chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was administerd to patient below age 18, no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA309972 (same reporter).  This case involves two patient (below the age of 18) who was vaccinated with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number not reported via unknown route in unknown administration site), on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  The physician stated that the standard packaging for both the Flublok Quad and the Fluzone Quad look the same.  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 batch number is requested.
Sex: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given the Fluzone Quad 0.5 ml instead of the high dose, no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was Linked with 2019SA310470 (same reporter).  This case involves a 71 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported via intramuscular route in unknown administration site), on 25-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to wrong vaccine administered.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Wrong product administered
Clinical narrative: given the Fluzone Quad 0.5 ml instead of the Fluzone high dose/no ae; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was Linked with 2019SA310468 (same reporter).  This case involves a 66 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported via intramuscular route in unknown administration site), on unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to wrong vaccine administered.  At the time of reporting the adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Product distribution issue, Product storage error
Clinical narrative: patient received a flu-zone quad that was out of range due to  delayed shipment/no AE; patient received a flu-zone quad that was out of range due to  delayed shipment/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311020, 2019SA311021, 2019SA311022, 2019SA311023, 2019SA311024 and 2019SA311025 (same reporter)  This case involves a 56 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30Jun2020, Box: Lot UT6713KA, Exp. Date: 30Jun2020) on 04-Nov-2019 after product received late due to delayed shipment.  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 Incorrect product storage and Product shipment delay.  It was not confirmed whether 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.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Product distribution issue, Product storage error
Clinical narrative: delayed shipment vaccine of Fluzone Quadrivalent receivced by a patient/no AE; delayed shipment vaccine of Fluzone Quadrivalent receivced by a patient/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311015, 2019SA311021, 2019SA311022, 2019SA311023, 2019SA311024 and 2019SA311025 (same reporter)  This case involves a 48 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30-Jun-2020, Box: Lot UT6713KA, Exp. Date: 30-Jun-2020) on 04-Nov-2019 after product received late due to delayed shipment.  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 Incorrect product storage and Product shipment delay.  It was not confirmed whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Product distribution issue, Product storage error
Clinical narrative: 7 patient's that received a delayed shipment of Fluzone Quadrivalent injection/no ae; 7 patient's that received a delayed shipment of Fluzone Quadrivalent injection/no ae; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311020, 2019SA311015, 2019SA311022, 2019SA311023, 2019SA311024 and 2019SA311025 (same reporter)  This case involves a 44 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30Jun2020, Box: Lot UT6713KA, Exp. Date: 30Jun2020) on 04-nov-2019 after product received late due to delayed shipment.  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 Incorrect product storage and Product shipment delay.  It was not confirmed whether 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.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Product distribution issue, Product storage error
Clinical narrative: delayed shipment vaccine of Fluzone Quadrivalent was given to a patient/no AE; delayed shipment vaccine of Fluzone Quadrivalent was given to a patient/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311015, 2019SA311021, 2019SA311020, 2019SA311023, 2019SA311024 and 2019SA311025 (same reporter)  This case involves a 46 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30-Jun-2020, Box: Lot UT6713KA, Exp. Date: 30-Jun-2020) on 04-Nov-2019 after product received late due to delayed shipment.  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 Incorrect product storage and Product shipment delay.  It was not confirmed whether 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.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Product distribution issue, Product storage error
Clinical narrative: delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311015, 2019SA311021, 2019SA311020, 2019SA311022, 2019SA311024 and 2019SA311025 (same reporter)  This case involves a 41 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30-Jun-2020, Box: Lot UT6713KA, Exp. Date: 30-Jun-2020) on 05-Nov-2019 after product received late due to delayed shipment.  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 Incorrect product storage and Product shipment delay.  It was not confirmed whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Product distribution issue, Product storage error
Clinical narrative: delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311015, 2019SA311021, 2019SA311020, 2019SA311022, 2019SA311023 and 2019SA311025 (same reporter)  This case involves a 41 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30-Jun-2020, Box: Lot UT6713KA, Exp. Date: 30-Jun-2020) on 05-nov-2019 after product received late due to delayed shipment.  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 Incorrect product storage and Product shipment delay.  It was not confirmed whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Product distribution issue, Product storage error
Clinical narrative: delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311015, 2019SA311021, 2019SA311020, 2019SA311022, 2019SA311023 and 2019SA311024 (same reporter)  This case involves a 63 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30-Jun-2020, Box: Lot UT6713KA, Exp. Date: 30-Jun-2020) on 05-nov-2019 after product received late due to delayed shipment.  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 Incorrect product storage and Product shipment delay.  It was not confirmed whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Alopecia, Arthralgia, Condition aggravated
Clinical narrative: joint pain in her hands and knees; increased hair loss; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced increased hair loss and joint pain in her hands and knees (Arthralgia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included Alopecia and Arthritis.  The patient's Concomitant medication was not reported.   On 04-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route.  On an unknown date, the patient developed a non-serious joint pain in her hands and knees (arthralgia) and increased hair loss (alopecia), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab data was reported.  Final diagnosis was increased hair loss and joint pain in her hands and knees.  No corrective treatment was received by patient   The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for joint pain in her hands and increased hair loss.  Information on batch number is requested.
