chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash formed on body; This is a spontaneous report from a contactable healthcare professional (patient's parent) via a Pfizer sales representative. A 4-month-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in Aug2019 as single dose for immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unspecified date for immunization. The 4-month-old patient received second dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) two months ago (Aug2019) and rash formed on body. The outcome of the event was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Pain in extremity
Clinical narrative: she still has enough pain in her arm to keep her up at night; This is a spontaneous report from a contactable consumer (the patient).  A female patient of an unspecified age received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced pain in her arm on an unspecified date. She reported that she still has enough pain in her arm to keep her up at night after two weeks from vaccination. The event is non-serious with outcome of not recovered.  Therapeutic measures taken as a result of the event includes treatment with ALEVE.  The information on the batch/lot number has been requested.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a Flu shot from an extended shipment of Fluzone Quadrivalent, no AE; Based on information received on 04-Oct-2019, the report previously considered as non-valid became valid: patient identifier reported.  Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer in United States.   This case is linked to cases 2019SA278134, 2019SA278135, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278140 and 2019SA278141 (same reporter).  This case involves patient of an unknown demographics who was administered with a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in unknown administration site on 27-Oct-2019.  It was a actual medication error case due to incorrect product storage.  It was reported that on 27Oct2019 nine patients received a Flu shot from an extended shipment of Fluzone Quadrivalent.  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.  Follow-up information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.   Case became valid. Event description updated.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: received a total of two-doses of Fluzone High-Dose a day apart/no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 73 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] twice a day apart.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant therapy was received.  On 01-Oct-2019 and 30-Sep-2019, the patient received doses of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ246AA via intramuscular route in the left arm...  It was of actual medication error case due to extra dose administered.  It was unknown whether vaccines were used or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 60 year old male female was administered with Fluzone High-Dose/no AE; 60 year old male female was administered with Fluzone High-Dose/no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA274328 (same reporter).  This case involves a 60 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, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route.  It was of actual medication error case due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate age) and overdose (overdose).  It was unknown whether adverse event was noted or not.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was administered to a 64 years old female/no AE; Fluzone HD was administered to a 64 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 2019SA274329 (same reporter).  This case involves a 64 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 left 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.
Age: 5.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 year old female patient accidentally received a Flublok Quadrivalent vaccine in Right Thigh. No adverse event; 5 year old female patient accidentally received a Flublok Quadrivalent vaccine. No adverse event; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old female patient who was accidentally administered a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1924, expiry date:  30-Jun-2020 via intramuscular route in the right thigh on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   It was an actual medication error due to vaccine administered at inappropriate site and inappropriate age at vaccine administration.  The patient did not experience any adverse Events 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 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: Headache, Incorrect route of product administration, Injection site swelling, Injection site warmth
Clinical narrative: headache; injected arm became swollen and hot to touch about the size of an egg; injected arm became swollen about the size of an egg; injected arm became hot to touch; a 55 years old patient received a dose of Flublok Quadrivalent via subcutaneous route; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 55 years old female patient who experienced headache, injected arm became swollen and hot to touch about the size of an egg (vaccination site inflammation), injected arm became swollen about the size of an egg (vaccination site swelling) and injected arm became hot to touch (vaccination site warmth), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1925 via subcutaneous route in the left arm.  On an unknown date, the patient experienced a non-serious headache, injected arm became swollen and hot to touch about the size of an egg (vaccination site inflammation), injected arm became swollen about the size of an egg (vaccination site swelling) and injected arm became hot to touch (vaccination site warmth)   (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was an actual medication error due to inappropriate route of vaccination. A 55 years old patient received a dose of flublok quadrivalent via subcutaneous route.  Employee Health visit 03Oct2019.   (Other relevant tests included no lab data.)  Final diagnosis was injected arm became swollen and hot to touch about the size of an egg and headache.   Treatment: Steroid cream and ice to injection site.  The patient outcome was not reported for headache and  injected arm became swollen and hot to touch about the size of an egg. The patient was not recovered from injected arm became hot to touch. The patient was recovering from injected arm became swollen about the size of an egg.  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: Overdose, Product administered to patient of inappropriate age
Clinical narrative: a 62 year old male patient was administered a dose of Fluzone High Dose/No AE; a 62 year old male patient was administered a dose of Fluzone High Dose/No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 62 years old male patient who a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot 6j281a, expiry date: 16-May-2020 via intramuscular route in the left deltoid on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Doctor visit on 04-Oct-2019.  It was an 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: a 58 years old female patient received a 0.5 mL dose of Fluzone High Dose in error/No AE; a 58 years old female patient received a 0.5 mL dose of Fluzone High Dose in error/No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 58 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in error lot UJ232AA, expiry date: 10-Apr-2020 via intramuscular route in the left arm on 04-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 inappropriate age at vaccine administration and overdose.  At the time of report, no adverse event was reported.  Flu clinic visit 04-Oct-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a 65 year old patient had inadvertently been administered the Fluzone Quadrivalent rather than the Fluzone High dose, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old female patient who received a dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] via unknown route in unknown site of administration.  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.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: consumer only receiving the Dtap-IPV portion and not the ActHib from pentacel, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 6 months old male patient who only received the 0.5 ml DTAP-IPV portion and not the ACT-HIB] from vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot: UJ148ABA, expiry date: 03Feb2021, Act-Hib: lot: UJ148AB, expiry date: 03Feb2021, Vial: Lot: U6424BA, expiry date: 03Feb2021) via intramuscular route in the right thigh (anterior lateral right thigh), on 02-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  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 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: 73.0
Sex: F
Vaccine: FLU3, FLUA3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient had received a Flu shot (Fluad) x 3 strains older on 16Sep2019 and Fluzone HD on 03oct2019, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 73 years old female patient who received vaccine INFLUENZA VACCINE INACT SAG 3V [FLUAD] (lot 260389 via unknown route in unknown administration site) on 16-Sep-2019 and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ252AA, Exp. Date 04-May-2020 via unknown route in the left deltoid) on 03-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to extra dose administered.  It was reported that she gave a Fluzone HD on 03-Oct-2019 during a vaccine visit only. Even though the Fluzone HD was appropriate for her age the caller asked if she had received any vaccines recently and the patient stated "No". Caller saw information after injecting the Fluzone HD that patient had received a Flu shot (Fluad) x 3 strains for patient 65 years old and older on 16-Sep-2019.   At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: expired dose of Fluzone was given to a 24 year old pregnant patient, no AE; expired dose of Fluzone was given to a 24 year old pregnant patient, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 24 years old female patient who received expired dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number not reported, that expired in June) 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 vaccination occurred at unknown gestation period. 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 an actual medication error case due to expired vaccine used.  It was also a case of vaccine exposure during pregnancy.  At the time of report, no adverse event was reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  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: FLU4
Symptoms: Expired product administered
Clinical narrative: expired Fluzone Quadrivalent was inadvertently administered to a patient/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient who received an expired dos of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6261JA (Expiration Date: 30-Jun-2019).  It was of actual medication error case due to expired vaccine used  It was unknown whether adverse event was noticed 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.
Sex: U
Vaccine: FLUX
Symptoms: Poor quality product administered, Product distribution issue
Clinical narrative: patients received a Flu shot from an extended shipment of Fluzone Quadrivalent/no AE; patients received a Flu shot from an extended shipment of Fluzone Quadrivalent/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA271944, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278140, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received Deteriorated dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On Oct-2019, patient received a multi-dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) (no dosing details were reported.  It was of actual medication error case due to Deteriorated drug administered (Poor quality product administered) and Product shipment delay (Product distribution issue).  It was unknown whether adverse event was noticed 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.
Sex: U
Vaccine: FLU4
Symptoms: Poor quality product administered, Product distribution issue
Clinical narrative: patients received a Flu shot from an extended shipment of Fluzone Quadrivalent/no AE; patients received a Flu shot from an extended shipment of Fluzone Quadrivalent/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA278134, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278140, 2019SA278141, 2019SA271944 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received Deteriorated dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On Oct-2019, patient received a multi-dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) (no dosing details were reported.  It was of actual medication error case due to Deteriorated drug administered (Poor quality product administered) and Product shipment delay (Product distribution issue).  It was unknown whether adverse event was noticed 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.
Sex: U
Vaccine: FLUX
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a Flu shot from an extended shipment of Fluzone Quadrivalent, no adverse event; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff).  This case is linked to cases 2019SA271944, 2019SA278134, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278140, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received a dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On 27-Oct-2019, patient received a dose from a multi-dose vial of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC), exp date: 30J-un-2020, (no dosing details, route and site of administration were reported).  It was of actual medication error case due to product storage error.  It was reported that a patient received a Flu shot from an extended shipment of Fluzone Quadrivalent.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Poor quality product administered, Product distribution issue
Clinical narrative: they were not suitable for use due to extended shipment/no AE; they were not suitable for use due to extended shipment/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA271944, 2019SA278134, 2019SA278136, 2019SA278138, 2019SA278139, 2019SA278140, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received Deteriorated dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On Oct-2019, patient received a multi-dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) (no dosing details were reported.  It was of actual medication error case due to Deteriorated drug administered (Poor quality product administered) and Product shipment delay (Product distribution issue).  It was unknown whether adverse event was noticed 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.
Sex: U
Vaccine: FLUX
Symptoms: Poor quality product administered, Product distribution issue
Clinical narrative: they were not suitable for use due to extended shipment/no AE; they were not suitable for use due to extended shipment/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA271944, 2019SA278134, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278140, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received Deteriorated dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On Oct-2019, patient received a multi-dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) (no dosing details were reported.  It was of actual medication error case due to Deteriorated drug administered (Poor quality product administered) and Product shipment delay (Product distribution issue).  It was unknown whether adverse event was noticed 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.
