Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Musculoskeletal pain, Pain, Swelling
Clinical narrative: SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD; SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD; SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD; PAINFUL TO WALK; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD) in an adult male 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.    There was no reported medical history.  Concurrent medical conditions included Hidradenitis suppurativa.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced HAEMORRHAGE (SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD) (seriousness criterion medically significant), SWELLING (SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD), MUSCULOSKELETAL PAIN (SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD) and PAIN (PAINFUL TO WALK). At the time of the report, HAEMORRHAGE (SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD), MUSCULOSKELETAL PAIN (SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD) and PAIN (PAINFUL TO WALK) outcome was unknown and SWELLING (SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD) had not resolved.            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.  Concomitant medications were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medications were not reported.  The reporter's causality for the event(s) of swelling on the left buttock along with pain and sometimes leaking blood unknown onset, swelling on the left buttock along with pain and sometimes leaking blood unknown onset and painful to walk was not provided. the reporter's causality for the event(s) of swelling on the left buttock along with pain and sometimes leaking blood unknown onset with humira (adalimumab) was a reasonable possibility.  Company comment: This spontaneous case concerns an adult male patient with concurrent condition of hidradenitis suppurativa, who experienced the expected, serious (medically significant) event of  Haemorrhage (reported as SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD), unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose with the same vaccine, 1 month ago with no reported adverse events. No information on risk factors, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Co suspect adalimumab could be confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with concurrent condition of hidradenitis suppurativa, who experienced the expected, serious (medically significant) event of  Haemorrhage (reported as SWELLING ON THE LEFT BUTTOCK ALONG WITH PAIN AND SOMETIMES LEAKING BLOOD), unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose with the same vaccine, 1 month ago with no reported adverse events. No information on risk factors, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Co suspect adalimumab could be confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.