Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Oral pain, Respiratory tract oedema, Speech disorder, Stomatitis
Clinical narrative: Angioedema; Bleeding from soars/ulcerations throughout the mouth and under the tongue; swelling of upper airway; mouth is full of sores; mouth is swollen; Redness; Unusual taste; inability to eat; inability to drink or swallow; sensitivity to hot and cold; accompanied by considerable pain and discomfort; difficulty with clarity in enunciation; loss of pigmentation (similar to Vitiligo); This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema), ULCER HAEMORRHAGE (Bleeding from soars/ulcerations throughout the mouth and under the tongue) and RESPIRATORY TRACT OEDEMA (swelling of upper airway) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Reaction: Yeast Infections), Cervical disc disease since 1972 and Spinal stenosis since 1972. Concomitant products included MELOXICAM and VARENICLINE TARTRATE (CHANTIX) for an unknown indication.   On 06-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), ULCER HAEMORRHAGE (Bleeding from soars/ulcerations throughout the mouth and under the tongue) (seriousness criterion medically significant), RESPIRATORY TRACT OEDEMA (swelling of upper airway) (seriousness criterion medically significant), STOMATITIS (mouth is full of sores), MOUTH SWELLING (mouth is swollen), ERYTHEMA (Redness), TASTE DISORDER (Unusual taste), FEEDING DISORDER (inability to eat), DYSPHAGIA (inability to drink or swallow), GINGIVAL PAIN (sensitivity to hot and cold), ORAL PAIN (accompanied by considerable pain and discomfort), SPEECH DISORDER (difficulty with clarity in enunciation) and VITILIGO (loss of pigmentation (similar to Vitiligo)). The patient was treated with ACICLOVIR (ACYLOVIR) at a dose of 800 mg twice a day. At the time of the report, ANGIOEDEMA (Angioedema), ULCER HAEMORRHAGE (Bleeding from soars/ulcerations throughout the mouth and under the tongue), RESPIRATORY TRACT OEDEMA (swelling of upper airway), STOMATITIS (mouth is full of sores), MOUTH SWELLING (mouth is swollen), ERYTHEMA (Redness), TASTE DISORDER (Unusual taste), FEEDING DISORDER (inability to eat), DYSPHAGIA (inability to drink or swallow), GINGIVAL PAIN (sensitivity to hot and cold), ORAL PAIN (accompanied by considerable pain and discomfort), SPEECH DISORDER (difficulty with clarity in enunciation) and VITILIGO (loss of pigmentation (similar to Vitiligo)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 MOD21-039623 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Updated patient demographics. Patient medical history updated, suspect product details provided, concomitant medication added, additional event also added; 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.