| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2837732 | 79 | F | 04/24/2025 |
COVID19 FLU3 |
UNKNOWN MANUFACTURER SANOFI PASTEUR |
6024MF020 UT8454EA |
Eye swelling; Eye swelling
Eye swelling; Eye swelling
|
Eye swelling; Initial information received on 31-Mar-2025 regarding an unsolicited valid non-seriou...
Eye swelling; Initial information received on 31-Mar-2025 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 79 years old female patient who experienced eye swelling after receiving Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] and COVID-19 vaccine prot. subunit (NVX CoV 2373) [Novavax COVID-19 Vaccine]. No concomitants used/reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Dec-2024, the patient received an unknown dose (dose 1) of suspect COVID-19 vaccine prot. subunit (NVX CoV 2373), Injection not produced by Sanofi Pasteur (lot 6024MF020, strength 0.5mL; strength not reported) via intramuscular route in unknown administration site for COVID-19 immunization. On an unknown date, the patient received an unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot UT8454EA, strength 0.5mL; expiry date not reported) via intramuscular route in unknown administration site for Drug Use for Unknown Indication (Product used for unknown indication). On 13-Dec-2024, the patient developed eye swelling (latency 1 day) following the administration of COVID-19 vaccine prot. subunit (NVX CoV 2373) and (latency unknown) Influenza USP Trival A-B High Dose Subvirion Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. Sender's comment - This 79-year-old Female experienced Eye swelling after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Eye swelling was reported as non-serious.Based on the spontaneous nature of the report, the causal relationship between the vaccine and the event is considered Possible.
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| 2837733 | 0.17 | F | MT | 04/24/2025 |
HIBV |
SANOFI PASTEUR |
UK107AB |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
medication error due to administration of incorrect reconstitution of ACTHIB with no reported advers...
medication error due to administration of incorrect reconstitution of ACTHIB with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 2 months old female patient who received HIB (PRP/T) vaccine [ACT-HIB] incorrectly reconstituted 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 rotavirus vaccine, pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20) and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (pediarix), all for Immunisation. On 19-Mar-2025, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength with lot UK107AB and expiry date 30-Sep-2025 via intramuscular route in the left thigh for Immunization that was incorrectly reconstituted with no reported adverse event (product preparation error) (Latency same day) Reportedly, Reporter stated that, administered ACTHIB that was reconstituted with sterile water Action taken was not applicable. 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.
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| 2837734 | CA | 04/24/2025 |
HIBV |
SANOFI PASTEUR |
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No adverse event, Product preparation error
No adverse event, Product preparation error
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gave ACT-HIB using a separate sterile diluent with no adverse event; Initial information received on...
gave ACT-HIB using a separate sterile diluent with no adverse event; Initial information received on 28-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient to whom gave HIB (PRP/T) vaccine [ACT-HIB] using a separate sterile diluent with no 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 received an unknown dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization using a separate sterile diluent with no adverse event (Product preparation error) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, A medical assistant states that one of their medical assistants gave ACT-HIB using a separate sterile diluent, so they want to know if patient needs to be revaccinated and if there is anything that they need to look out for. Action taken was not applicable. 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.
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| 2837735 | 56 | M | IL | 04/24/2025 |
YF |
SANOFI PASTEUR |
UK125AA |
Product preparation error
Product preparation error
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inappropriate use due to being diluted with a diluent that was not supplied by the manufacturer with...
inappropriate use due to being diluted with a diluent that was not supplied by the manufacturer with no reported adverse event; Initial information received on 31-Mar-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 56 years old male patient for whom yellow fever vaccine - [YF-VAX], inappropriate use due to being diluted with a diluent that was not supplied by the manufacturer with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Mar-2025, the patient received an unknown dose (0.5ml) of suspect yellow fever vaccine; Solution for injection with unknown strength (lot UK125AA with expiry date 30-Oct-2026) via subcutaneous route in the left arm for Immunization, inappropriate use due to being diluted with a diluent that was not supplied by the manufacturer with no reported adverse event (product preparation error) (latency: same day). Action taken was not applicable. 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.
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| 2837736 | 30 | F | IL | 04/24/2025 |
TDAP |
SANOFI PASTEUR |
UA115AA |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
|
intramuscular formulation admistered by other route; administration of ADACEL to a pregnant patient ...
intramuscular formulation admistered by other route; administration of ADACEL to a pregnant patient by subcutaneous route with no reported adverse event; Initial information received on 01-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 30 years old pregnant female patient who was inappropriately administered to Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] of intramuscular formulation by subcutaneous route with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal exporsure during pregnancy occurred at 30 Weeks of pregnancy. The date of last menstrual period was not reported. The estimated due date is 10-Jun-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 31-Mar-2025, the patient received 0.5mL of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, Suspension for injection (lot UA115AA, expiry date 01-Mar-2026,strength standard and frequency once) via subcutaneous route in unknown administration site for Immunisation and inappropriate use due to the administration of adacel to a pregnant patient by subcutaneous route with no reported adverse event (incorrect route of product administration), (exposure during pregnancy). Reportedly, there was no other vaccines as concomitants involved. Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing. 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.
