chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: yesterday she gave the TYPHOID Vi vaccine that was 8 weeks expired with no adverse event; Initial information received on 17-Jun-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 given TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] vaccine that was 8 weeks expired.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included YELLOW FEVER VACCINE LIVE (17D-204) (YF-VAX) for Immunisation.  On 16-Jun-2022, the patient received 0.25 ml total dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot T2A371M, exp date: 13-Apr-2022) via intramuscular route in the left deltoid for Immunization.  On 16-JUN-2022 the patient developed a non-serious event "yesterday she gave the typhoid vi vaccine that was 8 weeks expired with no adverse event" (expired product administered) following the administration of TYPHOID VI POLYSACCHARIDE 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 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: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally gave a patient expired MENACTRA with no reported adverse event; Initial information received on 17-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center  This case involves a 19 years old male patient who experienced accidentally gave a patient expired menactra with no reported adverse event while receiving 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 17-Jun-2022, the patient received a  0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (batch lot number : U6952AA,Expiry date :09-Jun-2022)(unknown strength) via intramuscular route in the right deltoid.  On 17-Jun-2022 (latency :same day) the patient developed a non-serious event of  accidentally gave a patient expired menactra with no reported adverse event (expired product administered) following the administration of meningococcal a-c-y-w135 (d 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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired MENACTRA was administered to a patient with no reported adverse event; Initial information received on 17-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call canter.  This case involves a 17 years old male patient who experienced expired menactra was administered to a patient with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 17-JUN-2022, the patient received a 0.5 ml (total) dose of suspect meningococcal a-c-y-w135 (d conj) vaccine lot U6952AA, expiry date: 09-Jun-2022 (strength, formulation, frequency: unknown) via intramuscular route in the left deltoid as Immunization.  On 17-JUN-2022 the patient developed a non-serious event expired menactra was administered to a patient 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 was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  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 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: Medication error, No adverse event, Poor quality product administered, Product preparation error
Clinical narrative: acthib may have been administered when it was reconstituted with sterile water with no reported adverse event; acthib may have been administered when it was reconstituted with sterile water with no reported adverse event; Initial information received on 21-Jun-2022 regarding an unsolicited valid non-serious case received from a pharmacist. Inquiry number: 01156214  This case reports ACT-HIB (HIB (PRP/T) VACCINE) may have been administered when it was reconstituted with sterile water with no reported adverse event.  The patient 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 acthib may have been administered when it was reconstituted with sterile water at (unknown formulation, strength, dose, lot number, route, administration site) for prophylactic vaccination (product preparation error, poor quality product administered, same day latency). It was not the first-time product was used. Patient was not using product now.  It was reported that "Caller states that ACTHIB may have been administered when it was reconstituted with sterile water. She would like to know the steps they could do moving forward. This situation is reported as a medication error due to administration of the vaccine using incorrect diluent."   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both 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: M
Vaccine: DTAPIPVHIB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: gave pentacel instead of adacel with no reported adverse event; Initial information received on 21-Jun-2022 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves an 11 years old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] instead of 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.  Concomitant medications included HIB vaccine conj (TET TOX) (ACTHIB).  On 20-Jun-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (lot number: UJ659AA, expiry date: 31-Jan, 2023; formulation, strength not reported) via intramuscular route in the left deltoid for immunization.  On 20-Jun-2022 the patient was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event (wrong product administered).  Action taken was 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: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: they inadvertently gave an expired MENACTRA vaccine to a patient with no reported adverse event; Initial information received on 21-Jun-2022 regarding an unsolicited valid non-serious case received from nurse. GMI number: 01156569  This case involves a 20-year-old female patient to whom inadvertently expired Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra] vaccine was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In June 2019, the nurse inadvertently gave patient dose of suspect Menactra (lot U6952AA, expiry date: 09-Jun-2022) at (unknown: formulation, strength, dose, route, site) for prophylactic vaccination (expired product administered, same day latency).  It was reported that "nurse states they inadvertently gave an expired MENACTRA vaccine to a patient. Is this dose valid or what do they need to do at this point? MIA transferred nurse who asks if a dose of Menactra which expired 09JUN2022 would need to be repeated? This situation is reported as a medication error due to expired vaccine given".   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: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: given an extra dose of MENACTRA (with no reported adverse event); Initial information received on 21-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old female patient who was given an extra dose of menactra (with no reported adverse event) while 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 21-Jun-2022, the patient received a 0.5ml of dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength: unknown) lot U7268AA, expiration date: 22-Apr-2023, via intramuscular route in the right arm as Immunisation. The patient used the product for the first time.  On 21-JUN-2022 the patient was given an extra dose of menactra (with no reported adverse event) (extra dose administered) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (given an extra dose of MENACTRA (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: 0.42
