Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 5: Moderna, Dose Number: 4: Moderna / Dose Number: 3: Moderna / Dose Number: 2: Pfizer / Dose Number 1: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 17Apr2022 as dose 2, single (Lot number: EW0150) at the age of 58 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 1, single (Lot number: 0121421B), in left leg, on 22Apr2022 as dose 2, single (Lot number: 056A22A), in left arm and on 14Sep2022 as dose 3 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "ibs" (unspecified if ongoing); "Sulfa Medications" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 5: Moderna, Dose Number: 4: Moderna / Dose Number: 3: Moderna / Dose Number: 2: Pfizer / Dose Number 1: Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I tested negative for several days; (24Oct2022) positive; (unspecified date) positive; (22Oct2022) Negative.  Clinical course: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 15Oct2022,Treatment stop date: 20Oct2022, Indication: Treatment of COVID-19, Other medication details: Other medication in 2weeks product: Blood Pressure Med, Other medication in 2weeks brand: Lisinopril, Other medication in 2weeks start date: 01Jan2022, I tested negative for several days, and even a negative PCR test from (pharmacy name withheld) on Saturday 22Oct2022) and this morning I am very positive again. All home tests have solid line, and I did another PCR at (pharmacy name withheld)  that I expect to say positive. We have a machine at home that also show positive this morning.  This is a notification generated from the system.  As part of the LOE simplification process, the following Complaint Records were classified as  Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state  referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process. Refer to the below table for details: Product Description (CR): Compound BNT162 Covid-19 Vaccine Suspension for Intramuscular 2ml Multiple Dose Vial X 1, Lot-# (CR): EN6208 Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine Injectable lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. 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 or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed, Product Description (CR): Compound BNT162 Covid-19 Vaccine Suspension for Intramuscular 2ml Multiple Dose Vial X 1, Lot-# (CR): EW0150, Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine Injectable lot EW0150 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 EW0150, fill lot EP8690, and the formulated drug product lot EP8587. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature. PR ID of Previously Completed Inv.