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| 2837737 | 0.33 | M | TX | 04/24/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK225AB |
No adverse event
No adverse event
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vaccines were administered before they could be quarantined. One Pentacel vaccine was given with no...
vaccines were administered before they could be quarantined. One Pentacel vaccine was given with no reported adverse event; Initial information received on 01-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who was administered with Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] before they could be quarantined 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 Pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and Rotavirus vaccine LIVE Reassort Oral 5V (Rotateq) for Immunisation. On 31-Mar-2025 or 01-Apr-2025, the patient received a 0.5ml dose of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection standard strength, frequency-once (lot UK225AB, expiry date-unknown) via intramuscular route in unknown administration site for Immunization and was administered before they could be quarantined no reported adverse event (poor quality product administered) (latency- same day). Reportedly- One Pentacel vaccine was given and two Prevnar vaccines were given. Action taken was not applicable. 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.
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| 2837738 | 0.33 | F | TX | 04/24/2025 |
HIBV |
SANOFI PASTEUR |
UK010AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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administration of an expired dose of ACT-HIB, with no reported adverse event; Initial information re...
administration of an expired dose of ACT-HIB, with no reported adverse event; Initial information received on 02-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who was administration with an expired dose of HIB (PRP/T) Vaccine ACT-HIB], 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) for Immunisation; and Hepatitis b vaccine (Hepatitis b) for Immunisation. On 01-Apr-2025, the patient received 0.5mL (dose 2) of suspect HIB (PRP/T) Vaccine,Powder and solvent for solution for injection (lot UK010AA, expiry date 28-Feb-2025, frequency once and strength standard) via intramuscular route in the right thigh for Immunisation and administration of an expired dose of act-hib, with no reported adverse event (expired product administered) (latency same day). Reportedly, ACT-HIB was administered to a patient but they did not noticed that the vaccine was expired. They need to see what they need to do on their side. Action taken was not applicable. 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.
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| 2837739 | 1 | F | WA | 04/24/2025 |
HIBV |
SANOFI PASTEUR |
UK0218A |
No adverse event, Product preparation error
No adverse event, Product preparation error
|
administered ACTHIB with diluent that was not provided with the ActHIB vaccine, with no reported adv...
administered ACTHIB with diluent that was not provided with the ActHIB vaccine, with no reported adverse event; Initial information received on 02-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administered HIB (PRP/T) Vaccine [ACT-HIB] with diluent that was not provided with the acthib vaccine, 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 Pneumococcal vaccine (Pneumococcal vaccine); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); Influenza vaccine (Influenza) for and Varicella zoster vaccine (Varicella vaccine) for Immunisation. On 10-Jan-2025, the patient received 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK0218A, expiry date 05-Feb-2028, frequency one and strength standard) via intramuscular route in right VL(abbreviation of VL is not reported) site for Immunisation and it was administered with diluent that was not provided with the ACTHIB vaccine, with no reported adverse event (product preparation error) (latency same day). Reportedly, Medical assistant called and stated she administered ACTHIB with diluent that was not provided with the ActHIB vaccine. She requested information for appropriate follow-up. Action taken was not applicable. 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.
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| 2837741 | 0.17 | F | 04/24/2025 |
HIBV |
SANOFI PASTEUR |
|
Expired product administered, No adverse event
Expired product administered, No adverse event
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administered an expired dose of Act-Hib vaccine to a 2-month-old baby, with no reported adverse even...
administered an expired dose of Act-Hib vaccine to a 2-month-old baby, with no reported adverse event; Initial information received on 02-Apr-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 months old female patient who received an expired dose of Hib (Prp/T) vaccine [Act-Hib] 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 in Apr-2025, the patient received an expired dose of suspect Hib (Prp/T) vaccine, Powder and solvent for solution for injection, (unknown strength), Expiry date 31-Mar-2025, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation) with no reported adverse event (Expired product administered) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence will not be available. Reportedly, medical assistant had administered an Act-Hib vaccine to a 2-month-old baby, noting that the vaccine expired in Mar-2025.She asked whether there is a grace period for using the vaccine past its expiration date. Action taken was not applicable 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.
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| 2837742 | 42 | M | WA | 04/24/2025 |
FLU3 |
SANOFI PASTEUR |
U8442BA |
No adverse event, Product storage error
No adverse event, Product storage error
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Temperature excursion/temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝC for 30 minutes with no reported adve...
Temperature excursion/temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝC for 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to US-SA-2025SA112035 This case involves a 42 years old male patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] and the vaccine was exposed to temperature excursion where max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Apr-2025, influenza USP TRIVAL A-B subvirion vaccine [Fluzone] Suspension for injection (once) (strength- standard, expiry date- 20-Jun-2025and lot U8442BA) for Influenza immunisation was exposed to temperature excursion where max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30 minutes with no reported adverse event (product storage error). On 14-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the left deltoid for immunization. Reportedly, reason: Monthly cycle count, inventory checking. There was no previous excursion. Human error was involved. Product was administered post excursion. Action taken was not applicable. 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.; Sender's Comments: US-SA-2025SA114290: US-SA-2025SA113179: US-SA-2025SA113257: US-SA-2025SA112035: US-SA-2025SA113835:
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| 2837743 | 24 | F | WA | 04/24/2025 |
FLU3 |
SANOFI PASTEUR |
U8442BA |
No adverse event, Product storage error
No adverse event, Product storage error
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Max/low temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝCDuration: 30 minutes with no reported adverse event...
