Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Oropharyngeal discomfort, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Extreme itchiness; Numbness of lips; Closing of throat; Extremely high blood pressure 180/111mmHg; Anaphylaxis; Numbness; Numbness of tongue; Shortness of Breath; The patient's O2 sat would drop as well, O2 levels were reported to be 88%; 135bmp resting heart rate; Tachycardia; Sleepiness; Swollen eyes; A Spontaneous report was received from a Healthcare professional , concerning a male patient of 39 age , who received Moderna's COVID-19 vaccine experienced Anaphylactic reaction/Anaphylaxis, Hypoaesthesia/Numbness, Eye swelling/Swollen eyes, Hypoaesthesia oral/ Numbness of tongue, Hypoaesthesia oral/ Numbness of lips, Oropharyngeal discomfort/ Closing of throat, Blood pressure increased/Extremely high blood pressure 180/111mmHg, Somnolence/Sleepiness, Pruritus/ Extreme itchiness, Heart rate increased / 35bmp resting heart rate, Dyspnoea/Shortness of Breath, the patient's O2 sat would drop as well, O2 levels were reported to be 88%/and Tachycardia /Tachycardia.  The patient had a medical history of celiac disease and is a kidney patient (other kidney surgically removed). The reporter states that Patient's concomitant medications are gabapentin and duloxetine hydrochloride for chronic back pain.  On 11 Mar 2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (unknown lot number) via intamuscular route on left arm for COVID-19 infection prophylaxis.  On 11 Mar 2021, anaphylaxis 3 minutes post receiving the first dose of vaccine the patient developed numbness and his eyes became swollen, then numbness of the tongue, lips and closing of the throat, which all happened at the vaccination site.The attending EMT provided 3 pills of oral 50mg Benadryl (diphenhydramine) and did not apply an EpiPen. Patient's blood pressure went extremely high (180/111mmHg) instead of dropping. At that moment, it was decided to contact 911. The paramedics placed the patient on a stretcher and loaded him onto the emergency vehicle to be rushed to the hospital. On the way, the patient was given an EpiPen. While in the hospital, the patient was given more diphenhydramine and injected with methylprednisolone. Patient was in observation for 4 hours and then released with a prescription of an EpiPen. It was reported that the patient was extremely sleepy due to the medications given. When the patient arrived home, he went straight to bed. The patient was hospitalized on 11 Mar 2021 for Anaphylactic reaction, Hypoaesthesia, Eye swelling, Hypoaesthesia oral, Hypoaesthesia oral, Oropharyngeal discomfort, Blood pressure increased, Pruritus and released on same day after 4 hours. The next day, Friday (12 Mar 2021) the patient got up around 10:00am. Then at 10:05am, the symptoms began to reoccur with numbness of the lips, tongue, closing of throat and extreme itchiness. As soon as patient's husband noticed, he did not apply EpiPen and drove the patient to the emergency room. The emergency room followed the same protocol with methyprednisolone steroid, EpiPen and diphenhydramine. On Saturday (13 Mar 2021) and Sunday (14 Mar 2021), the doctor was seen and the patient was advised to take diphenhydramine every 4 hours. Then this past Monday (15 Mar 2021), patient started developing shortness of breath and a resting heart rate of 135bmp. That day, the patient was taken to urgent care.  There he was administered diphenhydramine and the patient's heart was checked. Urgent care agreed that his heart was acting up and his blood pressure was acting up for an unknown reason. Reporter states that the patient had been developing tachycardia for no reason for a week now. Since the tachycardia had occurred, reporter would check patient's oxygen (O2) levels. When the tachycardia had started, the patient's oxygen saturation (O2 sat ) would drop as well. O2 levels were reported to be 88% and resting heart rate of 103bmp. The reporter would let 5 minutes pass, recheck, and everything would return to normal. On Monday (22 Mar 2021), patient is scheduled to see a cardiologist who will place the patient on a machine to check his heart rate for 3 days to see what is going on. Follow-up with various health care providers was scheduled for the rest of the week. Nephrologist will be seen on Monday, Neurologist will be seen on Tuesday, and Kaiser will be visited on Wednesday. Reporter stated that even though asked to run bloodwork and images, the emergency room did not do it.  Lab work was performed on Monday (15 Mar 021) which came back normal. A check for blockage of the heart, also had looked fine.  Action taken with mRNA-1273 in response to the event Anaphylactic reaction, Hypoaesthesia, Eye swelling, Hypoaesthesia oral, Hypoaesthesia oral, Oropharyngeal discomfort, Blood pressure increased, Somnolence, Pruritus, Hypoaesthesia oral, Oropharyngeal discomfort, Blood pressure increased, Somnolence, Pruritus, Tachycardia, Heart rate increased, and Dyspnoea was unknown.  The outcome of the event Anaphylactic reaction, Hypoaesthesia, Eye swelling, Hypoaesthesia oral, Hypoaesthesia oral, Oropharyngeal discomfort, Blood pressure increased, Somnolence, Pruritus, Hypoaesthesia oral, Oropharyngeal discomfort, Blood pressure increased, Somnolence, Pruritus, Tachycardia, Heart rate increased, Dyspnoea, and the patient's O2 sat would drop as well, O2 levels were reported to be 88% was considered to be unknown at the time of this report.  The treatment medications diphenhydramine, EpiPen injection x 2,  and Methylprednisolone steroid injection x 2 was reported to be taken by the patient.  The events Anaphylactic reaction, Anaphylactic reaction/Anaphylaxis, Hypoaesthesia/Numbness, Eye swelling/Swollen eyes, Hypoaesthesia oral/ Numbness of tongue, Hypoaesthesia oral/ Numbness of lips, Oropharyngeal discomfort/ Closing of throat, Blood pressure increased/Extremely high blood pressure 180/111mmHg, Pruritus/ Extreme itchiness were considered meet seriousness criteria of hospitalization,  life threatening, and medically important..  The events Somnolence/Sleepiness, Pruritus/ Extreme itchiness, Heart rate increased / 35bmp resting heart rate, Dyspnoea/Shortness of Breath, and Tachycardia /Tachycardia were considered medically important.  The causality per reporter was not provided.; Reporter's Comments: This case concerns a 39 Y/O M hospitalized with a serious expected anaphylactic reaction and unexpected BP increased, oropharyngeal discomfort, eye swelling, hypoaesthesia, pruritus, and NS unexpected somnolence, tachycardia, heart rate increased, and dyspnea with O2 saturation decreased. Event onset 3 minutes after first dose mRNA-1273. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded