Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | unknown | — |
The patient received the second dose of RabAvert and experienced fever and right groin lymph node was swollen; The patient received the second dose of RabAvert and experienced fever and right groin lymph node was swollen; Case reference number US-BN-2025-000884 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV25-0957) on 28-Apr-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, 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 unknown dose, route or site of administration for unknown indication. On 26-Apr-2025 also reported as three-day series, unknown amount of time from the first dose, the patient received second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route or site of administration. On 27-Apr-2025, one day after the vaccination with second dose of RabAvert, the patient experienced a fever and right groin lymph node was swollen. At the time of the initial report, the patient did not recover from the events 'swollen lymph nodes' and 'fever', as reported ongoing. The reporter assessed the events 'swollen lymph nodes' and 'fever' as non-serious and did not provide causality assessment. No further information was provided.; Reporter's Comments: This case concerns a female patient of unknown age/age group who experienced non-serious events of lymphadenopathy and pyrexia, one day after the vaccination with second dose of RabAvert for unknown indication. Lymphadenopathy and pyrexia are listed per CCDS V4 and expected per USPI. Patient's medical history and concomitant medications was not reported. Outcome of these events was not recovered/not resolved. Based on the limited information provided regarding this case, along with the latency of 1 day, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events are considered related to the suspect vaccine. This case is considered as non-serious.; Sender's Comments: This case concerns a female patient of unknown age/age group who experienced non-serious events of lymphadenopathy and pyrexia, one day after the vaccination with second dose of RabAvert for unknown indication. Lymphadenopathy and pyrexia are listed per CCDS V4 and expected per USPI. Patient's medical history and concomitant medications was not reported. Outcome of these events was not recovered/not resolved. Based on the limited information provided regarding this case, along with the latency of 1 day, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events are considered related to the suspect vaccine. This case is considered as non-serious.
Comments: NONE