chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient received an unnecessary hib dose as well as an extra IPV dose; patient was inadvertently given PENTACEL instead of the ordered DAPTACEL; Initial information received on 18-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who experienced patient was inadvertently given pentacel instead of the ordered daptacel and patient received an unnecessary hib dose as well as an extra ipv dose 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA ZOSTER VACCINE) for Immunisation.  On 18-Aug-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE once (lot UJ651AAA; expiry date: 25-Feb-2023) via intramuscular route in the left thigh for prophylactic vaccination.  On 18-AUG-2022 the patient reported  patient was inadvertently given pentacel instead of the ordered daptacel (wrong product administered) and received an unnecessary hib dose as well as an extra ipv dose (extra dose 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 wrong product administered and extra dose 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.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: reported liquid DTaP-IPV portion of PENTACEL given without the Hib component with no reported adverse event; reported liquid DTaP-IPV portion of PENTACEL given without the Hib component with no reported adverse event; Initial information received on 18-Aug-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old male patient to whom liquid dtap-ipv portion of pentacel given without the hib component 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 live reassort oral 5V (Rotateq) both for Prophylactic vaccination.  On 01-Aug-2022, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine at a dose of 0.5 ml total (lot U7198AA, expiry date: 28-Jan-2023) via intramuscular route in the left thigh for immunisation.  On 01-Aug-2022 liquid dtap-ipv portion of pentacel given without the hib component with no reported adverse event (single component of a two-component product administered, Product preparation error) same day latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  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: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was administered Menactra 4 weeks after receiving a dose of Menactra instead of the ordered Men B vaccine with no reported adverse event; Patient was administered Menactra 4 weeks after receiving a dose of Menactra instead of the ordered Men B vaccine with no reported adverse event; Initial information received on 18-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old male patient who was administered meningococcal A-C-Y-W135 (D conj) vaccine [Menactra] 4 weeks after receiving a dose of menactra instead of the ordered men b vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Aug-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D conj) vaccine once (formulation and strength not reported; lot U7492AA, expiry date: 26-Oct-2023) via intramuscular route in the left deltoid for immunization.  On 18-Aug-2022 the patient was administered menactra 4 weeks after receiving a dose of menactra instead of the ordered men b vaccine with no reported adverse event (wrong product administered) and (extra dose administered) following the administration of meningococcal A-C-Y-W135 (D conj) vaccine.   It was reported, the patient received MENACTRA 4 weeks ago 18JUL2022 and returned today for a Men B vaccine. The patient was mistakenly given this 2nd dose of MENACTRA within a 4 week time frame. Caller is also asking how long to wait before given MEN B since the patient did get an extra dose of MENACTRA.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both 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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: She was administering the medication to the patient the product leaked with no reported adverse event; Initial information received on 18-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who was given the MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI to the patient the product leaked and incomplete dose was administered 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 (T CONJ) VACCINE (dose, formulation, strength: unknown) (lot U7294AA, Exp date: 23-May-2024) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "she was administering the medication to the patient the product leaked with no reported adverse event (incorrect dose administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was reported "caller states she was administering a dose to a patient when the product leaked out from the tip of the syringe. Caller is not sure how much vaccine product the patient may have received and would like to know if they should revaccinate. Caller states they withdrew the product from the vial using one of their own syringes. She stated they expelled the air bubbles from the syringe like she normally would, and did not notice any leaking at the time. However as she was administering the medication to the patient the product leaked and is not sure how much product the patient may have received.  The product leaked out from where the syringe and needle connect Leaking".   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 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: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: ACTHIB administered with sterile water instead of provided diluent, with no reported adverse event; Initial information received on 19-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who administered acthib with sterile water instead of provided diluent, with no reported adverse event after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  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 (DAPTACEL) for Prophylactic vaccination.  On 18-Aug-2022, the patient received a dose number 4 of suspect HIB (PRP/T) VACCINE (lot UJ6353AA and expiration date:27-Jan-2023) at a dose of 0.5ml  via intramuscular route in the right thigh for immunization.  On 18-Aug-2022 (latency: same day) ,the patient developed a non-serious event of act hib administered with sterile water instead of provided diluent, with no reported adverse event (product preparation error) .   Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the event.   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: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient was administered quadracel subcutaneously instead of intramuscularly due to patient moving around during administration with no reported adverse event; Initial information received on 19-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old female patient to whom DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] was administered  subcutaneously instead of intramuscularly due to patient moving around during administration 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 Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, suspension for injection (strength not reported) (lot number: C5970AA; Expiration Date: 02-Feb-2024) via subcutaneous route in the thigh nos for prophylactic vaccination instead of intramuscularly due to patient moving around during administration with no reported adverse event (incorrect route of product administration) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event incorrect route of product administration.   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.   Additional information was received on 19-Aug-2022: concomitant vaccine MMR added, dosing details with batch no. and expiration date was added for Quadracel. Text amended accordingly.
