Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Skin discolouration, Urticaria
Clinical narrative: hives in all the head and all body hives were so bad that patient needed to go to ER head spread like every were; couldn't even move; temperature  changes; my feet swell up hands swell up; it's hard to walk; itchy; when scratches turns read immediately my face is purple  turn reds; face is purple  turn reds and gets really hot; face is purple, turn reds and gets really hot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives in all the head and all body hives were so bad that patient needed to go to ER head spread like every were), MOBILITY DECREASED (couldn't even move), BODY TEMPERATURE FLUCTUATION (temperature  changes), PERIPHERAL SWELLING (my feet swell up hands swell up), GAIT DISTURBANCE (it's hard to walk), PRURITUS (itchy), ERYTHEMA (when scratches turns read immediately my face is purple  turn reds), SKIN DISCOLOURATION (face is purple  turn reds and gets really hot) and FEELING HOT (face is purple, turn reds and gets really hot) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 024M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced URTICARIA (hives in all the head and all body hives were so bad that patient needed to go to ER head spread like every were) (seriousness criterion medically significant), MOBILITY DECREASED (couldn't even move) (seriousness criterion medically significant), BODY TEMPERATURE FLUCTUATION (temperature  changes) (seriousness criterion medically significant), PERIPHERAL SWELLING (my feet swell up hands swell up) (seriousness criterion medically significant), GAIT DISTURBANCE (it's hard to walk) (seriousness criterion medically significant), PRURITUS (itchy) (seriousness criterion medically significant), ERYTHEMA (when scratches turns read immediately my face is purple  turn reds) (seriousness criterion medically significant), SKIN DISCOLOURATION (face is purple  turn reds and gets really hot) (seriousness criterion medically significant) and FEELING HOT (face is purple, turn reds and gets really hot) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency; PREDNISONE for Adverse reaction, at an unspecified dose and frequency and CETIRIZINE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives in all the head and all body hives were so bad that patient needed to go to ER head spread like every were), MOBILITY DECREASED (couldn't even move), BODY TEMPERATURE FLUCTUATION (temperature  changes), PERIPHERAL SWELLING (my feet swell up hands swell up), GAIT DISTURBANCE (it's hard to walk), PRURITUS (itchy), ERYTHEMA (when scratches turns read immediately my face is purple  turn reds), SKIN DISCOLOURATION (face is purple  turn reds and gets really hot) and FEELING HOT (face is purple, turn reds and gets really hot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment medication include Hidroxemine, Xamamine.  No concomitant medication was reported.  Company comment This case concerns a 32-year-old male patient, with no medical history reported, who experienced the serious unexpected events of urticaria, mobility decreased, body temperature fluctuation, peripheral swelling, gait disturbance, pruritus, erythema, skin discolouration and feeling hot. The events occurred approximately 11 days after the third dose of mRNA-1273. The patient stated that one night, 3 days after 1st reaction, hives were so bad that patient needed to go to ER. The doctor indicated Prednisone, Hidroxemine, Cetrozine and Xamamine as treatments. The symptoms got better but didn't go away completely. The rechallenge was not applicable since the AEs occurred after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 32-year-old male patient, with no medical history reported, who experienced the serious unexpected events of urticaria, mobility decreased, body temperature fluctuation, peripheral swelling, gait disturbance, pruritus, erythema, skin discoloration and feeling hot. The events occurred approximately 11 days after the third dose of mRNA-1273. The patient stated that one night, 3 days after 1st reaction, hives were so bad that patient needed to go to ER. The doctor indicated Prednisone, Hidroxemine, Cetrozine and Xamamine as treatments. The symptoms got better but didn't go away completely. The rechallenge was not applicable since the AEs occurred after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.