Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She had mild case of covid back in August; She had mild case of covid back in August; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 22Jun2021 as dose 1, single (Lot number: EV0181), on 13Jul2021 as dose 2, single (Lot number: EW0198) and on 09Feb2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN, start date: 10Dec2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "She had mild case of covid back in August". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: She was diagnosed with covid in Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient was diagnosed with covid after three doses of Pfizer covid vaccines. The Paxlovid (tablet, Batch/lot number: Unknown) was given to patient from Aug2022 to Aug2022 via mouth for mild case of covid. The patient had mild case of covid back in August of last year. She took the 5 days regimen of Paxlovid. The dose was unknown, 3 pills in the morning and 3 pills at night, it was taken as prescribed. She remembers they were kind of big round tablets, and it was at least three in one point of the day. It was a 5-day regimen. Her doctor said she may not need Paxlovid since she has had all the vaccinations and booster and said that the Paxlovid may make the symptoms lighter. She was diagnosed with covid in Aug2022, towards the middle or end of the month. When querying other medications and medical conditions reports she had a right hip replacement in 10Jun2022, the medications she was given was pain pills, gabapentin and has not taken these medications in months. She was given gabapentin at different times. She has a bottle of gabapentin from 10Dec2021. She took a course of gabapentin after her surgery for a course of 3 or 4 weeks. Clarifies she does have a different bottle from after her surgery it is dispensed in pharmacy vial and cannot provide lot, expiration, ndc or manufacturer. She never had any intestinal issues at all in her entire life, bowel never constipated and is very regular.   Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizerbiontech Covid-19 Vaccine Injectable lot EW0198 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0198, fill lot ET8441, and the formulated drug product lot EP8623. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for "Pfizerbiontech Covid-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9729. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed.