer downloaded from the database and received via Regulatory Authority BE-FAMHP-DHH-N2021-75690 . A 90-year-old female patient received first dose of BNT162B2 (COMIRNATY) on 13Jan2021 at single dose for COVID-19 vaccination. Medical history included atrial fibrillation and overactive bladder. Concomitant medications included bisoprolol fumarate (BISOPROLOL EG), dexpanthenol (PANTOMED), quetiapine fumarate (QUETIAPINE EG), apixaban (ELIQUIS), cyanocobalamin, pyridoxine, thiamine (BEFACT), paracetamol (PARACETAMOL EG), amiodarone, and spironolactone (ALDACTONE). The patient experienced Unwell, Respiratory disorder, Bilateral disorder, Oxygen saturation decreased, Dopiness on 14Jan2021. The patient was admission to hospital on 14Jan2021 and death on 16Jan2021, probably not related to covid vaccination the day before. Treatment received included antibiotherapy, oxygen Evolution. Lab data included blood analysis: CRP 180; leucocytes 15,000 (left shift), yeasts from HC. Reporter Comment : admission to hospital on 14Jan and death on 16Jan, probably not related to covid vaccination the day before Treatment - Yes antibiotherapy, oxygen Evolution of the ADR - Died Examinations - blood analysis: CRP 180; leucocytes 15,000 (left shift); yeasts from HC. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain; Sender''s Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: Oxygen saturation decreased; Unwell; Bilateral pneumonia; Dopiness; Oxygen saturation decreased


VAERS ID: 1010239 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory failure, Death, General physical health deterioration, Oxygen saturation decreased, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLOR; SERTRALINE; LOSFERRON; ASAFLOW; ISOTEN; MOXONIDINE; VIMPAT; COVERSYL [PERINDOPRIL ARGININE]; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis (Mild); Bronchopneumonia (Recurrent, favored by broncho-inhalations); Chronic renal failure (with probable nephroangiosclerosis, Stage IV); Depression; Emphysema pulmonary; Gastroduodenal ulcer; Hemangioma of liver; Hepatic cyst (Multiple); Hiatus hernia (with beginner Schatzky ring); Hypoxaemia (nocturnal, with probable sleep apnea syndrome); Hypoxemia; Malnutrition (Severe); Mitral insufficiency (moderate); Nephroangiosclerosis (probable); Pulmonary arterial hypertension (57 mmHg + PVC with hypoxemia, Severe); Rotator cuff syndrome (right, without surgical sanction); Schatzki''s ring (beginner); Sleep apnea syndrome; Tricuspid insufficiency (moderate)
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: BEPFIZER INC2021098049

Write-up: Hypoxemia; Bilateral bronchopneumonia; General physical health deterioration; Acute respiratory failure; Oxygen saturation decreased; Acute renal insufficiency; This is a spontaneous report from a contactable physician from the database, Regulatory authority report number is BE-FAMHP-DHH-N2021-75743. A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 15Jan2021at single dose for Covid-19 vaccination. Medical history included Stage IV chronic renal failure with probable nephroangiosclerosis, Multiple hepatic cysts and hepatic angioma. Gastro-duodenal ulcers in 2017. Hiatus hernia with beginner Schatzky ring. Mild aortic stenosis, moderate mitral insufficiency, moderate tricuspid insufficiency, Severe pulmonary arterial hypertension (57 mmHg + PVC) with hypoxemia in 2017. depression, Involvement of the right rotator cuff without surgical sanction. Recurrent right basal bronchopneumonia favored by broncho-inhalations in 2017. Severe undernutrition in 2017. Pulmonary emphysema, nocturnal hypoxemia with probable sleep apnea syndrome in 2017. Concomitant medications included amlodipine besilate (AMLOR), sertraline, ferrous gluconate (LOSFERRON), acetylsalicylic acid (ASAFLOW), bisoprolol fumarate (ISOTEN), moxonidine, lacosamide (VIMPAT), perindopril arginine (COVERSYL), omeprazole. The patient experienced oxygen saturation decreased on 19Jan2021, acute renal insufficiency on 19Jan2021, hypoxemia on 21Jan2021, bilateral bronchopneumonia on 19Jan2021, general physical health deterioration on 19Jan2021, acute respiratory failure on 19Jan2021. Seriousness Criteria for all events was reported as death. The outcome of the events oxygen saturation decreased, acute renal insufficiency, hypoxemia, bilateral bronchopneumonia, general physical health deterioration, acute respiratory failure was fatal. The patient died on 21Jan2021. It was unknown if an autopsy was performed. Casual relationship between bnt162b2 (COMIRNATY) and all events per FAMHP, WHO: unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: oxygen saturation decreased; acute renal insufficiency; Hypoxemia; Bilateral bronchopneumonia; General physical health deterioration; Acute respiratory failure


VAERS ID: 1010240 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block complete, Blood lactate dehydrogenase, Body temperature, C-reactive protein, COVID-19, COVID-19 pneumonia, Drug ineffective, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Serum ferritin
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Conduction defects (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), 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: 2021-01-19
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: LDH; Result Unstructured Data: Test Result:unknown results; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: fever 39 Celsius degree; Test Name: crp; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Name: Ferritin; Result Unstructured Data: Test Result:unknown results
CDC Split Type: BEPFIZER INC2021098156

Write-up: COVID-19 pneumonitis; fever 39 Celsius degree; Atrioventricular block third degree; Oxygen saturation decreased; drug ineffective; Radiographic Image of Covid Pneumonitis + Positive PCR Test; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) Regulatory Authority-WEB BE-FAMHP-DHH-N2021-75795. An 84-year-old male patient received bnt162b2 (COMIRNATY), via unknown route of administration on 11Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient experienced drug ineffective and covid-19 on an unspecified date with outcome of unknown, oxygen saturation decreased on 13Jan2021, covid-19 pneumonitis on 13Jan2021, fever on 13Jan2021, atrioventricular block third degree on 13Jan2021. On 13Jan2021 symptom onset. On 15Jan2021 admission with covid pneumonitis (desaturation, fever 39 Celsius degree) and 3rd degree AV block. The patient died on 19Jan2021. The outcome of the other events was fatal.Treatment was unknown. The patient underwent lab tests and procedures which included blood lactate dehydrogenase: unknown results, c-reactive protein: unknown results, serum ferritin: unknown results on unknown date and Radiographic Image of Covid Pneumonitis + Positive PCR Test. It was not reported if an autopsy was performed. Reporter''s comment: 11/1 covid vaccine in RVT 13/1 symptom onset 15/1 admission with covid pneumonitis (desaturation, fever 39 Celsius degree) and 3rd degree AV block. Treatment -Unknown. Evolution of the ADR - Died. Examinations - Clinical, Biochemical (CRP, Ferritin, LDH) and Radiographic Image of Covid Pneumonitis + Positive PCR Test. Event assessment: FAMHP/to all events/unlikely. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: 11/1 covid vaccine in RVT 13/1 symptom onset 15/1 admission with covid pneumonitis (desaturation, fever 39 Celsius degree) and 3rd degree AV block Treatment - Unknown Evolution of the ADR - Died Examinations - Clinical, Biochemical (CRP, Ferritin, LDH) and Radiographic Image of Covid Pneumonitis + Positive PCR Test; Reported Cause(s) of Death: COVID-19 pneumonitis; Oxygen saturation decreased; Atrioventricular block third degree; fever 39 Celsius degree


VAERS ID: 1010246 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, No reaction on previous exposure to drug, Oxygen saturation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HALOPERIDOL; CLOMETHIAZOLE; ACETYLSALICYLIC ACID; DONEPEZIL; DIAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Expressive aphasia; Mental deterioration
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: Blood pressure; Result Unstructured Data: Test Result:reported as unknown and decreased; Test Date: 20210125; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:reported as unknown and decreased
CDC Split Type: CYPFIZER INC2021098045

Write-up: No reaction on previous exposure to vaccine; 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 (PVPR). The regulatory authority report number is CY-CYPPVPR-270121KK9. A 90-year-old female patient received the first and second doses of the bnt162b2 (COMIRNATY), on 28Dec2020 (Lot Number: EJ6796) and 18Jan2021 (Lot Number: EJ6796); both via intramuscularly at 0.3 mL, single for COVID-19 immunization. Medical history included mental deterioration from an unknown date and unknown if ongoing, expressive aphasia from an unknown date and unknown if ongoing, bedridden from an unknown date and unknown if ongoing. Concomitant medications included haloperidol (MANUFACTURER UNKNOWN), clomethiazole (MANUFACTURER UNKNOWN), acetylsalicylic acid (MANUFACTURER UNKNOWN), donepezil (MANUFACTURER UNKNOWN), diazepam (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date. On 26Jan2021, the patient experienced: "death not related to vaccine" (also medically significant). On an unspecified date, the patient experienced: "no reaction on previous exposure to vaccine" (death; as reported). The patient underwent lab tests and procedures which included blood pressure: reported as unknown and decreased, oxygen saturation: reported as unknown and decreased; both on 25Jan2021. The clinical outcome of the events was reported as fatal. The patient died on 26Jan2021 due to being bedridden and mental deterioration. An autopsy was performed and results were not provided. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The reported event "no reaction on previous exposure to vaccine" is considered not related to BNT162B2, but due to underlying disease.; Reported Cause(s) of Death: Bedridden; Mental deterioration


VAERS ID: 1010251 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-08
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: 2021-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Multimorbidity; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021097557

Write-up: Death, as a possible consequence of covid vaccination; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-DCGMA-21187688. A 86-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included multimorbidity, pneumonia, hypertension. The patient''s concomitant medications were not reported. The patient experienced death, as a possible consequence of covid vaccination on 16Jan2021 with outcome of fatal. It was not reported if an autopsy was performed. The cause of death was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death, as a possible consequence of covid vaccination


VAERS ID: 1010255 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hydrocephalus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021098302

Write-up: Influenza like illness; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (EMA) Regulatory Authorithy-WEB DE-PEI-CADRPEI-2021013344. An 80-year-old male patient was vaccinated with the first dose of BNT162B2 (COMIRNATY, lot number not known) via an unspecified route of administration on 08Jan2021 at a single dose for prophylaxis. Medical history included Hydrocephalus. Concomitant medication was not reported. The patient developed influenza like illness on 09Jan2021 and died on 15Jan2021 due to the event. It was not reported if an autopsy was performed. Causality between the event and product was unclassifiable.; Reported Cause(s) of Death: Influenza like illness


VAERS ID: 1010256 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-01-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical condition abnormal, Incorrect route of product administration, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug abuse and dependence (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast cancer metastatic (bone metastases); Palliative care
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Chemotherapy; Mastectomy bilateral
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021097581

Write-up: Rapid deterioration in general condition 3 days after vaccination. Died 14 days after vaccination but had end-stage breast cancer, with palliative treatment; Deterioration in general condition; patient received BNT162B2 subcutaneously; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. This is a report received from the Regulatory Authority. Regulatory authority report number was DE-PEI-CADRPEI-2021013746. An 80-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), subcutaneous on 02Jan2021 as a single dose for COVID-19 immunisation. Medical history included breast cancer from 2018 with surgical removal of both breasts on an unknown date, ongoing metastatic breast cancer (bone metastases) from 2020, cancer therapy from an unknown date to Nov2020, and ongoing palliative care from an unknown date. The patient''s concomitant medications were not reported. On 05Jan2021 (also reported as 04Jan2021), the patient experienced deterioration in general condition. She had a rapid deterioration in general condition 3 days after vaccination and died 14 days after vaccination but had end-stage breast cancer, with palliative treatment. The patient died on 15Jan2021 and cause of death was reported as sudden death. It was not reported if an autopsy was performed. The Regulatory Authority assessed the causality between the events and the vaccine as indeterminate. No follow-up attempts are possible; information about lot number cannot be obtained.; Reporter''s Comments: First corona vaccination on 2Jan2021; 4Jan2021 General condition deterioration; 15Jan2021 Died; Reported Cause(s) of Death: Sudden death NOS.


VAERS ID: 1010258 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory distress
SMQs:, Anaphylactic reaction (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: 10
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: Allergy; Inflammation (Dec-2020 an operation of the hip joint (artificial) because of inflammation); Surgery (Dec-2020 an operation of the hip joint (artificial) because of inflammation); Weight loss (lost a lot of weight)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021097583

Write-up: respiratory distress; This is a spontaneous report from consumer or other non hcp downloaded from the Regulatory Authority-WEB DE-PEI-CADRPEI-2021013776. A 83-years-old female patient received bnt162b2 (COMIRNATY; batch no.: was not reported), intramuscular on 10Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included had allergies, since September 2020 she has lost a lot of weight. In December2020 an operation of the hip joint (artificial) because of an inflammation. The patient''s concomitant medications were not reported. The patient experienced respiratory distress on 17Jan2021. 8 days after vaccination the patient developed Respiratory distress, lasting for 9 days. The patient died in hospital. Death cause was reported as Respiratory distress. Reported respiratory distress with stop date 25Jan2021. The patient died on 27Jan2021. It was not reported if an autopsy was performed. Reporter''s comments: From 17Jan patient got worse and worse until reporter could hear a slight simmer on 22Jan. On 23Jan the noises were very loud and patient had severe shortness of breath! She was admitted to hospital PRIVACY, where she died on 27Jan.; Reported Cause(s) of Death: Respiratory distress


VAERS ID: 1010262 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Respiratory failure, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glioblastoma
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210117; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: DEPFIZER INC2021098046

Write-up: Lethal death with unclear cause of death; Respiratory failure; Lethal death with unclear cause of death; This is a spontaneous report from a non-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 DE-PEI-PEI2021001614. A 64-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), via an unspecified route of administration on 14Jan2021 as a single dose for COVID-19 immunisation. Medical history included glioblastoma from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 11Jan2021, the patient had a negative SARS-CoV-2 test. On 14Jan2021, the patient received the vaccination. On 17Jan2021, patient had another negative SARS-CoV-2 test. On 19Jan2021, the patient experienced respiratory failure and death with unclear cause of death. The patient died on 19Jan2021 and the reported cause of death was sudden death, cause unknown. An autopsy was not performed. The clinical outcome of the respiratory failure was also reported as fatal. The Regulatory Authority assessed the causality between the respiratory failure and sudden death and suspect vaccine as indeterminate.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1010263 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021098048

Write-up: Died/ dead/ Unknown cause of death; Deterioration of the general condition; This is a spontaneous report from a non-contactable physician from the Regulatory Authority. An 84 years old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, batch/lot number: EM0477), intramuscular on 18Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that 4 day(s) after vaccination the patient developed General physical condition abnormal (21Jan2021) and Unknown cause of death (25Jan2021), lasting for 5 day(s). The patient was dead. The patient died on 25Jan2021. Death cause was reported as unknown cause of death. It was unknown if an autopsy was performed. The outcome of "Died/ dead/ Unknown cause of death" was fatal, of the other event was unknown. Comirnaty/Unknown cause of death, General physical condition abnormal. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Died/ dead/ Unknown cause of death


VAERS ID: 1010264 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOHEXAL; FENTANYL; NOVAMINSULFON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; Coronary heart disease; Hypertension arterial; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021098157

Write-up: Sudden death chronologically related to vaccination; Another stroke was suspected to be the cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021001650. A 95-year-old female patient was vaccinated with the first dose of BNT162B2 (COMIRNATY, lot number was not reported) via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunisation. Medical history included Stroke with hemiparesis, Cardiac insufficiency, Coronary heart disease, Hypertension arterial. Concomitant medications included bisoprolol fumarate (BISOHEXAL), novaminsulfon and fentanyl. The patient developed Death sudden and Accident cerebrovascular after 4 days vaccination. Death cause was reported as Accident cerebrovascular. It was reported an autopsy was not performed. Causality between the event and product was indeterminate. No follow-up attempts possible; information regarding batch/lot cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular


VAERS ID: 1010265 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RISPERIDON; ENALAPRIL; NITRENDIPINE; ASS; SIMVASTATIN; MIRTAZAPINE; PANTOPRAZOLE; TORASEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pain; COPD; Coronary heart disease; Dementia; Dizziness; Hypercholesteraemia; Hypertension arterial; Myocardial infarction; Renal insufficiency; Sleep disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021098154

Write-up: The presumed cause of death is a renewed heart attack; Sudden death in chronologicall connection with vaccination; This is a spontaneous report from physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021001651 A non-contactable physician reported for an 89-year-old male patient received first dose of bnt162b2 (COMIRNATY, Batch and lot tested and found within specifications), intramuscular on 05Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Coronary heart disease, Hypertension arterial, Renal insufficiency, Dementia, Sleep disorder, Hypercholesteraemia, COPD, Myocardial infarction, Dizziness, Chronic pain, all from an unknown date and unknown if ongoing. Concomitant medication included risperidone (RISPERIDON), enalapril (ENALAPRIL), nitrendipine (NITRENDIPINE), acetylsalicylic acid (ASS), simvastatin (SIMVASTATIN), mirtazapine (MIRTAZAPINE), pantoprazole (PANTOPRAZOLE), torasemide (TORASEMIDE). 5 days after vaccination the patient developed Sudden death in chronologicall connection with vaccination and Myocardial re infarction (The presumed cause of death is a renewed heart attack) on 10Jan2021. The patient died on 10Jan2021. No autopsy was performed. No follow-up attempts possible. Information about lot/batch# cannot be obtained.; Reported Cause(s) of Death: Sudden death in chronologicall connection with vaccination; Myocardial reinfarction


VAERS ID: 1010266 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-17
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 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: 2021-01-17
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021098158

Write-up: Sudden death, cause unknown; This is a spontaneous report from a non-contactable physician. This is a report received from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority number DE-PEI-PEI2021001652. A 96-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot: EJ6796), intramuscular on 30Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Jan2021, the patient developed Sudden death, cause unknown. The patient is dead. The outcome of the event was fatal. The patient died on 17Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1010269 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Peripheral vascular disorder, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)

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:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; Coronary heart disease; Gastrointestinal haemorrhage
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021097692

Write-up: Vomiting; Circulatory collapse; hypotonic circulatory failure; This is a spontaneous report from a non-contactable physician downloaded from the Medicines (MA) Regulatory Authority-WEB Regulatory Authority number DE-PEI-PEI2021001758. A 91-year-old female patient received her second dose of bnt162b2 (COMIRNATY, batch/lot no.: EK9788), intramuscular on 20Jan2021 at single dose for COVID-19 immunization. Medical history included gastrointestinal haemorrhage from 2020, coronary artery disease, Cardiac insufficiency. The patient''s concomitant medications were not reported. The patient previously took her first dose of Comirnaty on 28Dec2020 for COVID-19 immunization and experienced no adverse reaction. 1 day after vaccination on 21Jan2021, the patient developed vomiting and circulatory disorder peripheral and hypotonic circulatory failure, lasting for 4 hour(s). The patient was dead. Death cause was reported as Circulatory failure. The patient died on 21Jan2021. It was unknown if an autopsy was performed. Comirnaty/Vomiting, Circulatory disorder peripheral, Circulatory failure/Regulatory Authority/D. Unclassifiable.; Reported Cause(s) of Death: Circulatory failure; Vomiting; Circulatory disorder peripheral


VAERS ID: 1010282 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Renal failure, Respiratory failure, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ARAX; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; MULTI-TABS [ASCORBIC ACID;COLECALCIFEROL;RETINOL]; CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; ELIQUIS; VENLAFAXIN; ELTROXIN
Current Illness: Dementia; Epistaxis; General physical condition decreased; Renal impairment
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201231; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210109; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021095781

Write-up: Respiratory failure due to severe course of COVID19 infection; COVID-19 aggravated / infected with COVID19; COVID-19 aggravated / infected with COVID19; renal failure; This is a spontaneous report downloaded from Regulatory Authority-WEB [DK-DKMA-WBS-0029669]. The case was received from a contactable physician via Agency . A 82-years-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot/Batch number: EJ6797), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. Ongoing medical history included renal impairment, dementia, decreased general physical condition and epistaxis. Concomitant medication included hydroxyzine hydrochloride (ARAX) from 24Mar2017 for pain, macrogol 3350 / potassium chloride / sodium bicarbonate / sodium chloride (MOVICOL) from 19May2017 for constipation, ascorbic acid / colecalciferol / retinol (MULTI-TABS) from 10Apr2016 00 for vitamin supplementation, calcium carbonate / colecalciferol (CALCIUM + VITAMIN D) from 07Oct2020 for vitamin D deficiency, apixaban (ELIQUIS) from 05Apr2019 for thrombosis prophylaxis, venlafaxine from 20Aug2013 for depression, levothyroxine sodium (ELTROXIN) from 27May2013 for hypometabolism. The patient previously received Past drug included pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 28Apr2020 and influenza vaccine inact sag 4v (INFLUVACTETRA) on 08Oct2020, both for immunization. The patient was at the hospital on 07Jan2021 with nosebleeds and physician suspected she got infected with covid19 here. 9 days after vaccine on 09Jan2021 the patient infected with COVID19 and develops symptoms of this: fever, breathing difficult, pain and later renal failure (Jan2021). The patient received treatment at the hospital, where the patient then experiences renal failure. It is then assessed to stop the treatment afterwards, as it will not help further and the patient was discharged on the 18Jan2021. On 10Jan2021, 10 days after vaccination, the patient developed respiratory failure and COVID-19 aggravated which reported as fatal on 19Jan2021. Cause of death was respiratory failure due to severe course of COVID19 infection. It was unknown if autopsy was performed. COVID-19 virus test on 31Dec2020 was negative. COVID-19 virus test on 09Jan2021 was positive. The outcome of COVID-19 aggravated and respiratory failure was fatal (died on 19Jan2021). The outcome of other events was unknown. Causality: The physician reports on suspicion that the COVID-19 vaccine may aggravate a COVID-19 disease course if you become infected in close relation to having received the vaccine. Therefore, she is too much in doubt not to report it as an adverse reaction. The physician believes that the patient has died of COVID-19 and that the vaccine has only worsened the course and is therefore not directly responsible for the death.; Reported Cause(s) of Death: COVID-19 aggravated / infected with COVID19; COVID-19 aggravated / infected with COVID19; Respiratory failure


