Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: trouble swallowing; trouble talking; hardness in throat/voice was really horse; hardness in chest; swelling of mouth; swelling of lips; Angioedema; hives; swollen of tongue which was about the size of three tongues of regular size; trouble breathing; I would stand up and fall down back to bed; could barely walk; dehydrated; spasms were in chest; rash; high fever; hurt all over; worst headache I ever had in my life; muscles hurt so bad; Itchy throat; Itching; Weakness and dizziness; voice was really horse; very very dizzy; This spontaneous case was reported by a patient and describes the occurrence of ANGIOEDEMA (Angioedema) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives. Concurrent medical conditions included Hypertension since 03-Oct-2020. Concomitant products included METOPROLOL SUCCINATE from 03-Nov-2020 to an unknown date, LISINOPRIL from 03-Oct-2020 to an unknown date and AMLODIPINE from 05-Apr-2020 to an unknown date for Hypertension.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced DIZZINESS (very very dizzy), DYSPHONIA (voice was really horse) and ASTHENIA (Weakness and dizziness). On 28-Jul-2021, the patient experienced THROAT IRRITATION (Itchy throat) and PRURITUS (Itching). On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), URTICARIA (hives), SWOLLEN TONGUE (swollen of tongue which was about the size of three tongues of regular size), DYSPNOEA (trouble breathing), DYSPHAGIA (trouble swallowing), DYSARTHRIA (trouble talking), THROAT TIGHTNESS (hardness in throat/voice was really horse), CHEST DISCOMFORT (hardness in chest), MOUTH SWELLING (swelling of mouth), LIP SWELLING (swelling of lips), DYSSTASIA (I would stand up and fall down back to bed), GAIT DISTURBANCE (could barely walk), DEHYDRATION (dehydrated), MUSCLE SPASMS (spasms were in chest), RASH (rash), PYREXIA (high fever), MYALGIA (hurt all over), HEADACHE (worst headache I ever had in my life) and MYALGIA (muscles hurt so bad). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) (oral) from 17-Jul-2021 to 20-Jul-2021 at a dose of 25 mg/daily and PREDNISONE (oral) from 28-Jul-2021 to 06-Aug-2021 at a dose of 20 mg/daily. At the time of the report, ANGIOEDEMA (Angioedema), URTICARIA (hives), SWOLLEN TONGUE (swollen of tongue which was about the size of three tongues of regular size), DYSPNOEA (trouble breathing), DYSPHAGIA (trouble swallowing), DYSARTHRIA (trouble talking), THROAT TIGHTNESS (hardness in throat/voice was really horse), CHEST DISCOMFORT (hardness in chest), MOUTH SWELLING (swelling of mouth), LIP SWELLING (swelling of lips), DYSSTASIA (I would stand up and fall down back to bed), GAIT DISTURBANCE (could barely walk), DEHYDRATION (dehydrated), MUSCLE SPASMS (spasms were in chest), RASH (rash), PYREXIA (high fever), MYALGIA (hurt all over), HEADACHE (worst headache I ever had in my life) and MYALGIA (muscles hurt so bad) outcome was unknown, DIZZINESS (very very dizzy) and ASTHENIA (Weakness and dizziness) had resolved and DYSPHONIA (voice was really horse), THROAT IRRITATION (Itchy throat) and PRURITUS (Itching) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, Body temperature: high (High) 104.7 degree Fahrenheit. On 28-Jul-2021, Blood pressure measurement: normal (normal) 132/82 mmhg. On 28-Jul-2021, Body temperature: normal (normal) 97.6 degree Fahrenheit. On 28-Jul-2021, Heart rate: normal (normal) 64 beats per minute.. On 28-Jul-2021, Respiratory rate: normal (normal) 16 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was shocked with a defibrillator. This happened twice.  Company comment: This case refers to a 59-year-old female patient with a medical history of hives who experienced the unexpected event of Angioedema after an unspecified number days post exposure to the first dose of Spikevax. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The medical history of hives remains as a confounder. The benefit-risk relationship of Spikevax is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Patient past medical history added, Lab data added, concomitant and treatment medications added, Events of weakness , dizziness , hoarseness outcome changed from unknown to recovered.; Sender's Comments: This case refers to a 59-year-old female patient with a medical history of hives who experienced the unexpected event of Angioedema after an unspecified number days post exposure to the first dose of Spikevax. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The medical history of hives remains as a confounder. The benefit-risk relationship of Spikevax is not affected by this report.