Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: also have neuropathy in my feet; treating me for pneumonitis, even though I don't have it, because he said my body thinks I do; began having GI issues, where I had unexplained 'number 2' explosions, even if just standing there; really bad shortness of breath during this time/mild emphysema; went to do stress test, but was told that patient couldn't because her b/p was 210/120; able to walk only half as far as on Sunday and able to walk only half as much as Monday; Flu-like aches and pains; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (also have neuropathy in my feet), PNEUMONITIS (treating me for pneumonitis, even though I don't have it, because he said my body thinks I do) and HYPERTENSION (went to do stress test, but was told that patient couldn't because her b/p was 210/120) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 025ADLA and 010M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (Taking a low dose of blood pressure meds for 12 years).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aches and pains). On 25-Oct-2021, the patient experienced GAIT DISTURBANCE (able to walk only half as far as on Sunday and able to walk only half as much as Monday). On 29-Oct-2021, the patient experienced HYPERTENSION (went to do stress test, but was told that patient couldn't because her b/p was 210/120) (seriousness criterion medically significant). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (also have neuropathy in my feet) (seriousness criterion medically significant), PNEUMONITIS (treating me for pneumonitis, even though I don't have it, because he said my body thinks I do) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (began having GI issues, where I had unexplained 'number 2' explosions, even if just standing there) and EMPHYSEMA (really bad shortness of breath during this time/mild emphysema). The patient was treated with LISINOPRIL ongoing since an unknown date at a dose of 40 milligram; METOPROLOL at a dose of 50 milligram; SIMVASTATIN at a dose of 40 milligram; AMLODIPINE at a dose of 10 milligram; DEXAMETHASONE at an unspecified dose and frequency; FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) at a dose of 100 microgram and OXYGEN at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (also have neuropathy in my feet), PNEUMONITIS (treating me for pneumonitis, even though I don't have it, because he said my body thinks I do), INFLUENZA LIKE ILLNESS (Flu-like aches and pains), GAIT DISTURBANCE (able to walk only half as far as on Sunday and able to walk only half as much as Monday) and EMPHYSEMA (really bad shortness of breath during this time/mild emphysema) outcome was unknown and HYPERTENSION (went to do stress test, but was told that patient couldn't because her b/p was 210/120) and ABDOMINAL DISCOMFORT (began having GI issues, where I had unexplained 'number 2' explosions, even if just standing there) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Blood pressure measurement: 210/120.. On an unknown date, Blood pressure measurement: Patient bp pressure went down to 150/90. and stayed in the 220/120 range. On an unknown date, Computerised tomogram: Showed that patient  had mild emphysema.. On an unknown date, Oxygen saturation: O2 sats were going down. On an unknown date, SARS-CoV-2 test: (Negative) week ago, took a blood test for Covid. It was negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NEUROPATHY PERIPHERAL (also have neuropathy in my feet), PNEUMONITIS (treating me for pneumonitis, even though I don't have it, because he said my body thinks I do), HYPERTENSION (went to do stress test, but was told that patient couldn't because her b/p was 210/120), INFLUENZA LIKE ILLNESS (Flu-like aches and pains), GAIT DISTURBANCE (able to walk only half as far as on Sunday and able to walk only half as much as Monday), ABDOMINAL DISCOMFORT (began having GI issues, where I had unexplained 'number 2' explosions, even if just standing there) and EMPHYSEMA (really bad shortness of breath during this time/mild emphysema) to be related.    Patient has been taking a low dose of blood pressure meds for 12 yrs. Patient normal b/p was always 130/80.  It was reported that patient developed Flu-like aches and pains, on 25-Oct-2021, patient was able to walk only half as far as on Sunday (24-Oct-2021). On 26-Oct-2021, patient was able to walk only half as much as Monday (25-Oct-2021). Patient spoke with her Dr. and on 29-Oct-2021 (15 days after 1st booster), patient went to do stress test, but was told that she couldn't because her b/p was High.  Patient went to see a kidney specialist who changed her b/p meds, but her pressure stayed in the 220/120 range and patient went to the emergency room was given 2 IV blood pressure meds and her pressure went down to 150/90 and it took 4 months to get her Blood pressure under control.  