Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Epigastric discomfort, Fatigue, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Bruise and stiffness in her arm; Bruise and stiffness in her arm; Chest pain; Numbness in her hands and feet; Fatigue; Metal taste in mouth; Loss of smell and taste; Loss of smell and taste; Shortness of breath; Felt like she was being squeezed on her stomach area; Soreness; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Metal taste in mouth), ANOSMIA (Loss of smell and taste), AGEUSIA (Loss of smell and taste), DYSPNOEA (Shortness of breath) and EPIGASTRIC DISCOMFORT (Felt like she was being squeezed on her stomach area) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0530219) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and White blood cell count low.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced DYSGEUSIA (Metal taste in mouth), ANOSMIA (Loss of smell and taste), AGEUSIA (Loss of smell and taste), DYSPNOEA (Shortness of breath), EPIGASTRIC DISCOMFORT (Felt like she was being squeezed on her stomach area), MYALGIA (Soreness), HYPOAESTHESIA (Numbness in her hands and feet) and FATIGUE (Fatigue). On an unknown date, the patient experienced CONTUSION (Bruise and stiffness in her arm), MUSCULOSKELETAL STIFFNESS (Bruise and stiffness in her arm) and CHEST PAIN (Chest pain). At the time of the report, DYSGEUSIA (Metal taste in mouth), ANOSMIA (Loss of smell and taste), AGEUSIA (Loss of smell and taste), DYSPNOEA (Shortness of breath), EPIGASTRIC DISCOMFORT (Felt like she was being squeezed on her stomach area), MYALGIA (Soreness), CONTUSION (Bruise and stiffness in her arm), MUSCULOSKELETAL STIFFNESS (Bruise and stiffness in her arm), HYPOAESTHESIA (Numbness in her hands and feet) and FATIGUE (Fatigue) had resolved and CHEST PAIN (Chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative. On an unknown date, Weight: gained. On an unknown date, X-ray: did not find anything.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given.  In the first minutes after receiving the Moderna Covid 19 vaccine patient experienced a metal taste in her mouth and a loss of smell and taste. After 2 hours she felt the vaccine in her nose stroll. On the first hour patient felt like she was being squeezed on her stomach area also experienced soreness and fatigue and felt numbness in her hands and feet. This lasted for 5 days. Bruise and stiffness in her arm, which lasted 6 months. Patient states her doctor thinks this was a reaction to the vaccine and does not know if she should be getting the next dose of the vaccine.  Patient did not have pericarditis or myocarditis.  No treatment medication was reported. Company comment: This spontaneous case concerns a 51-year-old, female patient with medical history of Low white blood cell count and Immunocompromised state, who experienced the unexpected, non-serious AESI of Anosmia and Ageusia. The events occurred on the same day of administration of first day of administration of first dose of mRNA-1273. On an unknown date, SARS-CoV-2 test was done which yielded a negative result and an X-ray with normal findings. It has been reported that patient experienced metallic taste which progressed to loss of taste and loss of smell. Afterwards, patient experienced squeezing sensation of her stomach, soreness, fatigue and numbness of her hands and feet which lasted for 5 days. Details of concomitant medications, clinical course and treatment were not provided. The events have resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51-year-old, female patient with medical history of Low white blood cell count and Immunocompromised state, who experienced the unexpected, non-serious AESI of Anosmia and Ageusia. The events occurred on the same day of administration of first day of administration of first dose of mRNA-1273. On an unknown date, SARS-CoV-2 test was done which yielded a negative result and an X-ray with normal findings. It has been reported that patient experienced metallic taste which progressed to loss of taste and loss of smell. Afterwards, patient experienced squeezing sensation of her stomach, soreness, fatigue and numbness of her hands and feet which lasted for 5 days. Details of concomitant medications, clinical course and treatment were not provided. The events have resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.