Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | IM |
Nauseous; Case reference number US-BN-2024-001964 is a spontaneous case initially received from a consumer via Med Communications (reference number USBAV24-1183) on 29-May-2024 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 was bitten by cat. On an unspecified date, reported as on Sunday, for an unknown amount of time after cat bite, the patient was vaccinated with a dose of RabAvert (batch number: unknown), at unknown dose or site administration, intramuscularly, for cat bite, and co-suspect immunoglobulins (brand name: unknown, batch number: unknown), at an unknown dose, around the bite, for cat bite. The patient was treated with antibiotics (brand name: unknown, batch number: unknown), at an unknown dose, route or site administration, for an unknown indication. On an unspecified date, the patient felt nauseous and as reported took some medication for nausea. At the time of initial report, it was unknown if the patient recovered from the event of nausea. The reporter assessed the event of nausea as non-serious and possibly related to RabAvert product or, as reported antibiotics. No further information was provided.; Reporter's Comments: A female patient of unspecified age felt nauseous and as reported took some medication for nausea was vaccinated with a dose of RabAvert, at unknown dose or site administration, intramuscularly, for cat bite, and co-suspect immunoglobulins, at an unknown dose, around the bite, for cat bite. The patient was also treated with antibiotics. Nausea is listed and expected for RabAvert. At this point it was unknown if the patient recovered from the event of nausea. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. Causal relationship is however confounded with co-suspect product and antibiotic treatment. The case is non-serious.; Sender's Comments: A female patient of unspecified age felt nauseous and as reported took some medication for nausea was vaccinated with a dose of RabAvert, at unknown dose or site administration, intramuscularly, for cat bite, and co-suspect immunoglobulins, at an unknown dose, around the bite, for cat bite. The patient was also treated with antibiotics. Nausea is listed and expected for RabAvert. At this point it was unknown if the patient recovered from the event of nausea. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. Causal relationship is however confounded with co-suspect product and antibiotic treatment. The case is non-serious.
Comments: None.
Immunoglobulins