chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nurse gave a 40 year old pregnant patient an injection of FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event; nurse gave a 40 year old pregnant patient an injection of FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event; Initial information received on 27-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 40 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in context of nurse gave a 40 year old pregnant patient an injection of fluzone high dose quadrivalent with no reported adverse event .Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was 31 weeks pregnant.  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 27-Jan-2022, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, injection ( strength: unknown) lot UJ768AC via intramuscular route in unknown administration site as Immunisation.  On 27-JAN-2022 the patient developed a non-serious event "nurse gave a 40 year old pregnant patient an injection of fluzone high dose quadrivalent with no reported adverse event" (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 27-JAN-2022 the patient developed a non-serious event "nurse gave a 40 year old pregnant patient an injection of fluzone high dose quadrivalent with no reported adverse event" (exposure during pregnancy) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (nurse gave a 40 year old pregnant patient an injection of FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event)  At time of reporting, the outcome was Unknown for the event nurse gave a 40 year old pregnant patient an injection of fluzone high dose quadrivalent with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is 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: 0.25
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: 11 patients received IPOL from the punctured multi-dose vial of IPOL after the first excursion with no adverse event; Initial information received on 28-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old female patient who 11 patients received ipol from the punctured multi-dose vial of ipol after the first excursion with no adverse event while receiving vaccine IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown (with an unknown batch number) for Immunization.  On 10-Dec-2021, the patient received a  dose of suspect IPV (VERO) with the dose of 0.5 ml (lot U1A45M) via intramuscular route in (unknown administration site, frequency, strength, and expiry date).  On 10-DEC-2021 the patient received ipol from the punctured multi-dose vial of ipol after the first excursion with no adverse event (product temperature excursion issue) (unknown latency) following the first dose intake and (unknown latency 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 (11 patients received IPOL from the punctured multi-dose vial of IPOL after the first excursion with no adverse event).  At time of reporting, the outcome was Unknown for the event 11 patients received ipol from the punctured multi-dose vial of ipol after the first excursion 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Hypersensitivity, Snake bite, Urticaria
Clinical narrative: snake bite; allergic symptoms; hives and trouble breathing; hives and trouble breathing; Initial information received on 30-Jan-2022 (processed as non case) and follow-up information received on 04-Feb-2022 regarding a unsolicited valid serious case received from the patient.  This case involves a 63 years old male patient who experienced snake bite, allergic symptoms, hives and trouble breathing while receiving vaccine influenza quadrival a-b vaccine (Fluzone QIV).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing highly allergic to animal-based vaccines (Food allergy).    On an unknown date, the patient received suspension for injection suspect influenza quadrival a-b vaccine dose and lot number not reported via unknown route in unknown administration site for prophylactic vaccination. Information on Batch number was requested.  Reportedly patient wants to know if there are any flu shots that do not have any animal products. Patient stated he took the swine and flu combination decades ago and went to the emergency room with hives (urticaria) (unknown latency) and trouble breathing(dyspnoea) (unknown latency). Patient stated he took the antivenom for a snake bite (unknown latency) and ended up in the hospital with allergic symptoms (hypersensitivity) (unknown latency). The reaction to the swine/flu shot was end of 1990's to early 2000. Caller states he was not allergic to eggs since he eats them all the time.   Action taken: not applicable.  The patient was treated with snake venom antiserum (Antivenom) for Snake bite.  At time of reporting, the outcome was Unknown for the event hives and trouble breathing, was Unknown for the event hives and trouble breathing, was Unknown for the event allergic symptoms and was Unknown for the event snake bite. Seriousness criteria: Patient was hospitalized for snake bite and allergic symptoms  Follow up information received on 04-Feb-2022 from patient: Events added: snake bite, allergic symptoms, hives and trouble breathing. Text amended accordingly.; Sender's Comments: Sanofi company comment dated 09-Feb-2022: This case concerns 63 years old male patient who was vaccinated with influenza quadrival a-b vaccine (Fluzone QIV) and at unspecified date after vaccination the patient experienced snake bite. A significant temporal relationship cannot be established due to lack of information on event onset date and vaccination date. Furthermore, information regarding condition at the time of vaccination, medical history, concomitants, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history, pre-natal genetic study (if any) would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: DTAP, DTAPIPVHIB, FLU4, HIBV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: refrigerator temperature reached 32.5 degrees Fahrenheit and the excursion lasted for 6 hours and 41 minutes with no ae; Initial information received on 31-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient with unknown demographics whos refrigerator temperature reached 32.5 degrees fahrenheit and the excursion lasted for 6 hours and 41 minutes with no ae while receiving vaccines [ACT-HIB], [ADACEL],[MENACTRA],[DAPTACEL], [PENTACEL] [FLUZONE HIGH-DOSE QUADRIVALENT] and with the use of medical device FLUZONE QIV-ID PRE-FILLED SYRINGE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started using FLUZONE QIV-ID PRE-FILLED SYRINGE Unknown dosage unknown (with an unknown batch number) for Immunization.  On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot ASKU via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot ASKU via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot ASKU via unknown route in unknown administration site.  