Sex: F
Vaccine: RAB
Symptoms: Chest pain, Inflammation, Product dose omission issue
Clinical narrative: Chest pain; A probable Inflammation; Second dose was missing; Case reference number US-BN-2022-004807 is a spontaneous case initially received on 30-Nov-2022 from a nurse via Communication (reference number: USBAV22-2030) and concerns *33-year-old* female patient.  The patient's medical history and concomitant medications were not provided.  On 23-Nov-2022, the patient was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury LEP) (PCEC); batch number: unknown) at an unknown dose, route or site of administration, for pre-exposure to rabies (active immunization).  On an unspecified date, on an unspecified amount of time after the first RabAvert dose, it was reported that the patient was seen in urgent care for chest pain, without diagnosis, and by a cardiologist where it seemed to be a probable inflammation. Patient was prescribed with corticosteroids (prednisolone) for five days. It was reported that patient didn't start using them yet.  As reported, the nurse stated that the question was asked whether the second dose should be delayed and when patient can receive the next dose. *The second dose was not administered* (explicitly coded as 'missed dose').  At the time of reporting, the outcome of events 'chest pain' and 'inflammation' was unknown.  The reporter assessed the event of 'chest pain' and 'inflammation' as non-serious and *not related to the product*.  Additional information received on 01-Dec-2022 included the local ID number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received on 19-Dec-2022 from a nurse: New information included details about the patient, causality assessment for adverse events and confirmation that the second dose of RabAvert was missed.; Reporter's Comments: A 33-year-old female patient was vaccinated with first dose of Rabipur at an unknown dose, route or site of administration, for pre-exposure to Rabies (active immunization). Within a week after the first Rabipur dose, it's reported that the patient was seen in urgent care for chest pain, without diagnosis, and by cardiologist where it seems to be probable inflammation. Reportedly, the second dose was not administered, which is considered as product dose omission issue. Chest pain and inflammation are unlisted for Rabipur according to guidelines, whilst product dose omission issue is listed per company convention. The patient's medical history and concomitant medications were not provided. Due to plausible temporal relationship, lack of alternative explanation and since contributory role of the suspect product cannot be fully excluded, chest pain and inflammation are both assessed as related. Product dose omission issue is not related to Rabipur, but to a human factor. The case is non-serious.; Sender's Comments: A 33-year-old female patient was vaccinated with first dose of Rabipur at an unknown dose, route or site of administration, for pre-exposure to Rabies (active immunization). Within a week after the first Rabipur dose, it's reported that the patient was seen in urgent care for chest pain, without diagnosis, and by cardiologist where it seems to be probable inflammation. Reportedly, the second dose was not administered, which is considered as product dose omission issue. Chest pain and inflammation are unlisted for Rabipur according to guidelines, whilst product dose omission issue is listed per company convention. The patient's medical history and concomitant medications were not provided. Due to plausible temporal relationship, lack of alternative explanation and since contributory role of the suspect product cannot be fully excluded, chest pain and inflammation are both assessed as related. Product dose omission issue is not related to Rabipur, but to a human factor. The case is non-serious.