Received May 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
HPV infection; Influenza A virus subtype H1N1 test positive; Sinusitis; Viral diarrhea; This non-serious case was reported by a consumer and described the occurrence of viral diarrhea in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included human papilloma virus infection (HPV reappeared after being cleared for 2 years on most recent pap. (Viral diarrhea)). Previously administered products included Flu vaccine (patient was vaccinated for both flu and covid in the autumn.) and COVID (patient was vaccinated for both flu and covid in the autumn.). On 01-OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 15-OCT-2024, 14 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced viral diarrhea (Verbatim: Viral diarrhea). On 03-DEC-2024, the patient experienced sinusitis (Verbatim: Sinusitis). On 30-JAN-2025, the patient experienced influenza a virus subtype h1n1 test positive (Verbatim: Influenza A virus subtype H1N1 test positive). On 14-FEB-2025, the patient experienced hpv infection (Verbatim: HPV infection). On 30-NOV-2024, the outcome of the viral diarrhea was resolved with sequelae (duration 1 month 15 days). On 08-FEB-2025, the outcome of the influenza a virus subtype h1n1 test positive was resolved (duration 9 days). On 29-MAR-2025, the outcome of the sinusitis was resolved with sequelae (duration 3 months 26 days). The outcome of the hpv infection was not resolved. It was unknown if the reporter considered the viral diarrhea, sinusitis, hpv infection and influenza a virus subtype h1n1 test positive to be related to Shingrix and Shingrix. It was unknown if the company considered the viral diarrhea, sinusitis, hpv infection and influenza a virus subtype h1n1 test positive to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 28-APR-2025 Patient was vaccinated for both Flu and Covid in the autumn. Patient have never had the flu before but was sick in January. Patient shared a room or bed with an immunocompromised person and they did not get sick. Sinusitis had to be treated by ENT and was ongoing after repeated antibiotics and steroids (systemic and local). At the time of reporting patient was on steroid nasal rinse. HPV reappeared after being cleared for 2 years on most recent pap. (Viral diarrhea).
Medical History/Concurrent Conditions: Human papilloma virus infection (HPV reappeared after being cleared for 2 years on most recent pap. (Viral diarrhea))
Test Name: virus subtype H1N1 test; Result Unstructured Data: (Test Result:Positive,Unit:unknown,Normal Low:,Normal High:)