chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired Fluzone Quadrivalent 0.25 ml, no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient who was inadvertently vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (frequency once) lot UT6315RA, expiry date: 30-Jun-2019 via intramuscular route in an unknown administration site on 07-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is 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.  List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 month old baby administered Fluzone Quadrivalent / no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received 0.25 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6647ja (Expiry date 30 June 2020) via intramuscular route in the left thigh on 02-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) ; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) ; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and HEPATITIS B VACCINE (HEPATITIS B VACCIN).  It was an actual medication error case due to inappropriate age at vaccine administration.   At a 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.  List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 53 year old. was given a Fluzone HD today S.C/no AE; 53 year old. was given a Fluzone HD today S.C/no AE; 53 year old. was given a Fluzone HD today S.C/no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 53 years old female patient 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 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ238AA via subcutaneous route in the right deltoid.  It was of actual medication error due to Inappropriate route of vaccination, overdose NOS, Inappropriate age at vaccine administration.  It was reported that no adverse event was noted.  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: Product distribution issue, Product storage error
Clinical narrative: received shipment of Fluzone High-Dose four days late and the product is considered expired/no AE; received shipment of Fluzone High-Dose four days late and the product is considered expired/no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves four patients of unknown demographics who received dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] after the product was received late due to delay in shipment.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ284AB (expiry date: 05-May-2025) via unknown route in unknown administration site.  It was of actual medication error case due to incorrect product storage (Product storage error) and Product shipment delay (Product distribution issue).  It was unknown whether any adverse event was noted or not.  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: 13.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublock Quadrivalent was administered to a 13 years old female patient/no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case was linked to 2019SA279974 (same reporter).  This case involves a 13 years old female 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.  Patient was not on any concomitant therapy.   On 04-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1929 via intramuscular route in the left deltoid.   It was of actual medication error case due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate age).  It was unknown whether any adverse event was noted or not.  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: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublock Quadrivalent was administered to a 12 years old female patient/no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case was linked to 2019SA279962 (same reporter).  This case involves a 12 years old female 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.  Patient was not on any concomitant therapy.   On 04-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1929 via intramuscular route in the left deltoid.   It was of actual medication error case due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate age).  It was unknown whether any adverse event was noted or not.  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: 57.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: a patient received Fluzone High Dose at the age of 57, no AE; a patient received Fluzone High Dose at the age of 57, no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 57 years old patient (gender not reported) who received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ242AA, expiry date: 04-May-2020, via intramuscular route in left arm on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant treatment was received.  It was of actual medication error due to overdose and inappropriate age at vaccine administration.  It was reported that, no adverse event was observed.  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.  List of documents held by sender: none.
Age: 1.5
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was given a expired dose of Daptcel vaccine/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old patient who was given a 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (fourth dose) lot C5281aa, expiry date:05-Oct-2019 via intramuscular route in the right thigh on 07-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA) and HEPATITIS A VACCINE (HEPATITIS A).  It was an actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  Doctor Visit on 07-Oct-2019.  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.  List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient only received Dtap/IPV component of Pentacel/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a four and a half year old female patient who received only the dtap/ipv component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/ IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UI952ABA, exp dat: 30Jun2020, via intramuscular route in the left thigh (4th dose) on 30-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and INFLUENZA VACCINE (INFLUENZA VACCINE).  It was an actual medication error due to inappropriate reconstitution technique.  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.  List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP administered an expired Pentacel vaccine to a patient/No AE; Initial information received on 08-Oct-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 first 0.5 mL dose of expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot 5529AA, expiry date-04-Oct-2019 via unknown route in the left thigh On 07-Oct-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) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  There were no side effects reported related to this expired vaccine.  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.  Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Two patients were given the ActHib portion of the Pentacel vaccine that was improperly reconstituted with "sterile diluent" from MMR and varicella vaccines/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves two patients of an unknown demographics who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was improperly reconstituted with "sterile diluent" from MMR and varicella vaccines lot UJ015AAA, expiry 26-Oct-2020 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 a case of actual medication error due to Wrong solution used in drug reconstitution.  Two patients were given the ActHib portion of the Pentacel vaccine that was improperly reconstituted with "sterile diluent" from MMR and varicella vaccines. A new nurse employee was responsible for the error. DTaP-IPV diluent lot (not administered) is U6469AC expiry 26-Feb-2021.  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.  Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave a Menactra vaccine to a patient, and after they saw it was expired,/NO AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 11 years old female patient who received 0.5 mL expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6002AA, expiry date-11-Sep-2019 via intramuscular route in the left deltoid On 27-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines administered.  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.  Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient received a dose of Adacel vaccine on 07-Oct-2019 which was already expired on 05-Oct-2019/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a patient of unknown demographics who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 07-Oct-2-019 which was already expired on 05-Oct-2019 lot number and expiry date not reported 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 an 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 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.  List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness around injection site; itchiness around injection site; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to cases 2019SA281762, 2019SA281763 and 2019SA281764 (same reporter).  This case involves five patient who experienced redness around injection site (vaccination site erythema) and itchiness around injection site (vaccination site pruritus), 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 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6656KA, expiry date: 30-Jun-2020 via unknown route in unknown administration site.  On an unknown date, the patient had redness around injection site (erythema) and itchiness around injection site (pruritus) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site erythema and vaccination site pruritus.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for vaccination site erythema and vaccination site pruritus.  List of document held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: skin redness at the thigh injection site; induration at the thigh injection site; Initial information received on 08-Oct-2019 and additional information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA281611 and 2019SA281612 same reporter.  This case involves a 7 years old female patient who experienced skin redness at the thigh injection site (vaccination site erythema) and induration at the thigh injection site (vaccination site induration), 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. No other vaccines administered.  On 02-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Frequency = 8th) lot UJ223AA, Expiration Date: 30-Jun-2020 via intramuscular route in the right thigh.  On an unknown date, the patient developed a non-serious skin redness at the thigh injection site (vaccination site erythema) and induration at the thigh injection site (vaccination site induration) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  (Other relevant tests included no lab data.)  Final diagnosis was induration at the thigh injection site and skin redness at the thigh injection site.   The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and used Ice.  The outcome of the event was Unknown.  Documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Fluzone Quadrivalent 0.25 mL was administered to a 14 year old boy instead of the Fluzone Quadrivalent 0.5 ml/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA281534 same reporter.  This case involves a 14 years old male patient who received 0.25 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot U6653BD, Expiration Date: 30-Jun-2020 via unknown route in the left deltoid on 04-Oct-2019, instead of 0.5 mL dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive other vaccines on that day.   It was a case of actual medication error due to vaccine underdose.  No side effects noted.  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.  Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Hives on her skin; swollen, red area at the injection site; swollen at the injection site; red area at the injection site; Initial information received on 08-Oct-2019 and additional information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA281538 and 2019SA281612 same reporter.  This case involves a 5 years old female patient who experienced hives on her skin (urticaria) and swollen, red area at the injection site (vaccination site inflammation), (vaccination site swelling) and (vaccination site erythema), 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. No other vaccines administered.  On 02-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Frequency = 6th) lot UJ223AA, Expiration Date: 30-Jun-2020 via intramuscular route in the left thigh.  On an unknown date, the patient developed a non-serious hives on her skin (urticaria),  swollen, red area at the injection site (vaccination site inflammation), (vaccination site swelling) and (vaccination site erythema) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  (Other relevant tests included no lab data.)  Final diagnosis was swollen, red area at the injection site and hives on her skin.   The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and used Ice.  The outcome of the event was Unknown.  Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash where the flu shot was given; red angry spot where the flu shot was given; Initial information received on 08-Oct-2019 and additional information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA281611 and 2019SA281538 same reporter.  This case involves a 2 years old female patient who experienced rash where the flu shot was given (vaccination site rash) and red angry spot where the flu shot was given (vaccination site erythema), 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. No other vaccines administered.  On 02-Oct-2019, the patient received a 0.25 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Frequency =4) lot UJ223AA, Expiration Date: 30-Jun-2020 via intramuscular route in the left thigh.  On an unknown date, the patient developed a non-serious rash where the flu shot was given (vaccination site rash) and red angry spot where the flu shot was given (vaccination site erythema) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  (Other relevant tests included no lab data.)  Final diagnosis was red angry spot where the flu shot was given and rash where the flu shot was given.   The patient was treated with ACETAMINOPHEN (ACETAMINOPHEN), PREDNISONE (PREDNISONE), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and IBUPROFEN (IBUPROFEN).  The outcome of the event was Unknown.  Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: the patient did not get the full dose; Fluzone Quadrivalent prefilled syringe that leaked from where the needle attaches; some of the vaccine ran down the patient's arm; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 24 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that the patient did not get the full dose (underdose), Fluzone Quadrivalent prefilled syringe that leaked from where the needle attaches (syringe issue)and some of the vaccine ran down the patient's arm (exposure via skin contact).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6681LA via unknown route in unknown administration site.  It was a case of actual medication error due to vaccine underdose.  It was also a case of syringe issue and exposure via skin contact.  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.  List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to cases 2019SA281531, 2019SA281763 and 2019SA281764 (same reporter).  This case involves a patient who experienced swelling at injection site (vaccination site swelling), 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 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6656KA via unknown route in unknown administration site.  