Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Inappropriate schedule of product administration, Vaccination site swelling
Clinical narrative: High blood pressure; Big swelling in her right arm rather than her left; She just stayed in bed again; Heart rate irregular; COVID-19; inappropriate schedule of vaccine administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Oct-2021 and was forwarded to Moderna on 26-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High blood pressure), VACCINATION SITE SWELLING (Big swelling in her right arm rather than her left), BEDRIDDEN (She just stayed in bed again), HEART RATE IRREGULAR (Heart rate irregular) and COVID-19 (COVID-19) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia (Patient was put on a gluten-free diet, and her fibromyalgia, Hashimoto's, and eye problems went away.), Hashimoto's disease (Patient was put on a gluten-free diet, and her fibromyalgia, Hashimoto's, and eye problems went away.) and Eye disorder NOS (Patient was put on a gluten-free diet, and her fibromyalgia, Hashimoto's, and eye problems went away.).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). In August 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (High blood pressure), VACCINATION SITE SWELLING (Big swelling in her right arm rather than her left), BEDRIDDEN (She just stayed in bed again) and HEART RATE IRREGULAR (Heart rate irregular). The patient was treated with HYDROCODONE for Adverse event, at an unspecified dose and frequency. On 29-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (High blood pressure), VACCINATION SITE SWELLING (Big swelling in her right arm rather than her left), BEDRIDDEN (She just stayed in bed again), HEART RATE IRREGULAR (Heart rate irregular) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Heart rate: irregular (abnormal) Irregular.         No concomitant medication was reported. No treatment medication was reported. It was reported that Patient had fibromyalgia for 10 years and it was difficult to diagnose. She was put on a gluten-free diet, and her fibromyalgia, Hashimoto's, and eye problems went away. The patient had irregular heart beat, and her blood pressure was 200 over 100.  Company's comment: This is a spontaneous case concerning a 80-year-old, female patient with medical history of fibromyalgia and Hashimoto disease, who experienced the unexpected non serious (AESI) event of COVID 19. The event occurred approximately 5 months after the first dose and 4 months after the second dose  of Moderna COVID-19 vaccine. Since the latency between doses was inappropriate (48 days) this is not considered a lack of efficacy case. The rechallenge is not applicable. Patients´s age is a confounder for the event. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-361760 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 80-year-old, female patient with medical history of fibromyalgia and Hashimoto disease, who experienced the unexpected non serious (AESI) event of COVID 19. The event occurred approximately 5 months after the first dose and 4 months after the second dose  of Moderna COVID-19 vaccine. Since the latency between doses was inappropriate (48 days) this is not considered a lack of efficacy case. The rechallenge is not applicable. Patients´s age is a confounder for the event. The benefit-risk relationship of Spikevax is not affected by this report.