Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Aphthous ulcer, Blister, Blood pressure measurement, Body temperature
Clinical narrative: Difficulty breathing; Tonsillitis acute; Swelling lips; Swelling throat; Uvula swelling; Difficulty talking; Itching; Sensation of throat closing; Bronchospasm/wheezing; Bronchospasm/wheezing; Cough; Numbness; Hypersensitivity reaction; Mouth is always full of saliva, if open your mouth comes out as a yellow liquid; Lost 7 lbs; Anaphylactic reaction; Body rash; Whole legs are red; Color was white; Fatigue; Mouth and tongue were swollen; Swelling of tongue; Mouth and tongue were red; Could not swallow; Blister; Severe canker sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty breathing) and ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfa (redness and swelling of the mucous membrane)) since 1961, Osteoporosis (Arolia injection in 2 years, bone density increased) since 20-Jan-1999, High cholesterol since 2011 and Osteoarthritis since 25-Feb-2021.   On 26-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MOUTH SWELLING (Mouth and tongue were swollen), SWOLLEN TONGUE (Swelling of tongue), ORAL MUCOSAL ERYTHEMA (Mouth and tongue were red), DYSPHAGIA (Could not swallow), BLISTER (Blister), APHTHOUS ULCER (Severe canker sore), TONGUE DISCOLOURATION (Color was white) and FATIGUE (Fatigue). On 01-Apr-2021, the patient experienced ERYTHEMA (Whole legs are red) and RASH (Body rash). On 24-May-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), WEIGHT DECREASED (Lost 7 lbs), TONSILLITIS (Tonsillitis acute), LIP SWELLING (Swelling lips), PHARYNGEAL SWELLING (Swelling throat), ENLARGED UVULA (Uvula swelling), SPEECH DISORDER (Difficulty talking), PRURITUS (Itching), THROAT TIGHTNESS (Sensation of throat closing), BRONCHOSPASM (Bronchospasm/wheezing), WHEEZING (Bronchospasm/wheezing), COUGH (Cough), HYPOAESTHESIA (Numbness), HYPERSENSITIVITY (Hypersensitivity reaction) and SALIVARY HYPERSECRETION (Mouth is always full of saliva, if open your mouth comes out as a yellow liquid). At the time of the report, DYSPNOEA (Difficulty breathing), ANAPHYLACTIC REACTION (Anaphylactic reaction), MOUTH SWELLING (Mouth and tongue were swollen), SWOLLEN TONGUE (Swelling of tongue), ORAL MUCOSAL ERYTHEMA (Mouth and tongue were red), DYSPHAGIA (Could not swallow), BLISTER (Blister), APHTHOUS ULCER (Severe canker sore), WEIGHT DECREASED (Lost 7 lbs), TONGUE DISCOLOURATION (Color was white), ERYTHEMA (Whole legs are red), TONSILLITIS (Tonsillitis acute), LIP SWELLING (Swelling lips), PHARYNGEAL SWELLING (Swelling throat), ENLARGED UVULA (Uvula swelling), SPEECH DISORDER (Difficulty talking), PRURITUS (Itching), THROAT TIGHTNESS (Sensation of throat closing), BRONCHOSPASM (Bronchospasm/wheezing), WHEEZING (Bronchospasm/wheezing), COUGH (Cough), HYPOAESTHESIA (Numbness), HYPERSENSITIVITY (Hypersensitivity reaction), SALIVARY HYPERSECRETION (Mouth is always full of saliva, if open your mouth comes out as a yellow liquid), RASH (Body rash) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure measurement: 140/85 (High) high 140/85 mmHg. On 25-Mar-2021, Body temperature: 97.9 (normal) normal. On 25-Mar-2021, Heart rate: 67 (normal) normal 67 beats per minute.. On 25-Mar-2021, Respiratory rate: 16 (normal) 16 breaths per minute. On 26-Mar-2021, Blood pressure measurement: 116/67 (normal) normal 116/67 mmHg. On 26-Mar-2021, Body temperature: 98.7 (normal) normal. On 26-Mar-2021, Heart rate: 55 (normal) normal 55 beats per minute..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications included amoxicillin-clavulanate, paracetamol, prednisone and diphenhydramine.  Follow-up report received on 25MAY2021 included no new information.    This case was linked to US-MODERNATX, INC.-MOD-2021-066665, US-MODERNATX, INC.-MOD-2021-066647 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-may-2021 contains non-significant information On 20-May-2021: Duplicate  On 24-May-2021: Hypersensitivity form received, AE updates. Case is upgraded to Serious. Additional medical history was provided; treatment details were provided; vital signs/diagnostic results provided On 25-May-2021: Sender's Comments: Very limited and confuse information regarding these events has been provided by the patient at this time.  Further information has been requested to the Physician. US-MODERNATX, INC.-MOD-2021-066665:Crosslinked (MOD21-068818) US-MODERNATX, INC.-MOD-2021-066647:Crosslinked (MOD21-068818)