chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was administered to 57 years old female/no AE; Fluzone HD was administered to 57 years old female/no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a Other Health Care Professional.  This case is linked to case 2019SA274402 (same reporter).  This case involves a 57 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant therapy at the time of vaccination.   On 30-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number UJ268AAA via Intramuscular route in right deltoid.  It was of actual medication error case due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate age) and overdose (overdose). The vaccine was administered by a Physician or a Healthcare professional (not confirmed).  It was unknown whether adverse event was noted or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Fluzone HD was given on 01Oct2019 inadvertently, no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demography who inadvertently received a expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], on 01-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 expired vaccine used.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High-Dose was given to a 13 year old/ No AE; Fluzone High-Dose was given to a 13 year old/ No AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid serious case received from a pharmacist.  This case involves a 13 years old male patient who received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ232AB, expiry date-10-04-2020 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 15 month old patient was administered expired dose of Daptacel, No AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who received an expired 0.5 mL dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5254AA, expiry date- 18-Sep-2019 via unknown route in unknown administration site on 01-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines administered.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 62 yr old consumer received the Fluzone HD, no AE; 62 yr old consumer received the Fluzone HD, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 years old 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 02-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to overdose and Inappropriate age at vaccine administration and 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 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: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: a patient was given high dose fluzone that is not in the recommended age range and the patient is pregnant/No AE; a patient was given high dose fluzone that is not in the recommended age range and the patient is pregnant/No AE; a patient was given high dose fluzone that is not in the recommended age range and the patient is pregnant/No AE; a patient was given high dose fluzone that is not in the recommended age range and the patient is pregnant/No AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves female patient of an unknown age who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on an unknown date, while she was pregnant.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine exposure during pregnancy. The patient was pregnant when she received vaccine.  It was also the case of actual medication error due to inappropriate age at vaccine administration, product use in unapproved population and overdose.  Caller says that a patient was given high dose fluzone that is not in the recommended age range and the patient is pregnant.  At the time of report, no adverse event was reported.  Pregnancy outcome was unknown at the time of report.  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: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: there is a 28 year old pregnant female who received the Fluzone HD/No AE; there is a 28 year old pregnant female who received the Fluzone HD/No AE; there is a 28 year old pregnant female who received the Fluzone HD/No AE; there is a 28 year old pregnant female who received the Fluzone HD/No AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from consumer/non-hcp.  This case involves 28 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on an unknown date, while she was pregnant.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine exposure during pregnancy. The patient was pregnant when she received vaccine.  It was also the case of actual medication error due to inappropriate age at vaccine administration, product use in unapproved population and overdose.  At the time of report, no adverse event was reported.  Pregnancy outcome was unknown at the time of report.  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: FLU3, FLU4
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient who is 57 years old was given Fluzone high dose instead of Fluzone Quadrivalent/ No AE; patient who is 57 years old was given Fluzone high dose instead of Fluzone Quadrivalent/ No AE; patient who is 57 years old was given Fluzone high dose instead of Fluzone Quadrivalent/ No AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 57 years old female patient who received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ284AA, expiry date 25-05-2020 via intramuscular route in the right deltoid on 02-Oct-2019 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. No other vaccines received.   It was a case of actual medication error due to Wrong vaccine administered, Inappropriate age at vaccine administration and Overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 60.0
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: they gave a patient Fluzone Quad but was meant to give the Flublok, no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a 60 years old patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number not reported via unknown route in unknown administration site instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Haemophilia.  It was an actual medication error case due to wrong vaccine administered.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of 18 degrees C for 24 hours, no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves two unknown demographic patients who were vaccinated with a dose of vaccine QUADRIVALENT INFLUENZA VACCINE [INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED] lot number not reported via unknown route in unknown administration site which had temperature excursion of 18 degrees c for 24 hours on an unknown date.  It is a actual medication error case due to incorrect product storage.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received a vaccine that too low in the muscle and and may have been considered subcutaneous/ no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 55 years old female patient who received 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UJ257AD (Expiry date 30-Jun-2020) via subcutaneous route in the left arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate route of vaccination.  It was reported that patient received a vaccine that was too low in the muscle and may have been considered subcutaneous.  At a time of reporting no adverse effect 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: F
Vaccine: FLU4
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: stiff neck in the back of her neck; discomfort there as well as in her upper back on the side but her arm seemed fine; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 51 years old female patient who experienced stiff neck in the back of her neck (musculoskeletal stiffness) and discomfort there as well as in her upper back on the side but her arm seemed fine (musculoskeletal discomfort), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ247AB (Expiry date 30-jun-2020) via unknown route in the left deltoid.  On 02-Oct-2019, the patient developed a non-serious stiff neck in the back of her neck (musculoskeletal stiffness) and discomfort there as well as in her upper back on the side but her arm seemed fine (musculoskeletal discomfort) 1 hour 30 min following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was stiff neck and Back discomfort.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for stiff neck and Back discomfort.  List of documents held by sender: none.
