chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: YF-VAX was administered to a patient through the intramuscular route instead of the subcutaneous route, with no reported adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 66 years old female patient who was administered Yellow Fever Vaccine [YF-VAX] through the intramuscular route instead of the subcutaneous route, 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 5-Component, Tetanus Vaccine Toxoid (Adacel) and Hepatitis A Vaccine (Hepatitis A) for prophylactic vaccination (Immunisation).  On 14-Jul-2022, the patient received a 0.5 ml dose of suspect Yellow Fever Vaccine (Solution for injection) (lot: UJ602AA; expiry date: 13-Jul-2023) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation).  On 14-Jul-2022 the patient was administered Yellow Fever Vaccine [YF-VAX] through the intramuscular route instead of the subcutaneous route, with no reported adverse event (incorrect route of product administration) (latency: same day).  Action taken: not applicable.  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: 38.0
Sex: M
Vaccine: YF
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: YF-VAX being administered to a patient through the intramuscular route instead of the subcutaneous route with no reported adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 38 years old male patient to whom YELLOW FEVER VACCINE - [YF-VAX] being administered through the intramuscular route instead of the subcutaneous route 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 (HEPATITIS A) for Hepatitis A; HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Hepatitis B; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 14-Jul-2022, the patient received a 0.5ml  dose of suspect YELLOW FEVER VACCINE -  (formulation , strength was unknown, lot UJ602AA and expiry date: 13-Jul-2023) via intramuscular route in the left deltoid for Immunization.  On 14-Jul-2022 the patient developed a non-serious event of yf-vax being administered to a patient through the intramuscular route instead of the subcutaneous route with no reported adverse event (incorrect route of product administration, Latency: same day).   Action taken : not applicable.  Outcome: Unknown  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: 53.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: YF-VAX was administered to a patient through the intramuscular route instead of the subcutaneous route with no adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 53 years old female patient and yf-vax(YELLOW FEVER VACCINE - ) was administered to a patient through the intramuscular route instead of the subcutaneous 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 HEPATITIS A VACCINE (HEPATITIS A); HEPATITIS B VACCINE (HEPATITIS B VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) all for Immunisation.  On 14-Jul-2022, the patient received a dose of 0.5 ml of suspect YELLOW FEVER VACCINE - lot UJ602AA, expiration date:13-Jul-2024, via intramuscular route in the left deltoid as Immunization. The patient used the product previously.  On 14-JUL-2022 the yf-vax was administered to a patient through the intramuscular route instead of the subcutaneous route with no adverse event (incorrect route of product administration) same day following the administration of YELLOW FEVER VACCINE - . Caller would like to know if the dose was valid. This situation was reported as a medication error.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (YF-VAX was administered to a patient through the intramuscular route instead of the subcutaneous route with no adverse 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.
