chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAP, DTAPHEPBIP, IPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: A 4-month-old patient received IPOL and PEDIARIX on the same day no AE; A patient received PEDIARIX in error instead of a stand alone DTap dose no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via nurse via consumer/non-health care professional via Medical Information (MI) (Reference number- 00809307) and transmitted to Sanofi on 12-Oct-2021.  This case involves a 4-month-old male patient who was received POLIOMYELITIS VACCINE (INACTIVATED) IPV (VERO) [IPOL] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) on the same day (extra dose administered) instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTap) (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and HIB VACCINE for Prophylactic vaccination.  On 12-Oct-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) (lot T1D481M, expiry: 25-Jul-2022) via intramuscular route in the left thigh for prophylactic vaccination.  On 12-Oct-2021, the patient received a 0.5 mL dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number and expiry not reported) via intramuscular route in unknown administration site for prophylactic vaccination instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  It was a case of an actual medication error due to extra dose administered and wrong vaccine administered (latency same day).  It was reported "A Nurse wanting to know how to proceed after a 4-month-old received two doses, on the same day, of Inactivated polio vaccine (IPV) in error described as getting the IPOL and the Pediarix vaccine that contains the IPV. The nurse reported that the consumer was ordered to get IPOL and a stand alone DTap dose but in error the Pediarix was given along with the IPOL and that the mother of the consumer wanted the vaccines to be given separately."  No other adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: F
Vaccine: FLU4
Symptoms: Injection site extravasation, Underdose
Clinical narrative: child moved her arm and a small amount of the liquid came out of injection site; Initial information regarding an unsolicited valid non-serious case was received from pharmacist and physician via Medical Information (Reference number- 00809341) and transmitted to Sanofi on 12-Oct-2021.  This case involves a 5-year-old female child patient moved her arm and a small amount of the liquid came out of injection site (injection site extravasation) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 12-Oct-2021, the patient received 0.5ml (total) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7330MA and expiry date: 30-Jun-2022) (Frequency = once) (Strength = standard) via intramuscular route in the left arm for prophylactic vaccination.  On 12-Oct-2021 the child patient moved her arm, and a small amount of the liquid came out of injection site (injection site extravasation) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller (PharmD) (Doctor of pharmacy) requesting information regarding re-administration of FLUZONE QUADRIVALENT (Prefilled); caller states the facility administered a dose to a child (age 5/female) and as the injection was being done. Caller states that the guardian of the patient does not think that re-administration/re-vaccination is in order, but PharmD would like verification; all demographics obtained by MIA (manufacturing and importation authorization)".  No relevant laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was not resolved for the event.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: they gave an expired IPOL and it was expired for 14 days. lot number and expiration date she states that she doesn't have it and that it disappeared off her screen with no ae; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from an other health care professional and consumer non health care professional via Medical Information (MI) number: 00809601.  This case involves an unknown age and unknown gender patient who was administered an expired dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (Expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) via an unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  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 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: Medication error, Syringe issue, Underdose
Clinical narrative: Patient got a partial dose of Fluzone HD with no adverse event; syringe leaked on her arm with no advese event; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Agency (under the reference 00810589).  This case involves a 67 years old female patient who got a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (underdose) but syringe leaked on her arm (syringe issue).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (0.6 ml, lot UJ747AA and expiration date: 30-jun-2022) via unknown route in an unknown administration site for prophylactic vaccination.  It was actual an medication error due to vaccine underose and syring leak (same day latency).  It was reported "Consumer states that she just received the HD FLU vaccine 0.7 mL but when it was injected, the syringe leaked on her arm. The nurse thought it was a little bit but the consumer felt it was more than a little. she got a partial dose of Fluzone HD. She states the HCP said she felt she got 0.6 ml of the dose. The vaccine came out of the syringe and ran down her arm."  At time of reporting, the outcome was unknown for 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 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: 71.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine accidentally administered/ no AE; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/non-healthcare professional via call center via Medical Information (Reference number- 00810618).  This case is linked to case 2021SA340303(CLUSTER).  This case involves a 71-year-old female patient who was vaccinated with an expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE; and HEPATITIS B VACCINE for prophylactic vaccination.  On 13-Oct-2021, the patient received a 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R2A741M and expiry date: 05-Oct-2021) (frequency: once) via intramuscular route in the right upper arm  for prophylactic vaccination.  It was reported "Even though the expiration date stated 10/5/2021, the nurse just focused on the 10/21 and assumed that the TYPHIM VI did not expire until the end of the Oct2021. The nurse did not realize the the TYPHIM VI actually expired on 05Oct2021 until she was entering it into the computer after the 2 vaccines were completed."  It was an actual medication error case due to expired vaccine used (latency: same day).  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 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: 1.08
