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

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



Case Details

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VAERS ID: 1250236 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Cerebrovascular accident, SARS-CoV-2 antibody test
SMQs:, Cardiac failure (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 29
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LETROX; EBIXA; ROCALTROL; LACTULOSA; QUETIAPIN; ATORIS; BETALOC ZOK; TAMSULOSINA APOTEX; PRESTARIUM NEO; APO-PANTOPRAZOLE; ZIBOR; BURONIL
Current Illness: Dementia Alzheimer''s type (Alzheimer''s dementia); Dyslipidemia (dyslipidemia); Hyperparathyroidism secondary (secondary hyperparathyroidism); Hypertension (hypertension); Hypothyroidism (hypothyroidism); Polyneuropathy (polyneuropathy); Renal failure chronic (grade 3 chronic renal failure)
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular event (Ischaemic vascular event - Oct2017, 2021); Prostate transurethral resection (transurethral resection of the prostate); STEMI (STEMI of the bottom wall)
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Test Date: 20210329; Test Name: SARS-CoV-2 virus; Result Unstructured Data: Test Result:negative
CDC Split Type: CZPFIZER INC2021431366

Write-up: heart failure; Accident cerebrovascular; This is a spontaneous report downloaded from the Medicines Agency (MA) u8jjm,ljk,l,kl,m,n -WEB with regulatory authority number CZ-CZSUKL-21003534. A 80-years-old male patient received first dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on 05Mar2021 10:30 as single dose for COVID-19 immunization. Medical history included transurethral prostatectomy, ongoing polyneuropathy, cerebrovascular accident from Oct2017, ongoing dyslipidaemia, ongoing chronic kidney disease, ongoing dementia alzheimer''s type, ongoing hypothyroidism , acute myocardial infarction ,ongoing hyperparathyroidism secondary, ongoing hypertension. Concomitant medication(s) included levothyroxine sodium (LETROX); memantine hydrochloride (EBIXA); calcitriol (ROCALTROL); lactulosa (LACTULOSA); quetiapine fumarate (QUETIAPIN); atorvastatin calcium (ATORIS); metoprolol succinate (BETALOC ZOK); tamsulosin hydrochloride (TAMSULOSINA APO-TEX); perindopril arginine (PRESTARIUM NEO); pantoprazole sodium sesquihydrate (APO-PANTOPRAZOLE; bemiparin sodium (ZIBOR); melperone hydrochloride (BURONIL) all taken for an unspecified indication, start and stop date were not reported. It was reported that an patient received his first dose of BNT162B2 on 05Mar2021 at 10:30. The next day on 06Mar2021 at 9:45 a patient suffered a cerebrovascular accident. He was taken to the hospital by the ambulance service and after a week transferred to the long-term care department, where he died on the 05Apr2021. On the 29Mar2021, the patient was quarantined for risk contact. The antigen test for the presence of SARS-CoV-2 virus was negative on the 29Mar2021, and the PCR test was not completed before death. The day before death, the patient had an elevated body temperature of 37.9 Centigrade. The cause of death was determined as heart failure with possible alternatives - recurrence of stroke, COVID-19, acute coronary stroke. The outcome of the event accident cerebrovascular was recovered with sequelae and for event heart failure was death. The patient died on 05Apr2021.The autopsy was not performed. The outcome of the event accident cerebrovascular was recovered with sequelae and for event heart failure was fatal. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: possible alternative according to the doctor; cause of death; possible alternative according to the doctor; possible alternative according to the doctor


VAERS ID: 1250237 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Aphasia, Blood pressure measurement, Body temperature, Cerebral thrombosis, Computerised tomogram head, Diabetes mellitus management, Facial paralysis, Haematoma, Heart rate, Hemiplegia, International normalised ratio, Nystagmus, Oxygen saturation, Patient uncooperative, Posture abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Vestibular disorders (broad), Ocular motility disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 3
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BETALOC ZOK; ALLOPURINOL; STACYL; MICTONETTEN; OMEPRAZOL; FURON [FUROSEMIDE SODIUM]; PREDUCTAL PROLONG; MONOMACK
Current Illness: Asymptomatic bacteriuria; Atrial fibrillation paroxysmal (no preemptive anticoagulation therapy because of hemoptysis); Dyslipidemia; Gastroesophageal reflux; GDU; Hypertension arterial; Ischemic heart disease; Nephropathy (chronic); Osteopenia; Osteoporosis; Type II diabetes mellitus; Vertebrogenic pain syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Grawitz tumor; Infarct myocardial; Nephrectomy (left side); Radiofrequency ablation; Transient ischaemic attack (expressive phatic disorder)
Allergies:
Diagnostic Lab Data: Test Date: 20210403; Test Name: CT angiography; Result Unstructured Data: Test Result:obstruction of arteria carotis media sinistra; Comments: obstruction of arteria carotis media sinistra - segment M1 (Alberta stroke programme early CT score - 9); Test Date: 20210403; Test Name: Blood pressure; Result Unstructured Data: Test Result:147/93 mmHg; Test Date: 20210403; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210403; Test Name: Brain computerized tomography; Result Unstructured Data: Test Result:chronic ischemic changes; Comments: nativ: chronic ischemic changes, it seems that there are only minor changes on the left side,; Test Date: 20210403; Test Name: Glycemia control; Result Unstructured Data: Test Result:6.7 mmol/L; Test Date: 20210403; Test Name: Heart rate; Result Unstructured Data: Test Result:95; Comments: Units:/min; Test Date: 20210403; Test Name: International normalized ratio; Result Unstructured Data: Test Result:1,2; Test Date: 20210403; Test Name: O2 saturation; Test Result: 91 %
CDC Split Type: CZPFIZER INC2021430198

Write-up: blood clots in brain vessels; right hip and right thigh hematomas; right-sided plegia of upper and lower limb; central facial palsy right-sided; she does not cooperate; complete aphasia; she moves eyeballs to the left, cannot look to the right; Head posture abnormal; This is a spontaneous report downloaded from the Medicines Agency (MA) -WEB with regulatory authority number CZ-CZSUKL-21004025. An 88-years-old female patient received her second dose of bnt162b2 (COMIRNATY), intramuscular on 02Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing osteoporosis, ongoing Gastroesophageal reflux, Transient ischaemic attack from Sep2020 (expressive phatic disorder), Radiofrequency ablation from 2016 to 2016, ongoing Vertebrogenic pain syndrome, ongoing type 2 diabetes mellitus, ongoing Asymptomatic bacteriuria, ongoing osteopenia, ongoing Ischemic heart disease, ongoing GDU, ongoing Nephropathy (chronic), ongoing Hypertension arterial, ongoing Atrial fibrillation paroxysmal (no preemptive anticoagulation therapy because of hemoptysis), ongoing Dyslipidemia, Grawitz tumor, Infarct myocardial, Nephrectomy from 1997 to 1997 (left side). Concomitant medications included metoprolol succinate (BETALOC ZOK); allopurinol; acetylsalicylic acid (STACYL); propiverine hydrochloride (MICTONETTEN); omeprazole (OMEPRAZOL); furosemide sodium (FURON [FUROSEMIDE SODIUM]); trimetazidine hydrochloride (PREDUCTAL PROLONG); isosorbide mononitrate (MONOMACK). The patient received her first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 immunisation. The patient experienced blood clots in brain vessels, right-sided plegia of upper and lower limb , central facial palsy right-sided, she does not cooperate, complete aphasia, she moves eyeballs to the left, cannot look to the right, head posture abnormal on 03Apr2021 and right hip and right thigh hematomas on an unspecified date. The event cerebral thrombosis was assessed as fatal, life-threatening, hospitalization on an unspecified date, medically significant and disablity. The patient underwent lab tests and procedures which included CT angiography: obstruction of arteria carotis media sinistra (obstruction of arteria carotis media sinistra - segment M1 (Alberta stroke programme early CT score - 9), blood pressure: 147/93 mmhg, body temperature: 36.5 centigrade, Brain computerized tomography: chronic ischemic changes (nativ: chronic ischemic changes, it seems that there are only minor changes on the left side), Glycemia control: 6.7 mmol/l, heart rate: 95/min , international normalised ratio: 1,2 and oxygen saturation: 91 % on 03Apr2021. Therapeutic measures were taken as a result of blood clots in brain vessels (cerebral thrombosis). Outcome of the event cerebral thrombosis was fatal while outcome of the event Hemiplegia was not recovered. Outcome of the remaining events was unknown. The patient died on 06Apr2021 due to cerebral thrombosis. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: blood clots in brain vessels


VAERS ID: 1250240 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-03-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Intestinal ischaemia, Platelet disorder, SARS-CoV-2 test, Subileus
SMQs:, Haematopoietic thrombocytopenia (broad), Gastrointestinal obstruction (narrow), Ischaemic colitis (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Cholecystectomy; Laparotomy; Skin carcinoma NOS; Comments: Laparatomy performed.
Allergies:
Diagnostic Lab Data: Test Name: CRP init; Test Result: 15 mg/dl; Test Name: CRP init; Test Result: 31 mg/dl; Test Name: PLT; Result Unstructured Data: Test Result:186,000; Comments: / ul; Test Date: 20210330; Test Name: SARS-CoV-2-PCR test; Result Unstructured Data: Test Result:negative
CDC Split Type: DEPFIZER INC2021431280

Write-up: Bowel ischemia; subileus; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100032183. An 85-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 21Mar2021 (lot number and expiration date were unknown) as single dose (at the age of 85-years-old) for COVID-19 immunisation. Medical history included cholecystectomy not ongoing, skin carcinoma NOS unknown if ongoing, appendicectomy not ongoing, and laparatomy performed. On 30Mar2021, the patient experienced bowel ischemia. Bowel ischemia was considered serious for death, hospitalization and life threatening. The outcome of subileus was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter''s Comment: Follow-up information 09Apr2021 PLT 186,000 / ul, D-Dim not carried out, CRP init. 15 mg / dl, increase to 31 (norm <0.5) SARS-CoV-2-PCR test negative (30Mar2021) Initial suspicion of subileus, diagnosis after laparotomy No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Follow-up information 09Apr2021 PLT 186,000 / ul, D-Dim not carried out, CRP init. 15 mg / dl, increase to 31 (norm <0.5) SARS-CoV-2-PCR test negative (30Mar2021) Initial suspicion of subileus, diagnosis after laparotomy; Reported Cause(s) of Death: Bowel ischemia


VAERS ID: 1250242 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-31
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia absoluta; Atrial fibrillation; Prostate cancer metastatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021431474

Write-up: Ischemic stroke (MCA right) severe course; This is a spontaneous report was received from a Physician via from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100034479. A 83-year-old male patient received a unknown dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 18Mar2021, as single dose for COVID-19 immunisation. The patient''s medical history included prostate cancer metastatic, arrhythmia absoluta and atrial fibrillation. The concomitant medications were not reported. Historical vaccine included a unknown dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date, as single dose Prophylactic vaccination. On 31Mar2021 the patient experienced Ischemic stroke (MCA right) severe course and on 04Apr2021 the patient experienced Death. Regulatory Authority causality assessment: Unclassifiable. This report is serious - death, hospitalization, life threatening. Sender Comment: cMRT temporal relationship of cerebral ischemia (in multimorbid patient). The outcome of the events was fatal as reported. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on known disease pathophysiology, the event of ischemic stroke is assessed as not related to suspected drug Comirnaty and more likely due to underlying medical condition of cancer metastasis, atrial fibrillation and arrhythmias .; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1250243 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-28
Onset:2021-03-10
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 2021-03-13
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Short of breath; Weakness
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021431470

Write-up: Increased shortness of breath, died; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100034480. An 89-year-old male patient received bnt162b2 (COMIRNATY; Lot Number: not reported), via an unspecified route of administration on 28Feb2021, at 0.3 m single, for covid-19 immunisation. Medical history included asthenia and dyspnoea both unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced increased shortness of breath on 10Mar2021 which required hospitalization. The patient died on 13Mar2021. Cause of death was reported as increased shortness of breath. It was unknown if an autopsy was performed. Causality assessment from Regulatory Authority was provided as D (Unclassifiable). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: increased shortness of breath


VAERS ID: 1250246 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021431449

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100034487. An 86-year-old female patient received BNT162B2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021, at 0.3 mL, single, for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on an unspecified date in 2021, three weeks before the second vaccination. The patient died on an unspecified date in 2021. It was unknown if autopsy was performed. This report was assessed as serious - death, life threatening. Reporter''s comments: The patient died suddenly and unexpected few hours after second vaccination with Comirnaty, at the time point of her death no potential disease was known, the patient was treated with Clozapin. No follow-up attempts are possible, information about the lot/batch number cannot be obtained.; Reporter''s comments: The patient died suddenly and unexpected few hours after second vaccination with Comirnaty, at the time point of her death no potential disease was known, the patient was treated with Clozapin.; Reported Cause(s) of Death: Death


VAERS ID: 1250247 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-04-09
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac catheter ablation; Ischemic stroke; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021431456

Write-up: found lifeless in chair (death); This is a spontaneous report from a non-contactable healthcare professional downloaded from the Agency Regulatory Authority-WEB. Regulatory authority report number DE-PEI-202100034642. An 82-year-old female patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 22Mar2021 (Lot Number: ER7812, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and ischemic stroke, both unknown if ongoing; catheter ablation with atrial fibrillation and right anterior infarction. The patient''s concomitant medications were not reported. The patient also received her first dose of COMIRNATY vaccine on 01Mar2021 (strength: 0.3 ml; unknown lot number and expiration) as prophylactic vaccination. The patient was found lifeless in chair (death) on 09Apr2021, died due to unknown cause. Autopsy was performed. The event was assessed as serious (fatal and life threatening). Sender''s comments: Autopsy commissioned, relevant medical history: status after catheter ablation with atrial fibrillation, status after right anterior infarction, transient sensitization disorder of the right half of the body, most likely cervical genesis. Causality assessment: The event was assessed as "D. Unclassifiable" by Regulatory Authority. No follow-up attempts needed; follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: found lifeless in chair (death)


VAERS ID: 1250248 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-24
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: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021431459

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB, company number DE-PEI-202100034728. An 80-year-old male patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 30Mar2021 at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 07Apr2021 the patient experienced unknown cause of death. The patient died on 07Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1250252 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: Medical History/Concurrent Conditions: Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021431569

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) -WEB, company number DE-PEI-202100035458. An 85-years-old male patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 08Apr2021 as 0.3 mL single for covid-19 immunisation. Relevant medical history included pneumonia on 17Feb2021 for which patient was hospitalized. Concomitant medications were not reported. On an unspecified date in 2021 he patient died due to an unknown cause. An autopsy was not performed. Causal relationship between the adverse event(s) and the administration of COMIRNATY was assessed as "Unclassifiable" by the regulatory authority. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1250260 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Pneumonia, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   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: Parkinson''s disease (for 30 years)
Preexisting Conditions: Medical History/Concurrent Conditions: Weakness
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021431476

Write-up: Respiratory distress; Pneumonia; severe fatigue; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADRPEI-2021012563. An 84-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number was not reported), via an unspecified route of administration on 30Dec2020 as a single dose for covid-19 immunisation. The patient medical history included ongoing parkinson''s disease for 30 years. The patient was also weakened. The patient''s concomitant medications were not reported. On 31Dec2020 (as reported) two days after vaccination, the patient developed respiratory distress, pneumonia and severe fatigue lasting for 4 days. Clinical course details as reported as the patient was weakened. Severe fatigue and pneumonia. The Covid-19 vaccination was certainly not the only reason for death. On 24Dec2020 he still actively celebrated Christmas. Covid-19 vaccination has also contributed to the weakening of the body. In the opinion of the reporter, the vaccine should not be given to weakened people. The patient died on 03Jan2021. Cause of death were respiratory distress, pneumonia and severe fatigue. The outcome of the events was fatal. It was unknown if an autopsy was performed. Causality to COMIRNATY: Regulatory Authority: Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Respiratory distress; Pneumonia; severe fatigue


VAERS ID: 1250265 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Chest X-ray, Dyspnoea, Fibrin D dimer, Idiopathic pulmonary fibrosis, PCO2, PO2, White blood cell count
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OXYGEN
Current Illness: Idiopathic pulmonary fibrosis; Palliative care (With oxygen treatment at 6 L/min); Pulmonary failure (Terminal lung failure due to Idiopathic pulmonary fibrosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Without new changes; Test Date: 202103; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30; Test Date: 202103; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:1.9; Test Date: 202103; Test Name: PCO2; Result Unstructured Data: Test Result:6.1; Test Date: 202103; Test Name: PO2; Result Unstructured Data: Test Result:25; Test Date: 202103; Test Name: Leucocyte count; Result Unstructured Data: Test Result:11.9
CDC Split Type: DKPFIZER INC2021430033

Write-up: Gradual worsening of habitual dyspnea; Idiopathic pulmonary fibrosis; This is a spontaneous report received and downloaded from the regulatory authority (Regulatory Authority Report Number: DK-DKMA-WBS-0060742). A contactable physician reported that a 64-year-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: ET3674, Expiration Date: Jul2021), intramuscular, on 24Mar2021, at a single dose, for COVID-19 immunization. The patient''s medical history included idiopathic pulmonary fibrosis, pulmonary failure (terminal lung failure due to idiopathic pulmonary fibrosis), and the patient was in palliative care (with oxygen treatment at 6 L/min); all were ongoing. The patient''s concomitant medication included ongoing oxygen. The patient previously took the first dose of BNT162B2 (COMIRNATY; Lot Number: ER2659, Expiration Date: 30Jun2021) on 01Mar2021 for COVID-19 immunization (intramuscular). On 27Mar2021, the patient developed dyspnoea exacerbated (gradual worsening of habitual dyspnea). The patient was treated with oxygen (16 L/min). The adverse drug reaction (ADR) was reported as fatal and resulting in hospitalization from Mar2021. The patient underwent laboratory tests and procedures in Mar2021 which included thorax X-ray: without new changes, C-reactive protein: 30, fibrin D dimer: 1.9, PCO2 (measured in atrial blood gas on 15 L oxygen): 6.1, PO2 (measured in atrial blood gas on 15 L oxygen): 25, and leucocyte count: 11.9. The reported causes of death were dyspnoea exacerbated and idiopathic pulmonary fibrosis. Per causality from the physician, they cannot rule out that the exacerbation of dyspnea may have influenced on death, but the patient was terminally ill and idiopathic pulmonary fibrosis is considered the primary cause of death. The outcome of the events was fatal. The patient died on 30Mar2021. An autopsy was not performed. COMMENT FROM DKMA: This report has been received twice due to technical issues. MAH should therefore consider version 2 of the master as the initial report. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Gradual worsening of habitual dyspnea; Idiopathic pulmonary fibrosis


VAERS ID: 1250266 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   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: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; FURIX [FUROSEMIDE]; DULCOLAX [BISACODYL]; CALCIUM AND VITAMIN D; PLAVIX; PANODIL; MORFIN DAK; NORVASC; CONTALGIN; KALEORID; NUTRIDRINK COMPACT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Hypertension; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021430042

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0060855, received via the Regulatory Authority. Additional case identifier: DK-DKMA-ADR 25051365. An 81-year-old female patient received bnt162b2 (COMIRNATY), dose 1, via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EP9605; Expiration Date: Jun2021) as single dose for covid-19 immunisation. Medical history included constipation, pain, and hypertension. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) taken for constipation from 01Jul2020, furosemide (FURIX [FUROSEMIDE]) taken for diuretic therapy from 24Feb2021, bisacodyl (DULCOLAX [BISACODYL]) taken for constipation from 11Feb2020, calcium carbonate, ergocalciferol (CALCIUM AND VITAMIN D) taken for calcium supplementation from 22Jul2020, clopidogrel bisulfate (PLAVIX) taken for thrombosis prophylaxis from 02Jul2020, paracetamol (PANODIL) taken for pain from 17Jul2020, morphine hydrochloride (MORFIN DAK) taken for pain from 30Jun2020, amlodipine besilate (NORVASC) taken for hypertension from 17Feb2020, morphine sulfate (CONTALGIN) taken for pain from 17Jul2020, potassium chloride (KALEORID) taken for potassium supplementation from 10Jul2020, carbohydrates nos, choline, fats nos, minerals nos, proteins nos, vitamins nos (NUTRIDRINK COMPACT) for nutritional preparation and multi-vitamin preparation taken for vitamin supplementation from 30Jun2020. The patient died on 10Mar2021 due to an unknown cause. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1250267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Heart valve disorders ((awaited assessment with respect to surgery))
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021430025

Write-up: dead / fell about in the home; dead / fell about in the home; This is a spontaneous report from a contactable physician reporting for a patient downloaded from the Medicines Agency (MA) -WEB, regulatory authority number DK-DKMA-WBS-0061472, received via the Medicines Agency. An 80-year-old male patient received bnt162b2 (COMIRNATY), the second dose on 06Apr2021 (Batch/Lot Number: ET3674; Expiration Date: Jul2021) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes and Heart valve disorders from an unknown date and unknown if ongoing (awaited assessment with respect to surgery). The patient''s concomitant medications were not reported. The patient received the first dose of bnt162b2 (COMIRNATY) via intramuscular on 16Mar2021 (Batch/Lot Number: ER2659; Expiration Date: Jun2021) for covid-19 immunisation. The patient experienced dead / fell about in the home on 07Apr2021. On 07Apr2021 the patient fell about in the home. Cardiopulmonary resuscitation was started but the patient could not be rescued. Reported cause of death was sudden death. Police assessed that there was no need for autopsy. There is no information regarding test results. The patient died on 07Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fell about in the home; Sudden death


VAERS ID: 1250271 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood glucose abnormal, Blood pressure measurement, Incorrect route of product administration, Loss of consciousness, Oxygen saturation, Respiratory distress
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), Drug abuse and dependence (broad), Acute central respiratory depression (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), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   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: Hypertension arterial; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:tachycardic; Test Date: 202103; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:Vesicular murmur preserved, no added sounds; Test Date: 202103; Test Name: DXT; Result Unstructured Data: Test Result:200; Test Date: 202103; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/70 mmHg; Test Date: 202103; Test Name: O2 Saturation; Test Result: 66 %
CDC Split Type: ESPFIZER INC2021431577

Write-up: Respiratory distress; sudden loss of consciousness; Incorrect route of product administration; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) -WEB, regulatory authority number ES-AEMPS-812966. A 96-years-old female patient received first dose of bnt162b2 (COMIRNATY), subcutaneous on 30Mar2021 12 AM; at age of 96-year-old, (Batch/Lot Number: EW2239; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took eutirox. The patient vaccinated with Comirnaty suffered of sudden loss of consciousness, without tonic-clonic movements or sphincter relaxation. Spontaneous recovery. Relatives report that prior to this episode, the patient reported significant dyspnoea. On arrival (as reported), the patient was in poor general condition, conscious, cyanotic, tachypnoeic, with abdominal pulling. The patient underwent lab tests and procedures which included auscultation: tachycardic on Mar2021, auscultation: vesicular murmur preserved, no added sounds on Mar2021, blood glucose abnormal: 200 on Mar2021, blood pressure measurement: 150/70 mmhg on Mar2021, oxygen saturation: 66 % on Mar2021. At home, the patient suffered cardiorespiratory arrest, cardiopulmonary resuscitation and cardio pulmonary resuscitation started without success. The patient experienced respiratory distress on 30Mar2021. The patient died on 30Mar2021 (at 22H in the evening) due to respiratory distress. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardio-respiratory arrest (10007617)


VAERS ID: 1250279 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Coronary artery disease; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021431356

Write-up: Breathing difficult; Malaise; Chills; fever/ Pyrexia; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FI-FIMEA-20211835. A 72-year-old male patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) intramuscular on 24Mar2021 at a single dose for COVID-19 immunisation. Medical history included coronary artery disease, acute myocardial infarction from Nov2019 and Parkinson''s disease. The patient''s concomitant medications were not reported. On 27Mar2021 the patient developed fever/ pyrexia with chills. On 28Mar2021, the patient experienced malaise and breathing difficult. The patient died in the evening. The patient died on 28Mar2021. 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: Breathing difficult; Chills; fever/ Pyrexia; Malaise


