Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
diagnosed him with Lupus/feeling bad/lost a lot of weight/lost his hair/joints cause a lot of pain; pass out; "mess up" his ribs; pain in his neck; decrease in testosterone levels; bruises; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosed him with Lupus/feeling bad/lost a lot of weight/lost his hair/joints cause a lot of pain), LOSS OF CONSCIOUSNESS (pass out) and CHEST INJURY ("mess up" his ribs) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosed him with Lupus/feeling bad/lost a lot of weight/lost his hair/joints cause a lot of pain) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), CHEST INJURY ("mess up" his ribs) (seriousness criterion medically significant), NECK PAIN (pain in his neck), BLOOD TESTOSTERONE DECREASED (decrease in testosterone levels) and CONTUSION (bruises). The patient was treated with Acetylsalicylic acid (Aspirin) at an unspecified dose and frequency and Testosterone at an unspecified dose and frequency. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosed him with Lupus/feeling bad/lost a lot of weight/lost his hair/joints cause a lot of pain), LOSS OF CONSCIOUSNESS (pass out), CHEST INJURY ("mess up" his ribs), NECK PAIN (pain in his neck) and CONTUSION (bruises) had not resolved and BLOOD TESTOSTERONE DECREASED (decrease in testosterone levels) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: very high blood pressure. On an unknown date, Blood testosterone: decrease in testosterone levels. On an unknown date, Weight: lost a lot of weight. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that patient took Moderna Covid vaccines in 2021 and after 2 weeks patient felt bad, his liver and kidney were not working properly, had a lot of diarrheas and vomiting and he also lost a lot of weight. Doctors were not able to treat him but finally diagnosed him with Lupus. He reported that no one in his family had lupus and that the mRNA vaccine must have played in his DNA to change it and caused this disease. It was reported that he had been going on with this condition for 5 years. He tried from time to time to gain back his weight. But then sometimes he would need to take an aspirin, or any medication and it would make him feel as if his skin was on fire. It was also reported that his body was rejecting everything. He also experienced a lot of pain in his joints, and he lost his hair due to decrease in testosterone levels and he now needs to take testosterone injections. He also mentioned that after the vaccine he developed very high blood pressure, that would cause pain in his neck, and he would then pass out and hit the floor and he would have bruises and mess up his ribs. It was unknown if the patient experienced any additional symptoms or events; Reporter's Comments: Company comment: Events chest injury and contusion were assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
Test Name: blood pressure; Result Unstructured Data: very high blood pressure; Test Name: testosterone levels; Result Unstructured Data: decrease in testosterone levels; Test Name: weight; Result Unstructured Data: lost a lot of weight