Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna/Spikevax Dose Number 4; 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 24-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL9266), on 09Mar2021 as dose 2, single (Lot number: EN6204) and on 11Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 22 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Oct2022 as dose 4 (booster), single (Lot number: AS7164B) and on 12Oct2023 as dose 5 (booster), single (Lot number: 8058081) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Allergies: Latex" (unspecified if ongoing); "Allergies: seasonal/pollens" (unspecified if ongoing); "Allergies: seasonal/pollens" (unspecified if ongoing); "Allergies: Nickel" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tramadol, reaction(s): "Allergies: tramadol"; Sage, reaction(s): "Allergies: sage"; Ritalin, reaction(s): "Allergies: Ritalin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2022, outcome "unknown", described as "Moderna/Spikevax Dose Number 4"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 31Oct2023.  Product Quality Group provided investigational results on 08Nov2023 for bnt162b2: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL9266 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 EL9266, fill lot EL9257, and the formulated drug product lot EL9248. 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 lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6204 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 EN6204, fill lot EN5335, and the formulated drug product lot EN5325. 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 lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FH8020 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. 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.