Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Confusional state, Contusion, Insomnia, Limb discomfort
Clinical narrative: Confused; Biggest problem was when was laying down tried to sleep, could not sleep; Zaps in his leg; Charley horse in thigh; ached/ aches and pains; Arthritis/Like somebody punched them in the arm/Solid knot/Bump inside arm/pain and agony in shoulder like arthritis, ached; Tendonitis; Degenerative cup shoulder area; Bruise on left upper arm area; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis/Like somebody punched them in the arm/Solid knot/Bump inside arm/pain and agony in shoulder like arthritis, ached), TENDONITIS (Tendonitis), OSTEOARTHRITIS (Degenerative cup shoulder area), CONTUSION (Bruise on left upper arm area) and CONFUSIONAL STATE (Confused) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 044A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included Back injury (Former back injury), Ruptured intervertebral disc (Had surgery in the past for ruptured disc), Fragmented intervertebral disc (Had surgery in the past for floating fragments) and Pinched nerve (Had surgery in the past for pinched nerve). Concurrent medical conditions included Gout and Kidney stones. Concomitant products included ALLOPURINOL for Gout and Kidney stones, GABAPENTIN for Leg discomfort, Ruptured intervertebral disc, Fragmented intervertebral disc and Pinched nerve, LISINOPRIL and SIMVASTATIN for an unknown indication.  On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2022, the patient experienced ARTHRITIS (Arthritis/Like somebody punched them in the arm/Solid knot/Bump inside arm/pain and agony in shoulder like arthritis, ached), TENDONITIS (Tendonitis), OSTEOARTHRITIS (Degenerative cup shoulder area) and MYALGIA (ached/ aches and pains). On an unknown date, the patient experienced CONTUSION (Bruise on left upper arm area), CONFUSIONAL STATE (Confused), INSOMNIA (Biggest problem was when was laying down tried to sleep, could not sleep), LIMB DISCOMFORT (Zaps in his leg) and MUSCLE SPASMS (Charley horse in thigh). The patient was treated with PARACETAMOL (TYLENOL ARTHRITIS) for Arthritis, Tendonitis and Degenerative joint disease, at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) for Arthritis, Tendonitis and Osteoarthritis, at an unspecified dose and frequency; DICLOFENAC for Arthritis, Tendonitis and Osteoarthritis, at a dose of 1 % percent; HYDROCODONE for Arthritis, Tendonitis and Osteoarthritis, at a dose of 325 milligram at bedtime; DICLOFENAC for Arthritis, Tendonitis and Osteoarthritis, at a dose of 75 milligram and MELOXICAM for Arthritis, Tendonitis and Osteoarthritis, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (Arthritis/Like somebody punched them in the arm/Solid knot/Bump inside arm/pain and agony in shoulder like arthritis, ached), TENDONITIS (Tendonitis), OSTEOARTHRITIS (Degenerative cup shoulder area), INSOMNIA (Biggest problem was when was laying down tried to sleep, could not sleep), LIMB DISCOMFORT (Zaps in his leg), MUSCLE SPASMS (Charley horse in thigh) and MYALGIA (ached/ aches and pains) outcome was unknown, CONTUSION (Bruise on left upper arm area) had resolved and CONFUSIONAL STATE (Confused) had not resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2022, X-ray: arthritis, tendonitis, degenerative shoulder Arthritis, tendonitis and degenerative cup shoulder area.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that after the booster dose, the patient was like somebody punched in the arm for 2,3,4 days and that had not cleared. The patient had not known why after 14-15 days he had aches and pains. The patient had pains radiated down to fingertips in right arm and wrist in left arm when lay down tried to sleep. The patient was cleaning out his car and that pain started to re-occur and he started to have zaps in his leg. The patient had not known if that was associated with the shoulder because of the muscle part of it. The patient never had been tested or had the symptoms of COVID.  Company Comment: This is a spontaneous case concerning a 75-year-old male patient with reported medical history of Gout, who experienced the unexpected non-serious adverse event of special interest, Arthritis, which occurred approximately 3 months after receiving the third dose of mRNA-1273 Vaccine. As reported, patient was treated with Paracetamol, Naprxen Sodium, Diclofenac, and Meloxicam, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The medical history of gout remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-522969, MOD-2022-522968, MOD-2022-523033 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow up received includes suspect vaccine batch numbers were added for the first dose, second dose and booster dose and start date was updated for the second dose.; Sender's Comments: This is a spontaneous case concerning a 75-year-old male patient with reported medical history of Gout, who experienced the unexpected non-serious adverse event of special interest, Arthritis, which occurred approximately 3 months after receiving the third dose of mRNA-1273 Vaccine. As reported, patient was treated with Paracetamol, Naprxen Sodium, Diclofenac, and Meloxicam, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The medical history of gout remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.