Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Low blood pressure; Sweating; Concussion; Diarrhea; Irregular menstrual cycle; Lightheadedness; Dehydrated; Heart pounding; Fever; Covid arm of left arm which was hard in between elbow and shoulder; like hives and was pink; like hives and was pink; Weakness; Eye discomfort; Fainted; Woke up covered in blood gashed forehead open above right eye; Stomach pain; Nausea; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) and HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Chronic myeloid leukemia. Concomitant products included DASATINIB MONOHYDRATE (SPRYCEL) for Chemotherapy, VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (Nausea). On 09-Jun-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (Heart pounding), ASTHENIA (Weakness), OCULAR DISCOMFORT (Eye discomfort), HYPOTENSION (Low blood pressure), HYPERHIDROSIS (Sweating), CONCUSSION (Concussion), DIARRHOEA (Diarrhea), MENSTRUATION IRREGULAR (Irregular menstrual cycle), DIZZINESS (Lightheadedness), DEHYDRATION (Dehydrated), PYREXIA (Fever), VACCINATION SITE INDURATION (Covid arm of left arm which was hard in between elbow and shoulder), VACCINATION SITE ERYTHEMA (like hives and was pink) and VACCINATION SITE URTICARIA (like hives and was pink). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SYNCOPE (Fainted), HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye), PALPITATIONS (Heart pounding), ABDOMINAL PAIN UPPER (Stomach pain), ASTHENIA (Weakness), OCULAR DISCOMFORT (Eye discomfort), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPOTENSION (Low blood pressure), HYPERHIDROSIS (Sweating), CONCUSSION (Concussion), MENSTRUATION IRREGULAR (Irregular menstrual cycle), DIZZINESS (Lightheadedness), DEHYDRATION (Dehydrated), NAUSEA (Nausea), PYREXIA (Fever), VACCINATION SITE INDURATION (Covid arm of left arm which was hard in between elbow and shoulder), VACCINATION SITE ERYTHEMA (like hives and was pink) and VACCINATION SITE URTICARIA (like hives and was pink) outcome was unknown and DIARRHOEA (Diarrhea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 67/30 (Low) 67/30. On an unknown date, Heart rate: low (Low) Low.         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.   This case was linked to MOD-2021-253122 (Patient Link).; 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.