Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid; had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID:. The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), on 16Mar2021 as dose 2, single (Lot number: ER2613), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller reports he began having flu symptoms last week. His Covid test was positive. He has had all Pfizer shots and a couple of boosters. This is the third time he has contracted Covid. He states his symptoms are mild and his nose is stuffed up every so often. He got all of his Pfizer BioNTech COVID-19 Vaccine and a couple of boosters; he is contracted COVID again; Third time he contracted COVID. Transferring agent stated, "I have a caller that needs to report an adverse event on the COVID-19 Vaccine. The caller states that he got all of his Pfizer BioNTech COVID-19 Vaccine and a couple of boosters and he is contracted COVID again, he said this is the third time he contracted COVID." Consumer stated, "I do not have the either. All I have the first dose of Pfizer and I gave you the number. I gave you the number already EN6200."When probed for previous immunization with Pfizer Vaccine, consumer stated, "Yes, I have several shots. I have two boosters. I have like let me see one, two, three, four and five. Five shots all together." When probed for any other vaccines within four weeks prior to the Pfizer COVID Vaccine, consumer stated, "21Oct, 22Oct. It was my last vaccine." Consumer stated, "I am not understanding what you are asking. I do not know what you are talking about. I do not see a 10 digit number on my card." Consumer stated, "The clinic site. The contact number all I have is the Healthcare Professional or Clinic Site that is (Withheld)." Outcome of reaction/event at the time of last observation: Unknown. Treatment for COVID: Consumer stated, "The only thing my doctor prescribed Paxlovid that I have taken now." outcome of event: consumer stated, "I have seen the things is getting better. Yes." If still experience, consumer stated, "Like I said each time I have the COVID. I have very minor symptoms and is just that I had this last contact it was like a flu like symptoms that was it. I have  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received. Follow-up (21Aug2023): This is a Spontaneous follow-up report received from contactable consumer. This 74-year-old Consumer (Patient) reported that: Updated Information Included: Reporter information (Last name updated. Address, city, state and postal code added). Patient information (Last name updated. Address, city, state and postal code added). Patient details (DOB, age and unit added). Race added. Dosage regimen (Suspect drug: Dose number added; Co-Suspect drug: BNT162B2 Coded). Follow-up (22Aug2023): This is a follow-up report from product quality group providing investigation results. This report included that: Updated Information Included: Product  Quality investigation results on 22Aug2023 for lot EN6200 and ER2613    Conclusion for lot EN6200 of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6200 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 EN6200, fill lot EN5332, and the formulated drug product lot EN5321. 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. Conclusion of lot  ER2613 of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER2613 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 ER2613, fill lot EP8678, and the formulated drug product lot EP8565. 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.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received. Follow-up (15Oct2023): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300281467 same reporter and drug; different events;