Received Jul 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | — |
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | UNK | Unknown | — |
hallucinations; chest pain; The patient got sick with like Insomnia; shaking really bad, like really bad tremors; Ringing in ears; Heart palpitations; The patient didn't eat any more; The patient got sick with like Insomnia; The patient pretty bad reaction; The patient received one dose of RabAvert and one dose of Imovax; Case reference number US-BN-2025-001178 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV25-1646) on 08-Jul-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date also reported as in Mar-2025, the patient received the 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, route, or site of administration for an unknown indication (explicitly coded 'interchange of vaccine products') On an unspecified date also reported as in Mar-2025, an unknown time from the vaccination with RabAvert, the patient received the second dose of the co-suspect vaccine Imovax (batch number: unknown) at an unknown dose, route, or site of administration for an unknown indication. On an unspecified date, an unknown time from the vaccination with RabAvert, the patient experienced pretty bad reaction, got sick with like insomnia, had some hallucinations, did not eat any more, had a lot of chest pain, started having heart palpitations, and shaking really badly, like really bad tremors. On an unspecified date, the patient experienced ringing in the ears and stuff like that. On an unspecified dates, as reported since March, the patient had been in and out of the hospital. At the time of the initial report, it was unknown if the patient had recovered from the events of hallucinations, 'insomnia', 'decreased appetite', chest pain, 'palpitations', 'tremor', 'sickness' and 'adverse reaction' and did not recover from event of ringing in ears, as reported and was still dealing with ringing in the ears and stuff like that. The reporter did not provide a seriousness assessment for the events of hallucinations, 'insomnia', 'decreased appetite', chest pain, 'palpitations', 'tremor', ringing in ears, 'sickness' and 'adverse reaction', however the events assessed serious due to seriousness criteria of hospitalization and evet of hallucinations was assessed as serious due seriousness criteria of medical significance. The reporter assessed the events of hallucinations, 'insomnia', 'decreased appetite', chest pain, 'palpitations', 'tremor', ringing in ears, 'sickness' and 'adverse reaction' as possibly related to the product RabAvert. No further information was provided.; Reporter's Comments: A female patient of unspecified age received the first dose of RabAvert for an unknown indication, and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date, an unknown time from the vaccination with RabAvert, the patient experienced serious events of bad reaction, got sick with like insomnia, had some hallucinations (medical significance), did not eat any more, had a lot of chest pain, started having heart palpitations, and shaking badly, like bad tremors (hospitalization). Decreased appetite is listed for RabAvert per CCDS v5 and unexpected per USPI, whilst palpitations is unlisted and expected. Hallucination, chest pain, insomnia, tremor and tinnitus are unlisted and unexpected. Illness, adverse reaction and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. The patient's co-suspect vaccination confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to RabAvert. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance and hospitalization.; Sender's Comments: A female patient of unspecified age received the first dose of RabAvert for an unknown indication, and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date, an unknown time from the vaccination with RabAvert, the patient experienced serious events of bad reaction, got sick with like insomnia, had some hallucinations (medical significance), did not eat any more, had a lot of chest pain, started having heart palpitations, and shaking badly, like bad tremors (hospitalization). Decreased appetite is listed for RabAvert per CCDS v5 and unexpected per USPI, whilst palpitations is unlisted and expected. Hallucination, chest pain, insomnia, tremor and tinnitus are unlisted and unexpected. Illness, adverse reaction and interchange of vaccine products are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. The patient's co-suspect vaccination confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to RabAvert. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance and hospitalization.
Comments: NONE