Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Myalgia, Pyrexia, Vaccination site erythema, Vaccination site mass
Clinical narrative: She could barely move it. A big huge red hard ball in her arm for around 3 weeks; Had a sore arm; A big huge red hard ball in her arm for around 3 weeks; Body aches very painful; After 2nd booster patient experienced fever of 102°F; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (She could barely move it.), VACCINATION SITE MASS (A big huge red hard ball in her arm for around 3 weeks), VACCINATION SITE PAIN (Had a sore arm), VACCINATION SITE ERYTHEMA (A big huge red hard ball in her arm for around 3 weeks) and MYALGIA (Body aches very painful) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 071F21A, 031A21A and 030M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus (Under control), Osteoarthritis (Under control), Cholesterol (Under control), Blood pressure high (Under control) and Drug allergy (Allergy to a lot of medications maybe 15.). Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for Type 2 diabetes mellitus.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (She could barely move it.), VACCINATION SITE MASS (A big huge red hard ball in her arm for around 3 weeks), VACCINATION SITE PAIN (Had a sore arm), VACCINATION SITE ERYTHEMA (A big huge red hard ball in her arm for around 3 weeks), MYALGIA (Body aches very painful) and PYREXIA (After 2nd booster patient experienced fever of 102°F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-May-2022, MYALGIA (Body aches very painful) and PYREXIA (After 2nd booster patient experienced fever of 102°F) had resolved. On 03-Jun-2022, VACCINATION SITE MOVEMENT IMPAIRMENT (She could barely move it.), VACCINATION SITE MASS (A big huge red hard ball in her arm for around 3 weeks), VACCINATION SITE PAIN (Had a sore arm) and VACCINATION SITE ERYTHEMA (A big huge red hard ball in her arm for around 3 weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever of 102 F.         After second booster dose, the patient experienced fever of 102 F and body aches very painful during 12 hours, The patient also informed that, the vaccination provider had squeezed muscle to administer the injection, and it caused a big huge red hard ball in arm for around 3 weeks, and had a sore arm and could barely move it. The physician prescribed Tylenol to treat the symptoms. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. AE caused patient to seek medical care. The patient had not experienced a similar event in the past.   This case was linked to MOD-2022-648651 (Patient Link).