Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Periarthritis
Clinical narrative: 9/2022 diagnosed frozen shoulder; Cough; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIARTHRITIS (9/2022 diagnosed frozen shoulder) and COUGH (Cough) in a 69-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     The patient's past medical history included Coronary artery stenosis (Coronary artery stent x10) from 2010 to 2020, Eczema nummular and Sleep apnea. Previously administered products included for Hyperlipidemia: ROSUVASTATIN CALCIUM (40 mg - PO - QHS (at 21:00)) on 15-Nov-2007; for Drug use for unknown indication: Metoprolol (ER - 25 mg - PO - QD (at 13:00)) on 18-Mar-2010, Aspirin (ER - 81 mg - PO - QD (at 7:00)) on 12-Jun-2010, Ketoconazole (2% Cream - Topical) on 14-Dec-2016 and Centrum Multivitamin (at 7:00) on 21-Mar-2020; for Hyperglycemia: METFORMIN HCL (500 mg- PO - QD (7:00)) on 29-Sep-2015; for GERD: ESOMEPRAZOLE (40 mg - PO - QD (at 7:00)) on 28-Nov-2018; for Idiopathic pulmonary fibrosis: Pirfenidone (801 mg- PO- TID (at 7:00; 13:00; 19:00)) on 11-May-2020; for COVID-19 prophylaxis: Moderna (lot number: 037K20A; 1st dose) on 30-Dec-2020, Moderna (lot number: 032L20A; 2nd dose) in January 2021 and Moderna (lot number: 026A21A; 3rd dose; booster) on 14-Aug-2021; for Supplementation therapy: Injectafer (750 mg - IV- 2 doses) on 05-May-2021; for Skin disorder NOS: Triamcinolone Acetonide (Cream USP - 0.1% - Topical) on 27-Jul-2021; for Eczema nummular: Betamethasone dipropionate (Ointment and USP - 0.1% - Topical) on 27-Jul-2021. Past adverse reactions to the above products included No adverse reaction with Aspirin, Betamethasone dipropionate, Centrum Multivitamin, ESOMEPRAZOLE, Injectafer, Ketoconazole, METFORMIN HCL, Metoprolol, Moderna, Moderna, Moderna, Pirfenidone, ROSUVASTATIN CALCIUM and Triamcinolone Acetonide. Concurrent medical conditions included Allergic reaction to antibiotics (Doxycycline), Idiopathic pulmonary fibrosis since 2019, Pre-diabetes since 2010, Hyperlipidemia, Hyperglycemia and GERD. Concomitant products included BUDESONIDE from 17-May-2022 to an unknown date and FORMOTEROL FUMARATE from 17-May-2022 to an unknown date for Idiopathic pulmonary fibrosis.    On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced COUGH (Cough). In September 2022, the patient experienced PERIARTHRITIS (9/2022 diagnosed frozen shoulder). The patient was treated with BENZONATATE on 18-Apr-2022 for Cough suppression, at a dose of 200 milligram three times a day; GUAIFENESIN (oral use) on 24-Jun-2022 for Expectoration, at a dose of 600 milligram once a day and CODEINE PHOSPHATE (CODEIN) on 11-May-2022 for Cough suppression, at a dose of 100- 10 mg/5 ml SOl - PO - 10 ml - Q6hr -PRN. On 30-Jan-2023, PERIARTHRITIS (9/2022 diagnosed frozen shoulder) had resolved. At the time of the report, COUGH (Cough) outcome was unknown.            Current condition also included cabbage CAB6 x3 since 2010. On 31-Jan-2011, patient had Bi-PAP device for CNS sleep apnea. On 30-Apr-2013, patient ha CTx4 (1.1% Sodium fluoride Dental gel TID) for dental caries preventive. On 03-Dec-2013, patient had GC MI paste plus (0.2% Sodium fluoride Dental gel - HS) for dental caries preventive.  In Sep-2022, patient was diagnosed with frozen shoulder left site of administration.  On 06-Dec-2022, patient took 5th dose of Moderna bivalent booster, batch no.: 019H22A.  On 29-Nov-2023, patient took 6th dose of Moderna -Spikevax, batch no.: 3030948.  On 14-Jun-2024, patient took 7th dose of Spikevax, batch no.: 204H23-2A.  Company Comment: This is a Spontaneous case concerning a 69-year-old male patient with non-relevant medical history, who experienced the non-serious unexpected AESI of Periarthritis (reported as frozen shoulder) which occurred about five months after a dose of mRNA-1273 received as the fourth dose of COVID-19 Vaccination schedule. No further clinical information or diagnostic tests results were disclosed for analysis. Patient's advanced age remains a confounding risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2024-770784 (Patient Link).