Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Electrocardiogram, Erythema, Fatigue, Impaired quality of life
Clinical narrative: ER 4 weeks after due to chest pain; Difficulty swallowing; Prickling/Tingling; Chest tightness; hands and feet on fire/ body continues to feel like it is on fire (milder) and the hives continue; Angioedema; spontaneous urticaria,broke out in hives with dermographia/The itch progreed to full on hives outbreak the next day with hands and feet on fire/ the hives continue/ chronic urticaria; hives with dermographia; It was life changing/quit job due to this; physically and mentally exhausting to deal; began to see red marks running across body - principally arms, legs and back/ arms have deep red swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (ER 4 weeks after due to chest pain) and ANGIOEDEMA (Angioedema) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 036821A and 0462a21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Herpes zoster (No recent change) since 2003.   On 03-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. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021 at 4:00 PM, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), URTICARIA CHRONIC (spontaneous urticaria,broke out in hives with dermographia/The itch progreed to full on hives outbreak the next day with hands and feet on fire/ the hives continue/ chronic urticaria) and MECHANICAL URTICARIA (hives with dermographia). On 09-Nov-2021, the patient experienced BURNING SENSATION (hands and feet on fire/ body continues to feel like it is on fire (milder) and the hives continue). In November 2021, the patient experienced ERYTHEMA (began to see red marks running across body - principally arms, legs and back/ arms have deep red swelling), IMPAIRED QUALITY OF LIFE (It was life changing/quit job due to this) and FATIGUE (physically and mentally exhausting to deal). On an unknown date, the patient experienced CHEST PAIN (ER 4 weeks after due to chest pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (Chest tightness), DYSPHAGIA (Difficulty swallowing) and PARAESTHESIA (Prickling/Tingling). The patient was hospitalized from 13-Dec-2021 to 13-Dec-2021 due to CHEST PAIN. The patient was treated with PREDNISONE at a dose of UNK UNK, bid for 5 days; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing from 11-Sep-2021 at a dose of 10 milligram AM and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing from 11-Sep-2021 at a dose of 5 milligram PM. At the time of the report, CHEST PAIN (ER 4 weeks after due to chest pain), ANGIOEDEMA (Angioedema), URTICARIA CHRONIC (spontaneous urticaria,broke out in hives with dermographia/The itch progreed to full on hives outbreak the next day with hands and feet on fire/ the hives continue/ chronic urticaria), MECHANICAL URTICARIA (hives with dermographia), BURNING SENSATION (hands and feet on fire/ body continues to feel like it is on fire (milder) and the hives continue), IMPAIRED QUALITY OF LIFE (It was life changing/quit job due to this) and FATIGUE (physically and mentally exhausting to deal) had not resolved and CHEST DISCOMFORT (Chest tightness), ERYTHEMA (began to see red marks running across body - principally arms, legs and back/ arms have deep red swelling), DYSPHAGIA (Difficulty swallowing) and PARAESTHESIA (Prickling/Tingling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal/unremarkable. On an unknown date, Electrocardiogram: normal (normal) normal/unremarkable.         No Concomitant medication was reported. The ER doctor has given to patient an injectable steroid . The doctor recommended to continue anti histamine. The patient experienced spontaneous urticaria, broke out in hives with dermographia. This was going on for 8 weeks. She went to the ER 4 weeks after the booster dose because she was experiencing chest pain. Patient had long red streaks that would run across legs or back but there was no pain. They would come and go in about ten minutes. Patient's arms have deep red swelling that makes me feel like body is hemmorging. The hives continued along with chest pain that would last for 5-7 minutes. The prednisone helped but did not resolve the symptoms. Patient also wound up having a herpes outbreak after the prednisone.   Company Comment - This spontaneous case concerns a 49 year old female patient with no relevant medical history, who experienced the serious (hospitalization) unexpected events of chest pain and angioedema. The event occurred 5 days after the third dose of mRNA-1273 vaccine while the event chest pain occurred 4 weeks after receiving the booster dose. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-438925 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2022: Added new events, Updated reporter's address,Patient Demographics, lab data, Dosage of treatment drugs, event outcome for angioedema and urticaria.; Sender's Comments: This spontaneous case concerns a 49 year old female patient with no relevant medical history, who experienced the serious (hospitalization) unexpected events of chest pain and angioedema. The event occurred 5 days after the third dose of mRNA-1273 vaccine while the event chest pain occurred 4 weeks after receiving the booster dose. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.