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From the 11/19/2021 release of VAERS data:

Found 19,249 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

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Case Details

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VAERS ID: 1347944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021571448

Write-up: cardiac disorder; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 55711], license party for COMIRNATY. This is a spontaneous report from a contactable other healthcare professional (HCP). A male patient of an unspecified age received first dose of BNT162B2 (COMIRNATY) via unspecified route single dose for COVID-19 immunisation on unspecified date. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cardiac disorder on an unspecified date. The patient died on an unspecified date. It was reported the patient died after 1. dose (not vaccine related, he had cardiac problems). It was unknown if an autopsy was performed. Outcome of the event was fatal. Lot/batch number has been requested.; Sender''s Comments: Based on the current available information, the event cardiac disorder is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: cardiac disorder


VAERS ID: 1347946 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-30
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Platelet count, SARS-CoV-2 test, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMID; SODIUM PICOSULFATE; CANDESARTAN; BISOPROLOL; APIXABAN; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia absoluta; Arterial hypertension; Chronic renal insufficiency; Heart failure; Rectal carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210330; Test Name: thrombocytopenia; Result Unstructured Data: Test Result:2; Comments: /nl; Test Date: 20210325; Test Name: SARS-CoV 2 test; Test Result: Negative
CDC Split Type: DEPFIZER INC2021574601

Write-up: suspicion on intracerebral bleeding; Thrombocytopenia until 2/nl; This is a spontaneous report from a non-contactable physician. A 85-year-old female patient received second dose of bnt162b2 (COMIRNATY) intramuscular on 15Mar2021 (Batch/Lot Number: Unknown) as 2nd dose, single for covid-19 immunisation. Medical history included arterial hypertension, state after rectum carcinoma from 2008, heart failure from 2008, chronic renal insufficiency from 2008, absolute arrhythmia from 2008. Historical vaccine included first dose of bnt162b2 (COMIRNATY) intramuscular on 16Feb2021 (Batch/Lot Number: Unknown) for covid-19 immunisation. Concomitant medications included furosemide (FUROSEMID); sodium picosulfate; candesartan; bisoprolol; apixaban; amlodipine; all taken for an unspecified indication, start and stop date were not reported. The patient experienced thrombocytopenia until 2/nl on 30Mar2021. Event seriousness criteria was death. Treatment received for the adverse event included imungglobulines and romiplostim. The lab test included sars-cov-2 test: negative on 25Mar2021. The patient died on 25Apr2021. Cause of death was reported as suspicion on intracerebral bleeding. An autopsy was not performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on chronological connection to the vaccine, a causal relationship between events thrombocytopenia and intracerebral bleeding and BNT162B2 (COMIRNATY) vaccine 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: suspicion on intracerebral bleeding; Thrombocytopenia until 2/nl


