Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication, Vaccination site pruritus, Vaccination site warmth, Vision blurred
Clinical narrative: Heart rate irregular; vision was blurry; pale; face was itchy/itching all over body sporadic and not localized; Redness in face/blotchy red hot; metallic taste afte the vaccine was administered; anaphylatic reaction; warmness up the arm and into the neck after getting the vaccine; facial swelling; Hives; Irritable; didn't feel good/truck ran over her; Vaccination site warmth; itchiness at injection site; Fatigue; Headache; Nausea; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylatic reaction) in a 40-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.     Concurrent medical conditions included Sulfonamide allergy (developed hives and stomach upset when young adult) and Drug allergy (Erythromycin -developed hives when young adult).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 11-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylatic reaction) (seriousness criterion medically significant), FEELING HOT (warmness up the arm and into the neck after getting the vaccine), SWELLING FACE (facial swelling), URTICARIA (Hives), IRRITABILITY (Irritable), VACCINATION COMPLICATION (didn't feel good/truck ran over her), PALLOR (pale), PRURITUS (face was itchy/itching all over body sporadic and not localized), ERYTHEMA (Redness in face/blotchy red hot), DYSGEUSIA (metallic taste afte the vaccine was administered), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (itchiness at injection site), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Jan-2021, the patient experienced VISION BLURRED (vision was blurry). On an unknown date, the patient experienced HEART RATE IRREGULAR (Heart rate irregular). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) on 11-Jan-2021 for Nausea, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) on 11-Jan-2021 for Nausea, at an unspecified dose and frequency; EPINEPHRINE on 11-Jan-2021 at an unspecified dose and frequency and PREDNISONE on 11-Jan-2021 at an unspecified dose and frequency. On 19-Jan-2021, ANAPHYLACTIC REACTION (anaphylatic reaction) had resolved. At the time of the report, FEELING HOT (warmness up the arm and into the neck after getting the vaccine), SWELLING FACE (facial swelling), URTICARIA (Hives), IRRITABILITY (Irritable), VACCINATION COMPLICATION (didn't feel good/truck ran over her), PALLOR (pale), PRURITUS (face was itchy/itching all over body sporadic and not localized), ERYTHEMA (Redness in face/blotchy red hot), VACCINATION SITE PRURITUS (itchiness at injection site), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) had resolved, VISION BLURRED (vision was blurry) had not resolved and DYSGEUSIA (metallic taste afte the vaccine was administered), HEART RATE IRREGULAR (Heart rate irregular) and VACCINATION SITE WARMTH (Vaccination site warmth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Blood pressure measurement (120-80 mmHg): 104/60 mmHg (Inconclusive) at 10:16 am and 164/90 mmHg (Inconclusive) at 10:25 am. On 11-Jan-2021, Heart rate: 129 (Inconclusive) at 10:16 am, 79 (Inconclusive) at 10:20 am and 125 (Inconclusive) at 10:25 am. On 11-Jan-2021, Oxygen saturation: 84 (Inconclusive) 84 and 97 (Inconclusive) 97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous), the reporter did not provide any causality assessments.   The patient received the vaccine at 9:50 am on 11-Jan-2021 and returned to the room at 10:10 am with the symptoms. EMS was notified and Epi Pen administered at 10:16 am. The patient's oxygen saturation was initially 80% and the hands were very cold. The patient was transported to ER and was dismissed later on in the day.  The signs and symptoms of anaphylactic reaction were reported as itching/pruritis, hives/uriticria, irregular heart rate/palpitations, nausea, difficulty breathing, swelling of upper airway, sensation of throat closing, angioedema, prickling/tingling sensation, feeling hot and flushing.  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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: Additional event was updated. On 14-Apr-2021: The diagnosis, symptoms, patient information and vaccination site details were updated.; 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.