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

Found 17,128 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 142 out of 172

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VAERS ID: 1494471 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-22
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Myocardial infarction, Myocarditis
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiomyopathy; Heart enlarged; Pulmonary function test decreased; Total lung capacity low
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021857597

Write-up: heart muscle inflammation/infarct myocardial; sudden heart failure; Heart muscle inflammation/myocarditis; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021120092 with safety report unique identifier DE-PEI-202100116525. A 73-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration on 10Jun2021 as dose 2, 0.3 mL single for covid-19 immunisation. Ongoing medical histories included severely enlarged heart; cardiomyopathy; pulmonary function test decreased and; 60% lung volume. The patient''s concomitant medications were not reported. The patient had a severely enlarged heart and cardiomyopathy, but nobody knew about this beforehand, neither did the patient himself. At the time the patient had only 60% lung volume, so he decided to have the vaccination because he was afraid of Covid. On 22Jun2021 the patient experienced heart muscle inflammation/infarct myocardial and heart muscle inflammation. Sudden heart failure in the night on 22Jun2021, backwards failure and resuscitation was unsuccessful. A severely enlarged heart was found with myocarditis. The patient had not recovered from myocarditis. Infarct myocardial and heart failure were fatal. The patient died on 22Jun2021. Autopsy was performed and the exact autopsy report will follow in a few weeks. Relatedness of drug to reactions/events performed by HA, result of assessment "D. Unclassifiable". No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: sudden heart failure; Infarct myocardial


VAERS ID: 1494497 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, 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: 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: COPD; Nicotine abuse; Polyglobulia; Primary hyperthyroidism; Stroke
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021857671

Write-up: death; Shortness of breath; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021124269. A 61-year-old female patient received bnt162b2 (COMIRNATY, Strength: 0.3 mL; Lot number was not reported), via an unspecified route of administration on 26May2021 as dose 2, 0.3 mL single for covid-19 immunisation. The patient medical history included COPD, apoplectic stroke, polyglobulia, nicotine abuse, and primary hyperthyroidism; all from an unknown date and ongoing. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced shortness of breath (dyspnoea) and death. The outcome of shortness of breath (dyspnoea) was not recovered; and outcome of death was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1494498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Intracerebral haemorrhage
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021857605

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB DE-PEI-CADR2021124306. An 80-year-old female patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 29Apr2021 as dose 1, 0.3 mL, single for COVID-19 immunisation. The patient''s medical history included intracerebral haemorrhage. Concomitant medications were not reported. The patient experienced unknown cause of death on an unspecified date (14 days after vaccination). Patient died on an unspecified date. An autopsy was not performed. Relatedness of drug to reactions/events was considered D. Unclassifiable by HA. 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: 1494499 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Myocardial infarction, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   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: CLIACIL; NIMES; ENALAPRIL; MIRTAZAPINE; SERTRALINE
Current Illness: Hypercholesterolaemia; Nicotine dependence; Overweight
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021857678

Write-up: Angina pectoris - discomfort after vaccination.; Angina pectoris - discomfort after vaccination; ventricular fibrillation; infarct myocardial; This is a spontaneous report received from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021124412 and Safety report unique identifier is DE-PEI-202100120565. A 52-year-old male patient received dose 1 of bnt162b2 (COMIRNATY) via an unspecified route of administration on 04Jun2021 as a single dose for COVID-19 immunization. Medical history included nicotine dependence, hypercholesterolaemia, and overweight. Concomitant medications included phenoxymethylpenicillin potassium (CLIACIL), nimesulide (NIMES), enalapril, mirtazapine, and sertraline from unknown dates for unknown indications. On an unspecified date the patient experienced angina pectoris with discomfort after vaccination. It was reported the patient experienced event of ventricular fibrillation on 12Jun2021 , reported with seriousness criteria of death, and on unspecified date the patient also experienced angina pectoris. Events were also reported as "angina pectoris - discomfort after vaccination." The outcome of angina pectoris was reported as not recovered and outcome of ventricular fibrillation was fatal. The reported cause of death on 12Jun2021 was infarct myocardial. Relatedness of drug to reactions/events was assessed by the health authority as "D unclassifiable." Sender''s Comment: "Information on risk factors or previous illnesses Nicotine abuse, obesity, hypercholesterolemia. Medication: Cliacil, Nimes 100, Enalapril, Mirtazapine, Sertraline. Vaccinating practice nothing about the medication and risk factors. / on 12Jun2021, the patient was found lifeless at home and reanimated. Emergency doctor found ventricular fibrillation. The patient died in the clinic about 1.5 hours later with ongoing resuscitation. No autopsy ordered." No follow-up attempts are possible. Information about batch/lot number cannot be obtained.; Reporter''s Comments: Sender Comment: Information on risk factors or previous illnesses Nicotine abuse, obesity, hypercholesterolemia. Medication: Cliacil, Nimes 100, Enalapril, Mirtazapine, Sertraline. Vaccinating practice nothing about the medication and risk factors. / on 12Jun2021, the patient was found lifeless at home and reanimated. Emergency doctor found ventricular fibrillation. The patient died in the clinic about 1.5 hours later with ongoing resuscitation. No autopsy ordered.; Reported Cause(s) of Death: ventricular fibrillation; Infarct myocardial


VAERS ID: 1494527 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021833570

Write-up: Death; strong headache; This is a spontaneous report from a non-contactable consumer or other non-health care professional. This is first case from two cases for same product, same adverse event, different patient. (This is mother case) An unspecified age non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown, Expiration date was not reported), via an unspecified route of administration on 07Apr2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced death on 25Apr2021, strong headache on Apr2021. Reporters mother and father were very healthy and in good conditions until 13-14April. There were complications after vaccination. Reporter wanted Pfizer to help him to investigate this case if he also agrees to the exhumation. In (country), an incredible number of people die after vaccination. asking for help. It was not reported if an autopsy was performed. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. The outcome of event death was fatal, Strong headache was unknown. Follow-up attempt are not possible. No expected further information.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021833572 same product, same adverse event, different patient; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1494529 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-03
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Intestinal ischaemia, Platelet count, Thrombocytosis
SMQs:, Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 28
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: Thrombocyte count; Result Unstructured Data: Test Result:6000000
CDC Split Type: DEPFIZER INC2021861394

Write-up: extreme thrombocytosis; Intestinal ischemia; This is a spontaneous report from a contactable physician based on information received by Pfizer from BioNTech [manufacturer reference number: 72122], license party for COMIRNATY. A patient of unspecified age and gender 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''s medical history and concomitant medications were not reported. The patient experienced extreme thrombocytosis (death) on 03May2021, intestinal ischemia (death) on 03May2021. The patient underwent lab tests and procedures which included Thrombocyte count: 6000000. The patient died on 31May2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: A possible contributory role of the suspect drug to the reported events "extreme thrombocytosis and Intestinal ischemia" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: extreme thrombocytosis; Intestinal ischemia


VAERS ID: 1495519 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-13
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Basophil count, Body temperature, COVID-19, CSF lymphocyte count, Eosinophil count, Fibrin D dimer, Haematocrit, Haemoglobin, Investigation, Lymphocyte count, Mean cell haemoglobin, Mean cell volume, Musculoskeletal pain, Myelodysplastic syndrome, Neuralgia, Neutrophil count, Platelet count, Pyrexia, Red blood cell count, SARS-CoV-2 test, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Blood premalignant disorders (narrow), Myelodysplastic syndrome (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: ALLOPURINOL [ALLOPURINOL SODIUM]; EUCREAS; TRANKIMAZIN; FLUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypercholesterolemia
Allergies:
Diagnostic Lab Data: Test Name: Anemia; Result Unstructured Data: Test Result:7.3 g/dl; Test Name: Basophils; Result Unstructured Data: Test Result:0.03; Comments: 0.03 x10e3 / ugL (0.0 - 0.3); Test Name: Basophils; Result Unstructured Data: Test Result:0.2; Comments: 0.2% (0.0 - 3.0); Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210418; Test Name: CSF lymphocyte count; Result Unstructured Data: Test Result:Presence; Comments: Presence; Test Name: Eosinophils; Result Unstructured Data: Test Result:0.02; Comments: 0.02 x10e3 / ugL (0.1 - 0.6); Test Name: Eosinophils; Result Unstructured Data: Test Result:0.2; Comments: 0.2% (2.0 - 7.0); Test Date: 20210418; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:2148 ng/ml; Test Name: Hematocrit; Test Result: 25.1 %; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8 g/dl; Test Name: Anisocytosis coefficient; Test Result: 14.1 %; Test Name: Average platelet volume; Result Unstructured Data: Test Result:9.1; Comments: 9.1 fL; Test Name: Conc. Hemog. Corpuscular Mean; Result Unstructured Data: Test Result:31.9 g/dl; Test Name: Lymphocytes; Result Unstructured Data: Test Result:1.1; Comments: 1.1 x10e3 / ugL; Test Name: Lymphocytes; Result Unstructured Data: Test Result:9.0; Comments: 9.0% (20.0 - 50.0); Test Name: Mean Corpuscular Hemoglobin; Test Result: 33.9 pg; Test Name: Mean Corpuscular Volume; Result Unstructured Data: Test Result:106.4; Comments: 106.4 fL; Test Name: Neutrophils; Result Unstructured Data: Test Result:9.72; Comments: 9.72 x10e3 / ugL (1.5 - 7.5); Test Name: Neutrophils; Result Unstructured Data: Test Result:79.2; Comments: 79.2% (40.0 - 75.0); Test Name: Platelet count; Result Unstructured Data: Test Result:385; Comments: 385.0 x10e3 / ugL; Test Name: Red blood cells; Result Unstructured Data: Test Result:2.36; Comments: 2.36 x10e6 / ugL; Test Date: 20210418; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Negative; Test Name: Leukocytes; Result Unstructured Data: Test Result:12.27; Comments: 12.27 x10e3
CDC Split Type: ESPFIZER INC2021848576

Write-up: Developed COVID which caused his death; Myelodysplastic syndrome; Anaemia; Neuralgia; Arthromyalgia; Fever; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB [ES-AEMPS-928092]. An 80-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: ER9470), intramuscular on 29Mar2021 as single dose for COVID-19 immunisation. The patient''s medical history included hypercholesterolemia and diabetes mellitus (DM) 2. The patient''s concomitant medications included allopurinol sodium (ALLOPURINOL); metformin hydrochloride, vildagliptin (EUCREAS); alprazolam (TRANKIMAZIN); and fluvastatin. The patient experienced anaemia, neuralgia, arthromyalgia and fever on 13Apr2021. The patient also experienced myelodysplastic syndrome on 29Apr2021. The events resulted to hospitalization prolonged. As a result of this, the patient became very weak and developed COVID which caused his death on an unspecified date (reported as 1 month later). The patient underwent lab tests and procedures which included anemia: 7.3 g/dl on an unspecified date; basophils: 0.03 x10e3 / ugL (0.0 - 0.3) and 0.2% (0.0 - 3.0) on an unspecified date; body temperature: 38 Centigrade on an unspecified date; CSF lymphocyte count: presence on 18Apr2021; eosinophils: 0.02 x10e3 / ugL (0.1 - 0.6) and 0.2% (2.0 - 7.0) on an unspecified date; fibrin D dimer: 2148 ng/ml on 18Apr2021; hematocrit: 25.1 % on an unspecified date; hemoglobin: 8 g/dl on an unspecified date; anisocytosis coefficient: 14.1 % on an unspecified date; average platelet volume: 9.1 fL on an unspecified date; conc. hemog. corpuscular mean: 31.9 g/dl on an unspecified date; lymphocytes: 1.1 x10e3 / ugL and 9.0% (20.0 - 50.0) on an unspecified date; mean corpuscular hemoglobin: 33.9 pg on an unspecified date; mean corpuscular volume: 106.4 fL on an unspecified date; neutrophils: 9.72 x10e3 / ugL (1.5 - 7.5) and 79.2% (40.0 - 75.0) on an unspecified date; platelet count: 385.0 x10e3 / ugL on an unspecified date; red blood cells: 2.36 x10e6 / ugL on an unspecified date; COVID-19 PCR test: negative on 18Apr2021; leukocytes: 12.27 x10e3 on an unspecified date. Therapeutic measures were taken as a result of anaemia. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event COVID was fatal; anaemia was not recovered and the outcome of the other events were unknown. The clinical course was reported as follows: He went to the emergency room for 11 days of arthromyalgia, right hemicranial headache, dry cough and fever of 38 ?C, sat baseline at home 94%. They requested PCR SARS CoV2 14.04 which was negative. Denies close contact with COVID-19. COVID-19 vaccine on 29Mar21 first dose, second dose would be administered on 19Apr2021. Physical Exploration: BP 140/80 mmHg HR 88 bpm, sat 98% with 0.5bpm, afebrile. Conscious and oriented. Well hydrated and perfumed. Pale. Eupneic at rest. CyC no increase in PVY Rhythmic ac. AP mv decreased in bases, minimal crackles. Globular abdomen, somewhat filled but not peritonitic, no pain. Rectal examination: glove finger without blood debris, no manes, no rectal bleeding. LES no edema, no signs of Deep Vain Thrombosis ( DVT), palpable pulse. Complementary Explorations: Chest X-ray: normal CTI. Effacement of right sinuses with augmentation with diffuse bilateral infiltrates of predominance in both lung bases. Basic Coagulation: D-dimer 2148.0 ng / mL 500 TEC. Marrowly hypercellular bone marrow, with dysplasia in several lines and marked granulocytic hyperplasia and megakaryocytic; compatible with Myelodysplasic syndrome/Neoplasia. Thoracic Computed Thomography (CT) with contrast IV. Pulmonary angiography was performed with PET protocol on 320-detector CT with iodine map. No filling defects in main, lobar, or segmental pulmonary arteries suggesting signs of acute or chronic PTSD. Cone of the pulmonary caliber at the upper limit of normality. LV / DV ratio 1. No inversion of the DV / LV ratio. No pleural or pericardial effusion. No significant lung hypoperfusion areas are identified on the iodine map. In the lung parenchyma, a subtle thickening of peripherally located septa is observed - subpleural in practically all lung lobes, with some area of ??opacity with attenuation in Ground glass also in basal and posterior segments of both lower lobes. If you suspect it clinical condition is high and there is subsequent microbiological confirmation, the findings described could be compatible with involvement of the lung parenchyma due to COVID-19 infection, although the degree of suspicion is low-intermediate (CORADS3). The other possibility could be fibrosing disease without a pattern. defined at the present time, without honeycombing or traction bronchiectasis. Chronic inflammatory changes of the bronchial walls. Mild right pleural effusion. Small reactive-looking mediastinal lymphadenopathy. Bone frame with signs of dorsal spondylosis. Conclusion: No signs of acute or chronic PTSD. Subtle thickening of peripheral-subpleural septa in practically all lobes pulmonary, with some area of opacity with ground glass attenuation also in segments basal and posterior of both lower lobes. If the clinical suspicion is high and there is subsequent microbiological confirmation, the findings described could be compatible with involvement of the lung parenchyma due to COVID-19 infection, although the degree of suspicion is low-intermediate (CORADS3). The other possibility could be fibrosing disease without a defined pattern in the current moment, without honeycombing or traction bronchiectasis. Evolution: Very favorable. Upon admission, the marked elevation of acute phase reactants CRP 400, ESR 100, without fever, with mild cough, without dyspnea, with little need for o2 support. In addition, anemia of 7.3 g / dl macrocytic without externalize any bleeding, perfectly tolerated (which on the first day we attributed to hematological pathology due to follow-up in H RyC in this service, but his son clarifies that it was due to monocytosis and never due to anemia). It only had 38?C at admission, negative HC and UCR. Enter the plant as suspected COVID. We performed chest angioCT (no PET, slight infiltrates reported as possible incipient fibrosis rather than COVID) and abdominal CT without relevant findings. PCR COVID 2 negative. Positive IgG serologies corresponding to vaccine antibodies. It had started in the ER dexamethasone 6 mg with the suspicion of COVID and that we maintained due to the great improvement in the parameters inflammatory despite having ruled out COVID. We maintained antibiotic therapy with ceftriaxone although normal urine, due to dysuria (although only nocturnal and that impresses with prostatism, in echo bladder of possible fight and an enlarged prostate that was already known). Cranial CT (without lesions) and lumbar puncture were performed, presenting 17 cells in CSF, all of them monocytes, they are glucose consumption, high proteins, perhaps in favor of an unflammatory liquid, already correcting itself (under the effect of dexamethasone). Posterior cranial MRI, finding small frontal hygromas. We discuss image with Neuro Surgery. We transfused 2 concentrates on 04/20, which made it profitable and rose to 10.5 g / dl upon discharge. COOMBS was negative and a nondescript smear, without dysplastic features. Due to the suspicion of MDS, a bone marrow biopsy was performed by Hematology, confirming low-risk myelodysplastic syndrome that does not require treatment at the moment. We detected in the tests suppressed TSH with elevated T4 with echo with goiter / thyroiditis and suppressed scintigraphy, perhaps a phenomenon of Jod Basedow after iodine contrasts of CT on previous goiter. We started sumial and levothyroxine due to tachycardia, hypertension and nervousness and after commenting with Endocrinology. Upon admission, he complained of specific discomfort in the right upper quadrant. In CT and ECHO, lithiasis of 16 mm, without data of cholecystitis. MR cholangio without alterations. In CT and X-ray signs of redistribution and mild pleural effusion, with elevated BNP (1500), we requested TTE without detecting relevant findings. LVEF 59%, ECG without data of ischemia, possible liver stasis. We guide half-compressed security, follow-up in consultations. At discharge, excellent general condition, no fever, no oxygen needs, no pain in any location. Diagnostic Trial: Probable post-vaccination reaction (1st dose PFIZER 29.03 vaccine): neurological involvement (neuralgia and lymphocytosis in lcr) + fever + breakdown + self-limited cough + very high reactants + severe anemia + Hyper DD. Severe macrocytic anemia (transfusion support) in an inflammatory context and myelodipslastic syndrome. Hyperthyroidism / thyroiditis perhaps Jod Basedow phenomenon on goiter. Self-limited hemicranial headache with resolved neuropathic profile. Small frontal hygromas probably secondary to cerebral atrophy. Prostatic hypertrophy. Doubtful prostatitis. Moderately filled bladder with apparent diffuse wall thickening with a pseudodiverticular aspect. Bladder fighting? Acute renal failure due to low intake ?, obstructive ?, clearance MDR CKD EPI 53 ml / min. Mild-moderate hepatic steatosis. Baseline poorly controlled type 2 diabetes mellitus + meta-steroidal component. HTN not known, meta-steroid?; Reported Cause(s) of Death: Developed COVID which caused his death


VAERS ID: 1495538 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Antiphospholipid antibodies, CSF cell count, Computerised tomogram, Electroencephalogram, Electromyogram, Epstein-Barr virus test, Scan, Status epilepticus, Toxoplasmosis, Urinary tract infection
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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: VALPROATE; PHENYTOIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hydrocephalus (Posterior hydrocephalus with implantation of a bypass valve); Lymphocytic meningitis; Otitis media; Partial seizures; Urinary infection
Allergies:
Diagnostic Lab Data: Test Name: Lupus anticoagulant; Test Result: Positive ; Test Name: thoracoabdominal CT; Result Unstructured Data: Test Result:no images; Test Name: Cerebrospinal fluid; Result Unstructured Data: Test Result:high proteins, low cellularity; Test Name: Electroencephalogram; Result Unstructured Data: Test Result:barbiturate coma; Comments: only suppression with barbiturate coma was obtained; Test Name: electromyogram; Result Unstructured Data: Test Result:negative Guillain Barr; Comments: negative CSF filmarray, indeterminate quantiferon CSF tuberculosis PCR negative; Test Name: epstein-Barr; Test Result: Negative ; Test Name: Toxoplasmosis; Test Result: Negative ; Test Name: Imaging tests; Result Unstructured Data: Test Result:venous thrombosis ruled out
CDC Split Type: ESPFIZER INC2021848505

Write-up: Status epilepticus; suspected urinary infection; This is a spontaneous report from a contactable pharmacist downloaded from the Agency-WEB ES-AEMPS-934563. A 71-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 09Apr2021 (at the age of 71 years) (Batch/Lot Number: EW2243) as 0.3 mL, single for COVID-19 immunization. Medical history included lymphocytic meningitis from 1983, drained left temporo-parietal subdural epiema secondary to otitis media, posterior hydrocephalus with implantation of a bypass valve, partial seizures sequelae, urine infections. Concomitant medications included valproate sodium (VALPROATE) and phenytoin. The patient experienced status epilepticus on 09Apr2021. On an unspecified date, the patient underwent lab tests and procedures which included lupus anticoagulant: positive, thoracoabdominal CT: no images, cerebrospinal fluid: high proteins, low cellularity, electroencephalogram: barbiturate coma, only suppression with barbiturate coma was obtained, electromyogram: negative Guillain Barr, negative CSF film array, indeterminate quantiferon CSF tuberculosis PCR negative, epstein-barr virus test: negative, and toxoplasmosis: negative; all on an unspecified date. Clinical course was reported as follows: On the same day of the vaccination, 09Apr2021, patient presented with a seizure (without fever with positive urine combustion and initiation of ceftriaxone) that is repeated the next day with functional deterioration. Admission to the intensive care unit due to epileptic status. Patient was treated with valproate, levetiracetam, phenytoin, sedation with midazolam and propofol, shows initiation in electroencephalogram, only suppression with barbiturate coma was obtained. The cause has not been found. Cerebrospinal fluid: high proteins, low cellularity, electromyogram to rule out negative Guillain Barre. negative CSF filmarray, indeterminate quantiferon CSF tuberculosis PCR negative, thoracoabdominal CT no images. Toxoplamosis, epstein-Barr, ACE blood negative. Positive lupus anticoagulant, venous thrombosis ruled out by imaging tests. Ceftriaxone was started after presenting a seizure due to suspected urinary infection. He has previously received ceftriaxone in other admissions for urinary tract infections without adverse reactions to ceftriaxone. In the context of other infections, he had had seizures that resolved. Outcome of the event status epilepticus was fatal and of the event suspected urinary infection was unknown. The patient died on 25May2021. An autopsy has not been requested. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Status epilepticus


VAERS ID: 1495601 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Body mass index, Haemoglobin, Ischaemic stroke, Magnetic resonance imaging head, Platelet count, White blood cell count
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LERCANIDIPINE HCL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal wall wound; Appendectomy; Body mass index high; Hypertension arterial; Inguinal hernia; Lithiasis; Surgery (Surgery for lithiasis under maxillary G in June 2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: creatinine; Result Unstructured Data: Test Result:77 umol/l; Test Name: BMI; Result Unstructured Data: Test Result:31; Test Date: 20210708; Test Name: hemoglobin; Result Unstructured Data: Test Result:153 g/l; Test Date: 20210707; Test Name: brain mri; Result Unstructured Data: Test Result:total sylvian left ischemic stroke; Comments: total sylvian left ischemic stroke, with extensive lesions in DWI, ASPECTS 1/10, not visible in FLAIR; Test Date: 20210708; Test Name: platelets; Result Unstructured Data: Test Result:617; Comments: Giga per liter; Test Date: 20210708; Test Name: WBC; Result Unstructured Data: Test Result:25.15; Comments: giga per liter
CDC Split Type: FRPFIZER INC2021896194

