Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: like a bad flu; congestion; they thought she must have the COVID virus as well; they thought she must have the COVID virus as well; Headache; more fatigue; loss of appetite; This is a spontaneous report from a contactable Nurse (patient's husband) via Pfizer sponsored program. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8730) via an unspecified route, administered on Left arm on 28Mar2021 in the morning (71-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The report was related to study or programme. Vaccination facility type was reported as pharmacy. The patient's medical history included asthma, Covid-19 from Dec2021 to an unknown date. The patient's family medical history was reported as none. The patient's concomitant medications were not reported. No additional vaccines were administered on the same date of Pfizer suspect. The patient had not received any other vaccine within four weeks prior to vaccination. The patient had not experienced any adverse events following prior to vaccinations. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: Unknown) via an unspecified route, administered on Left arm on 28Feb2021 in the morning (71-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. Registered nurse called regarding the Pfizer COVID 19 vaccine. The reporter stated he and his wife got the COVID virus back in Dec2020. Added their symptoms were very minimal and they were told to wait 90 days for the COVID vaccine. Reported they got the vaccine in Mar2021; then on the 16Sep2021 he was positive for COVID. Added he imagined it was the new variant. His wife also had symptoms at the same time. Reported his granddaughter, who lives with them, had the first dose 10Sep2021 but then showed symptoms of the virus on 14Sep2021. He took her to have the COVID test and it was positive. They all got like a bad flu. She had asthma so he wanted to verify she had COVID so they could put her on steroids prophylactically. She was not tested but had the same symptoms at the same time on 15Sep2021, as the reporter who tested positive for COVID so they thought she must have the COVID virus as well. He reported that his wife had more fatigue; congestion; headache; and loss of appetite. Added she was so fatigued she was going to bed at 10:00 PM. No relevant tests were reported. These adverse events did not result emergency room/physician office visit. Rated all of patient's events as medically significant. States she was improving. When asked causality reports stated no, not related. The outcome of the events influenza like illness and nasal congestion, headache, fatigue, and loss of appetite were recovering, drug ineffective and suspected covid19 were unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events  (Decreased appetite, Suspected Covid-19, Drug ineffective, headache , Nasal Congestion, Influenza like illness,Fatigue )and the administration of the vaccine cannot be excluded. 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.