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Write-up: Queasy; Cough; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 28-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included resection of lung cancer. Concomitant medications included telmisartan, sitagliptin phosphate (JANUVIA), magnesium oxide, brotizolam, aluminium magnesium silicate, diastase, taka (S.M COMBINATION POWDER), esomeprazole magnesium (NEXIUM), pitavastatin calcium (PITAVASTATIN CA). On 04Jun2021 at 14:15 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021), at vaccination age of 28 years, intramuscular in the left arm for COVID-19 immunization. On 04Jun2021 at 14:30 (15 minutes after the vaccination), the patient experienced queasy and cough. The reporter stated the events result in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered with treatment including injection of Hydrocortisone. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for events queasy and cough. 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.
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