sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR010378 Additional Information: GSK Receipt Date: 11-JAN-2025 This case was reported by a patient via interactive digital media. Patient got two of the shots and they both made him/her sick. For tolerance of the 2nd dose, refer linked case US2025AMR010378, reported by the same reporter.; Sender’s Comments: US-GSK-US2025AMR010378:same patient

Suspected vaccination failure; DID NOT ELIMINATE SHINGLES, IN FACT MOVED TO OTHER SIDE OF MY BODY; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: DID NOT ELIMINATE SHINGLES, IN FACT MOVED TO OTHER SIDE OF MY BODY). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 18-JAN-2025 The reporter reported that the patient received the 2 shots of Shingrix vaccine and experienced the Shingles. Shingles did not eliminate in fact they moved to other side of body. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender’s Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1 and Shingrix dose 2.

General malaise; This non-serious case was reported by a consumer via sales rep and described the occurrence of general malaise in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 11-JAN-2025, the patient received the 1st dose of Shingrix (left arm). On 12-JAN-2025, 1 days after receiving Shingrix, the patient experienced general malaise (Verbatim: General malaise). On 13-JAN-2025, the outcome of the general malaise was resolved (duration 1 day). The reporter considered the general malaise to be related to Shingrix. The company considered the general malaise to be related to Shingrix. Additional Information: GSK Receipt Date: 15-JAN-2025 The reporter reported that the patient received receive first dose of Shingrix. The patient had general malaise.

after 3 vaccines I still get outbreaks on my lower back / suspected vaccination failure; outbreaks on my lower back; extra dose administered; This serious case was reported by a other health professional and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. The patient’s past medical history included hip replacement (The patient underwent hip replacement surgery 5 years ago.). Concomitant products included valaciclovir (Valacyclovir). On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: after 3 vaccines I still get outbreaks on my lower back / suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: outbreaks on my lower back) and extra dose administered (Verbatim: extra dose administered). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 14-JAN-2025 The drug dosage for Shingles was reported as 30mg. It was reported that after the patient had a hip replacement 5 years ago and after 3 vaccines, the patient still got outbreaks on her lower back (exhaustion), which led to extra dose administered. The outcome for exhaustion was reported as resolved with sequelae. The symptoms were treated. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding herpes zoster were unknown at the time of reporting.; Sender’s Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1, 2 & 3).

No additional AE; PROQUAD was administered during a temperature excursion on 1/23/2025.; This spontaneous report was received from a medical assistant, concerning to a patient of unknown age and gender. The patient’s medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection experienced a temperature excursion (TE), for unknown time at unknown temperature. No previous TE reported. On 23-JAN-2025, the patient was vaccinated with the first dose of the vaccine involved in the TE measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, and route of administration were not provided; lot #Y013583 has been verified to be valid for this vaccine, expiration date reported and confirmed as 03-FEB-2026). (Product use issue). No additional adverse event was reported (No adverse event).

No adverse event; HCP calling to report T/E. HCP stated PROQUAD (s) are not back in range. PROQUAD was administered during a temperature excursion on 1/23/2025. No additional AE reported. NO PQC reported. Was the product administered? YES, PROQUAD Y013583 2/03/2; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient’s medical history, concurrent conditions and concomitant therapies were not provided. On 23-JAN-2025, the patient was vaccinated with the first, improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # Y013583 has been verified to be a valid lot number, expiration date was not provided, but upon internal validation was established as 03-FEB-2026 (exact dose, route of administration and anatomical location were nor provided) for prophylaxis. On 23-JAN-2025, administered dose of vaccine was exposed to the temperature excursion (product storage error). No more information available. No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).

No additional adverse event was reported; the needle and it instead came off the syringe and caused a needle stick in the staff members left hand.; CALLER CONFIRMED JUST THE NEEDLE CAME OFF, NO PART OF THE SYRINGE CAME OFF/ needle pooped off; Was the product administered or exposed to patient’s bodily fluids (i.e. biohazardous)? YES; Was the product administered or exposed to patient’s bodily fluids (i.e. biohazardous)? YES; device connection issue; Poor quality device used; This spontaneous report was received from registered nurse and refers to a 30-year-old female. The patient’s medical history was not reported. The patient’s concurrent conditions were not reported. Concomitant therapies were not reported. On 21-JAN-2025, the patient was vaccinated with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, unk, lot #1973259, expiration date: 03-MAR-2026 (strength, route of administration, and indication were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #X026222, expiration date: 06-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided). The reporter stated that the needle popped off a diluent syringe after it was used to administered a vaccine. The problem occurred when the staff member tried to engage the safety on the needle and it instead came off the syringe and caused a needle stick in the staff member left hand (Injury associated with device, needle issue, device connection issue and poor quality device used). The product was administered to the patients body fluids (Occupational exposure to product and accidental exposure to product). No additional adverse event was reported.

