Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic steatosis, Hidradenitis, Increased tendency to bruise, Injection site pain, Loss of consciousness
Clinical narrative: Hidradenitis suppurativa / HIDRADENITIS SUPPURATIVA FLARE; Increased tendency to bruise / BRUISES EASILY; Appetite absent / NO APPETITE; Fatigue; Pain during injection / PAINFUL INJECTION; Fatty liver / FATTY LIVER SPOTS; Exhaustion / EXHAUSTED; Bruise / BLACK AND BLUE; Passed out; Abdominal pain / INTENSE ABDOMINAL PAIN SO SEVERE THAT PATIENT PASSES OUT; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 42-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.    The patient's past medical history included Hidradenitis suppurativa. Concurrent medical conditions included Foot injury (SHATTERED RIGHT FOOT) since 2019.   On 02-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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In November 2020, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and ABDOMINAL PAIN (Abdominal pain / INTENSE ABDOMINAL PAIN SO SEVERE THAT PATIENT PASSES OUT). In May 2021, the patient experienced FATIGUE (Exhaustion / EXHAUSTED). In 2021, the patient experienced CONTUSION (Bruise / BLACK AND BLUE). In November 2021, the patient experienced HEPATIC STEATOSIS (Fatty liver / FATTY LIVER SPOTS) and INJECTION SITE PAIN (Pain during injection / PAINFUL INJECTION). On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa / HIDRADENITIS SUPPURATIVA FLARE), INCREASED TENDENCY TO BRUISE (Increased tendency to bruise / BRUISES EASILY), DECREASED APPETITE (Appetite absent / NO APPETITE) and FATIGUE (Fatigue). In 2021, FATIGUE (Exhaustion / EXHAUSTED) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HEPATIC STEATOSIS (Fatty liver / FATTY LIVER SPOTS), CONTUSION (Bruise / BLACK AND BLUE), HIDRADENITIS (Hidradenitis suppurativa / HIDRADENITIS SUPPURATIVA FLARE), INCREASED TENDENCY TO BRUISE (Increased tendency to bruise / BRUISES EASILY), DECREASED APPETITE (Appetite absent / NO APPETITE), ABDOMINAL PAIN (Abdominal pain / INTENSE ABDOMINAL PAIN SO SEVERE THAT PATIENT PASSES OUT), FATIGUE (Fatigue) and INJECTION SITE PAIN (Pain during injection / PAINFUL INJECTION) outcome was unknown.               No concomitant medications were provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient received HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB). The patient had four special needs children who she had physical interactions with.  The reporter's causality for the event(s) of intense abdominal pain so severe that patient passes out onset in November 2020, intense abdominal pain so severe that patient passes out onset in November 2020, fatty liver spots, elevated alanine transaminase, exhausted, painful injection, black and blue, hidradenitis suppurativa flare, lost 40 pounds, bruises easily, no appetite and fatigue was not provided.  No treatment medications were provided by the reporter.  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 42 years with no relevant medical history reported, who experienced unexpected serious (medically significant) event of Loss of consciousness that occurred on unknown date in Nov.2020 in the context of mRNA-1273 vaccine. Patient had intense abdominal pain, it was so severe patient passes out. No further information on detailed clinical course, lab investigations, treatment received was available in the report. Outcome of the event was not known at the time of report. Patient had received two doses of same vaccine at an interval of one month. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient aged 42 years with no relevant medical history reported, who experienced unexpected serious (medically significant) event of Loss of consciousness that occurred on unknown date in Nov.2020 in the context of mRNA-1273 vaccine. Patient had intense abdominal pain, it was so severe patient passes out. No further information on detailed clinical course, lab investigations, treatment received was available in the report. Outcome of the event was not known at the time of report. Patient had received two doses of same vaccine at an interval of one month. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.