Sex: F
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Diabetes mellitus, Herpes zoster, Rash, Skin exfoliation
Clinical narrative: skin peel off; Amyotrophic lateral sclerosis; diabetes; shingles; broke out in a rash from head to toes/ three different rashes at the same time/ lower legs/ arms, head, back/; This spontaneous case was reported by a patient and describes the occurrence of DIABETES MELLITUS (diabetes) and AMYOTROPHIC LATERAL SCLEROSIS (Amyotrophic lateral sclerosis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 006C21A and 040(8orB)21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis, Fibromyalgia and Penicillin allergy.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced HERPES ZOSTER (shingles) and RASH (broke out in a rash from head to toes/ three different rashes at the same time/ lower legs/ arms, head, back/). On 17-Dec-2022, the patient experienced DIABETES MELLITUS (diabetes) (seriousness criterion medically significant). On 10-Jul-2023, the patient experienced AMYOTROPHIC LATERAL SCLEROSIS (Amyotrophic lateral sclerosis) (seriousness criterion medically significant). On an unknown date, the patient experienced SKIN EXFOLIATION (skin peel off). At the time of the report, DIABETES MELLITUS (diabetes), AMYOTROPHIC LATERAL SCLEROSIS (Amyotrophic lateral sclerosis), SKIN EXFOLIATION (skin peel off), HERPES ZOSTER (shingles) and RASH (broke out in a rash from head to toes/ three different rashes at the same time/ lower legs/ arms, head, back/) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIABETES MELLITUS (diabetes), AMYOTROPHIC LATERAL SCLEROSIS (Amyotrophic lateral sclerosis), SKIN EXFOLIATION (skin peel off), HERPES ZOSTER (shingles) and RASH (broke out in a rash from head to toes/ three different rashes at the same time/ lower legs/ arms, head, back/) to be related.    Concomitant medications were not reported.  Patient got a bad vaccine. It was the second shot, by the next morning patient knew there was something not right. Patient was blaming it on her fibromyalgia but knew it was not fibromyalgia because of the way patient felt. Patient broke out in a rash from head to toes, three different rashes at the same time. The one across the abdomen there was two rows about two inches wide that went the entire way around their abdomen and looked than shingles. The other one on her lower legs looked like pink polka dots but they were raised. Patient also had the same type on arms, head, back. Then patient had a pink rash that would fade if patient pulled her skin. All of these rashes were extremely painful and then her skin started to peel off where the rashes were. Patient thighs, when they peeled went down to her fat tissues, it looked like patient had a flesh-eating disease. Patient started getting weak and patient was falling. Before the second shot, patient was able to run two miles. Patient was in an unmotorized wheelchair. Patient hands were all contractured, losing ability to speak, swallow and losing control of bladder and bowels. Patient reported that day after patient got the second dose, patient started going downhill bad. Patient was in bed for 3 weeks. Treatment medications were not reported.  Company Comment: This spontaneous case concerns a female patient of an unknown age with no relevant medical history reported, who experienced the unexpected, serious (medically significant), events of diabetes and Amyotrophic lateral sclerosis. Diabetes was diagnosed approximately 1 year after the third dose of mRNA-1273 and about 6 months later, Amyotrophic lateral sclerosis was diagnosed. Previously, the patient had received 2 doses of mRNA-1273 within the appropriate vaccination schedule. It was reported that after the second dose, the patient broke out in a rash from head to toes, three different rashes at the same time. The one across the abdomen there was two rows about two inches wide that went the entire way around their abdomen and looked than shingles. The other one on her lower legs looked like pink polka dots but they were raised. Patient also had the same type on arms, head, back. Then patient had a pink rash that would fade if patient pulled her skin. All of these rashes were extremely painful and then her skin started to peel off where the rashes were. Patient thighs, when they peeled went down to her fat tissues, it looked like patient had a flesh-eating disease. Patient started getting weak and patient was falling. Before the second shot, patient was able to run two miles. Patient was in an unmotorized wheelchair. Patient hands were all contractured, losing ability to speak, swallow and losing control of bladder and bowels. Patient reported that day after patient got the second dose, patient started going downhill bad. Patient was in bed for 3 weeks. No further clinical information was provided for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.