Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I was positive /they ran an antigen test and put it into an electronic box and said I had Covid.; I was positive /they ran an antigen test and put it into an electronic box and said I had Covid.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3248), in right arm, on 18Feb2021 as dose 2, single (Lot number: EN6198), in right arm, on 25Sep2021 as dose 3 (booster), single (Lot number: FC3183), in right arm and on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DULOXETINE. Past drug history included: Metronidazole, reaction(s): "Allergy"; Ciprofloxacin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "not recovered" and all described as "I was positive /they ran an antigen test and put it into an electronic box and said I had Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: I was exposed to Covid on a plane; (21May2022) Negative; (22May2022) Negative; (29May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medication in 2 weeks was Duloxetine 60 mg with lot number lot number#G105873. The patient was exposed to Covid on a plane coming from withheld to withheld on 12May. On Monday afternoon 16May she felt quite sick (fever, headache, runny nose, neck pain, body aches and just lousy overall.) The next morning she tested herself and she was positive so she went to a Facility (Name withheld) and they ran an antigen test and put it into an electronic box and said she had Covid. She prescribed the anti-viral Paxlovid and was treated with Paxlovid for COVID-19 from 17May2022 to 21May2022. She was sick in bed all week but felt a little better Thursday and felt completely better Friday and so Saturday 21May, and again 22May she tested herself and she was negative both times. She went back to work Monday (with a mask) and Saturday afternoon 28May. She began to feel quite sick - the same way she did on 16May. She tested myself then and again today 29May and both times She was positive again. The patient wanted to know whether she could ignore it and go back to work with a mask or climb back in bed or need to go to the doctor and reinitiated treatment with Paxlovid. Device time stamp: 29May2022. Conclusion and investigation result for lot EL3248, lot EN6198 and lot FC3183 included: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3248, lot EN6198 and lot FC3183 were investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, analytical release test results and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. The final scope included the reported finished goods lot EN6198, fill lot EN5330, and the formulated drug product lot EN5319. The final scope was determined to be the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Product Description (CR): Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.