Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Fibromyalgia, Heart rate irregular, Hypertension
Clinical narrative: started getting her muscle problems; She can't turn over in bed and can't go to the bathroom; she needs her husband to help; Heartbeats irregular; back pain; Blood pressure was 200 over 100; Make me very sick with fibromyalgia; arm swelled up from elbow to her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure was 200 over 100) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia (For 10 years and it was difficult to diagnose. Patient was put on a gluten-free diet, and her fibromyalgia went away), Hashimoto's disease and Eye disorder.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up from elbow to her shoulder). On an unknown date, the patient experienced HYPERTENSION (Blood pressure was 200 over 100) (seriousness criterion medically significant), FIBROMYALGIA (Make me very sick with fibromyalgia), MUSCLE DISORDER (started getting her muscle problems), HYPOKINESIA (She can't turn over in bed and can't go to the bathroom; she needs her husband to help), HEART RATE IRREGULAR (Heartbeats irregular) and BACK PAIN (back pain). The patient was treated with HYDROCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (Blood pressure was 200 over 100), FIBROMYALGIA (Make me very sick with fibromyalgia), PERIPHERAL SWELLING (arm swelled up from elbow to her shoulder), HEART RATE IRREGULAR (Heartbeats irregular) and BACK PAIN (back pain) outcome was unknown and MUSCLE DISORDER (started getting her muscle problems) and HYPOKINESIA (She can't turn over in bed and can't go to the bathroom; she needs her husband to help) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200 (High) 200 over 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. The patient was treated with hydrocodone in the emergency room. Three to four days back, patient had started getting  muscle problems again. This had put patient to bed. Patient can't turn over in bed and can't go to the bathroom; patient needed her husband to help her. Patient wondered if the shot had gluten and casein in it because she wasn't having gluten. Patient had to stop taking her allergy shots. The patient had spent 5 hours in the emergency room. Patient had pain in her back, so she thought her fibromyalgia was coming back. This case concerns a 80-year-old female patient with medical history of Hashimoto, Fibromyalgia, who experienced the serious unexpected event of hypertension, non-serious unexpected event of special interest fibromyalgia, non-serious unexpected events of peripheral swelling, muscle disorder, hypokinesia, heart rate irregular, back pain. The events occurred on an unknown date after the first dose of Spikevax.  The medical history of Hashimoto, Fibromyalgia remain confounders. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-365219 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Added Reporter information, Patient demographic details- Date of birth and age, Dose 1 vaccine details, Treatment medication and Events. Upgraded Case from Non-serious to Serious.; Sender's Comments: This case concerns a 80-year-old female patient with medical history of Hashimoto, Fibromyalgia, who experienced the serious unexpected event of hypertension, non-serious unexpected event of special interest fibromyalgia, non-serious unexpected events of peripheral swelling, muscle disorder, hypokinesia, heart rate irregular, back pain. The events occurred on an unknown date after the first dose of Spikevax.  The medical history of Hashimoto, Fibromyalgia remain confounders. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.