VAERS ID: 1250284 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-18
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood lactic acid, Blood pH, Blood pressure measurement, Body temperature, COVID-19 pneumonia, Cardiac failure, Chest X-ray, Computerised tomogram head, Computerised tomogram thorax, Fall, Head injury, Heart rate, Hyperlactacidaemia, Oxygen saturation, PCO2, PO2, Physical examination, Respiratory acidosis, Respiratory rate, SARS-CoV-2 test, Vaccination failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (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 (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMIODARONE; CARVEDILOL; PREVISCAN [FLUINDIONE]; FUROSEMIDE; LASILIX [FUROSEMIDE]; LEVOTHYROX; PARACETAMOL; LACTULOSE
Current Illness: Artificial cardiac pacemaker user
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Cataract; Insufficiency cardiac; Ischaemic heart disease; Prostatectomy; Retinopathy
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: lactate; Result Unstructured Data: Test Result:1.6 mmol/L; Test Date: 2021; Test Name: lactate; Result Unstructured Data: Test Result:6.9 mmol/L; Comments: after 1st nebulization (hyperlactatemia); Test Date: 2021; Test Name: Blood gas pH; Result Unstructured Data: Test Result:7.32; Test Date: 2021; Test Name: Blood gas pH; Result Unstructured Data: Test Result:7.420; Comments: after 1st nebulization; Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:143/88 mmHg; Test Date: 20210318; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 2021; Test Name: body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Test Date: 2021; Test Name: pulmonary x-ray; Result Unstructured Data: Test Result:bilateral flaky opacities.; Test Date: 2021; Test Name: Cerebral and thoracic CT; Result Unstructured Data: Test Result:no intracranial bleeding,; Comments: no intracranial bleeding, no bone lesion of the cranial vault, facial mass, occipital hinge, sequelae of right frontal and left cerebellar stroke, minimal damage to COVID19, absence of pulmonary embolism until ''at the sub-segmental level, an aspect of left lower lobe pneumopathy.; Test Date: 2021; Test Name: heart rate; Result Unstructured Data: Test Result:69; Comments: 68 beats / min; Test Date: 2021; Test Name: examination; Result Unstructured Data: Test Result:bilateral and symmetrical vesicular murmur; Comments: bilateral and symmetrical vesicular murmur, diffuse and crackling sibilants at the bases with cough, thoraco-abdominal rocking and supraclavicular indrawing, with an improvement following the two aerosols made in the emergency room..Regular heart sounds without breath heard. Perceived radial pulse.Bilateral ocher dermatitis, painless and supple calf. edema of the lower limbs taking the scoop and jugular turgor; Test Date: 20210401; Test Name: oxygen saturation; Test Result: 86 %; Comments: 86% desaturation under 1.5l of oxygen; Test Date: 2021; Test Name: oxygen saturation; Test Result: 98 %; Comments: under 2L/min at 98%; Test Date: 2021; Test Name: oxygen saturation; Test Result: 94 %; Comments: under 4L / minute; Test Date: 2021; Test Name: pCO2; Result Unstructured Data: Test Result:65.3 mmHg; Test Date: 2021; Test Name: pCO2; Result Unstructured Data: Test Result:53.2 mmHg; Comments: after 1st nebulization (hypercapnic acidosis); Test Date: 2021; Test Name: pO2; Result Unstructured Data: Test Result:77.4 mmHg; Test Date: 2021; Test Name: pO2; Result Unstructured Data: Test Result:68 mmHg; Comments: after 1st nebulization; Test Date: 2021; Test Name: respiratory rate; Result Unstructured Data: Test Result:18 cycles per minute; Test Date: 20210323; Test Name: Sars-Cov-2 PCR test; Test Result: Negative ; Test Date: 20210329; Test Name: Sars-Cov-2 PCR test; Test Result: Positive ; Comments: RdRP gene / Sgene, Ngene positive therefore Sars-COV-2 genome detected, no information on the variant; Test Date: 2021; Test Name: thoracic CT; Result Unstructured Data: Test Result:no intracranial bleeding,; Comments: no bone lesion of the cranial vault, facial mass, occipital hinge, sequelae of right frontal and left cerebellar stroke, minimal damage to COVID19, absence of pulmonary embolism until ''at the sub-segmental level, an aspect of left lower lobe pneumopathy
CDC Split Type: FRPFIZER INC2021431487

Write-up: fell with head trauma in the context of Sars-Cov2 pneumonia; fell with head trauma in the context of Sars-Cov2 pneumonia; COVID-19 confirmed by positive COVID-19 test; hypoxemic Sars-Cov2 pneumonia is the cause of cardiac decompensation; Vaccination failure; hyperlactatemia; hypercapnic acidosis; acute respiratory failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [Regulatory authority report number is FR-AFSSAPS-AN20211285 and Safety report unique identifier FR-AFSSAPS-2021037695]. A 93-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY), on 12Feb2021 (Batch/Lot Number: Unknown) and first dose on 21Jan2021 (Batch/Lot Number: EJ67895) both given intramuscularly as SINGLE DOSE for COVID-19 immunization. Medical history included prostatectomy, cardiac insufficiency, atrial fibrillation (Afib), ischaemic heart disease, artificial cardiac pacemaker user (ongoing), cataract and retinopathy. Concomitant medications included amiodarone (AMIODARONE), carvedilol (CARVEDILOL), fluindione (PREVISCAN), furosemide (FUROSEMIDE), furosemide (LASILIX), levothyroxine sodium (LEVOTHYROX), paracetamol (PARACETAMOL) and lactulose (LACTULOSE) all taken for unspecified indications and therapy dates. On 18Mar2021, the patient presented with an episode of febrile dyspnea at 38.5 C with indrawing, worsened bronchial congestion requiring eight days of antibiotic therapy with amoxicillin/clavulanic acid (AUGMENTIN) switched by ceftriaxone (ROCEPHINE) due to the failure of the 8-day amoxicillin/clavulanic acid and corticosteroid/ albuterol (VENTOLINE) aerosols which improved symptoms on 26Mar2021. In 2021, examination showed SpO2 under 2L/min at 98%, blood pressure (PA) 143/88 mmHg, pulse: 68 beats/min and temperature: 35.7 C; bilateral and symmetrical vesicular murmur, diffuse and crackling sibilants at the bases with cough, thoraco-abdominal rocking and supraclavicular indrawing, with an improvement following the two aerosols made in the emergency room. Regular heart sounds without breath heard. Perceived radial pulse. Bilateral ocher dermatitis, painless and supple calf. Edema of the lower limbs taking the scoop and jugular turgor. Patient with dyspnoea under 4L/minute with 94% saturation and a respiratory rate of 18 cycles per minute. Cough ineffective, the patient was congested. Passed under 5L/min of O2. Bloated abdomen. Depressible painful on the left. No nausea and vomiting. Additional tests in 2021 indicated hypercapnic acidosis and hyperlactatemia as 1st Blood gas: pH: 7.32, pCO2: 65.3 mmHg, pO2: 77.4 mmHg, Lactates: 1.6 mmol/l. Then, blood gas after 1st nebulization: pH 7.420, pCO2: 53.2 mmHg, pO2: 68 mmHg, Lactates: 6.9 mmol/l. Pulmonary X-ray showed bilateral flaky opacities. Cerebral and thoracic CT: no intracranial bleeding, no bone lesion of the cranial vault, facial mass, occipital hinge, sequelae of right frontal and left cerebellar stroke, minimal damage to COVID19, absence of pulmonary embolism until ''at the sub-segmental level, an aspect of left lower lobe pneumopathy.PCR COVID-19 on 23Mar2021 was negative and then on 29Mar2021 was positive. On 01Apr2021, the patient''s respiratory state worsened with 86% desaturation under 1.5L of oxygen. He fell in facility for dependent elderly people with head trauma in 2021 without loss of consciousness in the context of Sars-Cov2 pneumonia. He was hospitalized in this context in 2021. Oxygen therapy was provided on 02Apr2021 with treatment with salbutamol aerosols and dexamethasone was started with antibiotic therapy with levofloxacin. Increase in LASILIX for the cardiac part in acute respiratory failure (in 2021). On 04Apr2021, the patient presented with respiratory degradation requiring high concentration mask oxygen therapy. In view of age and comorbidities, do not carry out invasive or intensive care treatments. Morphine and hypnovel treatment were introduced. The patient died on 05Apr2021 as the patient with fatal vaccine failure 34 days after his second dose of COMIRNATY vaccine. This hypoxemic Sars-Cov2 pneumonia was the cause of cardiac decompensation and a fall with head trauma. Outcome of the events of fall with head trauma, hypercapnic acidosis, hyperlactatemia and acute respiratory failure were unknown. An autopsy was not performed. No follow-up attempts are possible. Information regarding the lot/batch number (2nd dose) cannot be obtained.; Reported Cause(s) of Death: fatal vaccine failure; Sars-Cov2 pneumonia is the cause of cardiac decompensation; Sars-Cov2 pneumonia is the cause of cardiac decompensation


VAERS ID: 1250285 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood pressure measurement, Cardio-respiratory arrest, Diarrhoea, Heart rate, Oxygen saturation, Physical examination, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   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: PARACETAMOL; PLAVIX; FUROSEMIDE; AMLODIPINE; PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]; FOSFOMYCIN; ADENURIC; OMEPRAZOLE; UVEDOSE; ACTISKENAN; CANNABIDIOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign paroxysmal positional vertigo; Carotid endarterectomy (bilateral carotid endarterectomy); Cholecystectomy; Degenerative disc disease; Dyslipidaemia; Gouty arthritis; Hypertension arterial; Hypoacusis; Osteoarthritis of lumbar spine; Renal failure chronic; Septicemia; Transient ischaemic attack (transient neurological accident); Urinary tract infection; Vertebrobasilar insufficiency (vertebrobasilar insufficiency on left subclavian flight on subclavian artery stenosis)
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: blood pressure; Result Unstructured Data: Test Result:123/63 mmHg; Test Date: 202104; Test Name: heart rate; Result Unstructured Data: Test Result:73; Comments: 73 / min; Test Date: 202104; Test Name: oxygen saturation; Test Result: 96 %; Test Date: 202104; Test Name: physical assesment; Result Unstructured Data: Test Result:Regular muffled heart sounds without breath; Comments: Regular muffled heart sounds without breath, ankle swelling, soft and painless calves. Bilateral crackling, eupneic. Painless depressible supple abdomen. Lumbar pain on mobilization. No concept of fall a priori.; Test Date: 202104; Test Name: x rays; Result Unstructured Data: Test Result:Stiffness of the spine; Comments: X-rays of the lumbar spine similar to those taken in 2019:Stiffness of the spine, inter-somatic and posterior inter-articular osteoarthritis changes with appearance of a narrowed lumbar canal, aneurysm of the abdominal infra-renal aorta.
CDC Split Type: FRPFIZER INC2021431477

Write-up: severe right back pain; Cardio-respiratory arrest; Diarrhoea; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-AVPO20211651, Safety report unique identifier FR-AFSSAPS-2021037729. A 93-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular at the age of 93-years-old on 02Apr2021 (Lot Number: ER9470) as single dose for COVID-19 immunization; morphine sulfate (ACTISKENAN), via an unspecified route of administration from 02Apr2021 (Batch/Lot Number: Unknown) to an unspecified date, at 2 DF, 1x/day for pain; cannabidiol (CANNABIDIOL), oral from 02Apr2021 (Batch/Lot Number: Unknown) to an unspecified date, at for an unspecified indication. Medical history included transient ischaemic attack and vertebrobasilar insufficiency (reported as "transient neurological accident possibly related to vertebrobasilar insufficiency on left subclavian flight on subclavian artery stenosis"), arterial hypertension, carotid endarterectomy (bilateral carotid endarterectomy), dyslipidaemia, Renal failure chronic (Severe chronic renal failure (GFR: 30 ml / min) on probable benign nephroangiosclerosis and probable lesions of chronic tubulointerstitial nephritis), gouty polyarthritis, multiple urinary tract infections, paroxysmal benign right vertigo, discarthrosis, posterior lumbar interatrial osteoarthritis, septicemia starting urinary, bilateral paired hypoacusis, and cholecystectomy; all from unknown dates and unknown if ongoing. Concomitant medications included paracetamol; clopidogrel bisulfate (PLAVIX); furosemide; amlodipine; propranolol hydrochloride; fosfomycin; febuxostat (ADENURIC); omeprazole; colecalciferol (UVEDOSE); all taken for unspecified indications, start and stop dates were not reported. The patient experienced cardio-respiratory arrest on 04Apr2021, severe right back pain on 02Apr2021, and diarrhoea on 02Apr2021. The patient was hospitalized for severe right back pain from 02Apr2021 to an unknown date. On 02Apr2021, the day of the vaccination, she presented with severe right back pain (doubt about the existence of pain before the vaccination). She reported taking an over-the-counter CBD product in the afternoon (product name? Dose?). To decrease the pain and knowing of people taking CBD for pain, would have bought it and would have made a poorly tolerated infusion with diarrhea. The increase in pain required hospital treatment on 02Apr2021 in the evening. Clinically hemodynamic stable (123/63 mmHg, heart rate: 73 / min, SatO2: 96% in ambient air, afebrile. Regular muffled heart sounds without breath, ankle swelling, soft and painless calves. Bilateral crackling, eupneic. Painless depressible supple abdomen. Lumbar pain on mobilization. No concept of fall a priori. X-rays of the lumbar spine similar to those taken in 2019: Stiffness of the spine, inter-somatic and posterior inter-articular osteoarthritis changes with appearance of a narrowed lumbar canal, aneurysm of the abdominal infra-renal aorta. No notion of biological assessment or ECG. Administration of ORAMORPH 10 mg, ACTISKENAN 5 mg 1 gel x2, paracetamol 1 g and PRIMPERAN 5 mg. Improvement after a night''s rest. Return home on 03Apr2021 with prescription for ACTISKENAN 5 mg if needed (max: 4 / d), paracetamol 1 g x2 / d and MOVICOL 1 sachet / d for 7 days. Patient found deceased on 04Apr2021 by the family after having received the 2nd dose of the COMIRNATY vaccine two days earlier (lot number ER9470). The patient underwent lab tests and procedures which included blood pressure measurement: 123/63 mmHg on Apr2021, heart rate: 73 on Apr2021 (73 / min), oxygen saturation: 96 % on Apr2021, physical examination: regular muffled heart sounds without breath on Apr2021 (Regular muffled heart sounds without breath, ankle swelling, soft and painless calves. Bilateral crackling, eupneic. Painless depressible supple abdomen. Lumbar pain on mobilization. No concept of fall a priori), X-ray: stiffness of the spine on Apr2021 (X-rays of the lumbar spine similar to those taken in 2019: Stiffness of the spine, inter-somatic and posterior inter-articular osteoarthritis changes with appearance of a narrowed lumbar canal, aneurysm of the abdominal infra-renal aorta). The action taken in response to the events for morphine sulfate was not applicable and for cannabidiol was not applicable. Therapeutic measures were taken as a result of the events. The outcome for Cardio-respiratory arrest was fatal, for back pain was recovering while for diarrhoea was not recovered. The patient died on 04Apr2021. It was not reported if an autopsy was performed. Person at risk of developing a severe form of COVID19 disease due to their age and severe kidney disease. Person who has not had COVID-19 and has not been tested. File under investigation. No follow-up attempts possible. No further information expected. Information on lot number obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1250286 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Epistaxis, Haematemesis, Haemoglobin, Haemoglobin decreased, Haemorrhagic diathesis, Lymphocyte count, Neutrophil count, Pancytopenia, Platelet count decreased, Protein C, Protein C increased, Thrombocytopenia, White blood cell count, White blood cell count decreased
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 17
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: Duchenne muscular dystrophy (with myocardial impairment LVEF 45%)
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: hemoglobine; Result Unstructured Data: Test Result:12.3 g/dl; Test Date: 20210326; Test Name: hemoglobine; Result Unstructured Data: Test Result:11.4 g/dl; Test Date: 20210329; Test Name: hemoglobine; Result Unstructured Data: Test Result:10.9 g/dl; Test Date: 20210406; Test Name: hemoglobine; Result Unstructured Data: Test Result:9.6 g/dl; Test Date: 20210324; Test Name: lymphocytes; Result Unstructured Data: Test Result:301; Comments: Units:/uL; Test Date: 20210326; Test Name: lymphocytes; Result Unstructured Data: Test Result:460; Comments: Units:/uL; Test Date: 20210329; Test Name: lymphocytes; Result Unstructured Data: Test Result:320; Comments: Units:/uL; Test Date: 20210406; Test Name: lymphocytes; Result Unstructured Data: Test Result:629; Comments: Units:/uL; Test Date: 20210324; Test Name: neutrophiles; Test Result: 2889 uL; Test Date: 20210326; Test Name: neutrophiles; Test Result: 2028 uL; Test Date: 20210329; Test Name: neutrophiles; Test Result: 1719 uL; Test Date: 20210406; Test Name: neutrophiles; Test Result: 1441 uL; Test Date: 20210324; Test Name: platelets; Result Unstructured Data: Test Result:37000; Comments: Units:/uL; Test Date: 20210326; Test Name: platelets; Result Unstructured Data: Test Result:32000; Comments: Units:/uL; Test Date: 20210329; Test Name: platelets; Result Unstructured Data: Test Result:34000; Comments: Units:/uL; Test Date: 20210406; Test Name: platelets; Result Unstructured Data: Test Result:73000; Comments: Units:/uL; Test Date: 20210324; Test Name: Protein C; Result Unstructured Data: Test Result:39.2 mg/l; Comments: normal <5; Test Date: 20210324; Test Name: Protein C; Result Unstructured Data: Test Result:43.8 mg/l; Comments: normal <5; Test Date: 20210324; Test Name: leucocytes; Result Unstructured Data: Test Result:3460; Comments: Units:/uL; Test Date: 20210326; Test Name: leucocytes; Result Unstructured Data: Test Result:2790; Comments: Units:/uL; Test Date: 20210329; Test Name: leucocytes; Result Unstructured Data: Test Result:2190; Comments: Units:/uL; Test Date: 20210406; Test Name: leucocytes; Result Unstructured Data: Test Result:2410; Comments: Units:/uL
CDC Split Type: FRPFIZER INC2021431481

Write-up: Epistaxis; major hemorrhagic syndrome; Haematemesis; asthenia; protein c 39.2 on 24mar2021; thrombocytopenia at 32000 / ul; Pancytopenia; included haemoglobin: 12.3 g/dl on 24Mar2021; leucocytes 3460/uL on 24mar2021; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BR20211185, Safety Report Unique Identifier FR-AFSSAPS-2021037518. A 24-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: ET3620), second dose intramuscular, administered in Arm Left on 17Mar2021, single dose for covid-19 immunisation. Medical history included duchenne muscular dystrophy with myocardial impairment LVEF 45%. The patient''s concomitant medications were not reported. Patient experienced appearance of asthenia 15 days after the 2nd injection (01Apr2021). Biology shows pancytopenia without clinical signs with thrombocytopenia at 32000 / ul on 26Mar2021. Hematologic advice: weekly biological monitoring. Faced with good clinical tolerance, the patient and his family are not in favor of hospitalization (each hospitalization is badly lived). Last biology on 06Apr2021: improvement in platelets 73,000 / ul, hemoglobin at 9.6 g / dl (loss of one point compared to the previous week). On 08Apr2021, persistent asthenia but clinical nothing to report. The 10Apr2021: hematemesis and major hemorrhagic syndrome, major epistaxis with cardiopulmonary arrest.Intervention: urgent medical aid service to attempt resuscitation but failure and death of the patient. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included haemoglobin: 12.3 g/dl on 24Mar2021, haemoglobin: 11.4 g/dl on 26Mar2021, haemoglobin: 10.9 g/dl on 29Mar2021, haemoglobin: 9.6 g/dl on 06Apr2021, lymphocyte count: 301 on 24Mar2021 Units:/uL , lymphocyte count: 460 on 26Mar2021 Units:/uL, lymphocyte count: 320 on 29Mar2021 Units:/uL, lymphocyte count: 629 on 06Apr2021 Units:/uL, neutrophil count: 2889 ul on 24Mar2021, neutrophil count: 2028 ul on 26Mar2021, neutrophil count: 1719 ul on 29Mar2021, neutrophil count: 1441 ul on 06Apr2021, platelet count decreased: 37000 on 24Mar2021 Units:/uL, platelet count decreased: 32000 on 26Mar2021 Units:/uL , platelet count decreased: 34000 on 29Mar2021 Units:/uL. The outcome of the events Bleeding tendency, epistaxis, Haematemesis was fatal, other events was not recovered. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Haematemesis; Epistaxis; major hemorrhagic syndrome


VAERS ID: 1250287 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-04-07
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021431223

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-BX20212918, Safety Report Unique Identifier FR-AFSSAPS-2021036308. A 96-year-old female patient received her second dose of BNT162b2 (COMIRNATY, Lot Number: EJ6795), intramuscular on 10Mar2021 as SINGLE DOSE for COVID-19 immunisation. Medical history included breast cancer. The patient''s concomitant medications were not reported. The patient received her first dose of BNT162b2 (COMIRNATY, lot number: EJ6795) on 18Feb2021 for COVID-19 immunisation. The patient experienced unknown cause of death on 07Apr2021. Outcome of the event was fatal. The patient died on 07Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1250288 (history)  
Form: Version 2.0  
Age: 102.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asymptomatic COVID-19; Rectosigmoid cancer (pauci-symptomatic, untreated)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021431281

Write-up: The picture can be massive pulmonary embolism or myocardial infarction (MI); The picture can be massive pulmonary embolism or myocardial infarction (MI); Sudden death; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-BX20213007, Safety report unique identifier FR-AFSSAPS-2021037171. A 102-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left arm on 09Apr2021 (Lot Number: EW2239) as single dose for COVID-19 immunisation. Medical history included rectosigmoid cancer from Jan2021 and unknown if ongoing (pauci-symptomatic, untreated, discovered 3 months ago) and asymptomatic COVID -19 from Oct2020 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced sudden death on 09Apr2021. It was reported also as follows: death 6 hours after vaccination (dose 1) on 09Apr2021, around 11 a.m. The patient is on accommodation facility for dependent elderly people in autumn 2020 with good general condition, no particular antecedent except for a pauci-symptomatic rectosigmoid carcinoma, without metastasis or treatment, discovered 3 months ago. Discussion with the family the day before the vaccination on the relevance of the vaccination. On the day of the vaccination, after a lunch and an unusual snack, return to room around 4 p.m. Found dead in the chair around 5:30 p.m. Considering the age, no attempt at resuscitation. The picture can be massive pulmonary embolism or myocardial infarction (MI) depending on the doctor, because no cyanosis, no mottling, no sign of struggle. The patient died on 09Apr2021. An autopsy was not performed. Outcome of massive pulmonary embolism and myocardial infarction (MI) was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1250289 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-04-09
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood cholesterol, Blood count, Blood creatinine, Blood glucose, Death, Prostatic specific antigen, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism; Bipolar disorder; Varicose vein operation
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: cholesterol; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: blood count; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: Creatinine; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: glucose; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: prostatic specific antigen; Result Unstructured Data: Test Result:normal; Test Date: 202101; Test Name: Sars-Cov-2 PCR test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021431269

Write-up: Death unexplained; This is as spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) Database-WEB. The regulatory authority report number is FR-AFSSAPS-BX20213028. Safety report unique identifier FR-AFSSAPS-2021037367. A 43-year-old male patient received the second dose of BNT162B2 (vaccine; Lot Number: EJ6789), intramuscular, administered in right arm on 10Feb2021 at single dose for COVID-19 vaccination. The patient''s medical history included bipolar disorder, alcoholism, and lower limb varicose vein operation. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (vaccine) on an unspecified date for COVID-19 immunization. The patient experienced death unexplained on 09Apr2021. The patient underwent lab tests and procedures which included cholesterol, blood count, creatinine, glucose, and prostatic specific antigen, all with normal results on Mar2021; and Sars-Cov-2 PCR test: negative on Jan2021. The patient died on 09Apr2021. An autopsy was not performed. The clinical course was as follows: Approximately 2 months after vaccination, death of unknown cause, discovered approximately 24 hours after death. Rigid rigor making examination of the body difficult. Found lying down, must have died in his sleep. Presence of a stream of blood at the corner of the lips. nota bene.: Imputation made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected. Information on lot number obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1250291 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-04-01
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREVISCAN [FLUINDIONE]; BUDESONIDE; SALBUTAMOL; KARDEGIC; IPRATROPIUM; SPIRIVA; TOPALGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic cirrhosis; Anxiodepressive syndrome; Chronic alcoholism (hepatic cirrhosis); COPD (under oxygen 2L / min day and night); Hepatic cirrhosis; Hypertension arterial; Ischemic stroke; Tobacco user
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: positive with the presence of mutations suggestive of the variant
CDC Split Type: FRPFIZER INC2021431524

Write-up: suspected aspiration pneumonia; Vaccination failure/COVID-19 confirmed by positive COVID-19 test with symptoms; COVID-19 confirmed by positive COVID-19 test with symptoms; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB with regulatory authority number FR-AFSSAPS-DJ20210885 and Safety Report Unique Identifier is FR-AFSSAPS-2021037781. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 05Feb2021 (Lot Number: EJ6788) as a single dose; and dose 1 intramuscular on 15Jan2021 (Lot Number: EM0477) as a single dose for covid-19 immunisation. Medical history included tobacco user, anxio-depressive syndrome, hypertension arterial, chronic alcoholism (hepatic cirrhosis), alcoholic cirrhosis, chronic obstructive pulmonary disease (COPD) under oxygen 2L / min day and night and ischemic stroke from 2003 to an unknown date. Concomitant medications included fluindione (PREVISCAN); budesonide; salbutamol; acetylsalicylate lysine (KARDEGIC); ipratropium; tiotropium bromide (SPIRIVA); and tramadol hydrochloride (TOPALGIC), indication, start and stop date were not reported. It was reported that on 01Apr2021, the experienced covid-19 pcr test positive and vaccination failure. It was further reported that the patient received the first dose of COMIRNATY on 15Jan2021 and the second dose on 05Feb2021. On 01Apr2021, the patient is vomiting and was more tired. He didn''t have fever. On 02Apr2021, the RT-PCR is positive with the presence of mutations suggestive of the variant. Also on 02Apr2021, the death of the patient was observed at 6 a.m. in his bed before the results of the PCR. The reported cause of death was suspected aspiration pneumonia. The patient underwent lab tests and procedures which included COVID-19 PCR test was positive on 02Apr2021 which showed positive with the presence of mutations suggestive of the variant. The outcome of the events was fatal. The patient died on 02Apr2021. An autopsy was not performed. No follow-up attempts are possible, no information is expected.; Sender''s Comments: Linked Report(s) : FR-AFSSAPS-DJ20210888 AFSSAPS;FR-AFSSAPS-DJ20210896 AFSSAPS;FR-AFSSAPS-DJ20210890 AFSSAPS;FR-AFSSAPS-DJ20210892 AFSSAPS;FR-AFSSAPS-DJ20210893 AFSSAPS;FR-AFSSAPS-DJ20210886 AFSSAPS; Reported Cause(s) of Death: suspected aspiration pneumonia