Write-up: Ischemic stroke; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number FR-AFSSAPS-LY20217710. A 55-year-old male patient received second dose of bnt162b2 (COMIRNATY), dose 2 intramuscular on 05Jul2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included hypertension from an unknown date, BMI 31, lithiasis from an unknown date, surgery from Jun2021 to an unknown date (Surgery for lithiasis under maxillary G in Jun2021), abdominal wall wound from an unknown date(Abdominal wound by knife), appendicectomy from an unknown date , inguinal hernia from an unknown date and all unknown if ongoing. Concomitant medication included lercanidipine hcl (LERCANIDIPINE HCL) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY), for covid-19 immunization. The patient experienced ischemic stroke on 07Jul2021. The patient underwent lab tests and procedures which included blood creatinine: 77 umol/l on 08Jul2021 , body mass index: 31, haemoglobin: 153 g/l on 08Jul2021, magnetic resonance imaging head: total sylvian left ischemic stroke on 07Jul2021 total sylvian left ischemic stroke, with extensive lesions in DWI, ASPECTS 1/10, not visible in FLAIR , platelet count: 617 on 08Jul2021 Giga per liter , white blood cell count: 25.15 on 08Jul2021 giga per liter. The patient died on Jul2021. An autopsy was not performed. The clinical course was reported as follows: 05Jul2021 vaccination with a second dose of Comirnaty vaccine lot unknown. 07Jul2021 around 17:40 , right hemiplegia and aphasia, with description of initial loss of consciousness. Management in the outpatient department. Brain MRI at 19:20: total sylvian left ischemic stroke, with extensive lesions in DWI(?), ASPECTS 1/10, not visible in FLAIR. With occlusion at the GIC(?) termination. Transfer to neurology for thrombectomy. 08Jul2021 hemorrhagic transformation of the stroke and major edema with subfalcoral and temporal involvement, with brainstem compression. Given the severity of the lesions, no indication for craniectomy, referral for comfort care. Additional examinations: 08Jul2021 WBC 25.15G/L, Hb 153g/L, platelets 617 G/L, creatinine 77 umol/L. Lot number: Unknown. Event Outcome: Fatal. No follow-up attempts possible. Lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1495630 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood immunoglobulin G, Body mass index, Drug ineffective, Immunology test, Protein total, SARS-CoV-2 antibody test, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney transplant; Liver transplant
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: anti-S1 IgG; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: BMI; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: Immunogenicity Chemiluminescent microparticle immunoassays (CMIA); Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: nucleocapsid protein of SARS-CoV-2; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: SARS-CoV-2 spike protein; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: SARS-CoV-2 serology; Test Result: Negative
CDC Split Type: FRPFIZER INC202100910182

Write-up: severe COVID-19 /respiratory failure syndrome/developed Sars-Cov-2 infection 13 and 22 days after the second injection respectively; severe COVID-19 /respiratory failure syndrome/developed Sars-Cov-2 infection 13 and 22 days after the second injection respectively; This is a Literature report. This reporter reported similar events for 4 subjects. This is the 4th of 4 reports. A subject of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included liver and kidney transplant-recipient. The subject''s concomitant medications were not reported. It was reported that from Jan2021 to Apr2021, 143 SOT-recipients who received two doses (28 days apart) of BNT162b2 vaccine were retrospectively and consecutively included in our study, alongside a control group of healthcare workers (HCWs) with no major co-morbidities. Four subjects have developed severe COVID-19 between (n=2) and after the two doses (n=2; one with positive anti-S1 IgG (476 UA/mL; 68 BAU/ml) and one with negative anti-S1 IgG at the time of the diagnostic). In details, the latter two developed Sars-Cov-2 infection 13 and 22 days after the second injection respectively and required hospitalization. One of the two patients was liver and kidney transplant-recipient, required admission to intensive care and eventually died from the disease. They reported no major adverse events to the vaccine. Their data suggested that SOT-recipients remain at high risk for COVID-19 disease during the outbreak, as seen in our cohort. Indeed, they reported four cases of COVID-19 disease among patients, of which two received two doses of vaccine. One of them died from respiratory failure syndrome. The subject underwent lab tests and procedures which included anti-S1 IgG, body mass index (BMI), Immunogenicity Chemiluminescent microparticle immunoassays (CMIA), nucleocapsid protein of SARS-CoV-2, SARS-CoV-2 spike protein with unknown results in 2021 and SARS-CoV-2 serology with negative in 2021. The outcome of the events was fatal. It was unknown if autopsy done. No follow-up attempts are needed. No further information is expected. Information about batch number cannot be obtained.; Sender''s Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new 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) : FR-PFIZER INC-202100910063 Same article/drug, different patient; Reported Cause(s) of Death: severe COVID-19 /respiratory failure syndrome/developed Sars-Cov-2 infection 13 and 22 days after the second injection respectively; severe COVID-19 /respiratory failure syndrome/developed Sars-Cov-2 infection 13 and 22 days after the second injectio


VAERS ID: 1495639 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
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: Medical History/Concurrent Conditions: Bowel cancer (for 11 years prior to report time); Liver, cancer of (for 11 years prior to report time); Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021900660

Write-up: Death after vaccination by COMIRNATY; This is a spontaneous report received from a contactable consumer (reporting for niece) via Medical Information team. A 50-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included bowel cancer for 11 years prior to report time, liver cancer for 11 years prior to report time, lung cancer. She had bowel and liver cancer for 11 years, never went into remission, markers came back normal...lately it was the lungs. The patient''s concomitant medications were not reported. The patient experienced death after vaccination by comirnaty on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The patient added that she does not think her niece died because of the vaccine. Information on the batch/lot number has been requested.; Sender''s Comments: Based on the information currently available, the reported event was likely related to patient''s underlying medical history of bowel cancer, liver cancer and lung cancer and not related to BNT162B2.; Reported Cause(s) of Death: Death


VAERS ID: 1496478 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-20
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C14-02 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRJNJFOC20210743981

Write-up: HEART ATTACK; This spontaneous report received from a health care professional concerned a 7 decade old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 21C14-02 expiry: 31-MAR-2023) dose was not reported,1 total administered on 19-JUL-2021 11:00 a.m. at left deltoid for prophylactic vaccination. No concomitant medications were reported. Reporter stated that thirty two hours after vaccination patient died of heart attack at 21:45 p.m. on 20-JUL-2021. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210743981-Covid-19 vaccine ad26.cov2.s-Heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK


VAERS ID: 1496498 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021861575

Write-up: Heart attack; This is Spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report downloaded from the regulatory authority-WEB, regulatory authority number IE-HPRA-2021-073162, Safety Report Unique Identifier IE-HPRA-2021-073162 A male patient of an unspecified age 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 experienced a heart attack with fatal outcome post vaccination with Comirnaty 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.; Sender''s Comments: Linked Report(s) : IE-PFIZER INC-2021857633 same reporter/drug/event, diff patients; Reported Cause(s) of Death: Heart attack


VAERS ID: 1496503 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Illness
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: ITJNJFOC20210742180

Write-up: SUDDEN ILLNESS; This spontaneous report received from a consumer via social media concerned a 3 decade old of unspecified sex. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, 1 total, administered, 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, the patient died due to sudden illness. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210742186.; Sender''s Comments: V0:20210742180- covid-19 vaccine ad26.cov2.s -SUDDEN ILLNESS. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SUDDEN ILLNESS


VAERS ID: 1496504 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Illness
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: ITJNJFOC20210742186

Write-up: SUDDEN ILLNESS; This spontaneous report received from a consumer via social media and via a company representative, concerned a 3 decade old patient (in 20s; exact age unknown) of unspecified sex, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, and expiry: unknown) dose, start therapy date were not reported, 1 total, administered 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, following vaccination, the patient experienced sudden illness (unspecified) and died due to it. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sudden illness was fatal. This report was serious (Death). This case, from the same reporter is linked to 20210742180.; Sender''s Comments: 20210742180-COVID-19 VACCINE AD26.COV2.S-SUDDEN ILLNESS. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SUDDEN ILLNESS


VAERS ID: 1496517 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EZ1484 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dysstasia, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210112; Test Name: SARS-CoV-2/COVID-19 PCR test; Test Result: Negative ; Test Date: 20210114; Test Name: SARS-CoV-2/COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021848502

Write-up: On 12Jan2021, negative test. 13Jan, 1st dose of Pfizer vaccine, batch E21484. 14Jan2021 fever and positive swab. The fever continues intermittently./difficulty standing; On 12Jan2021, negative test. 13Jan, 1st dose of Pfizer vaccine, batch E21484. 14Jan2021 fever and positive swab. The fever continues intermittently.; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority, regulatory authority number IT-MINISAL02-752317. A 95-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in arm left (Administration site: left shoulder) on 13Jan2021 09:00 (Batch/Lot Number: EZ1484, also reported as E21484 and as EL1484; Expiration Date: 30Apr2021) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 12Jan2021, negative test (SARS-CoV-2 PCR test). 13Jan2021, 1st dose of Pfizer vaccine, batch E21484 (as reported). On 14Jan2021, fever and positive swab (COVID-19 PCR test, positive covid-19 test with symptoms). The fever continues intermittently. The patient also has difficulty standing. It was also reported that cause of death was unknown. The patient died on 04Feb2021. It was not reported if an autopsy was performed. Investigation report indicated that for this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot "EL1484". A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. Th process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause were identified as the complaint was not confirmed. Reporter comment: The lady was in the Nursing home. On 12Jan2021, a swab was performed with a negative result. On 13Jan the 1st dose of the vaccine was administered, on 14Jan, fever, positive swab and difficulty standing. The fever continues intermittently, until the death of the lady, which occurred on 04Feb2021. I report based on the story of the daughter of the deceased person. Sender''s comments: 01Jul2021: request to the reporter for a clinical report on the case complete with anamnesis. Waiting for a reply.; Reporter''s Comments: The lady was a quest in the Nursing home. On 12Jan2021, a swab was performed with a negative result. On 13Jan the 1st dose of the vaccine was administered, on 14Jan, fever, positive swab and difficulty standing. The fever continues intermittently, until the death of the lady, which occurred on 04Feb2021. I report based on the story of the daughter of the deceased person.; Reported Cause(s) of Death: On 12Jan2021, negative test. 13Jan, 1st dose of Pfizer vaccine, batch E21484. 14Jan2021 fever and positive swab. The fever continues intermittently./difficulty standing; On 12Jan2021, negative test. 13Jan, 1st dose of Pfizer vaccine, batch E21484. 14


VAERS ID: 1496546 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021874128

Write-up: Death during sleeping, cause heart failure; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via intramuscular in the left arm, on 22Jun2021 (at the age of 59-year-old) at single dose for COVID-19 immunisation, administered to the hospital. Historical vaccine included the first dose of BNT162B2 (COMIRNATY) administered on unknown date for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 25Jun2021, the patient experienced death during sleeping. The cause of death was heart failure. No autopsy was performed. No follow-up attempts are possible. Information about Batch/Lot number cannot be obtained.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1496550 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-23
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: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100923995

Write-up: Death; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A patient of unknown age and gender received BNT162b2 (COMIRNATY, Solution for injection), second dose on unknown date in May2021 (the day of vaccination) (Lot number unknown, Expiration date unknown) via an unspecified route of administration as single dose for COVID-19 immunization. The family history and medical history were not provided. Concomitant medications were not reported. The patient previously received BNT162b2 (COMIRNATY), first dose (Lot# unknown, Expiration date unknown) on unknown date in 2021 for COVID-19 immunisation. On unknown date in Jun2021 (4 days after the vaccination), the patient experienced death. The course of the event was as follows: At the end of May2021, the patient received the second dose of BNT162b2 vaccination. 4 days after the vaccination, the patient suddenly died. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162b2. It was unknown if Autopsy Done. On unknown date in Jun2021 (4 days after the vaccination), the outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history, concomitant medication and autopsy report, becomes available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1496571 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Neoplasm progression
SMQs:, Malignancy related conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Debility; Oesophageal carcinoma; Pneumonia (admitted to the reporting hospital); Terminal state
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021853757

Write-up: Aggravated general condition; This is a spontaneous report from a contactable physician via COVID-19 Adverse Event Self-Reporting Solution. An 88-years-old female patient (non-pregnant) received second dose of bnt162b2 (COMIRNATY), at the age of 88-years-old, intramuscular on 01Jul2021 14:00 (Lot Number: FA7338; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. Medical history included Middle thoracic oesophageal carcinoma (Stage IV) from Nov2020 to an unknown date, end-of-life care from Nov2020 to an unknown date, pneumonia from 07May2021 to an unknown date (admitted to the reporting hospital), debilitation started to progress gradually from Jun2021 to an unknown date. There were no known allergies. Concomitant medication included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported. Patient received first dose of bnt162b2 (COMIRNATY), at the age of 88-years-old, intramuscular on 10Jun2021 14:00 (Lot Number: FA5765; Expiration Date: 30Sep2021) for covid-19 immunisation. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced aggravated general condition on 02Jul2021 10:30. The patient died on 03Jul2021. An autopsy was not performed. On 02Jul2021 at 10:30 (1 day after the vaccination), the patient experienced aggravated general condition. On 03Jul2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: In Nov2020, the patient experienced middle thoracic oesophageal carcinoma (Stage IV), and end-of-life care was decided. On 07May2021, the patient was admitted to the reporting hospital because of pneumonia. In early Jun2021, debilitation started to progress gradually. On 01Jul2021 at 14:00 (the day of vaccination), the patient received the second BNT162b2 vaccination intramuscularly. On 02Jul2021 (1 day after the vaccination), the patient was noted to have aggravated general condition, was transferred to palliative care ward, and only received best supportive care. On 03Jul2021 at 13:38 (2 days after the vaccination), the patient died. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter stated that the adverse event resulted in prolonged hospitalization (the vaccine was given during the hospitalization) and death. The death cause was middle thoracic oesophageal carcinoma. No autopsy was performed. No treatment was given for the adverse event. The reporting physician assessed the event as serious (death). The causality of the event was not reported.; Sender''s Comments: Based on the information provided by the reporter, the causal association between the event "neoplasm progression" and BNT162B2 is assessed as unrelated. 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: Middle thoracic oesophageal carcinoma


VAERS ID: 1496580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Immune-mediated/autoimmune disorders (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: JPPFIZER INC2021855736

Write-up: Thrombocytopenic purpura; patient died on an unspecified date; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced thrombocytopenic purpura, which was serious for death. The patient died on an unspecified date due to thrombocytopenic purpura. 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: Thrombocytopenic purpura


VAERS ID: 1496584 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Pallor, Unresponsive to stimuli, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Knee operation
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021855914

Write-up: Death; did not respond to a call; pallor facial; Vomiting; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A non-pregnant 84-year-old female patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: FA7338; Expiration Date: 30Sep2021), intramuscularly in the left arm on 30Jun2021 at 13:00 at a single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Medical history included diabetes mellitus and knee surgery. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: FA5715, Expiration date 31Aug2021) on 09Jun2021 at 13:00 for COVID-19 immunisation. On 01Jul2021, the patient experienced vomiting. On 02Jul2021, the patient experienced pallor facial, she did not respond to a call, and died. The clinical course was as follows: on 30Jun2021 at 13:00 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscular in the arm left for COVID-19 immunization. On 01Jul2021 (1 day after vaccination), although the patient repeatedly had vomiting, she did not visit the hospital. On 02Jul2021 (2 days after vaccination), in the morning, the patient had pallor facial, and she did not respond to a call, and she was emergently transferred. The patient was confirmed to die. Cause of death was unknown. It was unknown whether an autopsy was performed. It was unknown whether the patient received some treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient died on 02Jul2021 due to unknown cause of death. It was not reported if an autopsy was performed.; Sender''s Comments: A reasonable possibility that the event unknown cause of death is related to vaccination with BNT162B2 cannot be completely excluded until further information regarding death cause is provided. Potential contributors include patient''s advanced age and underlying diabetes mellitus. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1496597 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Brain stem haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Diabetic nephropathy; Haemodialysis; Hemodiafiltration; Nephroureterectomy; Renal failure chronic (renal failure chronic due to diabetic nephropathy); Urothelial carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021857095

Write-up: Brain stem haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21118234. A 73-year-old and 3-month-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 01Jun2021 at 10:30 (Lot Number: FA5715; Expiration Date: 31Aug2021) as dose 2, single for COVID-19 immunisation. Body temperature before vaccination was 36.9 degrees centigrade (on 01Jun2021). Medical history included renal failure chronic due to diabetic nephropathy, maintenance hemodialysis from 20Mar2008, urothelial carcinoma in 2010, total nephroureterectomy for urothelial carcinoma in 2010, and cerebral haemorrhage (without late effects) in Oct2014. From 14Jul2018, the patient was being treated with a maintenance hemodiafiltration at the reporting hospital. The family history was not provided. Concomitant medication included ongoing oral acetylsalicylic acid (BAYASPIRIN). On 11May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: EX3617, Expiration date 31Aug2021) for COVID-19 immunisation. The patient had no side reactions after the vaccination. On 01Jun2021 at 10:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5715, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 02Jun2021 (1 day after vaccination) and 04Jun2021 (3 days after vaccination), a maintenance hemodiafiltration was performed as usual. On 06Jun2021 at 16:30 (5 days and 6 hours after the vaccination), the patient experienced brain stem haemorrhage. The patient fell at his home, and he was emergently transferred. The patient was diagnosed with brain stem haemorrhage. On the same day, the patient was admitted to a hospital. On 07Jun2021, the patient was transferred to another hospital. On 16Jun2021 (15 days after the vaccination), the outcome of the event brain stem haemorrhage was fatal. It was unknown if autopsy was performed. The reporting physician classified the event as serious (hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. It was not reported regarding other possible cause of the event such as any other diseases. No follow-up attempts are possible; information about batch number was already obtained.; Reported Cause(s) of Death: Brain stem haemorrhage


VAERS ID: 1496614 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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: Aortic aneurysm; Colon cancer; Gavage; Myocardial infarction; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased; Test Date: 20210706; Test Name: X-ray test; Result Unstructured Data: Test Result:revealed pneumonia findings
CDC Split Type: JPPFIZER INC2021857519

Write-up: Pneumonia; This is a spontaneous report from a contactable physician via Regulatory Agency. The patient was an elderly male. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no relevant past drug history. There were no known allergies. Other medical history included pneumonia aspiration, myocardial infarction, aortic aneurysm, colon cancer, and tube feeding via gastric fistula. The patient had experienced recurrent pneumonia aspiration and had been in the hospital for tube feeding via gastric fistula. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Jul2021 at unknown time, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscularly for COVID-19 immunization. After the vaccination, the patient experienced no abnormality. On 06Jun2021 (1 day after the vaccination), the patient experienced pneumonia. On 06Jul2021 around 10:00, the patient had decreased oxygen saturation and started to receive oxygen. X-ray test revealed pneumonia findings. Tube feeding was stopped, and the patient received transfusion and antibiotics. On 08Jul2021 (3 days after the vaccination), he died. The death cause was pneumonia. No autopsy was performed. Treatment given for the adverse event included antibiotics, fluid replacement, and steroids. The reporting physician assessed the event as serious (death). The causality of the event was not reported.; Sender''s Comments: Based on the information currently available,The casual association between the reported event "pneumonia" and suspected vaccine BNT162B2 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: Pneumonia


VAERS ID: 1496616 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Hypertension; Osteoporosis; Tuberculosis
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021857697

Write-up: Haematemesis; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21118715. An 85-year and 5-month-old female patient received second dose of BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 02Jul2021 at 14:40 (Lot Number: FA5765; Expiration Date: 30Sep2021) (at the age of 85-year-old) as single dose for COVID-19 immunisation. Medical history included tuberculosis, chronic obstructive pulmonary disease, hypertension and osteoporosis all from an unknown date and unknown if ongoing. The family history was not provided. The patient''s concomitant medications were not reported. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot Number and Expiration date were not reported). Body temperature before vaccination was 36.9 degrees centigrade. On 02Jul2021 at 14:40 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY). No abnormalities were observed on the medical interview. Since no change was observed in the physical condition while the patient was waiting for 15 minutes after the vaccination, she went home. On 04Jul2021, at around 15:00 (2 days after the vaccination), it was reported that the patient talked with her neighborhood with energy. On 05Jul2021 (3 days after the vaccination), the patient experienced haematemesis. In the morning, the patient did not respond to the contact from the family, and the family visited the patient. The patient died with haematemesis on the bed. It was not reported whether an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were as follows: The patient had tuberculosis when she was young. Recently, the patient was being treated with an inhalant and other medications for chronic obstructive pulmonary disease. The patient was being treated with administration of drugs for hypertension and osteoporosis.; Reported Cause(s) of Death: Haematemesis


VAERS ID: 1496618 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-29
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Pleural effusion, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lung cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic; Diabetes mellitus; Hypertension; Iodine allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021857834

Write-up: Left pleural effusion; Dyspnoea; Pain in vaccinated left upper arm; This is a spontaneous report from a contactable physician and nurse received from the Regulatory Agency (RA). Regulatory authority report numbers are v21118710 and v21118712. The patient was a 90-year and 11-month-old female. On 22Jun2021, body temperature before vaccination was 36.8 degrees Centigrade. Relevant medical history included lung cancer, diabetes mellitus and hypertension. The patient had allergy to cephem antibiotics, CRAVIT and iodine agent. On 01Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, at single dose, for COVID-19 immunization. After the first dose of vaccination, there was no complaint of pain and no change was noted in her condition of disease. On 22Jun2021 at 14:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot. EY5422, Expiration date: 31Aug2021) via an unspecified route of administration, at single dose, in the left upper arm, for COVID-19 immunization. On 29Jun2021 (7 days after the vaccination), the patient experienced vaccination site pain. On 02Jul2021 (10 days after the vaccination), the patient experienced difficult to expectorate sputum. On 03Jul2021 at 07:00 (11 days after the vaccination), the patient experienced dyspnoea. On 05Jul2021 (13 days after the vaccination), the patient experienced left pleural effusion. On 06Jul2021 at 14:49 (14 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: on 29Jun2021, the patient complaint of pain in the left upper arm (the vaccination site). After 30Jun2021, there was no complaint of pain. On 02Jul2021, as it was difficult to expectorate sputum, MUCOSOLVAN was prescribed. She did not complain of difficulty in breathing. On 03Jul2021, difficulty in breathing and shortness of breath on exertion were recognized. Therefore, administration of oxygen at 2L was started via transnasal catheter. On 04Jul2021, since oxygen saturation decreased, the dosage of oxygen was gradually increased to 6L and the route of oxygen administration was changed to an oxygen mask. Difficulty in breathing on exertion worsened. Therefore, after the physician talked to the patient, urethral catheter was placed. The patient complained that it was uncomfortable for her to wear an oxygen mask. Because of the patient''s wish and improvement of oxygen saturation, the dosage of oxygen was decreased to 4L, and the route of oxygen administration was changed to a transnasal catheter. On 05Jul2021, left pleural effusion was confirmed. The transnasal catheter was changed to an oxygen mask. On 06Jul2021 at 14:49, the patient passed away. The reporting physician classified the events of dyspnoea and pleural effusion as serious (fatal outcome) and assessed that the events were not related to BNT162b2. Lung cancer was considered as a possible cause of the events.; Sender''s Comments: The events considered as intercurrent conditions and unrelated to suspect products BNT162b2 (COMIRNATY). The events were attributed to lung cancer.; Reported Cause(s) of Death: Dyspnoea; Pleural effusion; Lung cancer


