Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | unknown | — |
The patient concerned that the vaccination failed; a stabbing kind of chest pain after first and second dose of RabAvert; flushing, like was going to feel faint after first and second dose of RabAvert; could feel it hitting lymph nodes after first, second and third dose of RabAvert; sinuses swelled after first and second dose of RabAvert; itchy rash after first and second dose of RabAvert; stabbing stomach pain after first, and second dose of RabAvert; pretty significant neurological side effects 48 to 60 hours after each dose of RabAvert; A little bit of swelling in face, after first and second dose of RabAvert; flushing, like was going to feel faint after first and second dose of RabAvert; RabAvert vaccine was kept two hours at room temperature prior reconstitution; RabAvert vaccine was kept two hours at room temperature prior reconstitution; RabAvert vaccine was kept two hours at room temperature prior reconstitution; Nurse being confused regarding her administrating the vaccine; Case reference number US-BN-2025-001729 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-000437) on 24-Oct-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient had contact with a bat. On an unspecified date, an unknown amount of time after contact with a bat, 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) for an unknown dose, route or site of administration, for indication post-exposure prophylaxis. On an unspecified date, five minutes within the vaccination with the first dose of RabAvert, the patient experienced an episode of little bit of swelling in face, reportedly like sinuses swelled, some flushing, feeling faint, a stabbing kind of chest pain as it went through patient's lymph system, then later, an itchy rash and a stabbing stomach pain. On an unspecified date, reported as 48 to 60 hours after vaccination with the first dose of RabAvert, the patient experienced an episode of significant neurological side effects. On an unknown date, an unknown amount of time after the first dose and an unknown amount of time after contact with a bat, the patient received the second dose of RabAvert vaccine, along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) for an unknown dose, route or site of administration. On an unspecified date, five minutes within the vaccination with the second dose of RabAvert, the patient experienced another episode of little bit of swelling in face, reportedly like sinuses swelled, some flushing, feeling faint, a stabbing kind of chest pain as it went through her lymph system, then later, an itchy rash and a stabbing stomach pain. On an unspecified date, reported as 48 to 60 hours after vaccination with the second dose of RabAvert, the patient experienced another episode of significant neurological side effects. On an unknown date, an unknown amount of time after the second dose and an unknown amount of time after contact with a bat, the patient received the third dose of RabAvert vaccine, along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) for an unknown dose, route or site of administration. It was reported that the vaccine was kept at room temperature for two hours prior to reconstitution. (coded explicitly as 'Product storage error', 'Product administration error' and 'Product temperature excursion issue'). On an unspecified date, an unknown amount of time after vaccination with the third dose of RabAvert, the patient felt a little bit of it going through lymph system. On an unspecified date, reported as 48 to 60 hours after vaccination with the third dose of RabAvert, the patient experienced another episode of significant neurological side effects. On an unspecified date, an unknown amount of time after vaccination with of RabAvert, the patient was concerned that the vaccination failed (coded explicitly as 'vaccination failure'). On an unspecified date, an unknown amount of time after vaccination with of RabAvert, the patient received HRIG (generic name: human rabies immune globulin) at unknown dose, route or site of administration for an unknown indication. On unspecified date, as reported both nurses who administered vaccineone of them said she had never given vaccine before, and was really confused, and didn't understand it. (coded explicitly as 'Potential for medication error') At the time of the initial report, it was unknown whether the patient recovered from the events 'felt faint', 'flushing', 'facial swelling', 'sinus swelling', 'chest pain', 'itchy rash', 'stomach pain' and 'lymph node pain' after first and second dose of RabAvert and 'neurological symptoms NOS' after each dose or RabAvert, and 'vaccination failure'. The reporter did not provide seriousness assessment for the events of 'felt faint', 'flushing', 'facial swelling', 'sinus swelling', 'chest pain', 'itchy rash', 'stomach pain' and 'lymph node pain' after first and second dose of RabAvert and 'neurological symptoms NOS' after each dose or RabAvert, and 'vaccination failure', However, the event of 'vaccination failure' was assessed as serious due to the seriousness criteria of medical significance. The reporter did not provide causality or seriousness assessment for the events. No further information was received.