Menveo 1 vial was administered to a patient over 55years of age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 67-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 7gf79, expiry date 31-DEC-2025) for prophylaxis. On 15-NOV-2024, the patient received Menveo. On 15-NOV-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo 1 vial was administered to a patient over 55years of age). The outcome of the inappropriate age at vaccine administration was unknown. Additional Information: GSK Receipt Date: 10-JAN-2025 The pharmacist called reporting Menveo 1 vial was administered to a patient over 55 years of age. The patient received it because she was going to be starting on a complement inhibitor. The pharmacist did not know if patient started treatment with this medication as she was waiting on the vaccines.

6 month old patient received an adult dose of Havrix; 6 month old patient received an adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old male patient who received HAV (Havrix) (batch number Z27PB, expiry date 27-AUG-2026) for prophylaxis. On 27-DEC-2024, the patient received Havrix. On 27-DEC-2024, an unknown time after receiving Havrix, the patient experienced overdose (Verbatim: 6 month old patient received an adult dose of Havrix) and adult product administered to child (Verbatim: 6 month old patient received an adult dose of Havrix). The outcome of the overdose and adult product administered to child were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-JAN-2025 The nurse reported a 6 month old patient received an adult dose of Havrix which led to adult product administered to child and overdose. The vaccine administration facility was the same as primary reporter.

Bump where the injection was given; Swollen arm; Very painful arm, arm is a little sore; Spinning; Dizziness/when she would lie down and close her eyes, the dizziness did not stop; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax (received Zostavax on an unknown date ). Concurrent medical conditions included herpes zoster. On 21-DEC-2024, the patient received the 1st dose of Shingrix (right arm). In DEC-2024, less than 2 weeks after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Bump where the injection was given), swelling arm (Verbatim: Swollen arm), pain in arm (Verbatim: Very painful arm, arm is a little sore), spinning sensation (Verbatim: Spinning) and dizziness (Verbatim: Dizziness/when she would lie down and close her eyes, the dizziness did not stop). The outcome of the injection site swelling, swelling arm and pain in arm were not resolved and the outcome of the spinning sensation and dizziness were resolved. It was unknown if the reporter considered the injection site swelling, swelling arm, pain in arm, spinning sensation and dizziness to be related to Shingrix. It was unknown if the company considered the injection site swelling, swelling arm, pain in arm, spinning sensation and dizziness to be related to Shingrix. Additional Information: GSK receipt date: 30-DEC-2024 The patient received the first dose of Shingrix and experienced a very painful arm, swollen arm, and a bump where the injection was given. On this day, the patient stated the arm was a little sore, a little swollen, and a little bump where the injection was given. About 3 to 4 days after the vaccine was given, that patient experienced dizziness, and spinning, night time was worse. Even when she would lie down and close her eyes, the dizziness does not stop and the dizziness had since resolved.

received the first dose of Shingrix 2 years ago/ Can she get the second dose now; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 2 years ago on an unknown date). On an unknown date, the did not patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix 2 years ago/ Can she get the second dose now). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 27-DEC-2024 The pharmacist called to ask if a patient could get the second dose of Shingrix, if the first dose was 2 years ago. The reporter wanted to know did patient needs to repeat the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.

Only dministered the shingrix vaccine as solution with no powder; Only dministered the shingrix vaccine as solution with no powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only dministered the shingrix vaccine as solution with no powder) and inappropriate dose of vaccine administered (Verbatim: Only dministered the shingrix vaccine as solution with no powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 27-DEC-2024 The reporter had visited with the patient and went to administer the Shingrix but only administered the solution with no powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter said that it was a general question as however when asking if a patient was administered and she was defensive when asking for safety data. No further data was collected.

Had a shingrix 2019 and last in 2024.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Had a shingrix 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Had a shingrix 2019 and last in 2024.). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 07-JAN-2025 The reporter had a Shingrix 2019 and last in 2024. The reporter asked does he/she still need a third shot. The patient received second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule.

dose of expired Engerix-B was administered to the pateint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (expiry date 01-AUG-2024) for prophylaxis. On 26-DEC-2024, the patient received Engerix B. On 26-DEC-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: dose of expired Engerix-B was administered to the pateint). The outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt Date: 30-DEC-2024 The manager of an urgent care reported that a dose of Engerix-B was expired, and a medical assistant administered it to a patient which led to, expired vaccine used.

