chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: received ACT-HIB that was reconstituted with sterile water instead of the accompanying saline diluent, with no reported adverse event; Initial information received on 29-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 year old female patient who received HIB (PRP/T) Vaccine [Act-Hib] which was reconstituted with sterile water instead of the accompanying saline diluent, with no reported adverse events.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella zoster vaccine live (Oka/Merck), Varicella zoster vaccine live (Oka/Merck) (Varivax) for Immunisation.  On 24-Apr-2025, the patient received 0.5ml dose (once) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection, Strength Standard, Expiry date 31-Mar-2026, lot UK193AA via intramuscular route in the left arm for immunisation which was reconstituted with sterile water instead of the accompanying saline diluent, 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.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event
Clinical narrative: pregnant patient received two adacel doses with no reported adverse event; 2-weeks pregnant patient was given two tdap within a six-week period with no reported adverse event; Initial information received on 29-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 26 years old female patient who was exposed to vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] in context of 2-weeks pregnant patient was given two tdap (adacel) within a six-week period with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was reported as 20-Aug-2024. The estimated due date is 20-May-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Mar-2025, the 2 weeks pregnant patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (strength: not reported) (lot: U8115AA, Expiry date: 31-Mar-2026) via intramuscular route in the right deltoid for immunization, with no reported adverse event (exposure during pregnancy) (latency: same day) and on 24-Apr-2025 she also received another 0.5 ml dose of vaccine (lot: U8232AA, Expiry date: 01-May-2026) via intramuscular route in the left deltoid for immunization, with no reported adverse event (extra dose administered) (latency: same day).  Action taken : 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.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion for vaccine as temperature reached: max: 4.3°C, low: 0.0°C duration: 1 hour with no reported adverse event; Initial information received on 29-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that had temperature excursion as temperature reached: max: 4.3 degree celsius, low: 0.0 degree celsius duration: 1 hour with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Apr-2025, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UK109AA and expiry date 30-Sep-2025) (frequency: once and strength standard) via intramuscular route in unknown administration site for immunization and that had temperature excursion as temperature reached: max: 4.3 degree Celsius, low: 0.0 degree Celsius, duration: 1 hour with no reported adverse event (poor quality product administered) (Latency same day).  Reportedly, There was no previous excursion. Human error was unknown and vaccine was administered post-excursion. Extended stability data did not 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.
Vaccine: TDAP
Symptoms: No adverse event, Transcription medication error
Clinical narrative: incorrect documentation of product administered/they think got the ADACEL but documented as Td with no reported adverse event; Initial information received on 30-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered with diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] but it was incorrectly documented as td 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 received an unknown dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection, lot number, strength and expiry not reported via unknown route in unknown administration site for immunization and it was incorrectly documented as td with no reported adverse event (transcription medication error).  Information on the batch number was requested corresponding to the one at time of event occurrence  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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired dose of act-hib with no reported ae; Initial information received on 30-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 15 months old male patient who administered 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 3-component, tetanus vaccine toxoid (Infanrix) and pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for immunisation.  On 30-Apr-2025, the patient received a dose of 0.5 ml of expired suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UK042AA and expiry date 31-Mar-2025) (frequency: once and strength: standard) via intramuscular route in the left thigh for Immunization with no reported adverse event (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: 0.5
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: They explained that the patient received ACTHIB and VAXELIS on the same day with no reported adverse event; Initial information received on 01-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to US-SA-2025SA128571  This case involves a 6-month-old male patient who received (Diphtheria vaccine toxoid, hepatitis b vaccine RHBSAG (yeast), HIB vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine INACT 3v (VERO), tetanus vaccine toxoid) (Vaxelis) and HIB (PRP/T) vaccine [ACT-HIB] on the same day with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Apr-2025, the patient received a 0.5ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UK107AB, expiry date-30-Sep-2025) standard strength via intramuscular route in the left thigh for Immunization and on the same day received an unknown dose of suspect Vaxelis not produced by Sanofi Pasteur Formulation, strength, expiry date and lot number-unknown via unknown route in unknown administration site for prophylactic vaccination (Immunisation) no reported adverse event (extra dose administered) (latency-same day).  Reportedly-The patient was given two doses of HIB, no treatment was 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.; Sender's Comments:  US-SA-2025SA128571:Vaxalis US-SA-2025SA128571:Vaxalis
