Sex: F
Vaccine: RAB, TTOX
Symptoms: Dizziness, Headache, Inappropriate schedule of product administration, Injection site pain, Malaise
Clinical narrative: HRIG in one thigh, Rabavert in the gluteal muscle, Tetanus shot one thigh, and an antibiotic in the other gluteal muscle; Inappropriate schedule of product administration; Headache; Dizziness; Injection site soreness; General; Case reference number US-BN-2021-002314 is a spontaneous case report initially received from other health professional via Agency (reference ID: USBAV21-0511) on 05-Oct-2021 and concerns a 46-year-old female patient.  The patient's concurrent condition included anxiety disorder, irregular menstruations and chronic migraine without aura.  The patient's concomitant medication details were not provided.   On 22-Sep-2021, the patient was bitten.  On the same day, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number: unknown), in the gluteal muscle, at unknown dose, administrated intramuscularly, for post-exposure (explicitly coded as Vaccine administered at inappropriate site').  On the same day, the patient was vaccinated with co-suspect HRIG (batch number: unknown) and Tetanus vaccine (batch number: unknown), both at an unknown dose and unknown route of administration,  all for unknown indication. The patient was also given co-suspect amoxicillin clavulanate (batch number: unknown), at 875/125 mg dose, twice a day, via unknown route of administration, for unknown indication.  On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise.  *On 23-Sep-2021, the experienced events were resolved.*  On 25-Sep-2021, the patient was vaccinated with the second dose of RabAvert (inactivated rabies virus vaccine; batch number: unknown), in the gluteal muscle, at unknown dose or route of administration for post-exposure. On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The evets were resolved within 24 hours.  On 29-Sep-2021, the patient was vaccinated with the third dose of RabAvert (inactivated rabies virus vaccine; batch number: unknown), in the gluteal muscle, at unknown dose or route of administration for post-exposure. *On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The evets were resolved within 24 hours.*  On 06-Oct-2021, RabAvert vaccines series were repeated, and the patient received a dose of RabAvert  (inactivated rabies virus vaccine; batch number: unknown),  intramuscularly in deltoid muscle, for unknown indication. *On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The evets were resolved within 24 hours.*  On 09-Oct-2021, the patient received another dose of RabAvert  (inactivated rabies virus vaccine; batch number: unknown), intramuscularly in deltoid muscle, for unknown indication. *On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The evets were resolved within 24 hours.*   On 13-Oct-2021, the patient received a dose of RabAvert  (inactivated rabies virus vaccine; batch number: unknown),  intramuscularly in deltoid muscle, for unknown indication. *On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The evets were resolved within 24 hours.*  On 20-Oct-2021, the patient received a dose of RabAvert  (inactivated rabies virus vaccine; batch number: unknown),  intramuscularly in deltoid muscle, for unknown indication ('Inappropriate schedule of vaccine administered'). *On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours.*  The events headache, dizziness, injection site soreness and general malaise, were assessed as non-serious and not related to 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 25-Oct-2021: New information included patient's details (initials and date of birth), confirmation that the patient was bitten, vaccination details (anatomical location, route of administration, Imovax was changed to RabAvert), unspecified antibiotic was amoxicillin clavulanate, the event 'Interchange of vaccine products' was removed and adverse events which the patient experienced were added.  Follow-up information was received from a reporter on 02-Nov-2021: New information included new dates and outcomes of the events.; Reporter's Comments: The 46-year-old female patient was bitten. As reported, on the same day, the patient was vaccinated with the first dose of RabAvert in the gluteal muscle for post-exposure, which is considered product administered at inappropriate site. On the same day, the patient was vaccinated with co-suspect HRIG and Tetanus vaccine all for unknown indication. On the same day, the patient was also given co-suspect amoxicillin clavulanate for unknown indication. Reportedly, on the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. On the next day, all the events were resolved. Three days after, the patient was vaccinated with the second dose of RabAvert in the gluteal muscle for post-exposure, which is considered product administered at inappropriate site. On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. On the day seven, the patient was vaccinated with the third dose of RabAvert in the gluteal muscle for post-exposure, which is considered product administered at inappropriate site. On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. On the day 14, RabAvert vaccines series were repeated, and the patient received a dose of RabAvert for unknown indication. On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. On the day 17, the patient received another dose of RabAvert for unknown indication, which is considered inappropriate schedule of product administration. On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. On the day 21, the patient received a dose of RabAvert and on the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. On the day 28, the patient received a dose of RabAvert for unknown indication. On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. The events of headache, dizziness, vaccination site pain and malaise are listed for RabAvert according to the local SmPC and Global Datasheet V6, while the events of product administered at inappropriate site and inappropriate schedule of product administration are considered listed per convention. The patient's concomitant medication details were not provided. The outcome of the events of headache, dizziness, vaccination site pain and malaise was recovered/resolved. The patient's co-suspect vaccination and medication may have contributed in the development of the events. However, due to suggestive temporal relationship and known vaccine safety profile, the causality for the events of headache, dizziness, vaccination site pain and malaise is assessed as possibly related to the suspect vaccine, as the contributory role of RabAvert cannot be excluded. Product administered at inappropriate site and inappropriate schedule of product administration are not related to the suspect product, but to a human action. This case is considered non-serious.; Sender's Comments: The 46-year-old female patient was bitten. As reported, on the same day, the patient was vaccinated with the first dose of RabAvert in the gluteal muscle for post-exposure, which is considered product administered at inappropriate site. On the same day, the patient was vaccinated with co-suspect HRIG and Tetanus vaccine all for unknown indication. On the same day, the patient was also given co-suspect amoxicillin clavulanate for unknown indication. Reportedly, on the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. On the next day, all the events were resolved. Three days after, the patient was vaccinated with the second dose of RabAvert in the gluteal muscle for post-exposure, which is considered product administered at inappropriate site. On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. On the day seven, the patient was vaccinated with the third dose of RabAvert in the gluteal muscle for post-exposure, which is considered product administered at inappropriate site. On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. On the day 14, RabAvert vaccines series were repeated, and the patient received a dose of RabAvert for unknown indication. On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. On the day 17, the patient received another dose of RabAvert for unknown indication, which is considered inappropriate schedule of product administration. On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. On the day 21, the patient received a dose of RabAvert and on the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. On the day 28, the patient received a dose of RabAvert for unknown indication. On the same day, the patient experienced headache, dizziness, injection site soreness and general malaise. The events were resolved within 24 hours. The events of headache, dizziness, vaccination site pain and malaise are listed for RabAvert according to the local SmPC and Global Datasheet V6, while the events of product administered at inappropriate site and inappropriate schedule of product administration are considered listed per convention. The patient's concomitant medication details were not provided. The outcome of the events of headache, dizziness, vaccination site pain and malaise was recovered/resolved. The patient's co-suspect vaccination and medication may have contributed in the development of the events. However, due to suggestive temporal relationship and known vaccine safety profile, the causality for the events of headache, dizziness, vaccination site pain and malaise is assessed as possibly related to the suspect vaccine, as the contributory role of RabAvert cannot be excluded. Product administered at inappropriate site and inappropriate schedule of product administration are not related to the suspect product, but to a human action. This case is considered non-serious.