Max/low temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝCDuration: 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to US-SA-2025SA112035 [master case] This case involves a 24 years old female patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] and the vaccine was exposed to temperature excursion where max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Apr-2025, influenza USP TRIVAL A-B subvirion vaccine [Fluzone], Suspension for injection (strength- standard, expiry date- 20-JUN-2025 and lot U8442BA) for Influenza immunisation was exposed to temperature excursion where max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30 minutes with no reported adverse event (product storage error)(latency: same day). On 11-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the left arm. Reportedly, Human error was involved. Previous Excursion: No. Human was present; Product was administered post excursion. The extended stability data Doesn't cover the excursion. Action taken was not applicable. 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.; Sender's Comments: US-SA-2025SA113179: US-SA-2025SA113257: US-SA-2025SA114290: US-SA-2025SA112035:
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| 2837744 | 2 | F | NV | 04/24/2025 |
DTAP |
SANOFI PASTEUR |
3CA55C1 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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2-year-old was administered dose of DAPTACEL which was not due again until 4 years of age with no re...
2-year-old was administered dose of DAPTACEL which was not due again until 4 years of age with no reported adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked t oUS-SA-2025SA113271 (cluster case) This case involves a 2 years old female patient who received a dose of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] which was not due again until 4 years of age 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 Measles vaccine, Mumps vaccine, Rubella vaccine (MMR) and Varicella zoster vaccine (Varicella vaccine) both for Immunisation. On an unknown date, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, Suspension for injection, (unknown strength, expiry date and lot number not reported,) via unknown route in unknown administration site for immunization On 17-Apr-2025, the patient received an extra 0.5ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, Suspension for injection, Strength Standard, frequency once, Expiry date 31-Aug-2026, lot 3CA55C1 via intramuscular route in the right thigh for immunization, which was not due again until 4 years of age with no reported adverse event (Extra dose administered) (Latency Same day). Action taken was not applicable. 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.; Sender's Comments: US-SA-2025SA113271:IPOL
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| 2837745 | FL | 04/24/2025 |
FLUX |
UNKNOWN MANUFACTURER |
No batch number |
Condition aggravated, Multiple sclerosis pseudo relapse
Condition aggravated, Multiple sclerosis pseudo relapse
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Multiple sclerosis (MS) pseudorelapse; This literature report (initial receipt 25-Mar-2025) concerns...
Multiple sclerosis (MS) pseudorelapse; This literature report (initial receipt 25-Mar-2025) concerns a unknown patient who was diagnosed with relapsing multiple sclerosis (RMS). Patients with RMS aged 18-55 years were grouped into three cohorts: cohort 1 (C1) received the influenza vaccine (trade name, manufacturer and lot number not reported - to be requested upon follow up) >/= 2 weeks before starting ofatumumab (OMB); cohort 2 (C2) received the vaccine >/= 4 weeks after starting OMB; and cohort 3 (C3) was currently being treated with interferon/glatiramer acetate and received the influenza vaccine =4 weeks after enrollment. One patient from cohort 2 experienced a serious adverse event (AE) (Multiple sclerosis (MS) pseudorelapse).; Reporter's Comments: Causality : Related. Due to the spontaneous nature of the case, it is considered related for reporting purposes. The event Multiple sclerosis pseudo relapse has no biological or pharmacological plausible relation for the product contributing to the event. The nature of underlying disease with tendency to relapse provide an alternative explanation.
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| 2837754 | 42 | F | CA | 04/24/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
N7CX5 |
Injection site pain, Pain
Injection site pain, Pain
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Pt developed pain in R deltoid that has persisted for approx 3 months, pain is gradually improving. ...
Pt developed pain in R deltoid that has persisted for approx 3 months, pain is gradually improving. Occasionally radiates to R side of neck
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| 2837764 | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster
Herpes zoster
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got shingles right after the vaccine; This non-serious case was reported by a consumer via interacti...
got shingles right after the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles (Verbatim: got shingles right after the vaccine). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 18-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got shingles right after the (Shingrix) vaccine.
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| 2837765 | 04/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain, Skin discolouration, Vaccination failure, Zoster sine herpete
Pain, Skin discolouration, Vaccination failure, Zoster sine herpete
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Suspected vaccination failure; internal shingles; This serious case was reported by a consumer via i...
Suspected vaccination failure; internal shingles; 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: internal shingles). The patient was treated with gabapentin, lidocaine, naproxen and tramadol. The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was not resolved. It was unknown if the reporter considered the vaccination failure and zoster sine herpete to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the zoster sine herpete to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she was dealing with it now. His/her were considered internal shingles, a few spots on his/her back but no blisters. The pain started with what felt like I was being stabbed in the back. He/she went to urgent aid, and they sent him/her to the Emergency Room checking for heart issues or a pulmonary embolism. After a day in the hospital, he/she ended up on gabapentin, lidocaine patches, antibacterial medications, prescription strength naproxen and tramadol. After 10 days he/she went off everything except the Naproxen and lidocaine patches. The pain was still there but at least after almost 3 weeks it was no longer excruciating. He/she had the vaccine, could not imagine how bad it would have been without it. Get the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for zoster sine herpete and laboratory confirmation regarding zoster sine herpete 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 Shingles vaccine.
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| 2837766 | M | MD | 04/24/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
PE24L |
Expired product administered
Expired product administered
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Pediarix expired with expiration date April 11, 2025 was administered to a patient in April 15, 2025...
Pediarix expired with expiration date April 11, 2025 was administered to a patient in April 15, 2025; 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 14-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number PE24L, expiry date 11-APR-2025) for prophylaxis. On 15-APR-2025, the patient received Pediarix. On 15-APR-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Pediarix expired with expiration date April 11, 2025 was administered to a patient in April 15, 2025). The outcome of the expired vaccine used was not applicable. 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 : 16-APR-2025 Medical assistant called to report a Pediarix expired with expiration date April 11, 2025 was administered to a patient in April 15, 2025 which led to expired vaccine used.
