Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Biopsy cervix, C1 esterase inhibitor test normal, Complement factor C3, Complement factor C4
Clinical narrative: urticial lesion on my left inner lower eyelid; cough; wheezing; swollen eyelid; Idiopathic urticaria; Generalised itching/pruritus; Hive like rash that keeps moving around her body, look similar to bulls eyes; Angioedema; swollen lips; Hives on left wrist/still experiencing hives.; Hoarseness; Generalized redness/erythema; Prickling/Tingling; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Angioedema), LIP SWELLING (swollen lips), URTICARIA (Hives on left wrist/still experiencing hives.), DYSPHONIA (Hoarseness), ERYTHEMA (Generalized redness/erythema), PARAESTHESIA (Prickling/Tingling), SWELLING OF EYELID (swollen eyelid), IDIOPATHIC URTICARIA (Idiopathic urticaria), PRURITUS (Generalised itching/pruritus), EYELID DISORDER (urticial lesion on my left inner lower eyelid), COUGH (cough), WHEEZING (wheezing) and RASH (Hive like rash that keeps moving around her body, look similar to bulls eyes) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression since 2006, Hypertension since 2005, Hypothyroidism since 2005, Kidney disorder since 2016, Obesity since 2019, GERD since 2014 and Restless legs syndrome since 2015. Concomitant products included FAMOTIDINE from 2020 to an unknown date for GERD, LOSARTAN from 2015 to an unknown date, SPIRONOLACTONE from 2015 to an unknown date and FUROSEMIDE from 2015 to an unknown date for Hypertension, LEVOTHYROXINE from 2005 to an unknown date for Hypothyroidism, MAGNESIUM OXIDE from 2016 to an unknown date for Magnesium low, POTASSIUM CHLORIDE from 2015 to an unknown date for Potassium low, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 2011 to an unknown date for Pulmonary embolism, ROPINIROLE from 2015 to an unknown date for Restless legs syndrome, COLECALCIFEROL (VITAMIN D 3) from 2015 to an unknown date for Vitamin D deficiency, LIRAGLUTIDE (SAXENDA) from February 2020 to an unknown date for Weight loss, VITAMIN B COMPLEX WITH C from 2016 to an unknown date for an unknown indication.   On 12-Jan-2021 at 10:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 4:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), LIP SWELLING (swollen lips) (seriousness criterion medically significant), URTICARIA (Hives on left wrist/still experiencing hives.) (seriousness criterion medically significant), DYSPHONIA (Hoarseness) (seriousness criterion medically significant), ERYTHEMA (Generalized redness/erythema) (seriousness criterion medically significant), PARAESTHESIA (Prickling/Tingling) (seriousness criterion medically significant), PRURITUS (Generalised itching/pruritus) (seriousness criterion medically significant) and RASH (Hive like rash that keeps moving around her body, look similar to bulls eyes) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING OF EYELID (swollen eyelid) (seriousness criterion medically significant), IDIOPATHIC URTICARIA (Idiopathic urticaria) (seriousness criterion medically significant), EYELID DISORDER (urticial lesion on my left inner lower eyelid) (seriousness criterion medically significant), COUGH (cough) (seriousness criterion medically significant) and WHEEZING (wheezing) (seriousness criterion medically significant). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itching, at a dose of 40 mg; METHYLPREDNISOLONE (MEDROL DOSEPAK) in February 2021 at a dose of 1 dosage form; PREDNISONE in March 2021 at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 1 dosage form; DOXYCYCLINE at a dose of 100 mg twice a day and CETIRIZINE at a dose of 1 dosage form. At the time of the report, ANGIOEDEMA (Angioedema), DYSPHONIA (Hoarseness), ERYTHEMA (Generalized redness/erythema), PARAESTHESIA (Prickling/Tingling), IDIOPATHIC URTICARIA (Idiopathic urticaria), PRURITUS (Generalised itching/pruritus), EYELID DISORDER (urticial lesion on my left inner lower eyelid), COUGH (cough) and WHEEZING (wheezing) outcome was unknown and LIP SWELLING (swollen lips), URTICARIA (Hives on left wrist/still experiencing hives.), SWELLING OF EYELID (swollen eyelid) and RASH (Hive like rash that keeps moving around her body, look similar to bulls eyes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy cervix: unknown (Inconclusive) Unknown. On an unknown date, C1 esterase inhibitor test normal: normal (normal) Normal. On an unknown date, Complement factor C3: normal (normal) Normal. On an unknown date, Complement factor C4: normal (normal) Normal. On an unknown date, Full blood count: normal (normal) Normal. On an unknown date, Metabolic function test: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had a dermatology consultation and was getting utricaria every day.Patient had taken intramuscular steroid injections in the month of march and april. Steroids gave relief but post 10 days therapy utricaria recurred. The action taken for mRNA-1273 was not applicable.  Most recent follow-up on 14-jun-2021 contain no significant information  Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product safety profile.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: significant followup added to include AE contact information,new events and lab details On 14-Jun-2021: The follow-up on 14-jun-2021 contain no significant information; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product safety profile.