chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 year old patient was administered with Flublok, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA305218 (same reporter).  This case involves a 15 years old female patient who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1936, expiry date: 30-Jun-2020 via unknown route in the left arm on 17-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting the patient had 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: U
Vaccine: DTAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine has temperature excursions below32F was administered to a patient, no advesre event; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient who was vaccinated with a dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number, Exp. Date, dose, route and site of administration not reported) on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage.  No adverse event reported at the time of reporting.  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 and Module VI of the 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.  Information on the batch number was requested.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient was administered expired Daptacel, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that patient was administered expired Daptacel (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  On 31-Oct-2019, the patient received 4th dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA and expiry date: 23-Oct-2019 via intramuscular route in the right vastus lateralis.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any 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: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Daptacel was given to a 4-year old female child and then it was realized that the dose expired on 23Oct2019, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that Daptacel was given to a 4-year old female child and then it was realized that the dose expired on 23-Oct-2019 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLUARIX); POLIO VACCINE INACT (IPV); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 01-Nov-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA and expiry date: 23-Oct-2019 via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any 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 and Module VI of the 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: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired Adacel to a patient, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 58 years old male patient who was inadvertently vaccinated with an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number: C5263AA, expiry date: 12-Sep-2019 via unknown route in the left arm on 01-Nov-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLU); and HEPATITIS A VACCINE INACT, HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).  It is an actual medication error case due to expired vaccine used.  At the time of report, no adverse event occurred.  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.
Age: 5.0
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Flublok to a 5 year-old child, rather than the intended Fluzone/ no AE; administered Flublok to a 5 year-old child, rather than the intended Fluzone/ no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5 years old patient who received 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1963 (Expiry date 30-Jun-2020)  via intramuscular route in the left deltoid on 01-Nov-2019 instead of intended INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered. It was reported that physician administered Flublok to a 5 year-old child, rather than the intended Fluzone.  At the time of reporting no adverse reaction was reported.  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.
Age: 4.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 year old patient was administered Flublok vaccine / no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 years old male patient who received 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1965 (Expiry date 30-Jun-2020) via intramuscular route in the left thigh on 01-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (QUADRACEL) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).   It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting no adverse reaction was reported.  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: F
Vaccine: FLUR4
Symptoms: Incorrect route of product administration, Wrong technique in product usage process
Clinical narrative: Flublok vaccine subcutaneously instead of in the muscle / no AE; improper needle size, 25g 5/8th inches / no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA307055.  This case involves two female patient who received dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1910 via subcutaneous route in the deltoid nos on 30-Oct-2019.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   It was an actual medication error due to Inappropriate route of vaccination and Incorrect needle gauge used.  At a time of reporting No AE symptoms reported.  It was reported that some patients received the Flublok vaccine subcutaneously instead of in the muscle and improper needle size, 25g 5/8th inches.  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 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: 91.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient was given 2 doses of Fluzone High-Dose / no AE; the patient was supposed to receive the Prevnar 13 but received Fluzone High-Dose second time/ no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 91 years old male patient who received 0.5 ml two doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ232AB (Expiry date 10-Apr-2020) via intramuscular route in the left deltoid on 01-Nov-2019 instead of PREVNAR 13.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient has not been allergic to Flu vaccines.  It was an actual medication error case due to wrong vaccine administered and extra dose administered.  It was reported that the patient was supposed to receive the Prevnar 13 during the visit but after the double dose the pharmacist contacted the doctor who instructed to not provide the patient the Prevnar 13 today. Caller did not have the doctor's name or information. Reporter mentioned that he got distracted during the administration and picked up the Fluzone High-Dose instead of the Prevnar 13. No other vaccines were given during this clinic to this patient.  At a time of reporting no adverse event reported.  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.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Incorrect dose administered, No adverse event, Overdose