VAERS ID: 1250293 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021431230

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LY20212917 with Safety Report Unique Identifier FR-AFSSAPS-2021037400. An 88-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number: EJ6788) via intramuscular on 10Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced sudden death on 16Feb2021. It was unknown if an autopsy was done or not. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1250303 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Hemiplegia, Loss of consciousness, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Auricular fibrillation; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: Covid 19 PCR test; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: FRPFIZER INC2021431231

Write-up: Consciousness loss; Hemiplegia; blindness; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MA20211240 with Safety Report Unique Identifier FR-AFSSAPS-2021035783. A 93-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6788), intramuscular, administered in arm left on 09Feb2021 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and hypertension arterial from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 11Feb2021, forty-eight (48) hours after vaccination, the patient presented with right hemiplegia with blindness and loss of consciousness. The patient was hospitalized for the events on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test: unknown results on 09Feb2021. The outcome of the events was fatal. The patient died on 24Feb2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: right hemiplegia; blindness; loss of consciousness


VAERS ID: 1250305 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-05
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time abnormal, Blood chloride, Blood creatine phosphokinase, Blood fibrinogen, Blood pressure measurement, Blood sodium, Body temperature, Cerebral haemorrhage, Coma scale, Computerised tomogram, Creatinine renal clearance, Disseminated intravascular coagulation, Fall, Hyperchloraemia, Hypernatraemia, Lymphocyte count, Lymphopenia, Malaise, Platelet count, Prothrombin level abnormal, Prothrombin time, Prothrombin time ratio, Rhabdomyolysis, Thrombocytopenia, Thrombosis, Ultrasound Doppler
SMQs:, Rhabdomyolysis/myopathy (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; XARELTO
Current Illness: Fibrillation atrial (treated with Bisoprolol and Xarelto); Intoxication (active)
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Hypertension; Shoulder osteoarthritis; Shoulder prosthesis user
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: hyperchloremia; Result Unstructured Data: Test Result:130 mmol/L; Comments: hyperchloremia; Test Date: 20210409; Test Name: rhabdomyolysis CPK; Result Unstructured Data: Test Result:$g8000; Comments: rhabdomyolysis; Test Date: 20210409; Test Name: fibrinogen; Result Unstructured Data: Test Result:0.74; Test Date: 20210409; Test Name: blood pressure; Result Unstructured Data: Test Result:hypotension; Test Date: 20210409; Test Name: hypernatremia; Result Unstructured Data: Test Result:170 mmol/L; Comments: hypernatremia; Test Date: 20210409; Test Name: body temperature; Result Unstructured Data: Test Result:hypothermic; Test Date: 20210409; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:13; Test Date: 20210409; Test Name: CT scan; Result Unstructured Data: Test Result:Balthazar pancreatitis D, mural thrombus of the ao; Comments: Balthazar pancreatitis D, mural thrombus of the aorta 4th portion; Test Date: 20210409; Test Name: clearance; Result Unstructured Data: Test Result:30; Test Date: 20210409; Test Name: lymphopenia; Result Unstructured Data: Test Result:216; Comments: lymphopenia; Test Date: 20210409; Test Name: thrombocytopenia; Result Unstructured Data: Test Result:34000/mm3; Comments: thrombocytopenia; Test Date: 20210409; Test Name: PT; Test Result: 38 %; Test Date: 20210409; Test Name: aPTT ratio; Result Unstructured Data: Test Result:1.3; Comments: with Xarelto; Test Date: 20210409; Test Name: Ultrasound Doppler; Result Unstructured Data: Test Result:right humeral artery occlusion; Comments: right humeral artery occlusion, right superficial femoral artery occlusion and right popliteal artery
CDC Split Type: FRPFIZER INC2021431341

Write-up: hypernatremia (170mmol / l); hyperchloremia (130mmol / l); lymphopenia at 216; rhabdomyolysis CPK$g 8000; PT 38%; aPTT ratio at 1.3; malaise; probable fall without witness (mechanism unknown); Disseminated intravascular coagulation; Thrombosis multiple; Thrombocytopenia; Cerebral hemorrhagic rearrangement; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB FR-AFSSAPS-MP20211145, Safety Report Unique Identifier FR-AFSSAPS-2021037785. A 72-year-old male patient received bnt162b2 (COMIRNATY; lot ER9470), intramuscular, administered in left arm on 26Mar2021 as single dose for COVID-19 immunisation. Medical history included ongoing fibrillation atrial treated with Bisoprolol and Xarelto, hypertension, ongoing chronic intoxication (active), arthritis, shoulder osteoarthritis, and bilateral shoulder prosthesis. Concomitant medications included bisoprolol, and rivaroxaban (XARELTO), both for atrial fibrillation. On 05Apr2021, 10 days post-vaccination, the patient experienced malaise, probable fall without witness (mechanism unknown), and prolonged ground station. On 09Apr2021, 14 days post-vaccination, the patient was found on the ground, face down, Glasgow was 13, hypotensive, hypothermic, and no respiratory distress. At the emergency department: hypernatremia (170mmol / l), hyperchloremia (130mmol / l), clearance at 30, thrombocytopenia (34000 / mm3), lymphopenia at 216, rhabdomyolysis CPK$g 8000, probable disseminated intravascular coagulation (DIC) with fibrinogen consumed at 0.74, PT 38% , aPTT ratio at 1.3 (with Xarelto). Computerised tomogram (CT) showed Balthazar pancreatitis D, mural thrombus of the aorta 4th portion and ultrasound doppler showed right humeral artery occlusion, right superficial femoral artery occlusion and right popliteal artery. Patient care in intensive care: Multivisceral failure at H12 of the care. Cardiologist opinion included extensive intra-cardiac thrombus and cerebral hemorrhagic rearrangement. It was concluded that probable DIC with multiple arterial thrombosis and thrombocytopenia on day 10 to day 14 post-vaccination, leading to the death of the patient with hypertension and anticoagulated atrial fibrillation. The patient died on 11Apr2021 due to cerebral hemorrhagic rearrangement, disseminated intravascular coagulation, thrombosis multiple and thrombocytopenia. An autopsy was not performed. Outcome of the rest of events was unknown. No follow-up attempts are possible, no information is expected.; Sender''s Comments: Based on event-vaccine chronological association a causal relationship between reported events and BNT162B2 (COMIRNATY0 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cerebral hemorrhagic rearrangement; Disseminated intravascular coagulation; Thrombosis multiple; Thrombocytopenia


VAERS ID: 1250307 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspnea; Pleural effusion
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: Covid-19 PCR test; Test Result: Negative ; Test Date: 20210408; Test Name: Covid-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021431469

Write-up: Patient''s COVID-19 PCR test was positive on 08Apr2021; Patient''s COVID-19 PCR test was positive on 08Apr2021; patient''s first dose given on 11Feb2021 and second dose on 25Mar2021; patient''s first dose given on 11Feb2021 and second dose on 25Mar2021; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20211192. A 99-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm on 25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization; bnt162b2 (COMIRNATY), dose 1 via unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included ongoing heart failure, dyspnea, and pleural effusion. The patient''s concomitant medications were not reported. The patient''s COVID-19 PCR test was positive on 08Apr2021. The patient underwent lab tests and procedures which included Covid-19 PCR test: negative on 01Apr2021 and Covid-19 PCR test: positive on 08Apr2021. The patient died on 10Apr2021 due to COVID-19. An autopsy was not performed. No follow-up attempts are possible; information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: Covid


VAERS ID: 1250308 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-03-23
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Brain natriuretic peptide, C-reactive protein, COVID-19, Computerised tomogram, Cough, Fibrin D dimer, Hypokalaemia, Investigation, Lung disorder, Lymphocyte count, Lymphopenia, Neutrophil count, Neutrophil count increased, Oxygen saturation, PCO2, PO2, Respiratory rate, SARS-CoV-2 test, Systemic inflammatory response syndrome, Tachycardia, Troponin, Vaccination failure, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow), Sepsis (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TAMSULOSIN; KARDEGIC; LANSOPRAZOLE; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute cholecystitis; Anemia; Arterial hypertension; Beta thalassemia minor; Hiatal hernia; Living in residential institution (GIR2 patient); Partial epilepsy; Pericarditis; Pleural effusion; Pneumonia; Polyneuritis; Pyloric stenosis; Transient ischemic attack; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: hypokalaemia; Result Unstructured Data: Test Result:3.07 mmol/L; Test Date: 20210403; Test Name: BNP; Result Unstructured Data: Test Result:465; Test Date: 20210403; Test Name: Thoracic CT; Result Unstructured Data: Test Result:pneumopathy in the lower right lobe; Test Date: 20210410; Test Name: CRP; Result Unstructured Data: Test Result:200 vs 100; Test Date: 20210403; Test Name: CRP; Result Unstructured Data: Test Result:189.6 mg/l; Test Date: 20210403; Test Name: D-dimer; Result Unstructured Data: Test Result:882; Test Date: 20210403; Test Name: Biology; Result Unstructured Data: Test Result:moderate anemia; Test Date: 20210403; Test Name: clinical examination; Result Unstructured Data: Test Result:oxygen-retaining at 6 L/ min; Comments: bilateral crackles, polypneic without sign of struggle, no sign of cardiac decompensation; Test Date: 20210410; Test Name: lymphocyte; Result Unstructured Data: Test Result:0.5 g/l; Test Date: 20210410; Test Name: neutrophil count; Result Unstructured Data: Test Result:10 g/l; Test Date: 20210410; Test Name: oxygen saturation; Test Result: 92 %; Comments: 92% SAO2 under 7L / min with glasses. Clinically fatty cough without expectoration: risk of major aspiration. No acute respiratory distress.; Test Date: 20210403; Test Name: pCO2; Result Unstructured Data: Test Result:36.0; Test Date: 20210403; Test Name: pH; Result Unstructured Data: Test Result:7.476; Test Date: 20210403; Test Name: pO2; Result Unstructured Data: Test Result:71.1; Test Date: 20210410; Test Name: Respiratory rate; Result Unstructured Data: Test Result:22 cpm; Test Date: 20210403; Test Name: Covid virus test; Result Unstructured Data: Test Result:presence of the VARIANT; Test Date: 20210323; Test Name: SARSCov2 PCR; Test Result: Positive ; Test Date: 20210403; Test Name: Troponin; Result Unstructured Data: Test Result:203; Test Date: 20210410; Test Name: WBC; Result Unstructured Data: Test Result:11 g/l
CDC Split Type: FRPFIZER INC2021431443

Write-up: Vaccination failure/ On 23Mar2021, patient tested PCR + for SARSCov2; Vaccination failure/ On 23Mar2021, patient tested PCR + for SARSCov2; hypokalaemia 3.07 mmol/L; increased SRIS; tachycardia; Clinically fatty cough without expectoration; neutrophil count 10 g/L; lymphopenia 0.5 g/L; Thoracic CT: pneumopathy in the lower right lobe; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-NC20211589 and the other case identifier is FR-AFSSAPS-2021038008. An 88-year-old male patient received BNT162B2 (COMIRNATY) on 28Jan2021 (lot number: EJ6788) as first dose and on 16Feb2021 (lot number: EJ6788) as second dose, both intramuscular at single dose for COVID-19 vaccination. Medical history included transient ischemic attack, anemia, beta thalassemia minor, acute cholecystitis, mixed vascular dementia (cortical and subcortical), partial epilepsy, hiatal hernia, arterial hypertension, pericarditis, pneumonia with pleural effusion from Feb2020, alcoholic polyneuritis, and pyloric stenosis. The patient is a GIR2 patient (as reported) residing in a nursing home. Concomitant medications included tamsulosin, acetylsalicylate lysine (KARDEGIC), lansoprazole, and folic acid. On 23Mar2021, the patient experienced vaccination failure as he tested PCR positive (+) for SARS-Cov-2; the patient became symptomatic: asthenia, hitchhiking and desaturation from 02Apr2021 prompting hospitalization on 03Apr2021. Clinical examination on 03Apr2021: oxygen-retaining at 6 L/min, bilateral crackles, polypneic without sign of struggle, no sign of cardiac decompensation. Biology: D-dimer at 882, moderate anemia, CRP at 189.6 mg/L, BNP at 465 and troponins at 203. GDS: pH: 7.476, pCO2: 36.0, pO2: 71.1. Thoracic CT: pneumopathy in the lower right lobe, presence of the VARIANT. Gradual degradation. On 10Apr2021, afebrile, stable HD, hypertension and tachycardia, 92% SAO2 under 7 L/ min with glasses. Clinically fatty cough without expectoration: risk of major aspiration. No acute respiratory distress. Respiratory rate 22 cpm, CRP 200 vs 100, and WBC 11 g/L including neutrophil count 10 g/L and persistence of lymphopenia 0.5 g/L, hypokalaemia 3.07 mmol/L. D3 of tazocillin: extended antibiotic therapy on increased SRIS, initiation of Dexamethasone on increase in O2 requirements above 6 L/ min, supplementation K + 1 g/24H in reaction + bio control H48, introduction of SAP midazolam 0.2 mg/H for anxiolysis because it removes O2. Summary of management: Hospitalized patient. Degradation in hospital with fatal outcome on 12Apr2021 in the morning. Conclusion: Vaccine ineffectiveness with fatal outcome. 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.84/50, January 24, 1985. Published in Therapy 1985; 40: 111-8. The patient died on 12Apr2021. The causes of death were vaccination failure and COVID-19. It was unknown if autopsy was performed. The outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure/ On 23Mar2021, patient tested PCR + for SARSCov2; Vaccination failure/ On 23Mar2021, patient tested PCR + for SARSCov2


VAERS ID: 1250309 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-21
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET2166 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRIVA; SYMBICORT; RHINOCORT [BUDESONIDE]; ZITHROMAX; THEOSTAT [THEOPHYLLINE]; SERESTA; AMLOR; LASILIX [FUROSEMIDE]; MOVICOL [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; TARKA LP; ESOMEPRAZOLE; SOLUPRED [PREDNISOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alpha-1 antitrypsin deficiency; Biopsy; Chronic renal failure; Chronic sinusitis; Colitis (Sigmoid segmental colitis); Colonoscopy (Diverticulosis (colonoscopy in 2016)); COPD (COPD Gold IV with pulmonary emphysema due to alpha antitrypsin deficiency); Deep vein thrombosis (Right deep vein thrombosis); Diverticulosis (Diverticulosis (colonoscopy in 2016)); Emphysema pulmonary; Infection; Laryngoscopy (Direct laryngoscopy with phono surgery for leukoplakic lesion of the right vocal cord (2015)); Pneumonia bacterial; Pneumopathy; Pulmonary arterial hypertension (Pulmonary arterial hypertension Group 3); Pulmonary embolism (Bilateral pulmonary embolism in 2010); Respiratory distress; Tracheostomy (Tracheostomy in Jul2018 on large arytenoid edema post biopsy of a lesion of the left vocal cord); Vocal cord disorder; Vocal cord polypectomy (Benign vocal cord polyps resected in 2017)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021431440

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The Regulatory Authority report number is FR-AFSSAPS-NC20211593. A 75-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: ET2166, expiration date not reported), intramuscular on 02Mar2021 as a single dose for COVID-19 immunisation. Medical history included Right deep vein thrombosis, pleuro pneumopathy in 2011, Bilateral pulmonary embolism in 2010, Benign vocal cord polyps resected in 2017, Sigmoid segmental colitis, Enterococcus faecalis pneumonia in 2017, Diverticulosis (colonoscopy in 2016), Direct laryngoscopy with phono surgery for leukoplakic lesion of the right vocal cord in 2015, Biopsy of lesion (polyp) of the left vocal cord in 2018), resection of the lesion was impossible with respiratory distress in the course of the process, tracheostomy in Jul2018 on large arytenoid edema post biopsy of a lesion of the left vocal cord, COPD Gold IV with pulmonary emphysema due to alpha antitrypsin deficiency, Chronic renal failure, Pulmonary arterial hypertension Group 3 and Chronic sinusitis. Concomitant medications included tiotropium bromide (SPIRIVA); budesonide, formoterol fumarate (SYMBICORT); budesonide (RHINOCORT); azithromycin (ZITHROMAX); theophylline (THEOSTAT); oxazepam (SERESTA); amlodipine besilate (AMLOR); furosemide (LASILIX); macrogol 4000, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL); trandolapril, verapamil hydrochloride (TARKA LP); esomeprazole; prednisolone (SOLUPRED) from an unspecified start date to 04Nov2018. The patient with serious comorbidities. It was reported that the patient had the first vaccination with COMIRNATY on 02Mar2021 during hospitalization from 26Feb2021 to 02Mar2021 for treatment of acute respiratory distress of infectious origin and favorable development. Cardio checkup was okay on 03Mar2021. On 21Mar2021, the patient experienced Cardio-respiratory arrest within 3 weeks after vaccination wherein patient complained of not being well, of having difficulty breathing, of feeling "burns" and then collapsing to the ground. The patient died on 21Mar2021 due to the event. 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: 1250323 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH GP9605 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021431339

Write-up: increase in respiratory problems; This is a spontaneous report from a contactable healthcare professional (HCP) downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20211014 with Safety Report Unique Identifier FR-AFSSAPS-2021036828. An 83-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot: GP9605), intramuscular in left arm on 12Mar2021 as single dose for covid-19 immunisation. Medical history included hypertension and asthma. The patient''s concomitant medications were not reported. The patient did not have Covid-19. The patient was not tested. Usual treatment were not specified. The patient experienced increase in respiratory problems on 19Mar2021. The patient died due to increase in respiratory problems on 19Mar2021. It was unknown if autopsy was performed. The reported evolution was died on 19Mar2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: increase in respiratory problems


VAERS ID: 1250324 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-29
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood alkaline phosphatase, Blood creatinine, Blood pressure measurement, Blood urea, Brain natriuretic peptide, C-reactive protein, COVID-19 pneumonia, Computerised tomogram thorax, Drug ineffective, Electrocardiogram, Gamma-glutamyltransferase, Glomerular filtration rate, Haemoglobin, Hepatic cytolysis, Investigation, Neutrophil count, Oxygen saturation, Platelet count, Procalcitonin, Renal failure, Respiratory rate, Respiratory tract infection bacterial, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LERCAPREL; MOPRAL [OMEPRAZOLE]; HYDREA; CRESTOR; EUPRESSYL [URAPIDIL HYDROCHLORIDE]; ALLOPURINOL; ELIQUIS; LERCAN; KARDEGIC; MONOPROST
Current Illness: Arterial hypertension; Hematological malignancy (treated with HYDREA)
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder; Cardiomyopathy; Pulmonary embolism; Thrombosis venous deep (treated with ELIQUIS)
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: ALP; Result Unstructured Data: Test Result:normal; Test Date: 20210329; Test Name: creatinine; Result Unstructured Data: Test Result:394 umol/l; Test Date: 20210329; Test Name: blood pressure; Result Unstructured Data: Test Result:137/50 mmHg; Test Date: 20210329; Test Name: urea; Result Unstructured Data: Test Result:31 mmol/L; Test Date: 20210329; Test Name: BNP; Result Unstructured Data: Test Result:139; Comments: normal; Test Date: 20210329; Test Name: lung CT scan; Result Unstructured Data: Test Result:ground glass appearance; Comments: ground glass appearance of the 2 upper lobes associated with a major infectious focus of the right lower lobe of bacterial origin; Test Date: 20210329; Test Name: C-reactive protein; Result Unstructured Data: Test Result:283; Test Date: 20210329; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm and regular, without other abnormalit; Test Date: 20210329; Test Name: GGT; Result Unstructured Data: Test Result:normal; Test Date: 20210329; Test Name: GFR; Result Unstructured Data: Test Result:13.5 ml/min; Comments: indicating end-stage renal disease; Test Date: 20210329; Test Name: hemoglobin; Result Unstructured Data: Test Result:12.1; Test Date: 20210329; Test Name: verbal rating scale; Result Unstructured Data: Test Result:zero; Test Date: 20210329; Test Name: PMN; Test Result: 92 %; Test Date: 20210329; Test Name: oxygen saturation; Test Result: 92 %; Comments: in ambient air; Test Date: 20210329; Test Name: thrombocyte count; Result Unstructured Data: Test Result:18 g/l; Test Date: 20210329; Test Name: PCT; Result Unstructured Data: Test Result:120 ng/L; Comments: very elevated; Test Date: 20210329; Test Name: respiratory rate; Result Unstructured Data: Test Result:20; Comments: per minute; Test Date: 20210329; Test Name: Sars-Cov 2 antigen test; Result Unstructured Data: Test Result:Positive; Test Date: 20210329; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210329; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:in progress; Test Date: 20210329; Test Name: RT-PCR; Result Unstructured Data: Test Result:in progress; Test Date: 20210329; Test Name: troponin; Result Unstructured Data: Test Result:elevated; Test Date: 20210329; Test Name: Troponin; Result Unstructured Data: Test Result:elevated; Comments: in the picture of renal failure; Test Date: 20210329; Test Name: white blood cell count; Result Unstructured Data: Test Result:39.1 g/l
CDC Split Type: FRPFIZER INC2021431260

Write-up: COVID-19 pneumonitis; COVID-19 pneumonitis; Pulmonary bacterial infection; Acure renal insufficiency; Hepatic cytolysis in connection with Covid-19 impairment; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-NY20210692, Safety Report Unique Identifier FR-AFSSAPS-2021035262. An 85-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 13Mar2021 (Batch/Lot Number: ER2659) as SINGLE DOSE for covid-19 immunisation. Medical history included Thrombosis venous deep from an unknown date and unknown if ongoing treated with ELIQUIS, ongoing Hematological malignancy treated with HYDREA, ongoing Arterial hypertension, Pulmonary embolism, Cardiomyopathy, heart disease. Concomitant medication included enalapril maleate, lercanidipine hydrochloride (LERCAPREL) omeprazole (MOPRAL [OMEPRAZOLE]); hydroxycarbamide (HYDREA); rosuvastatin calcium (CRESTOR); urapidil hydrochloride (EUPRESSYL [URAPIDIL HYDROCHLORIDE]), allopurinol (ALLOPURINOL), apixaban (ELIQUIS) to 29Mar2021, lercanidipine hydrochloride (LERCAN), acetylsalicylate lysine (KARDEGIC), latanoprost (MONOPROST). The patient experienced covid-19 pneumonitis, pulmonary bacterial infection, acure renal insufficiency, Hepatic cytolysis on 29Mar2021. The events required hospitalization since 29Mar2021, and died on 01Apr2021. Clinical course was provided as On 29Mar2021, patient hospitalized for dyspnea and profound deterioration in general condition with Sars COV-2 infection complicated by a major bacterial right basal pulmonary infection. Presence of renal failure linked to overall dehydration and dysarthria, suggesting ischemic stroke (post-Covid origin?). At the admission examination, precarious state: afebrile patient, zero on VRS (verbal rating scale), blood pressure 137/50 mmHg, respiratory rate 20 / min. 92% SaO2 in ambient air. Lung CT scan: ground glass appearance of the 2 upper lobes associated with a major infectious focus of the right lower lobe of bacterial origin. ECG: sinus rhythm and regular, without other abnormality. Biology: white blood cells 39.1 G/L with 92% of PMN, Hb 12.1 g/dL, thrombocytopenia on hemopathy at 18 G/L. Urea 31 mmol/L, creatinine 394 umol/L with GFR (MDRD) at 13,5 mL/min indicating end-stage renal disease. Hepatic cytolysis in connection with Covid-19 impairment (not documented), GGT and ALP in the norm. CRP 283 mg/L. BNP normal at 139 ng/L. Troponin elevated in the picture of renal failure (undocumented). Very high PCT 120 ng/L. Positive Sars-Cov 2 antigen test. RT-PCR in progress. Implementation of a hydration program, antibiotic therapy with piperacillin / tazobactam and OFLOCET. ELIQUIS shutdown relayed by CALCIPARINE. Unfavorable evolution: 12 hours after his arrival, occurrence of hyperthermic peaks ($g 40 C) poorly tolerated on the cardiovascular and pneumological levels. Implementation of oxygen therapy. No indication for heavy resuscitation (collegial opinion). Rapid deterioration of the patient''s condition, lack of improvement in biological values, implementation of palliative care with sedation leading to the death of the patient on 01Apr2021. Conclusion: COVID-19 lung disease complicated by a bacterial pulmonary infection, acute renal failure in an 85-year-old patient, 16 days after a first injection of the COMIRNATY vaccine (batch ER2659). Rapidly unfavorable development leading to the death of the patient. The patient died on 01Apr2021. It was not reported if an autopsy was performed. Imputability (according to the method): I1 (dubious) for COMIRNATY RA: Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Therapy 1985; No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Acure renal insufficiency; Pulmonary bacterial infection; Pneumopathie COVID-19; Hepatic cytolysis in connection with Covid-19 impairment; Pneumopathie COVID-19