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administered Ipol vaccine after it was suppose to be dis guarded after temp excursion / no adverse event; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 8 years and 8 months old female patient who received 0.5 ml IPV (VERO) [IPOL] lot P1E701M (Expiry date 09-NOV-2020) via intramuscular route in the left arm.  Patient's medical history, treatments, family history were not reported.  No other vaccines were given  It was a actual medication error case due to incorrect product storage.  It was reported that patient was administered Ipol vaccine after it was suppose to be dis guarded after temp excursion.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was administered with a DTap/IPV injection from a Vial instead of mixing it with the Hib to form a Pentacel, no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] in which only DTap/IPV injection was given from a Vial instead of mixing it with the Hib component (Pentacel lot: UJ015AAA, Expiration Date: 26Oct2020, Lot U6218AA, Expiration Date: 26Oct2020, and Lot UJ015AA, Expiration Date: 26Oct2020on 30-Sep-2019.  It is an actual medication error case due to Inappropriate reconstitution technique.  It was reported that 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.  List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose flu vaccine to a patient who is 63 years old in error, no AE; Fluzone High Dose flu vaccine to a patient who is 63 years old in error, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 63 years old 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 an unknown date.   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 administered to patient of inappropriate age
Clinical narrative: a 6 years 5 months old female patient received a dose of Flublok Quadrivalent on 25SEP2019/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a six years five months old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] pre-filled syringe on 25-Sep-2019 lot QFAA1925, expiry date: 30-Jun-2020 via intramuscular route in the left deltoid.  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 inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product packaging confusion, Product use complaint, Wrong product administered
Clinical narrative: 6 year old male received a dose of Flublok Quadrivalent in error due to the syringes of the Fluzone and the Flublok Quadrivalent are the same colored boxes and administrator grabbed the wrong one the label writing was also tiny/No AE; 6 year old male received a dose of Flublok Quadrivalent in error due to the syringes of the Fluzone and the Flublok Quadrivalent are the same colored boxes and administrator grabbed the wrong one the label writing was also tiny/No AE; 6 year old male received a dose of Flublok Quadrivalent in error due to the syringes of the Fluzone and the Flublok Quadrivalent are the same colored boxes and administrator grabbed the wrong one the label writing was also tiny/No AE; 6 year old male received a dose of Flublok Quadrivalent in error due to the syringes of the Fluzone and the Flublok Quadrivalent are the same colored boxes and administrator grabbed the wrong one the label writing was also tiny/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a six years old male patient who a 0.50 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1909 via intramuscular route in the left arm on 02-Oct-2019 in error due to the syringes of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and the flublok quadrivalent are the same colored boxes and administrator grabbed the wrong one the label writing was also tiny.  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 inappropriate age at vaccine administration, wrong vaccine administered, product label font size complaint and product packaging confusion.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Influenza, Pain, Pyrexia
Clinical narrative: body aches; joint pain; fever in bed for a few days; flu; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a female patient (age unknown) who experienced body aches (pain), joint pain (arthralgia), fever in bed for a few days (pyrexia) and flu (influenza like illness), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included granuloma annulare and Thyroid disorder. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Alpha gal Allergy.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious body aches (pain), joint pain (arthralgia), fever in bed for a few days (pyrexia) and flu (influenza like illness) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was flu, fever in bed for a few days, joint pain and body aches.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported was not reported for joint pain, fever in bed for a few days, flu and body aches.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a 90-year-old male patient inadvertently received two doses of Flublok Quadrivalent/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 90 years old male patient who was inadvertently received two 0.5 ml doses of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1930, expiry date: 30-Jun-2020 via intramuscular route in the right deltoid and left deltoid.  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 extra dose administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: severe shaking; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse and additional information received on same date.  This case is linked to cases 2019SA276203 and 2019SA276202 (same reporter).  This case involves a 70 years old male patient who experienced with severe shaking (tremor) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication   On 24-Sep-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ268AB via intramuscular route in the left deltoid.  On an unknown date, the patient experienced severe shaking (tremor) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   No Relevant laboratory test reported.  Final diagnosis was tremor.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as recovered for the events (lasted several hours).
