My doctor has prescribed me the Gardasil vaccine, however, I am outside of the normal recommended age to receive it. She has seen a great benefit to older women with my condition who have gotten Gardasil.; inability to afford medication; No additional AE; This spontaneous report was received from a consumer regarding herself, a female patient of unspecified age (reported as outside of the normal recommended age to receive Quadrivalent Human Papillomavirus [Types 6,11,16,18] Recomb. Vaccine [GARDASIL]). The patient’s medical history, historical drugs, known drug allergies, and concomitant therapies were not reported. Her concurrent conditions included an unspecified condition. On an unknown date, the physician prescribed her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, outside of the normal recommended age to receive this vaccine, as she had seen a great benefit to older women with her condition who have gotten it (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided) (Off label use). The physician was willing to give it her at her office, but her insurance would not pay for it. Local pharmacies won’t even give her the vaccine. She had been told it was well over $500 dollars for each vaccine and there were three of them. That was very costly for her at this time. She had checked out the company’s patient assistance programs but her income was over the limits. So she asked if there was anything the company could do to provide some assistance to lower the cost of the vaccine for her, as she would have to decide to not to get the vaccines if she was unable to receive some assistance, stating it was very troubling when decisions about her health had to come down to price (Inability to afford medication). No additional events were reported. Lot # is being requested and will be submitted if received.

I was diagnosed with a rare autoimmune disease anti gbm good pasture now a proven side effect of covid vaccine. There are other proven cases. I have end stage renal disease and am on dialysis.

patient had their pre-exposure in 1999 but the patient only had 1 dose with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who had her pre-exposure in 1999 but the patient only had 1 dose of rabies (HDC) vaccine [Imovax Rabies] with no reported adverse event . The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient had their pre-exposure in 1999 but the patient only had 1 dose with an unknown dose of rabies (HDC) vaccine Powder and solvent for suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization with no reported adverse event (routine immunisation schedule incomplete) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, patient received the vaccine from a different brand which the she could not remember. Patient told the specialist that her titers dropped and she would need a booster so she was asking on the number of shots that she should receive for the booster dose of Rabavert This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder’s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

administered only the lyophilized hib component of pentacel and used sterile water to dilute it with no reported adverse event; Initial information received on 23-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age / gender patient who was administered only the lyophilized HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and used sterile water to dilute it with no reported adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Jan-2025, the patient received an unknown dose of lyophilized HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site and used sterile water to dilute it with no reported adverse event (single component of a two-component product administered) (latency- same day). Reportedly, they wanted to know if the HIB dose counted as a dose. They had a follow up question with what they should do about the DTaP-IPV component. Information on the batch number was requested corresponding to the one at time of event occurrence. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder’s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Suspected vaccination failure; it burns /sick/ frequent outbreaks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: it burns /sick/ frequent outbreaks). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that it burned and reported not to get fooled by the vaccine. Both injections made patient sick as a dog and the patient had more frequent outbreaks. This case was considered as suspected vaccination failure as details regarding 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.

his dermatologist recommended he get the vaccine because he is experiencing warts in his hands/pharmacist refused to administer the vaccine to him because he was over the age of indicated use; No additional AE; This spontaneous report was received from a consumer and refers to a male patient over 50 years of age. The patient’s medical history was not reported. The patient’s concurrent conditions were not reported. Concomitant therapies were not reported. Patient report that his dermatologist recommended, he get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection because he was experiencing warts in his hands. He was scheduled to receive the first dose of vaccine on 16-JAN-2025 (also reported as today) but the pharmacist refused to administer the vaccine to him because he was over the age of indicated use and the pharmacist was worried, she would be audited, even though his insurance agreed to pay for it ((Product prescribing issue). No additional adverse events were reported. Additional information is not expected. This is one of two reports from the same reporter.; Sender’s Comments: US-009507513-2501USA004808: US-009507513-2501USA004808:

Pain in arm (Left) Limited motion in left arm – patient states she can’t lift arm above shoulder

after HPV vaccine administration, patient had syncope episode. Patient had LOC for about a minute, fell on floor and hit head. Patient regained consciousness. Vital signs monitored, blood sugar taken. Patient taken to ER, observed, EKG done. Patient had a follow up appointment the next day at the clinic patient reported feeling well, ambulating normal, and pain.

I’m filling this out the same day of the shot. Within two minutes of the shot, I notices prickly feelings in my left arm, hand, and fingers. I sat in my car for about 20 minutes after the shot. When I was driving away from the pharamcy, within the first hour of the shot, I felt two arrhythmia feelings: one at about 1/4 mile from the pharmacy where I got the shot, and one a bit further as I was entering the grocery parking lot (named for timing/distance from the pharmacy). It’s within 8 hours of receiving the shot, and I’m feeling prickly, needle-like feelings still in my left arm in various places, including under my arm, as well. I’m also feeling the prickly and numb sensations on both sides of my neck, on my ears, as well as my temples, up to the top of my head where I also have a headache sensation. It seems the prickly feeling is spreading to more than my arm and hand throughout the day.

1 day after vaccine developed pruritic hives on his chest and arms. Seen in clinic the next day and hives were covering 90% of his arms, chest, back, buttocks and thighs.