Clinical narrative: patient was administered with 1 ml of Fluzone Quadrivalent instead of 0.5 ml, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 32 years old female patient who received a 1 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT] instead of 0.5 ml dose (lot: UJ223AB and expiry date: 30-Jun-2020) via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to overdose. Staff member administered 1 ml of Fluzone Quad instead of .5 ml.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: the injection site was became very red & swollen with fine blisters that ran down her arm to her elbow; the injection site was became very red & swollen with fine blisters that ran down her arm to her elbow; the injection site was became very red & swollen with fine blisters that ran down her arm to her elbow; the injection site was became very red & swollen with fine blisters that ran down her arm to her elbow; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years (reported as 3 years and 5 month) old female patient who experienced the injection site was became very red & swollen with fine blisters that ran down her arm to her elbow (extensive swelling of vaccinated limb, erythema, vaccination site reaction and blister), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ237AB, expiry date: 30-Jun-2020, via intramuscular route in the left arm.  On an unknown date, the patient developed a non-serious the injection site was became very red & swollen with fine blisters that ran down her arm to her elbow (extensive swelling of vaccinated limb, erythema, vaccination site reaction and blister), unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Other relevant tests were not reported.  Final diagnosis was the injection site was became very red & swollen with fine blisters that ran down her arm to her elbow.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The outcome of the events was not reported.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: staff administered DTaP-IPV portion only of Pentacel/no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months old patient who was administered Dtap-IPV portion only of 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 SHANTHA) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 01-Nov-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6216AB via intramuscular route in the left vastus lateralis.  It was a case of actual  medication error due to Inappropriate reconstitution technique.  It was unknown if patient had any 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 Directive and Module VI of the 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: FLU4
Symptoms: Urticaria
Clinical narrative: Hives; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare.  This case is linked to case 2019SA307047 (same reporter).  This case involves a patient of an unknown demographics who experienced hives (urticaria), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE 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 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious hives (urticaria), Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was urticaria.   It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  Information on the batch number was requested.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received product that had undergone delayed shipping transit/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA307319, 2019SA307320, 2019SA307321 and 2019SA307322 (same reporter).  This case involves a 88 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] which had undergone delayed shipping transit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 31-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ290AB, expiry date- 09-JUN-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  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: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: patient was given Fluzone HD last year but it was given in half doses. One partial dose done and a week later the second partial dose was given/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA311164 same reporter.  This case involves a patient of an unknown demographics who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  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 INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site, in two half doses. One partial dose done and a week later the second partial dose was given.  It was a case of actual medication error due to Wrong technique in product usage process.  At the time of report no adverse event was reported.  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.  Information on the batch number was requested.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone High-Dose administered that had undergone delayed shipping transit/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA307301, 2019SA307319, 2019SA307321 and 2019SA307322 (same reporter).  This case involves an 85 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] that had undergone delayed transit during shipping.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ290AB, expiry date- 09-JUN-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  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.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone High-Dose administered that had undergone delayed shipping transit/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA307301, 2019SA307319, 2019SA307321 and 2019SA307322 (same reporter).  This case involves a 72 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] that had undergone delayed transit during shipping.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ290AB, expiry date- 09-JUN-2020 via intramuscular route in the Left Deltoid.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  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.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone High-Dose administered that had undergone delayed shipping transit/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA307301, 2019SA307319, 2019SA307320 and 2019SA307322 (same reporter).  This case involves a 75 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] that had undergone delayed shipping transit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ290AB, expiry date- 09-JUN-2020 via intramuscular route in the right deltoid.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  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.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone High-Dose administered that had undergone delayed shipping transit/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA307301, 2019SA307319, 2019SA307320 and 2019SA307321 (same reporter).  This case involves a 82 years old female patient who received  0.5 ml dose vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ290AB and expiry date:09-Jun-2020 intramuscular in the left deltoid, On an 31-Oct-2019, Which had undergone delayed transit during shipping.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.  At the time of reporting, no adverse event was reported.  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 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: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was inadvertently given a dose of expired Daptacel in the right thigh, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old female patient who was inadvertently vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5281AA, expiry date: 05-Oct-2019, via unknown route in unknown administration site on 28-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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.
