Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Felt pain over my latine body and left arm; stomach cramp; Lip bleeding; Inflammation; Sickness; Tiredness; Extreamely high fever; Chills; Blister on lips and mouth; Lip blister; Severe headache; Swelling lymphatic nodules; Lymphadema right  arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), ORAL MUCOSAL BLISTERING (Blister on lips and mouth), LIP BLISTER (Lip blister), PAIN (Felt pain over my latine body and left arm) and ABDOMINAL PAIN UPPER (stomach cramp) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014CZ1A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: XGEVA (body site: Left arm) on 31-Mar-2021 and FASLODEX (body site: Left arm) on 31-Mar-2021. Concurrent medical conditions included Acute ulcerative colitis, Metastatic breast cancer (PET CT scan shoeing changes. Start date 10-00-2021.) since 2021 and Type 2 diabetes mellitus. Concomitant products included PALBOCICLIB (IBRANCE), FULVESTRANT (FASLODEX), DENOSUMAB (XGEVA) and LISINOPRIL for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (Severe headache). 16-Mar-2021, the patient experienced LYMPHADENOPATHY (Swelling lymphatic nodules) and LYMPHOEDEMA (Lymphadema right  arm). On 23-Apr-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blister on lips and mouth), LIP BLISTER (Lip blister), PYREXIA (Extreamely high fever) and CHILLS (Chills). On an unknown date, the patient experienced ILLNESS (Sickness), PAIN (Felt pain over my latine body and left arm), ABDOMINAL PAIN UPPER (stomach cramp), LIP HAEMORRHAGE (Lip bleeding), INFLAMMATION (Inflammation) and FATIGUE (Tiredness). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Mouth bleeding, at a dose of 1 gram, 10 days; ACICLOVIR (ACYCLOVIR ACTAVIS) for Blisters, at a dose of five a day and Physical therapy for Lymphoedema. At the time of the report, ILLNESS (Sickness), ORAL MUCOSAL BLISTERING (Blister on lips and mouth), LIP BLISTER (Lip blister), PAIN (Felt pain over my latine body and left arm), ABDOMINAL PAIN UPPER (stomach cramp), LIP HAEMORRHAGE (Lip bleeding), INFLAMMATION (Inflammation), FATIGUE (Tiredness), PYREXIA (Extreamely high fever) and CHILLS (Chills) outcome was unknown and HEADACHE (Severe headache), LYMPHADENOPATHY (Swelling lymphatic nodules) and LYMPHOEDEMA (Lymphadema right  arm) had resolved with sequelae. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: high (High) High. On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Body temperature: 103 (High) fever as 103. On an unknown date, Computerised tomogram: abnormal (abnormal) PET CT scan showed nodularity in lungs, Bilateral ground glass opacity, right greater than left may be infections or inflammatory..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information includes medication for lips and cream for lips.  The patient had lymphadenopathy and lymphedema after breast re-incision surgery in 2019.   This case was linked to MOD-2021-055362 (Patient Link).