VAERS ID: 1010288 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Electrocardiogram, Heart rate, Sudden death, Troponin
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: 2021-01-01
   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: Cardiovascular disease, unspecified (Cardiovascular disease (excluding HT).); Chest pain (oppressive chest pain); Pain in arm; Comments: Enfermedad cardiovascular (excluida la HTA).
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Blood pressure; Result Unstructured Data: Test Result:167/76; Test Date: 20210120; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:EKG: sinus rhythm at 71 bpm; Comments: EKG: sinus rhythm at 71 bpm, normal axis and PR, QRS without blockage signs, possible LVH, no significant alterations in repolarization.; Test Date: 20210120; Test Name: Heart rate; Result Unstructured Data: Test Result:75; Test Date: 20210120; Test Name: Troponin; Result Unstructured Data: Test Result:1? troponin 91, 2? troponin 92
CDC Split Type: ESPFIZER INC2021098106

Write-up: Sudden death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB and received via Regulatory Authority ES-AEMPS-728115. A 61-year-old male patient received the first dose of bnt162b2 (COMIRNATY) on 21Jan2021 at single dose (Lot # EM0477) for covid-19 immunisation. Medical History included Cardiovascular disease (excluding HT). Cardiopathic patient under study who attended the hospital emergency department on 20Jan2021 for chest pain. The patient went to the hospital emergency room on 20Jan2021 and in the CH data it appears as a current disease: "he has had intermittent episodes of a few minutes duration of oppressive chest pain together with pain in right upper limb. Today (20Jan2021) a new episode lasting minutes that disappears with walking, not accompanied by vegetative courtship. No dyspnea or other symptoms. 1? troponin 91, 2? troponin 92. EKG: sinus rhythm at 71 bpm, axis and PR normal, QRS without signs of blockade, possible LVH, no significant alterations in repolarization. Blood pressure 167/76, HR 75. ". Discharged at home with a diagnosis of chest pain and a proposal for follow-up by cardiology. On 21Jan2021 the first dose of the vaccine was administered. On the morning of 23Jan2021, the family found him on the sofa, already passed away. The emergency services certify the death that would have occurred in the early morning of January 22-23. A judicial procedure for autopsy is being processed. No autopsy results available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1010300 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac ablation; Coronary artery disease; Diabetic diet (diabetes diet alone since Jan2019); Stent placement (stent in the circumflex and intraventricular artery); Ulcer (epoxy bleed out); Ulcer bleeding (epoxy bleed out)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021095018

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-LL20210225. An 81-year-old male patient received BNT162B2 (COMIRNATY; Lot number EJ6788), intramuscular in left arm on 20Jan2021 as first single dose for covid-19 immunization. Medical history includes history of bleeding from an ulcer from 2019; reported as epoxy bleed out, coronary artery disease and stent in the circumflex and intraventricular artery since unknown dates, diabetes diet alone since Jan2019 and atrial fibrillation catheter ablation on an unspecified date. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on 22Jan2021, which was serious as it lead to death. Details were as follows: On 22Jan2021, there was sudden death, reported as possible massive infarction or severe arrhythmia. No chest pain that could have alerted the patient, and no complaint were noted. He was found dead in the morning in his bathroom, razor in hand. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1010305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac failure, Glomerular filtration rate, Heart rate, Malaise, Oxygen saturation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (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:
Current Illness: Breast neoplasm female (untreated); Carotid artery stenosis; Chronic respiratory failure (requiring oxygen therapy by nasal probe: 3 L / min); Emphysema; Hematoma subdural; Hypertension arterial; Living in residential institution (reported as EHPAD); Mediastinal lymphadenopathy; Pulmonary fibrosis
Preexisting Conditions: Medical History/Concurrent Conditions: Melanoma (of the left knee)
Allergies:
Diagnostic Lab Data: Test Date: 20210118; Test Name: blood pressure; Result Unstructured Data: Test Result:138/76 mmHg; Comments: t 0; Test Date: 20210118; Test Name: blood pressure; Result Unstructured Data: Test Result:125/72 mmHg; Comments: t + 5 minutes; Test Date: 20210118; Test Name: blood pressure; Result Unstructured Data: Test Result:124/75 mmHg; Comments: t + 15 minutes; Test Date: 20210118; Test Name: temperature; Result Unstructured Data: Test Result:36.6 degrees Centigrade; Comments: post-vaccination surveillance; Test Name: GFR; Result Unstructured Data: Test Result:59.7 ml/min/1.73M2; Test Date: 20210118; Test Name: pulse; Result Unstructured Data: Test Result:101 bpm; Comments: t 0; Test Date: 20210118; Test Name: pulse; Result Unstructured Data: Test Result:93 bpm; Comments: t + 5 minutes; Test Date: 20210118; Test Name: pulse; Result Unstructured Data: Test Result:88 bpm; Comments: t + 15 minutes; Test Date: 20210118; Test Name: pulsed O2 saturation; Test Result: 82 %; Comments: t 0; Test Date: 20210118; Test Name: pulsed O2 saturation; Result Unstructured Data: Test Result:78% %; Comments: t + 5 minutes; without oxygen therapy; Test Date: 20210118; Test Name: pulsed O2 saturation; Test Result: 92 %; Comments: t + 15 minutes; under oxygen therapy 3L/min
CDC Split Type: FRPFIZER INC2021095027

Write-up: Sudden death; Decompensation cardiac; MALAISE; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (FR-AFSSAPS-MP20210116). A 94-year-old female patient started to receive BNT162B2 (COMIRNATY; Lot number: EM0477), intramuscularly, on 18Jan2021 11:07 at a single dose for COVID-19 vaccination. It was reported that the vaccine was prepared at 10:10. Medical history included ongoing mediastinal lymphadenopathy, ongoing cancerous tumor of the right breast (untreated), melanoma (of the left knee) from 2013, ongoing chronic respiratory failure (requiring oxygen therapy by nasal probe: 3 L/min), ongoing emphysema, ongoing appearance of pulmonary fibrosis, ongoing hematoma subdural, ongoing hypertension arterial, ongoing carotid artery stenosis, and ongoing residing in a retirement home . Concomitant medications included clopidogrel bisulfate (PLAVIX), paracetamol (DOLIPRANE), haloperidol (HALDOL; reported as HALDOL FORT), and colecaliciferol (ZYMAD). The patient experienced sudden death, decompensation cardiac, and malaise on 21Jan2021. All of the events were reported to be fatal. The clinical course was reported as follows: It is reported that the patient was desaturating more and more frequently. His biological assessment was slightly disturbed with a slight albuminemia, moderate renal insufficiency (glomerular filtration rate (GFR) 59.7 ml/min/1.73M2 on an unspecified date) and slight anemia. On 15Jan2021, there was no specific pre-vaccination consultation. On 18Jan2021, the patient received the vaccine and post-vaccination surveillance showed temperature of 36.6 degrees Centigrade on 18Jan2021. At time (t) 0 (as reported) on 18Jan2021: blood pressure was 138/76 mmHg; pulse at 101 beats per minute (bpm); pulsed oxygen (O2) saturation: 82%. At t + 5 minutes on 18Jan2021: blood pressure was 125/72 mmHg; pulse at 93 bpm; pulsed O2 saturation: 78% without oxygen therapy. And at t + 15 minutes on 18Jan2021: blood pressure was 124/75 mmHg; pulse at 88 bpm; O2 saturation was 92% under oxygen therapy 3L/min. On 21Jan2021, around 09:15, the patient experienced sudden cardiovascular decompensation with malaise, reported as rapidly fatal. The patient died on 21Jan2021. The causes of death were reported as sudden death, decompensation cardiac, and malaise. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: MALAISE; Sudden death; Decompensation cardiac


VAERS ID: 1010309 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EF6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disturbance
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021095014

Write-up: Infarct myocardial; 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 FR-AFSSAPS-PC20210079. A 100-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EF6795), intramuscular on 21Jan2021 (at the age of 100-years-old) as a single dose for COVID-19 vaccination. Medical history included cognitive disturbances from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 24Jan2021, the patient experienced myocardial infarction, which was fatal. The patient had a COVID-19 PCR test on 24Jan2021, which was negative. The patient died on 24Jan2021 and the occurrence of the myocardial infarction was responsible for the death. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1010318 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Body temperature, Death, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

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: BISOCE; LASILIX [FUROSEMIDE]; PLAVIX; PRAVASTATIN; FUMAFER; ROCALTROL; SYMBICORT; OMEPRAZOLE; ESCITALOPRAM; LEVOTHYROX; CETIRIZINE; DOLIPRANE; FUROSEMIDE; CLOPIDOGREL; PRAVASTATIN; CALCITRIOL; LEVOTHYROX; CETIRIZINE; ESCITALOPRAM; PARACETAM
Current Illness: Arterial hypertension; Cardiac failure chronic; Cardiac insufficiency; Chronic kidney disease stage 4 (rejected on dialysis); COPD; Dilated cardiomyopathy ((ischemic, chronic alcohol, hypertension)); General physical health deterioration; Hypertension; Renal failure chronic
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Asiderotic anemia; Autonomic dysfunction; Hospitalization; Iron deficiency anemia; Laparotomy (occlusive syndrome); Myocardial infarction; Pain; Sleep apnea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: fever; Result Unstructured Data: Test Result:no fever; Test Date: 20201223; Test Name: tested for COVID-19; Result Unstructured Data: Test Result:didn''t have COVID-19
CDC Split Type: FRPFIZER INC2021095038

Write-up: was at the end of his life/ death; abdominal pain; asthenia; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) FR-AFSSAPS-SE20210116 and received via Regulatory Authority. A 79-year-old male patient received bnt162b2 (COMINARTY, Solution for injection, batch/lot number: EM0477) intramuscularly on 12Jan2021 at single dose (1 dose form) in the left arm for COVID-19 vaccination, during hospitalization during a geriatric stay for deterioration of general condition with difficult home maintenance. The patient''s medical history included triple chamber defibrillator for severe multifactorial dilated cardiomyopathy (ischemic, chronic alcohol, hypertension), Renal failure chronic, Arterial hypertension, Chronic obstructive pulmonary disease (COPD), Cardiac insufficiency, Hypertention; Chronic kidney disease (IRC) stage IV rejected on dialysis, end-stage heart failure, deterioration of general condition, all ongoing; Asiderotic anemia from an unknow date and unknow if ongoing; paired sleep apnea syndrome from an unknow date and unknow if ongoing; Laparotomy for occlusive syndrome in 2018; Iron deficiency anemia; Myocardial infarction (IDM) in 2000; Autonomy loss; pain; anxiety; hospitalization. The patient''s concomitant medications included bisoprolol fumarate (BISOCE); furosemide (LASILIX [FUROSEMIDE]); clopidogrel bisulfate (PLAVIX); pravastatin; ferrous fumarate (FUMAFER); calcitriol (ROCALTROL); budesonide formoterol fumarate (SYMBICORT) (400/12 ?g); omeprazole; escitalopram; levothyroxine sodium (LEVOTHYROX); cetirizine; paracetamol (DOLIPRANE); furosemide; clopidogrel; pravastatin; calcitriol; levothyroxine sodium (LEVOTHYROX); cetirizine; escitalopram; paracetamol; tramadol for pain; ferrous fumarate (FUMAFER); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]); sodium bicarbonate; oxazepam for anxiety; formoterol fumarate (FORMOAIR); fluticasone propionate (FLIXOTIDE); lansoprazole; bisoprolol; delical boisson fruitee (NUTRIENTS NOS) (delical fruity multifruit drink). The day after the vaccination, he returned home, as planned (no adverse effects within 24 hours of vaccination). On 17Jan2021, he presented (according to his wife), abdominal pain with asthenia, no fever, no vomiting, supple stomach, no disturbance of consciousness. The Emergency medical services was called, with advice to continue the analgesics and to reassess. No medical intervention on site. The patient was multi-pathologic, and the wife said she knew her husband was at the end of his life. She did not wish to have him hospitalized again. No real symptom of discomfort according to her, with a more peaceful patient at the end of the day. The death occured at the beginning of the night (17Jan2021). No more details on the specific causes. No autopsy was performed. According to the doctor who took care of the patient during his hospitalization: No obvious causal link with the vaccination in view of the patient''s very severe polypathology. The patient didn''t have COVID-19. The patient had been tested for COVID-19 on 23Dec2020. The outcome of the event "was at the end of his life/ death" was fatal, of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: was at the end of his life/ death


VAERS ID: 1010322 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, General physical health deterioration, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL HEMIFUMARATE; CORDARONE; DIFFU K; ELIQUIS; LEVOTHYROX; PANTOPRAZOLE; RAMIPRIL; LASILIX SPECIAL [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Pulmonary arterial hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210116; Test Name: blood pressure; Result Unstructured Data: Test Result:88/60; Comments: (dropped); Test Date: 20210117; Test Name: blood pressure; Result Unstructured Data: Test Result:90/60; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:10/60
CDC Split Type: FRPFIZER INC2021095043

Write-up: Reduced general condition; Hypotension; This is a spontaneous report from a contactable physician downloaded from the regulatory a. This is a report received from the regulatory authority. Regulatory authority report number was FR-AFSSAPS-TO20210224. A 94-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477), intramuscular in the right deltoid on 08Jan2021 as a single dose for COVID-19 vaccination and furosemide (LASILIX SPECIAL), oral from an unspecified date at 1 dosage form once a day for arterial hypertension. Medical history included pulmonary arterial hypertension and heart failure; both from unknown dates and unknown if ongoing. Concomitant medications included bisoprolol hemifumarate (MANUFACTURER UNKNOWN), amiodarone hydrochloride (CORDARONE), potassium chloride (DIFFU K), apixaban (ELIQUIS), levothyroxine sodium (LEVOTHYROX), pantoprazole (MANUFACTURER UNKNOWN), and ramipril (MANUFACTURER UNKNOWN); all taken for unspecified indications from unknown dates and unknown if ongoing. On 16Jan2021, the patient experienced reduced general condition and hypotension; both serious for being fatal. The clinical course was as follows: The patient had onset of drop in blood pressure (88/60) on 16Jan2021. On 17Jan2021, blood pressure was 90/60. On 18Jan2021, the physician decreased the dose of furosemide (unspecified if the last dose of original regimen was on 17Jan2021 or 18Jan2021). On 19Jan2021, the patient presented a feeling of discomfort and an increase in edema of the lower limbs and blood pressure was 10/60 (as reported). On 20Jan2021, the patient died, and the cause of death was reported as reduced general condition. An autopsy was not performed.; Reported Cause(s) of Death: Reduced general condition


VAERS ID: 1010379 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Cardiac arrest, Decreased appetite, Fatigue, Lethargy, Nausea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma lung (treated); Diffuse large B-cell lymphoma (ON CHEMOTHERAPY r-GCVP started this Nov2020 5th cycle given 13Jan2020); Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: temperature; Result Unstructured Data: Test Result:developed
CDC Split Type: GBPFIZER INC2021100281

Write-up: developed temperature; tired; Sudden death; cardiac arrest; lethargic; nauseous; off fluids/food; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202101290801165170, Safety Report Unique Identifier GB-MHRA-ADR 24664184. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4243), via an unspecified route of administration on 19Jan2021 in morning at single dose for Covid-19 immunisation. Medical history included neoplasm (recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)), adenocarcinoma lung from 2019 and been treated, diffuse large B cell lymphoma from Oct2020 (on chemotherapy r-GCVP started this Nov2020 5th cycle given 13Jan2020). Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced sudden death on 19Jan2021, serious due to fatal. It was reported that patient been c/o tired and lethargic / nauseous ? presumed post chemotherapy side effect- also off food / fluids in afternoon on 19Jan2021, at around 18:00 developed temperature, cardiac arrest following this. Suspect Reactions. None details of any relevant investigations or tests conducted could be provided. The patient died on 19Jan2021. The outcome of the other events was unknown. It was unknown whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1010382 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH D4V3B / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Diarrhoea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 26
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: Comments: Pt had COVID vaccine on 17th Jan and died on 27th Jan 2021 Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021101243

Write-up: D&V; D&V; frail; Death; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101291229313620, Safety Report Unique Identifier GB-MHRA-ADR 24666545. A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: D4V3B, via an unspecified route of administration on 17Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient had COVID vaccine on 17Jan and died on 27Jan2021. Patient was very frail. He had diarrhea and vomiting after the vaccine was administered in Jan2021. He was admitted to hospital and died there. The cause of death was not reported. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 25Jan2021. The outcome of events diarrhea, vomiting and frail was unknown. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 1010384 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ELO739 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue, Nausea, SARS-CoV-2 test, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 6
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GATALIN XL; LEVOTHYROXINE
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Chest infection; Curvature of spine; Dementia; Frailty; Hyperthyroidism; Pneumonia (5 years earlier); Recurrent urinary tract infection; Comments: Mum had dementia, repeated UTIs and occasional chest infections. She had 5 years esrlier suffered from pneumonia. She had curavture of the spine and was very frail. She recently had the flu jab. A few weeks later the covid vaccine. She in the days after started to complain of nausea and increased fatigue. A longer term cough became a bit more persistent. She had a UTI and had received a single dose antibiotic. Shehpassed away at 515pm on the 30th January. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:no - negative covid-19 test
CDC Split Type: GBPFIZER INC2021100610

Write-up: fatigue; Nausea; longer term cough became a bit more persistent; UTI; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202101311214445570, Safety Report Unique Identifier GB-MHRA-ADR 24673468. An 86-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ELO739), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient has not tested positive for COVID-19 since having the vaccine. Medical history included suspected COVID-19 from 01Feb2020 and ongoing, dementia from an unknown date and unknown if ongoing, repeated urinary tract infections (UTIs) from an unknown date and unknown if ongoing, pneumonia in 2016 (5 years earlier), curvature of spine from an unknown date and unknown if ongoing, frail from an unknown date and unknown if ongoing, occasional chest infections from an unknown date and unknown if ongoing, hyperthyroidism from an unknown date and unknown if ongoing. Concomitant medications included galantamine hydrobromide (GATALIN XL) taken for dementia from 05Aug2018 to an unknown date, levothyroxine (MANUFACTURER UNKNOWN) taken for Hyperthyroidism 05May2010 to an unknown date. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on an unknown date. On 24Jan2021, the patient experienced nausea; which required hospitalization, and was assessed for disability, and being medically significant, life threatening, and resulted in death. On an unspecified date, the patient experienced fatigue; which required hospitalization, and was assessed for disability, and being medically significant, life threatening; longer term cough became a bit more persistent (non-serious); and UTI (non-serious). The clinical course was reported as follows: The patient had dementia, repeated UTIs and occasional chest infections. Five years earlier, the patient suffered from pneumonia. The patient also had curvature of the spine and was very frail. The patient recently had the flu vaccine (also reported as "jab"); and then a few weeks later the COVID vaccine. The patient in the days after, started to report of nausea and increased fatigue. A longer-term cough became a bit more persistent. The patient also had a UTI and had received a single dose antibiotic. The patient had passed away at 17:15 on 30Jan2021. When asked to provide details of any relevant investigations or tests conducted, the reporter responded: "As the patient died at home it is with the coroner." The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. Therapeutic measures were taken as a result of UTI. The clinical outcome of the event, nausea, was fatal. The clinical outcome of the event, fatigue, cough, and UTI was unknown. The patient died on 30Jan2021 at 17:15 due to nausea (as reported). It was unknown if an autopsy was performed. The patient was not enrolled in a clinical trial. It was reported that: "nausea, increased fatigue and potential underlying infections. It appeared as if the vaccine may have been a bit too much for her." No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Nausea


VAERS ID: 1010415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; ROSUTEC; NEO FERRO FOLGAMMA; SPIRON [SPIRONOLACTONE]; CLEXANE; VITAMIN D3; PANTOPRAZOLE; FENTANYL; ACETYLSALICYLIC ACID; CITROKALCIUM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021098468

Write-up: Death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB HU-OGYI-020821. A 90-year-old female patient received first dose of bnt162b2 (COMIRNATY, batch/lot number: EL1484), intramuscularly in the left upper arm on 09Jan2021 at 0.3 mL, single for COVID-19 vaccination. The patient medical history was not reported. Concomitant medication included furosemide, rosuvastatin calcium (ROSUTEC), ferrous sulfate, folic acid (NEO FERRO FOLGAMMA), spironolactone (SPIRON), enoxaparin sodium (CLEXANE), colecalciferol (VITAMIN D3), pantoprazole, fentanyl, acetylsalicylic acid, calcium citrate (CITROKALCIUM). The patient was in a fair general condition for the vaccination. On 19Jan2021 ten days after the vaccination at 5 pm, the patient had silently fallen asleep. The nurses found her dead. The patient died on 19Jan2021. It was unknown if an autopsy was performed. Sender Comment: An elderly vaccinated patient died 10 days after the vaccination. The patient was in a fair general condition for the vaccination. After the vaccination, no abnormalities were detected during the observation period. 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. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1010460 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Decreased appetite, Fatigue
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   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: SOBRIL; ZOPICLONE; SINEMET; PARACET [PARACETAMOL]; TOILAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Constipation; Living in nursing home; Parkinson''s disease; Vitamin D deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021095256

Write-up: ALTERED STATE OF CONSCIOUSNESS; DECREASED APPETITE; TIREDNESS; This is a spontaneous report from a contactable other health professional downloaded from the Medicines Agency (MA) Regulatory Authority NO-NOMAADVRE-FHI-2021-U4eaa, Safety Unique Identifier NO-NOMAADVRE-E2B_00014164. An 88-year-old female patient received first dose of BNT162B2 (COMIRNATY, Lot#EJ6795) via intramuscular on 08Jan2021 at single dose for COVID-19 vaccination. The medical history included living in nursing home, parkinson''s disease, alzheimer''s disease, vitamin d deficiency, constipation. Concomitant medication included oxazepam (SOBRIL), zopiclone, carbidopa/ levodopa (SINEMET), paracetamol (PARACET), bisacodyl (TOILAX). On 09Jan2021, the patient developed tiredness and decreased appetite. From 16Jan2021 the patient became bedridden and had altered state of consciousness. The patient died on 18Jan2021. t was not reported if an autopsy was performed. The outcome of events was fatal. The case was considered to be Serious. Sender Comment: The report concerns a patient in her 80s, who became increasingly tired and fatigued and had a reduced appetite from the day after the first dose of the Covid-19 vaccine Comirnaty. One week later, the patient became bedridden and uncontactable, and died a few days later. The patient was a resident of a nursing home and had underlying diseases. 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 passed after a few days. However, we cannot rule out that such relatively mild side effects may lead to a more serious course in severely debilitated 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 relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient later died, the message is also classified as serious, even though no causal link between the vaccine and the death has been established. Relatedness of drug to reactions/events: Source of assessment was Pharmacovigilance Center, Result of Assessment was Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Decreased appetite; Tiredness; Altered state of consciousness