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered a dose of Act-HIB that was reconstituted with a different diluent than the one provided with the product with no reported adverse event; Initial information received on 01-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who was administered a dose of HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with a different diluent than the one provided with the product 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), Pneumococcal vaccine conj 7v (CRM197) (Prevnar) and Hepatitis a vaccine, Hepatitis a vaccine (Hepatitis A) for Immunisation.  On 30-Apr-2025, the patient received a dose 4  dose of suspect HIB (PRP/T) VACCINE dose 0.5 ml 1x(once) Powder and solvent for solution for injection lot UK148AA expiry date- 30-Sep-2025 via unknown route in unknown administration site for immunization (strength unknown) that was reconstituted with a different diluent than the one provided with the product with no reported adverse event (product preparation error) (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: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Erythema, Induration, Nodule, Pruritus
Clinical narrative: it was a fluid filled blister; it got to be the size of a grapefruit, and it was hot; had a swollen hard knot the size of a baseball; ad a swollen hard knot the size of a baseball and it was red; itching; Initial information received on 01-May-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a 59 years old female patient who had itching, had a swollen hard knot the size of a baseball, ad a swollen hard knot the size of a baseball and it was red, it got to be the size of a grapefruit, and it was hot and it was a fluid filled blister 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 28-Apr-2025, the patient received 0.5 ml  dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection, lot U8115AA, unknown expiry date and strength, frequency: once, via unknown route in the right shoulder for immunisation.  On 28-Apr-2025 the patient had itching (vaccination site pruritus) (latency: same day).  On 29-Apr-2025 the patient had a swollen hard knot the size of a baseball (vaccination site swelling) and ad a swollen hard knot the size of a baseball and it was red (vaccination site erythema)  (latency: 1 day).  On 30-Apr-2025 the patient developed it got to be the size of a grapefruit, and it was hot (vaccination site warmth) and it was a fluid filled blister (vaccination site vesicles) (latency: 2 days).  Action taken was not applicable.  The patient was treated with Diphenhydramine hydrochloride, Diphenhydramine hydrochloride (Benadryl), Cetirizine hydrochloride, Cetirizine hydrochloride (Zyrtec), Famotidine, Famotidine (Pepcid) and Doxycycline, Doxycycline (Doxycycline) for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: it was a fluid filled blister; it got to be the size of a grapefruit, and it was hot; had a swollen hard knot the size of a baseball; ad a swollen hard knot the size of a baseball and it was red; itching; Initial information received on 01-May-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a 59 years old female patient who had itching, had a swollen hard knot the size of a baseball, ad a swollen hard knot the size of a baseball and it was red, it got to be the size of a grapefruit, and it was hot and it was a fluid filled blister 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 28-Apr-2025, the patient received 0.5 ml  dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection, lot U8115AA, unknown expiry date and strength, frequency: once, via unknown route in the right shoulder for immunisation.  On 28-Apr-2025 the patient had itching (vaccination site pruritus) (latency: same day).  On 29-Apr-2025 the patient had a swollen hard knot the size of a baseball (vaccination site swelling) and ad a swollen hard knot the size of a baseball and it was red (vaccination site erythema)  (latency: 1 day).  On 30-Apr-2025 the patient developed it got to be the size of a grapefruit, and it was hot (vaccination site warmth) and it was a fluid filled blister (vaccination site vesicles) (latency: 2 days).  Action taken was not applicable.  The patient was treated with Diphenhydramine hydrochloride, Diphenhydramine hydrochloride (Benadryl), Cetirizine hydrochloride, Cetirizine hydrochloride (Zyrtec), Famotidine, Famotidine (Pepcid) and Doxycycline, Doxycycline (Doxycycline) for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Age: 1.75
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired daptacel was administered to a patient with no reported adverse event; Initial information received on 01-May-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21 months old female patient who was administered with an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-May-2025, the patient received 0.5 ml of dose 4 of an expired diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength- standard, expiry date- 30-Apr-2025 and lot 2CA77C1) via intramuscular route in the left deltoid for Immunization with no reported adverse event (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.