Age: 29.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired typhim vi dose was administered with no other reported adverse event; Initial information received from on 22-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 29 years old female patient to whom expired TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] dose was administered with no other reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 22-Aug-2022, the patient received a 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (strength, formulation, lot number and expiry date was unknown) via intramuscular route in the left deltoid for Immunization. Information for batch and expiry date was requested.  On 22-Aug-2022 the patient developed a non-serious event of expired typhim vi dose was administered with no other reported adverse event (expired product administered) (Latency: same day) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  Action taken: not applicable.  Outcome: 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 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: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: lyophilized component of pentacel being reconstituted with sterile water, rather than with the liquid component of the pentacelvaccine with no reported adverse event; Initial information received on 22-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient to whom, while giving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lyophilized component being reconstituted with sterile water, rather than with the liquid component of the pentacelvaccine 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 WATER FOR INJECTION (STERILE WATER); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and HEPATITIS B VACCINE (VACCINE, HEPATITIS B) for Immunisation.  On 17-Aug-2022, the patient received 0.5ml, dose: 3 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot U7013AB, (expiry date:15-Oct-2022) via intramuscular route in the left vastus lateralis (left thigh) for iimmunisation.  On 17-Aug-2022 (latency: same day), the patient had a non-serious event "lyophilized component of pentacel being reconstituted with sterile water, rather than with the liquid component of the pentacelvaccine with no reported adverse event" (product preparation error).  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 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: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACT-HIB vaccine but one of the doses was mixed with saline and not the approved 0.4% diluent with no reported adverse event; Initial information received on 22-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reported a product preparation error (received Act-Hib vaccine but one of the doses was mixed with saline and not the approved 0.4% diluent with no reported adverse event ), for the vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown  dose of suspect HIB (PRP/T) VACCINE, with an unknown formulation and strength , ( lot: UJ522AA ; expiry date: 06-Aug-2022) for immunization.  The reporter stated that approximately 6 patients received the ACT-HIB vaccine but one of the doses was mixed with saline and not the approved 0.4% diluent with no reported adverse event (product preparation error) (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 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: F
Vaccine: UNK
Symptoms: Product preparation error
Clinical narrative: products not being mixed together before administration with no reported adverse event; receiving the liquid portion DTap-IPV and not the powder portion HIB due to the products not being mixed together before administration with no reported adverse event; Initial information received on 22-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient and reported that products not being mixed together before administration with no reported adverse event and receiving the liquid portion dtap-ipv and not the powder portion hib due to the products not being mixed together before administration with no reported adverse event , for the 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 HEPATITIS A VACCINE (HEPATITIS A) for Immunisation. On 18-Jul-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE , with an unknown formulation and strength , (lot: UJ622AAA ; expiry date: 07-Dec-2022) (frequency: once) via intramuscular route in the left thigh for immunization.  The clinic reported on behalf of a consumer having a medication error with PENTACEL  described as the patent only receiving the liquid portion DTap-IPV and not the powder portion HIB due to the products not being mixed together before administration with no reported adverse event (product preparation error) (single component of a two-component product administered) (onset date: 18-Jul-2022; latency: same day)   Action taken : not applicable for both the events.  Outcome: unknown for both 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 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: 65.0
Sex: M
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: patient received TENIVAC by mistake. The patient was supposed to receive PREVNAR with no adverse event; Initial information received on 22-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 65 years old male patient who received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] by mistake. The patient was supposed to receive prevnar with no adverse event.  The patient's past vaccination(s) included TENIVAC  in 1998, TENIVAC  on 18-Jan-2018, ADACEL and 5 doses the last 24 years of TETANUS and DIPTHERIA.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 22-Aug-2022, the patient received 0.5 ml total, 3rd dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation and lot number: unknown) via intramuscular route in unknown administration site as Immunization.  On 22-Aug-2022 (latency: same day) the patient developed a non-serious event "patient received tenivac by mistake. the patient was supposed to receive prevnar with no adverse event (wrong product administered).  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: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: 7 years old patient took the 4th dose of depatcel today with no reported adverse event; 7 years old patient took the 4th dose of depatcel today with no reported adverse event; Initial information received on 23-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old male patient who took the 4th dose of depatcel today with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Aug-2021, the patient received a 0.25 mL to 2 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation, route,lot number not reported) in unknown administration site. On 20-Nov-2021 he also received a  dose of the same vaccine  with an unknown batch number. On 20-Oct-2021 he also received a  dose of the same vaccine  with an unknown batch number. On 23-Aug-2022 he also received a  dose of the same vaccine  with an unknown batch number via unknown route.  On 23-AUG-2022 the patient reported 7 years old patient took the 4th dose of depatcel today with no reported adverse event (inappropriate schedule of product administration) (off-label use) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for 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 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:  0124120:
Age: 2.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child (2.5 years) was given Adacel inadvertently by HCP with no reported adverse event; Initial information received on 23-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 28 months old female patient who was given adacel inadvertently by health care professional with no reported adverse event, after  receiving vaccine 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 23-Aug-2022, the patient received a  total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE( lot U7461AA) at 0.5ml once via intramuscular route in unknown administration site for Immunization..  On 23-Aug-2022(latency: same day), the patient was given adacel inadvertently by health care professional with no reported adverse event (product administered to patient of inappropriate age)(latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event.   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: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Device connection issue, No adverse event, Product administered to patient of inappropriate age, Syringe issue
Clinical narrative: Patient was 81 years old was given FLUZONE HIGH DOSE QUADRIVALENT  with no reported adverse event; Initial information received on 24-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.   This case involves a 81 years old male patient was given INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] high dose quadrivalent 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 22-Aug-2022, the patient received less than 0.7ml once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE Prefilled syringe (strength was unknown, lot UJ875AE and expiry date: 30-Jun-2023) via intramuscular route in the right arm for Immunization. Patient was not taking it for the first time.   It was reported that patient was 81 years old was given fluzone high dose quadrivalent with no reported adverse event (product administered to patient of inappropriate age) (onset date: unknown, Latency: same day) and few drops of the fluzone vaccine leaked while it was being administered. The vaccine leak at the connection site of the needle and the barrel when the plunger was pushed for administration of the vaccine.  Reporter wants to know if they need to revaccinate and when to revaccinate a patient who was given Fluzone as a few drops of the vaccine leaked while it was being administered. The vaccine leak at the connection site of the needle and the barrel when the plunger was pushed for administration of the vaccine.  PTC(product technical complaint) assessment medical/Physical : Physical  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: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: IPOL being administered to a patient after the expiration date with no reported adverse event; Initial information received on 24-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient and it was reported that ipol (IPV (VERO)) being administered to a patient 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.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 19-Aug-2022, the patient received a fourth dose of suspect IPV (VERO) (formulation, strength: unknown) lot R1F801M, expiration date: 28-Sep-2021, via intramuscular route in the left arm as Immunization.  On 19-AUG-2022 the ipol being administered to a patient after the expiration date with no reported adverse event (expired product administered) same day following the administration of IPV (VERO). Caller stated that a patient was administered an expired dose of IPOL and would like to know if it a valid dose. Caller also wanted to provide feedback to Sanofi and suggested that the full year be written out in the expiration date with four numbers instead of two because they thought the first two numbers was the year that the product expired.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (IPOL being administered to a patient after the expiration date 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 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: 1.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Quadracel to 19-month-old patient with no adverse event; Initial information received on 24-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 19 months old female patient to whom diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) ; HIB VACCINE (HIB); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 25-Jul-2022, the 19-month-old patient was administered 0.5 ml dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection, strength; unknown (lot C5862BA; and expiry date 01-Apr-2023)  via intramuscular route in the left thigh for prophylactic vaccination with no 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 administered quadracel to 19-month-old patient with no 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 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: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: supposed to get a Men B vaccine today ,however another dose of MENQUADFI instead with no reported adverse event; Initial information received on 24-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient who was supposed to get a Men B vaccine today ,however  she got another dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] instead with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    In August 2022, the patient received 1st dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot number not reported via unknown route in unknown administration site as Immunization. On 24-Aug-2022 she also received dose:2, 0.5 ml of the same vaccine (lot U7294AB, Exp date: 24-May-2023) via intramuscular route in the left deltoid as Immunization.  