Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; vaccine brand: Other, vaccine brand other: Moderna/ vaccine brand: Pfizer / BioNTech; 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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 at 01:15 as dose 1, single (Lot number: ER8760), in left arm, on 16Apr2021 at 02:00 as dose 2, single (Lot number: EW0169), in left arm and on 05Nov2021 at 18:30 as dose 3 (booster), single (Lot number: FJ1611) at the age of 47 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Jul2022 at 17:45 as dose 4 (booster), single (Lot number: 059A22A), 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 22Sep2022 at 17:30 as dose 5 (booster), single (Lot number: A57165B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Morbid obesity" (unspecified if ongoing), notes: Morbid obesity; "asthma" (unspecified if ongoing); "PCOS" (unspecified if ongoing), notes: PCOS. Concomitant medication(s) included: SUDAFED 12 HOUR, start date: May2022; CETIRIZINE HCL, start date: Jan2022; ACETAMINOPHEN AND CAFFEINE, start date: Jan2018; FARMAPRAM, start date: Aug2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 06Jul2022 at 17:45, outcome "unknown", described as "vaccine brand: Other, vaccine brand other: Moderna/ vaccine brand: Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Dec2022) Negative; (02Dec2022) Negative; (09Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Covid symptoms resolved 01Dec with negative rapid antigen test on same day and 02Dec. Congestion and facial pain returned on 07Dec. Pain and congestion, with added unproductive cough continued. Positive rapid antigen on 09Dec. Currently: mild facial pain, exhaustion, dry hacking cough fits, mild numbness in fingertips. The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot EW0169 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 and product type. The final scope included the reported finished goods lot EW0169, fill lot EP8700, and the bulk formulated drug product EP8602. 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.  The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot FJ1611 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FJ1611, fill lot FH4344 and the bulk formulated drug product FJ8502. 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.