Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound kidney
Clinical narrative: 16 hrs trying to sleep; Fever; extreme joint pain/Severe mucle/joint pains; extreme muscle pain/Severe mucle/joint pains; fatigue/Extreme fatigue lasting for apprx one wk.; Very bad/painful headache/Severe Headache; Slight Nausea; terrible chills/Severe chills/Shivering; Backache; Very severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Very severe reaction), INSOMNIA (16 hrs trying to sleep), BACK PAIN (Backache), PYREXIA (Fever) and CHILLS (terrible chills/Severe chills/Shivering) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (changes in hip ,neck ,spine, hands) since 1990, Fibromyalgia, Penicillin allergy, Drug allergy (Allergic to Levaquin), Iodine allergy, Drug allergy (Allergic to prednisolone), Drug allergy (Allergic to aspirin), Drug allergy (Allergic to bystolic), Drug allergy (allergic to Norvasc), Drug allergy (Allergic to calcium tablets) and Drug allergy. Concomitant products included QUINAPRIL and CARVEDILOL for Blood pressure management, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, TRAZODONE, PARACETAMOL (TYLENOL), MULTIVITAMIN [VITAMINS NOS], KRILL OIL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ADVERSE REACTION (Very severe reaction), BACK PAIN (Backache), CHILLS (terrible chills/Severe chills/Shivering), MYALGIA (extreme muscle pain/Severe mucle/joint pains), FATIGUE (fatigue/Extreme fatigue lasting for apprx one wk.), HEADACHE (Very bad/painful headache/Severe Headache) and NAUSEA (Slight Nausea). On an unknown date, the patient experienced INSOMNIA (16 hrs trying to sleep), PYREXIA (Fever) and ARTHRALGIA (extreme joint pain/Severe mucle/joint pains). At the time of the report, ADVERSE REACTION (Very severe reaction), BACK PAIN (Backache), CHILLS (terrible chills/Severe chills/Shivering), MYALGIA (extreme muscle pain/Severe mucle/joint pains), FATIGUE (fatigue/Extreme fatigue lasting for apprx one wk.), HEADACHE (Very bad/painful headache/Severe Headache) and NAUSEA (Slight Nausea) had not resolved and INSOMNIA (16 hrs trying to sleep), PYREXIA (Fever) and ARTHRALGIA (extreme joint pain/Severe mucle/joint pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Ultrasound kidney: negative (Negative) Negative.         Concomitant medications include fenofibrilate and HCTZ and coq10-100mg one every other day  No treatment medications were reported.   This case was linked to MOD-2021-224013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-Jul-2021 contains added second dose information, patient demographics, concomitant medications, added new events and outcome of the events were updated.