Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Hiccups, Lip swelling, Mouth swelling
Clinical narrative: Swollen throat; Swollen lip; Swollen mouth; Swollen neck; Terrible stomach spasms; Continuous hiccups; Redness on back; Fatigue; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Swollen throat), LIP SWELLING (Swollen lip), MOUTH SWELLING (Swollen mouth), SWELLING (Swollen neck), MUSCLE SPASMS (Terrible stomach spasms) and HICCUPS (Continuous hiccups) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). On 10-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat) (seriousness criterion hospitalization), LIP SWELLING (Swollen lip) (seriousness criterion hospitalization), MOUTH SWELLING (Swollen mouth) (seriousness criterion hospitalization), SWELLING (Swollen neck) (seriousness criterion hospitalization), MUSCLE SPASMS (Terrible stomach spasms) (seriousness criterion hospitalization) and HICCUPS (Continuous hiccups) (seriousness criterion hospitalization). On 16-Mar-2021, the patient experienced ERYTHEMA (Redness on back). The patient was hospitalized on 10-Mar-2021 due to LIP SWELLING, MOUTH SWELLING, PHARYNGEAL SWELLING and SWELLING. On 07-Mar-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) had resolved. On 13-Mar-2021, MUSCLE SPASMS (Terrible stomach spasms) and HICCUPS (Continuous hiccups) had resolved. At the time of the report, PHARYNGEAL SWELLING (Swollen throat), LIP SWELLING (Swollen lip), MOUTH SWELLING (Swollen mouth), SWELLING (Swollen neck) and ERYTHEMA (Redness on back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reports. Treatment for the events included unspecified steroid injection, antihistamine and muscle relaxant. Description: The healthcare professional and pharmacist insisted that the patient should not receive their second dose. The patient emphasized and would like to receive the second dose, so the patient was provided with 2 epi pens.  This case concerns a 37-year-old female with serious unexpected events of pharyngeal swelling, lip swelling, mouth swelling, swelling, muscle spasms, hiccups, and nonserious expected events of pain in extremity, erythema, fatigue. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 37-year-old female with serious unexpected events of pharyngeal swelling, lip swelling, mouth swelling, swelling, muscle spasms, hiccups, and nonserious expected events of pain in extremity, erythema, fatigue. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.