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From the 9/17/2021 release of VAERS data:

Found 15,386 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1048277 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Atrial fibrillation, Blood pressure measurement, Body temperature, Chest X-ray, Chest pain, Dyspnoea, Hypoxia, Pneumonia, Pulmonary oedema, Respiratory acidosis, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OCULAC [POVIDONE]; BETOLVEX [CYANOCOBALAMIN]; PROPRANOLOL HYDROCHLORIDE; BETASERC; HJERDYL; KALEORID; CITALOPRAM STADA; TRADOLAN; GABAPENTIN STADA; PANTOPRAZOLE TEVA; MAGNESIUMHYDROXIDE; NITROLINGUAL; GANGIDEN; ALLOPURINOL; KALEORID; DIURAL
Current Illness: Cardiac insufficiency (Terminal cardiac insufficiency)
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis gouty; Cardiac disorder; Constipation; Depression; Dry eyes; Dyspnoea (Sees physician due to dyspnoea two days before second vaccination, afebrile and normal bp); Esophageal acid reflux; Meniere''s disease; Neuropathic pain; Pain; Tremor; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: Blood pressure; Result Unstructured Data: Test Result:Normal; Comments: Normal; Test Date: 20210129; Test Name: Body temperature; Result Unstructured Data: Test Result:Afebrile; Test Date: 20210201; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Possible pneumonia or pulmonary edema
CDC Split Type: DKPFIZER INC2021163659

Write-up: New case of atrial fibrillation; Acute respiratory decompensation; Respiratory insufficiency; pneumonia; pulmonary edema; Hospitalised due to sudden onset of central chest pain; Hospitalised due to sudden onset of dyspneoea; Increasing hypoxia during hospitalisation; increasing respiratory acidosis during hospitalisation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (DK-DKMA-WBS-0032508). A 92-year-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot number: EK9788; Expiration date: 31May2021), via an unspecified route of administration, on 31Jan2021 at a single dose for COVID-19 immunisation. Medical history included ongoing cardiac insufficiency (terminal cardiac insufficiency), non-ongoing dyspnoea from 29Jan2021 to an unspecified date (sees physician due to dyspnoea two days before second vaccination, afebrile and normal blood pressure (BP)), arthritis gouty, Meniere''s disease, depression, neuropathic pain, neuropathic pain, constipation, cardiac disorder, dry eyes, esophageal acid reflux, tremor, vitamin B12 deficiency, and pain. Concomitant medications included povidone (OCULAC) taken for dry eyes from 17Mar2020, cyanocobalamin (BETOLVEX) taken for vitamin B12 deficiency from 12Jun2020, propranolol hydrochloride (MANUFACTURER UNKNOWN) taken for tremor from 21Feb2020, betahistine hydrochloride (BETASERC) taken for Meniere''s disease from 17May2017, acetylsalicylic acid (HJERDYL) taken for anticoagulant therapy from 16Aug2007, potassium chloride (KALEORID) taken for potassium supplementation from 11Aug2020, citalopram hydrobromide (MANUFACTURED BY: STADA) taken for depression from 03Aug2017, tramadol hydrochloride (TRADOLAN) taken for pain from 10Nov2020, gabapentin (MANUFACTURED BY: STADA) taken for neuropathic pain from 25Apr2017, pantoprazole sodium sesquihydrate (MANUFACTURED BY: TEVA) taken for esophageal acid reflux from 28Mar2017, magnesium hydroxide (MANUFACTURER UNKNOWN) taken for constipation from 18Aug2020, glyceryl trinitrate (NITROLINGUAL) taken for cardiac disorder from 31Oct2020, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (GANGIDEN) taken for constipation from 19Jan2020, allopurinol (MANUFACTURER UNKNOWN) taken for arthritis gouty from 10Jun2020, potassium chloride (KALEORID) taken for potassium supplementation from 11Aug2020, furosemide (DIURAL) taken for diuretic therapy from 04Oct2019, lidocaine hydrochloride (XYLOCAIN) taken for itch from 20Nov2020, diphenhydramine hydrochloride (reported as: acrivastine; BENADRYL) taken for itch from 21Dec2020, oxazepam (OXAPAX) taken for sedative therapy from 11Nov2020, furosemide (FURIX) taken for diuretic therapy from 31Oct2020, and paracetamol (PINEX) taken for pain from 23May2016. The patient previously received the first dose of BNT162B2 (COMIRNATY; Lot number: EM0477) on 07Jan2021 for COVID-19 immunisation and experienced possible dyspnea. The patient experienced new case of atrial fibrillation, acute respiratory decompensation, and respiratory insufficiency on 01Feb2021, which were reported as fatal. The patient was also hospitalised due to sudden onset of central chest pain, hospitalised due to sudden onset of dyspneoea, increasing hypoxia during hospitalisation, and increasing respiratory acidosis during hospitalisation on 01Feb2021. It was also reported that the patient experienced pneumonia and pulmonary edema on 01Feb2021 as reported that: possible as seen on x-ray when hospitalized and possible cause of death. All of the events caused hospitalization. The patient underwent lab tests and procedures which included blood pressure: normal on 29Jan2021, body temperature: afebrile on 29Jan2021, and thorax x-ray: possible pneumonia or pulmonary edema on 01Feb2021. No treatment due to the events was reported. The clinical outcome of new case of atrial fibrillation, acute respiratory decompensation, respiratory insufficiency, pneumonia, and pulmonary edema was fatal; hospitalised due to sudden onset of central chest pain and hospitalised due to sudden onset of dyspneoea were unknown; and of increasing hypoxia during hospitalisation and increasing respiratory acidosis during hospitalization was not recovered. The patient died on 02Feb2021. The cause of death was reported as respiratory insufficiency, pneumonia, atrial fibrillation, acute respiratory decompensation, and pulmonary edema. An autopsy was not performed. The causality was reported as: the physician states that due to the timing, they are reporting the adverse drug reactions on the Comirnaty vaccine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: pulmonary edema; Respiratory insufficiency; Pneumonia; Atrial fibrillation; Acute respiratory decompensation


VAERS ID: 1048279 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021158473

Write-up: Oxygen saturation decreased; This is a spontaneous report from a contactable consumer reporting different events for the same patient, downloaded from the Medicines Agency (MA) -WEB and received via Regulatory Authority ES-AEMPS-735202. An elderly male patient received 2nd dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 29Dec2020 for covid-19 immunisation, days later he was positive for COVID-19. The patient was administered the second dose on 19Jan2021, after four days oxygen desaturation was detected and he was transferred to the hospital. He dies two days later (25Jan2021). The patient''s doctor does not associate the vaccine with the fatal outcome. The patient died on 25Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain; Reported Cause(s) of Death: Oxygen saturation decreased


VAERS ID: 1048282 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-19
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 21
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: Chronic renal failure; Dementia Alzheimer''s type
Preexisting Conditions: Medical History/Concurrent Conditions: Fibrillation atrial
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive
CDC Split Type: ESPFIZER INC2021169112

Write-up: COVID-19; COVID-19; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-Web [Regulatory Authority number ES-AEMPS-746451] from a contactable consumer. A 99-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in the arm, on 05Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing chronic kidney disease, ongoing dementia Alzheimer''s type and atrial fibrillation. Concomitant medications were not reported. The patient experienced COVID-19 on 19Jan2021. The patient presented symptoms and was hospitalized due to the event from 01Feb2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 19Jan2021. The patient died on 09Feb2021 due to the event. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1048283 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood immunoglobulin G, Body temperature, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Very recent and recovering Covid-19); Comments: Ha pasado la COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: Immunoglobulin G; Result Unstructured Data: Test Result:positive; Test Date: 202102; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210108; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: ESPFIZER INC2021169108

Write-up: Acute respiratory failure; This is a spontaneous report downloaded from the Regulatory Authority-WEB [Regulatory Authority number ES-AEMPS-749279] from a contactable physician. An 86-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, lot# EL8723), via an unspecified route of administration, on 04Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Jan2021 to an unknown date (very recent and recovering Covid-19) and ongoing dementia Alzheimer''s type. She was vaccinated in the COVID-19 convalescent period. Concomitant medications were not reported. The patient experienced acute respiratory failure on 05Feb2021 with fatal outcome the same day. Therapeutic measures were taken as a result of the event and included sedation. The patient underwent lab tests and procedures which included blood immunoglobulin G: positive on 28Jan2021, body temperature: 39 C in Feb2021 (at dawn from the 4th to the 5th), COVID-19 PCR test: positive on 08Jan2021. An autopsy was not performed. The reporting physician stated that the AUP just before death, right hemithorax MVC, the left crackles of liquid. The reporting physician suspected that patient''s state of high fragility due to age, associated pathologies, Alzheimer''s and due to a state of greater deterioration due to being recent and convalescing from COVID-19, have been able to contribute to the outcome by giving her the vaccine so early that it could precipitate her death given her high fragility. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute respiratory failure


VAERS ID: 1048290 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1419 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Dysphagia, Hypotonia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANADOL FORTE [PARACETAMOL]; OXYNORM; NORSPAN [BUPRENORPHINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (for years)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: fever; Result Unstructured Data: Test Result:fever
CDC Split Type: FIPFIZER INC2021159022

Write-up: Death; mild fever; swallowing worsened; muscle tone decreasead; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB FI-FIMEA-20210506. An 87-year-old female patient received first dose bnt162b2 (COMIRNATY, Solution for injection, lot number: EL1419), intramuscular on 20Jan2021 at single dose for COVID-19 vaccination. Medical history included sufferring from Alzheimer''s disease for years. Concomitant medications included paracetamol (PANADOL FORTE), oxycodone hydrochloride (OXYNORM), buprenorphine (NORSPAN). The patient experienced death on 31Jan2021. Since the beginning of Jan2021, mild fever, swallowing worsened and muscle tone decreasead. Transferred to hospice care on 29Jan2021, only painkillers were used then in the treatment. Exitus on 31Jan2021. Therapeutic measures were taken as a result of mild fever, swallowing worsened, muscle tone decreasead. The patient died on 31Jan2021. It was not reported if an autopsy was performed. The outcome of the event death was fatal. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1048291 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXANEST; FURESIS; MEMANTIN ORION; KALEORID; OXYNORM; THEOFOL; CARDACE [RAMIPRIL]; LUMIGAN; SOMAC; SPIRIVA RESPIMAT; MAREVAN; VENTOLINE [SALBUTAMOL SULFATE]; SERETIDE EVOHALER; PRIMPERAN; LEVOLAC; ZOFRAN [ONDANSETRON]; SIMVASTATIN ACTAVIS; P
Current Illness: Chronic atrial fibrillation; Chronic obstructive pulmonary disease
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Arteriosclerosis obliterans; Atrial enlargement; Cerebellar infarction; Coronary artery disease; Glaucoma; Heart valve incompetence; Hyperparathyroidism; Lung cancer NOS (In 2013 received radiotherapy for that); Meningioma; Myocardial infarction; Osteoporosis; Radiotherapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021159023

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB FI-FIMEA-20210510. An 84-year-old female patient received the first dose of bnt162b2 (COMIRNATY) via Intramuscular on 14Jan2021 at single dose (Lot # EJ6795) for covid-19 immunisation. Medical history included Alzheimer disease, ongoing chronic atrial fibrillation, Coronary artery disease, experienced myocardial infarction, ongoing Chronic obstructive pulmonary disease, difficult Arteriosclerosis obliterans, glaucoma, osteoporosis, Hyperparathyroidism and enlarged left atrium as well as leaking in mitral, tricuspid and aortic valves diagnosed by heart ultrasound. In 2011 experienced cerebellum infarction. Earlier cerebellum meningioma treated with radiotherapy. In 2010 in the left lung tumor was diagnosed. In 2013 received radiotherapy for that and declined further investigations. From time to time abundant mucosity and in January again more mucosity. No allergies. Concomitant medications included oxycodone hydrochloride (OXANEST) via intravenous as needed, furosemide (FURESIS) orally at 40 mg, daily, memantine hydrochloride (MEMANTIN ORION) orally at 10 mg, daily, potassium chloride (KALEORID) orally at 2 g, daily, oxycodone hydrochloride (OXYNORM) orally as needed, theophylline (THEOFOL) orally as needed, ramipril (CARDACE) orally at 10 mg, daily, bimatoprost (LUMIGAN) Ophthalmic at 1 drop, daily, pantoprazole sodium sesquihydrate (SOMAC) at 40 mg, daily, tiotropium bromide (SPIRIVA RESPIMAT) Resp Inhalation at 5 ug, daily, warfarin sodium (MAREVAN) orally, salbutamol sulfate (VENTOLINE) Resp Inhalation as needed, fluticasone propionate, salmeterol (SERETIDE EVOHALER) Resp Inhalation at 4 DF, daily, metoclopramide hydrochloride (PRIMPERAN) orally as needed, lactulose (LEVOLAC) orally as needed, ondansetron (ZOFRAN) orally as needed, simvastatin (SIMVASTATIN ACTAVIS) orally ay 20 mg, daily, paracetamol (PANADOL FORTE) orally as needed, zopiclone (IMOVANE) orally as needed, carbomer (OFTAGEL) Ophthalmic at 6 drop, daily, buprenorphine (NORSPAN) Transdermal, denosumab (PROLIA) 12 mg, cyclic (yearly), macrogol 4000 (PEGORION) orally 36 g, weekly. She was death on 15Jan2021. It is unknown if autopsy was done. Outcome of the event was fatal. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1048293 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Fatigue, General physical health deterioration, Heart rate increased, Hyperventilation, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade
CDC Split Type: FIPFIZER INC2021165834

Write-up: Heart rate increased; Fatigue; Dyspnoea; Respiratory arrest; General physical health deterioration; Pyrexia; heavy breathing; This is a spontaneous report from a non-contactable nurse downloaded from the Agency Regulatory Authority-WEB FI-FIMEA-20210566. A 79-year-old male patient received bnt162b2 (COMIRNATY, lot number: EJ6134), intramuscular on 26Jan2021 at single dose for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced heart rate increased, fatigue, dyspnoea, respiratory arrest, general physical health deterioration, and pyrexia on 27Jan2021. The events were reported as serious, serious criteria was fatal. The day after vaccination (27Jan2021), mild fever (37.3), fatigue, heavy breathing, occasionally high heart rate. Symptoms were being followed, as they did not seem severe. The next day (28Jan2021), in the evening, severe shortness of breath and a decrease in general condition, paramedics were called. Died when paramedics were moving him on a stretcher to the hospital, breathing stopped. The patient underwent lab tests and procedures which included body temperature: 37.3 centigrade on 27Jan2021. The patient died on 28Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Heart rate increased; Fatigue; Dyspnoea; Respiratory arrest; General physical health deterioration; Pyrexia


VAERS ID: 1048297 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Gaze palsy, Opisthotonus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dystonia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; PAMOL; MEMANTINE; MAREVAN; BISOPROLOL; NEXIUM MUPS [ESOMEPRAZOLE MAGNESIUM]; ISMOX; RISPERIDON ORION; MELATONIN; MIRTAZAPIN ORION; CALCICHEW D3 FORTE; EXELON [RIVASTIGMINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Atrial fibrillation; Behaviour disorder; Cerebral infarction; Gastrointestinal disorder prophylaxis; Hypertension; Insomnia; Pain; Sleep disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021165949

Write-up: Death; Back arched backward/stiffened back; Laboured breathing/to breathe heavily; Upward deviation of eyes; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB FI-FIMEA-20210629. A 91-year-old female patient receives the first dose of BNT162B2 (COMIRNATY, lot number: EJ6134), intramuscularly from 26Jan2021 10:26 in left upper arm, at single dose for covid-19 vaccination. Medical history included dementia Alzheimer disease, hypertension, atrial fibrillation, cerebral infarction in 2019, pain, gastrointestinal disorder prophylaxis, behaviour disorder, sleep disorder, insomnia. Concomitant medication included amlodipine from 21Jul2020 for hypertension, paracetamol (PAMOL) from 02Jun2020 for pain, memantine from 21Jul2020 for Alzheimer''s disease, warfarin sodium (MAREVAN) from 23Aug2019 for Atrial fibrillation, bisoprolol from 21Jul2020 for hypertension, esomeprazole magnesium (NEXIUM MUPS) from 29Nov2013 for gastrointestinal disorder prophylaxis, isosorbide mononitrate (ISMOX) from 21Jul2020 for hypertension, risperidone (RISPERIDON ORION) from 19Sep2019 for Behaviour disorder, melatonin from 24Oct2019 for Sleep disorder, mirtazapine (MIRTAZAPIN ORION) from 19Dec2019 for Insomnia, calcium carbonate, colecalciferol (CALCICHEW D3 FORTE) from 21Jul2020, rivastigmine (EXELON) from 21Jul2020 for Alzheimer''s disease. The patient received the vaccine at about 10:26 in the left upper arm. Vaccinated, according to the nurse supervisor and was monitored until about 12 noon, during that time, according to the records, there were no abnormalities in the health condition. According to the patient records, at about 4 p.m., during the meal, the patient began to breathe heavily/ laboured breathing, stiffened back/ back arched backward, and the gaze deviated upwards/ upward deviation of eyes. Staff took the patient to the corridor where an attempt was made to make her cough. This was not successful, an attempt was made to manually remove food or other obstacles from the mouth, but the patient teeth remained firmly closed. An ambulance was called, however, the patient went lifeless before the ambulance arrival. The patient diagnosed as dead at 4.15 pm by the first aid. A colleague also certified the patient at 19.25 as dead. The patient died on 26Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Upward deviation of eyes; Death; Back arched backward/stiffened back; Laboured breathing/to breathe heavily


VAERS ID: 1048298 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, General physical health deterioration, Pneumonia aspiration
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 10
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: Alzheimer''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021165950

Write-up: confusion; Pneumonia aspiration; General physical health deterioration; This is a spontaneous report from a non-contactable nurse downloaded from the Medicines Agency (MA) Regulatory authority-WEB FI-FIMEA-20210630. An 84-years-old male patient received 2nd dose of bnt162b2 (COMIRNATY), intramuscular on 25Jan2021 at single dose for COVID-19 vaccination. Medical history included Alzheimer disease from Aug2018 and no allergies. The patient''s concomitant medications were not reported. The historical vaccine included 1st dose of bnt162b2 on 04Jan2021 for COVID-19 vaccination. After the boost dose vaccination on 25Jan2021 the general health condition of patient worsened rapidly (26Jan2021) and on 05Feb2021 at 3 am. in the night the patient died. The patient experienced confusion, general health condition worsening. He had to come to emergency room, there aspiration pneumonia diagnosed on 02Feb2021. It was not reported if an autopsy was performed. The events aspiration pneumonia, general health condition worsening outcome was fatal, of the other was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: general health condition worsening; Pneumonia aspiration


VAERS ID: 1048299 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal carcinoma, Pneumonia, Pneumoperitoneum, Tumour perforation
SMQs:, Malignancy related conditions (narrow), Gastrointestinal perforation (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibrosis lung; Neurodegenerative disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021164862

Write-up: pneumoperitoneum; tumor digestive perforation; tumor digestive perforation; Infectious pneumonitis/infectious lung disease; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, FR-AFSSAPS-BR20210146. This is a report received from the Regulatory Authority. An 83-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number EK0477 (as reported, also "EM0477" was provided)), via intramuscular on 20Jan2021 at single dose (reported as "1 DF") in left arm for COVID-19 vaccination. Medical history included fibrosis lung, neurodegenerative disorder, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced infectious pneumonitis (infectious lung disease) on 27Jan2021. The event was reported as serious due to death and life threatening. Transfer to Emergency. Discovery of a pneumoperitoneum probably linked to a tumor digestive perforation. Urgent medical intervention. The patient died on an unspecified date for infectious pneumonitis (infectious lung disease). It was unknown if an autopsy was performed. The outcome of the rest events was unknown. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained. ; Reported Cause(s) of Death: Infectious pneumonitis (infectious lung disease)


VAERS ID: 1048300 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiogenic shock, Myocardial infarction, SARS-CoV-2 test negative, Troponin
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Diabetes mellitus insulin-dependent; Hypertension arterial (arterial); Pseudopolyarthritis; Senile macular degeneration
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: blood pressure; Result Unstructured Data: Test Result:suspected low; Test Date: 202102; Test Name: SARS CoV-2; Test Result: Negative ; Test Date: 202102; Test Name: troponin; Result Unstructured Data: Test Result:very high
CDC Split Type: FRPFIZER INC2021169036

Write-up: Infarct myocardial; Cardiogenic shock; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority number FR-AFSSAPS-BR20210213. A 91-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, Lot/batch n EJ6788) intramuscular on 04Feb2021 at single dose for covid-19 immunisation. Medical history included pseudopolyarthritis, hypertension arterial, asthma, Diabetes mellitus insulin-dependent, Senile macular degeneration. he patient''s concomitant medications were not reported. On 08Feb2021 she was admitted to the emergency room for suspicion of low blood pressure and deterioration of her general condition. The patient experienced infarct myocardial on 06Feb2021. The patient underwent lab tests and procedures which included blood pressure measurement: suspected low in Feb2021, Sars-cov-2 PCR test: negative in Feb2021, troponin: very high in Feb2021. Conclusion: acute coronary syndrome seen late because of digestive symptomatology, cardiogenic shock. Unfavorable evolution towards rapid death. The patient died on 08Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiogenic shock; Infarct myocardial


VAERS ID: 1048303 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   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: COTAREG
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioedema (over 40 years ago when she ate asparagus); Giant hives; Head injury (hit her head on a door (not serious) in the days before vaccination); Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021160039

Write-up: Death unexplained; Asthenia; very marked headaches; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory Authority number was FR-AFSSAPS-BX20210504. A 77-year-old female patient received her 1st dose of BNT162B2 (COMIRNATY, lot number EJ6789) at single dose on 06Feb20021 around noon intramuscular in left arm for COVID-19 immunization. Medical history included giant hives, hypertension treated with hydrochlorothiazide, valsartan (COTAREG), hit her head on a door (not serious) in the days before vaccination. Patient lived at home with her daughter with very good general condition. Patient had history of angioedema over 40 years ago (as of 15Feb2021) when she ate asparagus. Concomitant drug included hydrochlorothiazide, valsartan (COTAREG) for high blood pressure. On 06Feb2021, patient experienced very marked headaches and asthenia in the afternoon. On 07Feb2021 around 8 am, patient found dead in bed. Intervention included transportable services for emergency response. Resuscitation attempt including intubation, unsuccessful. No visible lesions on the body. No edema seen during intubation. No autopsy performed. The family does not want medical-scientific expertise. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Asthenia; very marked headaches; Death unexplained


VAERS ID: 1048305 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy; Atrial fibrillation (episode); Dyslipidaemia; Eschar (stage 4 multiple); Hospitalization; Hypertension; Obstructive sleep apnea syndrome; Peripheral arterial occlusive disease; Pseudomonal sepsis (P. aeruginosa); Spastic paraplegia (in spinal cord compression treated by laminectomy); Total knee replacement; Type II diabetes mellitus; Urinary catheter insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021164513

Write-up: dead; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MA20210345. An 89-year-old male patient received received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477), intramuscularly at the site of right deltoid on 19Jan2021 at single dose for COVID-19 immunization. Medical history included peripheral arterial occlusive disease, pseudomonal sepsis (P. aeruginosa), dyslipidaemia, obstructive sleep apnea syndrome, spastic paraplegia (in spinal cord compression treated by laminectomy), eschar (stage 4 multiple), atrial fibrillation (episode), hypertension, type II diabetes, total knee replacement, arteriopathy obliterating of the lower limbs, indwelling urinary catheter and hospitalizations from 30Mar2020, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Clinical course: The patient was entry into nursing home on 03Jan2021 after leaving follow-up and rehabilitation care after several emergency room stays and hospitalizations from 30Mar2020. After first dose of vaccination, the patient presents no adverse effects during post-vaccination monitoring. On 23Jan2021 at 5:55 p.m., the patient was found dead without problem either the day before or the same day (as reported). The patient died on 23Jan2021. An autopsy was not performed. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: dead


VAERS ID: 1048306 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Blood creatine phosphokinase, Blood test, Body temperature, Computerised tomogram, Disorientation, Fall, Gamma-glutamyltransferase, Influenza virus test, Neutrophil count, Pyrexia, Restlessness, SARS-CoV-2 test, Sleep talking, Sudden death, Urinary tract infection bacterial, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   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: CANDESARTAN; DAFALGAN; HALDOL; MACROGOL; SERESTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Aortic stenosis; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: creatine phosphokinase; Result Unstructured Data: Test Result:normal; Test Date: 20210126; Test Name: creatine phosphokinase; Result Unstructured Data: Test Result:246; Test Date: 20210125; Test Name: Blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210124; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20210125; Test Name: computed tomography scan; Result Unstructured Data: Test Result:nothing in particular; Comments: in particular no intracerebral bleeding; Test Date: 20210125; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:41; Test Date: 20210125; Test Name: influenza serology; Test Result: Negative ; Test Date: 20210125; Test Name: Neutrophils; Result Unstructured Data: Test Result:4000; Test Date: 20210126; Test Name: Neutrophils; Result Unstructured Data: Test Result:2930; Comments: remained unremarkable; Test Date: 20210125; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210126; Test Name: Urine examination (cytobacteriological examination of urine); Test Result: Positive
CDC Split Type: FRPFIZER INC2021169150

Write-up: Sudden death; disorientation and agitation a little increased compared to usual; disorientation and agitation a little increased compared to usual; positive cytobacteriological examination of urine; The patient fell 3 times; more restless; talked in sleep; Febricule / low fever at 37.8 Celsius degrees; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority number FR-AFSSAPS-MP20210171). A 92 years old female patient received the first single dose of BNT162B2 (COMIRNATY; lot EJ6788) intramuscular, in right arm, on 21Jan2021 at 14:42, for COVID-19 vaccination. The patient was considered to be at risk of developing a severe form of the disease COVID-19. The patient had no history of COVID-19. Medical history included aortic stenosis, hypertension arterial, Alzheimer''s disease, all from an unknown date and unknown if ongoing. Concomitant medications included candesartan 8 mg, paracetamol (DAFALGAN) 3 g, haloperidol (HALDOL) 2 mg, macrogol, oxazepam (SERESTA) 10 mg. Normal immediate monitoring. On 24Jan2021 more restless patient, talked in sleep, low fever at 37.8 Celsius degrees. On 25Jan2021 the patient underwent blood test and COVID-19 PCR test which was negative, normal creatine phosphokinase (CPK), neutrophils 4000, Gamma-glutamyltransferase 41, influenza serology negative. The patient fell 3 times during the day and a computed tomography scan was performed showing nothing in particular (in particular no intracerebral bleeding). On 26Jan2021 creatine phosphokinase (CPK) 246, neutrophils 2930, remained unremarkable. Urine examination positive cytobacteriological examination of urine: prescription of a sachet of fosfomycin (FOSFOCIN). On 27Jan2021 disorientation and agitation a little increased compared to usual with Haldol 2 mg per day for a long time. Evolution: on 29Jan2021 the patient was found deceased in her bed in the early morning holding a glass in her hand. It was unknown if an autopsy was done. Sudden death and febricula were reported as fatal events. The outcome of the other events was unknown. Accountability made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Ministry of Health No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death; Febricule / low fever at 37.8 Celsius degrees


VAERS ID: 1048308 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Diabetes; Hypertension arterial; Obesity; Obstructive sleep apnea syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021169163

Write-up: Infarct myocardial; Chest pain; This is a spontaneous report from a contactable physician, received from the Medicines Agency (MA) Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20210177. An 91-year-old male patient received the first dose of BNT162B2 (COMIRNATY), from lot EJ6788, via intramuscular route in the left arm on 25Jan2021 at single dose for covid-19 immunisation. Medical history included hypertension arterial, chronic obstructive pulmonary disease, obesity, diabetes, obstructive sleep apnea syndrome, all from an unknown date and unknown if ongoing. No COVID prior vaccination. Concomitant medications were not reported. On 30Jan2021 the patient experienced Chest pain and pain in the left arm and onset of sweating, nausea, vomiting, after physical exertion (wanted to move his chair). The patient experienced an infarct myocardial. The patient died due to infarct myocardial on the same date. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1048309 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021169148

Write-up: COVID-19 aggravated; This is a spontaneous report from a contactable consumer reporting on behalf of the father and downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority number FR-AFSSAPS-NC20210377). A 94 years old male patient received the first single dose of BNT162B2 (COMIRNATY; lot EJ6788) intramuscular, on 29Jan2021, for COVID-19 immunisation. The patient was resident at the nursing home. Other medical history and concomitant medications were not reported. The anti-COVID vaccine was administered to the patient at the nursing home on 29Jan2021. Following 1 positive case of COVID detected in the nursing home, the residents were confined to their rooms from 30Jan2021. The patient tested positive for COVID on 03Feb2021, as well as 2 other residents of the residence. His state of health quickly deteriorated and he died on 06Feb2021 in the nursing home due to COVID-19 aggravated. It was unknown if an autopsy was done. The pharmacovigilant notes: accountability score(s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Official Bulletin of the Minister in charge of Health. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: COVID-19 aggravated


VAERS ID: 1048310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Dementia; Dyslipidaemia; Osteoporosis; Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021160109

Write-up: General physical health deterioration; Rectum to skin fistula; Abdomen enlarged; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB FR-AFSSAPS-NY20210243. An 89-year-old patient female patient received the first dose of bnt162b2 (COMIRNATY) via Intramuscular on 04Feb2021 Arm Left at single dose (Lot # EJ6788) for covid-19 immunisation. Medical history included bedridden, dementia, severe psoriasis, osteoporosis, dyslipidemia all unknown if ongoing. 24 hours after the injection (05Feb2021), deterioration of the general condition with abdominal distension in the context of a wound in the buttock, deterioration of the general condition a few days earlier in a communicating patient. No general infectious symptoms, nor skin. Following the discovery of stool in the wound of internal origin with the presence of a commensal germ of digestive origin on the wound, suspicion of an anorecto-cutaneous fistula. Abdominal enlarged, general physical health deterioration and suspicion of rectum to skin fistula in the patient after a vaccination on 05Feb2021. 06Feb2021, death of the patient. Unfavorable evolution with death of the patient. All events were death and Life-threatening. It is unknown if autopsy was done. Outcome of the events was fatal. No accountability in the absence of direct causation according to the declarant. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information currently available, there was not a reasonable possibility that the events "General physical health deterioration, Rectum to skin fistula and Abdomen enlarged" were related to bnt162b2. The patient''s advance age with multiple underlying disease provide plausible alternative explanation.; Reported Cause(s) of Death: General physical health deterioration; Rectum to skin fistula; Abdomen enlarged


VAERS ID: 1048311 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiectasis; Lung lobectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021164521

