Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune system disorder, Immunisation reaction, Loss of personal independence in daily activities, Rash, Respiratory disorder
Clinical narrative: when they got that under control they got a respiratory illness; Had a bad reaction to the three Moderna shots; their immune system is shock; Could not leave the house; Their skin was peeling off; whole side of face was red, crack and  pealing; the rash came back but it did not come back as strong; Broke into a rash, after 10 days of having the Moderna booster, that cover their face and arms/whole side of face was red; This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY DISORDER (when they got that under control they got a respiratory illness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031h21a, 017c21a and 020b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. Patient not had COVID positive test or diagnosis. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Food allergy, Allergy to nuts and Milk allergy. Concomitant products included ESTRADIOL (DIVIGEL) for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced RASH (Broke into a rash, after 10 days of having the Moderna booster, that cover their face and arms/whole side of face was red). On an unknown date, the patient experienced RESPIRATORY DISORDER (when they got that under control they got a respiratory illness) (seriousness criterion medically significant), IMMUNISATION REACTION (Had a bad reaction to the three Moderna shots), IMMUNE SYSTEM DISORDER (their immune system is shock), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not leave the house), SKIN EXFOLIATION (Their skin was peeling off), SKIN FISSURES (whole side of face was red, crack and  pealing) and RASH (the rash came back but it did not come back as strong). In April 2022, RASH (Broke into a rash, after 10 days of having the Moderna booster, that cover their face and arms/whole side of face was red) had resolved. At the time of the report, RESPIRATORY DISORDER (when they got that under control they got a respiratory illness), IMMUNISATION REACTION (Had a bad reaction to the three Moderna shots), IMMUNE SYSTEM DISORDER (their immune system is shock), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not leave the house), SKIN EXFOLIATION (Their skin was peeling off), SKIN FISSURES (whole side of face was red, crack and  pealing) and RASH (the rash came back but it did not come back as strong) had not resolved.            They stated that they had a bad reaction to the three Moderna shots. They stated that their immune system was shock, they broke into a rash, after 10 days of having the Moderna booster, that cover their face and arms, from 17Dec2021 until Apr-2022,  when they got that under control they got a respiratory illness, they are a very healthy person and they took care of their body, and they did not have a cold in 6 years, and the rash came back. They had two weeks of no rash and filling healthy, and the rash came back, but it did not come back as strong, but could not leave the house, it hurts, like shingles, their skin was peeling off.  The second rash seems to be a candida responds, like a fungal. The initially rash felt like shingles, like bug bits, it was horrible, really bad, whole side of face was red, crack and pealing, it was awful, it hurt really badly. Patient did not experience a similar event in the past. symptoms were improved. No treatment details were reported.  Company Comment: This spontaneous case concerns a 54-year-old female patient with no medical history, who experienced unexpected serious (medically significant) event of respiratory disorders, which occurred unspecified days after third (booster) dose of mRNA-1273 vaccine. It is reported that patient had bad reaction with three doses of mRNA-1273 vaccine and their immune system was shock, they broke into rash after 10 days of having Moderna booster, that cover their face and arms after it got under control they got respiratory illness, did not have cold in 6 years, and the rash came back, for 2 weeks patient don't have rash and rash came back, but it was not as strong as first rash, but could not leave the house it hurts like shingles, their skin was peeling off, and second rash was like fungal infection, initial rash felt like shingles like bug bites, it was horrible, really bad, whole side of face was red, crack and pealing, it was awful, it hurts really badly, patient did not experience a similar event in the past. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-586368, MOD-2022-586550 (Patient Link).; Sender's Comments: This spontaneous case concerns a 54-year-old female patient with no medical history, who experienced unexpected serious (medically significant) event of respiratory disorders, which occurred unspecified days after third (booster) dose of mRNA-1273 vaccine. It is reported that patient had bad reaction with three doses of mRNA-1273 vaccine and their immune system was shock, they broke into rash after 10 days of having Moderna booster, that cover their face and arms after it got under control they got respiratory illness, did not have cold in 6 years, and the rash came back, for 2 weeks patient don't have rash and rash came back, but it was not as strong as first rash, but could not leave the house it hurts like shingles, their skin was peeling off, and second rash was like fungal infection, initial rash felt like shingles like bug bites, it was horrible, really bad, whole side of face was red, crack and pealing, it was awful, it hurts really badly, patient did not experience a similar event in the past. The benefit-risk relationship of mRNA-1273 is not affected by this report.