Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pain assessment, Postural orthostatic tachycardia syndrome
Clinical narrative: muscles spasms throughout the body; nausea; increased heart rate; shortness of breathe; increased chest pain/Pain level in chest was an 8; intense headache; POTS; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (increased chest pain/Pain level in chest was an 8), MUSCLE SPASMS (muscles spasms throughout the body), DYSPNOEA (shortness of breathe), HEART RATE INCREASED (increased heart rate), HEADACHE (intense headache) and NAUSEA (nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE, ALPRAZOLAM (XANAX), FAMOTIDINE (PEPCID [FAMOTIDINE]), ATENOLOL, IVABRADINE HYDROCHLORIDE (CORLANOR) and FEXOFENADINE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HEART RATE INCREASED (increased heart rate) (seriousness criterion hospitalization). On an unknown date, the patient experienced CHEST PAIN (increased chest pain/Pain level in chest was an 8) (seriousness criterion hospitalization), MUSCLE SPASMS (muscles spasms throughout the body) (seriousness criterion hospitalization), DYSPNOEA (shortness of breathe) (seriousness criterion hospitalization), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS), HEADACHE (intense headache) (seriousness criterion hospitalization) and NAUSEA (nausea) (seriousness criterion hospitalization). The patient was hospitalized from 07-Apr-2021 to 09-Apr-2021 due to CHEST PAIN, DYSPNOEA and HEADACHE, then on 07-Apr-2021 due to MUSCLE SPASMS, and then on 14-Apr-2021 due to NAUSEA. At the time of the report, CHEST PAIN (increased chest pain/Pain level in chest was an 8), MUSCLE SPASMS (muscles spasms throughout the body), DYSPNOEA (shortness of breathe), HEART RATE INCREASED (increased heart rate), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS) and NAUSEA (nausea) outcome was unknown and HEADACHE (intense headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: 160. In 2021, Pain assessment: Pain level in chest was an 8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  Treatment information include Nitroglycerin to help with chest pain, Tylenol and Aleve to get some relief from headaches.  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.  Patient was vaccinated on 02Apr2021 and experienced a series adverse effects ranging from muscles spasms throughout the body, increase in heart rate reaching 160 beats per minute, which led to hospitalization. Patient reported pain in the chest, headaches as well as shortness of breathe and was hospitalized on 07Apr2021 due to complications of these side effects and discharged on 09Apr2021. After being discharged patient still reported chest pain, nausea, intense beating of the heart, shortness of breathe and muscle spasms. Patient was admitted again on 14April2021 in the hospital but did not provide a discharge date for this second time. On day of reporting patient still had heart rate fluctuations and shortness of breathe. She stated that they had been diagnosed with POTS by the Doctor and their Health Care Provider had recommended for the patient to not receive the 2nd vaccination due to the adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Upon internal review on 08-DEC-2022 non-significant corrections performed to update "case received from field" to blank; 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.