Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, SARS-CoV-2 antibody test
Clinical narrative: Injection site stinging; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PAIN (Injection site stinging) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Depression, Hypothyroidism, Blood pressure high, Migraine, Non-smoker, Abstains from alcohol, Penicillin allergy (Hives), Allergy to antibiotic (Hives), Drug allergy (throat swelling, increased blood pressure, increased heart rate and felt like a heart attack), Allergy to antibiotic (Hives) and Rheumatoid arthritis. Concomitant products included MONTELUKAST SODIUM and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, LOSARTAN POTASSIUM for Blood pressure high, VENLAFAXINE for Depression, LEVOTHYROXINE SODIUM for Hypothyroidism, TOPIRAMATE for Migraine, DESMOPRESSIN ACETATE, ATORVASTATIN, METHOTREXATE, FOLIC ACID and TRAZODONE for an unknown indication.   In May 2016, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg every two weeks. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site stinging). At the time of the report, INJECTION SITE PAIN (Injection site stinging) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, SARS-CoV-2 antibody test: negative (Negative) Did not develop antibody for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication desmopressin acetate indication was reported as "urine." No treatment medication was reported.  The patient reported COVID-19 antibody test negative (10084495) SARS-CoV-2 antibody test negative (10084509); which was captured as a Lab data as per, not having MEASURABLE antibodies is neither an adverse event nor an evidence of therapeutic failure; as per there is no specific threshold considered protective for COVID-19 vaccines, there are multiple methods to measure antibodies (with different threshold sensitivity), antibodies measurement might be IgG, IgM, total, or anti-spike antibodies. The method of measuring antibodies is not explained in narrative and rapid methods are unreliable. Immunosuppressed patients often do not develop antibody response to vaccines and that is not considered AE of the vaccine.  For the event, injection site pain, based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: For the event, injection site pain, based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.