VAERS ID: 1347948 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-26
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Antibody test, Auscultation, Autoantibody positive, Autopsy, Biopsy lung, Blood creatinine, Blood lactate dehydrogenase, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, COVID-19, Chest X-ray, Colonoscopy, Diarrhoea, Drug ineffective, Endoscopy upper gastrointestinal tract, Haemoglobin, Hypernatraemia, Laboratory test, Oxygen saturation, Platelet count, Renal failure, Respiratory failure, SARS-CoV-2 test, Ultrasound abdomen, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (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), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   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: Medical History/Concurrent Conditions: Arterial hypertension; Chronic venous insufficiency; Dementia; Prostate carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: (nucleocapsid) NCP- IgG/IgM; Result Unstructured Data: Test Result:not elicited (<0.1 U/ml); Comments: not elicited (<0.1 U/ml, reference value $g1.0 U/ml; Roche ECLIATM); Test Date: 20210126; Test Name: Antigen test; Result Unstructured Data: Test Result:were negative; Test Date: 20210202; Test Name: lung auscultation; Result Unstructured Data: Test Result:displayed crackles; Test Date: 20210202; Test Name: antibody response; Result Unstructured Data: Test Result:8.7; Comments: 8.7 U/ml, reference value <0.8-1.2 U/ml; Roche ECLIATM; Test Date: 2021; Test Name: Postmortem study; Result Unstructured Data: Test Result:revealed acute bilateral bronchopneumonia with abs; Comments: revealed acute bilateral bronchopneumonia with abscesses, sometimes being surrounded by bacterial cocci (Figure 1). There were no findings of commonly described manifestations of COVID-19-associated pneumonitis. In the heart, we found biventricular hypertrophy (weight 580 g) and histologically, we diagnosed ischemic cardiomyopathy. We detected amyloidosis of the transthyretin type in the heart and to a lesser extent in the lungs. The kidneys revealed both chronic damage with arteriolosclerosis and interstitial fibrosis, and acute renal failure with hydropic tubular degeneration. The examination of the brain revealed a left parietal pseudocystic tissue necrosis, which was diagnosed as an old infarction area.; Test Date: 20210131; Test Name: Lung uscultation; Result Unstructured Data: Test Result:Lung uscultation with any pathological signs, hype; Comments: Lung uscultation with any pathological signs, hypernatremia.; Test Date: 20210126; Test Name: Creatinine; Test Result: 1.91 mg/dl; Comments: day 18; Test Date: 20210127; Test Name: Creatinine; Test Result: 1.78 mg/dl; Comments: day 19; Test Date: 20210131; Test Name: Creatinine; Test Result: 2.04 mg/dl; Comments: day 23; Test Date: 20210202; Test Name: Creatinine; Test Result: 2.17 mg/dl; Comments: day 25; Test Date: 20210203; Test Name: Creatinine; Test Result: 3.23 mg/dl; Comments: day 26; Test Date: 2021; Test Name: creatinine serum levels; Result Unstructured Data: Test Result:increased; Test Date: 20210126; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:179 IU/l; Comments: day 18; Test Date: 20210127; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:165 IU/l; Comments: day 19; Test Date: 20210203; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:439 IU/l; Comments: day 26; Test Date: 20210123; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/70 mmHg; Comments: day 15; Test Date: 20210126; Test Name: Blood pressure; Result Unstructured Data: Test Result:187/83 mmHg; Comments: day 18; Test Date: 20210131; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/80 mmHg; Comments: day 23; Test Date: 20210201; Test Name: Blood pressure; Result Unstructured Data: Test Result:166/73 mmHg; Comments: day 24; Test Date: 20210202; Test Name: Blood pressure; Result Unstructured Data: Test Result:160/80 mmHg; Comments: day 25; Test Date: 20210126; Test Name: Sodium; Result Unstructured Data: Test Result:138 mmol/L; Comments: day 18; Test Date: 20210127; Test Name: Sodium; Result Unstructured Data: Test Result:138 mmol/L; Comments: day 19; Test Date: 20210131; Test Name: Sodium; Result Unstructured Data: Test Result:154 mmol/L; Comments: day 23; Test Date: 20210201; Test Name: Sodium; Result Unstructured Data: Test Result:155 mmol/L; Comments: day 24; Test Date: 20210203; Test Name: Sodium; Result Unstructured Data: Test Result:156 mmol/L; Comments: day 26; Test Date: 20210126; Test Name: Temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: day 18; Test Date: 20210131; Test Name: Temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: day 23; Test Date: 20210201; Test Name: Temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: day 24; Test Date: 20210202; Test Name: Temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Comments: day 25; Test Date: 20210202; Test Name: chest radiograph; Result Unstructured Data: Test Result:minimal infiltrates; Comments: minimal infiltrates. Dehydration, lung auscultation with crackles.; Test Date: 20210126; Test Name: colonoscopy; Result Unstructured Data: Test Result:demonstrated ulcerative lesion of the left colonic; Comments: were performed to investigate the cause of diarrhea further, demonstrated an ulcerative lesion of the left colonic flexure, which was histologically diagnosed as ischemic colitis; Test Date: 20210128; Test Name: colonoscopy; Result Unstructured Data: Test Result:ischemic colitis; Test Date: 20210126; Test Name: C-reactive protein; Test Result: 1.0 mg/dl; Comments: day 18; Test Date: 20210127; Test Name: C-reactive protein; Test Result: 0.8 mg/dl; Comments: day 19; Test Date: 20210131; Test Name: C-reactive protein; Test Result: 2.0 mg/dl; Comments: day 23; Test Date: 20210203; Test Name: C-reactive protein; Test Result: 8.8 mg/dl; Comments: day 26; Test Date: 20210126; Test Name: Gastroscopy; Result Unstructured Data: Test Result:mild gastritis; Comments: (mild gastritis), were performed to investigate the cause of diarrhea further; Test Date: 20210126; Test Name: Hemoglobin; Result Unstructured Data: Test Result:7.4 g/dl; Comments: day 18; Test Date: 20210127; Test Name: Hemoglobin; Result Unstructured Data: Test Result:7.1 g/dl; Comments: day 19; Test Date: 20210128; Test Name: Hemoglobin; Result Unstructured Data: Test Result:7.2 g/dl; Comments: day 20; Test Date: 20210131; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8.0 g/dl; Comments: day 23; Test Date: 20210202; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8.6 g/dl; Comments: day 25; Test Date: 20210203; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9.3 g/dl; Comments: day 26; Test Date: 20210126; Test Name: Laboratory testing; Result Unstructured Data: Test Result:revealed hypochromic anemia and increased creatini; Comments: revealed hypochromic anemia and increased creatinine serum levels; Test Date: 20210126; Test Name: Oxygen saturation; Test Result: 97 %; Comments: day 18; Test Date: 20210202; Test Name: Oxygen saturation; Test Result: 97 %; Comments: day 25 97%+2l Q2; Test Date: 20210126; Test Name: Platelet count; Result Unstructured Data: Test Result:267; Comments: /nl, day18; Test Date: 20210127; Test Name: Platelet count; Result Unstructured Data: Test Result:263; Comments: day 19; Test Date: 20210128; Test Name: Platelet count; Result Unstructured Data: Test Result:262; Comments: day 20; Test Date: 20210131; Test Name: Platelet count; Result Unstructured Data: Test Result:254; Comments: day 23; Test Date: 20210202; Test Name: Platelet count; Result Unstructured Data: Test Result:204; Comments: day 25; Test Date: 20210203; Test Name: Platelet count; Result Unstructured Data: Test Result:196; Comments: day 26; Test Date: 20210126; Test Name: biopsy/SARS-CoV-2/polymerase chain reaction PCR; Result Unstructured Data: Test Result:was negative for SARS-CoV-2; Test Date: 20210126; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Antigen-test: negative PCR-test: negative; Comments: day 18; Test Date: 20210128; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:PCR-test: negative; Comments: day 20; Test Date: 20210201; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: positive SARS-CoV-2 RT-PCR test (Ct,15); Test Date: 20210202; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:RT-PCR-test: positive (Ct, 20); Comments: day 25; Test Date: 20210127; Test Name: abdominal ultrasound; Result Unstructured Data: Test Result:unknown result; Test Date: 20210126; Test Name: White-cell count; Result Unstructured Data: Test Result:6.6; Comments: /nl, day 18; Test Date: 20210127; Test Name: White-cell count; Result Unstructured Data: Test Result:7.1; Comments: day 19; Test Date: 20210128; Test Name: White-cell count; Result Unstructured Data: Test Result:12.1; Comments: day 20; Test Date: 20210131; Test Name: White-cell count; Result Unstructured Data: Test Result:13.5; Comments: day 23; Test Date: 20210202; Test Name: White-cell count; Result Unstructured Data: Test Result:9.2; Comments: day 25; Test Date: 20210203; Test Name: White-cell count; Result Unstructured Data: Test Result:15.2; Comments: day 26
CDC Split Type: DEPFIZER INC2021577668