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: possibly administered to a patient after the excursion; Duration of temperature excursion: 14 minutesMaximum/minimum temperature reached: 46.2° Fahrenheit with no reported adverse event; Initial information received on 01-May-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 had been possibly administered IPV (VERO) [IPOL] after the excursion; Duration of temperature excursion: 14 minutesMaximum/minimum temperature reached: 46.2° Fahrenheit with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient had been possibly administered IPV (VERO) (Suspension for injection) (lot number: Y1A201M; expiry date: 31-Jan-2027) (strength unknown) after the excursion; Duration of temperature excursion: 14 minutesMaximum/minimum temperature reached: 46.2° Fahrenheit with no reported adverse event for Immunization (poor quality product administered) (latency: same day).   Reportedly, "Was it related to a human error? No"   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: 52.0
Vaccine: TDAP, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administration of ADACEL outside of the recommended interval with no reported adverse event; Initial information received on 02-May-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 52 years old and unknown gender patient for whom diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], administration of adacel outside of the recommended interval with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Apr-2025, the patient received an unknown dose (0.5ml) of diphtheria-2/tetanus/5 AC pertussis vaccine; Suspension for injection with unknown strength (lot U8122AA with expiry date 30-APR-2026) via intramuscular route in the right arm for Immunization and On 06-Mar-2025, the patient received an unknown dose of suspect diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunisation)  On 29-APR-2025 the patient developed administration of adacel outside of the recommended interval 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.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event, Product preparation issue
Clinical narrative: administered 2 doses of ACTHIB on the same day on one patient, with no reported adverse event; 2 doses of ACTHIB was administered to a patient that were both incorrectly reconstituted with sterile water, with no reported adverse event; Initial information received on 05-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who incorrectly administered 2 doses of Hib (PRP/T) vaccine [Act-Hib] on the same day with no reported adverse event and these 2 doses were  incorrectly reconstituted with sterile water, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix)  and rotavirus vaccine live reassort oral 5v (Rotateq) both for Immunisation..  On 30-Apr-2025, the patient received a (dose 2)  of 1 ml dose of suspect Hib (PRP/T) vaccine, Powder and solvent for solution for injection, lot UK169AC, expiry date:28-Feb-2026,unknown strength, frequency: once, via intramuscular route in the right thigh for Immunization which was incorrectly administered to one patient on same day twice (extra dose administered) and both doses were incorrectly reconstituted with sterile water, 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.
