Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain of skin, Pruritus, Urticaria
Clinical narrative: I am still having trouble sleeping; made my life horrible; severe pain of my skin; whole body was affected by the hives; whole body was affected by the blistering; I was getting nose bleeds (due to dryness from allergy meds); skin was still inflamed after coming into contact with anything/ Skin still swelling / Skin still irritated/whole body was affected by the irritation; causing my skin to itch,itching was excruciating/itching was uncontrollable/seemed to make the itchiness subside/I was still having itchines/Itchiness returned after steroid prescription/itchiness; experiencing trouble breathing randomly throughout the day and night/continued to have difficulty breathing from time to time/my breathing difficulty; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (causing my skin to itch,itching was excruciating/itching was uncontrollable/seemed to make the itchiness subside/I was still having itchines/Itchiness returned after steroid prescription/itchiness), DYSPNOEA (experiencing trouble breathing randomly throughout the day and night/continued to have difficulty breathing from time to time/my breathing difficulty), URTICARIA (whole body was affected by the hives), BLISTER (whole body was affected by the blistering), EPISTAXIS (I was getting nose bleeds (due to dryness from allergy meds)), DERMATITIS (skin was still inflamed after coming into contact with anything/ Skin still swelling / Skin still irritated/whole body was affected by the irritation), INSOMNIA (I am still having trouble sleeping), FEELING ABNORMAL (made my life horrible) and PAIN OF SKIN (severe pain of my skin) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRURITUS (causing my skin to itch,itching was excruciating/itching was uncontrollable/seemed to make the itchiness subside/I was still having itchines/Itchiness returned after steroid prescription/itchiness) (seriousness criterion medically significant), DYSPNOEA (experiencing trouble breathing randomly throughout the day and night/continued to have difficulty breathing from time to time/my breathing difficulty) (seriousness criterion medically significant) and DERMATITIS (skin was still inflamed after coming into contact with anything/ Skin still swelling / Skin still irritated/whole body was affected by the irritation) (seriousness criterion medically significant). On 10-Nov-2021, the patient experienced URTICARIA (whole body was affected by the hives) (seriousness criterion medically significant), BLISTER (whole body was affected by the blistering) (seriousness criterion medically significant) and EPISTAXIS (I was getting nose bleeds (due to dryness from allergy meds)) (seriousness criterion medically significant). On 30-Nov-2021, the patient experienced INSOMNIA (I am still having trouble sleeping) (seriousness criterion medically significant), FEELING ABNORMAL (made my life horrible) (seriousness criterion medically significant) and PAIN OF SKIN (severe pain of my skin) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; HYDROCORTISONE for Adverse event, at an unspecified dose and frequency; TRIAMCINOLONE ACETONIDE for Itchy, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency; FAMOTIDINE for Adverse event, at an unspecified dose and frequency; MONTELUKAST SODIUM (SINGULAIR) for Breathing difficult, at an unspecified dose and frequency; ALBUTEROL SULFATE for Breathing difficult, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRATAB) for Adverse event, at an unspecified dose and frequency; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Adverse event, at a dose of 2 doses in evening and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 2 doses in morning. At the time of the report, PRURITUS (causing my skin to itch,itching was excruciating/itching was uncontrollable/seemed to make the itchiness subside/I was still having itchines/Itchiness returned after steroid prescription/itchiness) and DYSPNOEA (experiencing trouble breathing randomly throughout the day and night/continued to have difficulty breathing from time to time/my breathing difficulty) had not resolved and URTICARIA (whole body was affected by the hives), BLISTER (whole body was affected by the blistering), EPISTAXIS (I was getting nose bleeds (due to dryness from allergy meds)), DERMATITIS (skin was still inflamed after coming into contact with anything/ Skin still swelling / Skin still irritated/whole body was affected by the irritation), INSOMNIA (I am still having trouble sleeping), FEELING ABNORMAL (made my life horrible) and PAIN OF SKIN (severe pain of my skin) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 10-Nov-2021, the patient was prescribed with Prednisone for three days. Dermatologist instructed the patient to take 2 doses of Zyrtec in the morning and 2 doses of Claritin in the evening. Patient's lab data included blood test for allergy testing and chest X-ray. Patient was prescribed with Prednisone with a heavier dosage. Patient was instructed to take a dose of Allegra along with the Famotidine in the morning and a dose of Zyrtec and Singulair in the evenings. As soon as steroid prescription was completed, the itchiness returned.  Company comment: This spontaneous case concerns a 41-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Dyspnoea, Pruritus, Dermatitis, Urticaria and Blister after mRNA- 1273 Moderna vaccine. The onset of the events occurred approximately 11 days after the booster dose of mRNA- 1273 vaccine. The events could be in connection with each other. The patient reported dyspnoea and that his whole body was affected by hives, blistering and irritation.  Dermatologic and allergy consultation was performed. Chest X ray and laboratory results were solicited, but results are not available at this moment. Treatment with antihistamines and glucocorticoids (local and systemics) was prescribed. Additionally, due to dyspnoea patient was treated with Montelukast and Albuterol. At the time of the report, pruritus and dyspnoea had not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Dyspnoea, Pruritus, Dermatitis, Urticaria and Blister after mRNA- 1273 Moderna vaccine. The onset of the events occurred approximately 11 days after the booster dose of mRNA- 1273 vaccine. The events could be in connection with each other. The patient reported dyspnoea and that his whole body was affected by hives, blistering and irritation.  Dermatologic and allergy consultation was performed. Chest X ray and laboratory results were solicited, but results are not available at this moment. Treatment with antihistamines and glucocorticoids (local and systemics) was prescribed. Additionally, due to dyspnoea patient was treated with Montelukast and Albuterol. At the time of the report, pruritus and dyspnoea had not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.