Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular discomfort, Pruritus, Sleep disorder, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (he started breaking out in hives  and they have not gone away ever since/the hives occur in different places of the body/One time it occurred on his head and back, another time on his feet and legs, and another time in the flank areas), PRURITUS (hives are very itchy), LIP SWELLING (lips are swelling up/lips were swollen like I got botox injection), MOUTH SWELLING (mouth and eyes swell up) and EYE SWELLING (mouth and eyes swell up) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B212A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced URTICARIA (he started breaking out in hives  and they have not gone away ever since/the hives occur in different places of the body/One time it occurred on his head and back, another time on his feet and legs, and another time in the flank areas). On an unknown date, the patient experienced PRURITUS (hives are very itchy), LIP SWELLING (lips are swelling up/lips were swollen like I got botox injection), MOUTH SWELLING (mouth and eyes swell up), EYE SWELLING (mouth and eyes swell up), DYSPHAGIA (Sometimes it is tough for him to swallow but he does not have any breathing issues), CONTUSION (the areas where the hives have happened for a long time, bruising starts to happen), OCULAR DISCOMFORT (woke up one morning and my eyes were swollen shut) and SLEEP DISORDER (the only way he can sleep is if he takes sleep medications). At the time of the report, URTICARIA (he started breaking out in hives  and they have not gone away ever since/the hives occur in different places of the body/One time it occurred on his head and back, another time on his feet and legs, and another time in the flank areas), PRURITUS (hives are very itchy), LIP SWELLING (lips are swelling up/lips were swollen like I got botox injection), MOUTH SWELLING (mouth and eyes swell up), EYE SWELLING (mouth and eyes swell up), DYSPHAGIA (Sometimes it is tough for him to swallow but he does not have any breathing issues), CONTUSION (the areas where the hives have happened for a long time, bruising starts to happen), OCULAR DISCOMFORT (woke up one morning and my eyes were swollen shut) and SLEEP DISORDER (the only way he can sleep is if he takes sleep medications) had not resolved. The only way patient could sleep was if he takes sleep medications. He had seen multiple doctors and had multiple tests done but it still had not been figured out as to why he had these hives. He had been tested for food allergies as well as other allergies but so far, they had all been negative. He said that his lips, mouth, and eyes swell up. He had been put on multiple medications, none of which seem to be working. He was on medications 24/7. He said that he was normally a healthy individual who had never been on any medications previously. He had even been given an Epipen in case he needs it. He had not used the Epipen yet. It had been 3.5 months since he had to deal with this issue. He said that he had spent a lot of money on testing and specialists and had not gotten any answers. No concomitant medications were reported. No treatment medications were reported.