Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oral herpes
Clinical narrative: severe constant dry mouth; mouth herpes/ a case of mouth herpes; numb; My lips were also swollen again, tender, cut; tender lips; upper and lower lips puffed up/ swollen lips; I got clear or white small bumps inside of my lower lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP DISORDER (I got clear or white small bumps inside of my lower lip), DRY MOUTH (severe constant dry mouth), ORAL HERPES (mouth herpes/ a case of mouth herpes), LIP SWELLING (upper and lower lips puffed up/ swollen lips) and HYPOAESTHESIA (numb) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History reported.  Concomitant products included BUPROPION for Depression and Anxiety, GABAPENTIN for Nerve pain, CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]) for Supplementation therapy, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN for Vitamin supplementation, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced LIP DISORDER (I got clear or white small bumps inside of my lower lip), LIP SWELLING (upper and lower lips puffed up/ swollen lips) and LIP PAIN (tender lips). On 04-Jun-2021, the patient experienced LIP INJURY (My lips were also swollen again, tender, cut). On an unknown date, the patient experienced DRY MOUTH (severe constant dry mouth), ORAL HERPES (mouth herpes/ a case of mouth herpes) and HYPOAESTHESIA (numb). The patient was treated with BIOTIN at a dose of UNK dosage form and VALACYCLOVIR [VALACICLOVIR] from 04-May-2021 to 19-May-2021 at a dose of 1 gram 2/d. At the time of the report, LIP DISORDER (I got clear or white small bumps inside of my lower lip) and LIP PAIN (tender lips) had not resolved and DRY MOUTH (severe constant dry mouth), ORAL HERPES (mouth herpes/ a case of mouth herpes), LIP SWELLING (upper and lower lips puffed up/ swollen lips), HYPOAESTHESIA (numb) and LIP INJURY (My lips were also swollen again, tender, cut) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that she consulted two doctor's and a dentist for the white bumps inside her lower lip.  Treatment provided included hydration paste and blistex.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: ADR form appended. Added patient demographics, race, health care professional contact details, concomitant medications, start date of events, outcome, new events and treatment medications.