Sex: M
Vaccine: SMALLMNK
Symptoms: Neck mass, Rash vesicular, Skin burning sensation, Skin weeping
Clinical narrative: rash/blister that was seeping under chin, hairs and burns; Large lump behind ear at the lymph nodes; Case reference number US-BN-2024-002719 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: BN_2024_03058) on 06-Nov-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  The patient's historical vaccination included unspecified HIV vaccine (brand name unknown).  On 17-Sep-2024, the patient was vaccinated with the first dose of Jynneos (batch number: unknown) 0.5 milliliter, via unspecified route in the arm, for unknown indication.  On the same day, reported as immediately, the patient noticed a large lump behind ear at the lymph nodes, but as days went by, it started to get smaller.   On unspecified date, unknown amount of time after receiving Jynneos, the patient started having blistering on chin described as rash/blister that was 'seeping' under chin, hairs and burns. As reported, the patient went to dermatologist who 'couldn't help'. The patient then went to primary care physician who gave the patient antibiotics and a topical lotion. The patient indicated that the chin area was covered with blemishes/rash.   At the time of the initial report, the outcome for the events of 'blistery rash' and 'lymph nodes enlarged' was unknown.  The reporter did not provide seriousness or causality assessment for the events of 'blistery rash' and 'lymph nodes enlarged'.  No further information was provided.; Reporter's Comments: A male patient of unspecified age noticed a large lump behind ear at the lymph nodes on the day 0 after the patient was vaccinated with the first dose of Jynneos for unknown indication. On unspecified date, an unknown amount of time after receiving Jynneos, the patient started having blistering on chin described as rash/blister that was seeping under chin, hairs and burns. Rash vesicular is unlisted and unexpected for Jynneos per CCDS v7 and USPI, whilst lymphadenopathy is listed per CCDS v7 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided, and historical vaccination included unspecified HIV vaccine. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Jynneos. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age noticed a large lump behind ear at the lymph nodes on the day 0 after the patient was vaccinated with the first dose of Jynneos for unknown indication. On unspecified date, an unknown amount of time after receiving Jynneos, the patient started having blistering on chin described as rash/blister that was seeping under chin, hairs and burns. Rash vesicular is unlisted and unexpected for Jynneos per CCDS v7 and USPI, whilst lymphadenopathy is listed per CCDS v7 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided, and historical vaccination included unspecified HIV vaccine. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Jynneos. This case is considered as non-serious.