Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 4 | FDP00721 | RA |
left lower neck; migraine; light sensitivity; noise sensitivity; Left eye twitching; left hip pain; pain or paresthesia in the wound site; Stomach aches; pain at her initial vaccination site - left deltoid/right hip pain; headache; pain at her initial vaccination site - left deltoid; Case reference number US-BN-2025-001811 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: BN_2025_00343, CASE-000766) on 16-Nov-2025 and concerns a female patient of an unknown age. The patient's medical history and concomitant medication details were not provided. On 01-Nov-2025, the patient received first dose of Rabipur along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00721), at an unknown dose, site or route of administration for exposure to bat. On an unspecified date in Nov-2025, (two weeks ago in her left deltoid) the patient received second and third dose of Rabipur along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00721), at an unknown dose, site or route of administration for exposure to bat. On 15-Nov-2025 (2 weeks after her first left arm injection) the patient began having pain in her left deltoid. It hurts to the touch and with movement and was still present almost a month later. On 19-Nov-2025, the patient received fourth dose of Rabipur along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00721), at an unknown dose, site or route of administration for exposure to bat. On an unspecified date, she experienced pain at her initial vaccination site - left deltoid, as well as pain in her left elbow/right hip pain and left lower neck. They were concerned about the possibility of some live virus being in the product since the first symptoms of rabies was also pain or paresthesia in the wound site. The patient was having left eye twitching for the past week and stomach aches for the past 5 days. The patient had a migraine, headache, light sensitivity, noise sensitivity during the vaccine course (which she never had before). On an unspecified date, the patient had right hip pain. On an unspecified date, she had received two additional doses in her right deltoid since then. She had no symptoms with her shots until last day to the time of this report. She currently still has left deltoid arm pain. It hurts with movement and to the touch. She also has been having left eye twitching for the past week and stomachaches for the past five days. had a migraine about 10 days ago with sound and light intolerance, which she never had before. At the time of this report, the outcome of the events of pain at her initial vaccination site - left deltoid, as well as pain in her left elbow/right hip pain and left lower neck, pain or paresthesia in the wound site, migraine, headache, light sensitivity, noise sensitivity and hip discomfort was unknown. At the time of this report, the patient was not recovered from the events pain at her initial vaccination site - left deltoid, left eye twitching, stomach aches. The reporter assessed the events pain at her initial vaccination site - left deltoid, as well as pain in her left elbow/right hip pain, and left lower neck, pain or paresthesia in the wound site, migraine, headache, light sensitivity, noise sensitivity, left eye twitching, stomach and hip discomfort aches as non-serious and did not provide a causality assessment. No further information was provided. Additional information received on 17-Nov-2025, and on 11-Dec-2025: Additional event details and reference numbers were added.; Sender's Comments: This case concerns a female patient of an unknown age, who experienced non-serious events of neck pain, migraine, photophobia, hyperacusis, blepharospasm, musculoskeletal discomfort, vaccination site paraesthesia, abdominal pain upper, injection site pain, arthralgia and headache, on unspecified date and time, after the patient receiving the dose of RabAvert vaccine, for an indication of exposure to bat. Events vaccination site paraesthesia, injection site pain, arthralgia and headache are listed per CCDS v6 and expected per Regulatory Agency, whilst neck pain, migraine, photophobia, hyperacusis, blepharospasm and musculoskeletal discomfort are unlisted and unexpected. Abdominal pain upper, is listed and unexpected. Patient's medical history and concomitant medication details were not provided. Outcome is not recovered for blepharospasm, injection site pain, abdominal pain upper and unknown for rest. Considering compatible temporal relationship and biological plausibility, for regulatory reporting purposes the causality for the reported events, is assessed as possibly related to suspect. This case is considered as non-serious.
Comments: None.