Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Electrocardiogram, Insomnia, Osteoarthritis, Pain
Clinical narrative: unable to sleep; painful to lie down; Osteoarthritis; severe hip to knee pain; severe pain in right arm from shoulder to elbow; excruciating arm pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (unable to sleep), PAIN (painful to lie down), PAIN IN EXTREMITY (excruciating arm pain), PAIN IN EXTREMITY (severe pain in right arm from shoulder to elbow) and OSTEOARTHRITIS (Osteoarthritis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Painful R arm and Knee replacement (Had a knee replacement 2 years ago) in 2019. Concurrent medical conditions included AFib since 02-Feb-2014, Shellfish allergy and Latex allergy. Concomitant products included METOPROLOL from 01-Apr-2016 to an unknown date and FLECAINIDE from 01-Apr-2016 to an unknown date for an unknown indication.   On 09-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021 at 2:30 AM, the patient experienced PAIN IN EXTREMITY (excruciating arm pain). On 10-Feb-2021 at 1:00 AM, the patient experienced PAIN IN EXTREMITY (severe pain in right arm from shoulder to elbow). On 14-Feb-2021 at 11:18 AM, the patient experienced ARTHRALGIA (severe hip to knee pain). On an unknown date, the patient experienced INSOMNIA (unable to sleep), PAIN (painful to lie down) and OSTEOARTHRITIS (Osteoarthritis). The patient was treated with FENTANYL on 10-Feb-2021 for Pain in arm, at a dose of three injections of fentanyl; PARACETAMOL (TYLENOL) on 09-Feb-2021 for Painful R arm, at an unspecified dose and frequency; PREDNISOLONE on 10-Feb-2021 for Painful R arm, at an unspecified dose and frequency; LIDOCAINE HYDROCHLORIDE (LOCAINE) on 10-Feb-2021 for Painful R arm, at an unspecified dose and frequency; KETOROLAC on 10-Feb-2021 for Painful R arm, at an unspecified dose and frequency; MORPHINE on 10-Feb-2021 for Painful R arm, at an unspecified dose and frequency; ONDANSETRON on 10-Feb-2021 for Painful R arm, at an unspecified dose and frequency; SODIUM CHLORIDE (iv drip) on 10-Feb-2021 for Hyponatremia, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) on 14-Feb-2021 for Pain in knee, at an unspecified dose and frequency. On 12-Feb-2021, PAIN IN EXTREMITY (severe pain in right arm from shoulder to elbow) had resolved. On 16-Feb-2021, ARTHRALGIA (severe hip to knee pain) had resolved. At the time of the report, INSOMNIA (unable to sleep), PAIN (painful to lie down), PAIN IN EXTREMITY (excruciating arm pain) and OSTEOARTHRITIS (Osteoarthritis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Electrocardiogram: normal (normal) Good. On 10-Feb-2021, X-ray: normal (normal) Good. On 14-Feb-2021, X-ray: normal (normal) Everything ok except some osteoarthritis.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Treatment medications and concomitant medications were added. New events Osteoarthritis and pain in hip were added. Medical history and lab details were added. On 15-Jul-2021: Follow-up received on 15 Jul 2021 and contains No New Information On 17-Jul-2021: Follow up received on 17-JUL-2021 and contains No New Information