VAERS ID: 1496619 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021857863

Write-up: Death; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 71-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection), at the age of 71-year-old, via an unspecified route of administration on 05Jul2021 (the day of vaccination) (Lot number unknown, Expiration date unknown) as single dose for COVID-19 immunization. The patient had no allergies and no underlying diseases. Concomitant medications were not reported. On 06Jul2021 (one day after the vaccination), the patient died. The cause of death was not reported. The course of the event was as follows: On 05Jul2021 (the day of vaccination), the patient received a dose of BNT162b2 vaccination. The patient was followed up for approximately 15 minutes at the clinic. No abnormalities were observed, thus, he went home. On 06Jul2021 (one day after vaccination), the patient died at his home. Since this report was obtained from the police, the cause of death and others were unknown. The causality between the event and BNT162b2 was not provided. It was not reported if Autopsy Done. The outcome of the event was Fatal.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event death and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The contribution of patient''s age cannot be completely ruled out in the occurrence of the event death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1496634 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Cerebellar infarction, Computerised tomogram head, Eye movement disorder, Feeding disorder, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (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), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Von Recklinghausen''s disease (of nerve)
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210705; Test Name: Head CT; Result Unstructured Data: Test Result:bilateral cerebellar infarction
CDC Split Type: JPPFIZER INC2021858625

Write-up: Cerebellar infarction; Consciousness disturbed; Unable to eat; Ocular deviation; muscle weakness right upper limb; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118246. A 55-year and 11-month-old female patient received first dose of bnt162b2 (COMIRNATY; Lot Number: EY3860; Expiration Date: 31Aug2021), via an unspecified route of administration on 29Jun2021 at 10:00 (at 55 years) as single dose for covid-19 immunisation. Medical history included Von Recklinghausen''s disease (not ongoing, as reported). Family history and concomitant drugs were not provided. Body temperature before vaccination on 29Jun2021 was 36.1 degrees Centigrade.On 05Jul2021 (6 days after the vaccination, as reported), the patient experienced cerebellar infarction. The course of the events was also described as follows: On 05Jul2021 in the morning, as there was something wrong with the patient''s condition and she could not consume her lunch (feeding disorder), she visited the reporter''s hospital. Consciousness disturbed, ocular deviation (conjugation to left) and muscle weakness right upper limb were noted. Head CT scan showed bilateral cerebellar infarction. On the same day, the patient was admitted to a different hospital.Treatment was given.On 06Jul2021 (7 days after the vaccination), the patient died. It was not reported if an autopsy was performed. Event cerebellar infarction was fatal; outcome of the other events was unknown. The reporting physician classified the event as serious (hospitalization) and assessed the causality between the event and BNT162b2 as unassessable. Atherothrombosis was considered as a possible cause of the event. The physician commented that the patient had medical history of Von Recklinghausen''s disease.; Reported Cause(s) of Death: Atherothrombosis; Cerebellar infarction


VAERS ID: 1496644 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021859112

Write-up: Myocardial infarction; This is a spontaneous report from a contactable consumer received via Medical information team. A 57-year-old patient of an unspecified gender received BNT162b2 (COMIRNATY, Solution for injection, Lot number, and Expiration date were not reported) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date at night (the day of vaccination), the patient experienced myocardial infarction and died. The reporter stated as follows. Recently, a neighbor received the vaccine and on the same day at night, the neighbor developed myocardial infarction and died in a bathroom. It was unknown whether an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1496654 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Arthralgia, Dyspnoea, Groin pain, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021862365

Write-up: unconsciousness; Suspected aortic dissection; pain from the left hip to the left groin; difficulty in breathing; pain in the shoulder (on the injected side)/pain from the left hip; This is a spontaneous report from a contactable pharmacist received from the Regulatory authority. Regulatory authority report number is v21118324. The patient was a 75-year and 10-month-old female. Body temperature before vaccination was not provided. On 24Jun2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. It was not reported if the patient had medical history or if the patient was receiving concomitant medications. On 25Jun2021, pain in the shoulder (on the injected side) appeared and it persisted for a while. On 30Jun2021 at around 08:00, pain from the left hip to the left groin was noted. Thereafter difficulty in breathing appeared. On 01Jul2021 in the evening, because of the above mentioned symptoms, the patient visited a hospital out of consultation hours. Then, she returned home. On 02Jul2021 in the morning (8 days after the vaccination), the patient experienced suspected aortic dissection. On 02Jul2021 at 07:31, the patient was found in a state unconsciousness at home. An emergency service was requested. Cardia massage was performed, and the ambulance arrived at the hospital. At 07:34, at 07:37, and at 07:43, BOSMIN injection 1 mg was administered, but the resuscitation did not succeed and it was stopped. It was not reported if an autopsy was performed. The reporting pharmacist classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. The reporting pharmacist commented as follows: The causal relationship between the symptoms in this case and BNT162b2 was uncertain.; Reported Cause(s) of Death: unconsciousness; Suspected aortic dissection


VAERS ID: 1496657 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Acute respiratory failure, Body temperature, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: 2021-07-02
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Convulsion; Emphysema; Heart disease, unspecified; Lung cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210627; Test Name: SpO2; Result Unstructured Data: Test Result:decreased; Test Date: 20210627; Test Name: SpO2; Result Unstructured Data: Test Result:around 88 %
CDC Split Type: JPPFIZER INC2021862375

Write-up: SpO2 decreased; Pneumonia; Acute respiratory failure; pyrexia; vomited; abdominal pain; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118328. A 81-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration (at the age of 81-year-old) on 25Jun2021 13:30 (Lot Number: EY4834; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. Medical history included heart disease, cerebral infarction, previous convulsion (stopped on unspecified date), emphysema and lung cancer. Concomitant medication included warfarin. The patient previously received the first dose of bnt162b2 (COMIRNATY) for covid-19 immunization. The patient was an 81-year and 2-month-old male. Body temperature before vaccination was 36.6 degrees centigrade. The patient experienced pneumonia (death, hospitalization from 27Jun2021) on 25Jun2021 15:30, acute respiratory failure (death, hospitalization from 27Jun2021) on 25Jun2021 15:30, spo2 decreased (hospitalization from 27Jun2021) on 27Jun2021, abdominal pain on 25Jun2021 15:30, vomited on 26Jun2021, pyrexia on 27Jun2021. The clinical course was as follows: On 25Jun2021 at 15:30 (2 hours after the vaccination), the patient experienced pneumonia and acute respiratory failure. On 02Jul2021 (7 days after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. On 25Jun2021 at 13:30 (the day of vaccination), the patient received the vaccination at the facility. Around 15:30, abdominal pain developed. On 26Jun2021 around 00:00 (1 day after the vaccination), the patient vomited a large amount of food residue. On 27Jun2021 around 00:00 (2 days after the vaccination), the SpO2 decreased. With oxygen administration at 10L, the SpO2 was around 88%, and the patient was transported by ambulance to the reporting hospital. He was admitted to the hospital for pneumonia and acute respiratory failure. The patient had pyrexia and received antibiotics since admission. Oxygen administration was performed with an open face mask. On 02Jul2021 (7 days after the vaccination), the level declined, and endotracheal intubation was performed. Although mechanically ventilated, the patient died at 12:13. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible causes of the events such as any other diseases were emphysema and lung cancer. The reporting physician commented as follows: The patient died of pneumonia. The outcome of the events pneumonia and acute respiratory failure was fatal, others was unknown. The patient died on 02Jul2021 12:13 due to events pneumonia and acute respiratory failure. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Pneumonia; Acute respiratory failure


VAERS ID: 1496658 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021862376

Write-up: died of unknown cause; This is an initial spontaneous report from a contactable physician received from a Pfizer sales representative. This physician reported similar event for two patients. This is the first of two reports. A patient of unspecified age and gender received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number not reported, Expiration date not reported), via an unspecified route of administration on an unspecified date (the day of vaccination) at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient died of unknown cause. It was not reported whether autopsy was done. The patient was scheduled for the second vaccination at the group vaccination site, and the family called to cancel the appointment. The reason for cancellation was death of patient after the first vaccination. It was unknown when the patient died after the first vaccination. The death cause and causality with BNT162b2 intramuscular injection were also unknown. The event was classified as serious (death). The outcome of 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; 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.,Linked Report(s) : JP-PFIZER INC-2021864640 Same source document/product/dose number/ event, different patient; Reported Cause(s) of Death: died of unknown cause


VAERS ID: 1496660 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: ASPIRIN [ACETYLSALICYLIC ACID]; LANSOPRAZOLE; MARZULENE [SODIUM GUALENATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021862382

Write-up: Loss of consciousness; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 101-year-old female patient received bnt162b2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 26May2021 as dose 1, single for covid-19 immunisation. The patient medical history included hypertension and ischaemic heart disease. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lansoprazole,; and sodium gualenate (MARZULENE [SODIUM GUALENATE]); and LOSARMEDO (as reported); all were taken for an unspecified indication, start and stop date were not reported. On 01Jun2021, the patient experienced loss of consciousness. Clinical course details: On 26May2021 (the day of vaccination), the patient was vaccinated. On 01Jun2021 (6 days after the vaccination), the patient experienced loss of consciousness at home and was transported to the hospital, but she died without recovery. The outcome of the event was fatal. Cause of death was loss of consciousness. The patient died on 01Jun2021. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on available limited information, a possible contributory role of BNT162B2 vaccine cannot be totally excluded for the reported event of "Loss of consciousness" due to temporal relationship and current known drug safety profile. 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: loss of consciousness


VAERS ID: 1496661 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heat illness, 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: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: JANUVIA [SITAGLIPTIN PHOSPHATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Gastrectomy partial (5 years ago); Gastric cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021862383

Write-up: death while taking a bath/sudden death; death due to heat illness was suspected; This is a spontaneous report from a contactable other health professional received from the Regulatory authority. Regulatory authority report number is v21118718. A 77-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on 30Jun2021 at age of 77-year-old at single dose for COVID-19 immunisation. Medical history included diabetes mellitus and surgery for gastric cancer (two-thirds excision) 5 years ago, but details were unknown since the reporting hospital conducted postmortem examination. Body temperature before vaccination was not reported. Family history was not reported. Concomitant medication included sitagliptin phosphate (JANUVIA) 50 mg taken orally for diabetes mellitus, start date was not reported and ongoing. The patient previously received the first dose of BNT162b2 (COMIRNATY) for COVID-19 immunisation on an unspecified date. On 02Jul2021 at 23:30 (1 days after the vaccination), the patient experienced death while taking a bath and death due to heat illness was suspected. The course of the event was as follows: On 30Jun2021, the patient received the second dose of COMIRNATY at another clinic. On 02Jul2021 at around 23:15, the patient took a bath. Since the patient was coming out of the bathroom late, the patient''s younger sister went to confirm that the patient''s trunk sank in the bath. The patient was dead and excreta was floating. Five years ago, the patient underwent surgery for gastric cancer at another medical center (two-thirds excision) and it did not recur as of May2021. The patient had diabetes mellitus, which was being treated at a nearby hospital and the patient was taking oral medication (JANUVIA 50 mg). The patient always liked a hot bath. It was sudden death while taking a bath after the vaccination and death due to heat illness was suspected. On 02Jul2021 (2 days after the vaccination), the outcome of the event was fatal. The reporting other health professional classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. The reporting other health professional commented as follows: It was known that most cases of sudden death while taking a bath were due to heat illness. After the vaccination, patients were susceptible to dehydration and were prone to develop heat illness. Elderly and vulnerable patients were needed to be informed about water intake and avoiding taking a bath and take a shower instead. Information on lot/batch number has been requested.; Reported Cause(s) of Death: death due to heat illness was suspected


VAERS ID: 1496680 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: IMIDAPRIL HYDROCHLORIDE; DIPYRIDAMOLE; SITAGLIPTIN PHOSPHATE MONOHYDRATE; IMIDAFENACIN; FEXOFENADINE HYDROCHLORIDE; ROSUVASTATIN CALCIUM; BETAHISTINE MESILATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Frailty; Geromarasmus; Hypertension; Lipid metabolism disorder; Oral intake reduced; Overactive bladder; Parenteral nutrition; Rhinitis allergic; Type 2 diabetes mellitus; Vertigo
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:No increased body temperature was observed; Test Date: 20210703; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: in morning
CDC Split Type: JPPFIZER INC2021862719

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21118723. An 87-year-old (as reported 87-year and 10-month-old) female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration at the age of 87-year-old (as reported 87-year and 10-month-old) on 03Jul2021 14:05 (Lot Number: EW0201; Expiration Date: 30Sep2021) as single dose for COVID-19 immunisation. Medical history included hypertension, angina pectoris, type 2 diabetes mellitus, lipid metabolism disorder, overactive bladder, rhinitis allergic, and inner ear vertigo, Frailty progressed, poor oral intake, parenteral nutrition, geromarasmus. Body temperature before vaccination was 36.6 degrees centigrade on 03Jul2021. The vaccination and disease within one month: the patient did not receive vaccination. Frailty progressed, and the patient had poor oral intake, for which a parenteral nutrition was prescribed. Concomitant medications included imidapril hydrochloride; dipyridamole; sitagliptin phosphate monohydrate; imidafenacin; fexofenadine hydrochloride; rosuvastatin calcium; betahistine mesylate, all taken for an unspecified indication from an unspecified start date and ongoing; other concomitant medication also included parenteral nutrition 400 mL 2x. On 05Jul2021 (2 days after the vaccination), the patient experienced cardio-respiratory arrest. On 05Jul2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 05Jun2021 (2 days after vaccination), when the patient''s daughter cared for the patient in the morning, the body temperature was 37.1 degrees Celsius, and she had slight hot feeling around the neck by touch. The daughter made the patient had a little fluid, and she took over to the patient''s son. In the afternoon, the son made the patient had a little fluid and lay her down. No increased body temperature was observed. In the evening, the son saw how the patient was doing, and he noticed that the patient was not breathing. An ambulance was called, and the patient was transferred to the accident and emergency department in the university hospital, where the patient died. The patient was diagnosed with geromarasmus by the attending physician at the emergency department (the physician seemed not to explain that the patient received the BNT162b2 vaccination on 03Jul2021). The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: The frailty progressed since 1 to 2 weeks before, and the amount of meal intake and fluid intake significantly decreased. The reporting physician commented as follows: Since the patient was an elderly of 87-year-old, and she had various underlying diseases, and the frailty progressed, the attending physician considered that the patient died due to geromarasmus. It was considered unlikely that the first dose of BNT162b2 vaccination was related to the death. The family understood the course until the death. The family also did not consider that the death was affected by the BNT162b2 vaccination. However, since the patient died 2 days after the BNT162b2 vaccination, this case was reported with unknown causality. The patient underwent lab tests and procedures which included body temperature: 36.6 centigrade on 03Jul2021 (Before vaccination), body temperature: 37.1 centigrade on 05Jul2021 (in morning), body temperature: no increased body temperature was observed on 05Jul2021. The patient died on 05Jul2021. It was not reported if an autopsy was performed. The outcome of event was fatal.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1496681 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral haemorrhage, Disease recurrence, Oxygen saturation, Pneumonia aspiration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Hydrocephalus
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210617; Test Name: SpO2; Test Result: 75 %; Comments: decreased
CDC Split Type: JPPFIZER INC2021862746

Write-up: Late effects of intracerebral hemorrhage was considered as a possible cause of the event.; Late effects of intracerebral hemorrhage was considered as a possible cause of the event.; Pneumonia aspiration; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118372. A 83-years-old male patient received bnt162b2 (COMIRNATY), at the age of 83-years-old, dose 1 via an unspecified route of administration on 01Jun2021 15:00 (Lot Number: EY5420; Expiration Date: 31Aug2021) as SINGLE for covid-19 immunisation. Medical history included late effects of intracerebral hemorrhage, hydrocephalus. The patient''s concomitant medications were not reported. The patient experienced pneumonia aspiration on 17Jun2021 08:30, late effects of intracerebral hemorrhage was considered as a possible cause of the event on an unspecified date. The patient was hospitalized for pneumonia aspiration from 17Jun2021 to an unknown date. The patient was hospitalized for late effects of intracerebral hemorrhage was considered as a possible cause of the event from 17Jun2021 to an unknown date. The patient died on 29Jun2021. It was not reported if an autopsy was performed. Clinical course as follows: The patient was an 83-year and 7-month-old male. Body temperature before vaccination was 36.7 degrees Centigrade. On 01Jun2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY5420, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 17Jun2021 at 08:30 (16 days after the vaccination), the patient experienced pneumonia aspiration. The patient was hospitalized. On 29Jun2021 (28 days after the vaccination), the patient died. On 17Jun2021, SpO2 (oxygen saturation percutaneous) decreased to 75%. Suction was performed but SpO2 did not recover. The patient was admitted to a different hospital where pneumonia aspiration was diagnosed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Late effects of intracerebral hemorrhage was considered as a possible cause of the event.; Reported Cause(s) of Death: Late effects of intracerebral hemorrhage; Pneumonia aspiration


VAERS ID: 1496682 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021862752

Write-up: Pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118376. An 80-year and 9-month-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration (age at vaccination reported as 80-year-old) on 03Jul2021 10:50 (Lot Number: EY5422; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Jul2021 (4 days after the vaccination), the patient experienced pyrexia. It was not reported if an autopsy was performed. The course of the events was as follows: The reporting physician was informed by the patient''s family that the patient developed fever and after that, he died. The patient underwent lab tests and procedures which included body temperature before vaccination: 36.4 centigrade on 03Jul2021. The patient died on 08Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Pyrexia


VAERS ID: 1496683 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-07-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210626; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021862772

Write-up: Dissecting aortic aneurysm; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118377. A 72-year-old female patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration at age of 72-years, on 26Jun2021 14:00 (Lot Number: EY3860; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dissecting aortic aneurysm on 02Jul2021. She was hospitalized for it from 02Jul2021 to an unknown date (On 02Jul2021 (6 days after the vaccination), the patient experienced dissecting aortic aneurysm and she was admitted to a different hospital. On the same day, the patient died). The patient underwent lab tests and procedures which included body temperature before vaccination was 36.7 degrees Centigrade on 26Jun2021. Therapeutic measures were taken. The patient died on 02Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and considered that the event was not related to BNT162b2. It was not reported if there was possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dissecting aortic aneurysm


VAERS ID: 1496684 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, 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: 2021-07-08
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021862773

Write-up: CPA; Dissecting aortic aneurysm; This is an initial spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A non-pregnant 74-years-old female patient received bnt162b2 (COMIRNATY), single dose via an unspecified route of administration on 08Jul2021 10:00 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunization at doctor''s office (age at vaccination of 74 years old). The patient''s medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported whether the patient received any other medications within 2 weeks of vaccination. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Historical vaccine included on 17Jun2021 at 09:30, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EW0201, Expiration date 30Sep2021) via an unspecified route of administration for COVID-19 immunization. The patient experienced Cardiopulmonary arrest (CPA) and dissecting aortic aneurysm, both on 08Jul2021 13:00 (3 hours after the vaccination). The patient died on 08Jul2021. The events resulted in emergency room visit and death. No treatment was provided for the events. Autopsy was not performed. The reporting physician classified the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the limited information in the case report, a possible causal relationship between event Cardio-respiratory arrest, Aortic dissection and suspect product BNT162B2 cannot be 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: CPA; Dissecting aortic aneurysm


VAERS ID: 1496685 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Interstitial lung disease, Pyrexia, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: CT; Result Unstructured Data: Test Result:suggestive of interstitial pneumonia
CDC Split Type: JPPFIZER INC2021862775

Write-up: respiratory distress; Acute exacerbation of interstitial pneumonia; pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118432. A 73-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 16May2021 in the morning (the day of vaccination) (Lot Number: EX3617; Expiration Date: 31Aug2021) as single dose for covid-19 immunization at the age of 73 years old. The patient medical history and concomitant medications were not reported.The patient experienced acute exacerbation of interstitial pneumonia on 25May2021 15:00 (9 days after the vaccination). On 31May2021 (15 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 25May2021, the patient visited a hospital due to pyrexia. On 29May2021, the patient visited a hospital again due to pyrexia. Computed tomography (CT) result was suggestive of interstitial pneumonia. On 31May2021, the patient was hospitalized due to respiratory distress. On 02Jun2021, therapeutic effect was not observed and the patient died. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Since finding of interstitial pneumonia was not observed in the past imaging, there was possibility that the event was adverse reaction of the vaccine. Body temperature before vaccination was not reported. Family history and medical history were not reported. The patient died on 02Jun2021. It was not reported if an autopsy was performed. On 02Jun2021 (17 days after the vaccination), the outcome of the event Interstitial pneumonia aggravated was fatal and was unknown for the rest events.; Reported Cause(s) of Death: Acute exacerbation of interstitial pneumonia


VAERS ID: 1496691 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Decreased appetite, Hyponatraemia, Pneumonia, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (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: 2021-07-05
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before the first vaccination; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before the second vaccination; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:pyrexia Centigrade; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:declined Centigrade
CDC Split Type: JPPFIZER INC2021862838

Write-up: Cardio-respiratory arrest; Pneumonia was considered; Vomiting; Hyponatraemia; Pyrexia; Inappetence; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118379. An 83-year-old male received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration on 18Jun2021, at patient age of 83-year-old, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 28May2021 at unknown time, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. Body temperature was 36.1 degrees centigrade before the first vaccination. On 18Jun2021 at unknown time (the day of vaccination), the patient received the second dose of BNT162b2. Body temperature was 36.9 degrees centigrade before the second vaccination. On 18Jun2021 (the day of vaccination), pyrexia and inappetence were present (+) after the second vaccination. The body temperature declined, but inappetence persisted. On 01Jul2021 (13 days after the vaccination), treatment with intravenous drip was continued for hyponatraemia, but on 04Jul2021 (16 days after the vaccination), vomiting occurred and was followed by pyrexia; pneumonia was considered, and antibiotics were administered. However, on 05Jul2021 before dawn at 03:22 (17 days after the vaccination), the patient was found in a state of cardio-respiratory arrest. On the same day, his death was confirmed. It was not reported whether autopsy was done. The outcome of the event cardio-respiratory arrest and pneumonia was fatal. The outcome of the event inappetence was not resolved. The outcome of the other events was unknown. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: The vaccination could not be denied as the cause of appetite impaired. ; Reported Cause(s) of Death: Cardio-respiratory arrest; Pneumonia was considered


VAERS ID: 1496695 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature, Cardio-respiratory arrest, Pneumonia, Pyrexia, Respiratory disorder, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: 2021-07-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021862870

