Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6199), on 26Mar2021 as dose 2, single (Lot number: ER8732) and on 06Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Oct2022 at 12:00 as dose 4 (booster), single (Lot number: 057F22A), in left arm for covid-19 immunisation. The patient's family history included: "chronic clinical depression" (unspecified if ongoing), notes: Well controlled with medications for 30 years. . Concomitant medication(s) included: BUSPIRONE, start date: Jan2010; MIRTAZAPINE, start date: Jan2010; ARIPIPRAZOLE, start date: Jan2017; TRINTELLIX, start date: Jan2019. The patient also took other concomitant therapy. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Oct2022 at 12:00, outcome "unknown", described as "Vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 07Jan2024 to 11Jan2024. Clinical course: Chronic clinical depression for most of her life. (Runs in the family). Well controlled with medications for 30 years. No other health issues. She was extremely healthy. Patient had no known allergies.  Based on investigation result conclusion: The complaint for a Lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot 30145BA, ER8732 and EN6199 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 Privacy. The final scope was determined to be lot 30145BA, it also included the reported finished goods lot ER8732, fill lot EP8684, and bulk formulation lot EP8571; for lot EN6199, fill lot EN5331, and the formulated drug product lot EN5320. No quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notification or AQRTs were held as a result of this complaint. The compliant 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, bulk release testing and certificate of analysis indicates all product testing was determined to be acceptable at time of release. 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.