Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Pregnancy in 1973, Pregnancy in 1981, Crohn's disease aggravated, Basal cell carcinoma and Small bowel resection (Two). Family history included Congestive heart failure (Father had Congestive heart failure) and Lung cancer (Mother had Lung cancer). Concurrent medical conditions included Drug allergy, Alcohol use, Non-tobacco user, Hypothyroidism and Vitamin D low. Concomitant products included LEVOTHYROXINE for Hypothyroidism, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN for Multi-vitamin maintenance, VITAMIN D3 for Vitamin D low, METHOTREXATE and FOLIC ACID for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-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) 40MG/0.4ML(40 Milligram, Solution for injection in pre-filled pen). In February 2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) had resolved.            Patient had No Illicit drug use.  The patient had basal cell carcinoma on her nose and forehead that was in the past and she was not sure if it was before being on HUMIRA. Patient said that it popped up about ten years later and patient thought she might be on HUMIRA at that time. Patient had injection site soreness with each. In Jan-2022, patient had sore throat and congestion. Patient was experiencing stress at the thought of having a virtual visit. In Jul-2021, patient was tested positive for COVID-19. Patient had headache, cough, slight fever, nausea and diarrhea if she tried were her symptoms.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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-2021-623610 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Live follow up attached. Event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description updated. On 19-Jan-2022: Live follow up attached. Patient demographics, medical history, suspect drug information, concomitant drug information and narrative description updated. Dose 2 information added. Retaining only the event of vaccination site pain (LLT Vaccination site pain, Nonserious), and remove al the event capture all the rest of the events in dose 2 based on the case narrative.