Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypopnoea, Illness, Nasopharyngitis, Neck pain, Oropharyngeal pain
Clinical narrative: After second dose her blood sugar went really up; arm getting itchy; a lump; Developed a lump at the injection site; Breathing felt shallow; Felt weak, could barely stand up; Felt weak, could barely stand up; Hip bones hurt; Fever; Felt very cold with chills; felt very cold with chills; Injection site warm to the touch; Felt very sick; She felt slightly achy; Left arm was hurting at injection site; Developed a red circle at the injection site; Tired, fatigued; Ears started to hurt; Sore throat; titanium fusion in neck hurt more than the 1st shot; Eyes were sore and hurt; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Eyes were sore and hurt), OROPHARYNGEAL PAIN (Sore throat), EAR PAIN (Ears started to hurt), VACCINATION SITE WARMTH (Injection site warm to the touch) and VACCINATION SITE MASS (Developed a lump at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (tendon release), Laminectomy spinal (Back L5- S1) in 2010, Neck surgery (posterior Fusion C3 to T1, Titanium cages, screws etc (stenosis degeneration). Post op nerve syndrome little use of arms, limited strength overall with physical therapy) in 2018, Cataract operation (L and R lenses replaced) in April 2020, Laser therapy NOS (diabetic Retinopathy - laser treatment L on 1/20, R on 2/20) in 2020 and Strabismus (surgery of both eyes) on 06-Jul-2020. Previously administered products included for Product used for unknown indication: shingles (1st shot - very sore arm; 2nd shot - welt on arm, arm got red and sore until late Thursday (20-may-2021). Fever, aches in muscles, neural symptoms in arms and legs, muscle weakness, fatigue, ribs hurt, lungs hurt - discomfort breathing and difficulty walking. Better by Sunday evening (22-may-2021)) from 20-Feb-2020 to 21-May-2020. Past adverse reactions to the above products included Adverse reaction with shingles. Concurrent medical conditions included Environmental allergy (certain scents, flowers, grasses, some unknown plant allergies, wool, feathers; manure), Latex allergy (latex sensitivity uncooked), Pollen allergy (some tree pollens especially chest nut trees because so close to latex, corn pollen), Cosmetic allergy (some lotions, shampoo, reaction to SPF over 10 percent), Smoke sensitivity (tobacco/ cigarettes), Fruit allergy (some watermelons, pineapples, cantaloupes, kiwi, bananas), Drug allergy (Severe reaction to Levemir(Insulin Detemir); reaction to preservatives in eye drops; reaction to Dorzolamide Hydrochloride and Timolol maleate preservative free ophthalmic solution USP by Aurobindo (Generic cosopt preservative free); very sensitive to analgesics, anesthetics/anaesthesias, norcotics, tramadol, gabapentin, pregabalin, most medications in general, caffeine, aspirin), Alcohol allergy (very sensitivity to alcohol 3 to 5 pinto per million in the air etc), Insect sting allergy (certain venoms: some from spiders, bees, wasps, other insects, snake venom), Gestational diabetes (diagnosed in 1999.  better control with switch from Lantus to Humulin) since 1985, Arthritis (found some in right toe joint. Now in spine. right thumb joint etc), Variant angina (Spasm Variant Angina (SVA) only in Rapid Eye Movement (REM) stage of sleep. Diltiazem controls it. No episodes for over an year and half, maybe 1-2 per year prior to that. Be fore treatment episodes almost nightly) since 2014, Preglaucoma, unspecified since 2014 and Thyroid disorder NOS (Thyroidism). Concomitant products included PRAVASTATIN for Cholesterol, METFORMIN HCL for Diabetes, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) from 22-May-2020 to an unknown date for Diabetes and Glucose abnormal NOS, DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT PF) for Glaucoma, LOSARTAN POTASSIUM for Kidney disorder, ETHINYLESTRADIOL, GESTODENE (ESTROVAL G) for Menopausal, BERBERINE, ASCORBIC ACID (VIT C), VITAMIN B COMPLEX (VIT B COMPLEX), COLECALCIFEROL (D3), UBIQUINOL, GLUCOSAMINE SULFATE and BIOTIN for Supplementation therapy, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Thyroid disorder NOS, DILTIAZEM for Variant angina, NITROGLYCERIN for an unknown indication.   