chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: sick; pain radiates to the chest when sleeping; pain in the joint of the arm; sleeping a lot; pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire; fever; chills; Initial information received on 20-Feb-2025 regarding an unsolicited valid non-serious case received from a Patient.  This case involves a 24 years old female patient who experienced sick, pain radiates to the chest when sleeping, pain in the joint of the arm, sleeping a lot, pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire, fever and chills after receiving Diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength, lot/batch number and expiration date: not provided) for Prophylactic vaccination (immunization).  On an unknown date the patient developed sick (illness), pain radiates to the chest when sleeping (chest pain), pain in the joint of the arm (pain in extremity), sleeping a lot (hypersomnia), pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire (vaccination site pain), fever (pyrexia)  and chills (unknown latency).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire, pain radiates to the chest when sleeping, sleeping a lot, pain in the joint of the arm was Unknown for the event fever, sick, chills.
Age: 0.42
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: used outside of indicated administration age with no reported adverse event; Initial information received on 21-Feb-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 5 months old male patient to whom had received Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] and outside of indicated administration 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 DIPHTHERIA Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap); HIB vaccine conj (tet tox) (Act hib); Pneumococcal vaccine polysacch 23v (Pneumovax) and Iodinated glycerol (Ipol) for Immunisation.  On 17-Feb-2025, the 5 months old male patient received a 0.5 ml dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved Suspension for injection (strength: standard, frequency: once, expiry date: unknown and lot AE2J7) via intramuscular route in unknown administration site as immunization and outside of indicated administration age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: 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.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of PENTACEL was inadvertently administered  with no adverse event; Initial information received on 21-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient and expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was inadvertently administered to him with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis b vaccine rHBsAg (yeast) (Engerix); Influenza vaccine (Flu); Pneumococcal vaccine conj 7v (CRM197) (Prevnar); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); and Varicella zoster vaccine live (Oka/Merck) (Varivax) all for Immunisation.  On 21-Feb-2025, the patient was inadvertently administered an expired dose once of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Powder and suspension for suspension for injection) (lot: UJ981AA; expiry date: 11-Feb-2025) (strength unknown) via intramuscular route in the right thigh for Immunisation (expired product 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.
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: instead of the provided diluent, the vaccine was mixed with sterile water (with no reported adverse event); instead of the provided diluent, the vaccine was mixed with sterile water (with no reported adverse event); Initial information received on 21-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 25 years old female patient to whom had administered Yellow Fever Vaccine - [YF-VAX] was mixed with sterile water instead of the provided diluent (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Feb-2025, the patient received a 0.5 ml  dose of suspect Yellow Fever Vaccine - Solution for injection (strength: standard, frequency: once, expiry date: 31-Oct-2025 and lot UK125AA) a via subcutaneous route in the left arm as immunization and instead of the provided diluent, the vaccine was mixed with sterile water (with no reported adverse event) (product preparation error) (poor quality product administered) (latency: same day).  Action taken: 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.
Age: 22.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: patient was supposed to receive a PPD dose, but received IPOL via subdermal route with no adverse event; patient was supposed to receive a PPD dose, but received IPOL via subdermal route with no adverse event; Initial information received on 24-Feb-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 22 years old female patient who was supposed to receive a ppd dose, but received IPV (VERO) [IPOL] via subdermal route with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza Vaccine and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP) for Immunisation.  On 24-Feb-2025, the patient received a 0.1 ml dose of suspect IPV (VERO) (lot X1C891M , Expiry: 31-Oct-2026, with unknown strength) via subdermal route in the left forearm as Immunization (incorrect route of product administration) but was supposed to receive PPD with no adverse event (wrong product administered) (Latency: same day).  Action taken: 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.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was given to a today that had expired with no reported ae; Initial information received on 24-Feb-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 4 years old female patient who had received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] was given to a today that had expired 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) for Immunisation; and Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for Immunisation.  On 24-Feb-2025, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UJ981AA, Expiry date : 11-Feb-2025, strength was unknown via intramuscular route in unknown administration site for Immunization of vaccine was given to a today that had expired with no reported ae (expired product 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.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Max/low temperature reached Negative 1.5 F (NEGATIVE 18.6 C) for 48 hours and 45 minutes for and tenivac was administered after excursion occurred with no reported ae; Initial information received on 24-Feb-2025 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 58 years old female patient where max/low temperature reached negative 1.5 F (negative 18.6 c) for 48 hours and 45 minutes for Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] and was administered after excursion occurred with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Feb-2025, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot- U8303BA and expiration date- 30-SEP-2026) via intramuscular route in the left deltoid (strength: not provided) for Immunization and max/low temperature reached negative 1.5 f (negative 18.6 c) for 48 hours and 45 minutes for and tenivac was administered after excursion occurred with no reported ae (poor quality product administered) (latency- same day).  Reportedly, Previous Excursion, Yes; Does extended stability data cover the excursion, No.  Action taken- 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.  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.