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| 2837767 | CA | 04/24/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
AHAVB349BA |
Expired product administered
Expired product administered
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Expired Dose Administered; This non-serious case was reported by a other health professional via cal...
Expired Dose Administered; 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 HAV (Havrix) (batch number AHAVB349BA) for prophylaxis. On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the expired vaccine used was not applicable. 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: 17-APR-2025 CMA (clinic assistant manager) was trying to obtain a lot number for what she stated was a Havrix vaccine. She stated that according to what she was looking at, the vaccine expired in 2006 but was administered in 2010, which led to expired vaccine used. Upon checking the lot number with the batch number tool, it did not pull up as a vaccine. However, the HCP stated that it said Havrix. The Vaccine Administration Facility is the same as Primary Reporter. The reporter declined to provide any patient information and declined followup.
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| 2837768 | IN | 04/24/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Incorrect route of product administration
Incorrect route of product administration
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unfortunately some of them have been administered intramuscularly; This non-serious case was reporte...
unfortunately some of them have been administered intramuscularly; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in specified number of patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: unfortunately some of them have been administered intramuscularly). The outcome of the subcutaneous injection formulation administered by other route was not applicable. 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: 21-APR-2025 The Clinical Pharmacy Manager called to inform the following about Priorix vaccine but unfortunately some of them had been administered intramuscularly, which led to subcutaneous injection formulation administered by other route. The reporter clarified that two patients had received Priorix via intramuscular administration. The gender of the patients was unknown, as well as other details such as lot number, expiration date or date of administration. The reported consented to follow up.
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| 2837769 | 65 | F | NY | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
MVM/SZA/SZA/SZA |
Lip swelling, Pruritus, Urticaria
Lip swelling, Pruritus, Urticaria
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Started at around 12:00am same night I received the vaccine. Woke up with large very itchy hives on ...
Started at around 12:00am same night I received the vaccine. Woke up with large very itchy hives on both inner thighs, inner arms, armpits, Has continued every night since. Took Allgra hives medication about 2 days later which seems to calm the hive down but they return next night. Several days later, experienced swelling on left side of upper lip and swollen bottom lip. Used ice to calm down. Returned again when bottom lip swelled again. Went to local walk in clinic. Doctor mentioned that the swelling of lip might have more to do with my blood pressure med and that I should see my doctor. He prescribed a 5 day steroid. I am on day 3. Went to see my doctor who prescribed and different bp med and recommended that I see an allergist. Have appointment next week. This morning woke up with hives on inner left and right arms and inner thighs (l&r).
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| 2837770 | 79 | F | MA | 04/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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Depression, Diarrhoea, Pain assessment
Depression, Diarrhoea, Pain assessment
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Depressed/depression; It has caused diarrhea that has persisted for 8 weeks; Soreness/her shoulder w...
Depressed/depression; It has caused diarrhea that has persisted for 8 weeks; Soreness/her shoulder was sore; This is spontaneous report received from a Consumers (patient sister, Caregiver and patient). This is report 1 of 2. This report is in regard to the reporter's sister. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown, NDC number: Unknown, Expiry Date: Unknown), via unspecified route of administration on an un-specified date (about two months ago) as 2nd dose single for covid-19 immunization. The patient had History with Oral lichen planus From an Unspecified date and unknown if ongoing). Concomitant medications were not reported. Patient did not have any other product. Reporter stated that, she doesn't know the specific day of vaccination. It has caused diarrhea to the patient that has persisted for 8 weeks. GI doc gave Lomotil, and it helped a little bit. She has had to change her diet and cut out vegetables because it made the diarrhea worse. Patient was very depressed. Patient wanted to know if It was reported earlier and why would it cause the ongoing diarrhea. Patient had seen that that it causes sometimes severe diarrhea, but it didn't say how long it will last. Patient was concerning about if someone need to take an immunosuppressive medication to stop the diarrhea. She was afraid her doctor is going to tell her she needs to take an immunosuppressant medication. It also had stated like, if the Pfizer aware that people have to take medications that shut down the immune system. Upon follow up on 27May2021, reporter stated that, patient was very depressed (on unspecified date) about it. She had a tendency of having autoimmune problems, that she had oral lichen planus, sometimes called burning mouth syndrome. Her doctor diagnosed her with oral lichen planus, which is an autoimmune reaction to bell peppers, she was eating a lot of bell peppers. patient has a hyper immune system. She did not take any type of autoimmune medications no Humira or immunosuppressive medications. Patient took the COVID-19 vac-cine 8 weeks ago and patient developed the diarrhea by the 4th day after the vaccine. Patient had never had diarrhea her entire life. Patient went into shock. Her sister's diarrhea was still ongoing. The gastro doctor gave her sister Lomotil and the Lomotil was working to a point, it prevents the worst of the diarrhea. Her stool was coming out very loose. Reporter did not have the NDC number, lot number and expiry date for the Lomotil, stating it was a prescription, chemical name called atropine or something (as reporter). Patient changed her diet and was becoming depressed. Normally, her sister is a person very concerned for her health and she would have a plant-based diet with multiple vegetables, and now her sister can't do that. patient felt her life depends on having a healthy diet. Patient had vaccinated at pharmacy or something, reporter was concerned that, patient got a good vaccination that was not corrupt in any way. Reporter was urging patient to get the vaccine because she travels and this and that. So, she could be able to travel. patient has a hyperactive immune system; it appears so anyway. Reporter was using her own words when she uses the term hyperactive immune system, so this may not be medically accurate. Her sister has oral lichen planus which is a bad problem. patient was eating a lot of bell peppers. Bell peppers produce an immune reaction, because they contain a chemical called solanine. patient was eating a lot of bell peppers because the internet said they were healthy and contained a lot of vitamin A. she got an immune reaction to the bell peppers, and the immune reaction produced sores under her sister's tongue, very painful sores. Patient had side effects happen three or four days later after the vaccine- it started as diarrhea, and she thought it would stop. Patient's shoulder was sore. reporter mentioned she doesn't know when patient's soreness began and ended. The soreness did completely go away for patient. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Event Did not require any visit to emergency Room or Physician Office. Prior Vaccinations within 4 weeks of the suspect vaccine and events following prior vaccinations were none. Patient's Family Medical History was related to the autoimmune stuff, clarified as the oral lichen planus. Patient had oral lichen planus and was previously treated with steroids. The oral lichen planus started with sores under her sister's tongue. Her sister was treated twice with steroids. Patient said the steroids were successful. Patient's sores were treated with a steroid once and then the sore returned so she went back to the same doctor, and the doctor treated her again with steroids. The second time, the sores went away. At that point, this condition was called burning mouth syndrome, which is on the internet, it was a known condition that is very painful. The doctor diagnosed it as burning mouth syndrome. The diarrhea her sister is experiencing was causing a psychological effect. Reporter stated that, there was no warnings of if a person who has an overactive immune system shouldn't take the COVID vaccine, there was no kind of warning. Reporter seriousness for all the events were Unspecified. Outcome of all the events were unknown. Information on the lot/batch number has been requested. Follow-up (25Jun2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. This follow-up is being submitted to notify that the lot/batch number is not available de-spite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. Follow-up (22Apr2025): This is a spontaneous follow-up report received from a Consumer or other non HCP. Updated information: reporter information (new reporter Consumer), patient information updated. Batch/lot number is not provided, and it cannot be obtained.
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| 2837784 | 28 | F | OH | 04/24/2025 |
HEP MMR UNK VARCEL |
DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. UNKNOWN MANUFACTURER MERCK & CO. INC. |
945660 X022135 83821 X021931 |
Erythema, Pain, Pruritus, Skin warm; Erythema, Pain, Pruritus, Skin warm; Erythe...
Erythema, Pain, Pruritus, Skin warm; Erythema, Pain, Pruritus, Skin warm; Erythema, Pain, Pruritus, Skin warm; Erythema, Pain, Pruritus, Skin warm
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Pt states sx's started eve of 4/21/25. Pain, warmth, redness, itching. Not relieved by cold, he...
Pt states sx's started eve of 4/21/25. Pain, warmth, redness, itching. Not relieved by cold, heat, benadryl.
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| 2837794 | 13 | F | NJ | 04/24/2025 |
HPV9 |
MERCK & CO. INC. |
Y010466 |
Dizziness
Dizziness
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Patient complains of dizziness a minute after the admonition of HPV9. She recovered after 5 minutes.
Patient complains of dizziness a minute after the admonition of HPV9. She recovered after 5 minutes.
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| 2837842 | 19 | IA | 04/24/2025 |
HEPA |
MERCK & CO. INC. |
Y006122 |
No adverse event, Underdose
No adverse event, Underdose
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No additional AE/PQC; HCP called to ask if a 19 year old patient received a pediatric dose of VAQTA ...
No additional AE/PQC; HCP called to ask if a 19 year old patient received a pediatric dose of VAQTA will it be counted as valid or they should restart the adult vaccine The dose was administered on 03/12/2025. No symptoms reported. Consent was provided to follow up with; This spontaneous report was received from a licensed practiced nurse (LPN) via a company representative referring to a 19-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported. On 12-MAR-2025, the patient was vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5 (0.5 ml once, lot#: y006122, expiration date: 17-MAY-2025) via route of intramuscular (IM) for prophylaxis by a healthcare professional (underdose). No additional adverse events were reported (no adverse event).
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| 2837843 | MI | 04/24/2025 |
DTPPVHBHPB HIBV |
MSP VACCINE COMPANY MERCK & CO. INC. |
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Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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here were no symptomatic events from the patient. No additional AE; a patient was co-administered VA...
here were no symptomatic events from the patient. No additional AE; a patient was co-administered VAXELIS and PEDVAXHIB. Both products contain the Haemophilus b Conjugate in the vaccines; This spontaneous report was received from Other health professional and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 21-APR-2025, the patient was co-vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Injection 0.5 mL and with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine (VAXELIS), Injection 0.5 mL; both administered as prophylaxis (route of administration, anatomical site of injection, vaccination scheme frequency, lot number and expiration date were not reported for any of the administered vaccines). Both products contain the Haemophilus b Conjugate in the vaccines (Overdose). There were no symptomatic events, and no additional adverse event was reported for the patient.
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| 2837844 | CO | 04/24/2025 |
HEPA |
MERCK & CO. INC. |
X025482 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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no adverse event; HCP called to report inadvertent administration of expired VAQTA to a patient. Vac...
no adverse event; HCP called to report inadvertent administration of expired VAQTA to a patient. Vaccine expired on 12APR2025 and was administered to a patient on 22APR2025. Limited patient demographics provided. No additional AE/PQC. No additional information.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-Apr-2025, the patient was inadvertently vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), lot #X025482, expiration date: 12-Apr-2025, administered for prophylaxis (dose, strength, route of administration and anatomical site of injection where not provided) (Expired product administered). Limited patient demographics was provided. No additional adverse event and no additional information were provided (no adverse event).