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inappropriate administration of MENACTRA with no reported adverse event; Initial information received on 21-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old male patient who had an inappropriate administration of menactra with no reported adverse event, while 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. Concomitant vaccines  included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX).  On 21-Jun-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE( lot U7191AA and expiration date: 18-Jan-2023) at a dose of 0.5ml via intramuscular route in the right anterior thigh as prophylactic vaccination.  On 21-JUN-2022, the patient had an inappropriate administration of menactra with no reported adverse event (product administered to patient of inappropriate age)(latency: same day).   Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the event .   At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: identified another patient that received the IPOL after the excursion occurred  with no adverse event; temperature excursion that occurred during stocking and inventory/the temperature mentioned 9.9 for 30 minutes no adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center.  This case involves a 3 years old male patient who received the ipol after the excursion occurred with no adverse event and temperature excursion that occurred during stocking and inventory/the temperature mentioned 9.9 for 30 minutes no adverse event after 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, Tetanus and Acellular Pertussis Vaccine (Adacel) for Immunization; and Tuberculin Test (Tubersol) for Tuberculin Test.  On 13-Jun-2022, the patient received a 0.5 ml {total} dose of suspect IPV (VERO) lot T1E872M frequency: once (strength, formulation, and expiry date: unknown) via intramuscular route in Left thigh for immunization.  On 08-JUN-2022 the patient developed a non-serious event temperature excursion that occurred during stocking and inventory/the temperature mentioned 9.9 for 30 minutes no adverse event (product storage error) latency same day following the administration of IPV (VERO). On 13-JUN-2022 the patient developed a non-serious event identified another patient that received the ipol after the excursion occurred  with no adverse event  (poor quality product administered) latency: 5 days following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  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: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received the QUADRACEL vaccine instead of the PENTACEL vaccine by accident with no reported adverse event.; Initial information received on 22-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who received the diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] instead of the Pentacel vaccine by accident with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 02-Jun-2022, the patient received 0.5ml dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, (formulation: unknown) (lot C5862BA; expiry date; 01-Apr-2023; strength and not reported) via intramuscular route in the right thigh for prophylactic vaccination.  On 02-Jun-2022,the patient received the quadracel vaccine instead of the pentacel vaccine by accident with no reported adverse event (wrong product administered) (same day latency).  It was asked if the child should get a separate HIB injection and what would the proper diluent be.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received the QUADRACEL vaccine instead of the PENTACEL vaccine by accident with no reported adverse event.).  At time of reporting, the outcome was Unknown for the event patient received the quadracel vaccine instead of the pentacel vaccine by accident 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received the QUADRACEL vaccine instead of the PENTACEL vaccine by accident with no reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient received the diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] instead of the Pentacel vaccine by accident with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination.  On 02-Jun-2022, the patient received 0.5ml dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (lot C5862BA; expiry date; 01-Apr-2023; strength and not reported) via intramuscular route in the right thigh for prophylactic vaccination.  On 02-JUN-2022, it was reported that patient received the quadracel vaccine instead of the pentacel vaccine by accident with no reported adverse event (wrong product administered) (latency same day).  It was asked "if the child should get a separate HIB injection and what would the proper diluent be"  Action taken : Not applicable.  At time of reporting, the outcome was Unknown for the event patient received the quadracel vaccine instead of the pentacel vaccine by accident 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: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 4 month old child received an expired dose of ACT-HIB with no reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 4-month-old female patient who received an expired dose of act-hib with no reported adverse event while receiving vaccine Hib (Prp/T) Vaccine [Act-Hib].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (Hepatitis B Vaccine) for Prophylactic vaccination (immunization).  On 15-Jun-2022, the patient received a 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE (3rd dose without the pentacle) lot number, formulation, strength not reported, expiry date: 14-May-2022 frequency: once via intramuscular (IM) route in the thigh nos (IM/R vastus lateralis) for prophylactic vaccination (immunization).  On 15-Jun-2022, the patient developed a non-serious event 4 month old child received an expired dose of act-hib with no reported adverse event (expired product administered) (latency 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 (expired product administered).  