chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of fluzone high dose quadrivalent was inadvertently administered with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 74 years old female patient to whom an expired dose of fluzone high dose quadrivalent was inadvertently administered with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Sep-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ769AC, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic immunization.  On 08-Sep-2022, (latency: same day) the patient had an expired dose of fluzone high dose quadrivalent was inadvertently administered with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of QUADRACEL with no adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who received an expired dose of Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine live (enders-edmonston), mumps vaccine live (Jeryl lynn), rubella vaccine live (Wistar ra 27/3), varicella zoster vaccine live (Mka/merck) (Proquad) for Immunisation.  On 08-Sep-2022, the patient received first dose, 0.5 ml once of Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV(MRC5) vaccine (lot C5763AA, exp date: 26-ug-2022) via intramuscular route in the right thigh for Immunization.  On 08-Sep-2022, (latency: same day) the patient received an expired dose of quadracel with no adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome 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 the 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: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a possible dose of IPOL after the IPOL was involved in a temperature excursion that made the product not suitable for use with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who received a possible dose of IPV (VERO) [IPOL] after the Ipol was involved in a temperature excursion that made the product not suitable for use with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received a  dose of suspect IPV (VERO)   vaccines exposed to a temperature range of 35.6 degrees F (Fahrenheit) to 50.2 degrees F for 27-minutes due to the clinic's air condition not working and stocking a new shipment of vaccines into the refrigerator. Vaccines Involved were Acthib, Ipol, Menquadfi, PentaceL, and Fluzone 0.5 ml. 07-Sep-2022; that the excursion occurred between 12:42 pm to 01:12 pm, on 07-Sep-2022; that at 01:12 pm the reading came in at 50.2 degrees F; that the excursion was not noted until the next day, that the alarms did not sound at the time of the excursion.  One-dose of IPOL was administered from the open bottle of IPOL (lot V1A024M exp: 17-Feb-2024) via intramuscular route in the left thigh as Immunization post excursion (poor quality product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of DAPTACEL after expiration with no reported adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid non-serious case received via health professional. GMI Inquiry Number: 01271929  This case involves patient of unknown demographics to whom Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] administration after expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Aug-2022, the patient received suspect Daptacel vaccine after expiration at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination with no reported adverse event (expired product administered) same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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: Urticaria
Clinical narrative: hives on the face; Initial information received on 09-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Infant (6 months and older) and unknown gender patient who was diagnosed with hives on the face while receiving 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 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Immunization    On an unknown date the patient had hives on the face (urticaria) 4 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (hives on the face).  At time of reporting, the outcome was Unknown for the event hives on the face.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: FLUZONE HIGH DOSE was administered accidentally with no reported adverse event; Initial information received  on 09-Sep-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 4 years old female patient to whom influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]was administered accidentally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) , MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and COVID-19 VACCINE (COVID-19 VACCINE) for Prophylactic vaccination.  On 09-Sep-2022, the patient administered 0.7ml once (1x) dose of suspect influenza quadrival A-B high dose HV vaccine (lot UJ901AC and Expiration Date :30-Jun-2023) via intramuscular route in the left thigh for immunization accidentally with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). The physician prescribed FLUZONE QUAD for the patient. However, another nurse in the practice accidentally "grabbed the wrong dose" and administered the FLUZONE HIGH DOSE instead. The patient was retained in the office for 20 minutes following the administration with no noted issues.  Action taken : not applicable.  Outcome : 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Device malfunction
Clinical narrative: was in hospital for 5 days; Two hours after the injection, his defibrillator (ICD) went off once; Initial information received on 09-Sep-2022 regarding an unsolicited valid serious case received from a patient's wife (non healthcare professional).  This case involves a elderly male patient who was in hospital for 5 days and two hours after the injection, his defibrillator (ICD) went off once, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included had a defibrillator (implantable defibrillator insertion). The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an  unknown date in 2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, at dose of 0.7 ml once (1X) , wit an unknown formulation, strength, dose, batch number and expiry date , in unknown administration site. for immunization. Information on batch number has been requested.  On the same day in 2021, two hours after the injection, his defibrillator (ICD) went off once (device malfunction). His defibrillator never went off before that time. He had a defibrillator for years. He was in the hospital for 5 days afterwards (hospitalisation) (onset date: 2021; latency: few days) (seriousness criteria: hospitalization), and all the physicians told him that the event had nothing to do with his receipt of a flu shot. Patient is over 65 years old, so she (wife) believes he probably got a high dose shot, but she is not sure and did not have the exact name of it. She does know for sure that the flu vaccine was made by Sanofi, because she called the store from whom it was received, and they told him it was a Sanofi flu shot. She did not have the lot or expiry, but said she could find that out and either call back, or would put it on a questionnaire if she received one.   