Received Apr 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | 046A21A | IM |
tardive dyskinesia; psoriasis type um reaction/ it caused reddened heated skin and it just gets worse and worse with whatever medication take now; This spontaneous case was reported by a consumer and describes the occurrence of TARDIVE DYSKINESIA (tardive dyskinesia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 038B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Disability NOS and Mental disorder NOS. Concomitant products included Benzatropine mesilate (Cogentin), Valaciclovir hydrochloride (Valacyclovir) and Haloperidol (Halperol) for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TARDIVE DYSKINESIA (tardive dyskinesia) (seriousness criterion medically significant) and PSORIASIS (psoriasis type um reaction/ it caused reddened heated skin and it just gets worse and worse with whatever medication take now). At the time of the report, TARDIVE DYSKINESIA (tardive dyskinesia) and PSORIASIS (psoriasis type um reaction/ it caused reddened heated skin and it just gets worse and worse with whatever medication take now) had not resolved. It was reported that the patient was involved in cancer studies. It was unknown if the patient received any vaccines within the past 4 weeks and had any medical conditions. It was reported that the patient was a mental health patient and was required to take medications. The Moderna vaccine was administered at the patient's clinic. The condition of the patient progressively worsened with each medication taken thereafter. The patient experienced a severe reaction to other medications. The patient received the vaccine during the COVID-19 pandemic in 2021. It was stated that the patient had informed the clinic of her intention to pursue legal action as reported that the clinic was no longer able to assist her. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Initial information along with live follow-up 1 and 2 received on 09-Apr-2026 has been processed together in the same case cycle. Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2026: Live follow-up received contains non-significant information includes route of administration added for second dose, reference IDs added and updated narrative. On 09-Apr-2026: Live follow-up received contains non-significant information includes reporter details updated, reference IDs added.; Reporter's Comments: Concomitant haloperidol remains as a risk factor for Tardive dyskinesia. The benefit-risk relationship of product is not affected by this report.
Disability NOS; Mental disorder NOS
Cogentin; Valacyclovir; Halperol