Sex: U
Vaccine: YF
Symptoms: Product preparation error
Clinical narrative: YF-Vax was administered to a patient after it was reconstituted with sterile water with no reported adverse event; Initial information received on 15-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient of unknown demographics and it was reported that yf-vax (YELLOW FEVER VACCINE) was administered to a patient after it was reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Jul-2022, the patient received a dose of 0.5ml of suspect YELLOW FEVER VACCINE, formulation: powder, strength, route: unknown, lot UJ371AB, expiration date: 21-Jul-2022, in unknown administration site as Immunization.  On 14-JUL-2022 the yf-vax was administered to a patient after it was reconstituted with sterile water with no reported adverse event (product preparation error) same day following the administration of YELLOW FEVER VACCINE. The diluent used said "sterile diluent for live vaccines, contains no preservative." The nurse who administered the dose intentionally substituted the sterile water as the diluent because the diluent that came along with the Yf-Vax powder was already expired. Caller would like to know the clinical result of the vaccine with sterile water and if the patient needs to be revaccinated. Still using product-No  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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: Expired product administered, No adverse event
Clinical narrative: 2 month old child was given an expired dose of PENTACEL with no reported adverse event; Initial information received on 15-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who experienced 2 month old child was given an expired dose of pentacel with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13V (CRM197) (prevnar 13) and rotavirus vaccine (rotavirus vaccine) for Immunisation.  On 14-Jul-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (0.5 ML 1X (Once) and Drug Treatment Duration: NA) (lot number: UJ542AA; expiration date: 10-Jul-2022)  via intramuscular route in the left thigh for Immunization   .  On 14-JUL-2022 the patient developed a non-serious event 2 month old child was given an expired dose of pentacel with no reported adverse event (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event expired product administered.   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: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: approximately 40 patients over the age of 64 have received ADACEL with no reported adverse event; Initial information received on 15-Jul-2022 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves elderly and unknown gender approximately 40 patients over the age of 64 have received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2018 the patient developed a non-serious approximately 40 patients over the age of 64 have received Adacel at (unknown: formulation, strength, dose, frequency, route, administration site, batch number) for prophylactic vaccination with no reported adverse event (product use issue, unknown latency).  It was reported that "Pharmacist did not have any individual patient information available currently. Pharmacist states that she is compiling this information and agreed to follow-up to provide this information. Pharmacist states that email is the best method to communicate with her. No additional information provided by the reporter."   Action taken: Not applicable.  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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered MENACTRA after the expiration date with no reported adverse event; Initial information received on 15-Jul-2022 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 meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] after the expiration date 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 a  dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine, solution for injection (dose, frequency, batch lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination  On an unknown date it was reported that patient was administered menactra after the expiration date with no reported adverse event (expired product administered) (unknown latency).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event patient was administered menactra after the expiration date with no reported adverse 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 guidelines. 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: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired QUADRACEL given to a patient with no reported adverse event; Initial information received on 15-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom expired diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was given 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.   On an unknown date, the patient received an expired dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection,(dose and strength not reported) (lot C5755AB; expiry date: 10-Jul-2022) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) (unknown latency).  It was asked  if revaccination is necessary after giving expired QUADRACEL to a patient.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event expired quadracel given to a patient with no reported adverse 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 guidelines. 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: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: received a dose of an expired ACT-HIB diluent with no reported adverse event; Initial information received on 15-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who received a dose of an expired act-hib (HIB (PRP/T) VACCINE) diluent with no reported adverse event after receiving vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunisation.  On 14-Jul-2022, the patient received a  dose (0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test-0.5 ML) of suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot U6999AB, expiration date: 11-Jul-2022, via intramuscular route in the left thigh as Immunization.The patient used the product for the first time.  On 14-JUL-2022 the patient received a dose of an expired act-hib diluent with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (received a dose of an expired ACT-HIB diluent with no reported adverse 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 guidelines. 