Age: 0.17
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received ipol in the left leg and pediarix right leg. the ipol dose was an extra dose against polio because pediarix contains a dose against polio as one of its components with no reported ae; Initial information received on 05-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 weeks old male patient who received IPV (VERO) [IPOL] in the left leg and pediarix right leg the ipol dose was an extra dose against polio because pediarix contains a dose against polio as one of its components with no reported ae (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, Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid, Tetanus vaccine toxoid (Pediarix), HIB vaccine (HIB vaccine) and Rotavirus vaccine for Immunisation.  On 05-May-2025, the patient received IPV (VERO) dose 0.5 ml 1x(once) Suspension for injection lot Y1A201M expiry date-31-Jan-2027 via unknown route in the left leg for Immunization (strength unknown) and pediarix right leg. the ipol dose was an extra dose against polio because pediarix contains a dose against polio as one of its components with no reported ae (extra dose 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: 3.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACTHIB that was reconstituted with a different diluent (0.9% Sodium Chloride) was administered to a patient, with no reported adverse event; Initial information received on 06-May-2025 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 3 years old female patient for whom HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with a different diluent (0.9% sodium chloride) was administered 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. The list of concomitants as no other vaccines  On 29-Apr-2025, the patient received a dose 4 of suspect HIB (PRP/T) VACCINE dose 0.5 ml 1x(once),Powder and solvent for solution for injection (Strength = standard) lot UK208AA expiry date-30-Apr-2026 via intramuscular route in the left deltoid for immunization that was reconstituted with a different diluent (0.9% sodium chloride) was administered to a patient, with no reported adverse event (product preparation error) (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.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose on PENTACEL, with no reported adverse event; Initial information received on 06-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case involves an unknown age male patient who received an expired dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel], 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 b vaccine and Pneumococcal vaccine conj 20v (CRM197), Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation.  On 06-May-2025, the patient received an expired 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (Strength- standard, frequency- once) lot UK024AA and expiry date- 30-APR-2025 via intramuscular route in the left interior thigh for Immunisation with no reported adverse event (expired 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.
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only the Dtap-IPV component was administered to a patient, with no reported adverse event; Initial information received on 07-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case involves a 19 months old and unknown gender patient where only the dtap-ipv component of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered 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 Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation.  On 29-Apr-2025, the patient received a dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Strength- standard) Suspension for injection (lot- UK026AA and expiration date- 30-JUN-2025) via intramuscular route in the left thigh for Immunisation where only the dtap-ipv component was administered to a patient, with no reported adverse event (single component of a two-component 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: 0.17
Sex: M
Vaccine: RV1
Symptoms: Unevaluable event
Clinical narrative: The 1st dose of vaccine was administered at 2 months of age outside our facility on 3/11/2024. Patient started establishing care with our office later until 6 months old. the data of vaccine records was not entered to the office system until 8/22/2024, which caused misinterpretation of vaccine history. otherwise patient is not experiencing any adverse effects
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Nausea, Vomiting
Clinical narrative: The vaccine was administered at 06:45, the patient had 2 episodes of vomiting which lasted roughly 45 minutes. The patient began vomiting at 06:57 this episode of nausea/vomiting lasted about 10 minutes. Pt started to feel better and then began vomiting again at 07:15 which again lasted about 10 minutes. At 07:30 the patient was taken to see a medical provider and evaluated.                           Pt denies itching, rash, throat swelling or lip swelling  after discussion with pharmacy advised against further typhoid vaccines  pt was monitored without further progression of reaction and returned to training as symptoms resolved.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Miliaria, Rash
Clinical narrative: It was like burning rash and it broke out on both arms at the same time. And then it went to my legs and my back, I went to the ER in 08 or 09 2024 and they told me it was a heat rash I waited until like a month ago to see a dermatologist.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Influenza like illness, Pain, Palpitations
Clinical narrative: 12 hours after vaccine was awaken with serious FLU like symptoms.  I felt like I had been hit by a truck, SEVERE headache, and heart palpitations.  The racing heart while lying down was very concerning that I considered getting medical help.   Issue were serious enough I was unable to work and was in bed like 20 hours.   Took Advil and did not help with symptoms.  I could not function in any capacity and would not have taken 2nd shot had I known of effects.  Felt better after 2 days and wanted to report issues I had.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Injection site induration, Injection site oedema, Injection site reaction, Macule
Clinical narrative: 2 days after the immunization, mother brings child because of fever, runny nose and mild cough - sister had bee sick for 5 days. During physical exam a red macula of 6x7 c, indurated, non tender and not itchy, non-fluctuant, is noted in the right deltoid area. Edema is noticed, no pitting.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: 2 days after the immunization, mother brings child because of fever, runny nose and mild cough - sister had bee sick for 5 days. During physical exam a red macula of 6x7 c, indurated, non tender and not itchy, non-fluctuant, is noted in the right deltoid area. Edema is noticed, no pitting.
