Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Increased viscosity of upper respiratory secretion, Oesophageal ulcer, Product use issue, Swollen tongue, Urticaria
Clinical narrative: breaking out with hives; tongue swelling; blood pressure is very high, her blood pressure is 193/93; esophageal ulcer; thick white mucus settling in her throat; heavy breathing; face is flushed; dupilumab 300 mg every other week for severe persistent asthma, uncomplicated; very ill; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out with hives), SWOLLEN TONGUE (tongue swelling), HYPERTENSION (blood pressure is very high, her blood pressure is 193/93) and OESOPHAGEAL ULCER (esophageal ulcer) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB solution for injection for Asthma.    The patient's past medical history, medical treatment(s), and family history were not provided.  Concomitant products included PREDNISONE for an unknown indication.   On 10-Aug-2020, the patient started DUPILUMAB (Subcutaneous) 600 mg once a day. On 24-Aug-2020, DUPILUMAB (unknown route) dosage was changed to 300 mg. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced URTICARIA (breaking out with hives) (seriousness criterion hospitalization), SWOLLEN TONGUE (tongue swelling) (seriousness criterion hospitalization), HYPERTENSION (blood pressure is very high, her blood pressure is 193/93) (seriousness criterion hospitalization) and ILLNESS (very ill). On an unknown date, the patient experienced OESOPHAGEAL ULCER (esophageal ulcer) (seriousness criterion medically significant), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (thick white mucus settling in her throat), DYSPNOEA (heavy breathing), FLUSHING (face is flushed) and PRODUCT USE ISSUE (dupilumab 300 mg every other week for severe persistent asthma, uncomplicated). The last dose administered for DUPILUMAB (DUPILUMAB) was sometime in April 2021. The patient was treated with FAMOTIDINE for Esophageal ulcer, at a dose of UNK dosage form. At the time of the report, URTICARIA (breaking out with hives), SWOLLEN TONGUE (tongue swelling), OESOPHAGEAL ULCER (esophageal ulcer), ILLNESS (very ill), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (thick white mucus settling in her throat), DYSPNOEA (heavy breathing) and PRODUCT USE ISSUE (dupilumab 300 mg every other week for severe persistent asthma, uncomplicated) outcome was unknown and HYPERTENSION (blood pressure is very high, her blood pressure is 193/93) and FLUSHING (face is flushed) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2020, Weight increased: 13 (Inconclusive) from 242 lbs to 255 lbs. Gained 13 pounds.. On 15-Mar-2021, Blood pressure measurement: incresed (High) results are unknown. On 07-May-2021, Blood pressure measurement: 193/93 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient experienced hives, tongue swelling and high blood pressure following covid-19 vaccine (Moderna)  administration on an unspecified date in Apr-2021 and fell very ill. She was hospitalized. Treatment information included famotidine for esophageal ulcer, oxygen for heavy breathing and unknown treatment for rest of the events. It was reported that the patient experienced esophageal ulcer, thick white mucus in throat and heavy breathing on an unknown date in 2020. It was reported that the patient had stopped taking Dupilumab, three weeks prior to the vaccine administration.  Company Comment : Very limited information regarding these events has been provided at this time. Further information has been requested. This report refers to a case of Product use issue (Unapproved dose administered) for mRNA-1273, lot # unknown is assessed as not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. This report refers to a case of Product use issue (Unapproved dose administered) for mRNA-1273, lot # unknown is assessed as not applicable.