Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Joint injury, Lymphoedema, Peripheral swelling
Clinical narrative: Right leg started to swell; I normally weigh 110 lbs. Now I'm 128 lbs.; Lymphedema worsened/It's mainly fluid in my upper legs & groin. It moves down to my feet & ankles at night; Tested positive for Covid-19; Lack of drug effect; knee injury/had a knee injury; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (knee injury/had a knee injury), PERIPHERAL SWELLING (Right leg started to swell), WEIGHT INCREASED (I normally weigh 110 lbs. Now I'm 128 lbs.), LYMPHOEDEMA (Lymphedema worsened/It's mainly fluid in my upper legs & groin. It moves down to my feet & ankles at night) and COVID-19 (Tested positive for Covid-19) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002021A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fall. Concurrent medical conditions included Lymphedema, Ovarian cancer since 2018 and Unsteadiness.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced JOINT INJURY (knee injury/had a knee injury). On 12-Jan-2022, the patient experienced COVID-19 (Tested positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PERIPHERAL SWELLING (Right leg started to swell), WEIGHT INCREASED (I normally weigh 110 lbs. Now I'm 128 lbs.) and LYMPHOEDEMA (Lymphedema worsened/It's mainly fluid in my upper legs & groin. It moves down to my feet & ankles at night). The patient was treated with Physical therapy for Joint injury. At the time of the report, JOINT INJURY (knee injury/had a knee injury), PERIPHERAL SWELLING (Right leg started to swell), WEIGHT INCREASED (I normally weigh 110 lbs. Now I'm 128 lbs.) and LYMPHOEDEMA (Lymphedema worsened/It's mainly fluid in my upper legs & groin. It moves down to my feet & ankles at night) had not resolved, COVID-19 (Tested positive for Covid-19) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Ultrasound Doppler: result not provided Result not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. Patient had doppler test to check if it was a blood clot after knee injury. Patient did not receive booster dose. Patient stated in late March or April she had a knee injury & had been doing physical therapy when her right leg started to swell. They stopped the physical therapy and it got increasingly worse. Did AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized) was given as a  Yes Patient reported that she normally weighs 110 lbs and now she was 128 lbs. On 13-Jan-2022 patient received Monoclonal Antibody treatment. She was treated at a lymphedema clinic for her lymphedema. Patient reported that she went to vascular, kidney & neurology specialists and also had visited to oncologist.  Company comment:  This regulatory authority case concerns a 74-year-old female patient with no relevant medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 10 months after the 2nd dose of the mRNA-1273.  The symptoms reported were cough and pyrexia. The patient was treated with monoclonal antibodies. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-487379 (Patient Link).; Sender's Comments: This regulatory authority case concerns a 74-year-old female patient with no relevant medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 10 months after the 2nd dose of the mRNA-1273.  The symptoms reported were cough and pyrexia. The patient was treated with monoclonal antibodies. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.