Sex: F
Vaccine: RAB
Symptoms: Back pain, Decreased appetite, Dizziness, Headache, Incomplete course of vaccination
Clinical narrative: The patient chosen not to get the third rabies vaccination; Headache; Feel dizzy; Nausea; Felt very thirsty; Back pain; Loss of apetite; Case reference number BN-2021-002494, initially downloaded on 06-Dec-2021, is a spontaneous case received from other health professional via health authority (safety report ID: 1854569-1) and concerns a 38-year-old female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On an unspecified date, the patient was vaccinated with the first dose of Rabipur (inactivated rabies virus vaccine; batch number: unknown) at unknown dose or route of administration, for unknown indication.   On 01-Nov-2021, the patient was vaccinated with the second dose of Rabipur (inactivated rabies virus vaccine; batch number: ARBA51YA) at unknown dose, administered intramuscularly in left arm, and for unknown indication.   On the same day, two hours after second vaccination, the patient began to feel dizzy, back pain, headache, nausea, and a loss of appetite. She also felt very thirsty. As reported, the patient went to office visit.  On 03-Nov-2021, three days after, all symptoms resolved.  As reported, the patient had chosen not to get the third dose of Rabipur vaccine (explicitly coded as 'Incomplete course of vaccination').  The case was assessed as non-serious. The reporter assessed the events of 'dizzy', headache, and nausea as related to Rabipur, causality for the events 'increased thirst', 'back pain', 'decreased appetite' was not reported.  No further information was provided.; Reporter's Comments: The 38-year-old female patient experienced non-serious events of headache, dizziness, nausea, thirst, back pain and decreased appetite on the day 0 after the second dose of Rabipur, as reported, 2 hours after the vaccination. The patient had chosen not to get the third dose of Rabipur vaccine, as reported, which is considered as incomplete course of vaccination. Headache, nausea, dizziness and decreased appetite are listed, whilst thirst and back pain are not listed for Rabipur according to the Datasheet V6. Incomplete course of vaccination is considered as listed per convention. The patient had no relevant medical history and was not taking any concomitant medications. The outcome was recovered/resolved. Considering suggestive temporal relationship, absence of confounding factors and since contributory role of the suspect vaccine cannot be excluded, the events of headache, dizziness, nausea, thirst, back pain and decreased appetite have been considered as related to Rabipur. Incomplete course of vaccination has been considered as not related to Rabipur, but to a human action. This case is considered as non-serious.; Sender's Comments: The 38-year-old female patient experienced non-serious events of headache, dizziness, nausea, thirst, back pain and decreased appetite on the day 0 after the second dose of Rabipur, as reported, 2 hours after the vaccination. The patient had chosen not to get the third dose of Rabipur vaccine, as reported, which is considered as incomplete course of vaccination. Headache, nausea, dizziness and decreased appetite are listed, whilst thirst and back pain are not listed for Rabipur according to the Datasheet V6. Incomplete course of vaccination is considered as listed per convention. The patient had no relevant medical history and was not taking any concomitant medications. The outcome was recovered/resolved. Considering suggestive temporal relationship, absence of confounding factors and since contributory role of the suspect vaccine cannot be excluded, the events of headache, dizziness, nausea, thirst, back pain and decreased appetite have been considered as related to Rabipur. Incomplete course of vaccination has been considered as not related to Rabipur, but to a human action. This case is considered as non-serious.