Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort
Clinical narrative: lip feels different; lip swollen; didn't feel right; edge of lower lip was white; pink part of lip was inverted in a V; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (lip feels different), LIP SWELLING (lip swollen), MALAISE (didn't feel right), LIP DISCOLOURATION (edge of lower lip was white) and LIP DISORDER (pink part of lip was inverted in a V) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Glaucoma since an unknown date, Hypertension since an unknown date, Heartbeats irregular since an unknown date, Arthritis since an unknown date, Inflammation since an unknown date, Asthma since an unknown date, Vertigo since an unknown date and Headache since an unknown date. Concurrent medical conditions included Pollen allergy, Ragweed allergy, Allergy to animal (cats), Drug allergy (allergic to clindamycin) and Latex allergy. Concomitant products included MONTELUKAST SODIUM for Allergy, MELOXICAM for Arthritis, FLUTICASONE PROPIONATE (FLOVENT HFA) for Asthma, LATANOPROST (XALATAN drops 0.005%) for Glaucoma, PARACETAMOL (Tylenol Extra Strength) for Headache, ATENOLOL for Heartbeats irregular, LOSARTAN POTASSIUM for Hypertension, MESCALINE for Vertigo, FISH OIL, MULTIVITAMIN [VITAMINS NOS], IRON FERROUS SULFATE, ALPRAZOLAM and CARMELLOSE SODIUM (THERA TEARS) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ORAL DISCOMFORT (lip feels different), LIP SWELLING (lip swollen), MALAISE (didn't feel right), LIP DISCOLOURATION (edge of lower lip was white), LIP DISORDER (pink part of lip was inverted in a V) and DIZZINESS (dizziness). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, ORAL DISCOMFORT (lip feels different), LIP SWELLING (lip swollen), MALAISE (didn't feel right), LIP DISCOLOURATION (edge of lower lip was white), LIP DISORDER (pink part of lip was inverted in a V) and DIZZINESS (dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Tylenol   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Outcome of events, Concomitant medications, Asthma medical history This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (lip feels different), LIP SWELLING (lip swollen), MALAISE (didn't feel right), LIP DISCOLOURATION (edge of lower lip was white) and LIP DISORDER (pink part of lip was inverted in a V) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Glaucoma since an unknown date, Hypertension since an unknown date, Heartbeats irregular since an unknown date, Arthritis since an unknown date, Inflammation since an unknown date, Asthma since an unknown date, Vertigo since an unknown date and Headache since an unknown date. Concurrent medical conditions included Pollen allergy, Ragweed allergy, Allergy to animal (cats), Drug allergy (allergic to clindamycin) and Latex allergy. Concomitant products included MONTELUKAST SODIUM for Allergy, MELOXICAM for Arthritis, FLUTICASONE PROPIONATE (FLOVENT HFA) for Asthma, LATANOPROST (XALATAN drops 0.005%) for Glaucoma, PARACETAMOL (Tylenol Extra Strength) for Headache, ATENOLOL for Heartbeats irregular, LOSARTAN POTASSIUM for Hypertension, MESCALINE for Vertigo, FISH OIL, MULTIVITAMIN [VITAMINS NOS], IRON FERROUS SULFATE, ALPRAZOLAM and CARMELLOSE SODIUM (THERA TEARS) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ORAL DISCOMFORT (lip feels different), LIP SWELLING (lip swollen), MALAISE (didn't feel right), LIP DISCOLOURATION (edge of lower lip was white), LIP DISORDER (pink part of lip was inverted in a V) and DIZZINESS (dizziness). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, ORAL DISCOMFORT (lip feels different), LIP SWELLING (lip swollen), MALAISE (didn't feel right), LIP DISCOLOURATION (edge of lower lip was white), LIP DISORDER (pink part of lip was inverted in a V) and DIZZINESS (dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Tylenol   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Outcome of events, Concomitant medications, Asthma medical history