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was accidentally inoculated with Fluzone High Dose; patient was accidentally inoculated with Fluzone High Dose;Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from consumer/non-healthcare professional via call center via Medical Information (Reference number- 00810818).  This case involves a 13-month-old female patient who accidentally inoculated INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 07-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency: same day).  It was reported "Is there any thing I should be concerned about? What should I monitor?"  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.  There will be no information available on the batch number for this case.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: female patient age 54 was given FLUZONE HIGH DOSE with no reported adverse event; female patient inadvertently was administered Fluzone High-Dose Quadrivalent vaccine rather than Fluzone Quadrivalent vaccine with no reported adverse event; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case from other health professional and physician via Agency(under reference 00810932).  This case involves a 54 years old female patient who inadvertently was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age and wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received no concomitant vaccines.   On 28-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ690AB and expiration date: 30-Jun-2022) via unknown route in the arm for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (same day latency).  It was reported "Caller states on 28SEP2021, a female patient age 54 was given FLUZONE HIGH DOSE; caller would like to report the incident and obtain information regarding re-vaccination and adverse effects to look out for; caller asked for any efficacy and safety information on Fluzone High-Dose administered to patients younger than 65 years of age, and any comparison information on the Fluzone High-Dose and Fluzone vaccines. Reporter was unsure whether it was administered in the left arm or right arm."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 1.58
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: accidentally administered a QUADRACEL vaccination in the thigh; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional via Media Information (MI) (under reference:00811118).  This case involves a 19-month-old patient of unknown gender who was accidentally administered a DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] in the thigh (product administered at inappropriate site).   The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 12-Oct-2021, the patient received a dose of 0.5mL suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (once, lot C5851AA, expiry date 25-Mar-2023) via an unknown route in the thigh nos (otherwise not specified) for prophylactic vaccination.  This is a case of actual medication error due to vaccine administered at inappropriate site (same day latency).  it was reported "caller states that the doctor in her practice accidentally administered a QUADRACEL vaccination to a 19 month old patient on 12OCT2021. Caller asked for information on how they should proceed. Caller asked if Medical Information was able to provide her with the name of her Sanofi Sales Representative. Caller asked if she could place the doctor on the call and whether or not the doctor could be provided answers to questions or if it would be read from a pre-written script."   Laboratory data was not reported.  At 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 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: 70.0
Sex: M
Vaccine: FLUR4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: A patient asked for B12 shot and received the flu vaccine no AE; The patient received a flu vaccine had a flu vaccine a month ago no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Regulatory authority (Reference number- 00811126) and transmitted to Sanofi on 13-Oct-2021.  This case is linked to case 2021SA343570 (same reporter).  This case involves a 70-year-old male patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and had a flu vaccine a month ago too (extra dose administered) instead of CYANOCOBALAMIN [B12 shot] (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 12-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ7725AA, expiry: 30-Jun-2022) via intramuscular route in the right arm for prophylactic vaccination instead of CYANOCOBALAMIN [b12 shot].  It was a case of an actual medication error due to wrong vaccine administered and extra dose administered (latency same day).  It was reported "Medical assistant reports two patients who are husband and wife came in for B12 shot and received the flu vaccine. They both had the flu vaccine a month ago. She asks for appropriate follow-up. She asks what specifically to monitor for and also any information regarding one patient has history of renal transplant."  No other 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 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: FLUR4
Symptoms: Wrong product administered
Clinical narrative: A patient asked for B12 shot and received the flu vaccine/ no AE; The patient received a flu vaccine had a flu vaccine a month ago too/ no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00811175) and transmitted to Sanofi on 13-Oct-2021.  This case is linked to case 2021SA342362 (same reporter).  This case involves a 64-year-old female patient who received a 0.5 mL (once) dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ7725AA, expiry date 30-Jun-2022) via intramuscular route in the right arm on 12-Oct-2021 for prophylactic vaccination instead of CYANOCOBALAMIN [B12 shot] (wrong product administered) and she had a flu vaccine a month ago too (extra dose administered).  The patient's medical history included Renal transplant.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of an actual medication error due to wrong vaccine administered and extra dose administered (latency was on same day).  It was reported "Medical assistant reports two patients who are husband and wife came in for B12 shot and received the flu vaccine. They both had the flu vaccine a month ago. She asks for appropriate follow-up."  No other 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 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: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: was given expired Pentacel with no reported adverse event; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (Reference number- 00811243).  