Write-up: received the first dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks later /tested SARS-CoV-2 positive; received the first dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks later /tested SARS-CoV-2 positive; the patient died from acute renal and respiratory failure on the following day; the patient died from acute renal and respiratory failure on the following day; hypernatremia; Anemia; worsening diarrhea; This is a literature report from a publication. We report on an 86-year-old male resident of a retirement home who received vaccine against SARS-CoV-2. Past medical history included systemic arterial hypertension, chronic venous insufficiency, dementia and prostate carcinoma. On January 9, 2021, the man received lipid nanoparticle-formulated, nucleosidemodified RNA vaccine BNT162b2 in a 30 mg dose. On that day and in the following 2 weeks, he presented with no clinical symptoms (Table 1). On day 18 (26Jan2021), he was admitted to hospital for worsening diarrhea. Since he did not present with any clinical signs of COVID- 19, isolation in a specific setting did not occur. Laboratory testing revealed hypochromic anemia and increased creatinine serum levels. Antigen test and polymerase chain reaction (PCR) for SARSCoV-2 were negative. Gastroscopy and colonoscopy were performed to investigate the cause of diarrhea further. Colonoscopy, in particular, demonstrated an ulcerative lesion of the left colonic flexure, which was histologically diagnosed as ischemic colitis. PCR-analysis on biopsy specimens, following a previously reported method, was negative for SARS-CoV-2. Treatment was supportive with mesalazine and intravenous iron substitution. Subsequently, the patient''s condition deteriorated under the development of renal insufficiency. On day 24 (01Feb2021), a patient in the same hospital room as our case tested positive for SARS-CoV-2. On day 25 (02Feb2021), our patient tested SARS-CoV-2 positive by real-time PCR (RT-PCR), with a low cycle threshold (Ct) value indicating high virus load. On further analysis of the swab sample, there was no evidence for mutant SARS-CoV-2 variants B.1.1.7, B.1.351 or B.1.1.28.1. Taken together, it appears the patient became infected from the patient in his hospital room. Our patient now presented with fever and respiratory discomfort, and lung auscultation displayed crackles. Despite starting supplemental oxygen (2L per minute) and antibiotic therapy by ceftriaxone, the patient died from acute renal and respiratory failure on the following day. Immunogenicity assessment by measuring spike protein (S1) antigen-binding immunoglobulin (Ig) G in the serum samples obtained at day 25 (02Feb2021) showed antibody response (8.7 U/ml, reference value <0.8-1.2 U/ml; Roche ECLIATM), while (nucleocapsid) NCP- IgG/IgM was not elicited (<0.1 U/ml, reference value $g1.0 U/ml; Roche ECLIATM). These results indicate that the patient had already developed relevant immunogenicity through vaccination. Postmortem study revealed acute bilateral bronchopneumonia with abscesses, sometimes being surrounded by bacterial cocci (Figure 1). There were no findings of commonly described manifestations of COVID-19-associated pneumonitis. In the heart, we found biventricular hypertrophy (weight 580 g) and histologically, we diagnosed ischemic cardiomyopathy. We detected amyloidosis of the transthyretin type in the heart and to a lesser extent in the lungs. The kidneys revealed both chronic damage with arteriolosclerosis and interstitial fibrosis, and acute renal failure with hydropic tubular degeneration. The examination of the brain revealed a left parietal pseudocystic tissue necrosis, which was diagnosed as an old infarction area. Figure 1 showed that synopsis of the relevant histological findings and the results of molecular mapping is presented. The histomorphology is obtained by standard hematoxylin and eosin reaction, except for the myocardium on the right side (Congo red staining). The magnification is shown by bars. Note that in the lungs, we also observed colonies of cocci (arrow) in granulocytic areas. In addition, the results of molecular mapping are given as evaluated cycle threshold values of the real-time polymerase chain reaction for SARSCoV- 2. Note that only in the olfactory bulb and the liver SARS-CoV-2 could not be detected. Table 1 showed Summary of major features of the patient''s history, clinical symptoms and laboratory findings, including SARS-CoV-2 testing (reference values given in brackets). On day1 (09Jan2021), the patient vaccination, No relevant symptoms recorded. On day 15 (23Jan2021), the patient collapse during breakfast and no further relevant symptoms recorded, blood pressure (mmHg) 130/70. On day 18 (26Jan2021), the patient admission to hospital; gastroscopy (mild gastritis) and diarrhea. The temperature (C) was 36.4, blood pressure (mmHg) 187/83, Oxygen saturation (SpO2) 97%, SARS-CoV-2 test: Antigen-test: negative PCR-test: negative. White-cell count (4-9/nl): 6.6. Platelet count (140-400/nl): 267. Hemoglobin (14.0-8.0 g/dl): 7.4. Lactate dehydrogenase (135-250 U/L): 179. Creatinine (0.7-1.2 mg/dl): 1.91. C-reactive protein (<0.5 mg/dl): 1.0. Sodium (135-145 mmol/l): 138. On day 19 (27Jan2021), the patient had abdominal ultrasound, initiating intravenous