Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in a 61-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2022, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In December 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). The patient was treated with ADALIMUMAB (HUMIRA) in September 2023 for Rheumatoid arthritis, at a dose of UNK, q2wk; KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency; METHOTREXATE in 2023 at an unspecified dose and frequency and PREDNISONE in 2023 at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2023, Neutrophil count: 39 % Normal. On 27-Dec-2023, Neutrophil count: 28 % dipped. On 07-Mar-2024, Neutrophil count: 31 % low again. On an unknown date, Neutrophil count: 38 % Normal.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered RHEUMATOID ARTHRITIS (Rheumatoid arthritis) to be related.    No concomitant medications were reported.  It was reported that patient was super healthy and had received 6 doses of Moderna vaccines by following CDC guidelines on when to get them. Patient was over 50 when COVID pandemic declared. Last year diagnosed with RA, doing well on treatment. Patient ad mild neutropenia diagnosed in September and the doctor repeated blood test for it. It was resolved since then, but they thought maybe had an immune reaction to COVID vaccine. Neutrophils were just rechecked and it's mildly low again. Patient has an appointment to see a hematologist to investigate why the neutropenia and if it needs to be worked up further. RA issue being cared for by rheumatologist at hospital there had seen some info on autoimmune diseases in people post COVID vaccine, and HCP wanted to see what exists in the literature about it. HCP never had COVID into the knowledge, so vaccines worked well. Rheumatologist said they have a registry with all people listed with autoimmune diseases that might be related to vaccines and wanted to learn more about this situation about the patient. Neutrophils tracked over time and were always normal. Routine lab test afterwards showed neutrophils were low. Symptoms started form Dec-2022, pulling heavy suitcase in snow. Patient had severe shoulder pain when came back and diagnosed with tendonitis. Patients first attack of RA was in December 2022 and got a shot of Toradol in urgent centre. Felt fine until March 2023 and then was on a trip and developed severe pain on the wrist and thought it was carpal tunnel and almost had a lock jaw for a few hours.   This case was linked to MOD-2024-763293 (Patient Link).  Company comment: This spontaneous case concerns a 61-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (AESI). The first symptoms of rheumatoid arthritis occurred approx. 3 months after the fifth dose of SPIKEVAX NOS, with final diagnosis being made approx. one year after 5th dose. As reported, symptoms started form 3 months post fifth dose; after pulling heavy suitcase in snow patient had severe shoulder pain and diagnosed with tendonitis. At later paint this was considered as first attack of RA. Patient felt fine until 3 months later and then was on a trip and developed severe pain on the wrist and thought it was carpal tunnel and almost had a lock jaw for a few hours. Patient was diagnosed with RA one year after fifth dose by confirmatory laboratory workup shoving highly positive for RA. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.