Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: took a rapid covid test which was expired and it came back positive; took a rapid covid test which was expired and it came back positive; interchange of vaccine products; 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 62-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 6 (booster), 0.3ml single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6202, Expiration Date: 30Jun2021), on 26Mar2021 as dose 2, single (Lot number: EP6955, Expiration Date: 30Jun2021) and on 21Oct2021 as dose 3 (booster), single (Lot number: 32030BD) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23May2022 as dose 4 (booster), single (Lot number: 054A22A), on 23May2022 as dose 4 (booster), single (Lot number: 0541A22A), on 12Sep2022 as dose 5 (booster), single (Lot number: A57145B) and on 12Sep2022 as dose 5 (booster), single (Lot number: AS7145B) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "had gall bladder removed" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "took a rapid covid test which was expired and it came back positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) negative, notes: she tested twice last Monday, one shows negative, one is positive; (Sep2023) positive, notes: she tested twice last Monday, one shows negative, one is positive; (unspecified date) Unknown Results; SARS-CoV-2 test negative: (24Sep2023) negative; SARS-CoV-2 test positive: (24Sep2023) Positive, notes: she tested twice last Monday, one shows negative, one is positive.  Clinical course: The patient received a Comirnaty vaccination last Wednesday and then on Sunday took a rapid covid test which was expired and it came back positive and then took another rapid test that was not expired and it came back negative and is awaiting the results of a PCR test; she is awaiting the results of a PCR test and asked if the Comirnaty vaccine could give her a false positive. Upon follow-up on 26Sep2023, it was reported that patient got the Comirnaty 12 23 24 last Wednesday, she tested twice last Monday, one shows negative, one is positive, asking if it is as live virus injected to her that can cause a false positive result.  Product Quality Group provided investigational results on 27Sep2023 for BNT162B2 lot EN6202 : The complaint for lack of effect of the Pfizer-BioNTech Covid-19 Vaccine lot EN6202 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 EN6202, fill lot EN5334, and the formulated drug product lot EN5323. 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. Product Quality Group provided investigational results on 27Sep2023 for BNT162B2 lot EP6955 : The complaint for lack of effect of the Pfizer-BioNTech Covid-19 Vaccine lot EP6955 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 EP6955, fill lot EP6954, and the formulated drug product lot EP6953. 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. Product Quality Group provided investigational results on 27Sep2023 for BNT162B2 lot 32030BD : The complaint for a Lack of effect of the Pfizer-BioNTech Covid-19 Vaccine lot 32030BD 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 (Site name withheld). The final scope was determined to be lot 32030BD. 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 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.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.  Follow-up (27Sep2023 and 26Sep2023): This is a follow-up report from product quality group providing investigation results and from the same contactable Consumer respectively. Updated Information included: lab test, Lot number for dose 3 and dose 5, clinical information.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.