On an unknown date the patients refrigerator temperature reached 32.5 degrees fahrenheit and the excursion lasted for 6 hours and 41 minutes with no ae (product storage error) (unknown latency) after starting use of FLUZONE QIV-ID PRE-FILLED SYRINGE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (refrigerator temperature reached 32.5 degrees Fahrenheit and the excursion lasted for 6 hours and 41 minutes with no ae).  At time of reporting, the outcome was Unknown for the event refrigerator temperature reached 32.5 degrees fahrenheit and the excursion lasted for 6 hours and 41 minutes with no ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: RAB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: did not show up for their scheduled third dose of IMOVAX with no reported adverse event; Initial information received on 01-Feb-2022  regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient with unknown demographics who  did not show up for their scheduled third dose of imovax with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Dec-2021, the patient received a  dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site.  On 30-DEC-2021 the patient developed a non-serious did not show up for their scheduled third dose of imovax with no reported adverse event (product dose omission issue) 15 days following the administration of RABIES (HDC) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (did not show up for their scheduled third dose of IMOVAX with no reported adverse event).  At time of reporting, the outcome was Unknown for the event did not show up for their scheduled third dose of imovax with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2nd dose of fluzone high dose quadrivalent was administered 11 days after the first dose was given with no reported adverse event; Initial information received on 01-Feb-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 6 month old and unknown gender patient to whom 2nd dose of influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] was administered 11 days after the first dose was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received the first dose of suspect influenza quadrival a-b high dose hv vaccine once (lot number and expiry date: unknown) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient received the second dose of the same vaccine once (lot: UT7376NA and expiry date: 30-Jun-2022) unk via unknown route in unknown administration site as prophylactic vaccination.  It was reported that the second dose of fluzone high dose quadrivalent was administered 11 days after the first dose was given (Inappropriate schedule of product administration, latency: unknown). The reporter enquired if there would be any harm to the baby as well as was asking for a suggestion if they needed to give another dose.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (2nd dose of fluzone high dose quadrivalent was administered 11 days after the first dose was given with no reported adverse event).  At time of reporting, the outcome was Unknown for the event 2nd dose of fluzone high dose quadrivalent was administered 11 days after the first dose was given 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: 56.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Patient received an expired dose of IPOL with no reported adverse event; Initial information received on 01-Feb-2022 regarding an unsolicited valid  non-serious case received from health professional.  This case involves a 56 years old male patient who received an expired dose of ipol with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13), Hepatitis B Vaccine (HEP B VACCINE ADULT CIPLA), HIB VACCINE (HIB) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) all for Prophylactic vaccination.  On 27-Dec-2021, the patient received suspect IPV (VERO) at a dose of 0.5 ml once (lot R1S972M, expiry date: 03-Oct-2021, strength, form not reported) via unknown route in the right deltoid for immunization.  On 27-Dec-2021 the patient received an expired dose of ipol with no reported adverse event (expired product administered) same day of latency following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Patient received an expired dose of IPOL with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received an expired dose of ipol 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: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Menactra booster dose was given at 14 years age with no reported adverse event; Initial information received on 01-Feb-2022 regarding an unsolicited valid non-serious case was received from the health professional.  This case involves a 14 years old female patient to whom meningococcal a-c-y-w135 (d conj) vaccine (Menactra) booster dose was given at 14 years age with no reported adverse event.  The patient's past medical history, medical treatment(s), and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 01-Feb-2022, the patient received a booster dose of suspect meningococcal a-c-y-w135 (d conj) vaccine at 0.5 ml total (lot number: U6951AA) via intramuscular route in right deltoid for immunization (product administered to patient of inappropriate age) (latency: same day). Reportedly, the patient was inadvertently administered a booster dose of meningococcal a-c-y-w135 (d conj) vaccine too early. Healthcare professional asked if there was any special to watch for in terms of safety or if there was any information on the validity of a dose given early and in response to the information provided in the "Booster Dose" SRD, whether it means in this case that the child could get the Menactra booster dose "when the child reaches at least the minimum age" or since this inadvertent dose was given at 14, would the patient have to wait 3 years until age 17 before getting a Menactra booster, since "the repeat dose should be spaced after the invalid dose by the recommended minimum interval." HCP stated that she had spoken to the patient's mother about three hours after the inadvertently dose, and the patient was fine and not experiencing any issues so far.  Action taken with meningococcal a-c-y-w135 (d conj) vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: medication error Adacel was inadvertently given to a two year old patient. with no AE; Initial information received on 01-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old and unknown gender patient who reported medication error adacel was inadvertently given to a two year old patient with no ae while 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 an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "medication error adacel was inadvertently given to a two year old patient with no ae" (product administered to patient of inappropriate age) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (medication error Adacel was inadvertently given to a two year old patient with no AE).  