On 24-Aug-2022 (latency: same day) the patient developed a non-serious event "supposed to get a men b vaccine today ,however another dose of menquadfi instead with no reported adverse event" (wrong product administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  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 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: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACTHIB was administered using a sterile water diluent instead of the provided diluent with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received from health professional on 24-Aug-2022.  This case involves a 15-month-old female patient who was administered vaccine HIB (PRP/T) VACCINE [ACT-HIB] using a sterile water diluent instead of the provided diluent with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13) for Immunization.  On 23-Aug-2022, the patient received 4th dose of suspect ACT-HIB vaccine at dose 0.5ml once (lot UJ594AA) via intramuscular route in the left thigh for prophylactic vaccination administered using a sterile water diluent instead of the provided diluent with no reported adverse event (product preparation error) same day latency.  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 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: 2.0
Sex: F
Vaccine: HIBV, UNK
Symptoms: Poor quality product administered, Product preparation error
Clinical narrative: administered Acthib, diluted incorrectly with a room  temperature sterile water diluent with no reported adverse event; administered Acthib, diluted incorrectly with a room  temperature sterile water diluent with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. 01250757  This case involves a 2-year-old female patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] diluted incorrectly with a room temperature sterile water diluent 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 for Immunization; Hepatitis A Vaccine for Immunization; and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) for Immunization.  On 24-Aug-2022, the patient administered Suspect ACT-HIB vaccine with diluent sterile water at room temperature at dose 0.5ml once (lot: UJ647AAA, expiry date: 02-MAR-2023) via (unknown: formulation, strength, route) in the left thigh for prophylactic vaccination with no reported adverse event (product preparation error, Poor quality product administered) at same day latency.  It was reported that "A staff member gave HIB vaccine that was diluted incorrectly to two sibling patients. The first patient received Act-HIB diluted with sterile water. The dose was diluted incorrectly with a room temperature sterile water diluent that is meant for live virus vaccines. Normally, the facility attaches vaccines to their diluents by a band when the vaccines are received, to prevent this type of error".   Action taken: Not applicable for both suspects.  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: 0.25
Sex: M
Vaccine: UNK, UNK
Symptoms: Product preparation error
Clinical narrative: received the powder portion of PENTACEL diluted with sterile water with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA356995.  This case involves a 3 months old male patient who had received the powder portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] diluted with WATER FOR INJECTION [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 PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 24-Aug-2022 the patient developed a non-serious event of received the powder portion of pentacel (strength, formulation was unknown, dose: 0.5ml, once (1X), Batch number: U791AA and expiry date: 10-Oct-2023) diluted with sterile water with no reported adverse event (product preparation error,onset date: 24-Aug-2022, Latency: same day) for prophylactic vaccination.  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: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurse administered an expired menactra to a patient with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 22 years old male patient who was administered an expired menactra  with no reported adverse event , after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  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 ( lot U6952AA and expiarion date: 09-Jun-2022) at a dose 0f 0.25ml via intramuscular route in the left deltoid for immnuization.  On an unknown date , the patient administered an expired menactra with no reported adverse event (expired product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  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.
Sex: U
Vaccine: IPV
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: IPOL was given to a child in the arm and the child pulled the arm away and only received half the dose (with no reported adverse event); Initial information received on 25-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Child and unknown gender patient to whom IPV (VERO) [IPOL] was given in the arm and the child pulled the arm away and only received half the dose (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 IPV (VERO), suspension for injection (dose, strength, lot number and expiry date not reported) via unknown route in arm Nos for immunization and the child pulled the arm away and only received half the dose (with no reported adverse event) (incorrect dose administered) (unknown latency). Caller is wanted to know if they should re administer.  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: U
Vaccine: YF
Symptoms: Rash
Clinical narrative: had developed rashes over the past week after receiving the YF-VAX; Initial information received on 25-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves 2 unknown age and unknown gender patient who experienced had developed rashes over the past week after receiving the YELLOW FEVER VACCINE - [YF-VAX].  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 YELLOW FEVER VACCINE, solution for injection (lot number and expiry date not reported) via unknown route in unknown administration site for Immunization  On an unknown date the patient developed rashes over the past week after receiving the yf-vax (rash) (unknown latency).  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (had developed rashes over the past week after receiving the YF-VAX).  At time of reporting, the outcome was Unknown for the event had developed rashes over the past week after receiving the yf-vax.