Age: 16.0
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no reaction experienced by patient, vaccine was given at wrong time. Mother of patient notified of event.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis, Condition aggravated, Exostosis, Injection site pain, Magnetic resonance imaging abnormal
Clinical narrative: Persistent lingering left deltoid injection site pain since the immunization. Pain increases after work once he settles at home. Heating pad and ibuprofen is not helping. PredniSONE (Deltasone) 20 MG tablet; Take 2 Tablets by mouth one time a day for 5 days. Physical Therapy referral.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Tendon disorder, Tendon rupture, X-ray limb abnormal
Clinical narrative: Persistent lingering left deltoid injection site pain since the immunization. Pain increases after work once he settles at home. Heating pad and ibuprofen is not helping. PredniSONE (Deltasone) 20 MG tablet; Take 2 Tablets by mouth one time a day for 5 days. Physical Therapy referral.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was accidently MMR Combo along with a separate Varicella vaccine.
Age: 64.0
Sex: F
Vaccine: IPV, PNC21
Symptoms: Burning sensation, Erythema, Skin warm
Clinical narrative: redness, 4 inches long down her arm towards her elbow, burning sensation, hot to touch, ibuprofen and benadryl prn
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: PT WAS GIVEN EXTRA DOSE OF HEP B
Age: 39.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, warmth, swelling at injection site, 6 cm in diameter
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: Pt has a large area of discoloration, redness and warmth at and below injection site. Onset of sx reported to have started the following day.
Age: 38.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site erythema
Clinical narrative: Erythema to injection site noted two day after immunization
Age: 40.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was for the 2nd series of a 2-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling at injection site.  He also developed a headache that worsened with sitting up.  The headache lasted for about 3 days.  A similar but more severe case of this reaction happened to his sister when she received the 2nd dose of the same vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PT SAYS SHE HAS HAD ARM PAIN SINCE A COUPLE OF DAYS AFTER RECEIVING IMZ AND IT IS STILL AFFECTING HER RANGE OF MOTION STILL TO THE PRESENT DAY . SHE HAS TAKE NO MEDS FOR IT ON ONLY USED "SPRAY ICE"
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Pt was administered pentacel when not needed.
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 53.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Severe redness and swelling at injection site >3 days since injection
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: pt was given covid vaccine from age group 12-18 instead of her age gap.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered to 17-year-old. No patient issues.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given wrong age group vaccine. Patient was given dose for 12 yrs - 18 yrs.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema multiforme, Urticaria
Clinical narrative: 4 days after vaccine patient developed hives and suspected erythema multiforme. Hives have improved but EM rash is still present.
Age: 31.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second series of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 73.0
Sex: M
Vaccine: HEPA, IPV, TDAP, YF
Symptoms: Abdominal pain upper, Dehydration, Diarrhoea, Pyrexia
Clinical narrative: Late friday night I got at stomach ache with bad runs and my wife called 911. I was dehydrated with a low grade fever and they admitted me for a couple of days.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Computerised tomogram normal, Electroencephalogram normal, Laboratory test normal, Magnetic resonance imaging head normal
Clinical narrative: 2ND COVID BOOSTER PROVIDED ON JULY 1 2021, PATIENT HAD A HEART ATTACK IN AUGUST 2021 (HOSPITALIZED); ONSET OF TREMOR AND COGNITIVE DECLINE SEPTEMBER 2021; DX WITH LUPUS AND SJOGRENS SYNDROME 2025.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Sjogren's syndrome, Systemic lupus erythematosus, Tremor
Clinical narrative: 2ND COVID BOOSTER PROVIDED ON JULY 1 2021, PATIENT HAD A HEART ATTACK IN AUGUST 2021 (HOSPITALIZED); ONSET OF TREMOR AND COGNITIVE DECLINE SEPTEMBER 2021; DX WITH LUPUS AND SJOGRENS SYNDROME 2025.