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a 73 years old patient received a dose of Fluzone High Dose on 02OCT2019 who had received the vaccine earlier from another facility within 30 days/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 73 years old female patient who received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 02-Oct-2019 lot UJ238AA via intramuscular route in the left deltoid who had received the vaccine earlier from another facility within 30 days.  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 extra dose administered  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 65 years old female patient received a 0.5 ml dose of Fluzone High Dose on 03oct2019 which was already expired on 05Jun2019/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff).  This case involves a 66 years old female patient received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 03-Oct-2019 which was already expired on 05-Jun-2019 lot UJ051AB via intramuscular route in the left deltoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: uncontrollable shivering; high fever; Initial information received on 03-Oct-2019 and additional information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves three patients (demographics unknown) who experienced uncontrollable shivering (chills) and high fever (pyrexia), when 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.   From 01-Oct-2019 to 03-Oct-2019, the patients received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious uncontrollable shivering (chills) and high fever (pyrexia) (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 high fever and uncontrollable shivering.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for uncontrollable shivering and high fever.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Sepsis, Tremor
Clinical narrative: shaking; fever; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse and additional information received on same date.  This case is linked to cases 2019SA276203 and 2019SA276197 (same reporter).  This case involves a 81 years old male patient who experienced with sepsis (Sepsis) and fever (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication   On 01-Oct-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ268AB via intramuscular route in the left deltoid.  On an unknown date, the patient experienced fever (pyrexia) and shaking (tremor) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   No Relevant laboratory test reported.  Final diagnosis was sepsis and fever.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as recovered for the events (lasted several hours).
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Mobility decreased, Peripheral swelling
Clinical narrative: being barely able to lift it after; right arm being swollen; feeling like it was on fire; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 45 years (possibly) old female patient who experienced barely able to lift it after (mobility decreased), right arm being swollen (peripheral swelling) and feeling like it was on fire (burning sensation), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) in right arm.   On 02-Oct-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  The patient also received an unspecified flu shot in her left arm the same day without any reactions.  On an unknown date, the patient had barely able to lift it after (mobility decreased), right arm being swollen (peripheral swelling) and feeling like it was on fire (burning sensation) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Lab data was not reported.  Final diagnosis was mobility decreased, peripheral swelling and burning sensation.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for mobility decreased, peripheral swelling and burning sensation.  Information on the batch number was requested.  List of document held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received Adacel vaccination into the posterior upper left arm, subcutaneously; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 38 years old female patient who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6272AA (Expiration date not obtained) via subcutaneous route in the left arm on 06-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines administered.   It was a case of actual medication error due to Inappropriate route of vaccination.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 1.83
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: a child was given and EXP vaccine/no AE; a child was given and EXP vaccine of 4th dose at 22 months/no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 22 months old male patient who received an expired dose of vaccine, while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLU VACCINE VII); PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE); HEPATITIS A VACCINE (HEPATITIS A VACCINE); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  On 02-Oct-2019, the patient received a 4th single 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot UI908AAA, expiry date: 14-Sep-2019 via intramuscular route in the left deltoid.  It was of actual medication error case due to Inappropriate schedule of vaccine administered and expired vaccine used.  It was unknown whether any delayed adverse event was noted or not..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: itchy rash covering the upper part of his arm around the injection site; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp and additional information was received on 03-Oct-2019.  This case is linked to cases 2019SA277288 and 2019SA278150 (same reporter).  This case involves a 8 years old male patient who experienced itchy rash covering the upper part of arm around the injection site (rash pruritic), while he received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ237AB.  On an unknown date, The patient developed a non-serious itchy rash covering the upper part of arm around the injection site (rash pruritic) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  No lab test reported.  Final diagnosis was rash pruritic   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient outcome is reported as Recovering / Resolving for itchy rash.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Vaccine is from 2017-2018 formula but was administered in 2019. Vaccine expired 11 May 2018/no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who received an expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (UI871AB) (expiry date: 11 May 2018).  It was of actual medication error case due to expired vaccine used. Vaccine is from 2017-2018 formula but was administered in 2019.  It was unknown whether adverse event was noted or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 62 years old patient received the Fluzone High-Dose in error not the standard dose that was ordered, no AE; 62 years old patient received the Fluzone High-Dose in error not the standard dose that was ordered, no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 62 years old patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date not reported) 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 and overdose.  It was reported that the age of 62 years old patient received the Fluzone High-Dose in error not the standard dose that was ordered. Nurse inadvertently gave high dose flu vaccine.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Left Arm swollen, Hot Itching
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient returned on 10/10, stated that left deltoid site was bruised, onset 10/5 and is resolving, wanted to show us how it looked. Patient is on Eliquis
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Pyrexia
Clinical narrative: fever  39 C
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Tired; Fatigue; Body Aches; Fast Heartbeat; Headache; Dizziness; Shivering/Chills; Stomach Pain