Sex: F
Vaccine: RAB
Symptoms: Antibody test abnormal
Clinical narrative: The patient experienced a titer drawn, a titer was not sufficient amount; Case reference number BN-2022-000891 is a spontaneous case report initially received from a physician via Communication (reference number: USBAV22-0117) on 05-Apr-2022 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 15-Sep-2021, the patient was vaccinated with the first dose of Rabipur (rabies virus (inactivated, strain flury LEP) (PCEC); batch number: unknown), intramuscularly, at an unknown dose or site of administration, for pre exposure.  On 22-Sep-2021, seven days after the first dose, the patient was vaccinated with the second dose of Rabipur (batch number: unknown), intramuscularly, at an unknown dose or site of administration.  On 06-Oct-2021, 21 days after the first dose, the patient was vaccinated with the third dose of Rabipur (batch number: unknown), intramuscularly, at an unknown dose or site of administration.  On an unspecified date, reported as last month, the patient experienced a titer drawn, a titer was not sufficient amount. The patient was informed that should be covered for 2 years.   At the time of this report, the outcome for the event antibody test abnormal was unknown.  Seriousness and causality assessment were not provided for the event.  Additional information received on 06-Apr-2022 included the local case ID.; Reporter's Comments: A female patient of unknown age experienced a non-serious event of antibody test abnormal, an unknown amount of time after the patient was vaccinated with 3 doses of Rabipur for pre exposure, as reported. The event of antibody test abnormal is not listed for Rabipur according to the Datasheet v6. Time-to-onset was not provided, therefore, chronology needs more clarification. The patient's medical history and concomitant medication details were not provided. Reportedly, the outcome for the event antibody test abnormal was unknown. Considering the absence of confounding factors and since the contributory role of the suspect vaccine cannot be excluded with certainty, at this moment, the event of antibody test abnormal has been conservatively considered as related to the suspect vaccine. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age experienced a non-serious event of antibody test abnormal, an unknown amount of time after the patient was vaccinated with 3 doses of Rabipur for pre exposure, as reported. The event of antibody test abnormal is not listed for Rabipur according to the Datasheet v6. Time-to-onset was not provided, therefore, chronology needs more clarification. The patient's medical history and concomitant medication details were not provided. Reportedly, the outcome for the event antibody test abnormal was unknown. Considering the absence of confounding factors and since the contributory role of the suspect vaccine cannot be excluded with certainty, at this moment, the event of antibody test abnormal has been conservatively considered as related to the suspect vaccine. This case is considered as non-serious.