Age: 38.0
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 bivalent booster; 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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: En6206), in left arm, on 24Mar2021 as dose 2, single (Lot number: Ep7534), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: 30145ba) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 10Sep2022 at 17:30 as dose 4 (booster), single (Lot number: A57143c), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "obesity" (unspecified if ongoing); "ptsd" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "pcos" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 10Sep2022 at 17:30, outcome "unknown", described as "Vaccine brand other : Moderna bivalent booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Oct2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Oct2022) Positive, notes: 25Oct: First symptoms approx 6pm 10:26 Positive test at 10:15am, paxlovid started early afternoon; (31Oct2022) Negative, notes: 31Oct: Symptoms ended, quarantine ended (continued masking), tested negative on rapid antigen; (03Nov2022) Unknown results, notes: 03Nov: Symptoms returned, tested  (cough, nasal congestion, fever, exhaustion). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Investigation results received on 07Nov2022. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EN6206 , fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed. The complaint for lack of effect of the pfizer-biontech covid-19 vaccine lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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. The complaint for a Lack of effect of the Pfizer-biontech covid-19 vaccine lot 30145BA 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. The final scope was determined to be lot 30145BA. No quality issues were identified during the investigation. There is no impact on product quality. An 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.