At time of reporting, the outcome was Unknown for the event medication error adacel was inadvertently given to a two year old patient with no ae.  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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Medical Assist reconstituted the Hib component of PENTACEL with normal saline, administered it to a patient/DTaP-IPV portion of PENTACEL was not given to the patient, this is how they discovered that only the Hib portion was given with no reported ae; Initial information received on 02-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient whose medical assist (assistant) reconstituted the hib component of pentacel with normal saline, administered it to a patient/dtap-ipv portion of pentacel was not given to the patient, this is how they discovered that only the hib portion was given with no reported ae (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 Sodium Chloride (Normal Saline).  On 06-Jan-2022, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE , once, (formulation, strength: unknown) lot UJ502AA via intramuscular route in unknown administration site as Immunisation.  On 06-JAN-2022 the medical assist reconstituted the hib component of pentacel with normal saline, administered it to a patient/dtap-ipv portion of pentacel was not given to the patient, this is how they discovered that only the hib portion was given with no reported ae (product preparation error) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received a dose of pentacle but the nurse made an error and used saline diluent for the hib component instead of using the dtap/ipv as the diluent, with no reported adverse event'; Initial information received on 02-Feb-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 a dose of pentacle but the nurse made an error and used saline diluent for the hib component instead of using the dtap ipv as the diluent, with no reported adverse event while receiving vaccine [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 01-Feb-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ571AA via intramuscular route in unknown administration site.  On an unknown date the patient received a dose of pentacle but the nurse made an error and used saline diluent for the hib component instead of using the dtap ipv as the diluent, with no reported adverse event (wrong product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received a dose of pentacle but the nurse made an error and used saline diluent for the hib component instead of using the dtap/ipv as the diluent, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received a dose of pentacle but the nurse made an error and used saline diluent for the hib component instead of using the dtap ipv as the diluent, 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 holders 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: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: temperature excursion due to vaccine not being put into the fridge; Initial information received on 02-Feb-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a patient with unknown demographics who had temperature excursion due to vaccine not being put into the fridge 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.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE,lot UJ572AAA via (unknown route, administration site,dose,frequency,strength).  On an unknown date the patient had temperature excursion due to vaccine not being put into the fridge (product temperature excursion issue) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion due to vaccine not being put into the fridge).  At time of reporting, the outcome was Unknown for the event temperature excursion due to vaccine not being put into the fridge.
Sex: F
Vaccine: TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received TENIVAC instead of ADACEL WITH NO REPORTED ADVERSE EVENT; Initial information received on 04-Feb-2022 regarding an unsolicited valid non-serious case was received from an other health professional.  This case involves a 36 year old female patient who received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Tenivac) instead of adacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Feb-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult vaccine once (lot U6831AA, expiry date: unknown) via unknown route in unknown administration site as prophylactic vaccination instead of Adacel (wrong product administered, latency: same day). The reporter was questioning on how long the patient needed to wait until administration of adacel.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (received tenivac instead of adacel with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received tenivac instead of adacel with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACT-HIB has been reconstituted with sterile dilute instead of the appropriate one with no advese event; Initial information received on 04-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported act-hib has been reconstituted with sterile dilute instead of the appropriate one with no advese 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.   On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE (lot-UJ611AAB,30-Nov-2022) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "act-hib has been reconstituted with sterile dilute instead of the appropriate one with no advese event" (product preparation error) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  It was reported "She thinks there may be three patients but she is not sure who they are as she is still investigating who gave the product".  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event act-hib has been reconstituted with sterile dilute instead of the appropriate one 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: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: nurse just administered the green vial with the Hib power that was reconstituted with a sterile water diluent from another vaccine and not the blue vial with no reported adverse event; Initial information received on 04-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient whose nurse just administered the green vial with the hib power that was reconstituted with a sterile water diluent from another vaccine and not the blue vial 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 ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 02-Feb-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot-UJ572AAA,11-Sep-2022) via intramuscular route in the right vastus lateralis for immunization.  On an unknown date the patient developed a non-serious event "nurse just administered the green vial with the hib power that was reconstituted with a sterile water diluent from another vaccine and not the blue vial with no reported adverse event" (product preparation error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was reported "nurse just administered the green vial with the Hib power that was reconstituted with a sterile water diluent from another vaccine and not the blue vial. She would like to know how to proceed with the patient and if what they did receive would be considered a valid Hib dose".  