Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hernia, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Hernia; COVID-19; Dose 1 and 2 received on 03 Mar 2021 and 21 May 2021 , 35 days beyond; This spontaneous case was reported by a consumer and describes the occurrence of HERNIA (Hernia) and COVID-19 (COVID-19) in an adult 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 Ulcerative colitis and Rheumatoid arthritis.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-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) cf. On an unknown date, the patient experienced HERNIA (Hernia) (seriousness criterion medically significant), COVID-19 (COVID-19) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 03 Mar 2021 and 21 May 2021 , 35 days beyond). The patient was treated with Surgery for Hernia. At the time of the report, HERNIA (Hernia) was resolving, COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 03 Mar 2021 and 21 May 2021 , 35 days beyond) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medication information was provided. Patient had Hernia Surgery. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were provided.  Company comment  This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, who experienced the unexpected, serious ( Medically significant) event of Hernia and the unexpected, non-serious AESI of Covid 19, unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient previously received the 1 dose of Moderna vaccine at an interval of about 80 days between the two primary doses. Inappropriate Schedule of Product Administration was reported as an additional non serious event. SARS-CoV-2 test was positive on an unknown date. No information was provided regarding the comorbidities, risk factors, symptoms, clinical course, labs and diagnostic procedures It was reported that the patient underwent Hernia Surgery for Hernia. The event hernia was resolving, and covid 19 had not resolved. The ongoing covid 19 Pandemia remains as a confounder. Concomitant use of Adalimumab (HUMIRA) for Ulcerative colitis and Rheumatoid arthritis is a risk factor for the event Covid 19.   The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2022: Updated outcome for hernia from not resolved to resolving.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, who experienced the unexpected, serious ( Medically significant) event of Hernia and the unexpected, non-serious AESI of Covid 19, unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient previously received the 1 dose of Moderna vaccine at an interval of about 80 days between the two primary doses. Inappropriate Schedule of Product Administration was reported as an additional non serious event. SARS-CoV-2 test was positive on an unknown date. No information was provided regarding the comorbidities, risk factors, symptoms, clinical course, labs and diagnostic procedures It was reported that the patient underwent Hernia Surgery for Hernia. The event hernia was resolving, and covid 19 had not resolved. The ongoing covid 19 Pandemia remains as a confounder. Concomitant use of Adalimumab (HUMIRA) for Ulcerative colitis and Rheumatoid arthritis is a risk factor for the event Covid 19.   The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per medical judgement.