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: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: one dose of IPOL administered post excursion with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid non-serious case via health professional. GMI number: 01193802  This case involves a 4-year-old female patient who experienced one dose of IPV (VERO) [IPOL] administered post excursion 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 Immunization; Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) for Immunization; and Varicella Vaccine for Immunization.  The caller reported a temperature excursion of OPENED IPOL MDV with 69F for 10 hours of unknown cause because no human error as no one was present at the time of excursion, maybe due to a storm.   On 11-Jul-2022, the patient received opened IPOL MDV at dose 1 dosage form (DF) once (lot: T1D481M, expiry date:  via intramuscular route in the left thigh for prophylactic vaccination, administered was post excursion with no reported adverse event (poor quality product administered).  It was reported that "this situation is reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard. No further information provided by the reporter."  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    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 guidelines. 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: 1.83
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of Quadracel vaccine to 22-month-old child with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 22 months old female patient  to whom diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] administered with no reported adverse event.  The patient's past vaccination(s) included DTaP/IPV on 03-DEC-2021. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 13-Jul-2022, the patient received 0.5 ml  dose of suspect  diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection, (strength; unknown)  (lot C5862BA: expiry date; 01-APR-2023)  via intramuscular route in unknown side of leg for (Immunization)Prophylactic vaccination.  On 13-Jul-2022 it was reported administration of quadracel vaccine to 22-month-old child with no reported adverse event (product administered to patient of inappropriate age) (latency; same day)  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event administration of quadracel vaccine to 22-month-old child with no reported adverse 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 guidelines. 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: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 3 year old received a dose of Pediarix and IPOL at the same visit extra doses of IPOL being administered with no adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who was administered an extra dose of IPV (vero) [IPOL] with no 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) for Prophylactic vaccination.  On 24-Jun-2022, the patient received 0.5 mL dose of suspect IPV (vero) (lot Z1A121M; formulation and strength not reported) via subcutaneous route in the right thigh for immunization.  On 24-Jun-2022, the patient received a dose of pediarix and ipol at the same visit extra doses of ipol being administered with no adverse event (extra dose administered) following the administration of IPV (vero).  Action taken was not applicable.  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: 5.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: extra doses of IPOL; received a dose of Pediarix and IPOL at the same visit; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who had extra doses of ipol (IPV (VERO)) and received a dose of pediarix and ipol at the same visit.   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) for Immunisation.  On 24-Jun-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) lot Z1A121M via subcutaneous route in the right thigh as immunization.  On 24-JUN-2022 the patient had extra doses of ipol (extra dose administered) and received a dose of pediarix and ipol at the same visit  (vaccine coadministration) same day following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events   At time of reporting, the outcome was Unknown for all the events.   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 guidelines. 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: 5.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Opened IPOL MDV at a high of 47.5F out of range for 20 minutes with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who experienced opened ipol mdv at a high of 47.5f out of range for 20 minutes with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP),  HEPATITIS A VACCINE (HEPATITIS A,  MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) all for Immunisation.  On 15-Jul-2022, the patient received a  0.5 ml dose of suspect IPV (VERO) vaccine once (lot Z1A024N; expiry date: 17-Feb-2024) via intramuscular route in the left thigh for immunization.  On an unknown date the patient reported opened ipol mdv at a high of 47.5f out of range for 20 minutes with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  Action taken :not applicable.   At time of reporting, the outcome was Unknown for the event opened ipol mdv at a high of 47.5f out of range for 20 minutes with no reported adverse 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 guidelines. 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: U
Vaccine: RAB
Symptoms: Product dose omission issue
Clinical narrative: patient did not receive her 3rd dose as patient needed last Thursday with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of unknown age who did not receive her 3rd dose as patient needed last thursday with no reported adverse event after receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s),concomitant medication,  vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect RABIES (HDC) VACCINE(formulation, strength, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization. Information for batch and expiry date was requested.  It was reported that patient had a non-serious event of patient received her first dose on the day of exposure in the emergency room, came in for her second dose on day 3, but patient did not receive her 3rd dose as she needed last Thursday with no reported adverse event (product dose omission issue) (onset and latency: unknown).  Action taken : not applicable.  