Sex: F
Vaccine: SMALLMNK
Symptoms: Anxiety, Headache, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: The patient was worried; Headache; The pain was tender; The patient developed hard lump at the injection site that was painful to touch; The patient developed hard lump at the injection site that was painful to touch; Case reference number US-BN-2022-001909 is a spontaneous case report initially received on 16-Aug-2022 from a consumer via agency (reference number: USBAV22-1029) and concerns an adult female patient.  The patient's concurrent medical history included staph infection, depression and anxiety, for which the patient used unspecified medications.  On 08-Aug-2022, the patient received the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown), with an unknown dose in the back of the arm for the high-risk indication (as reported). On the same day, the patient developed lump at the injection site that was getting worse, and was painful to touch. The lump was at  the size of a quarter but had grown after and was still hard. The pain was reported as tender, similar to the pain of staph infection the patient had before. T  On an unspecified date, the patient was worried, and experienced headache which was treated with Aspirin (acetylsalicylic acid).  At the time of this report, the outcome of the events: 'worry', ' injection site lump, ' headache', 'tenderness' and 'injection site pain' was reported as not resolved/ongoing.  The reporter considered the events as related to Jynneos, and did not provide seriousness assessment of the events.  Additional information received on 17-Aug-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: An adult female patient experienced non-serious events of injection site mass, tenderness and injection site pain on the day 0 after the vaccination with the first dose of Jynneos, with an unknown dose in the back of the arm for the high-risk indication, as reported. Reportedly, on an unspecified date, the patient experienced non-serious events of anxiety and headache. The events of injection site pain and headache are listed, whilst tenderness, injection site mass and anxiety are not listed for Jynneos according to the agency 1 and agency 2. The patient's concurrent medical history included staph infection, depression, and anxiety, for which the patient used unspecified medications. The events were not resolved, as reported. Since the evaluation did not find sufficient evidence to completely exclude a contributory role of the suspect vaccine to the development of the events, all the events have been considered as related to the Jynneos. This case is considered as non-serious.; Sender's Comments: An adult female patient experienced non-serious events of injection site mass, tenderness and injection site pain on the day 0 after the vaccination with the first dose of Jynneos, with an unknown dose in the back of the arm for the high-risk indication, as reported. Reportedly, on an unspecified date, the patient experienced non-serious events of anxiety and headache. The events of injection site pain and headache are listed, whilst tenderness, injection site mass and anxiety are not listed for Jynneos according to the agency 1 and agency 2. The patient's concurrent medical history included staph infection, depression, and anxiety, for which the patient used unspecified medications. The events were not resolved, as reported. Since the evaluation did not find sufficient evidence to completely exclude a contributory role of the suspect vaccine to the development of the events, all the events have been considered as related to the Jynneos. This case is considered as non-serious.