Write-up: Cardio-respiratory arrest; Bronchial asthma attack; pneumonia could not be excluded; respiratory discomfort; wheezing; low grade fever; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118378. The patient was an 89-year and 5-month-old female. Body temperature before vaccination was 36.4 degrees centigrade. Family history was not reported. Medical history included cardiogenic cerebral infarction. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 30Jun2021 at unknown time (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5295, Expiration date 30Sep2021), at the age of 89 years old, via an unspecified route of administration as a single dose for COVID-19 immunisation. On 04Jul2021 (4 days after the vaccination), the patient experienced Bronchial asthma attack, respiratory discomfort, wheezing, and low grade fever. On 05Jul2021 at 03:00 (5 days after the vaccination), the patient experienced cardio-respiratory arrest. On 05Jul2021 (5 days after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: The patient had cardiogenic cerebral infarction. On 30Jun2021 (the day of vaccination), no remarkable side effects were noted also after the second vaccination. However, on 04Jul2021 (4 days after the vaccination), respiratory discomfort and wheezing developed, and a house call was therefore made. Low grade fever was also noted. Although pneumonia could not be excluded as well, bronchodilators and steroids were administered, leading to alleviation. Thereafter, on 05Jul2021 at 03:00 (5 days after the vaccination), the patient was found in a state of cardio-respiratory arrest. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases was bronchial asthma attack. The reporting physician commented as follows: While it could not be denied that wheezing was due to aspiration, the effect of the vaccine could not be denied too. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Bronchial asthma attack; Cardio-respiratory arrest


VAERS ID: 1496704 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood test, Body temperature, Glycosylated haemoglobin, Low density lipoprotein
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: Blood (cardiac blood); Result Unstructured Data: Test Result:troponin T positive; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210626; Test Name: HbA1c; Test Result: 8.0 %; Test Date: 20210626; Test Name: LDL cholesterol; Result Unstructured Data: Test Result:137
CDC Split Type: JPPFIZER INC2021864163

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable other health professional received from the Regulatory Agency (RA). Regulatory authority report number is v21118591. This is also received from a contactable pharmacist received via other Regulatory Agency. A 76 year 7 months years old male patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) intramuscular on 03Jul2021 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.2 degrees centigrade. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included diabetes mellitus. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY, Lot# FA7338, Expiration date 30Sep2021), via an unspecified route of administration on 12Jun2021 as dose 1, single for COVID-19 immunisation. On 03Jul2021 (the day of vaccination), the patient received the second single dose of BNT162b2. On 08Jul2021 estimated at 03:00 (5 days after the vaccination), the patient died by acute myocardial infarction. The course of the event was as follows: On 26Jun2021, HbA1C was 8.0% and LDL cholesterol was 137. On 07Jul2021 at 21:30, the patient was last confirmed alive. On 08Jul2021 at 06:00, the patient was found to fell in a toilet, for which ambulance was requested. However, since postmortem rigidity was observed, the patient was not transferred. On the same day, autopsy was conducted at the reporting hospital. Blood (cardiac blood) showed troponin T positive and it was assessed as acute myocardial infarction. Death date and time was 08Jul2021 at 03:00 (estimation). Since the vaccination, it was unknown whether the patient has been tested for COVID-19. The outcome of the event was fatal without treatment. The reporting pharmacist classified the event as serious (death). The reporting other health professional classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. The reporting other health professional commented as follows: Causality could not be denied. ; Reported Cause(s) of Death: Acute myocardial infarction; Autopsy-determined Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1496706 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021864640

Write-up: died of unknown cause; This is an initial spontaneous report from a contactable physician received from a Pfizer sales representative. This physician reported similar event for two patients. This is the second of two reports. A patient of unspecified age and gender received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number not reported, Expiration date not reported), via an unspecified route of administration on an unspecified date (the day of vaccination) at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient died of unknown cause. It was not reported whether autopsy was done. The patient was scheduled for the second vaccination at the group vaccination site, and the family called to cancel the appointment. The reason for cancellation was death of patient after the first vaccination. It was unknown when the patient died after the first vaccination. The death cause and causality with BNT162b2 intramuscular injection were also unknown. The event was classified as serious (death). The outcome of 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; 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.,Linked Report(s) : JP-PFIZER INC-2021862376 Same source document/product/dose number/ event, different patient; Reported Cause(s) of Death: died of unknown cause


VAERS ID: 1496730 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2495 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Body temperature, Body temperature increased, Cardio-respiratory arrest, Chills, Cough, Decreased appetite, Dyspnoea, Fatigue, Haemodynamic instability, Myalgia, Pain, Pyrexia, SARS-CoV-2 test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Arterial hypertension (30-years evolution); Diabetes mellitus (40-years evolution); Renal disease (2-months evolution)
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Hemodialysis
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: fever; Result Unstructured Data: Test Result:greater than 38 Centigrade; Comments: 21:00; Test Date: 20210604; Test Name: temperature; Result Unstructured Data: Test Result:increase; Comments: 21:00; Test Date: 20210606; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: MXPFIZER INC2021862272

Write-up: cardio-respiratory arrest; hemodynamic deterioration; fever greater than 38?C; Asthenia/Adynamia; fatigue; Chills; Pain/sensitivity; temperature increase; hyporexia; cough; myalgia; arthralgia; dyspnoea/dyspnea; This is a spontaneous report from a non-contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number 16029-7. A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 04Jun2021 12:00 (Lot Number: FC2495, at the age of 74-year-old) as single dose for covid-19 immunisation. Medical history included allergy, ongoing diabetes mellitus from 1981 (40-years evolution), ongoing arterial hypertension from 1991 (30-years evolution), ongoing chronic renal disease from Apr2021 (2-months evolution), hemodialysis. The patient''s concomitant medications were not reported. On 04Jun2021 21:00, the patient experienced fever greater than 38?C, asthenia, fatigue, adynamia, chills, pain/sensitivity, temperature increase, hyporexia, cough, myalgia, arthralgia, dyspnoea. On 06Jun2021, the patient experienced hemodynamic deterioration and cardio-respiratory arrest. Event was further described as follows: Patient presented symptoms at approximately 9 hr characterized by myalgias, arthralgias, asthenia, adynamia, later hyporexia, fever, cough and dyspnea were added. He went to this unit on 06Jun2021 due to hemodynamic deterioration, he was admitted as a suspected covid, however, with a negative rapid test, he was discharged to the regular emergency room where he presented cardio-respiratory arrest for which he required ventilatory support and resuscitation maneuvers. He was currently reported as serious. Treatment included omeprazol 40 mg, calcium gluconate 1 g, furosemide 40 mg and azithromycin 500. Hospitalization was required for events hemodynamic deterioration and cardio-respiratory arrest. The outcome of the events hemodynamic deterioration and cardio-respiratory arrest was fatal, for other events was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardio-respiratory arrest; hemodynamic deterioration


VAERS ID: 1496981 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-11
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Cardiac arrest, Computerised tomogram, Dyspnoea, Echocardiogram, Electrocardiogram, Laboratory test, Leukopenia, Respiratory failure, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SODIUM THIOSULFATE; NADROPARINE
Current Illness: Ovarian carcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood gas; Result Unstructured Data: Test Result:unknown; Test Name: CT scan; Result Unstructured Data: Test Result:unknown; Test Name: echo cor; Result Unstructured Data: Test Result:unknown; Test Name: ECG; Result Unstructured Data: Test Result:unknown; Test Name: lab; Result Unstructured Data: Test Result:unknown
CDC Split Type: NLPFIZER INC2021848525

Write-up: cardiac arrest; respiratory insufficiency - cause still unclear; Postoperative thrombocytopenia; severe leukocytopenia; Dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB NL-LRB-00604341. A 69-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 28May2021 (Batch/Lot Number: FA8016) as DOSE 1, SINGLE for covid-19 immunisation; cisplatin, intraperitoneal from 09Jun2021 (Batch/Lot Number: Unknown) to 09Jun2021, at 150 mg, single for treatment ovarian carcinoma. Medical history included ongoing ovarian cancer. Concomitant medications included sodium thiosulfate; nadroparin calcium (NADROPARINE). On 11Jun2021, patient experienced, Postoperative thrombocytopenia, dyspnea and severe leukocytopenia. On an unknown date, patient experienced cardiac arrest and respiratory insufficiency.Day 2 (12Jun2021) patient died unexpectedly for unknown reasons. No previous COVID-19 infection. Other: diagnostic procedures: when dyspnea developed, a CT scan, lab, blood gas, echo cor, ECG were performed - autopsy after death. The outcome of the events was fatal. Autopsy was done but no results available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Dyspnoea; severe leukocytopenia; Postoperative thrombocytopenia; respiratory insufficiency - cause still unclear; cardiac arrest - cause still unclear


VAERS ID: 1497021 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021863077

Write-up: Dizziness; This is a spontaneous report from a contactable other hcp from the Regulatory Agency. The regulatory authority report number is PH-PHFDA-300088920. A 67-years-old male patient received bnt162b2 (COMIRNATY), intramuscularly at the age of 67-years-old on 24Jun2021 (Lot Number: FD5996) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dizziness on 25Jun2021 06:00. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event dizziness was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dizziness


VAERS ID: 1497023 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PHPFIZER INC2021863079

Write-up: sudden loss of consciousness; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300089203. A 46-years-old female patient received bnt162b2 (COMIRNATY), via intramuscular on 25Jun2021 (Batch/Lot Number: FD5996) at the age of 46-years-old, at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sudden loss of consciousness (death) on 25Jun2021. The outcome of event was fatal. The patient died on an unspecified date. The cause of death was sudden loss of consciousness. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden loss of consciousness


VAERS ID: 1497104 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dehydration, General physical health deterioration, Pain, Sepsis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pelvic fracture; Renal failure (3 years ago)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: increased
CDC Split Type: SKMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of SEPSIS, GENERAL PHYSICAL HEALTH DETERIORATION, DEHYDRATION and PAIN in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002188) for COVID-19 vaccination. The patient''s past medical history included Pelvic fracture and Renal failure (3 years ago). Concomitant products included FUROSEMIDE for an unknown indication. On 24-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEPSIS (seriousness criteria death, hospitalization and medically significant), GENERAL PHYSICAL HEALTH DETERIORATION (seriousness criterion hospitalization), DEHYDRATION (seriousness criterion hospitalization) and PAIN (seriousness criterion hospitalization). The patient died on an unknown date. The reported cause of death was Sepsis. An autopsy was performed, but no results were provided. At the time of death, GENERAL PHYSICAL HEALTH DETERIORATION, DEHYDRATION and PAIN outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) increased. Treatment information was not provided. This is a case of an 82-year-old male patient with medical history of pelvic fracture and renal failure who developed Sepsis, General physical health deterioration, Dehydration and Pain. The patient died due to sepsis. An autopsy was performed, but no results were provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Sender''s Comments: This is a case of an 82-year-old male patient with medical history of pelvic fracture and renal failure who developed Sepsis, General physical health deterioration, Dehydration and Pain. The patient died due to sepsis. An autopsy was performed, but no results were provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Sepsis


VAERS ID: 1497596 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Emphysema; Porphyria
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021872016

Write-up: Died; This is a spontaneous report from a contactable pharmacist. A 74-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 at the age of 74-year-old administration on 18Jun2021 at 09:14 (Batch/Lot Number: FD0927; Expiration Date: 30Sep2021) as single dose for covid-19 immunization. The diluent batch#L19452, exp date May2023. The vaccine reconstituted on 18Jun2021. Medical history included porphyria:emphysema. The patient''s concomitant medications were not reported. The patient is reported to have died on 23Jun2021. It was unknown if an autopsy was performed. The outcome of the event was Fatal. No further information was provided.; Sender''s Comments: based on the available data the causal relationship between the suspect vaccine comirnaty and death cannot be excluded completely since the available data of events and cause of death is minimal , case can be reassessed once the data is available for the meaningful assessment of causality .; Reported Cause(s) of Death: Died


VAERS ID: 1497732 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Chest X-ray, Drug ineffective, Inappropriate schedule of product administration, Pneumonia bacterial, Pulmonary imaging procedure, Respiratory failure, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; B-cell chronic lymphocytic leukaemia (Cluster of differentiation: 38 low, UM-CLL in Feb2009, and del13q14 in May2008); Lung nodule
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia aggravated; Kidney angiomyolipoma; Monoclonal antibody chemoimmunoconjugate therapy (Chemoimmunotherapy according to FCR-lite; 6 cycles); Partial nephrectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210501; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Name: Pulmonary imaging procedure; Result Unstructured Data: Test Result:Multiple pulmonary nodules of unknown origin; Test Date: 20210505; Test Name: SARS-CoV-2 antibody test; Test Result: Positive ; Comments: Nucleocapsid negative-spike protein 27 BAU/ml; Test Date: 20210501; Test Name: COVID-19 PCR test (SARS-CoV2 antigen test); Test Result: Positive ; Comments: Ct value 12.8 PCR sequencing: B.1.1.7, N501Y, del69/70; Test Date: 20210515; Test Name: COVID-19 PCR test (SARS-CoV2 antigen test); Test Result: Positive
CDC Split Type: ATPFIZER INC2021857629

Write-up: Vaccination breakthrough, infection despite two vaccinations; SARS-CoV-19 infection; COVID-19 pneumonia; Vaccination breakthrough, infection despite two vaccinations; SARS-CoV-19 infection; COVID-19 pneumonia; Partial respiratory failure; COVID-19 pneumonia with bacterial superinfection; Second dose of the COVID-19 vaccine was administered 17 days after the first dose; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-25847. An 88-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 02Apr2021 (Lot Number: EW4815), as dose 1, single, and then intramuscular, on 19Apr2021 (Lot Number: ET7205), as dose 2, single, for COVID-19 immunization. The patient''s medical history included B-cell chronic lymphocytic leukaemia (CLL) from May2005 and ongoing (chronic lymphatic B-cell leukemia initial diagnosis in May2005, cluster of differentiation: 38 low, UM-CLL in Feb2009, and del13q14 in May2008); condition after partial kidney resection in angiomyolipoma; monoclonal antibody chemoimmunoconjugate therapy (chemoimmunotherapy according to FCR-lite; 6 cycles) from Apr2010 to Oct2010 for increasing anemia from Apr2010 (unknown if ongoing); ongoing arterial hypertension; and ongoing multiple pulmonary nodules of unknown origin (in pulmonary imaging procedure). The patient''s concomitant medications were not reported. The patient previously took cyclophosphamide and fludarabine, both from Apr2010 to Oct2010; and rituximab. The second dose of the COVID-19 vaccine was administered on 19Apr2021, 17 days after the first dose on 02Apr2021. On 01May2021, the patient experienced vaccination breakthrough, infection despite two vaccinations; SARS-CoV-19 infection with partial respiratory failure in COVID-19 pneumonia with bacterial superinfection. The patient was hospitalized from the events from 01May2021. From 04May2021 to 10May2021, the patient underwent non-invasive ventilation or NH-flow therapy as treatment to the events. The patient underwent laboratory tests and procedures on 01May2021 which included COVID-19 PCR test that was positive (Ct value 12.8 PCR sequencing: B.1.1.7, N501Y, del69/70), and chest X-ray (unknown results); and on 05May2021 which included SARS-CoV-2 antibody test that was positive (nucleocapsid negative-spike protein 27 BAU/ml). SARS-CoV2 antigen test continuously positive until death (15May2021). The outcome of the events was fatal. The patient died on 15May2021. It was unknown if an autopsy was performed. As of 11Jul2021, product quality complaint investigation summary report details were provided from Regulatory Authority for lot EW4815. The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation, investigation, and analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot EW4815. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The Regulatory Authority process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination breakthrough, infection despite two vaccinations; SARS-CoV-19 infection; COVID-19 pneumonia; Vaccination breakthrough, infection despite two vaccinations; SARS-CoV-19 infection; COVID-19 pneumonia; Partial respiratory failure; COVID-19 pn


VAERS ID: 1497754 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-07-06
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Haemorrhagic cerebral infarction, Hypertensive crisis, Intraventricular haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypertension (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial; Peripheral arterial occlusive disease
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis leg; Prostatic cancer; Stroke; Comments: aHT, Z.n. Insult, pAVK; Z.n. Prostata Ca, Z.n. TBVT li 2013, Z.n. Covid Impfung
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100915654

Write-up: Intracerebral haemorrhage; Haemorrhagic cerebral infarction; Intraventricular haemorrhage; Hypertensive crisis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority WEB AT-BASGAGES-2021-36814. A 72-year-old male patient received second dose of bnt162b2 (COMINARTY, Solution for injection, Lot Number and expiry date were not provided) via an unspecified route of administration on 10Jun2021 as a single dose for COVID-19 immunisation. Medical history and concurrent conditions included hypertension arterial (ongoing), peripheral arterial occlusive disease (ongoing), stroke (not ongoing), prostatic cancer (not ongoing) and deep vein thrombosis leg (not ongoing). Concomitant medication was not reported. Patient had previously received first dose of bnt162b2 (COMINARTY, Solution for injection, Lot Number and expiry date were not provided) on an unspecified date as a single dose for COVID-19 immunisation. On 06Jul2021 at 01:00, the patient experienced intracerebral haemorrhage (life threatening), haemorrhagic cerebral infarction (life threatening), intraventricular haemorrhage (life threatening) and hypertensive crisis (life threatening). The patient died on 09Jul2021, due to Intracerebral haemorrhage, haemorrhagic cerebral infarction, intraventricular haemorrhage and hypertensive crisis. The outcome for all events was fatal. It was unknown whether autopsy was performed. Sender Comment: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Intracerebral haemorrhage; Hypertensive crisis; Haemorrhagic cerebral infarction; Intraventricular haemorrhage


VAERS ID: 1497880 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 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: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021865063

Write-up: Pulmonary embolus; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100126072. An 85-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Jun2021 (at the age of 85 years) (Batch/Lot Number: FE6975) as DOSE NUMBER UNKNOWN, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Jul2021 the patient experienced died of pulmonary embolus. The outcome for event was fatal. The patient died on 02Jul2021. It was not reported if an autopsy was performed. Event assessment : Comirnaty/ all events /Result of Assessment : D. Unclassifiable. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Vertical deviation as directed by a doctor Pulmonary embolism


VAERS ID: 1497881 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-25
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Autopsy, Cardiogenic shock, Left ventricular failure, Myocardial oedema, Myocarditis, Necrosis, Rib fracture, Shock
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Osteoporosis/osteopenia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Pathological-anatomical diagnoses; Result Unstructured Data: Test Result:Findings of lymphocytic myocarditis
CDC Split Type: DEPFIZER INC2021865052

Write-up: Left ventricular failure; Cardiac arrhythmia; Myocarditis/lymphocytic myocarditis; rib fractures 3rd-5th (Right rib); interstitial myocardial edema; Incipient single fiber necrosis with blurred transverse stripes of the left ventricular cardiomyocytes/fresh necroses of the proximal Tubular epithelial cells; cardiogenic shock; kidney shock; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100126077. A 34-year-old male patient received bnt162b2 (COMIRNATY 0.3 ML, also reported as mRNA TOZINAMERAN; batch/lot number: unknown; expiration date not provided), via an unspecified route of administration on 11May2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient''s medical history and concomitant medications were not reported. The patient experienced left ventricular failure, cardiac arrhythmia, ''myocarditis/lymphocytic myocarditis'', ''rib fractures 3rd-5th (Right rib)'', ''interstitial myocardial edema'', ''Incipient single fiber necrosis with blurred transverse stripes of the left ventricular cardiomyocytes/fresh necroses of the proximal Tubular epithelial cells'', ''cardiogenic shock'', and ''kidney shock'' on 25May2021. Pathological-anatomical diagnoses: Cardiac weight (550 grams) with acute right ventricular dilatation (15.5 cm tricuspid valve circumference, right ventricular wall thickness 3 mm). No evidence of coronary artery sclerosa, heterogeneously pronounced, overall low interstitial myocardial fibrosis, slight signs of hypertrophy in the cardiomyocytes with beginning so-called "myo: Eiber disarray" in the septal and left ventricular myocardium (septal thickness 11 mm, chamber wall thickness 16 mm left ). The morphological findings are inadequate for the diagnosis of hypertrophobic cardiomyopathy, here (HOCM). Arrhythmogenic right ventricular dysplasia cardiomyopathy (ARVD) is not present. Findings of lymphocytic myocarditis (immunohistochemical to z 15 lymphocytes and 25 macrophages per mm2). Signs of prolonged resuscitation: Mediosternal impression after mechanical resuscitation aid. Rib fractures 3rd-5th Right rib. Interstitial myocardial edema. Incipient single fiber necrosis with blurred transverse stripes of the left ventricular cardiomyocytes. Signs of cardiogenic shock: interstitial and alveolar pulmonary edema with dystelectasis. Shock kidney with fresh necroses of the proximal Tubular epithelial cells, hypoxic vacuolization of the pericentral hepatocytes. The patient underwent lab tests and procedures which included ''Pathological-anatomical diagnoses'' with result of ''Findings of lymphocytic myocarditis'' on an unspecified date. Outcome of the events was fatal. The patient died on 25May2021. An autopsy (Pathological-anatomical diagnoses) was performed. The reported causes of death were left ventricular failure, cardiac arrhythmia, ''myocarditis/lymphocytic myocarditis'', ''rib fractures 3rd-5th (Right rib)'', ''interstitial myocardial edema'', ''Incipient single fiber necrosis with blurred transverse stripes of the left ventricular cardiomyocytes/fresh necroses of the proximal Tubular epithelial cells'', ''cardiogenic shock'', and ''kidney shock''. Relatedness of drug to reactions/events were not reported. Source of assessment. Result of Assessment was reported as ''D. Unclassifiable''. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Cardiac arrhythmia; Left ventricular failure; rib fractures 3rd-5th (Right rib); interstitial myocardial edema; Incipient single fiber necrosis with blurred transverse stripes of the left ventricular cardiomyocytes/fresh necroses of the proximal Tubu; Autopsy-determined Cause(s) of Death: Myocarditis/lymphocytic myocarditis


VAERS ID: 1498793 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Contusion, Dizziness, Fall, Hypoaesthesia, Myocarditis, Pyrexia
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 40
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: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:40.1 Centigrade
CDC Split Type: DEPFIZER INC2021865208

Write-up: Attested myocarditis; the emergency doctor was called and when he arrived there was a temperature of 40.1 ? C; On 28May2021 a stair fall with the consequence of severe bruises in the entire facial area; On 28May2021 a stair fall with the consequence of severe bruises in the entire facial area; Dizziness; numbness; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021106605. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100100438. An 87-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 04May2021 (Batch/Lot Number: EX8679) as single dose for COVID-19 immunisation. Patient age at vaccination was 87-year-old. Medical history included dementia. The patient''s concomitant medications were not reported. On 04May2021, patient experienced increased discomfort after the vaccination - dizziness, numbness. On 28May2021, patient experienced a stair fall with the consequence of severe bruises in the entire facial area. On 03Jun2021, patient, who had always done her things (household, food) on her own until the vaccination, was found in a helpless state (e.g. wet). When the emergency doctor arrived, temperature of 40.1 C. Death on 13Jun2021. Attested myocarditis. Patient was hospitalized for temperature of 40.1 C and myocarditis. Outcome of dizziness, numbness and temperature of 40.1 C was not resolved. Outcome of fall and severe bruises in the entire facial area was unknown. Outcome of myocarditis was fatal. An autopsy was not performed. No follow-up activities possible. No further information expected.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1498797 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Limb discomfort, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic valve stenosis; COPD (stage 4); Diabetes mellitus; Hepatic cirrhosis; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021857705

