Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, SARS-CoV-2 test, Weight
Clinical narrative: pneumonia; Pain flare/if i get a flare the pain is 10/10 in my jaw and hip/RA was getting worse+worse; Cold; Fever; Chills; Covid-19/ Had Covid 3 times; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (pneumonia) and RHEUMATOID ARTHRITIS (Pain flare/if i get a flare the pain is 10/10 in my jaw and hip/RA was getting worse+worse) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis, ADALIMUMAB (HUMIRA) for an unknown indication and METHOTREXATE for an unknown indication.    Previously administered products included for Drug use for unknown indication: MULTIVITAMIN (ascorbic acid, calcium pantothenate, chromium, colecalciferol, copper, cyanocobalamin,  folic acid, iodine, iron, magnesium. manganese, nicotinamide, pyridoxine hydrochloride,  retinol, riboflavin, selenium. thiamine hydrochloride, tocopherol, zinc), PROBIOTIC (bifidobacterium bifidum. bifidobacterium lactis, bifidobacterium longum. lactobacillus  acidophilus and lactobacillus rhamnosus). Past adverse reactions to the above products included No adverse event with MULTIVITAMIN and PROBIOTIC. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and INFLUENZA VACCINE INACT SAG 4V (FLUAD QUAD) for an unknown indication.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form., TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 11 milligram, ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose and METHOTREXATE (unknown route) at an unspecified dose. In February 2023, the patient experienced COVID-19 (Covid-19/ Had Covid 3 times). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant), RHEUMATOID ARTHRITIS (Pain flare/if i get a flare the pain is 10/10 in my jaw and hip/RA was getting worse+worse) (seriousness criterion medically significant), NASOPHARYNGITIS (Cold), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PNEUMONIA (pneumonia), NASOPHARYNGITIS (Cold), PYREXIA (Fever), CHILLS (Chills) and COVID-19 (Covid-19/ Had Covid 3 times) outcome was unknown and RHEUMATOID ARTHRITIS (Pain flare/if i get a flare the pain is 10/10 in my jaw and hip/RA was getting worse+worse) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Weight: weight loss-lost 75 lbs. In February 2023, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered PNEUMONIA (pneumonia) to be not related. No further causality assessments were provided for RHEUMATOID ARTHRITIS (Pain flare/if i get a flare the pain is 10/10 in my jaw and hip/RA was getting worse+worse), NASOPHARYNGITIS (Cold), PYREXIA (Fever), CHILLS (Chills) and COVID-19 (Covid-19/ Had Covid 3 times).    On 02-Feb-2023, patient had unspecified illness.  Patient tested positive for covid last week. Patient had a mild cold and feels fine overall. Cold had improved, but she still had a sinus drip.  Patient had outpatient surgery for tummy tuck due to weight loss in Mar-2023 to remove all skin. Patient had IV infusion for first time. It was reported that patient can't have combination drug of methotrexate and humira as it caused to be hospitalized with pneumonia (not while on Xeljanz). It was reported that patient eats right, no sugar intake, walk daily, lifts weights, does yoga and had ran half marathon. It was reported that patient's RA seems controlled on XELJANZ XR and if not in pain, its skipped here and there. If any pain at all tablet was taken daily which really helped. It really helps patient with little to no side effects. When pain was felt, it was a definite 10. It was reported that flare lasts only a few days.  No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by other health care professional, concerning a female patient of unknown age, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Pneumonia, and the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up), which occurred related to 2 doses of SPIKEVAX NOS vaccine. Since no vaccination, nor events dates were provided, temporal association and latency cannot be properly assessed. As reported, methotrexate and adalimumab caused the patient to be hospitalized with pneumonia (they remain as co-suspect products). Her rheumatoid arthritis was getting worse, and it was controlled by tofacitinib citrate. Causality for Pneumonia was assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2024: Significant follow up received included : Case upgraded to valid and serious, Medical history updated (Moderna vaccine removed and coded as suspect), lab data, co-suspects, concomitant drugs, events (pneumonia, RA flare up, fever, chills, cold) were added.