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event nurse just administered the green vial with the hib power that was reconstituted with a sterile water diluent from another vaccine and not the blue vial with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Menactra dose that was given on 31Jan2022 had expired on 09Jan2022, with no reported adverse event; Initial information received on 07-Feb-2022 regarding an unsolicited valid non-serious case was received from a pharmacist.  This case involves an unknown age and unknown gender patient who received meningococcal a-c-y-w135 (d conj) vaccine (Menactra) dose that was given on 31-Jan-2022 had expired on 09-Jan-2022, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Jan-2022, the patient received a 0.5 ml, total dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (lot number not reported, expiry date: 09-Jan-2022) via unknown route in unknown administration site for immunization (expired product administered, latency: same day).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (The Menactra dose that was given on 31Jan2022 had expired on 09Jan2022, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event the menactra dose that was given on 31jan2022 had expired on 09jan2022, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: a partial dose of Fluzone High-Dose Quadrivalent was administered due to due to leaking of the vaccine during administration with no reported adverse event; Initial information received on 07-Feb-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 71 years old female patient who had a partial dose of fluzone high-dose quadrivalent was administered due to due to leaking of the vaccine during administration with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  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 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UJ772AA via intramuscular route in unknown administration site as Immunisation.  On 07-FEB-2022 the patient had a partial dose of Fluzone high-dose quadrivalent was administered due to due to leaking of the vaccine during administration with no reported adverse event (incorrect dose administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  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.
Sex: F
Vaccine: RAB
Symptoms: Animal bite, Inappropriate schedule of product administration
Clinical narrative: protected with the deviation in vaccination schedule; she was bitten on the hand by a cat; Initial information received on 07-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced protected with the deviation in vaccination schedule and she was bitten on the hand by a cat while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TETANUS VACCINE (TETANUS VACCINE) for Cat bite.  On 05-Jan-2022, the patient received a  dose of suspect RABIES (HDC) VACCINE (lot number , Strength, formulation and expiry date was unknown) via unknown route in unknown administration site for immunization.  On 05-JAN-2022 the patient developed a non-serious event "protected with the deviation in vaccination schedule" (inappropriate schedule of product administration) following the administration of RABIES (HDC) VACCINE.  On 31-DEC-2021 the patient developed a non-serious  event "she was bitten on the hand by a cat "(animal bite) following the administration of RABIES (HDC) VACCINE.  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  It was not reported if the patient received a corrective treatment for the events (protected with the deviation in vaccination schedule, she was bitten on the hand by a cat).  At time of reporting, the outcome was Unknown for the event protected with the deviation in vaccination schedule and was Unknown for the event she was bitten on the hand by a cat.     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: TD
Symptoms: Medication error, Product storage error
Clinical narrative: TENIVAC has been drawn into syringe for 25min in 70F; Initial information received on 07-Feb-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient with unknown demographics whos tenivac has been drawn into syringe for 25min in 70f while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported.  On an unknown date the patient tenivac has been drawn into syringe for 25min in 70f (product storage error) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (TENIVAC has been drawn into syringe for 25min in 70F).  At time of reporting, the outcome was Unknown for the event tenivac has been drawn into syringe for 25min in 70f.     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: DTAP, HIBV, HIBV, IPV, TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Temperature excursion at a high of 66F for 27 minutes due to the refrigerator being accidentally left opened with no reported adverse event; Initial information received on 08-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient with unknown demographics who had temperature excursion at a high of 66f for 27 minutes due to the refrigerator being accidentally left opened with no reported adverse event while receiving vaccines [ACT-HIB], [IPOL],[ADACEL],[DAPTACEL].  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 HIB (PRP/T) VACCINE with  lot UJ579AA via unknown route in unknown administration site with(unknown dosage form, strength, frequency)for immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5829BA via unknown route in unknown administration site with(unknown dosage form, strength, frequency)for immunization.  On an unknown date, the patient received a  dose of suspect ACTHIB not produced by Sanofi Pasteur lot UJ579AA via unknown route in unknown administration site with(unknown dosage form, strength, frequency)for immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7055AA via unknown route in unknown administration site with(unknown dosage form, strength, frequency)for immunization.  On an unknown date, the patient received a  dose of suspect IPV (VERO) lot T1E87 via unknown route in unknown administration site with(unknown dosage form, strength, frequency)for immunization.   On an unknown date the patient had temperature excursion at a high of 66f for 27 minutes due to the refrigerator being accidentally left opened with no reported adverse event (product storage error) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Temperature excursion at a high of 66F for 27 minutes due to the refrigerator being accidentally left opened with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion at a high of 66f for 27 minutes due to the refrigerator being accidentally left opened 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.