Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngeal swelling, Product dose omission issue, Swelling, Swollen tongue
Clinical narrative: Swelling of the throat, swelling got worse, difficulty to swallow and tongue is numb /still swollen throat,/ still suffering from chronic swelling on her throat and tongue; Allergic reaction; Reflux; Sometimes the tongue has some sporadic sharp pain.; Swelling on throat and tongue; Sometimes swelling on nose; Sometimes throat hurts; Didn't get the 2nd dose; Swelling of the throat, swelling got worse, difficulty to swallow and tongue is numb; Swelling of the throat, swelling got worse, difficulty to swallow and tongue is numb/some weird sensation while swallowing like its still swollen throat,; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction) and PHARYNGEAL SWELLING (Swelling of the throat, swelling got worse, difficulty to swallow and tongue is numb /still swollen throat,/ still suffering from chronic swelling on her throat and tongue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DYSPHAGIA (Swelling of the throat, swelling got worse, difficulty to swallow and tongue is numb/some weird sensation while swallowing like its still swollen throat,). On 01-Feb-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction) (seriousness criterion hospitalization) and HYPOAESTHESIA ORAL (Swelling of the throat, swelling got worse, difficulty to swallow and tongue is numb). On 07-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Swelling of the throat, swelling got worse, difficulty to swallow and tongue is numb /still swollen throat,/ still suffering from chronic swelling on her throat and tongue) (seriousness criterion hospitalization). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Reflux), GLOSSODYNIA (Sometimes the tongue has some sporadic sharp pain.), SWOLLEN TONGUE (Swelling on throat and tongue), SWELLING (Sometimes swelling on nose), OROPHARYNGEAL PAIN (Sometimes throat hurts) and PRODUCT DOSE OMISSION ISSUE (Didn't get the 2nd dose). The patient was hospitalized from sometime in February 2021 to sometime in February 2021 due to ALLERGY TO VACCINE and PHARYNGEAL SWELLING. The patient was treated with PREDNISONE for Throat swelling, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Allergic reaction NOS, at a dose of 1 dosage form; CETIRIZINE for Allergic reaction NOS, at a dose of 1 dosage form; MONTELUKAST for Allergic reaction, at a dose of 1 dosage form and HYDROXYZINE for Allergic reaction and COVID-19 vaccination, at a dose of 1 dosage form. At the time of the report, ALLERGY TO VACCINE (Allergic reaction), HYPOAESTHESIA ORAL (Swelling of the throat, swelling got worse, difficulty to swallow and tongue is numb), SWOLLEN TONGUE (Swelling on throat and tongue), SWELLING (Sometimes swelling on nose) and OROPHARYNGEAL PAIN (Sometimes throat hurts) outcome was unknown, PHARYNGEAL SWELLING (Swelling of the throat, swelling got worse, difficulty to swallow and tongue is numb /still swollen throat,/ still suffering from chronic swelling on her throat and tongue), DYSPHAGIA (Swelling of the throat, swelling got worse, difficulty to swallow and tongue is numb/some weird sensation while swallowing like its still swollen throat,), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux) and GLOSSODYNIA (Sometimes the tongue has some sporadic sharp pain.) had not resolved and PRODUCT DOSE OMISSION ISSUE (Didn't get the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported she also takes unspecified birth control pills.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: The follow-up was received on 8-JULY-2021. Events were updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.