On 15-Apr-2021 at 11:35 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced HEADACHE (Slight headache). On 15-Apr-2021 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE PAIN (Eyes were sore and hurt). On 15-Apr-2021 at 3:30 PM, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and NECK PAIN (titanium fusion in neck hurt more than the 1st shot). On 15-Apr-2021 at 4:00 PM, the patient experienced EAR PAIN (Ears started to hurt). On 15-Apr-2021 at 6:00 PM, the patient experienced FATIGUE (Tired, fatigued). On 16-Apr-2021, the patient experienced ILLNESS (Felt very sick), PAIN (She felt slightly achy), VACCINATION SITE PAIN (Left arm was hurting at injection site) and VACCINATION SITE ERYTHEMA (Developed a red circle at the injection site). On 16-Apr-2021 at 1:00 PM, the patient experienced VACCINATION SITE WARMTH (Injection site warm to the touch). On 16-Apr-2021 at 3:00 PM, the patient experienced NASOPHARYNGITIS (felt very cold with chills) and PYREXIA (Fever). 16-Apr-2021 at 3:00 PM, the patient experienced CHILLS (Felt very cold with chills). On 16-Apr-2021 at 8:00 PM, the patient experienced HYPOPNOEA (Breathing felt shallow). 16-Apr-2021 at 8:00 PM, the patient experienced ASTHENIA (Felt weak, could barely stand up) and DYSSTASIA (Felt weak, could barely stand up). 16-Apr-2021 at 8:00 PM, the patient experienced ARTHRALGIA (Hip bones hurt). On 18-Apr-2021, the patient experienced VACCINATION SITE MASS (Developed a lump at the injection site). 18-Apr-2021, the patient experienced PRURITUS (arm getting itchy) and VACCINATION SITE MASS (a lump). On 20-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (After second dose her blood sugar went really up). On 19-Apr-2021, HYPOPNOEA (Breathing felt shallow) had resolved. On 20-Apr-2021, EYE PAIN (Eyes were sore and hurt), OROPHARYNGEAL PAIN (Sore throat), EAR PAIN (Ears started to hurt), VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE MASS (Developed a lump at the injection site), NASOPHARYNGITIS (felt very cold with chills), ASTHENIA (Felt weak, could barely stand up), DYSSTASIA (Felt weak, could barely stand up), NECK PAIN (titanium fusion in neck hurt more than the 1st shot), PRURITUS (arm getting itchy), VACCINATION SITE MASS (a lump), ILLNESS (Felt very sick), PAIN (She felt slightly achy), HEADACHE (Slight headache), VACCINATION SITE PAIN (Left arm was hurting at injection site), VACCINATION SITE ERYTHEMA (Developed a red circle at the injection site), PYREXIA (Fever), CHILLS (Felt very cold with chills) and ARTHRALGIA (Hip bones hurt) had resolved. On 24-Apr-2021, FATIGUE (Tired, fatigued) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (After second dose her blood sugar went really up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood glucose: 200 mg/dl (High) got worse. On 17-Apr-2021, Blood glucose: 215 mg/dl High. On 18-Apr-2021, Blood glucose: 302 mg/dl High. On 19-Apr-2021, Blood glucose: 198 mg/dl High. On 20-Apr-2021, Blood glucose: 126 mg/dl normal. On 21-Apr-2021, Blood glucose: 112 mg/dl (normal) to 117.         Treatment information were not provided.   This case was linked to, INC.-MOD-2021-052975 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow-up information received on 21-APR-2021, Event added.  Patient stated that she was diabetic, and her blood sugar levels increased after the 2nd shot of vaccine.  Added lab data. On 24-May-2021: Follow-up information received on 24-MAY-2021, ADR form with event updates.    Patient stated that On 15-apr-2021 Thursday at 1PM, eyes ached a little just had to sleep. At 3:30PM, she woke up with her eyes hurting more, had sore throat, her titanium fusion in neck hurt more than the 1st shot. At 4 Pm, neck, eyes, throat hurt even more and now her ears hurt. At 6 PM, felt very good but very tired.   On 16-apr-2021 Friday, fatigued. At 1pm, left arm really hurt, got red around shot site 2inch circle and it got very hot. Felt unwell and unsteady. At 3pm, chills and fever. She was so cold and wrapped in blankets and could not stop shivering until a large heating pad was put in the blankets. At 8pm shallow breathing, so weak could hardly get up from a chair. Took more than one tries. Started using spirometer but could barely move if. Hip bones hurt; eyes hurt even worse.   On 17-apr-2021 Saturday, sick all day, chills, and fever.   Friday and Saturday sort of ran together with her husband she was so sick.  On 18-apr-2021 Sunday, red on arm, fading and not so hot, getting itchy and now a lump, breathing still shallow but spirometer getting easier.   On 19-apr-2021 Monday, much better but weak and still fever, breathing about normal.   On 20-apr-2021 Tuesday, fever gone, felt better but fatigued. Blood sugar 1st normal under 120 reading since the shot it was go over 350.   Still took 3 or 4 days to recover from fatigue.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-052975:1st dose events