VAERS ID: 1010461 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cerebral haemorrhage, Death, Heart rate increased, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 4
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: Atrial fibrillation; Dementia; Hypertension; Living in residential institution
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: Blood pressure; Result Unstructured Data: Test Result:156/100 mmHg; Test Date: 20210113; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210113; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:Confirms major haemorrhage.; Test Date: 20210113; Test Name: C-reactive protein; Result Unstructured Data: Test Result:51 mg/l; Test Date: 20210113; Test Name: Heart rate; Result Unstructured Data: Test Result:136; Comments: Units:{beats}/min; Test Date: 202101; Test Name: Heart rate; Result Unstructured Data: Test Result:Stable around 100 bpm.; Test Date: 20210113; Test Name: Respiratory rate; Result Unstructured Data: Test Result:34; Comments: Units:{breaths}/min
CDC Split Type: NOPFIZER INC2021095239

Write-up: Fever, high pulse - further large cerebral haemorrhage the same day.; Fever, high pulse - further large cerebral haemorrhage the same day.; Fever, high pulse - further large cerebral haemorrhage the same day.; consciousness became altered; started vomiting; unknown cause of death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB [NO-NOMAADVRE-FHI-2021-U5ea5]. A 90-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6795), via intramuscular on left arm on 06Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unknown date, living in residential institution from an unknown date, atrial fibrillation from an unknown date, dementia from an unknown date. The patient''s concomitant medications were not reported. The patient experienced fever, high pulse - further large cerebral haemorrhage the same day on 13Jan2021. The events were reported as serious due to hospitalization. Narrative was reported as on 13Jan2021, the patient developed fever, high pulse rate. After a while, the patient''s consciousness became altered and she started vomiting. Cerebral haemorrhage was suspected and confirmed by computerised tomomgram. The patient underwent lab tests and procedures which included blood pressure measurement: 156/100 mmHg on 13Jan2021; body temperature: 38 centigrade on 13Jan2021; computerised tomogram head: confirms major haemorrhage on 13Jan2021; c-reactive protein: 51 mg/l on 13Jan2021; heart rate: 136 (Units:{beats}/min) on 13Jan2021, heart rate: stable around 100 bpm in Jan2021; respiratory rate: 34 (Units:{breaths}/min) on 13Jan2021. The patient died on 17Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The outcome of the event unknown cause of death was fatal, while other events were unknown. Sender''s comment: The report concerns a patient in his 90s, who developed a fever, high heart rate and cerebral haemorrhage a few days after the first dose of the Covid-19 vaccine Comirnaty. The patient died a few days after the event. The patient had known dementia, hypertension and atrial fibrillation. With the exception of fever, the reported symptoms are not among the adverse reactions reported in the participants in the clinical trials at Comirnaty. Data from use in frail, multi-sick elderly patients are nevertheless limited. When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events may occur shortly after vaccination. In each case, it is difficult to know whether the events are due to the vaccine, the patient''s underlying disease or other random, concurrent cause that has nothing to do with the vaccination in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. Nor can we rule out rare side effects. There should be a low threshold for reporting rare or unexpected side effects that occur after vaccination. Since the vaccine is new, it is subject to special surveillance in order to detect new safety information as quickly as possible. It is especially important that serious and / or unusual side effects are reported. Your message is therefore important to increase knowledge about side effects that have not been discovered in the studies. 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: unknown cause of death


VAERS ID: 1010462 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:increased
CDC Split Type: NOPFIZER INC2021095232

Write-up: REDUCED GENERAL CONDITION; C-REACTIVE PROTEIN INCREASED; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB regulatory authority NO-NOMAADVRE-FHI-2021-Uggnm. A 97-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 vaccination. Medical history included and urinary tract infection. The concomitant medications were not reported. The patient experienced reduced general condition and C-reactive protein increased in Jan2021 and died a week after vaccination in Jan2021. The events were fatal. The patient died in Jan2021. It was not reported if an autopsy was performed. Senders Comment: A woman in her 90s, a nursing home patient, was vaccinated with the covid-19 vaccine Comirnaty. Rising CRP and declining general condition, and she died a week after vaccination. In the time from vaccination to the patients death, she was simultaneously treated for urinary tract infection. The doctor indicates little suspicion of a causal link between the Corminaty vaccine and the patients death. Comment: The most common adverse reactions in participants in the vaccine studies were injection site pain (Less than 80percent ), fatigue (greater than 60percent ), headache (greater than 50percent ), myalgia and chills (greater than 30percent ), arthralgia (greater than 20percent ), fever and swelling at the injection site (greater than 10percent ). They occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and passed after a few days. It is stated in the report that the patient had a concomitant urinary tract infection during the time of vaccination. This can also be the cause of rising CRP and declining general condition. However, it cannot be ruled out that the vaccine may have contributed to some of the symptoms in the course of the disease to the already established infection. 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. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: REDUCED GENERAL CONDITION; C-REACTIVE PROTEIN INCREASED


VAERS ID: 1010465 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Cardiac failure, Conjunctivitis, Death, Electrocardiogram, Fatigue, General physical health deterioration, Heart rate, Heart rate increased, Hyperkalaemia, Hypertension, Hyperventilation, Infection, Leukocytosis, Pain in extremity, Paralysis, Urinary tract infection, Urine analysis
SMQs:, Cardiac failure (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Conjunctival disorders (narrow), Ocular infections (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aphasia (some aphasia); Chronic pulmonary heart disease; Dementia; Dysarthria; Heart failure; Kidney failure; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: Blood test; Result Unstructured Data: Test Result:almost unchanged severe renal failure, mild hyperk; Comments: samples that showed almost unchanged severe renal failure, mild hyperkalaemia, increased heart failure and leukocytosis.; Test Date: 20210109; Test Name: ECG; Result Unstructured Data: Test Result:No acute pathology; Test Date: 20210110; Test Name: Urine strip test; Result Unstructured Data: Test Result:UTI; Test Date: 202101; Test Name: blood pressure; Result Unstructured Data: Test Result:hypertension; Test Date: 202101; Test Name: heart rate; Result Unstructured Data: Test Result:high
CDC Split Type: NOPFIZER INC2021095235

Write-up: FOUND DEAD; mild hyperkalemia; UTI; leukocytosis; concomitant bilateral conjunctivitis; a bit tired; reduced general condition; increasing infection paralyzed shortly after vaccination; increasing infection paralyzed shortly after vaccination; increased heart failure; severe pain in both arms; hyperventilated; hypertension; high heart rate; This is a spontaneous report from contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uzjg2. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014154. A 97-year-old male patient received bnt162b2 (COMIRNATY) (Batch/lot number EJ6796), intramuscular on 06Jan2021 14:30 at SINGLE DOSE for covid-19 immunization. Vaccine location was right arm. Medical history included living in nursing home, dementia, stroke in 2009 with sequelae such as dysarthria / some aphasia, pulmonary heart disease, heart failure, kidney failure. The medical history all ongoing except for stroke. The patient was functioning well. He used to be up, eating and drinking well. The patient''s concomitant medications were not reported. After about 3 days after vaccination against COVID - he complained of severe pain in both arms, he was hyperventilated, had hypertension and high heart rate. The ambulance was called. ECG showed no acute pathology. Patient received Nitroglycerin - with effect. Patient was better the next day but was somewhat confused. With suspicion of UTI, u-Stix was taken which showed UTI. In addition, it was taken among others. samples that showed almost unchanged severe renal failure, mild hyperkalaemia, increased heart failure and leukocytosis. Patient was rapidly habitual after starting AB treatment with Selexid 200 mg x 3. In addition, the patient developed concomitant bilateral conjunctivitis and started treatment with Chloramphenicol eye ointment. One day after starting with AB, the patient was better clinically. He was up, eating and drinking well. He was still a bit tired and needed more help with care. 1 week after vaccination he was out in the corridor. Ate well and went to his room to watch TV. About 20 min. after that he was found dead sitting in the chair of his room on 13Jan2021. Due to the rapidly declining AT, increasing infection paralyzed shortly after vaccination, it is suspected that if coronary vaccine was the cause of this. Relatives were informed and they denied an autopsy. It was also reported that UTI (09Jan2021), hyperkalemia (09Jan2021), conjunctivitis (Jan2021), death. On Jan2021, the patient developed reduced general condition. Relevant laboratory findings and investigations included in the report (ECG, 09Jan2021) (urine strip test, 10Jan2021)(blood test, 10Jan2021). One week after vaccination the patient was found dead. The patient''s outcome was Fatal, at the time of the report. The outcome of events "severe pain in both arms, he was hyperventilated, had hypertension and high heart rate" was recovering, the outcome of other events was unknown. The case was considered to be Serious. Reporter''s comment: Patient who was 97 years old man. Known from before with dementia, stroke in 2009 with sequelae such as dysarthria / some aphasia, pulmonary heart disease, heart failure, kidney failure. The patient was functioning well. He used to be up, eating and drinking well. After about 3 days after vaccination against COVID - he complained of severe pain in both arms, he was hyperventilated, had hypertension and high heart rate. The ambulance was called. ECG showed no acute pathology. Patient received Nitroglycerin - with effect. Patient was better the next day but was somewhat confused. With suspicion of UTI, u-stix was taken which showed UTI. In addition, it was taken among others. samples that showed almost unchanged severe renal failure, mild hyperkalaemia, increased heart failure and leukocytosis. Patient was rapidly habitual after starting AB treatment with Selexid 200 mg x 3. In addition, the patient developed concomitant bilateral conjunctivitis and started treatment with Chloramphenicol eye ointment. One day after starting with AB, the patient was better clinically. He was up, eating and drinking well. He was still a bit tired and needed more help with care. 1 week after vaccination he was out in the corridor. Ate well and went to his room to watch TV. About 20 min. after that he was found dead sitting in the chair of his room. Due to the rapidly declining AT, increasing infection paralyzed shortly after vaccination, it is suspected that coronary vaccine was the cause of this? Relatives were informed and they denied an autopsy. EMA Comment: Local reaction with swelling, redness, heat and pain at the injection site may occur after all vaccines, and is a known side effect of this vaccine. Local reaction. Local reactions usually begin during the first 2 days, and can last for many days. Nonspecific symptoms such as fever, malaise, headache, dizziness and general malaise occur in the first days after vaccination. The symptoms described may thus suit a reaction to the vaccine. However, the report also describes that the patient had an acute infection with UTI and bilateral conjunctivitis. This can also be the cause of the patient''s ailments. An improvement in symptoms before the patient was suddenly found dead is further described. It is difficult to imagine how the vaccine will cause sudden death seven days after vaccination in a patient who was otherwise recovering. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur in the period after vaccination without any connection to vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or other accidental, concurrent cause that has nothing to do with the vaccination in question. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur in the period after vaccination without any connection to vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or other 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 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: FOUND DEAD


VAERS ID: 1010472 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Depression; Epilepsy; Hypokalaemia; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021098056

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB SE-MPA-1611755997275, Safety Report Unique Identifier SE-MPA-2021-001827. An 81-year-old male patient received bnt162b2 (COMIRNATY, lot number EJ6795) , intramuscular in Jan2021 at single dose for COVID-19 vaccination. Medical history included hypokalaemia, stroke, alcohol abuse, epilepsy, depression, all of which were from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The reported adverse reaction is sudden death in Jan2021. The patient dies unexpectedly and not witnessed the night after the vaccination without prior deterioration. Report assessed as serious, death. The patient died on an unspecified date in Jan2021. An autopsy cannot determine the cause of death according to the reporter.; Reported Cause(s) of Death: sudden death


VAERS ID: 1010476 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Dyspnoea, General physical health deterioration, Infection, Oxygen saturation, Oxygen saturation abnormal, Pulse abnormal, Pyrexia
SMQs:, Anaphylactic reaction (narrow), 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), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN / HIDROCLOROTIAZIDA; PREDNISOLON [PREDNISOLONE]; MOXALOLE; PARACETAMOL; BUPREMYL; MIRTAZAPIN; KAJOS; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypereosinophilic syndrome; Hypertension; Nightmares (betablocker gave nightmares.); Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 202101; Test Name: pulse oximetry; Result Unstructured Data: Test Result:severely impaired
CDC Split Type: SEPFIZER INC2021095262

Write-up: Infection NOS; impaired general condition; fever; affected breathing with severely impaired pulse oximetry; affected breathing with severely impaired pulse oximetry; affected breathing with severely impaired pulse oximetry; decreased blood pressure; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB, Regulatory Authority number SE-MPA-2021-000479. Other case identifier number SE-MPA-1610717478720. An 85-year-old female patient received bnt162b2 (COMIRNATY, lot number: EJ6795), via intramuscular on unspecified date in Jan2021 at single dose for COVID-19 immunization. The relevant medical history included nightmares (betablocker gave nightmares), vascular dementia, hypertension, hypereosinophilic syndrome, all from unspecified dates and unknown if ongoing. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN / HIDROCLOROTIAZIDA), prednisolone, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOXALOLE), paracetamol, buprenorphine (BUPREMYL), mirtazapine (MIRTAZAPIN), potassium citrate (KAJOS), bisoprolol. Reported suspected adverse event was infection nos, the day after vaccination in Jan2021. Treated with Penomax. According to rapporteur "Suddenly impaired general condition, fever, affected breathing with severely impaired pulse oximetry and decreased blood pressure". The patient died five days after vaccination on an unspecified date in 2021. Report assessed as serious, death. No autopsy performed, cause of death was infection nos. The outcome of the event infection nos was fatal, while other events were unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infection NOS


VAERS ID: 1010478 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL 1484 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; RAMIPRIL; ATORBIR; WARAN; SOBRIL; LEVAXIN; HYDROCHLOROTHIAZIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Atrial fibrillation; Hyperlipidaemia; Hypertension; Hypothyroidism; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095518

Write-up: death; This is a spontaneous report from a contactable consumer or other non hcp and an other HCP downloaded from the Medicines Agency (MA) Regulatory Authority-WEB SE-MPA-2021-000677, Other case identifier number SE-MPA-1611061284120. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot EL 1484), intramuscularly on Jan2021 at 0.3 mL, single dose for COVID-19 vaccination. Medical history included hypothyroidism, anxiety, stroke from 1992, atrial fibrillation, hypertension, hyperlipidaemia. Concomitant medication included bisoprolol, ramipril, atorvastatin calcium (ATORBIR), warfarin sodium (WARAN), oxazepam (SOBRIL) , levothyroxine sodium (LEVAXIN), hydrochlorothiazide. The woman was found dead in the morning two days after vaccination in Jan2021. According to consumer reporter, the patient was healthy but sensitive to medicines before vaccination. Consumer reporter also write that according to doctor cause of death was unknown. The woman was not autopsied. Report assessed as serious, death. The outcome of event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1010479 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: Hypertension; Renal failure; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095408

Write-up: acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA)R Regulatory Authority -WEB, Regulatory Authority number SE-MPA-2021-001016. Other case identifier number SE-MPA-1611233695800. An 83-year-old female patient received (COMIRNATY, lot number: EL1484) intramuscular on Jan2021 at 0.3 ml single for COVID-19 immunisation. Medical history included diabetes type 2, kidney failure and hypertension. Concomitant medications were unknown. The patient was vaccinated in the morning, in the evening she felt well but was found dead the next day in the morning, died during the night on Jan2021. Cause of death was acute myocardial infarction. The patient was not autopsied. Report assessed as serious, death. Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1010480 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: QUETIAPINE; ZOPICLONE; HEMINEVRIN [CLOMETHIAZOLE EDISILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Frontotemporal dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021096129

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB SE-MPA-2021-001018, Other case identifier number SE-MPA-1611233985028. A 70-year-old male patient received bnt162b2 (COMIRNATY), via intramuscular on Jan2021 at single dose for covid-19 immunisation. Medical history included frontotemporal dementia from an unknown date and unknown if ongoing. Concomitant medication included quetiapine, zopiclone and clomethiazole edisilate (HEMINEVRIN [CLOMETHIAZOLE EDISILATE]), all from unknown date for unknown indication. The patient died unexpected 8 days after vaccination. The patient was autopsied. The Medical Products Agency have requested for autopsy report. Outcome of the event was fatal. No follow-up attempts are possible, information on batch numbers cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1010481 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Hypothyreosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095397

Write-up: Death; Tiredness; This is a spontaneous report from a contactable healthcare professional downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-001257. Other case identifier number SE-MPA-1611395632614. A 90-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EL1484), intramuscularly in Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included dementia Alzheimer''s type and hypothyroidism. No previous known drug reactions. The patient''s concomitant medications were none. The patient experienced death, and tiredness in Jan2021. The day after the vaccination, the woman developed increasing tiredness and stopped eating and drinking (orally). Apart from that, her health condition was entirely without remarks according to the reporter. The woman died 5 days after the vaccination. The patient died on an unspecified date. Outcome of event tiredness was unknown. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1010482 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiopulmonary failure, General physical health deterioration
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Palliative care; TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095409

Write-up: Cardiopulmonary failure; general physical health deterioration; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB SE-MPA-2021-001508. A 98-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot number: EL1484) Intramuscular at single dose in Jan2021 for COVID-19 vaccination. Medical history included angina pectoris and status post TIA (transient ischaemic attack). The woman had been in palliative care in 2019 and a renewed decision was made in May2020. No concomitant medication. The patient was vaccinated with the first dose of Comirnaty in Jan2021. A renewed decision regarding palliative care was made three days after the vaccination. Six days after the vaccination, the patient died. Causes of death were cardiopulmonary failure and general physical health deterioration. Report assessed as serious, death. The MPA has requested further information. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Cardiopulmonary failure; General physical health deterioration


VAERS ID: 1010483 (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: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / 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: 2021-01-14
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXASCAND; MEMANTINE; ACETYLSALICYLIC ACID; SIMVASTATIN; BETOLVEX [CYANOCOBALAMIN]; FOLVIDON; MIRTAZAPINE; LEVAXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive lung disease; Dementia Alzheimer''s type (late onset)
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021095406

Write-up: Death in COVID 19, VIRUS positive; Death in COVID 19, VIRUS positive; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (SE-MPA-2021-001581 and SE-MPA-1611603955343). An 86-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6795), intramuscularly, on 05Jan2021 at a single dose for COVID-19 immunisation. Medical history included chronic obstructive lung disease and dementia Alzheimer''s type (late onset). Concomitant medications included oxazepam (OXASCAND) from 2012, memantine (MANUFACTURER UNKNOWN) from 2016, acetylsalicylic acid (MANUFACTURER UNKNOWN) from 2009, simvastatin (MANUFACTURER UNKNOWN) from 2009, cyanocobalamin (BETOLVEX) from 2009, folic acid (FOLVIDON) from 2009, mirtazapine (MANUFACTURER UNKNOWN) from 2012, and levothyroxine sodium (LEVAXIN) from 2009. The patient had no previous drug reactions. The patient experienced death in COVID 19, virus positive on 07Jan2021, which was reported as fatal. The clinical course was reported as follows: Two days after the vaccination, the patient suddenly desaturated and was sent to a hospital, where a COVID-19 virus test was taken, which came back positive on 07Jan2021. The man was treated with high levels of oxygen and parenteral fluid and nutrition, but his consciousness decreased, and he died after a week in the hospital, reported as 9 days after the vaccination. The physician reported that the patient was probably already infected, both health care providers and residents had verified ongoing COVID-19 during that time and the man tested positive 2 days after the first dose of vaccination. The patient died on 14Jan2021. The cause of death was reported as COVID-19. It was not reported if an autopsy was performed. The physician reported that the vaccination in itself is not suspected to have caused the death and does not suspect aggravated COVID-19 infection due to vaccination.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1010484 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021095412

Write-up: Circulatory failure/circulatory arrest; chest pain; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB and received via Regulatory Authority SE-MPA-2021-001718. Other case identifier number SE-MPA-1611673292424. A 61-years-old female patient received bnt162b2 (COMIRNATY), lot number: EL1484, intramuscular in Jan2021 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported three days after vaccination in 2021, the patient suddenly experienced chest pain. Fell down and Circulatory failure/circulatory arrest. The patient died after one hour with cardiopulmonary rescue. Reporter wrote no clinical suspicion of correlation with vaccination. The report was reported as serious with death. Autopsy was ordered by reporter. The Medical Products Agency had requested for autopsy protocols and epicrisis. The patient died of Circulatory failure/circulatory arrest on an unspecified date in 2021. The outcome of events chest pain and fell down was unknown. It was not reported if an autopsy was performed at the time of report.; Sender''s Comments: Based on temporal association, the causal relationship between bnt162b2 and the events circulatory collapse and chest pain cannot be excluded. The contributory role of the pre-existing COPD and hypertension cannot be excluded as well. It is noted that an autopsy has been requested. 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: Circulatory failure/circulatory arrest


VAERS ID: 1014882 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-23
   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 EJ6796 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Death, General physical health deterioration
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: FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]; NOVALGIN [CAFFEINE;PARACETAMOL;PROPYPHENAZONE]; PARACETAMOL; CONCOR
Current Illness: Bronchial neoplasm (N. Bronchi suspicion); Schizophrenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20190702; Test Name: CT Thorax; Result Unstructured Data: Test Result:Results NOS
CDC Split Type: ATPFIZER INC2021104335

Write-up: reduced general condition in the context of advanced tumor disease; Death NOS death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB , Regulatory Authority number: AT-BASGAGES-2021-00605. A 65-year-old male patient received second dose of bnt162b2 (COMIRNATY, lot: EJ6796), intramuscularly at deltoid left on 22Jan2021 at 0.3 mL (2nd dose) single for COVID19 mRNA vaccination. Medical history included Bronchial neoplasm N. Bronchi suspicion from Mar2020 and ongoing, schizophrenia from 01Dec1991 and ongoing. Concomitant medication included beclometasone dipropionate, formoterol fumarate (FOSTER) from 2020, caffeine, paracetamol, propyphenazone (NOVALGIN) from 2020, paracetamol from 2020, bisoprolol fumarate (CONCOR). The patient previously took CISORDINOL (reported as CISCORDINOL) from 1991 to Mar2020, first dose of bnt162b2 (COMIRNATY) on 29Dec2020. Patient found dead in the room. The day before, 2nd gift of Comirnaty. Given at the express request of the patient. Clinically mucous, reduced general condition in the context of advanced tumor disease. On 23Jan2021 the patient experienced Death NOS death. The patient experienced also General physical condition decreased. The patient''s outcome was fatal for General physical condition decreased, fatal for Death NOS. The patient died on 23Jan2021 from Vaccination adverse reaction, Embolism, Bronchial neoplasm. Relatedness of drug to events was assessed by reporter as possible for both events (Death NOS and General physical condition decreased). The patient underwent lab tests and procedures which included computerised tomogram: results nos on 02Jul2019. The patient died on 23Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Mainly side effect Comirnaty (2nd dose) DD: Embolism as a result of the tumor disease; Mainly side effect Comirnaty (2nd dose) DD: Embolism as a result of the tumor disease; Mainly side effect Comirnaty (2nd dose) DD: Embolism as a result of the tumo


