Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | OT |
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | UNK | — | OT |
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Unknown | — |
Myoclonus; Condition aggravated; Malaise; The patient received one dose of Rabaver and one dose of Imovax; jump at sleep /could not sleep/insomnia (insomnia); Hallucination; Anxiety; really bad ringing in my ears that persisted has been since the injection/tinnitus (tinnitus); tremors in hands (tremor); lost 20 pounds (weight decreased); could not eat (Feeding disorder); , firework feeling in their chest like a heart attack (chest pain) (palpitations),; firework feeling in their chest like a heart attack (chest pain) (palpitations); very sick (illness); Case reference number US-BN-2025-001383 initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 04-Aug-2025, is a spontaneous case received from consumer via Health Authority (VAERS ID: 2849913-1) and concerns a 37-year-old female patient. The patient's medical history includes anxiety disorder and hypochondriacal personality. The patient's concomitant medications were not provided. On an unspecified date, as reported, the patient had a bat in their kitchen and the doctor recommended to get vaccination just in case. On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 to be confirmed) on day zero, the patient received the first dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, or site of administration for indication prophylactic vaccination (immunisation). On an unspecified date in Mar-2025 (also reported on 01-Mar-2025 and around 11-Mar-2025 to be confirmed) , reported as seven days after RabAvert vaccination, the patient received the second dose of the co-suspect vaccine Imovax (batch number: unknown) at unknown dose, route, at an unknown site of administration for indication rabies (rabies immunisation) (explicitly coded as 'interchange of vaccine products'). On an unspecified date in 2025, unknown of time after the vaccination, the patient experienced hallucinations, very sick, chest pains, firework feeling in their chest like a heart attack, chest pains, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears that persisted has been since the injection, tinnitus and could not eat. On an unspecified date, unknown of time after vaccination the patient experienced condition aggravated, malaise and myoclonus. As reported, the first two months were bad, the patient could not eat or sleep and experiencing tremors never been vaccinated before and had always been kind of hypochondriac, so that may be where the anxiety was from and may be it was their body being unused with vaccination. It was not reported if the patient received the corrective treatment. On an unspecified dates, as reported the patient has been very sick and has been in and out of hospital. At the time of initial report, it was unknown if the patient recovered from the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain' and 'palpitations' and not recovered from the events of anxiety, hallucination, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter assessed the event of hallucination as serious due to seriousness criteria of medically significance and assessed the events of 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. The reporter did not provide causality assessment for the same events of hallucination, 'illness', 'eating disorder', 'weight decreased', 'chest pain', 'palpitations', anxiety, condition aggravated, 'insomnia', malaise, myoclonus, 'tinnitus' and tremor. Additional information received from consumer via Bavarian Nordic (reference number: BN_2025_00183) on 07-Aug-2025: Information included reference number, and patient details.; Reporter's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.; Sender's Comments: A 37-year-old female patient received the first dose of RabAvert vaccine for indication prophylactic vaccination (immunisation) and the second dose of the co-suspect vaccine Imovax, which is considered as interchange of vaccine products. On an unspecified date within the same year, unknown of time after the vaccination, the patient experienced a serious event of hallucinations (medical significance) and non-serious events of very sick, chest pains, firework feeling in their chest like a heart attack, jump at sleep, could not sleep, insomnia, lost 20 pounds, tremors in hands, anxiety, really bad ringing in ears, tinnitus, could not eat, condition aggravated, malaise and myoclonus. Malaise is listed and expected for RabAvert per CCDS v5 and USPI, whilst hallucination, anxiety, condition aggravated, insomnia, myoclonus, tinnitus, tremor, weight decreased, eating disorder and chest pain are unlisted and unexpected. Palpitations is unlisted per CCDS v5 and expected per USPI. Illness and interchange of vaccine products are considered as listed per company convention. The patient's medical history includes anxiety disorder and hypochondriacal personality, and concomitant medications were not provided. It was unknown if the patient recovered from the events. The patient's vaccination with Imovax confounded the causality. However, considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.
Medical History/Concurrent Conditions: Anxiety disorder; Hypochondriacal personality
Test Date: 2025; Test Name: Body weight; Result Unstructured Data: Test Result:/ ;Weight loss; Comments: /