Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other= Moderna, vaccine administration date=19Mar2022/ Vaccine brand= Pfizer / BioNTech, vaccine administration date=05Sep2021; 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 28Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 05Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Mar2022 as dose 4 (booster), single (Lot number: 027L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 19Mar2022, outcome "unknown", described as "Vaccine brand other= Moderna, vaccine administration date=19Mar2022/ Vaccine brand= Pfizer / BioNTech, vaccine administration date=05Sep2021"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (15Aug2022) Positive, notes: After 5 days of paxlovid I had a very faint positive line on test kit for 2 more days; (16Aug2022) Positive, notes: After 5 days of paxlovid I had a very faint positive line on test kit for 2 more days; (17Aug2022) Positive, notes: After 5 days of paxlovid I had a very faint positive line on test kit for 2 more days; (18Aug2022) Negative, notes: Then negative test on 3rd day; (19Aug2022) Positive, notes: Today I've tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course:Patient received vaccine. Patient did not received other medication in 2 weeks.Patient received Anti-viral (Paxlovid) for COVID 19 Treatment Brand was Paxlovid. Treatment start date on 10Aug2022 and stopped on stop date=14Aug2022 (lot number= GE7067). On 18Aug2022, Patient had Sinus symptoms, runny nose past 2 days. After 5 days of paxlovid I had a very faint positive line on test kit for 2 more days. Then negative test on 3rd day. Today I've tested positive again. Outcome is Not recovered. If treatment ae: No. No Known allergies  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EM9809 and EN6203 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EM9809, fill lot EM9807, and the formulated drug product lot EM9805 and EN5324. 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.  Conclusion of Previously Completed Investigation: The complaint for a Lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot 30130BA was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled and packaged by Pfizer withheld. The final scope was determined to be lot 30130BA. No quality issues were identified during the investigation. There is no impact on product quality.  Was not issued for the complaint. No regulatory notification or SQRTs/AQRTs were held as a result of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. The root cause was not determined to be manufacture or vendor related as incoming quality component testing and the results of all analytical tests performed at the time of lot release confirmed that the batch met potency specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior any lot being released to the market. No further investigation required.  No follow-up attempts are possible. No further information is expected.