Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Urine analysis, Vaccination failure, X-ray
Clinical narrative: Vaccination failure; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and VACCINATION FAILURE (Vaccination failure) in a 29-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) solution for injection for an unknown indication.    The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Latent tuberculosis (tested positive) since 2019.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-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. In July 2022, the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure). In 2022, COVID-19 (Covid-19) had resolved. At the time of the report, VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Urine analysis: blood in urine. On an unknown date, X-ray: Clear.         No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. In 2020, the patient experienced COVID-19. In Aug-2021, the patient experienced intermittent blood in urine. In Jul-2022, the patient experienced COVID-19 which was resolved in 2022. Patient's additional laboratory data on an unspecified date included unspecified scan (result: unknown) and ultrasound scan (result: unknown). The reporter's causality for the events of latent tuberculosis, intermittent blood in urine, covid-19 onset in 2020 and COVID-19 onset in Jul-2022 was not provided. Reporter assessed events latent tuberculosis, intermittent blood in urine, covid-19 onset in 2020 and COVID-19 onset in Jul-2022 was reported as possibly related to Moderna COVID-19 vaccine.   No treatment details were reported.  Company comment: This is a spontaneous case reported by a consumer regarding a 29-year-old female patient, in treatment with Adalimumab for an unknown indication, and with medical history of latent tuberculosis  and COVID-19 (2020). She completed a two-dose primary series of mRNA-1273 vaccine with an interval of 31 days between doses and experienced non serious event of COVID-19 (AESI) approximately 1 year after the last dose. An additional event of vaccination failure was considered. On an unknown date, X-ray was reported as clear. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Co-suspect product Adalimumab could increase the risk for developing infections. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer regarding a 29-year-old female patient, in treatment with Adalimumab for an unknown indication, and with medical history of latent tuberculosis and COVID-19 (2020). She completed a two-dose primary series of mRNA-1273 vaccine with an interval of 31 days between doses and experienced non serious event of COVID-19 (AESI) approximately 1 year after the last dose. An additional event of vaccination failure was considered. On an unknown date, X-ray was reported as clear. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Co-suspect product Adalimumab could increase the risk for developing infections. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.