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

Found 2,281 cases where Vaccine is COVID19 and Symptom is COVID-19 and Patient Died



Case Details (Sorted by Age)

This is page 7 out of 229

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VAERS ID: 1000288 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2021-01-08
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210113; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021095822

Write-up: positive COVID-19 virus test; COVID-19; Back pain; This is a spontaneous report received from a contactable healthcare professional by Pfizer from the products Regulatory Agency. The regulatory authority report number is GB-MHRA-ADR 24648457. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 17Dec2020 at a single dose for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced COVID-19 on 13Jan2021, which was reported as fatal. The patient also experienced positive COVID-19 virus test on 13Jan2021 and back pain on 08Jan2021. The clinical course was reported as follows: The patient was admitted with back pain and multiple co-morbidities and COVID-19 virus test was negative on admission on 08Jan2021. On 13Jan2021, the COVID-19 virus test was positive (reported as 3 weeks and 6 days after his first vaccination on 17Dec2020). The clinical outcome of positive COVID-19 virus test and COVID-19 was fatal and of back pain was unknown. The patient died on 20Jan2021. The cause of death was reported as positive COVID-19 virus test and COVID-19. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1000375 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Death, Dyspnoea, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; ATORVASTATIN; HYDRALAZINE; LANSOPRAZOL; MONOMIL XL; RIVAROXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Atrial fibrillation; Cardiac pacemaker insertion (cardiac pace maker in situ); Chronic lymphocytic leukaemia; DVT; Heart failure; Hypertension; Prostate cancer; Type 2 diabetes mellitus; Comments: Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021095923

Write-up: COVID-19 pneumonia/sars-cov-2 infection/dyspnoea, cough and pyrexia; COVID-19 pneumonia; SARS-CoV-2 infection; pyrexia; cough; Dyspnoea; This is a spontaneous report received from a contactable physician by Pfizer from the products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101261732199850. Safety Report Unique Identifier GB-MHRA-ADR 24651485. A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK1768), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history included cardiac pacemaker insertion, hypertension, chronic lymphocytic leukaemia, atrial fibrillation, type 2 diabetes mellitus, angina pectoris, prostate cancer, deep vein thrombosis, cardiac failure. Concomitant medication included allopurinol, atorvastatin, hydralazine, lansoprazol, isosorbide mononitrate (MONOMIL XL), rivaroxaban for atrial fibrillation. On 17Jan2021, patient was admitted with shortness of breath/ dyspnoea, cough and pyrexia, he was suspected covid-19 then confirmed having sars-cov-2 infection and covid-19 pneumonia. The patient underwent lab tests included COVID-19 virus test: positive on 17Jan2021. It was not sure if he was carrying the virus at the time of vaccination. He said he didn''t have any temperature at the time of the vaccination. Outcome of event covid-19 pneumonia was fatal, sars-cov-2 infection was not recovered, and the events pyrexia, cough, dyspnoea was unknown. The patient died on 21Jan2021. It was not reported if an autopsy was performed. The cause of death was covid-19 pneumonia/drug ineffective. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 pneumonia


VAERS ID: 1000376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-24
Onset:2020-12-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Dementia; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20201228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:COVID/SARS-CoV-2 infection
CDC Split Type: GBPFIZER INC2021096190

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101261748200590, Safety Report Unique Identifier GB-MHRA-ADR 24651574. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing, chronic kidney disease from an unknown date and unknown if ongoing. Text for relevant medical history and concurrent conditions: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced SARS-COV-2 infection (death) on 28Dec2020. Reported that patient developed COVID on 28Dec2020, died on 03Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: COVID/SARS-CoV-2 infection (Positive) on 28Dec2020, COVID-19 virus test: NO - Negative covid-19 test on an unknown date. The patient died on 03Jan2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection


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

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block complete, Blood lactate dehydrogenase, Body temperature, C-reactive protein, COVID-19, COVID-19 pneumonia, Drug ineffective, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Serum ferritin
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Conduction defects (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: LDH; Result Unstructured Data: Test Result:unknown results; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: fever 39 Celsius degree; Test Name: crp; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Name: Ferritin; Result Unstructured Data: Test Result:unknown results
CDC Split Type: BEPFIZER INC2021098156

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


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

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

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

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


VAERS ID: 1010483 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXASCAND; MEMANTINE; ACETYLSALICYLIC ACID; SIMVASTATIN; BETOLVEX [CYANOCOBALAMIN]; FOLVIDON; MIRTAZAPINE; LEVAXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive lung disease; Dementia Alzheimer''s type (late onset)
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021095406

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TAMSULOSIN; MOPRAL [OMEPRAZOLE MAGNESIUM]; BACTRIM FORTE; ELIQUIS; VALACICLOVIR; PROPRANOLOL; TIBSOVO; PERMIXON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myeloid leukemia (with unfavorable karyotype, associated with an IDH1 R132C mutation, escaping after 38 VIDAZA cycles); Bateman''s purpura senilis; Benign prostatic hyperplasia; Bilateral cataracts; Coronary stent placement; Deep vein thrombosis (Pulmonary embolism on left deep vein thrombosis); Dupuytren''s contracture (Dupuytren of the right hand); Embolism pulmonary (Pulmonary embolism on left deep vein thrombosis); Essential tremor; Infarct myocardial (myocardial infarction with thrombolysis and stent in 2003); Monoclonal gammopathy; Monoclonal immunoglobulin present; Osteonecrosis (bilateral femoral heads); Rhizomelic pseudopolyarthritis; Sensory polyneuropathy axonal (Sensitive-motor axonal polyneuropathy); Sleep apnea syndrome (Sleep apnea syndrome non-treated with CPAP); Smoldering myeloma (recent evidence of multiple myeloma lesions); Thrombolysis
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID PCR; Test Result: Positive
CDC Split Type: FRPFIZER INC2021095023

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACET [PARACETAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Living in nursing home; Pneumonia recurrent
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: NOPFIZER INC2021095230

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


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

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

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

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


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

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

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

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


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