Write-up: Embolism pulmonary/pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-NY20210244 received from the Regulatory Authority. A 77-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477), intramuscular in left arm on 21Jan2021 at single dose for covid-19 immunisation. The patient''s medical history included bronchiectasis and lobectomy in 1972. Concomitant medications were not reported. On 23Jan2021, The patient experienced an evidence of pulmonary embolism. The patient died on an unknown date. It was not reported if an autopsy was performed. The cause of death was embolism pulmonary/pulmonary embolism. The event was considered as fatal and life-threatening. Conclusion: pulmonary embolism demonstrated 2 days after vaccination with COMIRNATY (lot EM0477). Urgent medical intervention, involving the vital prognosis. Death of the patient. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Embolism pulmonary/pulmonary embolism


VAERS ID: 1048312 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Lower respiratory tract congestion, Lung abscess, Pleural effusion, Pyrexia
SMQs:, Cardiac failure (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Disease Parkinson''s (stabilized with appropriate treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: temperature; Result Unstructured Data: Test Result:up to 39.7 Centigrade; Comments: fever
CDC Split Type: FRPFIZER INC2021164519

Write-up: Bronchial congestion; Abscess of lung; Fever; Pleural effusion; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NY20210245. This is a report received from the Regulatory Authority. An 81-year-old male patient in care home received the first dose of BNT162B2 (COMIRNATY) (Batch/Lot number and expiration date unknown), intramuscular in the right arm on 19Jan2021 at single dose for COVID-19 vaccination. The patient''s medical history included ongoing Parkinson''s disease (stabilized with appropriate treatment). Concomitant medications were not reported. On 20Jan2021, the onset of fever (up to 39.7 Celsius degrees) followed by congestion of the bronchi then an abscess in the lung (requiring maximum respiratory assistance at 15L) and pleural effusion. The patient was hospitalized due to the above mentioned events. On 27Jan2021, death of the patient. The outcome of the events was reported as death one week later. The patient died on 27Jan2021. It was not reported if an autopsy was performed. Conclusion (as reported): Fever, bronchial congestion, lung abscess and pleural effusion in an 81-year-old patient the day after a first injection of the vaccine COMIRNATY (lot not documented). Unfavorable evolution: death of the patient one week later. No accountability in the absence of medical evidence. Fever, bronchial congestion, abscess of lung, pleural effusion in a 81 year-old man one day after a COVID-19 vaccination with COMIRNATY (batch unknown). Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Therapy. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Bronchial congestion; Abscess of lung; Fever; Pleural effusion


VAERS ID: 1048315 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-04
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUTHYROX; SEROPLEX; EDUCTYL; SPECIAFOLDINE; COSOPT; FORTIMEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (Former breast cancer (2004). in remission); COVID-19; Dementia; Meningioma (partially calcified frontal anterior right); Psychosis; Thyroid cancer; Thyroidectomy (Thyroidectomy for thyroid cancer in 2011, Dysthyroidism)
Allergies:
Diagnostic Lab Data: Test Date: 20200407; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021169146

Write-up: Sudden death; This is a spontaneous report from a physician. This is a report received from the Regulatory Authority. Regulatory authority report number {enter regulatory authority number}. A 88-years-old female patient started to receive bnt162b2 (COMIRNATY) , intramuscular from 27Jan2021 to 27Jan2021 at 0.3 mL, single for covid-19 immunisation . Medical history included meningioma from 2019 to an unknown date partially calcified frontal anterior right , dementia from an unknown date and unknown if ongoing , covid-19 from 07Apr2020 to an unknown date , psychotic disorder from an unknown date and unknown if ongoing , breast cancer from 2004 to an unknown date Former breast cancer (2004). in remission , thyroidectomy from 2011 to an unknown date Thyroidectomy for thyroid cancer in 2011, Dysthyroidism , thyroid cancer from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (EUTHYROX), escitalopram oxalate (SEROPLEX), potassium bitartrate, sodium bicarbonate (EDUCTYL), folic acid (SPECIAFOLDINE), dorzolamide hydrochloride, timolol maleate (COSOPT) , nutrients nos (FORTIMEL). The patient experienced sudden death (sudden death) (death) on 04Feb2021 05:00. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Apr2020 . The action taken in response to the event(s) for bnt162b2 was not applicable. The patient died on 04Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1048316 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Conduction disorder; Diabetes; End stage renal failure; Ischaemic heart disease; Permanent cardiac pacemaker insertion; Renal dialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021164518

Write-up: patient was found at her deceased home on the scheduled day of her dialysis.; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB with regulatory authority number FR-AFSSAPS-PB20210265. A 73-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscularly on 28Jan2021 at single dose for covid-19 immunization. Medical history included diabetes, permanent cardiac pacemaker insertion, atrial fibrillation, renal dialysis, Ischaemic heart disease, end stage renal failure and conduction disorder, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The circumstances are unknown and unexplained. She was found at her deceased home on the scheduled day of her dialysis. The patient died on 31Jan2021. 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: patient was found at her deceased home on the scheduled day of her dialysis.


VAERS ID: 1048317 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK 9788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, C-reactive protein, Death, Investigation, Physical examination, Pyrexia, SARS-CoV-2 test, Subileus, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENOXAPARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of colon stage II (T2N0M0); Colectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: blood test; Result Unstructured Data: Test Result:not showing any ionic disturbances; Test Date: 20210205; Test Name: body temperature; Result Unstructured Data: Test Result:38; Test Date: 20210204; Test Name: CRP; Result Unstructured Data: Test Result:13; Test Date: 20210206; Test Name: CRP; Result Unstructured Data: Test Result:200; Test Date: 20210204; Test Name: imaging test; Result Unstructured Data: Test Result:not showing any ionic disturbances; Test Date: 20210206; Test Name: clinical examination; Result Unstructured Data: Test Result:without particularities, flexible calves; Test Date: 20210205; Test Name: COVID PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210206; Test Name: leukocytes; Result Unstructured Data: Test Result:3000
CDC Split Type: FRPFIZER INC2021169133

Write-up: Death NOS; fever at 38; Subocclusive syndrome; This is a spontaneous report from a contactable physician via The National Agency for Medicines and Health Products Safety downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-PB20210301. An 81-years-old female patient received the first dose of bnt162b2 (COMIRNATY, lot/batch EK 9788), intramuscular on 03Feb2021 at single dose for covid-19 immunisation. Medical history included very recent discovery of early stage colon cancer (T2N0M0) in Jan2021 for which the patient had a right colectomy on 20Jan2021, hospitalization for a few days, simple consequences, return home, with preventive anticoagulant treatment. The patient had no particular ACTD, lived at home with her husband, who was totally independent. The patient''s concomitant medications included enoxaparin. The patient experienced subocclusive syndrome on 04Feb2021. It was reported onset the next day of vaccination of digestive disorders such as vomiting, leading her to consult on 04Feb2021: diagnosis of subocclusive syndrome, carrying out of tests (blood, imaging) not showing any ionic disturbances, CRP at 13, patient on an empty stomach and insertion of a gastric tube. Favorable evolution over the following days, from 05Feb2021 gastric probe not very productive, supple stomach, in the evening fever at 38, carrying out a negative COVID PCR test. Saturday 06Feb2021 was better on the digestive plan, was refueling, clinical examination without particularities, flexible calves. On biology, CRP raised to 200 and in parallel, leukocytes to 3000. The patient died on 07Feb2021. It was not reported if an autopsy was performed. Patient found dead at 5:30 a.m. On Sunday 07Feb2021 morning, during the 3 a.m. tour, the nurse noted that the patient was asleep. Conclusion: unexplained death, in an 81-year-old female patient, with no specific ATCD, in a context of sub-occlusive syndrome occurring hours after vaccination. No physical complaint overnight. No signs suggesting venous thrombosis or pulmonary embolism in this patient treated with preventive enoxaparin for 3 weeks. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unexplained death


VAERS ID: 1048319 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EF6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Aspartate aminotransferase, Atrial fibrillation, Blood bicarbonate, Blood creatinine, Blood lactic acid, Brain natriuretic peptide, Electrocardiogram, Fibrin D dimer, Laboratory test, Myocardial infarction, PCO2, PO2, Respiratory distress, SARS-CoV-2 test, Troponin, Venous oxygen saturation, Venous oxygen saturation decreased, Vomiting, pH body fluid
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   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: Arterial hypertension; Hypertensive heart disease NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:35 times above normal; Test Date: 20210128; Test Name: Bicarbonates; Result Unstructured Data: Test Result:17; Comments: Blood gases: Bicarbonates at 17; Test Date: 20210128; Test Name: creatinine; Result Unstructured Data: Test Result:140; Comments: creatinine at 140 (versus 90 baseline); Test Date: 20210128; Test Name: Lactates; Result Unstructured Data: Test Result:4.2; Comments: Blood gases: Lactates at 4.2; Test Date: 20210129; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:2800; Test Date: 20210128; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm with LBBB; Comments: ECG in sinus rhythm with left bundle branch block at 8:50 p.m.; Test Date: 20210128; Test Name: DDimer; Result Unstructured Data: Test Result:3980 /mm3; Comments: D-Dimer to 3980 / mm3; Test Date: 20210128; Test Name: laboratory test; Result Unstructured Data: Test Result:inflammatory syndrome; Comments: inflammatory syndrome with polynuclear neutrophils at 21000; Test Date: 20210128; Test Name: pCO2; Result Unstructured Data: Test Result:28; Comments: Blood gases: pCO2 = 28; Test Date: 20210128; Test Name: pH; Result Unstructured Data: Test Result:7.4; Comments: Blood gases: pH 7.4; Test Date: 20210128; Test Name: pO2; Result Unstructured Data: Test Result:51; Comments: Blood gases: pO2 = 51; Test Date: 20210128; Test Name: PCR Covid test; Test Result: Negative ; Test Date: 20210129; Test Name: PCR Covid test; Test Result: Negative ; Test Date: 20210129; Test Name: Troponin; Result Unstructured Data: Test Result:above 25.000; Test Date: 20210128; Test Name: venous oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: FRPFIZER INC2021164520

Write-up: Distress respiratory; Atrial fibrillation aggravated; Infarct myocardial; Venous oxygen saturation decreased; Emesis; Acute coronary syndrome; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-PC20210191. A 91-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number EF6795), intramuscular on 28Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included hypertensive heart disease NOS and arterial hypertension both unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced infarct myocardial on 28Jan2021, distress respiratory on 31Jan2021, venous oxygen saturation decreased on 28Jan2021, emesis on 28Jan2021, acute coronary syndrome on 28Jan2021, atrial fibrillation aggravated on 31Jan2021. Clinical course: After dinner, episode of vomiting with 78% desaturation in ambient air - Call to the firefighters who brought the patient to the emergency department. At the emergency room: ECG in sinus rhythm with left bundle branch block at 8:50 p.m. Respiratory distress - Biological assessment which finds an inflammatory syndrome with polynuclear neutrophils at 21000. - renal failure with creatinine at 140 (versus 90 baseline). aspartate aminotransferase at 35 times above normal. DDimer to 3980 / mm3. Blood gases: pH 7.4 - pO2 = 51 - pCO2 = 28 - Bicarbonates at 17 - Lactates at 4.2. PCR Covid negative. Scanner suggestive of Covid19. In UGA on 29Jan2021: Troponin above 25.000. Brain natriuretic peptide (BNP) at 2800. negative COVID control PCR, Cardiac advice request: Acute Coronary Syndrome Complicated IV Left + global hypokinesia + 20% visual ejection fraction. Initiation of medical treatment: aspirin 250mg IV + plavix 75 + heparin calcium at an effective dose. 31Jan2021: Clinical degradation with progression to rapid atrial fibrillation without resolution following the administration of 3 Cordarone tablets. Faced with the deterioration of the state of vigilance and the persistence of a picture of acute respiratory distress, referral to exclusive palliative care with the introduction of morphine and hypnovel. Evolution: Death 03Feb2021. The patient died on 03Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Distress respiratory; Venous oxygen saturation decreased; Emesis; Acute coronary syndrome; Atrial fibrillation aggravated; Infarct myocardial


VAERS ID: 1048321 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-02-04
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (Dysrhythmic heart disease in atrial fibrillation); Chronic obstructive airways disease; Parotid tumor (untreated); Prostatic cancer (under hormone therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021165956

Write-up: inhalation pneumonitis; heart failure; Sudden death/natural death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-RE20210275. A 93-year-old male patient received bnt162b2 (COMIRNATY) (lot: EM0477) intramuscularly on the left arm on 13Jan2021 at a single dose for COVID-19 immunisation. Medical history included progressive tumor of the parotid, untreated, prostate cancer under hormone therapy, dysrhythmic heart disease in atrial fibrillation, chronic obstructive pulmonary disease. Concomitant medications were not reported. HISTORY OF THE DISEASE: Patient considered to be at risk of developing a severe form of the COVID-19 disease: ''comorbidities, uncontrolled cancer'', not having contracted COVID-19 and not having been tested. Patient experienced sudden death/natural death on 04Feb2021. Event was considered serious due to hospitalization and death. 04Feb2021: Death of the patient: ''natural death, inhalation pneumonitis and heart failure probable''. "No resuscitation measures given the advanced stage of the parotid tumor and the comorbidities". The outcome of inhalation pneumonitis and heart failure was unknown. It was not reported if an autopsy was performed. Sender''s Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code) (Sudden death, cause unknown). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death/natural death


VAERS ID: 1048322 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-07
Onset:2021-02-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, C-reactive protein, Haemoglobin, Heart rate, Hyperleukocytosis, Lung disorder, Neutrophil count, Oxygen saturation, Physical examination, Polymerase chain reaction, Renal function test, Respiratory distress, Respiratory rate, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Malignancy related conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TEMESTA [LORAZEPAM]; MICROPAKINE; AMLODIPINE; TIAPRIDAL; PANTOPRAZOL [PANTOPRAZOLE]; PARACETAMOL; SPECIAFOLDINE; PHOSPHONEUROS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertension arterial; Malnutrition; Starvation (malnutrition); Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: blood pressure; Result Unstructured Data: Test Result:130/82 mmHg; Comments: On arrival; Test Date: 20210208; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: On arrival; Test Date: 20210208; Test Name: CRP; Result Unstructured Data: Test Result:141 mg/l; Test Date: 20210208; Test Name: Hb; Result Unstructured Data: Test Result:14.9 g/dl; Test Date: 20210208; Test Name: Heart rate; Result Unstructured Data: Test Result:91 bpm; Comments: On arrival; Test Date: 20210208; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result:17.9 g/l; Test Date: 20210208; Test Name: Neutrophils; Result Unstructured Data: Test Result:16.5 g/l; Test Date: 20210208; Test Name: saturation; Test Result: 96 %; Comments: On arrival: SaO2 at 96% under 3l / min O2; Test Date: 20210208; Test Name: saturation; Result Unstructured Data: Test Result:<80 %; Comments: Rapid deterioration of the respiratory state with desaturation <80%, high concentration mask put on; Test Date: 20210208; Test Name: saturation; Test Result: 76 %; Comments: 76% desaturation in ambient air; Test Date: 20210208; Test Name: saturation; Test Result: 96 %; Comments: Put under oxygen with glasses, saturation at 96% under 3l / min of O2.; Test Date: 20210208; Test Name: saturation; Test Result: 88 %; Comments: Worsening of dyspnea on 08Feb21 at the end of the day, with 88% desaturation under 3l / min of O2, requiring emergency transfer for treatment.; Test Date: 20210208; Test Name: clinical examination; Result Unstructured Data: Test Result:found signs of dehydration (skin fold, roasted ton; Comments: pulmonary auscultation with bilateral bronchial rales of stasis, ineffective cough, trouble swallowing, normal abdominal examination.; Test Date: 20210208; Test Name: PCR on nasal swab; Test Result: Negative ; Comments: PCR on nasal swab: negative influenza; Test Date: 20210208; Test Name: renal function; Result Unstructured Data: Test Result:normal; Test Date: 20210208; Test Name: respiratory rate; Result Unstructured Data: Test Result:16/min; Comments: On arrival; Test Date: 20210208; Test Name: PCR on nasal swab; Test Result: Negative ; Comments: PCR on nasal swab: Covid-19
CDC Split Type: FRPFIZER INC2021164860

Write-up: Distress respiratory; Pneumopathy; This is a spontaneous report from a contactable physician from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-RN20210395. An 82-years-old male patient received second dose of bnt162b2 (COMIRNATY, lot: EJ6789), intramuscular on 07Feb2021 at SINGLE DOSE on Arm Left for covid-19 immunisation. Medical history included starvation, malnutrition, transient ischaemic attack, dementia, Hypertension arterial all from an unknown date and unknown if ongoing. No known allergy. Concomitant medication included lorazepam (TEMESTA [LORAZEPAM]), valproate sodium, valproic acid (MICROPAKINE), amlodipine (AMLODIPINE), tiapride hydrochloride (TIAPRIDAL), pantoprazol [pantoprazole] (PANTOPRAZOL [PANTOPRAZOLE]) , paracetamol (PARACETAMOL), folic acid (SPECIAFOLDINE), calcium phosphate monobasic, magnesium glycerophosphate, phosphoric acid, sodium phosphate dibasic (PHOSPHONEUROS). Historical Vaccine included comirnaty, 1st dose for Covid-19 immunisation, single dose No noticeable reaction during the 1st injection. No noticeable reaction during the 1st injection. No sign of current infection at the time of injection, including apyrexia. The patient experienced distress respiratory and pneumopathy on 08Feb2021. It was reported that the patient presented on 08Feb21 acute respiratory distress in the morning, with 76% desaturation in ambient air. Put under oxygen, saturation at 96% under 3l / min of O2. Introduction of antibiotic therapy with Ceftriaxone for a suspicion of infectious pneumopathy in front of a fever. Worsening of dyspnea on 08Feb21 at the end of the day, with 88% desaturation under 3l / min of O2, requiring emergency transfer for treatment. On arrival on 08Feb2021 of the patient: T 37.5 c, SaO2 at 96% under 3l / min O2, respiratory rate.(fr FR) 16 / min, Heart rate (fr FC) 91bpm, Blood pressure 130 / 82mmHg. The clinical examination found signs of dehydration (skin fold, roasted tongue), pulmonary auscultation with bilateral bronchial rales of stasis, ineffective cough, trouble swallowing, normal abdominal examination. The biology found hyperleukocytosis at 17.9 g/l with Neutrophils (fr PNN) 16.5G / L, Hb 14.9 g/dl, CRP 141mg / l, ionogram and normal renal function. PCR on nasal swab: negative influenza and Covid-19. Rapid deterioration of the respiratory state with desaturation <80%, high concentration mask put on. No resuscitation measure given the very limited autonomy and also after a call from the wife, who does not want therapeutic persistence. Death at 10:24 p.m. on 08Feb2021. It was not reported if an autopsy was performed. Subject to other elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Ministry in charge of health n ? 84/50, 24Jan1985 Published in: Therapy 1985; 40: 111-8 No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumopathy; Distress respiratory


VAERS ID: 1048323 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Asymptomatic COVID-19, Auscultation, Blood pressure measurement, COVID-19, Cardiopulmonary failure, Culture urine, Death, Disorientation, Electrocardiogram, Heart rate, Hypotension, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Pallor, Physical examination, Respiratory distress, SARS-CoV-2 test, Sinus tachycardia, Tachycardia, Tachypnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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 (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemic (treated by a transfusion of 2 red blood cells bags); Cognitive disturbance (Moderate); Diabetes mellitus insulin-dependent; Escherichia coli infection; Hospitalization (due to deterioration of general condition and vomiting revealing cardiac decompensation); Hypertension arterial (HTA treated and balanced)
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: pulmonary auscultation; Result Unstructured Data: Test Result:Clear and symmetrical; Comments: No right or left cardiac insufficiency sign; Test Date: 20210202; Test Name: Blood pressure; Result Unstructured Data: Test Result:still low at 9/5; Test Date: 20210204; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/80; Test Date: 20210112; Test Name: cytobacteriological urine exam; Result Unstructured Data: Test Result:positive to E. coli; Comments: sensitive to Amoxicillin; Test Date: 20210204; Test Name: ECG; Result Unstructured Data: Test Result:sinus tachycardia; Comments: sinus tachycardia with a shift in particular in V5-V6; Test Date: 20210201; Test Name: Heart rate; Result Unstructured Data: Test Result:100; Comments: Tachycardia around 100 bpm; Test Date: 20210202; Test Name: Heart rate; Result Unstructured Data: Test Result:115; Comments: tachycardia at 115 bpm; Test Date: 20210204; Test Name: Heart rate; Result Unstructured Data: Test Result:145 bpm; Test Date: 20210204; Test Name: saturation; Test Result: 80 %; Test Date: 20210201; Test Name: physical examination; Result Unstructured Data: Test Result:Soft, painless calves. Hydroaeric noises ok; Comments: abdomen soft, no guarding, no tenderness. No urinary symptoms. No externalized bleeding observed.; Test Date: 20210202; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021164911

Write-up: sudden death / Death unexplained; acute respiratory distress; 80% desaturation; agitation without disturbance of consciousness; Polypnea, thoraco-abdominal rocking, pursed lip; slight edema of the lower limbs; a sinus tachycardia with a shift in particular in V5-V6; a sinus tachycardia with a shift in particular in V5-V6; cardio-respiratory failure; Blood pressure still low at 9/5; Positive COVID test; Positive COVID test (screening as part of a cluster in the service; disoriented in time and space; Tachycardia around 100 bpm; slight pallor; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-RS20210171. An 83-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot/batch number: EJ6788), intramuscularly on 01Feb2021 at single dose for COVID-19 immunization. Medical history included hypertension arterial (HTA treated and balanced), cognitive disturbance (moderate), diabetes mellitus insulin-dependent, hospitalized due to deterioration of general condition and vomiting revealing cardiac decompensation, anemic syndrome associated with melena treated by a transfusion of 2 red blood cells bags and E. coli infection, all from an unknown date and unknown if ongoing. Concomitant medication included amoxicillin from 12Jan2021 to 18Jan2021 for E. coli infection. Clinical course: On 12Jan2021, the patient was hospitalized due to deterioration of general condition and vomiting revealing cardiac decompensation. The selected decompensation factors are an infection with a cytobacterioligical urine exam positive to E. coli sensitive to Amoxicillin, treated with amoxicillin 1 g x 3 for 7 days as well as an anemic syndrome associated with melena, treated by a transfusion of 2 red blood cells bags. Progressive resolution of the cardiological symptoms and progressive regression of the inflammatory syndrome during hospitalization. After vaccination, medical observation of 01Feb2021: rather coherent remarks, but patient disoriented in time and space. No somatic complaint. Tachycardia around 100 bpm, slight pallor. Clear and symmetrical pulmonary auscultation. No right or left cardiac insufficiency sign. Physical examination: Soft, painless calves. Hydroaeric noises ok, abdomen soft, no guarding, no tenderness. No urinary symptoms. No externalized bleeding observed. 02Feb2021: Patient partially oriented in time. Blood pressure still low at 9/5, tachycardia at 115 bpm. Stable clinical condition. Cardio-pulmonary auscultation: aortic stenosis, abdomen soft, no guarding, no tenderness. Positive COVID test (screening as part of a cluster in the service). Asymptomatic patient. 03Feb2021: good constants, patient "as usual". 04Feb2021: without an established cause according to the declarant. Call for acute respiratory distress with 80% desaturation and with agitation without disturbance of consciousness. BP 140/80, 145bpm. Polypnea, thoraco-abdominal rocking, pursed lip. No cyanosis observed. Patient placed under O2 in a high concentration mask between 10 and 15L allowing correct saturation$g 90%. Crackling in the 2 fields, frothy sputum in a second step, slight edema of the lower limbs. ECG made finding a sinus tachycardia with a shift in particular in V5-V6 already present on the previous ECG. Rapid degradation, no improvement after 40mg of furosemide (LASILIX) IV. Then cardio-respiratory failure, start of an external heart massage, no flow <1min. Initial notice to the resuscitator on call, resuscitation continued. Non-shockable rhythm, administration of 2x1mg of adrenaline. Decision not to continue resuscitation after review of the file, after 20min of CPR. Sudden death occurred; death noted at 3:05 am. Coded as "unexplained death" (because death without an established cause according to the declarant) pending the final hospitalization report for update of the file. The patient died at 3:05 am on 04Feb2021. It was not reported if an autopsy was performed. The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death / Death unexplained


VAERS ID: 1048324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-03
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, COVID-19, Drug ineffective, Haemoglobin, Heart rate, International normalised ratio, Oxygen saturation, Platelet count, SARS-CoV-2 test, Spinal X-ray, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COUMADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathic disease; Atrial fibrillation; Cardiac arrhythmia; Chronic cor pulmonale; COPD; Dementia aggravated; Dementia with Lewy bodies; Hernia hiatal; Hyperthermia (hyperthermia and sudden desaturation); Oxygen saturation decreased (hyperthermia and sudden desaturation); Thromboendarterectomy (Bilateral pulmonary thromboendarterectomy); Thyroidectomy; Ulcer
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: BP; Result Unstructured Data: Test Result:retained; Test Date: 20210121; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210203; Test Name: body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Test Date: 20210126; Test Name: haemoglobin; Result Unstructured Data: Test Result:16.4 g/dl; Test Date: 20210203; Test Name: pulse; Result Unstructured Data: Test Result:Rapid pulse +++; Test Date: 20210123; Test Name: international normalized ratio; Result Unstructured Data: Test Result:2.9; Test Date: 20210126; Test Name: international normalized ratio; Result Unstructured Data: Test Result:New rise in INR; Comments: New rise in INR despite reduction in dose of COUMADINE.; Test Date: 20210129; Test Name: international normalized ratio; Result Unstructured Data: Test Result:1.7; Test Date: 20210202; Test Name: international normalized ratio; Result Unstructured Data: Test Result:1.7; Test Date: 20210203; Test Name: oxygen saturation; Result Unstructured Data: Test Result:below 70 %; Test Date: 20210126; Test Name: platelets; Result Unstructured Data: Test Result:277 x10 9/l; Test Date: 20201231; Test Name: PCR COVID-19 test; Test Result: Negative ; Test Date: 20210203; Test Name: PCR COVID-19 test; Test Result: Positive ; Test Date: 20210126; Test Name: sacro-coccygeal abscess; Result Unstructured Data: Test Result:sacro-coccygeal abscess; Test Date: 20210126; Test Name: leucocyte; Result Unstructured Data: Test Result:8.7 x10 9/l
CDC Split Type: FRPFIZER INC2021164512

Write-up: COVID-19 infection; COVID-19 infection; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB regulatory authority FR-AFSSAPS-RS20210172. A 73-year-old female patient received the first dose bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscular on 21Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Cardiac arrhythmia, Dementia with Lewy bodies, Atrial fibrillation, COPD, Ulcer, Chronic cor pulmonale, Thyroidectomy, Arteriopathic disease, Hernia hiatal, all from unknown date and unknown of ongoing, Bilateral pulmonary thromboendarterectomy in 2000, severe dementia from Oct2020, hyperthermia and sudden desaturation from 31Dec2020. Concomitant medication included warfarin sodium (COUMADINE). The patient previously received clozapine (LEPONEX) for dementia, ceftriaxone sodium (ROCEPHINE), amoxicillin clavulanic acid (AUGMENTIN), and ofloxacin. The patient experienced COVID-19 infection on 03Feb2021 with outcome of fatal. Clinical course: In Oct2020, the patient presented psychotic symptoms of severe dementia. Introduction of clozapine. 31Dec2020: episode of hyperthermia and sudden desaturation. PCR COVID negative. Treatment with ceftriaxone sodium in probabilistic mode. Switch ceftriaxone sodium to amoxicillin clavulanic acid + ofloxacin for cutaneous + urinary tract. 14Jan2021: seat lesion on the way to healing but widening of the orifice of the lesion which is flush with the anus. 21Jan2021: vaccination with bnt162b2. Apyretic patient at 36.5 deg C before injection. No reaction 15 minutes after injection. Patient under warfarin sodium (COUMADINE) (not administered on 20Jan2021 in the evening). Long compression at the injection site, no hematoma. Medical observations following vaccination: 23Jan2021: INR 2.9 check. 26Jan2021: biologically: Hb 16, 4 g / dL; Leuco 8.7 G / L; platelets 277 G / L. New rise in INR despite reduction in dose of warfarin sodium, new warfarin sodium treatment regimen. Hemoconcentration, it is recommended that the patient drink well. 29Jan2021 and 02Feb2021: INR 1.7. 03Feb2021: occurrence of acute asphyxial febrile respiratory distress on massive PAO, call from the IDE for acute dyspnea with desaturation below 70 percent. Fever at 38.7 deg C. Stage IV dyspnea. Rales diffuse in the 2 pulmonary fields. No edema of the MIG. Rapid pulse +++ BP retained. 03Feb2021: SARS-Cov2 RT-PCR positive. COVID 19 infection GD. Poor short-term prognosis. Part of cardiac decompensation on AC / AF rapid. The patient died on 03Feb2021 at 5:15 p.m. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: COVID-19 infection; COVID-19 infection


VAERS ID: 1048325 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Bedridden; Hypertension arterial; Hypertensive heart disease
Allergies:
Diagnostic Lab Data: Test Name: COVID test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021169144

Write-up: acute pulmonary edema; This is a spontaneous report from a contactable physician, received from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RS20210184. A 97-year-old female patient, living in care home, received the first dose of BNT162B2 (COMIRNATY), from lot #EM0477, via intramuscular route in the left arm on 15Jan2021 at single dose for covid-19 immunisation. Medical history included Bedridden, Hypertension arterial, Severe stage Alzheimer''s disease, Hypertensive heart disease, all from an unknown date and unknown if ongoing. No sign of allergy or reactogenicity since vaccination. Concomitant medications were not reported. On 29Jan2021, she presented with food vomiting with inhalation overnight and then left cardiac decompensation. On the morning of the 29Jan2021 she was in acute pulmonary edema and given the age and context, clinicians quickly turned to symptomatic treatment. The evolution was then unfavorable with death on 05Feb2021, despite diuretic treatment. It was unknown if an autopsy was performed. Lab data included a SARS-CoV-2 test with negative result on unknown date. The coincidence vaccine death seems rather fortuitous. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available, the event acute pulmonary edema is attributed to an intercurrent medical condition and assessed unrelated to BNT162B2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: acute pulmonary edema


VAERS ID: 1048327 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-11
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac failure, Disease recurrence, Drug ineffective, Dyspnoea, Haemodynamic instability, Hypoxia, Lung disorder, Pneumonia, Respiratory distress, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 12
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; Anxiety; Cardiomyopathy; Chronic renal failure; Cognitive disturbance; Decompensation cardiac; Depression; Hyperthyroidism; Insulin-requiring type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: antigenic Covid test; Test Result: Negative ; Test Date: 20210121; Test Name: antigenic Covid test; Test Result: Negative ; Test Date: 20210121; Test Name: Covid PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021159197

