Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: flu-like symptoms; Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6207), on 10Apr2021 as dose 2, single (Lot number: EP7533) and on 08Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 59 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Mar2022, outcome "unknown" and all described as "Tested positive for covid"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) around 5 feet 6 inches or 5 feet 7 inches., notes: Height: around 5 feet 6 inches or 5 feet 7 inches; SARS-CoV-2 test: (28Mar2022) positive, notes: Result: positive; Unit: Not Provided; (02Apr2022) positive, notes: On Saturday 02Apr2022, his partner took the home antigen test and was positive; (03Apr2022) negative, notes: On Sunday 03Apr2022 and Monday 04Apr2022 his partner was negative, clarifying also tested by the home antigen test; (04Apr2022) negative, notes: On Sunday 03Apr2022 and Monday 04Apr2022 his partner was negative, clarifying also tested by the home antigen test; (06Apr2022) Positive, notes: On Wednesday 06Apr2022, his partner felt a stuffy nose and he thought to test to make sure, he took the home antigen test and it was Positive on 06Apr2022; (07Apr2022) Positive, notes: His partner also did a second home test yesterday 07Apr2022 and it was also positive; Weight: (unspecified date) Around 190lbs, notes: Weight: Around 190lbs. Therapeutic measures were taken as a result of covid-19.  Clinical course: The caller is a consumer, calling about Paxlovid. Both caller himself and his partner tested positive for covid 19, and we both prescribed the Paxlovid for it. His partner is a male patient, and after his partner completed the 5 days of the Paxlovid treatment, on day 7 his partner tested negative for covid, as well as on day 8, but then on day 10 his partner tested positive for covid 19. Agent confirms that there are no adverse events for the caller himself, the caller is now negative. However, his partner has symptoms for covid now stronger than the initial symptoms he had before Paxlovid. Caller wanted to know if that is normal or has been reported. Paxlovid: He does not have any Lot number or expiry to provide as it has been discarded. When probed for the dose, caller states that it was just the standard regular dose, 3 pills twice a day, the packaging is clear about that, he doesnt recall but was 300 or 100mg or something like that for 5 days.  The complaint for lack of effect of the Pfizerbiontech covid-19 vaccine lot EN6207 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 EN6207, fill lot EN5340, and the formulated drug product lot EN5328. 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.