Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | Unknown | — |
The patient was getting the second dose of RabAvert one day late (on April 15th), three days after first dose; The patient received only two doses of RabAvert; Case reference number US-BN-2025-000837 is a spontaneous case initially received from nurse via Med Communication (reference number: USBAV25-0834) on 15-Apr-2025 and concerns a *22-years-old* female patient. The patient's medical history and concomitant medication details were not provided. On 11-Apr-2025, the patient was bitten by dog. On the same day, the patient received the first dose of RabAvert (reported as rabies vaccine) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for indication post-exposure. As reported, the patient started treatment at the emergency room (ER). On 15-Apr-2025, four days after the exposure to dog bite, as reported one day late, the patient received the second dose of RabAvert (reported as rabies vaccine) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00530 and expiration date: 30-Dec-2027), at a dose of 1 ml, intramuscularly in the left deltoid (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the patient did not show for the scheduled follow-up appointments and received only two doses of RabAvert (explicitly coded as 'incomplete course of vaccination'). At the time of the follow-up report, the patient did not experience any of adverse events due to RabAvert. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a nurse on 01-May-2025: New information included RabAvert dosing details, post-exposure details, and confirmation that the patient did not show for the scheduled follow-up appointments, received only two doses of RabAvert and patient did not experience any of adverse events due to RabAvert. Follow up information received from a nurse on 13-May-2025: New information included patient demographics.; Reporter's Comments: This case concerned a 22-years-old female patient, who had received the first dose of RabAvert vaccine, on the same day for an indication of post-exposure. Reportedly, four days after first dose (one day late), the patient received the second dose of RabAvert which is considered as inappropriate schedule of product administration. Reportedly, the patient did not show for the scheduled follow-up appointments and received only two doses of RabAvert which is considered as incomplete course of vaccination. At this point the patient did not experience any of adverse events due to RabAvert. Inappropriate schedule of product administration and incomplete course of vaccination are both considered listed as per company convention. The patients' medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and incomplete course of vaccination are both assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerned a 22-years-old female patient, who had received the first dose of RabAvert vaccine, on the same day for an indication of post-exposure. Reportedly, four days after first dose (one day late), the patient received the second dose of RabAvert which is considered as inappropriate schedule of product administration. Reportedly, the patient did not show for the scheduled follow-up appointments and received only two doses of RabAvert which is considered as incomplete course of vaccination. At this point the patient did not experience any of adverse events due to RabAvert. Inappropriate schedule of product administration and incomplete course of vaccination are both considered listed as per company convention. The patients' medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and incomplete course of vaccination are both assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None