Sex: F
Vaccine: RAB
Symptoms: Anxiety, Extra dose administered
Clinical narrative: Caller is worried about the vaccine she received and if they are going to be covered; When we initially got the vaccine for post exposure we got 4 injections; Case reference number US-BN-2021-002326 is a spontaneous case report initially received from a consumer via regulatory authority (reference number: USBAV21-0514) on 7-Oct-2021 and concerns a female patient born in 1969.   The patients' medical history and concomitant medication details were not provided.  On unspecified date, reported as a couple of years ago, the patient was vaccinated with the first dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided) at unknown dose, at unknown route or site of administration, for post-exposure prophylaxis.  On unspecified date, reported as a couple of years ago, the patient was vaccinated with the second dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided) at unknown dose, at unknown route or site of administration, for post-exposure prophylaxis.  On unspecified date, reported as a couple of years ago, the patient was vaccinated with the third dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided) at unknown dose, at unknown route or site of administration, for post-exposure prophylaxis.  On unspecified date, reported as a couple of years ago, the patient was vaccinated with the fourth dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided) at unknown dose, at unknown route or site of administration, for post-exposure prophylaxis (Incomplete course of vaccination).  On 01-Oct-2021, the patient was vaccinated with the booster dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided) at a dose reported as one vaccine per dose, at unknown route or site of administration, for post-exposure prophylaxis.  On 04-Oct-2021, the patient was vaccinated with the booster dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided) at a dose reported as one vaccine per dose, at unknown route or site of administration, for post-exposure prophylaxis.  The reporter stated that she was worried about the administered vaccines. The reporter stated that she was initially administered with only four injections for post exposure. It was reported that the four injections were administered a couple of years ago. (explicitly coded as Incomplete course of vaccination).   The reporter also stated that she received two booster doses, first on 01-Oct-2021 and second on 04-Oct-2021. The reporter stated that the second booster vaccine was a little pink prior to administration.  At the time of this report, outcome of the event of anxiety is unknown.  The reporter assessed the case as not related to RabAvert vaccine.  The reporter did not provide seriousness criteria.  This case is linked with US-BN-2021-002327 (same reporter).  Minor case correction was performed on 14-Oct-2021 included the BN local case ID: BN_2021_00113.  No further information was provided.; Reporter's Comments: A female patient born in 1969 was vaccinated with four doses of RabAvert couple years ago (post exposure) which is considered incomplete course of vaccination per the PI and is listed by convention. Anxiety is unlisted and unexpected for RabAvert as per datasheet and the PI. The patient received two booster doses for post exposure prophylaxis three days prior to reporting and she was worried about the administered vaccines and if she is going to be covered. No information regarding concomitant medications and medical history was provided. Anxiety and incomplete course of vaccination have been considered not related to the suspect product.; Sender's Comments: A female patient born in 1969 was vaccinated with four doses of RabAvert couple years ago (post exposure) which is considered incomplete course of vaccination per the PI and is listed by convention. Anxiety is unlisted and unexpected for RabAvert as per datasheet and the PI. The patient received two booster doses for post exposure prophylaxis three days prior to reporting and she was worried about the administered vaccines and if she is going to be covered. No information regarding concomitant medications and medical history was provided. Anxiety and incomplete course of vaccination have been considered not related to the suspect product.