iron application. The patient had anemia. White-cell count (4-9/nl): 7.1. Platelet count (140-400/nl): 263. Hemoglobin (14.0-8.0 g/dl): 7.1. Lactate dehydrogenase (135-250 U/L): 165. Creatinine (0.7-1.2 mg/dl): 1.78. C-reactive protein (<0.5 mg/dl): 0.8. Sodium (135-145 mmol/l): 138. On day 20 (28Jan2021): the patient had colonoscopy (ischemic colitis), initiating mesalazine. Still had anemia. SARS-CoV-2 test: PCR-test: negative. White-cell count (4-9/nl): 12.1. Platelet count (140-400/nl): 262. Hemoglobin (14.0-8.0 g/dl): 7.2. On day 23 (31Jan2021): the patient had acute renal insufficiency, initiating intravenous glucose application. Lung uscultation with any pathological signs, hypernatremia. The temperature (C) was 36.8. Blood pressure (mmHg) 180/80. White-cell count (4-9/nl): 13.5. Platelet count (140-400/nl): 254. Hemoglobin (14.0-8.0 g/dl): 8.0. Creatinine (0.7-1.2 mg/dl): 2.04. C-reactive protein (<0.5 mg/dl): 2.0. Sodium (135-145 mmol/l): 154. On day 24 (01Feb2021): Patient in same hospital room has positive SARS-CoV-2 RT-PCR test (Ct,15) and hypernatremia. The temperature (C) was 36.2. Blood pressure (mmHg) 166/73. Sodium (135-145 mmol/l): 155. On day 25 (02Feb2021): Patient somnolent, initiating antibiotic therapy, chest radiograph with minimal infiltrates. Dehydration, lung auscultation with crackles. The temperature (C) was 38.8, blood pressure (mmHg) 160/80, Oxygen saturation (SpO2) 97% + 2l O2, SARS-CoV-2 test: RT-PCR-test: positive (Ct, 20). White-cell count (4-9/nl): 9.2. Platelet count (140-400/nl): 204. Hemoglobin (14.0-8.0 g/dl): 8.6. Creatinine (0.7-1.2 mg/dl): 2.17. On day 26 (03Feb2021): the patient death at 14:30 due to acute renal and respiratory failure. White-cell count (4-9/nl): 15.2. Platelet count (140-400/nl): 196. Hemoglobin (14.0-8.0 g/dl): 9.3. Lactate dehydrogenase (135-250 U/L): 439. Creatinine (0.7-1.2 mg/dl): 3.23. C-reactive protein (<0.5 mg/dl): 8.8. Sodium (135-145 mmol/l): 156. We conducted molecular mapping of 9 different anatomical parts of formalin-fixed paraffin-embedded tissue as previously described. RNA was extracted from paraffin sections using the specific method. Multiplex RT-PCR analysis targeted 2 independent genes of the SARS-CoV-2-genome (Fluorotype SARS-CoV-2 plus Kit): RNA-dependent RNA polymerase (Target 1) and nucleopeptide (Target 2). The negative cut-off value was Ct $g45. We examined 9 different tissue samples for known and relevant pathways of virus spreading in the human body (Figure 1). To prevent cross-contamination, each specimen was directly embedded in separate tissue cassettes and separately fixed in 4% phosphate-buffered saline-buffered formalin. We demonstrated viral RNA in nearly all organs examined except for the liver and the olfactory bulb (Figure 1). A detailed autopsy study including molecular virus mapping of a patient vaccinated against SARS-CoV-2 with a positive SARS-CoV-2 test post-vaccination has not previously been reported, to the authors'' knowledge. We suggest that a single treatment with BNT162b2 RNA vaccine elicited significant immunogenicity, as reflected in the reported spike proteinbased neutralizing IgG serum values. From the weeks before vaccination, through vaccination (day 1), to shortly before death (day 24), the patient was free of any clinical symptoms typically ascribed to COVID-19. Furthermore, blood work did not show an IgM titer that is generally observed 7-14 days after symptom onset (Kim et al., 2020). However, the patient tested SARS-CoV-2 positive. Both the Ct value measured in nasopharyngeal swab and values measured in formalin-fixed paraffinembedded autopsy specimens indicate viral load and suggest transmissibility. Because our patient died approximately 2 days after his first positive SARS-CoV-2 test result, we suppose that the molecular mapping data reflects an early stage of viral infection. An early stage of infection might also explain why different regions such as the olfactory bulb and liver were not (yet) affected by systemic viral spread. We did not observe any characteristic morphological features of COVID-19 reported in comprehensive morphological autopsy studies so far. We did not find any typical signs of diffuse alveolar damage in the lungs, but we identified extensive acute bronchopneumonia, possibly of bacterial origin. We concluded that the In summary, the results of our autopsy case study in a patient with mRNA vaccine confirm the view that by first dose of vaccination against SARS-CoV-2 immunogenicity can already be induced, while sterile immunity is not adequately developed.; Sender''s Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out. There is a reasonable possibility that the event diarrhea is related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events "renal failure, respiratory failure, hypernatremia, and anemia" with BNT162b2 cannot be completely excluded. Possible contribution from patient''s advanced age and underlying medical conditions are assessed as possible. 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: the patient died from acute renal and respiratory failure on the following day; the patient died from acute renal and respiratory failure on the following day; COVID-19; received the first dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks l


