Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Periarthritis, SARS-CoV-2 test
Clinical narrative: First Dizzy spells; frozen shoulder/ It never got better; severe shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (frozen shoulder/ It never got better) and ARTHRALGIA (severe shoulder pain) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Implantable defibrillator user (Unclear as to why.Ongoing/Chronic) since 2014, Heart rate, Asthma, Pain, Heart disease, unspecified (Reed BiVICD- 23/Jan/2018) since 12-Oct-2016 and Frozen shoulder (Frozen shoulder (Left)) since 08-Dec-2021. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, ASPIRIN [ACETYLSALICYLIC ACID] for Heart disease, unspecified, METOPROLOL from 11-Dec-2018 to an unknown date for Heart rate, GABAPENTINE for Pain, MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC), MAGNESIUM OXIDE, SACUBITRIL, VALSARTAN (ENTRESTO) from 09-Jan-2018 to an unknown date and FUROSEMIDE from 26-Dec-2018 to an unknown date for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (severe shoulder pain) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced PERIARTHRITIS (frozen shoulder/ It never got better) (seriousness criterion medically significant). On 02-Dec-2021, the patient experienced DIZZINESS (First Dizzy spells). The patient was treated with Physical therapy for Periarthritis. At the time of the report, PERIARTHRITIS (frozen shoulder/ It never got better) had not resolved, DIZZINESS (First Dizzy spells) was resolving and ARTHRALGIA (severe shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative all times.         Patient had covid-19 test several times all negative  Treatment medications were not provided.  08-dec-2021 patient  had office visit with PCP and on 20Dec2021 patient had 8 Physical Therapy sessions. The pain settled in the left shoulder was reported that patient had severe pain in shoulder travelling up into the head, same side as booster was given which lasted at least 4 days. The patient was on able to move the arm at the shoulder due to which he was not able to drive. He had dizzy spells, he could not figure out how to stand up first, then he could not walk straight this lasted for 15 minutes but second dizzy spells came few days later. On 08-Dec-2021 patient had doctor's appointment and doctor suggested physical therapy for dizziness and the frozen shoulder. Doctor thinks that the dizziness was due to the crystal in the inner ear. Patient stated that dizziness was definitely not from the crystal in the inner ear, so he continued to work on the frozen shoulder over the next 7 sessions with the final one on 13-Jan-2022. Patient stated that dizziness seems to be better. The shoulder function was pretty good raising up in the front of the body but side motion is not there at all. Further it was also reported that patient. Physiotherapist suggested it was permanent. The exercises PT gave for home are still being done twice daily.   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2022: Follow up received included events were added, event start date were updated. On 12-Feb-2022: Follow up received, patient's demographic details, product details for first second and booster dose, historical conditions and concomitant drug were added. On 12-Feb-2022: Follow up received included no new information. On 14-Feb-2022: Follow up received does not contain any new information.; Sender's Comments: This is a spontaneous case concerning a 78-year-old, male patient with relevant medical history of unspecified heart disease and with concurrent medical condition of implantable defibrillator user, who experienced the unexpected serious (medically significant) events of shoulder pain and frozen shoulder and expected non-serious event of dizziness. The events shoulder pain and frozen shoulder occurred 1 day and 2 days respectively after the third dose of mRNA-1273 vaccine administration while the event dizziness occurred 10 days after third dose of mRNA-1273 vaccine administration. The events were described as 1 day after the third dose of mRNA-1273 vaccine administration patient experienced severe pain in shoulder same side as vaccination site which radiates to head. The day after, patient woke up with painful frozen shoulder. Patient could not move his arm at the shoulder which limits his activity. 10 days after the third dose of mRNA-1273 vaccine administration patient experienced first episode of dizziness which lasted for about 15 minutes and then second episode of dizziness occurred few days later. Patient sought consult and suggested physical therapy for frozen shoulder and dizziness. According to the doctor the patient's dizziness is coming from the crystals in the inner ear. Patient underwent physical therapy. The outcome of the event shoulder pain was unknown, the event frozen shoulder was not resolved while the event dizziness the outcome was resolving from the time of last observation. The medical history of unspecified heart disease and with concurrent medical condition of implantable defibrillator user remain confounders for the event dizziness while the patient's age remain confounder for the events shoulder pain and frozen shoulder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.