Sex: F
Vaccine: RAB
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: Second dose of Rabavert administred 108 days after the first dose since the patient was ill; Second dose of Rabavert administred 108 days after the first dose since the patient was ill; Case reference number US-BN-2022-001675 is a spontaneous case report initially received on 27-Jul-2022 from a health professional from via Communication (reference number: USBAV22-0702) and concerns an adult female patient born in 1982.  The patient's medical history and concomitant medication details were not provided.  On 10-Apr-2022, the patient was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury lep) (pcec); batch number: YRBAA31A), at unknown dose, via unknown route of administration, for unknown indication.  On an unspecified date, an unknown amount of time after the vaccination, the patient was ill.  On 27-Jul-2022, 108 days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: YRBAA31B), at unknown dose, via unknown route of administration, for unknown indication (explicitly coded as 'inappropriate schedule of product administration').  At the time of this report, the outcome of the event 'illness' was unknown.  The reporter did not provide seriousness and causality assessment for the event 'illness'.  Additional information received on 28-Jul-2022 included local case ID.; Reporter's Comments: An adult female patient born in 1982 was vaccinated with the first dose of RabAvert, at unknown dose, via unknown route of administration, for unknown indication and experienced illness unknown time after the vaccination. 108 days after the first dose, the patient was vaccinated with the second dose of RabAvert, at unknown dose, via unknown route of administration, for unknown indication which is considered as inappropriate schedule of vaccine administered. Illness is considered listed according to guidelines for Rabies, Inactivated, Whole Virus Vaccine while inappropriate schedule of product administration is considered listed per company conventions. At this point, the outcome of the event illness was unknown. The patient's medical history and concomitant medication details were not provided. Considering the known product safety profile and since contributory role of the suspect product cannot be fully excluded, causality is assessed as related for the event illness. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult female patient born in 1982 was vaccinated with the first dose of RabAvert, at unknown dose, via unknown route of administration, for unknown indication and experienced illness unknown time after the vaccination. 108 days after the first dose, the patient was vaccinated with the second dose of RabAvert, at unknown dose, via unknown route of administration, for unknown indication which is considered as inappropriate schedule of vaccine administered. Illness is considered listed according to guidelines for Rabies, Inactivated, Whole Virus Vaccine while inappropriate schedule of product administration is considered listed per company conventions. At this point, the outcome of the event illness was unknown. The patient's medical history and concomitant medication details were not provided. Considering the known product safety profile and since contributory role of the suspect product cannot be fully excluded, causality is assessed as related for the event illness. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.