Reporte zur Charge SEY0584

Symptomtext

respiratory distress; inflammatory systems and response syndrome; High fever; body aches; severe headache; high blood pressure; cough; lab results white blood cells 17,000; dehydration; This is a spontaneous report from a contactable nurse (patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Left on 10Jul2021 16:00 (Lot Number: SEY0584, expiration date unknown) at age of 69 years old as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism due to totalthyroidectomy surgery, high blood pressure, allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID); diltiazem hydrochloride; hydroxychloroquine sulfate (PLAQUENIL). The patient experienced respiratory distress, inflammatory systems and response syndrome, high fever, body aches, severe headache, high blood pressure, cough, lab results white blood cells 17,000, dehydration, all on 11Jul2021 08:00. The patient was hospitalized for all events for 4 days. The patient underwent lab tests and procedures which included influenza virus test: negative on 15Jul2021 Blood test, SARS-COV-2 RNA (RT-PCR): negative on 15Jul2021 Nasal Swab, white blood cell count: 17,000 on 11Jul2021. The outcome of the events was resolving. Therapeutic measures were taken as a result of all events. The treatment included respiratory therapy with albutero,methilpredniloz. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2. 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