Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Musculoskeletal disorder
Clinical narrative: Lower extremity dysfunction/Feet lasting for about an hour; Ankle arthropathy/Ankle lasting for about an hour; Dizziness; Injection site itching; Fatigue; Headache; Recurrent injection site bruising; Injection site bruising; Injection site itching; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Recurrent injection site bruising), MUSCULOSKELETAL DISORDER (Lower extremity dysfunction/Feet lasting for about an hour), ARTHROPATHY (Ankle arthropathy/Ankle lasting for about an hour), INJECTION SITE BRUISING (Injection site bruising) and DIZZINESS (Dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) 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.    Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE NRVV AD26 (Route of administration: Intra-muscular Batch number:041A21A) on 02-Apr-2021. Past adverse reactions to the above products included No adverse reaction with COVID-19 VACCINE NRVV AD26.   On 29-Sep-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 11-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced the first episode of INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE ERYTHEMA (Injection site redness). On 11-Nov-2021, the patient experienced INJECTION SITE BRUISING (Injection site bruising). On 24-Nov-2021, the patient experienced INJECTION SITE BRUISING (Recurrent injection site bruising). On an unknown date, the patient experienced MUSCULOSKELETAL DISORDER (Lower extremity dysfunction/Feet lasting for about an hour), ARTHROPATHY (Ankle arthropathy/Ankle lasting for about an hour), DIZZINESS (Dizziness), the second episode of INJECTION SITE PRURITUS (Injection site itching), FATIGUE (Fatigue) and HEADACHE (Headache). On 10-Nov-2021, INJECTION SITE ERYTHEMA (Injection site redness) had resolved. In November 2021, INJECTION SITE BRUISING (Injection site bruising) had resolved. At the time of the report, INJECTION SITE BRUISING (Recurrent injection site bruising) was resolving, MUSCULOSKELETAL DISORDER (Lower extremity dysfunction/Feet lasting for about an hour), ARTHROPATHY (Ankle arthropathy/Ankle lasting for about an hour), the last episode of INJECTION SITE PRURITUS (Injection site itching), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved and DIZZINESS (Dizziness) had not resolved.            On 10 Nov 2021, the patient experienced removed cap 1 first followed by cap 2 without twisting/waited for 4 to 5 seconds before lifted the pen/ more medication end up on top of the injection site/received a partial injection(Wrong injection technique), fluid around injection site/unsure if got full dose/felt like pen did not fully inject/yellow flag all the way down(Inappropriate dose of drug administered) (Device issue) and outcome for the events was unknown. The reporter's causality for the event(s) of fatigue, dizziness, itching around injection site, headache, injection site redness and injection site itchiness with Humira 40MG/0.4ML(Adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of feet lasting for about an hour, removed cap 1 first followed by cap 2 without twisting/waited for 4 to 5 seconds before lifted the pen/ more medication end up on top of the injection site/received a partial injection, fluid around injection site/unsure if got full dose/felt like pen did not fully inject/yellow flag all the way down onset 10 Nov 2021, fluid around injection site/unsure if got full dose/felt like pen did not fully inject/yellow flag all the way down onset 10 Nov 2021 and ankle lasting for about an hour was not provided. The reporter's causality for the event(s) of recurrent injection site bruising and injection site bruising with Humira 40mg/0.4ml(Adalimumab) was no reasonable possibility.  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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow up report received and Added product and event information.