Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor, Pyrexia, Thirst, Tinnitus
Clinical narrative: she looked pale; whole left arm was really sore; low-grade fever (99.5 oF); severe headache; joint pain; felt bad chills; very hot sweaty; felt ringing sounds in her ear; felt very thirsty; black spots in front of her eyes; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TINNITUS (felt ringing sounds in her ear), THIRST (felt very thirsty), VISUAL IMPAIRMENT (black spots in front of her eyes), PALLOR (she looked pale) and PAIN IN EXTREMITY (whole left arm was really sore) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ALFACALCIDOL (ADECAL [ALFACALCIDOL]) from an unknown date to 06-Apr-2021 for ADD, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Anxiety, BREXPIPRAZOLE (REXULTI) for Depression, OMEGA 3 DHA [ASCORBIC ACID;ERGOCALCIFEROL;FISH OIL;LINUM USITATISSIMUM SEED OIL;RETINOL PALMITATE;SALVIA HISPANICA;TOCOPHERYL ACETATE] and VITAMIN D3 for Supplementation therapy.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 29-Dec-2020, the patient experienced TINNITUS (felt ringing sounds in her ear), THIRST (felt very thirsty), VISUAL IMPAIRMENT (black spots in front of her eyes), HYPERHIDROSIS (very hot sweaty) and CHILLS (felt bad chills). On 30-Dec-2020, the patient experienced PALLOR (she looked pale), PAIN IN EXTREMITY (whole left arm was really sore), PYREXIA (low-grade fever (99.5 oF)), HEADACHE (severe headache) and ARTHRALGIA (joint pain). On 29-Dec-2020, TINNITUS (felt ringing sounds in her ear), THIRST (felt very thirsty), VISUAL IMPAIRMENT (black spots in front of her eyes), HYPERHIDROSIS (very hot sweaty) and CHILLS (felt bad chills) had resolved. On 01-Jan-2021, HEADACHE (severe headache) had resolved. At the time of the report, PALLOR (she looked pale), PAIN IN EXTREMITY (whole left arm was really sore), PYREXIA (low-grade fever (99.5 oF)) and ARTHRALGIA (joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature: 99.5 f (abnormal) Low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment: On 30DEC2020, patient took Tylenol 1000mg one time and 1 to 2 hours after that she took Aleve (220 mg) 2 tablets to treat her symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Adverse events (felt ringing sounds in her ear, felt very thirsty, black spots in front of her eyes,she looked pale, whole left arm was really sore) and also concomitant medications along with respective indications (  ADECAL  for ADD, CYMBALTA for Anxiety,  REXULTI for Depression, OMEGA 3 DHA and VITAMIN D3 for Supplementation therapy) updated.; Reporter'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.