Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Ear swelling, Eye swelling, Feeling hot
Clinical narrative: face got pale; got dizzy; start sweatting; feeling nausea; balls at back of my head, hot areas; stomach was on pain with diarrhea; left leg was from the bottom to almost my knee with black and blue marks all over; stomach was on pain with diarrhea; headache; ears swollen; back on my head was swollen too (like bumps on the back of my head; heart beating faster; body was tired like low energy; hands swollen; eyes swollen; pruritis/body completely red and itchy; chest pain; all body was on pain; Fever; body is all disfigured; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (pruritis/body completely red and itchy), CHEST PAIN (chest pain), DEFORMITY (body is all disfigured), EYE SWELLING (eyes swollen) and PERIPHERAL SWELLING (hands swollen) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy and Dermographism. Concomitant products included SERTRALINE for Depression and Anxiety, BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), ZOLPIDEM and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced DEFORMITY (body is all disfigured). On 18-May-2021, the patient experienced PAIN (all body was on pain) and PYREXIA (Fever). On 19-May-2021, the patient experienced PRURITUS (pruritis/body completely red and itchy), CHEST PAIN (chest pain) and EYE SWELLING (eyes swollen). On 20-May-2021, the patient experienced PERIPHERAL SWELLING (hands swollen). On 21-May-2021, the patient experienced TACHYCARDIA (heart beating faster) and ASTHENIA (body was tired like low energy). On 22-May-2021, the patient experienced EAR SWELLING (ears swollen), SWELLING (back on my head was swollen too (like bumps on the back of my head) and HEADACHE (headache). On 27-May-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach was on pain with diarrhea), CONTUSION (left leg was from the bottom to almost my knee with black and blue marks all over) and DIARRHOEA (stomach was on pain with diarrhea). On 28-May-2021, the patient experienced FEELING HOT (balls at back of my head, hot areas). On 30-May-2021, the patient experienced PALLOR (face got pale), DIZZINESS (got dizzy), HYPERHIDROSIS (start sweatting) and NAUSEA (feeling nausea). The patient was treated with EPINEPHRINE on 26-May-2021 at a dose of UNK dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 26-May-2021 at a dose of UNK dosage form; PREDNISONE (oral) at a dose of 40 mg once a day; FAMOTIDINE on 19-May-2021 at a dose of UNK dosage form; IOHEXOL on 19-May-2021 at a dose of UNK dosage form; KETOROLAC on 19-May-2021 at a dose of UNK dosage form and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU-MEDROL) on 19-May-2021 at a dose of UNK dosage form. On 18-May-2021, PYREXIA (Fever) had resolved. On 27-May-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, PRURITUS (pruritis/body completely red and itchy), DEFORMITY (body is all disfigured), EYE SWELLING (eyes swollen), PERIPHERAL SWELLING (hands swollen), FEELING HOT (balls at back of my head, hot areas), PALLOR (face got pale), DIZZINESS (got dizzy), HYPERHIDROSIS (start sweatting), TACHYCARDIA (heart beating faster), ASTHENIA (body was tired like low energy), PAIN (all body was on pain), EAR SWELLING (ears swollen), SWELLING (back on my head was swollen too (like bumps on the back of my head), ABDOMINAL PAIN UPPER (stomach was on pain with diarrhea), CONTUSION (left leg was from the bottom to almost my knee with black and blue marks all over), DIARRHOEA (stomach was on pain with diarrhea), HEADACHE (headache) and NAUSEA (feeling nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment mediation included injectable steroids in emergency room.  On 19-May-2021 the patient went to the ER and they did a chest x-ray, ECG (electrocardiogram) and cardiac monitoring.  Results were not provided. On 22-May-2021 the patient went to the ER again. The patient was advised to follow up with her primary care physician. The patient stated that Benadryl effect only lasted like 15 minutes and she cannot take more than 6 per day. She had an appointment scheduled with an allergist and immunologic doctor on 03-Jun-2021.  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 01-Jun-2021: events that occurred 30 may 2021 has been 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.