Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, COVID-19 pneumonia, Illness, Inappropriate schedule of product administration
Clinical narrative: pustules on both arms; DEVELOPEMENT OF PLAQUE PSORIASIS; COVID; Knuckles hurt; COVID PNEUMONIA; sicker than everyone else, felt extremely not well; Patient received first dose of Moderna vaccine on 27-Oct-2021 and second dose of Moderna vaccine on 29-Mar-2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID PNEUMONIA) in a 61-year-old male patient who received mRNA-1273 (Spikevax) 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 Crohn's disease and Fatigue extreme.    Concurrent medical conditions included Crohn's disease (Moderate to Severe Adult Crohn's Disease) and Fatigue extreme.   On 27-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 29-Mar-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 30-Sep-2022, received third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 27-Oct-2021 and second dose of Moderna vaccine on 29-Mar-2022). In August 2022, the patient experienced COVID-19 PNEUMONIA (COVID PNEUMONIA) (seriousness criterion medically significant) and ILLNESS (sicker than everyone else, felt extremely not well). On an unknown date, the patient experienced PUSTULE (pustules on both arms), PSORIASIS (DEVELOPEMENT OF PLAQUE PSORIASIS), COVID-19 (COVID) and ARTHRALGIA (Knuckles hurt). In 2022, COVID-19 PNEUMONIA (COVID PNEUMONIA) had resolved. At the time of the report, ILLNESS (sicker than everyone else, felt extremely not well), PUSTULE (pustules on both arms), PSORIASIS (DEVELOPEMENT OF PLAQUE PSORIASIS), COVID-19 (COVID), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 27-Oct-2021 and second dose of Moderna vaccine on 29-Mar-2022) and ARTHRALGIA (Knuckles hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.         No concomitant medication information was reported.    With respect to Moderna COVID-19 vaccine, the reporter causality for the events of COVID pneumonia, knuckles hurt and sicker than everyone else was provided as reasonable possibility.  With respect to co-suspect Humira (adalimumab) solution for injection, the reporter causality for the events of COVID, development of plaque psoriasis, felt extremely not well, knuckles hurt, sicker than everyone else and pustules on both arms was not provided and that of COVID pneumonia was reported as reasonable possibility.  No treatment medication information was reported.  Company comment: This spontaneous case concerns a 61-year-old male patient with relevant concurrent condition of Chron´s disease treated with Adalimumab (reported as co-suspect), who experienced the unexpected serious (medically significant) event of COVID-19 pneumonia along with other non-serious events such as illness, arthralgia, pustules and psoriasis, after receiving two doses of mRNA-1273 vaccine given as first and second doses (in an inappropriate interval-approximately 5 months). Details of symptoms, clinical course, investigation reports and treatment were not provided. The current pandemic situation of COVID-19 could be a confounder. Elderly age of the patient and treatment with Adalimumab remains as possible risk factors. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.