Sex: F
Vaccine: COVID19
Symptoms: Abscess, Chest pain, Impaired healing, Rectal ulcer
Clinical narrative: Rectal ulcer; Abscess; burning sensation across chest; twelve open wounds around rectal area that never really healed; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL ULCER (Rectal ulcer) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 and Crohn's disease.    The patient's past medical history included Surgery (to drain an abscess) in 2019. Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe) and Crohn's disease (moderate to severe).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RECTAL ULCER (Rectal ulcer) (seriousness criterion medically significant), ABSCESS (Abscess), CHEST PAIN (burning sensation across chest) and IMPAIRED HEALING (twelve open wounds around rectal area that never really healed). At the time of the report, RECTAL ULCER (Rectal ulcer), ABSCESS (Abscess), CHEST PAIN (burning sensation across chest) and IMPAIRED HEALING (twelve open wounds around rectal area that never really healed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The formulation for Humira was reported as Solution for injection in pre-filled pen.  In 2019, she had surgery to drain an abscess and the physician that done it really created a large drain about an inch around and four incisions and right around patient rectal area, had twelve open wounds around the area that never really healed. Only got one shot had a burning sensation across patient chest and was not able to get the COVID-19 vaccination. Causality for surgery was reported as no reasonable possibility.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter causality for the events of abscess, twelve open wounds around rectal area that never really healed unknown onset and twelve open wounds around rectal area that never really healed unknown onset was not provided. The reporter causality for the events of burning sensation across chest with Humira(adalimumab) was no reasonable possibility.  No treatment medications were reported.  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.  Company comment: This spontaneous case concerns an adult female patient with concurrent hidradenitis suppurativa and Crohn s disease, who experienced the unexpected serious (medically significant) event of Rectal ulcer,  unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. It was reported that the patient had twelve open wounds around rectal area that never healed after an incision and drainage was performed for a rectal abscess. Concurrent hidradenitis suppurativa and Crohn s disease could be risk factors for the event. No information on exact date of the events, detailed clinical course, relevant investigations, treatment and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient with concurrent hidradenitis suppurativa and Crohn s disease, who experienced the unexpected serious (medically significant) event of Rectal ulcer,  unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. It was reported that the patient had twelve open wounds around rectal area that never healed after an incision and drainage was performed for a rectal abscess. Concurrent hidradenitis suppurativa and Crohn s disease could be risk factors for the event. No information on exact date of the events, detailed clinical course, relevant investigations, treatment and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.