Write-up: 2019 novel coronavirus infection; Covid PCR test: positive; Pneumopathy; Dyspnoea; Hypoxia; worsening of the respiratory state, respiratory distress; hemodynamic instability; appearance of signs of cardiac decompensation; appearance of signs of cardiac decompensation; left basal pneumonia treated with antibiotics; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-ST20210155. A 90-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot/batch number and expiry date unknown), intramuscular on 05Jan2021 at unknown age at 0.3 mL single dose for covid-19 immunization. Medical history included atrial fibrillation, Cognitive disturbance, insulin-requiring type 2 diabetes mellitus, hyperthyroidism, anxiety, Chronic renal failure, Decompensation cardiac, depression, and cardiomyopathy, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced pneumopathy on 15Jan2021. On 11Jan2021, the patient had evidence of dyspnea with moderate hypoxia. On 15Jan2021, the patient had evidence of left basal pneumonia treated with antibiotics. On 17Jan2021, the patient performed an antigenic covid test with negative result. On 20Jan2021, the patient had worsening of the respiratory state with appearance of signs of cardiac decompensation. On 21Jan2021, the patient carried out of a new antigenic Covid test with negative result and Covid PCR test with positive test. On 22Jan2021, the patient was worsening of the respiratory state, respiratory distress and hemodynamic instability. The patient had comfort care in the service. The patient died on 23Jan2021. Seriousness criteria provided for hypoxia, pneumopathy, dyspnea, 2019 novel coronavirus infection and Covid PCR test with positive test was hospitalization and death. The reporter considered the picture of concomitant COVID-19 infection to be worsened by vaccination. The patient died for hypoxia, pneumopathy, dyspnea, 2019 novel coronavirus infection and Covid PCR test with positive test on 23Jan2021. An autopsy was not performed. Outcome of other events were unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number can not be obtained.; Reported Cause(s) of Death: dyspnea; hypoxia; Pneumopathy; 2019 novel coronavirus infection; covid pcr test: positive


VAERS ID: 1048386 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN; METROGEL; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Gout; Malignant melanoma; 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 INC2021166588

Write-up: atrial fibrillation; myocardial infarction; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102121200406190, Safety Report Unique Identifier GB-MHRA-ADR 24748777. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 vaccination. Medical history included gout from Feb2020, malignant melanoma from Oct2019, atrial fibrillation from Oct2019, all unknown if ongoing. Concomitant medications included apixaban, metronidazole (METROGEL), tamsulosin. The patient experienced myocardial infarction on 04Feb2021 and patient died on 04Feb2021. Cause of death reported as myocardial infarction and atrial fibrillation. An autopsy was performed and results were not available. It was reported that there''s no known causal link to the vaccine, but death occurred in a very close proximity to the vaccine date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: atrial fibrillation; Myocardial infarction


VAERS ID: 1048387 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2020-12-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 45
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20201215; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021170192

Write-up: Viral pneumonia; SARS-CoV-2 infection; SARS-CoV-2 infection; Sepsis; This is a spontaneous report from a contactable consumer, received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102121609242860, Safety Report Unique Identifier GB-MHRA-ADR 24750893. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunisation, on release from hospital. The patient medical history and the patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient felt at home on 24Dec2020 and was hospitalized. She was discovered to have sepsis, occurred on 23Dec2020. She improved and was released to a care home on 06Jan2021. She had a COVID-19 PCR test performed with a positive result on 02Feb2021 and shortly after was rushed to hospital. She was diagnosed with viral pneumonia and died on 06Feb2021 of viral pneumonia. It was not reported if an autopsy was performed. The patient underwent lab test included a sars-cov-2 test: negative on 15Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Viral pneumonia


VAERS ID: 1048388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-02-02
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021159508

Write-up: Sudden death; This is a spontaneous report from a contactable consumer. This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202102141035416710, Safety Report Unique Identifier GB-MHRA-ADR 24759210. A 77-years-old male patient received first dose of BNT162B2 (lot number: ek4243), via an unspecified route of administration, on 02Jan2021 at single dose for COVID-19 immunisation. The patient medical history included high blood pressure (BP) and pacemaker. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient previously received warfarin. The patient''s concomitant medications were not reported. The patient experienced sudden death on 02Feb2021. Had vaccine and dead in morning. The seriousness criteria of the event was reported as life threatening. The patient underwent lab tests and procedures which included COVID-19 virus test: negative covid-19 test on an unknown date. Patient had not tested positive for COVID-19 since having the vaccine. The details of any relevant investigations or tests conducted: "Post-mortem said natural causes due to a fib condition but had pacemaker". The outcome of the event was fatal. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: sudden death; Autopsy-determined Cause(s) of Death: a fib condition


VAERS ID: 1048389 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-24
Onset:2020-12-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-29
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: BP; Result Unstructured Data: Test Result:Low
CDC Split Type: GBPFIZER INC2021170308

Write-up: Vomit aspiration; Diarrhea; Low BP; This is a spontaneous report from a contactable consumer received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102141939491930, Safety Report Unique Identifier GB-MHRA-ADR 24760587. An 83-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 24Dec2020 at single dose for covid-19 immunisation. The patient medical history and the patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. On 26Dec2020 the patient experienced vomit aspiration, diarrhea and low bp. The outcome of the events diarrhea and low BP was reported as not recovered. The outcome of the event vomit aspiration was reported as fatal. The patient died on 29Dec2020. 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: Vomit aspiration


VAERS ID: 1048390 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-24
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, COVID-19, Confusional state, Drug ineffective, Electroencephalogram, Encephalopathy, Hallucination, Hypertonia, Myoclonus, SARS-CoV-2 test, Seizure, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 19
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: AMLODIPINE; ATORVASTATIN; BISOPROLOL; COLECALCIFEROL; EDOXABAN; FAMOTIDINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Gingival hypertrophy; Hepatic steatosis; Hypertension; Ischaemic stroke; Pulmonary embolism; Pulmonary sarcoidosis; Sensorineural hearing loss
Allergies:
Diagnostic Lab Data: Test Name: EEG; Result Unstructured Data: Test Result:showed general slowing, nil specific; Test Date: 20210131; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive COVID-19 test; Test Date: 20210206; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:suspected positive
CDC Split Type: GBPFIZER INC2021170185

Write-up: confusion; hallucinations; increased tone in arms; tremor; myoclonic jerks; Acute kidney injury; Seizures; Drug ineffective; SARS-CoV-2 infection; Encephalopathy acute; This is a spontaneous report from a contactable physician, received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202102151314380170 , Safety Report Unique Identifier GB-MHRA-ADR 24765082. A 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history included deafness neurosensory, pulmonary embolism, ischaemic stroke, gingival hypertrophy, hypertension, chronic kidney disease, stage 2 pulmonary sarcoid and liver steatosis, all unknown if ongoing. Concomitant medications included amlodipine, atorvastatin, bisoprolol, colecalciferol, edoxaban, famotidine. The patient experienced encephalopathy acute on 24Jan2021 and was admitted to hospital on 27Jan2021 with few days history of confusion and hallucinations, tremor, increased tone in arms. Also had Acute kidney injury (resolved in days with treatment). Developed myoclonic jerks and then seizures on 01Feb2021. Tested positive for covid around a week into admission on 31Jan2021. Lab data included a suspected covid-19 infection on 06Feb2021. Neurology opinion sought - unable to perform LP due to agitations and seizures, too unwell by the time CEPOD available. MRI unable to do due to covid and then deterioration. EEG showed general slowing, nil specific. Treated with intravenous acyclovir and ceftriaxone empirically (possible infective cause). Loaded on levetiracetam. Deteriorating level of consciousness throughout admission. Started on steroids, however, went to palliative care on 12Feb2021. 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: drug ineffective; confusion; hallucination; hypertonia; tremor; myoclonus; seizure; covid-19; encephalopathy


VAERS ID: 1048391 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-23
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; OLANZAPINE; PREGABALIN; TEGRETOL RETARD
Current Illness: Exposure to COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Behavioural disorder; Learning disorder (Severe learning difficulties with self-harm); Low mood
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021170024

Write-up: unwell; Death NOS; sars-cov-2 infection; sars-cov-2 infection; This is a spontaneous report from a contactable healthcare professional received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202102151354130980, Safety Report Unique Identifier GB-MHRA-ADR 24765674. A 53-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot EJ1688), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunisation. Medical history included learning disorder from an unknown date and unknown if ongoing reported as severe learning difficulties with self-harm, low mood and behavioural disorder. Patient was not enrolled in clinical trial. Concomitant medication included citalopram (unknown manufacturer), olanzapine (unknown manufacturer), pregabalin (unknown manufacturer), carbamazepine (TEGRETOL RETARD). The patient experienced death nos on 13Feb2021. The patient experienced also unwell on an unspecified date with outcome of recovered and sars-cov-2 infection on 23Jan2021 with outcome of unknown. The events were life-threatening. The patient underwent lab tests and procedures which included positive covid-19 test on 23Jan2021. The patient died on 13Feb2021. An autopsy was not performed. The events were reported as mild non specific malaise. Contact with carrier positive so screened and found positive. Not acutely unwell when went to bed, found dead in morning of 13Feb2021. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1048392 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4244 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; INCRUSE; WARFARIN
Current Illness: Dialysis
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Atrial fibrillation; Chronic renal failure (receiving dialysis); COPD; Diverticular disease; Ejection fraction decreased; IHD; Peripheral vascular disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021170371

Write-up: Death / died suddenly; pain at injection site; feeling achey; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority number GB-MHRA-WEBCOVID-202102151620228570, Safety Report Unique Identifier GB-MHRA-ADR 24766485. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK4244) on 12Feb2021, at single dose, for COVID-19 immunisation. Medical history included chronic renal failure (receiving dialysis), atrial fibrillation, LVSD, PVD, IHD, aortic valve replacement, diverticular disease and COPD. Concomitant medications included bisoprolol, umeclidinium bromide (INCRUSE) for COPD and warfarin for atrial fibrillation. The patient had a negative COVID-19 virus test on 02Feb2021. The patient had not had symptoms associated with COVID-19, was not enrolled in clinical trial and had not tested positive for COVID-19 since having the vaccine. On 12Feb2021 the patient had vaccination in the morning and went to dialysis in the afternoon. In the evening he started to c/o pain at injection site and feeling achey. He took paracetamol shortly after got up out of bed and then died suddenly on 13Feb2021. It was unknown if an autopsy was done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death / died suddenly


VAERS ID: 1048395 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Cardiac arrest, Chest pain, Circulatory collapse, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 15
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: Cardiac arrest
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021170071

Write-up: Death; cardiac arrest; collpased; chest pain; abdominal pain; This is a spontaneous report from a contactable physician received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202102160535174720, Safety Report Unique Identifier GB-MHRA-ADR 24769812. A 28-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Feb2021 at single dose for covid-19 immunisation. Medical history included cardiac arrest. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced death on 16Feb2021, chest pain and cardiac arrest in Feb2021 with outcome of unknown. The patient died on 16Feb2021. It was not reported if an autopsy was performed. It was reported that the patient presented to A&E just before Midnight with severe Abdominal and Chest Pain. Reception informed Pfizer vaccine administered that evening at local centre. Patient collapsed, Cardiac Arrest. 15 Minutes upon arrival. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1048396 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN3924 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUMETANIDE; SIMVASTATIN; SPIOLTO RESPIMAT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021169865

Write-up: Sudden death; cardiac arrest; chest pain; This is a spontaneous report from a contactable physician received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102161122363260, Safety Report Unique Identifier GB-MHRA-ADR 24771782. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EN3924) via an unspecified route of administration at single dose on 05Feb2021 for Covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). Concomitant medication included bumetanide for diuresis, simvastatin for cholesterol, olodaterol hydrochloride, tiotropium bromide monohydrate (SPIOLTO RESPIMAT). On 07Feb2021, the patient experienced chest pain, cardiac arrest, sudden death. Autopsy was performed. The events were assessed by the reporter as life threatening. The events were described as follows: She was known to have severe COPD on BiPAP at home. Seen by respiratory nurse at home on 04Feb2021. She had vaccine on 05Feb2021. On 07Feb2021 she complained of chest pain following which she had cardiac arrest and paramedics were not been successful to resuscitate her. The patient had not been tested for COVID-19 since the vaccination. The patient had not been tested positive 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 are possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1048403 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021170379

Write-up: Passed away; This is a spontaneous report from a contactable consumer (patient''s son). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient passed away 19 days after receiving the vaccine, on an unknown date. No further information about case of death was provided. It was unknown if an autopsy was done. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away


VAERS ID: 1048408 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SOLOSA; VESOMNI; TOVIAZ; ZOMARIST [VILDAGLIPTIN]; MENTIFAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder papilloma; Diabetes mellitus NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021164522

Write-up: Dyspnea; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB GR-GREOF-20211120. An 87-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY) via intramuscular on 21Jan2021 at a single dose for covid-19 immunisation. Medical history included Diabetes mellitus NOS and Papilloma of urinary bladder. Concomitant medication included glimepiride (SOLOSA) taken from unknown date to unknown date for unknown indication; solifenacin succinate, tamsulosin hydrochloride (VESOMNI) taken from unknown date to unknown date for unknown indication; fesoterodine fumarate (TOVIAZ) taken from unknown date to unknown date for unknown indication; vildagliptin (ZOMARIST) taken from unknown date to unknown date for unknown indication; memantine hydrochloride (MENTIFAR) taken from unknown date to unknown date for unknown indication; all orally. The patient the day after the first dose of Comirnaty (21Jan2021) presented dyspnea and on 23Jan2021 asked his son to take him to hospital but finally he did not feel so discomfort and postponed the visit. On 24Jan2021 (early hours) he died and dyspnea was fatal outcome. An autopsy was not performed. No follow-up attempts possible. Information about lot/batch cannot be obtained.; Reported Cause(s) of Death: Dyspnea


VAERS ID: 1048409 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Medical History/Concurrent Conditions: Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021186804

Write-up: pulmonary edema; dyspnea; This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. A 75-year-old male patient was administered the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 27Jan2021 at a single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus. The patient''s concomitant medications were not reported. The patient passed away on 01Feb2021 due to pulmonary edema. Patient mentioned experiencing dyspnea 10mins before death. The action taken in response to the events for bnt162b2 was not applicable. It was unknown if an autopsy was performed. The outcome of event dyspnea was unknown. As per attending physician causality not suspected. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary oedema


VAERS ID: 1048413 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Dyspnoea, Heart rate increased, Myocarditis, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:heart inflammation
CDC Split Type: ILPFIZER INC2021170222

Write-up: myocarditis- inflammation of the heart muscle; accelerated heartbeat; shortness of breath; sharp pains that were radiating down his left arm; This is a spontaneous report from two contactable consumers. A 19-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient developed myocarditis on unspecified date and died on 01Feb2021 five days after second dose. Patient had no underlying medical conditions prior to the event. Patient was hospitalized in ICU with myocarditis - inflammation of the heart muscle, five days after receiving his second dose of the coronavirus vaccine. The young patient received treatment at a (PRIVACY) clinical center on Sunday night before being transferred for further treatment to (PRIVACY) Medical Center. From when he had received the second dose, he had experienced an accelerated heartbeat, along with shortness of breath and sharp pains that were radiating down his left arm on unspecified date. Lab data included blood tests on unspecified date that revealed the heart inflammation. The patient died on 01Feb2021. It was unknown if autopsy was performed. According to the clinic, it has still not been confirmed that the inflammation was developed as a side effect of the vaccination. However, a number of COVID-19-related myocarditis cases have been reported, according to the Institute of Health. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1048428 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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: Test Date: 20210210; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210210; Test Name: Oxygen saturation; Test Result: 80 %
CDC Split Type: ITPFIZER INC2021166008

Write-up: HYPERPYREXIA (38 ?) DESATURATION (88% IN AIR) WITH NEED OF O2 THERAPY; HYPERPYREXIA (38 ?) DESATURATION (88% IN AIR) WITH NEED OF O2 THERAPY; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-676412. A 76-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number: EL0725, expiration date: 31Mar2021), intramuscular in left arm on 09Feb2021 15:10 at 0.3 ml single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced hyperpyrexia (38 ?) desaturation (88% in air) with need of O2 therapy on 10Feb2021. The patient died on 11Feb2021. The cause of death was hyperpyrexia (38 ?) desaturation (88% in air). It was unknown if an autopsy was performed. The outcome of the events was fatal. Sender Comment: the reporter has already been contacted and a detailed clinical report has already been requested, as soon as it is available it will be included in Pharmacovigilance database. No follow-up attempts possible. No further information expected.; Sender''s Comments: The reported event hyperpyrexia was confirmed with temperature value below 41.5?C (or 106.7?F), a value which, from a medical point of view is not consistent with hyperpyrexia. The Company therefore coded this event as pyrexia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: DESATURATION (88% IN AIR); HYPERPYREXIA (38 ?)


VAERS ID: 1048429 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Coma, Computerised tomogram head, Hypotonia, Investigation, Multiple organ dysfunction syndrome, Sepsis, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Chronic renal failure; Cognitive impairment; Disability; Malignant melanoma excision; Meningioma surgery (since then disabled)
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: Skull CT scan without contrast; Result Unstructured Data: Test Result:non significative; Test Date: 20210206; Test Name: TNF; Test Result: Negative
CDC Split Type: ITPFIZER INC2021166058

Write-up: Sudden death; Suspected severe sepsis with MOF; Suspected severe sepsis with MOF; Irreversible cardiac arrest; sudden comatose state with flaccidity in the 4 limbs/ deep comatose state; sudden comatose state with flaccidity in the 4 limbs; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-676420. A 92-years-old female patient received second dose of BNT162B2 (COMIRNATY, lot number: EL0725, expiration date: 31Mar2021) intramuscular in left arm on 05Feb2021 09:53 at 0.3 ml, single for COVID-19 immunisation; first dose (lot number: EJ6797, expiration date: 30Apr2021) via an unspecified route of administration in left deltoid on 14Jan2021 10:24 AM at single dose for COVID-19 immunisation. Medical history included arterial hypertension; chronic renal failure; cognitive impairment of severe degree; excision of dorsal meningioma in 1988, since then disabled; melanoma exeresis of the right thigh in 1995. Concomitant medications were not reported. The patient previously took tramadol and experienced allergy to it. The patient experienced sudden comatose state with flaccidity in the 4 limbs (on 06Feb2021) following inculation of second dose of COVID vaccine performed the previous day (on 05Feb2021); sudden death on 09Feb2021. It was reported that on 06Feb2021 patient was admitted to the hospital filter area. Skull CT scan without contrast non significative. Deep comatose state persists in hospital. Suspected severe sepsis with MOF. TNF negative. Irreversible cardiac arrest. Outcome of the events coma and flaccidity was fatal; outcome of events suspected severe sepsis with MOF and irreversible cardiac arrest was unknown. It was unknown if an autopsy was done or not. Reporter''s comment: "In the history: arterial hypertension, chronic renal failure, cognitive impairment of severe degree. excision of dorsal meningioma (1988, since then disabled), melanoma exeresis of the right thigh (1995). Allergy to tramadol. The 05Feb performs 2 dose Pfizer vaccine. On 06Feb she was admitted to the PRIVACY hospital filter area. Skull CT scan without contrast non significative. Deep comatose state persists in hospital. Suspected severe sepsis with MOF. TNF negative. Irreversible cardiac arrest". No follow-up attempts possible. No further information expected.; Reporter''s Comments: In the history: arterial hypertension, chronic renal failure, cognitive impairment of severe degree. excision of dorsal meningioma (1988, since then disabled), melanoma exeresis of the right thigh (1995). Allergy to tramadol. The 05Feb performs 2 dose pfizer vaccine. On 06Feb she was admitted to the PRIVACY hospital filter area. Skull CT scan without contrast non significative. Deep comatose state persists in hospital. Suspected severe sepsis with MOF. TNF negative. Irreversible cardiac arrest.; Reported Cause(s) of Death: sudden comatose state with flaccidity in the 4 limbs/ deep comatose state; sudden comatose state with flaccidity in the 4 limbs; sudden death


VAERS ID: 1048591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nausea, Pyrexia, SARS-CoV-2 test positive
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; AMLODIPINE; ACENOCOUMAROL; HYDROCHLOORTHIAZIDE
Current Illness: Heart failure
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (little disease symptoms)
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: pyrexia; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Test Date: 20200909; Test Name: corona test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021158428

Write-up: Nausea; Fever: 38 to 40.5 degrees Celsius/pyrexia; Headache; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NL-LRB-00439085. An 85 years old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EM0477, Solution for injection) via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunisation. Medical history included ongoing heart failure, COVID-19 on 09Sep2020. Previous COVID-19 infection was included little disease symptoms. Concomitant medication included paracetamol tablet 500mg, hydrochloorthiazide tablet 12,5mg, acenocoumarol tablet 1mg, amlodipine tablet 5mg. There was no past drug therapy reported. It was reported patient experienced nausea (death), fever: 38 to 40.5 degrees Celsius/pyrexia (death), headache, all events occurred on 03Feb2021 (1 days after start). The drugs and latency were 1 day. It was not sure if death was due to vaccine. There was fever in elderly client with heart complaints. There was confounding factors: heart failure. The patient underwent lab tests and procedures which included corona test on 09Sep2020: positive. There were no other diagnostic procedures. The patient recovered from headache on 03Feb2021, the outcome of nausea and fever: 38 to 40.5 degrees Celsius/pyrexia were fatal. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Fever: 38 to 40.5 degrees Celsius/pyrexia; Nausea


VAERS ID: 1048592 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pallor, SARS-CoV-2 test, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; PARACETAMOL; MOVICOLON; CALCI CHEW D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Humerus fracture (Admitted to a nursing home for temporary admission due to this fracture); Transient ischemic attack (clopidogrel therapy had been initiated)
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: NLPFIZER INC2021158430

Write-up: sudden cardiac death (death); Patient got dyspneic in the morning; Suddenly looked pale; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory-WEB with Regulatory authority report number [NL-LRB-00439117]. A 91-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/lot number: EM0477), via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation. Medical history included humerus fracture from Jan2021 to an unknown date, the patient was admitted to a nursing home for temporary admission due to this fracture, transient ischaemic attack from an unknown date, for which clopidogrel therapy had been initiated. Concomitant medication included clopidogrel (tablet), paracetamol (tablet), macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON), calcium carbonate, colecalciferol (CALCI CHEW D3). Routine COVID-19 test at day of admission, 6 days prior to vaccination on 28Jan2021 was negative. The patient experienced sudden cardiac death (death) on 05Feb2021, reported as serious with serious criteria death, patient got dyspneic in the morning and suddenly looked pale on 05Feb2021, reported as non-serious. It was also reported that the patient did not experience any side effects from vaccination. Whilst sitting in a chair patient became suddenly dyspnoeic and pale, collapsed and died within 10-15 minutes. The patient underwent lab test which included COVID-19 test: negative on 28Jan2021. The patient died on 05Feb2021. It was not reported if an autopsy was performed. The outcome of events dyspnoea and pallor facial was unknown and the outcome of sudden cardiac death was fatal. Nursing home physician rated relationship with vaccination as unlikely ("probably sheer coincidence") and named "sudden cardiac death" as most probably cause of death.; Reported Cause(s) of Death: sudden cardiac death


VAERS ID: 1048594 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation, Oxygen saturation decreased, Respiratory rate
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: ESOMEPRAZOLE
Current Illness: Aspiration pneumonia; Axonal neuropathy; Malnutrition; Mixed dementia (end stage); Venous insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia (probably myelodysplastic syndrome); Gastric haemorrhage; Reflux oesophagitis
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: saturation; Test Result: 72 %; Test Date: 20210129; Test Name: respiratory rate; Result Unstructured Data: Test Result:95 breaths per minute
CDC Split Type: NLPFIZER INC2021158441

Write-up: decreased oxygen saturation; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. This is a report received from the Regulatory Authority. Regulatory authority report numbers were NL-LRB-00441201 and NL-LRB-00441824. A 68-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EM0477), via an unspecified route of administration on 28Jan2021 as a single dose for COVID-19 immunisation. Ongoing medical history included venous insufficiency from Jun2020, end stage mixed dementia from Aug2017, pneumonia aspiration from Jan2021, mild sensorimotor axonal polyneuropathy from 2012, and poor nutritional status from an unknown date. Other relevant medical history included gastric haemorrhage from Dec2020 to an unknown date, reflux oesophagitis from an unknown date and unknown if ongoing, and anaemia (probably myelodysplastic syndrome) from 2019 to an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included esomeprazole (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date and unknown if ongoing. On 29Jan2021, the patient experienced decreased oxygen saturation; which was fatal. The clinical course was as follows: Shortly before the vaccination, the patient experienced an aspiration pneumonia. One day after vaccination, the patient experienced decreased oxygen saturation at 72% and high breathing frequency of 95 breaths per minute. A Corona test was not performed. Two days after vaccination, the patient was deceased. The clinical outcome of oxygen saturation decreased was reported as fatal. The patient died on 30Jan2021. An autopsy was not performed. According to the reporting physician, the patient''s death was caused by the aspiration pneumonia which occurred just before the vaccination. The patient''s nutritional status was bad and the patient had an advanced stage of dementia. The representative of the patient suspected the COVID-19 vaccine. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: decreased oxygen saturation; Aspiration pneumonia


VAERS ID: 1048596 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Nausea, Oxygen saturation decreased, Pneumonia aspiration, Pyrexia, SARS-CoV-2 test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   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: PARACETAMOL; COLECALCIFEROL; OMEPRAZOL; MACROGOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Intellectual disability
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210110; Test Name: corona, confirmed by test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021163812

Write-up: low saturation; then fever, temperature 38.5 centigrade; Vomiting; Nausea; suspected aspiration pneumonia; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NL-LRB-00441933, received from Regulatory Authority. A 94-year-old female patient received 1st dose of bnt162b2 (COMIRNATY, strength: 0.3 ml, lot number: EM0477), via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation, oxycodone hydrochloride (OXYCODON, strength: 5 mg), via an unspecified route of administration from 02Feb2021 to 05Feb2021 at Freq:8 h;3d5mg for pain with fracture humerus. Medical history included COVID-19 from 10Jan2021, intellectual disability. Concomitant medication included paracetamol (strength: 500 mg), colecalciferol, omeprazole (strength: 40 mg), macrogol. The patient experienced low saturation, then fever, temperature 38.5 centigrade, vomiting, nausea on 04Feb2021. Later on the day after vaccination (04Feb2021), abnormalities were seen in the lungs. Suspicion of reported: aspiration pneumonia. Treatment: Nausea was treated with metoclopramide zetpil 10mg 3 times a day 1. Drugs and latency: 1. covid-19 vaccine pfizer Injectable solution for events: 1 day after start; 2. oxycodon capsule 5mg for events: 2 days after start. The patient underwent lab tests and procedures which included body temperature: 38.5 centigrade on 04Feb2021, corona confirmed by test: positive on 10Jan2021. The action taken in response to the events for oxycodone hydrochloride was permanently withdrawn on 05Feb2021. The outcome of events was fatal. The patient died on 06Feb2021. It was not reported if an autopsy was performed. Case Summary and Reporter''s Comments Text: BioNTech/Pfizer vaccine (Comirnaty) ----------------------Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no ---------- vomiting, then fever and low saturation ----------------------Additional information ADR: Patient with intellectual disability, living in institution. Patient had a positive COVID test on 10Jan2021, but has not been very ill. Therefore consciously opted for vaccination. Day after vaccination vomiting and possible pain from humerus fracture, also temperature 38.5 centigrade. Later in the day also some abnormalities of the lungs. Suspicion aspiration pneumonia. She passed away on 06Feb2021. ---------- COVID19 ----------------------Previous COVID-19 infection: disease symptoms: none ---------- Other ----------------------diagnostic procedures: no No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of Reporter Comment: Patient with intellectual disability, living in institution. Positive COVID test on 10Jan2021, but has not been very ill. Therefore consciously opted for vaccination. Day after vaccination vomiting and possible pain from humerus fracture, also temperature 38.5 C. Later in the day also some abnormalities of the lungs. Suspicion aspiration pneumonia. She passed away on 06Feb2021. Previous COVID-19 infection: disease symptoms: none, Other diagnostic procedures: no; Reported Cause(s) of Death: low saturation; then fever, temperature 38.5 centigrade; Vomiting; Nausea; suspected aspiration pneumonia


VAERS ID: 1048597 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Death, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: FENTANYL
Current Illness: Anemia; Palliative care; Renal failure
Preexisting Conditions: Medical History/Concurrent Conditions: Dehydration
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: blood check; Result Unstructured Data: Test Result:unknown results; Test Date: 20210201; Test Name: blood check; Result Unstructured Data: Test Result:anemia appeared to be better than expected
CDC Split Type: NLPFIZER INC2021163972

Write-up: Death; Unwell; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NL-LRB-00442005, received from Regulatory Authority. A 67-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot# unknown, 0.3ml), via an unspecified route of administration on 26Jan2021 at 0.3 mL, single for covid-19 immunisation; fentanyl (manufacturer unknown, 25 ug), via an unspecified route of administration from an unspecified date to 25Jan2021 at 12 ug, 1x per 3 days, then from 26Jan2021 and ongoing at 25 ug, 1x per 3 days for pain. Medical history included ongoing anemia, ongoing palliative care, ongoing terminal renal failure and dehydration. The patient had already palliative care and was known with increasing anemia. The patient''s concomitant medications were not reported. At the same day as the day of vaccination (26Jan2021), the fentanyl dosage was increased from 12 to 25 ug per hour and blood check was requested for the anemia. Two days after increasing the dosage of fentanyl and administration of Covid 19 vaccine (28Jan2021), the patient became unwell. From that moment, the palliative care was continued and 6 days after vaccination and increasing dosage of fentanyl on 01Feb2021, once more blood check was requested. Anemia appeared to be better than expected but the patient had a terminal renal failure which was induced by dehydration of an already terminal patient. The patient experienced death in Feb2021. The action taken in response to the events for fentanyl was dose not changed. The patient died in Feb2021. It was not reported if an autopsy was performed. Outcome of unwell was unknown. Reporter''s Comment: On 26Jan2021, the decision was made to increase the fentanyl patch and request a lab check. It was known to have an increasing anemia. On Thursday, 28Jan2021, patient became unwell. From that moment on, the palliative policy was continued and on Monday 01Feb2021 a lab test was done. It showed that the anemia was not too bad, but she had terminal kidney failure. This terminal kidney failure can be caused by dehydration in an already terminal lady. Confounding factors: patient was already palliative and it is unclear if this was precipitated. Diagnostic procedures: it was not thought until the time of death, that vaccination may have played a role. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: From that moment on, the palliative policy was continued and on Monday 01Feb2021 a lab test was done. It showed that the anemia was not too bad, but she had terminal kidney failure. This terminal kidney failure can be caused by dehydration in an already terminal lady. Confounding factors: patient was already palliative and it is unclear if this was precipitated. Diagnostic procedures: it was not thought until the time of death, that vaccination may have played a role.; Reported Cause(s) of Death: Death


