Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | FDP00824 | IM / RA |
redness >2x2 and warmth to injection site; redness >2x2 and warmth to injection site; Case reference number US-BN-2026-000736 is a spontaneous case initially received from other health professional (reference number: BN-2026-00070) on 07-May-2026 and concerns a *27-year-old female patient. * The patient's medical history and concomitant medication details were not provided. *On 29-Apr-2026, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00824; expiration date: 31-Jan-2029), at a dose of 1 ml, intramuscularly, in the right arm, for rabies immunization program.* On *06-May-2026*, *seven* days after the first dose, the patient received the second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: *FDP00825; expiration date: 31-Jan-2029), at a dose of 1 ml, intramuscularly, in the right arm.* On *06-May-2026* (same day), an unknown amount of time after vaccination with RabAvert, the patient experienced redness more than 2x2 and warmth to injection site. There was no itching, rash, or other symptoms reported. *On the same day, an unknown amount of time after the event onset, the patient recovered from the events of 'injection site erythema' and 'injection site warmth'. * *On 20-May-2026, 21 days after the first dose, the patient received the third dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: * FDP00825; expiration date: 31-Jan-2029*), *at a dose of 1 ml, intramuscularly, in the right arm.* *The reporter assessed the events of 'injection site erythema' and 'injection site warmth' as non-serious, mild in intensity, and possibly related to RabAvert*. Additional information received from other health professional on 08-May-2026: Confirmation received as country of occurrence. Follow-up information was received from other health professional on 13-May-2026. New information included: patient details, RabAvert dosing details, and event details (seriousness, causality, severity, start date, stop date and outcome). Additional information was received from other health professional on 14-Jun-2026. New information included: updated RabAvert dosing details, severity, start date and stop date for the events.; Reporter's Comments: A 27-year-old female patient experienced redness more than 2x2 and warmth to injection site on the same day she was vaccinated with a second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at a dose of 1 ml, intramuscularly, in the right arm. Injection site erythema and injection site warmth are both listed and expected according to CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. Reporter's causality assessment was possibly related while and seriousness assessment was not serious. Injection site erythema and injection site warmth are both assessed as possibly related due to plausible temporal relationship, known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A 27-year-old female patient experienced redness more than 2x2 and warmth to injection site on the same day she was vaccinated with a second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at a dose of 1 ml, intramuscularly, in the right arm. Injection site erythema and injection site warmth are both listed and expected according to CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. Reporter's causality assessment was possibly related while and seriousness assessment was not serious. Injection site erythema and injection site warmth are both assessed as possibly related due to plausible temporal relationship, known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. The case is non-serious.
Comments: None.