VAERS ID: 1014883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-22
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arrhythmia (Cardiac arrhythmia including unconsciousness as a result several times, but ECG examinations were unremarkable.); Unconsciousness (Cardiac arrhythmia including unconsciousness as a result several times, but ECG examinations were unremarkable.)
Preexisting Conditions: Medical History/Concurrent Conditions: Colitis ulcerative (Ulcerative colitis earlier, no longer acute)
Allergies:
Diagnostic Lab Data: Test Name: post-mortem examination; Result Unstructured Data: Test Result:the definite cause of death as "death due to cardi; Comments: "death due to cardiac arrhythmia"; Test Name: ECG examinations; Result Unstructured Data: Test Result:unremarkable
CDC Split Type: ATPFIZER INC2021104337

Write-up: Death due to cardiac arrhythmia according to autopsy; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, number AT-BASGAGES-2021-00720. An 80-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 13Jan2021 at single dose for Vaccination against Sars-Cov-2. The patient''s medical history and concurrent conditions included: Arrhythmia (continuing), Cardiac arrhythmia including unconsciousness (contiue) as a result several times, but ECG examinations were unremarkable, Colitis ulcerative earlier, no linger acute. The patient''s concomitant medications were not reported. The patient previously took bisphosphonates. Nine days after the Pfizer-Biontec SarsCoV-2 vaccination "Comirnaty", the patient (care level 3) was found lying dead in the bathroom on 22Jan2021. Until then, the patient was still in good health. A post-mortem examination revealed the definite cause of death as "death due to cardiac arrhythmia" (Cardiac arrhythmia according to autopsy). On 22Jan2021 the patient experienced Arrhythmia death. An autopsy was performed and results were not provided. Sender Comment: Confounding factors: underlying arrhythmia,elderly age The available information was considered inadequate to fully assess the case. No follow-up attempts are possible. Batch/Lot# and expiry date not provided and not possible to obtain.; Reported Cause(s) of Death: Cardiac arrhythmia according to autopsy


VAERS ID: 1014886 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-29
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

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:
Current Illness: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular block third degree (Condition after AV block 3 with pacemaker implantation 2014); Cerebral infarction (Condition after cerebral insult with left paresis in 2015); Pacemaker insertion (cardiac) (Condition after AV block 3 with pacemaker implantation 2014); Paresis (Condition after cerebral insult with left paresis in 2015)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021109645

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-00813 and received via Regulatory Authority. A 78-years-old female patient received bnt162b2 (COMIRNATY) , Lot# EJ6797 intramuscular on unspecified date in Jan2021 at single dose for covid-19 immunisation . The patient''s medical history and concurrent conditions included: Hypertension arterial (continuing), Cerebral infarction (Condition after cerebral insult with left paresis in 2015) not ongoing , Paresis (Condition after cerebral insult with left paresis in 2015) unknown if ongoing, Atrioventricular block third degree (Condition after AV block 3 with pacemaker implantation 2014) not ongoing, Pacemaker insertion (cardiac) (Condition after AV block 3 with pacemaker implantation 2014) not ongoing .The patient''s concomitant medications were not reported. The patient experienced death nos on 29Jan2021.It was not reported if an autopsy was performed. The patient''s outcome was: fatal for Death NOS. Sender Comment: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death NOS


VAERS ID: 1014887 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   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 EM0477 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood pressure measurement, Cardiac arrest, Heart rate, Malaise, Nausea, Oxygen saturation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Deep vein thrombosis; Hypertension; Ischemic cardiomyopathy; Mitral insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: Blood pressure; Result Unstructured Data: Test Result:160/70 mmHg; Test Date: 20210113; Test Name: Pulse rate; Result Unstructured Data: Test Result:59 beats per minute; Test Date: 20210113; Test Name: Oxygen saturation; Test Result: 90 %
CDC Split Type: BEPFIZER INC2021097913

Write-up: In cardiac arrest and resuscitation fails; the patient feels unwell; Nausea; Anxiety; 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 BE-FAMHP-DHH-N2021-75817. A 98-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477), via an unspecified route of administration on 13Jan2021 (at the age of 98-year-old) as a single dose for COVID-19 vaccination and domperidone (MANUFACTURER UNKNOWN), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history included hypertension, ischaemic cardiomyopathy, mitral valve insufficiency, aortic insufficiency, and deep vein thrombosis; all from unknown dates and unknown if ongoing. The patient''s concomitant medications were not reported. On 13Jan2021 at 23:00, the patient experienced nausea and anxiety. On 13Jan2021, the patient underwent lab tests and procedures which included blood pressure measurement: 160/70 mmhg, pulse rate: 59 beats per minute, and oxygen saturation: 90 %. On 14Jan2021, the patient experienced feeling unwell. On 14Jan2021, the patient had cardiac arrest and cardiopulmonary resuscitation failed. It was decided that an acute heart attack was the cause. The physician did not see any relationship with the vaccine. The action taken in response to the events for domperidone was unknown. The clinical outcomes of the cardiac arrest, nausea, anxiety, and feeling unwell were fatal. The patient died on 14Jan2021. It was not reported if an autopsy was performed. The regulatory authority assessed the causality between the vaccine and cardiac arrest, nausea, anxiety, and feeling unwell as unclassifiable. The regulatory authority assessed the causality of the domperidone to cardiac arrest and feeling unwell as unclassifiable and that to nausea and anxiety as unlikely. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Nearly 99 years old (born PRIVACY ), history of Hypertension, ischemic cardiomyopathy, mitral insufficiency, aortic insufficiency, deep vein thrombosis. I don''t see any relationship with the vaccine. Patient in cardiac arrest and CPR fails. It is decided that an acute heart attack is the cause.; Sender''s Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.; Reported Cause(s) of Death: cardiac arrest; feeling unwell; nausea; anxiety


VAERS ID: 1014895 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-21
   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 EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Peripheral vascular disorder, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
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: PANTOPRAZOLE; METOCLOPRAMIDE; ACETYLSALICYLIC ACID; TORASEMIDE; AMLODIPINE; SIMVASTATINE
Current Illness: Cardiac insufficiency; Coronary heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure; Arterial hypertension; Arteriosclerosis; Cardiac failure; Cerebral ischaemia; Chronic gastritis; COVID-19 respiratory infection; Multi-infarct dementia; Pneumonia; Upper gastrointestinal haemorrhage; Vomiting
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021103840

Write-up: hypotonic circulatory failure; Circulatory collapse; Vomiting; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB other manufacturer number DE-DCGMA-21187686. A female 91-year-old patient, born on PRIVACY, was vaccinated with the second dose of BNT162B2 (COMIRNATY, batch no.: EK9788) for COVID-19 immunisation, Intramuscular on 20Jan2021. Concomitant medications included: pantoprazol, metoclopramide, acetylsalicylic acid, torasemid, amlodipin, simvastatin Patient past drug therapy: Comirnaty (start date: 28Dec2020, No adverse reaction). Medical history included: Pneumonia, Acute renal failure, Upper gastrointestinal haemorrhage, Multi-infarct dementia, COVID-19 respiratory infection, Arterial hypertension, Cerebral ischaemia, Arteriosclerosis, Chronic gastritis, Cardiac failure, Vomiting, Coronary heart disease, Cardiac insufficiency. 1 day after vaccination the patient developed Vomiting and Circulatory disorder peripheral and Circulatory failure, lasting for 4 hour(s). The patient is dead. Death cause was reported as Circulatory failure. ADDITIONAL INFORMATION ON DRUG PROVIDED IN PRODUCT NOTES: Second vaccination Adverse events: increasing hypotensive circulatory failure in the following hours, no response to infusion therapy, bradycardic arrhythmia, asystole/death at 11.15 am. 1st Covid-19 vaccination on 28Dec2020 was well tolerated; pat was in good, stable until 20Jan21, 2nd Covid-19 vaccination on 1/20Jan2021; sudden onset of symptoms described above starting at approximately 7 am on 21Jan2021. Measures: Considering the patient''s age and general condition with infusion therapy. Supplement for Reporter''s comments: Ringer''s lactate, 1 MCP 10 mg ampoule IV, later Akrinor IV from the emergency doctor; no stat. Instruction or resuscitation (living will was available) No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Adverse events: increasing hypotensive circulatory failure in the following hours, no response to infusion therapy, bradycardic arrhythmia, asystole/death at 11.15 am. 1st Covid-19 vaccination on 28Dec2020 was well tolerated; pat was in good, stable until 20Jan21, 2nd Covid-19 vaccination on 1/20Jan2021; sudden onset of symptoms described above starting at approximately 7 am on 21Jan2021. Measures: Considering the patient''s age and general condition with infusion therapy; Reported Cause(s) of Death: Circulatory failure


VAERS ID: 1014897 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
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 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Cyanosis, Death, General physical health deterioration, Pneumonia, Respiratory failure, Syncope, Urinary tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Arterial stent insertion (Stent-PTA of the popliteal artery and the right tibiofibular trunk in 2011); Atrial fibrillation (Permanent atrial fibrillation - NOAC with Pradaxa); Cholecystolithiasis; Chronic gastritis; Chronic renal insufficiency (stage II); Depressive disorder; Hepatomegaly; Hyperlipidaemia; Hypertensive heart disease; Hyperuricemia; Liver fatty (Grade II); Peripheral arterial occlusive disease Fontaine stage I; Triple vessel disease; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: CT chest; Result Unstructured Data: Test Result:pronounced pneumonia
CDC Split Type: DEPFIZER INC2021103905

Write-up: Respiratory failure; Syncope; Pneumonia; Cyanosis; General physical condition decreased; Unknown cause of death; urinary tract infection; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [DE-PEI-CADRPEI-2021013072]. An 85-year-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscularly on 14Jan2021 at single dose for prophylactic vaccination. Medical history included Peripheral arterial occlusive disease Fontaine stage I, Arterial stent insertion (Stent-PTA of the popliteal artery and the right tibiofibular trunk in 2011), Atrial fibrillation (Permanent atrial fibrillation - NOAC with Pradaxa), Triple vessel disease, Type 2 diabetes mellitus, Arterial hypertension, Hypertensive heart disease, Chronic renal insufficiency stage II, Hyperlipidaemia, Chronic gastritis, Cholecystolithiasis, Grade II Liver fatty, Hepatomegaly, Depressive disorder, Hyperuricemia, all were ongoing. The patient''s concomitant medications were not reported. 8 days after vaccination (as reported), on 21Jan2021 the patient developed Respiratory failure and Syncope and Cyanosis and General physical condition decreased and Pneumonia, lasting for unknown. Patient in the PFH syncopated and fallen out of bed, dyspnoic, resp. partial insufficiency, with oxygen requirement -$g hospital admission -$g oxygen demand 8l/min, antibiotics for urinary tract infection, pronounced pneumonia in the CT chest. The patient was dead on 21Jan2021. The patient had not recovered from the events Respiratory failure and Syncope and Cyanosis and General physical condition decreased and Pneumonia at the date of reporting, and outcome of urinary tract infection was unknown. Death cause was reported as Unknown cause of death. It was not reported if an autopsy was performed. Senders comment: Peripheral arterial occlusive disease stage I; Stent-PTA of the popliteal artery and the right tibiofibular trunk in 2011; Permanent atrial fibrillation - NOAC with Pradaxa; Three vessel coronary disease; Type 2 diabetes mellitus; Arterial hypertension with hypertensive heart disease; Chronic renal insufficiency St. II; Hyperlipidemia; Chronic gastritis; Cholecystolithiasis; Grade II fatty liver with hepatomegaly; Depressive disorder; Hyperuricemia. Patient in the PFH syncopated and fallen out of bed, dyspnoic, resp. partial insufficiency. with oxygen requirement -$g hospital admission -$g oxygen demand 8l/min, antibiotics for urinary tract infection, pronounced pneumonia in the CT chest, both, anamnestic vaccination COVID 19 on 14Jan2021. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014898 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   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 EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, General physical health deterioration, Incorrect route of product administration
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (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: Adrenal insufficiency; Atrial fibrillation; Dementia; Diabetes; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021103902

Write-up: Reduced general condition; Dyspnea; Inappropriate route of administration/intravenously; This is a spontaneous report from a non-contactable other health care professional (Other HCP). This is a report received from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority or other manufacturer number DE-PEI-CADRPEI-2021013125. An elderly male patient received bnt162b2 (COMIRNATY) (batch/lot: EJ6797) intravenously (Inappropriate route of administration) on 15Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing adrenal insufficiency, ongoing dementia, ongoing diabetes, ongoing atrial fibrillation, ongoing hypertension. Concomitant medications were not reported. 7 days after vaccination, the patient developed dyspnea and reduced general condition on 21Jan2021, lasting for unknown. Events dyspnea and reduced general condition were considered serious as fatal. The patient is dead on an unspecified date. It was not reported if an autopsy was performed. Sender Comment: Atrial fibrillation, renal insufficiency, Hypertension, dementia, diabetes. AZ reduced on 21Jan2021, got hard to breathe.; Reported Cause(s) of Death: Reduced general condition; dyspnea


VAERS ID: 1014899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome, Pyrexia
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic obstructive pulmonary disease; General physical condition decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021103903

Write-up: Death due to non-receding fever after vaccination, multi-organ failure; Death due to non-receding fever after vaccination, multi-organ failure; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority, number DE-PEI-CADRPEI-2021013126. A 71-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing General physical condition decreased, ongoing chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. The patient experienced Death due to non-receding fever after vaccination, multi-organ failure since 14Jan2021. Detail clinical course was reported as on the same day after vaccination the patient developed Fever and Multiorgan failure, lasting for unknown, fever did not go down; antibiotics or Novalgin etc. did not help. The patient died on Jan2021. An autopsy was performed that revealed multiorgan failure. Death cause was reported as Multiorgan failure. The event outcome was fatal. Sender Comment: COPD, poor general condition, fever did not go down; antibiotics or Novalgin etc. did not help. Comirnaty/Fever/PEI/A. Consistent causal association to Comirnaty/Multiorgan failure/PEI/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: Multiorgan failure; Fever; Autopsy-determined Cause(s) of Death: Multiorgan failure


VAERS ID: 1014900 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-10
   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 - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021114082

Write-up: Died 3 days after vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (DE-PEI-CADRPEI-2021013143). A 90-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 07Jan2021 at a single dose for COVID-19 immunisation. Medical history included ongoing dementia and ongoing hypertension. The patient''s concomitant medications were not reported. The patient died 3 days after vaccination on 10Jan2021. The cause of death was unknown and not reported. An autopsy was not performed. The causality assessment of the event was reported as unclassifiable by Paul-Ehrlich-Institut (PEI). No follow-up attempts are possible; information on batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014901 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-16
   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 UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Dementia (condition after apoplexy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021110103

Write-up: death; General physical health deterioration; General physical health deterioration and progressive breakdown until death within a few days; This is a spontaneous report from consumer or other non hcp downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-CADRPEI-2021013996 and received via Regulatory Authority. A 97-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) intramuscular at single dose at arm on 15Jan2021 for covid-19 immunisation Medical history included dementia, condition after apoplexy. The patient''s concomitant medications were not reported. On 16Jan2021 (also reported as 2 days after vaccination) the patient developed Influenza like illness and general physical health deterioration and progressive breakdown until death within a few days lasting for 5 days (considered fatal). The patient died on 20Jan2021. It was not reported if an autopsy was performed. Cause of death was unknown. Reporter''s comments: It is unclear whether the general physical health deterioration is related to the vaccination; there has been no similar short-term deterioration in the general physical health deterioration in the past 2 years Batch/Lot# and expiry date not provided and not possible to obtain. No follow-up attempts possible. No further information expected.; Reporter''s Comments: It is unclear whether the general physical health deterioration is related to the vaccination; there has been no similar short-term deterioration in the general physical health deterioration in the past 2 years; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014902 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-06
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   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: Medical History/Concurrent Conditions: Apoplexy; COVID-19; Crohn''s disease; Hypertension; Ileocecal resection; Renal artery aneurysm; Vascular encephalopathy; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: post-stroke condition
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021110102

Write-up: Exitus letalis; On 06Jan2021 first vaccination against Covid-19 with feverish reaction.; This is a spontaneous report from a consumer or other non hcp downloaded from the regulatory authority-WEB DE-PEI-CADRPEI-2021014030. A 78-year-old male patient received bnt162b2 (COMIRNATY) intramuscular at single dose 1st dose on 06Jan2021, and 2nd on 27Jan2021 for covid-19 immunisation. Medical history included apoplexy, vascular encephalopathy, post-stroke condition, renal artery aneurysm, Crohn''s disease with ileo resection, hypertension, Covid 19 disease in Apr2020. The patient''s concomitant medications were not reported. The patient experienced feverish reaction on 06Jan2021 after the 1st dose, fever of 39 on 27Jan2021 after the 2nd dose, exitus letalis (death) on 28Jan2021. On 28Jan2021, the patient was still asleep, 15 minutes later the nurse found him dead in bed. The nurse did the inquest and called the police on suspicion of unnatural death. It was not reported if an autopsy was performed. Sender''s comments: Hypertension, post-stroke condition, vascular encephalopathy, renal artery aneurysm, post-ileum resection due to Crohn''s disease. - All old diagnoses. Causality for fever / regulatory authority /Consistent causal association to Causality for death/ regulatory authority / Unclassifiable No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: in April 2020 Covid 19 disease. On 06Jan2021 first vaccination against Covid-19 with feverish reaction. On 27Jan2021 second vaccination with a fever of 39, death on 28Jan2021.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014905 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-25
   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 M0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensation cardiac
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021097562

Write-up: Pneumonia; Lung oedema; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-PEI-PEI2021001761]. A 95 years old female patient received first dose of bnt162b2 (COMIRNATY, Lot Number M0477 and Expiration Date unknown) via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history included decompensation cardiac from Nov2020 and unknown if it was ongoing. The concomitant medications was not reported. After 5 days of vaccination (25Jan2021), the patient developed lung oedema and pneumonia, lasting for unknown and patient dead in 2021. Unknown if autopsy was done. Outcome of events was fatal. Reporters comment: A precise connection between death and vaccination cannot be established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: lung oedema; pneumonia


VAERS ID: 1014906 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   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 EM0477 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Death, Malaise, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Apoplexy; Cardiac insufficiency; Dementia; Renal insufficiency; Vascular encephalopathy
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Body temperature; Result Unstructured Data: Test Result:increased after first shot Centigrade; Test Date: 20210127; Test Name: Body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Comments: increased
CDC Split Type: DEPFIZER INC2021103849

Write-up: Found lifeless; tremble; Elevated temperature 38.7C; malaise; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) DE-PEI-PEI2021001818 and received via Regulatory Authority (PEI). This is the first of two reports. An unknown 77-year-old patient, born on PRIVACY, was vaccinated with the second dose of BNT162B2 (COMIRNATY, lot/batch no.: EM0477) for COVID-19 immunisation, Intramuscular on 27Jan2021. Concomitant medication included: concomitant medication was not reported. Patient past drug therapy: Comirnaty (start date: 06Jan2021, reaction: Body temperature increased). Medical history included: Dementia, Vascular encephalopathy, Apoplexy, Renal insufficiency, Cardiac insufficiency. 1 day(s) after vaccination the patient developed Unknown cause of death. On 27Jan2021, patient developed Body temperature increased 38.7C and Malaise and Trembling, lasting for unknown. The patient is dead. Death cause was reported as Unknown cause of death. Follow-up information has been requested. Patient''s notes: Anamnestic: fever episodes during interventions, patient multimorbid. Assesment for all the events were reported by PEI Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014907 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-27
   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 EK9788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021103800

Write-up: Death; This is a spontaneous report from a non-contactable physician via Regulatory Authority-WEB DE-PEI-PEI2021001836. An 89 years old female patient received the first dose of bnt162b2 (COMIRNATY, lot/batch no: EK9788), intramuscular on 24Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 27Jan2021. It was not reported if an autopsy was performed. Death cause was reported as Unknown cause of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014908 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-06
   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 UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Haemoglobin, Ileus paralytic, Microcytic anaemia, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (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), Gastrointestinal obstruction (narrow), Eosinophilic pneumonia (broad), Tumour lysis syndrome (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: 2021-01-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: Haemoglobin; Result Unstructured Data: Test Result:6.9 g/dl
CDC Split Type: DEPFIZER INC2021103811

Write-up: Ileus paralytic; Pneumonia; Microcytic anemia; Acute renal failure; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-PEI-PEI2021001837]. A 97-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Hypertension arterial from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 06Jan2021 the patient developed Ileus paralytic and Microcytic anemia and Pneumonia and Death and Acute renal failure, lasting for unknown. The patient is dead and was hospitalized. The patient underwent lab tests and procedures which included haemoglobin: 6.9 g/dl. The patient died on 08Jan2021. Death cause was Ileus paralytic, Pneumonia, Microcytic anemia, Acute renal failure. It was unknown if an autopsy was performed. No follow-up attempts possible, batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Pneumonia; Microcytic anemia; Acute renal failure; Ileus paralytic


VAERS ID: 1014909 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-24
   Days after vaccination:12
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: 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Cardiac insufficiency; Chronic pain; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021103804

Write-up: Sudden death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB [DE-PEI-PEI2021001842]. A 87-year-old female patient received first dose of BNT162B2 (COMIRNATY) Lot number EM0477, on 12Jan2021 at single dose for COVID-19 immunisation. Medical history included: Parkinson''s disease, Aortic valve insufficiency, Cardiac insufficiency, Chronic pain, all unknown if ongoing. Concomitant medication was not reported. 12 day(s) after vaccination (24Jan2021) the patient developed Death sudden. The patient was dead. Death cause was reported as Sudden death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1014910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
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 - / 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 INC2021103820

