Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Polymyositis, Respiratory syncytial virus test, Restlessness, SARS-CoV-2 test, Streptococcus test
Clinical narrative: low blood pressure; Polymyositis; restless; twitchy legs; needs help walking from room to room; twice the size she was before; cannot control her bowels; coughs nonstop; she could not move around; felt faint; flu like symptoms; This spontaneous case was reported by a patient family member or friend and describes the occurrence of POLYMYOSITIS (Polymyositis) and HYPOTENSION (low blood pressure) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     has never had Covid-19 infection. The patient was healthy prior to her second Moderna Covid-19.  Concomitant products included PREDNISONE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). In April 2021, the patient experienced POLYMYOSITIS (Polymyositis) (seriousness criteria hospitalization and medically significant), ANAL INCONTINENCE (cannot control her bowels), COUGH (coughs nonstop), HYPOKINESIA (she could not move around) and DIZZINESS (felt faint). On an unknown date, the patient experienced HYPOTENSION (low blood pressure) (seriousness criterion hospitalization), RESTLESSNESS (restless), MUSCLE TWITCHING (twitchy legs), GAIT DISTURBANCE (needs help walking from room to room) and WEIGHT FLUCTUATION (twice the size she was before). The patient was hospitalized on sometime in April 2021 due to HYPOTENSION and POLYMYOSITIS. At the time of the report, POLYMYOSITIS (Polymyositis), HYPOTENSION (low blood pressure), ANAL INCONTINENCE (cannot control her bowels), COUGH (coughs nonstop) and HYPOKINESIA (she could not move around) had not resolved, RESTLESSNESS (restless), MUSCLE TWITCHING (twitchy legs), GAIT DISTURBANCE (needs help walking from room to room), WEIGHT FLUCTUATION (twice the size she was before) and DIZZINESS (felt faint) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: nothing over 99.6 degrees Fahrenheit. In March 2021, SARS-CoV-2 test: Negative. In April 2021, Oxygen saturation: was 80 to 85%. On 08-May-2023, Blood creatine phosphokinase: in the 6000's. On 08-May-2023, Influenza virus test: Negative. On 08-May-2023, Oxygen saturation: 87 % at 3:54 PM. On 08-May-2023, Respiratory syncytial virus test: Negative. On 08-May-2023, SARS-CoV-2 test: Negative. On 08-May-2023, Streptococcus test: Negative. On an unknown date, Biopsy: Based on the Biopsies the Clinic concluded that the patients lack of being able to move around and breathe normally is due to the patient having received the Moderna Covid-19 vaccine primary series.. On an unknown date, Biopsy lung: Based on the Biopsies the Clinic concluded that the patients lack of being able to move around and breathe normally is due to the patient having received the Moderna Covid-19 vaccine primary series. On an unknown date, Blood pressure measurement: During each hospitalization the patient presents with a high fever and then upon exam is found to have a low blood pressure and low Oxygen Saturation. On an unknown date, Body temperature: During each hospitalization the patient presents with a high fever and then upon exam is found to have a low blood pressure and low Oxygen Saturation, 103.6 103.6 degrees Fahrenheit, 101 101 degrees Fahrenheit and 104 104 degrees Fahrenheit. On an unknown date, Oxygen saturation: During each hospitalization the patient presents with a high fever and then upon exam is found to have a low blood pressure and low Oxygen Saturation. On an unknown date, White blood cell count: currently high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered POLYMYOSITIS (Polymyositis), INFLUENZA LIKE ILLNESS (flu like symptoms) and DIZZINESS (felt faint) to be related. No further causality assessments were provided for HYPOTENSION (low blood pressure), ANAL INCONTINENCE (cannot control her bowels), COUGH (coughs nonstop), HYPOKINESIA (she could not move around), RESTLESSNESS (restless), MUSCLE TWITCHING (twitchy legs), GAIT DISTURBANCE (needs help walking from room to room) and WEIGHT FLUCTUATION (twice the size she was before).    Patient takes 19 medications however her daughter was not sure of what the medications are.  On 05-Mar-2021, the patient had mild flu like symptoms, low grade fever nothing over 99.6 degrees Fahrenheit, minor muscle aches that are more like a soreness. These symptoms lasted for about a week. Patient did go see her doctor and was given a Covid-19 test that came back negative. Patient has never had Covid-19 and is tested weekly since 2021 because she has so many healthcare appointments and hospitalizations and constantly has a high temperature. Patient was also routinely checked for Flu and Strep along with Covid-19. About 2 weeks after the second dose, patient visited hospital because she could not breathe and was having trouble catching her breath with any movement. Patient felt faint. The patient went to the hospital and was ruled out for Pneumonia. Because the patient could not move Physical Therapy came to see her and Physical Therapy concluded that the patients' muscles were not "firing up" and that Physical Therapy was not going to work for this condition. Biopsies of the patient's lung were taken and sent to the Lab. Three days after the lung biopsy a biopsy of the patient's leg was taken and sent to the clinic because the patient complained that she could not move around. Based on the Biopsies the Clinic concluded that the patients lack of being able to move around and breathe normally is due to the patient having received the Moderna Covid-19 vaccine primary series. The caller has no other information as to why the Clinic came to this conclusion. The patient was diagnosed with Polymyositis in Apr-2021 at her first hospital visit. The patient developed breathing problems which continued to become more severe after her hospitalization in Apr-2021. The breathing problem gradually got worse. The caller says that in the weeks since her mom's first hospitalization in Apr-2021 that her mom continued to experience Polymyositis.  Company Comment This spontaneous case concerns a 51-years-old-female patient, with  medical history of  Concomitant products included PREDNISONE and a dose of mRNA-1273 who experienced the unexpected seriousness criterion medically significant and hospitalization event of polymyositis, the unexpected events of hypotension (seriousness criterion hospitalization), anal incontinence, cough, hypokinesia, restlessness, muscle twitching, gait disturbance, weight fluctuation, influenza like illness, and other expected event in the context of the 2nd.  dose of  mRNA- 1273 vaccine administrated on April 2022. One day after 1st. dose, the patient began with influenza like illness and in the same month of the second one with the other events (included the serious. On an unknown date based on the Biopsies the Clinic concluded that the patients lack of being able to move around and breathe normally is due to the patient having received the Moderna Covid-19 vaccine primary series. The benefit-risk relationship of mRNA-1273  vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.  Most recent FOLLOW-UP information incorporated above includes: On 09-May-2023: Non-significant follow up.; Sender's Comments: Company Comment This spontaneous case concerns a 51-years-old-female patient, with  medical history of  Concomitant products included PREDNISONE and a dose of mRNA-1273 who experienced the unexpected seriousness criterion medically significant and hospitalization event of polymyositis, the unexpected events of hypotension (seriousness criterion hospitalization), anal incontinence, cough, hypokinesia, restlessness, muscle twitching, gait disturbance, weight fluctuation, influenza like illness, and other expected event in the context of the 2nd.  dose of  mRNA- 1273 vaccine administrated on April 2022. One day after 1st. dose, the patient began with influenza like illness and in the same month of the second one with the other events (included the serious. On an unknown date based on the Biopsies the Clinic concluded that the patients lack of being able to move around and breathe normally is due to the patient having received the Moderna Covid-19 vaccine primary series. The benefit-risk relationship of mRNA-1273  vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.