Sex: F
Vaccine: RAB, UNK
Symptoms: Headache, Interchange of vaccine products, Peripheral swelling, Pyrexia
Clinical narrative: Arm got swollen; Low grade headache; Fever; Patient received RabAvert and Imovax; Case reference number US-BN-2022-004640 is a spontaneous case report initially received from a consumer (reference number: 2022SA398011) on 08-Nov-2022 and concerns an adult female patient.  The patient's medical history was not provided.  The patient's concomitant medication included diphenhydramine hydrochloride, anti-allergy medicine, nasal spray and corticosteroids.  On 22-Aug-2022, the patient started a vaccination series with RabAvert (rabies virus (inactivated, strain flury lep), batch number: unknown) and Imovax (rabies vaccine). The patient received four doses, all at an unknown dose or route of administration, for unknown indication (explicitly coded as 'interchange of vaccine products').  As reported, after the first two doses, the patient did not experience any adverse events.  On an unspecified date, an unknown amount of time after the vaccination, the patient developed headache, arm got swollen and fever.  On an unspecified date, the patient recovered from the events.  The reporter assessed the events as non-serious and related to RabAvert.   No further information was provided.; Reporter's Comments: An adult female patient started a vaccination series with RabAvert and Imovax (rabies vaccine). The patient received four doses, all at an unknown dose or route of administration, for unknown indication, which is considered as interchange of vaccine products. On an unspecified date, an unknown amount of time after the vaccination, the patient developed headache, arm got swollen and fever. Pyrexia and headache are listed, whilst peripheral swelling is unlisted for Rabipur according to datasheet and insert. Interchange of vaccine product is listed per company convention. The patient's medical history was not provided, and concomitant medication included diphenhydramine hydrochloride, anti-allergy medicine, nasal spray and corticosteroids. Having in mind the lack of information on onset date of the events, dates of vaccinations, circumstances surrounding the events and patient's medical history, the evaluation did not find enough evidence at this point to exclude a causal relationship between RabAvert and none of the reported events, therefore the causality is assessed conservatively as related to RabAvert. Interchange of vaccine product is assessed as not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: An adult female patient started a vaccination series with RabAvert and Imovax (rabies vaccine). The patient received four doses, all at an unknown dose or route of administration, for unknown indication, which is considered as interchange of vaccine products. On an unspecified date, an unknown amount of time after the vaccination, the patient developed headache, arm got swollen and fever. Pyrexia and headache are listed, whilst peripheral swelling is unlisted for Rabipur according to datasheet and insert. Interchange of vaccine product is listed per company convention. The patient's medical history was not provided, and concomitant medication included diphenhydramine hydrochloride, anti-allergy medicine, nasal spray and corticosteroids. Having in mind the lack of information on onset date of the events, dates of vaccinations, circumstances surrounding the events and patient's medical history, the evaluation did not find enough evidence at this point to exclude a causal relationship between RabAvert and none of the reported events, therefore the causality is assessed conservatively as related to RabAvert. Interchange of vaccine product is assessed as not related to RabAvert, but to a human factor. The case is non-serious.