Received May 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | LM2210 | RA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 388527 | LA |
Tested positive for Covid, Experiencing mild symptoms; This spontaneous case, initially received on 12-May-2025, was reported by a non health professional and concerns an adult female patient. Historical drug included unspecified product (reaction: allergy). Administration of company suspect drug: On 03-Oct-2024, the patient received Flucelvax (TIV) for an indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Left arm, Lot number: 388527. Non-company suspect drugs: On 03-Oct-2024, the patient received Pfizer BioNTech COVID-19 vaccine (Tozinameran) for an indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Right Deltoid, Lot number: LM2210. On 07-Apr-2025, the patient received Pfizer BioNTech COVID-19 vaccine (Tozinameran) for an indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Right Not Reported, Lot number: LM2210. Adverse reactions/events and outcomes: On 09-May-2025, the patient experienced Tested positive for Covid, Experiencing mild symptoms (outcome: Recovering / Resolving). Intensity: Mild Additional information received as event started on 09-May-2025 as well. In other words, patient felt symptoms on 09-May-2025 and took a Covid test that same day, which was how patient became aware she had Covid. It was reported that this report that Tested positive for Covid. Experiencing mild symptoms, appeared to be related to efficacy of the drug which was not device related. As there was no issue reported with the device (Tozinameran), this would be closed as not device related. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter considered the event Tested positive for Covid, Experiencing mild symptoms as non-serious and did not provide causality assessment. Follow up (19-May-2025) received from consumer: New reporter added (second), New dosing regimen added for co-suspect, event onset date updated to 09-May-2025. Upon internal review, race had been removed from patient tab and updated with other, narrative updated accordingly.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, the event covid-19 is considered coincidental with no biological and temporal plausibility (7 months after vaccination) for Flucelvax to cause/contribute. Of note, there could be a lack of effect with non company COVID-19 vaccine (Tozinameran).
Comments: None