Age: 22.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Device issue, Diarrhoea, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Device issue/ HAD A HUMIRA PEN MISFIRED AND GOT MEDICATION ON SKIN; Dose-1-21-APR-2021 and Dose-2-28 May-2021; PAIN AT THE INJECTION SITE; Loose stools/ INCREASED FREQUENCY LOOSE STOOLS; LOT OF STRESS; Inflammation; Fatigue; Headache; Fatigue/ EXHAUSTED; Vaccination site pain/ SORE ARM AT INJECTION SITE; General body pain/ FULL BODY ACHES; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain/ FULL BODY ACHES), STRESS (LOT OF STRESS), INFLAMMATION (Inflammation), DEVICE ISSUE (Device issue/ HAD A HUMIRA PEN MISFIRED AND GOT MEDICATION ON SKIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-APR-2021 and Dose-2-28 May-2021) in a 22-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 Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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) at an unspecified dose. In May 2021, the patient experienced PAIN (General body pain/ FULL BODY ACHES), VACCINATION SITE PAIN (Vaccination site pain/ SORE ARM AT INJECTION SITE), HEADACHE (Headache) and FATIGUE (Fatigue/ EXHAUSTED). In August 2021, the patient experienced STRESS (LOT OF STRESS), INFLAMMATION (Inflammation), DIARRHOEA (Loose stools/ INCREASED FREQUENCY LOOSE STOOLS) and FATIGUE (Fatigue). On an unknown date, the patient experienced DEVICE ISSUE (Device issue/ HAD A HUMIRA PEN MISFIRED AND GOT MEDICATION ON SKIN), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-APR-2021 and Dose-2-28 May-2021) and INJECTION SITE PAIN (PAIN AT THE INJECTION SITE). In 2021, PAIN (General body pain/ FULL BODY ACHES), STRESS (LOT OF STRESS), INFLAMMATION (Inflammation), DIARRHOEA (Loose stools/ INCREASED FREQUENCY LOOSE STOOLS), VACCINATION SITE PAIN (Vaccination site pain/ SORE ARM AT INJECTION SITE), FATIGUE (Fatigue), HEADACHE (Headache) and FATIGUE (Fatigue/ EXHAUSTED) had resolved. At the time of the report, DEVICE ISSUE (Device issue/ HAD A HUMIRA PEN MISFIRED AND GOT MEDICATION ON SKIN), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-APR-2021 and Dose-2-28 May-2021) and INJECTION SITE PAIN (PAIN AT THE INJECTION SITE) had resolved.      It was reported that on an unknown date, the patient had a Humira Pen misfired and got medication on skin (device issue) and which cause the pain at the injection site.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna.  There was no reported medical history.   Concomitant medication was not provided.  No information regarding treatment medication was provided.