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| 2837845 | 47 | F | OH | 04/24/2025 |
HPV9 |
MERCK & CO. INC. |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No additional adverse event (AE); Pharmacist reports 47 year old female received first dose of GARDA...
No additional adverse event (AE); Pharmacist reports 47 year old female received first dose of GARDASIL 9 on 3/24/2025; This spontaneous report was received from a Pharmacist on 21-Apr-2025 and refers to a 47-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-Mar-2025, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age). No additional adverse event (AE). Lot # is being requested and will be submitted if received.
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| 2837846 | 68 | F | IA | 04/24/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
47Y5M |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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administered Infanrix to adult patient; This non-serious case was reported by a nurse via call cente...
administered Infanrix to adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 68-year-old female patient who received DTPa (Infanrix) (batch number 47Y5M, expiry date 06-JUN-2026) for prophylaxis. On 14-APR-2025, the patient received Infanrix. On 14-APR-2025, an unknown time after receiving Infanrix, the patient experienced adult use of a child product (Verbatim: administered Infanrix to adult patient). The outcome of the adult use of a child product was not applicable. 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: 18-APR-2025 The reporter administered DTAP instead of TDAP to an adult female patient, which led to adult use of a child product.
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| 2837847 | M | 04/24/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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1st Twinrix dose was administer on 02-MAR-2025; This non-serious case was reported by a pharmacist v...
1st Twinrix dose was administer on 02-MAR-2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX) and Hepatitis b vaccine rHBsAg (yeast) (Heplisav b). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st Twinrix dose was administer on 02-MAR-2025). The outcome of the incomplete course of vaccination was not applicable. 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 : 14-APR-2025 The reporter were given a patient a dose of twinrix, on the 2nd of march and they followed the 0,1,6 month vaccine schedule but apparently they had a floater pharmacist who had given the 2nd dose Heplisav instead of Twinrix. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
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| 2837848 | 57 | M | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product preparation issue
Product preparation issue
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shingrix adjuvant only given; shingrix adjuvant only given; This non-serious case was reported by a ...
shingrix adjuvant only given; shingrix adjuvant only given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old male 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: shingrix adjuvant only given) and inappropriate dose of vaccine administered (Verbatim: shingrix adjuvant only given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 14-APR-2025 The patient received Shingrix adjuvant only which led inappropriate preparation of medication and inappropriate dose of vaccine administered.
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| 2837849 | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Therapeutic response unexpected
Therapeutic response unexpected
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significantly reduced my cold sore episodes; This non-serious case was reported by a consumer via ot...
significantly reduced my cold sore episodes; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of unexpected therapeutic effect in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (I've also had shingles at least three times) and cold sores (I have had bad cold sores since I was a child). Previously administered products included methotrexate with an associated reaction of herpes zoster (since I started methotrexate in 2016). On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: significantly reduced my cold sore episodes). The outcome of the unexpected therapeutic effect was not applicable. Additional Information: GSK Receipt Date: 15-APR-2025 Consumer reported that he/she had bad cold sores since was a child, and it only got worse since started methotrexate in 2016. Consumer also had shingles at least three times. Consumer reported about not sure if they're related but received the Shingrix vaccine in 2020 when patient was 25years old and it significantly reduced cold sore episodes. Patient was a huge abreva fan, especially if he/she not able to get valaciclovir prescribed quickly. Consumer It was expensive but find it lessens healing time by about half.
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| 2837850 | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Rash
Rash
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Developed rash after vaccine; This non-serious case was reported by a consumer via interactive digit...
Developed rash after vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash (Verbatim: Developed rash after vaccine). The outcome of the rash was not reported. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date: 15-APR-2025 The patient self-reported this case. The patient developed rash after Shingrix vaccine
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| 2837851 | F | 04/24/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Cough, Fatigue, Malaise
Cough, Fatigue, Malaise
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Coughing; exhausted; Sick; This non-serious case was reported by a consumer via interactive digital ...
Coughing; exhausted; Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In OCT-2024, the patient received RSV vaccine. In OCT-2024, 2 days after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sick). On an unknown date, the patient experienced cough (Verbatim: Coughing) and exhaustion (Verbatim: exhausted). The outcome of the sickness, cough and exhaustion were not reported. It was unknown if the reporter considered the sickness, cough and exhaustion to be related to RSV vaccine. It was unknown if the company considered the sickness, cough and exhaustion to be related to RSV vaccine. Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by a patient's husband via interactive digital media. The patient and reporter got the RSV shot in October and 2 days later they got very sick. The patient and the reporter were coughing, sick and exhausted for more than 6 months. This case is linked with case US2025AMR046636, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR046636:Same reporter
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| 2837852 | 04/24/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu...
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; I had shingles this year (24); This serious case was reported by a co...
Suspected vaccination failure; I had shingles this year (24); 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: I had shingles this year (24)). 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 to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 18-APR-2025 This case was reported by a patient via interactive digital media. Reporter stated that he/she had shingles this year in 24 and stated believe me hurt. Patient also had the 2 shots and he/she was sure they would have been so much worse. Patient indicated that his/her were small but oh the pain. 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 about clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
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| 2837853 | 04/24/2025 |
VARZOS VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK UNK |
Erythema, Haemorrhage, Herpes zoster, Neuralgia, Peripheral swelling; Skin disco...
