Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye pain, Fatigue, Ocular hyperaemia, Therapeutic response shortened
Clinical narrative: Wearing off effect; Tiredness; Arthralgia aggravated; Eye redness; Eye pain; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Eye redness), EYE PAIN (Eye pain), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), ARTHRALGIA (Arthralgia aggravated) and FATIGUE (Tiredness) in a 62-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 Panuveitis and Ankylosing spondylitis.    The patient's past medical history included Cigarette smoker (TOBACCO USE FIVE CIGARETTES IN A DAY) from 1975 to 2010 and Alcohol use (ALCOHOL OCCASIONALLY) from 1975 to 2005. Concurrent medical conditions included Allergy, Milk allergy (DAIRY ALLERGY MANIFESTED BY CHEST HURTS), Celiac disease since 2019, Constipation, Gastrooesophageal reflux disease, Panuveitis and Ankylosing spondylitis. Concomitant products included CETIRIZINE for Allergy, DOCUSATE for Constipation, OMEPRAZOLE for Gastrooesophageal reflux disease.   In August 2019, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40MG/0.4ML(40 Milligram) (1 in 1 wk). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 10-Dec-2021, the patient experienced OCULAR HYPERAEMIA (Eye redness), EYE PAIN (Eye pain) and ARTHRALGIA (Arthralgia aggravated). On an unknown date, the patient experienced THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and FATIGUE (Tiredness). At the time of the report, OCULAR HYPERAEMIA (Eye redness), EYE PAIN (Eye pain) and ARTHRALGIA (Arthralgia aggravated) had not resolved and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and FATIGUE (Tiredness) outcome was unknown.            It was reported that, patient had other concomitant therapy of NSAIDs. Humira seemed to wear off too early/wears off two days before shot. Patient experienced worsened joint pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided.  Company Comment: This is a spontaneous case concerning a 62-year-old female patient with intake of the co-suspect, non-company product Adalimumab (Humira) as treatment for Panuveitis and Ankylosing spondylitis, who experienced the unexpected, non-serious, events of Ocular Hyperemia, Eye Pain, and the expected, non-serious events of Arthralgia and Fatigue. This is also a case of Therapeutic Response Shortened (reported as "Humira seemed to wear off too early/wears off two days"). The events Ocular Hyperemia, Eye Pain, and Arthralgia occurred on an unknown interval (no vaccination date was provided) after receiving a dose of mRNA-1273 Vaccine and the co-suspect, non-company product Adalimumab (Humira) while Therapeutic Response Shortened and Fatigue occurred on an unknown interval. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The reported outcome of Ocular Hyperemia, Eye Pain, and Arthralgia has not resolved while the rest was unknown unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 62-year-old female patient with intake of the co-suspect, non-company product Adalimumab (Humira) as treatment for Panuveitis and Ankylosing spondylitis, who experienced the unexpected, non-serious, events of Ocular Hyperemia, Eye Pain, and the expected, non-serious events of Arthralgia and Fatigue. This is also a case of Therapeutic Response Shortened (reported as "Humira seemed to wear off too early/wears off two days"). The events Ocular Hyperemia, Eye Pain, and Arthralgia occurred on an unknown interval (no vaccination date was provided) after receiving a dose of mRNA-1273 Vaccine and the co-suspect, non-company product Adalimumab (Humira) while Therapeutic Response Shortened and Fatigue occurred on an unknown interval. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The reported outcome of Ocular Hyperemia, Eye Pain, and Arthralgia has not resolved while the rest was unknown unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.