Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | FDP00683 | IM |
the patient did not receive the second dose of RabAvert seven days after the first, it was a day 10 and the patient still did not receive it; Patient got severely ill with gastroenteritis; Case reference number US-BN-2025-001311 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV25-1810) on 24-Jul-2025 and concerns a 22-year-old female patient. The patient's medical history included thyroid disorder. The patient's concomitant medication details were not provided. On 14-Jul-2025, the patient received the first dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683), intramuscularly, at an unknown dose or site of administration for the indication of pre-exposure. On 20-Jul-2025, six days after the vaccination with the first dose of RabAvert, the patient got severely ill with gastroenteritis. On 24-Jul-2025, the patient recovered from the event of 'gastroenteritis'. On an unspecified date, also reported as day ten the patient did not receive the second dose (explicitly coded 'incomplete course of vaccination'). The reporter assessed the event 'gastroenteritis' as non-serious and not related to the RabAvert. No further information was provided.; Reporter's Comments: This case concerns a 22-year-old female patient, who experienced non-serious events of gastroenteritis, 6 days after the patient received the first dose of RabAvert vaccine for an indication of pre-exposure. As reported as on day ten the patient did not receive the second dose, which is considered as incomplete course of vaccination. Gastroenteritis is unlisted per CCDS v6 and unexpected per SmPC. The patient's medical history includes included thyroid disorder and concomitant medication details were not provided. Outcome was recovered. Based on the limited information provided regarding this case, the causal role of the suspect vaccine cannot be excluded in the occurrence of the event, therefore the causality is assessed as related. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a 22-year-old female patient, who experienced non-serious events of gastroenteritis, 6 days after the patient received the first dose of RabAvert vaccine for an indication of pre-exposure. As reported as on day ten the patient did not receive the second dose, which is considered as incomplete course of vaccination. Gastroenteritis is unlisted per CCDS v6 and unexpected per SmPC. The patient's medical history includes included thyroid disorder and concomitant medication details were not provided. Outcome was recovered. Based on the limited information provided regarding this case, the causal role of the suspect vaccine cannot be excluded in the occurrence of the event, therefore the causality is assessed as related. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Medical History/Concurrent Conditions: Thyroid disorder