Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Mycobacterium tuberculosis complex test, Ultrasound liver, Vomiting
Clinical narrative: Coughing; Fatigue; Vomited; Recurred injection site pain due to COVID-19 vaccination; Recurred headache due to COVID-19 vaccination; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Coughing), INJECTION SITE PAIN (Recurred injection site pain due to COVID-19 vaccination), HEADACHE (Recurred headache due to COVID-19 vaccination), FATIGUE (Fatigue) and VOMITING (Vomited) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037KZ0A) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Rheumatoid arthritis and METHOTREXATE for Psoriasis.    The patient's past medical history included Cyst ovary from April 2020 to September 2020, Appendicitis in January 2015, Psoriasis in 2016, Shingles from November 2020 to December 2020, Fatigue, Appendectomy in January 2015, Hysterectomy on 30-Jun-2020 and Colonoscopy (Vomited during colonoscopy procedure) in March 2021. Concurrent medical conditions included Diabetes since 2016, Fatty liver and Drug allergy (Sulfa drugs allergy associated with manifestations of itching and burning skin). Concomitant products included DOXYCYCLINE for Folliculitis, LIDOCAINE from September 2020 to October 2020 for Shingles.   In 2010, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. In July 2010, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg every two weeks. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-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 METHOTREXATE (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE PAIN (Recurred injection site pain due to COVID-19 vaccination) and HEADACHE (Recurred headache due to COVID-19 vaccination). In March 2021, the patient experienced VOMITING (Vomited). On an unknown date, the patient experienced COUGH (Coughing) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; EXENATIDE (BYDUREON BCISE) at an unspecified dose and frequency and METFORMIN at an unspecified dose and frequency. On 30-Jan-2021, INJECTION SITE PAIN (Recurred injection site pain due to COVID-19 vaccination) and HEADACHE (Recurred headache due to COVID-19 vaccination) had resolved. At the time of the report, COUGH (Coughing), FATIGUE (Fatigue) and VOMITING (Vomited) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2012, Weight: increased (High) Weight gain. In January 2015, Abdominal X-ray: abnormal (abnormal) Confirmed Appendicitis. In January 2015, Computerised tomogram abdomen: abnormal (abnormal) Confirmed Appendicitis. In 2016, Glycosylated haemoglobin: abnormal (abnormal) Diabetes. In 2017, Ultrasound liver: abnormal (abnormal) Elevated liver enzyme. On an unknown date, Mycobacterium tuberculosis complex test: false positive (Inconclusive) False positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-MAY-2021 contains no new information.