Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test, Sinusitis, Vaccination failure
Clinical narrative: sinus infection; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable other healthcare professional (patient, physician assistant) reported for a 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiration date not provided), via intramuscular, in left arm, on 23Dec2020 (at the age of 48-year-old), at single dose, for COVID-19 immunization; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiration date not provided), via intramuscular, in arm left, on 12Jan2021 09:30 (at the age of 48-year-old), at single dose, for COVID-19 immunization. Medical history included regional lymphadenopathy (on the left side where vaccine received), lymphadenopathy of the axillary and groin. She had to have lymph node biopsy. Patient reported she had a COVID 19 antibody test before she received the COVID 19 vaccine and it was negative. So she did have a baseline. Concomitant medications were not reported. The patient previously took flu vaccine (one flu shot, a long time ago). Patient had her second COVID 19 vaccine on 12Jan2021 and tested positive for the COVID 19 virus on 09Mar2021. She reported she was symptomatic but with the COVID 19 vaccine probably did not get as sick as she could have. She felt like she had a sinus infection (visit physician office) but never had a fever. She was seen at an Ear, Nose, and Throat doctor who diagnosed her with a sinus infection. The doctor prescribed a methylprednisolone (MEDROL DOSE PACK) and cefdinir 300mg one tablet twice daily for 14 days. She lost her taste and smell only after she started feeling better. The patient underwent lab tests and procedures, which included COVID 19 rapid test was positive on 09Mar2021 and an unknown date, COVID-19 PCR test was positive on three unknown dates. She had her blood drawn for a viral load. Event was reported as non-serious. The causality assessment between event "tested positive for COVID 19 virus" and vaccine was provided as "unrelated". The outcome of the event "sinus infection" was unknown; of other events was recovering.; Sender's Comments: Based on the available information, a causal relationship between the event vaccination failure with COVID-19 and probably associated sinus infection and the suspected vaccine BNT162B2 cannot be completely excluded. However, given the current SARs-COV-2 pandemic in country of incidence, there is an inherently higher risk of COVID-19 infection; and the efficacy of the vaccination may be affected by multiple factors.  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.