Sex: M
Vaccine: RAB
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Second Rabavert dose administered 20 days after the initial dose; The patient got day zero dose of Rabavert, later tested positive for COVID-19 and was not able to get day seven dose; Case reference number BN-2022-001013 is a spontaneous case report initially received on 05-May-2022 from a health care professional via Communication (reference number: USBAV22-0165) and concerns a 24-year-old male patient.  The patient had no medical history.  The patient's concomitant medication details were not provided.  On 27-Apr-2022, the patient was vaccinated with the first dose of Rabavert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC), batch number: YRBA821A), at a dose of 2.5 of rabies antigen (1 mL), intramuscularly, in the left deltoid for pre-exposure immunisation.  On 04-May-2022, seven days after the first dose, the patient was tested positive for COVID-19.  On 11-May-2022, the patient recovered from the event of 'COVID-19'.  *On 17-May-2022, 20 days after the initial dose, the patient was vaccinated with the second dose of Rabavert (batch number: YRBA821A), at a dose of 1 mL, intramuscularly, in the left deltoid region (explicitly coded as 'inappropriate schedule of vaccine administered').*  The reporter assessed the event 'COVID-19' as non-serious and did not provide causality assessment.  All follow up information are blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information was received from a nurse on 13-May-2022: New information included patient's age and medical history, dosage regimen for the first dose, information regarding the second dose, start and end date and outcome for the event of 'COVID-19'.  Follow up information was received from a nurse on 23-May-2022: New information included the second RabAvert dose details.; Reporter's Comments: A 24-year-old male patient was vaccinated with the first dose of RabAvert for pre-exposure immunization, and on the day 7 after the vaccination, the patient was tested positive for COVID-19. Reportedly, on the day 20 after the first dose, the patient was vaccinated with the second dose of Rabavert, which is considered as inappropriate schedule of vaccine administered. COVID-19 is unlisted for RabAvert according to datasheet version 6.0, whilst inappropriate schedule of vaccine administered is considered as listed per company convention. The patient had no medical history and concomitant medication details were not provided. Reportedly, the patient recovered from the event. Considering pathophysiology of COVID-19, there is not enough evidence to suggest a reasonable possibility of a causal relationship between this event and RabAvert, therefore causality is assessed as not related. Inappropriate schedule of vaccine administered is also not related to Rabipur, but to a human factor. The case is considered as non-serious.; Sender's Comments: A 24-year-old male patient was vaccinated with the first dose of RabAvert for pre-exposure immunization, and on the day 7 after the vaccination, the patient was tested positive for COVID-19. Reportedly, on the day 20 after the first dose, the patient was vaccinated with the second dose of Rabavert, which is considered as inappropriate schedule of vaccine administered. COVID-19 is unlisted for RabAvert according to datasheet version 6.0, whilst inappropriate schedule of vaccine administered is considered as listed per company convention. The patient had no medical history and concomitant medication details were not provided. Reportedly, the patient recovered from the event. Considering pathophysiology of COVID-19, there is not enough evidence to suggest a reasonable possibility of a causal relationship between this event and RabAvert, therefore causality is assessed as not related. Inappropriate schedule of vaccine administered is also not related to Rabipur, but to a human factor. The case is considered as non-serious.