Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Headache, Hidradenitis, Myalgia, Nasopharyngitis
Clinical narrative: HIDRADENITIS SUPPURATIVA FLARE UP; Hidradenitis suppurativa; Cold; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UP) and HIDRADENITIS (Hidradenitis suppurativa) in a 52-year-old 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 Rheumatoid arthritis and Hidradenitis suppurativa.    The patient's past medical history included Hidradenitis suppurativa.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-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) at an unspecified dose. In 2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). In August 2021, the patient experienced NASOPHARYNGITIS (Cold). In October 2021, the patient experienced HIDRADENITIS (Hidradenitis suppurativa) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UP) (seriousness criterion hospitalization). At the time of the report, CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UP), HIDRADENITIS (Hidradenitis suppurativa), NASOPHARYNGITIS (Cold), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.            No concomitant medication information was reported. No treatment medication information was reported. After second COVID vaccination, patient had body aches, bad headache and cold. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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 a female patient aged 52 years with relevant medical history of HIDRADENITIS SUPPURATIVA reported, who experienced the unexpected serious (Hospitalization) events of Hidradenitis and Condition aggravated (HIDRADENITIS SUPPURATIVA FLARE UP) that occurred on an unknown date (in October 2021)approximately 2 months after second dose of mRNA-1273 vaccination. Patient had a flare up for which she went to the hospital to had it lanced. She had body ache, headache and cold after 2nd dose. Patient had received initial two doses of mRNA-1273 at an interval of 28 days. No further information on risk factors, concurrent illness, detailed clinical course, investigations, was available in the report. Outcome of the events was not known 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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Significant follow up- Events and seriousness criteria updated.; Sender's Comments: This spontaneous case concerns a female patient aged 52 years with relevant medical history of HIDRADENITIS SUPPURATIVA reported, who experienced the unexpected serious (Hospitalization) events of Hidradenitis and Condition aggravated (HIDRADENITIS SUPPURATIVA FLARE UP) that occurred on an unknown date (in October 2021)approximately 2 months after second dose of mRNA-1273 vaccination. Patient had a flare up for which she went to the hospital to had it lanced. She had body ache, headache and cold after 2nd dose. Patient had received initial two doses of mRNA-1273 at an interval of 28 days. No further information on risk factors, concurrent illness, detailed clinical course, investigations, was available in the report. Outcome of the events was not known 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.