Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Anything that touches him makes his skin goes in flames; skin swelling; skin irritated; felt achy; chest tightness; he felt like his lungs are soaked in gas, it was so inflammed; it has prevented me from being able to hold my child from time to time due to the severe pain of my skin; poisoned by your vaccine,nothing is working,suffering for a month/It is messing with his DNA/This isn't a minor side effect it is life altering.; I am still having trouble sleeping; made my life a living hell; severe pain of my skin; whole body was affected by the hives/skin 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; experiencing trouble breathing randomly throughout the day and night/continued to have difficulty breathing from time to time/my breathing difficulty; 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; Fatigue; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (experiencing trouble breathing randomly throughout the day and night/continued to have difficulty breathing from time to time/my breathing difficulty), INSOMNIA (I am still having trouble sleeping), VACCINATION COMPLICATION (poisoned by your vaccine,nothing is working,suffering for a month/It is messing with his DNA/This isn't a minor side effect it is life altering.), URTICARIA (whole body was affected by the hives/skin 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), PAIN OF SKIN (severe pain of my skin), SKIN BURNING SENSATION (Anything that touches him makes his skin goes in flames), 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), SKIN SWELLING (skin swelling) and SKIN IRRITATION (skin irritated) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A, 006M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (Fatigue). On 08-Nov-2021, the patient experienced DYSPNOEA (experiencing trouble breathing randomly throughout the day and night/continued to have difficulty breathing from time to time/my breathing difficulty) (seriousness criteria disability and medically significant), 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 criteria disability and medically significant) and 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 criteria disability and medically significant). On 10-Nov-2021, the patient experienced URTICARIA (whole body was affected by the hives/skin hives) (seriousness criteria disability and medically significant), BLISTER (whole body was affected by the blistering) (seriousness criteria disability and medically significant) and EPISTAXIS (I was getting nose bleeds (due to dryness from allergy meds)) (seriousness criteria disability and medically significant). On 30-Nov-2021, the patient experienced INSOMNIA (I am still having trouble sleeping) (seriousness criteria disability and medically significant), PAIN OF SKIN (severe pain of my skin) (seriousness criteria disability and medically significant) and FEELING ABNORMAL (made my life a living hell). On an unknown date, the patient experienced VACCINATION COMPLICATION (poisoned by your vaccine,nothing is working,suffering for a month/It is messing with his DNA/This isn't a minor side effect it is life altering.) (seriousness criteria disability and medically significant), SKIN BURNING SENSATION (Anything that touches him makes his skin goes in flames) (seriousness criteria disability and medically significant), SKIN SWELLING (skin swelling) (seriousness criteria disability and medically significant), SKIN IRRITATION (skin irritated) (seriousness criteria disability and medically significant), CHEST DISCOMFORT (chest tightness), PNEUMONITIS (he felt like his lungs are soaked in gas, it was so inflammed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it has prevented me from being able to hold my child from time to time due to the severe pain of my skin) and MYALGIA (felt achy). 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) (oral) 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, DYSPNOEA (experiencing trouble breathing randomly throughout the day and night/continued to have difficulty breathing from time to time/my breathing difficulty), INSOMNIA (I am still having trouble sleeping), VACCINATION COMPLICATION (poisoned by your vaccine,nothing is working,suffering for a month/It is messing with his DNA/This isn't a minor side effect it is life altering.), URTICARIA (whole body was affected by the hives/skin hives), 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), CHEST DISCOMFORT (chest tightness), PNEUMONITIS (he felt like his lungs are soaked in gas, it was so inflammed) and MYALGIA (felt achy) had not resolved, 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), PAIN OF SKIN (severe pain of my skin), SKIN BURNING SENSATION (Anything that touches him makes his skin goes in flames), SKIN SWELLING (skin swelling), SKIN IRRITATION (skin irritated), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it has prevented me from being able to hold my child from time to time due to the severe pain of my skin) and FEELING ABNORMAL (made my life a living hell) outcome was unknown and INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (Fatigue) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2021: Follow-up received on 08-Dec-2021, which contains updated event. On 09-Dec-2021: Follow-up information received on 09-Dec-2021, updated narrative On 20-Dec-2021: Significant Follow up, events added; 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.