Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Hypokalaemia, Pharyngeal swelling, Swelling
Clinical narrative: Anaphylactic shock; Potassium "dropped to 1%"; Cold and numb sensation; Sweating; Chest pressure; Blood pressure was 223/105-110; Neck swelling; Numb lips; Throat swelling; Disability NOS; A spontaneous report was received from a 69-year-old, female, patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced anaphylactic shock, potassium dropped to 1%, cold and numb sensation, sweating, chest pressure, blood pressure was 223/105-110,Neck swelling, Throat swelling, Numb lips and disability.  The patient's medical history, as provided by the reporter, included allergies to yellow 5 (tartrazine), shellfish, and bee stings. Concomitant product use was not provided by the reporter.  On 19 Jan 2021 at 11:42 AM, approximately two minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 19 Jan 2021, minutes after receiving the vaccine, the patient experienced a cold and numb sensation on the upper right part of her back. The sensation extended around her shoulder and into her clavicle region. Approximately 30 minutes after vaccination she started sweating and felt like she was going into anaphylactic shock, which she had experienced in the past. The patient felt like her throat was swelling and her neck started to visibly swell. One hour after vaccination, the patients lips went numb, the clavicular numbness continued, and she started to experience chest pressure. A paramedic then evaluated the patient, her blood pressure was 223/105-110 mmHg, she was placed in an ambulance, given diphenhydramine and solumedrol, then taken to the emergency room. At the emergency room, the patient received a chest x-ray, computed tomography scan, blood tests, and an electrocardiogram. Previously, the patient had a blood test which showed a potassium of 4.3 to 3.9 "or something." At the emergency room, her potassium had "dropped to 1%." The patient was administered potassium in the hospital and was held for observation until approximately 10:00 PM, then discharged.   On 20 Jan 2021, the patient continued to experience chest tightness.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events anaphylactic shock, potassium dropped to 1%, cold and numb sensation, sweating,blood pressure was 223/105-110 ,Neck swelling, Throat swelling, Numb lips and disability was unknown. The event, chest pressure was considered not resolved.; Reporter's Comments: This case concerns a 69-year-old, female patient with medical history of allergies to yellow 5 (tartrazine), shellfish, and bee stings, who experienced a serious, unexpected event of anaphylactic shock, sweating, hypoaesthesia, pharyngeal swelling, neck swelling, numb lips, chest discomfort, hypertension, hypokalemia and disability NOS. The event occurred the day the first dose of mRNA-1273 was administered. 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.