Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site bruising, Injection site pain, Limb discomfort, Muscular weakness
Clinical narrative: Injection site bruising; Injection site pain; Injection site tenderness; Weakness; Weakness of arms; Heaviness in arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Injection site bruising), ASTHENIA (Weakness), MUSCULAR WEAKNESS (Weakness of arms), LIMB DISCOMFORT (Heaviness in arm) and INJECTION SITE PAIN (Injection site pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and ADALIMUMAB (HUMIRA) for Crohn's disease.    Previously administered products included for Product used for unknown indication: ZOLOFT (Zoloft allergy manifested by depression), CIPRO [CIPROFLOXACIN] (Cipro allergy manifested by vomiting) and BACTRIM (Bactrim allergy manifested by vomiting). Past adverse reactions to the above products included Depression with ZOLOFT; and Vomiting with BACTRIM and CIPRO [CIPROFLOXACIN]. Concurrent medical conditions included Smoker (About 20 cigarettes per day (started 2009)), Alcohol use (A dhot of liquor once or twice a month), Perianal discomfort (Perianal disease), Crohn's aggravated (Crohn's flare up), Topical adhesive allergy (Adhesive allergy manifested by burning and itching on skin), Allergic reaction to antibiotics (Cipro allergy manifested by vomiting), Allergic reaction to antibiotics (Bactrim allergy manifested by vomiting) and Drug allergy (Zoloft allergy manifested by depression). Concomitant products included BUSPIRONE for Anxiety, PREDNISONE for Crohn's disease, PANTOPRAZOLE for Hyperacidity, BACLOFEN for Spasms.   On 01-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. On 11-Nov-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram twice a day. On 25-Nov-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 80 milligram twice a day. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 01-Jul-2021, the patient experienced ASTHENIA (Weakness), MUSCULAR WEAKNESS (Weakness of arms), LIMB DISCOMFORT (Heaviness in arm) and INJECTION SITE PAIN (Injection site tenderness). On 11-Nov-2021, the patient experienced INJECTION SITE BRUISING (Injection site bruising) and INJECTION SITE PAIN (Injection site pain). In 2021, INJECTION SITE PAIN (Injection site pain) had resolved. On 04-Jul-2021, INJECTION SITE PAIN (Injection site tenderness) had resolved. In July 2021, ASTHENIA (Weakness), MUSCULAR WEAKNESS (Weakness of arms) and LIMB DISCOMFORT (Heaviness in arm) had resolved. At the time of the report, INJECTION SITE BRUISING (Injection site bruising) was resolving.     On 01-Jul-2021, the patient experienced reoccurred weakness, injection site tenderness recurred, and arms felt heavy and dead recurred. On 04-Jul-2021, the injection site tenderness recurred resolved. In July 2021, the reoccurred weakness, arms felt heavy and dead recurred, arms felt heavy and dead recurred, and arms felt heavy, and dead resolved.  In 2021, the injection site burning/injection site pain resolved  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Humira 40mg/0.4ml (Adalimumab) for the events of weakness, reoccurred weakness, injection site tenderness, injection site tenderness, recurred, arms felt heavy and dead, recurred, arms felt heavy and dead, recurred, and arms felt heavy and dead onset 01-Jul-2021 was not provided. The reporter's causality for the event of injection site burning/injection site pain with Humira 40mg/0.4ml (Adalimumab) was no reasonable possibility.   The reporter's causality for Humira 80mg/0.8ml (Adalimumab) for the events of weakness, reoccurred weakness, injection site burning/injection site pain, injection site tenderness, injection site tenderness, recurred, arms felt heavy and dead, recurred, arms felt heavy and dead, recurred, and arms felt heavy and dead onset 01-Jul-2021 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.   This case was linked to MOD-2021-626038 (Patient Link).