Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, like her head was being squeezed in a vice and a screwdriver was in the right side of her skull; Vomiting; Coughing; Anaphylactic Reaction; Blood pressure was very high; started rubbing chest, did not feel the same way as when they first arrived at the facility; Dizzy; Vertigo; Feeling unwell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic Reaction) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anaphylaxis, Hypersensitivity reaction, Asthma, Hives (Hives/urticaria), Drug allergy (Codeine-Severe Vomiting. Morphine-Fell asleep within minutes of receiving Medication.), Hives (Severe Hives (High Tryptase Level). Under Care of Allergist, taking Bee Sting Shots and Xolair Shots.  No hives since November of 2020,) since 01-Aug-2019 and Hydrocephalus on 01-Aug-2004. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 01-May-2020 to an unknown date and FAMOTIDINE from 01-May-2020 to an unknown date for Hives. On 01-Apr-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VERTIGO (Vertigo), MALAISE (Feeling unwell) and DIZZINESS (Dizzy). On 01-Apr-2021 at 1:15 PM, the patient experienced CHEST DISCOMFORT (started rubbing chest, did not feel the same way as when they first arrived at the facility). On 01-Apr-2021 at 1:20 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic Reaction) (seriousness criterion medically significant) and BLOOD PRESSURE INCREASED (Blood pressure was very high). On 01-Apr-2021 at 1:30 PM, the patient experienced COUGH (Coughing). On 01-Apr-2021 at 1:35 PM, the patient experienced VOMITING (Vomiting). On 01-Apr-2021 at 5:30 PM, the patient experienced HEADACHE (Headache, like her head was being squeezed in a vice and a screwdriver was in the right side of her skull). On 02-Apr-2021 at 1:00 PM, ANAPHYLACTIC REACTION (Anaphylactic Reaction) had resolved. At the time of the report, VERTIGO (Vertigo), COUGH (Coughing), MALAISE (Feeling unwell), DIZZINESS (Dizzy), CHEST DISCOMFORT (started rubbing chest, did not feel the same way as when they first arrived at the facility), VOMITING (Vomiting) and HEADACHE (Headache, like her head was being squeezed in a vice and a screwdriver was in the right side of her skull) had resolved and BLOOD PRESSURE INCREASED (Blood pressure was very high) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood chloride (96-106): 109 mmol/l High. On 01-Apr-2021, Blood pressure measurement (unk-unk mmHg): 224/107 mmHg (High) The nurse called the EMT who took her blood pressure about 20 minutes after receiving the injection. Her blood pressure was very high. She didn't remember exact numbers, but stated it was something like 224/107. The EMT asked her if she had taken her blood pressure medications that morning and she told him she does not take blood pressure medications., 194/107 mmHg (High) @15:15 and 194/110 mmHg (High) @16:30. On 01-Apr-2021, Carbon dioxide (24-32): 22 mmol/l Low. On 01-Apr-2021, Chest X-ray: normal (normal) Clear lungs. Thoracic portion of a ventriculoperitoneal shunt catheter was seen to the right of midline and appeared intact. On 01-Apr-2021, Electrocardiogram: normal (normal) EMT did an EKG and stated it was normal. On 01-Apr-2021, Full blood count: normal (normal) normal. On 01-Apr-2021, Metabolic function test: normal (normal) normal. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Patient was given two baby aspirin by mouth on 01 Apr 2021 and was then sent to the emergency room (ER) due to her blood pressure. Patient was not given anything for vomiting, but had continued to fill multiple emesis bags. Additional tests included cardiac monitor and continuous pulse oximetry. On 01 Apr 2021 at 19:30, the nurse started an IV and administered Zofran plus another medication the patient could not recall. The patient began to feel better, finished the IV and was able to stand without dizziness. The patient saw another ER physician at 23:30 who did not think the event were related to the vaccine. This physician sent the patient home (discharged at approximately 1:00 on 02 Apr 2021). On 08 Apr 2021, the patient saw her allergist who confirmed it was an anaphylactic reaction to the vaccine. Patient indicated that nausea/vomiting, difficulty breathing, chest tightness, and cough were signs and symptoms experienced. The patient's allergist informed the patient they were not to get the second Moderna shot. 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 06-May-2021: No New Information (NNI). On 19-May-2021: ADR response received which provided additional event details, outcomes, treatments, ER lab/diagnostic results.