Age: 78.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, 0.3 ml single (Lot number: GH2642, Expiration Date: Oct2023) at the age of 78 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 15Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing), notes: heart disease diagnosed 35 or 40 years ago; "Diabetes" (unspecified if ongoing), notes: Diabetes diagnosed about 15 years ago or so, unsure; "Obesity" (unspecified if ongoing), notes: he is a big boy and does not want to be asked when he was diagnosed with this. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single, Lot: EL9265), administration date: 26Jan2021, when the patient was 75-year-old, for covid-19 immunization; bnt162b2 (Dose 2, single, Lot: EL9267), administration date: 17Feb2021, when the patient was 75-year-old, for covid-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: 30130BA), administration date: 24Sep2021, when the patient was 76-year-old, for covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Lot: FK9895), administration date: 31Mar2022, when the patient was 76-year-old, for covid-19 immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Lot: GJ2524), administration date: 13Sep2022, when the patient was 77-year-old, for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Sep2023, outcome "not recovered" and all described as "tested positive for COVID". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2023) Positive, notes: self tested at home Monday morning and got an absolute minimal positive reading and then tested twice and both were the same; (18Sep2023) Positive, notes: tested twice and both were the same; (18Sep2023) Positive, notes: tested twice and both were the same; (18Sep2023) Positive, notes: At first the test came up inconclusive and then doctor told him it was positive for Covid; (20Sep2023) Positive, notes: came up as a very thin line was very big wide and bold. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller explained that he got a dose of the Comirnaty booster last Friday (15Sep2023). 4 hours later, he went to a dinner with someone that had covid, which he found out later. He started having mild symptoms on Sunday (17Sep2023), and then tested positive for COVID on Monday(18Sep2023). He was aware of some recommendations stating that a patient should wait 3 months in order to get another dose of the vaccine. He wanted to know if he should receive an additional dose of Comirnaty. Caller wanted to know if the vaccine would still be effective under his circumstances (being in contact with COVID 4 hours after vaccination). Investigation performed. Comirnaty 12 plus covid 23/24 SDV, injection in unknown arm. Stated the receipt says quantity 0.3, does not have a dosage unit or anything listed after 0.3. Patient weight was 255 after covid. Sunday(17Sep2023) was day zero when he started having symptoms of covid. He tested positive for covid on Monday 18Sep2023. Symptoms have worsened. He started taking Paxlovid today (20Spe2023). He was not given a vaccine card for this most recent dose. He has a receipt that only has the NDC number (00069-2362-10) and does not the lot number or expiration date. Prior Vaccinations (within 4 weeks): received a flu shot the same date 15Sep2023, given in opposite arm of the covid vaccine, cannot confirm which arm received which vaccine, it was not written down. No family history relevant to adverse events. Specific relevant test for thromboembolic events with thrombocytopenia, not applicable reported.  No emergency room visit. Physician Office: self-tested at home Monday morning and got an absolute minimal positive reading, and then tested twice and both were the same, so he then went to (name withheld) and it was confirmed positive there. At first the test came up inconclusive and then doctor told him it was positive for covid, this was on Monday. Testing: He self-tested again today (20Sep2023) for covid and it came up as a very thin line was very big wide and bold. He talked to the previous agent which could not answer his question, referred him to his hcp which he understands. He hopes he is helping with that and that there will be an answer to his question in the future. If he gets covid immediately, should he take another dose three months after he gets rid of Covid, or will this still protect him even though he got covid within hours of taking it. He knows he was not with anyone at all Thursday or Wednesday prior, then when he left home he went straight to pharmacy. Family Medical History Relevant to Adverse Events was none. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL9265, EL9267, FK9895 and GJ2524 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 EL9265, fill lot EL9256, and the formulated drug product lot EL9247. The final scope included the reported finished goods lot EL9267, fill lot EL9258, and the formulated drug product lot EL9249. The final scope was determined to be the associated lot(s) of the reported lot FK9895. The final scope was determined to be the associated lot(s) of the reported lot GJ2524, PGS (withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. 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 a Lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot 30130BA 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 30130BA. 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.