On an unknown date patient began having GI issues, where she had unexplained 'number 2' explosions, even if she was just standing there. Patient changed her diet, and was under better control right now. Patient also got really bad shortness of breath during this time. she had a lung CT scan, which showed that she had mild emphysema.  On an unknown date, patient went to the pulmonologist, because her O2 sats were going down, she was treated with steroids and after 7-8 days, patient breathing got better. But when she got off the steroids, her breathing got bad again, so patient was put on a slow taper of steroids. Patient was also treated for pneumonitis, even though she doesn't have it, because patient doctor said that her body thinks she do. She uses oxygen at night and use a portable oxygen tank if needed when walking.  All the patient doctors said that all her events are related to the Moderna booster dose.  Company Comment: This is a spontaneous case reported by a patient concerning a 67-year-old female patient, with medical history of blood pressure high, who experienced the unexpected, serious (medically significant) events of neuropathy peripheral, hypertension and pneumonitis. The patient completed a two-dose primary series of mRNA-1273 vaccine within an appropriate schedule between doses and received a third dose of mRNA-1273. Exact onset dates of events were unknown, thus, exact latency between vaccination and onset of the event could not be assessed. According to the report, patient has been taking a low dose of blood pressure medication for 12 years and her normal blood pressure was always 130/80. It was reported that patient developed Flu-like aches and pains, one or two days after the third dose of mRNA-1273. On the fourth day after the third dose, the patient was able to walk only half as much as the day before. 15 days after the first booster, patient went to do stress test, but was told that she couldn't because her blood pressure was High. Patient went to see a kidney specialist who changed her medication, but her pressure stayed in the 220/120 range and patient went to the emergency room was given two intravenous medications for blood pressure and it went down to 150/90 and it took 4 months to get her Blood pressure under control. Patient also experienced dyspnoea, so she had a lung tomography scan, which showed that she had mild emphysema. She went to the pulmonologist because her oxygen saturation was decreasing. She started with steroids that relieved her dyspnoea but when she stopped, the dyspnoea came back. Therefore, she was put on a slow tappering of steroids. Patient was also treated for pneumonitis. She used oxygen at night and used a portable oxygen tank if needed when walking. All the doctors said that all her events were related to the Moderna booster dose. The medical history of blood pressure high could be a contributory factor for neuropathy peripheral and hypertension. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a patient concerning a 67-year-old female patient, with medical history of blood pressure high, who experienced the unexpected, serious (medically significant) events of neuropathy peripheral, hypertension and pneumonitis. The patient completed a two-dose primary series of mRNA-1273 vaccine within an appropriate schedule between doses and received a third dose of mRNA-1273. Exact onset dates of events were unknown, thus, exact latency between vaccination and onset of the event could not be assessed. According to the report, patient has been taking a low dose of blood pressure medication for 12 years and her normal blood pressure was always 130/80. It was reported that patient developed Flu-like aches and pains, one or two days after the third dose of mRNA-1273. On the fourth day after the third dose, the patient was able to walk only half as much as the day before. 15 days after the first booster, patient went to do stress test, but was told that she couldn't because her blood pressure was High. Patient went to see a kidney specialist who changed her medication, but her pressure stayed in the 220/120 range and patient went to the emergency room was given two intravenous medications for blood pressure and it went down to 150/90 and it took 4 months to get her Blood pressure under control. Patient also experienced dyspnoea, so she had a lung tomography scan, which showed that she had mild emphysema. She went to the pulmonologist because her oxygen saturation was decreasing. She started with steroids that relieved her dyspnoea but when she stopped, the dyspnoea came back. Therefore, she was put on a slow tappering of steroids. Patient was also treated for pneumonitis. She used oxygen at night and used a portable oxygen tank if needed when walking. All the doctors said that all her events were related to the Moderna booster dose. The medical history of blood pressure high could be a contributory factor for neuropathy peripheral and hypertension. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.