Received Jul 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Unknown | — |
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 1 | Unknown | — |
had to think about how to drive or could not remember how to drive; trouble walking; Patient was feeling a little under the weather/ Really felt out of it; Patient was sick on top of that; Case reference number US-BN-2025-001117 is a spontaneous case initially received from a pharmacist via Communication (reference number: USBAV25-1523) on 24-Jun-2025 and concerns a 43-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient received the first dose of Jynneos (batch number: unknown), at an unknown dose, via unknown route at unknown site of administration for smallpox / monkeypox, along with some other inactivated vaccines, among which was the influenza vaccine. On an unspecified date, unknown amount of time after the first dose of Jynneos, the patient was feeling a little under the weather. The patient felt really out of it and felt like having trouble with walking. The patient also reported wanting to drive but had to think about how to do so, or could not remember how to drive, the patient was sick on top of that. Because of these experiences, there is hesitation about receiving the second dose of Jynneos. The patient was due for their second dose of Jynneos on 27-Jun-2025. At the time of the initial report, the outcome of the events of malaise, gait disturbance, illness and mental impairment was unknown. The reporter assessed the events of malaise, gait disturbance, illness and mental impairment as non-serious and not related to Jynneos, since the patient received multiple shots, influenza shot etcetera. However the event of mental impairment was assessed as serious due to medically significance. Additional information received from pharmacist via Bavarian Nordic on 25-Jun-2025 included: MedComm reference number: USBAV25-1536, reporter details, causality assessment. Additional information received from pharmacist via Bavarian Nordic on 26-Jun-2025 included: MedComm reference number: USBAV25-1555, co-suspect medication, causality assessment updated, additional event.; Reporter's Comments: A 43-year-old male patient experienced a serious event of mental impairment (medical significance) and non-serious events of gait disturbance, malaise and illness on an unspecified date, unknown amount of time after the patient received the first dose of Jynneos for smallpox / monkey pox, along with some other inactivated vaccines, among which was the influenza vaccine. Mental impairment and gait disturbance are unlisted and unexpected for Jynneos per RA1 v7 and RA, whilst malaise is listed and unexpected. Illness is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. The patient's co-suspect vaccination confounded the causality. Due to missing critical clinical details (including onset, dose, route, duration, patient comorbidities, outcome, and timing), and presence of confounding factors (co-administered vaccines), the causality of the reported adverse events in relation to Jynneos in the context of the available information appears unlikely related. This case is considered as serious due to medical significance.; Sender's Comments: A 43-year-old male patient experienced a serious event of mental impairment (medical significance) and non-serious events of gait disturbance, malaise and illness on an unspecified date, unknown amount of time after the patient received the first dose of Jynneos for smallpox / monkey pox, along with some other inactivated vaccines, among which was the influenza vaccine. Mental impairment and gait disturbance are unlisted and unexpected for Jynneos per RA1 v7 and RA, whilst malaise is listed and unexpected. Illness is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. The patient's co-suspect vaccination confounded the causality. Due to missing critical clinical details (including onset, dose, route, duration, patient comorbidities, outcome, and timing), and presence of confounding factors (co-administered vaccines), the causality of the reported adverse events in relation to Jynneos in the context of the available information appears unlikely related. This case is considered as serious due to medical significance.
Comments: None.