Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vertigo
Clinical narrative: Blockage in stool; Rheumatoid arthritis flare ups after taking the covid shot/Morning stiffness/ Knee buckled; COVID-19; Enlarged spleen after taking the covid shot; Enlarged liver after taking the covid shot; Irritable bowel syndrome with constipation; Gastrointestinal inflammation; Sprained right wrist; Vertigo after taking the covid shot; Heart palpitations after taking the covid shot; Inflammation after taking the covid shot; Hives; This spontaneous case was reported by a consumer and describes the occurrence of FAECALOMA (Blockage in stool) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare ups after taking the covid shot/Morning stiffness/ Knee buckled) 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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, the patient experienced FAECALOMA (Blockage in stool) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare ups after taking the covid shot/Morning stiffness/ Knee buckled) (seriousness criterion medically significant), COVID-19 (COVID-19), SPLENOMEGALY (Enlarged spleen after taking the covid shot), HEPATOMEGALY (Enlarged liver after taking the covid shot), IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome with constipation), GASTROINTESTINAL INFLAMMATION (Gastrointestinal inflammation), LIGAMENT SPRAIN (Sprained right wrist), VERTIGO (Vertigo after taking the covid shot), PALPITATIONS (Heart palpitations after taking the covid shot), INFLAMMATION (Inflammation after taking the covid shot) and URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FAECALOMA (Blockage in stool), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare ups after taking the covid shot/Morning stiffness/ Knee buckled), COVID-19 (COVID-19), SPLENOMEGALY (Enlarged spleen after taking the covid shot), HEPATOMEGALY (Enlarged liver after taking the covid shot), IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome with constipation), GASTROINTESTINAL INFLAMMATION (Gastrointestinal inflammation), LIGAMENT SPRAIN (Sprained right wrist), VERTIGO (Vertigo after taking the covid shot), PALPITATIONS (Heart palpitations after taking the covid shot), INFLAMMATION (Inflammation after taking the covid shot) and URTICARIA (Hives) outcome was unknown.            Concomitant medications were not reported.  Patient did CAT scan on unknown date with no results. Formulation of Humira was reported as Solution for injection in pre-filled pen.  Reporter's causality for drug HUMIRA for events blockage in stool, enlarged spleen after taking the covid shot, enlarged liver after taking the covid shot, vertigo after taking the covid shot, heart palpitations after taking the covid shot, inflammation after taking the covid shot, rheumatoid arthritis flare ups after taking the covid shot was provided as no reasonable possibility. Reporter's causality for drug HUMIRA for events COVID-19, irritable bowel syndrome with constipation, gastrointestinal inflammation, sprained right wrist, knee buckled, morning stiffness, hives was provided as not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an adult female patient of unspecified age with concurrent condition of Rheumatoid arthritis reported, experienced unexpected serious (medically significant) events of Faecaloma and AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) along with unexpected non serious AESI of COVID 19 on unknown dates in the context of mRNA-1273 vaccination. She also experienced multiple non serious events of Ligament sprain, Vertigo, Palpitations, Inflammation and Urticaria. Patient received the first and second doses at an interval of 30 days and booster dose on unknown date. No further information on detailed clinical course, investigations, treatment of the events was available in the report. CAT scan done on unknown date with no results. Outcome of the events was unknown at the time of report. Relevant medical history remains a confounder to the event Rheumatoid arthritis flare up. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an adult female patient of unspecified age with concurrent condition of Rheumatoid arthritis reported, experienced unexpected serious (medically significant) events of Faecaloma and AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) along with unexpected non serious AESI of COVID 19 on unknown dates in the context of mRNA-1273 vaccination. She also experienced multiple non serious events of Ligament sprain, Vertigo, Palpitations, Inflammation and Urticaria. Patient received the first and second doses at an interval of 30 days and booster dose on unknown date. No further information on detailed clinical course, investigations, treatment of the events was available in the report. CAT scan done on unknown date with no results. Outcome of the events was unknown at the time of report. Relevant medical history remains a confounder to the event Rheumatoid arthritis flare up. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.