Outcome: Unknown  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: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: product was expired at the time of administration with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 59 years old female patient who was administered vaccine expired at the time of administration with no reported adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination.  On 18-Jul-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE( lot UJ542AAAand expiration date: 10-Jul-2022) at a dose of 0.5ml via unknown route in the left deltoid for immunization.  On 18-Jul-2022 (latency: same day),the patient was administered vaccine expired at the time of administration with no  reported adverse event (expired product administered). The patient needed the vaccine for a stem cell transplant.  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 guidelines. 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: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 9 week-old boy received ActHIB vaccine that had expired on 5/21/2022 with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 9-week-old boy who received HIB (PRP/T) Vaccine [ACT-HIB] vaccine that had expired on 21-May-2022 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 13V (CRM197) (Prevnar 13) and Rotavirus Vaccine Live Reassort Oral 5V (Rotateq) both for Prophylactic vaccination (Immunization).  On 13-Jul-2022, the patient received a 0.5 ml dose once total of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot: UJ472AA & U6940BA; expiry date: 21-Jul-2022; strength: standard) via intramuscular route in the right thigh for Prophylactic vaccination (Immunization).  On 13-Jul-2022, a 9 week-old boy received HIB (PRP/T) vaccine that had expired on 5/21/2022 with no reported adverse event (expired product administered) (latency: same day).  It was unknown if there were lab data/results available.  Action taken: Not applicable.  Outcome: Unknown.   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 guidelines. 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: 1.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient was given ACTHIB and PENTACEL on the same day medication error due to patient receiving an extra dose of HIB vaccine with no reported adverse event; Initial information received on 19-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA295304(CLUSTER) for same patient.  This case involves a 14 months old female patient who was given HIB (PRP/T) VACCINE [ACT-HIB] and Pentacel on the same day medication error due to patient receiving an extra dose of HIB vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 19-Jul-2022, the patient received 0.5 ml  (dose 4) of suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection (lot UJ649AA; strength and expiry date not provided) via intramuscular route in the right thigh for prophylactic vaccination  On 19-JUL-2022 on same day it was reported that patient was given acthib and pentacel on the same day medication error due to patient receiving an extra dose of hib vaccine with no reported adverse event (extra dose administered). Reporter asked if there were any concerns about the patient receiving two doses of HIB in the same day.  Action taken : not applicable.  Outcome : Unknown.   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: 1.17
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given ACTHIB and PENTACEL on the same day extra dose adminstered with no reported adverse event; Initial information received on 19-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA294411 for same patient.  This case involves a 14 months old female patient who experienced patient was given ACT-HIB and diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] on the same day extra dose adminstered 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), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 19-Jul-2022, the patient received a 0.5ml (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection  (lot UJ660AA;strength and expiry date not provided) via intramuscular route in the left thigh for prophylactic vaccination.  On 19-Jul-2022 on same day it was reported patient was given acthib and pentacel on the same day extra dose adminstered with no reported adverse event (extra dose administered). Reporter asked if there were any concerns about the patient receiving two doses of HIB in the same day.  Action taken : not applicable.  Outcome : Unknown.   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: F
Vaccine: FLUC3
Symptoms: Urticaria
Clinical narrative: Hives/almost anaphylaxis; This spontaneous case was received on 15-Jul-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-01739) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included Flucelvax Quadrivalent (influenza vaccine inact sag 4v, bathc number: 252679) received in 2018, after which she developed hives and almost anaphylaxis.  On an unspecified date in 2019, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration, anatomical location, dose and indication: not reported). The batch number reported was 261213.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient had reaction of hives and almost anaphylaxis.   The outcome of the event was not reported.  The reporter assessed the event of 'hives' as related to Flucelvax Quadrivalent. She had reactions of hives and almost anaphylaxis and she was asking if Flucelvax Quadrivalent contain any mRNA technology as she heard they snuck mRNA into vaccine starting in 2017.  The event of 'hives' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked with case 202202848 (the same patient).  Company comment: A patient of an unreported age developed Urticaria an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. It is reported that the patient almost had anaphylaxis. The patient's medical history and concomitant drugs were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.; Reporter's Comments: She had reactions of hives and almost anaphylaxis and she was asking if Flucelvax Quadrivalent contain any mRNA technology as she heard they snuck mRNA into vaccine starting in 2017.; Sender's Comments: A patient of an unreported age developed Urticaria an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. It is reported that the patient almost had anaphylaxis. The patient's medical history and concomitant drugs were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.
