Sex: M
Vaccine: SMALLMNK
Symptoms: Acne, Incorrect route of product administration, Influenza like illness, Injection site erythema, Injection site mass
Clinical narrative: The Jynneos vaccine was administered at a dose of 0.1 ml; The Jynneos vaccine was administered intradermally instead of subcutaneously; Itching in the right foot, no rash; Starting with the flu, flu like symptoms; Sore throat; Congestion in nose/phlegm in nose; On the site of the injection was still red with a little bump; On the site of the injection was still red with a little bump; The patient had a pimple on top of his left elbow; Case reference number US-BN-2022-002186 is a spontaneous case report initially received from a consumer (reference number: USBAV22-1243) on 31-Aug-2022 and concerns a 72-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 26-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided) administered intradermally in the left forearm (explicitly coded as 'inappropriate route of vaccination'), at a dose of 0.1 mL (explicitly coded as 'underdose'), for monkeypox prophylaxis (exposure to someone with monkeypox). On the same day, the patient developed a little pimple on his left elbow, as reported, two hours after the vaccination. Also, the patient still had the bandage on the injection site which was red with a little bump.  On 27-Aug-2022, one day after the first Jynneos dose, the patient started having sore throat and congestion in his nose/phlegm in nose so applied few drops of Fluticasone nasal spray 50mg. The patient did not have fever, however started having flu like symptoms.  On 29-Aug-2022, three day after the first dose, the patient developed itching in the right foot without rash. On the same day, the patient recovered from the events 'oropharyngeal pain' and 'pruritus' (after applying cortisone cream).  At the time of this report, the outcome of the events 'acne', 'injection site erythema', 'injection site mass', 'nasal congestion' and 'influenza like illness' was reported as not resolved/ongoing.  The reporter assessed all the events as non-serious and possibly related to Jynneos.  Additional information received from Bavarian Nordic on 01-Sep-2022 included local case ID.; Reporter's Comments: A 72-year-old male patient was vaccinated with the first dose of Jynneos administered intradermally in the left forearm, which is considered as inappropriate route of vaccination, at a dose of 0.1 mL, which is considered as underdose, for monkeypox prophylaxis (exposure to someone with monkeypox). Reportedly, on the day 0 after the vaccination, the patient experienced non-serious events of acne, injection site mass and injection site erythema. On the day 1 after the vaccination, the patient experienced non-serious events of oropharyngeal pain, nasal congestion, and influenza like illness. Reportedly, on the day 3 after the vaccination, the patient experienced a non-serious event of pruritus. Injection site erythema is listed for Jynneos according to the insert, whilst underdose and incorrect route of product administration are considered as listed per company convention. Influenza like illness, injection site mass, oropharyngeal pain, nasal congestion, and pruritus are listed per insert and unlisted per insert. Acne is unlisted both per insert. The patient's medical history and concomitant medication details were not provided. The patient recovered from the events of oropharyngeal pain and pruritus, whilst the outcome for the rest of the events was reported as not resolved. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, all the events have been considered as related to Jynneos. Underdose and incorrect route of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 72-year-old male patient was vaccinated with the first dose of Jynneos administered intradermally in the left forearm, which is considered as inappropriate route of vaccination, at a dose of 0.1 mL, which is considered as underdose, for monkeypox prophylaxis (exposure to someone with monkeypox). Reportedly, on the day 0 after the vaccination, the patient experienced non-serious events of acne, injection site mass and injection site erythema. On the day 1 after the vaccination, the patient experienced non-serious events of oropharyngeal pain, nasal congestion, and influenza like illness. Reportedly, on the day 3 after the vaccination, the patient experienced a non-serious event of pruritus. Injection site erythema is listed for Jynneos according to the insert, whilst underdose and incorrect route of product administration are considered as listed per company. Influenza like illness, injection site mass, oropharyngeal pain, nasal congestion, and pruritus are listed per insert and unlisted per insert. Acne is unlisted both per insert. The patient's medical history and concomitant medication details were not provided. The patient recovered from the events of oropharyngeal pain and pruritus, whilst the outcome for the rest of the events was reported as not resolved. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, all the events have been considered as related to Jynneos. Underdose and incorrect route of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.