Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Magnetic resonance imaging, Pain in extremity, Periarthritis
Clinical narrative: frozen shoulder syndrome (adhesive capsulitis); Booster dose administered before second dose; sore right arm; This spontaneous case was reported by a patient and describes the occurrence of PERIARTHRITIS (frozen shoulder syndrome (adhesive capsulitis)), PAIN IN EXTREMITY (sore right arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose administered before second dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 030A21A and 048C21A) for COVID-19 vaccination.     No medical history information was reported.  The patient never had COVID positive test or diagnosis. The patient had no allergies.  Concomitant products included ASCORBIC ACID (VITA C [ASCORBIC ACID]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose administered before second dose). In 2022, the patient experienced PAIN IN EXTREMITY (sore right arm). In August 2022, the patient experienced PERIARTHRITIS (frozen shoulder syndrome (adhesive capsulitis)). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PERIARTHRITIS (frozen shoulder syndrome (adhesive capsulitis)) and PAIN IN EXTREMITY (sore right arm) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose administered before second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, Magnetic resonance imaging: was diagnosed with frozen shoulder syndrome known as adhesive capsulitis.         Patient received a First Second and Booster Moderna Covid-19 vaccine in vaccination facility in contact number 2. Patient experienced a sore right arm side effect after every single dose. This symptom got better over time but now patient has a problem with his right shoulder. After 7 months received his booster dose patient was diagnosed with frozen shoulder syndrome known as adhesive capsulitis. His doctor said this might be related or not to the vaccine (be believes that as well) since sometimes after vaccinated an immune response occur in the injection site.   Patient was not experienced a similar event in the past.  No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of Vaccination was reported.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Physical therapy was suggested.  Patient took Tylenol for the pain which improved symptoms a little bit.  Company comment: This spontaneous case concerns a 49-year-old male patient, with no reported medical history, who experienced the unexpected non-serious adverse event of special interest of Periarthritis after receiving the booster dose of mRNA-1273 vaccine. Patient reported that 7 months after receiving booster dose he was diagnosed with frozen shoulder syndrome known as adhesive capsulitis as confirmed by magnetic resonance imaging. Patient took Tylenol for pain which offered slight relief. Clinical course was not reported. It was reported that patient received 3 doses of mRNA-1273 vaccine and experienced sore right arm every after dose. The outcome of event was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-629044, MOD-2022-629048 (Patient Link).; Sender's Comments: This spontaneous case concerns a 49-year-old male patient, with no reported medical history, who experienced the unexpected non-serious adverse event of special interest of Periarthritis after receiving the booster dose of mRNA-1273 vaccine. Patient reported that 7 months after receiving booster dose he was diagnosed with frozen shoulder syndrome known as adhesive capsulitis as confirmed by magnetic resonance imaging. Patient took Tylenol for pain which offered slight relief. Clinical course was not reported. It was reported that patient received 3 doses of mRNA-1273 vaccine and experienced sore right arm every after dose. The outcome of event was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.