VAERS ID: 1048599 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Off label use, Product use issue
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; NITROGLYCERINE; METOPROLOL; ALFACALCIDOL; SERETIDE; PANTOPRAZOL [PANTOPRAZOLE]; FUROSEMIDE; DEXAMETHASON [DEXAMETHASONE]; SPIRIVA RESPIMAT; DESURIC; DUTASTERIDE; ATROVENT; CALCI CHEW D3
Current Illness: COPD; Dialysis; Heart failure; Renal insufficiency; Vascular dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Colon carcinoma; Myocardial infarct; Pneumonia; Suspected COVID-19 (disease symptoms: quite)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021163946

Write-up: patient received bnt162b2 with concomitant medication dexamethasone; patient received bnt162b2 with concomitant medication dexamethasone; Sudden death within 24 hours after 2nd vaccination; This is a spontaneous report from contactable physician downloaded from the Agency Regulatory Authority-WEB NL-LRB-00442456. An 89-year-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Feb2021 at single dose for covid-19 immunisation. Medical history included ongoing renal insufficiency, ongoing dialysis, ongoing COPD, pneumonia, ongoing heart failure, myocardial infarct, ongoing vascular dementia, colon carcinoma, and suspected COVID-19 from 01Aug2020 (disease symptoms: quite). Concomitant medications included clopidogrel, glyceryl trinitrate (NITROGLYCERINE), metoprolol, alfacalcidol, fluticasone propionate, salmeterol xinafoate (SERETIDE), pantoprazole (PANTOPRAZOL), furosemide, dexamethasone (DEXAMETHASON), tiotropium bromide (SPIRIVA RESPIMAT), benzbromarone (DESURIC), dutasteride, ipratropium bromide (ATROVENT), calcium carbonate, colecalciferol (CALCI CHEW D3). Patient previously received first dose of bnt162b2 (COMIRNATY) on 19Jan2021 at single dose for covid-19 immunisation. The patient experienced sudden death within 24 hours after 2nd vaccination on 10Feb2021. An autopsy was performed, and no autopsy result was available. The reporter described that the patient was not ill and had no specific complaints the days before the second vaccination. It was unknown if the patient experienced any events after the first administration. No follow-up attempts are possible, information about batch number cannot be obtained. ; Reported Cause(s) of Death: Sudden death within 24 hours after 2nd vaccination


VAERS ID: 1048600 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-02
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Computerised tomogram head, Hemiparesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Vascular disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Paresis; Postictal state (hemiparesis was interpreted as a result of it)
Allergies:
Diagnostic Lab Data: Test Name: CT brain; Result Unstructured Data: Test Result:fitting post-ictal picture
CDC Split Type: NLPFIZER INC2021158619

Write-up: Cerebral haemorrhage; with left hemiparesis; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NL-LRB-00441293. A 72-year-old male patient received bnt162b2 (COMIRNATY) in Jan2021 at single dose for COVID-19 immunisation, started to receive apixaban from an unknown date at 2dd per day for atrial flutter. Medical history included paresis, ongoing vascular disorder (non-specified), several weeks before the cerebral haemorrhage started, postictal state (hemiparesis was interpreted as a result of it), bloody stroke (CVA); no previous COVID-19 infection. Concomitant medications were not provided. The patient previously did not receive bnt162b2 as past drug therapy. The patient experienced cerebral haemorrhage with hemiparesis (left) on 02Feb2021, 3 days after administration of bnt162b2 and within 2 years after apixaban. The events caused death, life threatening, hospitalization for 2 days. The patient underwent lab tests and procedures, which included other diagnostic procedures: in it hospital: CT brain has several weeks before the bloody stroke (CVA) also went through a hemi picture, then indicated as fitting post-ictal picture. The patient deceased in Feb2021 within 9 days after vaccination due to the cerebral haemorrhage with hemiparesis. The reporter described that another circumstance which might have influenced the event was non-specified vascular disorder. Action taken with apixaban was unknown. The patient died in Feb2021. The reported cause of death was cerebral hemorrhage with hemiparesis left. Health Authority Comment: BioNTech / Pfizer vaccine (Comirnaty); Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no; Cerebral hemorrhage with hemiparesis links Hospitalization information: 2 days Additional information ADR: continuously present Social Security Number; BSN available: yes confounding factors, confounding factors: Vascular disease COVID19, Previous COVID-19 infection: No, Other diagnostic procedures: in it hospital: CT brain Mr. has several weeks before the bloody stroke (CVA) also went through a hemi picture, then indicated as fitting post-ictal picture. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: with left hemiparesis; Cerebral hemorrhage


VAERS ID: 1048601 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Basilar artery thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (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: TEGRETOL; AMOXICILLIN/CLAVULANIC ACID; LEVETIRACETAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021163915

Write-up: Ischemic cerebrovascular accident; basilar thrombosis; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NL-LRB-00442479. An adult female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunization. The patient''s medical history was not reported. Concomitant medication included carbamazepine (TEGRETOL, tablet, strength: 100 mg), amoxicillin trihydrate, clavulanate potassium (AMOXICILLIN/CLAVULANIC ACID, strength: 500/125mg), levetiracetam. It was reported that 5 days after vaccination on 31Jan2021, the patient experienced an ischemic CVA (ischemic cerebrovascular accident), namely a basilar artery thrombosis. The patient was treated with thrombolysis and stenting. The patient deceased an unknown period in 2021 after the basilar artery thrombosis. It was not reported if an autopsy was performed. Sender Comment: The age of the patient is unknown, therefore "adult" was chosen as patient age group. Case Summary and Reporter''s Comments Text: ---------- BioNTech / Pfizer vaccine (Comirnaty) ---------------------- Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): unknown ---------- Ischemic CVA; basilar thrombosis ---------------------- Additional information ADR: - ---------- COVID19 -------- -------------- Previous COVID-19 infection: No ---------- Other ------------------ ---- diagnostic procedures: - No follow-up attempts possible, no further information expected. information about lot/batch number cannot be obtained.; Reporter''s Comments: ---------- BioNTech / Pfizer vaccine (Comirnaty) ---------------------- Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): unknown ---------- Ischemic CVA; basilar thrombosis ---------------------- Additional information ADR: - ---------- COVID19 -------- -------------- Previous COVID-19 infection: No ---------- Other ------------------ ---- diagnostic procedures: -; Reported Cause(s) of Death: Ischemic cerebrovascular accident; basilar thrombosis


VAERS ID: 1048602 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Dyspnoea, Malaise
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021163615

Write-up: Short of breath; Dehydration; General malaise; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. This is a report received from the regulatory authority. The regulatory authority report number is NL-LRB-00442893. An 88-year-old female patient received the first dose of the bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. The patient''s medical history included dementia from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 06Feb2021, the patient experienced: short of breath, dehydration, general malaise, following administration of the bnt162b2 vaccine; all of which resulted in death. The clinical outcome of the events was fatal. The patient was deceased two to seven days after the vaccination. The patient died on an unspecified date in Feb2021 due to an unknown cause of death (as reported). It was unknown if an autopsy was performed. Reporter''s Comments Text: There was no past drug therapy with the BioNTech / Pfizer vaccine (COMIRNATY). Additional information ADR: "Complete chaos arise in and around the body." Confounding factors: Dementia. There was no previous COVID-19 infection. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1048603 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Fatigue, Malaise, Myalgia, Nausea, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL; AMLODIPINE; ENALAPRIL; COLECALCIFEROL
Current Illness: Fasting blood glucose abnormal; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever
CDC Split Type: NLPFIZER INC2021169354

Write-up: Injection site pain; Muscle pain; Fatigue; Nausea; Not feeling well; Fever; Transient slightly shortness of breath; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [Lareb (LRB) number NL-LRB-00442904] from a contactable physician. An 87 years od female patient received the 1st dose of bnt162b2 (COMIRNATY, lot# EJ6788), via an unspecified route of administration, on 09Feb2021, at single dose, for COVID-19 immunisation. Medical history included ongoing hypertension and ongoing fasting blood glucose abnormal. Concomitant medications included colecalciferol (unknown manufacturer), amlodipine (unknown manufacturer), enalapril (unknown manufacturer), metoprolol (unknown manufacturer). The patient experienced transient slightly shortness of breath, nausea, muscle pain, not feeling well, fatigue, injection site pain, fever on 10Feb2021 with fatal outcome the same day. It was unknown if an autopsy was performed. Reporter comment: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no -transient slightly short of breath / short of breath - Additional information ADR: onset within 24 after vaccination - COVID19 - Previous COVID-19 infection: Remarks report form: Woman died 1 day after vaccination, complaints such as described before vaccination not present, woman had hypertension and an abnormal fasting glucose as risk factors Heart and vascular disease, was not known further with Heart and vascular disease. Drug-reaction(s) / Event(s) Matrix for the suspect and for all events Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number): 1 Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit): days.; Reporter''s Comments: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no -transient slightly short of breath / short of breath - Additional information ADR: onset within 24 after vaccination - COVID19 - Previous COVID-19 infection: Remarks report form: Woman died 1 day after vaccination, complaints such as described before vaccination not present, woman had hypertension and an abnormal fasting glucose as risk factors Heart and vascular disease, was not known further with Heart and vascular disease.; Reported Cause(s) of Death: Muscle pain; fatigue; nausea; Not feeling well; pyrexia; Transient slightly shortness of breath; Injection site pain


VAERS ID: 1048604 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: General physical health deterioration; Multimorbidity; Reduced general condition (Gradually declining general condition and malnutrition over several weeks in the short-term ward.)
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia (Refrained from endoscopic examination based on an overall assessment.); Confusion (Increasing confusion in January 2021, delirium?); Kidney cancer; Malnutrition NOS (Gradually declining general condition and malnutrition over several weeks in the short-term ward); Melena (Refrained from endoscopic examination based on an overall assessment.); Pelvic fracture (With prolonged course and loss of function.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021163720

Write-up: Multiorgan failure; REDUCED GENERAL CONDITION; TERMINAL STATE; MALNUTRITION; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority number NO-NOMAADVRE-FHI-2021-U1xny. Other case identifier number NO-NOMAADVRE-E2B_00014991.A 87-years-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number: EJ 6136), the second dose, intramuscular on 28Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included Melena from Dec2020 to an unknown date Refrained from endoscopic examination based on an overall assessment, Malnutrition NOS from Jan2021 which Gradually declining general condition and malnutrition over several weeks in the short-term ward, pelvic fracture from Nov2020 With prolonged course and loss of function, Reduced general condition from Jan2021 and ongoing which Gradually declining general condition and malnutrition over several weeks in the short-term ward, ongoing multimorbidity, general physical health deterioration from Nov2020 and ongoing , confusion from Jan2021 Increasing confusion in January 2021, delirium? , Kidney cancer from 2014, anaemia from Dec2020 which Refrained from endoscopic examination based on an overall assessment. The patient''s concomitant medications were not reported. On 28Jan2021, the patient developed Reduced general condition, terminal state, malnutrition. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. The patient died on 31Jan2021. It was not reported if an autopsy was performed.Reporter''s comment: 87-year-old multimorbid patient with clear-cell renal carcinoma in 2014, pelvic fracture in /11/2020 with prolonged course and loss of function, melena and anemia in Dec2020, but an endoscopic examination was excluded based on an overall assessment. Gradually declining AT and malnutrition over several weeks in the short-term ward, increasing confusion in January 2021, delirium? He received 2. dose Covid-19 vaccine on Thursday 28Jan2021 (BioNTech / Pfizer, Batch EJ 6136), terminal development within 3 days with total nutritional failure and severly reduced AT, but afebrile. Patient died peacefully 31Jan2021 due to suspected multi-organ failure. Event Assessment: For all events / Regional Pharmacovigilance Center / Possible. Sender Comment: When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or due to some other random simultaneous cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the message is classified as serious. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: MULTIORGAN FAILURE


VAERS ID: 1048605 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HEMOFER [FERROUS SULFATE]; BEHEPAN [CYANOCOBALAMIN]; PRADAXA; VENTOLINE [SALBUTAMOL]; BURINEX; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; QUETIAPIN SANDOZ; PARACET [PARACETAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aphasia; Constipation; Diuretic therapy; Fibromyalgia; Frontotemporal dementia; Laboured breathing; Living in residential institution; Lumbalgia; Nervous system disorder NOS; Pain; Sleep disorder NOS; Vitamin B12 supplementation
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021163717

Write-up: FOUND DEAD; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U1xqy, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014950. An 81-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot# EM0477), via intramuscular on 28Jan2021 10:00 in right arm at single dose for Covid-19 vaccination. The medical history included living in residential institution, frontotemporal dementia, lumbalgia, aphasia, sleep disorder nos, nervous system disorder nos, fibromyalgia, vitamin b12 supplementation, laboured breathing, diuretic therapy, pain and constipation. As concomitant medication the patient was given ferrous sulfate (HEMOFER, 9 mg) from 09Apr2019; cyanocobalamin (BEHEPAN, 1 mg) for vitamin b12 supplementation from 09Apr2019; dabigatran etexilate mesilate (PRADAXA, 110 mg) for cerebrovascular accident prophylaxis from 25Aug2020; SALBUTAMOL (VENTOLINE, 0.1 mg) for laboured breathing from 03Apr2019; bumetanide (BURINEX, 1mg) for diuretic therapy from 22Sep2020; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL, 13.125 g/46.6 mg/350.7 mg/178.5 mg) for constipation; quetiapine fumarate (QUETIAPIN SANDOZ, 25mg) for frontotemporal dementia from 12Jan2018; paracetamol (PARACET, 1g) for pain. The patient previously took the first dose of bnt162b2 (COMIRNATY) for COVID-19 vaccination on an unspecified date. On the morning of 04Feb2021, the patient was found dead in her bed. The reporter stated that there had not been noted any changes in the patient''s health condition after vaccination, and that the patient was in her habitual state the evening before and during the night. No specific information of cause of death was stated, and no further information on cause of death will be sought for this report. It was not reported if an autopsy had been performed. The patient''s outcome was fatal, at the time of the report. The case was considered to be serious. Sender Comment: The report concerns a patient in her 80s, who was found dead in her bed one week after the second dose of the Covid-19 vaccine Comirnaty. The patient had not shown any previous symptoms, and was considered to be in her habitual state before the death occurred. The patient had several serious, underlying diseases. Normally, between 300 and 400 people die per week in nursing homes and similar institutions in international. In a international study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and find, among other things, that the risk of death has increased in the first four months after hospitalization, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebro-vascular disease accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (20%), respiratory and infectious diseases (including pneumonia and sepsis) (15%), and cancer (10%). When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. In the individual case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or due to some other random, simultaneous 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. Data from use in frail patients with co-morbidity are nevertheless limited, and such lack of information will be obtained in post-marketing studies, among other things. Since the vaccine is new, it is subject to special monitoring 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 link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the message is also classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: FOUND DEAD


VAERS ID: 1048607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   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: TAMBOCOR; LIVOSTIN; CALCIGRAN FORTE; LEVAXIN; LEVAXIN; PARACET [PARACETAMOL]; SOBRIL; ABILIFY; PRADAXA; EXELON [RIVASTIGMINE]; BETMIGA; AVAMYS; DAKTACORT; OVESTERIN; APODORM
Current Illness: Alzheimer''s disease; Depression; Diastolic dysfunction; Home care (The patients has help from homenursing); Hypertension; Hyperthyroidism; Living alone; Mitral insufficiency; Multimorbidity; Paroxysmal atrial fibrillation
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder operation NOS; High cholesterol; Mammoplasty; Orthostatic hypotension; Syncope
Allergies:
Diagnostic Lab Data: Test Date: 202004; Test Name: Echocardiogram; Result Unstructured Data: Test Result:MITRAL INSUFFICIENCY
CDC Split Type: NOPFIZER INC2021158457

Write-up: SUDDEN DEATH UNEXPLAINED; Daughter called later in the evening and then she was not quite in shape/general condition reduced; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U7yy5, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00015078. An 86 years old Female patient received 1st dose of Comirnaty (Batch/lot no: EJ6136) Intramuscular on the 03Feb2021 11:30 at single dose for covid-19 immunization. The medical history included Mammoplasty, Bladder operation, ongoing multimorbidity, living alone, ongoing home care, ongoing hypertension, high cholesterol, ongoing hyperthyroidism, ongoing mitral insufficiency, ongoing paroxysmal atrial fibrillation, ongoing alzheimer''s disease, ongoing depression, syncope, ongoing diastolic dysfunction, orthostatic hypotension. As concomitant medication the patient was given calcium carbonate/colecalciferol (CALCIGRAN FORTE), dabigatran etexilate mesilate (PRADAXA), flecainide acetate (TAMBOCOR), mirabegron (BETMIGA), levothyroxine sodium (LEVAXIN), paracetamol (PARACET), aripiprazole (ABILIFY), rivastigmine (EXELON), fluticasone furoate (AVAMYS), levocabastine hydrochloride (LIVOSTIN), hydrocortisone/miconazole nitrate (DAKTACORT), oxazepam (SOBRIL), nitrazepam (APODORM), estriol (OVESTERIN). The patient was treated in the past with Candesartan, but this drug was withdrawn after an episode with syncope, where the patients afterwards was found to have orthostatic hypotension. During the afternoon/evening of the 03Feb2021 the patient described herself as general condition reduced. On 04Feb2021, the patient was found dead by the home nurse. The reporting physician reported this as SUDDEN DEATH UNEXPLAINED. Relevant laboratory findings and investigations included was otherwise not included in the report. Echocardiogram: mitral insufficiency in Apr2020. Since the patient''s outcome was fatal, at the time of the report this case was considered to be serious. This case was received from a Physician. Daughter called later in the evening and then she was not quite in shape. Sender''s Comment: Causality assessment: Symptoms such as general malaise occurred in the first days after vaccination with all vaccines. A large proportion of those vaccinated who received Comirnaty reported fatigue, joint and muscle pain, and a small proportion developed fever and chills after this vaccine. Fever and malaise occurred more often after the second dose. Generally, such reactions occurred within 1-2 days after vaccination. They were usually of mild or moderate intensity and passed after a few days. The side effects occur less frequently in the elderly ($g 55 years) than in younger adults. In the current incident, the patient became ill the same evening as the patient received the first dose of the vaccine and was found dead the next day. It is stated in the report that the patient had known underlying diseases. When vaccinating elderly patients who are ill with many underlying diseases, some serious incidents, including death, may occur shortly after vaccination without any connection to vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or other accidental, concurrent cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal 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 is classified as possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Daughter called later in the evening and then she was not quite in shape/general condition reduced; SUDDEN DEATH UNEXPLAINED


VAERS ID: 1048608 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Death, Dehydration, Investigation, Vital signs measurement
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIFLUCAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Death imminent; Living in nursing home; Malnutrition; Multimorbidity
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:16; Test Name: HB control; Result Unstructured Data: Test Result:over 8; Test Name: vital signs; Result Unstructured Data: Test Result:Normal
CDC Split Type: NOPFIZER INC2021163710

Write-up: Death; dehydration; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority- NO-NOMAADVRE-FHI-2021-U8x3n, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014869. Fatal outcome of a 95-year-old male seven days after vaccination with BNT162B2 (COMIRNATY, lot number: EJ6795) received first dose on 13Jan2021 14:00 intramuscularly at a single dose for COVID-19 immunization. Medical history included death imminent from 09Jan2021 to an unknown date, multimorbidity, malnutrition, living in nursing home. As concomitant medication the patient was given fluconazole (DIFLUCAN, strength: 100 mg) from 11Jan2021 to 18Jan2021 due to fungal infection of the mouth. The patient was multimorbid, malnutritioned before the vaccination and was designated as preterminal from 09Jan2021 until death 20Jan2021. Reporter believed that the outcome would most likely be the same regardless of vaccination, but that it is difficult to say whether the outcome was accelerated due to the vaccination or not. Multimorbid patient. The patient has been ill in the last year and has been preterminal 3-4 times before but has recovered each time. Reporter would not really have recommended vaccination for the patient in question. This patient has DNR-Code and had tendency for bleeding. The reporter believed that the patient had heart and kidney failure but does not remember completely (does not have the opportunity to look up in the journal). Timeline - notes from journal note: 11Jan2021 13:20: The patient has eaten little in the last 2-3 days, and he seems bothered. On examination today, the patient has coating on the tongue and a little on the pharyngeal mucosa. It is agreed to start with fluconazole for fungal infection, 200 mg the first day and then 100 mg daily, assess effect in 1 week to assess effect and possible treatment time. 11Jan2021 14:14: Following recommendations, the patient is offered bnt162b2 vaccine. The patient/relative has given consent for him to receive the vaccine. Vaccination is voluntary. 13Jan2021 14:00: COMIRNATY was given. On 18Jan2021 12:44: The Patient has been reduced last week, was put on fluconazole due to fungus from 11Jan2021, but the patient is still reduced and lying in bed. The patient eats and drinks very little. At the weekend ate and drank very little, lying in bed, slept a lot. Attempts were made to treat with intravenous fluids (1000 Ringer) daily for three days in regards to dehydration, without much effect. During supervision today, the patient is lying in bed, lies with his mouth open, does not make contact, no eye contact. The patient does not respond to indictment, does not appear like he is in pain or short of breath. Normal vital signs, last CRP of 16, HB control over 8. Lungs and abdomen without remarks. No signs or focus of infection, stable HB, not helped with fluid therapy for dehydration. Further measures: He is perceived as preterminal, no indication for antibiotic treatment or further intravenous fluid treatment. The patient must be observed in the future. In the event of a persistent clinical condition, he must be treated as the preterminal/terminal patient and treated with four drugs for the end-of-life phase. Treatment intensity: The patient must be treated in a nursing home unless there is an indication for hospitalization in the event of a treatment failure (relief) which leads to many troublesome symptoms that we are unable to alleviate in the nursing home. It should be discussed with the hospital / doctor before admission. 19Jan2021 14:51: The patient lies with his mouth open, notices that the doctor is present and makes "almost" eye contact. Appears clearly weakened. Moistens the mouth with a sponge, he cannot suck on it. Slightly answers no to the question if he has any ailments and answers yes to the question if he is okay, otherwise not possible with any dialogue. Patient does not appear bothered, respiration is free and effortless. Does not hurt when the abdomen is palpitated. Lower extremities slim and warm. Papers are signed. Conversations with the son who seem to understand that it seems to be coming to an end. 26Jan2021 - 08:42: The patient died quietly 20Jan2021 in the morning. The doctor confirmed the death the same day and also spoke to the son. Sender Comment: A 95-year-old man who received the first dose of COMIRNATY 13Jan2021 died 20Jan2021. The patient also started treatment with fluconazole 11Jan2021 due to a fungal infection in the mouth. The patient was previously multimorbid, malnourished and was described as a preterminal from 09Jan2021. Reporter believes that the outcome would most likely be the same, regardless of vaccination, but that it is difficult to say whether the outcome was accelerated due to the vaccination. When vaccinating patients with frailty who are ill with many underlying diseases, some serious incidents, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or some other random, simultaneous cause that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the message is classified as serious, even though no causal link between the vaccine and the death has been established. Reporter comment: On 11Feb2021: additional information received. The following fields have been updated: event description, disease. No follow-up attempts possible. No further information expected.; Reporter''s Comments: 11Feb2021: additional information received. The following fields have been updated: event description, disease.; Reported Cause(s) of Death: Death; dehydration


VAERS ID: 1048609 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Living in nursing home; TIA (Several incidences during the last year.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021163703

Write-up: DEATH; This is a spontaneous report from a contactable healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is NO-NOMAADVRE-FHI-2021-U9qpz. Other Safety unique identifier number NO-NOMAADVRE-E2B_00014932. An 89-year-old male patient received BNT162B2 (COMIRNATY; Lot number EM0477), intramuscular on 27Jan2021, at 11:30 as single dose for covid-19 immunisation. Medical history included living in nursing home from Aug2019, dementia from an unknown date and transient ischaemic attack from an unknown date (several incidences during the last year). The patient''s concomitant medications were not reported. The patient experienced death on 01Feb2021. Details were as follows: Initially the reporter had stated: Progressive dementia. Symptoms of cerebrovascular insult from 24Jan2021. According to palliative plan, the patient should not be transferred to hospital if for instance a stroke occurred, but received care at the nursing home where the patient had been a resident since Aug2019. First dose the COVID -vaccine given on 06Jan2021 and second dose on 27Jan2021. The patient died on 01Feb2021. The patient received the second dose on 27Jan2021 for vaccination. The first dose was given on 06Jan2021. The patient had progressive dementia, several incidences of TIA over the last year, and a cerebrovascular accident on 24Jan2021. According to the patient''s palliative care plan, the patient was not to be transferred to hospital if any cerebrovascular accident happened, but rather be cared for in familiar surroundings in the nursing home where he had been a resident since Aug2019. After the cerebrovascular accident on 24Jan2021, the patient''s condition deteriorated and the patient died on 01Feb2021. The reporter stated that the report was filed due to death occurring five days after the second dose of Comirnaty, but that it is considered unlikely that the death is associated with vaccination. The cerebrovascular accident is considered as cause of death and was not unexpected considering the patient''s medical history. They do not suspect any association between the cerebrovascular accident and vaccination and there was no marked deterioration in the patient''s condition as a result of the second dose of BNT162B2. The patient''s outcome was fatal, at the time of the report. The case was considered to be serious. The patient died on 01Feb2021. It was not reported if an autopsy was performed. Sender''s Comments (TRANSLATION): The report concerns a patient in his 80s, who died a few days after the second dose of the Covid-19 vaccine Comirnaty. The reporter states that the death is reported as a possible side effect due to a close temporal relationship to the second dose, but that it is considered unlikely that the death is related to the vaccine. The patient had developed symptoms of cerebral insult a few days before the second dose was given, and this is also considered a cause of death, according to the reporter. It is also not considered that the cerebral insult is related to the vaccination, according to reporter. Normally, between 300 and 400 people die per week in nursing homes and similar institutions in Norway. In a Norwegian study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and show, among other things, that the risk of death is increased in the first four months after admission to nursing home, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebro-vascular disease were accounted for 1 out of 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (about 20%), respiratory and infectious diseases (including pneumonia and sepsis) (about 15%), and cancer (about 10%). It is stated in the report that the patient had an underlying illness / diseases before vaccination. According to incident description, it is more likely that these diseases are behind the incident. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination. On the basis of the information in the report, only the reporter''s causal assessment is registered, which is set as unlikely. An improbable causal relationship is defined as a reaction, including pathological laboratory tests, that occurs in such a temporal relationship to the use of a drug that a causal relationship is unlikely (but not impossible), and where underlying disease, other drugs or chemicals may explain the reaction. Since the patient died, the report is also classified as serious, even if a causal relationship with vaccination has not been established. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 09Jan2021 RELIS: Additional information received by phone from reporter. Additional information about patient''s medical history and the event.; Reported Cause(s) of Death: CEREBROVASCULAR ACCIDENT


VAERS ID: 1048610 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, General symptom, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3, dropped to 37.3; Test Date: 20210123; Test Name: C-reactive protein; Result Unstructured Data: Test Result:38; Test Date: 20210124; Test Name: Covid-19 nasopharynx test; Test Result: Negative
CDC Split Type: NOPFIZER INC2021163726

Write-up: GENERAL SYMPTOM NOS; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Ugamy, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014863. A 74-year-old male patient received second dose of bnt162b2 (COMIRNATY, lot number EM0477), via an unspecified route of administration in arm right on 19Jan2021 at single dose for covid-19 immunisation. Medical history included Living in nursing home, no adverse drug reaction to first dose of bnt162b2 (COMIRNATY) for COVID-19 immunization on 29Dec2020. The patient''s concomitant medications were not reported. The patient experienced general symptom nos (death) on 22Jan2021. Clinical course: On 22Jan2021, the patient developed GENERAL SYMPTOM NOS. The case was considered to be Serious. This case was received from a Physician. The patient died on 27Jan2021. It was not reported if an autopsy was performed. Reporter''s comment: The patient developed rapidly increasing general symptoms from 22Jan2021. A new viral respiratory infection may be the cause of the disease, but as the worsening occurred a few days after the second injection with the vaccine, it may have been related to the vaccine. CRP taken 23Jan2021 was at 38, temp in Jan2021: 38.3, dropped to 37.3. NB: no intolerance to first injection of Comirnaty 29Dec2020. 24Jan2021: Covid-19 nasopharynx test negative. Additional information requested in Sender''s comment: On the basis of the information in the report 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. Reporter''s comment: 12feb2021 RELIS: requested additional information. If new medical information is received, report will be updated. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The patient developed rapidly increasing general symptoms from 22Jan2021. A new viral respiratory infection may be the cause of the disease, but as the worsening occurred a few days after the second injection with the vaccine, it may have been related to the vaccine.; Reported Cause(s) of Death: GENERAL SYMPTOM NOS


VAERS ID: 1048611 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EMO477 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dyspnoea, Feeling cold, Malaise
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: SOBRIL; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; LAXOBERAL; SOMAC; OXYNORM; OXYCONTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ALS; BIPAP (Used at night); Feeding tube user (Daily use); Living in nursing home (Palliative ward)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021163714

Write-up: Breathing problem/difficulty breathing; CHILLS; feeling cold; FEELING UNWELL; This is a spontaneous report from a contactable other health professional downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Umnnq, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00015063. A 61 years old male patient received BNT162B2 (Comirnaty, lot number EMO477) second dose on 28Jan2021 intramuscularly on left arm at 0.3 ml single dose for vaccination. Medical history included Feeding tube user, BIPAP Used at night (Bilevel positive airway pressure), ALS (Amyotrophic lateral sclerosis), Living in nursing home. Concomitant medications included oxazepam (SOBRIL) for anxiety, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) for constipation, sodium picosulfate (LAXOBERAL) from 2020 for constipation, pantoprazole sodium sesquihydrate (SOMAC) from 2020 for antacid therapy, oxycodone hydrochloride (OXYNORM) for pain relief from 01Nov2020, oxycodone hydrochloride (OXYCONTIN) from 01Dec2020 for pain relief. The patient previously took Comirnaty first dose at single dose for COVID-19 immunization. In the afternoon (28Jan2021) after vaccination with the second dose of Comirnaty, he was feeling unwell. The next day (29Jan2021) he went home on leave from palliative ward at the nursing home at about 5 p.m. He then had chills, was feeling cold and was tucked in a blanket. The next morning (30Jan2021) he had difficulty breathing. Oxynorm and Sobril given by a home health nurse had no effect. An ambulance transported the patient to hospital, and he died there later the same day (30Jan2021). The outcome of events feeling unwell, chills, feeling cold was unknown. It was unknown if autopsy was done. Reporter''s comments: 12Feb2021: requested additional information. If new medical information is received, report will be updated. Sender''s Comment: Background: Patient in his sixties with ALS used BIPAP at night and received tube feeding daily. After receiving the second dose of Comirnaty, he did not feel fit in the afternoon. At around 5pm the day after the vaccination, he returned home from the palliative care ward at the nursing home on leave. Then he had fever chills and was cold and was wrapped in a blanket. The next morning the patient had breathing problems. Oxynorm and Sobril provided by home care did not help. An ambulance was called, and the patient was admitted to privay (hospital) where he died the same day. Comment: The most common adverse reactions in study participants were injection site pain ($g 80%), fatigue ($g 60%), headache ($g 50%), myalgia and chills ($g 30%), arthralgia ($g 20%), fever and swelling at the injection site ($g 10%). They occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and passed after a few days. Systemic side effects are often more pronounced after the second dose than after the first dose of this vaccine. When vaccinating patients with underlying diseases and risk factors for disease, some serious events, including death, may occur relatively soon after vaccination, without any connection to vaccination. In this case, the report does not contain sufficient information to be able to assess what this has been. Since the report describes a suspected side effect that is serious and in order to better assess the incident that was reported, we will contact Privacy (hospital) with a request for an epicrisis. 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 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. Additional information is required to make a satisfactory assessment. Based on given criteria, the report is considered serious. We will send a new assessment of the incident if we receive additional information that changes our assessment No follow-up attempts possible. No further information expected.; Reporter''s Comments: 12Feb2021: requested additional information. If new medical information is received, report will be updated.; Reported Cause(s) of Death: Breathing problem/difficulty breathing