Sex: F
Vaccine: FLUC3
Symptoms: Urticaria
Clinical narrative: Hives/almost anaphylaxis; This spontaneous case was received on 15-Jul-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-01739) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2018, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration, anatomical location, dose and indication: not reported). The batch number reported was 252679.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient had reaction of hives and almost anaphylaxis.   The outcome of event was not reported.  The reporter assessed the event of 'hives' as related to Flucelvax Quadrivalent. She had reactions of hives and almost anaphylaxis and she was asking if Flucelvax Quadrivalent contain any mRNA technology as she heard they snuck mRNA into vaccine starting in 2017.  The event of 'hives' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  This case is linked with case 202202828 (the same patient).  Company comment: A patient of an unreported age developed urticaria an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. It is reported that the patient almost had anaphylaxis. The patient's medical history and concomitant drugs were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.; Reporter's Comments: She had reactions of hives and almost anaphylaxis and she was asking if Flucelvax Quadrivalent contain any mRNA technology as she heard they snuck mRNA into vaccine starting in 2017.; Sender's Comments: A patient of an unreported age developed urticaria an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. It is reported that the patient almost had anaphylaxis. The patient's medical history and concomitant drugs were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Hair texture abnormal
Clinical narrative: I have noticed his hair thinning and the texture has changed
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: EXTEMITIES
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: swollen and hot at the injection site-Mild, Additional Details: wife called and said  her husband got swollen at the injection site and hot
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Product preparation error
Clinical narrative: Peds Pfizer vax given without diluting. Pt waited 15 min for monitoring with no reactions or symptoms of concern. Discharged with mother.
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Peds Pfizer vax given without diluting. Pt waited 15 min for monitoring with no reactions or symptoms of concern. Discharged with mother.
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Peds Pfizer vax given without diluting. Pt waited 15 min for monitoring with no reactions or symptoms of concern. Discharged with mother.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Sore arm where shot was given, fatigue, muscle pain
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Disorientation, Incontinence, Pyrexia
Clinical narrative: Chills followed by fever followed by loss of balance and  incontinence.  Pretty intense but relatively short lived. I stayed in bed most of the following day and within 24hours of the onset of symptoms felt pretty normal.  I was disoriented at the lowest point and considered going to the emergency room at 2 am.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Ped pfizer vaccine given to pt without diluting. Pt was monitored for 15 min with no signs, symptoms or issues. Discharged home with parents.
Age: 1.75
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Peds Pfizer vaccine given to patient without dilution. Patient monitored 15 min for any signs or symptoms of reaction. None observed. Patient discharged home with parent.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called pharmacy when we were closed and left a voicemail on 7/23/22 at 919 pm reporting the adverse event from the vaccine she received on 7/22/22 around 4 pm. I listened/received her voicemail on the next business day 7/24/22 around 835am. She said 4-5 hours after receiving Pneumovax 23 her deltoid muscle became red, painful, itchy, hard, and swollen about the size of a softball. She put ice on it and took Ibuprofen and benadryl. She says it seems a little better today (7/23/22 when she called) but it is still sore and the redness extends under her arm.  She is going to let her doctor know about it.
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: Injection site haematoma, Injection site haemorrhage, Injection site swelling
Clinical narrative: Patient had excessive bleeding and immediate swelling at the site (hematoma like).
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: RINGING IN THE RIGHT EAR, FEELING OF WATER IN EAR
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: right arm red, swollen, hot to touch starting 4 inches below acromian process approximately 3.5x4.5 inch area.  This is about 1-2 inches below the injection site and appears to be subcutaneous.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmic migraine, Photopsia, Visual field defect, Visual impairment
Clinical narrative: Vision in right eye affected - flashing 'lights' no peripheral vision.  Suspected torn retina.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Gait disturbance, Heart rate increased
Clinical narrative: Heart rate increase, weakness, unsteady, difficulty walking
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema marginatum, Rash
Clinical narrative: Erythema Marginatum rash on L leg 36 hours after vaccine
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Dizziness started 1 day after vaccination, getting better every day but not feeling 100%
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Welt on arm shot was given at injection sight.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site swelling
Clinical narrative: Patient reported awakening in the early morning after receiving his booster dose with chills and later developed redness and swelling along his right arm extending to the elbow.