Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
Pain at the lymph nodes under the armpit after the 3rd dose of Rabavert; Injection site soreness after first dose of RabAvert; Injection site soreness after second dose of RabAvert; Injection site soreness increased after third doses of RabAvert; Fever; Case reference number US-BN-2026-000311 is a spontaneous case report initially received from a consumer via Bavarian Nordic (reference number: CASE-002268) on 20-Feb-2026 and concerns a 10-years-old male patient. The patient's medical history and concomitant medications were not provided. On unspecified date, 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 and site of administration, for unknown indication. On an unspecified date, unknown time after the vaccination, the patient had soreness at the injection site. On unspecified date, unknown time 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 an unknown dose, at an unknown route and site of administration. On unspecified date, unknown time after the vaccination, the patient experienced injection site soreness. On unspecified date, unknown time after the first vaccine, the patient received the third 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 and site of administration. On unspecified date, unknown time after the vaccination, the patient experienced increased soreness at injection site, fever of 101.2 and pain at the lymph nodes under the armpit. At the time of the initial report, it was unknown if the patient recovered from the events of 'injection site pain' after the first, second and third dose of RabAvert, 'fever' and 'lymph node pain'. The reporter did not provide seriousness and causality assessment for the events of 'injection site pain' after the first, second and third dose of RabAvert, 'fever' and 'lymph node pain'. No further information was provided.; Reporter's Comments: A 10-year-old male patient received three doses of RabAvert vaccine for unknown indication. Reportedly, the patient experienced non-serious events of soreness at the injection site after each dose of RabAvert, and on unspecified date, unknown time after the vaccination, the patient experienced a non-serious event of pain at the lymph nodes. Pyrexia and injection site pain are listed and expected for RabAvert, whilst lymph node pain is unlisted and unexpected. The patient's medical history and concomitant medications were not provided. The outcome was unknown. Considering compatible 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 received three doses of RabAvert vaccine for unknown indication. Reportedly, the patient experienced non-serious events of soreness at the injection site after each dose of RabAvert, and on unspecified date, unknown time after the vaccination, the patient experienced a non-serious event of pain at the lymph nodes. Pyrexia and injection site pain are listed and expected for RabAvert, whilst lymph node pain is unlisted and unexpected. The patient's medical history and concomitant medications were not provided. The outcome was unknown. Considering compatible 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.