This case involves a two-month-old male patient who was vaccinated with an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  On 11-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ402AAA and expiry date: 10-Oct-2021) (frequency: once) via intramuscular route in the right thigh for prophylactic vaccination.  It was reported "nurse told him it may not be necessary to re-administer because it is only one day expired, however, to follow-up with manufacturer."  It was an actual medication error case due to expired vaccine used (latency: same day).  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 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: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered FLUBLOK to a 14 year old patient/ no AE; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-healthcare professional and physician via call center via Medical Information (Reference number- 00811402).  This case involves a 14-year-old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 12-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: UJ724AA and expiry date: 30-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  It was reported "Clinical supervisor reports that one of their staff administered FLUBLOK to a 14 year old patient."  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.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 49 years old patient received a dose of FLUZONE HIGH-DOSE QUADRIVALENT/ No AE; A 49 years old patient received a dose of FLUZONE HIGH-DOSE QUADRIVALENT/ No AE; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a other health care professional via consumer via phone via regulatory authority: 00812423.   This case is linked to cases 2021SA343492, 2021SA343828 and 2021SA343988 (same reporter).  This case involves a 49 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   No concomitant vaccines given to patient.  On 13-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ769AC, expiry date: 30-Jun-2022, frequency/ drug interval dosage: once, strength: standard via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day for both the events).  It was reported "Caller reported last night a family of four who are all under the age of 65 were giving the FLUZONE HIGH DOSE VACCINE. Caller reported there are no adverse events at this time but wanted to make sure there was nothing to expect and what they should do from here."  Emergency room/ Doctor visit on 13-Oct-2021. Product used: Used and Still using product: No.  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: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 11 year old was administered Flublok with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (under the reference 00812454).  This case involves a 11 years old female patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.   On 13-Oct-2021, the patient received a dose of suspect FLUBLOK QIV (0.5 ml, total, injection, lot QFAA2108 and expiration date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to Inappropriate age at vaccine administration (same day latency).  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: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient under age 65 were given the Fluzone HD Quad with no reported adverse event; patient under age 65 were given the Fluzone HD Quad with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to case 2021SA342449(same reporter).  This case involves a 12-year-old male patient who was under age 65 were given INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 13-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ769AC and expiry date: not reported] via an intramuscular route in right deltoid administration site prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age and overdose [Latency: on the same day].   It was reported "the caller was the director of clinical services. 4 members of the same family, under age 65 were given the Fluzone HD Quad, all the same lot and expiry date".  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for 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 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.  There will be no information available on the batch number for this case.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a other health care professional via consumer via phone via Agency number: 00812470.  This case is linked to cases 2021SA343449, 2021SA343828 and 2021SA343988 (same reporter).  This case involves a 13 year-old male patient who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant vaccines given to patient.  On 13-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Injection; lot number: UJ769AC, expiry date: 30-Jun-2022, frequency/ drug interval dosage: once, strength: standard) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day for both the events).  It was reported "Caller reported last night a family of four who are all under the age of 65 were giving the FLUZONE HIGH DOSE VACCINE. Caller reported there are no adverse events at this time but wanted to make sure there was nothing to expect and what they should do from here."  Emergency room/ Doctor visit on 13-Oct-2021. Product used: Used and Still using product: No.  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: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Fluzone high dose was administered to a 60 year old patient with no adverse event; Fluzone high dose was administered to a 60 year old patient with no adverse event; Initial information regarding an unsolicited valid non serious case was received from pharmacist and consumer or non-health professional via Agency Information  (Reference number: 00812522) and transmitted to Sanofi on 14-Oct-2021.  This case involved a 60-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On 13-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Influenza Quadrival A-B High Dose Hv, frequency: once, dose: 0.7mL, Strength: standard, lot UJ733AC, expiry date: 30-Jun-2022]  via an intramuscular route in the left arm for prophylactic vaccination.  This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose.  It was reporter "Pharmacist reports fluzone high dose (HD) was administered to a 60-year-old. Patient states it was not worried about repeating because of immunogenicity, however, asks for safety information."  no other vaccines.  At the time of this report the patient was fine and had no adverse events after the vaccination.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error. .
