Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, SARS-CoV-2 test, Vaccination site bruising, Vaccination site irritation
Clinical narrative: Extremities burning sensation of; Vaccination site pain/Sore and arm on fire; Fatigue; Injection site irritation; Injection site bruising; Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Injection site irritation), VACCINATION SITE BRUISING (Injection site bruising), BURNING SENSATION (Extremities burning sensation of), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Vaccination site pain/Sore and arm on fire) in an 18-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 product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   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 06-Jan-2022, 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 February 2022, the patient experienced VACCINATION SITE BRUISING (Injection site bruising) and VACCINATION SITE PRURITUS (Injection site itching). On 16-Feb-2022, the patient experienced VACCINATION SITE IRRITATION (Injection site irritation). On an unknown date, the patient experienced BURNING SENSATION (Extremities burning sensation of), VACCINATION SITE PAIN (Vaccination site pain/Sore and arm on fire) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE IRRITATION (Injection site irritation) was resolving and VACCINATION SITE BRUISING (Injection site bruising), BURNING SENSATION (Extremities burning sensation of), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Vaccination site pain/Sore and arm on fire) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: (Positive) Positive.         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 concomitant medication was provided. Humira daily dose was reported as Citrate free. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of injection area irritation/bruises/itching onset 16 Feb 2022 with  HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of injection area irritation/bruises/itching onset in February 2022, injection area irritation/bruises/itching onset in February 2022, sore and arm on fire/fatigue after COVID-19 SHOT unknown onset, sore and arm on fire/fatigue after COVID-19 SHOT unknown onset, headache after both COVID-19 SHOTS and COVID-19 positive was not provided. The reporter's causality for the events of sore and arm on fire/fatigue after COVID-19 SHOT unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility.   This case was linked to MOD-2022-624712 (Patient Link).