Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) and HEADACHE (Headache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis. Concurrent medical conditions included Ulcerative colitis. On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2022, received third 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. In June 2022, the patient experienced AGEUSIA (Loss of taste). On 14-Aug-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). In June 2022, AGEUSIA (Loss of taste) had resolved. On 15-Aug-2022, HEADACHE (Headache) had resolved. No concomitant drug information was provided. The causality of the events reported with respective to Humira was not related. It was unknown if the patient was enrolled in COVID-19 vaccine trail. Patient was treated with ADVIL. Company comment: This is a spontaneous case concerning a 28-year-old, male patient with no relevant medical history. The patient has co-suspect medication of Adalimumab (Humira) for ulcerative colitis with unknown therapy dates. The patient experienced the unexpected non-serious AESI event of ageusia, and the unexpected non-serious event of headache. The patient received first and second dose of mRNA-1273 vaccine with dosage interval of 28 days. The patient received third dose (booster) of mRNA-1273 vaccine approximately 223 days after the second dose of mRNA-1273 vaccine administration. The event ageusia occurred the same month with the administration of the third dose (booster) of mRNA-1273 vaccine. The event headache occurred approximately 58 days after the administration of the third dose (booster) of mRNA-1273 vaccine with approximately 1 day duration. On unknown date, the patient was treated with Ibuprofen (Advil) for unspecified event. No further clinical information was available for medical review. The outcome of the events was reported as resolved. The co-suspect medication of Adalimumab (Humira) remain confounder for the event headache. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 28-year-old, male patient with no relevant medical history. The patient has co-suspect medication of Adalimumab (Humira) for ulcerative colitis with unknown therapy dates. The patient experienced the unexpected non-serious AESI event of ageusia, and the unexpected non-serious event of headache. The patient received first and second dose of mRNA-1273 vaccine with dosage interval of 28 days. The patient received third dose (booster) of mRNA-1273 vaccine approximately 223 days after the second dose of mRNA-1273 vaccine administration. The event ageusia occurred the same month with the administration of the third dose (booster) of mRNA-1273 vaccine. The event headache occurred approximately 58 days after the administration of the third dose (booster) of mRNA-1273 vaccine with approximately 1 day duration. On unknown date, the patient was treated with Ibuprofen (Advil) for unspecified event. No further clinical information was available for medical review. The outcome of the events was reported as resolved. The co-suspect medication of Adalimumab (Humira) remain confounder for the event headache. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.