Sex: U
Vaccine: FLUX
Symptoms: Poor quality product administered, Product distribution issue
Clinical narrative: they were not suitable for use/no AE; they were not suitable for use/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.   This case is linked to cases 2019SA271944, 2019SA278134, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received Deteriorated dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On Oct-2019, patient received a multi-dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) (no dosing details were reported.  It was of actual medication error case due to Deteriorated drug administered (Poor quality product administered) and Product shipment delay (Product distribution issue).  It was unknown whether adverse event was noticed 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.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: patients received a Flu shot from an extended shipment of Fluzone Quadrivalent, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to cases 2019SA278134, 2019SA278135, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278140 and 2019SA271944 (same reporter).  This case involves a patient who received a dose of QUADRIVALENT INFLUENZA VACCINE [FLUZONE] (lot: UJ254AC, expiry date: 30-Jun-2020) via unknown route in unknown administration site, on an unknown date, from an extended shipment and they were not suitable for use.   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.  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.  List of documents held by sender: none.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient received a dose of expired ActHIB due to a provider oversight, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 months old female patient who received a 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (Lot: UI908AAA, expiry date: 14-Sep-2019) via intramuscular in the left leg on 24-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included HEPATITIS A VACCINE (HEPATITIS A VACCINE); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE); PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation on 24-Sep-2019.  It was an actual medication error due to expired vaccine used. Apatient received a dose of expired ActHIB due to a provider oversight.  It was reported that the state regulatory body and caregiver have been informed.   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.  List of documents held by sender: none.
Sex: U
Vaccine: MMR, MNQ
Symptoms: Product preparation issue
Clinical narrative: Menactra vaccine was used as a diluent for MMR vaccine, administered Menactra in the same syringe/No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] as a diluent for MMR.  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 HIV infection.   On 02-Oct-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On 02-Oct-2019, the patient received a dose of suspect MENINGOCOCCAL VACCINE (MMR) not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Wrong technique in product usage process.  There is no more AE information available for this 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.  Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: temp excursion of 9.6 C for 1 hour 12 mins/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  It was a non-valid case since no patient was involved.  It was reported that there was a temp excursion of 9.6 c for 1 hour 12 mins in vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ065AA) due to door to fridge being left opened.  It was of potential medication error case due to incorrect product storage.  Product was unopened hence no use of vaccine was there.  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: Incorrect route of product administration, No adverse event
Clinical narrative: a female patient received a dose of Fluzone Quadrivalent 0.5 mL prefilled syringe via subcutaneous route rather than intramuscular route/No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient (age unknown) who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe via subcutaneous route rather than intramuscular route lot number and expiry date not reported via subcutaneous route in unknown administration site on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient did not receive any other concomitant vaccines.   It was an 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: red blotchy rash all over body; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves two patients of unknown demographics who experienced red blotchy rash all over body (rash generalised), while 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.   On an unknown date, the patients received a 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 patients experienced a non-serious red blotchy rash all over body (rash generalised) (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 red blotchy rash all over body.   It was not reported if the patients received a corrective treatment.  The patients outcome was not reported for red blotchy rash all over body.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Incorrect route of product administration, Local reaction
Clinical narrative: significant local reaction; I have a Flublok given SQ not IM; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient who experienced significant local reaction (local reaction), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via subcutaneous route.  On an unknown date, The patient developed a non-serious significant local reaction (local reaction) Unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was of actual medication error case due to Inappropriate route of vaccination.  No lab test reported.  Final diagnosis was significant local reaction.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for significant local reaction.  Information on the batch number was request.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Gait inability, Headache, Malaise, Pain
Clinical narrative: couldn't  walk; got very ill; pounding headache/could not pick her head; body aches; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a female patient of unknown age who couldn't  walk (gait disturbance), got very ill (malaise), pounding headache/could not pick her head (headache) and body aches (pain), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ223AA via unknown route.  On an unknown date, The patient developed a non-serious couldn't  walk (gait disturbance), got very ill (malaise), pounding headache/could not pick her head (headache) and body aches (pain) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  No lab test reported.   Final diagnosis was body aches, pounding headache/could not pick her head, got very ill and couldn't  walk.   It was not reported if the patient received a corrective treatment.  The patient's event outcome was not reported..
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Decreased appetite, Irritability, Screaming
Clinical narrative: About 3 hours after the shots, patient woke up from a nap and ate. After he ate he was a bit fussy. The fussiness soon turned to screaming and crying uncontrollable for about 2 hours. We finally got him to sleep on our shoulder and he did for about an hour. He woke up screaming loudly. I tried to nurse him and bottle feed him and he didnt take either. He then screamed and cried for another 1-2 hours straight not being able to be controlled. He fell asleep again and woke up again...not interested in eating. We got him to eat around 9:30PM and the fussiness was better.
Age: 2.5
Sex: M
Vaccine: MMRV
Symptoms: Herpes zoster
Clinical narrative: Classical Herpes Zoster on left leg
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Urticaria
Clinical narrative: Hives and facial swelling