VAERS ID: 1347959 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021566035

Write-up: Cardio-respiratory arrest; This is a spontaneous report received from a contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is ES-AEMPS-736198. A male patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died of cardio-respiratory arrest in Jan2021 within 24 hours of having the vaccine administered. The patient died in Jan2021. It was unknown if an autopsy was performed. The reporter wanted to know why the reporter was not able to see in the report from the agency on adverse reactions reported in the area from 27Dec2020 to 12Jan2021, those who died after having the vaccine administered. The health center to which the reporter''s deceased uncle belonged informed reporter that they would notify the agency and, consulting the report, the reporter did not find any deaths, when the reporter''s uncle died of cardio-respiratory arrest within 24 hours of having the vaccine administered. Any explanation why the case was not included in the report, please. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1347998 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Breath sounds abnormal, Cardiac death, Dyspnoea
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 (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   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: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; FURESIS; CITALOPRAM; LYRICA; MONTELUKAST; PANADOL FORTE [PARACETAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Atrial fibrillation; Coronary artery disease; Disability; Leg amputation; Loss of personal independence in daily activities; Lower limb ischaemia; Shortness of breath (Episodes of shortness of breath, swelling in the past while living in an assisted living facility); Swelling (Episodes of shortness of breath, swelling in the past while living in an assisted living facility)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021572963

Write-up: Cardiac death; Coarse breath sounds; Dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB FI-FIMEA-20212550. An 89-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: EW4815 and expiration date not provided), via intramuscular, on 29Apr2021 (at the age of 89-year-old), at single dose, for COVID-19 immunization. Medical history included patient was multi-disabled, had been in 24-hour care for over a year, advanced Alzheimer''s disease, coronary artery disease, atrial fibrilation, acute lower limb ischaemia from Nov2019, left thigh amputation, restricted to hospital transfers. Patient had episodes of shortness of breath, swelling in the past while living in an assisted living facility. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL); furosemide (FURESIS); citalopram; pregabalin (LYRICA); montelukast; and paracetamol (PANADOL FORTE). Patient previously took first dose of BNT162B2 (COMIRNATY, lot number: EJ6134 and expiration date not provided), via unknown route of administration, on unknown date, at single dose, for COVID-19 immunization. The patient received vaccine on 29Apr2021, and later that day patient experienced cardiac death (death), coarse breath sounds (death), and dyspnoea (death). Patient had an increase in breathlessness, which was treated symptomatically (ventoline oral solution) and the dose of furosemide (FURESIS) was increased. The following day, as the symptoms persisted, an additional oral cortisone course was started, as there had been intermittent episodes of obstruction in the past, although the patient had no previous diagnosis of lung disease, but was no longer in a good enough overall health to warrant further investigation. With changes in medication, the patient''s condition improved and on 03May2021 the patient was already back to normal. On 05May2021 evening developed shortness of breath and wheezing, during the night patient received symptomatic medication, on 06May2021 morning patient exitus. The death was thought to be cardiac-related and a death certificate was issued. The situation has not yet been discussed with the infectious disease doctor, the coronary vaccine and death have a time link but no causal link was established, filing an incident report was nevertheless recommended. It was reported that it can''t be directly concluded that the drug harm was fatal, and on the other hand, the recovery from the possible harm remains a question mark. Therapeutic measures were taken as a result of events coarse breath sounds and dyspnoea. The outcome of the events were fatal. The patient died on 06May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac death; coarse breath sounds; dyspnoea


