Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pain sometimes in back; Could not mover her body / not able to climb into her bed or her car sometimes; Pain is sometimes in shoulder; Damage in left eye; Had a lot of pain; excruciating muscle cramp in the leg that moved around the body / Cramps and pain all over body; arm hurt; body pain that lasted three days / pain all over body / Pain sometimes on both sides of her body; I had fever; I felt dizzy; I had dry mouth; swollen; redness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain is sometimes in shoulder), EYE INJURY (Damage in left eye), BACK PAIN (Pain sometimes in back), MOBILITY DECREASED (Could not mover her body / not able to climb into her bed or her car sometimes) and PAIN (Had a lot of pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 02A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced DIZZINESS (I felt dizzy), DRY MOUTH (I had dry mouth), PERIPHERAL SWELLING (swollen), ERYTHEMA (redness), PAIN IN EXTREMITY (arm hurt), MYALGIA (body pain that lasted three days / pain all over body / Pain sometimes on both sides of her body) and PYREXIA (I had fever). On 04-Jun-2021, the patient experienced EYE INJURY (Damage in left eye) (seriousness criterion hospitalization) and PAIN (Had a lot of pain) (seriousness criterion hospitalization). 04-Jun-2021, the patient experienced MUSCLE SPASMS (excruciating muscle cramp in the leg that moved around the body / Cramps and pain all over body). On an unknown date, the patient experienced ARTHRALGIA (Pain is sometimes in shoulder) (seriousness criterion hospitalization), BACK PAIN (Pain sometimes in back) (seriousness criterion hospitalization) and MOBILITY DECREASED (Could not mover her body / not able to climb into her bed or her car sometimes) (seriousness criterion hospitalization). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (Pain is sometimes in shoulder), EYE INJURY (Damage in left eye), BACK PAIN (Pain sometimes in back), MOBILITY DECREASED (Could not mover her body / not able to climb into her bed or her car sometimes), PAIN (Had a lot of pain), DIZZINESS (I felt dizzy), DRY MOUTH (I had dry mouth), PERIPHERAL SWELLING (swollen), ERYTHEMA (redness), MUSCLE SPASMS (excruciating muscle cramp in the leg that moved around the body / Cramps and pain all over body), PAIN IN EXTREMITY (arm hurt), MYALGIA (body pain that lasted three days / pain all over body / Pain sometimes on both sides of her body) and PYREXIA (I had fever) outcome was unknown.            No concomitant medication was provided.  This case concerns a 58-year-old female with serious unexpected events of eye injury, back pain, arthralgia, mobility decreased, pain, and non-serious dizziness, dry mouth, peripheral swelling, erythema, muscle spasms, pain in extremity, myalgia, and pyrexia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-245665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received contains additional events of shoulder pain, eye damage, back pain, mobility decreased and pain with seriousness criteria of hospitalization. Updated second dose start date from 24-Apr-2021 to 26-Apr-2021. Corrected first dose start date from Mar-2021 to 26-Mar-2021. Updated batch/lot number of first dose.; Sender's Comments: This case concerns a 58-year-old female with serious unexpected events of eye injury, back pain, arthralgia, mobility decreased, pain, and non-serious dizziness, dry mouth, peripheral swelling, erythema, muscle spasms, pain in extremity, myalgia, and pyrexia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.