Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 4 | FDP00552 | IM / LA |
Potential viral meningitis; Tightness of the neck; Headache that wraps around the front; Light headed; Case reference number US-BN-2024-002579 is a spontaneous case initially received from a pharmacist via Communications (reference number: USBAV24-2574) on 01-Oct-2024 and concerns a 45-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was exposed to a bat with a bite. As reported, the patient was asleep in his yard and woke up with a bat on his arm. The patient sought medical care two days post the exposure because a neighbor reported a bat at their home tested positive for rabies. On an unspecified date, unknown amount of time after exposure to the bat, the patient was vaccinated with the first, second and third dose of RabAvert (batch number: FDP00552, expiry date: 30-Nov-2027), at a dose of one milliliter, intramuscularly in left deltoid, for post exposure. On 20-Sep-2024, unknown amount of time after exposure to the bat, the patient was vaccinated with the fourth dose of RabAvert (batch number: FDP00552, expiry date: 30-Nov-2027), at a dose of one milliliter, intramuscularly in left deltoid. On the same day, reported as almost immediately after receiving the fourth dose of RabAvert, the patient felt light headed. On unspecified date, unknown amount of time after receiving the fourth dose of RabAvert, the patient experienced headache that wraps around the front, lasting for over a week, compounded with the tightness of the neck. On unspecified date, the patient visited primary care physician, and it was thought that patient potentially developed viral meningitis. The patient was prescribed with ivermectin. At the time of the initial report, the outcome for the events of viral meningitis, tightness of the neck, light headed and headache was unknown. The reporter assessed the events of viral meningitis, tightness of the neck, light headed and headache as non-serious, however additionally the event of viral meningitis was assessed as serious due to criteria of medical significance. Causality assessment for the same events was not provided. Non-significant case correction received from Manufacturer on 14-Oct-2024 included: new reference number. Non-significant case correction identified on 04-Nov-2024 included: new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20241001-f1244b to US-BAVARIAN NORDIC A/S-US-BN-2024-002579, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 45-year-old male patient experienced a non-serious event of lightheaded on the day 0 after the patient was vaccinated with the fourth dose of RabAvert for post exposure. On unspecified date, an unknown amount of time after receiving the fourth dose of RabAvert, the patient experienced non-serious events of headache with the tightness of the neck. Reportedly, the patient visited primary care physician, and it was thought that patient potentially developed a serious event of viral meningitis (medical significance). Headache and dizziness are listed and expected for RabAvert per CCDS v4 and USPI, whilst meningitis viral and muscle tightness are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the events of headache, dizziness and muscle tightness are considered as related to RabAvert. Meningitis viral is not related to the suspect vaccine. This case is considered as non-serious.; Sender's Comments: A 45-year-old male patient experienced a non-serious event of lightheaded on the day 0 after the patient was vaccinated with the fourth dose of RabAvert for post exposure. On unspecified date, an unknown amount of time after receiving the fourth dose of RabAvert, the patient experienced non-serious events of headache with the tightness of the neck. Reportedly, the patient visited primary care physician, and it was thought that patient potentially developed a serious event of viral meningitis (medical significance). Headache and dizziness are listed and expected for RabAvert per CCDS v4 and USPI, whilst meningitis viral and muscle tightness are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the events of headache, dizziness and muscle tightness are considered as related to RabAvert. Meningitis viral is not related to the suspect vaccine. This case is considered as non-serious.
Comments: None.