VAERS ID: 1347999 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Echocardiogram, Fatigue, Insomnia, 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: 2021-04-06
   Days after onset: 66
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUODART; DICLOMEX [DICLOFENAC POTASSIUM]; METFORMIN; MAREVAN; JARDIANCE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes (compensated diabetes); Echocardiogram; Obesity (There was a family obesity problem, and due to diet he lost 10 kg since the beginning of January.); Repeated surgical procedure (undergone 12 operations in one leg); Traffic accident (In his youth, he suffered a car accident and had a severe post-traumatic injury.); Traumatic injury (severe post-traumatic injury); Venous thrombosis (It was also treated and his general condition was pretty normal for a long time.); Venous thrombosis limb (had been diagnosed with lower limb venous stoppages)
Allergies:
Diagnostic Lab Data: Test Name: echocardiogram; Result Unstructured Data: Test Result:There was no heart failure
CDC Split Type: FIPFIZER INC2021572962

Write-up: Death; Thrombosis; Fatigue; Insomnia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FI-FIMEA-20212565. A 64-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 26Jan2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included in his youth, he suffered a car accident and had a severe post-traumatic injury, obesity (there was a family obesity problem, and due to diet he lost 10 kg since the beginning of January), It was taken care of. For a long time everything was fine. Before coming to work in this country, he had a venous thrombosis recurred. It was also treated and his general condition was pretty normal for a long time. He had undergone 12 operations in one leg and had been diagnosed with lower limb venous stoppages. It was taken care of. For a long time everything was fine. There was compensated diabetes, there was no heart failure (he was examined in another country in autumn, had an echocardiogram, lab test) and no changes were found, just well compensated diabetes. Concomitant medications included dutasteride, tamsulosin hydrochloride (DUODART) taken for an unspecified indication, start and stop date were not reported; diclofenac potassium (DICLOMEX) taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported; warfarin sodium (MAREVAN) taken for an unspecified indication from Jan2021 to an unspecified stop date; empagliflozin (JARDIANCE) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 vaccination on 05Jan2021. The patient experienced thrombosis (death) on 29Jan2021, fatigue (death) on 29Jan2021, insomnia (death) on 29Jan2021. The reporter stated that: My husband, specialist physician, died suddenly at home on 06Apr2021. He received Covid-19 vaccine twice in Jan2021, and the vaccine resulted in death. The whole face became blue. Was not sore. He came to his home country on holiday to get his health in order. He arrived by car himself at one. And he lived at home for another 3 days and suddenly died. Clinically it was a thrombus. He was monitoring his health. Had a lot of plans in life. After the vaccine started new symptoms in the same leg, he started using marevan (marevan was at home) and the symptoms got better, but did not completely go away. There was a lot of fatigue. The onset of insomnia. There was no reason why he could die, only COVID19 vaccine and thrombosis in the background. He always feared thrombosis. No one has said that after the vaccine there can be thrombosis. The patient died on 06Apr2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. The event Death occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death; Insomnia; Fatigue; Thrombosis


VAERS ID: 1348004 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-26
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: AFib; Ischaemic heart disease (Stented ischemic heart disease)
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Arrhythmia (complete arrhythmia by atrial fibrillation anticoagulated and treated with amiodarone); BPH (benign prostatic hyperplasia with 2 transurethral resection of the prostate); Cataract (left); Cholecystectomy; Defibrillation; Glaucoma; Hypotension (Syncope due to severe hypotension, hospitalized in 2014 with malaise); Knee meniscectomy; Malaise (Syncope due to severe hypotension, hospitalized in 2014 with malaise); Pacemaker insertion (cardiac); Parkinson''s disease; Right inguinal hernia; Syncope (Syncope due to severe hypotension, hospitalized in 2014 with malaise); Transurethral prostatectomy
Allergies:
Diagnostic Lab Data: Test Name: blood culture; Test Result: Negative ; Test Name: Computerised tomography chest scan; Result Unstructured Data: Test Result:in favour; Test Date: 20210426; Test Name: COVID-19 virus test positive; Test Result: Positive
CDC Split Type: FRPFIZER INC2021572956

Write-up: Vaccination failure; covid-19/respiratory distress; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021053331. A 93-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 31Mar2021 (Batch/Lot Number: ER9470) as single dose; dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included ongoing stented ischemic heart disease, ongoing atrial fibrillation, Syncope due to severe hypotension and hospitalized in 2014 with malaise, complete arrhythmia by atrial fibrillation anticoagulated and treated with amiodarone (defibrillation on 10Sep2014), pacemaker in 2015, benign prostatic hypertrophy (2 transurethral resections of the prostate), glaucoma, cataract left eye, cholecystectomy, appendicectomy, Right inguinal hernia cure, Meniscectomy right knee and Parkinson''s (as reported). The patient had no allergy. The patient''s concomitant medications were not reported. Patient who completed his complete vaccination schedule with Comirnaty with administration of the 2nd dose on 31Mar2021. The patient had COVID on 26Apr2021 (26 days after the 2nd dose). Computerized tomography chest scan in favour. Negative blood culture. The patient was however placed on antibiotics. Death of the patient from respiratory distress on 06May2021. Overall, vaccine failure with COVID-19 infection 26 days after the 2nd dose of Comirnaty. The patient was hospitalized due to the event. The patient underwent lab tests and procedures which included COVID-19 virus test positive on 26Apr2021. The patient died on 06May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.; Reported Cause(s) of Death: COVID-19; Distress respiratory/COVID-19


