Sex: F
Vaccine: RAB, RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: encephalitis; could not sleep and was up all night; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; she couldn't differentiate between her purse and the seatbelt, showing altered mental status; patient began to be disoriented, dizzy and was feeling unwell; patient started not eating well; adverse reaction to a rabies vaccine; patient began to be disoriented, dizzy and was feeling unwell; patient began to be disoriented, dizzy and was feeling unwell; Patient received RabAvert vaccine right above glutes; Case reference number US-BN-2025-001372 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-1919) on 06-Aug-2025 and concerns an 82-year-old female.  The patient's medical history included a Waldenstrom's. The patient was reported to be immunocompromised.   The patient's concomitant medication details were not provided.  On 25-Jul-2025, the patient received RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683) right above her glutes, at an unknown dose or route of administration for an unknown indication. (explicitly coded as 'Product administered at inappropriate site')  On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient experienced a likely adverse reaction.  On unspecified date, reported as two days after vaccination with RabAvert at night, the patient could not sleep and was up all night.   On unspecified date, reported as on the third day, the patient began to be disoriented, dizzy and was feeling unwell.   On unspecified date, reported as on the fourth day, the patient's daughter took her to the doctor and the patient was still following commands like put your seatbelt on', but by the evening she couldn't differentiate between her purse and the seatbelt, showing altered mental status.   On 31-Jul-2025, the patient started not eating well and was taken to the ER. The patient reportedly thought it was 1923 and had lost sense of time and space.   On an unspecified date, the patient was hospitalized.  On an unspecified date, an unknown amount of time after the vaccination with RabAvert, the patient was found to have encephalitis through lumbar puncture.   On an unspecified date, laboratory tests included MRTs, CT scan, tests for toxins, bacteria, fungi, and a cardiac bubble test. It was reported that most of the tests came back negative.  At the time of the initial report, it was unknown whether the patient recovered from 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise'.  The reporter assessed the events 'difficulty sleeping ', 'confused ', 'mental status changes ', 'decreased appetite ', 'disorientation', 'encephalitis', 'adverse reaction', 'dizziness', and 'malaise' as serious due to seriousness criteria of hospitalisation and related to the product RabAvert. However, the event 'encephalitis' was assessed as serious due to medical significance.  Additional information received from a consumer via Med Communication (reference number: USBAV25-1981) on 11-Aug-2025 included: reporter details, additional events, seriousness and causality assessment, medical history, laboratory tests.  Additional information received from a consumer via Communication (reference number: USBAV25-1985) on 11-Aug-2025 included: reporter details, lot number; Reporter's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.; Sender's Comments: This case concerns an 82-year-old female patient, who had experienced serious events of encephalitis (hospitalisation and medically significant); insomnia, confusional state, metal status changes, disorientation, decreased appetite, adverse reaction, dizziness and malaise (hospitalisation) on unspecified date after the first dose of RabAvert vaccine for an unknown indication. As reported patient received the first dose of RabAvert right above glutes, which is considered as product administered at inappropriate site. Encephalitis, adverse reaction, dizziness and malaise are listed and expected for Rabipur per CCDS v6 and USPI whilst insomnia, confusional state, metal status changes are unlisted and unexpected. Disorientation is unlisted in CCDS v6 and expected per USPI whilst decreased appetite is listed in CCDS v6 and unexpected per USPI. Product administered at inappropriate site is considered as listed as per company convention. The patient's medical history included a Waldenstrom's, and concomitant medication details were not provided. Outcome was unknown. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the causality for events are assessed as related to RabAvert vaccine. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalisation and medically significant criteria.