Erythema, Haemorrhage, Herpes zoster, Neuralgia, Peripheral swelling; Skin discolouration, Vaccination failure; Erythema, Haemorrhage, Herpes zoster, Neuralgia, Peripheral swelling; Skin discolouration, Vaccination failure
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nerve pain; Suspected vaccination failure; diagnosed with Shingles on arm today/ white swollen line ...
nerve pain; Suspected vaccination failure; diagnosed with Shingles on arm today/ white swollen line at first. Next day had 6 red spots that bled; 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 16-APR-2025, 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: diagnosed with Shingles on arm today/ white swollen line at first. Next day had 6 red spots that bled). On an unknown date, the patient experienced nerve pain (Verbatim: nerve pain). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the nerve pain was resolved. It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and nerve pain to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The patient reported he/she was diagnosed with Shingles on arm today. It started on vacation and waited to come home to their own doctor. It was a white swollen line at first and next day had 6 red spots that bled and nerve pain. The patient had both shingles shots so did not think they could get it, but still can get it (Shingles). The patient reported it as a mild case and did not need the antibiotics and if it spreads they will be put on antibiotics. The patient reported he/she was not in pain and putting antibiotic cream on it twice a day. The patient suggested to others get the vaccine shots. The patient stated he/she so glad they did got vaccine or I would be in pain and have a bad case. This case was considered as suspected vaccination failure as details regarding completion of 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
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| 2837854 | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Hypersensitivity
Hypersensitivity
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I am allergic; This non-serious case was reported by a consumer via interactive digital media and de...
I am allergic; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction 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 allergic reaction (Verbatim: I am allergic). The outcome of the allergic reaction was not reported. It was unknown if the reporter considered the allergic reaction to be related to Shingrix. It was unknown if the company considered the allergic reaction to be related to Shingrix. Additional Information: GSK receipt date: 18-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he /she allergic to the Shingrix vaccination. The follow-up could not be possible as no contact details were available.
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| 2837855 | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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never took the second; This non-serious case was reported by a consumer via interactive digital medi...
never took the second; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never took the second). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported and took the first Shingrix shot but never took the second. The reporter asked do the reporter start over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
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| 2837856 | 04/24/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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suspected vaccination failure; had shingles twice, received both vaccine, currently have another shi...
suspected vaccination failure; had shingles twice, received both vaccine, currently have another shingles outbreak; 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. The patient's past medical history included shingles. 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: had shingles twice, received both vaccine, currently have another shingles outbreak). 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 Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 18-APR-2025 This case was reported by a patient via interactive digital media. The patient had shingles twice. The patient received the vaccine, the both injections, after the first time, that was 2 years ago. The patient currently had another shingles outbreak. 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 about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2)..
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| 2837857 | M | 04/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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my brother got very sick from the shot; This non-serious case was reported by a consumer via interac...
my brother got very sick from the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: my brother got very sick from the shot). 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. Additional Information: GSK receipt date: 19-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that they had had it was no big deal but, his/her brother had gotten very sick from the shot.
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| 2837858 | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Malaise
Malaise
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got sick for 3 days; This non-serious case was reported by a consumer via interactive digital media ...
got sick for 3 days; 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 (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles in 2015, terrible, had them for 8 months.). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: got sick for 3 days). The outcome of the sickness was resolved (duration 3 days). It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR049613 Additional Information: GSK Receipt Date: 19-APR-2025 This case was reported by a patient via interactive digital media. The patient also had shingles in 2015, terrible, had them for 8 months. The patient eventually got the 1st shot, and like got sick for 3 days. But if it will prevent it, then it was worth it. The patient did not ever want to go thru that again.
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| 2837859 | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Malaise
Malaise
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got sick for 3 days; This non-serious case was reported by a consumer via interactive digital media ...
got sick for 3 days; 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 (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles in 2015, terrible, had them for 8 months.). Previously administered products included Shingrix (For tolerance to 1st dose, refer case US2025AMR049326.). 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 sickness (Verbatim: got sick for 3 days). The outcome of the sickness was resolved (duration 3 days). It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR049326 Additional Information: GSK Receipt Date: 19-APR-2025 This case was reported by a patient via interactive digital media. The patient also had shingles in 2015, terrible, had them for 8 months. Then time for 2nd dose and was leery. The patient got the 2nd shot, and like got sick for 3 days. But if it will prevent it, then it was worth it. The patient did not ever want to go thru that again.
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| 2837860 | OK | 04/24/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4N222 |
Incorrect route of product administration
Incorrect route of product administration
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administered an intramuscular dose instead of subcutaneously; This non-serious case was reported by ...
administered an intramuscular dose instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: administered an intramuscular dose instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was not applicable. 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: 16-APR-2025 Pharmacist called to ask, one of the pharmacist administered an intramuscular dose of Priorix instead of subcutaneously, which led subcutaneous injection formulation administered by other route. The reporter asked did have any guidance on this topic, did need to revaccinate. The reporter consented to follow up.
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| 2837861 | 68 | F | TX | 04/24/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Incorrect route of product administration
Incorrect route of product administration
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patient received Priorix intramuscularly instead of subcutaneously; This non-serious case was report...
patient received Priorix intramuscularly instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 68-year-old female patient who received MMR (Priorix) for prophylaxis. On 08-APR-2025, the patient received Priorix (intramuscular). On 08-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: patient received Priorix intramuscularly instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was not applicable. 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: 16-APR-2025 The pharmacist called to report the following that the pharmacist had a question about the Priorix vaccine. The pharmacist had a patient that received it intramuscularly instead of subcutaneously which led to subcutaneous injection formulation administration by other route and the patient was wondering if he needed to be revaccinated.
