Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood test, Computerised tomogram, Intervertebral disc protrusion, Lupus-like syndrome
Clinical narrative: Herniated disc in back; Drug-induced Lupus/ forget things/Headaches in the back of her head; Polymyositis; This spontaneous case was reported by a nurse and describes the occurrence of LUPUS-LIKE SYNDROME (Drug-induced Lupus/ forget things/Headaches in the back of her head) and POLYMYOSITIS (Polymyositis) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A2 and 029L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2022, the patient experienced LUPUS-LIKE SYNDROME (Drug-induced Lupus/ forget things/Headaches in the back of her head) (seriousness criterion medically significant) and POLYMYOSITIS (Polymyositis) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Herniated disc in back). At the time of the report, LUPUS-LIKE SYNDROME (Drug-induced Lupus/ forget things/Headaches in the back of her head) and POLYMYOSITIS (Polymyositis) had not resolved and INTERVERTEBRAL DISC PROTRUSION (Herniated disc in back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Antinuclear antibody: results not reported No results provided however final diagnosis of Drug-induced Lupus and Polymyositis. In 2022, Blood test: results not reported No results provided however final diagnosis of Drug-induced Lupus and Polymyositis. In 2022, Computerised tomogram: results not reported No results provided however final diagnosis of Drug-induced Lupus and Polymyositis. In 2022, Magnetic resonance imaging: results not reported No results provided however final diagnosis of Drug-induced Lupus and Polymyositis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. Treatment information mentioned medication NOS for inflammation.  Patient received primary and booster series of Moderna and noted that it crippled her. She is not able to do anything to the point she needs to use her arms to lift herself to do anything. Falls down all the time, is clumsy, got a herniated disc in back and forgets things. She must write it down or wont remember. Cant remember phone conversations and it feels like dementia. Has a tough time understanding people and is made fun of at work due to this. Her body hurt every day, knees and ankles including and it felt like her spine was burning. She takes a lot of time to get ready in the morning now too. Feels like an invalid. Has never felt or had this before COVID and vaccine. She took a blood test, ANA, CT and MRI scan, no results provided however around 11JUN2022, a final diagnosis of drug-induced lupus and polymyositis was made, which has a 5 year life expectancy.  Complains of achy muscles and the pain is brutal. Does not take any treatment apart from medication for the inflammation NOS. Post the first and second dose too had some symptoms.  Company Comment:   This case was linked to MOD-2022-598089, MOD-2022-598087, MOD-2022-598091 (Patient Link).; Sender's Comments: This spontaneous case concerns a 23-year-old, female patient with no reported medical history and intake of concomitant medications, who experienced the unexpected, serious (medically significant) events of Lupus-like syndrome and Polymyositis. The non-serious Intervertebral disc protrusion was also reported. Exact onset dates of symptoms were not specified, although it was mentioned that immediately after vaccination (unspecified dose number), the patient started having movement difficulties due to generalized body pain and lower extremities joint pain. She has also started feeling a burning sensation from her spine and reported disc protrusion. This prevented her to effectively perform activities of daily living, which she had no previous difficulty doing. The patient also noticed that she has started to be forgetful post-vaccination and had a hard time understanding conversations. After the first dose, she started having recurrent fever and headaches, and after the second dose, noted facial erythema, specifically in the cheeks, along with burning sensation of the skin and sore muscles. She was later seen by a neurologist where unspecified blood tests, antinuclear antibody test, computed tomography scan and magnetic resonance imaging were conducted approximately 6 months after receiving first booster dose of mRNA-1273; but the results were not provided in the case. The patient was then diagnosed with Drug-induced Lupus and Polymyositis and was prescribed with unspecified anti-inflammatory medications. The reported pain symptoms could be associated with lupus and with polymyositis, and the latter would also present with worsening muscle weakness which may also contribute to the reported movement difficulties. Additionally, the recurrent fever, headaches and memory impairment could be a manifestations of lupus. The benefit-risk relationship of mRNA-1273 is not affected by this report.