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACTHIB given to a patient, with no reported adverse event; Initial information received on 24-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of an unknown age and gender who was given expired 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 2025, the patient was given expired HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (expiry date: 31-Dec-2024) (strength unknown) with no reported adverse event (expired product administered) (latency: same day) via unknown route in unknown administration site for Immunisation.  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.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only the DTap-IPV solution was given and the Hib component was not reconstituted with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 weeks old female patient who experienced only the DTAP-IPV solution was given and the HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was not reconstituted with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Feb-2025, the patient received only the DTAP-IPV solution with an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength- unknown, expiry date- 3-Aug-2025 and lot UKD43AA) via intramuscular route in unknown administration site for Immunization and the HIB component was not reconstituted with no reported adverse event (single component of a two-component product 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.
Age: 47.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: ipol was administered instead of tubersol with no reported adverse event; patient received 0.1cc of IPOL intradermally with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 47 years old female patient who received IPV (VERO) [IPOL] instead of tuberculin test [Tubersol] and received intradermally with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started taking dosage unknown route unknown for Tuberculin test. On 25-Feb-2025, the patient received 0.1 cc of IPV (VERO) Suspension for injection with standard strength (expiry date- 17-NOV-2025 and lot WIC741M) once via intradermal route in the left forearm (incorrect route of product administration) for Immunization instead of Tuberculin test Solution for injection with strength- 5-TU (Tuberculin unit) (lot and expiry date- unknown) (wrong product administered) with no reported adverse event (latency- same day).   Reportedly, patient visited the ER (Emergency room) right after receiving IPOL and no adverse event was reported.  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.
Age: 0.08
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE PFS NP if it was given to a 1-month-old with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 1-month-old of unknown gender patient whom influenza USP trival A-B subvirion no preservative vaccine [Fluzone] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Feb-2025, the 1-month-old patient received a 0.5 ml dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection strength: standard of lot UT8514NA and expiry date: 30-Jun-2025 via intramuscular route in the right thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).  Action taken was not applicable.  Reportedly, Nurse clarified that no adverse event has been reported   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.
Age: 52.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to the administration of an expired dose of IPOL to a patient with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 52 years old female patient as inappropriate use due to the administration of an expired dose of IPV (VERO) [IPOL] to a patient 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 Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix); Yellow fever vaccine (Yellow fever vaccine); and Typhoid vaccine (Typhoid) for Immunisation.  On 24-Feb-2025, the patient received IPV (VERO) Suspension for injection dose 0.5 ml 1x(once) (strength-standard) lot W1A102M expiry-10-Feb-2025 via intramuscular route in the left deltoid for immunization, inappropriate use due to the administration of an expired dose of ipol to a patient with no reported adverse event (expired product administered) (latency same day).  Action take: 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.
Age: 0.83
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to the administration of an expired dose of ipol to a patient with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 10 months old male patient where patient had inappropriate use of IPV (Vero) [IPOL] due to the administration of an expired dose of ipol to a patient 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, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix); HIB vaccine conj (tet tox) (ACTHIB) and pneumococcal vaccine conj 20V (CRM197) for Immunisation.  On 25-Feb-2025, inappropriate use due to the administration of 0.5 ml (once) dose of suspect IPV (VERO) Suspension for injection (Strength- standard) (lot- W1A191M and expiry date- 16-FEB-2025) via intramuscular route in the left thigh for immunization and expired dose of vaccine to a patient with no reported adverse event (expired product administered) (latency- same day).  Action taken- 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.  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.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, PNC20
Symptoms: Haematochezia, Immunisation reaction, Immunoglobulin therapy, Mouth haemorrhage, Petechiae
Clinical narrative: Patient vaccinated at 4mos appointment on 11/01/2024. Symptoms occurred on n 11/06/2024. Symptoms included: blood in stool in diaper, petechiae all over body/inside mouth. Upon advice nurse recommendations-made appt for next day. On arrival at appointment on 11/07/2024 the doctor knew something was wrong and ordered blood stay and had us wait in office for results. Patients blood results came back at 6,000 platelets?normal range is about 130,000-400,00. Patient immediately sent to hospital and admitted upon arrival. IVIG treatment given next day.  Platelets increased. Treatment worked to increase platelets for a month and then platelets dropped again to 100,000 in beginning of Jan 2025, then 50,000 in beginning Feb. Still unresolved and unstable condition. Advised by many doctors that this event was a direct result and reaction of the vaccines. Now advised to stop vaccine use until patient shows stability with platelets.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, PNC20
Symptoms: Platelet count decreased