Action taken:  not applicable.  It was not reported if the patient received a corrective treatment for the events (Two hours after the injection, his defibrillator (ICD) went off once, was in hospital for 5 days).  Outcome: unknown for both the events; Sender's Comments: Sanofi company comment dated 16-Sep-2022: This case involves a elderly male patient who was in hospital for 5 days and two hours after the injection, his defibrillator (ICD) went off once, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].. Case will be reevaluated post further update on concomitant medications, concurrent condition during vaccination, underlying disease, laboratory investigations excluding alternative etiologies for the reported event which will aid a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of 28.2 degrees Fahrenheit for 2 hours and 29 minutes and 30 degrees Fahrenheit for 6 hours and 11 minutes with no reported adverse event; The vaccine was administered to patient post temperature excursion of 28.2 degrees Fahrenheit for 2 hours and 29 minutes and 30 degrees Fahrenheit for 6 hours and 11 minutes with no reported adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA377293 and 2022SA379737.  This case involves a 68 years old female patient who was administered vaccine post temperature excursion of 28.2 degrees Fahrenheit for 2 hours and 29 minutes and 30 degrees Fahrenheit for 6 hours and 11 minutes with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE was exposed to a temperature excursion of 28.2 degrees Fahrenheit for 2 hours and 29 minutes and 30 degrees Fahrenheit for 6 hours and 11 minutes with no reported adverse event (product storage error).  On 07-Sep-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ875AD, expiry date: 30-Jun-2023; formulation not reported) via intramuscular route in the left deltoid for immunization.  On 07-Sep-2022, (latency: same day) the patient was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE post temperature excursion of 28.2 degrees Fahrenheit for 2 hours and 29 minutes and 30 degrees Fahrenheit for 6 hours and 11 minutes with no reported adverse event (poor quality product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 the guidelines. 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: 0.5
Sex: U
Vaccine: DTAPIPV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 6 month old child received the product QUADRACEL instead of PENTACEL with no reported adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old and unknown gender patient who received the product DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength and lot number not reported) via unknown route in unknown administration site for prophylactic immunization.  On an unknown date, (latency: same day) the patient a 6 month old child received the product quadracel instead of pentacel with no reported adverse event (wrong product administered).   It was reported, a 6 month old child received the product QUADRACEL instead of PENTACEL.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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: 65.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was involved in a temperature excursion reached 28.2 degrees Fahrenheit for 2 hours and 29 minutes. and 30 degrees Fahrenheit for 6 hours and 11 minutes and administered to patient with no reported adverse event; Initial information received from on 09-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2022SA377287(CLUSTER) and 2022SA379737(CLUSTER).  This case involves a 65 years old male patient who was administered Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] vaccine after temperature excursion reached 28.2 degrees fahrenheit for 2 hours and 29 minutes. and 30 degrees fahrenheit for 6 hours and 11 minutes.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received 0.7 ml, once dose of suspect Influenza quadrival A-B high dose HV vaccine unknown formulation (lot UJ875AD, Exp date: 30-Jun-23) via intramuscular route in the left deltoid for intramuscular.  On 07-Sep-2022 the patient developed a non-serious "vaccine was involved in a temperature excursion reached 28.2 degrees fahrenheit for 2 hours and 29 minutes. and 30 degrees fahrenheit for 6 hours and 11 minutes and administered to patient with no reported adverse event (poor quality product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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 dose administered, No adverse event
Clinical narrative: patient jerked she didn't get all of the dose but she doesn't know how much with no reported adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who jerked while getting INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] she didn't get all of the dose but she doesn't know how much with no reported adverse event.  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 HIGH DOSE HV VACCINE (formulation, strength, dose, lot number: unknown) via unknown route in unknown administration site for Immunization.  While receiving vaccine patient jerked she didn't get all of the dose but she doesn't know how much with no reported adverse event (incorrect dose administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Accidental exposure to product, Device connection issue, Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: the product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event; the product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2022SA379788(CLUSTER).  This case involves a 50 years old male patient to whom while administering INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] the product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Sep-2022, the patient received a 0.5 ml dose once of suspect INFLUENZA QUADRIVAL A-B VACCINE, unknown formulation (Exp: 30-Jun-2023, Lot  UT7680KA) not reported via intramuscular route in the left arm for Immunization and product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event (incorrect dose administered) (Accidental exposure to product) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, No adverse event, Underdose
