Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
The area around the bite has some decent swelling and it is red and hot; typical inflammatory response; The area around the bite has some decent swelling and it is red and hot; The area around the bite has some decent swelling and it is red and hot; RabAvert vaccine was received around the bite instead of the immunoglobulin; Case reference number US-BN-2026-000302 is a spontaneous case report initially received from a pharmacist via Bavarian Nordic (reference number: CASE-002246) on 19-Feb-2026 and concerns a 23-years-old female patient. The patient's medical history and concomitant medications were not provided. On unspecified date, as reported, the patient was bitten by a stray cat. On 16-Feb-2026, the patient received the first dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, at an unknown route of administration, at right elbow for postexposure prophylaxis (explicitly coded as 'product administered at inappropriate site'). On the same day, the patient also received HRIG (brand name: HyperRab), at an unknown dose, at an unknown route of administration, at right deltoid for postexposure prophylaxis. On unspecified date, unknown time after the vaccination, the patient's area around the bite had some decent swelling and it was red and hot, as reported a typical inflammatory response. On 19-Feb-2026, three days after the first vaccine, the patient received the second dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, at an unknown route of administration, in right deltoid. At the time of the initial report, it was unknown if the patient recovered from the events of 'injection site warmth', 'injection site redness', 'injection site inflammation' and 'injection site swelling'. The reporter did not provide seriousness assessment for the events of 'injection site warmth', 'injection site redness', 'injection site inflammation' and 'injection site swelling'. The reporter assessed the events of 'injection site warmth', 'injection site redness', 'injection site inflammation' and 'injection site swelling' as possibly related to the RabAvert vaccine, as reported, it appeared that it is a reaction to the vaccine. No further information was provided.; Reporter's Comments: A 23-year-old female patient received the first dose of RabAvert vaccine around the bite, at right elbow for postexposure prophylaxis, which is considered as product administered at inappropriate site. On unspecified date, unknown time after the vaccination, the patient's area around the bite had some decent swelling and it was red and hot, as reported a typical inflammatory response. Injection site erythema, injection site inflammation, injection site swelling and injection site warmth are considered as listed and expected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as related to the suspect vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A 23-year-old female patient received the first dose of RabAvert vaccine around the bite, at right elbow for postexposure prophylaxis, which is considered as product administered at inappropriate site. On unspecified date, unknown time after the vaccination, the patient's area around the bite had some decent swelling and it was red and hot, as reported a typical inflammatory response. Injection site erythema, injection site inflammation, injection site swelling and injection site warmth are considered as listed and expected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as related to the suspect vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None
HYPERRAB