Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin A, Blood immunoglobulin G, Blood test, Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: There are now lumps on her feet; torn meniscus; 5th toe on both feet started to get numb/ 4th and the 5th toes on both feet were affected (numb)/ numbness is now at her foot pads up to the beginning of the arches on both feet; 1st dose - 20Feb2021 and 2nd dose - 31Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (There are now lumps on her feet), MENISCUS INJURY (torn meniscus), HYPOAESTHESIA (5th toe on both feet started to get numb/ 4th and the 5th toes on both feet were affected (numb)/ numbness is now at her foot pads up to the beginning of the arches on both feet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 20Feb2021 and 2nd dose - 31Mar2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 061E21A, 007B21A and 024M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cholesterol (On medication).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-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 10-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 20Feb2021 and 2nd dose - 31Mar2021). In May 2022, the patient experienced HYPOAESTHESIA (5th toe on both feet started to get numb/ 4th and the 5th toes on both feet were affected (numb)/ numbness is now at her foot pads up to the beginning of the arches on both feet). In March 2023, the patient experienced MENISCUS INJURY (torn meniscus). On an unknown date, the patient experienced LIMB MASS (There are now lumps on her feet). At the time of the report, LIMB MASS (There are now lumps on her feet) and HYPOAESTHESIA (5th toe on both feet started to get numb/ 4th and the 5th toes on both feet were affected (numb)/ numbness is now at her foot pads up to the beginning of the arches on both feet) had not resolved and MENISCUS INJURY (torn meniscus) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 20Feb2021 and 2nd dose - 31Mar2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin A: low. On an unknown date, Blood immunoglobulin G: low. On an unknown date, Blood test: IgM was elevated at 1200 (normal range: 300).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included blood thinner and cholesterol medication.  On an unknown date in May-2022, her 5th toe on both feet started to get numb. She did not pay attention to this until in Aug-2022, the 4th and the 5th toes on both feet were now affected (numb). She consulted with a lot of doctors and one neurologist requested for a blood test and the result showed that IgM was elevated. She consulted with a hematologist and had biopsy thinking that this was multiple myeloma. She thinks that her immune system was stimulated that's why her IgM was elevated.  At the time of reporting, the numbness was at her foot pads up to the beginning of the arches on both feet. She was healthy and plays tennis.  No treatment drug was reported.