Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00447 | IM / LA |
The patient receive the second dose of RabAvert on day 8 due to disease; The patient was sick with fever, described as viral illness; The patient was sick with fever, described as viral illness; Case reference number US-BN-2024-002277 is a spontaneous case initially received from nurse via Communication (reference number USBAV24-1827) on 31-Jul-2024 and concerns a 6-year-old child male patient born. The patient's medical history and concomitant medication were not reported. On 24-Jul-2024, reported as week ago, the patient received the first dose of RabAvert (batch number: FDP00447, expiration date: 30-Nov-2025), at a dose of 0.5 cc, administered intramuscular at left deltoid, for pre-exposure vaccination. On 27-Jul-2024, reported as three to four days after first vaccination the patient experienced moderate fever, which patient's mother described as viral illness. As reported, no laboratory test or investigation were performed because fever. On an unspecified date, the patient was sick with fever. On 30-Jul-2024, the patient recovered from moderate fever and *viral infection.* On 01-Aug-2024, eight days after first dose of RabAvert, patient received the second dose of RabAvert (batch number: FDP00555, expiration date: 30-Sep-2027), at a dose of 0.5 cc, administered intramuscular at left deltoid (explicitly coded as 'Inappropriate schedule of vaccine administered'). As reported, the patient did not receive second dose of RabAvert vaccine on scheduled date due do disease and second dose was delayed by one day. As reported, there were no complications during recovery from the events of 'fever' and 'viral infection'. *As reported, none of other medications were reported by patient's parent at the time of the events of viral infection and fever or two weeks before the events started.* The reporter assessed the events 'viral infection' and 'fever' as non-serious and causality assessment for the events 'viral infection' and 'fever' was reported as not related. The case is linked to case ID US-BN-2024-002276 due to same report and family member. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Additional information received from a nurse on 01-Aug-2024: included reference number (US-20240731-20bdca). Follow up information received from the reporter on 13-Aug-2024, new information included: patient's details, RabAvert dosing information for the first and second dose, stop date and outcome for the event of 'fever', clarification that the event of 'sickness' was described as viral illness (event recoded to PT: Viral infection), outcome for the event of 'viral infection', causality assessment for the events of 'fever' and 'viral infection' and confirmation that no laboratory test or investigation were performed due to moderate fever. Follow up information received from the reporter on 28-Aug-2024: New information included start and stop date for event of viral infection and confirmation that none of other medications were reported at the time of the events of viral infection and fever or two weeks before the events started.; Reporter's Comments: A 6-year-old male child experienced fever, three days after the first dose of RabAvert. This was described to be associated with a viral illness. The patient's second dose was delayed by one day, which is considered inappropriate schedule of vaccine administered. Viral infection is unlisted and unexpected, whereas fever is listed and expected per CCDS v4.0 and USPI for RabAvert. Inappropriate schedule of product administration is considered listed per company convention. The patient recovered. The patient's medical history and concomitant medication were not reported. The viral infection and pyrexia are assessed as unrelated to RabAvert, but to an unspecified viral disease in this pediatric patient. Inappropriate schedule of product administration is assessed as not related to suspect product, but to human factors. The case is non-serious.; Sender's Comments: A 6-year-old male child experienced fever, three days after the first dose of RabAvert. This was described to be associated with a viral illness. The patient's second dose was delayed by one day, which is considered inappropriate schedule of vaccine administered. Viral infection is unlisted and unexpected, whereas fever is listed and expected per CCDS v4.0 and USPI for RabAvert. Inappropriate schedule of product administration is considered listed per company convention. The patient recovered. The patient's medical history and concomitant medication were not reported. The viral infection and pyrexia are assessed as unrelated to RabAvert, but to an unspecified viral disease in this pediatric patient. Inappropriate schedule of product administration is assessed as not related to suspect product, but to human factors. The case is non-serious. USBAV24-1827:
Comments: None