Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Hives all over torso/ Hives on hands and legs; Throat was swollen; Bottom lip was swollen; Eye lid swelling; Palms of hands swelled up; The emergency room doctor recommended that she do not take the 2nd dose; Joint pains; Headache; Injection site painful; Nauseous; Left arm was swollen at injection site; her knees were crampy, elbow was cramping; COVID arm; Was hot to touch, very warm; Inflammation in her ankle joints; Immune system ramped up; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over torso/ Hives on hands and legs) and PHARYNGEAL SWELLING (Throat was swollen) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (Immune system ramped up), ARTHRITIS (Inflammation in her ankle joints), MUSCLE SPASMS (her knees were crampy, elbow was cramping), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Was hot to touch, very warm), VACCINATION SITE SWELLING (Left arm was swollen at injection site), VACCINATION SITE PAIN (Injection site painful) and NAUSEA (Nauseous). On 21-Aug-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced URTICARIA (Hives all over torso/ Hives on hands and legs) (seriousness criterion medically significant), PHARYNGEAL SWELLING (Throat was swollen) (seriousness criterion medically significant), LIP SWELLING (Bottom lip was swollen), SWELLING OF EYELID (Eye lid swelling), PERIPHERAL SWELLING (Palms of hands swelled up), OFF LABEL USE (The emergency room doctor recommended that she do not take the 2nd dose ) and ARTHRALGIA (Joint pains). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over torso/ Hives on hands and legs), PHARYNGEAL SWELLING (Throat was swollen), VACCINATION COMPLICATION (Immune system ramped up), LIP SWELLING (Bottom lip was swollen), SWELLING OF EYELID (Eye lid swelling), ARTHRITIS (Inflammation in her ankle joints), PERIPHERAL SWELLING (Palms of hands swelled up), MUSCLE SPASMS (her knees were crampy, elbow was cramping), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Was hot to touch, very warm), OFF LABEL USE (The emergency room doctor recommended that she do not take the 2nd dose ), VACCINATION SITE SWELLING (Left arm was swollen at injection site), VACCINATION SITE PAIN (Injection site painful), NAUSEA (Nauseous) and ARTHRALGIA (Joint pains) outcome was unknown and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment medication included steroids.  The patient reported that the Emergency Room doctor recommended that she not take the 2nd dose.  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.