Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Hypoaesthesia oral, Muscle tightness, Palpitations
Clinical narrative: bitter taste; Palpitations; Flushing; Feeling hot; Swelling of upper Airway; chills; fatigue; headache; Fever; swelling of the arm of the injection; her face was red; tongue was numb/ numbness of the tip of my tongue and mouth; muscle tightness; running nose; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (swelling of the arm of the injection), RHINORRHOEA (running nose), ERYTHEMA (her face was red), HYPOAESTHESIA ORAL (tongue was numb/ numbness of the tip of my tongue and mouth) and MUSCLE TIGHTNESS (muscle tightness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036L30A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Patient was allergic to sulfa drugs associated with body rash and swelling), Rash (Patient was allergic to sulfa drugs associated with body rash and swelling) and Swelling (Patient was allergic to sulfa drugs associated with body rash and swelling). Concomitant products included ESTROGENS ESTERIFIED, METHYLTESTOSTERONE (ESTRATEST) from 01-Nov-2020 to an unknown date and PRASTERONE (INTRAROSA) for Hormone therapy, TEMAZEPAM for Sleep disorder, CLONAZEPAM for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced RHINORRHOEA (running nose). On 08-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling of the arm of the injection), ERYTHEMA (her face was red), HYPOAESTHESIA ORAL (tongue was numb/ numbness of the tip of my tongue and mouth), MUSCLE TIGHTNESS (muscle tightness), HEADACHE (headache) and PYREXIA (Fever). On 09-Jan-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). On an unknown date, the patient experienced DYSGEUSIA (bitter taste), PALPITATIONS (Palpitations), FLUSHING (Flushing), FEELING HOT (Feeling hot) and UPPER RESPIRATORY TRACT INFLAMMATION (Swelling of upper Airway). At the time of the report, PERIPHERAL SWELLING (swelling of the arm of the injection), RHINORRHOEA (running nose), PYREXIA (Fever), PALPITATIONS (Palpitations), FLUSHING (Flushing), FEELING HOT (Feeling hot) and UPPER RESPIRATORY TRACT INFLAMMATION (Swelling of upper Airway) outcome was unknown, ERYTHEMA (her face was red), MUSCLE TIGHTNESS (muscle tightness), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) had resolved and HYPOAESTHESIA ORAL (tongue was numb/ numbness of the tip of my tongue and mouth) and DYSGEUSIA (bitter taste) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PERIPHERAL SWELLING (swelling of the arm of the injection), RHINORRHOEA (running nose), ERYTHEMA (her face was red), HYPOAESTHESIA ORAL (tongue was numb/ numbness of the tip of my tongue and mouth), MUSCLE TIGHTNESS (muscle tightness), DYSGEUSIA (bitter taste), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (Fever) to be possibly related. No further causality assessments were provided for PALPITATIONS (Palpitations), FLUSHING (Flushing), FEELING HOT (Feeling hot) and UPPER RESPIRATORY TRACT INFLAMMATION (Swelling of upper Airway).    No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-033294 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Significant Follow-up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.