Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased
Clinical narrative: Pain in the sternum that moved up to her chest after booster and caused chest pain; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in the sternum that moved up to her chest after booster and caused chest pain) and DYSPNOEA (Shortness of breath) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 021C21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included GERD and Drug allergy (Allergic to the prescription medicine for GERD.). Concomitant products included CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for GERD, ATENOLOL for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced CHEST PAIN (Pain in the sternum that moved up to her chest after booster and caused chest pain) and DYSPNOEA (Shortness of breath). At the time of the report, CHEST PAIN (Pain in the sternum that moved up to her chest after booster and caused chest pain) had not resolved and DYSPNOEA (Shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2021, Blood pressure measurement: 180/89 (High) 180/89 mmHg. On 09-Dec-2021, Heart rate increased: 109 (High) 109 BPM.. On 18-Dec-2021, Blood pressure measurement: normal (normal) Normal. On 18-Dec-2021, Blood test: normal (normal) Normal. On 18-Dec-2021, Chest X-ray: normal (normal) Normal. On 18-Dec-2021, Electrocardiogram: normal (normal) Normal. On 23-Dec-2021, Blood pressure measurement: 122/69 (normal) 122/69. On 23-Dec-2021, Heart rate increased: 70 (normal) 70.         Since patient was allergic to prescription medicine for GERD, she took TUMS as needed.  Ten minutes after the booster shot, the patient experienced pain in the sternum that moved up to her chest and caused chest pain. In fact, the chest pain is still ongoing as reported. She also had shortness of breath, high blood pressure of 180/89 mmHg and high pulse rate of 109 bpm. The medical doctor observed her at the vaccination site and sent her home.  On 18Dec2021, the patient visited the Emergency Room. Her blood pressure was normal and she had chest pain. The Chest X-ray, Electrocardiogram and blood works were done (results not provided). The doctors decided that it was not cardiac-related.  On 21Dec2021, the patient went back to the same hospital and repeated the tests and was informed that is was not cardiac-related again. On 23Dec2021, her blood pressure was normal at 122/69 mmHg and pulse rate was normal at 70 bpm.  The patient stated that nobody evaluated her for GERD when she went to the hospital.  Company Comment includes This spontaneous case concerns a 67-year-old, female patient with relevant medical history of Gastroesophageal Reflux Disease (GERD), who experienced the unexpected, non-serious events of chest pain and dyspnoea. The events occurred 10 minutes after administration of the booster dose of the Moderna mRNA-1273 vaccine. The physician at the vaccination site observed her and then sent her home. With the persistence of the chest pain, the patient sought consult at the Emergency Room. Treatment information was not provided. She was told that the symptoms were not cardiac-related. The event chest pain had not resolved at the time of the report. The outcome of the event dyspnoea was unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The medical history of GERD, which may mimic chest pain (acid reflux in the sternal area), remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old, female patient with relevant medical history of Gastroesophageal Reflux Disease (GERD), who experienced the unexpected, non-serious events of chest pain and dyspnoea. The events occurred 10 minutes after administration of the booster dose of the Moderna mRNA-1273 vaccine. The physician at the vaccination site observed her and then sent her home. With the persistence of the chest pain, the patient sought consult at the Emergency Room. Treatment information was not provided. She was told that the symptoms were not cardiac-related. The event chest pain had not resolved at the time of the report. The outcome of the event dyspnoea was unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The medical history of GERD, which may mimic chest pain (acid reflux in the sternal area), remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.