patient was given expired dose of vaccine with no reported adverse event; Initial information received on 16-Jan-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an unknown age and unknown gender patient who was given expired dose of HIB (PRP/T) Vaccine [ACT-HIB] vaccine with no reported adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Jan-2025, the patient received an expired dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot- uk007ab and expiry- 01-Dec-2024) via unknown route in unknown administration site for immunization (dose, strength: not provided) with no reported adverse event (expired product administered) (latency- same day). 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.

they have an opened vial that has been left outside for 12 hours , with no reported adverse event; Initial information received on 16-Jan-2025 regarding an unsolicited non-valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient and reporter stated that they have an opened IPV (VERO) [IPOL] vial that has been left outside for 12 hours, with no reported adverse event. The patient’s past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the suspect opened IPV (VERO) Suspension for injection (Unknown strength, lot and expiry date) for immunisation, vial that has been left outside for 12 hours, with no reported adverse event (product storage error). Pharmacist called to ask regarding multidose vials of IPOL. They wanted to know what the expiration date was for punctured vials. They said that they have an opened vial that has been left outside for 12 hours that they were going to dispose of anyway and wanted the information for reference. Pharmacist declined to report about the aforementioned IPOL. They were asking because they could not agree with their partner if they should be disposing these vials by the expiration date or after 28 days. 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.

bumps; can not sleep at night; pain from shoulder to hand on same side as FLUZONE HD injection site; Initial information received on 15-Jan-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 91 years old female patient who experienced bumps, can not sleep at night and pain from shoulder to hand on same side after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD]. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Jul-2024, the patient received a unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (expiry date: 30-Jun-2025 and lot U8527AA) via unknown route in unknown administration site as immunization. On an unknown date in 2024 the patient developed bumps (swelling), can not sleep at night (sleep disorder) and pain from shoulder to hand on same side as fluzone hd injection site (pain in extremity) (latency: few days approximately). Action taken: not applicable. It was not reported if the patient received a corrective treatment for all events. At time of reporting, the outcome was Unknown for all events.

administration of only the liquid DTAP-IPV portion of PENTACEL, the dose administered did not include the ACTHIB portion with no reported adverse event; Initial information received on 14-Jan-2025 regarding an unsolicited non-valid non-serious case received from a other health professional. This case involves, the unknown age and gender patient who was administration of only the liquid DTAP-IPV portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel], the dose administered did not include the ACT HIB portion with no reported adverse. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient administration of only the liquid DTAP-IPV portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (lot UK043AA, expiry date: 31-Aug-2025), the dose administered did not include the ACT HIB portion with no reported adverse event (single component of a two-component product administered) (unknown latency). Reportedly, Caller did not have specific details or patient specific information available at the time of the call. No other details were available in regards to this situation. 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.

This situation is pre-assessed as a medication error/an inappropriate use due to ACT-HIB was reconstituted with sterile water. with no reported adverse event; Initial information received on 15-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves, this situation is pre-assessed as a medication error/an inappropriate use due to a 1 year old female patient received HIB (PRP/T) Vaccine [ACT-HIB] that was reconstituted with sterile water with no reported adverse event. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP); RSV Vaccine and Pneumococcal Vaccine CONJ for Immunization. On 09-Jan-2025, this situation is pre-assessed as a medication error/an inappropriate use due to the patient received 0.25 ml to 2 ml (once) dose of suspect (standard) HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UJ992AA, expiry date: 28-Feb-2025) (unknown strength) via intramuscular route in left thigh for Immunization that was reconstituted with sterile water with no reported adverse event (product preparation error) (latency-same day). Reportedly, Medical assistant reported that she used sterile water instead. She asks if the dose is still valid or do they need to re-administer the dose. 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.

rash at the injection site/it is red and it is warm; rash at the injection site/it is red and it is warm; rash at the injection site/it is red and it is warm; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jan2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset Jan2025, outcome “unknown” and all described as “rash at the injection site/it is red and it is warm”. Additional information: The patient was calling “today” (17Jan2025) about the Prevnar 20 vaccine and she stated she had this shot exactly one week ago “today” (Jan2025). she had a rash at the injection site, it was red and it was warm but it did not hurt or anything and she just wanted to call to find out if the rash was normal. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.

Has to put on the adapter and, putting liquid syringe to connect it, luer lock broke as she was twisting it.; This is a spontaneous report received from a Pharmacist, Program ID. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: Sep2025) for immunisation, Device Lot Number: HM8389; H764, Device Expiration Date: Sep2025. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), described as “Has to put on the adapter and, putting liquid syringe to connect it, luer lock broke as she was twisting it.”. Additional information: Expiry date of Abrysvo Vial Adapter is 01Jun2028 (for lot H764). NDC number of Abrysvo Carton: 0069-0344-01. NDC number of Abrysvo Antigen Powder Vial: 00690207-01. NDC number of Abrysvo Diluent Syringe: 0069-0250-01.

fatigue; fever; This is a spontaneous report received from a Pharmacist. An 89-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14Jan2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient’s relevant medical history included: “Restless leg syndrome” (unspecified if ongoing); “depression” (unspecified if ongoing); “type 2 diabetes” (unspecified if ongoing); “hypertension” (unspecified if ongoing); “CHF” (unspecified if ongoing); “CAD” (unspecified if ongoing); “hypercholesterolemia” (unspecified if ongoing); “obesity” (unspecified if ongoing); “hypothyroidism” (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; ASCORBIC ACID; ASPIRIN (E.C.); CETIRIZINE; VIT D3; DULOXETINE; FUROSEMIDE; LACTOBACILLUS ACIDOPHILUS; LEVOTHYROXINE; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; OLOPATADINE; OMEGA 3 FISH OIL [FISH OIL]; OMEPRAZOLE; POLYETHYLENE GLYCOL COMPOUND; KCL oral; ROPINIROLE; ROSUVASTATIN; TROSPIUM. Past drug history included: No, reaction(s): “Hypersensitivity”. The following information was reported: FATIGUE (non-serious) with onset 15Jan2025, outcome “recovered” (15Jan2025); PYREXIA (non-serious) with onset 15Jan2025, outcome “recovered” (15Jan2025), described as “fever”. Therapeutic measures were taken as a result of fatigue, pyrexia. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.

Hashimoto’s thyroiditis; her memory recall has not been good since the HPV vaccine; Psoriasis; health issues; Patient was not able to confirm if the vaccine she received was the GARDASIL or GARDASIL 9; This spontaneous report was received from a female patient of unknown age concerning herself. Patient did not have pertinent medical history or concurrent conditions. Concomitant medications included vitamin C. On an unknown date (also reported as a while ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (reported as HPV vaccine) route of administration reported as injection, for prevention (strength, dose, frequency, anatomical location, lot number and expiration date were not provided) (product origin unknown). On an unknown date, the patient’s memory recall and was not good since HPV vaccination. After the vaccination the patient experienced psoriasis and Hashimoto’s thyroiditis. She went to a natural doctor and was being treated with some of the treatment that involved circulation with vitamin C and an unknown product. The patient mentioned that her life crippled and cannot advance in her career due to her health issues. At the time of this report, the patient had not recovered from the events. The causal relationship between the vaccine and the events was not provided. Upon internal review, Hashimoto’s thyroiditis was determined to be a medically significant event.

Red patch where vaccine was administered