Clinical narrative: Patient vaccinated at 4mos appointment on 11/01/2024. Symptoms occurred on n 11/06/2024. Symptoms included: blood in stool in diaper, petechiae all over body/inside mouth. Upon advice nurse recommendations-made appt for next day. On arrival at appointment on 11/07/2024 the doctor knew something was wrong and ordered blood stay and had us wait in office for results. Patients blood results came back at 6,000 platelets?normal range is about 130,000-400,00. Patient immediately sent to hospital and admitted upon arrival. IVIG treatment given next day.  Platelets increased. Treatment worked to increase platelets for a month and then platelets dropped again to 100,000 in beginning of Jan 2025, then 50,000 in beginning Feb. Still unresolved and unstable condition. Advised by many doctors that this event was a direct result and reaction of the vaccines. Now advised to stop vaccine use until patient shows stability with platelets.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 23-JUN-2021 received 1st dose).   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: Late 2nd dose.). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 24-FEB-2025 The patient got the first dose of Shingrix and had not gotten the 2nd one yet.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.92
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired vaccine to a patient with no reported adverse event; Initial information received on 26-Feb-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11-month-old male patient who had administration of an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Feb-2025, the patient received a 0.5 ml dose of expired suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection of lot UJ983AA and expiry date: 12-Feb-2025 via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product administered) (latency: on 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.
Age: 0.25
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: HiB 1/19/1995; HiB 12/16/1993; This spontaneous report has been received from a lawyer, via an immunization record from a case in litigation for Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (case # 2249323), concerning a 5-month-old female patient.  Concurrent condition and medical history were not reported. Concomitant vaccine included diphtheria vaccine toxoid (+) pertussis vaccine (+) tetanus vaccine toxoid (DTP).  On 21-OCT-1993, the patient was vaccinated with the 1st dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) suspension for injection, administered for prophylaxis at a hospital (strength, dose, route, lot#, and expiration date were not reported). On 16-DEC-1993, the patient was vaccinated with the 2nd dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (Inappropriate schedule of product administration). On 18-JUL-1994, the patient was vaccinated with the 3rd dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown). On 19-JAN-1995, the patient was vaccinated with the 4th dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (Extra dose administered).  This is one of several reports for the same patient.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose on June 4th 2024, and Here for the Second Dose Now; Initial report received on 07-Feb-2025.  A pharmacist reported that a 50-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose yet.  No medical history or concomitant medications were reported.  On 04-Jun-2024, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available).    On 07-Feb-2025, 248 days after having been vaccinated with HEPLISAV-B, the patient presented to a pharmacy to receive the second dose of HEPLISAV-B. The pharmacist inquired if the patient needed to restart the vaccine series as the first dose was received more than one month prior. The patient has not received the second dose of HEPLISAV-B yet but was in the pharmacy to receive the second dose. No adverse reactions were reported.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 Year Old Received Dose 1 of HEPLISAV-B; Initial report received on 11-Feb-2025.  A nurse reported that a 16-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No medical history was reported.  No concomitant medications were reported.     On 10-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 945660, expiration date 31-Jan-2027, NDC# 43528-0003-05)] intramuscularly in the arm. The patient was 16 years old at the time she received HEPLISAV-B.  The patient had no adverse effects.    No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Received First Dose in Dec 2023, But Has Not Had the Second Dose; Initial report received on 11-Feb-2025.  A nurse reported that a male (age, race, and ethnicity not reported) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Dec-2023 but has not had the second dose yet.  No medical history or concomitant medications were reported.  In Dec-2023, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available).    In Feb-2025, at the time of reporting the patient had not received the second dose yet. No adverse reactions were reported.   The reporter declined to provide further information.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ankle fracture, Cardiac failure congestive, Immediate post-injection reaction, Incomplete course of vaccination, Myocardial infarction
Clinical narrative: Heart attack; Congestive heart failure; Broken ankle; Inappropriate schedule of vaccine administered; This serious case was reported by a consumer via call center representative and described the occurrence of heart attack in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In APR-2024, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient did not receive the 2nd dose of Shingrix. In APR-2024, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced heart attack (Verbatim: Heart attack) (serious criteria hospitalization and GSK medically significant), congestive heart failure (Verbatim: Congestive heart failure) (serious criteria hospitalization and GSK medically significant) and ankle fracture (Verbatim: Broken ankle) (serious criteria hospitalization). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the heart attack, congestive heart failure and ankle fracture were resolved with sequelae and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the heart attack, congestive heart failure and ankle fracture to be related to Shingrix.     