very painful; sores; prone to infection; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES; Rash vesicular/Blistery rash; rash; WOUND; This non-serious case was reported by a consumer via regulatory authority and described the occurrence of loss of personal independence in daily activities in a 33-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) for prophylaxis. Co-suspect products included COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) for prophylaxis. The patient’s past medical history included generalized anxiety disorder, post-traumatic stress disorder, post-acute covid-19 syndrome and major depressive disorder. Concurrent medical conditions included drug allergy (allergy to cehlore, gabapentin, propanalol). Concomitant products included bupropion, lamotrigine (Lamictal), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall) and formoterol fumarate, mometasone furoate (Dulera). On 22-OCT-2024, the patient received the 1st dose of FluLaval Quadrivalent 2024-2025 season (intramuscular) and the 1st dose of Novavax COVID-19 Vaccine (intramuscular). On 02-NOV-2024, 11 days after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced loss of personal independence in daily activities (Verbatim: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES), vesicular rash (Verbatim: Rash vesicular/Blistery rash), rash (Verbatim: rash) and wound (Verbatim: WOUND). On an unknown date, the patient experienced pain (Verbatim: very painful), skin ulcer (Verbatim: sores) and infection (Verbatim: prone to infection). The outcome of the loss of personal independence in daily activities, vesicular rash, rash and wound were not resolved and the outcome of the pain, skin ulcer and infection were not reported. It was unknown if the reporter considered the loss of personal independence in daily activities, vesicular rash, rash, wound, pain, skin ulcer and infection to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device. It was unknown if the company considered the loss of personal independence in daily activities, vesicular rash, rash, wound, pain, skin ulcer and infection to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 26-DEC-2024 The patient experienced loss of personal independence in daily activities, rash, rash vesicular and wound after receiving Flulaval and Novavax COVID-19 Vaccine, Adjuvanted (2024 – 2025 Formula) on 12 Day. Experienced blistering rash that spread throughout right armpit and left open sores on torso, in armpit and up the inside of right bicept. The sores were very painful, prone to infection and significantly adversely impacted ability to function normally. The causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 – 2025 Formula) and events loss of personal independence in daily activities, rash, rash vesicular and wound was considered possible.

Autonomic injuries; autoimmune injury/Gardasil-induced autoimmune disorder; fibromyalgia/fatigue, joint pain, neck stiffness, neck pain, brain fog, shortness of breath, headaches; exacerbation of pre-existing anxiety; exacerbation of pre-existing depression; idiopathic hypersomnia/neurological injuries; falling asleep while driving, falling asleep while talking; excessive daytime sleepiness; joint inflammation/decreased range of motion; Information has been received from a lawyer, regarding a case in litigation and concerning an adult female patient (pt). Prior to receiving quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt was able to work longer hours, go to school, and stay engaged in family and social relationships. No other information concerning the pt’s medical history, concurrent conditions or concomitant medications was provided. On 09-SEP-2019, at the age of 26 years old, the pt received her first dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On 25-OCT-2019, the pt received her second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On unspecified dates, after receiving the first and second vaccinations, the pt began experiencing fatigue, falling asleep while driving, falling asleep while talking, excessive daytime sleepiness, and exacerbation of pre-existing anxiety. On 12-JUN-2020, the pt received her third dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On unspecified dates, after receiving the third vaccination, the pt’s symptoms worsened and she began experiencing joint pain, joint inflammation, neck stiffness, neck pain, decreased range of motion, brain fog, shortness of breath, exacerbation of pre-existing depression and headaches, and exacerbation of fatigue, falling asleep while driving, falling asleep while talking, and excessive daytime sleepiness. As a result of her post-quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been unable to engage in activities that a normal young person would enjoy. Her fatigue and sleep issues overwhelm her life. She falls asleep at work and even while driving. Her joint pain makes it difficult to complete daily personal and professional responsibilities. On unknown dates, based upon her chronic and severe post-quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been diagnosed with various medical conditions, including but not limited to, idiopathic hypersomnia and fibromyalgia. The pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop and exacerbate serious and debilitating autoimmune, autonomic, and neurological injuries and resulting sequelae, including but not limited to idiopathic hypersomnia and fibromyalgia, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. The pt has suffered at the time of report and continued to suffer severe and permanent physical injuries and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. She also has a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt had suffered and at the time of report continued 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 of autonomic neuropathy, autoimmune disorder, idiopathic hypersomnia, fibromyalgia, exacerbation of anxiety, arthritis and depression aggravated was considered to be not recovered. The lawyer considered the events of autonomic neuropathy, autoimmune disorder, idiopathic hypersomnia, fibromyalgia, exacerbation of anxiety, arthritis and depression aggravated to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). Upon internal review, the events of autonomic neuropathy and autoimmune disorder was determined to be medically significant. The events of autonomic neuropathy, autoimmune disorder, idiopathic hypersomnia, fibromyalgia, exacerbation of anxiety, arthritis and depression aggravated was considered to be disabling.

No additional AE; an infant received their first dose of ROTATEQ at 19 weeks of age instead of the recommended 6-12 weeks; This spontaneous report was received from a nurse and refers to a 19-week-old (also reported as 5-month-old) patient of unknown gender. The patient’s medical history was not reported. The patient’s concurrent conditions were not reported. Concomitant therapies were not reported. On 19-DEC-2024, at 19 weeks of age instead of the recommended 6-12 weeks as outlined in the prescribing information, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml / series, administered orally for prophylaxis (lot #2032353, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 21-OCT-2025; strength was not provided) (Inappropriate schedule of product administration). No symptomatic events were reported. No additional information was provided. There was no additional adverse event (AE) or product quality complaint (PQC) reported.