Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site induration
Clinical narrative: swelling of the lymph nodes in the same arm of the injection; headache; chills; muscle pain; achiness, achy all over; very lethargic; There is a bump a little red; Swelling (hardness) at injection site after 1st dose; waking up every morning with body aches in her joint; fatigue; swollen; very itchy; red; injection site pain,injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness, achy all over), LETHARGY (very lethargic), VACCINATION SITE NODULE (There is a bump a little red), INJECTION SITE INDURATION (Swelling (hardness) at injection site after 1st dose) and ARTHRALGIA (waking up every morning with body aches in her joint) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE and LISINOPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, METOPROLOL for Heart rate irregular, LEVOTHYROXINE for Thyroid hormone replacement therapy, BUPROPION, ESCITALOPRAM OXALATE (LEXAPRO), ACETYLSALICYLIC ACID (BABY ASPIRIN), CLONAZEPAM and VITAMINS NOS for an unknown indication.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2. On an unknown date, the patient experienced PAIN (achiness, achy all over), LETHARGY (very lethargic), VACCINATION SITE NODULE (There is a bump a little red), INJECTION SITE INDURATION (Swelling (hardness) at injection site after 1st dose), ARTHRALGIA (waking up every morning with body aches in her joint), FATIGUE (fatigue), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (red), INJECTION SITE PAIN (injection site pain,injection site tenderness), LYMPHADENOPATHY (swelling of the lymph nodes in the same arm of the injection), HEADACHE (headache), CHILLS (chills) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN (achiness, achy all over), LETHARGY (very lethargic), VACCINATION SITE NODULE (There is a bump a little red), INJECTION SITE INDURATION (Swelling (hardness) at injection site after 1st dose), ARTHRALGIA (waking up every morning with body aches in her joint), FATIGUE (fatigue), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (red), INJECTION SITE PAIN (injection site pain,injection site tenderness), LYMPHADENOPATHY (swelling of the lymph nodes in the same arm of the injection), HEADACHE (headache), CHILLS (chills) and MYALGIA (muscle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-070143, MOD21-074414 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: doses and indications and of concomitant medications ;  second dose batch number was added; Sender's Comments:  MOD21-070143: MOD21-074414: