Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain in extremity, Paraesthesia, Paraesthesia oral, Urticaria
Clinical narrative: nose was congested; throat was scratchy; really bad headache; feeling a lot of fatigue/feeling more tired than he usually is; severe allergic reaction/allergic reaction to the vaccine; fingers tingling; tongue felt abnormally large; bumps on his face, back, chest and stomach; pattient felt very uncomfortable; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine) (seriousness criteria medically significant and life threatening), PARAESTHESIA (fingers tingling), PARAESTHESIA ORAL (tongue felt abnormally large), URTICARIA (bumps on his face, back, chest and stomach), FEELING ABNORMAL (pattient felt very uncomfortable) and PAIN IN EXTREMITY (Sore arm). On 18-Jun-2021, the patient experienced NASAL CONGESTION (nose was congested), OROPHARYNGEAL DISCOMFORT (throat was scratchy), HEADACHE (really bad headache) and FATIGUE (feeling a lot of fatigue/feeling more tired than he usually is). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at a dose of 1 dosage form; EPINEPHRINE (EPIPEN) for Allergic reaction, at a dose of 1 dosage form and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. On 05-Jun-2021, HYPERSENSITIVITY (severe allergic reaction/allergic reaction to the vaccine), PARAESTHESIA (fingers tingling), PARAESTHESIA ORAL (tongue felt abnormally large), URTICARIA (bumps on his face, back, chest and stomach) and FEELING ABNORMAL (pattient felt very uncomfortable) had resolved. On 07-Jun-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, NASAL CONGESTION (nose was congested), OROPHARYNGEAL DISCOMFORT (throat was scratchy), HEADACHE (really bad headache) and FATIGUE (feeling a lot of fatigue/feeling more tired than he usually is) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use is not provided by the reporter.  Reportedly, patient stayed at hospital for one hour until treatment made effect.   The patient is thinking whether to take a second dose of moderna or not.  Company Comment:  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.; 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.