chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 7 month old who received two doses of Fluzone Quadrivalent that were less than 4 weeks apart, no AE; Upon second medical examination of the case during internal review, a significant correction was performed on 01-Nov-2019 to update/ correct valid case from non-case.  Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 months old patient who received two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], first dose on 22-Sep-2019 and second dose was less than 4 weeks later.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error case due to Inappropriate schedule of vaccine administered.  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 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 batch number is requested.  Addendum: 01-Nov-2019:  significant correction was performed on 01-Nov-2019 to update/ correct valid case from non-case.
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Nausea, Pain
Clinical narrative: body aches; Joint pain; nausea; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a male patient who of an unknown age who experienced joint pain (arthralgia), nausea (nausea) and body aches (pain), while he received 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.  Concomitant medications included TUBERCULIN PPD (TUBERCULIN PPD) for Tuberculin test.  On 29-Oct-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6321AA expiry date: 21-Jun-2020 via intramuscular route in the left deltoid.  On 29-Oct-2019, the patient developed a non-serious joint pain (arthralgia), nausea (nausea) and body aches(pain) on same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Final diagnosis was body aches, nausea and joint pain.  The patient was treated with Paracetamol (Tylenol) for pain.  The outcome of the events was Unknown.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel has been administered after temperature excursion, were exposed to room temperature (72F) for 4-5 days (96-120) due to fridge wasn't working/No AE; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA317553 (same reporter).  This case involves male patient of an unknown age who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] after temperature excursion.  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 C5666AA, expiry date- 19-04-2021 via unknown route in unknown administration site.  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: 9.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 9 year old male patient received the Fluzone High Dose with no AE; 9 year old male patient received the Fluzone High Dose with no AE; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA311567 (same reporter).  This case involves a 9 year old male patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot no: UJ288AA, Expiry date: 02-Jun-2020) via intramuscular route in the left deltoid on 06-Nov-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Inappropriate age at vaccine administration and overdose.  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: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pruritus, Injection site pustule
Clinical narrative: severe allergic reaction; itched at the injection site; violent red pustule; Initial information regarding an unsolicited valid non-serious case received from a consumer/non-hcp and transmitted to Sanofi on 06-Nov-2019.  This case involves an unknown age female patient who received influenza vaccine, and reported severe allergic reaction (PT- Vaccination site hypersensitivity) with violent red pustule (PT- Injection site erythema) and it itched at the injection site (PT- Injection site pruritus).  The 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 vaccine produced by unknown manufacturer lot number not reported via unknown route.  On unknown date, (latency unknown) patient who received influenza vaccine, and reported severe allergic reaction (PT- Vaccination site hypersensitivity) with violent red pustule (PT- Injection site erythema) and it itched at the injection site (PT- Injection site pruritus).   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for all events.  Information on the batch number was requested.
Age: 11.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: 11 year old patient was given Flublok in the thigh, no AE; 11 year old patient was given Flublok in the thigh, no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from Health Authorities.  This case involves a 11 year old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  It was actual medication error case due to inappropriate age at vaccine administration and vaccine administered at inappropriate site.  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.
Sex: U
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 16 year old patient received adacel shot before due date / No AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA314548 (same reporter).  This case involves a 16 year old patient received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] before due date.  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 4V (FLUZONE QUADRIVALENT) for Immunization.  On 30-Oct-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6512AA (Expiry date 23-10-2021) via unknown route in the right deltoid.  It was actual medication error case due to inappropriate schedule of product administration.  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.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: during pregnancy patient received Adacel vaccine/No AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves female patient of an unknown age who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date, dose, route and site of administration were unknown) on an unspecified date, while she was pregnant.  Data regarding this pregnancy were received prospectively.   The date of last menstrual period was not reported.  The estimated due date was not reported.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was the case of vaccine exposure during pregnancy. The patient was pregnant when she received vaccine.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  Information on the batch number was requested.
Sex: U
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 12 year old patient received adacel shot before due date / No AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA314534 (same reporter).  This case involves a 12 year old patient received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] before due date.  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 4V (FLUZONE QUADRIVALENT) for Immunization.  On 30-Oct-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6518AA (Expiry date 05-Nov-2021) via unknown route in the right deltoid.  It was actual medication error case due to inappropriate schedule of product administration.  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.
Age: 3.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3 year old patient was given Flublok today in her left leg with no AE; Initial information was received on 08-Nov-2019 regarding this unsolicited valid non-serious case from a nurse.  This case involves a 3 year (reported as 3 years and 11 months)  old female patient received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1923, expiry date- 30-Jun-2020) via unknown route in unknown administration site (reported as left leg) on 08-Nov-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported.   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 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: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was given to a 3 year old patient because she has a severe anaphylactic reaction to egg products with no AE; Initial information received regarding this unsolicited valid non-serious case from a nurse was received and transmitted to Sanofi on 08-Nov-2019.   This case involved a 3 years old female patient who received a dose 0.5 ml of Flublok quadrivalent INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] Lot- QFAA1930 (Expiry date-30-Jun-2020) via intramuscular route in unknown administration on 05-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug were not reported.   Concurrent condition included severe anaphylactic reaction to eggs.  It was a case of actual medication error case due to Inappropriate age at vaccine administration.  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: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, Immunisation, No adverse event, Syringe issue
Clinical narrative: the plunger was able to go down after removal of the needled from the skin; that the vaccine spilled out on arm when the plunger was pressed, that the pharmacy still has syringe with no AE; the plunger of a Fluzone High-Dose syringe becoming jammed after the needle was inserted into the consumer with no AE; Initial information regarding this unsolicited valid non-serious case received from Pharmacist and transmitted to Sanofi on 11-Nov-2019 and follow-up information was received on 12-Nov-2019.  This case involves a 67 year old male patient for whom the plunger was able to go down after removal of the needled from the skin; that the vaccine spilled out on arm when the plunger was pressed, that the pharmacy still has syringe [exposure via skin contact] and the plunger of a fluzone high-dose syringe becoming jammed after the needle was inserted into the consumer with no ae [Device connection issue ] was reported, while she 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 08-Nov-2019, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine [lot UJ301AA and Exp. Date 24-Jun-2020] via intravenous NOS route for prophylactic vaccination.  It was a case of actual medication error due to exposure via skin contact and also a case of Syringe connection issue .  The patient was injected with a another syringe to get his dose.  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: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: One of our pediatric patients were given a Fluzone Quadrivalent yesterday 10-Nov-2019 at pharmacy and part of the vaccine came out on the patient arm with no AE; One of our pediatric patients were given a Fluzone Quadrivalent yesterday 10-Nov-2019 at pharmacy and part of the vaccine came out on the patient arm with no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported, expiry date:  via unknown route in the arm NOS on 10-Nov-2019 and part of the vaccine came out on the patient arm.  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 vaccine underdose and exposure via skin contact.  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 .  Additional information regarding the batch number was requested.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Wrong product administered
Clinical narrative: Fluzone Quadrivalent was inadvertently administered to 10 patients instead of Fluzone HD; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA316262, 2019SA316289, 2019SA316290, 2019SA316263, 2019SA316286 and 2019SA316288.  This case involves a 70 years old male patient who inadvertently received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UJ305AA, expiry date: 30-Jun-2020), via intramuscular route in right deltoid, on 07-Nov-2019, instead of  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Relevant medical history and concomitant medication were unknown.  The patient did not receive any concomitant vaccinations.  It was an actual medication error due to the wrong vaccine administered. It was reported that the Fluzone Quadrivalent was inadvertently administered to the patients instead of Fluzone HD.  The patient did not report any AE symptoms.  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: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Fluzone Quadrivalent was inadvertently administered to 72 year old patient instead of Fluzone HD with no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA316288, 2019SA316290, 2019SA316262, 2019SA316255, 2019SA316259, 2019SA316260, 2019SA316261, 2019SA316263, and 2019SA316286 same reporter.  This case involves a 72 years old male patient for whom Fluzone Quadrivalent was inadvertently administered to 72 year old patient instead of Fluzone HD with no AE [Wrong product administered] was reported, while he received vaccines INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical treatment(s), vaccination(s) and family history were not provided.  On 07-Nov-2019 the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ305AA, Expiry date 30-Jun-2020] via intramuscular route in the left deltoid for immunization.  It was actual medication error case due to wrong product administration.  No AE had been 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: 77.0
Sex: M
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired dose of Flublok Quadrivalent with no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA316777, 2019SA316754 and 2019SA316760.  This case involves a 77 years old male patient who received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1824, expiry date: 30-Jun-2019) via unknown route on 06-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 expired vaccine used.   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: FLU3
Symptoms: Malaise, Myalgia
Clinical narrative: wasn't feeling well; muscle soreness; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Adult patient of unknown demographics who was not feeling well (PT: Malaise) and muscle soreness (Myalgia), while patient was vaccinated with 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) for prophylaxis.  On an unknown date, (latency unknown) patient wasnot feeling well (PT: Malaise) and muscle soreness (Myalgia). Also reported that she had some side effects a few days after her dose.  Action taken, corrective treatment and event outcome was unknown at the time of reporting.
Sex: M
Vaccine: RAB
Symptoms: Product dose omission, Syringe issue
Clinical narrative: patient missed their dose, no AE; twisting the new needle in where the plastic part is the plastic part came off the syringe and all ofit fell into the floor, no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 54 years old male patient who was supposed vaccinated with RABIES (HDC) VACCINE [IMOVAX RABIES] lot P1E522M expiry date: 30-Oct-2020 via unknown route in unknown administration site.  It was reported that twisting the new needle in where the plastic part is the plastic part came off the syringe and all of it fell into the floor. The patient missed their dose since they only had the one to administration prophylactically for traveling.  It was also the case of syringe issue.  It was a case of potential medication error due to product dose omission since patient missed their dose since they only had the one to administer prophylactically for traveling.  At the time of reporting, it was reported if the vaccine was not administered   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: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Vaccine was invalid due to prolonged shipping time; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a unknown.  This case is linked to case 2019SA317566.  This case involves a 11 years old male patient for whom it was reported vaccine was invalid due to prolonged shipping time (Product storage error), while he 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 11-Nov-2019, the patient received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE suspension for injection (batch number UJ3058a; expiration date 12-JUN-2020) via intramuscular route in the right deltoid for prophylactic vaccination.  It was reported that the vaccine was invalid due to prolonged shipping time (product storage error) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was Not Applicable vaccine was invalid due to prolonged shipping time.  Event outcome was not applicable.  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.    No other information was reported.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Pentacel as the DTAP-IPV portion was given but the ActHIB was not given, no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient (unknown demographic) who received 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on 15 November 2019 (lot number UJ060AAA expiry date:04-Oct-2020) not reported via unknown route in unknown administration site was inappropriately reconstituted.  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 reconstitution technique (product preparation issue). It was reported that the Pentacel was administered and only the DTaP and IPV were given and the Hib part was not reconstituted.  It was unknown whether the patient had any adverse reactions.  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: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: patient received the liquid component only of the vaccine, no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient who vaccinated DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was inappropriately reconstituted.  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 reconstitution technique (product preparation issue). It was reported that the patient received the liquid component only of the vaccine.  It was unknown whether the patient had any adverse reactions.  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: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: received a Diluent DTaP/IPV from the Pentacel without the ActHIB today, no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who received received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ192AAA expiry date:22-02-2021 and Diluent Vial Lot U6613AA Exp. Date: 22Feb2021,ActHIB Vial Lot: UJ192AA Exp. Date 22Feb2021,) via intramuscular route in the left thigh was inappropriately reconstituted.  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 VACCIN) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique (product preparation issue). It was reported that patient received a Diluent DTaP/IPV from the Pentacel without the ActHIB on 15-Nov-2019.  It was unknown whether the patient had any adverse reactions.  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.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel was administered to patient/No AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who received expired dose of vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 15-Nov-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5307AA Expiry Date: 23-OCT-2019] via unknown route in the left arm.  It was a case of actual medication error due to expired vaccine was administered to patient   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: M
Vaccine: DTAP, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered expired Daptacel and expired ActHIB/No AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves male patient of an unknown age who received expired dose of vaccines HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunization.  On 15-Nov-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5307AA expiry date: 23-OCT-2019) and HIB (PRP/T) VACCINE (lot UI915AAB expiry date: 23-OCT-2019) via intramuscular route in the deltoid nos.  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: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Immunisation, Syringe issue
Clinical narrative: liquid running down the patient's skin/No AE; syringe broke at the point where the barrel and luer lock meet; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], while vaccination nurse observed vaccine liquid running down by patient's skin.  The medical history, medical treatments, vaccinations and family history were not provided.  On 07-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ294AA Expiry Date: 30-Jun-2020] via intramuscular route in the right deltoid.  It was a case of actual medication error due to Exposure via skin contact.  It was also the case of Syringe issue.   At the time of report no adverse event was reported.  Patient was re-vaccinated immediately.  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: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient was given ADACEL SC instead of IM, no advesre event; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demographic who was vaccinated with a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] via subcutaneous route instead of intramuscular route on an unknown date (batch number, expiration date and dosing details not reported).  The medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate route of vaccination.  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.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: she accidentally administered a Fluzone High Dose that expired / no AE; 24 year old received Fluzone HD / no AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff).  This case involves a 24 years old female patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ048AA (Expiry date 31-May-2019) via intramuscular route in the left deltoid on 18-Nov-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to Expired vaccine used and inappropriate age at vaccine administration.  At a time of reporting No adverse reaction reported.  It was reported that accidentally administered a Fluzone High Dose that expired.  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: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 6 month old received Flublok Quadrivalent, no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. [Product administered to patient of inappropriate age].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1959 via intramuscular route in the right thigh.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of the 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: M
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired product was given; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves male patient of unknown age who received an expired dose of Expired product administered] QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV] 0.5 ml via intramuscular 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 a case of actual medication error due to expired product administered.  Description: Nurse noticed expired product was given. Was dated June 2019. Stated product was pulled out of box for the 2019-2020 season. Other doses stated 2020 expiration and this dose was 2019. The nurse re-immunized the patient with a non-expired dose.  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: 3.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3 1/2 year old received Flublok Quadrivalent/no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked to case ID 2019SA321865 (same reporter).  This case involves three and half years old patient of unknown gender who received a dose of QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV] [Product administered to patient of inappropriate age] intramuscularly in right thigh (lot number: Lot# QFAA1959 exp. 30-JUN-2020) on 15-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No treatment, no concurrent vaccines given.   It was a case of actual medication error due to inappropriate age at vaccine administration.  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: 65.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal distension, Diarrhoea
Clinical narrative: hard abdomen and bloating; diarrhea; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 65 years old female patient who experienced hard abdomen and bloating (abdominal distension) and diarrhea (diarrhoea), while she received vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  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 VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  On 14-Oct-2019, the patient received a 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot R2A264M, expiry date: 10-MAY-2021 via intramuscular route in the left deltoid.  On an unknown date, the patient experienced a non-serious hard abdomen and bloating (abdominal distension) and diarrhea (diarrhoea) (Unknown latency) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was diarrhea and hard abdomen and bloating.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for the events.