VAERS ID: 1250330 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood pressure measurement, Heart rate, Hot flush, Oxygen saturation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: XARELTO; CORDARONE; LASILIX [FUROSEMIDE]; RAMIPRIL; DIFFU K
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib (complete arrhythmia due to atrial fibrillation); Atrial tachycardia; Electric shock; Hypertension arterial; Tabaquism (active non-weaned smoking (COPD? not explored)
Allergies:
Diagnostic Lab Data: Test Date: 20210403; Test Name: BP; Result Unstructured Data: Test Result:108/65; Test Date: 20210403; Test Name: Heart rate; Result Unstructured Data: Test Result:68; Comments: /min; Test Date: 20210403; Test Name: O2 saturation; Test Result: 95 %
CDC Split Type: FRPFIZER INC2021431333

Write-up: reported back pain to her; Sudden death; notion of hot flash (sensation of heat); This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority numbers FR-AFSSAPS-PS20210758 and FR-AFSSAPS-2021037564. A 90-year-old female patient received bnt162b2 (COMIRNATY) (at 90 years of age), dose 1 intramuscular, administered in arm left on 03Apr2021 14:45 (Batch/Lot Number: EW2239) as a single dose for COVID-19 immunisation. Medical history included tabaquism (active non-weaned smoking (COPD? not explored)), complete arrhythmia due to atrial fibrillation (AFib), hypertension arterial and rapid atrial tachycardia (external electric shock in 2020). Concomitant medications included rivaroxaban (XARELTO), amiodarone hydrochloride (CORDARONE), furosemide (LASILIX [FUROSEMIDE]), ramipril (RAMIPRIL) and potassium chloride (DIFFU K), all taken for an unspecified indication, start and stop date were not reported. The patient had no history of Covid-19, she was not tested. She had no history of allergies. The patient experienced sudden death on 03Apr2021. It was reported that the patient got her 1st injection on 03Apr2021 at 2:45 p.m., she was vaccinated at home: somatic examination before vaccination without particularity, afebrile, saturation at 95, BP at 108/65, pulse at 68/min, no chest pain and no discomfort, monitoring 20 min after vaccination (nothing relevant). She was advised to take one gram of DOLIPRANE after vaccination. Description of the effect: according to the patient''s son notion of hot flash (sensation of heat) taking 1 g of DOLIPRANE (no information on the time of taking) then disappearance by the continuation of the sensations of heat; around 6:00 pm while talking to a friend, she reported back pain to her, then death. The patient accompanied the doctor to the door at around 3:05 p.m., i.e. 20 minutes after her vaccination. No information concerning the management of the patient after death. The outcome of "notion of hot flash (sensation of heat)" was recovered on 03Apr2021 while "reported back pain to her" was unknown; and therapeutic measure was taken for these events. The patient died on 03Apr2021. It was not reported if an autopsy was performed. No follow-up attempts needed. No further information expected, batch/lot number cannot be obtained.; Reported Cause(s) of Death: sudden death


VAERS ID: 1250331 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-04-05
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Malaise, 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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: CANDESARTAN; DESLORATADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial (Arterial hypertension under CANDESARTAN 4mg); Lymphoma; Pleurisy; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021431337

Write-up: Sudden death (patient with asystole, mydriasis, cyanosis, no gasp); Cardiac arrest; Malaise; This is a spontaneous report from a contactable pharmacist and physician downloaded from the Regulatory Authority (RA), regulatory authority number FR-AFSSAPS-PV20210791. A 70-year-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscular, administered in left arm on 31Mar2021 (Batch/Lot Number: ER9470) as 0.3 mL, single for COVID-19 vaccination; and levofloxacin hemihydrate (LEVOFLOXACINE ACCORD), oral from 25Mar2021 to 31Mar2021, at 500 mg, 1x/day, for bronchitis. Medical history included pleurisy, renal failure, arterial hypertension under CANDESARTAN 4mg, and lymphoma from an unknown date. Concomitant medication included candesartan taken for hypertension; and desloratadine taken for an unspecified indication. On 05Apr2021, an onset of malaise at 12:40 PM was reported. At 13:37, onset of cardiac arrest was experienced, the daughter called the Emergency medical services. At 1:51 PM, on arrival from the Emergency medical services: the patient is with asystole, mydriasis, cyanosis, no gasp. Resuscitation attempts include orotracheal intubation and self-filling balloon with unidirectional valve. Administration of 5 mg of adrenaline and 500 mL of crystalloids. Death of the patient was announced at 2:25 p.m. This was a sudden death on 05Apr2021 in a 70-year-old patient, with no identified cause. No autopsy was performed. It was also reported that initial declaration concerning the BNT162B2 vaccine administered 6 days previously. After analysis of the drug prescriptions found at home, identification of the dispensation 10 days previously of levofloxacin also added as a suspect drug. The outcome of cardiac arrest and malaise was unknown.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1250619 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (regulated under Diovan)
Allergies:
Diagnostic Lab Data: Test Name: arterial blood pressure; Result Unstructured Data: Test Result:up to 180 mmHg
CDC Split Type: GRPFIZER INC2021431497

Write-up: cardiac arrest; increased arterial pressure (up to 180 mmHg); Headache; Exhaustion; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number GR-GREOF-20212130 received from a Regulatory authority with report number GR-GREOF-20212130. An 87-year-old male patient received bnt162b2 (COMIRNATY; Batch/Lot Number was not reported), first dose on 01Mar2021 and second dose on 22Mar2021; both via an unspecified route of administration as single dose for covid-19 immunisation. Relevant Medical history included arterial hypertension (regulated under Diovan). The patient''s concomitant medications were not reported. After the first dose on an unspecified date, the patient presented with mild symptoms of exhaustion, increased arterial pressure (up to 180 mmHg) that was retreated with antihypertensive medication, and headache. After the second dose, these symptoms recurred on 22Mar2021, and were more intense. The patient died on 23Mar2021 (less than 24 hours since the vaccination). Patient''s cause of death was cardiac arrest. An autopsy was not performed. The events exhaustion, increased arterial pressure, and headache were reported as serious (death, medically significant). Sender Comment: initial report with additional information. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; exhaustion; increased arterial pressure; headache


VAERS ID: 1250620 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   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: DIOVAN; CHOLIB; MANYPER
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021431622

Write-up: Death; Loss of consciousness; Dysphoria; This is a spontaneous report from a contactable physician and a consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number GR-GREOF-20212149. This is a report received from the Regulatory Authority, with Regulatory authority report number GR-GREOF-20212149. A 75-years-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 31Mar2021 (Batch/Lot Number: Unknown) at SINGLE DOSE for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included oral valsartan (DIOVAN) taken for an unspecified indication, start and stop date were not reported; oral fenofibrate, simvastatin (CHOLIB) taken for an unspecified indication, start and stop date were not reported; oral manidipine hydrochloride (MANYPER) taken for an unspecified indication, start and stop date were not reported. On 04Apr2021 the patient felt dysphoria and lost his consciousness. The patient lost his consciousness when he was at home. An ambulance was called and within 20 minutes he was transferred to a health center. CPR was performed on him, in the ambulance and in the health center, but the patient did not revive. The reported events were death, loss of consciousness and dysphoria. The outcome of the adverse reactions was death on 04Apr2021. An autopsy was performed and results were not provided. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Loss of consciousness; death; Dysphoria


VAERS ID: 1250633 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: CARDIOASPIRIN; PROCORALAN; PERINDOPRIL; ZOFENOPRIL; ZYLORIC; METFORAL; DILATREND AP
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: IHD
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST in a 75-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included IHD on 01-Jan-2010 and Type 2 diabetes mellitus since 01-Jan-2010. Concomitant products included ACETYLSALICYLIC ACID (CARDIOASPIRIN), IVABRADINE HYDROCHLORIDE (PROCORALAN), PERINDOPRIL, ZOFENOPRIL, ALLOPURINOL (ZYLORIC), METFORMIN HYDROCHLORIDE (METFORAL) and CARVEDILOL (DILATREND AP) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 01-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIO-RESPIRATORY ARREST (seriousness criteria death and medically significant). The patient died on 01-Apr-2021. The reported cause of death was Cardio-respiratory arrest. It is unknown if an autopsy was performed. Action taken was not applicable. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. There was no treatment information provided; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1250635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-23
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Hypokalaemia, Hypothermia, Malaise, Pancreatitis acute, Renal failure, Retching, Urinary retention
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   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: LANOXIN; ELIQUIS; PLAUNAC; LASIX [FUROSEMIDE]; ZYLORIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Gallbladder removal; Gastric carcinoma; Heart disorder; Hypertension; Surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021431248

Write-up: Pancreatitis acute; kidney failure; hypotassemia; general malaise; widespread abdominal pain; urinary retention; retching; freezing body temperature; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-714980. A 92-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 01Mar2021 (Lot Number: EP9598) as single dose for COVID-19 immunization. Medical history included gastric carcinoma, surgery for gastric carcinoma from 1991 to 1991, removal of the gallbladder for stones from 1991 to 1991, hypertension, heart, NVAF. Concomitant medications included digoxin (LANOXIN) taken for the heart; apixaban (ELIQUIS) taken for prevention in patients with NVAF; olmesartan medoxomil (PLAUNAC) taken for hypertension; furosemide (LASIX [FUROSEMIDE]) taken for hypertension; allopurinol (ZYLORIC) taken for an unspecified indication; all start and stop dates were not reported. The patient experienced general malaise, abdominal pain, urinary retention, retching, freezing body temperature (hypothermia) on 23Mar2021 at about 4 o''clock. The patient also experienced Pancreatitis acute, kidney failure, "hypotassemia" on unspecified dates. The outcome of the events was fatal. The patient died on 24Mar2021. It was not reported if an autopsy was performed. Reporter''s comments: She was taking Lanoxin for the heart, Eliquis for prevention in patients with NVAF, Plaunac and Lasix for hypertension and Zyloric. In 1991 operated for gastric K and at the same time removal of the gallbladder for stones Description: Female, 92 years old, on 01Mar2021 she is vaccinated with Comirnaty, 1st dose; on 23Mar2021 at about 4 o''clock she first develops a general malaise, then abdominal pain, urinary retention, retching, hypothermia; hospitalized, she died on 24Mar2021. Comirnaty- 1st dose- batch EP9598- administered on 01Mar2021- Sender Comment: Severe ADR. She died on 24.03.2021, diagnosed with acute pancreatitis, renal failure, hypotassemia. No follow-up attempts needed. No further information expected.; Reporter''s Comments: She was taking Lanoxin for the heart, Eliquis for prevention in patients with NVAF, Plaunac and Lasix for hypertension and Zyloric. In 1991 operated for gastric K and at the same time removal of the gallbladder for stones; Reported Cause(s) of Death: Pancreatitis acute; kidney failure; hypotassemia; retching; widespread abdominal pain; urinary retention; freezing body temperature; general malaise


VAERS ID: 1250636 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: PROVISACOR; INCRUSE; REVINTY ELLIPTA; LOBIVON; COTAREG; XARELTO; GLUCOPHAGE [METFORMIN HYDROCHLORIDE]; LANOXIN
Current Illness: Vascular encephalopathy
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; COPD; Diabetes mellitus; Heart disease, unspecified; Hypercholesterolaemia; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021431411

Write-up: suspected ventricular fibrillation; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-715499. An 83-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Deltoid Left on 10Apr2021 09:44 (Lot Number: ET7205) as SINGLE DOSE for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease, heart disease, unspecified, atrial fibrillation, diabetes mellitus and hypercholesterolaemia from an unknown date and unknown if ongoing, ongoing chronic vascular encephalopathy and mini strock from 12Mar2017 to 12Mar2017. Concomitant medications included rosuvastatin calcium (PROVISACOR), umeclidinium bromide (INCRUSE), fluticasone furoate, vilanterol trifenatate (REVINTY ELLIPTA), nebivolol hydrochloride (LOBIVON), hydrochlorothiazide, valsartan (COTAREG), rivaroxaban (XARELTO), metformin hydrochloride (GLUCOPHAGE) and digoxin (LANOXIN); all taken for an unspecified indication, start and stop date were not reported. The patient experienced suspected ventricular fibrillation on 12Apr2021. The patient died on 12Apr2021 due to suspected ventricular fibrillation. The death was confirmed by the general practitioner at the patient''s home. The general practitioner was contacted by cohabitants, no decision is taken. Autopsy was requested. It was not reported if an autopsy was performed. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: suspected ventricular fibrillation


VAERS ID: 1250658 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-24
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: 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: LBPFIZER INC2021442492

Write-up: Died post vaccine; This is a spontaneous report from a contactable physician. This physician reported similar events for ten patients. This is one of ten reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration 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. On an unspecified date, the patient died post vaccine. It was not reported if an autopsy was performed. Follow-up attempts are completed; information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the available information, a possible contributory role of the subject vaccine cannot be excluded. However, there was no information provided regarding autopsy results, specific cause of death, complete medical history, co-morbid conditions, and concomitant medications, which does not allow a full assessment of the case. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : LB-PFIZER INC-2021442528 Same reporter, drug, and event; different patient;LB-PFIZER INC-2021442530 Same reporter, drug, and event; different patient;LB-PFIZER INC-2021442529 Same reporter, drug, and event; different patient;LB-PFIZER INC-2021442533 Same reporter, drug, and event; different patient;LB-PFIZER INC-2021442532 Same reporter, drug, and event; different patient;LB-PFIZER INC-2021442526 Same reporter, drug, and event; different patient;LB-PFIZER INC-2021442531 Same reporter, drug, and event; different patient;LB-PFIZER INC-2021442527 Same reporter, drug, and event; different patient;LB-PFIZER INC-2021424576 Same reporter, drug, and event; different patient; Reported Cause(s) of Death: Died post vaccine


VAERS ID: 1250659 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-24
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: 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: LBPFIZER INC2021442526

Write-up: death post vaccine; This is a spontaneous report from a contactable physician. This physician reported similar events for ten patients. This is the second of ten reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration 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. On an unspecified date, the patient died post vaccine. It was not reported if an autopsy was performed. Follow-up attempts are completed; information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the available information, a possible contributory role of the subject vaccine cannot be excluded. However, there was no information provided regarding autopsy results, specific cause of death, complete medical history, co-morbid conditions, and concomitant medications, which does not allow a full assessment of the case. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : LB-PFIZER INC-2021442492 Same reporter, drug and event; Reported Cause(s) of Death: died on an unspecified date post vaccine


VAERS ID: 1250660 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-24
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: 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: LBPFIZER INC2021442527

Write-up: Died post vaccine; This is a spontaneous report from a contactable physician. This physician reported similar events for ten patients. This is one of ten reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration 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. On an unspecified date, the patient died post vaccine. It was not reported if an autopsy was performed. Follow-up attempts are completed; information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the available information, a possible contributory role of the subject vaccine cannot be excluded. However, there was no information provided regarding autopsy results, specific cause of death, complete medical history, co-morbid conditions, and concomitant medications, which does not allow a full assessment of the case. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : LB-PFIZER INC-2021442492 Same reporter, drug, and event; different patient.; Reported Cause(s) of Death: Died post vaccine


VAERS ID: 1250661 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-24
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: 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: LBPFIZER INC2021442528

Write-up: died post vaccine; This is a spontaneous report from a contactable physician. This physician reported similar events for ten patients. This is one of ten reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient died post vaccine. It was not reported if an autopsy was performed. Follow-up attempts are completed; information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the available information, a possible contributory role of the subject vaccine cannot be excluded. However, there was no information provided regarding autopsy results, specific cause of death, complete medical history, co-morbid conditions, and concomitant medications, which does not allow a full assessment of the case. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : LB-PFIZER INC-2021442492 Same reporter, drug and event, different patient; Reported Cause(s) of Death: died on an unspecified date post vaccine


VAERS ID: 1250662 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-24
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: 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: LBPFIZER INC2021442529

Write-up: died post vaccine; This is a spontaneous report from a contactable physician. This physician reported similar events for ten patients. This is the fifth of ten reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiration date were not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient died post vaccine. 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 on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product Comirnaty as a cautionary measure and for reporting purposes. 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) : LB-PFIZER INC-2021442492 Same reporter, drug and event; different patient; Reported Cause(s) of Death: died post vaccine


VAERS ID: 1250689 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Malaise, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210217; Test Name: pyrexia; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Comments: Fever: 38 to 40.5 degrees Celsius
CDC Split Type: NLPFIZER INC2021431556

Write-up: Not feeling well; Fatigue; Fever: 38 to 40.5 degrees Celsius; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00496087. An 84-years-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Feb2021 (Batch/Lot Number: EJ6789) at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced not feeling well (malaise) on 16Feb2021, fatigue on 16Feb2021 and fever: 38 to 40.5 degrees celsius on 16Feb2021. The patient underwent lab tests and procedures which included pyrexia: 38 to 40.5 centigrade on 17Feb2021. Clinical outcome of the adverse events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: maliase; fatigue; pyrexia


VAERS ID: 1250693 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-11
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemoptysis, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   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: ESOMEPRAZOLUM; LERCANIDIPINE; PLANTAGO OVATA POWDER; AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021431597

Write-up: Unknown cause of death. She was a vital woman who suddenly fell dead while walking.; A small amount of clear blood withdrawn from the oral cavity post-mortum and during resuscitation. Could not detect a wound in the pharynx.; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB manufacturer report number NL-LRB-00507320. An 84 years old female patient received BNT162B2 (Comirnaty, solution for injection, lot number: ER7812) on 24Mar2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included esomeprazolum, lercanidipine, plantago ovata powder, amlodipine besilate, hydrochlorothiazide, valsartan (AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE).The patient received first dose of BNT162B2 on 14Feb2021 for Covid-19 immunisation. The patient experienced sputum bloody on 11Apr2021. It was reported that Sputum bloody has been treated with resuscitation, which was unsuccessful. After 7 minutes of wristless activity, non-shockable, the resuscitation was stopped. A small amount of blood has also been drawn out from the pharynx, a few milliliters. This again yielded several milliliters of blood. The patient died on 11Apr2021 for an unknown cause. Post-mortum there was also a remarkable amount of blood in the pharynx that was sucked out once more. This again yielded several milliliters of blood. The family denied permission for autopsy. Reporter comment : She was a vital woman who suddenly fell dead while walking. The family did not want an autopsy. They did not give permission for this. They did indicate that two other vital ladies in their mother''s ward had also died suddenly about two weeks after corona vaccination. A small amount of clear blood withdrawn from the oral cavity post-mortum and during resuscitation. Could not detect a wound in the pharynx. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: Unknown cause of death. She was a vital woman who suddenly fell dead while walking. The family did not want an autopsy. They did not give permission for this. They did indicate that in their mother''s ward two other vital ladies, about two; haemoptysi


VAERS ID: 1250694 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Extensive swelling of vaccinated limb, Fatigue, Headache, Malaise, Myalgia, Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: pyrexia; Result Unstructured Data: Test Result:Fever: 38 to 40.5 Centigrade
CDC Split Type: NLPFIZER INC2021431586

Write-up: Response at or around the injection site: extensive swelling of vaccinated limb; Reaction at or around the injection site: redness; Reaction at or around the injection site: pain; Nausea; Myalgia; Fever: 38 to 40.5 degrees Celsius; Cold shivers; Not feeling well; Pain in the joints; Headache; Fatigue; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority (RA) NL-LRB-00507502. A 44-years-old male patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had no previous COVID-19 infection. On 10Apr2021 the patient experienced extensive swelling of vaccinated limb, redness at or around the injection site, pain at or around the injection site, nausea, myalgia, fever: 38 to 40.5 degrees celsius, cold shivers, not feeling well, pain in the joints, headache and fatigue. The patient underwent lab tests and procedures which included body temperature at 38 to 40.5 centigrade on 10Apr2021. All the events were reported to have been fatal and the events extensive swelling of vaccinated limb, vaccination site redness and vaccination site pain were also assessed life-threatening (as reported). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Vaccination site erythema; Vaccination site pain; Nausea; Myalgia; Fever; cold shivers; not feeling well; pain in the joints; headache; Fatigue; extensive swelling of vaccinated limb


VAERS ID: 1250695 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-17
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Delirium, Drug ineffective, Feeding disorder, Fluid intake reduced, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pulmonary function test, SARS-CoV-2 test, Urine analysis, Ventilation/perfusion scan
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   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: Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (disease symptoms: hospitalization)
Allergies:
Diagnostic Lab Data: Test Date: 20210217; Test Name: Oxygen dropped; Result Unstructured Data: Test Result:dropped; Test Name: LUNG EXAMINATION; Result Unstructured Data: Test Result:unknown results; Test Date: 20210217; Test Name: corona, confirmed with test; Test Result: Positive ; Test Name: Urine examination; Result Unstructured Data: Test Result:unknown results; Test Name: Lung scan; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021431581

Write-up: He died on 22Feb; Apparently pneumonia; Oxygen dropped; couldn''t eat anymore; He had silent delirium and was absent; couldn''t drink anymore; Tested positive for corona on 17Feb2021; Drug ineffective; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Medicines Agency (MA) -WEB NL-LRB-00507869. A 72-years-old male patient received BNT162B2 (Pfizer-vaccine), dose 1 via an unspecified route of administration on 29Jan2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing dementia, covid-19 from Mar2020 to an unknown date (disease symptoms: hospitalization). The patient''s concomitant medications were not reported. The patient died on 22Feb2021; patient experienced oxygen dropped (oxygen saturation decreased) (death) on 17Feb2021, couldn''t eat anymore (feeding disorder) (death) on 17Feb2021 , he had silent delirium and was absent (delirium) (death) on 17Feb2021, couldn''t drink anymore (fluid intake reduced) (death) on 17Feb2021, tested positive for corona on 17feb2021 (covid-19) (death) on 17Feb2021, drug ineffective (drug ineffective) (death) on 17Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 17Feb2021, urine analysis unknown results on an unspecified date, ventilation/perfusion scan unknown results on an unspecified date, pulmonary function test unknown results on an unspecified date, oxygen saturation dropped on 17Feb2021. Therapeutic measures were taken as a result of oxygen dropped (oxygen saturation decreased), couldn''t eat anymore (feeding disorder), he had silent delirium and was absent (delirium), couldn''t drink anymore (fluid intake reduced) , tested positive for corona on 17feb2021 (covid-19). The patient died on 22Feb2021, cause of death was also reported as apparently pneumonia. It was not reported if an autopsy was performed. The clinical course was reported as follows: "This serious spontaneous report from a consumer or other non-health professional concerns a male aged 72 years, with death nos (death), Covid 19 (death), hypoactive delirium (death), unable to eat (death), oxygen saturation decreased (death), fluid intake reduced (death) following administration of covid-19 vaccine pfizer (Injection fluid) (action taken: not applicable) for Covid 19 immunisation. Treatment: on 18Feb2021 Covid 19 is treated with mechanical ventilation, on 18Feb2021 fluid intake reduced is treated with mechanical ventilation, on 18Feb2021 hypoactive delirium is treated with mechanical ventilation, on 18Feb2021 oxygen saturation decreased is treated with mechanical ventilation and on 18Feb2021 unable to eat is treated with mechanical ventilation. The outcome of Covid 19 is fatal, the outcome of death nos is fatal, the outcome of fluid intake reduced is fatal, the outcome of hypoactive delirium is fatal, the outcome of oxygen saturation decreased is fatal and the outcome of unable to eat is fatal. Drugs and latency: 1. Covid-19 vaccine pfizer (Injection fluid), death nos: 22 days after start, Covid 19: 19 days after start, hypoactive delirium: 19 days after start, unable to eat: 19 days after start, oxygen saturation decreased: 19 days after start, fluid intake reduced: 19 days after start. Concomitant medication: non specified drug. Medical history Covid 19, dementia. Additional information ADR: After vaccination on 29Jan2021 he was feeling well. He got fitter than before. Suddenly on 17Feb2021, he collapsed on. On 18Feb2021 - artificial respiration. He had silent delirium and was absent - could no longer eat and drink. Oxygen dropped. He had already had Corona in March and was quarantined for it. He never had a cold and had no complaints when he had corona last year. BSN available: yes. Confounding factors: dementia. Previous COVID-19 infection: disease symptoms: hospitalization. Other: diagnostic procedures: They examined lungs and a urine and did lung scan. Pfizer vaccine LOT number: UNKNOWN. Reporter Comment: Past drug therapy BioNTech/Pfizer vaccin : no. 22Feb died. Additional information ADR: After vaccination on 29Jan2021 he was feeling well. He got fitter than before. Suddenly on 17Feb2021, he collapsed on. On 18Feb2021 - artifical respiration. He had silent delirium and was absent - could no longer eat and drink. Oxygen dropped. He had already had Corona in March and was quarantined for it. He never had a cold and had no complaints when he had corona last year. BSN available: yes. Confounding factors: dementia. Previous COVID-19 infection: disease symptoms: hospitalization. Other: diagnostic procedures: They examined lungs and a urine and did lung scan. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Apparently pneumonia; Hypoactive delirium; Fluid intake reduced; COVID-19; Drug ineffective; Death NOS; Oxygen saturation decreased; Unable to eat


VAERS ID: 1250696 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOL [PANTOPRAZOLE]; SIMVASTATINE; AMLODIPINE; ASCAL CARDIO; IRBESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (hospitalization)
Allergies:
Diagnostic Lab Data: Test Date: 20201210; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021431090