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of swelling in face, reportedly like sinuses swelled, flushing, feeling faint, chest pain as it went through patient's lymph system, itchy rash and stabbing stomach pain on an unspecified dates, reported as five minutes within the vaccinations with the first and with the second dose of RabAvert for post-exposure prophylaxis, and the event of neurological side effects reported as 48 to 60 hours after each vaccination. On an unknown date, an unknown amount of time after the second dose and an unknown amount of time after contact with a bat, the patient received the third dose of RabAvert vaccine. It was reported that the vaccine was kept at room temperature for two hours prior to reconstitution, which is considered as product storage error, product administration error and product temperature excursion issue. An unknown amount of time after vaccination with the third dose of RabAvert, the patient felt a little bit of it going through lymph system. Also, reported as 48 to 60 hours after vaccination with the third dose of RabAvert, the patient experienced another episode of significant neurological side effects. On an unspecified date, an unknown amount of time after vaccination with RabAvert, the patient was concerned that the vaccination failed, which is considered as vaccination failure (medical significance). On unspecified date, as reported both nurses who administered vaccineone of them said she had never given vaccine before, and was really confused, and didn't understand it, which is considered as potential for medication error. Dizziness is listed and expected for RabAvert per CCDS v6 and USPI, whilst chest pain, flushing, lymph node pain, sinus congestion, rash pruritic, abdominal pain upper, neurological symptom and swelling face are unlisted and unexpected. Vaccination failure, product storage error, product administration error, product temperature excursion issue and circumstance or information capable of leading to medication error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering compatible temporal relationship, theoretical biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for all the reported events is assessed as related to the suspect vaccine. Vaccination failure, product storage error, product administration error, product temperature excursion issue and circumstance or information capable of leading to medication error are not related to the suspect vaccine. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered reportable.; Sender's Comments: A female patient of unspecified age experienced non-serious events of swelling in face, reportedly like sinuses swelled, flushing, feeling faint, chest pain as it went through patient's lymph system, itchy rash and stabbing stomach pain on an unspecified dates, reported as five minutes within the vaccinations with the first and with the second dose of RabAvert for post-exposure prophylaxis, and the event of neurological side effects reported as 48 to 60 hours after each vaccination. On an unknown date, an unknown amount of time after the second dose and an unknown amount of time after contact with a bat, the patient received the third dose of RabAvert vaccine. It was reported that the vaccine was kept at room temperature for two hours prior to reconstitution, which is considered as product storage error, product administration error and product temperature excursion issue. An unknown amount of time after vaccination with the third dose of RabAvert, the patient felt a little bit of it going through lymph system. Also, reported as 48 to 60 hours after vaccination with the third dose of RabAvert, the patient experienced another episode of significant neurological side effects. On an unspecified date, an unknown amount of time after vaccination with RabAvert, the patient was concerned that the vaccination failed, which is considered as vaccination failure (medical significance). On unspecified date, as reported both nurses who administered vaccineone of them said she had never given vaccine before, and was really confused, and didn't understand it, which is considered as potential for medication error. Dizziness is listed and expected for RabAvert per CCDS v6 and USPI, whilst chest pain, flushing, lymph node pain, sinus congestion, rash pruritic, abdominal pain upper, neurological symptom and swelling face are unlisted and unexpected. Vaccination failure, product storage error, product administration error, product temperature excursion issue and circumstance or information capable of leading to medication error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering compatible temporal relationship, theoretical biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for all the reported events is assessed as related to the suspect vaccine. Vaccination failure, product storage error, product administration error, product temperature excursion issue and circumstance or information capable of leading to medication error are not related to the suspect vaccine. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered reportable.
Comments: None.
HRIG