VAERS ID: 1348137 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Apnoea, Arrhythmia, Atrial fibrillation, Blood potassium, Blood sodium, Body temperature, C-reactive protein, Cardio-respiratory arrest, Computerised tomogram, Computerised tomogram head, Depressed level of consciousness, Hypernatraemia, Hypoxia, Infection, Ischaemic stroke, Lower respiratory tract congestion, Magnetic resonance imaging head, Oxygen saturation, Oxygen saturation decreased, Pyelonephritis acute, Pyrexia, SARS-CoV-2 test, Ultrasound Doppler, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 33
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: CANDESARTAN CILEXETIL; NORSET; RILMENIDINE; ESCITALOPRAM
Current Illness: Depression; Hip prosthesis insertion; Hypertension arterial; Knee prosthesis insertion; Shoulder tendinitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210327; Test Name: K+; Result Unstructured Data: Test Result:3.2 mmol/L; Test Date: 202103; Test Name: Hypernatraemia; Result Unstructured Data: Test Result:151 mmol/L; Test Date: 20210327; Test Name: body temperature; Result Unstructured Data: Test Result:febrile; Test Date: 202103; Test Name: CT thorax; Result Unstructured Data: Test Result:absence of pneumonia; Comments: absence of pneumonia; Test Date: 202103; Test Name: CT cerebral; Result Unstructured Data: Test Result:absence of hemorrhagic transformation; Comments: absence of hemorrhagic transformation; Test Date: 20210327; Test Name: CRP; Result Unstructured Data: Test Result:17 mg/l; Test Date: 20210327; Test Name: mri cerebral; Result Unstructured Data: Test Result:Semi-recent ischemic stroke; Comments: Semi-recent ischemic stroke of the right anterior cerebral territory with a long-standing ischemic history of the right posterior cerebral territory, multiple intracranial stenoses. ruled out a haemorrhagic transformation; Test Date: 20210327; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:desaturation; Test Date: 20210327; Test Name: PCR COVID; Test Result: Negative ; Test Date: 20210327; Test Name: Doppler of the neck vessels; Result Unstructured Data: Test Result:Multiple bilateral intracranial stenosis; Comments: Multiple bilateral intracranial stenosis predominantly on the right middle cerebral artery, basilar trunk not recorded.; Test Date: 20210327; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:undilated left ventricle; Comments: undilated left ventricle, LVEF 65%, homogeneous hypertrophic cardiomyopathy, left atrium moderately dilated
CDC Split Type: FRPFIZER INC2021572959

Write-up: Cardio-respiratory arrest; Ischemic stroke; ARDS; Obnubilation/clouding of consciousness; Hypoxaemia; AFib; febrile; arrhythmia; infectious syndrome; desaturation; bronchial congestion; respiratory pauses; Hypernatraemia at 151 mmol/L; suspected acute pyelonephritis; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-NY20210892. Safety report unique identifier FR-AFSSAPS-2021047876. A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 03Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. Medical history included ongoing knee prosthesis insertion, hypertension arterial, hip prosthesis insertion, shoulder tendinitis, depression. Concomitant medications included candesartan cilexetil taken for hypertension, start and stop date were not reported; mirtazapine (NORSET) taken for depression, start and stop date were not reported; rilmenidine taken for hypertension, start and stop date were not reported; escitalopram taken for depression, start and stop date were not reported. On 27Mar2021, the patient was hospitalised for ischemic stroke. On admission, atrial fibrillation, febrile, COVID-19 polymerase chain reaction negative. Patient also experienced complete arrhythmia by atrial fibrillation, respiratory distress syndrome, hypoxemia, clouding, acute pyelonephritis and died from cardiorespiratory arrest on 04Apr2021. On 27Mar2021, brain magnetic resonance imaging showed somewhat recent ischemic stroke. Doppler ultrasound showed multiple intracranial stenosis. Echography showed left ventricular ejection fraction 65%, hypertrophic cardiomyopathy homogenous potassium was 3.2 mmol/L, C-reactive protein was 17 mg/L and Covid-19 polymerase chain reaction test was negative. During hospital stay, brain scan did not evidence hemorrahgic transformation of stroke and chest scanner did not evidence pneumopathy. Acute pyelonephritis was suspected. The patient was intubated and ventilated. The patient died from cardiorespiratory arrest on 04Apr2021. Cerebral magnetic resonance imaging: Somewhat recent ischemic stroke of the right anterior cerebral region with a long-standing ischemic history of the right posterior cerebral region, multiple intracranial stenoses. Ultrasound of the neck vessels: bilateral multiple intracranial stenosis predominantly on the right middle cerebral artery, basilar trunk not recorded. Transthoracic ultrasound: left ventricle not dilated, left ventricular ejection fraction 65%, homogeneous hypertrophic cardiomyopathy, left atrium moderately dilated. Hypokalaemia at 3.2 mmol/L. C-reactive protein 17 mg/L. Due to complete arrhythmia by atrial fibrillation, implementation of ELIQUIS, but replaced immediately by curative CALCIPARINE 12,500 IU 3/day in view of the impossibility of taking medication orally. Evolution marked by the onset of an infectious syndrome with respiratory distress, desaturation and clouding of consciousness. Hypernatraemia at 151 mmol/L. The computerised tomography brain scan ruled out a haemorrhagic transformation. A computerised tomography chest scan did not reveal pneumonia. Unfavourable evolution with sudden degradation, bronchial congestion, respiratory pauses. Initiation of a double antibiotic therapy (ceftriaxone aminoglycoside) in view of the suspicion of severe pyelonephritis. Orotracheal intubation and ventilation implemented. Cardiorespiratory arrest and death on 04Apr2021. The serious criteria of events Cardio-respiratory arrest, Ischemic stroke, ARDS, Obnubilation/clouding of consciousness, Hypoxaemia was reported as Death and Hoapitalization, event suspected acute pyelonephritis was death, event AFib was Hoapitalization. The outcome of event AFib was not recovered, events Cardio-respiratory arrest, Ischemic stroke, ARDS, Obnubilation/clouding of consciousness, Hypoxaemia was fatal, other events was unknown. The patient died on 04Apr2021. It was not reported if an autopsy was performed. Conclusion: 75-year-old woman, treated for high blood pressure and depression, vaccinated with a first dose of COMIRNATY (batch not specified), who 25 days later was hospitalised for a somewhat recent ischemic stroke with multiple (prior) intracranial stenosis. Context of complete arrhythmia by atrial fibrillation unknown previously. Unfavourable evolution with onset of an infectious syndrome, respiratory distress, desaturation and clouding. Suspicion of acute pyelonephritis. Death 8 days after admission to hospital due to cardiorespiratory arrest. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: cardiorespiratory arrest; Ischemic stroke; ARDS; Obnubilation/clouding of consciousness; Hypoxaemia; suspected acute pyelonephritis


