Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Hypertension, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Blood pressure high; COVID-19; Inappropriate schedule of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure high), COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccination) in a 61-year-old male 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 Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-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) Solution for injection in pre-filled pen, Citrate free. On an unknown date, the patient experienced HYPERTENSION (Blood pressure high), COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccination). At the time of the report, HYPERTENSION (Blood pressure high) had not resolved and COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for Covid several times..         No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine trail. Daily dose was reported as Citrate free for HUMIRA. The reporter causality for the events high blood pressure and COVID-19 with Humira was reported as no reasonable possibility. No treatment information was reported.  Company comment: This spontaneous case concerns a 61-year-old male patient with relevant medical history of Moderate to severe adult Crohn's disease on Humira (Adalimumab), who experienced the unexpected non-serious AESI of COVID-19 on an unspecified date after receiving the third dose of mRNA-1273 vaccine. The outcome was reported as unknown. Details of symptoms, start date, clinical course, investigation reports, and treatment were not provided. The patient has taken three doses of mRNA-1273 vaccine but the interval between 1st and 2nd is 36 days (Inappropriate schedule of vaccine administered). Treatment with Humira (adalimumab) could be a risk factor while current pandemic situation of COVID-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-580201 (Patient Link).; Sender's Comments: This spontaneous case concerns a 61-year-old male patient with relevant medical history of Moderate to severe adult Crohn's disease on Humira (Adalimumab), who experienced the unexpected non-serious AESI of COVID-19 on an unspecified date after receiving the third dose of mRNA-1273 vaccine. The outcome was reported as unknown. Details of symptoms, start date, clinical course, investigation reports, and treatment were not provided. The patient has taken three doses of mRNA-1273 vaccine but the interval between 1st and 2nd is 36 days (Inappropriate schedule of vaccine administered). Treatment with Humira (adalimumab) could be a risk factor while current pandemic situation of COVID-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.