Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling, Weight increased
Clinical narrative: I had allergic reaction within 1st 20-30 min; The shot 100% triggered the MS, I had a flare up; The left arm soreness is real, It was terrible like a truck hit you; When I got in the car my belly started itching/OMG, itching lasted almost 2 weeks, itching so terribly; Breathing difficulty; I felt like I was swollen within 1-2 hours; I am not going to be able to walk; I was almost 5 pounds heavier; A little rash, little spots, I could feel it creeping throughout my body, scalp to toes; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (I had allergic reaction within 1st 20-30 min), CONDITION AGGRAVATED (The shot 100% triggered the MS, I had a flare up), PAIN IN EXTREMITY (The left arm soreness is real, It was terrible like a truck hit you), PRURITUS (When I got in the car my belly started itching/OMG, itching lasted almost 2 weeks, itching so terribly) and DYSPNOEA (Breathing difficulty) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included TERIFLUNOMIDE (AUBAGIO) for Multiple sclerosis, VITAMINS NOS for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced HYPERSENSITIVITY (I had allergic reaction within 1st 20-30 min), CONDITION AGGRAVATED (The shot 100% triggered the MS, I had a flare up), PAIN IN EXTREMITY (The left arm soreness is real, It was terrible like a truck hit you), PRURITUS (When I got in the car my belly started itching/OMG, itching lasted almost 2 weeks, itching so terribly), DYSPNOEA (Breathing difficulty), SWELLING (I felt like I was swollen within 1-2 hours), GAIT INABILITY (I am not going to be able to walk), WEIGHT INCREASED (I was almost 5 pounds heavier) and RASH (A little rash, little spots, I could feel it creeping throughout my body, scalp to toes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 30-Apr-2021 to 06-May-2021 for Hypersensitivity, at a dose of UNK, qd. On 30-Apr-2021, HYPERSENSITIVITY (I had allergic reaction within 1st 20-30 min), DYSPNOEA (Breathing difficulty) and GAIT INABILITY (I am not going to be able to walk) had resolved. On 04-May-2021, SWELLING (I felt like I was swollen within 1-2 hours), WEIGHT INCREASED (I was almost 5 pounds heavier) and RASH (A little rash, little spots, I could feel it creeping throughout my body, scalp to toes) had resolved. On 07-May-2021, PAIN IN EXTREMITY (The left arm soreness is real, It was terrible like a truck hit you) had resolved. On 26-May-2021, CONDITION AGGRAVATED (The shot 100% triggered the MS, I had a flare up) had resolved. At the time of the report, PRURITUS (When I got in the car my belly started itching/OMG, itching lasted almost 2 weeks, itching so terribly) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that all her medications were on hold weeks before and after getting the shot. She reported that her itching has got better (but was still there), the rash and little spots were gone, and the weight gain that she noticed on the scale went away in 3-4 days after the dose. The left arm soreness was gone within a week.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.