Received Jul 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 4 | 6H9703 | LA |
I took it again on yesterday (25Jun2025) and It was positive; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID. A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 4 (booster), single (Lot number: 6H9703) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Vaccination site: Left arm, Lot number: EN6202), administration date: 03Mar2021, when the patient was 69-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Vaccination site: Left arm, Lot number: EP6955, Expiration Date: 30Jun2021), administration date: 21Mar2021, when the patient was 69-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Vaccination site: Left arm, Lot number: FF8841), administration date: 15Oct2021, when the patient was 70-year-old, for COVID-19 Immunization. The following information was reported: COVID-19 (non-serious) with onset 25Jun2025, outcome "unknown", described as "I took it again on yesterday (25Jun2025) and It was positive". Relevant laboratory tests and procedures are available in the appropriate section. Product Quality Group provided investigational results on 27Jun2025 for BNT162B2 (Lot#EP6955): Investigation Summary and Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 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 EP6955, fill lot EP6954, and the formulated drug product lot EP6953. 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. Additional information: It was reported that the patient explained more about her experience with taking the vaccines from Pfizer (Covid Vaccine). She does currently has covid and is trying to get financial assistance for the Paxlovid. The reporter stated that it has been a few years since she has taken them. So, she has not had any issues in the meantime except when she was to a family reunion this past weekend. It was clarified that this is the first time the reporter has ever had COVID. She just tested yesterday (25Jun2025) (Clarified age as 74 years at the time of event). The reporter stated that she was hard to ever sick. she was not sick usually. She was sick on when she took the test on the 23Jun2025 which was Monday and it was negative and then she took it again on yesterday (25Jun2025) and it was positive. There's another Pfizer that she took. It looks like 6H9703. It could be a 4, these are handwritten. So, it looks like, she think it is 6H9703 and stated that these were all injections in her left arm for the anatomical site. Samples was not Available for Lot Number: FF8841, EN6202 and EP6955.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500077806 same patient/drug, different AE/dose;
Test Date: 20250623; Test Name: Lab Test; Test Result: Negative ; Test Date: 20250625; Test Name: Lab Test; Test Result: Positive