Clinical narrative: she was administering a shot to a patient when more than half the dose leaked out, and some leaked onto her pants with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2022SA378582(CLUSTER).  This case involves a 31 years old female who while administering a shot of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] to a patient more than half the dose leaked out, and some leaked onto her pants with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 10-Sep-2022, while administering suspect INFLUENZA QUADRIVAL A-B VACCINE pre filled syringe at an unknown dose (lot UT7680KA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunization to the patient more than half the dose leaked out, and some leaked onto her pants with no reported adverse event (accidental exposure to product) (latency: same day).  Action taken: Not applicable.  Outcome: 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 the 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: 5.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: IPOL given on that day was an extra dose/vaccine history for the child that showed he had received vaccination, with no adverse event; Initial information was received on 12-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who experienced IPOL given on that day was an extra dose/vaccine history for the child that showed he had received vaccination, with no adverse event vaccination while receiving vaccine IPV (VERO) [IPOL].  The patient's past vaccination(s) included IPOL POLIO VACCINE. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) for Immunisation.  On 06-Aug-2021, the patient received one dose of 0.5 ml of suspect IPV (VERO) (lot 49281-86-78) (formulation, strength, and expiry date: unknown) via intramuscular route in left thigh for prophylaxis vaccination.  On 06-AUG-2021 the patient developed a non-serious ipol given on that day was an extra dose/vaccine history for the child that showed he had received vaccination with no adverse event (extra dose administered) (Latency same day) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  At time of reporting, the outcome was Unknown for the event ipol given on that day was an extra dose/vaccine history for the child that showed he had received vaccination with 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 the guidelines. 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: 3.0
Sex: M
Vaccine: HIBV, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: receiving both a Pentacel dose and a dose of ACTHIB, on the same day with no reported adverse event; Initial information received  on 12-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 3 years old male patient who received both a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] dose and a dose of HIB (PRP/T) VACCINE [ACT-HIB], on the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) both for Prophylactic vaccination.  On 09-Aug-2022, the patient received suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml (lot UJ575AAA, expiry date: 20-Sep-2022) and suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ614AAA, expiry date: 25-Feb-2023) both via intramuscular route in the left arm for immunisation.  On 09-Aug-2022 the patient received both a pentacel dose and a dose of acthib, on the same day with no reported adverse event (extra dose administered) same day latency. It was unknown if the consumer was to receive the combo of DTAP and Hib in the same vaccine or if the consumer was to receive a stand alone DTap and a stand alone HIB vaccine.  Action taken: Not applicable.  Outcome: 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 the 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: 62.0
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient requested a FLUBLOK vaccine and was accidentally given FLUZONE with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 62 years old male patient who requested a INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and was accidentally given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Sep-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7681KA and expiry date: 30-Jun-2023) via intramuscular route in the deltoid nos for prophylactic immunization instead of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On 13-Sep-2022, (latency: same day) the patient requested a flublok vaccine and was accidentally given fluzone with no reported adverse event (wrong product administered).  Action taken was not applicable with both the suspects.  At time of reporting, the outcome was Unknown for the 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 the 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: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired doses of FLUZONE HIGH-DOSE QUADRIVALENT given with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 65 years old male patient to whom expired doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Sep-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength and lot number not reported; expiry date: 30-Jun-2022) via intramuscular route in unknown administration site for prophylactic vaccination.  On 13-Sep-2022, (latency: same day) the patient had expired doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE given with no reported adverse event (expired product administered).  Action taken was not applicable.  At time of reporting, the outcome was unknown for the 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 the 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: Accidental exposure to product, No adverse event, Syringe issue
Clinical narrative: little top piece that attaches to the needle popped out of place and starting leaking the vaccine out from under it, and vaccine dripped out the side and a few drops landed on patient with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient of unknown demographics and it was reported that a little top piece that attaches to the needle popped out of place and starting leaking the vaccine out from under it, and vaccine dripped out the side and a few drops landed on patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE 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 an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Immunization.  On an unknown date the little top piece that attaches to the needle popped out of place and starting leaking the vaccine out from under it, and vaccine dripped out the side and a few drops landed on patient with no reported adverse event (accidental exposure to product) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that that while giving the patient the vaccine the little top piece that attaches to the needle popped out of place and starting leaking the vaccine out from under it, so like it was not secured.Vaccine dripped out the side and a few drops landed on patient. Pharmacist would like to know if they should give the patient another dose because patient was claiming that she was not feeling anything.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the 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 the 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: 1.25
Sex: U