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: a new nurse at the practice administered vaccine had expired with no A/E; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received via an other health professional via consumer via phone call.  This case involves a 16-years old male patient who was administered with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] by a new nurse at the practice with no reported adverse event (expired product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6745AA and expiry date: 06-Oct-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Caller asking what they should do, is there a possibility that it is still good and when is it okay to administer another dose."  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 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: Product storage error
Clinical narrative: staff member noticed that it looked slightly frozen with no reported adverse event; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received via a nurse via Agency, Inquiry Number: 00812622).  This case was considered as valid case due to patient involvement.  This case involves an unknown age female patient who experienced was administered slightly frozen INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On an unknown date, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ768AC and expiry date: 30-Jun-2022 via intramuscular route in the deltoid for prophylactic vaccination.   It was reported "Nurse states that one of their staff members took home FLUZONE HIGH DOSE to administer to their mother, states the FLUZONE HIGH DOSE was placed directly on an ice pack in a Styrofoam cooler, states she is unable to report an exact temperature for temperature excursion because there was no temperature tag in the cooler; states it was there for 15-20 minutes. Nurse states when staff member took out the FLUZONE HIGH DOSE to administer, staff member noticed that it looked slightly frozen. Staff member thawed product by placing it against her skin then administered the product to her mother. Nurse states she thinks it was given 07OCT2021. Nurse does not know if it was the right or left deltoid Nurse asks if the product that was administered was still viable for use since it had appeared frozen, asks if the staff member's mother should be re-vaccinated. Agent provided nurse with stability data per Stability and Storage document, informed nurse we are unable to provide accurate suitability without a worst-case scenario temperature, agent informed nurse, per Stability and Storage document, vaccine should be discarded if it has been frozen. nurse states patient did not receive any treatment after receiving FLUZONE HIGH DOSE.nurse states patient was not pregnant at time of FLUZONE HIGH DOSE administration."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 67.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient had requested Fluzone HD Quad and instead received the Fluzone Quad with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional, consumer/non health care professional and physician via media Information (under reference 00812641).  This case involves a 67 years old male patient who requested INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and instead received the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered).  The patient had no other vaccines.   The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  14-Oct-2021, the patient received a 0.5 mL dose of suspect FLUZONE QUADRIVALENT (Solution for injection, Total, lot number: UT7317LA and expiration date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered (same day latency).  It was reported "Pharmacy intern is asking how to go about giving a patient the FLUZONE HD when they received the FLUZONE QUAD yesterday?"  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: FLU4
Symptoms: Extra dose administered, Medication error
Clinical narrative: 80 year old man received two doses of the FLUZONE HD within few weeks with no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer or non-healthcare professional and consumer/non-health care professional via Agency (Reference number- 00812846) and transmitted to Sanofi on 14-Oct-2021.  This case involves a 72-year-old male patient who received two vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within few weeks one on 17-Sep-2021 and another on 06-Oct-2021 (extra dose administered).  This case involves a 80-year-old male patient who received two vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within few weeks one on 27-Sep-2021 and another on 14-Oct-2021 (extra dose administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 14-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [influenza quadrival a-b high dose hv vaccine strength: high dose, drug structure dosage : 0.7ml drug interval dosage : once drug treatment duration: once, lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (latency: same day).  It was reported " 80 year old man received two doses of the FLUZONE HD. Patient received the first dose on 27-Sep-2021 and the second dose on 14-Oct-2021."  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.  There will be no information available on the batch number for this case.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Device connection issue, Needle issue, No adverse event, Underdose
Clinical narrative: needle was not properly on the syringe and some of the vaccine leaked out; needle was not properly on the syringe and some of the vaccine leaked out; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case from a Pharmacist via Regulatory authority (Reference number- 00812910).  This case involves a 69-year-old female patient who was vaccinated with suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] experienced needle was not properly on the syringe and some of the vaccine leaked out (underdose and syringe issue).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 14-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA and expiry date: 30-Jun-2022) (Frequency = once) (Solution for injection in pre-filled syringe) via intramuscular route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to vaccine underdose and syringe issue. (latency on same day).  It was reported "Caller is asking if the patient will need another injection."   At time of reporting, no adverse event was reported.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: was given the fluzone high dose quadrivalent with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00813036) and transmitted to Sanofi on 14-Oct-2021. This case involves a 74-year-old male patient who received FLUZONE HIGH-DOSE QUADRIVALENT (extra dose administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 14-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ730AB, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to extra dose administered. (latency: same day).  It was reported "a patient was given the FLUZONE HIGH DOSE QUADRIVALENT on 07-Oct-2021 and then 14-Oct-2021 in error".  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 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.