Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tympanic membrane perforation, Upper respiratory tract infection
Clinical narrative: Pneumonia; Ulcerative colitis; RUPTURED EAR DRUM; UPPER RESPIRATORY INFECTION; Extreme pain; contracted covid-19 third time; Second dose on 07-May-2021 and Booster dose on 07-Sep-2021; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and COLITIS ULCERATIVE (Ulcerative colitis) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    Concurrent medical conditions included Panuveitis.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, 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. On 07-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 07-May-2021 and Booster dose on 07-Sep-2021). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), COLITIS ULCERATIVE (Ulcerative colitis) (seriousness criterion medically significant), TYMPANIC MEMBRANE PERFORATION (RUPTURED EAR DRUM), UPPER RESPIRATORY TRACT INFECTION (UPPER RESPIRATORY INFECTION), PAIN (Extreme pain) and COVID-19 (contracted covid-19 third time). At the time of the report, PNEUMONIA (Pneumonia), TYMPANIC MEMBRANE PERFORATION (RUPTURED EAR DRUM) and UPPER RESPIRATORY TRACT INFECTION (UPPER RESPIRATORY INFECTION) had resolved, COLITIS ULCERATIVE (Ulcerative colitis) had not resolved and PAIN (Extreme pain), COVID-19 (contracted covid-19 third time) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 07-May-2021 and Booster dose on 07-Sep-2021) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.  Causality of pain aggravated with Humira was reported as Probable, Ulcerative colitis, Upper respiratory infection, Ear drum perforation, Pneumonia was not reported and COVID-19 recurrent was reported as not related.  Company comment: This is a spontaneous case concerning a 58-year-old female patient with reported medical history of panuveitis on treatment with Adalimumab, who experienced the unexpected serious (medically significant) events of pneumonia and colitis ulcerative among other non-serious events. The events occurred on unknown day after the third dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. Concomitant medication remains as a confounder. At the time of the report, event of pneumonia was resolved and colitis ulcerative  not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 58-year-old female patient with reported medical history of panuveitis on treatment with Adalimumab, who experienced the unexpected serious (medically significant) events of pneumonia and colitis ulcerative among other non-serious events. The events occurred on unknown day after the third dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. Concomitant medication remains as a confounder. At the time of the report, event of pneumonia was resolved and colitis ulcerative  not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.