Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood cholesterol, Blood pressure measurement, Computerised tomogram, Diarrhoea, Gastrooesophageal reflux disease
Clinical narrative: Acid reflux (esophageal); Diarrhea; Vaccination adverse reaction / BAD REACTION TO MORDERNA VACCINE; Arthralgia aggravated / WORSENED RHEUMATOID ARTHRITIS PAIN IN JOINTS/KNEE/HIP/SHOULDER/KNUCKLES/NECK; Immunodeficiency / IMMUNE SYSTEM LOW; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Arthralgia aggravated / WORSENED RHEUMATOID ARTHRITIS PAIN IN JOINTS/KNEE/HIP/SHOULDER/KNUCKLES/NECK) and IMMUNODEFICIENCY (Immunodeficiency / IMMUNE SYSTEM LOW) in a 72-year-old 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.    The patient's past medical history included Alcoholic in 1980, Tobacco user in 1985 and Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS). Previously administered products included for Drug use for unknown indication: MINOCYCLINE (MINOCYCLINE ALLERGY MANIFESTED BY FLU LIKE SYMPTOMS, FINGER NAILS TURNING BLACK, VOMITING, JOINT PAIN), METFORMIN (METFORMIN ALLERGY MANIFESTED BY SEVERE DIARRHEA and VOMITING); for Rheumatoid arthritis: ENBREL, ARAVA and METHOTREXATE. Past adverse reactions to the above products included Allergy to antibiotic with MINOCYCLINE; Drug allergy with METFORMIN; and No adverse event with ARAVA, ENBREL and METHOTREXATE. Concurrent medical conditions included Blood pressure high, High cholesterol, Diabetes, Barrett's esophagus, Pneumocystis jiroveci infection, Elevated liver enzymes and Precancerous cells present (PRE CANCER CELL IN ESOPHAGUS). Concomitant products included DEXLANSOPRAZOLE (DEXILANT) and FAMOTIDINE for Acid reflux (esophageal), LISINOPRIL for Blood pressure high, METFORMIN HYDROCHLORIDE (METFORMIN [METFORMIN HYDROCHLORIDE]) for Diabetes, PRAVASTATIN for High cholesterol.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2020, the patient experienced IMMUNODEFICIENCY (Immunodeficiency / IMMUNE SYSTEM LOW) (seriousness criterion medically significant). In 2021, the patient experienced RHEUMATOID ARTHRITIS (Arthralgia aggravated / WORSENED RHEUMATOID ARTHRITIS PAIN IN JOINTS/KNEE/HIP/SHOULDER/KNUCKLES/NECK) (seriousness criterion medically significant). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)), DIARRHOEA (Diarrhea) and IMMUNISATION REACTION (Vaccination adverse reaction / BAD REACTION TO MORDERNA VACCINE). At the time of the report, RHEUMATOID ARTHRITIS (Arthralgia aggravated / WORSENED RHEUMATOID ARTHRITIS PAIN IN JOINTS/KNEE/HIP/SHOULDER/KNUCKLES/NECK) was resolving and IMMUNODEFICIENCY (Immunodeficiency / IMMUNE SYSTEM LOW), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)), DIARRHOEA (Diarrhea) and IMMUNISATION REACTION (Vaccination adverse reaction / BAD REACTION TO MORDERNA VACCINE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: HIGH CHOLESTEROL. On an unknown date, Blood pressure measurement: HIGH BLOOD PRESSURE. On an unknown date, Computerised tomogram: unknown. On an unknown date, Hepatic enzyme: HIGH LIVER ENZYME. On an unknown date, Precancerous cells present: PRE CANCER CELL IN ESOPHAGUS. On an unknown date, X-ray: unknown.         The reporter's causality for the event(s) of IMMUNE SYSTEM LOW and WORSENED RHEUMATOID ARTHRITIS PAIN IN  JOINTS/KNEE/HIP/SHOULDER/KNUCKLES/NECK with HUMIRA(ADALIMUMAB) was a reasonable possibility with HUMIRA(ADALIMUMAB).   The reporter's  causality for the event(s) of ACID REFLUX, DIARRHEA and BAD REACTION TO MORDERNA VACCINE was not provided with HUMIRA(ADALIMUMAB).  No treatment medications were provided by the reporter.  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 a female patient aged 72 years with relevant medical history of RHEUMATOID ARTHRITIS, PNEUMOCYSTIS and PRE CANCER CELL IN ESOPHAGUS reported, who experienced the unexpected serious (medically significant) events of Rheumatoid arthritis (Rheumatoid arthritis aggravated) and Immunodeficiency that occurred in the context of mRNA-1273 vaccination. The event Rheumatoid arthritis (Rheumatoid arthritis aggravated) occurred on an unknown date in 2021 and is resolving. The event Immunodeficiency occurred in 2020 prior to mRNA-1273 vaccination with outcome unknown. No further information on risk factors, clinical course, investigations and treatment received was available in the report. Patient had received initial two doses of mRNA-1273  at an interval of 28 days and 3rd dose after 8 months. Relevant medical history of RHEUMATOID ARTHRITIS is confounder to the event Rheumatoid arthritis aggravated, PNEUMOCYSTIS and PRE CANCER CELL IN ESOPHAGUS could be confounders to the event Immunodeficiency.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient aged 72 years with relevant medical history of RHEUMATOID ARTHRITIS, PNEUMOCYSTIS and PRE CANCER CELL IN ESOPHAGUS reported, who experienced the unexpected serious (medically significant) events of Rheumatoid arthritis (Rheumatoid arthritis aggravated) and Immunodeficiency that occurred in the context of mRNA-1273 vaccination. The event Rheumatoid arthritis (Rheumatoid arthritis aggravated) occurred on an unknown date in 2021 and is resolving. The event Immunodeficiency occurred in 2020 prior to mRNA-1273 vaccination with outcome unknown. No further information on risk factors, clinical course, investigations and treatment received was available in the report. Patient had received initial two doses of mRNA-1273  at an interval of 28 days and 3rd dose after 8 months. Relevant medical history of RHEUMATOID ARTHRITIS is confounder to the event Rheumatoid arthritis aggravated, PNEUMOCYSTIS and PRE CANCER CELL IN ESOPHAGUS could be confounders to the event Immunodeficiency.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.