Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Type 2 DM" (unspecified if ongoing); "Hx of 2 separate breast cancers" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). The patient had no known allergies. Concomitant medications included: ESCITALOPRAM; METFORMIN; DIAZIDE [GLICLAZIDE]; ALLEGRA; NAMENDA; MELATONIN; L-THEANINE; PROOMEGA; QUERCETIN; ESTRADIOL; SKYRIZI [RISANKIZUMAB RZAA], start date: 18May2022; COSOPT ophthalmic; SINGULAIR; NORDIC NATURALS ARCTIC D COD LIVER OIL. Other concomitant medications included Multi vitamin mineral, Women's Formula once a day, and We like vitamins. Vaccination history included: BNT162b2 (lot number: FK9729, dose number: 4, location: left arm), administration date: 08Feb2022, for Covid-19 immunization, reaction(s): "Covid-19"; BNT162b2 (lot number: FD8448, dose number: 3, location: left arm), administration date: 28Aug2021, for Covid-19 immunization, reaction(s): "Covid-19"; BNT162b2 (lot number: EL9264, dose number: 2, location: left arm), administration date: 02Feb2021, for Covid-19 immunization, reaction(s): "Covid-19"; BNT162b2 (lot number: EL1283, dose number: 1, location: left arm), administration date: 10Jan2021, for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient started Paxlovid on 05Jun2022 (also reported as 06Jun2022) within 24 hours of the first symptoms. The patient had very mild symptoms of sore throat and fatigue. Expedited PCR positive because of known exposure. No problems tested negative on 13Jun2022. On 15Jun2022 and progressing to 16Jun2022, the patient felt rapidly worse with 101 of fever; the patient tested positive. The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (unspecified date) Positive, notes: PCR positive; (13Jun2022) Negative; (15Jun2022) Positive; (16Jun2022) Positive, notes: Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the event  and suspect drug  cannot be excluded.The case will be reviewed further with FU information. 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