Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "I was fully vaccinated (clarified as Pfizer Covid-19 vaccine) and boostered"; COVID-19 (medically significant), outcome "unknown", described as "I was taking to prevent the side-effects of COVID which was what I had been diagnosed with based on test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was taking to prevent the side-effects of COVID which was what I had been diagnosed with based on test. Therapeutic measures were taken as a result of drug ineffective, Covid-19.Investigation as Lot reported had been previously investigated as part of PR ID and PR ID #Unknown. Following was conclusion field from that investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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. Clinical details: the patient was taking the Paxlovid because she was 71 and has had cancer and so, the doctor put me on this. She asked for it which she thought would give her relief from the symptoms which it certainly has. She mentioned that she feels wonderful, but she was side-effects that are really concerning her. She can't think very clearly, and she was just hoping that isn't going to be a long-term effect of using this medicine because she was fully vaccinated with booster. The patient was wondering if the side effects are going to be permanent since the medicine is not fully approved by the FDA. The side effects she experienced included very dizzy sort of unstable, but she was also taking another medicine (Bupropion) that has this kind of a side-effect. She added that she does not remember which one causes that, tends to make a person, a little bit more of a and then there is another medicine that is the Lexapro, me of those have side-effects anyway of being, having a little dizziness. She mentioned that she forgot which one it is, but it certainly gets aggravated by this current medicine that I am taking to prevent the side-effects of COVID which is what she has been diagnosed with based on test (unknown results). She was concern about it but even more so than that she was concerned about her mind. She has been having trouble thinking clearly. She reads and she can't remember what she has read. She mentioned that it has aggravated. Maybe she has had that before, but it really seems to be aggravated by this Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): US-PFIZER INC-202200771228 Same patient, different drug, different event.