Age: 0.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of daptacel, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old female patient who received an expired 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5307AAand expiry date: 23-Oct-2019) from  on 04-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HIB VACCINE (HIB) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  Patient and family waited a 15-minute post vaccination observation period, and the family reported no adverse events as of that time.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired daptacel, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who received an expired 0.5 ml dose of vaccine  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL](lot number C5307AAand expiry date: 23-Oct-2019) via intramuscular route in left thigh on 25-Oct-2019.   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) (ACT-HIB).  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: received a vaccine that was expired by 2 days/No AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an 18 months old female patient who received expired dose of vaccine that was expired by 2 days, while she received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history included very little in body weight as it is. Past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] that was expired by 2 days lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  Information on the batch number was requested.  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.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient received just the DTap/IPV part of the Pentacel and the Acthib portion was not mixed/NO AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 15 months old male patient who received just the DTap/IPV part of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot U66113AA via intramuscular route in the right thigh on 01-Nov-2019.  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 Immunisation; and INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLUARIX) for Immunisation.  It was a case of actual medication error due to Inappropriate reconstitution technique. The doctors gave the DTAP/IPV part and did not know that the Acthib portion was not mixed.  At the time of report no adverse event was reported.  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.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: 1 month old was given expired Pentacel/ No AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an eight weeks old female patient who received 0.5 mL expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C5593AA, expiry date 27-Oct-2019, via intramuscular route in the right thigh on 04-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation.  It was a case of actual medication error due to expired vaccine used.   At the time of report, no adverse event was reported.  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.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered Pentacel with out the ActHib portion/No AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient who received 0.5 mL of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without the ACTHIB portion, lot U6524BA and Expiry date 02-MAR-2021 via unknown route in the right thigh on 04-NOV-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was a case of actual medication error due to Inappropriate reconstitution technique. Administered Pentacel with out the ActHib portion.   At the time of report no adverse event was reported.  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: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: one child received the ActHIB powder only from Pentacel vaccine, the ActHIB was diluted with another diluent because the diluent was not used/No AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves one patient of an unknown demographics, who had been given the ActHIB powder only from vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL].  No information regarding past medical history or concomitant drug was reported.   On an unknown date, the children received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL], lot number and expiry date not reported via unknown route in unknown administration site.  It was an actual medication error due to wrong solution used in drug reconstitution.  It was reported that one patient received the ActHIB powder only. ActHIB was diluted with another diluent because the diluent was not used. The Reconstitution Guide Site was given to the caller.  At the time of reporting, no adverse event was reported.  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 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.  Information on the batch number was requested.
Sex: M
Vaccine: MMR, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Menectra was mixed with a MMR vaccine as a diluent inadvertently, no AE; Menectra was mixed with a MMR vaccine as a diluent inadvertently, no AE; Initial and live follow-up information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse and processed together.  This case involves a 18 years old male patient who received 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6565AA, expiry date: 28-Mar-2021) which was mixed with 0.5 ml MENINGOCOCCAL VACCINE [MMR] as a diluent inadvertently, via subcutaneous route in the right arm, on 03-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to product preparation error and labelled drug-drug interaction medication error.  At the time of reporting, the patient had 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.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Imovax was given less than 24 hours after the expiration date, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse .  This case involves a 20 years old male patient who was vaccinated an expired dose of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included TYPHOID VACCINE (TYPHOID).  On 29-Oct-2019, the patient received expired dose of suspect RABIES (HDC) VACCINE lot number not reported (exp date: 28 Oct 2019) via intramuscular route in the left deltoid.  It was actual medication error due to Expired vaccine used.  No adverse event was reported.  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 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.  Information on the batch number was requested.
Age: 4.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 year old was administered with Flublok Quadrivalent / No AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 4 years old male patient who received a  0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA1965, Expiration Date: 30-Jun-2020) on 01-Nov-2019  The patient's past medical history ,treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  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 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: 54.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Fluzone high dose given to 54 year old, no AE; Fluzone high dose given to 54 year old, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 54 years old patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.  At the time of report, no adverse event was reported.  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 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.  Information on the batch number was requested.