VAERS ID: 1048612 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EMO 477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Drooling, Fall, General physical health deterioration, Headache, Motor dysfunction, Nausea, Speech disorder, Troponin, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 15
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: Delirium; Infection; Liver failure; Non STEMI (increased troponins)
Preexisting Conditions: Medical History/Concurrent Conditions: Dizziness (Dizziness for the last period of time, also before vaccination); Living in nursing home; Walking aid user
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Troponin; Result Unstructured Data: Test Result:Increased
CDC Split Type: NOPFIZER INC2021158455

Write-up: FALLING DOWN WITH PAIN IN BACK AND HEAD; reduced general condition; speaking difficulties; decreased functionality in hands; drooling; pain in the head and back; pain in the head and back; nausea; vomiting; This is a spontaneous report from contactable other health professional downloaded from the Agency Regulatory Authority-WEB regulatory authority or other manufacturer number NO-NOMAADVRE-FHI-2021-Umnpq, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00015087. A 92-year-old female patient received bnt162b2 (COMIRNATY, lot #: EMO 477), intramuscular on 14Jan2021 at single dose for covid-19 vaccination. Medical history included living in nursing home, walking aid user, dizziness for the last period of time, also before vaccination, infection with delirium, NSTEMI (increased troponins) and liver failure from Jan2021 and ongoing. The patient''s concomitant medications were not reported. The patient fell on the same day as she had been administered Comirnaty with pain in back and head, and the she developed reduced general condition with nausea and vomiting. On the following morning (15Jan2021) her condition was aggravated with speaking difficulties, decreased functionality in hands and drooling. She was admitted to hospital. The patient''s condition was further deteriorated when she returned from the hospital to the nursing home one week later (21Jan2021). The discharge summary indicated infection with delirium, NSTEMI (increased troponins) and liver failure during the admission. When returning to the nursing home, she was bedridden without eating and drinking, and died on 29Jan2021. Reported cause of death was fall and reduced general condition. The patient had been self-sufficient until the fall, but had dizziness also before the vaccination. Outcome of events fall and reduced general condition was fatal, and outcome of other events was unknown. It was not reported if an autopsy was performed. Sender''s Comments (TRANSLATION): Background: The patient experienced a fall with pain in the head and back the same day she received the covid-19 vaccine Comirnaty, and she had a reduced general condition with nausea and vomiting. The next morning, her condition worsened and she was hospitalized. From the epicrisis it appears that she had an infection with delirium, NSTEMI and liver failure during hospitalization. When she returned to the residential center after about a week, she was bedridden, did not take food and drink and died another week later. The patient had been self-capable before the fall, but also suffered from dizziness before the vaccine was given. Comments: It cannot be ruled out that discomfort following vaccination (eg a vasovagal reaction due to nausea or pain) may have caused or contributed to the fall, but the patient had also experienced dizziness previously. Cardiac cause must also be considered as she was diagnosed with NSTEMI at the hospital. Further course of events can be connected to the fall. When vaccinating marginal patients with underlying diseases and risk factors for disease, some serious events, including acute illness and / or death, may occur relatively soon after vaccination, without any connection to vaccination. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. Reaction/event as reported by primary source: Fall with pain in the back and head. After the fall on the evening of 14Jan, 21Jan, she had frequent supervision of staff, and that the emergency room was contacted in relation to reduced general condition, nausea and vomiting. On the morning twig the day after the fall, she became significant Event assessment: Regional Pharmacovigilance Center/Comirnaty/Falling down/Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: FALLING DOWN WITH PAIN IN BACK AND HEAD; reduced general condition


VAERS ID: 1048613 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood pressure measurement, C-reactive protein, Chills, Depressed level of consciousness, Dysphagia, Glomerular filtration rate, Heart rate, Muscle spasms, Oxygen saturation, Pain, Pruritus, Respiratory rate, Restlessness, Tremor, Urine analysis
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Akathisia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   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: METOPROLOL SANDOZ [METOPROLOL SUCCINATE]; ELIQUIS; ATROVENT; VENTOLINE [SALBUTAMOL]; SOBRIL; MEDISINSK OKSYGEN PRAXAIR; LAXOBERAL; SOMAC; REMERON; BURINEX; OXYCONTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Atrial fibrillation; Bladder catheter permanent; Cardiac failure; Chronic renal failure; Constipation; COPD; Frailty; Living in nursing home; Osteoporosis; Walking aid user
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: Blood pressure; Result Unstructured Data: Test Result:174/115 mmHg; Test Date: 20210202; Test Name: C-reactive protein; Result Unstructured Data: Test Result:138 mg/l; Test Date: 20210129; Test Name: Estimated GFR; Result Unstructured Data: Test Result:29 mL/min/1.73 m2; Test Date: 20210202; Test Name: Pulse rate; Result Unstructured Data: Test Result:97 beats/min; Test Date: 20210202; Test Name: Oxygen saturation; Test Result: 97 %; Test Date: 20210202; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18 breaths/min; Test Date: 20210202; Test Name: Urine strip test; Result Unstructured Data: Test Result:Leukocyte particle concentration; Comments: 3+, negative nitrate, protein 4+, erythrocytes 3+.
CDC Split Type: NOPFIZER INC2021163713

Write-up: DYSPHAGIA; CONSCIOUSNESS DECREASED; SPASM GENERALISED; tremors; SHIVERS; PAIN; ANXIETY; GENERALISED PRURITUS; UNREST; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (NO-NOMAADVRE-FHI-2021-Unynz and NO-NOMAADVRE-E2B_00014886). A 93-year-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot number: EM0477), intramuscularly in the left arm, on 27Jan2021 at 11:00 at a single dose for COVID-19 vaccination and oxycodone hydrochloride (OXYCONTIN), orally, from 01Feb2021 to 02Feb2021 at frequency: 12 hours for pelvic fracture and pain. Medical history included walking aid user, cardiac failure, bladder catheter permanent, atrial fibrillation, chronic obstructive pulmonary disease (COPD), osteoporosis, living in nursing home, frailty, chronic renal failure, constipation, and anxiety. Concomitant medications included metoprolol succinate (MANUFACTURED BY: SANDOZ) taken for cardiac failure from 06Nov2020 to 02Feb2021, apixaban (ELIQUIS) taken for atrial fibrillation from 30Oct2020 to 02Feb2021, ipratropium bromide (ATROVENT) taken for COPD from 22Jan2021 to 02Feb2021, salbutamol (VENTOLINE) taken for COPD from 22Jan2021 to 02Feb2021, oxazepam (SOBRIL) taken for anxiety from 06Nov2020 to 02Feb2021, oxygen (MEDISINSK OKSYGEN PRAXAIR) taken for hypoxaemia from 30Oct2020 to 02Feb2021, sodium picosulfate (LAXOBERAL) taken for constipation from 11Sep2020 to 02Feb2021, pantoprazole sodium sesquihydrate (SOMAC) taken for gastric ulcer prophylaxis from 30Oct2020 to 02Feb2021, mirtazapine (REMERON) from 06Nov2020 to 02Feb2021, and bumetanide (BURINEX) taken for cardiac failure from 30Oct2020 to 02Feb2021. The patient previously received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6795) on 05Jan2021 for COVID-19 immunization. The patient experienced anxiety, generalised pruritus, and unrest on 01Feb2021 and dysphagia, consciousness decreased, spasm generalised, tremors, shivers, and pain on 02Feb2021. All of the events were reported as fatal. The clinical course was reported as follows: The reporter stated that after vaccination the patient was in her habitual state (moving by walking aid, although somewhat unsteady, good appetite, in a good mood, labored breathing due to COPD and heart failure, general frailty). On 30Jan2021, the patient experienced a fall from her own height, after forgetting to remove the oxygen nasal canula upon rising from her seat. She was admitted to hospital with suspected femur fracture, but it was established stable. She was discharged back to the nursing home in a good general condition on 01Feb2021, with a new prescription of calcium carbonate, colecalciferol (CALCIGRAN FORTE) against osteoporosis from 01Feb2021 to 02Feb2021, and oxycodone hydrochloride and paracetamol (PARACET) for pain relief from 01Feb2021 to 02Feb2021. The patient was reported to be in good general condition at 18:00, but at 21:00, the patient became acutely ill with generalised pruritus (no rash), unrest, and anxiety, which continued during the night. The next day the patient also developed consciousness decreased, pain, dysphagia, spasm generalised/shivers, in addition to the generalised pruritus. The reporter stated that due to the high age, cardiac failure, chronic renal failure and general frailty, it was decided to start palliative care. The patient was calm when checked upon by the nursing home physician in the evening 02Feb2021 and died in the early hours of 03Feb2021. The cause of death was uncertain/not established at the time of the report, and no further information on cause of death will be sought for this report. The patient underwent lab tests and procedures which included estimated glomerular filtration rate (GFR): 29 mL/min/1.73 m2 on 29Jan2021 and all of the following on 02Feb2021: blood pressure: 174/115 mmHg, C-reactive protein: 138 mg/l, pulse rate: 97 beats/min, oxygen saturation: 97 %, respiratory rate: 18 breaths/min, and urine strip test: leukocyte particle concentration 3+, negative nitrate, protein 4+, erythrocytes 3+. The action taken in response to the events for oxycodone hydrochloride was unknown. The patient died on 03Feb2021. The cause of death was reported as unknown. It was not reported if an autopsy was performed. The reporter stated that due to close timely relationship between the vaccination and death, a report was filed, but that an association between the two are very uncertain. The reporter does not exclude the possibility that the patient''s symptoms could be caused by oxycodone hydrochloride (thus also stated as suspected drug), or that the patient had developed urosepsis with acute on chronic renal failure. Sender''s Comments: (TRANSLATION): The report concerns a patient in her 90s, who, four days after the second dose of the Covid-19 vaccine Comirnaty, became acutely ill with severe itching, restlessness and anxiety, decreased consciousness, tremors / cramps in the body. The patient also experienced severe pain and difficulty swallowing during the course and increased CRP and positive results on leukocytes and erythrocytes on urine sticks tests. The patient eventually received palliative care and died 7 days after vaccination. The reporter states that the functional reduction with subsequent death is reported as a possible side effect due to a close temporal relationship to the second dose, but that it is highly uncertain whether the death is related to the vaccine. Three days after vaccination, the patient had fallen from his own height after getting up from a chair, was diagnosed with a pelvic fracture and had started with OxyContin as pain relief as a result. Reporter therefore does not rule out that the incident in question could be a possible side effect of OxyContin, and also points to urosepsis with acute renal failure on top of chronic renal failure as a possible differential diagnosis. It is not possible to register Acute dysfunction as a side effect term in the WHO''s system, therefore we have registered the specific symptoms that are stated in the course of patient''s dysfunction. The reported symptoms are not among the known side effects of this vaccine, but several of the symptoms are known side effects of OxyContin. As the reporter himself points out, the incident in question may thus also be due to a side effect of OxyContin, but it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease or habitual condition. According to the incident description, it cannot be ruled out that other underlying factors, such as comorbidity and falls with subsequent fractures, may have contributed to the serious/severe course. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination. Normally, between 300 and 400 people die per week in nursing homes and similar institutions. In a study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and show, among other things, that the risk of death is increased in the first four months after admission to a nursing home, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebrovascular diseases were accounted for 1 out of 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (about 20%), respiratory and infectious diseases (including pneumonia and sepsis) (about 15%), and cancer (about 10%). Of external factors, falls are the most common cause of premature death among nursing home patients, according to a retrospective, epidemiological study. Based on the information in the report and in accordance with international criteria, we consider the causal relationship between the patient''s symptoms and drug use to be possible for both Comirnaty and OxyContin. 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. Based on information in the report, the reporter''s causal assessment is also registered, which is set as uncertain for Comirnaty and possible for OxyContin. Since the patient died, the report is also classified as serious, even if a causal relationship with vaccination and / or other drug use has not been established. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1048614 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALBYL-E; PARACET [PARACETAMOL]; ZOPIKLON MYLAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm of aorta; Chest pain (has been investigated, but no cause has been found); Chronic obstructive pulmonary disease; Dizziness (Lately, in the period before vaccination.); Fall (She fell Christmas eve 2020, and hit her head and hip. CT scan was performed afterwards (PRIVACY hospital name, city).); Head injury; Hip injury; Living alone (Lived alone in an apartment); Posterior myocardial infarction; TIA (Several TIA previously)
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:unknown
CDC Split Type: NOPFIZER INC2021163724

Write-up: FOUND DEAD; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority- WEB [NO-NOMAADVRE-FHI-2021-Ur74y] received via Regulatory Authority. Sender''s safety report unique identifier: [NO-NOMAADVRE-E2B_00014811]. A 90-years-old female patient received BNT162B2 (COMIRNATY) (lot: EM0477) intramuscular on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), previous aneurysm of aorta, dizziness - lately in the period before vaccination, lived alone in an apartment, chest pain has been investigated, but no cause has been found, several posterior circulatory infarctions previously, several TIA previously, fell on Christmas eve 2020 (24Dec2020), and hit her head and hip. CT scan was performed afterwards. Concomitant medication included acetylsalicylic acid, magnesium oxide (ALBYL-E), paracetamol (PARACET), zopiclone (ZOPIKLON MYLAN). The patient was unexpectedly found dead on 31Jan2021 in her apartment three days after vaccination with COVID-19 vaccine (Comirnaty). She lived alone. Not decided weather the death is related to the vaccine, treatment with acetylsalicylic acid or another cause. The patient died on 31Jan2021. It was not reported if an autopsy was performed. Causality assessment by Regional Pharmacovigilance Center for Comirnaty/Found dead: Possible. Reporter''s comments: 11Jan2021 RELIS: additional information received from GP (by phone). The following fields have been updated: Batch/Lot no., Disease. Sender Comment: The death of the patient has also been reported as a suspected side effect by another doctor. We have gathered the information from both side effects reports in a joint message. Both reporters receive this feedback. A 90-year-old woman was unexpectedly found dead three days after vaccination with covid-19 vaccine (Comirnaty). She lived alone. Concomitant diseases: COPD and previous aortic aneurysm, among others. Not determined whether the death is related to the vaccine, the treatment with acetylsalicylic acid or another cause. When vaccinating elderly patients, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease / more. In the case in question, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or some other random, simultaneous cause that has nothing to do with the vaccination in question. On the basis of the information in the notifications and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the message is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 11Jan2021 RELIS: additional information received from GP (by phone). The following fields have been updated: Batch/Lot no., Disease.; Reported Cause(s) of Death: dead


VAERS ID: 1048615 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Death, Decreased appetite, Depressed level of consciousness, Dyspnoea, Fatigue, Investigation
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BLOXAZOC; BURINEX; MAREVAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Heart valve replacement; Hypertension; Living in nursing home; Multimorbidity
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Body temperature; Result Unstructured Data: Test Result:afebrile; Test Date: 202101; Test Name: various tests; Result Unstructured Data: Test Result:No specific signs of infection
CDC Split Type: NOPFIZER INC2021163702

Write-up: died shortly thereafter; DYSPNEA; FATIGUE; weakness; DECREASED APPETITE; Decreased consciousness 3 weeks after vaccination; This is a spontaneous report from a contactable other Healthcare Professional (HCP) downloaded from the Medicines Agency (MA) Regulatory Authority WEB manufacturer report number NO-NOMAADVRE-FHI-2021-Urny1, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00015092. A 95-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6795), via intramuscular on right arm on 06Jan2021 at single dose for covid-19 immunisation. The relevant medical history included hypertension, multimorbidity, heart failure, heart valve replacement, living in nursing home. Concomitant medications included metoprolol succinate (BLOXAZOC), bumetanide (BURINEX), warfarin sodium (MAREVAN). The day after vaccination, the patient experienced weakness, fatigue, decreased appetite and dyspnea on 07Jan2021. Symptoms became persistent. The patient himself believed that it represented side effects of the vaccine. He was closely monitored by a physician and with various tests. No specific signs of infection, afebrile. Increasing need for oxygen supply and more bedridden. Decreased consciousness 3 weeks after vaccination and died shortly thereafter on 30Jan2021. It was unknown if autopsy was performed. The outcome of the event died shortly thereafter was fatal, while other events were unknown. Sender''s Comments: Symptoms such as general malaise, fatigue, decreased appetite and experience of shortness of breath have been reported in people who have received this vaccine. Symptoms due to inactivated vaccines (such as Comirnaty) usually begin within a day or two after vaccination and will usually resolve within a few days. The patient in question developed symptoms two days after vaccination, and it is considered that there is a temporal connection between the onset of symptoms and vaccination. However, one would expect these symptoms to resolve relatively quickly. It is difficult to know for sure whether the symptoms, with subsequent death, are due to the vaccine, the patient''s underlying disease / condition or another random, concurrent cause that has nothing to do with the vaccination in question. It cannot be ruled out that the described symptoms at the beginning of the course may represent side effects of the vaccine, and that the vaccination, with subsequent immune response, may in itself have contributed to a physiological stress / strain, which may have further affected the patient''s underlying condition / disease. Based on the information in the report and in accordance with international criteria, the causal link with vaccination is considered as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. When vaccinating marginal patients with underlying diseases and risk factors for disease, some serious events, including acute disease deaths, may occur in the post-vaccination period, unrelated to vaccination. Relatedness of drug to reaction(s)/event(s) Comirnaty/all events Source of assessment Regional Pharmacovigilance Center Result of Assessment Possible.; Reporter''s Comments: February 10th 2021: Additional information on previous illnesses and medications is obtained from the reporter by telephone. Posted under "Person" and "Disease" and "Product".; Reported Cause(s) of Death: died shortly thereafter


VAERS ID: 1048616 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body mass index, Body temperature, C-reactive protein, General physical health deterioration, Haemoglobin, Heart rate increased, Loss of consciousness, Oxygen saturation decreased, Respiratory arrest, Terminal state
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   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: ZOPICLONE ACTAVIS; BRONKYL; BURINEX; DUPHALAC [LACTULOSE]; LAMICTAL; OLANZAPINE TEVA; SOBRIL; MAREVAN; PANODIL
Current Illness: Anemia; Anxiety; Bedridden; Bipolar disorder; Blood in stool (Suspected GI-Cancer, not investigated); Cognitive impairment; Frailty; Heart failure; Heart valve replacement NOS; Increased bronchial secretion; Insomnia; Living in nursing home; Obstipation; Pain; Underweight (BMI 15)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:15; Test Date: 20210129; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210129; Test Name: C-reactive protein; Result Unstructured Data: Test Result:unknown results; Test Date: 20201120; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9.8 g/dl
CDC Split Type: NOPFIZER INC2021163696

Write-up: acutely oxygen saturation low; general physical health deterioration; respiratory arrest.; high heart rate; CONSCIOUSNESS LOSS; very weak; TERMINAL STATE; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB with regulatory authority Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014890, worldwide unique case identification number NO-NOMAADVRE-FHI-2021-Ux8wy. A 92-year-old female patient received the second dose of bnt162b2 (COMIRNATY), intramuscularly at the site of left arm at 12:11 on 27Jan2021 at single dose for COVID-19 immunization. Medical history included bipolar disorder from 2020, blood in stool (suspected GI-Cancer, not investigated), underweight (BMI 15), anemia, frailty, cognitive impairment, living in nursing home, bedridden from 2020, insomnia, increased bronchial secretion, heart failure, obstipation, bipolar disorder, anxiety, heart valve replacement nos and pain, all are ongoing. Concomitant medication included zopiclone (ZOPICLONE ACTAVIS) from 21Aug2019 to 29Jan2021 for insomnia, acetylcysteine (BRONKYL, strength: 200 mg) from 21Oct2020 to 02Feb2021 for increased bronchial secretion, bumetanide (BURINEX) from 08Sep2020 to 29Jan2021 for heart failure, lactulose (DUPHALAC) from 15Feb2019 to 29Jan2021 for obstipation, lamotrigine (LAMICTAL) from 12Jun2020 to 29Jan2021 for bipolar disorder, olanzapine (OLANZAPINE TEVA, strength: 10 mg) from 30Sep2020 to 02Feb2021 and from 21Oct2020 to 29Jan2021 for bipolar disorder and anxiety, oxazepam (SOBRIL, strength: 10 mg) from 29Jul2020 to 02Feb2021 for anxiety, warfarin sodium (MAREVAN, strength: 2.5 mg) from 18Jun2018 to 29Jan2021 for heart valve replacement nos, paracetamol (PANODIL) from 10Dec2019 to 29Jan2021 for pain. Clinical course: The patient had no adverse reactions to dose 1. On 29Jan2021, the patient developed acutely oxygen saturation low, general physical health deterioration, breathing arrested, high pulse rate, consciousness loss. The patient was provided with oxygen, but she was very weak. CRP could not be analysed and she was considered to be in terminal state. Palliative treatment with morphine (MORFIN), Midazolam Panpharma, and glycopyrronium bromide (ROBINUL) was started. Four days later, on the 02Feb2021 the patient died. The reporting physician states that the acute deterioration is unexplained and can be related to vaccination or an infection or decompensation of heart failure related to anaemia. All events were considered to be serious and seriousness criteria were fatal. The patient underwent lab tests and procedures which included body temperature: 38 centigrade on 29Jan2021, C-reactive protein with unknown results on 29Jan2021, hemoglobin: 9.8 g/dl on 20Nov2020. The patient died on 02Feb2021. It was not reported if an autopsy was performed. Sender''s Comments: CAUSALITY ASSESSMENT: Symptoms such as fever, headache and general malaise occur in the first days after vaccination with all vaccines. A large proportion of those vaccinated reported fatigue, joint and muscle pain, and a small proportion developed fever and chills after this vaccine. Fever and malaise occurred more often after the second dose. Such symptoms are short-term and transient. Based on what is known about this vaccine at the time, it is difficult to imagine how it will cause acute respiratory and cardiovascular symptoms as described here two days after vaccination. Another cause must therefore also be considered. In this case, it is stated that the patient had tolerated the first dose of vaccine well, but when vaccinating frail patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without necessarily being related to vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or another random simultaneous cause that has nothing to do with the vaccination in question. Based on the information in the report and in accordance with international criteria, the causal relationship between the patient''s acute exacerbation with death and the vaccination is considered as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is classified as serious, although the causal link between the vaccine and the death is classified as possible. Result of assessment of bnt162b2 was possible by Regional Pharmacovigilance Center. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: respiratory arrest; Terminal state; general physical health deterioration; high heart rate; CONSCIOUSNESS LOSS; acutely oxygen saturation low; very weak


VAERS ID: 1048617 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-23
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, Fatigue, Heart rate, Infection, Oxygen saturation, Oxygen saturation decreased, Productive cough, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   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: ELDEPRYL; CEFTRIAXON FRESENIUS KABI; SINEMET; SELEGILIN
Current Illness: Dementia due to Parkinson''s disease; Living in nursing home (For more than 4 years); Parkinson''s disease NOS; Physical impairment (Very reduced function, but has been stable.)
Preexisting Conditions: Medical History/Concurrent Conditions: Terminal state
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: C-reactive protein; Result Unstructured Data: Test Result:168; Test Date: 20210110; Test Name: Heart rate; Result Unstructured Data: Test Result:tachycardia 100; Test Date: 20210110; Test Name: Oxygen saturation; Test Result: 85 %; Test Date: 20210111; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:low %
CDC Split Type: NOPFIZER INC2021163704

Write-up: PHLEGM; she contracted a serious infection and died as a result; SaO2 85%/low O2 saturation; FEVER; Fatigue and mucus formation in the respiratory tract; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB regulatory authority Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014525, Worldwide unique case identification number NO-NOMAADVRE-FHI-2021-Uzrjd. An 81-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6795), intramuscularly on 06Jan2021 at age of 81 years old at single dose for COVID-19 vaccination. A female, 81 years old, Parkinson''s disease and dementia in Parkinson''s disease. Resident in a nursing home for a little over 4 years. Very reduced function, but has been stable. Vaccinated on 06Jan2021. The same day short-term loss (which she has occasionally had before and) with shaking in upper body. Spontaneously recovered. The patient experienced phlegm on 11Jan2021, fatigue and mucus formation in the respiratory tract on 09Jan2021, fever on 10Jan2021. From 09Jan2021, more reduced with fatigue and mucus. Fever, tachycardia 100 and SaO2 85% afternoon 10Jan2021. On 11Jan2021, assessed as seriously ill with fever, strained respiration with a lot of mucus formation, low O2 saturation and CRP 168. No intake per OS. Started treatment with ceftriaxone and fluid supplement. Clinically and biochemically slight improvement after two days, but still no intake per OS. Clear clinical deterioration night to 15Jan2021 with strained respiration, mucus formation and little contactability. Transition to palliative care. The patient died Sunday 17Jan2021. It was not reported if an autopsy was performed. Due to the development of disease close to the time of administration of bnt162b2, the death has been reported as a possible side effect, it cannot be ruled out that the vaccine has contributed. However, it is considered more likely that she contracted a serious infection and died as a result. A 81 Years old Female patient received bnt162b2 06Jan2021 for vaccination. As concomitant medication the patient was given carbidopa, levodopa (SINEMET, Tablet) 25/100 from an unspecified date to 15Jan2021 for Parkinson''s disease nos, selegiline hydrochloride (ELDEPRYL, strength: 10 mg) from an unspecified date to 15Jan2021 for Parkinson''s disease nos, ceftriaxone sodium (CEFTRIAXON FRESENIUS KABI, strength: 1 g) from 11Jan2021. Concomitant medications also included selegiline hydrochloride (SELEGILIN), and J07BX (Other virus vaccines). The medical history included ongoing Parkinson''s disease NOS, ongoing dementia due to Parkinson''s disease, ongoing living in nursing home, ongoing physical impairment, terminal state (15Jan2021). Relevant laboratory findings and investigations included in the report (HEART RATE, 10Jan2021) (OXYGEN SATURATION, 10Jan2021, 85%) (C-REACTIVE PROTEIN, 11Jan2021, 168). The patient''s outcome was Not recovered/not resolved, at the time of the report. The case was considered to be Serious. This case was received from a physician. New information added by regional pharmacovigilance center 02Feb2021: Phone call with reporter: causality with symptoms possible, and causality with death are uncertain, the adverse drug reaction are reported primary due to temporal relationship with the vaccine. Sender''s Comments: When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or another random simultaneous cause that has nothing to do with the vaccination in question. The report states that it is considered more likely that the patient contracted a serious infection and died as a result. Based on this and the information in the report, as well as in accordance with international criteria, the causal link with vaccination is considered as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts possible. No further information expected. .; Reported Cause(s) of Death: PHLEGM; Fatigue and mucus formation in the respiratory tract; FEVER; she contracted a serious infection and died as a result


VAERS ID: 1048618 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac death, Musculoskeletal pain
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021163744

Write-up: Death was probable caused by cardiac reasons (death during defecation).; Weakness; Very severe musculoskeletal pain; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB and received via Regulatory Authority PL-URPL-3-108-2021. An 85-year-old patient received first dose bnt162b2 (COMIRNATY, lot number: EJ6136, expiration date: 30Jan2021), via an unspecified route of administration, at left arm on 29Jan2021 10:20 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Jan2021 at 8:00 am, very severe muscular and bone pain (very severe musculoskeletal pain), weakness. Death on 01Feb2021 at 13.15, most likely for cardiac reasons (during defecation). The family refused to consent to the proposed post-mortem examination. The reporting person classified them as severe. The URPL also classified the report as severe (death). The data contained in the electronic report is all at the disposal of URPL - in the case of obtaining additional information, another version will be sent. The outcome of the event very severe musculoskeletal pain, weakness were unknown, of the other events was fatal. The patient died on 01Feb2021. An autopsy was not performed. Causality assessment was reported as Relatedness of drug to reaction Weakness , Musculoskeletal pain/ One agency /Another agency / possible for Unwitnessed cardiac death NCA / Agency / possible Sender Comment: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides). Bone and joint pain, fatigue is an expected side effect, included in the Summary of Product Characteristics for Corminaty, with a frequency of very common. There is a time relationship between drug administration and the occurrence of side effects. Due to insufficient information, it cannot be assessed whether the cardiac event, if it occurred at all ("possibly" was the cause of death), was related to vaccination. The reporting person classified them as severe. The URPL also classified the report as severe due to the nature of the adverse reaction resulting in death (possibly cardiac cause of death). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death was probable caused by cardiac reasons (death during defecation).


