Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Periorbital swelling, Pruritus, Pyrexia
Clinical narrative: every 3 wks or so I'm hit with another "wave" of the same side effects; Face itchy; eyes got puffy; again tongue burned; palate and tongue itchy; small bumps inside lips; nose (internally) had burning sensation; Allergic reaction to eating mangoes; Tongue felt burned/ again tongue burned/Nose (internally) had burning sensation; Tongue/palate itchy; Inside the lip had small bumps; Throat burned; fever; Joint pain/ muscle/joint pains; Slight nausea; fatigue/Extream fatigue lasting for apprx. one wk; muscle pain/muscle/joint pains; headache; Chills/ chills/Shivering; 16 hrs trying to sleep; Backache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (16 hrs trying to sleep), BACK PAIN (Backache), FOOD ALLERGY (Allergic reaction to eating mangoes), BURNING SENSATION (Tongue felt burned/ again tongue burned/Nose (internally) had burning sensation) and TONGUE PRURITUS (Tongue/palate itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu. Concurrent medical conditions included Fibromyalgia since 1980, Arthritis (changes in hip, neck, spine, hands) since 1990, Penicillin allergy (allergy to pcn), Drug allergy (allergy to levaquin), Iodine allergy, Drug allergy (allergy to prednisone), Drug allergy (allergy to aspirin), Drug allergy (allergy to Bystolic), Drug allergy (allergy to Norvasc), Drug allergy (allergy to calcium tablets) and Drug allergy (allergy to NSAIDS). Concomitant products included QUINAPRIL, HCTZ and CARVEDILOL for Blood pressure management, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol high, FENOFIBRATE for Triglycerides abnormal, TRAZODONE, MULTIVITAMIN [VITAMINS NOS], KRILL OIL (KRILL OIL OMEGA 3), ERGOCALCIFEROL (VIT D [ERGOCALCIFEROL]), COLECALCIFEROL, UBIDECARENONE (COQ10 + D3) and PARACETAMOL (TYLENOL) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INSOMNIA (16 hrs trying to sleep), BACK PAIN (Backache), PYREXIA (fever), ARTHRALGIA (Joint pain/ muscle/joint pains), NAUSEA (Slight nausea), FATIGUE (fatigue/Extream fatigue lasting for apprx. one wk), MYALGIA (muscle pain/muscle/joint pains), HEADACHE (headache) and CHILLS (Chills/ chills/Shivering). In June 2021, the patient experienced FOOD ALLERGY (Allergic reaction to eating mangoes), BURNING SENSATION (Tongue felt burned/ again tongue burned/Nose (internally) had burning sensation), TONGUE PRURITUS (Tongue/palate itchy), LIP DISORDER (Inside the lip had small bumps) and THROAT IRRITATION (Throat burned). On 07-Jul-2021, the patient experienced PRURITUS (Face itchy), PERIORBITAL SWELLING (eyes got puffy), BURNING SENSATION (again tongue burned), TONGUE PRURITUS (palate and tongue itchy), LIP DISORDER (small bumps inside lips) and BURNING SENSATION (nose (internally) had burning sensation). On an unknown date, the patient experienced EXTRAPYRAMIDAL DISORDER (every 3 wks or so I'm hit with another "wave" of the same side effects). At the time of the report, INSOMNIA (16 hrs trying to sleep), EXTRAPYRAMIDAL DISORDER (every 3 wks or so I'm hit with another "wave" of the same side effects), PYREXIA (fever), ARTHRALGIA (Joint pain/ muscle/joint pains), FATIGUE (fatigue/Extream fatigue lasting for apprx. one wk), MYALGIA (muscle pain/muscle/joint pains), HEADACHE (headache) and CHILLS (Chills/ chills/Shivering) had not resolved, BACK PAIN (Backache), FOOD ALLERGY (Allergic reaction to eating mangoes), BURNING SENSATION (Tongue felt burned/ again tongue burned/Nose (internally) had burning sensation), TONGUE PRURITUS (Tongue/palate itchy), LIP DISORDER (Inside the lip had small bumps), THROAT IRRITATION (Throat burned) and NAUSEA (Slight nausea) had resolved and PRURITUS (Face itchy), PERIORBITAL SWELLING (eyes got puffy), BURNING SENSATION (again tongue burned), TONGUE PRURITUS (palate and tongue itchy), LIP DISORDER (small bumps inside lips) and BURNING SENSATION (nose (internally) had burning sensation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Ultrasound kidney: negative (Negative) negative.         No treatment information was provided by the reporter.   This case was linked to MOD-2021-223983 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received including contains updated patient demographics , medical history , lab data , added concomitant medications, added new events and its outcome.