Write-up: Unknown cause of death; Limb discomfort; Fatigue; Malaise; Myalgia; This is a spontaneous report from a non-contactable consumer or other Non HCP downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021108634, Safety Report Unique Identifier DE-PEI-202100103249. Narrative: This spontaneous report was received from a Consumer or other non health professional and concerns a patient (Male), age: 70 Year (born: unknown date). This report is serious - death. The patient''s medical history and concurrent conditions included: Diabetes mellitus, Hepatic cirrhosis, Renal insufficiency, Aortic valve stenosis, COPD. The patient''s weight was 87 kg, and height was 179 cm. The patient was treated with Comirnaty (mRNA TOZINAMERAN), unknown dosage. Concomitant medications were: no concomitant medication reported. On 20Jan2021 the patient experienced Myalgia, Fatigue, Limb discomfort, Malaise. On 12Feb2021 the patient experienced Unknown cause of death. The patient''s outcome was: not recovered/not resolved for Myalgia, not recovered/not resolved for Fatigue, not recovered/not resolved for Limb discomfort, not recovered/not resolved for Malaise, fatal for Unknown cause of death. Senders comments: Do you or the person concerned have any known allergies? If yes, which ones? No. Information on risk factors or previous illnesses Deceased had several previous illnesses, blood glucose disease, liver cirrhosis, renal insufficiency, aortic valve stenosis, COPD stage 4 / batch number of the ingredient not available, impass of the deceased was no longer accessible to the relatives of the deceased, remains unknown. Relatedness of drug to reaction(s)/event(s) D. Unclassifiable Batch/ lot number unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1498798 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Dyspnoea, Pain in extremity, Peripheral coldness, Peripheral vascular disorder
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchitis; Impaired renal function
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021867070

Write-up: Diarrhea; SHORTNESS OF BREATH; Circulatory problems; His right foot was blue and freezing cold with severe pain and could no longer step on.; His right foot was blue and freezing cold with severe pain and could no longer step on.; Difficulty breathing to the point of suffocation; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021113725. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 03Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included bronchitis from Mar2021 and ongoing, ongoing Impaired renal function. The patient''s concomitant medications were not reported. On 04Mar2021 the patient experienced diarrhea, circulatory disorder peripheral, dyspnoea. The patient experienced also unknown cause of death in 2021. The outcome of events diarrhea, circulatory disorder peripheral, dyspnoea was not recovered. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Result of assessment was unclassifiable. Sender Comment: Are you or the person concerned known to have allergies? If yes, which? No. Information on risk factors or previous illnesses: Kidney disease / Has circulatory disorder. His right foot was blue and freezing cold with severe pain and could no longer step on. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1498800 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Death, Headache, Limb discomfort, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Artificial cardiac pacemaker wearer; Dialysis NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021857667

Write-up: death; Chills; Limb discomfort; Headache; Malaise; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority number DE-PEI-CADR2021118314. Other case identifier number DE-PEI-202100115123. A 79-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27Apr2021 (Batch/Lot Number: Unknown) as a single dose, for covid-19 immunisation Medical history included ongoing dialysis and an artificial cardiac pacemaker wearer. Concomitant medications were not reported. On 28Apr2021 the patient experienced Chills, Limb discomfort, Malaise, Headache. After visiting the doctor on 28Apr2021, the patient died on the same day in the afternoon. The patient''s outcome was: not recovered/not resolved for Chills, not recovered/not resolved for Limb discomfort, not recovered/not resolved for Malaise, not recovered/not resolved for Headache, fatal for Unknown cause of death. The patient died on 28Apr2021. It was not reported if an autopsy was performed. No follow-up activities possible. No further information expected. Batch/LOT number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1498807 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-13
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C006A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Pneumonia aspiration
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (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), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   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: Apoplexy; Hemiparesis (left); Multimorbidity; Peripheral arterial occlusive disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021857710

Write-up: Acute kidney failure; Aspiration pneumonia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021122955. A 71-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 20May2021 (Batch/Lot Number: 1C006A) as dose 2, single for COVID-19 immunization. Medical history included hemiparesis (left), Peripheral arterial occlusive disease, multimorbidity and apoplexy all from an unknown date and all ongoing. The patient''s concomitant medications were not reported. The patient experienced acute kidney failure and aspiration pneumonia on 13Jun2021. The patient died on 15Jun2021. The outcome of the events was fatal. An autopsy was performed and results were not provided. Senders comments: Do you or the person concerned have any known allergies? If yes, which ones? No. Information on risk factors or previous illnesses Multimorbid patient, post apoplexy with hemiparesis of the left side, PAOD. Nevertheless good general condition before, lived at home with husband and caregiver. Rapid deterioration of the patient''s condition on 13Jun / approx. 3 weeks after the 2nd vaccination deterioration of the general condition, then rapid progression with acute renal failure, aspiration pneumonia. Connection with vaccination unclear. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Aspiration pneumonia; Acute kidney failure


VAERS ID: 1498808 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Death, Myocarditis
SMQs:, Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Artificial cardiac pacemaker wearer
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral valve endocarditis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021865056

Write-up: Suspicion of myocarditis; Atrial fibrillation; Unknown cause of death; This is a spontaneous report from a non-contactable consumer or other non hpc downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021124003, Safety Report Unique Identifier DE-PEI-202100121154. A 39-year-old female patient received the second dose of BNT162B2 (COMIRNATY; Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history included ongoing artificial cardiac pacemaker wearer and mitral valve endocarditis. The patient''s concomitant medications were not reported. The patient had an unknown cause of death on an unspecified date. The patient experienced suspicion of myocarditis and atrial fibrillation on an unspecified date and was hospitalized. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event unknown cause of death was fatal and events suspicion of myocarditis and atrial fibrillation was not recovered. Senders comments: A 39-year-old female patient is reported who complained of palpitations following the second Biontech vaccination and was admitted by her cardiologist with the suspicion of atrial probe dysfunction and was required to be resuscitated on the day of admission and subsequently died. The patient had a significant history of disease following double valve replacement for double valve endocarditis 3 years ago and pacemaker implantation for 3rd degree AV block postoperatively. Otherwise, the patient was in a generally very good physical condition after this severe illness. The cause of the resuscitation event has not been clarified in the last instance. It is unclear whether it was a tachycardic arrhythmia provoked by the bradycardia, followed by ventricular fibrillation, or a previously undiagnosed malfunction of the ventricular pacemaker probe. However, in view of the temporal connection between the occurrence of the patient''s complaints and the second vaccination with the Biontech vaccine, it remains to be seen whether this was the case. Relatedness of drug to reaction(s)/event(s): D. Unclassifiable. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1498810 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac failure, Dyspnoea, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiovascular disorder; Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021865222

Write-up: Heart failure (NOS); Vomiting; Dyspnoea/sudden increase of dyspnoea; weakness; This is a spontaneous report from a non-contactable consumer downloaded from The Regulatory Authority WEB DE-PEI-CADR2021124154. Safety Report Unique Identifier is DE-PEI-202100121069. An 81-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FE6975) at single dose via an unknown route on 29Jun2021 for COVID-19 immunisation. Medical history and concurrent conditions included dementia and cardiovascular disorder. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (COMIRNATY) at single dose 6 weeks ago for COVID-19 immunisation without problems. Adverse event was reported as vomiting and dyspnoea, both with onset date of 26Jun2021 (as reported). Serious adverse event was reported as heart failure (NOS) with onset date of 30Jun2021 and seriousness criterion of death. Outcome of dyspnoea and vomiting was not resolved. Outcome of Heart failure (NOS) was fatal. Outcome of weakness was unknown. No autopsy was done. Sender''s commented that the person was not concerned having any known allergies. Details of risk factors or previous illnesses was dementia !!! cardio-vascular risk factors. 6 weeks ago 1st vaccination with BIONTECH without problems, since 3-4 days dyspnoea and weakness developed, once vomited at the weekend, on 29Jun2021 2nd vaccination with clinical stable condition, on 30Jun2021 sudden increase of dyspnoea and most likely sudden cardiac death, most likely only temporal but no causal relationship, clinically suspected consumptive disease. This report is serious with seriousness criteria of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Heart failure (NOS)


VAERS ID: 1498813 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dizziness, Malaise
SMQs:, Anticholinergic syndrome (broad), Vestibular 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021865068

Write-up: death; Light headedness; Malaise; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number is DE-PEI-CADR2021124788. A 73-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 27May2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced also malaise, light headedness, unknown cause of death. The patient did not recover from malaise and light headedness. The patient died on an unspecified date. An autopsy was not performed. Relatedness of drug to reactions/events from Regulatory Authority was D. Unclassifiable. Sender Comment: After the vaccination, dizziness and malaise occurred again and again. No follow-up attempts are possible; Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1499052 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6997 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Intracardiac thrombus
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 11
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: Left inguinal hernia; Surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021867876

Write-up: Cardiac thrombosis; Asthenia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021087835, Safety Report Unique Identifier FR-AFSSAPS-TO20215247. A 64-year-old male patient received BNT162B2 (COMIRNATY) dose 2 intramuscular, administered in arm left on 01Jun2021 (Lot Number: FC6997) as dose 2, single for covid-19 immunisation. Medical history included left inguinal hernia. There were no concomitant medications. No history other than surgery (left inguinal hernia). No tobacco, no alcohol. No long-term treatment. The patient experienced cardiac thrombosis on 13Jun2021 with outcome of fatal, asthenia on 02Jun2021 with outcome of not recovered. The patient died on 13Jun2021 due to cardiac thrombosis. An autopsy was not performed. Acute chest pain, at home, taken care of by the emergency medical service, which attempted resuscitation and took a blood sample. Death of the patient by probable cardiac thrombosis (acute chest pain), taken care of by emergency medical service. Death 1 hour after the onset of symptoms, before entering intensive care. No warning sign, except severe asthenia since vaccination with Pfizer (2nd injection). No ECG performed. No autopsy. Death of the patient due to probable cardiac thrombosis No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: probable cardiac thrombosis (acute chest pain)


VAERS ID: 1499077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-18
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, CSF pressure, Imaging procedure, Neurological examination, Perfusion brain scan, Ruptured cerebral aneurysm, Scan brain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: URBANYL
Current Illness: Anxiety; Overweight
Preexisting Conditions: Medical History/Concurrent Conditions: Cannabis use; Drug allergy; Nightmares; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: CT angiography; Result Unstructured Data: Test Result:brain death; Comments: a refractory intracranial hypertension picture inevitably progressing to a state of brain death confirmed by cerebral CT angiography; Test Date: 20210426; Test Name: intracranial pressure; Result Unstructured Data: Test Result:between 15 and 20 mmHg; Comments: controlled by the increase of drainage of the cerebrospinal fluid by the external ventricular bypass; Test Date: 20210427; Test Name: imaging control; Result Unstructured Data: Test Result:diffuse vasospasm; Comments: predominant on the carotid end and the M1 segment of the right middle sylvian artery, associated with numerous anomalies of the perfusion. Appearance of a right superficial sylvian ischemic sequela. Distal end of the external ventricular bypass at the level of the interventricular septum, with slight onset of dilation of the left lateral ventricular system. Stability of the rest of the exam.; Test Date: 20210419; Test Name: Neurological examination; Result Unstructured Data: Test Result:temporo-spatial disorientation; Comments: associated with Broca''s aphasia and right hemiparesis; Test Date: 20210421; Test Name: perfusion scan; Result Unstructured Data: Test Result:ischemic lesions; Comments: established ischemic lesions, recent, bilateral basi-frontal, bilateral superficial sylvic, right cingulate related to initial intracranial hypertension and subarachnoid hemorrhage; the absence of notable vasospasm or perfusion repercussions; stability of ventricular dilation with ventricular inundation within the occipital horns of the lateral ventricles.; Test Date: 20210418; Test Name: Cerebral scan; Result Unstructured Data: Test Result:grade IV subarachnoid hemorrhage; Comments: with hemorrhagic inundation of the basal cisterns extended to the two sylvian valleys, to the peri-mesencephalic spaces, to the furrows of the right and left convexity as well as to the 4th ventricle in connection with the rupture of a bulky 12 x 10 x 8 mm left posterior communicating artery aneurysm, right posterior communicating aneurysm mirror of about 3 mm. No hydrocephalus or any sign of brain involvement.; Test Date: 20210426; Test Name: Cerebral scan; Result Unstructured Data: Test Result:severe Willis polygon vasospasm; Comments: severe Willis polygon vasospasm, predominantly in the proximal segment of the artery of the right middle cerebral artery. The study of cerebral perfusion shows a predominant hypoperfusion in the right superficial Sylvian territory.
CDC Split Type: FRPFIZER INC2021905556

Write-up: Ruptured cerebral aneurysm; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-DJ20212528. A 37-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: EK9788), intramuscular, injected in left arm on 18Feb2021 (at an unspecified age) as dose 2, single for COVID-19 immunisation. Medical history included ongoing anxiety, ongoing overweight, drug allergy, smoking, cannabis use, nightmares. Concomitant medication included clobazam (URBANYL) from 15Apr2021 for nightmares. The patient experienced ruptured cerebral aneurysm (death) on 18Apr2021. Clinical details: There was no particular event after vaccination according to declarant. 18Apr2021, that was 2 months after vaccination patient was found unconscious at her home. She was treated by the emergency medical and resuscitation service. She was then described unconscious, the pupils were reactive intermediaries. She was intubated and then transferred to intensive care for the rest of the treatment. Cerebral scan performed 18Apr2021 showed a grade IV subarachnoid hemorrhage with hemorrhagic inundation of the basal cisterns extended to the two sylvian valleys, to the peri-mesencephalic spaces, to the furrows of the right and left convexity as well as to the 4th ventricle in connection with the rupture of a bulky 12 x 10 x 8 mm left posterior communicating artery aneurysm, right posterior communicating aneurysm mirror of about 3 mm. No hydrocephalus or any sign of brain involvement. She underwent arteriography for coiling embolization of the aneurysm, and placement of an external ventricular bypass. 19Apr2021, upon stopping the sedation, awakening was rapid and extubation occurs without difficulty. Neurological examination found temporo-spatial disorientation associated with Broca''s aphasia and right hemiparesis. The patient was then very drowsy. In the aftermath, due to a suspicion of vasospasm, a perfusion scan was performed on 21Apr2021 which showed established ischemic lesions, recent, bilateral basi-frontal, bilateral superficial sylvic, right cingulate related to initial intracranial hypertension and subarachnoid hemorrhage; the absence of notable vasospasm or perfusion repercussions; stability of ventricular dilation with ventricular inundation within the occipital horns of the lateral ventricles. 26Apr2021, new brain imaging was performed due to neurological degradation with discovery of left hemiparesis, and Wernicke''s aphasia. The measured intracranial pressure was then constantly increasing between 15 and 20mmHg controlled by the increase of drainage of the cerebrospinal fluid by the external ventricular bypass. This 26Apr2021 CT scan shows severe Willis polygon vasospasm, predominantly in the proximal segment of the artery of the right middle cerebral artery. The study of cerebral perfusion showed a predominant hypoperfusion in the right superficial Sylvian territory. A chemical dilation by perfused corotope of the right carotid end was performed as well as a mechanical dilation of the carotid end and of the right M1 portion and of the left M1. 27Apr2021, imaging control showed a diffuse vasospasm, predominant on the carotid end and the M1 segment of the right middle sylvian artery, associated with numerous anomalies of the perfusion. Appearance of a right superficial sylvian ischemic sequela. Distal end of the external ventricular bypass at the level of the interventricular septum, with slight onset of dilation of the left lateral ventricular system. Stability of the rest of the exam. She then benefitted from interventional neuroradiology treatment for chemical dilation by perfused corotrope at the left carotid end, and mechanical dilation of the carotid end and of the left M1 and right M1 portion. In the direct follow-up, she presented a refractory intracranial hypertension picture inevitably progressing to a state of brain death confirmed by cerebral CT angiography. Patient was declared deceased 28Apr2021 at 19:15. In total, a 37-year-old patient who presented with a subarachnoid hemorrhage following a ruptured cerebral aneurysm with death, 2 months after 2nd injection of COMIRNATY vaccine. No particular event reported after vaccination. The outcome of the event was fatal. The patient died on 28Apr2021. 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: Ruptured cerebral aneurysm


VAERS ID: 1499115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-05-11
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abnormal behaviour, Arterial haemorrhage, Asthenia, Blood pressure measurement, COVID-19, Condition aggravated, Cough, Cyanosis, Dehydration, Fall, Glomerular filtration rate, Head injury, Heart rate, Investigation, Oral fungal infection, Oxygen saturation, Oxygen saturation decreased, Physical examination, Respiratory distress, SARS-CoV-2 test, Vaccination failure, Wound
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 34
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: COVERSYL [PERINDOPRIL ARGININE]; KARDEGIC; NITRIDERM; PARACETAMOL; UVEDOSE; TEMERIT; AMLOR; LASILIX [FUROSEMIDE]
Current Illness: Arteritis (MI (bypass)); Deafness; Essential hypertension; Meningioma
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Cholecystectasia
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Blood pressure; Result Unstructured Data: Test Result:12; Test Date: 20210528; Test Name: Blood pressure; Result Unstructured Data: Test Result:12; Test Date: 20210528; Test Name: GFR; Result Unstructured Data: Test Result:15 ml/min; Test Date: 20210525; Test Name: pulse; Result Unstructured Data: Test Result:70; Comments: pulse at 70 bpm; Test Date: 20210528; Test Name: pulse; Result Unstructured Data: Test Result:65; Comments: pulse at 65 bpm; Test Date: 20210531; Test Name: pulse; Result Unstructured Data: Test Result:74; Comments: pulse is 74 bpm; Test Date: 20210511; Test Name: Chronic Kidney Disease Epidemiology Collaboration; Result Unstructured Data: Test Result:24 ml / min / 1.73 m2; Comments: 24 ml / min / 1.73 m2; Test Date: 20210524; Test Name: saturation; Test Result: 85 %; Test Date: 20210524; Test Name: saturation; Test Result: 80 %; Comments: In hospital; Test Date: 20210525; Test Name: saturation; Test Result: 84 %; Test Date: 20210528; Test Name: saturation; Test Result: 89 %; Test Date: 20210531; Test Name: saturation; Test Result: 96 %; Test Date: 20210607; Test Name: saturation; Test Result: 95 %; Test Date: 20210524; Test Name: Physical examination; Result Unstructured Data: Test Result:the sounds of the heart are regular; Comments: the sounds of the heart are regular and the pulmonary auscultation is free. The patient is eupneic. The abdomen is flexible. Awakening is good with cognitive impairment.; Test Date: 20210511; Test Name: PCR Coronavirus SARS-CoV2.; Test Result: Negative ; Test Date: 20210524; Test Name: TROD Covid (antigen test); Test Result: Positive
CDC Split Type: FRPFIZER INC202100915619

Write-up: desaturation; cyanosis of the extremities; asthenic; oral yeast infection (eats and drinks little); unusual behavior; Vaccination failure; COVID-19 infection without a seriousness factor; respiratory distress; persistent cough; occipital wound; bleeding arteriole in jet motivating 2 stitches; Fall of unknown origin; Cranial trauma; acute dehydration; progressive deterioration of her general condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-DJ20212542. A 95-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection) dose 1 intramuscular on 27Jan2021 (Batch/Lot Number: EJ6788) as dose 1, single and dose 2 intramuscular on 17Feb2021 (Batch/Lot Number: EK9788) as dose 2, single for covid-19 immunisation. The patient''s medical history included ongoing arteritis of the lower limbs (bypass), appendicectomy, ongoing right fronto-orbital meningioma, ongoing deafness, cholecystectomyfrom and ongoing essential hypertension. The patient''s concomitant medication(s) included perindopril arginine (COVERSYL), acetylsalicylate lysine (KARDEGIC) glyceryl trinitrate (NITRIDERM), paracetamol, colecalciferol (UVEDOSE), nebivolol hydrochloride (TEMERIT), amlodipine besilate (AMLOR) and furosemide (LASILIX). On 11May2021, to the passage to emergency a fall of unknown origin found on the ground at the nursing home. Cranial trauma with occipital wound with bleeding arteriole in jet motivating 2 stitches. Cranial trauma monitoring and acute dehydration (Chronic Kidney Disease Epidemiology Collaboration at 24 ml / min / 1.73 m2) therefore give drink and biological control within 48 hours. Note a negative PCR Coronavirus SARS-CoV2. furosemide (LASILIX) then perindopril arginine (COVERSYL) was discontinued on 14May2021 and 21May2021 respectively. On 24May2021, the SOS doctor call and hospitalization for oxygen therapy and treatment of a suspected right basal pneumonia on probable COVID-19 infection with 85 present desaturation. The patient does not keep oxygen therefore hospitalization. In hospital the patient is in respiratory distress on arrival with 80% saturation well tolerated. No cyanosis, no mottling, no print. Presence of a persistent cough. On clinical examination, the sounds of the heart are regular, and the pulmonary auscultation was free. The patient was eupneic. The abdomen was flexible. Awakening was good with cognitive impairment. TROD Covid (antigen test) positive but PCR impossible to perform because the patient was opposed to all treatments. Conclusion: COVID-19 infection without a seriousness factor on 24May2021 in the evening clinically. Return to nursing home the same day. On 25May2021, the patient was lying face down, consciousness normal but unusual behavior, she does not seem to be present, opposition to the examination. Blood pressure at 12, pulse at 70 bpm, SAO 2 at 84 percent in air. No dyspnea. Focal point of crackles located in the right lung. Do not eat. Prescriptions for a G5 percent infusion and treatment with ROCEPHINE (ceftiaxone) started on 25May2021. COVID isolation. 28May2021, the patient was reactive, blood pressure at 12 and pulse at 65 bpm, SaO 2 at 89 percent. No dyspnea and some crackles on pulmonary auscultation. The patient presents with an oral yeast infection (eats and drinks little). Biology still shows dehydration with a GFR of 15 ml / min. Prescription of TRIFLUCAN (fluconazole) and increase in the infusion of 1l G5%. On 31May2021, the patient is asthenic, she does not eat and has some cracklings in the bases. The pulse is 74 bpm and the SaO2 is 96 percent. The tongue is white. A biology required. In the following days, the patient remains asthenic with renal insufficiency motivating the continuation of the G5 percent infusions. She doesn''t eat, calls out, but can''t swallow. On 07Jun2021, she was wide awake, saturation was 95%, the pulmonary auscultation was unremarkable. The patient still presents with an oral yeast infection, but she was opposed to oral care. She says she was hungry but can''t swallow. Isolation was ended today. The patient was up at noon in the shell chair and taken to the dining room to stimulate her to eat by offering her sweet foods that are easy to swallow. On 08Jun2021, the G5 percent infusions were continued and the O2 was stopped. 10Jun2021, the patient fell from her bed, she has cyanosis of the extremities. In the following days, she presents a progressive deterioration of her general condition, she was very asthenic, does not eat. The patient died on 14Jun2021. In total, 95-year-old patient who presented with a confirmed vaccine failure with a positive antigen test on D97 of a 2nd dose of COMIRNATY vaccine and who may have played a role in the death of the patient. The patient died on 14Jun2021 due to vaccination failure and Covid-19. It was not reported if an autopsy was performed. The outcome of oral yeast infection (eats and drinks little) was not recovered, and outcome of other events was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202100915615 same reporter, different patient;FR-PFIZER INC-202100915606 same reporter. different patient;FR-PFIZER INC-202100915233 Same reporter, different patient;FR-PFIZER INC-202100915226 Same reporter, different patient;FR-PFIZER INC-202100915870 Same reporter, different patient;FR-PFIZER INC-202100915259 Same reporter, different patient;FR-PFIZER INC-202100915861 Same reporter, different patient;FR-PFIZER INC-202100915221 Same reporter, different patient;FR-PFIZER INC-202100915253 Same reporter, different patient;FR-PFIZER INC-202100915239 Same reporter, different patient;FR-PFIZER INC-202100915193 Same reporter, different patient; Reported Cause(s) of Death: Vaccination failure; Covid-19


