Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain, Pharyngeal paraesthesia, Product dose omission issue, Swollen tongue
Clinical narrative: Tongue swelling; Throat tingle; Missed dose; Muscles hurt, muscles pain; Face became all red again; Hard time breathing, difficulty breathing; Back of throat still hurts; She had an allergic reaction; She was really hot, entire body and ears hot; Itchy throat; Funny feeling in her throat; Felt her tongue was bigger; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (She had an allergic reaction), FEELING HOT (She was really hot, entire body and ears hot), THROAT IRRITATION (Itchy throat), OROPHARYNGEAL DISCOMFORT (Funny feeling in her throat) and TONGUE DISCOMFORT (Felt her tongue was bigger) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FAMOTIDINE and ONDANSETRON for an unknown indication.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced HYPERSENSITIVITY (She had an allergic reaction), FEELING HOT (She was really hot, entire body and ears hot), THROAT IRRITATION (Itchy throat), OROPHARYNGEAL DISCOMFORT (Funny feeling in her throat), TONGUE DISCOMFORT (Felt her tongue was bigger) and OROPHARYNGEAL PAIN (Back of throat still hurts). On 25-Dec-2020, the patient experienced ERYTHEMA (Face became all red again), DYSPNOEA (Hard time breathing, difficulty breathing) and MYALGIA (Muscles hurt, muscles pain). On an unknown date, the patient experienced SWOLLEN TONGUE (Tongue swelling), PHARYNGEAL PARAESTHESIA (Throat tingle) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. On 22-Dec-2020, HYPERSENSITIVITY (She had an allergic reaction) and FEELING HOT (She was really hot, entire body and ears hot) had resolved. On 23-Dec-2020, THROAT IRRITATION (Itchy throat) and OROPHARYNGEAL DISCOMFORT (Funny feeling in her throat) had resolved. On 12-Jan-2021, TONGUE DISCOMFORT (Felt her tongue was bigger), ERYTHEMA (Face became all red again), DYSPNOEA (Hard time breathing, difficulty breathing) and MYALGIA (Muscles hurt, muscles pain) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Back of throat still hurts) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved and SWOLLEN TONGUE (Tongue swelling) and PHARYNGEAL PARAESTHESIA (Throat tingle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was premeditated before taking the first dose. She also wanted to know if she could mix vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received contains No new information On 02-Aug-2021: NNI Case. On 02-Aug-2021: Significant follow up received. Concomitant medications and additional events of throat tingle, missed dose, tongue tingle were 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 event, a causal relationship cannot be excluded.