Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysphonia, Dyspnoea, Ear pain
Clinical narrative: Feeling unwell; Sore throat; Hoarsness; Blurred vision; Throat swelling; Decreased hearing left ear; Ear pain; Congestion; Light headness; Weakness; fatigue; bad headache; sinuses flared up; face swelled up; problems in breathing; This spontaneous case was reported by a nurse and describes the occurrence of SINUS DISORDER (sinuses flared up), SWELLING FACE (face swelled up), DYSPNOEA (problems in breathing), MALAISE (Feeling unwell) and OROPHARYNGEAL PAIN (Sore throat) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Obesity, Hypertension, Allergy to antibiotic (Augmentin) and Enlarged thyroid. Concomitant products included METOPROLOL and HCTZ for Blood pressure, CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIFLEX SOFT CHEWS) for Joint pain, ASA and MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN SODIUM PHOSPHATE;THIAMINE MONONITRATE;TOCOPHERYL ACETATE] for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced SINUS DISORDER (sinuses flared up), SWELLING FACE (face swelled up), DYSPNOEA (problems in breathing) and HEADACHE (bad headache). On an unknown date, the patient experienced MALAISE (Feeling unwell), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Hoarsness), VISION BLURRED (Blurred vision), PHARYNGEAL SWELLING (Throat swelling), HYPOACUSIS (Decreased hearing left ear), EAR PAIN (Ear pain), NASAL CONGESTION (Congestion), DIZZINESS (Light headness), ASTHENIA (Weakness) and FATIGUE (fatigue). The patient was treated with PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) at a dose of 1 dosage form; ALBUTEROL [SALBUTAMOL] at a dose of 1 dosage form; PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form; PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form and AZITHROMYCIN DIHYDRATE (AZITHROMYCIN [AZITHROMYCIN DIHYDRATE]) at a dose of 1 dosage form. At the time of the report, SINUS DISORDER (sinuses flared up), SWELLING FACE (face swelled up), DYSPNOEA (problems in breathing), MALAISE (Feeling unwell), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Hoarsness), VISION BLURRED (Blurred vision), PHARYNGEAL SWELLING (Throat swelling), HYPOACUSIS (Decreased hearing left ear), EAR PAIN (Ear pain), NASAL CONGESTION (Congestion), DIZZINESS (Light headness), ASTHENIA (Weakness), FATIGUE (fatigue) and HEADACHE (bad headache) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported having a clavicle/throat injury since 2008 which worsened after the injection. Patient also reported that Obesity and Hypertension worsened after the injection   This case was linked to MOD-2021-261609 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow-up was received. Updated patient information, medical history, concomitant and treatment medications, action taken and events outcome to not resolved. Added events.