Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | FDP00769 | IM / RA |
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | FDP00769 | IM / RA |
a 14 in X 6 in reddened warm area on right upper arm and elbow area with hives from rabies injection; a 14 in X 6 in reddened warm area on right upper arm and elbow area with hives from rabies injection; a 14 in X 6 in reddened warm area on right upper arm and elbow area with hives from rabies injection; discomfort due to the warmth of the skin; Case reference number US-BN-2026-000719 initially downloaded from the Vaccine Adverse Event Reporting System (VAERS) on 04-May-2026, is a spontaneous case received from other health professional via the Health Authority (VAERS ID: 2886579-1) and concerns a 26-years-old male patient. The patient's current medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with the 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 an unspecified date, unknown amount of time after first dose, the patient was vaccinated with the 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 for unknown indication. On 21-Feb-2026, unknown amount of time after the second dose, the patient was vaccinated with the third dose of RabAvert along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00769) at an unknown dose, intramuscularly on the right arm for unknown indication. On 22-Feb-2026, next day after receiving third dose of RabAvert, the patient presented with a 14 in x 6 in reddened warm area on right upper arm and elbow area with hives from rabies injection. The patient denies pain but reports discomfort due to warmth of the skin. The patient denies nausea, vomiting, or difficulty breathing. On 23-Feb-2026, the patient presented to MSA (Medical Services Area) office. At the time of initial report, the patient was not recovered from the events of injection site erythema, injection site urticaria, injection site warmth, injection site discomfort. The reporter assessed events of injection site erythema, injection site urticaria, injection site warmth, injection site discomfort as non-serious and did not provide a causality assessment. No further information was provided.; Reporter's Comments: A 26-years-old male patient presented with a 14 in x 6 in reddened warm area on right upper arm and elbow area with hives from rabies injection, one day after receiving third dose of RabAvert, along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution, at an unknown dose, intramuscularly on the right arm for unknown indication. The outcome was not resolved. Injection site erythema, injection site urticaria, injection site warmth and injection site discomfort are all listed and expected for RabAvert per CCDS v6 and USPI. The patient's current medical history and concomitant medication details were not provided. The reporter's causality assessment was not provided. Injection site erythema, injection site urticaria, injection site warmth and injection site discomfort are all assessed as related to suspect product due to plausible temporal relationship, lack of alternative explanation at this point, known product safety profile and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A 26-years-old male patient presented with a 14 in x 6 in reddened warm area on right upper arm and elbow area with hives from rabies injection, one day after receiving third dose of RabAvert, along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution, at an unknown dose, intramuscularly on the right arm for unknown indication. The outcome was not resolved. Injection site erythema, injection site urticaria, injection site warmth and injection site discomfort are all listed and expected for RabAvert per CCDS v6 and USPI. The patient's current medical history and concomitant medication details were not provided. The reporter's causality assessment was not provided. Injection site erythema, injection site urticaria, injection site warmth and injection site discomfort are all assessed as related to suspect product due to plausible temporal relationship, lack of alternative explanation at this point, known product safety profile and since contributory role of suspect product cannot be excluded. The case is non-serious.
Comments: None.