Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | Unknown | — |
The patient got cold and not feeling well; The patient got cold and not feeling well; The patient received three doses of RabAvert and did not receive the fourth dose; Case reference number US-BN-2026-000145 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-001796) on 26-Jan-2026 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient received the first dose of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, site or route administration for post-exposure administration. On an unspecified date, unknown amount of time after the first dose, the patient received the second dose of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, site or route administration. On an unspecified date, unknown amount of time after the second dose, the patient received the third dose of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, site or route administration. On an unspecified date, unknown amount of time after the vaccination with third dose of RabAvert, the patient experienced cold and was not feeling well. The patient received three doses of RabAvert and did not receive the fourth dose, (Inappropriate schedule of product administration). At the time of initial report, it was unknown if the patient was recovered from events of cold and feeling unwell. The reporter did not provide the seriousness and causality assessment for the event of cold and feeling unwell. No further information was provided.; Reporter's Comments: A female patient of unknown age experienced non-serious events of cold and was not feeling well on an unspecified date, unknown amount of time after the patient received the third dose of RabAvert vaccine for post-exposure administration. The patient received three doses of RabAvert and did not receive the fourth dose, which is considered as inappropriate schedule of product administration. Malaise is listed and expected for RabAvert, whilst nasopharyngitis is unlisted and unexpected. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for malaise is assessed as related to the suspect vaccine, and the causality for nasopharyngitis is not related to the suspect vaccine, considering the nature of the event. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A female patient of unknown age experienced non-serious events of cold and was not feeling well on an unspecified date, unknown amount of time after the patient received the third dose of RabAvert vaccine for post-exposure administration. The patient received three doses of RabAvert and did not receive the fourth dose, which is considered as inappropriate schedule of product administration. Malaise is listed and expected for RabAvert, whilst nasopharyngitis is unlisted and unexpected. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for malaise is assessed as related to the suspect vaccine, and the causality for nasopharyngitis is not related to the suspect vaccine, considering the nature of the event. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None