Write-up: Death; This is a spontaneous report from a non-contactable physician via Regulatory Authority downloaded from the Agency Regulatory Authority-WEB Regulatory Authority number DE-PEI-PEI2021001843. An 88 years old female patient received the first dose of bnt162b2 (COMIRNATY, lot/batch no: EJ6796), intramuscular on 30Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died (sudden death) on an unspecified date. It was not reported if an autopsy was performed. Death cause was reported as Unknown cause of death. Reporter Comment: During the follow-up period, no abnormalities were observed. I do not think that the death can be related to the vaccination. No follow-up attempts possible. No further information expected.; Reporter''s Comments: During the follow-up period, no abnormalities were observed. I do not think that the death can be related to the vaccination.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014928 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   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 EL1491 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021098081

Write-up: Aortic dissection; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authoity-WEB. The regulatory authority report number is ES-AEMPS-723023. A 64-year-old female patient receive BNT162B2 (COMIRNATY; Lot number EL1491), via an unspecified route of administration on 15Jan2021 as single dose for COVID-19 immunization. Medical history included hypercholesterolaemia from an unknown date. Concomitant medication included ongoing atorvastatin (MANUFACTURER UNKNOWN) for hypercholesterolaemia from 2012. There was no known hypertension, aneurysms, or any type of heart disease. The patient experienced aortic dissection on 15Jan2021, which was serious as it lead to death. The vaccine was administered in the morning of 15Jan2021, and the event occurred in the night of the same day, being intervened and ending in a fatal outcome the next day. The patient died on 16Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Aortic dissection


VAERS ID: 1014938 (history)  
Form: Version 2.0  
Age: 93.0  
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 UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, Chest X-ray, Dyspnoea, Loss of consciousness, Pyrexia
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications: LOSARTAN KRKA [LOSARTAN POTASSIUM]; FURESIS; SERETIDE EVOHALER; LIXIANA; MEMANTINE RATIOPHARM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abnormal chest sound; Asthma; Benign renal neoplasm; Cognitive deterioration; Heart failure; Hydronephrosis; Hypertension; Lung neoplasm; Memory impairment; Pneumonia (On 08Jan2021, prescribed Avelox due to cough, decreased general condition, and increased crp ad 68.); Pneumonia (Oct2020 was a hospitalization period due to a heart failure and pneumonia); Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: Temperature; Result Unstructured Data: Test Result:37.7; Test Name: lung x-ray; Result Unstructured Data: Test Result:suspected malignant tumor; Test Name: CRP; Result Unstructured Data: Test Result:increased crp ad 68; Test Date: 20210122; Test Name: CRP; Result Unstructured Data: Test Result:just over 80
CDC Split Type: FIPFIZER INC2021104360

Write-up: Pyrexia; C-reactive protein increased; Loss of consciousness; Dyspnoea/shortness of breath; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FI-FIMEA-20210274. A 93-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly on 21Jan2021 10:00 am at single dose for covid-19 vaccination. Concomitant medication included losartan potassium (LOSARTAN KRKA) for Hypertension, furosemide (FURESIS), fluticasone propionate, salmeterol (SERETIDE EVOHALER) for Asthma, edoxaban tosilate (LIXIANA) for Cerebrovascular accident prophylaxis, memantine hydrochloride (MEMANTINE RATIOPHARM) for Memory impairment. The patient''s medical history included Hypertension, Memory impairment, vascular cognitive decline diagnosed 2011, asthma, heart failure, hydronephrosis 2014 with suspected benign renal tumor in the background, RTG in autumn 2019 with suspected lung tumor. The patient refused the difficult investigations and treatments related to possible lung tumor, symptomatic treatment line. Transferred to a nursing home Jul2020. The condition was slowly declining. Oct2020 was a hospitalization period due to a heart failure and pneumonia. On lung x-ray suspected malignant tumor. During the hospitalization, a treatment plan was adviced in which hospital transfers would be avoided in the future, focus on effective symptomatic treatment, and, if necessary, consultation with the home-hospital from the nursing home. From the hospitalization period the patient remained permanently with harsh breath, a wheelchair patient. On 08Jan2021, the patient was prescribed Avelox antibiotic therapy orally due to cough, decreased general condition, and increased crp ad 68. Pneumonia was suspected. The issue was resolved. CRP monitoring was not considered indispensable since the patient had lung disease, it was speculated that crp may fluctuate due to lung disease. Last steps for the patient: On 21Jan2021, at about 10 a.m., the patient received bnt162b2 to prevent coronavirus infection. The same evening complained to shortness of breath (Dyspnoea) which relieved spontaneously. The next morning, 22Jan, shortness of breath was severe, thus the patient was administered Atrovent comp and oxynorm medications according to the treatment plan. Initially there was a response to these products, but after lunch, patient''s shortness of breath was strongly provoked. Temperature was measured it was 37.7 (Pyrexia), crp was measured and was just over 80 (C-reactive protein increased). The patient quickly went into an unconscious state (Loss of consciousness). Symptomatic treatment line according to a proactive treatment plan. The patient died in the presence of staff at 4.45 pm on 22Jan2021. Lung cancer has been identified as the primary cause of death, as it was the reason for the palliative treatment line and the proactive treatment plan. With regard to the underlying diseases, there may have been a prognosis for perhaps a few months; temporary association with bnt162b2 raised suspicions of adverse drug reaction, which was predisposed by lung cancer, asthma and heart failure. When writing a death certificate, a forensic doctor was consulted over the phone. No forensic autopsy considered necessary. The relative also did not want further clarifications. In the death certificate a vaccine adverse event was reported as a contributing factor to death. The outcome of the events was fatal. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Lung cancer; Dyspnoea/shortness of breath; Pyrexia; C-reactive protein increased; Loss of consciousness


VAERS ID: 1014939 (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: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Heartburn; Pain; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: fever; Result Unstructured Data: Test Result:fever
CDC Split Type: FIPFIZER INC2021104363

Write-up: slowly declining condition deteriorated further; fever; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB FI-FIMEA-20210275. An 88-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot/batch number and expiration date unknown), intramuscularly on 20Jan2021 at single dose (1 dose form) for COVID-19 vaccination. The patient''s medical history included Parkinson''s disease, atrial fibrillation, pain, heartburn. The patient had concomitant treatments and necessary medications for parkinson''s disease, atrial fibrillation, pain, heartburn. The patient received the vaccine on 20Jan2021, started with fever the next day on 21Jan2021, and the already slowly declining condition deteriorated further, there was no longer contact with the patient, a convalescent care decision was made. The patient died at the end of the a short convalescence treatment in the evening on 25Jan2021. It was unknown if an autopsy was performed. The general condition had been constantly fading before, it was speculated that the rise in fever seemed to that broke the camel''s back and burdened to such an extent that the well-being deteriorated further. The outcome of the events was fatal. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: fever; slowly declining condition deteriorated further


VAERS ID: 1014940 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-14
   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 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Dementia Alzheimer's type, Dyspnoea, General physical health deterioration, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (narrow), 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: 2021-01-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXIN; OXYNORM
Current Illness: Dementia (treated in a care home)
Preexisting Conditions: Medical History/Concurrent Conditions: Pain (from 10Jan swallowing difficulties); Reduced general condition; Shortness of breath (from 10Jan swallowing difficulties); Swallowing difficult (more than a year); Tooth infection
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: CRP; Result Unstructured Data: Test Result:52
CDC Split Type: FIPFIZER INC2021104518

Write-up: Alzheimer''s disease; General physical health deterioration; Pyrexia; Breathing difficult; Pneumonia; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB FI-FIMEA-20210280. A 92-year-old male patient received bnt162b2 (COMIRNATY, Lot/batch number and Expiration date were not provided), intramuscular on 12Jan2021 at single dose for covid-19 immunization. Medical history included ongoing end-stage dementia (treated in a care home), difficulty swallowing for more than a year, shortness of breath/pain from 10Jan2021 (from 10Jan swallowing difficulties), dental inflammation, General health condition declined. Concomitant medication included amoxicillin trihydrate (AMOXIN) for tooth infection, oxycodone hydrochloride (OXYNORM) from 10Jan2021 for Dyspnoea and pain. The patient experienced general physical health deterioration and pyrexia on 15Jan2021, breathing difficult and pneumonia on 14Jan2021, Alzheimer''s disease on unspecified date. The patient died from the events. A man with end-stage dementia living in a nursing home, treated in a care home according to a preventive treatment plan without intravenous medication, for symptomatic treatment in case of an emergency Oxynorm prescription written Jan2019. General health condition declined, was occasionally raised to sit by a crane. Difficulty swallowing for more than a year, from 10Jan swallowing difficulties, suspected shortness of breath/pain, therefore Oxynorm given as an emergency medicine 3mg 0-3 times a day. Physician went to evaluate the patient 12Jan2021 in the morning of the COVID vaccination day, then physician suspected dental inflammation as an aggravating factor in eating difficulties and started an antibiotic for that, no pneumonia. Physician had not made a convalescent treatment decision, as the patient at that time was able to eat and the convalescent treatment decision would have been inconsistent with the initiation of the antibiotic. And because the patient did not have a convalescent treatment decision, a COVID vaccine was given. CRP 52 on Jan2021. On 14Jan2021 the sounds of breathing were quiet and now even on a visit to the doctor the breathing was heavy, so physician suspected that the patient had pneumonia, however, the patient still ate. On 15Jan2021 the patient''s general condition collapsed, the fever rose and a convalescent treatment decision was made, the patient died the same evening. The patient died after receiving the COVID vaccine. Physician had no doubt about the patient dying due to COVID vaccine, physician had written Alzheimer''s disease on the death certificate. Under current guidelines, physician would not have given the COVID vaccine, but on 12Jan2021 the guideline was to not administer the COVID vaccine only in the absence of a convalescent treatment decision or if the patient refuses. The outcome of the events was fatal. The patient died on 15Jan2021. 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: Alzheimer''s disease; General physical health deterioration; Breathing difficult; Pneumonia; Pyrexia


VAERS ID: 1014941 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
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 EL1491 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; FLIXOTIDE; CALCICHEW D3 EXTRA APPELSIINI; HEINIX; FURESIS; BISOPROLOL
Current Illness: Dementia; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma; Atrial fibrillation; Cardiac insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021114235

Write-up: Increased upper airway secretion; Pyrexia; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB (FI-FIMEA-20210308). A 91-year-old female patient received BNT162B2 (COMIRNATY; Lot number: EL1491), intramuscularly, on 19Jan2021 at a single dose for COVID-19 vaccination. Medical history included atrial fibrillation, asthma, allergy, cardiac insufficiency, ongoing nursing home patient, and ongoing severe dementia. Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation from 22Jun2020, fluticasone propionate (FLIXOTIDE) taken for asthma from 07Apr2020, calcium carbonate, colecalciferol (CALCICHEW D3 EXTRA APPELSIINI) from 07Jun2017, cetirizine hydrochloride (HEINIX) taken for allergy from 14Mar2018, furosemide (FURESIS) taken for cardiac insufficiency from 21Sep2010, and bisoprolol (MANUFACTURER UNKNOWN) from 03Oct2011. The patient experienced increased upper airway secretion and pyrexia on 20Jan2021, which was reported as fatal. It was reported that the patient felt feverish and had mucous the next day after vaccination. The patient died on 20Jan2021. The cause of death was assessed as increased upper airway secretion and pyrexia. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Increased upper airway secretion; pyrexia


VAERS ID: 1014942 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-23
   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 EM0477 / 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: 2021-01-23
   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: Medical History/Concurrent Conditions: Alzheimer''s disease; Aortic valve disease mixed; Arterial hypertension; Cancer of prostate; COVID-19 (in March 2020); Diabetes; Disease coronary artery
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021103893

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable Physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-AM20210092. This is a report received from the Regulatory Authority. A 78-years-old male patient with multiple pathologies received first dose of bnt162b2 (COMIRNATY) (lot EM0477), intramuscular on 22Jan2021 at single dose in the left deltoid for covid-19 immunisation. Medical history included aortic valve disease mixed, Alzheimer''s disease, Disease coronary artery, covid-19 in Mar2020, Diabetes, Arterial hypertension, Cancer of prostate, all unknown if ongoing. The patient''s concomitant medications were not reported. On 23Jan2021, at 6 a.m., the patient was found dead in his bed. The patient experienced SUDDEN DEATH on 23Jan2021 06:00. It was not reported if an autopsy was performed. No significant event (no variation in blood pressure, fever, etc.) between the day of vaccination and the day of death. The patient was walking around and was independent before the vaccination. No worsening of his state of health reported before vaccination. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SUDDEN DEATH


VAERS ID: 1014943 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
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 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: ESOMEPRAZOLE; HALDOL; ESCITALOPRAM; DOLIPRANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: Covid-19 test: PCR; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021109778

Write-up: Reduced general condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-AN20210151 and received via Regulatory Authority (AFSSAPS). A 85-year-old female patient received bnt162b2 (COMIRNATY, lot number EM0477) via intramuscular in arm left on 15Jan2021 at single dose for COVID-19 vaccination. Medical history included Alzheimer''s disease unknown if ongoing. Concomitant medication included esomeprazole, haloperidol (HALDOL), escitalopram and paracetamol (DOLIPRANE). Clinical course: patient with advanced dementia, deterioration of general condition, false routes and swallowing disorders presenting clinical deterioration since late December - early January with thymic decline at the end of December signs of bronchial congestion motivating the introduction of the aerosol vaccination on the 15Jan2021, no signs of infection that day thereafter further deterioration of the general condition without marked worsening immediately after vaccination on the 21Jan2021 marked clinical deterioration, discontinuation of oral feeding. patient found deceased on 23Jan2021.Covid-19 test: PCR: carried out on 11Jan2021, result not specified on the declaration. CONCLUSION death 8 days after vaccination by comirnaty in an elderly patient with dementia, death seeming more related to the course of the disease of the patient whose condition had been declining for several weeks. usual treatment esomeprazole, haldol, escitalopram, doliprane, laxatives. The patient experienced reduced general condition in Jan2021 and death unexplained on 23Jan2021. The patient died of reduced general condition on 23Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Reduced general condition


VAERS ID: 1014944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-19
   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 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood culture, Blood pressure measurement, Body temperature, C-reactive protein, Cardiac monitoring, Culture stool, Electrocardiogram, Heart rate, Investigation, Laboratory test, Microbiology test, Oxygen saturation, Pneumonia, SARS-CoV-2 test, Scan, Troponin, Urine analysis, Weight
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? Yes
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Artificial cardiac pacemaker wearer; Cognitive disorders; Coronary arterial stent insertion; Deafness unilateral; Decreased appetite; Dementia Alzheimer''s type; General physical health deterioration (for a few months); Gonarthrosis; Inguinal hernia repair (2004); Major neurocognitive disorder; Malnutrition; Mixed dementia; Myocardial infarction; Osteoporosis with fracture (L1 settlement in 2015); Osteoporosis with fracture; Peripheral arterial occlusive disease; Stent placement; Tibial artery occlusion; Weight loss
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Auscultation; Result Unstructured Data: Test Result:congestion but no clear appearance of OAP.; Comments: Always oligo-anuric; Test Date: 20210119; Test Name: cardiopulmonary auscultation; Result Unstructured Data: Test Result:Normal cardiopulmonary auscultation,no focus found; Test Date: 20210120; Test Name: pulmonary auscultation; Result Unstructured Data: Test Result:indrawing, crackles of the 2 bases; Test Date: 20210119; Test Name: Blood cultures; Result Unstructured Data: Test Result:unknown results; Test Date: 20210120; Test Name: BP; Result Unstructured Data: Test Result:64/40 mm Hg; Test Date: 20210120; Test Name: BP; Result Unstructured Data: Test Result:69/40; Test Date: 20210120; Test Name: BP; Result Unstructured Data: Test Result:70/40 mm Hg; Comments: 7h; Test Date: 20210119; Test Name: fever; Result Unstructured Data: Test Result:39.1 Centigrade; Test Date: 20210119; Test Name: fever; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210120; Test Name: fever; Result Unstructured Data: Test Result:39.2 Centigrade; Test Date: 20210120; Test Name: fever; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210120; Test Name: cardiac auscultation; Result Unstructured Data: Test Result:BDC irregular; Test Date: 20210119; Test Name: CRP; Result Unstructured Data: Test Result:95; Test Date: 20210119; Test Name: fecaloma; Result Unstructured Data: Test Result:fecaloma +++; Test Date: 20210119; Test Name: ECG; Result Unstructured Data: Test Result:possible AC / FA 117 / min with disturbance; Comments: possible AC / FA 117 / min with disturbance of repolarization; Test Date: 20210120; Test Name: HR; Result Unstructured Data: Test Result:96 bpm; Test Date: 20210119; Test Name: pulse; Result Unstructured Data: Test Result:180 then 110 / min; Test Date: 20210120; Test Name: desaturation; Test Result: 65 %; Comments: in AA; Test Date: 20210119; Test Name: ECBU; Result Unstructured Data: Test Result:unknown results; Test Date: 20210120; Test Name: FR; Result Unstructured Data: Test Result:24; Test Date: 20210119; Test Name: MT; Result Unstructured Data: Test Result:MT 06/13; Test Date: 20210120; Test Name: FC; Result Unstructured Data: Test Result:128 bpm; Test Date: 20210119; Test Name: Biology; Result Unstructured Data: Test Result:CRP 95; Test Date: 20210119; Test Name: saturation; Test Result: 92 %; Comments: in AA; Test Date: 20210120; Test Name: saturation; Test Result: 96 %; Comments: under mask at high concentration 6 l / min; Test Date: 20210120; Test Name: saturation; Test Result: 93 %; Test Date: 20210119; Test Name: COVID + 19 sample; Test Result: Negative ; Test Date: 20210119; Test Name: scanner; Result Unstructured Data: Test Result:right base pneumonia, urinary globe ++, fecaloma +; Test Date: 20210119; Test Name: troponins; Test Result: Negative ; Test Date: 20210119; Test Name: urinary; Result Unstructured Data: Test Result:globe ++; Test Name: weight; Result Unstructured Data: Test Result:loss of 11 kg
CDC Split Type: FRPFIZER INC2021095013

Write-up: Pneumonia; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) FR-AFSSAPS-BR20210077 and received via Regulatory Authority (AFSSAPS). An 89-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, batch/lot number: EJ6795), intramuscular in the left arm on 18Jan2021 at single dose for COVID-19 vaccination. Medical history included osteoporosis with fracture from 1962, anxiodepressive syndrome from Jun2017, major neurocognitive disorder, coronary arterial stent insertion, myocardial infarction with stenting, artificial cardiac pacemaker wearer from May2017, secondary right deafness from 1962, inguinal hernias operated from 2003 (and 2004), fracture osteoporosis from 2015 (L1 settlement in 2015), gonarthrosis, obliterating arterial disease of the lower limbs, occlusion of the middle third of the left anterior tibial artery, neuro-cognitive disorders, probable Alzheimer''s dementia, mixed dementia, undernutrition, context of deterioration of the general condition for a few months, weight with loss of 11 kg in less than a year (small appetite). Patient at risk of developing a severe form of COVID-19 because of his age. Has not had COVID-19, has not been tested. The patient''s concomitant medications were not reported. The patient previously took mirtazapine (NORSET) from Jun2017 for anxio-depressive syndrome. The patient experienced pneumonia (death, life threatening) on 19Jan2021. Reported as follows: No adverse effects during monitoring for 15 minutes.19Jan2021 at 8 AM: fever at 38.1 C then 39.1 C, chills. Diffuse very sensitive abdomen. Normal cardiopulmonary auscultation, no focus found. 12:30 p.m .: contact with the emergency doctor who advises an emergency scan. Biology: CRP 95. Implementation of antibiotic therapy with ROCEPHINE 1 g / day in SC. 1 p.m .: negative troponins. 5:40 p.m .: MT 06/13, 92% saturation in AA, pulse 180 then 110 / min. ECG: possible AC / FA 117 / min with disturbance of repolarization. Opinion of the radiology intern on the scanner: right base pneumonia, urinary globe ++, fecaloma +++. To behave : COVID + 19 sample (negative sample). Blood cultures (unknown results), ECBU (unknown results). Normacol, continuation of antibiotic therapy with ROCEPHINE, LOVENOX 0.4 morning and evening. 20Jan2021 at 12:45 a.m .: call from the resident on call for 65% desaturation in AA, BP 64/40 mm Hg FC 128 bpm, fever at 39.2 C. Patient reactive. On arrival of the intern: hypovigilant patient, who cannot be woken up even to pain, G5 Y1V1M3, saturation 96% under mask at high concentration 6 l / min, BP 69/40, HR 96 bpm, cold knees not marbled, FR 24, indrawing, crackles of the 2 bases on pulmonary auscultation, BDC irregular on cardiac auscultation. The patient does not appear to be in pain. Addition of FLAGYL 500 mg 3 times / day + new 500 ml NaCl (free flow). If no improvement in the constants and if the patient seems uncomfortable, possibility of introducing morphine + HYPNOVEL. Family informed of the situation. 7h: patient still hypovigilant, BP 70/40 mm Hg, saturation 93% under high concentration mask, temperature at 36.8 C. New bag of NaCl 500 ml. 11:30 am: desaturation, congestion, disturbances in vigilance. Auscultation: congestion but no clear appearance of OAP. Always oligo-anuric. No hospitalization. Comfort care. 20Jan2021 at 4 p.m .: death. Overall: right basal pneumonia complicated by septic shock. Suspicion of salivary inhalation: frequent false routes to liquids. Therapeutic measures were taken as a result of pneumonia. AE result in Emergency Room Visit. The patient died on 20Jan2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1014946 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-23
   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 EJ6134 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

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: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Embolism pulmonary; Hypertension arterial; Ischaemic heart disease; Stroke; Unspecified hypertensive heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20201022; Test Name: Covid-19 test; Result Unstructured Data: Test Result:did not have Covid-19
CDC Split Type: FRPFIZER INC2021103853