VAERS ID: 1499116 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-26
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ankle fracture, Asthenia, Atrial fibrillation, Blood pressure measurement, COVID-19, Coma, Decreased appetite, Fall, Heart rate, Lower limb fracture, Oxygen saturation, Pain, Pain in extremity, Physical examination, Poor quality sleep, Rash macular, Respiratory distress, SARS-CoV-2 test, Somnolence, Tachypnoea, Tibia fracture, Urinary tract infection bacterial, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 63
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIPARINE; DEXERYL [CHLORPHENAMINE MALEATE;DEXTROMETHORPHAN HYDROBROMIDE;GUAIFENESIN;PHENYLEPHRINE HYDROCHLORID; EDUCTYL; LACRIFLUID; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; OMEPRAZOLE; PARACETAMOL;
Current Illness: AFib (non-anticoagulated); Deafness; Essential hypertension; Falling; Scoliosis (dorso-lumbar)
Preexisting Conditions: Medical History/Concurrent Conditions: Acute polysinusitis (Major left maxillary sinusitis + left sphenoidal and posterior ethmoidal); Colectomy; Hysterectomy; Malignant neoplasm of colon (Malignant tumor of the colon operated); Parathyroid gland excision
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: blood pressure; Result Unstructured Data: Test Result:9/6; Test Date: 20210528; Test Name: blood pressure; Result Unstructured Data: Test Result:9; Comments: At 6 p.m. the arterial pressure is 9; Test Date: 20210512; Test Name: heart rate; Result Unstructured Data: Test Result:68; Comments: 68 bpm; Test Date: 20210528; Test Name: heart rate; Result Unstructured Data: Test Result:90; Comments: an irregular pulse at 90 bpm (known atrial fibrillation); Test Date: 20210528; Test Name: heart rate; Result Unstructured Data: Test Result:rapid and shooting; Comments: the pulse is rapid and shooting; Test Date: 20210512; Test Name: saturation; Test Result: 98 %; Test Date: 20210528; Test Name: saturation; Test Result: 98 %; Comments: She is mildly polypneic with 98% oxygen saturation; Test Date: 20210528; Test Name: saturation; Result Unstructured Data: Test Result:an impregnable SaO2 %; Comments: at 6 p.m. an impregnable SaO2; Test Date: 20210528; Test Name: Physical examination; Result Unstructured Data: Test Result:She did not urinate overnight; Comments: She did not urinate overnight, but her abdomen is supple and there is no globe.; Test Date: 20210528; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202100915615

Write-up: acute respiratory distress with generalized blotch; acute respiratory distress with generalized blotch; patient is subcomatous; irregular pulse at 90bpm (atrial fibrillation); She is mildly polypneic; Vaccination failure; covid-19; patient did not eat; presented pain when mobilizing the left lower limb.; asthenia; drowsy; easily woken up; hurts all over; urinary tract infection with E. Coli and Proteus vulgaris; fracture of the right knee is not consolidated; falls from her chair; fracture of the right tibial plateau with a high risk of displacement (+ fibula); bimalleolar fracture of the right ankle.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-DJ20212545. A 101-year-old female patient received first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EJ6788) intramuscularly on 27Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EK9788) intramuscularly on 17Feb2021 as DOSE 2, SINGLE dose for COVID-19 immunisation. The patient''s medical history included medical and surgical history included acute sinusitis: major left maxillary sinusitis + left sphenoidal and posterior ethmoidal sinusitis in 2019, ongoing multiple falls, ongoing dorsolumbar scoliosis, malignant tumor of the colon operated, ongoing deafness, ongoing essential hypertension, ongoing non-anticoagulated atrial fibrillation, colectomy, parathyroidectomy, hysterectomy. Her usual treatment included: Concomitant medications heparin calcium (CALCIPARINE) taken for an unspecified indication, chlorphenamine maleate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (DEXERYL [CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE]) taken for an unspecified indication; potassium bitartrate, sodium bicarbonate (EDUCTYL) taken for an unspecified indication, carbomer (LACRIFLUID) taken for an unspecified indication, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE]) taken for an unspecified indication, omeprazole (OMEPRAZOLE) taken for an unspecified indication; paracetamol (PARACETAMOL) taken for an unspecified indication, colecalciferol (UVEDOSE) taken for an unspecified indication from unspecified date. It was reported that on 26Mar2021, the patient falls from her chair, found on her knees. She presented with a fracture of the right tibial plateau with a high risk of displacement (+ fibula) and a bimalleolar fracture of the right ankle. No surgery but Zimmer''s splint. On 11May2021, the fracture of the right knee is not consolidated, continuation of the Zimmer splint. On 12May2021: the patient presented with a urinary tract infection with E. Coli and Proteus vulgaris treated with ROCEPHINE (ceftriaxone). She has intense asthenia, she was drowsy, easily woken up, she says it hurts all over. No stool or urine abnormalities, blood pressure 9/6, saturation 98% and heart rate 68 bpm. The evolution of the general condition is unfavorable. On 28May2021, the patient did not eat, she presented pain when mobilizing the left lower limb. She was mildly polypneic with 98% oxygen saturation, an irregular pulse at 90 bpm (known atrial fibrillation). She did not urinate overnight, but her abdomen is supple and there is no globe. At 6 PM, the patient presented with acute respiratory distress with generalized mottling. The patient was subcomatous, the arterial pressure is 9 with an impregnable SaO2, the pulse was rapid and shooting. The family has been notified and agreed to terminal palliative care. Administration of oxygen therapy. The patient died at 8 PM in the presence of her family. On 28May2021, the COVID-19 RT-PCR was positive (significant viral shedding) with the detection of the Spike N501Y mutation. The profile was compatible with the 501Y.V1 (English) variant. The patient underwent lab tests and procedures which included blood pressure measurement: 9/6 on 12May2021, blood pressure measurement: the arterial pressure 9 on 28May2021 At 6 PM, heart rate: 68 bpm on 12May2021, heart rate: an irregular pulse at 90 bpm (known atrial fibrillation) on 28May2021, heart rate: the pulse is rapid and shooting on 28May2021, oxygen saturation: 98 % on 12May2021, oxygen saturation: She is mildly polypneic with 98% oxygen saturation on 28May2021, oxygen saturation: an impregnable SaO2 on 28May2021 at 6 PM, physical examination: She did not urinate overnight, but her abdomen is supple and there is no globe on 28May2021, COVID-19 RT-PCR (sars-cov-2 test): positive on 28May2021. In total, a 101-year-old patient who presented with confirmed vaccine failure with the detection of the English variant on D101 of a 2nd dose of COMIRNATY vaccine and the cause of her death. The patient died on 28May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information was expected. Sender''s Comments: Linked Report(s): FR-PFIZER INC-202100915619 same reporter, different patient;FR-PFIZER INC-202100915606 same reporter. different patient;FR-PFIZER INC-202100915221 Same reporter, different patient;FR-PFIZER INC-202100915233 Same reporter, different patient;FR-PFIZER INC-202100915226 Same reporter, different patient;FR-PFIZER INC-202100915870 Same reporter, different patient;FR-PFIZER INC-202100915259 Same reporter, different patient;FR-PFIZER INC-202100915861 Same reporter, different patient;FR-PFIZER INC-202100915253 Same reporter, different patient;FR-PFIZER INC-202100915239 Same reporter, different patient;FR-PFIZER INC-202100915193 Same reporter, different patient; Reported Cause(s) of Death: covid-19; confirmed vaccine failure


VAERS ID: 1499117 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Autopsy, Cardio-respiratory arrest, Headache, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUPRENORPHINE [BUPRENORPHINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: In vitro fertilisation
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Autopsy; Result Unstructured Data: Test Result:No useful findings, pulmonary edema and congestion; Comments: No useful findings, pulmonary edema and congestion. No pulmonary embolism, no visible cerebral thrombosis. The brain went completely into anapath, along with fragments of other organs.
CDC Split Type: FRPFIZER INC2021896198

Write-up: Cardio-respiratory arrest; intense headaches; asthenia; vomiting; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-GR20212885, Safety Report Unique Identifier: FR-AFSSAPS-2021091152. A 38-year-old female patient received second dose of bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Jul2021 13:54 (Batch/Lot Number: FE2296) as dose 2, 0.5 mL single for covid-19 immunisation. Medical history included in vitro fertilisation from 2019 to an unknown date (COVID-19 infection not specified; in vitro fertilization (2019)). Concomitant medication included buprenorphine hydrochloride (BUPRENORPHINE [BUPRENORPHINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported(Notion of buprenorphine (awaiting clarification)). The patient previously took first dose of bnt162b2 (COMIRNATY) on 25May2021 for covid-19 immunization. The patient experienced cardio-respiratory arrest on 05Jul2021 , intense headaches on 04Jul2021 20:49 , asthenia on 04Jul2021 20:49 , vomiting on 04Jul2021 20:49. The patient underwent lab tests and procedures which included autopsy: no useful findings, pulmonary edema and congestion on Jul2021 No useful findings, pulmonary edema and congestion. No pulmonary embolism, no visible cerebral thrombosis. The brain went completely into anapath, along with fragments of other organs. Therapeutic measures were taken as a result of cardio-respiratory arrest, intense headaches, asthenia, vomiting. The patient died on 05Jul2021. An autopsy was performed and results were not provided. Seriousness criteria of the events was death. The clinical course was reported as follows: On 25May2021, Dose 1 Comirnaty (lot number FC3558). On 04Jul2021 at 13:54, Dose 2 Comirnaty (lot number FE2296). On 04Jul2021 at 20:49, onset of intense headaches, asthenia and vomiting, prompting a call to the the urgent medical aid service which retains the effects in the aftermath of the vaccination. Differential diagnosis :- Initial hypothesis of subarachnoid hemorrhage but awaiting confirmation by autopsy. - Toxicological analyzes pending. Evolution : On 05Jul2021, the patient was discovered with cardiopulmonary arrest in her bed, with vomit all around. Advanced resuscitation, but ineffective. Death noted on 05Jul2021. Medico-legal obstacle. Autopsy reveals: No useful findings, pulmonary edema and congestion. No pulmonary embolism, no visible cerebral thrombosis. The brain went completely into anapath, along with fragments of other organs.; Reported Cause(s) of Death: Asystolia


VAERS ID: 1499133 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Influenza like illness, Malaise, Pain in extremity, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021905528

Write-up: pain in the arms; fever; fatigue; evoked malaise; Death unexplained; Had fainted on the motorcycle; Influenza like illness; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LY20217770. A 52-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 25May2021 (Lot Number: FC0681), at the age of 52-year-old, as dose 1, single for COVID-19 immunisation. Medical history was none. No history of COVID-19. The patient''s concomitant medications were not reported. The patient experienced influenza like illness on 25May2021, fever, pain in the arms and fatigue on an unknown date, fainted on the motorcycle, evoked malaise and death unexplained on 15Jun2021. The clinical course included on 25May2021 : Dose1 COMIRNATY. In the aftermath: fever, pain in the arms and fatigue. 3 weeks after Dose1 : death on a motorbike. Had fainted on the motorcycle. According to his wife, he still had a pain in his arms. In total: Death 3 weeks from Dose1 of COMIRNATY, on his motorbike (evoked malaise). The outcome of the event influenza like illness was recovered. The outcome of the event pain in the arms was not recovered. The outcome of the event death unexplained was fatal. The outcome of the other events was unknown. The patient died on 15Jun2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death unexplained


VAERS ID: 1499164 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CORENITEC
Current Illness: Heart valve disorders; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of endometrium (in remission)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021905367

Write-up: sudden death at home from cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PV20211920 A 77-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular on the left arm on 12Mar2021 (Lot Number: EP9605) at the age of 77-year-old as 0.3 ml dose for COVID-19 immunization. Medical history included cancer of endometrium in in remission and it wasn''t ongoing, hypertension arterial treated with corenitec and ongoing and asymptomatic valve disease, no anticoagulant therapy and ongoing. Regular cardiological monitoring without special features, no recent change of treatment or medical problem. Concomitant medication included enalapril maleate, hydrochlorothiazide (CORENITEC) taken for arterial hypertension. On 22Mar2021, the patient sudden death at home from cardiac arrest. No autopsy. The outcome of event was fatal. No follow-up attempts are possible; No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1499178 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-05-01
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dementia Alzheimer's type, General physical health deterioration
SMQs:, Dementia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 68
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RISPERDAL; SERESTA; VERATRAN
Current Illness: Alzheimer''s disease; Epilepsy; Insufficiency renal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021905434

Write-up: Death on 08Jul2021 following cardio-respiratory arrest.; deterioration of general condition; Progression of Alzheimer''s disease; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-TO20215412. A 75-year-old male patient received the second dose of bnt162b2 (COMIRNATY) via intramuscular on 04Feb2021 (Lot Number: EK9788) as single dose for covid-19 immunisation. Medical history included ongoing epilepsy, ongoing insufficiency renal, ongoing Alzheimer''s disease. No Covid-19 or no COVID test previously. Concomitant medications included risperidone (RISPERDAL) from an unspecified start date to 21Jun2021; oxazepam (SERESTA) from an unspecified start date to 07Jul2021; clotiazepam (VERATRAN) from an unspecified date to an unspecified date. The patient experienced progression of Alzheimer''s disease (Rapid worsening of his Alzheimer''s disease noted by the nursing home nurse) on May2021. And on 20Jun2021: deterioration of general condition. On 21Jun2021: stop of Risperdal. On 07Jul2021 in the evening: stop of Seresta (10 mg/day at 19h from march) and infusion of 500 cc of water; Seresta had replaced the Veratran in March. Death on 08Jul2021 following cardio-respiratory arrest. Found dead in his bed. Event outcome of progression of Alzheimer''s disease and deterioration of general condition was not recovered. The patient died on 08Jul2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death on 08Jul2021 following cardio-respiratory arrest.


VAERS ID: 1499880 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   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: Cardiac disorder; Cardiac failure (UNDER OBSERVATION.); Surgery (valve replacement)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021883220

Write-up: Death; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB, Regulatory Authority number GR-GREOF-20215468. An 85-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route, on 28Jun2021 at single dose for COVID-19 immunisation. Relevant medical history included severe cardiological disease with valvular replacement, and cardiac failure (under observation). No relevant concomitant medications were provided. On 28Jun2021, the patient experienced death. Cause of death was cardiac failure. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1499886 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-03-27
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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: 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: Arterial hypertension; Cardiomyopathy; Diabetes mellitus; Fibrillation atrial; Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210327; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: HRPFIZER INC2021400334

Write-up: tested positive for SARS CoV-2 virus/developed symptoms of Covid-19; developed symptoms of Covid-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority. The regulatory authority report number is HR-HALMED-300046228. An 83-year-old female patient received BNT162B2 (COMIRNATY) first dose (lot number: EL1491) on 05Jan2021 and second dose (lot number: EJ0136) on 26Jan2021; both administered via intramuscular route at 0.3 mL as single dose for COVID-19 immunization. The patient medical history includes living in nursing home, arterial hypertension, cardiomyopathy, diabetes mellitus and fibrillation atrial all ongoing. Concomitant medications were not reported. On 27Mar2021, the patient tested positive for SARS CoV-2 virus and developed symptoms of Covid-19. The events resulted in hospitalization. It was reported that the patient died on unspecified date in 2021. It was unknown if an autopsy was performed. Investigation result received on 09Jul2021 for complaint Comirnaty for LOE. Reasonably suggest device malfunction: No and Severity of Harm: N/A. Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL1491. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. We conclude that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Follow-up (09Jul2021 and 16Jul2021): New information received from Regulatory authority; HR-HALMED-300046228 includes: investigation result, medical history and reaction data (seriousness updated). Follow-up attempts completed. No further information expected.; Reported Cause(s) of Death: tested positive for SARS CoV-2 virus; developed symptoms of Covid-19


VAERS ID: 1499890 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-04-17
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, C-reactive protein, Cardiac arrest, Computerised tomogram thorax, Condition aggravated, Dyspnoea, Loss of consciousness, Multiple organ dysfunction syndrome, Pneumonia, Procalcitonin, SARS-CoV-2 test, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; POTASSIUM CHLORIDE; ASACTAL; DUOPRIL [FOSINOPRIL SODIUM;HYDROCHLOROTHIAZIDE]; LESCOL XL; METOPROLOL HEXAL Z; MILURIT; QUAMATEL; TENAXUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic sclerosis; Cardiomegaly; Unstable angina
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: Chest CT; Result Unstructured Data: Test Result:showed bronchopneumonia; Test Date: 20210418; Test Name: CRP; Result Unstructured Data: Test Result:elevated; Test Date: 20210418; Test Name: PCT; Result Unstructured Data: Test Result:elevated; Comments: with signs of multi-organ failure; Test Date: 20210418; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021858678

Write-up: multi-organ failure; vomiting; weakness; dyspnea / breathing worsened; bronchopneumonia; lost his consciousness; cardiac arrest; deteriorated general condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority, regulatory authority number HU-OGYI-543921. An 85-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscular, administered in right arm on 23Mar2021 (Batch/Lot Number: ET3620) at 0.3mL single dose for covid-19 immunisation. Medical history included unstable angina from 2006 to an unknown date, aortic arteriosclerosis from 2014 to an unknown date, and cardiomegaly from 2014 to an unknown date. Concomitant medications included furosemide, once a day taken for an unspecified indication, start and stop date were not reported; potassium chloride once a day taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASACTAL) 100 mg, 2x/day (each 12h) taken for an unspecified indication, start and stop date were not reported; fosinopril sodium, hydrochlorothiazide (DUOPRIL [FOSINOPRIL SODIUM;HYDROCHLOROTHIAZIDE]) once a day taken for an unspecified indication, start and stop date were not reported; fluvastatin sodium (LESCOL XL) 80 mg, 1x/day taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (METOPROLOL HEXAL Z) once a day taken for an unspecified indication, start and stop date were not reported; allopurinol (MILURIT) 300 mg, 1x/day taken for an unspecified indication, start and stop date were not reported; famotidine (QUAMATEL) 20 mg, 1x/day taken for an unspecified indication, start and stop date were not reported; rilmenidine phosphate (TENAXUM) 1 mg, 2x/day (each 12 h) taken for an unspecified indication, start and stop date were not reported. The patient experienced vomiting, weakness, dyspnea/breathing worsened on 17Apr2021; cardiac arrest, deteriorated general condition, multi-organ failure, bronchopneumonia, lost his consciousness on 18Apr2021. The clinical course was reported as follows: On 18Apr2021, the patient was hospitalized because of vomiting, weakness and dyspnea which has been ongoing for 2 days. On the same day (18Apr2021), Covid-19 antigen test was negative; Chest CT showed bronchopneumonia; Laboratory results showed elevated CRP, PCT levels elevated with signs of multi-organ failure. Intensive therapy was not started considering the patient condition and examination reports. The patient condition rapidly deteriorated, he lost his consciousness and his breathing worsened. The patient passed away on 18Apr2021 at 20:30 due to cardiac arrest, deteriorated general condition, and multi-organ failure. Outcome of the other events was unknown. An autopsy was not performed. Sender Comment: The patient was hospitalized due to multi-organ failure and died because of his deteriorated general condition, therefore the causal relationship is not related between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Sender''s Comments: The 85-year-old male patient had medical history included unstable angina, aortic arteriosclerosis, and cardiomegaly, and was on multiple concomitant medications. Based on information available, the reported fatal events cardiac arrest, multi-organ failure and deteriorated general condition were considered as due to underlying cardiac disease likely aggravated by intercurrent bronchopneumonia, and unrelated to vaccine BNT162B2 (COMIRNATY).; Reported Cause(s) of Death: multi-organ failure; cardiac arrest; deteriorated general condition


VAERS ID: 1499894 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-24
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Arteriosclerosis coronary artery, Cardiac failure, Pneumonia
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atherosclerosis generalised (for decades); Coronary sclerosis (for decades)
Preexisting Conditions: Medical History/Concurrent Conditions: Colon diverticulitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021870291

Write-up: hypostatic pneumonia; coronary sclerosis; general atherosclerosis; Death of my mother, due to heart failure; This is a spontaneous report received from a contactable consumer received via Regulatory Authority. This consumer reported similar event for two patients. This is the first of 2 reports. An 87-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, Lot Number was unknown), via an unspecified route of administration on 14Mar2021 (at the age of 87-year-old) as dose 2, single for COVID-19 immunization (administered in the Hospital). Medical history included ongoing general atherosclerosis for decades, ongoing coronary sclerosis for decades, and colon diverticulosis. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 21Feb2021 at single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced heart failure on 24Mar2021 06:30 (10 days after vaccination); and hypostatic pneumonia, coronary sclerosis, and general atherosclerosis on an unspecified date. Course of events as follows: At first the reporter thought that it is not related to vaccination, but the reporter has a colleague whose mother also received Pfizer COVID vaccination and his mother, aged 99 also died within two weeks after vaccination due to heart failure. Also, there are recent news about vaccination and heart problems. The patient also had hypostatic pneumonia, which the reporter was very surprised about, because the reporter was at her place the day before her death and she did not produce symptoms of pneumonia (she did not have a high fever), did not lie in bed, but got up, read, and so on. Her neighbors were also very surprised to learn of her death, as they had met her in the stairwell 3 days before her death, she went down for a walk in the name of the place. No treatment was received for the event heart failure. The patient died on 24Mar2021. Cause of death was heart failure, coronary sclerosis, general atherosclerosis and hypostatic pneumonia. An autopsy was performed that revealed heart failure, coronary sclerosis, general atherosclerosis and hypostatic pneumonia. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : HU-PFIZER INC-2021899902 same reporter, suspect product and event, different patient (reporter''s colleague''s mother''s case); Reported Cause(s) of Death: general atherosclerosis; hypostatic pneumonia; coronary sclerosis; heart failure; Autopsy-determined Cause(s) of Death: hypostatic pneumonia; coronary sclerosis; general atherosclerosis; heart failure


