Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Inappropriate schedule of product administration
Clinical narrative: Exposure to COVID-19; COVID-19; SECOND DOSE 15-APR-2021 and  BOOSTER DOSE 13-AUG-2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposure to COVID-19), COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (SECOND DOSE 15-APR-2021 and  BOOSTER DOSE 13-AUG-2021) in a 24-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 Panuveitis.    The patient's past medical history included Surgery in April 2022. Concurrent medical conditions included Uveitis (NON-INFECTIOUS INTERMEDIATE POSTERIOR AND PANUVEITIS).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Aug-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) UNK, Citrate Free. On 13-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (SECOND DOSE 15-APR-2021 and  BOOSTER DOSE 13-AUG-2021). In May 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and COVID-19 (COVID-19) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (SECOND DOSE 15-APR-2021 and  BOOSTER DOSE 13-AUG-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and COVID-19 (COVID-19) to be related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (SECOND DOSE 15-APR-2021 and  BOOSTER DOSE 13-AUG-2021).    No concomitant medication was reported.  Patient reported the surgery as an event and non-serious COVID exposure and COVID-19. On an unknown date April-2022 patient had surgery. Physician mentioned to stop Humira in the mid of April-2022. Unknown date in 2022 event COVID-19 resolved. It was unknown  if patient was enrolled in a COVID-19 Vaccine trial. Reporter causality for the events Exposure to COVID-19 and COVID-19 not provided for Humira. Senders Comment is that for Humira, there is no reasonable possibility for events Exposure to COVID-19 and COVID-19.  No treatment medication was reported.  Company Comment: This is a spontaneous case of inappropriate schedule of product administration for this 24-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Non-infectious Intermediate Posterior and Panuveitis, who experienced the unexpected, non-serious AESI of COVID-19 and the unexpected, non-serious event of exposure to SARS-CoV-2. The event COVID-19 occurred on an unspecified date in May2022 after receiving the first dose of the mRNA-1273 vaccine. The start date of the event exposure to SARS-CoV-2 was not provided. It was reported that on an unknown date, the patient was exposed to COVID-19. On the first week of May2022, it was reported that the patient had COVID-19. No further details were provided. Treatment information was also not provided. However, the event COVID-19 had resolved at the time of the report. Of note, the patient also received the second and third doses of the mRNA-1273 vaccine, with the third dose given 3 months, 29 days after the second dose which was less than the approved dosing interval of 5 months. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case of inappropriate schedule of product administration for this 24-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Non-infectious Intermediate Posterior and Panuveitis, who experienced the unexpected, non-serious AESI of COVID-19 and the unexpected, non-serious event of exposure to SARS-CoV-2. The event COVID-19 occurred on an unspecified date in May2022 after receiving the first dose of the mRNA-1273 vaccine. The start date of the event exposure to SARS-CoV-2 was not provided. It was reported that on an unknown date, the patient was exposed to COVID-19. On the first week of May2022, it was reported that the patient had COVID-19. No further details were provided. Treatment information was also not provided. However, the event COVID-19 had resolved at the time of the report. Of note, the patient also received the second and third doses of the mRNA-1273 vaccine, with the third dose given 3 months, 29 days after the second dose which was less than the approved dosing interval of 5 months. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.