Received Dec 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 946590 | — |
Swollen lymph node/lymph node flared up right after the vaccine; This spontaneous case initially received on 28-Nov-2025 (additional information received on the same day), was reported by a health professional and concerns an adult female patient. Concomitant Medications and medical history were unknown. Administration of company suspect drug: On 28-Oct-2024, the patient received Flucelvax (TIV) for Prevention of Influenza Disease, Dose regimen: 0.5 ml, Route of administration: Not reported, Anatomical site: Not reported, Lot number: 946590. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date around the week after taking the vaccine, the patient experienced Swollen lymph node/lymph node flared up right after the vaccine (outcome: Unknown). The patient had flu vaccines every year and this one in particular she had a swollen lymph node afterwards and it lasted for a quite a while. She don't know if it was related to the vaccine, but her lymph node flared up right after the vaccine, within the week after she took it. She received the Flucelvax last year, on 28-Oct-2024, but they wrote on the card that the expiration date of the vaccine was 30-Jun-2024, about 4 months prior the date she took it. So, she wanted to verify if she actually took an expired vaccine and that's why the lymph node appeared around the same time or if it was any type of mistake of the person who put the expiration date and they mixed the year, and it's 2025 instead of 2024. The lot of that vaccine was 946590. Verbalized to caller that per our records, Flucelvax with lot 946590 has an expiration date of 11-Jun-2025. Treatment measures associated with event: Unknown. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter assessed event as non-serious and did not provide the causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, the event is considered related for reporting purposes
Comments: List of non-encoded Patient Relevant History: None