Age: 57.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: COVID-19, Dizziness, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: I have been diagnosed with Covid 19; I have been diagnosed with Covid 19; I take several medications (Unspecified Medication) and I don't know which medication caused me to feel sick; stop taking other pill because I can't take it, it is making me sick; Severe dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2022 (Lot number: EW0158) at the age of 57 years as dose 2, single and administration date Nov2020 (Lot number: EN6203) as dose 1, single for covid-19 immunisation; pf-07321332, ritonavir (PAXLOVID), first regimen since Dec2021 (ongoing) (Lot number: FL4516, Expiration Date: Jul2022) at 100 mg (100 mg (100 mg written here and there is 2, 150 mg)) and second regimen since Dec2021 (ongoing) (Lot number: FL4516, Expiration Date: Jul2022) at 150 mg (150 mg (100 mg written here and there is 2, 150 mg)) for covid-19; buspirone hydrochloride (BUSPAR) (Batch/Lot number: unknown). Relevant medical history included: "Diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "COVID" (unspecified if ongoing). Concomitant medication(s) included: GLYBURIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have been diagnosed with Covid 19"; ILLNESS (non-serious), outcome "unknown", described as "I take several medications (Unspecified Medication) and I don't know which medication caused me to feel sick; stop taking other pill because I can't take it, it is making me sick"; DIZZINESS (non-serious), outcome "unknown", described as "Severe dizziness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: have been diagnosed with Covid 19. The action taken for pf-07321332, ritonavir and buspirone hydrochloride was dosage not changed. Therapeutic measures were taken as a result of drug ineffective, covid-19. The clinical course was reported as follows: The patient stated that he was told to call this number to report adverse reactions, side effects or anything. He called because he takes buspirone hydrochloride and the medications have caused him some problems. He has experienced severe dizziness and "it causes you to have like you are diseased also." The patient also reported that he was taking paxlovid. He started on Friday 06Dec2021 or 07Dec2021, or Friday morning. He was on day 4 this morning and tomorrow was (incomplete sentence). He had one and a half days left. This evening medication and tomorrow's medication and he would be finished with it. It was 3 in each day. It was 100 mg and then 3, 150 mg. There was a 100 mg written here and there was 2, 150 mg. Ritonavir 2 dose of 150 mg. That was 3, 400 total for each day, for the morning and another 400 total in the evening. The doctor prescribed that to the patient because he was diagnosed with Covid for the second time. He had it twice, in the last year and he got the Covid vaccine Nov2020 and then he got it again in Jan2022. The patient reported that he took a bunch of medications. He took several medications (unspecified medication) and he did not know which medication caused him to feel sick. He assumed it was the one he told us about (paxlovid), it might be. He took like 7 different pills and it could be any of them. He did not know how to find out which one it was because it said on the box that they could cause toxic levels if he took this medicine with the medication and so he was trying get a hold of his doctor. He wanted to find out which medication was causing this, so that he could stop taking it and stop taking the other pill because he could not take it, it was making him sick.  Investigation Results from Pfizer Product Quality Group in manufacturing location for Lot Number: EN6203. Product-Description: COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-#: EN6203. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EN6203 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 EN6203, fill lot EN5336, and the formulated drug product lot EN5324. A complaint sample was not returned. 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.  Investigation Results from Pfizer Product Quality Group in manufacturing location for Lot Number: EW0158. Product-Description: COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-#: EW0158. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EW0158 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0158, fill lot EP8693, and the bulk formulated drug product lot EW8072. 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 origin were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.