Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19 twice after receiving Pfizer COVID-19 Vaccines; Positive for COVID-19 twice after receiving Pfizer COVID-19 Vaccines; Positive for COVID-19 twice after receiving Pfizer COVID-19 Vaccines; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204) and on 31Mar2021 as dose 2, single (Lot number: EN6204) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension; "Pulmonary sarcoidosis" (unspecified if ongoing), notes: Pulmonary sarcoidosis, Has a history. It's not active. It was in her twenties.; "Renal issues" (unspecified if ongoing) (Attempted to clarify the renal issues. She was was taking Nexium for a long time and her EGFR dropped. Before she was given Iodine it was 64 in normal range, and the EGFR had gone down to 38. It had been a couple of years ago, and when she came off Nexium and it came back up. They are careful with her because of her history. Clarifies she was given Iodine during hospitalization on 16Jan2024 and EGFR dropped to 54 the next day. States hopefully she is recuperating now).. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Positive for COVID-19 twice after receiving Pfizer COVID-19 Vaccines"; DISEASE RECURRENCE (medically significant) with onset 02Jan2024, outcome "unknown", described as "Positive for COVID-19 twice after receiving Pfizer COVID-19 Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2024) Positive. Additional information: She went into the hospital on 16Jan2024, spent just one night in the hospital. Then was sent home on 17Jan2024 on blood thinners and antibiotics. She's on Eliquis now and she's doesn't like it, but has to take it. Her COVID was mild, had mild symptoms. It was worse than the first time she had COVID. She was scared to get the vaccines and thought if something happened she would already be at the hospital.  Only has had 2 doses. Clarifies she did not have COVID three years ago because it was after she was vaccinated. Clarifies the first time she had COVID, she thinks was Dec2021.  Investigation result was received on 24Jan2024 from product quality group. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6204 was investigated. The investigation included review of manufacturing and packaging batch records, deviation investigations, and an analysis of the complaint history for the reported lot. The final scope included  the reported finished goods lot EN6204, fill lot EN5335, and the formulated drug product lot EN5335. A complaint sample was not returned and photographs were not received.No related quality issues were identified during the investigation. There is no impact on 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.