VAERS ID: 1048626 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardio-respiratory arrest, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   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: ESOMEPRAZOLE; FUROSEMIDE; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastric ulcer; Melanoma; Penicillin allergy; Pneumonia; Stroke
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: PTPFIZER INC2021163772

Write-up: Cardio-respiratory arrest; conclusion that she caught Covid and the vaccine did not protect her/ extreme tiredness/ a slight cough/ a fever; This is as spontaneous report received from a contactable consumer downloaded from the Medicine Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is PT-INFARMED-T202102-951. A contactable consumer reported that a 92-years-old female patient received 1st dose of bnt162b2 (COMIRNATY), intramuscular on 19Jan2021 at 0.3 mL single for covid-19 immunisation. There was reference to clinical history in the past of melanoma, stroke, gastric ulcer, pneumonia and unknown if ongoing. There was a history of allergy to penicillin. Concomitant medication included esomeprazole, furosemide, clopidogrel. The adverse reaction, appeared about 6 days after the administration of the first dose of the suspected drug (25Jan2021), and was initially characterized by extreme tiredness that led her to eat in the bedroom and a slight cough. After 9 days of inoculation, a fever developed. The patient died on the 10th day (29Jan2021). The conclusion was that the patient caught COVID and the vaccine did not protect her associated with the use of bnt162b2 against COVID-19 (with modified nucleoside), 30 mcg/0.3 ml, concentrate for dispersion for injection, in 1st dose, for active immunization to prevent COVID-19 caused by the SARS-CoV virus-2, with the dosage of 2 intramuscular doses (0.3 ml each) with an interval of at least 21 days between each dose. The patient was not previously infected with the SARS-CoV-2 virus, according to the notifier, the patient was institutionalized and everyone tested Covid, they were confined to their rooms, the test result was negative. The patient died of cardiorespiratory arrest. No autopsy was performed. There was no concrete diagnosis of Covid infection, the notifier said in funeral homes say they would be treated as a suspect for Covid and, according to information from the institution, they were also hit hard by this plague. Evolution of adverse reaction was death. There was no reduction in dosage. The suspected drug was suspended once the vaccination schedule was incomplete, and the second dose was not administered. There was no suspicion of interaction between drugs. There is no information on the specific treatment of the reaction. The events outcome was fatal. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: conclusion that she caught Covid and the vaccine did not protect her/ extreme tiredness/ a slight cough/ a fever; Cardio-respiratory arrest


VAERS ID: 1049613 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KELINA; KETOZOL [KETOCONAZOLE]; ASS; PREGABALIN; FOLSAN; NOVAMINSULFON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-smoker; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210104; Test Name: PCR Corona test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021017031

Write-up: PCR Corona test positive; This is a spontaneous report based on information received by Pfizer from BIONTECH, license party for BNT162B2, from other healthcare professional from a nursing home. This reporter reported seven similar reports. This is the second of the seven reports. An 86-year-old female patient (resident number 1) of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient medical history included hypertension and former smoker. Concomitant medications included: kelina, ketoconazole (KETOZOL), acetylsalicylic acid (ASS), pregabalin, folic acid (FOLSAN) and novaminsulfon. The patient experienced PCR Corona test positive on 04Jan2021. Patient was quarantined. The patient displayed clinical signs at rest indicative of severe systemic illness included: Fever, dyspnea, respiratory complaints. The patient was hospitalized, also admitted to Intensive Care Unit. It was also reported from same reporter that the patient had not a positive test for SARS-CoV2. The patient was required supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation in Intensive Care Unit. The patient''s outcome with COVID-19 reported as Death on 17Jan2021. The patient died on 17Jan2021. It was unknown if an autopsy was performed and the reported cause of death was COVID-19. Information on the lot/batch number has been requested. Follow-up (18Feb2021): New information received from the contactable other healthcare professional from a nursing home includes: patient''s age, gender, medical history added, concomitant medications added, serious criteria for event COVID-19 upgraded as death. Event drug ineffective was removed. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: There is not a reasonable possibility that reported "PCR Corona test positive" is related to BNT162B2. Event occurred after 4 days of vaccination, when vaccine was not expected to achieve the effect.,Linked Report(s) : DE-PFIZER INC-2021016519 same reporter, same event, different patient; Reported Cause(s) of Death: PCR Corona test positive


VAERS ID: 1051036 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Erythema, Sudden death, Vaccination site erythema
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASIX [FUROSEMIDE]; SERLAIN [SERTRALINE HYDROCHLORIDE]; CARDIOASPIRINE; DAFALGAN; NOBITEN [NEBIVOLOL HYDROCHLORIDE]; TRADONAL; LYSANXIA; PANTOMED [DEXPANTHENOL]; ALDACTONE [SPIRONOLACTONE]; RISPERDAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Atrial tachycardia (atrial tachycardia episode (not excluded AF)); Fall (right post-traumatic hemothorax (fracture of the 8th and 9th right ribs on fall) in 2020); Hemothorax (right post-traumatic hemothorax (fracture of the 8th and 9th right ribs on fall) in 2020); Hypertensive heart disease; Ischemic colitis; Lumbar disc degeneration; Lumbar spinal stenosis; Rib fracture (right post-traumatic hemothorax (fracture of the 8th and 9th right ribs on fall) in 2020); Syncope vasovagal; Total knee replacement (left); Ureteric operation (right ureterotomy for lithiasis); Varicose veins stripping
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021173710

Write-up: Redness of the face; Suddenly died the next morning, probably cardiac disorder; Suddenly died the next morning, probably cardiac disorder; Injection site redness; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [Regulatory Authority number BE-FAMHP-DHH-N2021-76293] from a contactable physician. A 93-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, lot# EM0477), via an unspecified route of administration, on 29Jan2021, at single dose, for COVID-19 immunisation. Medical history included aortic stenosis, hypertensive heart disease, atrial tachycardia from 2018 (atrial tachycardia episode, not excluded AF), colitis ischaemic, syncope, lumbar spinal stenosis, intervertebral disc degeneration, ureteric operation (right ureterotomy for lithiasis), knee arthroplasty (left), varicose vein operation, hemothorax (right post-traumatic hemothorax (fracture of the 8th and 9th right ribs on fall) in 2020). Concomitant medications included furosemide (LASIX), sertraline hydrochloride (SERLAIN), acetylsalicylic acid (CARDIOASPIRINE), paracetamol (DAFALGAN), nebivolol hydrochloride (NOBITEN), tramadol hydrochloride (TRADONAL), prazepam (LYSANXIA), dexpanthenol (PANTOMED), spironolactone (ALDACTONE), risperidone (RISPERDAL). The patient experienced injection site redness on 29Jan2021, redness of the face on 30Jan2021, suddenly died the next morning, probably cardiac disorder on 30Jan2021. The patient died on 30Jan2021 due to the reported events. An autopsy was not performed. Reporter comment: Clinical frailty scale at 6; moves with her platform; help only needed for washing. No reaction within 15 min after the injection, local redness at the injection site observed by the caregivers on the evening / the next morning of the injection + a caregiver mentions redness of the face only the next morning of injection (timing that does not plead for anaphylaxis even if this symptom remains challenging). Causality: the cardiac cause still seems the most plausible. No autopsy request (the death certificate was made at the weekend by the doctor on duty). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Clinical frailty scale at 6; moves with her platform; help only needed for washing. No reaction within 15 min after the injection, local redness at the injection site observed by the caregivers on the evening / the next morning of the injection + a caregiver mentions redness of the face only the next morning of injection (timing that does not plead for anaphylaxis even if this symptom remains challenging). Causality: the cardiac cause still seems the most plausible. No autopsy request.; Reported Cause(s) of Death: Suddenly died the next morning, probably cardiac disorder; Redness of the face; Injection site redness; Suddenly died the next morning, probably cardiac disorder


VAERS ID: 1051047 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-24
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: 2021-02-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021173811

Write-up: Exitus letalis; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB DE-PEI-PEI2021002621. An 87-year-old male patient received BNT162B2 (COMIRNATY, lot number: EJ6795), intramuscular on 11Feb2021 (at the age of 87 years) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient died (exitus letalis) on 11Feb2021, the cause of death was unknown. It was not reported if an autopsy was performed. Reporter''s comment: Agency is investigating. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Agency is investigating; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1051048 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021173822

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regular Authority-WEB DE-PEI-PEI2021002622. A 32-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY, Lot/batch no.: EL8723) at single dose on 12Feb2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced exitus letalis in Feb2021, 13 hours after vaccination. Death cause was reported as Sudden death, cause unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1051049 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021173807

Write-up: Pneumonia; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-PEI2021002624 and received via Regulatory Authority. A 80-year-old male patient was vaccinated with the first dose of BNT162B2 (COMIRNATY, lot # EJ6797) for COVID-19 immunization, via unspecified route of administration on 07Jan2021 (at the age of 80 year). Medical history and Concomitant medications were not reported. On unknown date after the vaccination the patient developed pneumonia, lasting for 4 weeks. The patient died on unknown date. Death cause was reported as Pneumonia. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1051050 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Cardiogenic shock
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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 INC2021173800

Write-up: Cardiogenic shock; Acute cardiac insufficiency; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority number DE-PEI-PEI2021002626). A 100 years old female received the first single dose of BNT162B2 (COMIRNATY) on 15Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 19Jan2021, four days after vaccination, the patient developed cardiogenic shock and acute cardiac insufficiency, lasting for 5 days. The patient died on an unspecified date in 2021. Cause of death was reported as acute cardiac insufficiency, however both cardiogenic shock and acute cardiac insufficiency were reported with a fatal outcome. Stop date of both events was reported as 23Jan2021 (death date was not clearly specified). It was unknown if an autopsy was done. Relatedness of drug to reaction(s)/event(s) assessed as D. Unclassifiable by Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Acute cardiac insufficiency; Cardiogenic shock


VAERS ID: 1051074 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-08
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute abdomen, Anaemia, Aortic aneurysm, Auscultation, Blood bicarbonate, Blood calcium, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, Body temperature, Coma scale, Echocardiogram, Electrocardiogram, Gastrointestinal examination, Haemoglobin, Heart rate, Neurological examination, Oxygen saturation, PCO2, PO2, Sinus rhythm, Troponin, pH body fluid
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MONO-TILDIEM; PLAVIX; COLCHICINE OPOCALCIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Adenocarcinoma of prostate; Coronary bypass; Gastric ulcer, acute with hemorrhage; Gouty arthropathy; Hypertension arterial; Myocardial infarction; Prostatectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: Abdominal aortic aneurysm; Result Unstructured Data: Test Result:5.9 cm; Test Date: 20210208; Test Name: Cardiopulmonary auscultation; Result Unstructured Data: Test Result:Cardiopulmonary auscultation without abnormality; Comments: Cardiopulmonary auscultation without abnormality; Test Date: 20210208; Test Name: bicarbonate; Result Unstructured Data: Test Result:18 mmHg; Test Date: 20210208; Test Name: calcium; Result Unstructured Data: Test Result:1.02; Test Date: 20210208; Test Name: Arterial lactate; Result Unstructured Data: Test Result:0.3; Test Date: 20210208; Test Name: Potasium; Result Unstructured Data: Test Result:4.5; Test Date: 20210208; Test Name: BP; Result Unstructured Data: Test Result:100/68 mmHg; Comments: 7:30 am: BP 74/45 mm Hg; Test Date: 20210208; Test Name: Sodium; Result Unstructured Data: Test Result:139; Test Date: 20210208; Test Name: body temperature; Result Unstructured Data: Test Result:36 Centigrade; Test Date: 20210208; Test Name: glasgow score; Result Unstructured Data: Test Result:8; Comments: Worsening with Glasgow score of 8 shallow breathing; Test Date: 20210208; Test Name: Fast echo; Result Unstructured Data: Test Result:no dilation of the urinary tract, presence of smal; Comments: no dilation of the urinary tract, presence of small bilateral renal cysts, presence of fluid levels and intestinal dilation.; Test Date: 20210208; Test Name: ECG; Result Unstructured Data: Test Result:Known right bundle branch block; Comments: Known right bundle branch block; Test Date: 20210208; Test Name: Abdomen exam; Result Unstructured Data: Test Result:Weathered abdomen, Hydroaeric noises (BHA) not per; Comments: Weathered abdomen, Hydroaeric noises (BHA) not perceived, no gas perceived by the patient. No defense, no perceived abdominal mass, free hernial orifices. Diffuse abdominal pain, no contracture, no defense, no BHA, clean abdominal scar.; Test Date: 20210208; Test Name: haemoglobin; Result Unstructured Data: Test Result:12; Comments: 9.40 a.m .: Hemocuee at 5.9; Test Date: 20210208; Test Name: Pulse rate; Result Unstructured Data: Test Result:98 bpm; Comments: Reassessment at 7:30 90 bpm, patient sweating, no cyanosis, no mottling. Conscious, vigilant, oriented, asthenic patient.; Test Date: 20210208; Test Name: neurological examination; Result Unstructured Data: Test Result:Cold extremities without cyanosis or mottling, nor; Comments: Cold extremities without cyanosis or mottling, normal neurological examination.; Test Date: 20210208; Test Name: spo2; Test Result: 97 %; Test Date: 20210208; Test Name: pCO2; Result Unstructured Data: Test Result:34.9 mmHg; Test Date: 20210208; Test Name: pH; Result Unstructured Data: Test Result:7.32; Test Date: 20210208; Test Name: pO2; Result Unstructured Data: Test Result:82.4 mmHg; Test Date: 20210208; Test Name: sinus rhythm; Result Unstructured Data: Test Result:recovery from sinus rhythm to 100 bpm.; Comments: no transfer because cardio-respiratory arrest; 26 minutes resuscitation with intubation, 5 mg adrenaline, recovery from sinus rhythm to 100 bpm.; Test Date: 20210208; Test Name: Troponin; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021169035

Write-up: Acute anaemia; Syndrome abdominal acute; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-BX20210684. A 77-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number: EJ6795) , intramuscular on 21Jan2021 at single dose for COVID-19 immunization, diltiazem hydrochloride (MONO-TILDIEM, formulation: prolonged-release capsule, strength: 200 mg), oral from an unspecified date to an unspecified date at one dose form once a day, clopidogrel bisulfate (PLAVIX), oral from an unspecified date to an unspecified date at one dose form once a day and colchicine (COLCHICINE OPOCALCIUM), oral from an unspecified date to an unspecified date at one dose form once a day for gouty arthritis. The patient medical history included abdominal aortic aneurysm, hypertension arterial, coronary bypass, gouty arthropathy, myocardial infarction, adenocarcinoma of prostate, prostatectomy and gastric ulcer acute with hemorrhage, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received influenza vaccine on 08Nov2020 for immunization. The patient experienced acute anaemia and syndrome abdominal acute both on 08Feb2021 with fatal outcome. The events were serious (fatal and hospitalization). Clinical course: on 08Feb2021 at 9:15 arterial hypotension confirmed by arterial catheter at 70/45 mm Hg, started noradrenaline at 0.5 mg/h and ceftriaxone 1g, at 9:20: worsening with Glasgow score of 8 shallow breathing, at 9.40: hemoglobulin at 5.9, transfusion 1 gr pellet, decision to transfer to medical emergency, with 2nd gr pellet in progress, NaCl 500 mL in progress, 1 fresh frozen plasma in progress. At 11:10: no transfer because cardio-respiratory arrest; 26 minutes resuscitation with intubation, 5 mg adrenaline, recovery from sinus rhythm to 100 bpm. Death thereafter, the same day. On 08Feb2021, the patient underwent lab tests and procedures which included aortic aneurysm: 5.9 cm, cardiopulmonary auscultation: without abnormality, blood bicarbonate: 18 mmHg on 08Feb2021, blood calcium: 1.02, arterial lactate: 0.3, blood potassium: 4.5, blood pressure measurement: 100/68 mmHg and at 7:30 74/45 mmHg , blood sodium: 139, body temperature: 36 C, Glasgow score/coma scale: 8 (Worsening with Glasgow score of 8, shallow breathing) , echocardiogram: no dilation of the urinary tract presence of small bilateral renal cysts, presence of fluid levels and intestinal dilation, electrocardiogram (ECG): known right bundle branch block, abdomen exam/gastrointestinal examination: weathered abdomen, hydroaeric noises (BHA) not perceived, no gas perceived by the patient. No defense, no perceived abdominal mass, free hernial orifices. Diffuse abdominal pain, no contracture, no defense, no BHA, clean abdominal scar, hemoglobin: 12 and at 9.40 5.9, pulse rate: 98 bpm, reassessment at 7:30 90 bpm, patient sweating, no cyanosis, no mottling. Conscious, vigilant, oriented, asthenic patient. The action taken in response to the events for diltiazem hydrochloride, clopidogrel bisulfate and for colchicine was dose not changed. The patient died on 08Feb2021.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: Cardio-respiratory arrest


VAERS ID: 1051080 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiovascular disorder, Cerebrovascular accident, Chest injury, Fall, Haemarthrosis, Haematoma, Heart rate, Oxygen saturation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Accidents and injuries (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL FUMARATE; CANDESARTAN CILEXETIL; COSOPT; FUROSEMIDE; MONOPROST
Current Illness: AFib; Heart failure (with edema of the lower limbs and dyspnea on exertion); Hypertension; Hypertension ocular; Hyperuricaemia
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia absoluta; Cardiac arrest
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: Blood Pressure; Result Unstructured Data: Test Result:110 mmHg; Test Date: 20210204; Test Name: Blood Pressure; Result Unstructured Data: Test Result:117 mmHg; Test Date: 20210204; Test Name: pulse; Result Unstructured Data: Test Result:64 bpm; Test Date: 20210204; Test Name: oxygen saturation; Test Result: 95 %
CDC Split Type: FRPFIZER INC2021169075

Write-up: Cardiovascular cause selected by the doctor; probable hypothesis mentioned by the attending physician was a stroke; Sudden death; right rib trauma with hematoma; minor hematoma of the right knee; right rib trauma with hematoma; fall; This is a spontaneous report from a contactable Physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-AFSSAPS-PV20210200. This is a report received from the Regulatory Authority. A 93-year-old female patient received first dose of bnt162b2 (COMIRNATY, batch: EK9788), intramuscular on the left arm on 01Feb2021 at 0.3 ml, single dose for covid-19 immunization. Medical history included heart failure, hypertension, hyperuricemia, atrial fibrillation, ocular hypertension, all from an unknown date and ongoing (stopped when the patient died on 07Feb2021), complete arrhythmia by atrial fibrillation and cardiac arrest. Concomitant medication included bisoprolol fumarate, candesartan cilexetil, dorzolamide hydrochloride, timolol maleate (COSOPT), furosemide, latanoprost (MONOPROST). After the holidays, the autonomous patient had attacks of heart failure with edema of the lower limbs and dyspnea on exertion, the patient was treated with an increase in furosemide. Rather favorable evolution noted with regression of edema. On 21Jan2021, profuse epistaxis leading to the discontinuation of rivaroxaban (XARELTO) and a decrease in candesartan (Blood Pressure low at 110 mmHg). On 01Feb2021, the patient vaccination with the first dose of bnt162b2 and had no particular sign after vaccination, no fever. On 04Feb2021, the patient fall while slipping from a chair. The patient was constantly measured by an state nurse at home with result of Blood Pressure at 117 mmHg, pulse at 64 bpm, oxygen saturation in ambient air 95 percent. On 06Feb2021, the patient was visited by the attending home physician, right rib trauma with hematoma that did not interfere with breathing noticed, no hemothorax. The patient had minor hematoma of the right knee. On 07Feb2021, the patient was sudden death, patient found dead at her home. No outward sign of hemorrhage. Cardiovascular cause selected by the doctor from emergency services who declared decease. In total, death of unknown cause occurred 7 days after vaccination with bnt162b2 in a 93-year-old patient with cardiac arrest/atrial fibrillation and whose anticoagulant treatment with rivaroxaban had been suspended. No link with the vaccine selected by the attending physician. The most probable hypothesis mentioned by the attending physician was a stroke following stopping the anticoagulation treatment with rivaroxaban. Accountability without prejudice to investigative elements that could be carried out in the context of legal or amicable compensation procedures. The patient underwent lab tests and procedures which included blood pressure measurement: 110 mmhg on 21Jan2021, blood pressure measurement: 117 mmhg on 04Feb2021, heart rate: 64 bpm on 04Feb2021, oxygen saturation: 95 % on 04Feb2021. The outcome of fall, right rib trauma with hematoma, minor hematoma of the right knee was unknown, of other events was unknown. The patient died on 07Feb2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiovascular cause; stroke; Sudden death


VAERS ID: 1051082 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Dyspnoea, Loss of consciousness, Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: STAGID; MIRTAZAPINE; PRADAXA
Current Illness: Abdominal pain; Atrial fibrillation; Dysfunction thyroid; Hypertension arterial; Type 2 diabetes mellitus; Urinary tract disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021169060

Write-up: Sudden death; difficulty breathing; unconscious; stroke; myocardial infarction; This is a spontaneous report a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [regulatory authority FR-AFSSAPS-ST20210316]. A 92-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number EJ6788) , intramuscular on 02Feb2021 at single dose on left arm for COVID-19 vaccination. Medical history included ongoing dysfunction thyroid, ongoing type 2 diabetes mellitus , ongoing hypertension arterial, ongoing atrial fibrillation, ongoing abdominal pain, ongoing urinary disturbance, hospitalized in EHPAD for 3-4 months. Concomitant medication included metformin embonate (STAGID), mirtazapine, dabigatran etexilate mesilate (PRADAXA). The patient experienced sudden death on 06Feb2021. The patient was hospitalized in EHPAD for 3-4 months having been vaccinated by COMIRNATY. The reporter does not report any change in clinical status after vaccination or in the days following vaccination. The reporter wishes to report sudden death 4 days after vaccination in this patient. The patient was found lying in the bathroom, with difficulty breathing and unconscious, 4 days after the vaccination. Despite urgent medical intervention, the patient died on 06Feb2021. The reporter raised the hypothesis of a possible myocardial infarction or stroke possibly attributable to the vaccine and likely to have contributed to the death of the patient, but without the patient having presented any clinical signs, in the aftermath of the vaccination. No Covid-19 history. Treatment was received for the events. The patient died on 06Feb2021. An autopsy was not performed. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: difficulty breathing; unconscious; myocardial infarction; stroke; Sudden death unexplained


VAERS ID: 1051154 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-02-04
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cerebral haemorrhage, Contusion, Epistaxis, Haemorrhage, Headache, Heart rate, Loss of consciousness, Oxygen saturation, Platelet count, Retching, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   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: GABAPENTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy (some medicines relating to that, including some anti-coagulant, but I don''t know which.); Back pain; Bypass surgery; Headache; Nausea; Palpitations; Comments: As above, the patient had had a heart by-pass a couple of years ago, and was on some medicines relating to that, including some anti-coagulant, but I don''t know which. Also, some pain medicines for back pain, including gabapentin since Nov. 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: Test Date: 20210206; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:assessed as ok by practice nurse; Test Date: 20210206; Test Name: pulse; Result Unstructured Data: Test Result:assessed as ok by practice nurse; Test Date: 20210206; Test Name: blood oxygen; Result Unstructured Data: Test Result:assessed as ok by practice nurse; Test Date: 202102; Test Name: platelet count; Result Unstructured Data: Test Result:Zero
CDC Split Type: GBPFIZER INC2021177655

Write-up: headache; collapsed unconscious; retching; brain bleed; bleeding elsewhere in body; bruising on skin and in mouth; nose bleeding; Thrombocytopenia; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202102171436191650, Safety Report Unique Identifier GB-MHRA-ADR 24781178. An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient medical history included headache, nausea, back pain, palpitations, heart bypass and anticoagulant therapy (some medicines relating to that, including some anti-coagulant, but I don''t know which), all from an unknown date and unknown if ongoing. The patient''s concomitant medication included gabapentin from Nov2020. The patient experienced nose bleeding on 5Feb2021 evening (nothing noted previously), headache and nose bleeding on 06Feb2021 morning, collapsed unconscious after eating dinner on 6Feb2021 evening, after some retching, diagnosed in hospital with brain bleed, bleeding elsewhere in body, bruising on skin and in mouth. Platelet count zero, no known cause for the thrombocytopenia (04Feb2021 as reported). All events were serious. The patient underwent lab tests and procedures which included platelet count: zero in Feb2021; blood pressure, pulse and blood oxygen: assessed as ok by practice nurse on 06Feb2021. The patient died on 06Feb2021. It was not reported if an autopsy was performed. The patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient was not enrolled in clinical trial. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Thrombocytopenia


VAERS ID: 1051159 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2020-12-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-24
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: 2020-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Kidney disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021160932

Write-up: patient died around the Christmas - The day after the vaccine; The initial case was missing the following minimum criteria: the product is unspecified. Upon receipt of follow-up information on 17Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (cousin). A 94-year-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing problems with kidneys. The patient''s concomitant medications were not reported. Clinical course: the patient was very fit, he still played tennis up to 2 years ago (in 2019) and had also passed his driving retest recently. The day after the vaccine, he had breakfast and went to bed to have a bath and laid down on the bed and died. This occurred just prior to X-mas in Dec2020. The patient died in Dec2020. It was not reported if an autopsy was performed. The lot/batch number has been requested.; Reported Cause(s) of Death: patient died around the Christmas - The day after the vaccine


VAERS ID: 1051160 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4244 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Premature baby
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021191405

Write-up: Labor premature; maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer. This is baby case created from the mother''s case received from the Medicines Healthcare products Regulatory Agency (MHRA). Regulatory authority report number {GB-MHRA-WEBCOVID-202102101517193900}, Safety Report Unique Identifier GB-MHRA-ADR 24736001. This consumer reported information for both mother and baby. This is the baby report. Only this case is serious. A fetus patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK4244), transplacental on 04Feb2021 at single dose for covid-19 immunization. The mother''s medical history was not reported. The mother''s concomitant medication included folic acid as folic acid supplementation. The patient''s mother received BNT162B2 on 04Feb2021. The patient''s mother was exposed to the medicine Second-trimester (13-28 weeks). The patient''s mother had premature labor. Live infant delivered but passed away on 10Feb2021. Case was reported as hospitalization condition. The patient died on 10Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021147096 mother case; Reported Cause(s) of Death: Labor premature


VAERS ID: 1051172 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Oxygen saturation, Oxygen saturation decreased, Respiratory tract infection
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: SCOPODERM [HYOSCINE HYDROBROMIDE]; ESOMEPRAZOLE; MOVICOL APELSIN; PARACETAMOL; VIDISIC; QUETIAPINE; FENTANYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Activities of daily living impaired; Bedridden; Dementia (Advanced dementia); Frailty; Limb deformity; Low weight; Lower respiratory tract infection; Swallowing difficult
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: Oxygen saturation; Test Result: 79 %
CDC Split Type: IEPFIZER INC2021169015

Write-up: RESPIRATORY TRACT INFECTION; OXYGEN SATURATION DROPPED TO 79%; RESIDENT DERIORATED 4 DAYS AFTER VACCINE; This is a spontaneous report from a contactable other HCP downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, IE-HPRA-2021-065104. This is a report received from the Health Products Regulatory Authority (HPRA). A 91-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number EM0477), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included activities of daily living impaired, low weight, bedridden, limb deformity, dementia (Advanced dementia), lower respiratory tract infection, frailty, swallowing difficult. Concomitant medication included hyoscine hydrobromide (SCOPODERM), esomeprazole, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL APELSIN), paracetamol, carbomer (VIDISIC), quetiapine, fentanyl. The patient experienced respiratory tract infection, oxygen saturation dropped to 79%, resident deriorated 4 days after vaccine on 23Jan2021. It was reported that in Jan2021, 24 hours post vaccination, the patient was assessed by a GP and did not display any adverse effects of the vaccine. On 23Jan2021, four days post vaccination, the patient deteriorated significantly. The patient''s oxygen saturation dropped to 79% and she was seen by the Doctor on Call, who prescribed Augmentin 375 mg and diagnosed the patient with a respiratory tract infection. The patient''s deterioration continued and she died the following day, 24Jan2021, five days post vaccination and 24 hours after becoming acutely unwell. It was unknown if the vaccine contributed to the patient''s death. The reporter outlined that the patient was very frail and prone to respiratory tract infections. The patient was stable for 72 hours post vaccination and became unwell four days post vaccination. The outcome was fatal. The patient underwent lab tests and procedures which included oxygen saturation: 79 % on 23Jan2021. Therapeutic measures were taken as a result of the events. The patient died on 24Jan2021. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: RESIDENT DERIORATED 4 DAYS AFTER VACCINE; OXYGEN SATURATION DROPPED TO 79%; RESPIRATORY TRACT INFECTION


VAERS ID: 1051209 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Cough, Death, Hyperthermia, Productive cough, Pyrexia, SARS-CoV-2 antibody test negative
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Accidents and injuries (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperthermia (mild, on 05Feb2021 and 07Feb2021 resolved with paracetamol 1 g cpr); Ischemic heart disease (significant); Senile dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: hyperthermia; Result Unstructured Data: Test Result:mild; Test Date: 20210207; Test Name: hyperthermia; Result Unstructured Data: Test Result:mild; Test Date: 20210210; Test Name: hyperthermia; Result Unstructured Data: Test Result:hyperthermia; Test Date: 20210207; Test Name: SARS COVID 19 antigen test; Test Result: Negative
CDC Split Type: ITPFIZER INC2021169165

Write-up: Acute respiratory insufficiency; death; Fever; cough; sputum; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Medicines Agency (MA) Regulatory Authority- WEB [IT-MINISAL02-677675] received via Regulatory Authority. An 89-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY, Lot/batch EJ6797, expiration date 31Mar2021) intramuscular at single dose at left shoulder on 08Feb2021 for covid-19 immunisation. The patient medical history included significant ischemic heart disease and senile dementia, under pharmacological treatment with antipsychotics, hypotensive vasodilators. Negative SARS COVID 19 antigen test performed on the same date 07Feb2021. The patient experienced mild hyperthermia on 05Feb2021 and 07Feb2021 resolved with an administration of paracetamol 1 g cpr. The concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (COMIRNATY) at single dose at right deltoid on 18Jan2021 for covid-19 immunisation and no reaction occurred. On 10Feb2021 hyperthermia with cough and sputum took over more than 48 hours after the administration. Therapeutic measures were taken as a result of acute events: clinical evaluation, PV detection, tracheal aspiration (100cc) for presence of phlegm and oily cough. On 10Feb2021 at about 7 pm hyperthermia, acute respiratory failure, death occurred. The outcome of cough and sputum was unknown, of hyperthermia, acute respiratory failure, death was fatal. It was not reported if an autopsy was performed. Reporter''s comment: This is a patient with significant ischemic heart disease and senile dementia, under pharmacological treatment with antipsychotics, hypotensive vasodilators. No reaction to the first dose of COMIRNATY vaccine administered on 18Jan2021. Mild hyperthermia on 05Feb2021 and 07Feb2021 resolved with an administration of paracetamol 1 g cpr. Negative SARS COVID 19 antigen test performed on the same date (07Feb2021???). Hyperthermia with cough and sputum took over more than 48 hours after the administration.; Reporter''s Comments: This is a patient with significant ischemic heart disease and senile dementia, under pharmacological treatment with antipsychotics, hypotensive vasodilators. No reaction to the first dose of COMIRNATY vaccine administered on 18Jan2021.Mild hyperthermia on 05Feb2021 and 07Feb2021 resolved with an administration of paracetamol 1 g cpr Negative SARS COVID 19 antigen test performed on the same date (07Feb2021?).Hyperthermia with cough and sputum took over more than 48 hours after the administration.; Reported Cause(s) of Death: acute respiratory failure; hyperthermia


VAERS ID: 1051214 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / -

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

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: XEPLION
Current Illness: Palliative care
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; COPD; Decompensation cardiac; Decubitus; Psychiatric disorder NOS; Recurrent respiratory tract infections; Renal function disorder; Swallowing difficult
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021174431