Age: 60.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Lichen planus, Rash, Rash erythematous
Clinical narrative: Red bumps on arm and wrists consistent and hair loss consistent with Lichen Planus
Age: 23.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first two-series vaccination; the outcome was uneventful. With no symptoms or signs of reactions reported.
Age: 32.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: ITCHING TO LEFT ARM, 2 INCH DIAMETER, REDNESS SWELLING NO PAIN FOR 2 DAYS AFTER INJECTION TO SITE.  FOLLOWED UP 5 DAYS LATER AND THE ISSUE WAS RESOLVED.
Age: 45.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU3, TYP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Incorrect dose of Moderna Covid vaccine given to patient. No adverse event noticed. Patient was contacted and told they should be revaccinated with the correct dose to ensure protection.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Not able to contact patient, left a message on phone for a return call.  Priorix is to be given SQ and we administered IM.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired vaccination
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HPV9, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given the HPV shot that was meant for his 12 year old sister.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: Patient started developing warm, itchy spots on random parts of the body (arms, legs) after shower. Lasts about an hour and then goes away. Has persisted since vaccination 3/23/25 to today, 5/12/25, though the severity of the itchiness has gradually decreased
Age: 0.33
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP calling to report AE for a vaccine that was inadvertently administered after a temperature excursion.          ?    Name of vaccines involved (including lot/exp): ROTATEQ 2003166 9/8/2025        ?    Temperature: 1.5C        ?    Time frame; This spontaneous report was received from a registered nurse and refers to a) 4-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 14-APR-2025, the patient was inadvertently vaccinated with an improper stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (valid lot #2003166, expiration date reported as 08-SEP-2025, but upon internal validation established as 06-SEP-2025) 2 ml, once, administered by oral route as prophylaxis. The temperature excursion was reported 1.5 degree Celsius with a time frame of 50 minutes. No previous temperature excursion reported. In addition, the reported stated that the patient did not have any reactions or symptoms (no adverse event).
Age: 45.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second dose of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: On the afternoon of 5/8/2025, patient developed soreness at site of injections. Took Ibuprofen. The next morning she noticed tingling in RT hand and distal half of forearm when lifting hand toward face, noticed when applying make up. Still with pain at injection site and noticed mild redness and swelling. On exam she has 2cm x 2cm erythema and mild edema of RT deltoid area. RT hand and arm has good strength and tone and sensation intact.
Age: 62.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second dose of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Sleep disorder
Clinical narrative: Severe pain in shoulder causing lack of sleep and loss of strength in arm.  Patient has not slept a full night's sleep since pain began in November 2024.
Age: 0.25
Sex: M
Vaccine: RV1
Symptoms: Vomiting projectile
Clinical narrative: Projectile Vomiting x3
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pain
Clinical narrative: Redness and soreness around the area
Age: 65.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Fatigue, Hypersensitivity, Inflammation, Injection site erythema, Injection site pain
Clinical narrative: Documentation copied from provider's office visit note today (5/12/25):  "Patient is a 65 y.o. female who presents today to walk-in clinic regarding vaccine reaction.   Had tetanus and COVID vaccines on Friday (5/9/25). Afterwards, was not feeling well. Was fatigued, had fever 100.8 over the weekend. Was taking Benadryl and Tylenol over the weekend. Has noticed redness at injection sites on both her arms. Describes the areas as intermittently painful and pruritic. Was advised not to get her routine allergy shot today due to the symptoms. Her next shot is tomorrow, and following one will be Friday. Suspect patient's symptoms are due to recent vaccination injections. Notably, injections were administered to the mid-upper arm bilaterally, rather than higher in the deltoid. Suspect inflammatory and/or allergic reaction. Advised to continue with Zyrtec or Benadryl, Tylenol as needed for pain control, local ice/cold compresses to reduce inflammation. Cannot take NSAIDs due to prior stroke. Follow up if symptoms worsen or persist.  Skin Comments: Erythematous macular region present on bilateral upper arms, at sites of previous injections."