Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Myalgia, Oxygen saturation, PaO2/FiO2 ratio, Pain
Clinical narrative: COVID-19 test was positive; COVID pneumonia, COVID-19 test was positive; slight delirium; Arrhythmia; Abdominal pain; hypoxic; achy; myalgia; This is a spontaneous report from a contactable Physician reported in response to HCP letter sent via telephonic follow-up activity. A 70-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 12Mar2021 (age at vaccination 70-year-old) for COVID-19 immunization. Medical history included hodgkin's disease (HD) for 7 years, diabetes for 40 years/controlled, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), non-responder to hepatitis B vaccine, dialysis on 05Apr2021 from 6 years, asthma in youth, arthritis, right hip replacement 1 month ago on 20Feb2021 and developed deep vein thrombosis (DVT) and cerebrovascular accident (CVA), atrial fibrillation (Afib) also started at that time in Feb2021. Concomitant medication included carvedilol (COREG) 6.25, furosemide sodium (LASIX) 40, APIXABAN (ELIQUIS) 5mg twice daily, multivitamin, iron twice a day, atorvastatin calcium (LIPITOR) 80 mg, insulin 18 u at night, calcium acetate 667 mg 2 tablets 3 times a day w/meal, famotidine 20mg daily, calcitriol (CALCITROL) took 3 times a week (was on dosing algorithm depending on phosphorous and vit D levels). Past drug history included amlodipine, ibuprofen, lisinopril with reaction allergies, metformin with contraindication to patient on dialysis, not a true allergy and patient previously took first dose of BNT162B2 on 17Feb2021 for COVID-19 immunisation. No prior vaccinations within 4 weeks. The patient experienced COVID-19 test was positive, COVID pneumonia, slight delirium, arrhythmia, shortness of breath, tachypnea, abdominal pain on an unknown date, hypoxic on 14Apr2021, myalgia and achy in Apr2021. It was reported that patient in her hemodialysis unit who were vaccinated with BNT162b2 but were recently diagnosed with COVID-19. Patient COVID results were sent to the local health department for genetic sequencing (pending) and SARS titers were drawn (pending). He presented to HD unit with SOB on 05Apr2021 and routine COVID-19 test was positive. He was hospitalized for COVID pneumonia and put on high flow oxygen, he was still in hospital. He came in for dialysis on 05Apr2021 and was very short of breath. Patient reported that the night before they felt myalgia and achy. No fever. Sent straight to the ER from the dialysis unit to check fluid levels and was admitted. He was tested for Covid and was found positive. His oxygen saturation was at 90. Required 2-3 liters of oxygen and next day on 06Apr2021 graduated to high flow oxygen for several days. on 14Apr2021, the patient became more hypoxic and was transferred to ICU. Patient had slight delirium and was not acting like himself. He underwent lab test included respiratory rate (RR) greater than or equal to 30 breaths per minute, heart rate (HR) greater than or equal 125 beats per minute, use of vasopressors to maintain BP, SpO2 less than or equal 93% on room air, PaO2/FiO2 less than 300 mm Hg on an unknown date, dialysis, chest X-ray showed bilateral fluffy infiltrates, covid test positive, CT scan had classic ground glass look for covid, CT of chest w/ contrast and no embolism, white cell count 6.2, hemogolbin 11.2, hemocrit 34.6%, platelet 110, sodium133, blood urea (BUN) 38, creatinine 3.7, brain natriuretic peptide (BNP) 1962, troponin 0.125, albumin 2.9, aspartate aminotransferase (AST) 49, alanine aminotransferase (ALT) 27, Pulse O2 low at 90 on 05Apr2021 and blood immunoglobulin G, blood immunoglobulin M (IgM /IgG) had unofficial result as a titer of 1 on 06Apr2021. He displays clinical signs at rest indicative of severe systemic illness. He came in slightly tachycardic about 120 bpm. Hypotension caused by hospital pulling too much fluid not by disease. No mechanical ventilation needed. Patient required oxygen because O2 saturation was at 90. Required 2-3 liters of oxygen initially and next day graduated to high flow. He was complaining of severe GI distress. Sonogram was negative. CT scan scheduled for tonight. He was on anticoagulation from prior DVT. Patient received treatment with remdesivir for COVID-19 and hydroxychloroquine/chloroquine, azithromycin, corticosteroids, decadron steroid for other events. No immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Adverse events were resulted in emergency room, hospitalization and admitted to an Intensive Care Unit. The outcome of event COVID pneumonia was not recovered, whereas unknown for all other events.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events. 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.