Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Headache, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Extremities burning sensation of/Fatigue/Sore And Arm On Fire/Fatigue After Covid-19 Shot; Vaccination site pain; Fatigue/Sore And Arm On Fire/Fatigue After Covid-19 Shot; Patient took first dose of Moderna on 01-Mar-2021, second dose on 01-May-2021.; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), BURNING SENSATION (Extremities burning sensation of/Fatigue/Sore And Arm On Fire/Fatigue After Covid-19 Shot), VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Fatigue/Sore And Arm On Fire/Fatigue After Covid-19 Shot) and HEADACHE (Headache) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    There was no reported medical history.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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) UNK, Citrate free. On 05-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). On 01-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose of Moderna on 01-Mar-2021, second dose on 01-May-2021.). In 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced BURNING SENSATION (Extremities burning sensation of/Fatigue/Sore And Arm On Fire/Fatigue After Covid-19 Shot), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue/Sore And Arm On Fire/Fatigue After Covid-19 Shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 21-May-2021, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) had resolved. At the time of the report, BURNING SENSATION (Extremities burning sensation of/Fatigue/Sore And Arm On Fire/Fatigue After Covid-19 Shot), VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Fatigue/Sore And Arm On Fire/Fatigue After Covid-19 Shot), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose of Moderna on 01-Mar-2021, second dose on 01-May-2021.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: (Positive) Positive.   No concomitant medication details were provided.   Dosage form for HUMIRA was reported as Solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of vaccination site pain was no reasonable possibility and was not reported with other events.  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.   This case was linked to MOD-2022-623984 (Patient Link).