Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: swollen gums; got very sick when I got the first and second shot to the point I thought I was going to die; pain is worse than having a child; cant swallow/hard time drinking water/painful talking; hand, foot and mouth disease; They said it is a virus / They also said it could be hand, foot and mouth disease.; lymph nodes are swollen; severe white spots in mouth/mouth ulcers/blisters on roof of my mouth, gums, outside of lips and on the inside of my cheeks and throat/she has lesions in mouth ulcers which look like blisters; funny metallic taste; severe blisters with a funny metallic taste/she has lesions in mouth ulcers which look like blisters; lesions in my month; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (severe white spots in mouth/mouth ulcers/blisters on roof of my mouth, gums, outside of lips and on the inside of my cheeks and throat/she has lesions in mouth ulcers which look like blisters), HAND-FOOT-AND-MOUTH DISEASE (hand, foot and mouth disease), GINGIVAL SWELLING (swollen gums), ILLNESS (got very sick when I got the first and second shot to the point I thought I was going to die), ORAL MUCOSAL BLISTERING (severe blisters with a funny metallic taste/she has lesions in mouth ulcers which look like blisters), ORAL DISORDER (lesions in my month), ORAL PAIN (pain is worse than having a child), DYSPHAGIA (cant swallow/hard time drinking water/painful talking), DYSGEUSIA (funny metallic taste), VIRAL INFECTION (They said it is a virus / They also said it could be hand, foot and mouth disease.) and LYMPHADENOPATHY (lymph nodes are swollen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced MOUTH ULCERATION (severe white spots in mouth/mouth ulcers/blisters on roof of my mouth, gums, outside of lips and on the inside of my cheeks and throat/she has lesions in mouth ulcers which look like blisters) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (severe blisters with a funny metallic taste/she has lesions in mouth ulcers which look like blisters) (seriousness criterion medically significant), ORAL DISORDER (lesions in my month) (seriousness criterion medically significant), DYSGEUSIA (funny metallic taste) (seriousness criterion medically significant) and LYMPHADENOPATHY (lymph nodes are swollen) (seriousness criterion medically significant). On 03-Jul-2021, the patient experienced HAND-FOOT-AND-MOUTH DISEASE (hand, foot and mouth disease) (seriousness criterion medically significant) and VIRAL INFECTION (They said it is a virus / They also said it could be hand, foot and mouth disease.) (seriousness criterion medically significant). On an unknown date, the patient experienced GINGIVAL SWELLING (swollen gums) (seriousness criterion medically significant), ILLNESS (got very sick when I got the first and second shot to the point I thought I was going to die) (seriousness criterion medically significant), ORAL PAIN (pain is worse than having a child) (seriousness criterion medically significant) and DYSPHAGIA (cant swallow/hard time drinking water/painful talking) (seriousness criterion medically significant). The patient was treated with LIDOCAINE for Blisters, at an unspecified dose and frequency and AMOXICILLIN for Tooth infection, at an unspecified dose and frequency. At the time of the report, MOUTH ULCERATION (severe white spots in mouth/mouth ulcers/blisters on roof of my mouth, gums, outside of lips and on the inside of my cheeks and throat/she has lesions in mouth ulcers which look like blisters), HAND-FOOT-AND-MOUTH DISEASE (hand, foot and mouth disease), GINGIVAL SWELLING (swollen gums), ILLNESS (got very sick when I got the first and second shot to the point I thought I was going to die), ORAL MUCOSAL BLISTERING (severe blisters with a funny metallic taste/she has lesions in mouth ulcers which look like blisters), ORAL DISORDER (lesions in my month), ORAL PAIN (pain is worse than having a child), DYSPHAGIA (cant swallow/hard time drinking water/painful talking), DYSGEUSIA (funny metallic taste), VIRAL INFECTION (They said it is a virus / They also said it could be hand, foot and mouth disease.) and LYMPHADENOPATHY (lymph nodes are swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she got the first Moderna COVID-19 vaccination 28 days prior to second dose.  On 02-Jul-2021, she called her dentist who gave her amoxicillin for a tooth infection. She took this until she went to urgent care who told her it wasn't a tooth infection and to stop taking it. She went to urgent care on 03-Jul-2021 and the emergency room on 03-Jul-2021. On 06-Jul-2021, patient went to the doctor who told her she had lesions in mouth ulcers which look like blisters.   Patient also reported that a week after Halloween of 2020 her young child had a cough. He had a COVID test which tested positive. Her and her other son were in quarantine for two weeks but they never tested them so she doesn't know if she had COVID-19 or not.    Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medication has been reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-250541 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.