Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Eye pain, Fatigue, Headache
Clinical narrative: FLARE UP OF HIDRADENITIS SUPPURATIVA ON INNER THIGH/BUTTOCKS/UNDER ARMS/Stage three hidradenitis suppurativa flare up with drainage from right under arm, buttocks and inner thigh; FLARE UP OF HIDRADENITIS SUPPURATIVA ON INNER THIGH/BUTTOCKS/UNDER ARMS/Stage three hidradenitis suppurativa flare up with drainage from right under arm, buttocks and inner thigh; Restlessness; Pain; eyes hurt from light; Chills; Fatigue; Headache/SEVERE HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (FLARE UP OF HIDRADENITIS SUPPURATIVA ON INNER THIGH/BUTTOCKS/UNDER ARMS/Stage three hidradenitis suppurativa flare up with drainage from right under arm, buttocks and inner thigh) in a 28-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) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2021, received third 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) Daily dose: CF, Solution for injection in pre-filled pen. In 2022, the patient experienced HEADACHE (Headache/SEVERE HEADACHE). On an unknown date, the patient experienced HIDRADENITIS (FLARE UP OF HIDRADENITIS SUPPURATIVA ON INNER THIGH/BUTTOCKS/UNDER ARMS/Stage three hidradenitis suppurativa flare up with drainage from right under arm, buttocks and inner thigh) (seriousness criterion medically significant), CONDITION AGGRAVATED (FLARE UP OF HIDRADENITIS SUPPURATIVA ON INNER THIGH/BUTTOCKS/UNDER ARMS/Stage three hidradenitis suppurativa flare up with drainage from right under arm, buttocks and inner thigh), RESTLESSNESS (Restlessness), PAIN (Pain), EYE PAIN (eyes hurt from light), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, HIDRADENITIS (FLARE UP OF HIDRADENITIS SUPPURATIVA ON INNER THIGH/BUTTOCKS/UNDER ARMS/Stage three hidradenitis suppurativa flare up with drainage from right under arm, buttocks and inner thigh) and CONDITION AGGRAVATED (FLARE UP OF HIDRADENITIS SUPPURATIVA ON INNER THIGH/BUTTOCKS/UNDER ARMS/Stage three hidradenitis suppurativa flare up with drainage from right under arm, buttocks and inner thigh) had not resolved and RESTLESSNESS (Restlessness), PAIN (Pain), EYE PAIN (eyes hurt from light), HEADACHE (Headache/SEVERE HEADACHE), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Company comment : This spontaneous case concerns a 28-year-old, female patient with medical history of Moderate-to-severe Hidradenitis suppurativa treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) event of hidradenitis suppurativa flare-up, and other unexpected and expected, non-serious events. The event hidradenitis suppurativa flare-up occurred unknown number of days after receiving Humira and unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not reported and the event onset date was not provided, hence, the onset latency could not be assessed. The start date of the non-serious event headache was reported as unspecified date in 2022, hence, the onset latency could not be assessed. The start dates of the other events were not provided, hence, the onset latency also could not be assessed. It was reported that the patient experienced Stage 3 Hidradenitis suppurativa flare-up with drainage from the right under arm, buttocks and inner thigh. She also experienced severe headache, chills, pain, fatigue, restlessness, and her eyes hurt from the light. Treatment information was not provided. However, approximately 3 months after vaccination, the patient underwent surgery on her left axilla. The event hidradenitis suppurativa flare-up had not resolved at the time of the report. The medical history of Hidradenitis suppurativa, a chronic skin condition characterized by flare-ups, remains a confounder for the event hidradenitis suppurativa flare-up. The co-suspect product Humira also remains a confounder for the reported events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Concomitant drugs were not reported.  The reporter's causality for the event of flare up of hidradenitis suppurativa on inner thigh/ buttocks/ under arms with Humira(Adalimumab) was a reasonable possibility. The reporter's causality for the event of headache with Humira(adalimumab) was no reasonable possibility.  On 01-Apr-2022, the patient had surgery on left arm pit. Patient had stage three hidradenitis suppurativa flare up with drainage from right under arm, buttocks and inner thigh. Patient had a reaction of severe headache, chills, pain, fatigue, restlessness and eyes hurt from light after Moderna booster vaccine shot. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Events Chills, Fatigue, Restlessness, Pain and Eye pain was added. Vaccine administration dates updated. Lot number of non-company suspect added.; Sender's Comments: This spontaneous case concerns a 28-year-old, female patient with medical history of Moderate-to-severe Hidradenitis suppurativa treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) event of hidradenitis suppurativa flare-up, and other unexpected and expected, non-serious events. The event hidradenitis suppurativa flare-up occurred unknown number of days after receiving Humira and unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not reported and the event onset date was not provided, hence, the onset latency could not be assessed. The start date of the non-serious event headache was reported as unspecified date in 2022, hence, the onset latency could not be assessed. The start dates of the other events were not provided, hence, the onset latency also could not be assessed. It was reported that the patient experienced Stage 3 Hidradenitis suppurativa flare-up with drainage from the right under arm, buttocks and inner thigh. She also experienced severe headache, chills, pain, fatigue, restlessness, and her eyes hurt from the light. Treatment information was not provided. However, approximately 3 months after vaccination, the patient underwent surgery on her left axilla. The event hidradenitis suppurativa flare-up had not resolved at the time of the report. The medical history of Hidradenitis suppurativa, a chronic skin condition characterized by flare-ups, remains a confounder for the event hidradenitis suppurativa flare-up. The co-suspect product Humira also remains a confounder for the reported events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.