Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, SARS-CoV-2 test
Clinical narrative: headache like if had been in a 10-round boxing match; I have COVID; I have COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 76 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9265), in left arm, on 19Feb2021 as dose 2, single (Lot number: EN6201), in arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FE3590), in arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FK9895), in arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Arthritis Diagnosed for 2 years. Had full hip, replacement surgery 2 years ago, on the left hip.; "hip replacement surgery" (unspecified if ongoing), notes: Arthritis Diagnosed for 2 years. Had full hip replacement surgery 2 years ago, on the left hip. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2023, outcome "recovered" and all described as "I have COVID"; HEADACHE (non-serious), outcome "recovering", described as "headache like if had been in a 10-round boxing match". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2023) Positive, notes: Positive for COVID-19: Sunday night or Monday night she went and got tested. Results came in Monday night, 08May2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was just prescribed. The patient had COVID and received all the 5 Pfizer shots and booster, so much for that. With that said, the Doctor, he prescribed her Paxlovid, he had only taken it for a day, but he noticed this morning a terrible taste in the mouth, that taste terrible, she brushed her teeth, and it did not go away. She was just curious, she knew it was a new thing, under emergency, she was 76 and healthy, but COVID was just nasty, it's just nothing she was fine, she was located, in (withheld). She had a "unintelligible" headache like if had been in a 10-round boxing match, this was her 4th day and she was feeling better, but had her covid test; her Doctor called, and was shocked. She was still use mask and everything, and she got vaccinated, she did not have a problem, not even a sore arm. The caller mentioned she took her adult son to the ER due to a burn, and there were a lot of people in the ER without masks, so she believed that's where they got infected, because her son was also sick. The caller also added that caller had body aches, and 8 out of 10 of the symptoms. The caller mentioned she also had a little bit of loose stool and asked if this a side effect from the medication as well. The caller mentioned she had been eating before taking the 3 pills as recommended by her Doctor. The caller was prescribed with Paxlovid after getting Covid. She was also wondering why she had Covid after having 5 Pfizer Vaccines. She mentioned that after taking Paxlovid, she's had a metallic taste in her mouth and just wanted to know if that is one of the symptoms and was just curious about it. Stated she wasn't complaining, she was just curious. Hasn't previously had COVID-19, but has it now. She had her boosters for the COVID-19 Vaccines. She's 76 years old. At this end game, she thought she wouldn't get COVID-19. But she was so sick and didn't think it was COVID. They ran the test at urgent care and her doctor called telling her she has COVID-19. only been on Paxlovid for a day, has taken 6 pills. Terrible taste in the mouth: Reiterates it's just a bad taste in the mouth She took her first three Paxlovid pills last night, 09May2023. COVID-19 Vaccine: Positive for COVID-19: Sunday night or Monday night she went and got tested. Results came in Monday night, 08May2023. But caller didn't noticed the results until she saw the email Tuesday morning, 09May2023. Her doctor called in Paxlovid and then albuterol for wheezing. Doesn't know if wheezing is part of the COVID-19. She had wheezing before she began taking Paxlovid, she thinks it's part of COVID-19. It's horrible wheezing and her doctor ordered a chest x-ray. All 5 COVID-19 Vaccines she received were manufactured by Pfizer. Vaccine information is provided by caller's COVID-19 Vaccine card. Dose amount is unknown for all 5 vaccines. The sample of the product available to be returned, if requested: Not provided. The packaging sealed and intact.  As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252.  Conclusion of Previously Completed Investigation for Lots # (CR): EL9265, EN6201, FE3590, FK9895 and GJ6739: The complaint for lack of effect of the Pfizer biontech Covid-19 vaccine lot EL9265, EN6201, FE3590, FK9895 and GJ6739 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 reported finished goods lot EN6201, fill lot EN5333, and the formulated drug product lot EN5322; the reported finished goods lot FE3590, fill lot FA9134, and the bulk formulated drug product lot FE5064; the reported lot FK9895; the finished goods lot GJ6739, bulk and fill lots, GJ6726, and GJ6733. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (Withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No corrective or preventative actions were identified because it was determined that the controls in place were sufficient at preventing and removing defects that could cause a complaint of this nature. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300187833 same reporter/patient/product, different dose/event;