Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Injection site pain, Pain
Clinical narrative: Colitis ulcerative aggravated/ ulcerative colitis flare up; Immunodeficiency/ possible lowered immune system; Pain/ symptoms of pain have returned; Arthralgia aggravated/ more pain in joints; Injection site stinging/ stinging with injections; Sickness; Shingles; First dose on 30-MAR-2021 and second dose on 20-APR-2021; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated/ ulcerative colitis flare up) and IMMUNODEFICIENCY (Immunodeficiency/ possible lowered immune system) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, ADALIMUMAB (HUMIRA) for Psoriatic arthritis and ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-MAR-2021 and second dose on 20-APR-2021). In 2021, the patient experienced the first episode of ILLNESS (Sickness). In October 2021, the patient experienced HERPES ZOSTER (Shingles). In 2022, the patient experienced the second episode of ILLNESS (Sickness). On an unknown date, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated/ ulcerative colitis flare up) (seriousness criterion medically significant), IMMUNODEFICIENCY (Immunodeficiency/ possible lowered immune system) (seriousness criterion medically significant), PAIN (Pain/ symptoms of pain have returned), ARTHRALGIA (Arthralgia aggravated/ more pain in joints) and INJECTION SITE PAIN (Injection site stinging/ stinging with injections). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated/ ulcerative colitis flare up), IMMUNODEFICIENCY (Immunodeficiency/ possible lowered immune system), the last episode of ILLNESS (Sickness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-MAR-2021 and second dose on 20-APR-2021) outcome was unknown, HERPES ZOSTER (Shingles) and INJECTION SITE PAIN (Injection site stinging/ stinging with injections) had resolved and PAIN (Pain/ symptoms of pain have returned) and ARTHRALGIA (Arthralgia aggravated/ more pain in joints) had not resolved.            Relevant concomitant medications were not reported. Patient experienced more pain in joints, stinging with injections, symptoms of pain have returned, ulcerative colitis flare up and possible lowered immune system. In 2021, the patient experienced sick.  In October 2021, the patient experienced shingles. In 2022, the patient experienced sick. Treatment information was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Company comment: This spontaneous case concerns a 56-year-old, male patient with no reported medical history, who experienced the unexpected, serious (Medically significant) events of Colitis ulcerative and Immunodeficiency. The exact date of onset of the events was not specified in respect to the administration of first and second dose of mRNA-1273, hence latency could not be assessed. The interval between the two doses of mRNA-1273 is 21 days, the third dose of Tozinameran was given 8 months after. It has been reported that the patient experienced more pain in joints, injection site pain, flare up of ulcerative colitis and lowered immune system. Details of concomitant medications, medical history, clinical course and treatment were not provided. The event has not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old, male patient with no reported medical history, who experienced the unexpected, serious (Medically significant) events of Colitis ulcerative and Immunodeficiency. The exact date of onset of the events was not specified in respect to the administration of first and second dose of mRNA-1273, hence latency could not be assessed. The interval between the two doses of mRNA-1273 is 21 days, the third dose of Tozinameran was given 8 months after. It has been reported that the patient experienced more pain in joints, injection site pain, flare up of ulcerative colitis and lowered immune system. Details of concomitant medications, medical history, clinical course and treatment were not provided. The event has not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.