Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Ultrasound scan
Clinical narrative: Pain in both legs/ Right leg pain eventually got better/Left leg pain/Throbbing in left leg; Body aches; Sore throat; Fever; Headache; Chills; Difficult to walk/ Dragging leg around; Swelling in left leg/ Still had left leg swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both legs/ Right leg pain eventually got better/Left leg pain/Throbbing in left leg), PAIN (Body aches), PERIPHERAL SWELLING (Swelling in left leg/ Still had left leg swelling), OROPHARYNGEAL PAIN (Sore throat) and GAIT DISTURBANCE (Difficult to walk/ Dragging leg around) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high and Anxiety. Concurrent medical conditions included Drug allergy (Doxepin allergy), Drug allergy (Bupropion allergy), Drug allergy (Sertraline allergy - Severe urticaria), Drug allergy (Hydroxyzine allergy- Insomnia, tongue swelling) and Drug allergy (Steroid injectionsallergy - Breaks out in welts). Concomitant products included METOPROLOL for Blood pressure high, VITAMINS NOS for an unknown indication.   On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced PERIPHERAL SWELLING (Swelling in left leg/ Still had left leg swelling) and GAIT DISTURBANCE (Difficult to walk/ Dragging leg around). On 19-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in both legs/ Right leg pain eventually got better/Left leg pain/Throbbing in left leg), PAIN (Body aches), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with ACETYLSALICYLIC ACID (BAYER ASPIRIN) for Pain, at an unspecified dose and frequency. On 20-Nov-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in both legs/ Right leg pain eventually got better/Left leg pain/Throbbing in left leg), PAIN (Body aches) and PERIPHERAL SWELLING (Swelling in left leg/ Still had left leg swelling) had not resolved and OROPHARYNGEAL PAIN (Sore throat), GAIT DISTURBANCE (Difficult to walk/ Dragging leg around) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Ultrasound scan: results not provided Results not provided and normal (normal) Blood clots ruled out by result.         Concomitant medications also included anxiety medication.  Patient was prescribed pain medications and muscle relaxants for treatment. On 20-Nov-2021, the patient reported that the patient was still experiencing some body aches and pain in both legs. At the Emergency Room, the patient had undergone an ultrasound scan, and blood clots were ruled out from the result. Patient was placed on restriction for 2 days and was given compression stockings. The patient had consulted the vascular physician on 29-Nov-2021.  The patient reported that the muscle relaxants made the pain bearable. In the Thanksgiving weekend, the patient was in the bed and out of the bed only,  Patient had returned to work on 02-Dec-2021, and was scheduled for Venogram on 21-Dec-2021, as the physician was not able to clearly conclude from the ultrasound scan result.  Company Comment: This case concerns a 54-year-old female patient, with relevant medical history of Blood pressure high and concomitant intake of Metoprolol, who experienced the unexpected events of Pain in extremity, Pain, Peripheral swelling, Gait disturbance, Oropharyngeal pain, the expected events of Pyrexia, Headache and Chills. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The patient's medical history of  Blood pressure high and concomitant intake of Metoprolol, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 54-year-old female patient, with relevant medical history of Blood pressure high and concomitant intake of Metoprolol, who experienced the unexpected events of Pain in extremity, Pain, Peripheral swelling, Gait disturbance, Oropharyngeal pain, the expected events of Pyrexia, Headache and Chills. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The patient's medical history of  Blood pressure high and concomitant intake of Metoprolol, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.