Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ligament sprain, Muscle spasms, Pain, Vaccination site pruritus
Clinical narrative: Diagnosed with Cramp-Fasciculation Disorder; Couldn't walk up steps without cramping her legs; While lying down it felt like she sprang her left ankle tendon which was very painful; While lying down it felt like she sprang her left ankle tendon; Experienced shooting pain throughout her body at random places; middle of her face went numb; right arm at the injection site was itching; muscle spasms; felt woozy; This spontaneous case was reported by a consumer and describes the occurrence of CRAMP-FASCICULATION SYNDROME (Diagnosed with Cramp-Fasciculation Disorder) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A,) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (felt woozy). On 06-Apr-2021, the patient experienced PAIN (Experienced shooting pain throughout her body at random places), HYPOAESTHESIA (middle of her face went numb), VACCINATION SITE PRURITUS (right arm at the injection site was itching) and MUSCLE SPASMS (muscle spasms). On an unknown date, the patient experienced GAIT INABILITY (Couldn't walk up steps without cramping her legs), ARTHRALGIA (While lying down it felt like she sprang her left ankle tendon which was very painful), LIGAMENT SPRAIN (While lying down it felt like she sprang her left ankle tendon) and CRAMP-FASCICULATION SYNDROME (Diagnosed with Cramp-Fasciculation Disorder) (seriousness criterion medically significant). The patient was treated with BACLOFEN ongoing since an unknown date at a dose of 5 mg as required; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and GABAPENTIN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (Experienced shooting pain throughout her body at random places), DIZZINESS (felt woozy), HYPOAESTHESIA (middle of her face went numb), VACCINATION SITE PRURITUS (right arm at the injection site was itching), MUSCLE SPASMS (muscle spasms), GAIT INABILITY (Couldn't walk up steps without cramping her legs), ARTHRALGIA (While lying down it felt like she sprang her left ankle tendon which was very painful), LIGAMENT SPRAIN (While lying down it felt like she sprang her left ankle tendon) and CRAMP-FASCICULATION SYNDROME (Diagnosed with Cramp-Fasciculation Disorder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CRAMP-FASCICULATION SYNDROME (Diagnosed with Cramp-Fasciculation Disorder) to be related. No further causality assessments were provided for PAIN (Experienced shooting pain throughout her body at random places), DIZZINESS (felt woozy), HYPOAESTHESIA (middle of her face went numb), VACCINATION SITE PRURITUS (right arm at the injection site was itching), MUSCLE SPASMS (muscle spasms), GAIT INABILITY (Couldn't walk up steps without cramping her legs), ARTHRALGIA (While lying down it felt like she sprang her left ankle tendon which was very painful) and LIGAMENT SPRAIN (While lying down it felt like she sprang her left ankle tendon).    No concomitant medications were provided.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.   This case was linked to MOD-2021-256639 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.