Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: She had gotten Covid; One of them receive the D0 shot on 27th and she was supposed to come in today, but she cancelled; Feeling sick; Case reference number US-BN-2021-002145 is a spontaneous case report initially received on 03-Aug- 2021 from a health professional via regulatory authority (reference number: USBAV21-0394) and concerns a female patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On 27-Jul-2021, reported as day zero, the patient was vaccinated with first dose of RabAvert (inactivated Rabis Virus Vaccine, batch number: not provided) at an unknown dose or route of administration and for pre-exposure.  On an unspecified date in 2021 an unknown amount of time after receiving the first vaccination, the patient felt sick.  On 03-Aug-2021, one week after the first vaccination, the patient cancelled the scheduled second vaccination because she was feeling sick (explicitly coded as 'Incomplete course of vaccination').    *On an unspecified date, the patient developed COVID-19.*  The outcome of the events was not reported.   The reporter did not provide the seriousness and causality assessment for the event 'feeling sick'. *The reporter did not provide seriousness assessment for the event COVID-19, but assessed the event as not related to the RabAvert vaccine.*  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information was received from a reporter on 08-Sep-2021: New information included one additional event and causality assessment for this event.; Reporter's Comments: Malaise is listed for RabAvert per PI and Prescriber Information, COVID-19 is unlisted for RabAvert per PI and Prescriber Information and incomplete course of vaccination is listed per convention. Reportedly, the patient was feeling sick after vaccination with first dose of suspect vaccine, and the patient cancelled the second dose, which is considered incomplete course of vaccination. On an unspecified date, the patient developed COVID-19. No information regarding concomitant and co-suspect medication and medical history was provided. Based on provided information causality between suspect product and event malaise is assessed as possibly related. Due to lack of information and missing evidence for temporal causal relationship between the suspect drug and the reported event, the causality for the event of COVID-19 is not related. Reported event incomplete course of vaccination is not related to suspect vaccine, but to human action. The case is considered as non-serious.; Sender's Comments: Malaise is listed for RabAvert per PI and Prescriber Information, COVID-19 is unlisted for RabAvert per PI and Prescriber Information and incomplete course of vaccination is listed per convention. Reportedly, the patient was feeling sick after vaccination with first dose of suspect vaccine, and the patient cancelled the second dose, which is considered incomplete course of vaccination. On an unspecified date, the patient developed COVID-19. No information regarding concomitant and co-suspect medication and medical history was provided. Based on provided information causality between suspect product and event malaise is assessed as possibly related. Due to lack of information and missing evidence for temporal causal relationship between the suspect drug and the reported event, the causality for the event of COVID-19 is not related. Reported event incomplete course of vaccination is not related to suspect vaccine, but to human action. The case is considered as non-serious.