Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PAIN (Pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. There was no reported medical history. Concurrent medical conditions included Crohn's disease. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 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) at an unspecified dose. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PAIN (Pain). At the time of the report, COVID-19 (COVID-19) had resolved and PAIN (Pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2022, SARS-CoV-2 test: (Positive) Positive. Concomitant medication information was not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Reporter causality was reported as not related for the events with respect to HUMIRA (ADALIMUMAB). Treatment information was not provided by the reporter. Company comment: This spontaneous case concerns a 73-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest of COVID-19 after receiving the 3rd dose mRNA-1273 vaccine and suspect drug Adalimumab. It was reported that patient received Adalimumab for moderate to severe Crohn's disease on an unknown date. Patient received mRNA-1273 vaccine as primary on an unspecified date approximately 1 month interval, and 2nd dose was given approximately 8 months prior to the current mRNA-1273 vaccine. The event COVID-19 occurred on the same month of administration of 3rd dose of mRNA-1273 vaccine. Approximately seven months later, SARS-CoV-2 test was reported positive. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. Elderly age of the patient could be considered as a risk factor and current COVID-19 pandemic and suspect drug Adalimumab as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 73-year-old female patient, with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest of COVID-19 after receiving the 3rd dose mRNA-1273 vaccine and suspect drug Adalimumab. It was reported that patient received Adalimumab for moderate to severe Crohn's disease on an unknown date. Patient received mRNA-1273 vaccine as primary on an unspecified date approximately 1 month interval, and 2nd dose was given approximately 8 months prior to the current mRNA-1273 vaccine. The event COVID-19 occurred on the same month of administration of 3rd dose of mRNA-1273 vaccine. Approximately seven months later, SARS-CoV-2 test was reported positive. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. Elderly age of the patient could be considered as a risk factor and current COVID-19 pandemic and suspect drug Adalimumab as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.