chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Daptacel was given to a consumer that expired 2 days prior, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old female patient who was inadvertently vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (frequency once) lot C5254AB, expiry date: 18-Sep-2019 via intramuscular route in the left deltoid on  20-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  concomitant vaccine included hep A (hepatitis A vaccine) and Flu shot (influenza vaccine)  It is an actual medication error case due to expired vaccine used. It was reported that by mistake gave an expired Daptacel.   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: 30.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 30 year old male was given Fluzone High Dose, no AE; 30 year old male was given Fluzone High Dose, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 30 years old male patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on 19-Sep-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 overdose and 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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: a female patient received Flublok that was out of range for more than 24 hours because they donot have data logger/No AE; Initial information and additional information received on 20-Sep-2019 regarding an unsolicited non-valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA267191, 2019SA267208, 2019SA267209, 2019SA267210, 2019SA267211, 2019SA267212, 2019SA267213, 2019SA267214, 2019SA267215, 2019SA267216, 2019SA267217, 2019SA267218, 2019SA267219, 2019SA267220, 2019SA267221, 2019SA267222, 2019SA267223, 2019SA267224, 2019SA267225, 2019SA267226, 2019SA267227, 2019SA267228, 2019SA267229, 2019SA267230, 2019SA267231 and 2019SA267232.  This case involves a female patient (age unknown) who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] that was out of range for more than 24 hours because they do not have data logger (lot number and expiry date not reported).  It was an 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 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: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: patient received an expired dose of Fluzone / no AE; 56 year patient receive Fluzone HD dose/ no AE; 56 year patient receive Fluzone HD dose / no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 56 years old male patient who received 0.5 ml dose of  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ000AB (Expiry date Mar-2019) via intramuscular route in the left deltoid on 20-Sep-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to Expired vaccine used, inappropriate age at vaccine administration and overdose.   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.
Sex: M
Vaccine: FLU3
Symptoms: Food allergy
Clinical narrative: severe alpha-gal reaction; possible hives; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a male patient (age unknown) who experienced severe alpha-gal reaction (food allergy) and possible hives (urticaria), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious severe alpha-gal reaction (food allergy) and possible hives (urticaria) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was severe alpha-gal reaction.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for the events.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: MA mistakingly gave a pregnant patient preservative free Flublok in stead of preservative free Fluzone Quad/no AE; MA mistakingly gave a pregnant patient preservative free Flublok in stead of preservative free Fluzone Quad/no AE; Initial pregnancy information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA266136, 2019SA266138 and 2019SA266137 (same reporter).  This case involves a 23 years old female patient who was mistakenly exposed to preservative free vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of preservative free INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was pregnant.  Patient's gestation period at onset and gestation period at exposure was not reported, the date of last menstrual period was not reported, the estimated due date is 16-DEC-2019.  The patient's past medical history, previous pregnancy/ies, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant therapy.  On 20-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number 16-DEC-2019 via unknown route in the right deltoid.  It was a case of actual medication error due to wrong vaccine administered (Wrong product administered).  It was reported that patient did not experience any adverse event at the time of reporting.  Additionally, at time of reporting, the outcome of the pregnancy was unknown because patient's delivery due date is on 16-DEC-2019.  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: 39.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; Initial pregnancy information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA266135, 2019SA266138 and 2019SA266137 (same reporter).  This case involves a 39 years old female patient who was mistakenly exposed to preservative free vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of preservative free INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was pregnant.  Patient's gestation period at onset and gestation period at exposure was 3 weeks, the date of last menstrual period was 28-DEC-2018 and the estimated due date is 12-NOV-2019.  The patient's past medical history, previous pregnancy/ies, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant therapy. . On 20-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number 16-DEC-2019 via unknown route in the right deltoid.  It was a case of actual medication error due to wrong vaccine administered (Wrong product administered).  It was reported that patient did not experience any adverse event at the time of reporting.  Additionally, at time of reporting, the outcome of the pregnancy was unknown because patient's delivery due date is on 12-NOV-2019.  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: 25.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; Initial pregnancy information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA266135, 2019SA266138 and 2019SA266136 (same reporter).  This case involves a 25 years old female patient who was mistakenly exposed to preservative free vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of preservative free INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was pregnant.  Patient's gestation period at onset and gestation period at exposure was 3 weeks, the date of last menstrual period was 13-FEB-2019 and the estimated due date is 07-DEC-2019.  The patient's past medical history, previous pregnancy/ies, medical treatment(s), vaccination(s) and family history were not provided.  Patient received DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) as concomitant therapy on 20-Sep-2019 in the left deltoid.   On 20-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number 16-DEC-2019 via unknown route in the right deltoid.  It was a case of actual medication error due to wrong vaccine administered (Wrong product administered).  It was reported that patient did not experience any adverse event at the time of reporting.  Additionally, at time of reporting, the outcome of the pregnancy was unknown because patient's delivery due date is on 07-DEC-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 32.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; Initial pregnancy information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA266135, 2019SA266137 and 2019SA266136 (same reporter).  This case involves a 32 years old female patient who was mistakenly exposed to preservative free vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of preservative free INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was pregnant.  Patient's gestation period at onset and gestation period at exposure was unknown, the date of last menstrual period was 06-JAN-2019 and the estimated due date is 13-OCT-2019.  The patient's past medical history, previous pregnancy/ies, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was received.  On 20-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number 16-DEC-2019 via unknown route in the left deltoid.  It was a case of actual medication error due to wrong vaccine administered (Wrong product administered).  It was reported that patient did not experience any adverse event at the time of reporting.  Additionally, at time of reporting, the outcome of the pregnancy was unknown because patient's delivery due date is on 13-OCT-2019.  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: FLUX
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown demographics who experienced flu-like symptoms (influenza like illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, concomitant therapy, 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 an unknown date, The patient developed a non-serious flu-like symptoms (influenza like illness) Unknown latency following the administration of INFLUENZA VACCINE.  No lab test reported.  Final diagnosis was flu-like symptoms.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for flu-like symptoms.  Information on the batch number was requested.
Age: 12.0
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Flublok instead of Fluzone Quad/no AE; administered Flublok instead of Fluzone Quad/no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA267237.  This case involves a 12 years old patient who vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of 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 QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route.  It was of actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown where adverse event was experienced or not.  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.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267208; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267228; 2019SA267230; 2019SA267231; 2019SA267232, 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  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 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267228; 2019SA267230; 2019SA267231; 2019SA267232, 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left arm on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  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 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.  Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193 (same reporter).  This case involves (an adult) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left Upper deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.   This case involves (an elderly) female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193;.  This case involves (an elderly) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193;   This case involves (an elderly) female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves (an elderly) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)   This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193;.  This case involves (an elderly) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)   This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193;   This case involves (an adult) female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves (an adult) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves (an adult) female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves (an elderly) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and additional information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this Flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a male patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right upper deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 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.  Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a male patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  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 holders compliance with the requirements set out in Directiveand 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.  Documents held by sender: none.