Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Fourth dose of RabAvert was given nine days after the first dose (incorrect post exposure schedule); Case reference number US-BN-2022-001702 is a spontaneous case report initially received on 28-Jul-2022 from pharmacist via Communications (reference number: USBAV22-0721) and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was bitten by a groundhog.  On 12-Jul-2022, the patient was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury LEP) (PCEC); batch number: unknown) at a dose reported as 'standard', intramuscularly, at an unknown site of administration, for post-exposure immunisation.   On 15-Jul-2022, three days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch no. unknown) at a dose reported as 'standard', intramuscularly, at an unknown site of administration.  On 19-Jul-2022, seven days after the first dose, the patient was vaccinated with the third dose of RabAvert (batch no. unknown) at a dose reported as 'standard', intramuscularly, at an unknown site of administration.  On 21-Jul-2022, nine days after the first dose, the patient was vaccinated with the fourth dose of RabAvert (batch no. unknown) at a dose reported as 'standard', intramuscularly, at an unknown site of administration, for post-exposure immunisation (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced any adverse event due to RabAvert.  Additional information received on 29-Jul-2022 from included local case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with the first dose of Rabipur after being bitten by groundhog, at dose reported as standard, intramuscularly, at an unknown site of administration, for post-exposure immunisation. Three days after the first dose, the patient was vaccinated with the second dose of RabAvert, at a dose reported as standard, intramuscularly, at an unknown site of administration. Seven days after the first dose, the patient was vaccinated with the third dose of RabAvert at a dose reported as standard, intramuscularly, at an unknown site of administration. Nine days after the first dose, the patient was vaccinated with the fourth dose of RabAvert, at a dose reported as standard, intramuscularly, at an unknown site of administration, for post-exposure immunisation which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. The patient's medical history and concomitant medication details were not provided. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the first dose of Rabipur after being bitten by groundhog, at dose reported as standard, intramuscularly, at an unknown site of administration, for post-exposure immunisation. Three days after the first dose, the patient was vaccinated with the second dose of RabAvert, at a dose reported as standard, intramuscularly, at an unknown site of administration. Seven days after the first dose, the patient was vaccinated with the third dose of RabAvert at a dose reported as standard, intramuscularly, at an unknown site of administration. Nine days after the first dose, the patient was vaccinated with the fourth dose of RabAvert, at a dose reported as standard, intramuscularly, at an unknown site of administration, for post-exposure immunisation which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. The patient's medical history and concomitant medication details were not provided. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.