Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Tremor, Trismus
Clinical narrative: falling asleep 3 hours; Shaking, extremely cold.; extremely cold; my jaws freezed up and I couldn't speak.; heart rate increased/palpitations; Numbness; Chest tightness; Decreased level of consciousness; After weeks of medical testing costing thousands of dollars, it was found that I have an adenoma which is very close to to a phenochromocytoma/That is a small adrenal tumor that releases metanephrine which directly raises blood pressure; My blood pressure felt as if it was raising faster than ever in my life, well past 250/The next morning and for the next 5 weeks or so my blood pressure was extremely elevated, in the 190-230 range, even with bp medicine; thought he was going to loose consciousness; shortness of breath; terrible chills like he was going into shock,chills so bad he couldn't get out from under the blanket; head felt like it was being crushed by a cinderblock; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), ADRENAL ADENOMA (After weeks of medical testing costing thousands of dollars, it was found that I have an adenoma which is very close to to a phenochromocytoma/That is a small adrenal tumor that releases metanephrine which directly raises blood pressure) and BLOOD PRESSURE ABNORMAL (My blood pressure felt as if it was raising faster than ever in my life, well past 250/The next morning and for the next 5 weeks or so my blood pressure was extremely elevated, in the 190-230 range, even with bp medicine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Turned blue, could not breath,started passing out, couldn't stand, never given penicillin ever again) since 01-Jan-1977, Drug allergy (chlorine shortness of breath) since 01-Jan-1972, Lyme's disease (Autoimmune problems), Allergy (Chlorine,Previously had strong chlorine allergy, but had 2 chlorine gas exposures at this time with reactions last 2 weeks for each.  Reaction caused adrenal glands to hurt like I was stabbed.) since 28-Jul-2001 and Drug allergy (Had reactions to 2 different new bp pills: close to passing out, white flashes over eyes, vomitting) since 01-Mar-2001. Concomitant products included MONTELUKAST SODIUM from 06-Jan-2019 to an unknown date for Allergy, PROPRANOLOL from 01-Jan-2017 to an unknown date, ENALAPRIL MALEATE from 01-Jan-2017 to 18-Jun-2021 and METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) from 01-Jan-2012 to an unknown date for Blood pressure high.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021 at 7:45 AM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On 04-May-2021, the patient experienced PRESYNCOPE (thought he was going to loose consciousness), DYSPNOEA (shortness of breath), CHILLS (terrible chills like he was going into shock,chills so bad he couldn't get out from under the blanket) and HEADACHE (head felt like it was being crushed by a cinderblock). On an unknown date, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criterion medically significant), ADRENAL ADENOMA (After weeks of medical testing costing thousands of dollars, it was found that I have an adenoma which is very close to to a phenochromocytoma/That is a small adrenal tumor that releases metanephrine which directly raises blood pressure) (seriousness criterion medically significant), BLOOD PRESSURE ABNORMAL (My blood pressure felt as if it was raising faster than ever in my life, well past 250/The next morning and for the next 5 weeks or so my blood pressure was extremely elevated, in the 190-230 range, even with bp medicine) (seriousness criterion medically significant), INSOMNIA (falling asleep 3 hours), TREMOR (Shaking, extremely cold.), NASOPHARYNGITIS (extremely cold), TRISMUS (my jaws freezed up and I couldn't speak.), PALPITATIONS (heart rate increased/palpitations), HYPOAESTHESIA (Numbness) and CHEST DISCOMFORT (Chest tightness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), ADRENAL ADENOMA (After weeks of medical testing costing thousands of dollars, it was found that I have an adenoma which is very close to to a phenochromocytoma/That is a small adrenal tumor that releases metanephrine which directly raises blood pressure), BLOOD PRESSURE ABNORMAL (My blood pressure felt as if it was raising faster than ever in my life, well past 250/The next morning and for the next 5 weeks or so my blood pressure was extremely elevated, in the 190-230 range, even with bp medicine), PRESYNCOPE (thought he was going to loose consciousness), DYSPNOEA (shortness of breath), PALPITATIONS (heart rate increased/palpitations), HYPOAESTHESIA (Numbness), CHEST DISCOMFORT (Chest tightness) and HEADACHE (head felt like it was being crushed by a cinderblock) outcome was unknown and HYPERSENSITIVITY (Hypersensitivity reaction), INSOMNIA (falling asleep 3 hours), TREMOR (Shaking, extremely cold.), NASOPHARYNGITIS (extremely cold), TRISMUS (my jaws freezed up and I couldn't speak.) and CHILLS (terrible chills like he was going into shock,chills so bad he couldn't get out from under the blanket) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood pressure measurement: high (High) blood pressure last night was well over 250, today it's 190. In 2021, Blood test: abnormal (abnormal) The metanephrine was found to be three times past the normal limit in the blood test. In 2021, Heart rate: irregular (Inconclusive) Irregular.         Company Comment: 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 07-Jun-2021: Follow-up information received on 08-Jun-2021 updated with patient demographics,  concurrent medication and conditions. New events are updated. Treatment information added. On 28-Jul-2021: follow up received on 28-JUL-2021,Suspect drug details and medical history and concomitant medications, patient details  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.