Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Myalgia, Nausea, Pharyngeal swelling, Presyncope
Clinical narrative: Exhausted; Nausea; Allergic reaction; Throat swelling up; Couldn't breathe/winded; Trouble swallowing; Dizziness; Felt like passing out; Feel like a dog crapped on me; Feel like i've been hit by a mack truck; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), PHARYNGEAL SWELLING (Throat swelling up), DYSPNOEA (Couldn't breathe/winded) and DYSPHAGIA (Trouble swallowing) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CYCLOBENZAPRINE and IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant), PHARYNGEAL SWELLING (Throat swelling up) (seriousness criterion medically significant), DYSPNOEA (Couldn't breathe/winded) (seriousness criterion medically significant), DYSPHAGIA (Trouble swallowing) (seriousness criterion medically significant), DIZZINESS (Dizziness), PRESYNCOPE (Felt like passing out), FEELING ABNORMAL (Feel like a dog crapped on me), MYALGIA (Feel like i've been hit by a mack truck) and NAUSEA (Nausea). On 27-May-2021, the patient experienced FATIGUE (Exhausted). The patient was treated with EPINEPHRINE (EPIPEN) at a dose of UNK dosage form; DEXAMETHASONE (DECADRON [DEXAMETHASONE]) (intravenous) at a dose of UNK dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 26-May-2021, HYPERSENSITIVITY (Allergic reaction), PHARYNGEAL SWELLING (Throat swelling up), DYSPHAGIA (Trouble swallowing), DIZZINESS (Dizziness), PRESYNCOPE (Felt like passing out) and NAUSEA (Nausea) had resolved. At the time of the report, DYSPNOEA (Couldn't breathe/winded), FEELING ABNORMAL (Feel like a dog crapped on me), MYALGIA (Feel like i've been hit by a mack truck) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient called and reported that after receiving the vaccine dose, she developed a severe allergic reaction, and was having difficulty breathing and her throat had started to swell up. The pharmacy where the patient received the dose administered an epinephrine (Epipen) injection and called 911, after which the patient was taken to a hospital and monitored. During the ambul1ance ride the patient was administered IV steroid dexamethasone (Decadron). The patient was monitored by hospital staff and discharged on the night of 26-May-2021. On 27-May-2021 while at home, the patient was reporting symptoms including fatigue and exhaustion. 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. Further information has been requested.; 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. Further information has been requested