Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Swollen tongue, Urticaria
Clinical narrative: right arm is bruised; has some soreness there; face became reddened and was scratchy, itchy and blotchy; face became reddened and was scratchy, itchy and blotchy; face became reddened and was scratchy, itchy and blotchy; hives; swollen tongue; couldn't swallow; difficult to breathe through her mouth; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (face became reddened and was scratchy, itchy and blotchy), PRURITUS (face became reddened and was scratchy, itchy and blotchy), RASH MACULAR (face became reddened and was scratchy, itchy and blotchy), URTICARIA (hives) and SWOLLEN TONGUE (swollen tongue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 12-Jan-2021 at 7:23 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced ERYTHEMA (face became reddened and was scratchy, itchy and blotchy), PRURITUS (face became reddened and was scratchy, itchy and blotchy), RASH MACULAR (face became reddened and was scratchy, itchy and blotchy), URTICARIA (hives), SWOLLEN TONGUE (swollen tongue), DYSPHAGIA (couldn't swallow) and DYSPNOEA (difficult to breathe through her mouth). On 13-Jan-2021, the patient experienced CONTUSION (right arm is bruised) and PAIN IN EXTREMITY (has some soreness there). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 12-Jan-2021 for Adverse event, at a dose of 50 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Jan-2021 for Adverse event, at a dose of 25 mg and EPINEPHRINE (EPIPEN JR) on 12-Jan-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (face became reddened and was scratchy, itchy and blotchy), PRURITUS (face became reddened and was scratchy, itchy and blotchy), RASH MACULAR (face became reddened and was scratchy, itchy and blotchy), URTICARIA (hives), SWOLLEN TONGUE (swollen tongue), DYSPHAGIA (couldn't swallow), DYSPNOEA (difficult to breathe through her mouth), CONTUSION (right arm is bruised) and PAIN IN EXTREMITY (has some soreness there) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   Patient was taken to the Emergency Room (ER. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jan-2021 and was forwarded to Moderna on 14-Jan-2021.    This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (face became reddened and was scratchy, itchy and blotchy), PRURITUS (face became reddened and was scratchy, itchy and blotchy), RASH MACULAR (face became reddened and was scratchy, itchy and blotchy), URTICARIA (hives) and SWOLLEN TONGUE (swollen tongue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 12-Jan-2021 at 7:23 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced ERYTHEMA (face became reddened and was scratchy, itchy and blotchy), PRURITUS (face became reddened and was scratchy, itchy and blotchy), RASH MACULAR (face became reddened and was scratchy, itchy and blotchy), URTICARIA (hives), SWOLLEN TONGUE (swollen tongue), DYSPHAGIA (couldn't swallow) and DYSPNOEA (difficult to breathe through her mouth). On 13-Jan-2021, the patient experienced CONTUSION (right arm is bruised) and PAIN IN EXTREMITY (has some soreness there). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 12-Jan-2021 for Adverse event, at a dose of 50 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Jan-2021 for Adverse event, at a dose of 25 mg and EPINEPHRINE (EPIPEN JR) on 12-Jan-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (face became reddened and was scratchy, itchy and blotchy), PRURITUS (face became reddened and was scratchy, itchy and blotchy), RASH MACULAR (face became reddened and was scratchy, itchy and blotchy), URTICARIA (hives), SWOLLEN TONGUE (swollen tongue), DYSPHAGIA (couldn't swallow), DYSPNOEA (difficult to breathe through her mouth), CONTUSION (right arm is bruised) and PAIN IN EXTREMITY (has some soreness there) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   Patient was taken to the Emergency Room (ER.; 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.