Write-up: Death with pre-existing cardiac and pulmonary comorbidity; Fatigue; had fallen out of bed in the morning; Not feeling well; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [number NL-LRB-00442923] from a contactable physician. A 69-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY) (lot# EJ6795), via an unspecified route of administration, on 21Jan2021, at single dose, for COVID-19 immunisation. Medical history included renal impairment, dysphagia, chronic obstructive pulmonary disease, cardiac failure, mental disorder, anaemia, respiratory tract infection, ongoing palliative care, decubitus ulcer. Patient did not have COVID-19 previously. Concomitant medication included paliperidone palmitate (XEPLION). The patient experienced had fallen out of bed in the morning, death with pre-existing cardiac and pulmonary comorbidity, fatigue, not feeling well all on 24Jan2021 with fatal outcome the same day. It was not reported if an autopsy was performed. The reporter described that the patient was already vulnerable with existing cardiac and respiratory comorbidity and a palliative setting. Case summary and Reporter comment: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Death in co-morbidity pre-existent cardiac and pulmonary. Additional information ADR: Died 3 days after vaccination in pre-existing context of fragile medical setting at co-morbidity pre-existent cardiac and pulmonary. Confounding factors: Chronic obstructive pulmonary disease (COPD), decompensation cardiac, anemia, renal impairment, recurrent respiratory infections, decubitus, swallowing difficulties, psychiatry, had fallen out of bed in the morning on day of death. Previous COVID-19 infection: No. Other diagnostic procedures: No, patient had a palliative policy. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Died 3 days after vaccination in pre-existing context of fragile medical setting at co-morbidity pre-existent cardiac and pulmonary. Confounding factors: Chronic obstructive pulmonary disease (COPD), decompensation cardiac, anemia, renal impairment, recurrent respiratory infections, decubitus, swallowing difficulties, psychiatry, had fallen out of bed in the morning on day of death. Previous COVID-19 infection: No. Other diagnostic procedures: No, patient had a palliative policy.; Reported Cause(s) of Death: fatigue; Not feeling well; death


VAERS ID: 1051215 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial flutter, Blood pressure measurement, C-reactive protein, Chest X-ray, Heart rate, Oxygen saturation, Pneumonia
SMQs:, Supraventricular tachyarrhythmias (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: 2021-01-26
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMOXICILLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm; Atherosclerotic cardiovascular disease; Chronic obstructive pulmonary disease; Frailty (Frailty score 7); Leg amputation (Due to ischemia); Living in nursing home; Memory impaired; Pneumonia (with empyema/effusion); Smoker; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Date: 20210115; Test Name: Chest X-ray; Result Unstructured Data: Test Result:showed a thickening compatible with pneumonia; Comments: showed a thickening compatible with pneumonia; Test Date: 20210112; Test Name: C-reactive protein; Result Unstructured Data: Test Result:82; Comments: 82; Test Date: 20210115; Test Name: Heart rate; Result Unstructured Data: Test Result:150-200; Test Date: 20210115; Test Name: oxygen saturation; Result Unstructured Data: Test Result:Low
CDC Split Type: NOPFIZER INC2021163707

Write-up: Pneumonia with empyema / effusion; atrial flutter; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The Regulatory authority report number is NO-NOMAADVRE-FHI-2021-U4m2x and safety unique identifier NO-NOMAADVRE-E2B_00014998. An 88-year-old male patient received bnt162b2 (COMIRNATY; Lot number EJ6795), intramuscular from 14Jan2021, at 13:46 at single dose for covid-19 immunization. Medical history included aortic aneurysm from an unknown date, leg amputation on an unknown date, due to ischemia, frailty from an unknown date (frailty score 7), atherosclerotic cardiovascular disease from an unknown date, wheelchair user from an unknown date, memory impairment from an unknown date, smoker from an unknown date, pneumonia from 12Jan2021 with empyema/effusion, living in a nursing home from an unknown date, chronic obstructive pulmonary disease from an unknown date. Concomitant medication included amoxicillin (MANUFACTURER UNKNOWN), for lung infection from 12Jan2021. The patient previously took influenza vaccine for immunization. The patient experienced pneumonia with empyema / effusion in Jan2021 (reported as on 12Jan2021), which was serious as involved hospitalization and lead to death. On 17Jan2021, atrial flutter was noted, with unknown outcome. The patient underwent lab tests and procedures which included chest x-ray: showed a thickening compatible with pneumonia on 15Jan2021, c-reactive protein: 82 on 12Jan2021, heart rate: 150-200 on 15Jan2021. Therapeutic measures were taken as a result of pneumonia with empyema / effusion. Details were as follows: early morning on 12Jan2021, the patient was short of breath. This was assessed to be a lung infection and oral treatment with amoxicillin was started. On 14Jan2021, the patient felt better, the staff observed easier breathing than the day before. He was afebrile, a little tired, but considered to be improving with no signs of short life expectancy. Vaccinated the same day. Early in the morning on 15Jan2021, the patient experienced worsening and was admitted to the hospital where it was assessed that the patient had severe pneumonia with empyema/effusion. It was noted that changed antibiotics several times but not responded. On 26Jan2021, the patient died. Reporter does not interpret the course as a reaction from the vaccine, but as a pneumonia with gradually a storming course. No known allergies were noted. The patient had been vaccinated against influenza earlier on an unspecified date. The patient cared for himself, had a good mood and ate as normal and did not have shortness of breath or pain in the week before the event. Early morning on 12Jan2021, he was short of breath, had a good effect of Atrovent and Ventoline at 06:00, CRP at 82 5 hours later. Suspected lung infection and started treatment with amoxicillin immediately. Patient was still up in the chair and observed effortless respiration. In the evening pain, in the left upper abdomen/flank which was relieved by adjusting the bed rest. On the day 13Jan2021, noted soreness in the left abdominal region again as well as coughing, but effortless breathing. Interpreted as constipation or rib pain from coughing. He still cared for himself, ate a little less, but drank well. On 14Jan2021, he felt better, the staff observed easier breathing than the day before. He was afebrile, a little slack but considered to be improving with no signs of short life expectancy. Vaccinated the same day at 13:46. Self-help in self-care in the evening. On 15Jan2021 (04:30 am), noted increased pain in the upper left part of the abdomen, wheezing, cold and clammy, low blood pressure and low oxygen saturation. Patient was admitted to the hospital, observed productive cough, obstructive pulmonary physics, heart rate between 150 and 200, pleural fluid with 3 cm brake, possibly organized with septa. Assessed as severe pneumonia with empyema/effusion. Given Cefotaxim and Flagyl. Got thoracic drain with regression of fluid retention and improved breathing. Chest X-ray after this showed a thickening compatible with pneumonia. On 17Jan2021, atrial flutter was 200, attempted conversion. Relieved with midazolam and morphine on pain pump and oxygen until he died 26Jan2021. The doctor''s assessment noted that the patient was vaccinated due to COPD, smoking and widespread cardiovascular disease, frailty grade 7, regardless of help with personal care but in need of a nursing home due to reduced cognition. He had been physically stable and considered not to have a high risk of dying for the next 6 months. He was somewhat more improved from infection on the day of vaccination, but perceived as having an infection with a mild course. The flank/abdominal pain in the left side from 12Jan2021 is subsequently interpreted as a lung infection near the cleft palate with the development of slough in the cleft palate with increased pain, low blood pressure and failing lung function. Heart failure due to rapid heart rate may also have contributed to fluid in the lung cleft. Reporter did not interpret the course as a reaction from the vaccine, but a pneumonia with an eventually storming course. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Sender Comment: An 88 year old man was vaccinated with Comirnaty 14Jan2021. The patient is multimorbid with COPD, atherosclerotic disease, previous aortic aneurysm, amputated leg due to ischemia and impaired memory. The patient lived in a nursing home, used a wheelchair and smoked. Early in the morning 12Jan2021 the patient was short of breath which was believed to be a lung infection and treatment with amoxicillin was started immediately. On 14Jan2021 the patient felt better and the staff observed lighter breathing than the day before. The patient was afebrile, a little fatigued but considered to be improving with no signs of short life expectancy. The vaccine was given the same day. Early in the morning of 15Jan2021, the patient experienced deterioration and was admitted to hospital. The patient''s condition was assessed as severe pneumonia with empyema / effusion. The antibiotic was changed several times without the patient responding. 26Jan2021 the patient died. Reporter does not interpret the course as a reaction from the vaccine, but a pneumonia which turned into a rapidly deteriorating state. When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including death, may occur briefly time after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or other incidental cause. On the basis of the information in the notification and in accordance with international criteria, the causal relationship with vaccination is considered as possible, but which may also be due to underlying disease, other drugs or chemicals. Since the patient died, the message is classified as serious, even though no causal link between the vaccine and the death has been established. The death cause was noted as unknown. Relatedness of drug to reactions was reported as unlikely; Source of assessment Regional Pharmacovigilance Center: Possible No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1051221 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Death, Lividity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

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: Atherosclerosis generalized; Chronic heart failure; Hypertension; Ischemic heart disease; Permanent atrial fibrillation
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke (Left hemisphere stroke)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021176665

Write-up: Death; Limbs lividity; bruising of the limbs; This is a spontaneous report from a contactable physician via The Office for Registration of Medicinal Products (URPL) downloaded from the Medicines Agency (MA) Regulatory Authority-WEB PL-URPL-3-154-2021. A female patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY, lot number EJ6795, expiration date 08Jan2021), intramuscular in left arm on 04Jan2021 at 0.3 ml, single for covid-19 immunisation. Medical history included ongoing atrial fibrillation, left hemisphere stroke from 2007, ongoing hypertension, ongoing myocardial ischaemia, ongoing cardiac failure chronic, ongoing arteriosclerosis generalized. The patient''s concomitant medications were not reported. On 25Jan2021 12:50 the patient experienced death (fatal) and limbs lividity (medically significant) with outcome of unknown. The patient died on 25Jan2021. It was not reported if an autopsy was performed. On the application form it was marked: bruising of the limbs. In the description of the report, the doctor stated: the death of a patient in the health care facility on the 21st day after the vaccine was given. The second dose was not administered. A patient with generalized atherosclerosis after a stroke in the left hemisphere in 2007, with permanent atrial fibrillation, hypertension, ischemic heart disease, chronic circulatory failure. The patient has been staying in the health and care facility since 21Feb2020. The physician believed that the patient''s death was not related to the administration of the first dose of Comirnaty. Patient with multiple diseases as above. The reporting person classified them as severe. Due to the assessment of the reporting person and the patient''s death, URPL classified the application as "severe". Health result: death (21 days after administration of the vaccine) The data contained in the electronic report are all available to the URPL - if additional information is obtained, another version will be sent. Health Authority Comment: A bruising of the limbs is not an expected side effect. Until 09.21.2021, 3 cases of lividity following administration of Corminaty were reported in the Regulatory Authority database. It cannot be ruled out that the bruising of the patient''s limbs was related to her underlying circulatory diseases (e.g. circulatory failure). In the opinion of the physician reporting the patient''s death, it is not related to the administration of the vaccine. Due to the above, it was decided to assign an unlikely cause and effect relationship. The temporal relationship supports a cause and effect relationship (death occurred 21 days after vaccination). The reporting person classified them as severe. Due to the assessment of the reporting person and the patient''s death, URPL classified the application as "severe". No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1051222 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure measurement, Cardiac arrest, Dyspnoea, Heart rate, Heart rate increased, Loss of consciousness, Lymph node pain, Lymphadenopathy, Oxygen saturation, Oxygen saturation decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: Blood pressure; Result Unstructured Data: Test Result:120/98; Test Date: 20210127; Test Name: Heart rate; Result Unstructured Data: Test Result:120; Test Date: 20210127; Test Name: Oxygen saturation; Test Result: 82 %; Comments: Decreased
CDC Split Type: PLPFIZER INC2021176664

Write-up: Cardiac arrest; Oxygen saturation decreased; Sudden dyspnoea; Heart rate increased; Blood pressure abnormal; Loss of consciousness; Pain and enlargement of the lymph nodes; Pain and enlargement of the lymph nodes; This is a spontaneous report from a contactable physician via The Office for Registration of Medicinal Products (URPL) from the Medicines Agency (MA) Regulatory Authority-WEB PL-URPL-3-171-2021 . A 48-years-old male patient received the first dose of bnt162b2 (COMIRNATY, lot EL1491, exp. 25Jan2021), intramuscular in left arm on 22Jan2021 13:32 at 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cardiac arrest, oxygen saturation decreased, sudden dyspnoea, heart rate increased, blood pressure abnormal, loss of consciousness on 27Jan2021 07:50 all with fatal outcome. The patient experienced also pain and enlargement of the lymph nodes (medically significant) on 27Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 120/98 on 27Jan2021, heart rate: 120 on 27Jan2021, oxygen saturation: 82 % (Decreased) on 27Jan2021. The patient died on 27Jan2021. It was not reported if an autopsy was performed. On the application form, soreness and enlargement of the regional lymph nodes were indicated. In the description of the report, the doctor said: 27Jan2021 around 07:50 - sudden dyspnea, oxygen saturation 82%, blood pressure 120/98, pulse 120, then loss of consciousness, cardiac arrest, resuscitation - death of the patient. The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the patient''s death, URPL classified the report as severe. Health result: death. The data contained in the electronic report is all at the disposal of URPL - in the case of obtaining additional information, another version will be sent. Health Authority Comment: Enlargement of lymph nodes is an expected adverse reaction following the administration of Comirnaty (in the Summary of this vaccine, termed lymphadenopathy) Other side effects are unexpected. Until 09Feb2021, in the Regulatory Authority database, with the result of the patient death, 32 cases of dyspnoea and 18 cases of oxygen saturation decreased (URPL did not have information on any additional circumstances (drugs, chronic diseases, allergies, etc.) which could have resulted in the described side effects. The temporal relationship supports a cause-and-effect relationship. The reporting person classified them as severe. URPL, due to the assessment of the reporting person, the nature of the side effects and the patient death, classified the report as severe. Comirnaty/ Cardiac arrest, Oxygen saturation decreased, Dyspnoea, Heart rate increased, Blood pressure abnormal, Loss of consciousness/, agency / Possible. Comirnaty/ Enlargement of lymph nodes , agency/Probable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Oxygen saturation decreased; Sudden dyspnoea; Heart rate increased; Blood pressure abnormal; Loss of consciousness; cardiac arrest


VAERS ID: 1051259 (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: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Fatigue, 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: 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: OXYCODONE; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; OMEPRAZOL SANDOZ [OMEPRAZOLE]; FURIX [FUROSEMIDE]; FURIX [FUROSEMIDE]; MIRTAZAPIN ACTAVIS; BISOPROLOL SANDOZ; AIROMIR [SALBUTAMOL SULFATE]; IMPUGAN [F
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic atrial fibrillation; Heart failure; Heart valve disorders (they did not want to operate due to the woman''s general physical health deterioration); Reduced general condition
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: body temperature; Result Unstructured Data: Test Result:38.1
CDC Split Type: SEPFIZER INC2021176880

Write-up: Tiredness; Death; Fever (38.1); This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (Regulatory Authority number SE-MPA-2021-002958). A 95-year-old female patient received the second dose of BNT162B2 (COMIRNATY) intramuscular, on an unspecified date in Jan2021, at 0.3 ml single, for COVID-19 immunisation. The first Comirnaty dose was given on an unknown date for COVID-19 immunisation. Medical history included heart valve disorders (which they did not want to operate due to the woman''s general physical health deterioration), chronic atrial fibrillation, heart failure and reduced general condition, all from an unknown date and unknown if ongoing. Concomitant medications included oxycodone prolonged-release tablet, 5 mg, daily (oxycodone Depot 1A Farma), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) powder for oral solution, omeprazole (OMEPRAZOL SANDOZ; 20 mg gastro-resistant capsule, hard) 20 mg single, furosemide (FURIX; 10 mg/ml solution for injection) 1 DF daily, furosemide (FURIX; 40 mg tablet) 1 tablet 1-2 times daily, as needed, mirtazapine (MIRTAZAPINE ACTAVIS; 15 mg film-coated tablet) daily, bisoprolol fumarate (BISOPROLOL SANDOZ; 2.5 mg film-coated tablet) 2.5 mg daily, salbutamol sulfate (AIROMIR; 0.1 mg inhalation spray, suspension) 1-2 inhalations, as needed, furosemide (IMPUGAN; 40 mg tablet) 80 mg daily, sodium picosulfate (CILAXORAL; 7.5 mg/ml oral drops, solution) 10-15 drops at bed time, as needed, oxazepam (OXASCAND; 5 mg tablet) 15 mg, daily and 1 tablet extra per day, as needed, levothyroxine sodium (LEVAXIN; 75 ug tablet) 75 ug, daily, oxycodone hydrochloride (OXYNORM; 5 mg capsule hard) 1 DF as needed every 6th hour (max 2 DF daily), paracetamol (ALVEDON; 500 mg film coated tablet), spironolactone (SPIRONOLAKTON PFIZER; 50 mg tablet) 50 mg daily and hydrochlorothiazide (HYDROKLORTIAZID EVOLAN; 25 mg tablet) 25 mg daily. The day after vaccination, on an unspecified date in Jan2021, the patient became tired and in the evening a temperature of 38.1 was measured. The patient was treated with paracetamol (ALVEDON). The following night, on an unspecified date in 2021, the patient was found dead in her bed. The outcome of the events was fatal. It was unknown if an autopsy was done. Report assessed as serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death; Fever; Tiredness


VAERS ID: 1051260 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, Somnolence, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LANITOP; RIVASTIGMINE ACTAVIS; GLURENORM; CONTROLOC [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; PLIVIT D3; XARELTO; NOVOMIX; LEKADOL; EDEMID; MIRAPEXIN; AGLURAB; NAKOM MITE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC2021174280

Write-up: Unresponsive to stimuli; fever; Sleepiness; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority. Regulatory Authority Report Number: SI-JAZMP-NCPHV-2021SI0128_0128. Case identifiers: JAZMP-300011127. A 91-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot. EJ6797, expiration date: 30Apr2021) intramuscularly, at single dose, on 20Jan2021 at 15:30, for COVID-19 immunisation. Relevant medical history was unknown. Concomitant medications included oral metildigoxin (LANITOP) 0.1 mg tablet from 13Apr2017 to 27Jan2021; rivastigmine hydrogen tartrate (RIVASTIGMINE ACTAVIS) 1 DF, daily (4.6 mg/24h) transdermal patch, from 04Feb2020 to 28Jan2021; oral gliquidone (GLURENORM) 30 mg tablet from 15Jun2017 to 27Jan2021; oral pantoprazole sodium sesquihydrate (CONTROLOC) 20 mg gastro-resistant tablet from 13Apr2017 to 27Jan2021; oral colecalciferol (PLIVIT D3) 4000 UI/ml oral drops from 23Dec2020 to 27Jan2021; oral rivaroxaban (XARELTO) 15 mg film-coated tablet from 06May2019 to 28Jan2021; insulin aspart, insulin aspart protamine (crystalline) (NOVOMIX) Solution for injection in pre-filled pen, subcutaneously, 1 DF, from 05Dec2018 to 27Jan2021; oral paracetamol (LEKADOL) 500 mg tablet from 08Jan2021 to 27Jan2021; oral furosemide (EDEMID) 40 mg tablet from 13Apr2017 to 27Jan2021; oral pramipexole dihydrochloride (MIRAPEXIN) 0.18 mg tablet from 13Apr2017 to 27Jan2021; oral metformin hydrochloride (AGLURAB) 850 mg tablet from 11Mar2017 to 27Jan2021 and oral carbidopa, levodopa (NAKOM MITE) 1 DF (100 mg / 25 mg) tablet from 26Apr2018 to 27Jan2021. On 27Jan2021 the patient experienced sleepiness. The patient was less responsive. On 28Jan2021 the patient became febrile and unresponsive. The patient was referred to hospital. On 28Jan2021 the patient died. The adverse events were assessed as serious (hospitalization, medically significant and Death). Clinical outcome of the events was reported as fatal. It was unknown if autopsy was done. No additional data arrived in the initial case report. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sleepiness; Unresponsive to stimuli; Fever


VAERS ID: 1052321 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Epilepsy, Escherichia sepsis, Meningitis bacterial, Pyrexia, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: CANDESARTAN/HCT; TIMOPTIC
Current Illness: Aortic valve stenosis (severe aortic valve stenosis); Hypertension arterial; Prostatic hyperplasia; Renal cysts
Preexisting Conditions: Medical History/Concurrent Conditions: Confused
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: Body temperature; Result Unstructured Data: Test Result:41 Centigrade
CDC Split Type: ATPFIZER INC2021118472

Write-up: Suspected bacterial meningitis; Fever; Vomiting; Somnolence; Epileptic fit; Sepsis (E. coli in the liver and brain); This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory-WEB, regulatory authority number AT-BASGAGES-2021-00713. An 89-year-old male patient received first dose of BNT162B2 (COMIRNATY), from lot EL1491 via Intramuscular on 19Jan2021 at single dose for COVID-19 immunization. The patient''s medical history and concurrent conditions included: Hypertension arterial (continuing), Aortic valve stenosis (continuing), Prostatic hyperplasia (continuing), Renal cysts (continuing). The patient was so far in good health for his age, required almost no medication, was still able to go for a walk, he was only slightly confused. Concomitant medications included candesartan cilexetil, hydrochlorothiazide (CANDESARTAN/HCT) from 01Jan1970 for Hypertension arterial and timolol maleate (TIMOPTIC). On 22Jan2021 the patient experienced fever, vomiting, somnolence, epileptic fit and bacterial meningitis. On 22Jan2021 (three days after the first ''corona vaccination'') patient suddenly no longer knew his wife, patient collapses, fever rises to 41 ?C, patient dies of bacterial meningitis after admission to hospital the following day. Pathologists gave ''meningitis'' as the cause of death, but at the time the results of the blood culture were not ready: it showed sepsis (E. coli in the liver and brain), died on 23Jan2021 at around 8 pm. Hospital doctors suspect no connection to the vaccination, but for relatives ''it happened so quickly that the connection cannot be ruled out''. The patient died on 23Jan2021. Autopsy was done. Outcome of the events was fatal. The events were assessed serious life-threatening and fatal. Health Care professional/Comirnaty/to all events/ No reasonable possibility. No follow-up attempts possible. No further information expected. Follow-up(18Feb2021): New information downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (AT-BASGAGES-2021-00713) by a contactable physician included: suspect drug data, medical history, concomitant medication, new event (Sepsis (E. coli in the liver and brain)). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sepsis (E. coli in the liver and brain); meningitis bacterial; pyrexia; vomiting; somnolence; epilepsy


VAERS ID: 1052362 (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: 2021-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL 1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Cardiac arrest, Chronic obstructive pulmonary disease, 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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXASCAND; VENTOLINE EVOHALER; BEVIPLEX FORTE; ACETYLSALICYLIC ACID; CITALOPRAM; SPIOLTO RESPIMAT; LEVAXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol problem; Cardiac arrest; Chronic obstructive pulmonary disease; Depression; Stroke; Underweight (BMI=16)
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:16
CDC Split Type: SEPFIZER INC2021118803

Write-up: Death; Cardiac arrest; COPD; This is a spontaneous report from a contactable nurse downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (Regulatory Authority number SE-MPA-2021-002001, Other case identifier number SE-MPA-1611905718852). A 70-year-old female patient received BNT162B2 (COMIRNATY; lot EL 1484) intramuscular, on an unspecified date in Jan2021, at single dose, for COVID-19 immunisation. Medical history included stroke in 2015, chronic obstructive pulmonary disease, alcohol problem, cardiac arrest in Oct2020, underweight (BMI=16) and depression, all unknown if ongoing. Concomitant medications included oxazepam (OXASCAND) from 19Jun2020, salbutamol sulfate (VENTOLINE EVOHALER; Inhalation spray, suspension) from 19Aug2020, nicotinamide, pyridoxine HCl, riboflavin sodium phosphate, thiamine HCl (BEVIPLEX FORTE), from 20Jun2019, acetylsalicylic acid from 20Jun2019, citalopram from 20Jun2019, olodaterol hcl, tiotropium bromide monohydrate (SPIOLTO RESPIMAT; inhalation, solution) from 19Aug2020 and levothyroxine sodium (LEVAXIN) from 20Jun2019. In October 2020, the woman was found unconscious with a suspected cardiac arrest. CPR was started and the woman was taken by ambulance to hospital. No explanation was found. Suspected of cardiac arrest, but it could not be ensured and the patient has no arrhythmia as an explanation for it all. Then suspicion of underlying infection in the form of a COPD exacerbation. Eleven days after vaccination, on an unspecified date in Jan2021, the patient developed shortness of breath and inhaled Ventoline. About 10 minutes after inhalation, she had a cardiac arrest. Resuscitation attempts took place for about 20 minutes. On an unspecified date in Jan2021 the patient died. Death and cardiac arrest were reported as fatal events. It was unknown if an autopsy was performed. The patient died of COPD exacerbation. Report was assessed as serious for death. Follow-up (15Feb2021): Follow-up attempts completed. No further information expected. Follow up (19Feb2021). New information downloaded from Medicines Agency MA Regulatory Authority WEB SE-MPA-2021-002001. New information included: New fatal event COPD exacerbation added. New medical history. Dyspnea deleted. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COPD exacerbation; Death; Cardiac arrest


