Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood chloride, Blood sodium, Blood urea, COVID-19, Condition aggravated
Clinical narrative: She is still in the hospital, she is on high flow oxygen now, 50 Liters; COVID positive/tested positive; COVID positive/tested positive; elevated white blood cells; low sodium; Low chloride; high BUN; Low EGFR; This is a spontaneous report from a contactable physician. An 85-year-old female patient received the second dose of BNT162B2 (lot number: EW0162, expiration date: 31Jul2021), at the age of 85 years old, on 24Apr2021 and the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: ER8730, expiration date: 30Jul2021) on 30Mar2021, both at single dose for COVID-19 immunisation. Medical history included cardiac failure congestive, chronic obstructive pulmonary (COPD), diabetes, hypertension, cholesterol and she was on 2 Liters oxygen as needed before COVID. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) at 81 mg, daily; furosemide at 20 mg, daily; amlodipine at 10 mg, daily; isosorbide at 60 mg, daily; losartan at 50 mg, daily; metoprolol at 25 mg, twice daily; insulin at 12 DF via intravenous; simvastatin at 20 mg, daily. The patient had BNT162B2 and was tested positive (COVID positive) on 17Jul2021. The reporter thought the lot number of three patient were actually different. Reporter assumed that it was a variant but did not know for sure. Public Health did not know for sure, so they were sequencing DNA sample. If it was like a privacy concern, reporter had already discussed all. She was also on home oxygen even before COVID. She was on 2 Liters oxygen as needed before COVID. She was still in the hospital, she was on high flow oxygen now, 50 Liters. After COVID, the patient was put on dexamethasone (treatment). It was originally 6 mg for 10 days and then they escalated it to 20 mg for 5 days and then 10 mg for 5 days, we did the high dose because of the oxygen. The patient underwent lab tests and procedures which included chloride: low, sodium: low, blood urea nitrogen (BUN): high, epidermal growth factor receptor (EGFR): low, complete blood count (CBC): significant for elevated white blood cell, everything else normal, basic metabolic panel (BMP): significant for low sodium, low chloride, high BUN and Low EGFR, all (except COVID-19 test) in 2021, COVID-19 test: positive on 17Jul2021. The outcome of the event high flow oxygen now, 50 Liters was not recovered. The outcome of other events was unknown.; Sender's Comments: The events Covid 19 and condition aggravated are assessed as possibly related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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.