Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: hardness at injection site; Next day,she had redness and hardness at injection site; Patient started with headache after receiving 1st dose; Patient experienced fatigue; Patient experienced chills; Patient experienced Fever; Patient experienced nausea; Next day,she had redness and hardness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness at injection site), HEADACHE (Patient started with headache after receiving 1st dose), FATIGUE (Patient experienced fatigue), CHILLS (Patient experienced chills) and PYREXIA (Patient experienced Fever ) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression, Hypertension, Cholesterol, Anxiety and Gastritis. Concomitant products included DESLORATADINE (CLARINEX [DESLORATADINE]) for Allergy, ALPRAZOLAM (XANAX) for Anxiety, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Anxiety and Depression, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol high, METHYLPHENIDATE HYDROCHLORIDE (RITALIN) for Depression, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression and Anxiety, CALCIUM CARBONATE, FAMOTIDINE, MAGNESIUM HYDROXIDE (PEPCID COMPLETE) for Gastritis, BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Headache, OLMESARTAN MEDOXOMIL (BENICAR) for Hypertension, ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced HEADACHE (Patient started with headache after receiving 1st dose), FATIGUE (Patient experienced fatigue), CHILLS (Patient experienced chills), PYREXIA (Patient experienced Fever ), NAUSEA (Patient experienced nausea) and VACCINATION SITE PAIN (Next day,she had redness and hardness at injection site). On 28-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hardness at injection site) and VACCINATION SITE ERYTHEMA (Next day,she had redness and hardness at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (hardness at injection site), HEADACHE (Patient started with headache after receiving 1st dose), FATIGUE (Patient experienced fatigue), CHILLS (Patient experienced chills), PYREXIA (Patient experienced Fever ), NAUSEA (Patient experienced nausea), VACCINATION SITE PAIN (Next day,she had redness and hardness at injection site) and VACCINATION SITE ERYTHEMA (Next day,she had redness and hardness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow up received on 6-may-2021, it does not contain any new information. On 28-May-2021: follow up information received on 28-may-2021, Contains significant information. Added Medical History details, Concomitant medications added, Suspect drug information was updated.