Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Systemic lupus erythematosus; This serious case was reported in a literature article and described the occurrence of systemic lupus erythematosus in a 24-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis. Literature Reference. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis. Additional patient notes included Patient with no past medical history. On an unknown date, the patient received DTaP vaccine and Influenza vaccine. On an unknown date, 2 days after receiving DTaP vaccine and Influenza vaccine, the patient experienced systemic lupus erythematosus (Verbatim: Systemic lupus erythematosus) (serious criteria GSK medically significant). The patient was treated with hydroxychloroquine and Steroids. The outcome of the systemic lupus erythematosus was resolving. The reporter considered the systemic lupus erythematosus to be possibly related to DTaP vaccine and Influenza vaccine. The company considered the systemic lupus erythematosus to be unrelated to DTaP vaccine and Influenza vaccine. Additional Information: GSK receipt date: 07-NOV-2025 Patient was a healthy 24-year-old female with no past medical history presenting to rheumatology clinic after two months of small joint pain, intermittent tunnel vision, photosensitivity, and mouth sores that started two days after receiving routine Tdap and Influenza vaccines for employment. Physical exam revealed swelling and tenderness of the left 2nd PIP and 5th right PIP. Her CBC and CMP were within normal limits, and her UA revealed 1+ protein. Serology showed hypocomplementemia, Anti SSA of 134, positive ANA 1:2560, dsDNA more than 365, RNP 6.8, and + anti-histone. Patient was diagnosed with systemic lupus erythematosus (SLE) was prescribed hydroxychloroquine and steroids for treatment. Patient was now doing well 3 months after starting treatment and was avoiding both the Tdap and flu vaccines. Patient's lack of past medical history and her timing of symptoms suggest that immune hyperactivation status post vaccine likely led to the development of SLE. Author could not know for sure which exact vaccine was the cause of the development of SLE in patient, this case highlights a rare adverse effect and the possibility of SLE after common vaccines.; Sender's Comments: A case of Systemic lupus erythematosus, 2 days after receiving DTaP vaccine and Influenza vaccine, in a 24-year-old female patient. Causal relation is indeterminate considering two vaccines given concomitantly.
Comments: Patient with no past medical history.
Test Name: ANA; Result Unstructured Data: (Test Result:1:2560,Unit:unknown,Normal Low:,Normal High:); Test Name: anti-RNP antibody; Result Unstructured Data: (Test Result:6.8,Unit:unknown,Normal Low:,Normal High:); Test Name: dsDNA; Result Unstructured Data: (Test Result:more than 365,Unit:unknown,Normal Low:,Normal High:); Test Name: complete blood count; Result Unstructured Data: (Test Result:within normal limits,Unit:unknown,Normal Low:,Normal High:); Test Name: anti-histone; Test Result: Positive ; Test Name: urine analysis; Result Unstructured Data: (Test Result:revealed 1+ protein,Unit:unknown,Normal Low:,Normal High:); Comments: On unknown date: Physical exam revealed swelling and tenderness of the left 2nd PIP and 5th right PIP. On unknown date: Serology showed hypocomplementemia. On unknown date: anti Sjogren's syndrome related antigen A antibody-134