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 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: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired dose of MENACTRA being administered to a patient with no reported adverse events; Initial information received on 22-Jun-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 dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] being administered to a patient with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Jun-2022, the patient received expired dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine, solution for injection (lot number not reported and expiry date 09-Jun-2022 was administered to a patient with no reported adverse events (expired product administered).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of menactra being administered to a patient with no reprted adverse 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: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ADACEL was administered to a patient with no reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 25 years old male patient who was administered expired dose of Adacel 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 21-Jun-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6702AA and expiration date:20-Jun-2022) at a dose of 0.5ml via intramuscular route in the left deltoid as prophylactic vaccination.  On 21-Jun-2022(latency: same day), the patient was administered expired dose of adacel with no reported adverse event (expired product administered) 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 .   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: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: calling in regards to expired pentacel/therapy date: 21Jun2022 with no other reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 2 years old male patient who was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] with no other reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 21-Jun-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (lot number: UJ425AAA, expiry date: 21-May-2022; formulation, strength and route not reported) for immunization.  On 21-JUN-2022 the patient was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] with no other reported (expired product administered).   Action taken was 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: 0.75
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: receiving two polio doses in error with no adverse event; Initial information received on 23-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 months old female patient who was receiving two polio doses in error with no 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, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation.  On 22-Jun-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) lot U1C571M, expiration date: 17-Jun-2023, (formulation: unknown) strength: standard, via intramuscular route in the left leg as immunization. This would be third dose of the patient.  On 22-JUN-2022 the patient was receiving two polio doses in error with no adverse event (incorrect dose administered) 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 the event (receiving two polio doses in error with no adverse event).  At time of reporting, the outcome was Unknown for the event receiving two polio doses in error 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.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature excursion, low temperature 32.82 F for 25 minutes total time with no reported adverse event; IPOL was potentially administered to a patient after it was not suitable to use post excursion with no reported adverse event; Initial information received on 23-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender and it involved temperature excursion, low temperature 32.82 Fahrenheit (F) for 25 minutes total time with no reported adverse event and ipol was potentially administered to a patient after it was not suitable to use post excursion with no reported adverse event , for punctured vaccine IPV (VERO) [IPOL].   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 IPV (VERO), ( lot:  U1A601M ; expiry date: 2-Feb-2023) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date there was temperature excursion, low temperature 32.82 F for 25 minutes total time with no reported adverse event (product temperature excursion issue) (onset and unknown latency)  On an unknown date , Ipol was potentially administered to a patient after it was not suitable to use post excursion with no reported adverse event (poor quality product administered) (onset and unknown latency)    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.; Sender's Comments:  01160269: 01160330:
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Off label use, Wrong product administered
Clinical narrative: mistakenly given a PENTACEL injection instead of an intended Tdap vaccination with no reported adverse event; Initial information received on 23-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 68 years old male patient who was  mistakenly given a Pentacel injection instead of an intended Tdap vaccination with no reported adverse event , for 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 POLYSACCH 23V (PNEUMOVAX-23).  On 22-Jun-2022, the patient received a 0.5 ml  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, ( lot: UJ598AAA ; expiry date: 05-Dec-2022) via intramuscular route in the right arm for immunization. It was reported that the patient was mistakenly given a Pentacel injection on 22-Jun-2022 instead of an intended Tdap vaccination with no reported adverse event (off label use) (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: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy
Clinical narrative: has administered MENACTRA to a pregnant patient, with no reported adverse event; Initial information from received on 24-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an 18 years old female patient who was exposed to vaccine Meningococcal A-C-Y-W135 (D conj) vaccine [Menactra] during her pregnancy, with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported administration of Meningococcal A-C-Y-W135 (D conj) vaccine during pregnancy occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (lot: U7273BA, expiry date: 24-apr-2023; formulation not reported) via intramuscular route in the right deltoid for prophylactic immunization.  On an unknown date, the meningococcal A-C-Y-W135 (D CONJ) vaccine was administered to a pregnant patient, with no reported adverse event (exposure during pregnancy).  Action taken was not applicable.  Outcome: Unknown   Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bartonella test negative, Blood test normal, Borrelia test negative, Chest X-ray normal, Colonoscopy normal