Write-up: Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, FR-AFSSAPS-BX20210244. An 83-year-old female patient received 1st injection of bnt162b2 (COMIRNATY, Lot#: EJ6134), intramuscular at right arm on 15Jan2021 at single dose for covid-19 immunization. Medical history included arterial hypertension, unspecified hypertensive heart disease, ischemic heart disease, stroke, pulmonary embolism, dementia Alzheimer''s type. Patient who did not have Covid-19: test carried out on 22Oct2020. Person considered to be at risk of developing a severe form of Covid-19. Risk factors: deterioration of the general condition, heart disease. The patient''s concomitant medications were not reported. The patient experienced infarct myocardial on 23Jan2021 with fatal outcome. Description of the event: On Day 8 of the vaccination, 23Jan2021: Chest pain accompanied by a brief convulsion, then cardiac arrest. External cardiac massage, emergency services call, resuscitation measures put in place, unspecified anticoagulant taken, and death noted 1 hour later. It was not reported if an autopsy was done.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1014949 (history)  
Form: Version 2.0  
Age: 75.0  
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 EM 0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Death
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: Depressive symptom; Hypochondriacal personality; Non-insulin-dependent diabetes mellitus; Pulmonary arterial hypertension; Weakness generalized
Preexisting Conditions: Medical History/Concurrent Conditions: Anorexia; Cardiac valve disease (insertion of a biological valve in 2004); Chronic alcoholism; Hernia inguinal; Hyperplasia of the prostate
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021095012

Write-up: Death unexplained; agitated; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) Regulatory Authority. The regulatory authority report number is FR-AFSSAPS-CF20210095. A 75-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot/batch number: EM0477), intramuscular in the left arm on 18Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included Hyperplasia of the prostate from an unknown date and unknown if ongoing, ongoing pulmonary arterial hypertension, inguinal hernia from an unknown date and unknown if ongoing, ongoing depressive symptoms, ongoing non-insulin-dependent diabetes mellitus, anorexia from Dec2020 to an unknown date which present for 1 month, cardiac valve disease (cardiopathy/valvulopathy with insertion of a biological valve in 2004) from an unknown date and unknown if ongoing, chronic withdrawn alcoholism. The patient was a hypochondriac patient with a weakened general condition. The patient''s concomitant medications were not reported. The patient experienced death unexplained on 19Jan2021. The night after the vaccination, patient was very agitated. On the morning of 19Jan2021, the death of this patient was observed without any clinical warning sign (absence of edema, urticaria, respiratory and cardiocirculatory failure). The outcome of agitated was unknown, of another event was fatal. The patient died on 19Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death unexplained


VAERS ID: 1014950 (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: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATENOLOL; LASILIX [FUROSEMIDE]; DIFFU K; CALCIUM D3; CORTANCYL; DOLIPRANE; MOPRAL [OMEPRAZOLE MAGNESIUM]; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; SERESTA
Current Illness: Artificial cardiac pacemaker wearer; Heart failure (due to rhythmic heart disease)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: SARS-CoV2 PCR test; Test Result: Negative ; Test Name: weight; Result Unstructured Data: Test Result:gained 1.7 kg in one month
CDC Split Type: FRPFIZER INC2021103858

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) FR-AFSSAPS-CF20210108 and received via Regulatory Authority (AFSSAPS). Patient (83-year-old, female) vaccinated on 15Jan2021 by bnt162b2 (COMIRNATY) lot EM0477. Immediate "allergic" reaction signs: none. Evocative signs of adverse effects expected after this vaccine: none. General condition of the patient: she presents a loss of autonomy which led to institutionalization, "depressed by confinement", progress more and more difficult. Death noted by the care team at around 8:15 p.m., after dinner. The meal tray had been removed from the room around 7:15 p.m., the resident was fine. The doctor on call was called. He noticed the death at 10 p.m., and had the resident''s daughter on the phone, asked her if she wanted an autopsy, which she rejected. The doctor on duty contacted the declaring doctor by telephone on the morning of 20Jan2021 to explain to him that he had no obvious cause of death which occurred after the primary vaccination carried out on January 15 at 4:24 p.m. with COMIRNATY BioNTeck / Pfizer Lot EM0477. This patient had global heart failure due to rhythmic heart disease and was a carrier of a pacemaker. Hypotheses of death mentioned: acute heart failure (massive infarction?), Ventricular tachycardia? The "patient''s face was blue" hypothesis of a false food route away from the meal? Note that the patient had gained 1.7 kg in one month (fluid retention in heart failure?) "The declaration is made because it comes in the context of an epidemic of COVID 19, four days after the primary vaccination knowing that a screening by SARS-CoV2 PCR test on a nasopharyngeal swab had been carried out on January 14, the result of which was negative ". Usual treatment of the patient: atenolol 50 (1), lasilix 40 (1), diffu K 600, calcium D3 (1), cortancyl 5 (2.5 cp / d), Doliprane 500 (6 / d), Mopral 10 ( 1), Movicol (2) and Seresta 10 (1). COMPLETE FILE. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1014951 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-22
   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 EJ6788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood sodium normal, C-reactive protein, Cardiac failure, Creatinine renal clearance, Hypokalaemia, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Tension
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREGABALIN; PANTOPRAZOL [PANTOPRAZOLE]; VERAPAMIL; VENTOLIN [SALBUTAMOL]; ATROVENT; LASILIX [FUROSEMIDE]; PARACETAMOL; ANASTROZOLE; APIXABAN; KARDEGIC; CALCIDOSE VITAMINE D; SKENAN; DULOXETINE; CORTANCYL; SERESTA; ATARAX [HYDROXYZINE]; OPTI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amputation (Right thigh amputation secondary to a heel pressure ulcer with amyotrophy of the leg and retractions); Appendectomy; Atrial fibrillation; Breast cancer (treated with hormone therapy); Bridle procedure (Occlusion on bridle in 2013); Decompensation cardiac (Cardiorespiratory decompensation on 14Jan2021 with polypnea and wheezing. No fever. Irregular heart sounds.); Dysuria; Eventration repair (Cure of 3 eventrations with placement of plaque); Hysterectomy; Ileus; Inverse psoriasis; Osteoarthritis; Phlebitis; Polypnea; Pressure ulcer; Pulmonary embolism; Venous ulceration; Wheezing (polypnea)
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: blood pressure; Result Unstructured Data: Test Result:21/09; Comments: Blood pressure at 21/09 after an aerosol of VENTOLINE and ATROVENT; Test Name: sodium; Result Unstructured Data: Test Result:normal; Test Name: CRP; Result Unstructured Data: Test Result:Near-normal CRP; Comments: Near-normal CRP, good kidney function; Test Name: Creatinine Clearance; Result Unstructured Data: Test Result:89ml/min; Test Name: hypolalaemia; Result Unstructured Data: Test Result:hypolalaemia; Test Date: 20210115; Test Name: NT-proBNP; Result Unstructured Data: Test Result:604 ng/L; Comments: NT pro BNP 604ng/L (N<125); Test Date: 20210122; Test Name: saturation; Test Result: 88 %; Test Date: 20210122; Test Name: saturation; Test Result: 91 %; Comments: 91% saturation under 3 liters of O2; Test Date: 20210124; Test Name: saturation; Test Result: 94 %; Comments: 94% saturation under 4 liters of O2; Test Date: 20210122; Test Name: tension; Result Unstructured Data: Test Result:15/6
CDC Split Type: FRPFIZER INC2021095016

Write-up: Decompensation cardiac; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) Regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-CN20210115. An 88-year-old female patient received BNT162B2 (COMIRNATY; Lot number EJ6788), intramuscular on 20Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history from unknown dates included pulmonary embolism on phlebitis, osteoarthritis, atrial fibrillation, breast cancer, treated with hormone therapy, Ileus secondary to opioids, Chronic venous ulcers, eventration (cure of 3 eventrations with placement of plaque),inverse psoriasis, persistent dysuria, amputation (Right thigh amputation secondary to a heel pressure ulcer with amyotrophy of the leg and retractions), appendectomy, hysterectomy, heel pressure ulcer with amyotrophy of the leg and retractions. Medical history also included bridle from 2013 (occlusion on bridle in 2013) and cardiorespiratory decompensation (cardiorespiratory decompensation on 14Jan2021 with polypnea and wheezing. No fever, irregular heart sounds were noted. The onset dates for phlebitis, polypnea and wheezing were also unknown. Concomitant medication included pregabalin (MANUFACTURER UNKNOWN), pantoprazol (PANTOPRAZOLE), verapamil (MANUFACTURER UNKNOWN), salbutamol (VENTOLIN), ipratropium bromide (ATROVENT), furosemide (LASILIX), paracetamol (MANUFACTURER UNKNOWN), anastrozole (MANUFACTURER UNKNOWN), apixaban (MANUFACTURER UNKNOWN), acetylsalicylate lysine (KARDEGIC) , calcium carbonate, colecalciferol (CALCIDOSE VITAMINE D), morphine sulfate (SKENAN), duloxetine (MANUFACTURER UNKNOWN), prednisone (CORTANCYL), oxazepam (SERESTA) , hydroxyzine (ATARAX), cromoglicate sodium (OPTICRON). The patient experienced decompensation cardiac on 22Jan2021, which was serious per hospitalization and lead to death. The event was reported with a duration of three days. The patient was hospitalized for decompensation cardiac from 22Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: 21/09 on 22Jan2021; Blood pressure at 21/09 after an aerosol of VENTOLINE and ATROVENT; sodium: normal on an unspecified date; c-reactive protein: near-normal crp on an unspecified date ; Near-normal CRP, good kidney function; creatinine clearance: 89ml/min on an unspecified date; hypokalaemia: on an unspecified date; NT-proBNP (n-terminal prohormone brain natriuretic peptide): 604 ng/l on 15Jan2021 (NT pro BNP 604ng/L (N<125) ),saturation: 88 % on 22Jan2021; saturation: 91 % on 22Jan202 (91% saturation under 3 liters of O2 ), saturation: 94 % on 24Jan2021 (94% saturation under 4 liters of O2 ), tension: 15/6 on 22Jan2021. Details were as follows: On 22Jan2021, she presented hawking, 88% desaturation in the ambient air during the evening meal. Tension 15/6. Exhaustion. Blood pressure at 21/09 after an aerosol of VENTOLINE and ATROVENT, 91% saturation under 3 liters of O2 were noted. The patient had been hospitalized on 22Jan2021 for bronchial congestion with cardiac decompensation. On 23Jan2021, at 6h00 she vomited, groans diffuse, congested were noted, Under 9 Liters of O2. Ob 23Jan2021, at 11h00: end of oral treatments was noted. Prescription of antibiotics and SOLUMEDROL and Low Molecular Weight Heparin (LMWH) at curative dose and aerosols. GLUCIDION 1litre / 24h. Reduction of the furosemide dosage to 60 mg / day. Near-normal CRP, good kidney function noted. On 24Jan2021: 94% saturation under 4 liters of O2. Crackling : respiratory sounds. Introduction SCOPODERM noted. Normal natremia and hypokalemia noted. Recharged with oral potassium. Creatinine clearance at 89ml / min. Cardiac decompensation on bronchopneumopathy. Uncertain prognosis for recovery was noted. Death was noted at 22h30 on 24Jan2021. 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.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1014952 (history)  
Form: Version 2.0  
Age:   
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 EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood culture, Blood fibrinogen, Blood pressure measurement, Blood thyroid stimulating hormone, Body temperature, Brain natriuretic peptide, C-reactive protein, Chest X-ray, Coma scale, Electrocardiogram, Fibrin D dimer, Glomerular filtration rate, Heart rate, Hyperthyroidism, Ischaemic stroke, Laryngitis, Lymphocyte count, Monocyte count, Neutrophil count, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Procalcitonin, Pyrexia, Respiratory alkalosis, Respiratory arrest, Respiratory rate, SARS-CoV-2 test, Scan brain, Status epilepticus, Thyroxine, Troponin, White blood cell count
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hyperthyroidism (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DOLIPRANE; FLUDEX [INDAPAMIDE]; LERCANIDIPINE HCL; CLOMIPRAMINE HCL; PERINDOPRIL ARGININE; SELOKEN L; FEBUXOSTAT; ZYMAD; MAG 2 [MAGNESIUM PIDOLATE]; SERESTA; FORLAX; THYROZOL; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension arterial; Hyperthyroidism; Hyperuricemia; Morbid obesity (morbid (133kg for 1m67)); Psychiatric disorder NOS (PMD?, Obsessive neurosis, seismotherapy in 1975)
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:Pulmonary, did not reveal crackles or wheezing; Test Date: 20210117; Test Name: blood cultures; Test Result: Negative ; Comments: 2 blood cultures yielded negative results.; Test Date: 20210117; Test Name: Fibrinogen; Result Unstructured Data: Test Result:5.45 g/l; Test Date: 20210117; Test Name: blood pressure; Result Unstructured Data: Test Result:144/101 mmHg; Comments: In the emergency department around 3:30 p.m.; Test Date: 20210117; Test Name: blood pressure; Result Unstructured Data: Test Result:140/101 mmHg; Test Date: 20201218; Test Name: TSH; Result Unstructured Data: Test Result:0.196 MiU/L; Comments: below the normal range; Test Date: 20210111; Test Name: TSH; Result Unstructured Data: Test Result:below 0.005 MiU/L; Test Date: 20210117; Test Name: temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Comments: In the emergency department around 3:30 p.m.; Test Date: 20210117; Test Name: temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Comments: At 6 p.m.; Test Date: 20210117; Test Name: BNP; Result Unstructured Data: Test Result:48 ng/L; Test Date: 20210117; Test Name: chest X-ray; Result Unstructured Data: Test Result:no signs of fluid overload or pneumothorax; Test Date: 20210117; Test Name: Glasgow; Result Unstructured Data: Test Result:13; Comments: confused conversation, eyes open to verbal command; Test Date: 20210117; Test Name: Glasgow; Result Unstructured Data: Test Result:15/15; Test Date: 20210117; Test Name: CRP; Result Unstructured Data: Test Result:6.5 mg/l; Test Date: 20210117; Test Name: ECG; Result Unstructured Data: Test Result:''borderline'' (tachycardia?, atrial fibrillation?); Test Date: 20210117; Test Name: D-dimer level; Result Unstructured Data: Test Result:740 ug/L; Test Date: 20210117; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:33 ml/min; Test Date: 20210117; Test Name: heart rate; Result Unstructured Data: Test Result:115; Comments: 115 bpm; In the emergency department around 3:30 p.m.; Test Date: 20210117; Test Name: heart rate; Result Unstructured Data: Test Result:133; Comments: 133 bpm; Test Date: 20210117; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.1 x10 9/l; Test Date: 20210117; Test Name: monocytes; Result Unstructured Data: Test Result:1.50 x10 9/l; Test Date: 20210117; Test Name: ANC; Result Unstructured Data: Test Result:9.2 x10 9/l; Test Date: 20210117; Test Name: saturation; Test Result: 86 %; Comments: with oxygen flow rate of 3 l/min; In the emergency department around 3:30 p.m.; Test Date: 20210117; Test Name: saturation; Test Result: 87 %; Comments: in ambient air; Test Date: 20210117; Test Name: saturation; Test Result: 98 %; Comments: in ambient air; Test Date: 20210117; Test Name: PCT; Result Unstructured Data: Test Result:0.21 ug/L; Test Date: 20210117; Test Name: respiratory rate; Result Unstructured Data: Test Result:27; Comments: 27 breaths/min; In the emergency department around 3:30 p.m.; Test Date: 20210111; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210117; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210117; Test Name: Head scan; Result Unstructured Data: Test Result:possible ischaemic lesions; Comments: possible ''ischaemic lesions in the context of respiratory arrest in basal ganglia, unless these represented semi-recent lacunar infarcts''. There was an indication of leukoaraiosis, no encephalic expansive process, no signs of visualised cortical stroke or intracranial haemorrhage.; Test Date: 20201218; Test Name: T4L; Result Unstructured Data: Test Result:20.8 pmol/L; Test Date: 20210111; Test Name: T4L; Result Unstructured Data: Test Result:49.8 pmol/L; Test Date: 20210117; Test Name: Troponin level; Result Unstructured Data: Test Result:19.9 ng/L; Comments: elevated; Test Date: 20210117; Test Name: leukocytes; Result Unstructured Data: Test Result:11.9 x10 9/l
CDC Split Type: FRPFIZER INC2021109838

Write-up: Seizure/Suspicion of status epilepticus; possible ischaemic stroke; acute laryngitis/Stridor; Oxygen saturation decreased; respiratory alkalosis; hyperthermia/febrile; discrete oedemas of the lower limbs; respiratory arrest/Dyspnoea; thyrotoxicosis; This is a spontaneous report downloaded from the regulatory authority, reported by a contactable palliative care physician via the regulatory authority portal, regulatory authority number FR-AFSSAPS-DJ20210140. A 75-year-old female patient started to receive the first dose of BNT162B2 (COMIRNATY) (lot/batch number EM0477, expiry date not reported) on 13Jan2021 at a single dose intramuscularly in the arm for COVID-19 vaccination. Medical history included recently diagnosed hyperthyroidism, arterial hypertension, diabetes, morbid obesity (133 kg, 1.67 m), hyperuricaemia, psychiatric condition (Bipolar disorder?, obsessive-compulsive disorder, seismotherapy in 1975). As of 17Jan2021, her concomitant medications included magnesium pidolate (MAG 2 [MAGNESIUM PIDOLATE]), oxazepam (SERESTA), macrogol 4000 (FORLAX), thiamazole (THYROZOL), lansoprazole (LANSOPRAZOLE) , paracetamol (DOLIPRANE), indapamide (FLUDEX [INDAPAMIDE]), lercanidipine hcl (LERCANIDIPINE HCL), clomipramine hcl (CLOMIPRAMINE HCL), perindopril arginine (PERINDOPRIL ARGININE) , metoprolol tartrate (SELOKEN L), febuxostat (FEBUXOSTAT), colecalciferol (ZYMAD). The patient was admitted to a nursing facility on 14Dec2020. She was wheelchair-bound, living at home with her husband. A thyroid check-up was performed on 18Dec2020 due to an exophthalmos that according to the patient had been present for a long time. TSH (thyroid stimulating hormone) was below the normal range, 0.196 mIU/l (0.34-5.60), and T4L (thyroxine level) was 20.8 pmol/l (7.5-15). Treatment with THYROZOL was started on 19Dec2020 at a daily dose of 5 mg. On 06Jan2021, the patient manifested abdominal pain with nausea. Absence of stools was reported, but the abdomen was soft and the evolution was favourable upon PRIMPERAN (metoclopramide) treatment. On 11Jan2021, COVID-19 PCR test result was negative. On 13Jan2021, the patient received her first injection of COMIRNATY (batch EM0477) with no complications. Thyroid function test performed on the same day showed TSH below 0.005 mIU/l and T4L of 49.8 pmol/l. The dose of THYROZOL was increased to 20 mg daily, starting on 14Jan2021, and a thyroid ultrasound was scheduled (suspected plunging goiter). On 17Jan2021, in the afternoon, paramedics were called to the patient because of dyspnoea with desaturation and hyperthermia. During ambulance transfer to the hospital, the patient experienced respiratory arrest. In the emergency department around 3:30 p.m., blood pressure was 144/101 mmHg, heart rate 115 bpm, temperature 38.7 C, saturation 86% with oxygen flow rate of 3 l/min, respiratory rate 27 breaths/min, no disorders of consciousness. At 6 p.m., temperature was 38.8 C, Glasgow 13 (confused conversation, eyes open to verbal command). Dyspnoea was of laryngeal type with stridor and polypnoea at 26 cycles per minute, suprasternal retractions. SpO2 was 87% in ambient air. Pulmonary auscultation did not reveal crackles or wheezing. At times, pauses in breathing were observed. Haemodynamically, blood pressure was 140/101 mmHg with heart rate of 133 bpm. The extremities were warm and the calves soft, but discrete oedemas of the lower limbs were observed. The patient was continuously monitored and treated with 500 ml saline, nebulisation with BRICANYL (terbutaline) and ATROVENT (ipratropium bromide), 2 g magnesium sulfate, 200 mg hydrocortisone hemisuccinate, nebulisation with 2 mg adrenaline and paracetamol. Blood test revealed respiratory alkalosis, leukocytes 11.9 G/l (4.0-11.0) with ANC (absolute neutrophil count) 9.2 G/l (1.7-7.5), monocytes 1.50 G/l (0.20-0.80) and lymphocytes 1.1 G/l (1.1-4.4). Troponin level was elevated reaching 19.9 ng/l (0.0-11.6), Brain natriuretic peptide (BNP) was 48 ng/l (<100) with glomerular filtration rate of 33 ml/min (80-140). D-dimer level was 740 ug/l (<400). Fibrinogen was 5.45 g/l (2.00-4.00), C-reactive protein (CRP) 6.5 mg/l (<5) and Procalcitonin (PCT) 0.21 ug/l (<0.05). 2 blood cultures yielded negative results. COVID-19 PCR test performed on 17Jan2021 was negative. Electrocardiogram (ECG) was ''borderline'' (tachycardia?, atrial fibrillation?) and chest X-ray showed no signs of fluid overload or pneumothorax. The clinical development of the patient''s condition at the emergency department was rather favourable with normal, 98% saturation in ambient air. The patient was eupneic, conscious and fully oriented with Glasgow score of 15/15. Resolution of stridor and dyspnoea was reported. Head scan performed on 17Jan2021 revealed possible ''ischaemic lesions in the context of respiratory arrest in basal ganglia, unless these represented semi-recent lacunar infarcts''. There was an indication of leukoaraiosis, no encephalic expansive process, no signs of visualised cortical stroke or intracranial haemorrhage. Emergency department report mentioned the diagnosis of acute laryngitis and possible ischaemic stroke, and treatment with KARDEGIC 75 mg (lysine acetylsalicylate) and AUGMENTIN (amoxicillin/clavulanic acid) was recommended. The patient was transferred to the Palliative Care Unit on the same day due to possible repeated convulsive crises of undetermined aetiology. On examination, the patient still presented tremors in her feet and shoulders that had been observed by the palliative care physician who came to see the patient in the emergency department. The patient''s gaze was vague with intermittent pauses in breathing (an episode of this type observed in the emergency department) that succeeded without interruption. Suspicion of status epilepticus encouraged the administration of KEPPRA (levitracetam). EEG was not performed. The patient was still febrile. Despite anticonvulsant treatment with midazolam (bolus and syringe pump) and RIVOTRIL (clonazepam), no improvement as regards convulsions with progressive respiratory failure and loss of consciousness was reported. The patient did not present a tonic-clonic seizure but persistent trembling in the feet and shoulders was observed. Oxygen therapy at 2 l/min increased to 4 l/min was initiated. Due to retractions and respiratory arrest, 80 mg SOLUMEDROL (methylprednisolone) was administered with BRICANYL and ATROVENT aerosols, with no effect. As the patient''s neurological and respiratory status continued to deteriorate, the dose of midazolam was increased and a bolus of OXYNORM (oxycodone) aimed at restoring eupnoea was administered. The patient died at 11:40 p.m. on 17Jan2021. From semiological point of view, the cause of death had not been yet established. Different hypotheses had been put forward: thyrotoxicosis was first evoked by the doctor who took care of the patient at the palliative care unit and a COVID-19 infection by the doctor at the nursing facility because of desaturation and several positive cases in the patient''s surrounding (roommate and caregivers), but two COVID-19 PCR tests performed on 11 and 17 January proved negative. It should be noted that the patient did not present any signs of reactogenicity (fever...) in the immediate aftermath of the vaccination. The outcome of respiratory arrest was fatal, the outcome of thyrotoxicosis (reported as one hypothesis on cause of death) was fatal, the status epilepticus (suspicion of) was not resolved, the pyrexia was not resolved, the decreased oxygen saturation was recovered, the outcome of the possible ischaemic stroke, diagnosis of acute laryngitis, respiratory alkalosis and discrete oedemas of the lower limbs was unknown. It''s unspecified if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: respiratory arrest; thyrotoxicosis


