Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Had covid four times; First dose on 20-OCT-2021 and Second dose on 13-FEB-2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had covid four times) in a 53-year-old male 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 an unknown indication.    No Medical History information was reported.   On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2022, 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. On 13-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20-OCT-2021 and Second dose on 13-FEB-2022). In 2022, the patient experienced COVID-19 (Had covid four times) (seriousness criterion hospitalization). In 2022, COVID-19 (Had covid four times) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 20-OCT-2021 and Second dose on 13-FEB-2022) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. The patient had COVID four times in 2022 and "almost died three times while being at hospital", as reported. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event of had COVID four times was not provided. It was reported that there was no reasonable possibility that the event of had COVID four times was related to HUMIRA (ADALIMUMAB). Treatment information was not provided.  Company comment:  This spontaneous case report concerns a 53-year-old male patient with no medical history provided with concomitant treatment with adalimumab (reported as a co-suspect drug, for an unknown indication, since an unknown date). The patient  experienced serious (due to hospitalization) unexpected event of special interest COVID-19. Reportedly, the patient developed COVID-19 on four occasions out of which three required hospitalization. The exact start date of COVID-19 were not provided and there were no details regarding laboratory investigations, diagnostic procedures, duration of hospitalization and clinical course of the event. It was only provided that the patient recovered. Co-suspect medication adalimumab is considered as confounder having in mind that patients treated with adalimumab are at increased risk of infection. In addition, taking into consideration that the patient had received the second dose of the vaccine almost 4 months after the administration of the first dose, Inappropriate schedule of vaccine administration is also considered in this specific case report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-626300 (Patient Link).; Sender's Comments: This spontaneous case report concerns a 53-year-old male patient with no medical history provided with concomitant treatment with adalimumab (reported as a co-suspect drug, for an unknown indication, since an unknown date). The patient  experienced serious (due to hospitalization) unexpected event of special interest COVID-19. Reportedly, the patient developed COVID-19 on four occasions out of which three required hospitalization. The exact start date of COVID-19 were not provided and there were no details regarding laboratory investigations, diagnostic procedures, duration of hospitalization and clinical course of the event. It was only provided that the patient recovered. Co-suspect medication adalimumab is considered as confounder having in mind that patients treated with adalimumab are at increased risk of infection. In addition, taking into consideration that the patient had received the second dose of the vaccine almost 4 months after the administration of the first dose, Inappropriate schedule of vaccine administration is also considered in this specific case report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.