Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Feeling cold, Heart rate
Clinical narrative: On 28Jul2021, she started having really bad chest pain.; She had racing heart/Every time she would stand up, her heart rate would go up; She started getting really cold.; Same day after receiving 1st dose, She started dizziness/She had spinning head; She had chills.; She had increased heart rate.; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (She had increased heart rate.), CHEST PAIN (On 28Jul2021, she started having really bad chest pain.) and HEART RATE INCREASED (She had racing heart/Every time she would stand up, her heart rate would go up) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced HEART RATE INCREASED (She had increased heart rate.) (seriousness criterion medically significant), FEELING COLD (She started getting really cold.), DIZZINESS (Same day after receiving 1st dose, She started dizziness/She had spinning head) and CHILLS (She had chills.). On 28-Jul-2021, the patient experienced CHEST PAIN (On 28Jul2021, she started having really bad chest pain.) (seriousness criterion medically significant) and HEART RATE INCREASED (She had racing heart/Every time she would stand up, her heart rate would go up) (seriousness criterion medically significant). On 26-Jul-2021, HEART RATE INCREASED (She had increased heart rate.) had resolved. At the time of the report, CHEST PAIN (On 28Jul2021, she started having really bad chest pain.), HEART RATE INCREASED (She had racing heart/Every time she would stand up, her heart rate would go up), FEELING COLD (She started getting really cold.), DIZZINESS (Same day after receiving 1st dose, She started dizziness/She had spinning head) and CHILLS (She had chills.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2021, Heart rate: increased (High) Increased. On 28-Jul-2021, Heart rate: racing heart (High) racing heart.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter No treatment medications provided by the reporter.  Patient stated that on that day of vaccination, she waited in the room for 40 minutes. She started dizziness, spinning head, increased heart rate, getting really cold, chills. They took her to ER. She was in ER for about 3 hours till Heart Rate became more stable. Then she was discharged.  On 28-Jul-2021, the patient started having really bad chest pain, she was dizzy and had racing heart, so went to ER again. Every time she would stand up, her heart rate would go up. She had bills from ER and wanted to know if there was any compensation program.  Company Comment: This case concerns a 41 year-old, female subject with no relevant medical history, who experienced the unexpected events of Heart rate increased and chest pain. The event Heart rate increased occurred on the same date and two days after the first dose of Spikevax. The event Chest pain occurred two days after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of drug Spikevax is not affected by this report. All the events in this case were reported with hospitalization and IME seriousness criteria as reported in SD. However, based on information available on SD and as per medical criteria, hospitalization seriousness criteria was deleted for all the events, and only Heart rate increased and chest pain events were kept as IME, other events were classified as Non-serious.; Sender's Comments: This case concerns a 41 year-old, female subject with no relevant medical history, who experienced the unexpected events of Heart rate increased and chest pain. The event Heart rate increased occurred on the same date and two days after the first dose of Spikevax. The event Chest pain occurred two days after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of drug Spikevax is not affected by this report. All the events in this case were reported with hospitalization and IME seriousness criteria as reported in SD. However, based on information available on SD and as per medical criteria, hospitalization seriousness criteria was deleted for all the events, and only Heart rate increased and chest pain events were kept as IME, other events were classified as Non-serious.