Age: 77.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Mobility decreased, Pain
Clinical narrative: Could not move her left arm at all , raising arm causes pain; pain in her left arm was excruciating, worsened; pain is in upside of elbow and now its going towards shoulder; "A little" tiredness (2nd dose); Fever; Chills (2nd dose); Pain in both her right and left arms that interferes with sleep/pain when moving her arms, up down, or to the side/left arm pain from her elbow to her shoulder; Arm(s) sometimes throb/left arm hurts more than right arm; Arm pain interfering with sleep; pain is "moving up to her shoulder" in her left arm/the pain in her left arm was excruciating; This case was initially received via Medicines Agency (Reference number: US-irms-MOD21-123747   ) on 26-Apr-2021. The most recent information was received on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both her right and left arms that interferes with sleep/pain when moving her arms, up down, or to the side/left arm pain from her elbow to her shoulder), PAIN (Arm(s) sometimes throb/left arm hurts more than right arm), SLEEP DISORDER (Arm pain interfering with sleep), PAIN (pain is "moving up to her shoulder" in her left arm/the pain in her left arm was excruciating) and MOBILITY DECREASED (Could not move her left arm at all , raising arm causes pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE for Shingles.    No medical history was provided by the reporter.  The patient's past medical history included Cataract extraction since 13-Jul-2021. Concurrent medical conditions included Breast cancer and Allergy to antibiotic (Augmentin). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), LOSARTAN for Blood pressure, ANASTROZOLE for Cancer, SIMVASTATIN for Cholesterol, LEVOTHYROXINE for Thyroid disorder.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of VARICELLA ZOSTER VACCINE (unknown route) at an unspecified dose. On an unknown date, received dose of VARICELLA ZOSTER VACCINE (unknown route) dosage was changed to at an unspecified dose. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in both her right and left arms that interferes with sleep/pain when moving her arms, up down, or to the side/left arm pain from her elbow to her shoulder), PAIN (Arm(s) sometimes throb/left arm hurts more than right arm), SLEEP DISORDER (Arm pain interfering with sleep), PAIN (pain is "moving up to her shoulder" in her left arm/the pain in her left arm was excruciating), FATIGUE ("A little" tiredness (2nd dose)), PYREXIA (Fever ) and CHILLS (Chills (2nd dose)). On an unknown date, the patient experienced MOBILITY DECREASED (Could not move her left arm at all , raising arm causes pain), PAIN (pain in her left arm was excruciating, worsened) and ARTHRALGIA (pain is in upside of elbow and now its going towards shoulder). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Apr-2021, FATIGUE ("A little" tiredness (2nd dose)), PYREXIA (Fever ) and CHILLS (Chills (2nd dose)) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in both her right and left arms that interferes with sleep/pain when moving her arms, up down, or to the side/left arm pain from her elbow to her shoulder), PAIN (Arm(s) sometimes throb/left arm hurts more than right arm), SLEEP DISORDER (Arm pain interfering with sleep), PAIN (pain is "moving up to her shoulder" in her left arm/the pain in her left arm was excruciating), MOBILITY DECREASED (Could not move her left arm at all , raising arm causes pain), PAIN (pain in her left arm was excruciating, worsened) and ARTHRALGIA (pain is in upside of elbow and now its going towards shoulder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reports PMH significant for reaction post shingles vaccination (second dose), right arm rotator cuff injury and and torn tendon in right arm.Patient negative for PMH significant to left arm. She mentioned that her doctor checked for blood clots(blood work), and everything came back normal.   This case was linked to MOD-2021-090257 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Patients contact details was updated Had cataract surgery Post 2nd dose patient current condition Breast cancer was added Blood work was added normal new event was added. For event sleep disorder causality was changed to not applicable(previously possible). On 28-Jul-2021: Significant follow up received  Updated physician details, patient height and weight and race was added Allergy was added concomitant  medications was added Prior vaccine Information was added