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|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, Biopsy lung, Blood creatinine, Blood lactate dehydrogenase, Blood sodium, Body temperature, C-reactive protein, Chest X-ray, Colonoscopy, Diarrhoea, Drug ineffective, Endoscopy upper gastrointestinal tract, Haemoglobin, Hypernatraemia, Oxygen saturation, Platelet count, Renal failure, Respiratory failure, White blood cell count, Autopsy, Ultrasound abdomen, Laboratory test, Autoantibody positive, Antibody test, Auscultation, Blood pressure measurement, COVID-19, SARS-CoV-2 test
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:
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.18.104.22.168. 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
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