VAERS ID: 1014954 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-19
   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 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis (tight aortic stenosis with TAVI refusal on very poor general condition); Bedridden; Chronic renal failure (severe); General physical condition decreased (severe alteration of the general condition); Pressure sore (stage 4 pressure sore); TAVI (tight aortic stenosis with TAVI refusal on very poor general condition)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021109846

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority number FR-AFSSAPS-LL20210199. A 96-year-old female patient received bnt162b2 (COMIRNATY, Lot # EJ6796) intramuscular at single dose at left arm on 13Jan2021 for covid-19 immunisation, because clinically stable but 100% fragile who received her family in her room (vaccine to protect them). The patient medical history included bedridden patient, with severe alteration of the general condition, stage 4 pressure sore, severe chronic renal failure, tight aortic stenosis with TAVI refusal on very poor general condition. The concomitant medications were not reported. No reaction occurred immediately or in the days following vaccination. The patient died on 19Jan2021. It was not reported if an autopsy was performed. Unidentified cause of death. The physician considered there was not a reasonable possibility that the event death was related to the bnt162b2 vaccine: No link retained by the doctor, death expected. No follow-up attempts possible. No further information expected.; Sender''s Comments: The advanced old patient having multiple intractable coexisting diseases, the death is most likely attributed to the aggravation of the underlying severe comorbidities. However, further information especially death cause and autopsy results are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1014955 (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: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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: Medical History/Concurrent Conditions: Bedridden (at the end of life); Dementia Alzheimer''s type (at a very advanced stage)
Allergies:
Diagnostic Lab Data: Test Name: PCR sampling; Result Unstructured Data: Test Result:Unknown results; Test Name: Rapid antigenic Covid test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021103863

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-LY20210225 and received via Regulatory Authority . A 10-decade-old (aged 90 to 100) female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 20Jan2021 at single dose for covid-19 immunization. Medical history included Dementia Alzheimer''s type at a very advanced stage and bedridden at the end of life. The patient''s concomitant medications were not reported. Patient received 1st intramuscular injection of COMIRNATY vaccine as part of the vaccination against Covid-19 on 20Jan2021, 20 hours later (on 21Jan2021), the patient was found dead in bed in the early hours of the morning (the night shift did not notice anything abnormal during the rounds). Note that the patient had benefited from the recommended post-vaccination surveillance: no sign related to the vaccination identified during this surveillance. No notion of reaction at the injection site or local reaction, no sign of systemic vaccine reaction (no arterial hypertension, no tachycardia, no dyspnea, no fever, no malaise). The death seems rather to be part of the context of the end of life of this patient with severe Alzheimer''s disease, but the case was taken in principle because of the delay between the vaccination and the death. It was unknown if an autopsy done. Patient''s lab data included Negative Rapid antigenic Covid test and PCR sampling with unknown results on an unspecified date. No follow-up attempts possible. No further information expected. Lot/Batch number can not be obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1014956 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2021-01-16
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: TAMSULOSIN; MOPRAL [OMEPRAZOLE MAGNESIUM]; BACTRIM FORTE; ELIQUIS; VALACICLOVIR; PROPRANOLOL; TIBSOVO; PERMIXON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myeloid leukemia (with unfavorable karyotype, associated with an IDH1 R132C mutation, escaping after 38 VIDAZA cycles); Bateman''s purpura senilis; Benign prostatic hyperplasia; Bilateral cataracts; Coronary stent placement; Deep vein thrombosis (Pulmonary embolism on left deep vein thrombosis); Dupuytren''s contracture (Dupuytren of the right hand); Embolism pulmonary (Pulmonary embolism on left deep vein thrombosis); Essential tremor; Infarct myocardial (myocardial infarction with thrombolysis and stent in 2003); Monoclonal gammopathy; Monoclonal immunoglobulin present; Osteonecrosis (bilateral femoral heads); Rhizomelic pseudopolyarthritis; Sensory polyneuropathy axonal (Sensitive-motor axonal polyneuropathy); Sleep apnea syndrome (Sleep apnea syndrome non-treated with CPAP); Smoldering myeloma (recent evidence of multiple myeloma lesions); Thrombolysis
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID PCR; Test Result: Positive
CDC Split Type: FRPFIZER INC2021095023

Write-up: COVID-19; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-LY20210238. An 82-year-old male patient received BNT162B2 (COMIRNATY, lot number unknown) intramuscularly on 14Jan2021 at single dose for COVID-19 vaccination. The patient age also mentioned as 81 years old. Co-suspect drugs included lenalidomide (REVLIMID, 5mg capsule) orally at 5 mg once a day on day 1- day 21 from 28Dec2020 for monoclonal gammopathy, dexamethasone acetate (NEOFORDEX, strength 20mg) orally at 20 mg on day 1- day 8- day 15- day 22 from 28Dec2020 for monoclonal gammopathy. The patient''s medical history included acute myeloid leukemia with unfavorable karyotype, associated with an IDH1 R132C mutation, escaping after 38 VIDAZA cycles; Monoclonal gammopathy (Monoclonal immunoglobulin present) with recent evidence of multiple myeloma lesions which justified the initiation of lenalidomide and dexamethasone acetate; Sensitive-motor axonal polyneuropathy; Essential tremor; Rhizomelic pseudopolyarthritis; Benign prostatic hyperplasia; Bilateral osteonecrosis of the femoral heads after corticosteroid therapy; Bateman''s purpura senilis after corticosteroid therapy; myocardial infarction with thrombolysis and stent in 2003; Pulmonary embolism on left deep vein thrombosis in Jun2015; Sleep apnea syndrome non-treated with CPAP; Dupuytren of the right hand; Bilateral cataract. The patient''s concomitant medications included tamsulosine for benign prostatic hyperplasia; omeprazole magnesium (MOPRAL) for unspecified indication; sulfamethoxazole, trimethoprim (BACTRIM FORT) from 28Dec2020 for prophylaxis; apixaban (ELIQUIS) from 28Dec2020 for thrombosis prophylaxis; valaciclovir from 28Dec2020 for prophylaxis; propanolol for unspecified indication; ivosidenib (TIBSOVO) from Jul2020 for acute myeloid leukemia; serenoa repens extract (PERMIXON) for benign prostatic hyperplasia. The patient experienced COVID-19 on 16Jan2021. The physician reported hospitalization due to febrile dyspnea, positive COVID PCR during hospitalization. Evolution towards a febrile picture with marked inflammatory syndrome and pancytopenia. Management by probabilistic bi-antibiotic therapy (third generation cephalosporin and macrolide), blood transfusion (4 concentrated red blood cells) and platelets (3 CP), oxygen therapy. Evolution Multi-visceral degradation, increase in oxygen dependence on 19Jan2021, worsening of pancytopenia, degradation of renal function, evidence of hemolysis without disseminated intravascular coagulation. The patient died on 19Jan2021.; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1014958 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-12
   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 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood potassium, Blood sodium, C-reactive protein, Oxygen saturation, Pneumonia aspiration, SARS-CoV-2 test, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   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: SERESTA; REFRESH [POLYVINYL ALCOHOL;POVIDONE]; SALBUTAMOL; ZYMA-D2; MICROLAX [MACROGOL;SODIUM CITRATE;SODIUM LAURYL SULFATE;SORBIC ACID]; LANSOPRAZOLE; PARACETAMOL; NORMACOL [STERCULIA URENS GUM]; SODIUM CHLORIDE; NEFOPAM HYDROCHLORIDE; VIT
Current Illness: Alzheimer''s disease; Bronchial congestion; Bundle branch block; Cognitive impairment (mixed-onset cognitive impairment progressing since stroke); Dorsalgia (chronic dorsalgia in right scoliosis without neurological abnormality); Drug intolerance; Hernia hiatal; Hernia inguinal; Hip prosthesis user; Hyperlipaemia; Hypertension arterial; Hypokinesia; Ischemic stroke (Ischemic stroke on the right middle cerebral artery without motor sequelae); Left ventricular hypertrophy; Lumbar disc herniation (herniated disc (L1-L2)); Mitral insufficiency; Osteoma (left ethmoidal nasal sinus osteoma); Productive cough (prone to swallowing the wrong way and bronchial congestion with greasy cough); Scoliosis (chronic dorsalgia in right scoliosis without neurological abnormality); Swallowing disorder; Venous insufficiency (superficial venous insufficiency)
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Cataract (left); Cataract (right); Ectropion; Escherichia pyelonephritis; Fall; Fracture of humerus; Osteoarthritis; Osteosynthesis (osteosynthesis of a fracture of a third of the right ulna); Parathyroidectomy; Radius fracture; Thrombosis venous (thrombosis of the left internal twin veins and a right fibular vein); Ulna fracture (osteosynthesis of a fracture of a third of the right ulna)
Allergies:
Diagnostic Lab Data: Test Date: 20200822; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:free of any obstacle; Test Date: 20200914; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:free of any obstacle and symmetrical; Test Date: 20210109; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:no noise, but there are small thoracic amplificati; Comments: no noise, but there are small thoracic amplifications; Test Date: 20210111; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:there is no obvious obstruction; Test Date: 20210112; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:metabolic dyspnea with mottling on the lower limbs; Comments: metabolic dyspnea with mottling on the lower limbs, as well as a clear focus of left base pneumopathy; Test Date: 20210109; Test Name: blood potassium; Result Unstructured Data: Test Result:2.78 mM; Comments: hypokalemia; Test Date: 20210109; Test Name: blood sodium; Result Unstructured Data: Test Result:151 mM; Comments: hypernatremia; Test Date: 20210109; Test Name: C-reactive protein; Result Unstructured Data: Test Result:247 mg/l; Test Date: 20210113; Test Name: Saturation O2; Result Unstructured Data: Test Result:1L 82-85 percent; Test Date: 20210109; Test Name: COVID PCR; Test Result: Negative ; Test Date: 20210113; Test Name: polypnea; Result Unstructured Data: Test Result:34 c/m
CDC Split Type: FRPFIZER INC2021095031

Write-up: Aspiration pneumonia; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FR-AFSSAPS-NY20210103. This is a report received from the Regulatory Authority. A 99-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number EJ6795) , intramuscular on 08Jan2021 15:00 at single dose on left arm for COVID-19 vaccination. Medical History included: hyperlipidemia from 1985 and ongoing, hypertension arterial from 1993 and ongoing, right middle cerebral artery ischemic stroke with no motor sequelae from Sep2014 and ongoing, mixed-onset cognitive impairment progressing since stroke from 2015 and ongoing, Alzheimer''s disease from 2018 and ongoing, uncomplicated acute Escherichia pyelonephritis from 2015 to an unspecified date, ongoing superficial venous insufficiency, thrombosis of the left medial gastrocnemius veins and a right fibular vein in Jun2016, ongoing left ventricular hypertrophy with hypokinesia, ongoing grade 1 mitral insufficiency and right branch block (last left ventricular ejection fraction (LVEF): 45 percent in 2018), multifocal osteoarthritis from an unspecified date and unknown if ongoing, lumbar disc herniation/herniated disc (L1-L2) from 1985 and ongoing, hiatus hernia by sliding and rolling from 1985 and ongoing, hernia inguinal from 1985 and ongoing, ongoing chronic dorsalgia in right scoliosis without neurological abnormality, left ethmoidal nasosinusal osteoma from 2005 and ongoing, ongoing NSAID and tramadol intolerance (breathing pauses with 25 mg x 2/d), multiple falls in Dec2020, 2 of which were drug-related (NY201620822 and NY20171412), prone to swallowing the wrong way and bronchial congestion with greasy cough from an unspecified date and ongoing, hip prosthesis user from 1999 and ongoing. Surgical history included: appendectomy (1968), parathyroidectomy on the right (1999), cataract on the left (2005) and right (2006), osteosythesis of a fracture of one third of the right ulna (Mar2016), fracture of the upper end of the humerus and radius (2018), lacrimal ectropion (2018). Concomitant medication included oxazepam (SERESTA), polyvinyl alcohol, povidone (REFRESH), salbutamol, ergocalciferol (ZYMA-D2), macrogol, sodium citrate, sodium lauryl sulfate, sorbic acid (MICROLAX) , lansoprazole, paracetamol, sterculia urens gum (NORMACOL), sodium chloride , nefopam hydrochloride , retinol (VITAMINE A DULCIS), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL). The patient previously received a flu vaccine on 28Oct2020. The 99-year-old patient, resident in a long-term care unit since the end of Jul2016. The patient experienced aspiration pneumonia on 12Jan2021 and resulted in death on 14Jan2021. History of the disease: From the end of Aug2020 to mid-Sep2020: occurrence of fluctuating episodes of bronchial congestion and probable iterative swallowing the wrong way. On 22Aug2020, the patient presents a slightly oily cough (usual). We suspect a misdirection in swallowing. Pulmonary auscultation is free of any obstacle. Weekend of 12-13Sept2020, new episode of misdirection swallowing. On 14Sep2020, lung auscultation is free of any obstacle and symmetrical. The patient presents no fever. Implementation of chopped feed. 28Oct2020: the patient gets a flu vaccination (without specification of specialty/batch number). No notion of poor tolerance of vaccination. In Dec2020, the patient suffered multiple episodes of complicated falls from a few superficial wounds. On 06Jan2021, the patient cannot eat anything despite the chopped diet. Switch to a blended diet. On 08Jan2021 in the morning, the patient is tired (without further detail), does not present any infectious sign. At 3 p.m., vaccination against COVID19, 1st dose of COMIRNATY injected in the left arm. No particular incident. Pre-vaccination consultation carried out with informed information consent from the patient''s family and obtaining their consent. No symptomatic COVID infection in the previous 3 months. No contact with a symptomatic patient. On 09Jan2021, the patient is still tired, she still has her usual greasy cough. There is no noise added to the auscultation, but there are small thoracic amplifications. A skin fold is objectified, as well as dryness of the tongue. Routine biochemistry shows hypernatremia (151 mM), hypokalemia (2.78 mM) and C-reactive protein at 247 mg/L. The COVID PCR is negative. Diagnosis of biological infectious syndrome associated with dehydration in favor of lung infection on known swallowing disorders. Initiation of G5 percent hydration, administration of ceftriaxone and increase of DIFFU-K. On 10Jan2021 in the morning, the patient is wide awake, tired. She continues to show signs of dehydration. She does not have any obvious respiratory congestion. A greasy cough is still present. On 11Jan2021 in the morning, the patient is asthenic. Pulmonary auscultation is difficult, there is no obvious obstruction, the belly and calves are flexible. Increase of hydration. Introduction of sodium bicarbonate mouth care and preventive heparin therapy. On 12Jan2021 in the morning, the patient presents a metabolic dyspnea with mottling on the lower limbs, as well as a clear focus of left base pneumopathy on auscultation. She is reactive and moans at times. She seems uncomfortable. Initiation of morphine in syringe pump 0.1 mg/h for analgesic and eupnemising purposes. Around 3 :00 p.m., the doctor decided to increase the morphine syringe pump to 0.2 mg/hour because in the early afternoon the patient was uncomfortable and congested. Scopolamine is also administered. Some time later, the patient is at peace and does not present any perceptible congestion. Hydration is lowered (500 ml instead of 1L). On 13Jan2021 in the morning, the patient''s state of consciousness is altered. She has no reactions, presents a polypnea at 34 c/m without any sign of clogging. Saturation O2 at 1L 82-85percent. Increase oxygen flow to 2L. The patient moans and does not seem comfortable, therefore increase of morphine doses to 0.4 mg/h. Around 2:00 p.m., the patient is uncomfortable during treatment. She is anxious, which justifies a prescription of midazolam. On 14Jan2021 at 05:23 a.m., the patient died. Estimated time of death at 05:00 a.m., patient calm at death and pain-free. Evolution: lethal. Conclusion: 99-year-old patient, hypertensive, prone to swallowing disorders and fatty cough, having presented with swallowing pneumonia at Day 4 following the anti-COVID19 vaccination by COMIRNATY progressing to death on Day 6 of vaccination. Aspiration pneumonia in a 99 year-old female with history of swallowing and coughing disorders, 4 days after a COVID vaccination with COVID-19 mRNA Vaccine COMIRNATY. Outcome : death. Imputability (according to the Method) : I1 (dubious). PRIVACY Imputability without prejudice to the elements of investigation that could be carried out within the framework of legal or amicable compensation procedures. Treatment was received for the event. The patient died on 14Jan2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Aspiration pneumonia


VAERS ID: 1014960 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-17
   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 EJ6788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Bronchopneumopathy, Dehydration, General physical health deterioration, Heart rate, Oxygen saturation, Urine analysis, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALFUZOSIN HYDROCHLORIDE; DUTASTERIDE; DIFFU K; TRAMADOL; MIRTAZAPINE; ELIQUIS; FUROSEMIDE; SERESTA; FOLIC ACID; THERALENE; CERIS; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib (complete arrhythmia due to atrial fibrillation); Anaemia; Benign prostatic hyperplasia; Bladder distension (Hospitalization for bladder in November 2020 with placement of an indwelling catheter.); Carcinoma bladder; Cardiomyopathy (nonobstructive cardiomyopathy (CMNO)); Depression; Infarct myocardial; Pulmonary arterial hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210118; Test Name: BP; Result Unstructured Data: Test Result:12/7; Test Date: 20210118; Test Name: TA; Result Unstructured Data: Test Result:135/68 mmHg; Comments: at 3 p.m.; Test Date: 20210118; Test Name: TA; Result Unstructured Data: Test Result:150/82 mmHg; Comments: at 7 p.m.; Test Date: 20210118; Test Name: temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: at 3 p.m; Test Date: 20210118; Test Name: temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: at 7 p.m; Test Name: bilateral bronchopneumopathy; Result Unstructured Data: Test Result:unknown result; Test Date: 20210118; Test Name: Pulse; Result Unstructured Data: Test Result:94 bpm; Comments: at 3 p.m.; Test Date: 20210118; Test Name: Pulse; Result Unstructured Data: Test Result:111; Comments: at 7 p.m; Test Date: 20210118; Test Name: saturation; Test Result: 95 %; Test Date: 20210118; Test Name: saturation; Test Result: 96 %; Comments: at 3 p.m.; Test Date: 20210118; Test Name: saturation; Test Result: 98 %; Comments: at 7 p.m.; Test Date: 20210118; Test Name: Urinary biology; Result Unstructured Data: Test Result:races of ketone bodies, negative glycosuria,; Comments: leukocyturia at 500 GB / ?l, nitrites +, pH 8.5, proteinuria, hematuria.
CDC Split Type: FRPFIZER INC2021103868

Write-up: ALTERATION OF THE GENERAL CONDITION; SIGNS OF DEHYDRATION; Emesis; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Medicines Agency (MA) FR-AFSSAPS-NY20210114 and received via Regulatory Authority (AFSSAPS). 94 year old male. ATCD: carcinoma of the bladder, ACFA (complete arrhythmia due to atrial fibrillation), depression, anemia, benign prostatic hypertrophy. Other antecedents mentioned in the hospitalization report: nonobstructive cardiomyopathy (CMNO), MI (myocardial infarction?), pulmonary arterial hypertension (PAH). Hospitalization for bladder in November 2020 with placement of an indwelling catheter. No history of COVID disease (test every 2 weeks). Patient not communicating. Usual treatment: folic acid, alfuzosin, DIFFU K 600 (1-0-1), dutasteride 0.5 mg (1-0-0), ELIQUIS 5 mg (1-0-0), furosemide 20 mg (1-0-0), paracetamol, tramadol 50 mg (0-0-0-1), CERIS 20 (0-0-1), mirtazapine 15 (0-0-2), SERESTA 10 (0-0-1), THERALENE drops ( 0-0-15) On 15Jan2021, morning, vaccination with bnt162b2 (COMIRNATY) batch (EJ6788) (no further details available). On 17Jan2021, the patient seemed to be doing quite well, but the staff learned from his daughter (to whom he confided) that he had vomited in the morning. In the evening, vomiting again, but the patient is reactive, as usual. On the morning of 18Jan2021, the staff noticed that he was less reactive. At the end of the morning he is asleep. Around 1:30 p.m., he is awake but he is not very responsive and has his ''eyes in the void''. The constants are good (BP 12/7 FC 80, 95% saturation, no fever). He was transferred to the emergency room for reasons of deterioration in his general condition (mention ''sent for end of life''). On admission, no sign of respiratory distress but a few pauses in breathing during the examination, tongue rotie, skin dryness with skin folds, urinary catheter indwelling, abdomen sensitive but defenseless. Hydroaeric noise. Urinary biology: traces of ketone bodies, negative glycosuria, leukocyturia at 500 GB / ?l, nitrites +, pH 8.5, proteinuria, hematuria. 800 ml diuresis. Dextro 1.63 g / L; VAS 0 (but patient not communicating). Pulse 94 bpm at 3 p.m. and 111 at 7 p.m. Sat O2 96% at 3 p.m. and 98% at 7 p.m., TA 135/68 mmHg at 3 p.m. and 150/82 at 7 p.m. temperature 36.3 ? C at 3 p.m. and 7 p.m. No element for an infectious trigger except a positive BU on an indwelling urinary catheter, without infectious or inflammatory syndrome. Mention of a bronchial congestion and a bilateral bronchopneumopathy. Management by rehydration and oxygen therapy. Request not to do aggressive therapy or resuscitation, request for deep sedation. Patient put on HYPNOVEL and morphine. Death on 20Jan2021 at 1:25 am. Conclusion: 94-year-old man who presents with vomiting and a deterioration of his general condition with dehydration, two days after vaccination with COMIRNATY. End of life and death coverage 3 days later. General physical health deterioration, dehydration and vomiting leading to hospitalization in a 94-year-old man 2 days after COVID-19 vaccination with COMIRNATY (batch EJ6788). Outcome: patient died 3 days later. Imputability (according to the French Method): I1 (dubious) for COMIRNATY N.B. Accountability without prejudice to the elements of investigation that could be carried out within the framework of legal or amicable compensation procedures. Therapy 1985; 40: 111-8 No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1014961 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-25
   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 EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Anaemia; COPD; COVID-19; Lower limb fracture; Stricture of artery (tight calcified aortic stenosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021109893

