Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Limb discomfort, Muscle spasms, Myalgia, Off label use
Clinical narrative: Pain; Recommend that patient not get the second vaccine; struggling with muscle spasms in her lower extremities ever since/both legs are involved/groin area and behind the knees are the areas most often involved; Lower extremities; Inappropriate schedule of vaccine administered; pain and tightness in groin area; affecting ambulation; Pain and tightness has settled behind her right knee; Extreme tiredness; Muscular aches; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), OFF LABEL USE (Recommend that patient not get the second vaccine), MUSCLE SPASMS (struggling with muscle spasms in her lower extremities ever since/both legs are involved/groin area and behind the knees are the areas most often involved), LIMB DISCOMFORT (Lower extremities) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 13037B21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin infection and Hypercholesterolemia. Concurrent medical conditions included Drug allergy (to codeine: nausea, vomiting), Drug allergy (to sulfa: nausea, vomiting), Drug allergy (to most antibiotics: nausea, vomiting), Latex allergy, Gastroparesis, COPD, Coronary artery disease NOS, Urticaria NOS, Alcohol allergy (to Alcohol: nausea, vomiting) and Gastritis. Concomitant products included DUPILUMAB (DUPIXENT) for COPD, Eosinophilia and Urticaria, METOPROLOL TARTRATE for Coronary artery disease, LOSARTAN for Coronary artery disease and Hypertension, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Coronary artery disease and Syncope, ATORVASTATIN for Hypercholesterolemia, METOPROLOL TARTRATE (LOPRESSOR) for Hypertension and Syncope.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced PAIN (Pain), OFF LABEL USE (Recommend that patient not get the second vaccine), MUSCLE SPASMS (struggling with muscle spasms in her lower extremities ever since/both legs are involved/groin area and behind the knees are the areas most often involved), LIMB DISCOMFORT (Lower extremities), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), GROIN PAIN (pain and tightness in groin area), GAIT DISTURBANCE (affecting ambulation), ARTHRALGIA (Pain and tightness has settled behind her right knee), FATIGUE (Extreme tiredness) and MYALGIA (Muscular aches). The patient was treated with ANESTHETICS, LOCAL at a dose of 1 dosage form; THERAWORX RELIEF for Symptomatic treatment, at a dose of 1 dosage form; DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) for Symptomatic treatment, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, PAIN (Pain), MUSCLE SPASMS (struggling with muscle spasms in her lower extremities ever since/both legs are involved/groin area and behind the knees are the areas most often involved), LIMB DISCOMFORT (Lower extremities), GROIN PAIN (pain and tightness in groin area), GAIT DISTURBANCE (affecting ambulation), HYPERSENSITIVITY (Hypersensitivity reaction), ARTHRALGIA (Pain and tightness has settled behind her right knee), FATIGUE (Extreme tiredness) and MYALGIA (Muscular aches) had not resolved and OFF LABEL USE (Recommend that patient not get the second vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she had experienced pains and tightness in the groin area. She mentioned that she used local application of Theraworks and Voltaren. She discontinued her statin drug.  Her Lab work Potassium and magnesium  were with in the normal range. She mentioned that her diagnosis and treatment was ongoing.   This case was linked to MOD-2021-015751 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Significant FU Appended: Medical history updated, Batch number corrected. Concomitant medication updated. Event of hypersensitivity added and event of arthralgia updated.