Write-up: Not feeling well; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The Regulatory Authority report number is NL-LRB-00508181. A 79-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: ER7812 and expiration date not reported), via an unspecified route of administration on 26Mar2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19 from 10Dec2020 which required hospitalization. Concomitant medications included pantoprazole (PANTOPRAZOL); simvastatine; amlodipine; carbasalate calcium (ASCAL CARDIO); and irbesartan. The patient took the first dose of BNT162B2 (COMIRNATY) on 19Feb2021 for COVID-19 immunisation and experienced Slightly stiff arm. The patient experienced not feeling well on 27Mar2021. The patient underwent lab tests and procedures which included corona, confirmed with test which was positive on 10Dec2020. The patient died on an unspecified date due to the event. 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: Not feeling well


VAERS ID: 1250697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-04-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker; Vascular disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021431103

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB. The regulatory authority report number is NL-LRB-00508570. A 76-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number ET9096), via an unspecified route of administration on 11Apr2021 at a single dose for covid-19 immunization. Medical history included smoker and, vascular disorder. The patient has no previous covid-19 infection. The patient''s concomitant medication was reported as "covid-19 vaccine unspecified" (pending clarification). The patient experienced death after 2 days, on 13Apr2021, following the administration of covid-19 vaccine Pfizer injection. The patient died on 13Apr2021. It was unknown if an autopsy was performed. Case summary and reporter comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): No. Death. Additional information ADR: 1 to 2 days after vaccination. Confounding factors: smoker, vascular disorder. Previous COVID-19 infection: No. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): No. Death. Additional information ADR: 1 to 2 days after vaccination. Confounding factors: smoker, vascular disorder. Previous COVID-19 infection: No.; Reported Cause(s) of Death: death


VAERS ID: 1250700 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-09
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute cardiac event, Chronic obstructive pulmonary disease, Dyspnoea, Pulmonary embolism, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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: RISPERIDONE; SEREVENT; MOVICOLON; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021431099

Write-up: respiratory insufficiency; acute cardiac event; lung embolism; exacerbation of chronic obstructive pulmonary disease; acute dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00508880. An 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 28Jan2021 as SINGLE DOSE for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). The patient had no previous COVID-19 infection. Concomitant medications included risperidone; salmeterol xinafoate (SEREVENT); macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON); and salbutamol (SALBUTAMOL). On 09Feb2021, 12 days after start, the patient experienced acute dyspnoea. On an unspecified date, the patient experienced respiratory insufficiency, lung embolism, and acute cardiac event. The patient died on 11Feb2021. Patient had a symptomatic policy so no further investigations were done, which resulted in a difficulty to find out the cause of death. Cause of death according to reporter was respiratory insufficiency due to lung embolism or acute cardiac event or exacerbation of chronic obstructive pulmonary disease. It was not reported if an autopsy was performed. The events acute dyspnoea and respiratory insufficiency resulted to fatal outcome while outcome of lung embolism, acute cardiac event, and exacerbation of chronic obstructive pulmonary disease was unknown. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty): Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Acute dyspnoea: Additional information adverse drug reaction: A few days after vaccination severe shortness of breath, but also Chronic obstructive pulmonary disease in history COVID-19: Previous COVID-19 infection: No. Other: diagnostic procedures: Due to symptomatic policy, no additional research was performed, so that the cause of death cannot be properly determined No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty): Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Acute dyspnoea: Additional information adverse drug reaction: A few days after vaccination severe shortness of breath, but also Chronic obstructive pulmonary disease in history COVID-19: Previous COVID-19 infection: No. Other: diagnostic procedures: Due to symptomatic policy, no additional research was performed, so that the cause of death cannot be properly determined; Reported Cause(s) of Death: respiratory insufficiency; acute dyspnoea


VAERS ID: 1250701 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE; CIPRALEX [ESCITALOPRAM]; EBIXA; PANODIL; DIVISUN; VIMOVO; SOBRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Anxious depression; Back pain; Living in nursing home; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:Established a large cerebral bleed in right...; Comments: Established a large cerebral bleed in right hemisphere. No trauma/head injury registered before the incidence. Prognosis evaluated as poor and decision to start palliative care.
CDC Split Type: NOPFIZER INC2021431179

Write-up: CEREBRAL HEMORRHAGE; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number NO-FHI-2021-Uxz1p2. A 70-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: EJ6136), second dose 2 intramuscular, administered in Arm Left on 28Jan2021 at 13:00, single for covid-19 immunisation. Medical history included Alzheimer''s disease from an unknown date, living in residential institution from 2017; Anxious depression, vitamin d deficiency, back pain, all from an unknown date. The patient had previously received the first dose of bnt162b2 (COMIRNATY) for covid-19 immunisation, batch unknown on an unknown date. Concomitant medications included codeine taken for back pain from 28Jan2021 to 04Feb2021; escitalopram (CIPRALEX) taken for depression from 08Oct2020 to 04Feb2021; memantine hydrochloride (EBIXA) taken for dementia from 30Jan2018 to 04Feb2021; paracetamol (PANODIL) taken for back pain from 09Jun2020 to 04Feb2021; colecalciferol (DIVISUN) taken for vitamin d deficiency from 11Oct2018 to 04Feb2021; esomeprazole magnesium, naproxen (VIMOVO) taken for back pain from 08Oct2020 to 04Feb2021; oxazepam (SOBRIL) taken for anxiety from 09Jun2020 to 04Feb2021. The patient experienced cerebral hemorrhage on 05Feb2021. The patient underwent lab tests and procedures which included computerised tomogram head on 05Feb2021: Established a large cerebral bleed in right hemisphere, no trauma/head injury registered before the incidence, prognosis evaluated as poor and decision to start palliative care. The patient died on 08Feb2021. It was not reported if an autopsy was performed. The a regulatory authority has assessed the causal relationship between the suspect product and the event as Possible. The case was considered to be Serious.; Reported Cause(s) of Death: Cerebral hemorrhage


VAERS ID: 1250707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Asthenia, Blood glucose, Blood glucose increased, Blood pressure increased, COVID-19, Cardiac arrest, Chills, Circulatory collapse, Delirium, Dizziness, Drug ineffective, Electrocardiogram, Fall, Fatigue, Feeling cold, Loss of consciousness, Malaise, Mean arterial pressure, Oedema, Oxygen saturation, Pyrexia, Respiratory disorder, Respiratory failure, SARS-CoV-2 test, Shock, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood glucose; Result Unstructured Data: Test Result:154; Comments: 154 mg%; Test Name: ECG; Result Unstructured Data: Test Result:Asystole; Test Name: arterial pressure; Result Unstructured Data: Test Result:60; Comments: 60 min/Hg; Test Name: saturation; Test Result: 30 %; Test Date: 20210322; Test Name: sars-cov-2-test; Test Result: Positive
CDC Split Type: PLPFIZER INC2021436270

Write-up: general weakness; dizziness; fatigue/getting tired quickly; malaise; extreme drowsiness; fever deepening day by day; unexpected loss of consciousness; sudden fall/falling from bed while sleeping; fainting; disturbances of consciousness; delirium; periodic blood pressure increase; circulatory failure; respiratory failure; short, noisy breathing; shock; edema; increased glucose 154mg%; cardiac arrest/sudden cardiac arrest (SCA)/asystole; COVID-19 virus identified/showed a positive result; COVID-19 virus identified/showed a positive result; chills; feeling of cold; This is a spontaneous report from a contactable consumer (patient''s spouse). The consumer reported similar events for two patients. This is the first of two reports. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 10Mar2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Mar2021, the patient experienced symptoms suggesting a cold: chills, a feeling of bitter cold, and on an unspecified date in the following days general weakness, dizziness, fatigue, malaise, extreme drowsiness, fever deepening day by day, "snap", quick fatigue, additional unexpected loss of consciousness, sudden falls, fainting one of which ended with a pollutant (X-ray examination was not performed in the hospital due to the lack of, according to the statement of the paramedic of the COVID-surgical department) as well as falling from bed while sleeping, impaired consciousness and delirium, intermittent increases in blood pressure, and eventually circulatory and respiratory failure with short, noisy breathing, unconsciousness and ultimately cardiac arrest. The ambulance service stated the following symptoms: shock, SCA, edema, fainting, increased glucose 154mg%, saturation 30%, arterial pressure 60min / HG, EKG (asystole). The test carried out on 22Mar2021 COVID-19 virus identified showed a positive result. The reporter consider the numerous symptoms shown above as side effects of vaccination because they occurred at the same time after vaccination, which is no coincidence, they were identical in the initial stage of the disease, and in the case of my spouse they led to his death. In the reporter''s opinion, the system of qualifying patients for vaccination is flawed because, on the basis of top-down orders, it is based only on the prescribing physician asking a few basic questions to which the patient answers. There is no question that every patient has the right genetic testing before immunization, which is no lie. The result is that many patients who are already infected without knowing it are vaccinated and thus end their lives. The vaccinated and infected organism cannot cope with mutating the virus. The patient died on an unspecified date due to the events. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-2021436364 same reporter/vaccine, similar events, different patient.; Reported Cause(s) of Death: increased glucose 154mg%; unexpected loss of consciousness; sudden fall/falling from bed while sleeping; fainting; disturbances of consciousness; delirium; periodic blood pressure increase; circulatory failure; respiratory failure; short, noisy breat


VAERS ID: 1250708 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW 8904 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Dyspnoea, Fall, Hypotonic-hyporesponsive episode, Loss of consciousness, Presyncope
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), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: SYMTREND; ACARD; PRESTARIUM [PERINDOPRIL]; FUROSEMID; MONONIT; ATORIS
Current Illness: Arterial hypertension; Atherosclerosis of arteries of the extremities; Chronic heart failure; Coronary heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction (In 1998 and in 2005)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021431216

Write-up: Fall; Loss of consciousness; Hypotonic-hyporesponsive episode; Apnoea; Dyspnoea; Presyncope; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PL-URPL-3-510-2021. A 75 year old male patient received the second dose of bnt162b2 (COMIRNATY; Lot Number: EW 8904; Expiration Date: 07Jul2021), intramuscular, at the age of 75 years, administered on the left arm on 01Apr2021 10:00 at 0.3 mL, single for covid-19 immunisation. Medical history included ongoing cardiac failure chronic, myocardial infarction from an unknown date and unknown if ongoing, ongoing coronary artery disease, ongoing hypertension and ongoing peripheral arterial occlusive disease. Concomitant medications included carvedilol (SYMTREND) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ACARD) taken for an unspecified indication, start and stop date were not reported; perindopril (PRESTARIUM [PERINDOPRIL]) taken for an unspecified indication, start and stop date were not reported; furosemide (FUROSEMID) taken for an unspecified indication, start and stop date were not reported; isosorbide mononitrate (MONONIT) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORIS) taken for an unspecified indication, start and stop date were not reported. The following was noted on the post-vaccination adverse reaction report form: Hypotonic-hyporesponsive episode with loss of consciousness with apnea, Fall, Dyspnoea and Presyncope on 01Apr2021 at 20:30. On 01Apr2021, approx. at 8:30 PM returning from family celebrations (from his son) in the car, he felt faint and sudden breathlessness. Entering the apartment, he fainted. He collapsed in the hallway. An ambulance was called but patient was found dead. The family claims that the patient did not take alcohol after the vaccination, and that an autopsy will not be performed. The patient died on 01Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fall; Loss of consciousness; Hypotonic-hyporesponsive episode; Apnea; Dyspnea; Presyncope


VAERS ID: 1250710 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute pulmonary oedema, Aphasia, Blood creatinine, Cerebrovascular accident, Chronic kidney disease, Hemiplegia, Loss of personal independence in daily activities, Pneumonia, Purpura, Seizure, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 46
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: Creatinine; Result Unstructured Data: Test Result:4.5
CDC Split Type: PTPFIZER INC2021431194

Write-up: Symptoms suggestive of stroke (aphasia, seizure and hemiplegia); aphasia; seizure; hemiplegia; worsening of chronic renal failure (creatinine of 4.5); Urticarial purpura; Sepsis; Acute chronic renal failure; Bilateral pneumonia; Acute lung edema/ acute pulmonary edema; patient became dependent for his daily activities; This is a spontaneous report downloaded from the Medicines Agency (MA) -WEB [PT-INFARMED-B202104-143]. A 96-year-old male patient received bnt162b2 (Pfizer vaccine, Lot Number: EP9598), first dose intramuscular on 18Feb2021, 0.3 mL, single for covid-19 immunisation. The patient''s medical history was not reported. The patient is taking an unspecified chronic medication. No known allergic history. On 26Feb2021, the patient was hospitalized due to urticarial purpura, acute lung edema, bilateral pneumonia, sepsis and acute chronic renal failure. At the time of discharge, the purpura was resolved. However, the patient became dependent for his daily activities. Specific treatment to reverse the ADR with corticosteroid and antibiotic. The patient was hospitalized for approximately 1 month. One week later, (02Apr2021) the patient was admitted to hospital again with symptoms suggestive of stroke (aphasia, seizure and hemiplegia), complicated by pneumonia, sepsis, worsening of chronic renal failure (creatinine of 4.5) and acute pulmonary edema. The patient was hospitalized with a poor prognosis. Twelve days later (14Apr2021), the patient died. Outcome of the events was fatal. Relatedness of drug to reaction(s)/event(s) for event Purpura: Source of assessment: Notifier; Method of assessment: Unknown; Result of Assessment: Probable.; Reported Cause(s) of Death: patient became dependent for his daily activities; aphasia; seizure; hemiplegia; worsening of chronic renal failure (creatinine of 4.5); Urticarial purpura; Sepsis; Symptoms suggestive of stroke (aphasia, seizure and hemiplegia); Acute chronic renal


VAERS ID: 1250711 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVODOPA/CARBIDOPA; VENTILAN [SALBUTAMOL SULFATE]; ACETYLSALICYLIC ACID; DONEPEZIL; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Dementia; Transient ischaemic attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021431134

Write-up: Sudden cardiac death; This is a spontaneous report from a contactable nurse, the patient''s daughter, downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PT-INFARMED-F202104-1259. A 93-year-old male patient received the first dose of bnt162b2 (COMIRNATY; Lot Number: ER9470), intramuscular on 25Mar2021 at 0.3 mL, single for covid-19 immunisation. Medical history included dementia, transient ischaemic attack and asthma; all from an unknown date and unknown if ongoing. In addition, it was referred history of debilitated health and edema due to probable cardiac insufficiency. The patient had no prior history of adverse reactions to other drugs. Concomitant medications included carbidopa, levodopa (LEVODOPA/CARBIDOPA) taken for dementia, start and stop date were not reported (started recently with low response to treatment, although patient more calm); salbutamol sulfate (VENTILAN [SALBUTAMOL SULFATE]) inhaler taken as needed for asthma, start and stop date were not reported; acetylsalicylic acid (ACETYLSALICYLIC ACID) 100mg taken for transient ischaemic attack, start and stop date were not reported; donepezil (DONEPEZIL) 5mg taken for dementia, start and stop date were not reported (started recently); atorvastatin (ATORVASTATIN) 10mg taken for transient ischaemic attack, start and stop date were not reported. The patient experienced morte sudden cardiac death on 28Mar2021. There was no suspicion of drug interaction. The patient died on 28Mar2021. An autopsy was not performed. The reported cause of death was heart attack. No follow-up attempts are possible. No further Information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1250718 (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: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Dysphagia, General physical health deterioration, Parkinson's disease, Productive cough
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (narrow), 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), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Dysphagia; Parkinson''s disease; Productive cough
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021431257

Write-up: Clinical diagnosis of expected death in progressive Mb Parkinson''s; Aggravated dysphagia; Aggravation in cough, mucous formation; Reduction in general condition; Reduced underlying condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number SE-MPA-2021-025439. A 71-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on Jan2021 (lot number: EJ6134) as single dose for COVID-19 immunisation. Medical history included dementia, dysphagia, productive cough , and parkinson''s disease; all were ongoing. The patient''s concomitant medications were not reported. Reported suspect adverse events were condition aggravated: dysphagia, productive cough and reduced general condition on Jan2021. The woman has had Parkinson''s for several years with a progressive deterioration in motor skills and cognition. In the last six months added dysphagia, productive cough. Due to the deterioration, the woman received a nasogastric tube six days after the vaccination, which also worked for nutrition. The nasogastric tube stopped working in mid March and a new one could not be inserted. Thereafter, it was judged fruitless with further active treatment measures. The woman died 71 days after vaccination with Comirnaty. Report assessed as serious, death. No autopsy will be performed. Clinical diagnosis of expected death in progressive Mb Parkinson''s. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Clinical diagnosis of expected death in progressive Mb Parkinson''s.


VAERS ID: 1250720 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FURIX [FUROSEMIDE]; CANDESARTAN KRKA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Dilated cardiomyopathy; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021431228

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-026702. An 89-year-old male patient received bnt162b2 (COMIRNATY), second dose via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included dilated cardiomyopathy from an unknown date and unknown if ongoing, hypertension, cardiac failure from an unknown date to an unknown date. Concomitant medications included furosemide (FURIX) and candesartan cilexetil (CANDESARTAN KRKA); both taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 immunisation and no adverse event was experienced. The patient experienced cardiac arrest on Apr2021. According to the reporter, the man, after the second dose of the vaccination with Comirnaty, collapsed on the way home and lost consciousness. An ambulance that was on site within a few minutes found a cardiac arrest. The first analysis showed ventricular fibrillation and the man was defibrillated a total of three times on the way to the hospital. A relative who was present did not describe any symptoms in the man before the incident. The man did not complain of any symptoms and had felt well the days before. In the emergency room, the man regained spontaneous circulation afterabout 45 minutes of CPR with Cardiopulmonary Assist System, (a chest compression system) but never regained consciousness or his own breathing. When the prospects for recovery with or without intensive care were assessed non-existent, all measures were terminated and the man died. The patient died on Apr2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1250721 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Lung infiltration, SARS-CoV-2 test, X-ray
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), 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: 0000-00-00
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:
Current Illness: Rheumatoid arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Cognitive disorder; Pneumonitis; Progressive multifocal leukoencephalopathy; Radiation therapy (Due to breast cancer); Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Name: X-ray; Result Unstructured Data: Test Result:lung changes as in viral infection; Test Name: Body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Comments: Fever; Test Name: CRP; Result Unstructured Data: Test Result:130; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021431255

Write-up: Lung complication (lung changed as in virus infection); This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number SE-MPA-2021-026761. A 79-year-old female patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on Mar2021 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis, ulcerative colitis and cognitive disorder; suspected pneumonitis 20 years ago when treated with methotrexate, previous radiotherapy due to breast cancer may have been a contributing factor; PML (progressive multifocal leukoencephalopathy) after 2 infusions of rituximab (MABTHERA) in 2008, the reporter stated survived, but got cognitive disorder and fell ill with ulcerative colitis (extremely unusual because of the age). The patient''s concomitant medications were not reported. The patient experienced lung complication (lung changed as in virus infection) on Apr2021. Suspect adverse event was also reported as lung disorder (lung changes as in viral infection). The woman was in poor condition, fragile and has been strictly quarantined throughout the pandemic. COVID-19 virus test performed has been negative. The woman was vaccinated with her first dose of BNT162B2 at the end of March 2021. The day after the vaccination, the woman had a cough, wheezy breathing and after a few more days she had a fever of 38.6 degrees. The woman arrived at the emergency room and was admitted to the hospital. CRP (C-reactive protein) 130, X-ray showed lung changes as in viral infection. The woman died 17 days after the vaccination with BNT162B2 (2021). Report was assessed as serious, death. The outcome of the event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Lung complication (lung changed as in virus infection)


VAERS ID: 1250726 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Dehydration, Dyspnoea, General physical health deterioration, Hypoperfusion, Transient ischaemic attack
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS; IMDUR; VENTOLINE [SALBUTAMOL]; BISOPROLOL ORIFARM; SERETIDE EVOHALER
Current Illness: Asthma; Cardiac failure; Hypertension; Macular degeneration; Paroxysmal atrial fibrillation; Renal failure
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarct
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:Nothing new
CDC Split Type: SEPFIZER INC2021431300

Write-up: TIA; Breathing difficult; general physical health deterioration; hypoperfusion; dehydration; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number SE-MPA-2021-027221. A 97-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on Feb2021 (Lot Number: EP2163) as single dose for covid-19 immunisation. Medical history included cardiac failure, renal failure, macular degeneration, paroxysmal atrial fibrillation, hypertension, and asthma, all ongoing from an unknown date; and myocardial infarction from an unknown date (not ongoing). Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication from 19Sep2017 to an unspecified stop date; isosorbide mononitrate (IMDUR) taken for an unspecified indication from 01May2016 to an unspecified stop date; salbutamol (VENTOLINE) taken for an unspecified indication, start and stop date were not reported; bisoprolol fumarate (BISOPROLOL ORIFARM) taken for an unspecified indication from 11Apr2016 to an unspecified stop date; fluticasone propionate, salmeterol (SERETIDE EVOHALER) taken for an unspecified indication, start and stop date were not reported. The patient experienced TIA (transient ischaemic attack) in Mar2021. Clinical course was reported as follows. Reported suspected adverse event was transient ischaemic attack (TIA). Vaccination in Feb2021 with first dose. In Mar2021, the patient had a suspected TIA with onset 14 days after the vaccination, the patient arrived at the hospital with weakness in his right arm and had collapsed. The reporter wrote: hypoperfusion, dehydration? Nothing new on CT. The man''s general condition deteriorated and he died about a week later. Submitted causes of death were TIA, breathing difficulties and general physical health deterioration. Outcome of the events hypoperfusion, dehydration was unknown; while for the rest of the events was fatal. Report assessed as serious, death. The patient died on an unspecified date. It was unknown if autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: TIA; Breathing difficult; General physical health deterioration


VAERS ID: 1255787 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: Comments: The patient was very healthy
Allergies:
Diagnostic Lab Data:
CDC Split Type: VNJNJFOC20210435630

Write-up: DEATH; BLOOD COAGULATION; This spontaneous report received from a consumer concerned a 21 year old male. The patient''s weight, height, and medical history were not reported. It was noted the patient was very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, Expiry :UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported . Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in 2021, the patient developed blood coagulation, reported as "the vaccine caused blood coagulation". The patient subsequently died 10 days after vaccination; the cause of death was not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the event blood coagulation was not provided. The patient died on an unspecified date 10 days after vaccination. This report was serious (Death and Other Medically Important Condition).; Sender''s Comments: V0: This 21-year-old male patient was reported in social media to have developed "blood coagulation" after an unspecified duration of receiving COVID-19 VACCINE AD26.COV2.S. The patient died from an unspecified cause 10 days after vaccination. No other details was reported. Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information will be requested for further assessment once contact information is available.; Reported Cause(s) of Death: DEATH


VAERS ID: 1257482 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021442219

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 535669. A 94-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced adverse event following immunisation on 10Apr2021 with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1257483 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444534

Write-up: Unresponsive to stimuli; This is a spontaneous report from a contactable other health professional via the Medical Administration . Regulatory authority report number is 535872. An 80-year-old female patient received BNT162B2 (Pfizer vaccine) at single dose via an unknown route on an unknown date for COVID-19 immunisation. Medical history and concomitant drug were not provided. Patient experienced reaction of unresponsive to stimuli. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unresponsive to stimuli


VAERS ID: 1257484 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Disease progression
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444535

Write-up: disease progression; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number / TGA ADR# is 536304. An 86-year-old male patient BNT162B2 (COMIRNATY) at single dose via an unknown route on an unknown date for COVID-19 immunisation. Medical history and concomitant drug were not provided. Patient experienced Reaction Disease progression on 01Apr221. "Onset Time in Days" was reported as "1 days". Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: disease progression


VAERS ID: 1257485 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-11
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444541

Write-up: fall; myocardial infarction; This is a spontaneous report from a contactable other healthcare professional (HCP), received from the Agency Regulatory Authority. The regulatory authority report number is 538583. An 88-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 11Apr2021, the patient experienced fall and myocardial infarction, which both led to death. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: fall; myocardial infarction


VAERS ID: 1257486 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-06
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Cardiac arrest, Dyspnoea, Pulmonary embolism, Sepsis, Vomiting
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444547

Write-up: Cardiac arrest; Pulmonary embolism; Sepsis; Abdominal pain; Dyspnoea; Vomiting; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 538825. A 40-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest, pulmonary embolism, sepsis, abdominal pain, dyspnoea, vomiting on 06Apr2021. The patient died in Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: cardiac arrest; pulmonary embolism; sepsis; abdominal pain; dyspnoea; vomiting


VAERS ID: 1257487 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
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: AUPFIZER INC2021444548

Write-up: Adverse event following immunisation with fatal outcome; This is a spontaneous report from a contactable other health professional via the Administration. Regulatory authority report number is 539580. A 87-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced adverse event following immunisation with fatal outcome on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Adverse event following immunisation with fatal outcome


VAERS ID: 1257534 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Fatigue, Hyperglycaemia, Vision blurred
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULATARD [INSULIN HUMAN INJECTION, ISOPHANE]; VALSACOR; PREDNISON; MYFORTIC; FUROLIN; ACTRAPID; RILMENIDINE DIHYDROGEN PHOSPHATE; LANZUL; DETRALEX; NEURONTIN; ADVAGRAF; KAPIDIN; BETALOC [METOPROLOL TARTRATE]; VIGANTOL [COLECALCIFEROL]
Current Illness: Bee sting hypersensitivity (bee sting (swelling)); Chronic kidney disease; Enterorrhagia (due to diverticulum and hemorrhoids (colonoscopy finding)); IgA nephropathy (verified biopsically); Penicillin allergy (reaction - swelling); Secondary hypertension; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Abscess operations; Cholecystectomy (laparoscopy); Diverticulum ((colonoscopy finding)); Engraft failure; Finger amputation (last part of 2nd finger on the right hand due to trauma); Hemorrhoids ((colonoscopy finding)); Kidney transplant (from deceased donor); Urosepsis; Zona (on the chest)
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: Blood glucose; Result Unstructured Data: Test Result:7.2 mmol/L; Comments: after using insulin; Test Date: 20210315; Test Name: Blood glucose; Result Unstructured Data: Test Result:20 mmol/L
CDC Split Type: CZPFIZER INC2021399133

Write-up: blood glucose increased (20 mmol/l); cloudy vision; fatigue; This is as spontaneous report downloaded from the EudraVigilance-WEB. The regulatory authority report number CZ-CZSUKL-21003267 A contactable pharmacist reported that a male patient received the second dose of bnt162b2 (COMIRNATY, lot number: ET1831), intramuscular on 15Mar2021 (Batch/Lot Number: ET1831) as a single dose for COVID-19 immunization. Medical history included cholecystectomy (laparascopy), surgery of rectal abscess, zona on the chest, urosepsis, finger amputation (last part of 2nd finger on the right hand due to trauma) all from an unknown date. The patient also has penicillin allergy with a reaction of swelling, Type II diabetes mellitus, IgA nepropathy verified biospically, allergy to insect sting (bee sting, swelling), chronic kidney disease, secondary hypertension and enterorrhagia due to diverticulum and hemorrhoids (colonoscopy finding) all from an unknown date and ongoing. The patient had a kidney transplant on May2008 from a deceased donor and engraft failure on Mar2014. Concomitant medications included insulin human injection, isophane (INSULATARD [INSULIN HUMAN INJECTION, ISOPHANE]); valsartan (VALSACOR); prednisone (PREDNISON); mycophenolate sodium (MYFORTIC); nitrofurantoin (FUROLIN); insulin (ACTRAPID); rilmenidine dihydrogen phosphate (RILMENIDINE DIHYDROGEN PHOSPHATE); lansoprazole (LANZUL); diosmin, hesperidin (DETRALEX); gabapentin (NEURONTIN); tacrolimus (ADVAGRAF); lercanidipine hydrochloride (KAPIDIN); metoprolol tartrate (BETALOC [METOPROLOL TARTRATE]); colecalciferol (VIGANTOL [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported. On the day of vaccination on 15Mar2021, in the evening, the patient experienced glycemia as blood glucose increased to 20 mmol/l, usually it is 8 mmol/l, so he took insulin and glycemia decreased to 7.2 mmol/l. The patient also experienced cloudy vision and was sent to an ophthalmologist and fatigue. The patient received Actrapid and Insulatard as treatment for the events (as reported). The outcome of the events was unknown. The events ''blood glucose increased (20 mmol/l)'' and ''cloudy vision'' were reported as medically significant. No follow-up attempts possible. No further information expected.


