Sex: M
Vaccine: RAB
Symptoms: Anxiety, Product administration error
Clinical narrative: They have used a longer needle for RabAvert vaccination; Anxious; Case reference number US-BN-2022-001570 is a spontaneous case report initially received on 15-Jul-2022 from a consumer (reference number: USBAV22-0566) and concerns an adult male patient.  The patient's medical history was not reported.  The patient's concomitant medication included immunoglobulin.  On 08-Jul-2022, the patient was vaccinated with the first dose of Rabavert (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown), at a dose reported as standard, administered intramuscularly at an unknown region, for rabies post-exposure immunization.  On 11-Jul-2022, three days after the first dose, the patient was vaccinated with the second dose of Rabavert (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown), at a dose reported as standard, administered intramuscularly at an unknown region, for rabies post-exposure immunization.  On 15-Jul-2022, seven days after the first dose, the patient was vaccinated with the third dose of Rabavert (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown), at a dose reported as standard, administered intramuscularly at an unknown region, for rabies post-exposure immunization.  On an unspecified date in Jul-2022, after one of the vaccines, the patient was feeling anxious about the needle used during the vaccination because it seemed bigger than usual and stated that the longer needle for mixing the medication was used instead of a shorter one for injecting (explicitly coded as 'Product administration error').  At the time of this report, the outcome for the event of 'anxious' was not provided. No treatment was given for the event.  The reporter did not provide seriousness and causality assessment.  Additional information received on 18-Jul-2022 included local case ID.  Additional information received on 18-Jul-2022 included confirmation that the vaccine was not defected and that the case was not a PQC.; Reporter's Comments: An adult male patient was vaccinated with three doses of Rabavert administered intramuscularly at an unknown region, for rabies post-exposure immunization. After one of the vaccines, the patient was feeling anxious about the needle used during the vaccination because it seemed bigger than usual and stated that the longer needle for mixing the medication was used instead of a shorter one for injecting, which is considered as product administration error. Anxiety is unlisted for Rabipur according to datasheet, whilst product administration error is listed per company convention. The patient's medical history was not reported and concomitant medication included immunoglobulin. Having in mind that it is reported that patient felt anxiety because of the needle, the causality for this reported event is assessed as not related to Rabavert. Product administration error is not related to Rabavert as well, but to a human factor. The case is non-serious. Sender's Comments: An adult male patient was vaccinated with three doses of Rabavert administered intramuscularly at an unknown region, for rabies post-exposure immunization. After one of the vaccines, the patient was feeling anxious about the needle used during the vaccination because it seemed bigger than usual and stated that the longer needle for mixing the medication was used instead of a shorter one for injecting, which is considered as product administration error. Anxiety is unlisted for Rabipur according to datasheet, whilst product administration error is listed per company convention. The patient's medical history was not reported and concomitant medication included immunoglobulin. Having in mind that it is reported that patient felt anxiety because of the needle, the causality for this reported event is assessed as not related to Rabavert. Product administration error is not related to Rabavert as well, but to a human factor. The case is non-serious.