Age: 60.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case is linked to case 2019SA297927, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 60 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 44.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 44 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 22.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 22 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 49.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 49 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 26.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 26 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 33.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 33 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 61 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 56  years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 31.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 31 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 61 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 64 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 59 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 50.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalent, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 50 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 38 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 38 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317376 (same reporter).  This case involves a 61 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375 (same reporter).  This case involves a 61 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal X-ray, Abdominal pain, Amylase, C-reactive protein increased, Colitis
Clinical narrative: Abdominal Pain started 8-22-19 Epigastric/periumbilacal Nexium/Hyoscyamine 8-29-2019 ED for abd pain  CBC, Amylase, CRP, CMP, sed rate, GGT,Lipase, U/A, UPT CT of Abdomen & Pelvis Trace free fluid thickened colon wall - colitis  Abd x-ray, abd. U/S 8-30-19 Back to ED CBC, CRP increased, CMP, ESR increased, U/A Lipase, Abd x-ray Hyoscyamine - Carafate, Tylenol  ED-> Hosp 9-1-19 Admitted to hospital intractable abd. 9-4-19 Narcotic pain control, Nexium  9-3 EGD & colonoscopy gastritis & duodenitis Acute colitis (ileocolitis) Minimal terminal ileol involvement  Patchy Colitis (Acute)  2 months of uceris (Budosemide) ulcers post hospital pentasu QID 1000 mg QID Nexium QAM
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Colonoscopy abnormal, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis abnormal, Duodenitis, Enterocolitis
Clinical narrative: Abdominal Pain started 8-22-19 Epigastric/periumbilacal Nexium/Hyoscyamine 8-29-2019 ED for abd pain  CBC, Amylase, CRP, CMP, sed rate, GGT,Lipase, U/A, UPT CT of Abdomen & Pelvis Trace free fluid thickened colon wall - colitis  Abd x-ray, abd. U/S 8-30-19 Back to ED CBC, CRP increased, CMP, ESR increased, U/A Lipase, Abd x-ray Hyoscyamine - Carafate, Tylenol  ED-> Hosp 9-1-19 Admitted to hospital intractable abd. 9-4-19 Narcotic pain control, Nexium  9-3 EGD & colonoscopy gastritis & duodenitis Acute colitis (ileocolitis) Minimal terminal ileol involvement  Patchy Colitis (Acute)  2 months of uceris (Budosemide) ulcers post hospital pentasu QID 1000 mg QID Nexium QAM
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Epigastric discomfort, Full blood count, Gamma-glutamyltransferase, Gastritis, Lipase
Clinical narrative: Abdominal Pain started 8-22-19 Epigastric/periumbilacal Nexium/Hyoscyamine 8-29-2019 ED for abd pain  CBC, Amylase, CRP, CMP, sed rate, GGT,Lipase, U/A, UPT CT of Abdomen & Pelvis Trace free fluid thickened colon wall - colitis  Abd x-ray, abd. U/S 8-30-19 Back to ED CBC, CRP increased, CMP, ESR increased, U/A Lipase, Abd x-ray Hyoscyamine - Carafate, Tylenol  ED-> Hosp 9-1-19 Admitted to hospital intractable abd. 9-4-19 Narcotic pain control, Nexium  9-3 EGD & colonoscopy gastritis & duodenitis Acute colitis (ileocolitis) Minimal terminal ileol involvement  Patchy Colitis (Acute)  2 months of uceris (Budosemide) ulcers post hospital pentasu QID 1000 mg QID Nexium QAM
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Metabolic function test, Oesophagogastroduodenoscopy abnormal, Red blood cell sedimentation rate increased, Ulcer, Ultrasound scan
Clinical narrative: Abdominal Pain started 8-22-19 Epigastric/periumbilacal Nexium/Hyoscyamine 8-29-2019 ED for abd pain  CBC, Amylase, CRP, CMP, sed rate, GGT,Lipase, U/A, UPT CT of Abdomen & Pelvis Trace free fluid thickened colon wall - colitis  Abd x-ray, abd. U/S 8-30-19 Back to ED CBC, CRP increased, CMP, ESR increased, U/A Lipase, Abd x-ray Hyoscyamine - Carafate, Tylenol  ED-> Hosp 9-1-19 Admitted to hospital intractable abd. 9-4-19 Narcotic pain control, Nexium  9-3 EGD & colonoscopy gastritis & duodenitis Acute colitis (ileocolitis) Minimal terminal ileol involvement  Patchy Colitis (Acute)  2 months of uceris (Budosemide) ulcers post hospital pentasu QID 1000 mg QID Nexium QAM