VAERS ID: 1257542 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-10
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9877 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: PCR-Covid-Test; Test Result: Positive ; Test Date: 20210319; Test Name: PCR-Covid-Test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021436056

Write-up: Pneumonia; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from a regulatory authority-WEB [regulatory authority number: DE-PEI-CADR2021047458]. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 20Jan2021, dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot Number: EK9877); both at vaccination age of 85 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Mar2021 the patient experienced pneumonia, COVID-19, vaccination failure. The patient underwent lab tests and procedures which included PCR-Covid-Test: positive on 10Mar2021 and positive on 19Mar2021. The patient''s outcome was fatal for Pneumonia, fatal for COVID-19. The patient died on 31Mar2021. It was not reported if an autopsy was performed. Sender''s comment: The affected person received both vaccine doses from Comirnaty (20Jan21 and 10Feb21). One month after the second vaccination (10Mar21) the person got sick with Covid-19. The first symptoms were cough, runny nose and general symptoms of illness. On 19Mar2021 a PCR test was positive for Covid-19. On 25Mar2021, the affected person developed pneumonia. The affected person was treated on an outpatient basis and hospitalization was required. The person concerned died on 31Mar2021. Relatedness of drug to reaction/events: It was D. Unclassifiable for all events per a regulatory authority. No follow up attempts are possible, no further information is expected. ; Reported Cause(s) of Death: Pneumonia; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1257543 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-31
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   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: Type 1 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021436055

Write-up: Lung embolism; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority (RA), regulatory authority number DE-PEI-CADR2021048741. A 60-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing type 1 diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced lung embolism on 31Mar2021. The event cause death. The patient died on 31Mar2021. It was not reported if an autopsy was performed. Causality has been assessed as "D. Unclassifiable " for all events by the Institute. Sender''s comment: Does the patient has a medical history of allergies? No. Information about risk factors and pre-existing diseases: Diabetes tape 1. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1257551 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-26
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: 2021-04-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis (care level 5)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021441770

Write-up: death; This is a spontaneous report from a contactable consumer reporting for father. A 70-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included dialysis patient, care level 5. The patient''s concomitant medications were not reported. Historical Vaccine included first dose of Comirnaty for COVID-19 immunisation on 17Mar2021, without fever after 2 days he had to be hospitalized with pneumonia, then discharged. And on 14Apr2021 he got the second vaccination, no fever, no complaints, but died after 4 days. The emergency doctor could not determine the cause. The patient experienced death on 18Apr2021. It was not reported if an autopsy was performed. Information on Lot/Batch has been requested.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021441994 Same patient, same drug but different dose, different event(s); Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1257553 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000489 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Blood test, Chest pain, Colonoscopy, Death, Endoscopy upper gastrointestinal tract, Haemoglobin, Haemorrhage, Infarction, Pulmonary oedema, Thrombosis
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic stenosis (Moderate); Chronic disease (Severe); Hypercholesteraemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210318; Test Name: Blood pressure; Result Unstructured Data: Hypovolemic shock; Test Name: Blood test; Test Result: Inconclusive ; Result Unstructured Data: Broad arrange of blood tests; Test Date: 20210318; Test Name: Colonoscopy; Result Unstructured Data: left colon filled with clots.; Test Date: 20210318; Test Name: Gastroscopy; Result Unstructured Data: left colon filled with clots.; Test Date: 20210318; Test Name: Hemoglobin; Test Result: Inconclusive ; Result Unstructured Data: 2.8 Not specified
CDC Split Type: DKMODERNATX, INC.MOD20210

Write-up: Altered state of consciousness; During wake up at the hospital the PT develops high pressure lung oedema; Type II infarction; Acute gastro- and colonoscopy finds the left colon filled with clots.; Chest pain; death; Bleeding; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death), HAEMORRHAGE (Bleeding), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness), PULMONARY OEDEMA (During wake up at the hospital the PT develops high pressure lung oedema), INFARCTION (Type II infarction), THROMBOSIS (Acute gastro- and colonoscopy finds the left colon filled with clots.) and CHEST PAIN (Chest pain) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000489) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Aortic stenosis (Moderate), Hypercholesteraemia and Chronic disease (Severe). On 09-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion death), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) (seriousness criterion hospitalization), PULMONARY OEDEMA (During wake up at the hospital the PT develops high pressure lung oedema) (seriousness criterion hospitalization), INFARCTION (Type II infarction) (seriousness criterion hospitalization), THROMBOSIS (Acute gastro- and colonoscopy finds the left colon filled with clots.) (seriousness criterion hospitalization) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). The patient died on 21-Mar-2021. The reported cause of death was Circulatory failure, Bleeding and Chronic disease. An autopsy was not performed. At the time of death, ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness), PULMONARY OEDEMA (During wake up at the hospital the PT develops high pressure lung oedema), INFARCTION (Type II infarction), THROMBOSIS (Acute gastro- and colonoscopy finds the left colon filled with clots.) and CHEST PAIN (Chest pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Blood pressure measurement: 80/40 mmhg (Low) Hypovolemic shock. On 18-Mar-2021, Colonoscopy: abnormal (abnormal) left colon filled with clots.. On 18-Mar-2021, Endoscopy upper gastrointestinal tract: abnormal (abnormal) left colon filled with clots.. On 18-Mar-2021, Haemoglobin: incocnclusive (Inconclusive) 2.8 Not specified. On an unknown date, Blood test: incocnclusive (Inconclusive) Broad arrange of blood tests. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: This is a case of death in a 85-year-old male subject with a medical history of Hypertension, Aortic stenosis (Moderate), Hypercholesterolemia and unspecified chronic disease, who died 12 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 85-year-old male subject with a medical history of Hypertension, Aortic stenosis (Moderate), Hypercholesterolemia and unspecified chronic disease, who died 12 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Circulatory failure; Bleeding; Chronic disease


VAERS ID: 1257554 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Carbon monoxide poisoning, Condition aggravated, Lung disorder, Oxygen saturation decreased, Pneumonia
SMQs:, Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COMBIVENT; MAGNESIA [MAGNESIUM HYDROXIDE]; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; PRADAXA; PHENERGAN [PROMETHAZINE HYDROCHLORIDE]; KALEORID; FENTANYL ORION [FENTANYL]; OXYCODONE TEVA; ACTILAX [SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchospasm; Chronic obstructive pulmonary disease; Constipation; Gastrooesophageal reflux disease; Heart rate irregular; Iron deficiency; Lung disorder; Osteoporosis; Pain; Sleeplessness
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021430039

Write-up: Pneumonia; Concurrent lung disorder aggravated causing increasing need of oxygen; Concurrent lung disorder aggravated causing increasing need of oxygen; Carbon monoxide poisoning; Concurrent lung disorder aggravated causing increasing need of oxygen; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0060981. Report received from the Regulatory Authority). An 80-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Jan2021 (Lot Number: EM0477; Expiration Date: 30Apr2021) as SINGLE DOSE for COVID-19 immunization. Medical history included bronchospasm, constipation, pain, osteoporosis, chronic obstructive pulmonary disease, gastrooesophageal reflux disease, lung disorder, iron deficiency, sleeplessness and heart rate irregular; all from an unknown date and unknown if ongoing. Concomitant medications included ipratropium bromide, salbutamol sulfate (COMBIVENT) taken for bronchospasm from 29Aug2020 to an unspecified stop date; magnesium hydroxide (MAGNESIA) taken for constipation from 07Jul2015 to an unspecified stop date; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for constipation from 02Dec2020 to an unspecified stop date; dabigatran etexilate mesilate (PRADAXA) taken for thrombosis prophylaxis from 15Jun2015 to an unspecified stop date; promethazine hydrochloride (PHENERGAN) taken for insomnia from 02Dec2020 to an unspecified stop date; potassium chloride (KALEORID) taken for mineral supplementation from 02Dec2020 to an unspecified stop date; fentanyl (FENTANYL ORION) taken for pain from 02Dec2020 to an unspecified stop date; oxycodone hydrochloride (OXYCODONE TEVA) taken for pain from 26Oct2020 to an unspecified stop date; sodium picosulfate (ACTILAX) taken for constipation from 24Feb2020 to an unspecified stop date; alendronate sodium (ALENDRONAT AUROBINDO) taken for osteoporosis from 08Dec2020 to an unspecified stop date; metoprolol succinate (SELO-ZOK) taken for heart rate irregular from 08Mar2020 to an unspecified stop date; calcium, colecalciferol (CALCIUM & VITAMIN D) taken for vitamin supplementation from 02Dec2020 to an unspecified stop date; tiotropium bromide (SPIRIVA RESPIMAT) taken for chronic obstructive pulmonary disease from 30Aug2020 to an unspecified stop date; paracetamol (PAMOL) taken for pain from 01Sep2020 to an unspecified stop date; fenoterol hydrobromide, ipratropium bromide (BERODUAL) taken for chronic obstructive pulmonary disease from 05Dec2018 to an unspecified stop date; iron taken for iron deficiency from 02Dec2020 to an unspecified stop date; morphine sulfate pentahydrate (ORAMORPH) taken for an unspecified indication from 02Dec2020 to an unspecified stop date; fluticasone propionate, salmeterol xinafoate (SERETIDE) taken for chronic obstructive pulmonary disease from 02Dec2020 to an unspecified stop date; furosemide (DIURAL) taken for diuretic therapy from 02Dec2020 to an unspecified stop date; omeprazole (OMEPRAZOLE TEVA) taken for gastrooesophageal reflux disease from 02Dec2020 to an unspecified stop date. On 08Jan2021, the patient developed pneumonia and on an unknown date in 2021 the patient developed concurrent lung disorder aggravated. As a consequence of the pneumonia and concurrent lung disorder aggravated causing increased need for oxygen treatment resulting in a suspected carbon monoxide poisoning. The pneumonia was reported as resulting in hospitalization, however when the patient was discharged from the hospital the ambulance had to return to the hospital because the patient died in the ambulance. The concurrent lung disorder aggravated reported as being fatal by the physician. Increased need for oxygen treatment was reported but no medical procedures were reported performed due to the events. There is no information regarding test results. The reporting physician states that the patient had severe COPD and had constant oxygen treatment at home. The patient developed an increased need for oxygenation regulated according to the needs and it is unknown how much oxygen the patient received at the time of death. The reporting physician suspects that it is a carbon monoxide poisoning that caused the death. However, the physician cannot rule out that there may be a connection with the vaccine due to the time-based connection between the death and the vaccine. Original reporter did not conduct the autopsy; however, she informs that the death was not reported to police and the patient has been buried. The patient died on 18Jan2021. An autopsy was not performed. The outcome of the event pneumonia was recovered with sequelae. Follow-up is not possible, no further information expected.; Reported Cause(s) of Death: Concurrent lung disorder aggravated causing increasing need of oxygen; Concurrent lung disorder aggravated causing increasing need of oxygen; Carbon monoxide poisoning; Concurrent lung disorder aggravated causing increasing need of oxygen


VAERS ID: 1257555 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood lactic acid, Computerised tomogram, Disseminated intravascular coagulation, Gastrointestinal necrosis, Intestinal ischaemia, Rheumatoid arthritis, Splenic infarction, Thrombosis, Urinary tract infection, Urosepsis
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Arthritis (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   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: DULOXETIN KRKA; PREDNISOLON "DLF"; EMTHEXATE [METHOTREXATE SODIUM]; ALENDRONAT TEVA
Current Illness: Rheumatoid arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210328; Test Name: Lactate; Result Unstructured Data: Test Result:Increased; Test Date: 20210328; Test Name: CT scan; Result Unstructured Data: Test Result:Spleen infarct and possible intraabdominal abscess; Comments: Inflammatory process similar to the left kidney (pyelonephritis with incipient abscessing). Small high attenuating change in right liver patch, nonspecific, can be clarified with ultrasound with contrast low-attenuating areas in the liver. The usual place in segment 4 around the gallbladder - may be focal fat infiltration. Multiple microcysts in the kidneys and cyst in the right kidney. Gallstones in the gallbladder.; Test Date: 20210330; Test Name: CT scan; Result Unstructured Data: Test Result:High suspicion of ischemia in the small intestine; Comments: in the small pelvis. Note Bowel ischemia in the right colon. Right Colon: Sign of peritonite. Partial regression of abscess in the left kidney. Infarction in the spleen. Paralytic ileus in small intestine and colon. Pleural fluid bilaterally mild degree.
CDC Split Type: DKPFIZER INC2021436015

Write-up: Short and severe progress with Ischaemia bowel; Abdominal pain; Splenic infarction; Admitted with aggravated rheumatoid arthritis; Urinary tract infection; Necrosis bowel - the entire colon was necrotic; Disseminated intravascular coagulation - it is difficult to determine whether sepsis or DIC came first; Urosepsis - ischemia bowel, possible liver thrombosis and splenic infarction are possible due to urosepsis; Possible liver thrombosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB [DK-DKMA-WBS-0061040] via the Agency. A 76-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: ER2659; Expiration Date: 30Jun2021) via intramuscular at single dose on 15Mar2021 for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis; osteoporosis; depression. Concomitant medications included duloxetine hydrochloride (DULOXETIN KRKA, tablet) for depression from 28Feb2020; prednisolone (PREDNISOLON "DLF", tablet) for adrenocortical steroid therapy from 17Nov2020; methotrexate sodium (EMTHEXATE, tablet) for rheumatoid arthritis from 19Jul2018; alendronate sodium (ALENDRONAT TEVA, tablet) for osteoporosis from 28Dec2018. The patient experienced possible liver thrombosis in Mar2021; occurrence of abdominal pain on 28Mar2021; admitted with aggravated rheumatoid arthritis on 27Mar2021; disseminated intravascular coagulation - it was difficult to determine whether sepsis or DIC came first in Mar2021; short and severe progress with ischaemia bowel on 28Mar2021; urosepsis - ischemia bowel, possible liver thrombosis and splenic infarction were possible due to urosepsis in Mar2021; splenic infarction on 28Mar2021; urinary tract infection on 25Mar2021; necrosis bowel - the entire colon was necrotic in Mar2021. As a consequence of ischemia bowel, the patient experienced the following consequences colon necrotic and only 2 meters vital small intestine. The patient underwent lab tests and procedures which included lactate increased on 28Mar2021. CT scan on 28Mar2021: Spleen infarct and possible intraabdominal abscess. Inflammatory process similar to the left kidney (pyelonephritis with incipient abscessing). Small high attenuating change in right liver patch, nonspecific, can be clarified with ultrasound with contrast low-attenuating areas in the liver. The usual place in segment 4 around the gallbladder - may be focal fat infiltration. Multiple microcysts in the kidneys and cyst in the right kidney. Gallstones in the gallbladder. CT scan on 30Mar2021: High suspicion of ischemia in the small intestine in the small pelvis. Note Bowel ischemia in the right colon. Right Colon: Sign of peritonite. Partial regression of abscess in the left kidney. Infarction in the spleen. Paralytic ileus in small intestine and colon. Pleural fluid bilaterally mild degree. The ADRs were by the reporter reported as being fatal on 31Mar2021. The patient was treated antibiotic due to urinary tract infection. There was performed a medical procedure on 30Mar2021: Due to suspicion of ischemia bowel the patient was operated. Under the operation the entire colon was found necrotically and only 2 meters of vital small intestine. Pale gallbladder and ventricle and stasis-like liver. The patient died on 31Mar2021. An autopsy was performed and results were not provided. Reported causes of death were ischaemia bowel, disseminated intravascular coagulation and urosepsis. The outcome of events ischaemia bowel, disseminated intravascular coagulation and urosepsis was fatal. The outcome of rest events was unknown. Causality: In the process it was difficult to determine whether sepsis or DIC came first, as the patient had abdominal pain, splenic infarction and lactate increased already on the 28Mar2021. The reporter informs that there has been order a autopsy on the patient, but there is no answer yet. Sender Comment: Additional test information: CT scan 28Mar2021: Change in right liver patch: can be clarified with ultrasound with contrast low-attenuating areas in the liver." No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Urosepsis; Disseminated intravascular coagulation; Ischaemia bowel


VAERS ID: 1257567 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthenia (without weight loss or hyporexia or other symptoms); Depressive disorder; Dyslipidemia; Glaucoma; Hysterectomy; Packed red blood cell transfusion; Thyroid operation NOS
Allergies:
Diagnostic Lab Data: Test Date: 2020; Test Name: hemoglobin; Result Unstructured Data: Test Result:13; Test Date: 2021; Test Name: hemoglobin; Result Unstructured Data: Test Result:6
CDC Split Type: ESPFIZER INC2021441407

Write-up: Cerebral haemorrhage/symptoms of disorientation, weakness and fall/massive cerebral hemorrhage with poor prognosis; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Database-WEB, regulatory authority number ES-AEMPS-831042. A 87-year-old female patient received the first dose of bnt162b2 (Vaccine), via the unknown route on 31Mar2021 (Lot Number: EW2239) as 0.3 ML, single for covid-19 immunisation. Medical history included Dyslipidemia, Depressive syndrome, Glaucoma; Surgeries: hysterectomy, thyroid; Under study since 11Mar2021, due to a symptoms of marked asthenia without weight loss or hyporexia or other symptoms, an analysis was performed with Hb of 6 (previous one year ago of 13). 3 packed red blood cells were transfused. The patient''s concomitant medications were not reported. The patient experienced cerebral haemorrhage on 31Mar2021 19:30. In the afternoon, around 7:30 p.m. while she was out walking with a friend, she began with symptoms of disorientation, weakness and fall (going up the stairs at home, she fell backwards hitting her head and becoming unconscious. No visible lesions were observed, in a comatose state. It was oriented as massive cerebral hemorrhage with poor prognosis. The family decided to manage at home with comfort measures. She died on 02Apr2021. The outcome of the event was fatal. The patient died on 02Apr2021 due to event. 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: Cerebral haemorrhage/symptoms of disorientation, weakness and fall/massive cerebral hemorrhage with poor prognosis


VAERS ID: 1257580 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: End stage renal disease (ESRD)
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of lung; Colon cancer; Myelodysplasia; Open angle glaucoma; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Multi-organ failure; Thrombocytopenia; This regulatory authority case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Cancer of lung, Open angle glaucoma, Type 2 diabetes mellitus in 2002, End stage renal disease (ESRD) since an unknown date, Myelodysplasia and Colon cancer. On 17-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criterion death). The patient died on 31-Mar-2021. The reported cause of death was Multiorgan failure. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications were provided. Treatment medications was not provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Multi-organ failure


VAERS ID: 1257595 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KARDEGIC; ELISOR; COVERSYL [PERINDOPRIL ARGININE]; ESCITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Atrioventricular block; Bone metastases; Coronary stent placement; Ischaemic heart disease; Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021435912

Write-up: Death sudden/Patient GIR 1, more autonomous, no longer got up. Patient found deceased sitting in his chair, face calm; arrhythmia?/Patient GIR 1, more autonomous, no longer got up. Patient found deceased sitting in his chair, face calm; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number FR-AFSSAPS-NT20211105. A 79-year-old male patient received BNT162B2 (Pfizer vaccine), dose 2 intramuscular, administered in arm right on 18Feb2021 (Batch/Lot Number: EM6950) as single dose for COVID-19 immunisation. Medical history included prostate cancer with bone metastasis, Alzheimer''s disease, ischemic heart disease, coronary stent graft, atrioventricular block: (no indication for a pacemaker unless syncope). Concomitant medications included acetylsalicylate lysine (KARDEGIC), pravastatin sodium (ELISOR), perindopril arginine (COVERSYL [PERINDOPRIL ARGININE]) and escitalopram, all taken for an unspecified indication, start and stop date were not reported. The patient experienced GIR 1, more autonomous, no longer got up. Patient found deceased sitting in his chair, face calm on 19Feb2021. Reported Cause of Death: arrhythmia? (death sudden). No autopsy required because the doctor did not know at the time of the death declaration that the vaccination had been given the day before (thought it was planned the next day). According to the reporting physician: hypothesis of a probable arrhythmia. Patient died on 19Feb2021 and autopsy was not done. Outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death sudden/Patient GIR 1, more autonomous, no longer got up. Patient found deceased sitting in his chair, face calm; arrhythmia?/Patient GIR 1, more autonomous, no longer got up. Patient found deceased sitting in his chair, face calm


VAERS ID: 1257604 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension arterial; Hypertrophic cardiomyopathy; Kidney failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Death NOS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death NOS) in a 69-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Kidney failure, Hypertension arterial and Hypertrophic cardiomyopathy. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 10-Mar-2021 The patient died on 10-Mar-2021. The cause of death was not reported. An autopsy was not performed. No concomitant medication reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021033608 Company Comment: This case of a 69 year old female patient on the same day after the administration of mRNA-1273 vaccine. Although patient had strong confounders in the underlying condition diabetes, Kidney failure, Hypertension arterial and Hypertrophic cardiomyopathy, there is strong temporal association between the onset and the fatal outcome., hence a causal association cannot be excluded.; Sender''s Comments: This case of a 69 year old female patient on the same day after the administration of mRNA-1273 vaccine. Although patient had strong confounders in the underlying condition diabetes, Kidney failure, Hypertension arterial and Hypertrophic cardiomyopathy, there is strong temporal association between the onset and the fatal outcome., hence a causal association cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1257606 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective, Oxygen saturation, 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: 2021-02-22
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; ELIQUIS; NORSET; UVEDOSE; SERESTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210217; Test Name: body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Test Date: 20210217; Test Name: oxygen saturation; Test Result: 94 %; Comments: under 3l / min, goes back to 92% after respiratory physiotherapy, not painful.; Test Date: 20210216; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive; Comments: English variant B.1.1.7
CDC Split Type: FRPFIZER INC2021435901

Write-up: COVID-19; Drug ineffective; This is a spontaneous report from Medical Agency, regulatory authority number FR-AFSSAPS-TO20212594. A contactable physician reported that a 99 year old female patient received the second dose of BNT162B2 (Pfizer vaccine, Lot number unknown) intramuscularly at single dose for COVID-19 immunisation on 04Feb2021, the patient receive the first dose of Pfizer vaccine intramuscularly at single dose for COVID-19 immunisation on 12Jan2021. Relevant history included FA (arterial fibrillation) and HTA (arterial hypertension). Relevant concomitant drugs included folic ac, apixaban (ELIQUIS), mirtazapine (NORSET), colecalciferol (UVEDOSE), oxazepam (SERESTA), all were long-term used. The clinical course was reported as: 10Feb2021, the patient was asthenic and listless since. 13Feb2021: resident found reactive in bedroom; clinical signs: significant decrease in appetite, asthenia ++, desaturation, diarrhea; call of 15: put under O2: 2l / min and no hospitalization. 16Feb2021: Positive PCR test, English variant B.1.1.7. 17Feb2021: no longer takes anything orally, asthenia ++, fever at 38.6 deg C , desaturation at 94% under 3l / min, goes back to 92% after respiratory physiotherapy, not painful. Gradually deterioration of the general condition: introduction of 5% Glucose, comfort care; clinically: dyspnea on congestion: physiotherapist spends 2f / day to do respiratory physiotherapy; not painful, asthenia ++, black tongue. Respiratory physiotherapy continued on February 19, 20 and 21. Death was noted on 22Feb2021 at 6 am by the nursing team; SOS doctor came to notice the death in the morning. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Drug ineffective; COVID-19


