Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Exposure to SARS-CoV-2, Headache, Nasopharyngitis, Pain
Clinical narrative: Exposure to COVID-19/ Patient had been around people that were covid 19 positive; Suspected COVID-19/ Neighbor was diagnosed with covid/patient felt had it; Coughing; Cold symptoms; General body pain; Headache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposure to COVID-19/ Patient had been around people that were covid 19 positive), SUSPECTED COVID-19 (Suspected COVID-19/ Neighbor was diagnosed with covid/patient felt had it), COUGH (Coughing), NASOPHARYNGITIS (Cold symptoms) and PAIN (General body pain) in an adult 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) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 15-Apr-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to COVID-19/ Patient had been around people that were covid 19 positive), SUSPECTED COVID-19 (Suspected COVID-19/ Neighbor was diagnosed with covid/patient felt had it), COUGH (Coughing), NASOPHARYNGITIS (Cold symptoms), PAIN (General body pain), HEADACHE (Headache) and PYREXIA (Low grade fever). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposure to COVID-19/ Patient had been around people that were covid 19 positive), SUSPECTED COVID-19 (Suspected COVID-19/ Neighbor was diagnosed with covid/patient felt had it) and COUGH (Coughing) outcome was unknown and NASOPHARYNGITIS (Cold symptoms), PAIN (General body pain), HEADACHE (Headache) and PYREXIA (Low grade fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported.  The reporter's causality for the event(s) of PATIENT HAD BEEN AROUND PEOPLE THAT WERE COVID 19 POSITIVE, COUGHING, COLD SYMPTOMS, NEIGHBOR WAS DIAGNOSED WITH COVID/PATIENT FELT HAD IT/SUSPECTED COVID 19, HEADACHE, BODY PAIN/ACHE and LOW GRADE FEVER was not provided.  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  No treatment medications were reported.  Company comment: This spontaneous case concerns an adult female patient of unspecified age with concurrent medical condition of Psoriatic arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, non-serious AESI of Suspected COVID-19 and non-serious event of Exposure to SARS-CoV-2 that occurred in context to first dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. Patient experienced other events of Cough, Nasopharyngitis, pain, Headache and Pyrexia which remains the symptoms for suspected COVID-19. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was resolving. The Concurrent medical condition of Psoriatic arthritis that was treated with Adalimumab (Humira) the co-suspect and ongoing pandemic of COVID -19 remains a confounder to the event arthritis. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. Sender's Comments: This spontaneous case concerns an adult female patient of unspecified age with concurrent medical condition of Psoriatic arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, non-serious AESI of Suspected COVID-19 and non-serious event of Exposure to SARS-CoV-2 that occurred in context to first dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. Patient experienced other events of Cough, Nasopharyngitis, pain, Headache and Pyrexia which remains the symptoms for suspected COVID-19. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was resolving. The Concurrent medical condition of Psoriatic arthritis that was treated with Adalimumab (Humira) the co-suspect and ongoing pandemic of COVID -19 remains a confounder to the event arthritis. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.