Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 4 | FDP0052 | IM |
Loss of a sense of smell; Case reference number US-BN-2024-002414 is a spontaneous case initially received from health care professional via Med Communication (reference number: USBAV24-2166) on 29-Aug-2024 and concerns a 65-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 21-Aug-2024, the patient was vaccinated with the first dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration for post exposure from a bat bite. On 24-Aug-2024, three days after the first dose, the patient was vaccinated with the second dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration. On the same day, the patient experienced loss of smell. The patient did not receive any treatment for the event loss of smell. On 28-Aug-2024, seven days after the first dose, the patient was vaccinated with the third dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration. On 04-Sep-2024, 14 days after the first dose, the patient was vaccinated with the fourth dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration. On the same day, the patient recovered from the event loss of smell. The reporter assessed the seriousness of the event loss of smell as non-serious and causality was not provided for the event loss of smell. Additional information received from health care professional via Med Communication (reference number: USBAV24-2238) on 04-Sep-2024: Information included reference number (USBAV24-2238), Rabipur dosage information and updated outcome for the event of loss of smell.; Reporter's Comments: A 65-year-old male patient experienced a non-serious event of loss of smell on the day 0 after the patient was vaccinated with the second dose of Rabavert for post exposure from a bat bite. Anosmia is unlisted and unexpected for RabAvert. The patient's medical history and concomitant medication details were not provided. The patient recovered from the event. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of anosmia is considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: A 65-year-old male patient experienced a non-serious event of loss of smell on the day 0 after the patient was vaccinated with the second dose of Rabavert for post exposure from a bat bite. Anosmia is unlisted and unexpected for RabAvert. The patient's medical history and concomitant medication details were not provided. The patient recovered from the event. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of anosmia is considered as related to RabAvert. This case is considered as non-serious.
Comments: None.