VAERS ID: 1259826 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:pyrexia
CDC Split Type: AUPFIZER INC2021444536

Write-up: pyrexia; This is a spontaneous report from a contactable healthcare professional via Regulatory Authority. Regulatory authority report number is 536534. A 96-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pyrexia resulting in death on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pyrexia


VAERS ID: 1259827 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444538

Write-up: Unresponsive to stimuli; This is a spontaneous report from a contactable other health professional via a regulatory authority. Regulatory authority report number is 536914. A 93-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced unresponsive to stimuli on 09Apr2021 with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unresponsive to stimuli


VAERS ID: 1259828 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-11
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Fatigue, Pneumonia, Respiratory failure, Somnolence, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444539

Write-up: cough; fatigue; pneumonia; respiratory failure; somnolence; unresponsive to stimuli; This is a spontaneous report from a contactable health professional via the Regulatory Authority (TGA). Regulatory authority report number is 537307. A 93-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cough, fatigue, pneumonia, respiratory failure, somnolence, and unresponsive to stimuli on 11Mar2021. Outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: fatigue; cough; pneumonia; respiratory failure; somnolence; unresponsive to stimuli


VAERS ID: 1259829 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-06
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444540

Write-up: pulmonary embolism; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 537952. A 94-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced pulmonary embolism on 06Apr2021 with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pulmonary embolism


VAERS ID: 1259830 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-09
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444542

Write-up: pneumonia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 538589. A 92-years-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced pneumonia on 09Apr2021 (Onset Time in Days: 2). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: pneumonia


VAERS ID: 1259831 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia aspiration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444543

Write-up: pneumonia aspiration; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 538596. An 81-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced pneumonia aspiration on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: pneumonia aspiration


VAERS ID: 1259832 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444544

Write-up: decreased appetite; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 538631. A 95-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced decreased appetite on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: decreased appetite


VAERS ID: 1259833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444545

Write-up: Malaise; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 538633. A 100-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced malaise on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Malaise


VAERS ID: 1259834 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444546

Write-up: Malaise; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 538635. A 96-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced malaise (death) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Malaise


VAERS ID: 1259860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Peripheral arterial occlusive disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021436058

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021046783. A 58-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 08Apr2021 (Batch/Lot Number: EW8904) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing peripheral arterial occlusive disease and diabetes. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 10Apr2021. The patient died on 10Apr2021. It was not reported if an autopsy was performed. This case was serious due to death. Causality has been assessed as "D. Unclassifiable " for all events by the Regulatory Authority. Sender''s comment: Information about medical history and risk factors diabetes, Peripheral arterial occlusive disease. No follow-up attempts needed, follow-up automatically provided by Regulatory Authority. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1259866 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
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 INC2021435564

Write-up: vaccinated patient died as a result of Corona infection; vaccinated patient died as a result of Corona infection; This is a spontaneous report based on information received by Pfizer from BioNTech [manufacturer reference number: 42487], license party for COMIRNATY. A contactable consumer reported that an unknown age male patient received BNT162B2 (COMIRNATY) on an unspecific date at single dose for COVID-19 immunisation. Medical history and concomitant drug were not reported. This consumer reported: "My father died yesterday (19Apr2021) as a result of Corona infection. He was vaccinated against Covid-19 with the Biontech vaccine. We had hoped that the vaccination would help him, but unfortunately he did not make it. We suffered a very painful loss against the battle of Corona. I hope that the pandemic ends and that we can lead a normal life again." Outcome of the event was fatal. Information about lot/batch number has been requested.; Reported Cause(s) of Death: died as a result of Corona infection; died as a result of Corona infection


VAERS ID: 1259876 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   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: TREVICTA; OLANZAPINE TEVA
Current Illness: Overweight (increased the recent years); Schizophrenia (with delusions)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021441233

Write-up: found dead; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0062140. A 41-year-old female patient received the first dose of BNT162B2 (COMIRNATY, batch/lot number: ET3674 and expiration date: Jul2021), via an unspecified route of administration, on 26Mar2021, at single dose, for COVID-19 immunization. Medical history included ongoing schizophrenia with delusions, ongoing overweight increased the recent years. The patient had no history of thrombosis, embolism or bleeding. Concomitant medications included paliperidone palmitate (TREVICTA) from 30Oct2017 for mental disorder; olanzapine (OLANZAPINE TEVA) from 23Dec2020 for schizophrenia. The patient experienced found dead on 31Mar2021. On 09Apr2021 the patient was found dead in her home. The presumed time of death was 31Mar2021. The outcome of the event was fatal. The causality reported as "Despite being overweight, the death is unexpected, the physician can not rule out a possible influence of the vaccine". The cause of death was unknown. An autopsy was not performed, and would be performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: dead


VAERS ID: 1259890 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-04-08
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac ischemia; Hypertension arterial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021442050

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB, regulatory authority number ES-AEMPS-822341. A 84-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly on 30Mar2021 (Batch/Lot Number: EW2239) as single dose for COVID-19 immunisation; ranibizumab (LUCENTIS), via an unspecified route of administration from 03Mar2021 (Batch/Lot number was not reported) to 04Mar2021, at 2 doses for macular degeneration. Medical history included Cardiac ischemia, atrial fibrillation, type 2 diabetes mellitus, and Hypertension arterial. The patient''s concomitant medications were not reported. The patient previously took sintrom. The patient experienced cardio-respiratory arrest on 08Apr2021. The event seriousness criteria was reported as fatal. The action taken in response to the event for ranibizumab was not applicable. The patient died on 08Apr2021. It was unknown if autopsy was performed. Case summary and reporter comments text: Additional information: a person with a normal life with a medical history diabetes type II, hypertension, cardiac ischemia, atrial fibrillation in treatment with sintrom. He was with his family having dinner and suffered a sudden faintness with cardiorespiratory arrest. He had been vaccinated for covid-19 one week ago. He had been administered at the same day the 2 doses of Lucentis.; Reporter''s Comments: Additional information: a person with a normal life with a medical history diabetes type II, hypertension, cardiac ischemia, atrial fibrillation in treatment with sintrom. He was with his family having dinner and suffered a sudden faintness with cardiorespiratory arrest. He had been vaccinated for covid-19 one week ago. He had been administered at the same day the 2 doses of Lucentis.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1259895 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Amylase, Auscultation, Bilirubin urine, Blood alkaline phosphatase, Blood bilirubin, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood gases, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood pressure diastolic, Blood pressure measurement, Blood pressure systolic, Blood sodium, Blood urea, Body temperature, C-reactive protein, Chest X-ray, Coma scale, Computerised tomogram, Creatinine urine, Diagnostic aspiration, Echocardiogram, Gamma-glutamyltransferase, Glomerular filtration rate, Glucose urine, Haematocrit, Haemoglobin, Haemoglobin urine, Haemostasis, Heart rate, Lipase, Neurological examination, Nitrite urine, Oxygen saturation, Platelet count, Pneumonia, Procalcitonin, Protein urine, SARS-CoV-2 test, Septic shock, Urinary sediment, Urinary tract infection, Urine analysis, Urine ketone body, Urine osmolarity, Urine output, Urine potassium, Urine sodium, Urobilinogen urine, White blood cell count, White blood cells urine
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Toxic-septic shock conditions (narrow), Eosinophilic pneumonia (broad), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LISINOPRIL; RIVASTIGMINE; TAMSULOSIN; MIRTAZAPINE; FUROSEMIDE; TRAJENTA; QUETIAPINE; PREDNISONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Arterial hypertension; Chronic kidney disease; Chronic venous insufficiency; COVID-19 (COVID-19 bilateral pneumonia in May 2020); Diabetes; Heart failure; Nephritis (in admission from Dec2020 to Feb2021; In treatment with prednisone and follow-up by Nephrology); Prostatic hyperplasia; Subdural hematoma (Subdural hematoma after TBI in 2016); Ulcer
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: ALT; Test Result: 13 uL; Test Date: 20210410; Test Name: Amylase; Test Result: 62 uL; Test Date: 20201215; Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:Rhythmic without murmurs; Test Date: 20210410; Test Name: Lung auscultation; Result Unstructured Data: Test Result:without added noise; Comments: MVC (Vesicular murmur preserved) without added noise; Test Date: 20210410; Test Name: Bilirubin; Test Result: Negative ; Test Date: 20210410; Test Name: Alkaline phosphatase; Test Result: 86 uL; Test Date: 20210410; Test Name: Bilirubin; Test Result: 0.9 mg/dl; Test Date: 20210410; Test Name: CK; Test Result: 33 uL; Test Date: 20210410; Test Name: Creatinine; Test Result: 4.36 mg/dl; Test Date: 20201215; Test Name: CRP; Result Unstructured Data: Test Result:15; Test Date: 20210410; Test Name: Fibrinogen; Test Result: 600 mg/dl; Test Date: 20210410; Test Name: Venous blood gas; Result Unstructured Data: Test Result:pH 7.44; Comments: pH 7.44 pCO2 27 mm Hg pO2 152 mm Hg O2 saturation 99% Bicarbonate 18 mmol / L Standard bicarbonate 22 mmol / L Total CO2 19 mmol / L BEb -4.4 mmol / L BEecf -5.9 mmol / L Lactate 5.1 mmol / L Sodium venous blood 138 mmol / L Potassium venous blood 3.1 mmol / L -; Test Date: 20210410; Test Name: capillary blood glucose; Test Result: 126 mg/dl; Test Date: 20210410; Test Name: Glucose; Test Result: 61 mg/dl; Test Date: 20210410; Test Name: LDH; Test Result: 192 uL; Test Date: 20210410; Test Name: Potassium; Test Result: 3.2 mmol; Test Date: 20210410; Test Name: Diastolic blood pressure; Result Unstructured Data: Test Result:40 mmHg; Test Date: 20210410; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/60 mmHg; Test Date: 20210410; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:84 mmHg; Test Date: 20210410; Test Name: Sodium; Result Unstructured Data: Test Result:145 mmol/L; Test Date: 20210410; Test Name: Urea; Test Result: 148 mg/dl; Test Date: 20210410; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: later 37.2, and then increases in the afternoon to 38.1; Test Date: 20210410; Test Name: Body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20210410; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210410; Test Name: Chest XR; Result Unstructured Data: Test Result:Image; Test Date: 20210410; Test Name: Glasgow; Result Unstructured Data: Test Result:3/15; Test Date: 20210410; Test Name: Skull CT; Result Unstructured Data: Test Result:Abnormal; Comments: Study with multiple artifacts due to hardening of the bundle, added to involuntary movements of the patient, which limit the evaluation of the posterior fossa. The existence of hypodensity in the right hemiprotuberance is doubtful, which is probably due to the aforementioned artifacts, to be clinically correlated (or to assess control CT when the patient''s condition allows it). Chronic left parietal laminar subdural hematoma with interior calcifications and ipsilateral frontal and parietal trephine foramina. Periventricular white matter patchy hypodensities with extension to both semioval centers in relation to mild-moderate chronic microangiopathy. Left subinsular focal hypodensity suggestive of lacunar infarction of Old chronology versus dilated perivascular space. Encephaloventricular retraction pattern according to the age group of the patient. Centered midline reference structures. Conclusion: Preliminary report: suboptimal study for posterior fossa assessment with multiple artifacts due to bundle hardening. It is recommended to consider repeating the study when the patient''s conditions allow it. Chronic left parietal laminar subdural hematoma, unchanged. Chronic supratentorial microangiopathy in mild - moderate degree; Test Date: 20210410; Test Name: C-reactive protein; Test Result: 16.8 mg; Test Date: 20210410; Test Name: Creatinine; Result Unstructured Data: Test Result:Single void 72.1 mg/dl; Test Date: 20210410; Test Name: Chest radiograph; Result Unstructured Data: Test Result:possible consolidation of the right base pneumonia; Test Date: 20201215; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Abnormal; Comments: Left ventricle not dilated, with slightly concentrically increased wall thickness. Slightly depressed global systolic function (estimated LVEF 50%), due to global hypokinesia, without alterations in segmetal contraction. Impressive transmitral filling pattern of pseudonormal. - Slightly dilated left atrium. - Right atrium not dilated. - Undilated right ventricle, with normal global systolic function. TAPSE 21 mm. - Mitral valve with degenerative changes, without restriction to opening, mild to moderate insufficiency (II / IV) - Sclerosed aortic valve, without evidence of stenosis, functionally normal. - Morphologically normal tricuspid valve, slight insufficiency. - Pulmonary artery systolic pressure estimated at 30 mmHg. - Dilated inferior vena cava with physiological inspiratory collapse. - Minimal circumferential pericardial effusion, with maximum thickness over the right atrium, but in any case light and without compromise. - Undilated aortic root. - CKD due to nephroangiosclerosis (severe exacerbation in admission from Dec2020 to Feb2021 with dx of probable immunolaergic nephritis due to fcos. In treatment with prednisone and follow-up by Nephrology; Test Date: 20210410; Test Name: GGT; Test Result: 47 uL; Test Date: 20210410; Test Name: Filt. estimated glomerular CKD-EPI; Result Unstructured Data: Test Result:11 ml/min; Comments: 11 mL/min/1.72 m2; Test Date: 20210410; Test Name: Glucose urine; Test Result: Negative ; Test Date: 20210410; Test Name: Hematocrit; Test Result: 29.0 %; Test Date: 20210410; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9.7 g/dl; Test Date: 20210410; Test Name: Hemoglobin; Result Unstructured Data: Test Result:Apr. 150 eri./ L; Test Date: 20210410; Test Name: Hemostasis; Result Unstructured Data: Test Result:APTT 36 sec; Comments: A.P.T.T. (Activated partial thromboplastin time) 36 sec. CONTROL A.P.T.T. 29.2 RATIO A.P.T.T .2 ROTROMBINE TIME 17.2 sec. I.N.R. ( Inter national normalised ratio) 1.48; Test Date: 20210410; Test Name: Heart rate; Result Unstructured Data: Test Result:121 bpm; Test Date: 20210410; Test Name: Lipase; Test Result: 19 uL; Test Date: 20210410; Test Name: NRL; Result Unstructured Data: Test Result:Abnormal; Comments: right myotic and left mydriatic pupil, V par cranial abolished. Rest of non-assessable pairs. Does not respond to orders, does not open the eyes, does not make sounds. Bilateral extensor reflex. Lower limbs: edema to mid-erect with ulcers on both limbs. Low level of consciousness. No facial asymmetry, atony of 4 EE (Extremities); Test Date: 20210410; Test Name: Nitrite; Test Result: Negative ; Test Date: 20210410; Test Name: Oxygen saturation - baseline; Test Result: 95 %; Test Date: 20210410; Test Name: Saturation with oxygen in nasal goggles; Test Result: 96 %; Test Date: 20210410; Test Name: Platelets; Result Unstructured Data: Test Result:75 x10 3/mm3; Test Date: 20201215; Test Name: PCT; Result Unstructured Data: Test Result:71.14; Test Date: 20210410; Test Name: Procalcitonin; Result Unstructured Data: Test Result:71.14 g/l; Test Date: 20210410; Test Name: Proteins++; Result Unstructured Data: Test Result:Apr. 100 mg/dl; Test Date: 20210410; Test Name: COVID-19 PCR; Result Unstructured Data: Test Result:Pending result; Test Date: 20210410; Test Name: Urinary sediment; Result Unstructured Data: Test Result:Erythrocytes; Comments: Erythrocytes Severe hematuria Leukocytes Modeate pyuria Severe Bacteriria; Test Date: 20210410; Test Name: AO; Result Unstructured Data: Test Result:6 pH units; Test Date: 20210410; Test Name: Ketone bodies; Test Result: Negative ; Test Date: 20210410; Test Name: Osmolality; Result Unstructured Data: Test Result:Single void 316 mosm/kg; Test Date: 20210410; Test Name: Urine density; Result Unstructured Data: Test Result:1.010; Test Date: 20210410; Test Name: Potassium; Result Unstructured Data: Test Result:Single void 39.5 mmol/L; Test Date: 20210410; Test Name: Sodium; Result Unstructured Data: Test Result:Single void 61 mmol/L; Test Date: 20210410; Test Name: Urobilinogen; Test Result: Negative ; Test Date: 20210410; Test Name: Leukocytes; Result Unstructured Data: Test Result:15.50 x10 3/mm3; Test Date: 20210410; Test Name: Lukocyte esterase; Result Unstructured Data: Test Result:Apr. 75 cells/ L
CDC Split Type: ESPFIZER INC2021441807

Write-up: Septic shock; Pneumonia; Urinary infection; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB ES-AEMPS-830486. A 86-years-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 09Apr2021 (Batch/Lot Number: EW2243) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, peripheral venous disease, covid-19 from Apr2020 to May2020, chronic kidney disease, cardiac failure, benign prostatic hyperplasia, dementia alzheimer''s type, hypertension, subdural haematoma, nephritis from Dec2020 to Feb2021. Concomitant medications included lisinopril taken for hypertension, start and stop date were not reported; rivastigmine taken for dementia alzheimer''s type, start and stop date were not reported; tamsulosin taken for benign prostatic hyperplasia, start and stop date were not reported; mirtazapine taken for an unspecified indication, start and stop date were not reported; furosemide taken for cardiac failure, start and stop date were not reported; linagliptin (TRAJENTA) taken for diabetes mellitus, start and stop date were not reported; quetiapine taken for an unspecified indication, start and stop date were not reported; prednisone taken for an unspecified indication, start and stop date were not reported. The patient presents a fever of up to 38.1?C, weakness of the lower limbs and general malaise. Later he begins with a low level of consciousness, lack of response to stimuli and trachypnea. Yesterday he was vaccinated for covid19. Physical examination: Temperature (?C): 35.8, Systolic blood pressure (mmHg): 84, Diastolic blood pressure (mmHg): 40, Heart rate (beats / min): 121, Oxygen saturation - baseline (%): 95, Saturation with oxygen in nasal goggles (%): 96, Oxygen flow with nasal goggles (l / min): 4, Capillary blood glucose (mg / dl): 126.0. Poor general condition, FR: 30 resp / min, Sat O2: 95% with GN at 2L. TA: 70/40. (Cardiac auscultation): rhythmic without murmurs. (Lung auscultation): (Vesicular murmur preserved) without added noise. NRL: glasgow 3/15, right myotic and left mydriatic pupil, V par cranial abolished. Rest of non-assessable pairs. Does not respond to orders, does not open the eyes, does not make sounds. Bilateral extensor reflex. Lower limbs: edema to mid-erect with ulcers on both limbs. Summary of complementary tests: Laboratory: AS: Hemogram: Red blood cells 3.30 10E6 / L HEMOGLOBIN 9.7 g / dL Hematocrit 29.0% V.C.M. 87.8 fL H.C, M. 29.3 pg C.H.C.M. 33.4 g / dL A.D.E. 15.7% PLATELETS 75 10E3 / L LEUKOCYTES 15.50 10E3 / L Neu 14.3 10E3 / L Lin 0.3 10E3 / L - Hemostasis: A.P.T.T. 36 sec. CONTROL A.P.T.T. 29.2 RATIO A.P.T.T 1.2 ROTROMBINE TIME 17.2 sec. I.N.R. 1.48 Fibrinogen 600 mg / dL - Venous blood gas: pH 7.44 pCO2 27 mm Hg pO2 152 mm Hg O2 saturation 99% Bicarbonate 18 mmol / L Standard bicarbonate 22 mmol / L Total CO2 19 mmol / L BEb -4.4 mmol / L BEecf -5.9 mmol / L Lactate 5.1 mmol / L Sodium venous blood 138 mmol / L Potassium venous blood 3.1 mmol / L - Biochemistry: Glucose 61 mg / dL ALT 13 U / L Bilirubin 0.9 mg / dL GGT 47 U / L Alkaline phosphatase 86 U / L LDH 192 U / L CK 33 U / L Amylase 62 U / L Lipase 19 U / L Creatinine 4.36 mg / dL Filt. estimated glomerular (CKD-EPI) 11 mL / min / 1.73 m2 Urea 148 mg / dL Sodium 145 mmol / L Potassium 3.2 mmol / L C-reactive protein 16.8 mg / dL Procalcitonin 71.14 g / L AO: pH 6.0 Density 1,010 Glucose Negative Proteins ++ (Apr. 100 mg / dL) Ketone bodies Negative Bilirubin Negative Urobilinogen Negative Hemoglobin Apr. 150 eri./L Leukocyte esterase Apr. 75 cells / L Nitrite Negative Automatic sediment report. Urinary sediment: Erythrocytes Severe hematuria Leukocytes Moderate pyuria Severe Bacteriuria - Urine biochemistry: Osmolality single void 316 mOsm / kg Sodium single void 61 mmol / L Potassium single void 39.5 mmol / L Creatinine single void 72.1 mg / dL; Image: (Lung auscultation) and lat chest XR: Skull CT: Study with multiple artifacts due to hardening of the bundle, added to involuntary movements of the patient, which limit the evaluation of the posterior fossa. The existence of hypodensity in the right hemiprotuberance is doubtful, which is probably due to the aforementioned artifacts, to be clinically correlated (or to assess control CT when the patient''s condition allows it). Chronic left parietal laminar subdural hematoma with interior calcifications and ipsilateral frontal and parietal trephine foramina. Periventricular white matter patchy hypodensities with extension to both semioval centers in relation to mild-moderate chronic microangiopathy. Left subinsular focal hypodensity suggestive of lacunar infarction of Old chronology versus dilated perivascular space. Encephaloventricular retraction pattern according to the age group of the patient. Centered midline reference structures. Conclusion: Preliminary report: suboptimal study for posterior fossa assessment with multiple artifacts due to bundle hardening. It is recommended to consider repeating the study when the patient''s conditions allow it. Chronic left parietal laminar subdural hematoma, unchanged. Chronic supratentorial microangiopathy in mild - moderate degree. The patient with a history of Alzheimer''s disease GDS4 with DPABVD, CKD with a baseline score of around 3, with a suspected episode of NIIA for which he was prescribed oral corticosteroids (prednisone). He is referred by family members due to a progressive general malaise to a low level of consciousness, which began on the day of 10Apr2021. On 09Apr2021 he received the first dose of Pzifer vaccination. Upon awakening on 10Apr2021, the patient did not present deterioration of cognitive functions with respect to his baseline, but he did present weakness in Lower limbs.and fever (37.2?C), which increases in the afternoon to 38.1?C. Children of the patient notify agency who tell them to take Nolotil, and if paracetamol symptoms persist 4 hours later. After taking oral paracetamol at 11:00 p.m., he begins with work of breathing, erythema and facial swelling, and a low level of consciousness. Coinciding with the latter, he does not present cutaneous alterations in the form of erythema or hives on other parts of the body, no diarrhea, no vomiting, no dysphagia. In this center he goes through a shock room initially due to a low level of consciousness GCS (Glasgow coma scale) 3/15, arraective anisocoria (left miosis), RCPEB, generalized atony. Initially blood pressure of 110 / 60mmHg. Blood glucose in ambulance of 73 mg / dL. Tachypnea at 30rpm with shallow breathing, without rales or wheezing on auscultation. He moves to Observation and family members are notified, explaining dire short-term prognosis. He moves to Observation and relatives are notified, explaining dire prognosis in the short term. Upon arrival at Observation, he presented the following examination: LRN: low level of consciousness GCS (Glasgow coma scale) 3/15, arreactive anisochorium with left miosis, no facial asymmetry, atony of 4 EE (Extremities), RCPEB. No meningeal signs. - Skin: no skin changes, no hives, no petechial lesions or ecchymoses- AP (Lung auscultation) : rhythmic tones, no murmurs. Vesicular murmur preserved) with base hypoventilation. (Head and neck) : no oropharyngeal alterations. No Jugular venous engorgement). - Abdomen: RHA (Hyperacute rejection) +, globular, not painful, no peritoneal irritation. - Edematous lesions with superficial ulcers with fibrin plaque at the base, not suppurative or with clear signs of infection. Given the above, the following is performed urgently: - Administration of flumacenyl and later naloxone: without improvement in the level of consciousness. - Arterial blood gas: no elevation of pCO2, lactacidemia of 5.7, Ions in range. - Blood glucose of 136; subsequently 63 mg / dL (after 30h). - Simple cranial CT: no acute bleeding data or other alterations of interest for the current process. - Keppra 500mg dose to rule out postcritical (patient with previous subdural hematoma) without improvement in level of consciousness. In blood tests leukocytosis with left deviation, marked elevation of CRP (Plasma creatinine) (15) with PCT (Procalcitonin) of 71.14, data of coagulopathy (INR - normalised ratio - 1.48), with thrombopenia of 75,000 and over-chronic ARF with creatinine 4.36, GFR of 11 and uremia of 148. Analysis pending urine. Given the above, cold HCs (without fever all the time in the ER) and UC are requested. Empirical antibiotic therapy with meropenem and vancomycin is started. In addition, in this context, they warn of arterial hypotension of 70 / 30mmHg, so volumetric replacement with SSF 500cc in free fall + SG5% was started due to hypoglycemia of 70mg / dL, with subsequent improvement in figures (84/54 mmHg). In addition, a vssical probing is carried out. The chest radiograph shows a possible consolidation of the right base pneumonia. SARS-Cov-2 PCR extracted, pending result. 15Dec2020 ECHOCARDIOGRAM: Left ventricle not dilated, with slightly concentrically increased wall thickness. Slightly depressed global systolic function (estimated LVEF 50%), due to global hypokinesia, without alterations in segmetal contraction. Impressive transmitral filling pattern of pseudonormal. - Slightly dilated left atrium. - Right atrium not dilated. - Undilated right ventricle, with normal global systolic function. TAPSE 21 mm. - Mitral valve with degenerative changes, without restriction to opening, mild to moderate insufficiency (II / IV) - Sclerosed aortic valve, without evidence of stenosis, functionally normal. - Morphologically normal tricuspid valve, slight insufficiency. - Pulmonary artery systolic pressure estimated at 30 mmHg. - Dilated inferior vena cava with physiological inspiratory collapse. -Minimal circumferential pericardial effusion, with maximum thickness over the right atrium, but in any case light and without compromise. - Undilated aortic root. - CKD due to nephroangiosclerosis (severe exacerbation in admission from Dec2020 to Feb2021 with dx of probable immunolaergic nephritis due to fcos. In treatment with prednisone and follow-up by Nephrology). - Chronic venous insufficiency with chronic pretibial ulcers - Alzheimer''s disease GDS 4. (Seen at CCEE in Dec2019. No SPCD). - Diabetes Mellitus - Benign prostate hyperplasia - Arterial hypertension - Subdural hematoma after TBI in 2016. - COVID-19 bilateral pneumonia in May2020. Clinical judgement: 1. SEPTIC SHOCK OF DOUBTFUL ORIGIN (RESPIRATORY +/- INTRAABDOMINAL +/- CUTANEOUS DUE TO Lower limbs.ULCERS) with hypotension and arterial hyperlactacidemia 2. - Coverage with meropenem (antecedents of BGN ESBL) + vanillacomycin (we did not guide line thrombopeniazolid). 2. LOW LEVEL OF CONSCIOUSNESS SEVERE SECONDARY TO SNC DYSFUNCTION BY SEPSIS +/- UREMIA BY FRA-C. 11Apr2021 During the morning, greater worsening from the respiratory point of view with increased work and secretions. He persists in a coma. HypoTA of 70/40 and in oligoanuria. Later begins with apnea pauses. Finally the patient dies. Main diagnosis: SEPTIC SHOCK Other diagnoses: PNEUMONIA URINARY INFECTION EXITUS. It was unknown whether autopsy was done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia; Urinary infection; Septic shock