VAERS ID: 1499915 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003601 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   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: TORVAST; CARDIOASPIRIN; VASORETIC
Current Illness: Dyslipidaemia; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: COVID-19 PCR test positive
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CEREBRAL HAEMORRHAGE (EMORRAGIA CEREBRALE) in a 76-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003601) for COVID-19 vaccination. The patient''s past medical history included Abdominal aortic aneurysm on 01-Oct-2019 and Dyslipidaemia. Concurrent medical conditions included Hypertension arterial. Concomitant products included ATORVASTATIN CALCIUM (TORVAST), ACETYLSALICYLIC ACID (CARDIOASPIRIN) and ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE (VASORETIC) for an unknown indication. On 01-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced CEREBRAL HAEMORRHAGE (EMORRAGIA CEREBRALE) (seriousness criteria death and medically significant). The patient died on 10-Jul-2021. The reported cause of death was Cerebral haemorrhage. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, SARS-CoV-2 test: positive (Positive) COVID-19 PCR test positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 07-Jul-2021, laboratory tests of angiogram cerebral, brain CT and hematology were performed and results were not reported. Treatment information was not provided.; Sender''s Comments: This is a case of a 76-year-old male patient who experienced Cerebral haemorrhage 7 days following a dose of mRNA-1273 and subsequently died 10 days following vaccination. Very limited information regarding the event has been provided at this time. Detailed information regarding clinical course of the event was not provided. It is also unknown whether an autopsy was performed. Major confounder in this particular case is patient''s reported medical history of Hypertension arterial, in addition to patient''s advanced age.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1499925 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-24
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: JPPFIZER INC202100935722

Write-up: died; This is a spontaneous report from a contactable physician. This is the second of 4 report. The first report is a report from the Regulatory authority - v21118668. An unknown gender and age patient received the unknown single dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient died shortly after this vaccination. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died


VAERS ID: 1499938 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-07-04
   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: AMLODIPINE; DOMPERIDONE; POTASSIUM GLUCONATE; FAMOTIDINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Dementia; Gastric cancer (Gastric cancer after Surgery); Hypertension; Myocardial infarction; Pneumonia aspiration; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021859308

Write-up: Cardio-respiratory arrest state; This is a spontaneous report from two contactable physicians received via COVID-19 Vaccine Adverse Event Reporting System and via the Regulatory authority via regulatory authority report number is v21118557. A 94-year-old and 11-month-old female patient received the second dose of BNT162B2 (COMIRNATY, solution for injection) intramuscular, administered in Arm Right on 01Jul2021 10:00 (at the age of 94 years old) (Lot Number: EY3860; Expiration Date: 31Aug2021) as dose 2, single for COVID-19 immunisation. Medical history included myocardial infarction, gastric cancer postoperative, pneumonia aspiration, cerebral haemorrhage, urinary tract infection, dementia and hypertension. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received amlodipine, domperidone, potassium gluconate, famotidine within 2 weeks of vaccination; all taken for an unspecified indication, start and stop date were not reported. On 09Jun2021 at 11:00, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) intramuscular of administration in the right arm for COVID-19 immunization. Body temperature before the second dose vaccination was 36.1 degrees Centigrade (on 01Jul2021). After the vaccination on 01Jul2021, there were no side reactions or allergic reaction. On 04Jul2021 at 18:00 (3 days after the vaccination), there was no change when the patient was visited. At 19:40, the patient was found on the bed in a Cardio-respiratory arrest state. On 04Jul2021, although medical treatment was given, she did not respond to it and the patient''s death was confirmed at 20:55. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was possible cause of the event such as any other diseases. The patient died on 04Jul2021. It was not reported if an autopsy was performed. The reporting physician commented as follows: Since no problems were noted in her vital signs etc until 18: 00 (shortly before the patient died), it was considered that there was no causal relationship with BNT162b2.; Sender''s Comments: The association between the event fatal cardio-respiratory arrest with COMIRNATY use can not be fully excluded based on the temporal relationship and lack of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1499949 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Triple vessel disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021862935

Write-up: Myocardial infarction due to ventricular fibrillation; Myocardial infarction due to ventricular fibrillation; This is a spontaneous report from a contactable physician via a Pfizer sales representative. An 87-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 16Jun2021 (Lot number was not reported) at a single dose for covid-19 immunisation. Medical history included cardiac failure and triple vessel disease. The patient''s concomitant medications were not reported. It was reported that the patient died on 17Jun2021 due to myocardial infarction due to ventricular fibrillation on 17Jun2021. The patient was transferred the reporter''s hospital after he died. Therefore, the facility where the patient received the vaccination had not been confirmed by an emergency service team. Autopsy was not performed. The reporting physician classified the event as serious (fatal outcome). The reporter stated that the causal relationship with BNT162b2 was uncertain. Information about lot/batch number has been requested.; Sender''s Comments: Based on the available information, the events myocardial infarction due to ventricular fibrillation with fatal outcome is likely due to the underlying medical condition (cardiac failure and triple vessel disease) and not related to bnt162b2 (COMIRNATY).; Reported Cause(s) of Death: ventricular fibrillation; myocardial infarction


VAERS ID: 1499950 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral infarction, Condition aggravated, Insomnia, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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: Cerebellar ataxia; Cerebellar atrophy; Consciousness disturbed; Difficulty in standing; Difficulty in walking; Multiple cerebral infarction; Sleep apnoea syndrome (The patient did not receive the treatment with CPAP); Somnolence; Syncope (without arrhythmia, occasionally occurred)
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021862959

Write-up: Multiple cerebral infarction; Multiple cerebral infarction; repeated syncope; could not sleep because of the arm pain; arm pain; This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative and from the Regulatory authority via regulatory authority report number is v21118674. A 73-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Jul2021 (the day of vaccination), lot Number: EW0207; expiration date: 30Sep2021, as DOSE 2, SINGLE at the age of 73 years old for COVID-19 immunization at the reporter''s hospital. The patient previously had COMIRNATY dose 1, single on 14Jun2021, Lot# EY0779, Expiration date 31Aug2021 for COVID-19 immunisation. Body temperature before vaccination was 35.8 degrees Centigrade. Medical history included difficulty in standing up and walking, multiple cerebral infarction and repeated syncope, sleep apnoea syndrome (patient did not receive the treatment with CPAP (continuous positive airway pressure) because of difficulty in placement), cerebellar ataxia, cerebellar atrophy, consciousness disturbed in Jan2020, occasional syncope (without arrhythmia), tendency to somnolence. The patient''s concomitant medications were not reported. On 07Jul2021 (2 days after the vaccination), the patient''s wife (who was living together with the patient) found him dead. The patient was transferred to a different hospital from the reporter''s where CT scan was performed. The patient''s death was confirmed. From the night of 05Jul2021 at night (the day of vaccination) to the morning of 06Jul2021 (1 day after the vaccination), the patient could not sleep because of the arm pain. On 06Jul2021 (1 day after the vaccination) at 22:00, the patient took a bath by himself. On 07Jul2021 (2 days after the vaccination) in the morning, when the patient''s wife woke up, she found that all lights in the house were on and the patient was dead, crouching in the bathtub. The patient experienced sudden death. At the hospital where the patient was transferred, CT scan did not show any findings suggestive of cerebral infarction or near drowning. Multiple cerebral infarction and repeated syncope were considered as possible causes of the event. When the patient''s wife found him in the morning of 07Jul2021, it was not confirmed that the patient had already died at that time. Since postmortem CT scan did not show fluid retention in the lungs or cerebral infarction, it was unlikely to consider that the patient died of drowning. The patient died on 07Jul2021. An autopsy was not performed. Performing autopsy was refused. The reporting physician classified the event as serious (fatal outcome). Causal relationship between the event and BNT162b2 was uncertain (assessed the causality between the event and BNT162b2 as unassessable). The outcome of could not sleep because of arm pain was unknown.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Cerebral infarction, Syncope and the suspect drug BNT162B2. 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: Multiple cerebral infarction; Multiple cerebral infarction; repeated syncope


VAERS ID: 1499951 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Dysstasia, Fall
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Old cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021862965

Write-up: Cardio-respiratory arrest; Fall; could not stand up; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118380. The patient was an 83-year and 10-month-old male. Medical history included old cerebral infarction and chronic obstructive pulmonary disease (COPD). Body temperature before vaccination was 36.5 degrees centigrade. Family history was not reported. On an unknown date, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 30Jun2021 at unknown time (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5295, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 05Jul2021 at 05:45 (5 days after the vaccination), the patient experienced fall and cardio-respiratory arrest. On 05Jul2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: Although having underlying conditions of old cerebral infarction and COPD, the patient received the second coronavirus vaccination on 30Jun2021 (the day of vaccination). No notable side effects were noted, but on 05Jul2021 (5 days after the vaccination), the patient fell and could not stand up, and she had cardio-respiratory arrest in that posture. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases was COPD. The reporting physician commented as follows: Cardiopulmonary arrest (CPA) due to the underlying diseases could be considered, but the effect of the vaccination could not be denied as well.; Reported Cause(s) of Death: COPD; Cardio-respiratory arrest


VAERS ID: 1499957 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-07
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Body temperature, Cardiac arrest, Cardiac failure, Haematuria, Pallor, Respiratory arrest, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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: Angina pectoris (Bypass surgery); Bypass surgery; Cerebral infarction; Chronic kidney disease; Dementia; Hypertension; Myocardial infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021863341

Write-up: cardiac arrest; respiratory arrest; patient suddenly had vomiting (a small amount); pallor facial; back pain; Cardiac failure; Haematuria; This is a spontaneous report from a contactable physician, received from the Regulatory authority. Regulatory authority report number is v21118448. A 79-year-old (reported as 79-year and 10-month-old) male patient received dose 1 of BNT162B2 (COMIRNATY), via an unspecified route of administration on 14Jun2021 at 11:10 (Batch/Lot Number: FA7812; Expiration Date: 30Sep2021) single, for COVID-19 immunization. Medical history included cerebral infarction, angina pectoris (bypass surgery), chronic kidney disease, hypertension, dementia, and myocardial infarction. The patient''s concomitant medications were not reported. On 07Jul2021 at 06:10 (22 days and 19 hours after the vaccination), the patient experienced cardiac failure and haematuria. On an unknown date, the patient suddenly had vomiting (a small amount), pallor facial, and back pain. Shortly thereafter, the patient had cardiac arrest and respiratory arrest. At 06:30 (22 days, 19 hours, and 20 minutes after vaccination), the patient was confirmed to have died. The patient underwent laboratory tests and procedures which included body temperature: 36.5 Centigrade on 14Jun2021 (before vaccination). The patient died on 07Jul2021. Causes of death were cardiac failure and haematuria. It was not reported if an autopsy was performed. The reporting physician classified the events as serious (death) and assessed that the causality between the events and BNT162B2 as unassessable. Other possible causes of the event such as any other diseases were angina pectoris and myocardial infarction. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac failure; Haematuria


VAERS ID: 1499973 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacteraemia, Blood pressure decreased, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Depressed level of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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: Haemodialysis; Renal failure chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Comments: 8:15; Test Date: 20210707; Test Name: blood pressure; Result Unstructured Data: Test Result:immeasurable; Comments: 8:15; Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: after vaccination; Test Date: 20210707; Test Name: Body temperature; Result Unstructured Data: Test Result:40.1 Centigrade
CDC Split Type: JPPFIZER INC2021864594

Write-up: potential infection (bacteraemia); Cardio-respiratory arrest; Blood pressure decreased; Depressed level of consciousness; Pyrexia/body temperature was 38.3/body temperature was 40.1; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118401. An 81-year-old male patient (reported as 81-year and 11-month-old male) received second dose of bnt162b2 (COMIRNATY; batch/lot number: FC9880; expiration date not provided) via an unspecified route of administration on 06Jul2021 11:17 (at the age of 81-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient''s medical history included ongoing haemodialysis for renal failure chronic from an unspecified date. Patient''s family history was not reported. Concomitant medications were not reported. It was reported that patient''s body temperature before vaccination was 36.7 centigrade. Patient''s clinical course is as follows: On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported). On 06Jul2021 at 11:17 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC9880, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 06Jul2021 at 20:00 (8 hours and 43 minutes after the vaccination), the patient experienced pyrexia. On 07Jul2021 (1 day after the vaccination), the patient experienced depressed level of consciousness at 06:00 and blood pressure decreased at 08:15. The outcome of the events was not reported. The course of the events was as follows: On 06Jul2021 at 20:00 (8 hours and 43 minutes after the vaccination), the body temperature was 38.3 degrees centigrade. On 07Jul2021 at 00:30 (1 day after the vaccination), the body temperature was 40.1 degrees centigrade. At 06:00, depressed level of consciousness was noted. At 08:15, the blood pressure was immeasurable. The reporting physician classified the events as serious (life-threatening) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause of the events such as any other diseases included potential infection (bacteraemia). On 09Jul2021, new information included as follows: On 07Jul2021 at 20:55 (1 day after the vaccination), the patient experienced cardio-respiratory arrest. On 07Jul2021 (1 day after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: At 08:15, the blood pressure was immeasurable. Vasopressors and antibiotics were administered. At 20:55, cardio-respiratory arrest developed. The reporting physician classified the events as serious (death). Outcome of the events was fatal. Therapeutic measures which included vasopressors and antibiotics were taken as a result of all the events. The patient died on 07Jul2021. Causes death were ''Pyrexia/body temperature was 38.3/body temperature was 40.1'', ''Depressed level of consciousness'', ''Blood pressure decreased'', and ''Cardio-respiratory arrest''.; Reported Cause(s) of Death: potential infection (bacteraemia); Pyrexia/body temperature was 38.3/body temperature was 40.1; Depressed level of consciousness; Blood pressure decreased; Cardio-respiratory arrest


VAERS ID: 1499976 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Death, Decreased appetite
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: 2021-07-01
   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: AMLODIPINE; MEMANTINE; RISPERIDONE; YOKUKANSAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appetite lost; Dementia; Hypertension; Somnolence; Urination abnormal NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021864641

Write-up: Cardio-respiratory arrest; Appetite impaired; direct cause of death was unknown; This is a spontaneous report from a contactable nurse via a Pfizer company representative. A 94-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 at vaccination age of 94-year-old via an unspecified route of administration on 02Jul2021 (Lot number not reported, Expiration date not reported) as dose 1, single for covid-19 immunisation at his own home. Medical history included hypertension and dementia. On 22Jun2021, the patient had no appetite and was transported by ambulance. At that time, he tended to have somnolence, and no urination was noted, but the patient retuned home without being hospitalized. The patient was planning to enter to a nursing home. Concomitant medications included amlodipine; memantine; risperidone; and angelica acutiloba root, atractylodes lancea rhizome, bupleurum falcatum root, cnidium officinale rhizome, glycyrrhiza spp. root, poria cocos sclerotium, uncaria spp. hook (YOKUKANSAN); all indication, start and stop date were not reported. On 07Jul2021 (5 days after the vaccination), the patient experienced appetite impaired. On 08Jul2021 (6 days after the vaccination), an ambulance was called, but the patient was in a state of cardio-respiratory arrest on arrival. Although the direct cause of death was unknown, the reporter reported this case to the company representative in charge because it had occurred after the vaccination. The seriousness and causality of the events were not reported. The outcome of the event appetite impaired and cardio-respiratory arrest were unknown while the outcome of the other event was fatal. The patient died on Jul2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information in the case report, a possible causal relationship between cardio-respiratory arrest,death and suspect drug BNT162B2 cannot be 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: direct cause of death was unknown


VAERS ID: 1499986 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Gastritis; Hypertension; Neurosis; Sleeplessness
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021865409

Write-up: Unknown cause of death; felt sick; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a female in her 80s. The patient had medical histories of anxiety, neurosis, sleeplessness, gastritis, and hypertension. The family history and concomitant medications were not provided. On 09Jun2021 in her 80s, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) at a dose of 0.3 mL for COVID-19 immunisation. On 03Jul2021 (the day of vaccination) in her 80s, the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via unknown route of administration at a dose of 0.3 mL, single for COVID-19 immunization. On 06Jul2021 (3 days after the vaccination), the patient died of unknown cause. It was not reported whether an autopsy was performed. The course of the event was as follows: On 06Jul2021 (3 days after vaccination), the police contacted to the reporting physician that the patient died. According to the police, the patient''s family told that the patient said that she felt sick on 03Jul2021 (the day of the vaccination). Although the reporting physician tried to contact the family, he had trouble contacting them. The causality between the event and BNT162b2 was unknown. Th outcome of felt sick was unknown. Information on the lot/batch number has been requested.; 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: Unknown cause of death


VAERS ID: 1499987 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Oxygen saturation, Pallor, Respiratory arrest, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Consciousness disturbed; Disuse syndrome; Geromarasmus; Late effects of cerebral infarction; Pyrexia; Vomiting
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: 120/-; Comments: at 15:15; Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.5 Centigrade; Comments: before vaccination; Test Date: 20210706; Test Name: SpO2; Test Result: 98%; Comments: with 1 L/minute of oxygen; Test Date: 20210706; Test Name: SpO2; Result Unstructured Data: Test Result: 80s; Comments: at 15:15.
CDC Split Type: JPPFIZER INC2021865518

Write-up: Cardio-respiratory arrest; respiratory arrest; Vomiting; Pallor facial; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118461. The patient was a 94-year and 2-month-old female. Body temperature before vaccination was 36.5 degrees centigrade. Family history was unknown. Medical history included late effects of cerebral infarction, disuse syndrome, geromarasmus, repeated episodes of vomiting, pyrexia, and consciousness disturbed. Concomitant medication included lansoprazole (LANSOPRAZOLE) OD tablet (15 mg) 1 tablet once daily in the morning taken orally for an unspecified indication, start date was not reported and ongoing. On 06Jul2021 at 14:30 (the day of vaccination) at the age of 94-year-old, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 06Jul2021 at 15:15 (45 minutes after the vaccination), the patient experienced pallor facial and vomiting. On 06Jul2021 at 16:15, (1 hour 45 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 06Jul2021 (on the same day of the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 06Jul2021 at 12:30, the patient ate paste-like meal. At 14:30, the patient received the COVID-19 vaccine. At 15:15, the breath sound suddenly became oof oof sound, as if something welled up, and the patient had pallor facial. The patient was transferred to a bed and suction was conducted on the bed. The patient vomited food residue (paste-like meal). Blood pressure (BP) was 120/- and SpO2 was 80s. SpO2 became 98% with 1 L/minute of oxygen. Suction was repeated; however, at 15:45, the patient had respiratory arrest. Suction was conducted with endotracheal intubation; however, at 16:15, the patient had cardio-respiratory arrest. At 16:33, death was confirmed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were late effects of cerebral infarction and suspected vomit aspiration. The reporting physician commented as follows: Since the patient was admitted to the facility, the patient has had cerebral infarction and repeated episodes of vomiting, pyrexia, and consciousness disturbed. For the last 3 months, the condition was stable. Causality between the symptoms and the vaccine was unknown. The outcome of respiratory arrest, pallor facial and vomiting was unknown.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1499989 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 1 - / -

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: 2021-06-20
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021865649

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118556. A 70-year and 9-month-old female patient received BNT162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 20Jun2021 at 15:00 (at 70-year and 9-month-old) (Lot number EW0203, Expiration date 30Sep2021) at dose 1, single for COVID-19 immunization. Body temperature before vaccination was not provided. The family history and points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) was not provided. The patient regularly visited a department of orthopedics in a university hospital and received drug treatment (detail of prescription was unknown). On 20Jun2021 at 20:00 (5 hours after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: From 20:30 (5 hours and 30 minutes after vaccination) to 21:00 (6 hours after vaccination) on 20Jun2021, the patient was taking a bath. However, she did not get out of a bath. Thus, the family went to see how the patient was doing, and the patient was found dead in the bathtub. An ambulance was called (no standard cardiopulmonary resuscitation [CPR] was performed). At 22:14 (7 hours and 14 minutes after vaccination) on 20Jun2021, the patient was transferred to the reporting hospital. At the hospital visit, ECG showed asystole. Although CPR was performed, no return of spontaneous circulation (ROSC) was obtained. At 23:10 (8 hours and 10 minutes after vaccination) on 20Jun2021, the death was confirmed. Although an autopsy imaging (AI) was performed, the cause of death was unable to be specified. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was reported as present.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1499991 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: JPPFIZER INC2021865687

Write-up: This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A patient of unspecified age and gender receive BNT162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on unknown date in 2021 (Lot number unknown, Expiration date unknown) at unknown dose, single for COVID-19 immunization. The family history, medical history and concomitant medications were not provided. On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced death. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The reporting physician was not the vaccinator. A patient who visited the reporting hospital told that his/her acquaintance (in the village) died the following day when s/he received BNT162b2 vaccination. The causality between the event and BNT162b2 was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1499992 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021865699

Write-up: Death; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118512. An 81-year and 1-month-old female patient received BNT162b2 (COMIRNATY, Solution for injection) on 05Jul2021 at 16:20 (at 81-year and 1-month-old) (Lot number EW0207, Expiration date 30Sep2021) at dose 2, single for COVID-19 immunization. Body temperature before vaccination was 36.6 degrees centigrade. Family history was not reported. Medical history included hypertension and dyslipidaemia. The patient''s concomitant medications were not reported. On an unspecified date, the patient previously took the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported) as single dose for COVID-19 immunization. On 06Jul2021 (1 day after the vaccination), the patient experienced death. The course of the event was as follows: On 05Jul2021 in the afternoon, the patient received the vaccine. The patient was placed under observation for 15 minutes and then returned home. On 06Jul2021 at night, the patient''s son found that the patient was dead while taking a bath. On 07Jul2021, autopsy was conducted. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were cerebrovascular disorder and cardiovascular disorder.; Reported Cause(s) of Death: Death


VAERS ID: 1500008 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Disseminated intravascular coagulation, Loss of consciousness, Near drowning
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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: Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:Unknown result; Comments: before vaccination; Test Date: 202107; Test Name: CT test; Result Unstructured Data: Test Result:revealed no direct cause; Comments: revealed no direct cause that resulted in cardio-respiratory arrest
CDC Split Type: JPPFIZER INC2021866382

Write-up: Disseminated intravascular coagulation; Cardio-respiratory arrest; loss of consciousness; Near drowning; This is a spontaneous report from a contactable physician. This is a case received from the Regulatory authority. The regulatory authority report number is v21118460. An 87-year-old (also reported as 87-year and 5-month-old) female patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 06Jul2021 (lot number and expiration date not reported), as dose 2, single, for COVID-19 immunisation. Family history and medical history were unknown. Concomitant medications were not reported. Body temperature before vaccination on 06Jul2021 was unknown. Historical vaccine included BNT162B2 (COMIRNATY), on an unspecified date (lot number and expiration date not reported), as dose 1, single, for COVID-19 immunisation. On 07Jul2021 at 21:27 (1 day after the vaccination), the patient experienced disseminated intravascular coagulation and cardio-respiratory arrest. On 07Jul2021, the patient experienced loss of consciousness and near drowning. The course of the events was as follows: On 06Jul2021, after the vaccination, the patient had no adverse reaction. On 07Jul2021, the patient was found to have loss of consciousness in a bathtub. Cardiopulmonary resuscitation (CPR) was conducted; however, spontaneous circulation did not return. CT test in Jul2021 revealed no direct cause that resulted in cardio-respiratory arrest. On 07Jul2021 (1 day after the vaccination), the outcome of the events was fatal. The patient died on 07Jul2021. It was unknown if an autopsy was performed. The reporting physician classified the events as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was near drowning. The reporting physician commented as follows: Although causality between the event and the vaccine was unknown, the case was reported since the patient was vaccinated immediately before. Follow-up attempts are needed. Further information is expected.; Reported Cause(s) of Death: loss of consciousness; Disseminated intravascular coagulation; Cardio-respiratory arrest; Near drowning