On an unknown date, the patient had swelling at injection site (vaccination site swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site swelling.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for vaccination site swelling.  List of document held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: scratchy throat and irritated; irritated; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to cases 2019SA281762, 2019SA281531 and 2019SA281764 (same reporter).  This case involves a patient who experienced scratchy throat and irritated (throat irritation) and irritated (irritability), 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 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6656KA, expiry date: 30-Jun-2020 via unknown route in unknown administration site.  On an unknown date, the patient had scratchy throat and irritated (throat irritation) and irritated (irritability) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was throat irritation and irritability.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for throat irritation and irritability.  List of document held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: throat swelled up; Face swelled up; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to cases 2019SA281762, 2019SA281763 and 2019SA281531 (same reporter).  This case involves a patient who experienced throat swelled up (pharyngeal swelling) and face swelled up (swelling face), 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 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6656KA, expiry date: 30-Jun-2020 via unknown route in unknown administration site.  On an unknown date, the patient had throat swelled up (pharyngeal swelling) and face swelled up (swelling face) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was pharyngeal swelling and swelling face.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for pharyngeal swelling and swelling face.  List of document held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: gave a partial dose to the patient because the syringe leaked/ no adverse event; there was some leaking from the syringe; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 74 years old female patient who received a partial dose (underdose) of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] because the syringe leaked (syringe issue).   The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other vaccine was given.   On 07-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ282AA and expiry date: 23-May-2020 via unknown route in the right deltoid.  It was a case of actual medication error due to vaccine underdose.  It was also a case of syringe leak.  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.  List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Ipol was given to a patient, no AE; Initial and additional information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown demographics who received 0.5 ml dose of expired vaccine IPV (VERO) [IPOL] (lot number and Expiry date unknown) on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  At a 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.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: shipment of Flublok received, out of range and it was administered to patient, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to case 2019SA281957 (same reporter).  This case involves a 59 years old female patient who received 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1941, Exp. Date 30-Jun-2020) via intramuscular route in the left arm on 07-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  It was an actual medication error case due to incorrect product storage.  At the time of reporting, no adverse reactions were 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.  List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: shipment of Flublok received late and the stability of the vaccine could not be verified, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA281960 and 2019SA282001 (same reporter).  This case involves a 70 years old male patient who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1941, Exp. Date 30-Jun-2020) via unknown route in unknown administration site on 08-Oct-2019 (reported as this morning).  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 incorrect product storage.  Patient had no adverse reaction.  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.  List of documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: shipment of Flublok received late and the stability of the vaccine could not be verified, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA282000 and 2019SA281960 (same reporter).  This case involves a 85 years old female patient who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1941, Exp. Date 30-Jun-2020) via unknown route in unknown administration site on 07-Oct-2019 (reported as yesterday).  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 incorrect product storage.  Patient had no adverse reaction.  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.  List of documents held by sender: none.
Age: 6.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 6 years old recieved Flublock yesterday, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA281961 and 2019SA282007 (same reporter).  This case involves a six years old patient (gender not reported) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date (reported as yesterday).  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.  At the time of reporting, no adverse reactions were 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.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
Age: 8.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 8 years old recieved Flublock yesterday, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA282006 and 2019SA281961 (same reporter).  This case involves an eight years old patient (gender not reported) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date (reported as yesterday).  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.  At the time of reporting, no adverse reactions were 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.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: the plunger was more difficult than usual, sprayed some of the injection out upon removing the needle from the consumer arm/No AE; the plunger was more difficult than usual, sprayed some of the injection out upon removing the needle from the consumer arm/No AE; the plunger was more difficult than usual, sprayed some of the injection out upon removing the needle from the consumer arm/No AE; Initial information received on 11-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ221AB via unknown route in unknown administration site on 10-Sep-2019.  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. It was also the case of syringe issue. A pharmacist reporting having difficulty while pressing down the plunger of 1-Fluzone High-Dose. The caller reported that the consumer had her injection on 10Sep2019; that the plunger was more difficult than usual; that she has given this injection many times without an issue; that she is down to the last syringe from this LOT; that she may have sprayed some of the injection out upon removing the needle from the consumer arm; that the syringe was empty upon observation; that she does not recall any visible defect in the syringe, plunger, or needle; that she does not look too close to the needle prior to injection; that at the injection site there was not seen any liquid; that it is unknown to the caller where the consumer felt the wetness; that the syringe has been disposed of; and that the medication was not exposed to anything in the environment out of the ordinary 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.  Documents held by sender: none.