Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Mouth swelling, Oral mucosal blistering, Oral pain, Pain
Clinical narrative: Rash on shins of both legs; Woke up with pain at 3 AM; Mouth was hurting/it was more painful/it hurt so bad/it hurt when she ate or swallowed even drank; There was a line of blisters/blisters lasted half a week, was much better now; There were lot more blisters on the left side, roof and cheek; Left side of the mouth was swollen up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Woke up with pain at 3 AM), ORAL PAIN (Mouth was hurting/it was more painful/it hurt so bad/it hurt when she ate or swallowed even drank), BLISTER (There was a line of blisters/blisters lasted half a week, was much better now), ORAL MUCOSAL BLISTERING (There were lot more blisters on the left side, roof and cheek) and MOUTH SWELLING (Left side of the mouth was swollen up) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0024C21 and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS, Rheumatoid arthritis, Thyroid disorder and Asthma. Concomitant products included CETIRIZINE for Allergy, PROCATEROL HYDROCHLORIDE (PRO-AIR) for Asthma, LISINOPRIL for Blood pressure management, ATORVASTATIN for Cholesterol, CHLORTHALIDONE for Fluid retention, DILTIAZEM for Heart disorder, PREDNISONE for Rheumatoid arthritis, LEVOTHYROXINE for Thyroid disorder, VITAMIN B12 [VITAMIN B12 NOS] for Vitamin supplementation, POTASSIUM, HYDROXYCHLOROQUINE, CLOPIDOGREL BISULFATE (CLOPIDOGREL [CLOPIDOGREL BISULFATE]), PANTOPRAZOLE, URSODIOL, METHOTREXATE, GABAPENTIN, DULOXETINE, CYCLOBENZAPRINE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced PAIN (Woke up with pain at 3 AM), ORAL PAIN (Mouth was hurting/it was more painful/it hurt so bad/it hurt when she ate or swallowed even drank), BLISTER (There was a line of blisters/blisters lasted half a week, was much better now) and ORAL MUCOSAL BLISTERING (There were lot more blisters on the left side, roof and cheek). 22-May-2021, the patient experienced MOUTH SWELLING (Left side of the mouth was swollen up). On 25-May-2021, the patient experienced RASH (Rash on shins of both legs). The patient was treated with NYSTATIN (oral) on 22-May-2021 for Pain and Blistering of mouth, at an unspecified dose and frequency. At the time of the report, PAIN (Woke up with pain at 3 AM), ORAL PAIN (Mouth was hurting/it was more painful/it hurt so bad/it hurt when she ate or swallowed even drank) and MOUTH SWELLING (Left side of the mouth was swollen up) outcome was unknown, BLISTER (There was a line of blisters/blisters lasted half a week, was much better now) and ORAL MUCOSAL BLISTERING (There were lot more blisters on the left side, roof and cheek) had resolved and RASH (Rash on shins of both legs) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-162258 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: The event rash was added, outcome of blisters updated as recovered