Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | — |
After the first dose the patient was not feeling well, has sinus congestion, sore throat, brain fog and mild joint pain; After the first dose the patient was not feeling well, has sinus congestion, sore throat, brain fog and mild joint pain; After the first dose the patient was not feeling well, has sinus congestion, sore throat, brain fog and mild joint pain; After the first dose the patient was not feeling well, has sinus congestion, sore throat, brain fog and mild joint pain; After the first dose the patient was not feeling well, has sinus congestion, sore throat, brain fog and mild joint pain; temperature was 98.7 degrees/Fever; Case reference number US-BN-2025-002017 is a spontaneous case initially received from other health professional via Bavarian Nordic (reference number: CASE-001376) on 29-Dec-2025 and concerns a female patient. The patient's concomitant medication and medical history was not provided. On 22-Dec-2025, the patient received first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, site or route of administration for pre-exposure prophylaxis. On an unspecified date, the patient was not feeling well, and symptoms started 4 to 5 days ago. The patient's body temperature was 98.7 degrees. The patient did not take any fever-reducing medication in the last 12 hours. But the patient had sinus congestion, sore throat, brain fog, and mild joint pain. At the time of this report, it was unknown if the patient was recovered from sinus congestion, sore throat, brain fog, mild joint pain, not feeling well and fever was unknown. The reporter assessed events of sinus congestion, sore throat, mild joint pain, not feeling well and fever as non-serious and did not provide a causality assessment. No further information was provided.; Reporter's Comments: A female patient experienced non-serious events of sinus congestion, sore throat, mild joint pain, brain fog, not feeling well and fever on an unspecified date, an unknown amount of time after the patient received the first dose of RabAvert for pre-exposure prophylaxis. Pyrexia, malaise and arthralgia are listed and expected for RabAvert per CCDS v6 and USPI, whilst sinus congestion, brain fog and oropharyngeal pain are unlisted and unexpected. The patient's concomitant medication and medical history was 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 is assessed as related to the suspect vaccine. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A female patient born in 2000 experienced non-serious events of sinus congestion, sore throat, mild joint pain, brain fog, not feeling well and fever on an unspecified date, an unknown amount of time after the patient received the first dose of RabAvert for pre-exposure prophylaxis. Pyrexia, malaise and arthralgia are listed and expected for RabAvert per CCDS v6 and USPI, whilst sinus congestion, brain fog and oropharyngeal pain are unlisted and unexpected. The patient's concomitant medication and medical history was 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 is assessed as related to the suspect vaccine. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None.