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK dose to a 15 month old with no adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2022SA381687(CLUSTER).  This case involves a 15 months old and unknown gender patient to whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] dose was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date flublok dose was administered to a 15 month old with no adverse event (product administered to patient of inappropriate age) (same day latency). Physician said they received FLUBLOK by accident or they didn't order it but his staff is clearing that up. He wanted to know about safety issues and if it needs to be repeated.  Action taken: Not applicable.  Outcome: 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 the 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, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient that qualifies for FLUZONE HD was instead administered FLUZONE QUAD., with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA383250(CLUSTER).  This case involves an unknown age and unknown gender patient who qualifies for INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was instead administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event while receiving vaccine.   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 and  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, dose, formulation, route,lot number not reported) in unknown administration site both for prophylactic vaccination.  On an unknown date the patient reported  a non-serious patient that qualifies for fluzone hd was instead administered fluzone quad with no reported adverse event (Wrong product administered) (unknown latency).   Action taken:not applicable.  At time of reporting, the outcome was Unknown for the event Wrong product administered.   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 the 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, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient that qualifies for fluzone hd was instead administered fluzone quad with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2022SA383304(CLUSTER).  This case involves an unknown age and unknown gender patient who qualifies for INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was instead administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date the patient who qualified for INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number, expiry date: not reported) was instead administered INFLUENZA QUADRIVAL A-B VACCINE at unknown dose (lot number, expiry date, form, strength: not reported) with no reported adverse event (wrong product administered) (same day latency). Pharmacist wanted to know how should they re-dose the patient. Wanted to know the concentration of the 2 vaccines. Patient was to be administered the Fluzone High Dose but was given other.  Action taken: Not applicable.  Outcome: 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 the 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: 0.17
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: gave fluzone quadrivalent to a 2-month old,with no reported adverse event; Initial information was received on 14-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old and unknown gender patient who experienced gave fluzone quadrivalent to a 2-month old,with no reported adverse event while receiving 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 14-Sep-2022, the patient received one dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7689LA and expiry-30-06-23) (dose, formulation and strength:unknown) via unknown route in unknown administration site for immunization.  On 14-SEP-2022 the patient developed a non-serious gave fluzone quadrivalent to a 2-month old,with no reported adverse event (product administered to patient of inappropriate age) (Latency same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event gave fluzone quadrivalent to a 2-month old,with no reported 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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired FLUZONE HIGH-DOSE QUADRIVALENT to patient with no reported adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age male patient who reported administered expired fluzone high-dose quadrivalent to patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE 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 HIGH DOSE HV VACCINE (lot UJ769AC ; expiry date: 30-Jun-2022) via unknown route in the right arm for immunization.  On an unknown date the patient reported a non-serious administered expired fluzone high-dose quadrivalent to patient with no reported adverse event (expired product administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event expired product administered.   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 the 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: 80.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain started on shoulder and is descending along the arm, moving across the all arm elbow and now reaching the hand; Pain started on shoulder and is descending along the arm, moving across the all arm elbow and now reaching the hand; This spontaneous case was received on 30-Aug-2022 from other non-healthcare professional (consumer) via Agency (reference number SEQW22-02560) and concerned an 80-year-old, male patient.  The patient's concurrent condition included high blood pressure, Non Hodgkin lymphoma and atrial fibrillation. The patient's concomitant medications were not reported.    On 26-Aug-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0,5 ml, route of administration, anatomical location and indication: not reported). The butch number was not reported.  On 27-Aug-2022, one day after receiving Fluad Quadrivalent, the patient experienced pain that started on shoulder and was descending along the arm, moving across the all arm, elbow and reaching the hand.  At the time of initial reporting, the patient had not recovered from both events since it was reported that it was on going.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: Events pain in extremity and arthralgia are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: Events pain in extremity and arthralgia are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Age: 1.83
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: The vaccinator administered the COVID-19 vaccine in the left vastus lateralis using a 5/8" needle.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired quality of life, Tinnitus
Clinical narrative: Shortly after receiving my second covid vaccine, I experienced a high pitched buzzing / ringing in both ears. It has now been 3 days since and it has not subsided. It is adversely effecting my quality of life. I have an appointment with my primary care physician next week (week ending 9/24/22).
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: The vaccinator administered the COVID-19 vaccine in the left vastus lateralis using a 5/8" needle.