Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Electrocardiogram, Endoscopy, Heart rate irregular
Clinical narrative: Voice was constantly hoarse; Nose was constantly dry; Feeling like a there was a knot in her throat; Difficulty breathing when she lays down due to her dry nose; Wakes up in a profuse sweat; Doesn't feel good; Sensitivity to smells that started in December but has been getting worse; Diesel, smoke and fragrance smell cause an asthma like attack; very anxious because everything is getting worse; Experiencing joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHONIA (Voice was constantly hoarse), NASAL DRYNESS (Nose was constantly dry), SENSATION OF FOREIGN BODY (Feeling like a there was a knot in her throat), DYSPNOEA (Difficulty breathing when she lays down due to her dry nose) and HYPERHIDROSIS (Wakes up in a profuse sweat) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Difficulty breathing on 14-Jan-2021, Back pain in January 2021 and Physiotherapy (Had undergone physiotherapy due to severe back pain). Concurrent medical conditions included Oral lichen planus, Allergy (Diesel, smoke and fragrance smell cause an asthma like attack.) since December 2020, Smoke sensitivity (Diesel, smoke and fragrance smell cause an asthma like attack.) since December 2020, Fragrance sensitivity (Diesel, smoke and fragrance smell cause an asthma like attack.) since December 2020, Dust allergy, Bundle branch block (Bundle branch blockage on her left side) since 18-Nov-2020, Palpitations since 30-Dec-2020, Gastroesophageal reflux disease (Reflux started before the vaccine), Throat pain, Dysphagia and Osteoporosis. Concomitant products included LOSARTAN for Blood pressure management, CALCIUM CARBONATE, SODIUM ALGINATE (GAVISCON [CALCIUM CARBONATE;SODIUM ALGINATE]) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPHONIA (Voice was constantly hoarse), NASAL DRYNESS (Nose was constantly dry), SENSATION OF FOREIGN BODY (Feeling like a there was a knot in her throat), DYSPNOEA (Difficulty breathing when she lays down due to her dry nose), HYPERHIDROSIS (Wakes up in a profuse sweat), MALAISE (Doesn't feel good), HYPERSOMNIA (Sensitivity to smells that started in December but has been getting worse), ASTHMA (Diesel, smoke and fragrance smell cause an asthma like attack), ANXIETY (very anxious because everything is getting worse) and ARTHRALGIA (Experiencing joint pain). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of UNK dosage form; PREDNISONE at a dose of UNK dosage form; OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at a dose of UNK dosage form; SUCRALFATE (CARAFATE) at a dose of UNK dosage form; CORTISONE at a dose of UNK dosage form and SODIUM CHLORIDE (AYR SALINE) for Dry nose, at a dose of UNK dosage form. At the time of the report, DYSPHONIA (Voice was constantly hoarse), NASAL DRYNESS (Nose was constantly dry), SENSATION OF FOREIGN BODY (Feeling like a there was a knot in her throat), DYSPNOEA (Difficulty breathing when she lays down due to her dry nose), HYPERHIDROSIS (Wakes up in a profuse sweat), MALAISE (Doesn't feel good), HYPERSOMNIA (Sensitivity to smells that started in December but has been getting worse), ASTHMA (Diesel, smoke and fragrance smell cause an asthma like attack), ANXIETY (very anxious because everything is getting worse) and ARTHRALGIA (Experiencing joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Electrocardiogram: abnormal (abnormal) Bundle branch blockage on her left side. On 11-Feb-2021, Endoscopy: inconclusive (Inconclusive) Inconclusive. On 11-Feb-2021, pH body fluid: inconclusive (Inconclusive) Reported that a 24 hour pH study was conducted.. On 05-Apr-2021, Cardiac stress test: normal (normal) Reported to be fine. On an unknown date, Blood pressure measurement: high (High) Reported that the blood pressure was going up. On an unknown date, Heart rate irregular: abnormal (abnormal) Reported that heart rate goes up and down. On an unknown date, Weight: decreased (Low) Reported that she had lost 16 pounds multiple tests performed were all was negative. The patient was forcing to eat and had gained some of weight back..         patient went back to ER on 25 Jan 2021 due to difficulty in swallowing and throat pain who stopped all previously administered medications. On 11 Feb 2021 the patient saw a gastroenterologist. On 01 Mar 2021 a thyroid test was ordered. Patient had Verbatim term like she is scared,wishes she hadn't gotten the Moderna vaccine,has lost 16 pounds but has gained some back by forcing herself to eat and contact information updated.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-030743 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Additional document was received on 01-Jun-2021 and contains no new information. On 07-Jul-2021: NNI follow up