Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: ringing in the ears; headache; off and on hot flashes; hot sweats; fatigue, off and on fatigue; fevers, off and on fever; body aches, left arm is still sore; chills; joint pain; pain at the injection site, continued into the next day; swelling at the injection site, continued into the next day; redness at the injection site, continued into the next day; stopped menstrual cycle for May2021; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (hot sweats), MENSTRUATION IRREGULAR (stopped menstrual cycle for May2021), HOT FLUSH (off and on hot flashes), TINNITUS (ringing in the ears) and VACCINATION SITE PAIN (pain at the injection site, continued into the next day) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM (KLONOPIN), CEFIXIME (FLEXERIL [CEFIXIME]), DICLOFENAC POTASSIUM (VOLTAREN ACTI), FLUOXETINE HYDROCHLORIDE (PROZAC), IBUPROFEN, MELOXICAM (MOBIC), MULTIVITAMIN [VITAMINS NOS], CALCIUM and FISH OIL, OENOTHERA BIENNIS OIL, TOCOPHERYL ACETATE (OMEGA 3 & 6) for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced MENSTRUATION IRREGULAR (stopped menstrual cycle for May2021). On 19-May-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site, continued into the next day), VACCINATION SITE SWELLING (swelling at the injection site, continued into the next day) and VACCINATION SITE ERYTHEMA (redness at the injection site, continued into the next day). On 20-May-2021, the patient experienced HYPERHIDROSIS (hot sweats), FATIGUE (fatigue, off and on fatigue), PYREXIA (fevers, off and on fever), MYALGIA (body aches, left arm is still sore), CHILLS (chills) and ARTHRALGIA (joint pain). On 02-Jun-2021, the patient experienced HOT FLUSH (off and on hot flashes). On an unknown date, the patient experienced TINNITUS (ringing in the ears) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (hot sweats), MENSTRUATION IRREGULAR (stopped menstrual cycle for May2021), HOT FLUSH (off and on hot flashes), TINNITUS (ringing in the ears), VACCINATION SITE PAIN (pain at the injection site, continued into the next day), VACCINATION SITE SWELLING (swelling at the injection site, continued into the next day), VACCINATION SITE ERYTHEMA (redness at the injection site, continued into the next day), FATIGUE (fatigue, off and on fatigue), MYALGIA (body aches, left arm is still sore), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.