patient continued to experience swelling as the weeks went by. Her entire body was hurting due to swelling, especially in her hands, fingers, and ankles. Physician prescribed steroids, but she continued to experience pain for months; histoplasmosis; feeding tube placed; full hysterectomy; endometriosis/Abdominal pain; clots removed from her legs; lumps removed from her throat; had lost significant weight; difficulty swallowing; patient’s palms began to swell. Within 12 hours, patient’s tongue was enlarged and she could no longer swallow. Her husband took her to the emergency room for an allergic reaction to the vaccine; Patient was 35 years old when she received her first dosage of Gardasil; This initial spontaneous report was received from a lawyer on 24-JAN-2025 regarding a case in litigation and refers to a female patient (pt) of 35 years old. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 15-DEC-2020, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), intramuscular Injection route of administration, lot number and expiration date were not reported) for preventing cervical cancer (Product administered to patient of inappropriate age). The second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), intramuscular Injection route of administration, lot number and expiration date were not reported) for preventing cervical cancer was administered on 28-JAN-2021. It was reported that on 28-JAN-2021 within two hours of receiving the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)vaccine, pt.’s palms began to swell. Within 12 hours, pt.’s tongue was enlarged and she could no longer swallow. Her husband took her to the emergency room for an allergic reaction to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)vaccine (Allergy to vaccine). Pt. was given intravenous medication to reduce the swelling and was eventually discharged with an emergency EpiPen. Pt. continued to experience swelling as the weeks went by. Her entire body was hurting due to swelling, especially in her hands, fingers, and ankles. Physician prescribed steroids, but she continued to experience pain for months. Pt. was eventually diagnosed with autoimmune Lupus (Systemic lupus erythematosus). She had also been diagnosed with histoplasmosis, endometriosis, and had had a full hysterectomy. She continued to experience severe daily pain and fatigue. She has had clots removed from her legs several times (Thrombectomy), as well as lumps removed from her throat (Mass excision). She experienced abdominal pain and difficulty swallowing (Dysphagia) and had lost significant weight (Weight decreased). She had had a feeding tube placed (Gastrointestinal tube insertion) and must use it to take her daily medications. Before Vaccination, pt. was very active outdoors. She jogged every morning and was always at their children’s school functions. She would go swimming and work out at her local GYM. She enjoyed having fun with her family. They would take trips to theme parks. Since the Gardasil vaccine, Pt’s life had changed from a normal, healthy, active person to barely being able to get out of bed to go to the bathroom. She had a long-term goal of starting her own restaurant, but that has changed due to her health. She could no longer participate in her children’s school functions, go on trips, or do fun things with her family. As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)-induced injuries, patient had suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of the events was reported as not recovered. Causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was related. Upon internal review the events of Systemic lupus erythematosus, Histoplasmosis, Gastrointestinal tube insertion, hysterectomy, allergy to vaccine treated with given intravenous medication to reduce the swelling and was eventually discharged with an emergency EpiPen were considered medically significant. The events were considered disabling by the reporter.

tested positive for flu; received their second dose of GARDASIL 9 dose 3 weeks after their first dose, instead of the four weeks minimal interval; This spontaneous report has been received from a nurse practitioner regarding a 23-year-old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On an unspecified date, the patient received their second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, dose, scheme, route of administration, anatomical site, lot number and expiration date not reported) 3 weeks after their first dose, instead of the four weeks minimal interval (Inappropriate schedule of vaccine administered). On an unknown date (also reported as today), the caller stated that the patient tested positive for flu (Influenza virus test positive). The outcome of the events was unknown. The causal relationship between the suspect vaccine and the events was unknown.

The HCP stated the patient did no experience any adverse issues or side effects from the administered dose of PROQUAD; A HCP called to inquire about the viability of an expired dose of PROQUAD (X018814 01/07/2025) that was administered to a patient on 01/24/2025.; The HCP was unsure if the PROQUAD had ever undergone a temperature excursion (TE).; This spontaneous report was received from a nurse and refers to a 4-year-old patient of an unknown gender. The patient’s pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 24-JAN-2025, the patient was vaccinated with an expired and potentially improper storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live ([rHA recombinant human albumin]) (PROQUAD) injection, lot #X018814; which has been verified to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date: 07-JAN-2025, administered for prophylaxis (strength, vaccination schedule, exact quantity volume, route and anatomical site of administration were not provided) (Expired product administered; Product storage error). The reporter inquired about the viability of this expired dose. In addition, she stated she was not sure if it had ever undergone a temperature excursion (TE) and could not provide more information related to it. The patient did not experience any adverse issues or side effects (no adverse event).