Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Testicular abscess; Appetite absent; Depressed mood; Generalised aching; Headache; Painful R arm; Shoulder pain; Lost weight; Chest pain; Hidradenitis suppurativa; Low back pain; Difficulty sleeping; Unable to eat; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR ABSCESS (Testicular abscess) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    The patient's past medical history included Hidradenitis suppurativa on 06-Feb-2022. Concurrent medical conditions included Tobacco user (FOUR TO FIVE CIGARETTE STICKS PER DAY) and Abstains from alcohol. Concomitant products included DICLOFENAC for Muscle relaxant.   On 10-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 10-Jan-2022, the patient experienced PAIN IN EXTREMITY (Painful R arm). In January 2022, the patient experienced TESTICULAR ABSCESS (Testicular abscess) (seriousness criteria hospitalization and medically significant), WEIGHT DECREASED (Lost weight), CHEST PAIN (Chest pain), HIDRADENITIS (Hidradenitis suppurativa), BACK PAIN (Low back pain), INSOMNIA (Difficulty sleeping), FEEDING DISORDER (Unable to eat), ABDOMINAL PAIN (Abdominal pain) and ARTHRALGIA (Shoulder pain). On 09-Feb-2022, the patient experienced PAIN (Generalised aching) and HEADACHE (Headache). On an unknown date, the patient experienced DECREASED APPETITE (Appetite absent) and DEPRESSED MOOD (Depressed mood). The patient was treated with TRAMADOL at an unspecified dose and frequency; CLINDAMYCIN at an unspecified dose and frequency and Surgery (surgery to drain abscess) for Testicular abscess. On 11-Jan-2022, PAIN IN EXTREMITY (Painful R arm) had resolved. At the time of the report, TESTICULAR ABSCESS (Testicular abscess) was resolving, DECREASED APPETITE (Appetite absent), DEPRESSED MOOD (Depressed mood), HIDRADENITIS (Hidradenitis suppurativa) and HEADACHE (Headache) outcome was unknown and WEIGHT DECREASED (Lost weight), PAIN (Generalised aching), CHEST PAIN (Chest pain), BACK PAIN (Low back pain), INSOMNIA (Difficulty sleeping), FEEDING DISORDER (Unable to eat), ABDOMINAL PAIN (Abdominal pain) and ARTHRALGIA (Shoulder pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2022, Culture: Normal. On 06-Feb-2022, Culture: Normal. On an unknown date, Weight: 15 weight loss, 15 Pounds.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if he was enrolled in a COVID-19 vaccine trial. The patient abstains from alcohol. Scrotal pain (testicular pain), surgery, testicular swelling and testicular pain were subsumed under testicular abscess as a symptoms The patient had some problems getting new dose of HUMIRA medicine so he was off HUMIRA for two months. He was off Humira in Dec 2021 due to insurance change then, when he got back on Humira he started to feel sick. The event of sick he meant that it was abdominal pain, stomach pain, chest pain, shoulder pain, lower back hurts and swelling of testicles. He had COVID vaccine on 10 Jan 2022 and hidradenitis suppurativa symptoms got worse. He was on unknown antibiotics. On 09 Feb 2022, he took medication and felt horrible everything hurt headache, scrotum hurt look like a ball back hurt. He was hospitalized on 05 Feb 2022 to 06 Feb 2022 because the swelling of testicles worsened and it got hurt so bad. A surgery to drain the abscess in testicles was done on 06 Feb 2022. He had follow up appointment on 08 Feb 2022 to check the surgery that was done then he had surgery again on 11 Feb 2022 to drain the abscess in testicles. He mentioned that every time he got a Humira shot, he feels sick. He clarified that Moderna COVID 19 vaccine did not make his symptoms worse. He just felt his right arm hurting for one day after COVID 19 vaccine shot.  For HUMIRA, the reporter causality for the events of Surgery, Testicular swelling, Testicular abscess, Testicular pain, Appetite absent, Feeling sick, Lost weight, Scrotal pain, Feels bad, Depressed mood, Headache, Generalized aching, Chest pain, Abdominal pain, Hidradenitis suppurativa, Shoulder pain, Low back pain, Difficulty sleeping, Unable to eat, Painful R arm was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact.  Company comment: This spontaneous case concerns a 47-year-old male patient with no relevant medical history, who experienced the unexpected, serious (hospitalization) event of testicular abscess about a month after a dose of mRNA-1273. The patient describes that he experienced testicular pain and swelling which got worse until he was hospitalized for 1 day, where surgery to drain the abscess was performed. Another surgery was performed 6 days after the initial drainage. Cultures from the first surgery came back as normal. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 47-year-old male patient with no relevant medical history, who experienced the unexpected, serious (hospitalization) event of testicular abscess about a month after a dose of mRNA-1273. The patient describes that he experienced testicular pain and swelling which got worse until he was hospitalized for 1 day, where surgery to drain the abscess was performed. Another surgery was performed 6 days after the initial drainage. Cultures from the first surgery came back as normal. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.