Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | unknown | — |
soreness at injection site extending to his armpit; soreness at injection site extending to his armpit; fever of 101.2F; allergic reaction; Case reference number US-BN-2026-000305 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-002249) on 20-Feb-2026 and concerns a 10-year-old male patient. The patient's medical history and concomitant medications details were not provided. At an unspecified date, the patient was potentially exposed to rabies. On an unspecified date, reported as day 0, the patient received the first dose of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, site or route of administration, for post-exposure prophylaxis. On an unspecified date, reported as three days after the first dose, the patient received the second dose of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, site or route of administration. On an unspecified date, reported as seven days after the first dose, the patient received the third dose of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, site or route of administration. On an unspecified date, an unknown amount of time after vaccination with RabAvert, the patient experienced soreness at the injection site extending to his armpit, a fever of 101.2F, and a possible allergic reaction. At the time of the initial report, the outcome of the events ' injection site pain', 'axillary pain', 'fever' and 'allergic reaction' was unknown. The reporter did not provide seriousness and causality assessments for the events ' injection site pain', 'axillary pain', 'fever' and 'allergic reaction'. No further information was provided; Reporter's Comments: A 10-year-old male patient experienced non-serious events of soreness at the injection site extending to his armpit, fever and a possible allergic reaction on an unspecified date, an unknown amount of time after the patient received three doses of RabAvert vaccine for post-exposure prophylaxis. Pyrexia, hypersensitivity and injection site pain are listed and expected for RabAvert per CCDS v6 and Regulatory Agency, whilst axillary pain is unlisted and unexpected. The patient's medical history and concomitant medications 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. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A 10-year-old male patient experienced non-serious events of soreness at the injection site extending to his armpit, fever and a possible allergic reaction on an unspecified date, an unknown amount of time after the patient received three doses of RabAvert vaccine for post-exposure prophylaxis. Pyrexia, hypersensitivity and injection site pain are listed and expected for RabAvert per CCDS v6 and Regulatory Agency, whilst axillary pain is unlisted and unexpected. The patient's medical history and concomitant medications 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. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None
Test Name: Body temperature; Result Unstructured Data: Test Result:101.2 Fahrenheit;/; Comments: /