Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUC4 | INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) | SEQIRUS, INC. | 1 | 946635 | IM / LA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | lp1780 | IM / LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 946635 | IM / LA |
Dermatitis allergic; Redness at Injection site-Medium; Itching at Injection Site-Medium; Swelling at Injection Site-Medium; Itch Generalized-Mild; Rash Generalized-mild; This spontaneous case initially received on 25-Feb-2025, was reported by a health authority from Vaccine Adverse Event Reporting System (VAERS-US) (ID: 2822979-1) and concerns an adult female patient. Patient did receive the vaccine in 2020 and 2021. And also received Flucelvax on 2022. Administration of company suspect drug: On 11-Jan-2025, the patient received Flucelvax (TIV) for unknown indication, dose reported: not reported (reported as 1 DF), Route of administration: Intramuscular, anatomical location: left deltoid, Lot number: 946635. Non-company suspect drugs: Pfizer BioNTech COVID-19 vaccine (Tozinameran), Indication: Not reported, Intramuscular, anatomical location: left deltoid, Lot number: Ip1780. Adverse reactions/events and outcomes: On 14-Jan-2025, the patient experienced Dermatitis allergic (outcome: Not recovered / Not resolved), Redness at Injection site-Medium (outcome: Not recovered / Not resolved), Itching at Injection Site-Medium (outcome: Not recovered / Not resolved), Swelling at Injection Site-Medium (outcome: Not recovered / Not resolved), Itch Generalized-Mild (outcome: Not recovered / Not resolved), Rash Generalized-mild (outcome: Not recovered / Not resolved). Site: Itching at Injection Site Medium, Site: Redness at Injection Site Medium, Site: Swelling at Injection Site- Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild. Consumer calls and states she had an allergy dermatitis, and she did receive the vaccine in 2020 and 2021. And also received Flucelvax on 2022 and 2025. She was asking for the inactive ingredients of the vaccines to try to understand were de allergy may come from. Flucelvax (TIV) action taken: Not Applicable Reporter assessment: the reporter considered the events as non-serous and did not provide a causality assessment. Follow-up (19-Nov-2025) received from consumer. Reporter added, patient medical history updated. Narrative was updated.; Reporter's Comments: The events were assessed related due to chronological plausibility.
Medical History/Concurrent Conditions: Vaccination