Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeding disorder, Feeling cold, Feeling hot, Flushing
Clinical narrative: Angioedema; Skin is hypersensitive to touch, like dermatographia; Heartburn; Chest tightness; Cough; Prichling / Tingling sensation; Throat closing sensation; Bronchospasm; Feeling hot/felt hot; Flushing/ Forehead flushed; thirsty; Diarrhea; Dry mouth; chills / shivering; Sweating / Palms are sweaty; Asthma symptoms; shallow breathing; feeling cold; Suspected low blood sugar; Numbness of extremities; increasing asthma symptoms (wheezing); Dermatographia/A bit of dermatographia on arms from rest on desk/chair arms; Fast heartbeat/ Very intense heart palpitations; Lump in the throat feeling / Nearly constant lump in throat.; barely eat Xmas dinner; up all night with nausea and extreme acid reflux/ Tums help moderately, but not enough to get to sleep/ hard to get much sleep at night because of racing heart and itching/ still unable to sleep; Acid reflux; Nausea; that heat makes the rash and hives worse/splotches; Hives on the arms /Some on groin and legs but they are more concentrated in the upper half of the body; Red palms, splotches all over the face, back, chest and neck; Itchy, red palms; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F, 038B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever. Previously administered products included for Product used for unknown indication: Allegra and Zyrtec. Past adverse reactions to the above products included Drowsiness with Zyrtec; and Feeling strange with Allegra. Concurrent medical conditions included Pollen allergy since 2005, Allergy to molds since 2005, Seasonal allergy, Asthma (symptoms worsen with acid reflux after receiving booster dose of COVID-19 vaccine .) since 1994, Hypersensitivity, Food allergy since 2005 and Dust allergy since 2005. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Asthma.   On 18-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Dec-2021 at 4:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itchy, red palms). On 22-Dec-2021 at 6:00 AM, the patient experienced ERYTHEMA (Red palms, splotches all over the face, back, chest and neck ). On 23-Dec-2021, the patient experienced URTICARIA (Hives on the arms /Some on groin and legs but they are more concentrated in the upper half of the body) and RASH (that heat makes the rash and hives worse/splotches). On 24-Dec-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). 24-Dec-2021, the patient experienced INSOMNIA (up all night with nausea and extreme acid reflux/ Tums help moderately, but not enough to get to sleep/ hard to get much sleep at night because of racing heart and itching/ still unable to sleep). 24-Dec-2021, the patient experienced NAUSEA (Nausea). On 25-Dec-2021, the patient experienced FEEDING DISORDER (barely eat Xmas dinner). On 26-Dec-2021, the patient experienced SENSATION OF FOREIGN BODY (Lump in the throat feeling / Nearly constant lump in throat.). 26-Dec-2021, the patient experienced PALPITATIONS (Fast heartbeat/ Very intense heart palpitations). On 27-Dec-2021, the patient experienced MECHANICAL URTICARIA (Dermatographia/A bit of dermatographia on arms from rest on desk/chair arms). On 30-Dec-2021, the patient experienced WHEEZING (increasing asthma symptoms (wheezing)). 30-Dec-2021, the patient experienced HYPOPNOEA (shallow breathing), FEELING COLD (feeling cold), BLOOD GLUCOSE DECREASED (Suspected low blood sugar) and HYPOAESTHESIA (Numbness of extremities). On 30-Dec-2021 at 11:05 AM, the patient experienced ASTHMA (Asthma symptoms). On 31-Dec-2021, the patient experienced HYPERHIDROSIS (Sweating / Palms are sweaty) and DRY MOUTH (Dry mouth). 31-Dec-2021, the patient experienced DIARRHOEA (Diarrhea) and CHILLS (chills / shivering). On 01-Jan-2022, the patient experienced FEELING HOT (Feeling hot/felt hot) and FLUSHING (Flushing/ Forehead flushed). 01-Jan-2022, the patient experienced THIRST (thirsty). On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), SENSITIVE SKIN (Skin is hypersensitive to touch, like dermatographia), DYSPEPSIA (Heartburn), BRONCHOSPASM (Bronchospasm), CHEST DISCOMFORT (Chest tightness) and COUGH (Cough). an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat closing sensation) and PARAESTHESIA (Prichling / Tingling sensation). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 26-Dec-2021 to 31-Dec-2021 at a dose of 25 mg, every 4-6 hour; LORATADINE (CLARITINE) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date for Heartburn, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 31-Dec-2021 at a dose of 24 hour in evenings; PREDNISONE (oral) ongoing from 01-Jan-2022 at a dose of 40 mg - 5 days, 20mg - 5 days; CORTISONE (topical) ongoing from 31-Dec-2021 at a dose of 2.5 percent twice a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at an unspecified dose and frequency. On 01-Jan-2022, PALPITATIONS (Fast heartbeat/ Very intense heart palpitations) had resolved. At the time of the report, ANGIOEDEMA (Angioedema), PRURITUS (Itchy, red palms), SENSITIVE SKIN (Skin is hypersensitive to touch, like dermatographia), DYSPEPSIA (Heartburn), OROPHARYNGEAL DISCOMFORT (Throat closing sensation), BRONCHOSPASM (Bronchospasm), WHEEZING (increasing asthma symptoms (wheezing)), CHEST DISCOMFORT (Chest tightness), COUGH (Cough), PARAESTHESIA (Prichling / Tingling sensation), FEELING HOT (Feeling hot/felt hot), FLUSHING (Flushing/ Forehead flushed), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), INSOMNIA (up all night with nausea and extreme acid reflux/ Tums help moderately, but not enough to get to sleep/ hard to get much sleep at night because of racing heart and itching/ still unable to sleep), ASTHMA (Asthma symptoms), HYPOPNOEA (shallow breathing), FEELING COLD (feeling cold), BLOOD GLUCOSE DECREASED (Suspected low blood sugar), DRY MOUTH (Dry mouth), THIRST (thirsty), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Numbness of extremities), RASH (that heat makes the rash and hives worse/splotches), CHILLS (chills / shivering) and NAUSEA (Nausea) outcome was unknown and ERYTHEMA (Red palms, splotches all over the face, back, chest and neck ), SENSATION OF FOREIGN BODY (Lump in the throat feeling / Nearly constant lump in throat.), HYPERHIDROSIS (Sweating / Palms are sweaty), URTICARIA (Hives on the arms /Some on groin and legs but they are more concentrated in the upper half of the body), FEEDING DISORDER (barely eat Xmas dinner) and MECHANICAL URTICARIA (Dermatographia/A bit of dermatographia on arms from rest on desk/chair arms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Heart rate: heart rate >100 beats per min (High) Heart rate >100 beats per min and heart rate irregular (abnormal) Heart rate irregular.         Company comment This is a spontaneous case concerning a 27-year-old male patient with medical history of Hay fever, Pollen allergy, Seasonal allergy, Mycotic allergy, Asthma, Hypersensitivity, Food allergy and Dust allergy, who experienced the serious, unexpected event of angioedema and other non-serious events such as pruritus, erythema, sensitive skin, sensation of foreign body, dyspepsia, hyperhidrosis, oropharyngeal discomfort, chest discomfort, bronchospasm, wheezing, urticaria, cough, paraesthesia, feeling hot, flushing, gastrooesophageal reflux disease, feeding disorder, insomnia, mechanical urticaria, asthma, hypopnoea, feeling cold, suspected blood glucose decreased, dry mouth, thirst, diarrhoea, hypoaesthesia, rash, chills and nausea.  The events started developing approximately 10 days after the third dose of mRNA-1273 vaccine. As reported, there were no such events after the first two doses of mRNA-1273 vaccine. The rechallenge is not applicable since the events occurred after the third dose. The medical history of multiple allergies, Asthma, Hypersensitivity remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jan-2022: Follow-up received contains significant information. The case has been upgraded to serious. Updated patient demographics, medical history, and concurrent conditions Added the lab investigations and updated the route of administration for all the doses of suspect drug. Updated concomitant and treatment medications. Added new events and event outcome was updated.; Sender's Comments: This is a spontaneous case concerning a 27-year-old male patient with medical history of Hay fever, Pollen allergy, Seasonal allergy, Mycotic allergy, Asthma, Hypersensitivity, Food allergy and Dust allergy, who experienced the serious, unexpected event of angioedema and other non-serious events such as pruritus, erythema, sensitive skin, sensation of foreign body, dyspepsia, hyperhidrosis, oropharyngeal discomfort, chest discomfort, bronchospasm, wheezing, urticaria, cough, paraesthesia, feeling hot, flushing, gastrooesophageal reflux disease, feeding disorder, insomnia, mechanical urticaria, asthma, hypopnoea, feeling cold, suspected blood glucose decreased, dry mouth, thirst, diarrhoea, hypoaesthesia, rash, chills and nausea.  The events started developing approximately 10 days after the third dose of mRNA-1273 vaccine. As reported, there were no such events after the first two doses of mRNA-1273 vaccine. The rechallenge is not applicable since the events occurred after the third dose. The medical history of multiple allergies, Asthma, Hypersensitivity remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.