The company considered the heart attack, congestive heart failure and ankle fracture to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter stated she received first dose of Shingrix vaccine in April 2024. She stated that shortly thereafter she had broken her ankle and was in the hospital with a heart attack and congestive heart failure. She was now recovered and ambulatory and wanted to get dose 2 of vaccine Till the time of reporting, the patient did not receive the second dose of Shingrix vaccine, which led to incomplete course of vaccination.; Sender's Comments: Myocardial infarction, Cardiac failure congestive and Ankle fracture are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second Shingrix dose was 1 week late; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in AUG-2024).   On 24-FEB-2025, the patient received the 2nd dose of Shingrix. On 24-FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second Shingrix dose was 1 week late). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter was the patient and reported the second Shingrix dose was 1 week late. The reporter said her pharmacy did not call her that she needed the second dose until 21st February 2025. The reporter received the second Shingrix dose on 25th February 2025 which led to lengthening of vaccination schedule. The reporter did not had the date of the first dose of Shingrix other than it was in August 2024. The pharmacist told her since she was a week late that this would be considered her first dose and she would have to return to get another dose.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got the first shot almost 5 years ago and I got the shingles from the vaccine/I am having another horrible episode right now; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I got the first shot almost 5 years ago and I got the shingles from the vaccine/I am having another horrible episode right now). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-FEB-2025 This case was reported by a patient via interactive digital media. The patient got the first shot almost 5 years ago and got the shingles from the vaccine. It was reported as many people have got shingles from the new vaccines and knows about it. The patient was having another horrible episode right now. The patient thought that he/she was preventing shingles but got it from the 1st Shot and said they could not have the 2nd shot. The follow-up could not be possible as no contact details were available.
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel bad after the Shingrix vaccine/certianly did; This non-serious case was reported by a consumer and described the occurrence of feeling bad 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 feeling bad (Verbatim: feel bad after the Shingrix vaccine/certianly did ). The outcome of the feeling bad was resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-FEB-2025 The patient posted stating that, some people could feel pretty bad after the Shingrix vaccine, including themselves after receiving it. The patient certainly did. The patient commented that, they did not have any outbreak or a blistering rash.; Sender's Comments:  US-GSK-US2025AMR020275:same reporter different patient
Vaccine: VARZOS
Symptoms: Pruritus, Pustule, Rash vesicular
Clinical narrative: chicken-pox like violently itchy pustules; This non-serious case was reported by a consumer and described the occurrence of varicella-like rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: chicken-pox like violently itchy pustules). The outcome of the varicella-like rash was not resolved.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.     It was unknown if the company considered the varicella-like rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-FEB-2025 One week after vaccination developed chickenpox like violently itchy pustules. This case was linked with case US2025AMR023133 reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2025AMR023133:
Vaccine: VARZOS
Symptoms: Pruritus, Pustule, Rash vesicular
Clinical narrative: chickenpox-like itchy pustules; This non-serious case was reported by a consumer and described the occurrence of varicella-like rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: chickenpox-like itchy pustules). The outcome of the varicella-like rash was not resolved.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.     It was unknown if the company considered the varicella-like rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-FEB-2025 One week after vaccination developed chicken-pox like violently itchy pustules.; Sender's Comments:  US-GSK-US2025AMR023131:
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; 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.   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: Shingles). The patient was treated with aciclovir (Aclovir). 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: 22-FEB-2025 This case was reported by a patient via interactive digital media. The patient had both vaccines and have shingles.  The patient tried aclovir pills and topical cream and that still has not gotten rid of them. 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 and Shingles vaccine dose 2.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). 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 Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 22-FEB-2025 This case was reported by a patient via interactive digital media. The reporter stated that Shingles was a pain, but Shingrix was a disaster.  The patient had shingles and took the 2 doses of Shingrix and it came back.  The reporter stated that worst yet and his wife and he often breakfast at a small local diner and some of the guys at our group table have taken the double dose 4 times and in the 21 men. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming 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 vaccine Shingrix (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Can i take Tylenol for the muscle pain. I just have a shingles vaccine yesterday; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20-FEB-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced muscle pain (Verbatim: Can i take Tylenol for the muscle pain. I just have a shingles vaccine yesterday). The outcome of the muscle pain was not reported.   It was unknown if the reporter considered the muscle pain to be related to Shingles vaccine.     It was unknown if the company considered the muscle pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-FEB-2025 The case was received from the patient via interactive digital media. The reporter asked could he/she took Tylenol for the muscle pain. The patient just had a shingles vaccine a day before day of reporting.