Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | — |
The patient received series of RabAvert and allergic to them; lips would swell; Case reference number US-BN-2025-001519 is a spontaneous case initially received from a consumer via agency (reference number: USBAV25-2231) on 08-Sep-2025 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. The patient's current condition included bad back and patient has been reporting to a back doctor, a pain specialist for 6 years. On an unspecified date, the patient received RabAvert series along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, site, or route of administration following possible contact with a bat while sleeping in the same room in the mid-May (unspecified year). As reported the patient was allergic to the RabAvert series; lot of fillers and it was more unpleasant. The reaction was described as lip swelling and was reported to be unpleasant. To manage the symptoms, the patient required Benadryl (diphenhydramine) for three days. At the time of the initial report, it was unknown if the patient recovered from the events of 'drug allergy' and 'lip swelling'. The reporter did not provide the seriousness and causality assessment for the events of 'drug allergy' and 'lip swelling'. No further information was provided.; Reporter's Comments: This case concerns a patient of unknown age and gender, who had experienced non-serious events of drug hypersensitivity and lip swelling, on unspecified date after receiving the series of RabAvert vaccine doses, for an indication of contact with a bat. Drug hypersensitivity and lip swelling are unlisted as per CCDS v6 and unexpected per USPI. Patient's medical history and concomitant medication details were not provided. Outcome is unknown. Considering compatible temporal relationship and biological plausibility, for regulatory reporting purposes the causality for the reported events, is assessed as possibly related to suspect. This case is considered as non-serious.; Sender's Comments: This case concerns a patient of unknown age and gender, who had experienced non-serious events of drug hypersensitivity and lip swelling, on unspecified date after receiving the series of RabAvert vaccine doses, for an indication of contact with a bat. Drug hypersensitivity and lip swelling are unlisted as per CCDS v6 and unexpected per USPI. Patient's medical history and concomitant medication details were not provided. Outcome is unknown. Considering compatible temporal relationship and biological plausibility, for regulatory reporting purposes the causality for the reported events, is assessed as possibly related to suspect. This case is considered as non-serious.
Back pain