Sex: U
Vaccine: UNK
Symptoms: Dyspnoea, Hypersensitivity, Oropharyngeal discomfort, Pharyngeal swelling, Swollen tongue
Clinical narrative: Throat symptoms; Hives developing; The patient had another reaction; Swelling of the tongue; Severe allergic reaction requiring another Epipen; Allergic reaction with symptoms of throat swelling; Allergic reaction with symptoms of difficulty breathing; Case reference number US-BN-2022-001846 is a spontaneous case report initially received on 11-Aug-2022 from a consumer via Bavarian Nordic and concerns a patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On 02-Aug-2022 at 03:20 pm, the patient was vaccinated with the first dose of Modified Vaccinia Ankara  - Bavarian Nordic Live Virus (live-attenuated, non-replicating; brand name unknown; batch number: unknown) at an unknown dose, route or site of administration, for unknown indication. After the first 15-20 minutes, the patient felt normal and left. On the same day, around 04:30 pm, the patient had a mild allergic reaction with symptoms of throat swelling and difficulty breathing. As reported, the patient went to the emergency room (ER) and got high amounts of Benadryl (diphenhydramine hydrochloride; batch number: unknown) and steroids (unspecified).  On an unspecified dates, reported as for the next few days, the patient was feeling normal with minor throat symptoms.  On 06-Aug-2022, at 11:45 pm, four days after the vaccination, the patient experienced more severe reaction including swelling of the tongue and received an Epipen (epinephrine; batch number: unknown) in the emergency room. After being monitored, the patient was sent home at 2:30 am.  On 07-Aug-2022, at 04:00 am, five days after the vaccination, the patient experienced another severe reaction and received another Epipen (batch number: unknown) and steroids at the hospital.  On 08-Aug-2022 and 09-Aug-2022, the patient experienced mild symptoms, as reported.  On 10-Aug-2022, eight days after the vaccination, the patient experienced hives and another swelling of the tongue and received an Epipen (batch number: unknown) and high amount of steroids in the emergency room.  The outcome for all the events was not provided.  The reporter assessed the events of 'swollen tongue', 'hypersensitivity', 'pharyngeal swelling', 'dyspnoea', 'urticaria', 'adverse reaction' and 'oropharyngeal discomfort' as serious due to medical significance (reported as severe reactions) and as possibly related to the MVA-BN vaccine.  No further information was received.; Reporter's Comments: A patient of an unknown age experienced serious events of pharyngeal swelling and dyspnoea (seriousness criterion: medical significance) on the day 0 after the vaccination with the first dose of Modified Vaccinia Ankara - Bavarian Nordic Live Virus, at an unknown dose, route or site of administration, for unknown indication. On an unspecified date, reported as for the next few days, the patient was feeling normal with minor throat symptoms. Reportedly, on the day 4 after the vaccination, the patient experienced serious events of hypersensitivity and swollen tongue (seriousness criterion: medical significance). On the day 5 after the vaccination, the patient experienced a serious event of adverse reaction (seriousness criterion: medical significance). On the day 8, the patient experienced serious events of hives and another swelling of the tongue (seriousness criterion: medical significance). The event of hypersensitivity is listed for MVA-BN vaccine. The events of swollen tongue, pharyngeal swelling, dyspnoea and oropharyngeal discomfort are not listed. Urticaria is listed. Adverse reaction is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome for all the events was not provided. Since the evaluation did not find enough evidence to fully exclude a contributory role of the suspect vaccine to the development of the events, at this point, all the events have been considered as related to MVA-BN vaccine.; Sender's Comments: A patient of an unknown age experienced serious events of pharyngeal swelling and dyspnoea (seriousness criterion: medical significance) on the day 0 after the vaccination with the first dose of Modified Vaccinia Ankara - Bavarian Nordic Live Virus, at an unknown dose, route or site of administration, for unknown indication. On an unspecified date, reported as for the next few days, the patient was feeling normal with minor throat symptoms. Reportedly, on the day 4 after the vaccination, the patient experienced serious events of hypersensitivity and swollen tongue (seriousness criterion: medical significance). On the day 5 after the vaccination, the patient experienced a serious event of adverse reaction (seriousness criterion: medical significance). On the day 8, the patient experienced serious events of hives and another swelling of the tongue (seriousness criterion: medical significance). The event of hypersensitivity is listed for MVA-BN vaccine. The events of swollen tongue, pharyngeal swelling, dyspnoea and oropharyngeal discomfort are not listed. Urticaria is listed. Adverse reaction is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome for all the events was not provided. Since the evaluation did not find enough evidence to fully exclude a contributory role of the suspect vaccine to the development of the events, at this point, all the events have been considered as related to MVA-BN vaccine.