Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, COVID-19, Illness, Influenza virus test, Laryngitis
Clinical narrative: undefined illness; laryngitis; sore throat; Left shoulder froze; muscle and joint pain from the shot. Left arm; muscle and joint pain from the shot. Left arm; 2 degrees of fever; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), ILLNESS (undefined illness), LARYNGITIS (laryngitis), OROPHARYNGEAL PAIN (sore throat) and PERIARTHRITIS (Left shoulder froze) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DENOSUMAB (PROLIA) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer biontech COVID-19 vaccine (Lot number ER8727) on 23-Mar-2021, Pfizer Biontech COVID-19 vaccine (Lot number EW0169) on 22-Apr-2021, Pfizer Biontech COVID-19 vaccine (Lot number EW0175) on 20-Oct-2021 and Flu on 10-Nov-2022. Past adverse reactions to the above products included No adverse event with Flu, Pfizer Biontech COVID-19 vaccine, Pfizer Biontech COVID-19 vaccine and Pfizer biontech COVID-19 vaccine. Concurrent medical conditions included Osteoporosis.   On 29-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started DENOSUMAB (PROLIA) (unknown route) at an unspecified dose. On 07-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ILLNESS (undefined illness), LARYNGITIS (laryngitis), OROPHARYNGEAL PAIN (sore throat), PERIARTHRITIS (Left shoulder froze), MYALGIA (muscle and joint pain from the shot. Left arm), ARTHRALGIA (muscle and joint pain from the shot. Left arm) and PYREXIA (2 degrees of fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of every. At the time of the report, COVID-19 (COVID-19), ILLNESS (undefined illness), LARYNGITIS (laryngitis), OROPHARYNGEAL PAIN (sore throat), PERIARTHRITIS (Left shoulder froze), MYALGIA (muscle and joint pain from the shot. Left arm), ARTHRALGIA (muscle and joint pain from the shot. Left arm) and PYREXIA (2 degrees of fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Oct-2022, Influenza virus test: Negative. On 15-Oct-2022, SARS-CoV-2 test: Negative. On 15-Oct-2022, Streptococcus test: Negative. On 07-Feb-2023, SARS-CoV-2 test: Positive. On 07-Feb-2023, Streptococcus test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  The patient had been taking occupational therapy for her hands and finished first week in November. Taking Tylenol and everything. Went back to primary HCP. Therapist encouraged her to stretch her arm every day.  Company Comment: This is a spontaneous case concerning an adult female patient with a history of use of Denosumab as concomitant medication for osteoporosis, who experienced the non-serious, unexpected, AESI event of Periarthritis, together with other non-serious events,  which occurred on an unknown date after a dose of mRNA-1273 Bivalent .222 (MODERNA (original and omicron BA.4/BA.5) vaccine, received as the fourth dose of COVID-19 vaccination schedule. It was reported that the patient had been taking occupational therapy for her hands and finished. She was taking Tylenol and went back to primary HCP. Therapist encouraged her to stretch her arm every day. The outcome of the event was reported as recovered. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 bivalent .222 (original and omicron BA.4/BA.5) vaccine is not affected by this report.