VAERS ID: 1348163 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Circulatory collapse, Fatigue, Headache, Monoplegia, Pyrexia, Somnolence, Vertigo
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 44
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasilacton 20/100 mg; Kalioral; Pantoloc 40 mg; Folsan 5 mg; Hepamerz; Buronil 50 mg
Current Illness: Alcoholic steatohepatitis; Ascites; Depression; Disorder sleep; Gastritis (Gastritis); Hepatic encephalopathy (hepat.); Hypercholesteraemia; Hypertension arterial; Hypokalaemia; Lumbago (Lumbago)
Preexisting Conditions: Medical History/Concurrent Conditions: Bariatric surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: massive; This regulatory authority case was reported by a physician and describes the occurrence of CIRCULATORY COLLAPSE, the first episode of MONOPLEGIA and the second episode of MONOPLEGIA in a 54-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001531 and 300042721) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Depression since an unknown date, Gastritis (Gastritis) since an unknown date, Hepatic encephalopathy (hepat.) since an unknown date, Bariatric surgery, Ascites since an unknown date, Lumbago (Lumbago) since an unknown date, Disorder sleep since an unknown date, Hypertension arterial since an unknown date, Alcoholic steatohepatitis since an unknown date, Hypokalaemia since an unknown date and Hypercholesteraemia since an unknown date. Concomitant products included Lasilacton 20/100 mg for Ascites, Pantoloc 40 mg for Bariatric surgery and Gastritis, Buronil 50 mg for Disorder sleep, Kalioral for Hypokalaemia, Folsan 5 mg and Hepamerz for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced the first episode of MONOPLEGIA (seriousness criterion medically significant), the second episode of MONOPLEGIA (seriousness criterion medically significant), SOMNOLENCE, the first episode of VERTIGO, HEADACHE, FATIGUE and the first episode of PYREXIA. On 15-Apr-2021, the patient experienced the second episode of VERTIGO and the second episode of PYREXIA. 15-Apr-2021, the patient experienced HEADACHE (massive) and FATIGUE. On 15-Apr-2021 at 7:00 PM, the patient experienced CIRCULATORY COLLAPSE (seriousness criteria death and medically significant). The patient died on 15-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, last episode of MONOPLEGIA, SOMNOLENCE, HEADACHE and FATIGUE had resolved and last episode of VERTIGO, HEADACHE (massive), FATIGUE and the last episode of PYREXIA had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CIRCULATORY COLLAPSE, MONOPLEGIA, MONOPLEGIA, SOMNOLENCE, VERTIGO, VERTIGO, HEADACHE, HEADACHE (massive), FATIGUE, FATIGUE, PYREXIA and PYREXIA to be probably related. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to AT-BASGAGES-2021-25397, AT-BASGAGES-2021-24979 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-MAY-2021 contains non-significant information. On 13-May-2021: Translation received on 19-MAY-2021 and does not contain any new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. AT-BASGAGES-2021-25397: AT-BASGAGES-2021-24979:; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1348183 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-12
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhagic stroke
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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   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: Medical History/Concurrent Conditions: Peripheral arterial occlusive disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Haemorrhagic stroke; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGIC STROKE (Haemorrhagic stroke) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Peripheral arterial occlusive disease. On 30-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced HAEMORRHAGIC STROKE (Haemorrhagic stroke) (seriousness criteria death, hospitalization and medically significant). The patient died on 18-Apr-2021. The reported cause of death was accident. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not reported. Treatment information was not reported. Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021048327; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Accident


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https://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=1289&VAX=COVID19&VAXTYPES=COVID-19&DIED=Yes


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