Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, COVID-19 immunisation, Hypersomnia, Interchange of vaccine products, Liver injury
Clinical narrative: Psoriasis flare-up/Fatigue; body aches/generalized aching; Vaccination site pain/Sore arm following COVID vaccination; COVID-19; Patient took 2-dose primary series of Pfizer's COVID-19 vaccine/Took 3rd dose of MODERNA COVID-19 VACCINE; Patient took 2-dose primary series of Pfizer's COVID-19 vaccine/Took 3rd dose of MODERNA COVID-19 VACCINE; Liver damage; sleeping as much as 18 hours; This spontaneous case was reported by a consumer and describes the occurrence of LIVER INJURY (Liver damage) in a 27-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 products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 25-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 19-Jan-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient took 2-dose primary series of Pfizer's COVID-19 vaccine/Took 3rd dose of MODERNA COVID-19 VACCINE) and COVID-19 IMMUNISATION (Patient took 2-dose primary series of Pfizer's COVID-19 vaccine/Took 3rd dose of MODERNA COVID-19 VACCINE). In February 2022, the patient experienced COVID-19 (COVID-19). In 2022, the patient experienced LIVER INJURY (Liver damage) (seriousness criterion medically significant) and HYPERSOMNIA (sleeping as much as 18 hours). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/Fatigue), PAIN (body aches/generalized aching) and VACCINATION SITE PAIN (Vaccination site pain/Sore arm following COVID vaccination). At the time of the report, LIVER INJURY (Liver damage), COVID-19 (COVID-19), PSORIASIS (Psoriasis flare-up/Fatigue), INTERCHANGE OF VACCINE PRODUCTS (Patient took 2-dose primary series of Pfizer's COVID-19 vaccine/Took 3rd dose of MODERNA COVID-19 VACCINE), COVID-19 IMMUNISATION (Patient took 2-dose primary series of Pfizer's COVID-19 vaccine/Took 3rd dose of MODERNA COVID-19 VACCINE) and VACCINATION SITE PAIN (Vaccination site pain/Sore arm following COVID vaccination) outcome was unknown, HYPERSOMNIA (sleeping as much as 18 hours) was resolving and PAIN (body aches/generalized aching) had resolved.            Co suspect drug HUMIRA Dose description was reported as Solution for injection in pre-filled pen, Citrate free.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of fatigue, liver damage, sleeping as much as 18 hours, COVID vaccine related issues/second vaccine was the worst, sore arm, COVID 19, plaque psoriasis flare and body aches were not provided with Humira.  No concomitant medications were reported.  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  CC: This spontaneous case concerns a 27-year-old, female patient with a concurrent condition of chronic plaque psoriasis treated with adalimumab, who experienced an unexpected, medically significant AESI Liver injury and an unexpected, non-serious AESI COVID-19 in association with a 3rd dose of mRNA-1273 vaccine. Event liver injury reportedly occurred with hypersomnia within the same year as her 3rd COVID-19 vaccination. Event COVID-19 occurred the following month post-vaccination with mRNA-1273 vaccine. Patient experienced fatigue, sore arm following COVID-19 vaccination, plaque psoriasis flare, and body aches on unknown dates. Vaccination history included a 2-dose primary series of Pfizer's COVID-19 vaccine, given approximately 10 months before receiving a 3rd dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying chronic plaque psoriasis and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow up document contains patient demographics, event information, reporter opinion of causality, suspect drug information and narrative description were updated.; Sender's Comments: This spontaneous case concerns a 27-year-old, female patient with a concurrent condition of chronic plaque psoriasis treated with adalimumab, who experienced an unexpected, medically significant AESI Liver injury and an unexpected, non-serious AESI COVID-19 in association with a 3rd dose of mRNA-1273 vaccine. Event liver injury reportedly occurred with hypersomnia within the same year as her 3rd COVID-19 vaccination. Event COVID-19 occurred the following month post-vaccination with mRNA-1273 vaccine. Patient experienced fatigue, sore arm following COVID-19 vaccination, plaque psoriasis flare, and body aches on unknown dates. Vaccination history included a 2-dose primary series of Pfizer's COVID-19 vaccine, given approximately 10 months before receiving a 3rd dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying chronic plaque psoriasis and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.