Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Limb discomfort, Malaise, Metabolic function test, Myalgia
Clinical narrative: still don't feel 100% back to my prevaccine health; fatigue; bruised on both lower extremities; lower legs became extremely sore; fever went from 97.1 to 101.8; myalgia; arthralgia; headaches; chills; prodromal symptoms of HSV outbreak; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HERPES SIMPLEX (prodromal symptoms of HSV outbreak), CONTUSION (bruised on both lower extremities), LIMB DISCOMFORT (lower legs became extremely sore), MALAISE (still don't feel 100% back to my prevaccine health) and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included HSV infection and Bell's palsy (Experienced after the first dose of Moderna Vaccine) in January 2021. Concomitant products included CALCIUM for Bone disorder, VALACYCLOVIR [VALACICLOVIR] for HSV infection, VITAMIN D3 for Vitamin D low.   On 08-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced HERPES SIMPLEX (prodromal symptoms of HSV outbreak). On 05-Feb-2021 at 10:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever went from 97.1 to 101.8), MYALGIA (myalgia), ARTHRALGIA (arthralgia), HEADACHE (headaches) and CHILLS (chills). On 14-Feb-2021, the patient experienced CONTUSION (bruised on both lower extremities) and LIMB DISCOMFORT (lower legs became extremely sore). On an unknown date, the patient experienced MALAISE (still don't feel 100% back to my prevaccine health) and FATIGUE (fatigue). At the time of the report, HERPES SIMPLEX (prodromal symptoms of HSV outbreak), CONTUSION (bruised on both lower extremities), LIMB DISCOMFORT (lower legs became extremely sore), PYREXIA (fever went from 97.1 to 101.8), MYALGIA (myalgia), ARTHRALGIA (arthralgia), HEADACHE (headaches) and CHILLS (chills) had resolved and MALAISE (still don't feel 100% back to my prevaccine health) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Blood creatine phosphokinase: normal (normal) Around 3 pm, results were within normal limits.. On 06-Feb-2021, Body temperature: increased (High) At 1am  fever went from 97.1 to 101.8. On 06-Feb-2021, Metabolic function test: normal (normal) Around 3 pm, results were within normal limits.. On 06-Feb-2021, Renal function test: zero (Low) kidney output dropped to zero. On 06-Feb-2021, Specific gravity urine: low (Low) low due to my hydration of 3L of fluid.. On an unknown date, Blood creatine phosphokinase: normal (normal) normal. On an unknown date, C-reactive protein: normal (normal) Normal. On an unknown date, Full blood count: normal (normal) normal limits. On an unknown date, International normalised ratio: normal (normal) normal. On an unknown date, Metabolic function test: normal (normal) Normal. On an unknown date, Prothrombin time: normal (normal) normal. On an unknown date, Red blood cell sedimentation rate: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to events was not applicable.   Patient was discharged with stable vitals. The bruising resolved over the following week. The low-level fatigue remained. Patient experienced prodromal symptoms of HSV outbreak about 4 times (much more than  usual) and had to take valacyclovir for a few days each time.   This case was linked to MOD-2021-011418, MOD-2021-011418 (Patient Link).; 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.