Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: right side of his cheek swollen; right side of his lips swollen; right side of his cheek swollen; right side of his lips swollen; tongue swollen; tongue swollen enough that his speech was different; Right side of cheek swollen; Swollen lip to the cheek on left side; Tongue was swollen three times the normal size; Unable to breathe; Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue was swollen three times the normal size) and DYSPNOEA (Unable to breathe) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039420a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulder). On 09-Feb-2021, the patient experienced SWOLLEN TONGUE (Tongue was swollen three times the normal size) (seriousness criterion medically significant) and DYSPNOEA (Unable to breathe) (seriousness criterion medically significant). On 11-Feb-2021, the patient experienced SWELLING FACE (Right side of cheek swollen) and LIP SWELLING (Swollen lip to the cheek on left side). On 22-Feb-2021, the patient experienced the first episode of SWELLING FACE (right side of his cheek swollen), the first episode of LIP SWELLING (right side of his lips swollen), SWOLLEN TONGUE (tongue swollen) and SPEECH DISORDER (tongue swollen enough that his speech was different). On 24-Feb-2021, the patient experienced the second episode of SWELLING FACE (right side of his cheek swollen) and the second episode of LIP SWELLING (right side of his lips swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Tongue was swollen three times the normal size), DYSPNOEA (Unable to breathe), SWELLING FACE (Right side of cheek swollen), LIP SWELLING (Swollen lip to the cheek on left side), SWOLLEN TONGUE (tongue swollen), SPEECH DISORDER (tongue swollen enough that his speech was different), the last episode of SWELLING FACE (right side of his cheek swollen), the last episode of LIP SWELLING (right side of his lips swollen) and ARTHRALGIA (Sore shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Allergy test: unknown (Negative) Negative to food he ate (pistachios, tomatoes, shellfish, prawns).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a tongue swelling and reaction on the night on 09FEB2021 and was taken to the ER after calling 911. They released him in 3 hours and patient visited an allergist, who drew blood to check for a rare disease. Also did allergy testing for the foods that had eaten just prior was negative for them. The patient has never had allergy problems prior to this.  Company Comment: 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.; 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.