Age: 40.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Malaise, Pain
Clinical narrative: Mental feel off; Body pain; Joint pain; Sweating; Fever; Chills; Headache; The patient had been constipated; Lower back pain; Feeling off; Case reference number US-BN-2022-001661 is a spontaneous case report initially received on 26-Jul-2022 from other consumer via Communications (reference number: USBAV22-0667) and concerns a 40-year-old (also reported as 41 year-old) male patient.  The patient's medical history included HIV infection and back surgery.  The patient's concomitant medications were not provided.  On 18-Jul-2022, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) at a dose reported as 'standard', at an unknown route or site of administration for unknown indication.   On an unknown date, reported as Friday the patient started feeling off. On unspecified date, the patient experienced fevers with 102-103.6 degrees Fahrenheit, extreme chills, sweating, headache, body pain, joint pain, lower back pain, constipation and feel off mentaly. The patient was taking lot of cold and flu medicine to give him a relief from side effects (as reported).  It was unknown if the patient recovered from these events.  The reporter provided assess all events as serious and possibly related to the product.  Additional information received from communications on 27-Jul-2022 included additional references and additional reporter, different patient's DOB and age. On the same day additional information received included reference number.; Reporter's Comments: A 40-year-old male patient experienced serious events of constipation, emotional distress, hyperhidrosis, arthralgia, back pain, pain, malaise, pyrexia, chills and headache (seriousness criterion: medical significance) on unspecified date, an unknown amount of time after the vaccination with first dose of Jynneos for unknown indication. Pyrexia, chills, malaise and headache are listed, whilst constipation, emotional distress, hyperhidrosis, arthralgia, back pain and pain are not listed for Jynneos according to the agency. The patient's medical history included HIV infection and back surgery and concomitant medications were not provided. The outcome was unknown. The patient's medical history confounded the causality for the events. However, since the evaluation did not find enough 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 Jynneos.; Sender's Comments: A 40-year-old male patient experienced serious events of constipation, emotional distress, hyperhidrosis, arthralgia, back pain, pain, malaise, pyrexia, chills and headache (seriousness criterion: medical significance) on unspecified date, an unknown amount of time after the vaccination with first dose of Jynneos for unknown indication. Pyrexia, chills, malaise and headache are listed, whilst constipation, emotional distress, hyperhidrosis, arthralgia, back pain and pain are not listed for Jynneos according to the Agency. The patient's medical history included HIV infection and back surgery and concomitant medications were not provided. The outcome was unknown. The patient's medical history confounded the causality for the events. However, since the evaluation did not find enough 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 Jynneos.