Received Jul 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
reactivation of a Herpes/Varicella-Zoster virus (VZV) in a young male shortly after he received the Pfizer-BioNTech COVID-19 vaccine; This is a literature report for the following literature source(s): A 36-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "diagnosed with HIV" (unspecified if ongoing), notes: never compliant with his antiretrovirals; "immunocompromised state" (unspecified if ongoing), notes: weak immune system; "rash" (unspecified if ongoing), notes: on the left lower quadrant (LLQ) of his abdomen; "shingles" (unspecified if ongoing), notes: rash developed previously on the left lower quadrant (LLQ) of his abdomen three to four years ago. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for Covid-19 immunization. The following information was reported: HERPES ZOSTER REACTIVATION (hospitalization), 1 day after the suspect product(s) administration, outcome "recovered", described as "reactivation of a Herpes/Varicella-Zoster virus (VZV) in a young male shortly after he received the Pfizer-BioNTech COVID-19 vaccine". The patient was hospitalized for herpes zoster reactivation (hospitalization duration: 5 day(s)). The event "reactivation of a herpes/varicella-zoster virus (vzv) in a young male shortly after he received the pfizer-biontech covid-19 vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (9-46): 54 IU/l; Aspartate aminotransferase (10-36): 45 IU/l; Blood pressure measurement: 147/106; Body temperature: 99 DF, notes: 37.2°C; CD3 lymphocytes (57.5-86.2): 83.9 %; CD3 lymphocytes (622-2402): 1846 /mm3, notes: reported units (/ul); CD4 lymphocytes (30.8-58.5): 7.2 %; CD4 lymphocytes (359-1519): 158 /mm3, notes: units reported (/ul); CD4 lymphocytes (359-1519): 158; CD4/CD8 ratio (0.92-3.72): 0.10; CD8 lymphocytes (109-897): 1650 /mm3, notes: (unites reported/ul); CD8 lymphocytes (12.0-35.5): 75.0 %; Chest X-ray: was unremarkable, notes: and showed no radiographic evidence of any acute cardiopulmonary disease; Full blood count: relatively unremarkable; Heart rate: 120; Hepatitis B surface antibody: Non-Reactive; Hepatitis B surface antigen: Non-Reactive; Hepatitis C antibody: Non-Reactive; HIV antibody: HIV 1 Positive; HIV test: Reactive; Non-Reactive; 20,600, notes: copies/mL; Metabolic function test: relatively unremarkable; Neisseria test: Non-Reactive; Oxygen saturation: 98 %, notes: on room air; physical exam: rash on the ventral portion of right arm extending, notes: from the deltoid to his wrist. On his right anterior chest around the T2-T3 area consisted of an erythematous rash with many vesicles; Respiratory rate: 18; SARS-CoV-2 test: negative; negative; Syphilis test: Non-Reactive. Therapeutic measures were taken as a result of herpes zoster reactivation. Clinical course: A 36-year-old male presented to the emergency department with a unilateral ventral portion of right arm and right anterior chest painful rash that had been present for one week. The patient stated that after he received the second dose of the Pfizer COVID-19 vaccine in his left deltoid, he started to have a burning sensation all throughout his right upper extremity and midsternal area the next day. Two days later, the patient started developing blisters and vesicles, followed by the development of a red, maculopapular rash that was tender upon palpation, covering the patient's ventral portion of right arm, forearm, and right midsternal chest area. He attempted multiple self-remedies, such as ibuprofen, aspirin, hydrocortisone lotion, Icy-Hot topical pain reliever, calamine spray, all within the course of one week, with no success. Furthermore, the patient stated that he consumed 1.75 L of vodka daily to try and alleviate the pain, with no success. Patient could not bear the pain and decided to visit the emergency department. Vitals on admission were a temperature of 99 degree F (37.2 degree C), a blood pressure of 147/106, a pulse of 120, a respiratory rate of 18, and an SpO2 of 98% on room air. On the physical exam, the patient's rash on the ventral portion of right arm extending from the deltoid to his wrist.On his right anterior chest around the T2-T3 area consisted of an erythematous rash with many vesicles as appreciated. As per the patient, this rash was similar to the one he had developed previously on the left lower quadrant (LLQ) of his abdomen three to four years ago, when he had been diagnosed and treated for shingles. The patient otherwise was awake, alert and oriented to time, place and person but was very anxious and was tremulous when asked to stretch out his arms. The remainder of the physical exam was non-contributory. He also denied experiencing any headaches, blurry vision, chest pain, dyspnea, palpitations, abdominal pain, nausea, vomiting, diarrhea, constipation, urinary changes or weakness in his extremities. Patient had also