Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Impaired healing, Laboratory test, Nasal discomfort, Palpitations
Clinical narrative: heart burn; had a bad cavity that spread to the right side of the nostril. He said this cavity almost killed him; had delayed healing.; He thinks his immune system is overloaded/he thinks this vaccine has compromised his immune system/He said he's immunocompromised; he was fighting off something; rash or hives all over his body/He got rash from touching a goose down pillow/he's been breaking out in the rash in the last 8 weeks.; Blood count is messed up, red blood cell is down and white blood cell is up; "anaphylaxis shock"/When he touched the bleach, his airway closes/It's more like it blocks the airway, or like he's getting clicking in the back his lung.; very sick/feeling very sick in June and July; stomach pain went away very gradually each day/horrible stomach pain; shortness of breath felt like going away as well/shortness of breath is almost gone, he gets it when he's very anxious or if he starts running fast; couldn't eat anything; lost 12 lbs; rash or hives all over his body; anxiety/shortness of breath is almost gone, he gets it when he's very anxious or if he starts running fast/severe anxiety attack; his heart was racing at nighttime and felt like he was having a heart attack as his heart was shooting through the roof.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK ("anaphylaxis shock"/When he touched the bleach, his airway closes/It's more like it blocks the airway, or like he's getting clicking in the back his lung.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shortness of breath (since January), Abdominal pain (since January), Pain (since January), Fatigue (since January), Leg pain, Chest tightness and Stomach pain. Concurrent medical conditions included Coughing. Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ANAPHYLACTIC SHOCK ("anaphylaxis shock"/When he touched the bleach, his airway closes/It's more like it blocks the airway, or like he's getting clicking in the back his lung.) (seriousness criterion medically significant), ILLNESS (very sick/feeling very sick in June and July), ABDOMINAL PAIN UPPER (stomach pain went away very gradually each day/horrible stomach pain), DYSPNOEA (shortness of breath felt like going away as well/shortness of breath is almost gone, he gets it when he's very anxious or if he starts running fast), FEEDING DISORDER (couldn't eat anything), WEIGHT DECREASED (lost 12 lbs), URTICARIA (rash or hives all over his body), ANXIETY (anxiety/shortness of breath is almost gone, he gets it when he's very anxious or if he starts running fast/severe anxiety attack), PALPITATIONS (his heart was racing at nighttime and felt like he was having a heart attack as his heart was shooting through the roof.), NASAL DISCOMFORT (had a bad cavity that spread to the right side of the nostril. He said this cavity almost killed him), IMPAIRED HEALING (had delayed healing.), IMMUNE SYSTEM DISORDER (He thinks his immune system is overloaded/he thinks this vaccine has compromised his immune system/He said he's immunocompromised), VACCINATION COMPLICATION (he was fighting off something), RASH (rash or hives all over his body/He got rash from touching a goose down pillow/he's been breaking out in the rash in the last 8 weeks.) and FULL BLOOD COUNT ABNORMAL (Blood count is messed up, red blood cell is down and white blood cell is up). On an unknown date, the patient experienced DYSPEPSIA (heart burn). The patient was treated with FAMOTIDINE for Stomach discomfort, at a dose of 40 mg twice a day and ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC SHOCK ("anaphylaxis shock"/When he touched the bleach, his airway closes/It's more like it blocks the airway, or like he's getting clicking in the back his lung.), ILLNESS (very sick/feeling very sick in June and July), ABDOMINAL PAIN UPPER (stomach pain went away very gradually each day/horrible stomach pain), DYSPNOEA (shortness of breath felt like going away as well/shortness of breath is almost gone, he gets it when he's very anxious or if he starts running fast), FEEDING DISORDER (couldn't eat anything), WEIGHT DECREASED (lost 12 lbs), URTICARIA (rash or hives all over his body), ANXIETY (anxiety/shortness of breath is almost gone, he gets it when he's very anxious or if he starts running fast/severe anxiety attack), DYSPEPSIA (heart burn), NASAL DISCOMFORT (had a bad cavity that spread to the right side of the nostril. He said this cavity almost killed him), IMPAIRED HEALING (had delayed healing.), IMMUNE SYSTEM DISORDER (He thinks his immune system is overloaded/he thinks this vaccine has compromised his immune system/He said he's immunocompromised), VACCINATION COMPLICATION (he was fighting off something), RASH (rash or hives all over his body/He got rash from touching a goose down pillow/he's been breaking out in the rash in the last 8 weeks.) and FULL BLOOD COUNT ABNORMAL (Blood count is messed up, red blood cell is down and white blood cell is up) outcome was unknown and PALPITATIONS (his heart was racing at nighttime and felt like he was having a heart attack as his heart was shooting through the roof.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: negative (Negative) none of the tests came back positive for an allergy reaction. On an unknown date, Blood test: abnormal (abnormal) having anxiety from COVID.. On an unknown date, Laboratory test: normal (normal) didn't show. On an unknown date, Red blood cell count: low (Low) low. On an unknown date, Weight: lost 12 lbs (Low) Lost 12 lbs. On an unknown date, White blood cell count: high (High) high. On an unknown date, X-ray: normal (normal) lung x-ray didn't show.         Patient stated that Before his 1st dose,he was sore and fatigue, like he ran 100 miles. He believed he had COVID, although multiple tests and lung x-ray didn't show. They said he had constipation and he didn't believe it. He's been having these long-haulers symptoms since January. He also had pain in his leg. He had extreme tightness in his chest, stomach pain, then fatigue, and it was very hard to sleep during the time. He was forced to work because he didn't test positive for COVID.  Patient had blood test done, and doctor said he was having anxiety from COVID. He went to an allergist, but none of the tests came back positive for an allergy reaction. They said it might be gluten and told him to stay away from caffeine that was giving him the heart burn.  Patient mentioned that 9 to 10 people got COVID at work yesterday and he got an antibody test to show that he still has it. He was hoping vaccine will help him feel better. If he gets into a used vehicle, or if he touches fabric, he'd get goosebumps but bigger. He hasn't gotten on his chest and back since he switched detergent.  Patient stated He's been working 6 days a week and has seen 20 doctors. He has a therapist session scheduled at the end of the month as they think he has severe anxiety attack. What seems to be helping him is rest. Bleach, liquid softener, the dryer sheet, polyester all gave him reaction. He thinks his immune system is overloaded or he has antihistamine insufficiency or deficiency.  Treatment information provided was anxiety medication helps slightly. The albuterol inhaler did not help and made breathing worse. His doctor told him to take Clartin or Allegra. They thought he was having a food allergy. The patient's doctor didn't think they are related to the vaccine.  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. The patient is  diagnose by; 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. The patient is  diagnose by his doctor having anxiety that could be a confounding factor to the case.