VAERS ID: 1259897 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-04-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood creatinine, Blood fibrinogen, Blood glucose, Blood pressure measurement, Blood urea, Cerebral venous sinus thrombosis, Computerised tomogram, Electrocardiogram, Haematocrit, Haemoglobin, Haemorrhage intracranial, International normalised ratio, Mean cell volume, Platelet count, SARS-CoV-2 test, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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: EUTIROX; OMEPRAZOLE; PARACETAMOL; ALLOPURINOL [ALLOPURINOL SODIUM]; AMERIDE [AMILORIDE HYDROCHLORIDE;HYDROCHLOROTHIAZIDE]; EBASTEL FORTE FLAS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Anxiety disorder; Chronic kidney disease; Dyslipidemia; Hemithyroidectomy; Hyperhidrosis; Hypertension; Hyperuricemia; Hypothyroidism; Insomnia; Obesity; Osteoarthritis; Parathyroid adenoma removal; Sinus tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210403; Test Name: APTT; Result Unstructured Data: Test Result:30.7 sg; Comments: ratio: 0.99; Test Date: 20210403; Test Name: Creatinine; Result Unstructured Data: Test Result:1.15; Test Date: 20210403; Test Name: Fibrinogen; Test Result: 527 mg/dl; Test Date: 20210403; Test Name: Glucose; Test Result: 182 mg/dl; Test Date: 20210403; Test Name: BP; Result Unstructured Data: Test Result:180/80 mmHg; Test Date: 20210403; Test Name: Urea; Result Unstructured Data: Test Result:83.2; Test Date: 20210403; Test Name: CT; Result Unstructured Data: Test Result:Enlargement of the foci of acute; Comments: Enlargement of the foci of acute intraparenchymal hemorrhage in the upper right parietal region with a slight increase in perilesional edema and fof the acute SAH occupancies in the right parietoocipital sulci. All of this exerting a greater mass effect on the grooves of the right frontoparietal convexity and on the ipsilateral LV, now observing complete collapse of the occipital horn; Test Date: 20210403; Test Name: CT; Result Unstructured Data: Test Result:right parietal lobar hemorrhage; Comments: right parietal lobar hemorrhage secondary to massive thrombosis of the superior sagittal venous sinus and right transverse (partial left transverse).; Test Date: 20210404; Test Name: CT; Result Unstructured Data: Test Result:increased bleeding; Comments: increased bleeding and edema with mass effect that displaces the midline and collapses ventricles. Conclusion: Increased size of right intraparenchymal and subarachnoid hematomas with greater mass effect and herniation patterns. right parietal lobar hemorrhage secondary to massive thrombosis of the superior sagittal venous sinus and right transverse (partial left transverse); Test Name: Electrocardiogram; Result Unstructured Data: Test Result:sinus rhythm at 100 bpm; Comments: PR 180 msec, 0? axis, QRS less than 120 msec without repolarization alterations; Test Date: 20210403; Test Name: Hematocrit; Test Result: 36.5 %; Test Date: 20210403; Test Name: Hemoglobin; Result Unstructured Data: Test Result:12.2 g/dl; Test Date: 20210403; Test Name: INR; Result Unstructured Data: Test Result:0.98; Comments: TP ratio 0.98; Test Date: 20210403; Test Name: MCV; Result Unstructured Data: Test Result:86.4 fL; Test Date: 20210403; Test Name: Platelet count; Result Unstructured Data: Test Result:280000; Comments: 21-23hrs.; Test Date: 20210403; Test Name: Platelet count; Result Unstructured Data: Test Result:331000; Comments: TP 100%; Test Date: 20210403; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative; Test Date: 20210403; Test Name: Leukocytes; Result Unstructured Data: Test Result:11.500?L; Comments: (N 78.8% / L 13.5 / M 6.5 / E 0.6 / B 0.6)
CDC Split Type: ESPFIZER INC2021441377

Write-up: Haemorrhage intracranial; Cerebral venous sinus thrombosis; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB ES-AEMPS-830659. A 87-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 19Mar2021 (Batch/Lot Number: ER7812) as 0.3 mL, single for covid-19 immunisation. Medical history included obesity, chronic kidney disease, hypertension, dyslipidaemia, hyperuricaemia, hypothyroidism, anxiety disorder, hyperhidrosis, sinus tachycardia, osteoarthritis, allergic rhinitis, insomnia, IQ (08Jun2011) excision of parathyroid adenoma and right hemithyroidectomy (PA - compatible with parathyroid adenoma (0.6 g) non-encapsulated papillary thyroid carcinoma with microfollicular pattern (0.6x0.5x0.5), no evidence of angiolymphatic or perineural invasion (multinodular goiter)). No known drug allergies. Concomitant medications included levothyroxine sodium (EUTIROX); omeprazole (OMEPRAZOLE); paracetamol (PARACETAMOL); allopurinol sodium (ALLOPURINOL [ALLOPURINOL SODIUM]); amiloride hydrochloride, hydrochlorothiazide (AMERIDE [AMILORIDE HYDROCHLORIDE;HYDROCHLOROTHIAZIDE]); ebastine (EBASTEL FORTE FLAS). The patient previously took the first dose bnt162b2 (COMIRNATY, lot number EP9598), intramuscular on 26Feb2021 for COVID-19 immunisation. The patient experienced haemorrhage intracranial on 02Apr2021, cerebral venous sinus thrombosis on 02Apr2021. Both events were considered as serious with fatal outcome and hospitalization. She was admitted on 03Apr2021 due to right parietal hemorrhage in the context of extensive venous sinus thrombosis affecting the upper longitudinal sinus and both predominantly right transverse sinuses in the context of left hemiparesis, the patient began symptoms on 02Apr2021 at 10:30 p.m. Upon admission, she presented a PA (Blood pressure measurement) 180 / 80mmHg, which corrected by itself without treatment with the rest of the correct constants, BMTEST 170 mg / dL, and the general analysis showed 331,000 platelets with normal coagulation. Sodium heparin pump anticoagulation was started on 03Apr2021. Due to worsening of the symptoms and drowsiness, several control CTs (Computerized tomograms) were performed later, the last one performed on 04Apr2021 shows increased bleeding and edema with a mass effect that displaces the midline and collapses ventricles, which is why anticoagulant treatment is suspended. The family is informed of the severity of the patient and a consensus is reached on the adequacy of the therapeutic effort. On 08Apr2021 the patient died. The patient underwent lab tests and procedures which included: Electrocardiogram: sinus rhythm at 100 bpm, PR 180 msec, 0 axis, QRS less than 120 msec without repolarization alterations; Analytical (03Apr2021 21:00-06:00): Hematology: Leukocytes 11,500 / uL, (N 78.8% / L 13.5 / M 6.5 / E 0.6 / B 0.6), Hties 4, 23, Hb (hemoglobin) 12.2 g / dL, Hcto (Hematocrit) 36.5%, MCV (Mean cell volume) 86.4 fL, Platelets 331000 (TP 100%), INR (International normalised ratio) 0.98 (TP ratio 0.98), APTT (Activated partial thromboplastin time) 30.7 sg (APTT ratio 0.99), Fibrinogen 527 mg /dL. Biochemistry: Glucose 182 mg / dL, Urea 83.2, Creatinine 1.15. Blood pressure measurement: 180/80 mmhg on 03Apr2021. Simple and venous sinus computed tomography (CT) (03Apr2021):right parietal lobar hemorrhage secondary to massive thrombosis of the superior sagittal venous sinus and right transverse (partial left transverse). CT (03Apr2021): Enlargement of the foci of acute intraparenchymal hemorrhage in the upper right parietal region with a slight increase in perilesional edema and fof the acute SAH occupancies in the right parietoocipital sulci. All of this exerting a greater mass effect on the grooves of the right frontoparietal convexity and on the ipsilateral LV, now observing complete collapse of the occipital horn. Analytical (03Apr21-23h): 280,000 platelets. CT (04Apr2021): increased bleeding and edema with mass effect that displaces the midline and collapses ventricles, Conclusion: Increased size of right intraparenchymal and subarachnoid hematomas with greater mass effect and herniation patterns. Sars-cov-2 test (PCR): negative on 03Apr2021. It is medications prescribed before admission reported and maintained during admission: Levothyroxine (Eutirox ), Omeprazole, Paracetamol. Withdrawn upon admission: allopurinol, Ameride, Ebastel forte. Therapeutic measures were taken as a result of events. The patient died on 08Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: 87-year-old woman. No known drug allergies. As AP (Pathological history) highlights: HT (Hypertension), DLP (Dyslipidemia), Hyperuricemia, Obesity, Chronic kidney disease, IQ (08Jun2011) excision of parathyroid adenoma + right hemithyroidectomy. PA - compatible with parathyroid adenoma (0.6 g) non-encapsulated papillary thyroid carcinoma with microfollicular pattern (0.6x0.5x0.5), no evidence of angiolymphatic or perineural invasion (multinodular goiter), Hypothyroidism, Anxiety disorder, Hyperhidrosis, Sinus tachycardia, Osteoarthritis, Allergic rhinitis, Insomnia. She was admitted on 03Apr2021 due to right parietal hemorrhage in the context of extensive venous sinus thrombosis affecting the upper longitudinal sinus and both predominantly right transverse sinuses in the context of left hemiparesis, the patient began symptoms on 02Apr2021 at 10:30 p.m. Upon admission, she presented a PA (Blood pressure measurement) 180 / 80mmHg, which corrected by itself without treatment with the rest of the correct constants, BMTEST 170 mg / dL, and the general analysis showed 331,000 platelets with normal coagulation. Sodium heparin pump anticoagulation was started on 03Sep2021. Due to worsening of the symptoms and drowsiness, several control CTs (Computerized tomograms) were performed later, the last one performed on 04Apr2021 shows increased bleeding and edema with a mass effect that displaces the midline and collapses ventricles, which is why anticoagulant treatment is suspended. . The family is informed of the severity of the patient and a consensus is reached on the adequacy of the therapeutic effort. On 08Apr2021 the patient died. - Electrocardiogram: sinus rhythm at 100 bpm, PR 180 msec, 0 axis, QRS less than 120 msec without repolarization alterations - Analytical (03Apr2021 21:00-06:00): Hematology: Leukocytes 11,500 / uL, (N 78.8% / L 13.5 / M 6.5 / E 0.6 / B 0.6), Hties 4, 23 mill /uL, Hb (hemoglobin) 12.2 g / dL, Hcto (Hematocrit) 36.5%, MCV (Mean cell volume) 86.4 fL, Platelets 331000 / uL, TP 100%, INR (International normalised ratio) 0.98 TP ratio 0.98, APTT (Activated partial thromboplastin time) 30.7 sg, APTT ratio 0.99 Fibrinogen 527 mg / dL. Biochemistry: Glucose 182 mg / dL, Urea 83.2, Creatinine 1.15. - Simple and venous sinus computed tomography (CT) (03Apr2021): right parietal lobar hemorrhage secondary to massive thrombosis of the superior sagittal venous sinus and right transverse (+ partial left transverse). - PCR SARS-COV2 (03Apr2021): negative. - CT (03Apr2021): Enlargement of the foci of acute intraparenchymal hemorrhage in the upper right parietal region with a slight increase in perilesional edema and fof the acute SAH occupancies in the right parietoocipital sulci. All of this exerting a greater mass effect on the grooves of the right frontoparietal convexity and on the ipsilateral LV, now observing complete collapse of the occipital horn. - Analytical (03Apr21-23h): 280,000 platelets. - CT (04Apr2021): Conclusion: - Increased size of right intraparenchymal and subarachnoid hematomas with greater mass effect and herniation patterns. Medications prescribed before admission (chronic medication) and maintained during admission: Levothyroxine (Eutirox) 75 microgr every 24h, Omeprazole 20 mg every 24h, Paracetamol 1 gc / 8h. Withdrawn upon admission: allopurinol 100mg every 24h, Ameride 5/50 mg every 24h, Ebastel forte 1 tablet / 24h. VO; Reported Cause(s) of Death: Haemorrhage intracranial; Cerebral venous sinus thrombosis


VAERS ID: 1259925 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-04-14
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFEXOR; CANDESARTAN; KARDEGIC; XATRAL; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiolitis obliterans with organising pneumonia; Cardiac failure (with cardiac stimulator); Mixed dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021442233

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, reference c2d1f6bd-24d0-416e-8d31-b94eba35978c. A 92-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 24Feb2021 11:00 am (Batch/Lot Number: EP9598) as SINGLE DOSE for covid-19 immunisation. Vaccinations done in a nursing home / senior Living Facility. Medical history included cardiac failure with cardiac stimulator, mixed dementia, Bronchiolitis Obliterans Organising Pneumonia (BOOP). Concomitant medications included venlafaxine hydrochloride (EFFEXOR LP 37.5 mg); candesartan 4 mg (unspecified trade name); acetylsalicylate lysine (KARDEGIC 75 mg); alfuzosin hydrochloride (XATRAL LP); prednisolone 30mg (unspecified trade name). Historical Vaccine included COMIRNATY for covid-19 immunisation dose 1 intramuscular, administered in Arm Left on 03Feb2021 10:45 am (Batch/Lot Number: EJ6788) as SINGLE DOSE. The patient experienced sudden death on 14Apr2021 at 06:45 pm. It was not reported if an autopsy was performed. No symptomatic treatment given. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information currently available, the event sudden death most likely represents an intercurrent medical condition and is unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1260394 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-28
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiovascular examination, Dyspepsia, Ischaemia, Pallor, Paraesthesia, Pericardial haemorrhage, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Hypotonic-hyporesponsive episode (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Felt faint; Jaw disorder; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:fine; Test Date: 202008; Test Name: cardiovascular examination; Result Unstructured Data: Test Result:clear; Test Date: 20210326; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021437898

Write-up: pale; indigestion; temporary tingling in right arm; Haemopericardium; Ischaemia; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104182304304820, Safety Report Unique Identifier GB-MHRA-ADR 25158189. A 75-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on 18Feb2021 at a single dose for covid-19 immunisation. Medical history included jaw disorder, felt faint, non-smoker. It was reported that parents had heart history. Patient has not had symptoms associated with covid-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were reported as none. It was reported that the patient is fit, downhill skier who had walked in the alps everyday of lockdown over the past year. On unspecified date, the patient experienced pale, indigestion and temporary tingling in right arm. On 28Mar2021, the patient experienced ischaemia and haemopericardium. The patient underwent lab tests and procedures which included covid-19 virus test: no - negative covid-19 test on 26Mar2021; cardiovascular examination which showed clear in Aug2020; and blood test which showed fine on unspecified date. The patient has not tested positive for covid-19 since having the vaccine. Outcome of the events pale, indigestion and temporary tingling in right arm was unknown. Outcome of the event ischaemia was not recovered. The patient died on 28Mar2021 due to haemopericardium. An autopsy was performed and results were not provided. Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Haemopericardium


VAERS ID: 1260399 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Pulmonary oedema, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN; ATORVASTATIN; BISOPROLOL; DIGOXIN; MIRTAZAPINE; MISOPROSTOL; OMEPRAZOLE; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Atrial fibrillation; Back ache (chronic); Depression; Hypertension; Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021443349

Write-up: Myocardial infarction; Pulmonary oedema; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202104191602038740. Safety Report Unique Identifier GB-MHRA-ADR 25161734. A 79-year-old male patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: not known) for covid-19 immunisation. Medical history included anxiety, depression, back ache chronic, atrial fibrillation, hypertension, transient ischaemic attack. Patient received the first dose of BNT62B2 on unknown date for COVID-19 immunization. It was unsure if patient has had symptoms associated with COVID-19, unsure if patient was enrolled in clinical trial. Concomitant medications included apixaban, atorvastatin, bisoprolol, digoxin, mirtazapine, misoprostol, omeprazole, tamsulosin. The patient experienced myocardial infarction and pulmonary oedema, both on 16Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: results negative. The patient died on 16Apr2021. It was not reported if an autopsy was performed. Patient had not tested positive for COVID-19 since having the vaccine. Outcome of the events was fatal. The report did not relate to possible blood clots or low platelet counts. This report is serious with seriousness criteria-results in death. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarction; Pulmonary oedema


VAERS ID: 1260407 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC2021443016

Write-up: Death; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is [GB-MHRA-WEBCOVID-202104201828117220-UJ5GE]. Safety Report Unique Identifier is [GB-MHRA-ADR 25166165]. A patient of unspecified age and gender received the second dose of BNT162B2 (COMIRNATY) at single dose on 17Apr2021 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. COVID-19 virus test was no - negative. Patient had not tested positive for COVID-19 since having the vaccine. The report did not relate to possible blood clots or low platelet counts. Patient experienced death on 19Apr2021. It was unknown if an autopsy was performed or not. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1260409 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   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: Ischaemic heart disease; Myocardial infarction; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021443290

Write-up: myocardial infarction; acute coronary syndrome (ACS); out of hospital cardiac arrest; unwell; Death; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104210741496200-JCVKJ. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Not Known) dose: 2, via an unspecified route of administration on 27Mar2021, as a single dose for covid-19 immunisation. Medical history included ischaemic heart disease (four times from unspecified dates), myocardial infarction (two times from unspecified dates), and type 2 diabetes. The patient has not had symptoms associated with covid-19, has not had a covid-19 test, and is not enrolled in a clinical trial. Concomitant medications were not reported. The patient experienced death on 31Mar2021; and out of hospital cardiac arrest secondary to acute coronary syndrome (ACS)/myocardial infarction and unwell, all on unspecified dates. The reporter denied that the report relates to possible blood clots or low platelet counts. It was reported that there were no concerns after the vaccination and that the patient was entirely well on 29Mar2021 before suddenly becoming unwell. The patient died on 31Mar2021. An autopsy was not performed and the reported causes of death were myocardial infarction, ischaemic heart disease, and type 2 diabetes. It was reported that because of the time frame this was not thought to be related to the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Myocardial Infarction; Ischaemic Heart Disease; Type 2 Diabetes


VAERS ID: 1260457 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0866 / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021440958

Write-up: Was found dead in his apartment; This is a spontaneous report from a contactable other hcp via Regulatory Authority. A 35-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER0866) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. It was reported that the patient was found dead in his apartment on an unspecified date. Time range: 1 week. The other hcp reported "Please see attached a file with reports on death and hospitalization in the vicinity of receiving a vaccine against Corona. Transferred to the medical examiner, no autopsy report yet". The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Was found dead in his apartment


VAERS ID: 1260458 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER6166 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   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: Cardiovascular disorder; Diabetes; Hypertension; Kidney disorder; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021441071

Write-up: Suddenly lost consciousness and died; coughed couple of times; This is a spontaneous report received from a contactable other HCP via a regulatory authority. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 31Mar2021 at 09:20 at age of 87 years old (Batch/Lot Number: ER6166) as single dose for covid-19 immunisation. Medical history included hypertension, cardiovascular and blood vessels, diabetes, kidney disease, osteoporosis. The patient''s concomitant medications were not reported. The vaccine was done on 31Mar2021 during the morning hours at 09:20, after the vaccine without complaints, without allergic reactions, vital signal were normal without complaints during the visit and the follow up conversation this morning with the treating nurse. During the day without complaints, felt normal, according to her at night she asked to drink, after she drank she coughed, lost consciousness and died. Emergency ambulance was invited, attempts to bring back to life without successes. Circumstances of death: During the night she woke up, asked to drink, coughed couple of times and suddenly lost consciousness. Time range reported as 12 hours. The outcome of event cough was unknown. The outcome of event lost consciousness was fatal. The patient died on 31Mar2021. It was not reported if an autopsy was performed. No follow up attempts are possible, no further information is expected.; Sender''s Comments: The fatal event loss of consciousness is likely intercurrent and unrelated to the suspect drug BNT162B2. Case to be reassessed should a follow-up information becomes available.,Linked Report(s) : IL-PFIZER INC-2020517122 Same product, different event, different patient (Master case); Reported Cause(s) of Death: Suddenly lost consciousness and died


VAERS ID: 1260459 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0866 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood iron, Blood iron decreased, Body temperature, Cardiogenic shock, Chest pain, Chills, Dizziness, Fatigue, Myocarditis, Pyrexia, Troponin, Troponin increased, Vitamin B12, Vitamin B12 decreased
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopic dermatitis
Allergies:
Diagnostic Lab Data: Test Name: iron; Result Unstructured Data: Test Result:decrease in iron; Test Name: fever; Result Unstructured Data: Test Result:a sense of fever; Test Name: troponin; Result Unstructured Data: Test Result:10,000; Test Name: troponin; Result Unstructured Data: Test Result:270,000; Test Name: B12; Result Unstructured Data: Test Result:decrease in B12
CDC Split Type: ILPFIZER INC2021441169

Write-up: Myocarditis/fluminant myocarditis; Cardiogenic shock; chest pain/Pressure pain in the middle of the chest; general feeling of weakness/weakness; chills; sense of fever; fatigue; dizziness; decrease in iron and b12; Drastic increase in troponin from 10,000 to 270,000; decrease in iron and b12; This is a spontaneous report received from a contactable other HCP via Israeli MOH Epidemiology department. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER0866) as single dose for COVID-19 immunisation. Medical history included atopic dermatitis. The patient''s concomitant medications were not reported. The patient previously took first dose bnt162b2 for COVID-19 immunisation. The patient experienced myocarditis/fluminant myocarditis (death, hospitalization) on an unspecified date (Time range: 11 days), cardiogenic shock (death, hospitalization) on an unspecified date, chest pain/pressure pain in the middle of the chest (hospitalization) on an unspecified date, general feeling of weakness/weakness (hospitalization) on an unspecified date, chills (hospitalization) on an unspecified date, sense of fever (hospitalization) on an unspecified date, fatigue on an unspecified date, dizziness (hospitalization) on an unspecified date, decrease in iron and b12 (hospitalization) on an unspecified date, drastic increase in troponin from 10,000 to 270,000 (hospitalization) on an unspecified date. The clinical course was reported as follows : Arrived to the emergency room with chest pain and general feeling of weakness. In addition felt chills, with a sense of fever, fatigue and weakness and dizziness while standing. Pressure pain in the middle of the chest which ease while lying and worsened while breathing, not radiating. During the last months, decrease in iron and b12. Drastic increase in troponin from 10,000 to 270,000. She was with fulminant myocarditis and Cardiogenic shock. died.The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of events myocarditis/fluminant myocarditis and Cardiogenic shock was fatal. The outcome of other events was unknown. No follow up attempts are possible, no further information is expected.; Reported Cause(s) of Death: Myocarditis/fluminant myocarditis; Cardiogenic shock


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