Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Gait disturbance, Nerve injury, Pain in extremity
Clinical narrative: She feels like she has clots in her legs; has deep vein pain; her feet are so painful; she can barely walk at times; states that some type of nerve damage or something has happened to her feet.; This spontaneous case was reported by a nurse and describes the occurrence of THROMBOSIS (She feels like she has clots in her legs) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (She feels like she has clots in her legs) (seriousness criterion medically significant), VASCULAR PAIN (has deep vein pain), PAIN IN EXTREMITY (her feet are so painful), GAIT DISTURBANCE (she can barely walk at times) and NERVE INJURY (states that some type of nerve damage or something has happened to her feet.). At the time of the report, THROMBOSIS (She feels like she has clots in her legs), VASCULAR PAIN (has deep vein pain), PAIN IN EXTREMITY (her feet are so painful), GAIT DISTURBANCE (she can barely walk at times) and NERVE INJURY (states that some type of nerve damage or something has happened to her feet.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure has risen by a lot, increased. On an unknown date, Blood test: blood work done and claims that she is has had blood work done not diabetic or anything.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that there people dropping dead because of heart attacks and clots due to the vaccine. Her health has definitely been affected by this as well. She felt terrible that she was forced into getting the vaccine but as a nurse she had to get it. She said that ever since she got the booster dose of Moderna COVID-19 vaccine, her blood pressure has risen by a lot. She felt like she has clots in her legs because she had deep vein pain. She said that her feet was so painful that she can barely walk at times. She stated that some type of nerve damage or something has happened to her feet. However, her doctor does not agree with that assessment. She also added that she had blood work done and claims that she was not diabetic or anything. She said that her life has been cut short because people needed to make money and force vaccine down the American people. She does not have the Moderna vaccination records on her at that time. She asked how many reports like this does Moderna get in a day as she cannot be the only one going through this.  No treatment drug details was reported.  Company comment-This spontaneous case concerns an adult female patient of unknown age with no medical history reported, who experienced the unexpected serious (Medically significant) AESI event of Thrombosis (She feels like she has clots in her legs) unspecified days after booster dose of mRNA-1273.222 bivalent vaccination in covid -19 vaccination series. She also had non serious events of Vascular pain, Pain in extremity, Gait disturbance and Nerve injury. Latency cannot be assessed since onset date of event and date of vaccination was not disclosed. It was reported that after vaccination, patient's blood pressure has risen by a lot, patient feels like she has clots in her legs because she has deep vein pain, pain in her feet and can barely walk at times. She states that some type of nerve damage has occurred to her feet. However, her doctor does not agree with that assessment. Blood work done and patient claims that she is not diabetic or anything. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with no medical history reported, who experienced the unexpected serious (Medically significant) AESI event of Thrombosis (She feels like she has clots in her legs) unspecified days after booster dose of mRNA-1273.222 bivalent vaccination in covid -19 vaccination series. She also had non serious events of Vascular pain, Pain in extremity, Gait disturbance and Nerve injury. Latency cannot be assessed since onset date of event and date of vaccination was not disclosed. It was reported that after vaccination, patient's blood pressure has risen by a lot, patient feels like she has clots in her legs because she has deep vein pain, pain in her feet and can barely walk at times. She states that some type of nerve damage has occurred to her feet. However, her doctor does not agree with that assessment. Blood work done and patient claims that she is not diabetic or anything. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.