Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort, Wheezing
Clinical narrative: Heart rate increased; Loss of taste; Loss of sense of smell; Sore throat; Tiredness; headache; Phlegmy cough; Evening I started having chills; Bronchospasm; Wheezing; Feeling hot; Flushing; Difficulty breathing; Unusual taste; Immediate rush of fullness in my neck and head; Tongue burned; Chest tightness; Sinus pain; back pain; neck pain; Sharp deep pains on right side just below rib cage which hurt to touch; Pressure in sinuses; Pressure in head; Metal taste on tongue; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (Pressure in sinuses), HEAD DISCOMFORT (Pressure in head), DYSGEUSIA (Metal taste on tongue), BRONCHOSPASM (Bronchospasm) and WHEEZING (Wheezing) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives, Wheezing, Nausea, Carpal tunnel syndrome (Carpal Tunnel R. Hand) in 2000, Humerus fracture (R. Arm Shattered Humerus) in 2013, Rotator cuff repair (R. Shoulder Rotator Cuff (2) 2013 March & August) in March 2013, Hand fracture (Right Hand Fracture) in March 2018, Ankle fracture in January 2020, Cataract (right) on 17-Feb-2021, Cataract (left) on 24-Feb-2021, Tonsillectomy (Tonsils surgery) in 1970, Breast biopsy (Multiple Breast Biopsie) from 1980 to 1999, Cholecystectomy (Gall Bladder) in 1999, Hysterectomy (ovaries conserved) in 2000, Bladder sling procedure in 2000, Hip replacement (Left Hip Replacement) in December 2013 and Thyroidectomy on 30-Jun-2021. Previously administered products included for Cataract: Ofloxacin (Ofloxacin (Ocuflox) sol 0.3% eye drops 4 times daily for 10 days after surgery) until 10-Mar-2021, Prolensa (Prolensa Sol 0.07% 1 time daily for 30 days after surgery.) and Prednisolone Aceta Susp (Prednisolone Aceta Susp 1% 4 times daily for 30 days after surgery for each eye.). Past adverse reactions to the above products included No adverse event with Prednisolone Aceta Susp and Prolensa. Concurrent medical conditions included Drug allergy (Allergic to Cephalexin), Food allergy (Allergic to shell fish), General anesthesia, Asthma since 1980, Osteoporosis since 2017, Sleep apnea since 2005 and Papillary thyroid cancer since May 2016. Concomitant products included LEVOTHYROXINE SODIUM, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), LOSARTAN, HYDROCHLOROTHIAZIDE, CENTRUM SILVER WOMEN 50+, AMLODIPINE, LATANOPROST, MAGNESIUM COMPLEXE, ASCORBIC ACID (LIPOSOMAL C-VIT), CALCIUM CARBONATE, COLECALCIFEROL, VITAMIN K NOS (CITRACAL [CALCIUM CARBONATE;COLECALCIFEROL;VITAMIN K NOS]), ZINC SULFATE (LIQUID ZINC), ASCORBIC ACID, VACCINIUM MACROCARPON FRUIT (CRANBERRY CONCENTRATE [ASCORBIC ACID;VACCINIUM MACROCARPON FRUIT]) and ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]) for an unknown indication.    On 11-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PARANASAL SINUS DISCOMFORT (Pressure in sinuses), HEAD DISCOMFORT (Pressure in head), DYSGEUSIA (Metal taste on tongue), TONGUE DISCOMFORT (Tongue burned), CHEST DISCOMFORT (Chest tightness), SINUS PAIN (Sinus pain), MUSCULOSKELETAL CHEST PAIN (Sharp deep pains on right side just below rib cage which hurt to touch), BACK PAIN (back pain), NECK PAIN (neck pain) and MYALGIA (Arm pain). On 11-Mar-2021 at 4:00 PM, the patient experienced BRONCHOSPASM (Bronchospasm), WHEEZING (Wheezing), FEELING HOT (Feeling hot), FLUSHING (Flushing), DYSPNOEA (Difficulty breathing), TASTE DISORDER (Unusual taste) and FEELING ABNORMAL (Immediate rush of fullness in my neck and head). On 12-Mar-2021, the patient experienced CHILLS (Evening I started having chills). On 13-Mar-2021, the patient experienced PRODUCTIVE COUGH (Phlegmy cough) and HEADACHE (headache). On 14-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Tiredness). On 15-Mar-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of sense of smell). On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate increased). The patient was treated with PARACETAMOL (TYLENOL) on 12-Mar-2021 for Pain in arm, at an unspecified dose and frequency. On 11-Mar-2021, FLUSHING (Flushing) had resolved. On 11-Mar-2021 at 6:15 PM, FEELING ABNORMAL (Immediate rush of fullness in my neck and head) had resolved. On 12-Mar-2021, MUSCULOSKELETAL CHEST PAIN (Sharp deep pains on right side just below rib cage which hurt to touch) had resolved. On 13-Mar-2021, MYALGIA (Arm pain) had resolved. On 16-Mar-2021, TONGUE DISCOMFORT (Tongue burned), AGEUSIA (Loss of taste) and ANOSMIA (Loss of sense of smell) had resolved. On 16-Mar-2021 at 2:00 PM, TASTE DISORDER (Unusual taste) had resolved. On 18-Mar-2021, PARANASAL SINUS DISCOMFORT (Pressure in sinuses), HEAD DISCOMFORT (Pressure in head) and DYSGEUSIA (Metal taste on tongue) had resolved. At the time of the report, BRONCHOSPASM (Bronchospasm), WHEEZING (Wheezing), FEELING HOT (Feeling hot), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Chest tightness), SINUS PAIN (Sinus pain), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Phlegmy cough), BACK PAIN (back pain), NECK PAIN (neck pain), CHILLS (Evening I started having chills), FATIGUE (Tiredness), HEADACHE (headache) and HEART RATE INCREASED (Heart rate increased) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Heart rate: unknown (High) Increased. On 12-Mar-2021, Body temperature: 100.5 (High) High. On 13-Mar-2021, Body temperature: 97.9 (normal) Normal. On 14-Mar-2021, Body temperature: high (High) Slight temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took META MUCIL1 Tablespoon in water at night.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant information received about patient relevant history, concomitant drugs, treatment, new events and lab data were added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.