Sex: F
Vaccine: RAB
Symptoms: Illness, Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Got sick; Was supposed to get day 28 today, but she called and she cannot make it in today; She got day 1 and day 7 vaccines; Case reference number US-BN-2021-002433 is a spontaneous case report initially received from other health professional (nurse) via regulatory authority (reference number USBAV21-0580) on 16-Nov-2021 and concerns a 20-year-old female patient.  The patients' medical history and concomitant medication details were not provided.  On an unspecified dates, reported also on day one and day seven, the patient was vaccinated with the first two doses of RabAvert (inactivated rabies virus vaccine; batch number was not provided), at a dosage described as standard, administered intramuscularly, for pre-exposure due to future working with animals (explicitly coded as 'Inappropriate schedule of vaccine administered').  On an unspecified date, an unknown amount of time after administration with Rabipur, the patient got sick.  On an unspecified date, the patient was supposed to get the third dose on day 28 (today) but the patient called and said that she will not be able to make it in today (explicitly coded as 'Missed dose').   At the time of this report, the outcome of the event sickness was unknown.  The reporter did not provide seriousness assessment. The reporter assessed the event sickness as not related to the RabAvert vaccine.  No further information was provided.; Reporter's Comments: The 20-year-old female patient was vaccinated with the first two doses of RabAvert for pre-exposure, reported as on day one and day seven, which is considered as inappropriate schedule of product administration. As reported, on an unspecified date, an unknown amount of time after administration of RabAvert, the patient experienced the non-serious event of illness. Time-to-onset of the event of illness was not provided, and temporal relationship needs more clarification. Reportedly, the patient was supposed to get the third dose on day 28, but the patient called, and said that she will not be able to make it, which is considered as product dose omission issue. The event of illness is not listed for RabAvert according to the PI and Datasheet, whilst the events of inappropriate schedule of product administration and product dose omission issue are considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The outcome of the event of illness was unknown. Despite the absence of the time-to-onset of the event, at the moment, the event of illness has been considered as related to RabAvert, considering the absence of confounding factors, and since contributory role of RabAvert cannot be excluded with certainty. The events of inappropriate schedule of product administration and product dose omission issue have been considered as not related to RabAvert, but to a human action. This case is considered as non-serious.; Sender's Comments: The 20-year-old female patient was vaccinated with the first two doses of RabAvert for pre-exposure, reported as on day one and day seven, which is considered as inappropriate schedule of product administration. As reported, on an unspecified date, an unknown amount of time after administration of RabAvert, the patient experienced the non-serious event of illness. Time-to-onset of the event of illness was not provided, and temporal relationship needs more clarification. Reportedly, the patient was supposed to get the third dose on day 28, but the patient called, and said that she will not be able to make it, which is considered as product dose omission issue. The event of illness is not listed for RabAvert according to the PI and Datasheet, whilst the events of inappropriate schedule of product administration and product dose omission issue are considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The outcome of the event of illness was unknown. Despite the absence of the time-to-onset of the event, at the moment, the event of illness has been considered as related to RabAvert, considering the absence of confounding factors, and since contributory role of RabAvert cannot be excluded with certainty. The events of inappropriate schedule of product administration and product dose omission issue have been considered as not related to RabAvert, but to a human action. This case is considered as non-serious.