Write-up: Sudden death unexplained; The declarant mentions a probable death due to a rhythm disorder; Feeling sick; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-NY20210159 and received via Regulatory Authority . A 96-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot/batch EJ6788), intramuscularly in the left arm on 18Jan2021 at single dose for covid-19 immunisation. The patient was with a history of ACFA - complete arrhythmia due to atrial fibrillation (not anticoagulated because of anemia but the patient refuses the transfusion), COPD (Chronic obstructive pulmonary disease), tight RAC (calcified aortic stenosis) and impotence in walking following a fracture of the lower limb. In Apr2020, the patient presented with a COVID-19 infection, paucisymptomatic, discovered on borderline oxygen saturation (not documented), not requiring oxygen therapy. Since this infection, oxygen saturation has been around 90%. The patient''s concomitant medications were not reported. On 18Jan2021, first injection of the COMIRNATY vaccine (lot EJ6788) in the left arm. SaO2 before injection is between 88 and 90% for a usual value around 90%. Note a general condition preserved during the pre-vaccination consultation on 12Jan2021. Presence of OMI for ten days. No immediate side effect, good tolerance. On 25Jan2021, a few minutes after reporting a feeling of discomfort, the patient died. The declarant mentions a probable death due to a rhythm disorder or sudden death. Conclusion: 96-year-old patient with a history of ACFA (not anticoagulated because of anemia with refusal of transfusion), COPD, tight RAC, died 7 days after receiving a first injection of the COMIRNATY vaccine (batch EJ6788). Feeling unwell a few minutes earlier. Notion of IMO for ten days. Malaise, sudden death in a 96 yr-old woman 7 days after a COVID-19 vaccination with COMIRNATY (batch EJ6788). Outcome: patient died. Imputability : I1 (dubious) for COMIRNATY. NB: Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained; The declarant mentions a probable death due to a rhythm disorder; Feeling sick


VAERS ID: 1014964 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-24
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: LASILIX [FUROSEMIDE]; ELIQUIS; KARDEGIC; LIPTRUZET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary arterial stent insertion; CPAP; Hypertension arterial; Permanent cardiac pacemaker insertion; Sleep apnea syndrome (treated with CPAP); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: ejection fraction; Test Result: 50 %
CDC Split Type: FRPFIZER INC2021103886

Write-up: fell backwards; cardiac arrest; Sudden death; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from the regulatory authority-WEB FR-AFSSAPS-RN20210199. A 72-year-old male patient received bnt162b2 (COMIRNATY, lot EM0477), intramuscular in the right arm on 12Jan2021 21:00 at first single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension arterial, sleep apnea syndrome treated with continuous positive airway pressure (CPAP), arteriogram coronary with stent placement, permanent cardiac pacemaker insertion in May2020, dyspnea from Sep2020. The patient has no history of Covid or any test performed. The patient has no known allergy. The patient''s concomitant medications included furosemide (LASILIX), apixaban (ELIQUIS), acetylsalicylate lysine (KARDEGIC) and atorvastatin calcium, ezetimibe (LIPTRUZET) as well as anti-diabetic treatment (specialty not specified). The patient experienced sudden death on 24Jan2021. Event description: On 20Jan2021, the patient had a consultation (previously planned) who found dyspnea (already present in Sep2020), but no chest pain with an ejection fraction preserved at 50%. On 24Jan2021, around 8 p.m., the patient fell backwards, with the observation of a relaxation of the sphincters. The patient went into cardiac arrest having benefited from an immediate cardiac massage by the wife, then a relay by the rescue team, with a CPR of approximately one hour. The patient died on 24Jan2021. An autopsy was not performed.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1014966 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
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 EM0477 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: Exposure to SARS-CoV-2
Preexisting Conditions: Medical History/Concurrent Conditions: Deglutition disorder; Disease Parkinson''s; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: fever; Result Unstructured Data: Test Result:38.6 Centigrade
CDC Split Type: FRPFIZER INC2021103877

Write-up: Fever; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB FR-AFSSAPS-RS20210075. This is a report received from the Regulatory Authority. A 71-years-old female patient received bnt162b2 (COMIRNATY, lot EM0477), via intramuscular in the left arm on 19Jan2021 at first single dose for covid-19 immunisation. Medical history included hypertension, Parkinson s disease with swallowing disorders, exposure to SARS-CoV-2 from 17Jan2021 and ongoing. The patient''s concomitant medications were not reported. The patient was living in residential care home. Sunday 24Jan2021 morning: onset of fever at 38.6 Celsius. A nurse administered a dose of DOLIPRANE. Patient found dead 4 hours after the onset of fever. Very little medical information available regarding this case despite documentation from the reporting physician. The patient did not see any doctor between Tuesday and Sunday so no medical observations available in the meantime. It should be noted that on Sunday 17Jan2021, an interim nurse intervened in the patient''s residential care home sector (she provided close care to the patient). On 22Jan2021, this nurse tested positive for COVID19. All patients in the residential care homes sector. where it intervened on 17Jan2021 were therefore tested on 25Jan2021. Patient died on this date therefore not tested. Test results pending. Patient''s death certificate not available. It was unknown if autopsy was performed.; Reported Cause(s) of Death: fever


VAERS ID: 1014969 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-11
   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 EM0477 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, General physical health deterioration, Pyrexia, SARS-CoV-1 test
SMQs:, 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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   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: ROCEPHINE; LASILIX FAIBLE; DIFFU K
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Heart failure
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Test Date: 20210117; Test Name: body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Comments: morning; Test Date: 202101; Test Name: SARS-CoV-1 test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021095050

Write-up: Fever; Diarrhea; Reduced general condition; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) FR-AFSSAPS-TO20210225 and received via Regulatory Authority (AFSSAPS). A 96-years-old female patient received first dose of bnt162b2 (COMIRNATY, lot# EM0477), intramuscular on 08Jan2021 at SINGLE DOSE on right deltoid for covid-19 immunisation. Medical history included Dementia Alzheimer''s type, Heart failure, both from an unknown date and unknown if ongoing. Concomitant medication included ceftriaxone sodium (ROCEPHINE, Powder for solution for injection, 1g) since 12Jan2021 to 13Jan2021 for diarrhea, furosemide (LASILIX FAIBLE Tablet 20mg) from an unknown date and stopped on 14Jan2021, potassium chloride (DIFFU K capsule) stopped on 14Jan2021. Vaccine: tozinameran. The patient experienced fever on 13Jan2021, diarrhea on 11Jan2021, reduced general condition on 11Jan2021. For diarrhea, treatment included prescription of ROCEPHINE / ceftriaxone and rehydration. The patient underwent lab tests and procedures which included body temperature: 38.2 centigrade on 13Jan2021, body temperature: 38.9 centigrade on 17Jan2021 morning, sars-cov-1 test: negative on Jan2021. EVOLUTION: Death recorded on 17Jan2021. The event outcome was fatal. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fever; Diarrhea; Reduced general condition


VAERS ID: 1014970 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-24
   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 EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: CERIS; PARACETAMOL CODEINE; LEVOTHYROX; TRANSIPEG [MACROGOL]; PARACETAMOL; SERESTA; LOXAPAC [LOXAPINE]; GABAPENTIN; TETRABENAZINE; ZYMAD; IMOVANE; MIANSERINE [MIANSERIN]
Current Illness: Huntington''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021109933

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority R-AFSSAPS-TO20210247. A 69-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY, Lot # EJ6788) intramuscular at single dose at left arm on 18Jan2021 for covid-19 immunisation. Medical history included ongoing Huntington''s disease, resident not considered at the end of life. Concomitant medication included trospium chloride (CERIS) 20 mg, 1x/day, codeine phosphate, paracetamol (manufacturer unknown) oral 1 DF, 2x/day, levothyroxine sodium (manufacturer unknown) oral 25ug 1x/day, macrogol (TRANSIPEG) oral 1 sachet/day, paracetamol (manufacturer unknown) oral 500 mg, 4x/day (2/1/1), oxazepam (SERESTA 50mg) oral 100 mg, 1x/day (0.5DF/0.5 DF/1DF), loxapine (LOXAPAC, drops) oral 25 drop, 2x/day, gabapentin (GABAPENTIN, 100mg) oral 200 mg, 3x/day, tetrabenazine (manufacturer unknown) oral 2 DF, daily (0.5/0.5/1), colecalciferol (ZYMA D, 80,000u) oral d 80,000u every 2 months, zopiclone (IMOVANE, 3.75 mg) oral 3.75 mg, 1x/day, mianserine (manufacturer unknown, 30mg) oral 60 mg, 1x/day. The patient experienced cardiac arrest on 24Jan2021, 6 days after vaccination and died on 24Jan2021. On 24Jan2021 the patient ate lunch normally. At 10:35 am, call for medical aid for discomfort. On arrival , patient in cardio respiratory arrest. Urgent medical aid service call and cardiac massage started at 10:40 am. Arrival of the fire brigade at 11:10 a.m. End of resuscitation at 11:20 a.m. An autopsy was not performed.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1014971 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-28
   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 EJ6788 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Crohn''s disease; Diabetes mellitus insulin-dependent; Dysfunction thyroid
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021109938

Write-up: Emesis; General physical health deterioration; This is a spontaneous report from a contactable Physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-TO20210267. This is a report received from the Regulatory Authority. An 85-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, Lot/batch # EJ6788) intramuscular at single dose at left arm on 26Jan2021 for covid-19 immunisation. Medical history included Crohn''s disease, dysthyroidism, diabetes under insulin, Alzheimer''s disease. The patient''s concomitant medications were not reported. The patient experienced emesis and general physical health deterioration on 28Jan2021. The events vomiting and deterioration of general condition, involved the vital prognosis and were considered serious as life threatening with outcome death. The patient died on 28Jan2021. An autopsy was not performed.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1014972 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-20
   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: Blood creatinine, Blood potassium, Blood sodium, C-reactive protein, Dehydration, Malaise, Presyncope, Renal failure, Troponin, Urinary tract infection, Urine analysis, Urosepsis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), 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), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Breast cancer; Cardiac arrhythmia; CVA; Hypertension; Hypothyroidism; Ischemic heart disease; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: serum creatinine; Result Unstructured Data: Test Result:605 umol/l; Test Date: 20210123; Test Name: serum potassium; Result Unstructured Data: Test Result:10 mmol/L; Test Date: 20210123; Test Name: natremia; Result Unstructured Data: Test Result:157 mmol/L; Test Date: 20210123; Test Name: CRP; Result Unstructured Data: Test Result:58 mg/l; Test Date: 20210123; Test Name: troponin; Result Unstructured Data: Test Result:1940 ng/L; Test Date: 20210123; Test Name: urine; Result Unstructured Data: Test Result:culture of Escherichia coli; Test Date: 20210123; Test Name: leukocytes; Result Unstructured Data: Test Result:28,000 / mm?
CDC Split Type: FRPFIZER INC2021095046

Write-up: Urosepsis; Feeling sick; urinary infection; functional renal insufficiency progressing; Dehydration; Vagal discomfort; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-TS20210073. A 91-years-old female patient received the first dose bnt162b2 (COMIRNATY) , intramuscular on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation, cerebrovascular accident, cardiac arrhythmia, hypertension, ischemic heart disease, hypothyroidism, history of stroke, breast cancer. The patient''s concomitant medications were not reported. Consultation on 20Jan2021: no major dehydration. That day received an injection of Comirnaty vaccine. Vagal discomfort during the course of the injection, which resolves quickly after the patient has been lied down with her legs raised. The following days, continuation of the deterioration of the general condition, without fever. Dehydration. Initiation of a subcutaneous hydration infusion on 22Jan2021. 23Jan2021, marbling and desaturation (unspecified) resulting in transfer to the emergency department. Gasping during the transfer. Cardio-respiratory arrest on arrival at the emergency room. Subsequently, etiology was under investigation. Post-mortem biology (2 hours after death): urine (peas), culture of Escherichia coli, leukocytes 28,000 / mm?, CRP 58 mg / l, serum creatinine 605 ?mol / l, natremia 157 mmol / l, serum potassium 10 mmol / l, troponin 1940 ng / l. The clinician of the emergency department first carried out the process of declaration, then, after interview with the Agency about the clinical state of the patient in previous days and in view of the results of the investigation concluded urinary infection leading to probable sepsis with major dehydration and functional renal insufficiency progressing slowly It is considers that it is not a priori related to the vaccination. The patient had Urosepsis and Feeling sick on 23Jan2021. In total, an increase in a pre-existing deterioration in general condition in the days following a 1st vaccination with Comirnaty followed by malaise with desaturation then death on the 3rd day. Probable urinary infection leading to probable sepsis with major dehydration and renal failure. The patient died on 23Jan2021. The outcome of event Vagal discomfort was recovered on 20Jan2021; outcome of other events was fatal. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events of urosepsis, UTI, malaise, dehydration and renal failure. These reported events likely represent intercurrent medical conditions. Based on available information, a possible contributory role of subject product cannot be excluded for the reported event of vagal reaction, based on temporal relationship. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Feeling sick; Dehydration; urinary infection; functional renal insufficiency progressing; Urosepsis


VAERS ID: 1014992 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
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 EL0739 / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEZAFIBRATE; ENTACAPONE; FERROUS FUMARATE; MADOPAR; OMEPRAZOLE; RASAGILINE
Current Illness: Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021111033

Write-up: Sudden death; headache; felt unwell; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-APPCOVID-20210202131537. The Safety Report Unique Identifier is GB-MHRA-ADR 24685323. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0739) on 28Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing Parkinson''s disease. Date of LMP was 02Feb1991. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication included bezafibrate, entacapone, ferrous fumarate, benserazide hydrochloride, levodopa (MADOPAR), omeprazole, rasagiline. It was reported death/sudden death on unspecified date. Also reported patient had a bad headache, felt unwell, died overnight while in bed. It was unknown if autopsy was done. Serious criteria is life threatening. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1015440 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-10
   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: Autopsy, Death, Decreased appetite, Discomfort, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE; MODURETIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: post-mortem; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC2021100567

Write-up: Death; Ache; loss of appetite; body heaviness; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number is GB-MHRA-WEBCOVID-202101280909464820, Safety Report Unique Identifier GB-MHRA-ADR 24661327. An 83-year-old female patient received BNT162B2, via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date. Concomitant medication included levothyroxine and amiloride hydrochloride, hydrochlorothiazide (MODURETIC) from 2021 for Hypertension. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Immediately the day after the vaccine was administered, on 10Jan2021 the patient suffered from body heaviness and aches and loss of appetite. After complaining to her GP (general practitioner), she was told it was a side effect to the vaccine. The day after talking to her GP she died, on 14Jan2021. The cause of death was reported as Death unexplained. The events body heaviness, aches, loss of appetite and death were reported as serious with seriousness criterion Medically significant. The outcome of events body heaviness and aches and loss of appetite was not recovered. Patient has not tested positive for COVID-19 since having the vaccine. Post Mortem was ongoing. No follow-up attempts are possible; information about lot/batch number cannot be obtained; No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1015442 (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: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: ATORVASTATIN; CO-DYDRAMOL; FUROSEMIDE; LEVOTHYROXINE; OMEPRAZOL; RAMIPRIL; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Blood cholesterol increased; Hypertension; Pain; Comments: Had jab 7 days bilious vomiting since 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 INC2021101139

Write-up: Death unexplained; Vomiting; This is a spontaneous report received from a contactable physician, by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101291411544480 and Safety Report Unique Identifier GB-MHRA-ADR 24667412. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history included blood cholesterol increased, pain, hypertension, atrial fibrillation. Concomitant medication included atorvastatin for blood cholesterol increased, dihydrocodeine bitartrate, paracetamol (CO-DYDRAMOL) for pain, furosemide for hypertension, levothyroxine, omeprazole (OMEPRAZOL), ramipril, warfarin for atrial fibrillation. The patient experienced vomiting/ 7 days bilious vomiting from 23Jan2021, she had lessened in frequency now but still occurring with outcome of not recovered, and death unexplained with outcome of fatal. Patient had died in hospital on 31Jan2021. It was not reported if an autopsy was performed. The cause of death was unknown. 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: Death unexplained


VAERS ID: 1015443 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
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 NOT KNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021101030

Write-up: Death; This is a spontaneous report from a contactable consumer. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101311913496710, Safety Report Unique Identifier GB-MHRA-ADR 24674079. A patient of unspecified age and gender received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number not known) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in clinical trial. The patient''s medical history and concomitant medications were not reported. The patient died on 01Jan2021. It was not reported if an autopsy was performed. The patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts possible; information regarding batch/lot cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1015445 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
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: Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Comments: Hypertension 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 INC2021105269

Write-up: hypertension; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202101312228028800, Safety Report Unique Identifier GB-MHRA-ADR 24674273. A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. The patient was died on 14Jan2021. Cause of death on post-mortem was ruled as hypertension however GP found it difficult to come to conclusion on this, and the patient on medication for this. Despite this patient was in good health and death was unexpected. It was reported an autopsy was done. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. No signs of Covid seen in patient. No COVID -19 on post-mortem. No follow-up attempts possible; information regarding batch/lot cannot be obtained.; Reported Cause(s) of Death: hypertension


VAERS ID: 1015449 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-22
   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 EL0739 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, Incontinence, Muscular weakness
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; COPD; Heart failure; IHD
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021105479

Write-up: leg weakness; incontinence; cardiac arrest; Chest pain; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102011235560550, Safety Report Unique Identifier GB-MHRA-ADR 24677973. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0739), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient medical history included IHD, AF, Heart failure and copd. 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 chest pain on 22Jan2021 several minutes after vaccine lasting 5 minutes. Then went home but developed leg weakness and incontinence that persisted. Died of presumed cardiac arrest when ambulance called 26Jan2021. Patient has not tested positive for COVID-19 since having the vaccine. The events were reported as non-serious. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1015450 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-11
   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: Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021105730

Write-up: Paralysed; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authoriy. Regulatory authority report number GB-MHRA-WEBCOVID-202102011343357260, Safety Report Unique Identifier GB-MHRA-ADR 24681458. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # unknown), via an unspecified route of administration at single dose on 10Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced paralysed (paralysis) on 11Jan2021. The patient died on 12Jan2021. It was not reported if an autopsy was performed. Seriousness criteria of the event was reported as serious due to life threatening and death. The patient had not been tested for COVID-19 since the vaccination. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: Paralysed


VAERS ID: 1015452 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   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 EL0739 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARVEDILOL; CITALOPRAM; GLYCEROL SUPPOSITORIES; INSPRA; LAXIDO; PEPPERMINT OIL [MENTHA X PIPERITA OIL]; PERINDOPRIL; PRUCALOPRIDE; PYRIDOSTIGMINE BROMIDE; SENNA [SENNA ALEXANDRINA]; SIMETICONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation chronic; Depression; Duchenne muscular dystrophy; Left ventricular dysfunction; Mechanical ventilation; Wheelchair user; Comments: Had duchenne muscular dystrophy, on mechanical ventilation, cardiomyopathy, impaired left ventricular function, wheelchair user. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021105690

Write-up: cardiac arrest; sepsis; respiratory arrest; Death; This is a spontaneous report from a contactable physician received from the Regulatory authority report number GB-MHRA-WEBCOVID-202102011352252170, Safety Report Unique Identifier GB-MHRA-ADR 24679056. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0739), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. The patient medical history included mechanical ventilation, Duchenne muscular dystrophy, impaired left ventricular function, wheelchair user, depression and constipation chronic, all from an unknown date and unknown if ongoing. The patient concomitant medication included carvedilol, eplerenone (INSPRA) and perindopril, each for left ventricular dysfunction; citalopram for depression; glycerol/sodium chloride/sodium hydroxide/stearic acid (GLYCEROL SUPPOSITORIES), macrogol 3350/potassium chloride/sodium bicarbonate/sodium chloride (LAXIDO), senna alexandrina and prucalopride, each for constipation; peppermint oil; pyridostigmine bromide for Duchenne muscular dystrophy and simeticone. The patient experienced cardiac arrest, sepsis, respiratory arrest, all on an unspecified date. The patient died on 30Jan2021. It was not reported if an autopsy was performed. It was reported that all events were unlikely linked to vaccination, more likely just unfortunate set of circumstances. The patient did not have a COVID-19 test. Unsure if patient was enrolled in clinical trial. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1015454 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Diarrhoea, Fall, Hypopnoea, Illness, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   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: Breast cancer; Chemotherapy; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021105851

Write-up: fall; Death; shallow breathing; diarrhoea; sickness; weakness; This is a spontaneous report from a contactable pharmacist via the Regulatory Authority. The Regulatory Authority report number is GB-MHRA-WEBCOVID-202102011605180430, Safety Report Unique Identifier GB-MHRA-ADR 24680000. An 80-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EJ1688), via an unspecified route of administration, on 07Jan2021, at single dose, for COVID-19 immunisation. Medical history included neoplasm (recently had treatment for cancer), leukaemia or lymphoma (radiotherapy or chemotherapy), pulmonary embolism, breast cancer, chemotherapy from 30Dec2020 to an unknown date. Concomitant medications were not reported. The patient previously took dalteparin. The patient experienced death on 12Jan2021, diarrhoea on 11Jan2021 with outcome of unknown, sickness on 11Jan2021 with outcome of unknown, shallow breathing on 12Jan2021, weakness on 10Jan2021 with outcome of unknown, fall on 12Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative in Jan2021. It was unknown if an autopsy was performed. The events were considered serious as per life threatening. Clinical course: patient felt weak on 10Jan2021, sickness and diarrhoea on 11Jan2021, shallow breathing and fall leading to death on 12Jan2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death; shallow breathing; fall


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