denied any jerking motion, tongue biting, loss of consciousness, or urinary or bowel incontinence. Upon further questioning, the patient stated that he currently has HIV which was diagnosed in seven years prior, but was never compliant with his antiretrovirals. Laboratory results (complete blood count and comprehensive metabolic panel) on presentation were relatively unremarkable. Mild elevation in AST 45 U/L (10-36 U/L) and ALT 54 U/L (9-46 U/L), respectively. SARS-COV-2 PCR and antigen tests were negative. A chest X-ray was done on admission which was unremarkable and showed no radiographic evidence of any acute cardiopulmonary disease. The diagnosis of VZV reactivation during this event was made clinically based on the characteristics of the rash, the patient's typical signs and symptoms, the context of being immunosuppressed in view of his untreated HIV and his history of a previous VZV episode. The patient was admitted to the intensive care unit (ICU) in view of his potential to withdraw from alcohol and was started on acyclovir for the VZV and cefazolin to cover for a possible superimposed cellulitis following the recommendations of the Infectious Disease team. He was also started on gabapentin, which over the next 48 hours led to improvement in the patient's neuropathic pain. The next day, the patient was started on Biktarvy (bictegravir/emtricitabine/tenofovir) and was counseled on the importance of compliance with his HIV medications. He remained in the hospital for 5 days until his rash and neurologic pain had improved. On discharge, the long-term plan discussed with the patient was to refer him to our outpatient HIV clinic once his pain and rash had improved and he was no longer transmissible. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on limited information in the case provided and considering temporal association, there is reasonable possibility of causal association between the event HERPES ZOSTER REACTIVATION and the suspect drug COMIRNATY. 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.
Medical History/Concurrent Conditions: HIV positive (never compliant with his antiretrovirals); Immunocompromised (weak immune system); Rash (on the left lower quadrant (LLQ) of his abdomen); Shingles (rash developed previously on the left lower quadrant (LLQ) of his abdomen three to four years ago)
Test Name: ALT; Result Unstructured Data: Test Result:54 IU/l; Test Name: AST; Result Unstructured Data: Test Result:45 IU/l; Test Name: blood pressure; Result Unstructured Data: Test Result:147/106; Test Name: temperature; Test Result: 99 {DF}; Comments: 37.2°C; Test Name: % CD3 Positive Lymphocytes; Test Result: 83.9 %; Test Name: Absolute CD3; Result Unstructured Data: Test Result:1846 /mm3; Comments: reported units (/ul); Test Name: % CD4 Positive Lymphocytes; Test Result: 7.2 %; Test Name: Absolute CD4 Helper; Result Unstructured Data: Test Result:158 /mm3; Comments: units reported (/ul); Test Name: CD4 count; Result Unstructured Data: Test Result:158; Test Name: CD4/CD8 Ratio; Result Unstructured Data: Test Result:0.10; Test Name: Absolute CD8 Suppressor; Result Unstructured Data: Test Result:1650 /mm3; Comments: (unites reported/ul); Test Name: CD8 Positive Lymphocytes; Test Result: 75.0 %; Test Name: chest X-ray; Result Unstructured Data: Test Result:was unremarkable; Comments: and showed no radiographic evidence of any acute cardiopulmonary disease.; Test Name: complete blood count; Result Unstructured Data: Test Result:relatively unremarkable; Test Name: pulse; Result Unstructured Data: Test Result:120; Test Name: Hep B surface Ab; Result Unstructured Data: Test Result:Non-Reactive; Test Name: Hep B surface Ag; Result Unstructured Data: Test Result:Non-Reactive; Test Name: Hep C Ab; Result Unstructured Data: Test Result:Non-Reactive; Test Name: HIV Ab Interpretation; Result Unstructured Data: Test Result:HIV 1 Positive; Test Name: HIV 1 Ab; Result Unstructured Data: Test Result:Reactive; Test Name: HIV 2Ab; Result Unstructured Data: Test Result:Non-Reactive; Test Name: HIV-1 RNA via PCR; Result Unstructured Data: Test Result:20,600; Comments: copies/mL; Test Name: comprehensive metabolic panel; Result Unstructured Data: Test Result:relatively unremarkable; Test Name: Neisseria Gonorrhoeae; Result Unstructured Data: Test Result:Non-Reactive; Test Name: SpO2; Test Result: 98 %; Comments: on room air; Test Name: physical exam; Result Unstructured Data: Test Result:rash on the ventral portion of right arm extending; Comments: from the deltoid to his wrist. On his right anterior chest around the T2-T3 area consisted of an erythematous rash with many vesicles.; Test Name: respiratory rate; Result Unstructured Data: Test Result:18; Test Name: SARS-COV-2 PCR; Test Result: Negative ; Test Name: SARS-COV-2/antigen; Test Result: Negative ; Test Name: RPR / Syphilis; Result Unstructured Data: Test Result:Non-Reactive