Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | 009C21A | IM |
test results coming back positive for Lyme/lymph nodes that comes and goes from underneath her underarms to her neck, as well as her groin area; She did swell up because her legs swells up and her feet swells up to the point one leg is bigger than the other/They swell up underneath her neck, her underarm, her groin; hard to even walk and stand; hard to even walk and stand; This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE (test results coming back positive for Lyme/lymph nodes that comes and goes from underneath her underarms to her neck, as well as her groin area) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 041C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Kidney failure (stage 2 kidney failure). On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYME DISEASE (test results coming back positive for Lyme/lymph nodes that comes and goes from underneath her underarms to her neck, as well as her groin area) (seriousness criterion medically significant). In 2021, the patient experienced PERIPHERAL SWELLING (She did swell up because her legs swells up and her feet swells up to the point one leg is bigger than the other/They swell up underneath her neck, her underarm, her groin), GAIT DISTURBANCE (hard to even walk and stand) and DYSSTASIA (hard to even walk and stand). At the time of the report, LYME DISEASE (test results coming back positive for Lyme/lymph nodes that comes and goes from underneath her underarms to her neck, as well as her groin area), PERIPHERAL SWELLING (She did swell up because her legs swells up and her feet swells up to the point one leg is bigger than the other/They swell up underneath her neck, her underarm, her groin), GAIT DISTURBANCE (hard to even walk and stand) and DYSSTASIA (hard to even walk and stand) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatine phosphokinase: spike CK levels with creatine. On an unknown date, Blood creatinine: spike CK levels with creatine. On an unknown date, Blood prolactin: protein, her prolactin levels went up as if she was nursing again. On an unknown date, Blood test: blood levels for different things had been up and down since the vaccination. On an unknown date, Investigation: test results coming back positive for Lyme. On an unknown date, Protein total: protein, her prolactin levels went up as if she was nursing again. No concomitant medications were reported. On 20-May-2021, the first lymph node appeared underneath her left arm, and stayed for quite some time, until July 2021. The patient was still experiencing lymph nodes that came and went from underneath her underarms to her neck, as well as her groin area. They swell up underneath her neck, her underarm, her groin. She did swell up because her legs swell up and her feet swells up to the point one leg was bigger than the other at times, but it was not lymphedema. It had been like that since the vaccination in 2021. She had stage 2 kidney failure. Her leg swells up and her feet to the point she was on and off "cane" (unclear). The patient's daughter at the time was 3, she had stopped breastfeeding since she was 7 months. She was on lupus medication as well as steroids to try to get the swelling down on her legs. She had to see all different kinds of specialists from a vascular specialist doctor to a neurologist, she had different tests done to see what was going on because it triggered so bad after that to the point, she had work accommodation set at her job from the doctor because it was hard to even walk and stand at times.; Reporter's Comments: Concurrent medical conditions Kidney failure is a confounder for the events. Due to lack of biological plausibility, the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Kidney failure (stage 2 kidney failure)
Test Name: CK level; Result Unstructured Data: spike CK levels with creatine; Test Name: creatine; Result Unstructured Data: spike CK levels with creatine; Test Name: prolactin; Result Unstructured Data: protein, her prolactin levels went up as if she was nursing again; Test Name: blood test; Result Unstructured Data: blood levels for different things had been up and down since the vaccination; Test Name: test; Result Unstructured Data: test results coming back positive for Lyme; Test Name: protein; Result Unstructured Data: protein, her prolactin levels went up as if she was nursing again