Received May 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | LA |
Lichenoid related eruption; she's had a lupus flare up / rash all over body; she's had a lupus flare up / rash all over body; Bumps where vaccine was administered.; Reports a week later she started getting bumps where the vaccine was administered, that turned into a circular rash; Blisters started immediately with rash; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30Jan2026 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for immunisation. The patient's relevant medical history included: "Lupus", start date: 2016 (ongoing), notes: Diagnosed about 10 years ago; "Rheumatoid Arthritis", start date: 2016 (unspecified if ongoing), notes: Diagnosed about 10 years ago; "Sjogrens", start date: 2016 (unspecified if ongoing), notes: Diagnosed about 10 years ago. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE VESICLES (medically significant) with onset Feb2026, outcome "unknown", described as "Blisters started immediately with rash"; VACCINATION SITE MASS (medically significant) with onset Feb2026, outcome "unknown", described as "Bumps where vaccine was administered."; VACCINATION SITE RASH (medically significant) with onset Feb2026, outcome "unknown", described as "Reports a week later she started getting bumps where the vaccine was administered, that turned into a circular rash"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 15Feb2026, outcome "not recovered" and all described as "she's had a lupus flare up / rash all over body"; LICHENOID KERATOSIS (non-serious) with onset 16Mar2026, outcome "unknown", described as "Lichenoid related eruption". The patient underwent the following laboratory tests and procedures: Biopsy: (16Mar2026) Lichenoid related eruption, notes: 2 biopsies performed; one on arm; one on back. Therapeutic measures were taken as a result of vaccination site mass, vaccination site rash, vaccination site vesicles. Clinical course: Reporter was reporting she had the Prevnar vaccine on 30Jan2026 and ever since, she's had a lupus flare up and rash all over body. Confirmed rash since the middle of Feb. Confirmed Lupus for 10 years. States her doctors at withheld have been working with her. Her doctors believe this was a severe reaction to the Prevnar. They had been working with her and she doesn't want this to happen to anyone else. States the issues did not happen instantly. Reports a week later she started getting bumps where the vaccine was administered, that turned into a circular rash, and spread to her arms, hands, back, chest, private areas, legs, face, neck, and other arm, accompanied with blisters. Said the only places that don't has the rash are her feet and lower calves, they are fine. At first, she not know which Prevnar vaccine she was administered; she would be able to find that out by doctor at withheld but later in call, found that it was Prevnar 20. Reporter stated she was withheld with red blotches that are not going away. Reports that every medication her doctor tries to prescribe, insurance fights it. Said she was currently on prednisone 15mg; was on prednisone 60mg but it didn't do anything. Provided the doctor didn't know that this happened to her when asked if the dose was changed in response to the event. Reporter stated she was feeling like this was just like a circle, and it was frustrating. Said withheld has had her sign a bunch of disclosures and they were going to use it for teaching, since it was a teaching facility and send to us. Stated she was had lupus for 10 years and has never had a rash like this before and doesn't want it to happen to someone else. Reporter stated this all too much, and she has to go pick up her medication. Treatment with prednisone, 3 different creams that are not making it better. Creams mentioned by reporter as triamcinolone, betamethasone, tacrolimus creams. it was also reported suspect product was received in doctors office. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: The events vaccination site vesicles, vaccination site mass, vaccination site rash, systemic lupus erythematosus flarecondition aggravated, and lichenoid keratosis were assessed as related to pneumococcal 20-valent conjugate vaccine based on the close temporal association following vaccination, progression from local injection-site reactions to widespread cutaneous manifestations, biopsy findings consistent with lichenoid eruption, and absence of similar prior rash history despite longstanding lupus. The patient's underlying autoimmune conditions, including systemic lupus erythematosus, rheumatoid arthritis, and Sjogren's syndrome, were considered contributory risk factors for an exaggerated immune-mediated reaction.
Lupus erythematosus (Diagnosed about 10 years ago)
Medical History/Concurrent Conditions: Rheumatoid arthritis (Diagnosed about 10 years ago); Sjogren's (Diagnosed about 10 years ago)
Test Date: 20260316; Test Name: biopsies; Result Unstructured Data: Test Result:Lichenoid related eruption; Comments: 2 biopsies performed; one on arm; one on back