VAERS ID: 1500012 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Computerised tomogram, Drowning
SMQs:, Myocardial infarction (narrow), Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: CT; Result Unstructured Data: Test Result: No obvious intracranial lesions; Comments: No obvious intracranial lesions such as cerebral infarction and cerebral haemorrhage could be pointed out. Dissection and abdominal aortic aneurysm were difficult to be assessed due to vascular collapse. High density areas were scattered in the whole lung fields./calcification of the aorta and coronary arteries was noted.
CDC Split Type: JPPFIZER INC2021866505

Write-up: acute coronary syndrome (ACS); Drowning; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118511. An 86-year-old female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) via an unspecified route of administration on 04Jul2021 at 19:00 at 86 years old as a single dose for COVID-19 immunization. The medical history and concomitant medications were unknown because the patient received the vaccination at another institution. The family history was not provided. Body temperature before vaccination was not provided. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunization. On 05Jul2021 (one day after the vaccination), the patient experienced drowning. The course of the event was as follows: On 05Jul2021, at 22:00 (one day and 3 hours after vaccination), the patient was found drowning in the bathtub by her family, and an ambulance was called. At 22:53 (one day, 3 hours, and 53 minutes after vaccination), while a cardiopulmonary resuscitation (CPR) was being continued by the ambulance service, the patient arrived at the hospital. At 23:47 (one day, 4 hours, and 47 minutes after vaccination), the patient was confirmed to die. On 05Jul2021 (one day after the vaccination), the outcome of the event was fatal. On 06Jul2021, at 00:40 (one day, 5 hours, and 40 minutes after vaccination), an autopsy was performed by the police personnel (no traumatic changes were pointed out, and incidence was low.) The results of CT examination were as follows: No obvious intracranial lesions such as cerebral infarction and cerebral haemorrhage could be pointed out. Dissection and thoracoabdominal aortic aneurysm were difficult to be assessed due to vascular collapse. High density areas were scattered in the whole lung fields. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was acute coronary syndrome (ACS). The reporting physician commented as follows: It was considered that the patient had drowning due to some kinds of intrinsic effects while taking a bath. CT showed no large lesions such as cerebral infarction and cerebral haemorrhage. However, calcification of the aorta and coronary arteries was noted, and the possibility of the involvement of acute coronary syndrome (ACS) could not be ruled out. In addition, the possibility of side reactions to the vaccination could not be ruled out (unassessable), and thus, this case was reported.; Reported Cause(s) of Death: acute coronary syndrome (ACS); Drowning


VAERS ID: 1500034 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-07-06
   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: AMLODIPINE; BISOPROLOL; EVISTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (made regularly visits the reporting hospital); Osteoporosis (made regularly visits the reporting hospital).
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.3 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC2021867182

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician via the Regulatory Authority and from the Regulatory Agency, Regulatory authority report number is v21118673. A non-pregnant 88-year and 9-month-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 05Jul2021 15:30 (Lot Number: FA5765; Expiration Date: 30Sep2021) at age of 88 years old as single dose for covid-19 immunisation. Medical history included hypertension and osteoporosis, for which the patient made regularly visits the reporting hospital. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Family history was unknown.Concomitant medications within 2 weeks of vaccination included amlodipine taken for hypertension; bisoprolol taken for hypertension; raloxifene hydrochloride (EVISTA) taken for osteoporosis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.On 14Jun2021 at 15:30, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) intramuscularly in the left arm at age of 88 years old for COVID-19 immunisation. On 05Jul2021 at 15:30 (the day of vaccination), the patient received the second single dose of BNT162b2 at doctor''s office/urgent care. Body temperature before vaccination was 36.3 degrees centigrade. On 06Jul2021 (1 day after the vaccination), the patient experienced cardio-respiratory arrest at home in the afternoon and was transported by ambulance to another hospital. The patient died on 06Jul2021. This case was unrelated to any crime according to postmortem inspection. It was unknown whether autopsy was performed. It was unknown whether treatment was given for the adverse event. The outcome of event was fatal. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician assessed the event as serious (death). The reporting physician assessed the causality between the event and BNT162b2 as unassessable. It was unknown whether there were other possible causes of the event such as any other diseases.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the event Cardio-respiratory arrest cannot be excluded but also consider patient''s medical history of hypertension and elderly age as confounding factor. 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: Cardio-respiratory arrest


VAERS ID: 1500035 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021867187

Write-up: Pyrexia of 37.5 degrees centigrade or higher; This is a spontaneous report from a non-contactable consumer via COVID-19 Self-Reporting. The patient was an 84-year-old male. The most recent COVID-19 vaccine was administered at the hospital. It was unknown whether the patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. Other medical history included lung cancer and concurrent pneumonia aspiration. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19 since the vaccination. The patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration on 04Jul2021 at 15:00 (at the age of 84-year-old) for COVID-19 immunisation. On 04Jul2021 at unknown time (after the vaccination), the patient experienced pyrexia of 37.5 degrees centigrade or higher. On 07Jul2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had progression of lung cancer and had concurrent pneumonia aspiration. On 04Jul2021 (after the vaccination), the patient experienced pyrexia of 37.5 degrees centigrade or higher, which was determined to be unlikely due to the vaccine. On 07Jul2021 (3 days after the vaccination), the patient died. The reporter stated that the adverse event resulted in prolongation of the current hospitalization (the vaccination was given during the current hospitalization), and death. It was unknown whether an autopsy was performed. It was unknown whether treatment was given for the adverse event. Reported Cause(s) of Death: Pyrexia of 37.5 degrees centigrade or higher


VAERS ID: 1500043 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-30
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aberrant aortic arch, Aortic aneurysm rupture, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Loss of consciousness, Mediastinal haemorrhage, Ventricular hypertrophy
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   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: BAZEDOXIFENE; ELDECALCITOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoporosis
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:slightly high before with a maximal blood pressure; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021867512

Write-up: Left ventricle thickening was also recorded in the post-mortem certificate; A case of death due to dissecting aortic aneurysm rupture (mediastinal haemorrhage due to aortic arch hiatus); The patient was found unconscious; CPA; mediastinal haemorrhage due to aortic arch hiatus; excessive mediastinal haemorrhage due to aortic arch hiatus; This is a spontaneous report from a contactable physician via COVID-19 Adverse Event Self-Reporting Solution and Regulatory authority. Regulatory authority report number is v21119164. A 66-year and 10-month-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular, administered in Arm Left on 18Jun2021 14:30 (Lot Number: FC3661; Expiration Date: 30Sep2021) as single dose for covid-19 immunization at the age of 66 years old. The most recent COVID-19 vaccine was administered at the doctor''s office/urgent care. Medical history included osteoporosis. Family history was unknown. There were no other underlying conditions in particular. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication(s) was reported as List of any other medications the patient received within 2 weeks of vaccination/other medications in 2 weeks included bazedoxifene and eldecalcitol, both for osteoporosis. The patient experienced a case of death due to dissecting aortic aneurysm rupture, the patient was found unconscious, cpa on 30Jun2021. The clinical course was as follows: On 30Jun2021 (12 days after the vaccination), a case of death due to dissecting aortic aneurysm rupture (mediastinal haemorrhage due to aortic arch hiatus) occurred. The reporter stated that the adverse event resulted in death. The death cause was dissecting aortic aneurysm rupture. Autopsy was performed with remarks of excessive mediastinal haemorrhage due to aortic arch hiatus. Treatment was not given for the adverse event. The reporting physician assessed the event as serious (death). The causality of the event was not reported. On 10Jul2021, the clinical course was reported as follows: On 30Jun2021 in the morning (12 days after the vaccination), the patient was found unconscious by her family. An ambulance was called, but she was in a state of CPA. A call was made to the police and later the case was handled as unnatural death with autopsy done by a medical examiner. In the death certificate (reported by the family over the phone), a finding of excessive mediastinal haemorrhage due to dissecting aortic aneurysm rupture (aortic arch hiatus was noted) was written. (an inquiry was made because of the cancellation of the second vaccination, and the above was reported by the family). The reporting physician classified the events as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: Left ventricle thickening was also recorded in the post-mortem certificate. The blood pressure had been pointed out to be slightly high before with a maximal blood pressure of about 130 mmHg, and no oral treatment was suggested. The causal relationship with the vaccine was unknown, but considering that this case ended in sudden death although there were no serious underlying diseases, the causal relationship with the vaccine could not be also denied. Body temperature before vaccination was 35.6 degrees centigrade on 18Jun2021. The patient died on 30Jun2021. An autopsy was performed that revealed excessive mediastinal haemorrhage due to aortic arch hiatus, left ventricle thickening was also recorded in the post-mortem certificate. The outcome of the events was fatal. The reporter declined further attempts of follow-up.; Reported Cause(s) of Death: The patient was found unconscious; CPA; Dissecting aortic aneurysm rupture; Autopsy-determined Cause(s) of Death: excessive mediastinal haemorrhage due to aortic arch hiatus; Left ventricle thickening was also recorded in the post-mortem certificate; Excessive mediastinal haemorrhage due to aortic arch hiatus


VAERS ID: 1500050 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Loss of consciousness, N-terminal prohormone brain natriuretic peptide
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure chronic; Cardiac function decreased; Dementia; Dilated cardiomyopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: NT-proBNP; Result Unstructured Data: Test Result:around 5000 pg/mL; Test Date: 20210622; Test Name: NT-proBNP; Result Unstructured Data: Test Result:30661 pg/mL
CDC Split Type: JPPFIZER INC2021870600

Write-up: Cardiac failure aggravated acute; patient was found collapse on the street; This is a spontaneous report from a contactable physician received via COVID-19 Self-Reporting. A 81-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, lot number: FC5295, Expiration date: 30Sep2021), via an unspecified route of administration, on 19Jun2021, the day of vaccination (at the age of 81 years), as dose number unknown, single for covid-19 immunization. The patient medical history included cardiac failure chronic, dementia, dilated cardiomyopathy, and cardiac function severely decreased all ongoing. The patient was visiting the reporter''s hospital for cardiac failure chronic due to dilated cardiomyopathy. The patient received therapeutic medicine for cardiac failure and others within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. 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. On 22Jun2021 (3 days after the vaccination), the patient experienced cardiac failure aggravated acute. The event resulted in hospitalization. The event course was reported as on 19Jun2021 (the day of vaccination), the patient received a dose of BNT162B2 vaccination. On 22Jun2021 (3 days after vaccination), the patient visited the reporting hospital for regular visit. At that time, the blood examination was performed, which showed that cardiac failure was suddenly aggravated with N-terminal prohormone brain natriuretic peptide (NT-proBNT) of 30661 pg/mL (the course was usually observed with around 5000). Since the patient had dementia, he could not rest in bed. The patient was found collapse on the street. On 25Jun2021 (6 days after vaccination), the patient died during hospitalization. Therapeutic measures were taken as a result of cardiac failure aggravated acute and patient was found collapse on the street. The reporting physician assessed the event as serious (hospitalization). Sender''s Comments: As there is limited information in the case provided, the causal association between the event Cardiac failure aggravated, Loss of consciousness, and the suspect drug cannot be excluded, but consider also possible contributory effects from patient''s medical history of cardiac failure chronic. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate. Reported Cause(s) of Death: Cardiac failure aggravated; patient was found collapse on the street


VAERS ID: 1500057 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: Cancer surgery; Cerebral infarction; Dementia; Diabetes mellitus; Hepatic cancer; Large intestine carcinoma; Myocardial disorder
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination (1st dose); Test Date: 20210708; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: before vaccination (2nd dose)
CDC Split Type: JPPFIZER INC2021872268

Write-up: Cardiac failure acute; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118622. An 88-year-old male patient received bnt162b2 (COMIRNATY), at same age, dose 2 via an unspecified route of administration on 08Jul2021 14:30 (Batch/Lot Number: FC5947; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included dementia, cerebral infarction, myocardial disorder, large intestine carcinoma, Postoperative hepatic cancer, and diabetes mellitus. The patient''s concomitant medications were not reported. The patient was received first dose of bnt162b2 (COMIRNATY, Lot number FC5947, expiration date 30Sep2021) for covid-19 immunisation. On 09Jul2021 at 13:36 (23 hours 6 minutes after the vaccination), the patient experienced cardiac failure acute. On 09Jul2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was being hospitalized due to dementia and other disorders. On 08Jul2021, the patient received the second dose of COMIRNATY. On 09Jul2021, the patient died of cardiac failure acute. Anaphylactic symptoms were not confirmed. The patient had other disorders included cerebral infarction, myocardial disorder, large intestine carcinoma, surgery for hepatic cancer, diabetes mellitus, etc. The patient underwent lab tests and procedures which included body temperature: 36.3 centigrade on unspecified date before vaccination (1st dose), 35.9 centigrade on 08Jul2021 before vaccination (2nd dose). The patient died on 09Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no mention of ''Other possible cause of the event such as any other disease''. The reporting physician commented as follows: It was considered that causality between the event and COMIRNATY was low; however, it could not be denied completely considering temporal sequence.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1500058 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   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: BAYASPIRIN; LASIX [FUROSEMIDE]; PARIET; OLMESARTAN MEDOXOMIL; MAINTATE; ITOROL; CALONAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure congestive
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021872271

Write-up: Cardio-respiratory arrest; respiratory discomfort (Wheezing); This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21118672. A 77-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection) dose 2 via an unspecified route of administration on 02Jul2021 18:47 (Lot Number: FA7338; Expiration Date: 30Sep2021) as dose 2, single for covid-19 immunisation. Medical history included cardiac failure congestive. Ongoing concomitant medications included acetylsalicylic acid (BAYASPIRIN); furosemide (LASIX); rabeprazole sodium (PARIET); olmesartan medoxomil; bisoprolol fumarate (MAINTATE); isosorbide mononitrate (ITOROL); paracetamol (CALONAL). Body temperature before vaccination was 36.6 degrees centigrade. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown). On 03Jul2021 at 15:30 (20 hours/43 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 03Jul2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 03Jul2021 (5 hours and 13 minutes after vaccination), in the morning, the patient had respiratory discomfort (wheezing). At 14:30 (19 hours and 43 minutes after vaccination) on the same day, the patient was fine when her husband went out for shopping. At 15:30 (20 hours and 43 minutes after vaccination) on the same day, when the husband came back home, the patient was found to have respiratory arrest. An ambulance was called, and the patient was transferred to the reporting hospital. Cardiac massage was performed, and adrenaline was administered; however, the patient had cardiac arrest and pupils dilated. At 16:46 (21 hours and 59 minutes after vaccination), the patient was confirmed to die. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was cardiac failure congestive. The patient died on 03Jul2021. It was not reported if an autopsy was performed. Outcome of event wheezing was unknown.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1500060 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Cardiac failure acute, Cholecystitis, Cholelithiasis, Computerised tomogram, Decreased appetite, Malaise, Nausea
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: blood examination; Result Unstructured Data: Test Result:owed increased inflammatory findings and increased; Comments: owed increased inflammatory findings and increased liver function; Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:39.8 Centigrade; Comments: pyrexia of 39.8 degrees Celsius; Test Date: 20210709; Test Name: CT; Result Unstructured Data: Test Result:showed gallstones and gallbladder wall thickening; Comments: showed gallstones and gallbladder wall thickening
CDC Split Type: JPPFIZER INC2021872338

Write-up: Cardiac failure acute; gallstones; cholecystitis; queasy; malaise; inappetence; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21118671. The patient was an 80-year-old female. Body temperature before vaccination was 36.5 degrees centigrade 06Jul2021 (the day of vaccination). The family history was not provided. The patient had medical histories of diabetes mellitus, rheumatoid arthritis, and hypertension. The patient''s concomitant medications were not reported. On 06Jul2021 at 13:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 09Jul2021 at 14:40 (3 days/1 hour/10 minutes after the vaccination), the patient experienced cardiac failure acute. On 09Jul2021 (3 days after the vaccination), the patient was admitted to the hospital. On 09Jul2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 07Jul2021 (10 hours and 30 minutes after vaccination), the patient had malaise and inappetence. On 08Jul2021 (one day, 10 hours, and 30 minutes after vaccination), the patient had queasy. On 09Jul2021 (2 days, 10 hours, and 30 minutes after vaccination), the patient visited another hospital. The patient had pyrexia of 39.8 degrees Celsius and mild tenderness on the right hypochondrium. The blood examination showed increased inflammatory findings and increased liver function. CT showed gallstones and gallbladder wall thickening. The patient was diagnosed with gallstones and cholecystitis, and she was admitted to the hospital for treatment on the same day. At 14:40 (3 days, one hour, and 10 minutes after vaccination), the patient had cardiac arrest. Immediately, resuscitation was initiated; however, the patient did not recover. At 15:48 (3 day, 2 hours, and 18 minutes after vaccination), the patient was confirmed to die. The reporting physician classified the event as serious (hospitalization and death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: The patient was orally taking a steroid and an immunosuppressive drug for diabetes mellitus, hypertension, and rheumatoid arthritis chronic. CT showed coronary artery calcification. The reporting physician commented as follows: The death certificate in which the direct cause of death was cardiac failure acute was issued. The patient died on 09Jul2021. It was not reported if an autopsy was performed. The outcome of event cardiac failure acute was fatal, of other events was unknown. Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1500061 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Autopsy, Body temperature, Cardiac arrest, Coma scale, Computerised tomogram, Drowning, Myocardial infarction, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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 (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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: Dialysis; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Name: Ai of the head; Result Unstructured Data: Test Result:revealed no haemorrhage and No aortic rupture; Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4; Comments: before vaccination; Test Date: 20210707; Test Name: JSC; Result Unstructured Data: Test Result:III-300; Test Name: CT; Result Unstructured Data: Test Result:Near drowning was diagnosed
CDC Split Type: JPPFIZER INC2021872339

Write-up: severe arrhythmia; suspected myocardial infarction; Near Drowning/ drowning; asystole and respiratory arrest; asystole and respiratory arrest; This is a spontaneous report from a contactable pharmacist received from the Regulatory authority. Regulatory authority report number is v21119165. The patient was a 77-year-old male. Body temperature before vaccination was 36.4 degrees centigrade. Family history was not reported. Medical history included renal failure chronic (on dialysis). Concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported) as single dose for COVID-19 immunisation. On 06Jul2021 at unknown time (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) at age of 77-year-old via an unspecified route of administration as a single dose for COVID-19 immunisation. On 07Jul2021 at 17:00 (1 day after the vaccination), the patient experienced near drowning. On 07Jul2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 07Jul2021 around 16:00 (1 day after the vaccination), the patient was taking a bath. Around 17:00, his wife found him drowned in the bathtub. An ambulance was called. When the emergency crews arrived, the ''JSC'' score was III-300 with asystole and respiratory arrest, due to which chest compression was started and the patient was transported. At 18:28, he was confirmed dead without recovery. The cause of death was considered as drowning. The reporting pharmacist classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were severe arrhythmia and suspected myocardial infarction. The reporting pharmacist commented as follows: Autopsy imaging (Ai) of the head revealed no haemorrhage. No aortic (Ao) rupture was noted. The lung showed changes related to near drowning. Near drowning was diagnosed based on computerised tomography (CT). The outcome of event Near drowning /drowning was fatal, of the other events was unknown.; Reported Cause(s) of Death: drowning; Autopsy-determined Cause(s) of Death: The lung showed changes related to near drowning


VAERS ID: 1500063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-30
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), 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: 2021-06-30
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.3; Comments: Before the first dose of vaccination; Test Date: 20210623; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.1; Comments: Before the second dose of vaccination; Test Date: 20210630; Test Name: CT scan; Result Unstructured Data: Test Result: subarachnoid haemorrhage.
CDC Split Type: JPPFIZER INC2021872352

Write-up: Cardio-respiratory arrest; subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118590.A 93-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Jun2021 (Batch/Lot Number: FA7338; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY4834, Expiration date 31Aug2021) an unspecified route of administration as the first single dose on 02Jun2021 (the day of vaccination), for COVID-19 immunization. On 30Jun2021 at around 08:30, the patient was found in a state of cardio-respiratory arrest by the patient''s family and she was transferred to a hospital by an ambulance. From the result of CT scan, subarachnoid haemorrhage was diagnosed. At 09:37, the patient''s death was confirmed. It was not reported if an autopsy was performed. Body temperature before the second vaccination was 36.1 degrees Centigrade.Body temperature before the first dose of vaccination was 36.3 degrees Centigrade.The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. The physician considered that there was a possible cause of the events such as any other diseases. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: subarachnoid haemorrhage; Cardio-respiratory arrest


VAERS ID: 1500064 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CILOSTAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial thrombosis; Hypertension; Renal cyst
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021872355

Write-up: Pyrexia; This is a spontaneous report from a contactable physician via a Pfizer sales representative. An 87-year-old female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported), intramuscularly on 29Jun2021 at age of 87 years old at single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included arterial occlusive thrombosis, gigantic renal cyst and hypertension. Concomitant medications included oral cilostazol. Family history were not reported. On an unspecified date, the patient experienced pyrexia. On 03Jul2021 in the morning, the patient died. It was not reported whether an autopsy was performed. The cause of death was not reported. The assessment of causality between the event and BNT162b2 and seriousness of the event were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Pyrexia and the suspect drug BNT162B2. 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: Pyrexia


VAERS ID: 1500068 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Brain natriuretic peptide, Cardiac disorder, 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: 2021-07-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HEPARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cerebral infarction; Diabetes mellitus; Tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.0 Centigrade; Comments: Before vaccination; Test Date: 20210702; Test Name: BNP; Result Unstructured Data: Test Result: 959.6 pg/mL.
CDC Split Type: JPPFIZER INC2021872366

Write-up: cardiac disease; thrombosis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118772. A 90-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EX5420; Expiration Date: 31Aug2021), via an unspecified route of administration on 05Jul2021 13:52 (at unknown age) as single dose for COVID-19 immunisation. Medical history included cerebral infarction from 2015, 01Jun2021, diabetes mellitus, atrial fibrillation, tachycardia. Concomitant medication included heparin. The patient was a 90-year-old female. Body temperature before vaccination was 36.0 degrees Centigrade. Medical history included cerebral infarction (in around 2015 and 01Jun2021), diabetes mellitus and atrial fibrillation. The patient was receiving heparin (HEPARIN). Family history was not provided. On 05Jul2021 at 13:52 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EX5420, Expiration date 31Aug2021), via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Jul2021 at 12:58 (5 days after the vaccination), the patient died. It was unknown if an autopsy was performed. The course of the events was as follows: On 02Jul2021, tachycardia was noted. Blood test showed BNP (brain natriuretic peptide) 969.6 pg/mL. On 05Jul2021, the patient received the first dose of BNT162b2. On 10Jul2021 in the morning, the patient was able to have a conversation. At around 10:00, her condition suddenly changed and died. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. Cardiac failure and cerebral infarction were considered as possible causes of the event. The reporting physician commented as follows: The patient died due to cardiac disease or thrombosis. It was considered that there was no causal relationship with BNT162b2.; Sender''s Comments: Based on known information, the events of Cardiac failure and cerebral infarction are assessed as not related to the suspect product BNT162B2, and more likely due to underlying medical condition of the patient.; Reported Cause(s) of Death: cardiac disease; Thrombosis


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