Received Apr 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
unilateral conjunctival classic kaposi sarcoma; Safety information originally reported under manufacturer case PV202400061714 has been nullified and re-entered under this new manufacturer report number 202600077618. This is a literature report from the Program ID: 005851 for the following literature source(s). Other Case identifier(s): US-ABBVIE-5736567, US-MLMSERVICE-20240412-PI025797-00097-1. The 75-year-old woman presented due to conjunctival lesion in right eye (OD). Her past surgical history included removal of benign adrenal tumour in 1995 and appendectomy in 1969. She had history of benign adrenal tumour, hypertension, hypercholesterolaemia, advanced uveitic glaucoma both eyes (OU), epiretinal membrane OU, pseudophakic bullous keratopathy left eye (OS), pseudophakia OU, chronic iridocyclitis OU, posterior vitreous detachment OU, cystoid macular degeneration OS, presumed ocular histoplasmosis syndrome (POHS) and DED. She also had undergone laser trabeculoplasty OD, bilateral phacoemulsification with posterior chamber intraocular lens (PCIOL), bilateral trabeculectomy, descemet's stripping endothelial keratoplasty OS, capsulotomy OS, seton implant OS and penetrating keratoplasty OS. Her advanced uveitic glaucoma was being treated with latanoprost. She thereafter started receiving topical ciclosporin [cyclosporin] drop and topical loteprednol-etabonate [loteprednol] drop, OU, for DED. She was immunised with booster dose of tozinameran [Pfizer COVID vaccine], prior to the current presentation. However, after several weeks of tozinameran immunisation, she complained of red and irritated conjunctival area in OD, described as bubbling. Her uncorrected vision was 20/20-2 OD and LP OS, and the applanation intraocular pressure (IOP) was at 11 mmHg OU. She had a diffuse avascular bleb in the superior quadrant, and the anterior segment examination revealed an elevated nodular and plaque-like conjunctival lesions OD along with some bleb area involvement. The eye ultrasound revealed thickened conjunctival lesions OD with the largest lesion of 1.68mm height. The histopathology examination was consistent with KS. Based on these findings, unilateral conjunctival classic KS secondary to tozinameran, ciclosporin and loteprednol-etabonate was considered. The woman started receiving topical interferon-alpha-2b 1000000 units/mL 4 times/day for 6 weeks, for conjunctival lesion. Despite interferon-alpha-2b, the size of conjunctival lesions from the initial presentation failed to decrease/regress; indicating treatment failure with interferon-alpha-2b. Her uncorrected acuity remained at 20/20 OD. Thus, she was treated with electron therapy, leading to slow improvement for the next 3 months. Later, she remained disease-free with no KS recurrence. The authors hypothesize that tozinameran vaccination and the local immunosuppression caused by topical loteprednol-etabonate and ciclosporin were the major co-factors needed to induce the localized conjunctival KS in this case. However, topical interferon-alpha-2b therapy failed to decrease the size of the conjunctival lesions. No follow-up attempts are possible. Follow-up (25Jul2025): This is a literature report from the program, for the following literature source(s). Other Case identifier(s): US-ABBVIE-5736567, US-MLMSERVICE-20240412-PI025797-00097-1. The case was confirmed as duplicate of US-ABBVIE-5736567 & merged under the master case US-EMA-DD-20250718-7482663-110723. The duplicate case contained no new information. Follow-up (30Jul2025): This is a literature report from the following literature source(s). This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Updated information included: medical history and lab data. Safety information originally reported under manufacturer case PV202400061714 has been nullified and re-entered under this new manufacturer report number 202600077618. Follow-up (17Apr2026): This is a follow-up report to notify that the case PV202400061714 and 202600077618 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202600077618.; Sender's Comments: The event Kaposi's sarcoma is conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Dry eye (DED); Uveitic glaucoma
Medical History/Concurrent Conditions: Appendectomy; Benign adrenal neoplasm NOS; Benign tumour excision; Chronic iridocyclitis; Cystoid macular degeneration of retina; Epiretinal membrane; Hypercholesterolaemia; Hypertension; Keratoplasty; Lens capsulotomy; Phacoemulsification; Posterior vitreous detachment; Presumed ocular histoplasmosis syndrome; Pseudophakia; Pseudophakic bullous keratopathy; Trabeculectomy; Trabeculoplasty
LATANOPROST; CYCLOSPORIN; LOTEPREDNOL ETABONATE
Test Name: histopathology examination; Result Unstructured Data: Test Result:was consistent with KS; Test Name: applanation intraocular pressure; Result Unstructured Data: Test Result:11 mmHg; Comments: OU; Test Name: anterior segment examination; Result Unstructured Data: Test Result:revealed an elevated nodular; Comments: and plaque-like conjunctival lesions OD with some involvement of the bleb area; Test Name: eye ultrasound; Result Unstructured Data: Test Result:revealed thickened conjunctival lesions OD; Comments: with the largest lesion measuring 1.68 mm in height; Test Name: uncorrected vision; Result Unstructured Data: Test Result:uncorrected vision was 20/20-2 OD and LP OS; Test Name: uncorrected vision; Result Unstructured Data: Test Result:uncorrected acuity remained at 20/20 OD