Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | FDP00721 | — |
Bad headaches and coul not tolerate lights; Bad headaches and coul not tolerate lights; Case reference number US-BN-2025-001904 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: BN_2025_00348) on 25-Nov-2025 and concerns a adult female patient. The patient's medical history and concomitant medications details were provided. On an unspecified date, the patient had animal exposure. On an unspecified date, (five days ago), the patient completed Rabavert series along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00721), at an unknown dose, site or route of administration for the indication post exposure. On an unspecified date, the patient experienced bad headaches and could not tolerate lights. At the time of initial report, it was unknown if the patient recovered from events of headache and 'light sensitivity to eye'. The reporter did not provide seriousness criteria and causality assessment for the events of headache and 'light sensitivity to eye'. No further information was provided.; Reporter's Comments: A spontaneous case received from a consumer, concerning an adult female patient reported non-serious events of headache and light sensitivity to eye, which occurred 5 days after completion of the RabAvert vaccination series administered for post-exposure prophylaxis following animal exposure. The events headache is expected and light sensitivity to eye are unexpected as per CCDS V6.0 and USPI of Rabipur-RabAvert. The outcome of headache and light sensitivity to eye was unknown at the time of initial report. A temporal association exists between the and the events , but without further historical, clinical, and pharmacological information, a definitive causal link cannot be established. The case assessed as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A spontaneous case received from a consumer, concerning an adult female patient reported non-serious events of headache and light sensitivity to eye, which occurred 5 days after completion of the RabAvert vaccination series administered for post-exposure prophylaxis following animal exposure. The events headache is expected and light sensitivity to eye are unexpected as per CCDS V6.0 and USPI of Rabipur-RabAvert. The outcome of headache and light sensitivity to eye was unknown at the time of initial report. A temporal association exists between the and the events , but without further historical, clinical, and pharmacological information, a definitive causal link cannot be established. The case assessed as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None