Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hidradenitis, Rash
Clinical narrative: RASH ON HIS PELVIS AREA AND BELLY AREA; HIDRADENITIS SUPPURATIVA FLARE UP NEAR PELVIC AREA/ONE HEALS THEN ANOTHER POPPED OUT/HIDRADENITIS SUPPURATIVA BREAK/OUTBREAK/BREAKING OUT; HIDRADENITIS SUPPURATIVA FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE UP NEAR PELVIC AREA/ONE HEALS THEN ANOTHER POPPED OUT/HIDRADENITIS SUPPURATIVA BREAK/OUTBREAK/BREAKING OUT) and CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UP) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B212A, 030B21A and 027AL1A) 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 Herniated disc from 11-Sep-2021 to 2022, Nerve compression from 11-Sep-2021 to 2022, Hidradenitis suppurativa, Gallbladder removal, Appendectomy, Neck surgery and Hip surgery. Concurrent medical conditions included Food allergy, Non-smoker and Abstains from alcohol.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. In March 2022, the patient experienced HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE UP NEAR PELVIC AREA/ONE HEALS THEN ANOTHER POPPED OUT/HIDRADENITIS SUPPURATIVA BREAK/OUTBREAK/BREAKING OUT) (seriousness criterion medically significant) and CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UP) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH (RASH ON HIS PELVIS AREA AND BELLY AREA). In March 2022, HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE UP NEAR PELVIC AREA/ONE HEALS THEN ANOTHER POPPED OUT/HIDRADENITIS SUPPURATIVA BREAK/OUTBREAK/BREAKING OUT) had resolved. At the time of the report, CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UP) and RASH (RASH ON HIS PELVIS AREA AND BELLY AREA) outcome was unknown.      Company comment : This spontaneous case concerns a male patient aged 48 years with relevant  medical history of HIDRADENITIS SUPPURATIVA reported, who experienced the unexpected serious (medically significant) events of Hidradenitis and Condition aggravated (HIDRADENITIS SUPPURATIVA FLARE UP) that occurred on an unknown date (in March 2022)approximately 2 months after third dose of mRNA-1273 vaccination. Patient had received initial two doses of mRNA-1273 at an interval of 28 days and third dose approximately 6.5 months later. He had Hidradenitis Suppurativa flare up near pelvic area for four days. When one got healed another was popped up and then again breakout of Hidradenitis Suppurativa occurred and he had a lot of pain associated with bad rash on his pelvic and  belly area. No further information on risk factors, investigations and treatment received was available in the report. Outcome of the events was resolved at the time of report. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.     Concomitant Drugs Not Reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 11-Sep-2021, the patient underwent a back surgery in L5-S1 area because of herniation disk compresses a nerve. He had Hidradenitis Suppurativa flare up near pelvic area for four days. When one got healed then another was popped up and then again breakout of Hidradenitis Suppurativa happened and had a lot of pain because he missed one dose of HUMIRA in Mar-2022. He was not using painkillers and got very bad rash on his pelvis area and belly area. He was using walker. He did not have the list of his concomitant because he mentioned he need to print it out. In Sep-2021, Magnetic resonance imaging and X-ray was done 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.   This case was linked to MOD-2022-624768 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow Up received updated event details On 04-Mar-2022: follow up received updated event information. On 18-Mar-2022: follow up received updated event information. On 05-Apr-2022: follow up received updated patient demographics, medical history and event information. New event added; Sender's Comments: This spontaneous case concerns a male patient aged 48 years with relevant  medical history of HIDRADENITIS SUPPURATIVA reported, who experienced the unexpected serious (medically significant) events of Hidradenitis and Condition aggravated (HIDRADENITIS SUPPURATIVA FLARE UP) that occurred on an unknown date (in March 2022)approximately 2 months after third dose of mRNA-1273 vaccination. Patient had received initial two doses of mRNA-1273 at an interval of 28 days and third dose approximately 6.5 months later. He had Hidradenitis Suppurativa flare up near pelvic area for four days. When one got healed another was popped up and then again breakout of Hidradenitis Suppurativa occurred and he had a lot of pain associated with bad rash on his pelvic and  belly area. No further information on risk factors, investigations and treatment received was available in the report. Outcome of the events was resolved at the time of report. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.