VAERS ID: 1053626 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Angiogram, Antibody test, Asthenia, Atelectasis, Atrial fibrillation, Atrioventricular block, Bacterial test, Basophil count, Blood cholesterol, Blood creatinine, Blood culture, Blood folate, Blood potassium, Blood pressure measurement, Blood sodium, Blood thyroid stimulating hormone, Blood triglycerides, Bradycardia, Bradyphrenia, C-reactive protein, CSF cell count, Cardiac arrest, Cardio-respiratory arrest, Chest discomfort, Computerised tomogram, Computerised tomogram head, Diplopia, Dysarthria, Dyspnoea, Electroencephalogram, Electroencephalogram abnormal, Electrophoresis protein, Eosinophil count, Fatigue, General physical health deterioration, Haemoglobin, High density lipoprotein, Hypervitaminosis B12, Hypothermia, Investigation, Liver function test, Low density lipoprotein, Lumbar puncture, Lymphocyte count, Lymphopenia, Magnetic resonance imaging brain, Monocyte count, Myalgia, Nervous system disorder, Neutrophil count, Normocytic anaemia, Pain, Parkinsonism, Platelet count, Pneumonia aspiration, Pneumonia moraxella, Respiratory distress, Resuscitation, SARS-CoV-2 test, Sinus disorder, Speech disorder, Tachypnoea, Thrombocytopenia, Tracheal aspirate culture, Viral test, Vitamin B12
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Parkinson-like events (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRIMEBUTINE PFIZER; BROMAZEPAM TEVA; ALFUZOSINE EG; PRAVASTATIN ACCORD; LUMIGAN; MACROGOL; LARMABAK
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic anxiety; Kyphosis (1981); Neurofibromatosis, type 1 (von Recklinghausen''s disease)
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: digital subtraction angiography; Result Unstructured Data: Test Result:A posteriori re-reading of the data stored in the; Comments: A posteriori re-reading of the data stored in the DSA (digital subtraction angiography) in favor of a transient extrinsic bradycardia of poorly specified origin and no true asystole or regressive electro-mechanical dissociation after external cardiac massage and short-term mask ventilation.; Test Date: 20210128; Test Name: antibody test; Result Unstructured Data: Test Result:- Anti-neuronal antibodies by immunoblot on blood; Comments: - Anti-neuronal antibodies by immunoblot on blood sample (Anti-Tr, anti-GAD65 antibodies, anti-Zic4 antibodies, anti-Titine antibodies, anti-SOX1 antibodies, anti-Recoverine antibodies, anti-HU antibodies, anti-YO antibodies, Anti-RI Ab, Anti PNMA2 Ab, Anti-CV2 Ab, Anti-Amphiphysin Ab): negative - Anti-neuronal antibodies by immunoblot on CSF sample (anti-Tr, anti-GAD65 antibodies, anti-Zic4 antibodies, anti-Titin antibodies, anti-SOX1 antibodies, anti-Recoverine antibodies, anti-HU antibodies, anti-YO antibodies, Anti-RI Ab, Anti PNMA2 Ab, Anti-CV2 Ab, Anti-Amphiphysin Ab): in progress - Ac anti SSA, SSB, RNP, Scl70, JO1: negative - Ac anti DNA: uninterpretable - Anti nuclear ac: negative - Anti-neutrophil cytoplasmic antibodies: negative - Blot myosit (ac anti cN-1A, Ac anti OJ, Ac anti PL-12, Ac anti PL-7, Ac anti SRP, Ac anti JO-1, Ac anti PM-Scl75, Ac anti PM-Scl 100, Ac anti-KU, Ab anti SAE, Ab anti-NXP2, Ab anti-MDA5, Ab anti-TIF1 GAMMA, Ab anti helicase beta MI-2B, Ab anti helicase beta MI-ZA): negative - Anti-cardiolipin IgG antibody: negative - Anti-cardiolipin IgM antibody: negative - Anti-Beta 2 GP1 IgG antibodies: negative - Ac anti-Beta 2 GP1 IgM at 25.2 (N: less than 20: negative, 20 - 40: weakly positive) therefore weakly positive but done only once Results of anti NMDA( N-Methyl-D-aspartate) antibodies pending.; Test Date: 20210126; Test Name: bacteria test; Result Unstructured Data: Test Result:Legionella: negative, Streptococcus: negative; Comments: Legionella: negative, Streptococcus: negative; Test Date: 20210122; Test Name: Basophil; Result Unstructured Data: Test Result:0 x10 9/l; Test Date: 20210125; Test Name: Total cholesterol; Result Unstructured Data: Test Result:5.75 mmol/L; Test Date: 20210122; Test Name: creatinine; Result Unstructured Data: Test Result:60 umol/l; Test Date: 20210123; Test Name: blood culture; Result Unstructured Data: Test Result:negative; Test Date: 20210126; Test Name: blood culture; Result Unstructured Data: Test Result:negative; Test Date: 20210128; Test Name: blood culture; Result Unstructured Data: Test Result:negative; Test Date: 20210129; Test Name: blood culture; Result Unstructured Data: Test Result:negative; Test Date: 20210126; Test Name: serum folate; Result Unstructured Data: Test Result:9.3 nmol/L; Test Date: 20210122; Test Name: potassium; Result Unstructured Data: Test Result:4.7 mmol/L; Test Date: 20210113; Test Name: BP; Result Unstructured Data: Test Result:16; Comments: rather high at 16; Test Date: 20210122; Test Name: sodium; Result Unstructured Data: Test Result:144 mmol/L; Test Date: 20210125; Test Name: TSH; Result Unstructured Data: Test Result:2.56 IU/l; Test Date: 20210125; Test Name: Triglycerides; Result Unstructured Data: Test Result:within the standards; Test Date: 20210129; Test Name: bradycardia monitoring; Result Unstructured Data: Test Result:50/min; Test Date: 20210128; Test Name: Thoraco-Abdomino-Pelvic CT scan; Result Unstructured Data: Test Result:a lymphocytic immunophenotyping is recommended (+/; Comments: a lymphocytic immunophenotyping is recommended (+/- a myelogram depending on the results; Test Date: 20210122; Test Name: cerebral CT; Result Unstructured Data: Test Result:The cerebral CT scan and the ASDs did not find any; Comments: The cerebral CT scan and the ASDs did not find any abnormality,; Test Date: 20210128; Test Name: c-reactive protein; Result Unstructured Data: Test Result:16 mg/l; Test Date: 20210129; Test Name: c-reactive protein; Result Unstructured Data: Test Result:41 mg/l; Test Date: 20210129; Test Name: CSF; Result Unstructured Data: Test Result:clear, direct examination negative, leukocytes: 1; Comments: clear, direct examination negative, leukocytes: 1 / mm3, red blood cells: 11 / mm3, chlorurorachia (N: 120-125 mmol /): 118, proteinorachia (N: 0.15 -0.45 g / l): 0.53, glycorachia (N: 2.2-3.9 mmol / l): 3.2; Test Date: 20210129; Test Name: EEG; Result Unstructured Data: Test Result:The EEG found a very slowed down and poorly organi; Comments: The EEG found a very slowed down and poorly organized EEG tracing but without status epilepticus.; Test Date: 20210128; Test Name: serum protein electrophoresis; Result Unstructured Data: Test Result:Total proteins: 60 g / l (N: 64-83) g/l; Comments: Total proteins: 60 g / l (N: 64-83) Albumin: 34.3 g / l (N: 40-47) Alpha 1 globulins: 3.5 g / l (N: 2.1-3.5) Alpha 2 globulins: 7.4 g / l (N: 5.1-8.5) Beta 1 globulins: 3.2 g / l (N: 3.4-5.2) Beta 2 globulins: 2.9 g / l (N: 2.3-4.7) Gammaglobulins: 8.5 g / L (N: 8-13.5); Test Date: 20210122; Test Name: Eosinophil; Result Unstructured Data: Test Result:0 x10 9/l; Test Date: 20210122; Test Name: haemoglobin; Result Unstructured Data: Test Result:12.6 g/dl; Test Date: 20210128; Test Name: haemoglobin; Result Unstructured Data: Test Result:12 g/dl; Test Date: 20210129; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.1 g/dl; Test Date: 20210203; Test Name: haemoglobin; Result Unstructured Data: Test Result:8.7 g/dl; Test Date: 20210208; Test Name: haemoglobin; Result Unstructured Data: Test Result:7.9 g/dl; Test Date: 20210209; Test Name: haemoglobin; Result Unstructured Data: Test Result:7.7 g/dl; Test Date: 20210125; Test Name: HDL cholesterol; Result Unstructured Data: Test Result:within the standards; Test Date: 20210128; Test Name: hypothermia; Result Unstructured Data: Test Result:infectious assessment is negative; Comments: infectious assessment is negative; Test Date: 20210129; Test Name: autoimmune assessment; Result Unstructured Data: Test Result:A broad autoimmune assessment is carried out and r; Comments: A broad autoimmune assessment is carried out and returns negative for all. (Ac anti NMDA in progress); Test Date: 20210129; Test Name: Blood cultures, lumbar puncture, cytobacterioligical urine exam; Test Result: Negative ; Comments: The other infectious samples from 29Jan21 (Blood cultures, lumbar puncture, cytobacterioligical urine exam) all come back negative.; Test Date: 20210129; Test Name: infectious assessment; Result Unstructured Data: Test Result:An infectious assessment is carried out and comes; Comments: An infectious assessment is carried out and comes back negative for hepatitis A, B, C, HIV, HSV1, HSV2, VZV, EBV, syphilis. Presence of IgM and anti-CMV IgG. IgG avidity test in progress.; Test Date: 20210129; Test Name: Repiratory examination; Result Unstructured Data: Test Result:The patient presents atelectasis in the right base; Comments: The patient presents atelectasis in the right base, an alternation of dorsal and right lateral decubitus every 4 hours thus allows better oxygenation and reduction of FiO2 (Fraction of inspired oxygen).; Test Date: 20210125; Test Name: liver function; Result Unstructured Data: Test Result:normal; Test Date: 20210125; Test Name: LDL cholesterol; Result Unstructured Data: Test Result:within the standards; Test Date: 20210129; Test Name: lumbar puncture; Result Unstructured Data: Test Result:normal; Comments: The lumbar puncture is normal. An infectious assessment is carried out on the CSF(cerebro synovial fluid) and returns negative for HSV1, HSV2, VZV, enterovirus.; Test Date: 20210122; Test Name: Lymphocyte; Result Unstructured Data: Test Result:0.8 x10 9/l; Test Date: 20210125; Test Name: Lymphocyte; Result Unstructured Data: Test Result:0.6 x10 9/l; Test Date: 20210128; Test Name: Lymphocyte; Result Unstructured Data: Test Result:0.5 x10 9/l; Test Date: 20210129; Test Name: Lymphocyte; Result Unstructured Data: Test Result:0.1 x10 9/l; Test Date: 20210203; Test Name: Lymphocyte; Result Unstructured Data: Test Result:0.8 x10 9/l; Test Date: 20210208; Test Name: Lymphocyte; Result Unstructured Data: Test Result:0.6 x10 9/l; Test Date: 20210129; Test Name: Brain MRI; Result Unstructured Data: Test Result:The brain MRI does not find any abnormality.; Comments: The brain MRI of 29Jan2021 found no abnormality. She is not in favor of encephalitis after proofreading by a neurologist. Brain MRI of 29Jan2021: absence of recent or semi-recent ischemic lesion, no hemorrhagic lesion, slight T2 hypersignal non-specific periventricular flair, median structures in place, no mass effect, no cerebral edema, absence of anomalies of the arterial circle of the base.; Test Date: 20210122; Test Name: monocyte; Result Unstructured Data: Test Result:0.8 x10 9/l; Test Date: 20210122; Test Name: PNN; Result Unstructured Data: Test Result:5.5 x10 9/l; Test Date: 20210128; Test Name: PNN; Result Unstructured Data: Test Result:3.9 x10 9/l; Test Date: 20210129; Test Name: PNN; Result Unstructured Data: Test Result:8.2 x10 9/l; Test Date: 20210129; Test Name: PNN; Result Unstructured Data: Test Result:6.7 x10 9/l; Test Date: 20210203; Test Name: PNN; Result Unstructured Data: Test Result:7.4 x10 9/l; Test Date: 20210209; Test Name: PNN; Result Unstructured Data: Test Result:12.2 x10 9/l; Test Date: 20210122; Test Name: normocytic anemia; Result Unstructured Data: Test Result:12.5 g/dl; Test Date: 20210122; Test Name: platelet; Result Unstructured Data: Test Result:125 x10 9/l; Test Date: 20210125; Test Name: platelet; Result Unstructured Data: Test Result:119 x10 9/l; Test Date: 20210128; Test Name: platelet; Result Unstructured Data: Test Result:94 x10 9/l; Test Date: 20210129; Test Name: platelet; Result Unstructured Data: Test Result:73 x10 9/l; Test Date: 20210203; Test Name: platelet; Result Unstructured Data: Test Result:76 x10 9/l; Test Date: 20210209; Test Name: platelet; Result Unstructured Data: Test Result:473 x10 9/l; Test Date: 20210129; Test Name: cardiopulmonary resuscitation; Result Unstructured Data: Test Result:performed for an ill-estimated duration (5 to 10 m; Comments: performed for an ill-estimated duration (5 to 10 minutes) then the patient recovered a rhythm, initially sinus then quickly a passage not AF (Atrial fibrillation). The telemetry monitoring finally revealed asystole for 40 seconds before disconnection of the telemetry, in a context of sinus dysfunction and paroxysmal extrinsic AVB.; Test Date: 20210123; Test Name: covid-19 PCR; Test Result: Negative ; Test Date: 20210130; Test Name: covid-19 PCR; Test Result: Negative ; Test Date: 20210130; Test Name: tracheal suction; Result Unstructured Data: Test Result:The patient will remain on Augmentin until 04Feb20; Comments: The patient will remain on Augmentin until 04Feb2021, thus making it possible to treat his Branhamella catarrhalis pneumopathy sensitive to Augmentin found at 10 to the fifth in the tracheal suction of 30Jan2021; Test Date: 20210126; Test Name: virus serology test; Result Unstructured Data: Test Result:CMV serology: IgG and IgM positive. IgG avidity me; Comments: CMV serology: IgG and IgM positive. IgG avidity measurement underway to date infection EBV serology: negative, HSV serology: negative, HBV serology negative, HCV serology: negative, HIV serology: negative, Syphilis serology: negative VZV serology: in favor of old immunity; Test Date: 20210126; Test Name: vitamin B12; Result Unstructured Data: Test Result:1200 pmol/L
CDC Split Type: FRPFIZER INC2021102577

Write-up: Thrombocytopenia; lymphopenia at 0.8 G / L; slowness of responses; Binocular diplopia; Neurological disorder NOS; atelectasis in the right base; polypnea; worsening of his general condition with speech disorders; worsening of his general condition with speech disorders; Branhamella catarrhalis pneumopathy; cardio respiratory arrest; Bradycardia; Atrioventricular block; sinus dysfunction; respiratory distress due to inhalation pneumonia; Atrial fibrilation; Anaemia; Asystolia; Pneumonia aspiration; The EEG found a very slowed down and poorly organized EEG tracing; hematological impairment of progressive worsening with hypervitaminosis B12/Vitamin B12 (N: 145-569 pmol / l): 1200; Parkinson''s syndrome; Hypothermia; Generalised muscle aches; Asthenia; Dysarthria; Chest distressed feeling; great fatigue; diffuse pain; feeling of difficulty in breathing/dyspnea; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority FR-AFSSAPS-AN20210115. A 72-year-old male patient received BNT162B2 (COMIRNATY, lot# EM0477) intramuscular on 13Jan2021 at single dose at left arm for COVID-19 immunisation. Medical history included Kyphosis (1981), Neurofibromatosis, type 1 (von Recklinghausen''s disease), Chronic anxiety, all from unspecified date and unknown if ongoing. Patient did not have Covid-19 previously. Concomitant medications included trimebutine maleate (TRIMEBUTINE PFIZER), bromazepam (BROMAZEPAM TEVA) for Anxiety, alfuzosin hydrochloride (ALFUZOSINE EG), pravastatin sodium (PRAVASTATIN ACCORD), bimatoprost (LUMIGAN), debridate, macrogol, sodium chloride (LARMABAK). The patient experienced neurological disorder NOS on unspecified date, Generalised muscle aches on 14Jan2021, asthenia on 14Jan2021, Atrial fibrillation on 29Jan2021, Anaemia on 29Jan2021, Hypothermia on 22Jan2021, Thrombocytopenia on 22Jan2021, Pneumonia aspiration on 29Jan2021, Binocular diplopia on 20Jan2021, Asystolia on 29Jan2021, Dysarthria on 14Jan2021, Bradycardia on 29Jan2021, Parkinson''s syndrome on 22Jan2021, Atrioventricular block on 29Jan2021, all these events were reported as serious due to fatal outcome. The patient also experienced chest distressed feeling on 14Jan2021. It was reported that after the injection of BNT162B2 carried out on 13Jan2021, appearance on 14Jan2021 of a feeling of difficulty in breathing, great fatigue, diffuse pain. Clinical details reported as follows: Treatment and evolution: Evolution: Lack of healing. The patient was hospitalized on 22Jan2021. By resuming the history of the disease on admission: The patient reported asthenia and dyspnea of progressive onset limiting him in his Nordic walking activities. Weight gain since August (+ 4 kg) with preserved appetite. Recently and for 8 to 10 days, his wife noted a worsening of his general condition with speech disorders. The patient was brought to the emergency room on 22Jan2021: he presented with stammering but no aphasia, slowness of responses, binocular diplopia in the downward gaze. The cerebral CT scan and the ASDs (atrial septal defects) did not find any abnormality, the biology shows platelets at 125 G / L, lymphopenia at 0.8 G / L and normocytic anemia at 12.5 g / dl. He was then hospitalized. Faced with the presence of a resting tremor and rigidity, treatment with benserazide hydrochloride; levodopa (MODOPAR) was initiated and then stopped on 28Jan2021 in the face of the worsening of the cognitive and psychiatric state with agitation and inconsistent comments alternating with phases of mutism. In the presence of the hematological impairment of progressive worsening with hypervitaminosis B12, a hematologic opinion is taken: there is no sign of lymphoma on the TDM TAP (Thoraco-Abdomino-Pelvic CT scan)of 28Jan2021, a lymphocytic immunophenotyping is recommended (+/- a myelogram depending on the results). The patient also presents hypothermia for which the infectious assessment is negative. On 29Jan2021, the patient is telemetry in front of a bradycardia around 50 per minute. He had cardio respiratory arrest around 12:30 p.m. The defibrillator did not show a shockable rhythm, cardiopulmonary resuscitation was performed for an ill-estimated duration (5 to 10 minutes) then the patient recovered a rhythm, initially sinus then quickly a passage not AF (Atrial fibrillation). The telemetry monitoring finally revealed asystole for 40 seconds before disconnection of the telemetry, in a context of sinus dysfunction and paroxysmal extrinsic AVB (atrioventricular block). A posteriori re-reading of the data stored in the DSA (digital subtraction angiography) in favor of a transient extrinsic bradycardia of poorly specified origin and no true asystole or regressive electro-mechanical dissociation after external cardiac massage and short-term mask ventilation. He was transferred to a continuing care unit before a gradual awakening. The brain MRI does not find any abnormality. The EEG found a very slowed down and poorly organized EEG tracing but without status epilepticus. He was finally transferred to intensive care in front of the absence of improvement in the neurological state as well as respiratory distress on probable inhalation. On the respiratory level: The patient presents atelectasis in the right base, an alternation of dorsal and right lateral decubitus every 4 hours thus allows better oxygenation and reduction of FiO2 (Fraction of inspired oxygen). Cures as well as sedations can be stopped on 03Feb2021. The patient is extubated on 09Feb2021 with initial relay by non-invasive ventilation then oxygen mask. In view of this rapidly progressive neurological picture, it was decided, in agreement with the family, not to reintubate the patient in the event of deterioration. Absence of effective cough and appearance of congestion. 10Feb2021, introduction of IVSE morphine in response to polypnea. On the infectious level: The patient will remain on amoxicillin;clavulanic acid (AUGMENTIN) until 04Feb2021, thus making it possible to treat his Branhamella catarrhalis pneumopathy sensitive to Augmentin found at 10 to the fifth in the tracheal suction of 30Jan2021. The other infectious samples from 29Jan21 (Blood cultures, lumbar puncture, cytobacterioligical urine exam) will all come back negative. Neurologically: The brain MRI of 29Jan2021 found no abnormality. She is not in favor of encephalitis after proofreading by a neurologist. The lumbar puncture is normal. An infectious assessment is carried out on the CSF (Cerebro synovial fluid) and returns negative for HSV1, HSV2, VZV, enterovirus. The EEG found a very slowed down and poorly organized EEG tracing but without status epilepticus. An infectious assessment is carried out and comes back negative for hepatitis A, B, C, HIV, HSV1, HSV2, VZV, EBV, syphilis. Presence of IgM and anti-CMV IgG. IgG avidity test in progress. A broad autoimmune assessment is carried out and returns negative for all. (Ac anti NMDA in progress). In this context, it could be a rapidly progressive parkinson-like syndrome. The evolution is unfavorable on the respiratory plan with a significant congestion, the patient died on 11Feb2021 at 12:40 a.m. Additional tests included: Hb (N: 13-17): 12.6 g / dl (on 22Jan2021) - 12 g / dl (on 28Jan2021) - 10.1 (on 29Jan2021) - 8.7 - on (03Feb2021) - 7.9 (on 08Feb2021) - 7.7 (on 09Feb2021). Platelets (N: 150-400): 125 x10 9/l (on 22Jan2021) - 119 x10 9/l (on 25Jan2021) - 94 x10 9/l (on 28Jan2021) - 73 (on 29Jan2021) - 76 (03Feb2021) - 473 (09Feb2021). PNN (N: 1.7-7 x10 9/l): 5.5 (on 22Jan2021) - 3.9 (on 28Jan) - 8.2 (on 29Jan2021) -6.7 (on 29Jan2021) - 7.4 (03Feb2021) - 12.2 (09Feb2021). Eosinophil (N: 0-0.6 x10 9/l): 0 (on 22Jan2021). Basophil (N: 0-0.1 x10 9/l): 0 (on 22Jan2021). Lymphocytes (N: 1-4 x10 9/l): 0.8 (on 22Jan2021) - 0.6 (on 25Jan2021) - 0.5 (on 28Jan2021) - 0.1 (on 29Jan2021) - 0.8 (03Feb2021) - 0.6 (09Feb2021). Monocytes (N: 0.2-0.8 x10 9/l): 0.8 (on 22Jan2021). Sodium (N: 136-145 mmol / l): 144 mmol / l (on 22Jan2021). Potassium (N: 3.4-4.5): 4.7 mmol / l (on 22Jan2021). Creatinine: 60 umol / l (on 22Jan2021). Normal liver function test (25Jan2021). CRP: 16 mg / l (on 28Jan2021) - 41 (on 29Jan2021). No change in BP: rather high at 16 on 13Jan2021. Brain MRI of 29Jan2021: absence of recent or semi-recent ischemic lesion, no hemorrhagic lesion, slight T2 hypersignal non-specific periventricular flair, median structures in place, no mass effect, no cerebral edema, absence of anomalies of the arterial circle of the base. Lumbar puncture: normal. Lipid balance on 25Jan2021: Total cholesterol 5.75 mmol / l (N: 0-5), Triglycerides, HDL cholesterol, LDL cholesterol within the standards. TSH (N: 0.27-4.2 mIU / L): 2.56 (on 25Jan2021). Vitamin B12 (N: 145-569 pmol / l): 1200 (on 26Jan2021). Serum folate (N: 8.8-60.8 nmol / l): 9.3 (on 26Jan2021). PCR Covid: negative on 23Jan2021, 30Jan2021. On 26Jan2021: CMV serology: IgG and IgM positive. IgG avidity measurement underway to date infection. EBV serology: negative, HSV serology: negative, HBV serology negative, HCV serology: negative, HIV serology: negative, Syphilis serology: negative. VZV serology: in favor of old immunity. Bacteria test: Legionella: negative and Streptococcus: negative. Blood cultures on 23Jan2021, 26Jan2021, 28Jan2021, 29Jan2021: negative. CSF (Cerebrospinal fluid) analysis on 29Jan2021: rock water, direct examination negative. Leukocytes: 1 / mm3, red blood cells: 11 / mm3, chlorurorachia (N: 120-125 mmol /): 118, proteinorachia (N: 0.15 -0.45 g / l): 0.53, glycorachia (N: 2.2-3.9 mmol / l): 3.2. Electrophoresis of serum proteins (28Jan2021): Total proteins: 60 g / l (N: 64-83). Albumin: 34.3 g / l (N: 40-47). Alpha 1 globulins: 3.5 g / l (N: 2.1-3.5). Alpha 2 globulins: 7.4 g / l (N: 5.1-8.5). Beta 1 globulins: 3.2 g / l (N: 3.4-5.2). Beta 2 globulins: 2.9 g / l (N: 2.3-4.7). Gammaglobulins: 8.5 g / L (N: 8-13.5). Auto immune assessment negative on 28Jan2021: Anti-neuronal antibodies by immunoblot on blood sample (Anti-Tr, anti-GAD65 antibodies, anti-Zic4 antibodies, anti-Titine antibodies, anti-SOX1 antibodies, anti-Recoverine antibodies, anti-HU antibodies, anti-YO antibodies, Anti-RI Ab, Anti PNMA2 Ab, Anti-CV2 Ab, Anti-Amphiphysin Ab): negative. Anti-neuronal antibodies by immunoblot on CSF sample (anti-Tr, anti-GAD65 antibodies, anti-Zic4 antibodies, anti-Titin antibodies, anti-SOX1 antibodies, anti-Recoverine antibodies, anti-HU antibodies, anti-YO antibodies, Anti-RI Ab, Anti PNMA2 Ab, Anti-CV2 Ab, Anti-Amphiphysin Ab): in progress. Ac anti SSA, SSB, RNP, Scl70, JO1: negative. Ac anti DNA: uninterpretable. Anti nuclear ac: negative. Anti-neutrophil cytoplasmic antibodies: negative. Blot myosit (ac anti cN-1A, Ac anti OJ, Ac anti PL-12, Ac anti PL-7, Ac anti SRP, Ac anti JO-1, Ac anti PM-Scl75, Ac anti PM-Scl 100, Ac anti-KU, Ab anti SAE, Ab anti-NXP2, Ab anti-MDA5, Ab anti-TIF1 GAMMA, Ab anti helicase beta MI-2B, Ab anti helicase beta MI-ZA): negative. Anti-cardiolipin IgG antibody: negative. Anti-cardiolipin IgM antibody: negative. Anti-Beta 2 GP1 IgG antibodies: negative. Ac anti-Beta 2 GP1 IgM at 25.2 (N: less than 20: negative, 20 - 40: weakly positive) therefore weakly positive but done only once. Results of anti NMDA (N-Methyl-D-aspartate) antibodies pending. Conclusion: Neurological disorders (hypothesis of anti-NMDA antibody encephalitis or rapidly progressive Parkinson-like syndrome), cardiac arrhythmia (paroxysmal extrinsic AVB (atrioventricular block), sinus dysfunction, atrial fibrillation), and respiratory distress due to inhalation pneumonia which led to the death of the patient. The patient died on 11Feb2021 at 12:40 a.m, outcome of other events was unknown. It was unknown if autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sinus dysfunction; respiratory distress due to inhalation pneumonia; Neurological disorders; Generalised muscle aches; Asthenia; Atrial fibrilation; Anaemia; Hypothermia; Thrombocytopenia; Pneumonia aspiration; Binocular diplopia; Asystolia; Dysarthr


VAERS ID: 1055830 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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: 2021-01-29
   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: PARACETAMOL; EUTHYROX; PROLOPA; CRESTOR; ASAFLOW; BELSAR PLUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure; Adenocarcinoma gastric; Arteriopathy (peripheral arteriopathy); Atrial fibrillation; Extrapyramidal syndrome; Hashimoto''s thyroiditis; Hospitalization; Laparotomy; Perforation (In November 2020, perforation of gastrectomy suture); Respiratory failure; Septic shock (septic shock secondary to peritonitis); Total gastrectomy; Vertebral sclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: feverish peak; Result Unstructured Data: Test Result:39.5 Centigrade
CDC Split Type: BEPFIZER INC2021181923

Write-up: Febrile peak 39.5 ? C in the evening following vaccination, yielding to paracetamol; This is a spontaneous report from a contactable physician downloaded from the regulatory authority; BE-FAMHP-DHH-N2021-76313, received from Regulatory Authority. A 73-year-old female patient received the 1st dose of BNT162B2 (COMIRNATY, lot number: EM0477) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included combined spinal cord sclerosis, extra-pyramidal syndrome of the Parkinsonian type, gastric adenocarcinoma of the diffuse linite-type, total gastrectomy, Hashimoto''s thyroiditis, peripheral arteriopathy, perforation of gastrectomy suture in Nov2020, laparotomy, septic and intensive care stay marked by: shock secondary to peritonitis, atrial fibrillation, mixed respiratory failure on acute respiratory distress syndrome (ARDS) and bilateral pleural effusions, acute renal failure, discharged from hospital on 22Jan and admission to rest and care home. Concomitant medications included paracetamol, levothyroxine sodium (EUTHYROX), benserazide hydrochloride/levodopa (PROLOPA), rosuvastatin calcium (CRESTOR), acetylsalicylic acid (ASAFLOW), hydrochlorothiazide/olmesartan medoxomil (BELSAR PLUS). The patient experienced fever on 28Jan2021. The patient died on 29Jan2021. The autopsy was performed. Relatedness of drug to reaction/event fever was possible. Reporter''s comments: Treatment - Yes Paracetamol, Evolution of the ADR - Death. This was a normal build, fragile patient (according to the clinical frailty scale, score of 7-8), no longer autonomous. The patient ahd feverish peak at 39.5 ? C in the early evening, giving way to paracetamol. Passage of the nurse around 11 pm: afebrile, calm patient, no sign of particular worry. Death on 29Jan: no precise explanation for the death or autopsy. Given the fragile state of the patient and her clinical history (hospitalization in intensive care for several weeks at the end of 2020), the notifier considered the death to be natural. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Febrile peak 39.5 ? C in the evening following vaccination, yielding to paracetamol


VAERS ID: 1055837 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 44
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: Parkinson''s disease (treated for 4 years); Senile dementia (partial)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: several days after the vaccination; Test Date: 202101; Test Name: COVID-19 PCR test; Test Result: Negative ; Comments: before the vaccination
CDC Split Type: CZPFIZER INC2021181018

Write-up: COVID-19; COVID-19; General physical health deterioration; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. Regulatory Authority Report Number: CZ-CZSUKL-21001043. An 81-year-old female patient received first dose of BNT162B2 (COMIRNATY, Lot number and expiry date unknown) intramuscular on 21Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing Parkinson''s disease treated for a long time (about 4 years) with partial senile dementia. For better care, she was placed in a nursing home and the family was satisfied with the care. According to the attending physician, the patient was in a satisfactory physical condition, but the mental state was not optimal. Before vaccination, the patient was tested and COVID-19 PCR test was negative in Jan2021. The patient''s concomitant medications were not reported. On 21Jan2021, the patient was vaccinated with BNT162B2 vaccine. After a few days in Jan2021, she was placed in isolation because of Covid-19 positivity. On 11Feb2021 the husband was invited because the patient got much worse. She was in a desperate state, just wheezing and not perceiving her surroundings at all. She did not respond to the stroking of her hands and face and there was no eye contact. She did not recognize her husband or nephew with his wife. The nurses gave antibiotics in drink, the patient had an inserted cannula and artificial nutrition. For general worsening of the condition, the patient was taken by ambulance to the hospital, where she was placed in the infection department. On 14Feb2021, the patient died due to COVID-19 and general worsening of the condition. The outcome of the events was fatal. It was unknown if an autopsy was done. Events were considered as serious with death, medically significant, hospitalized and life-threatening from regulatory authority. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: COVID-19; General physical health deterioration


VAERS ID: 1055843 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Blindness; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021180635

Write-up: COVID-19 pneumonia; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded. A 93-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot/batch number: EK9788), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. Medical history included dementia from an unknown date and unknown if ongoing, apoplexy from an unknown date and unknown if ongoing, then partial blindness from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced COVID-19 pneumonia (death, medically significant) on 31Jan2021. On 31Jan2021 after vaccination the patient developed COVID-19 pneumonia, lasting for unknown. The patient died on 06Feb2021. Death cause was reported as COVID-19 pneumonia. It was not reported if an autopsy was performed. The outcome of the event was fatal. Event Assessment:: No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1055844 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMVASTATIN; PRAMIPEXOL [PRAMIPEXOLE]; METOPROLOL; APIXABAN; LERCANIDIPINE; ISOSORBIDE; MOXONIDIN; L-DOPA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Artificial cardiac pacemaker user; Atrial fibrillation; COPD; Dementia; Hypertension arterial; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021173793

Write-up: Death sudden; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority- WEB [DE-PEI-PEI2021002618] received via Regulatory Authority. An 86-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration at single dose on 10Feb2021 for covid-19 immunisation. Medical history included Parkinson''s disease, dementia, hypertension arterial, apoplexy, atrial fibrillation, artificial cardiac pacemaker user, COPD. Concomitant medication included simvastatin, pramipexol, metoprolol, apixaban, lercanidipine, isosorbide, moxonidine (MOXONIDIN), l-dopa. On 12Feb2021 after vaccination, the patient developed death sudden. The patient died on 12Feb2021. It was not reported if an autopsy was performed. Causality assessment by Agency for Comirnaty / Sudden death: D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1055846 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021195319

Write-up: Patient died; This is a spontaneous report from a contactable physician based on information received by Pfizer from BioNTech (manufacturer control number 17268), license party for BNT162B2. This physician reported similar events for seven patients. This is the first of seven reports. A patient of unspecified age and gender received BNT162B2 (COMIRNATY; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The physician reported that the patient was vaccinated in a nursing home in the period from 31Dec2020 to 05Feb2021. The patient died on day 13 after the first dose. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021196677 Same reporter, similar events in different patients;DE-PFIZER INC-2021196678 Same reporter, similar events in different patients;DE-PFIZER INC-2021196680 Same reporter, similar events in different patients;DE-PFIZER INC-2021196676 Same reporter, similar events in different patients;DE-PFIZER INC-2021196679 Same reporter, similar events in different patients;DE-PFIZER INC-2021196675 Same reporter, similar events in different patients;DE-PFIZER INC-2021196676 same reporter/drug/event, different patients; Reported Cause(s) of Death: Patient died


VAERS ID: 1055847 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021196675

Write-up: patient died; This is a spontaneous report from a contactable physician based on information received by Pfizer from BioNTech (manufacturer control number 17268), license party for BNT162B2. This physician reported similar events for seven patients. This is the second of the seven reports. A patient of unspecified age and gender received the first dose of BNT162B2 (COMIRNATY; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The physician reported that the patient was vaccinated in a nursing home in the period from 31Dec2020 to 05Feb2021. The patient died on day 14 after the first dose on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. The case will be re-assessed when relevant information, particularly the cause of death, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021195319 same reporter/drug/event, different patients.; Reported Cause(s) of Death: patient died


VAERS ID: 1055848 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021196676

Write-up: patient died; This is a spontaneous report from a contactable physician based on information received by Pfizer from BioNTech (manufacturer control number 17268), license party for BNT162B2. This physician reported similar events for seven patients. This is the sixth of seven reports. A patient of unspecified age and gender received second dose of BNT162B2 (COMIRNATY; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The physician reported that the patient was vaccinated in a nursing home in the period from 31Dec2020 to 05Feb2021. The patient died on day 11 after the second dose on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: The causal relationship between BNT162B2and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021195319 same reporter/drug/event, different patients; Reported Cause(s) of Death: patient died


VAERS ID: 1055849 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021196677

Write-up: died; This is a spontaneous report from a contactable physician based on information received by Pfizer from LLP-Biontech SE (manufacturer number 17268), license party for BNT162B2. This physician reported same event for 7 patients. This is the seventh of seven reports. A patient of unspecified age and gender received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The physician reported that the patient was vaccinated in a nursing home in the period from 31Dec2020 to 05Feb2021. The patient died on day 16 after the second dose. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: The causal relationship between BNT162B2and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021195319 same reporter/drug/events, different patient; Reported Cause(s) of Death: died


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