Clinical narrative: Weakness in arms and legs, weight loss of 15 lbs in a months time, nervous system in chaos, overall malaise, trouble concentrating, a period of insomnia and dark thoughts.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen normal, Computerised tomogram head normal, Computerised tomogram thorax normal, Dengue virus test negative, Disturbance in attention
Clinical narrative: Weakness in arms and legs, weight loss of 15 lbs in a months time, nervous system in chaos, overall malaise, trouble concentrating, a period of insomnia and dark thoughts.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Endoscopy normal, Insomnia, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Malaise
Clinical narrative: Weakness in arms and legs, weight loss of 15 lbs in a months time, nervous system in chaos, overall malaise, trouble concentrating, a period of insomnia and dark thoughts.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Negative thoughts, Nervous system disorder, SARS-CoV-2 test negative, Thyroid function test normal
Clinical narrative: Weakness in arms and legs, weight loss of 15 lbs in a months time, nervous system in chaos, overall malaise, trouble concentrating, a period of insomnia and dark thoughts.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Weakness in arms and legs, weight loss of 15 lbs in a months time, nervous system in chaos, overall malaise, trouble concentrating, a period of insomnia and dark thoughts.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pyrexia
Clinical narrative: Fever (> 101), headache, shortness of breath last around 12 hours
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired MENACTRA was administered to a patient with the expiration date of 23Aug2021 with no reportd adverse event; Initial information received on 24-Jun-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves 14 years old patient of unknown gender to  whom  expired menactra was administered with the expiration date of 23aug2021 with no reportd adverse event while 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.  Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation.  On 24-JUN-2022, the patient received a  0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, frequency, formulation was unknown, lot U66908AAA  and expiry date: 23-Aug-2021) via unknown intramuscular route in right deltoid for Immunization. Patient was not taking it for the first time.  On 24-JUN-2022 the patient developed a non-serious event of  expired menactra was administered to a patient with the expiration date of 23aug2021 with no reported adverse event (expired product administered) (same day latency) 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 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: DTAPIPV, HIBV, IPV, MNQ, TDAP, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: reported a temperature excursion due to an unknown cause, temperature reached 24.9 F with no adverse vent; Initial information received on 27-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (unknown age and gender) who reported a temperature excursion due to an unknown cause, temperature reached 24.9 f with no adverse vent while receiving vaccines menveo, kinrix, boostrix, diphtheria-2/tetanus/5 ac pertussis vaccine [adacel], HIB (PRP/T) vaccine [acthib] AND IPV (VERO) [IPOL].  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) (lot T1D481M; expiry date: 23-jun-2022) via unknown route in unknown administration site, suspect HIB (PRP/T) VACCINE (strength, dose, formulation, route, lot number and expiry date: not reported) via unknown route in unknown administration site, suspect diphtheria-2/tetanus/5 ac pertussis vaccine (strength, dose, formulation, route, lot number and expiry date: not reported), suspect boostrix not produced by sanofi pasteur(strength, dose, formulation, route, lot number and expiry date: not reported), suspect kinrix not produced by sanofi pasteur (strength, dose, formulation, route, lot number and expiry date: not reported) and suspect menveo not produced by Sanofi Pasteur (strength, dose, formulation, route, lot number and expiry date: not reported) all for prophylactic vaccination.  In JAN-2022 the patient a temperature excursion due to an unknown cause, temperature reached 24.9 f with no adverse vent (product storage error) (unknown latency) following the administration of IPV (VERO), menveo, kinrix, boostrix, diphtheria-2/tetanus/5 ac pertussis vaccine, HIB (PRP/T) 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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of MENACTRA was inadvertently administered to a patient with no reported adverse event; Initial information received on 27-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient who received an expired dose of meningococcal a-c-y-w135 (d conj) vaccine [Menactra] 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 Meningococcal Vaccine B and HPV Vaccine for Immunisation.  On 20-Jun-2022, the patient received a Dose:2 of suspect meningococcal a-c-y-w135 (d conj) vaccine (dose: 0.5 ml total, frequency: once, Strength: standard, lot U6951AB, expiry date: 06-Jun-2022, Solution for injection) via intramuscular route in the left deltoid for Immunisation.   On 20-Jun-2022 the patient developed a non-serious event as an expired dose of menactra was inadvertently administered with no reported adverse event (expired product administered) (Latency: same day). The caller wanted to know if the dose was valid and/or whether it should be repeated.   Action taken was 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: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: ACTHIB that was reconstituted with normal saline instead of the supplied ACTHIB diluent with no reported adverse event; Initial information received on 27-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who was being administered Acthib that was reconstituted with normal saline instead of the supplied Acthib diluent with no reported adverse event while 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 PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for. Prophylactic vaccination  On 27-Jun-2022, the patient received a  0.5 ml dose of suspect HIB (PRP/T) VACCINE, (lot: UJ589AAA ; expiry date: 25-Oct-2022) once via intramuscular route on left leg  and it was reported that the patient was being administered Acthib that was reconstituted with normal saline instead of the supplied Acthib 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 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.