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| 2837862 | KY | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered
Extra dose administered
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Potential received 3rd dose of Shingrix; This non-serious case was reported by a other health profes...
Potential received 3rd dose of Shingrix; This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date). On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Potential received 3rd dose of Shingrix). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 17-APR-2025 The field representative reported that what was the reports if a patient gets a 3rd dose of shingrix, because they did not remember that they already had two doses when they got the 3rd. The patient received 3rd dose of Shingrix which led to, extra dose administered.
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| 2837863 | F | IN | 04/24/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
32YB4 |
Incorrect route of product administration
Incorrect route of product administration
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Administration via intramuscular route; Above recommended age; This non-serious case was reported by...
Administration via intramuscular route; Above recommended age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 35-year-old female patient who received MMR (Priorix) (batch number 32YB4, expiry date 01-DEC-2026) for prophylaxis. On 17-APR-2025, the patient received Priorix (intramuscular). On 17-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Administration via intramuscular route) and inappropriate age at vaccine administration (Verbatim: Above recommended age). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration were not applicable. 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: 17-APR-2025 The pharmacist contacted to request data and recommendations after a 35 year old female patient which was accidentally administered a dose of Priorix via intramuscular route which led to inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route. They stated the patient had received a series in 1991 and a booster in 2001. The vaccine administration facility was the same as primary reporter.
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| 2837864 | 1.33 | F | TX | 04/24/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
DY3K7 |
Inappropriate schedule of product administration, Product administered to patien...
Inappropriate schedule of product administration, Product administered to patient of inappropriate age
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16 month-old patient received Boostrix; Dtap vaccine as the 4th dose in the Dtap series; This non-se...
16 month-old patient received Boostrix; Dtap vaccine as the 4th dose in the Dtap series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DY3K7, expiry date 14-JUN-2027) for prophylaxis. On 04-APR-2025, the patient received Boostrix. On 04-APR-2025, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 16 month-old patient received Boostrix) and inappropriate schedule of vaccine administered (Verbatim: Dtap vaccine as the 4th dose in the Dtap series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable. 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: 17-APR-2025 Nurse reported that a 16 month old patient received Boostrix instead of Dtap vaccine as the 4th dose in the Dtap series, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The nurse asked for recommendations on this topic.
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| 2837865 | TX | 04/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Blister
Blister
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blisters on nose and back; This non-serious case was reported by a other health professional via sal...
blisters on nose and back; This non-serious case was reported by a other health professional via sales rep and described the occurrence of blister in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 03-APR-2025, the patient received the 1st dose of Shingrix. On 03-APR-2025, less than a day after receiving Shingrix, the patient experienced blister (Verbatim: blisters on nose and back). The outcome of the blister was unknown. It was unknown if the reporter considered the blister to be related to Shingrix. It was unknown if the company considered the blister to be related to Shingrix. Additional Information: GSK Receipt Date: 17-APR-2025 Patient had adverse reaction developed blisters on nose and back same date she received first dose of Shingrix on 03 Apr 2025. They asked if they can administer second dose of Shingrix to patient or not.
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| 2837866 | F | FL | 04/24/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
D23D3 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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an adult dose of Engerix-B was administered to a pediatric patient; an adult dose of Engerix-B was a...
an adult dose of Engerix-B was administered to a pediatric patient; an adult dose of Engerix-B was administered to a pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-month-old female patient who received HBV (Engerix B adult) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis. On 14-FEB-2025, the patient received Engerix B adult. On 14-FEB-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: an adult dose of Engerix-B was administered to a pediatric patient) and overdose (Verbatim: an adult dose of Engerix-B was administered to a pediatric patient). The outcome of the adult product administered to child and overdose were not applicable. Additional Information: GSK Receipt Date : 14-APR-2025 Medical assistant called on April 18, 2025 to reported on February 14, 2025 an adult dose of Engerix-B was administered to a pediatric patient which led to adult product administered to child and overdose.
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| 2837867 | 1 | M | PA | 04/24/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
34mf9 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Inadvertent administration of Kinrix under 4 years; This non-serious case was reported by a other he...
Inadvertent administration of Kinrix under 4 years; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34mf9, expiry date 13-FEB-2026) for prophylaxis. Previously administered products included Kinrix (patient has 4 Dtaps now), Kinrix (patient has 4 Dtaps now) and Kinrix (patient has 4 Dtaps now). On 14-MAR-2025, the patient received Kinrix. On 14-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inadvertent administration of Kinrix under 4 years). The outcome of the inappropriate age at vaccine administration was not applicable. 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: 14-APR-2025 Other HCP reported that a 19 months old baby received Kinrix, which led to inappropriate age at vaccine administration. Counting this last Kinrix shot, patient has 4 Dtaps now and asked How to proceed
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| 2837868 | 72 | M | CO | 04/24/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
7942H |
Expired product administered
Expired product administered
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Expired dose administered.; This non-serious case was reported by a pharmacist via call center repre...
Expired dose administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7942H, expiry date 02-MAR-2025) for prophylaxis. On 21-APR-2025, the patient received Arexvy. On 21-APR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 22-APR-2025 The pharmacist reported that a patient in their facility gave Arexvy that expired, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.
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