chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patients that were administered the expired Fluzone with no AE; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-healthcare professional via call center via Agency (Reference number- 00814619).  This case is linked to case 2021SA345109(CLUSTER).  This case involves a 26-year-old female patient who received the expired dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 03-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA2017 and expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "they gave 15 patients expired Flublok vaccine, and wants to know what to do. There were 16 patients that were administered the expired Fluzone."  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: 88.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: A patient received 2 dose of FLUZONE HIGH-DOSE QUADRIVALENT no AE; A patient received 2 dose of flu vaccine instead of one flu vaccine and one pneumovax shot no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Medical Information (Reference number- 00814628) and transmitted to Sanofi on 15-Oct-2021.  This case involves an 88-year-old male patient who was received 2 dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Extra dose administered) instead of PNEUMOCOCCAL VACCINE (Wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 15-Oct-2021, the patient received two doses of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ766AA, expiry: 30-Jun-2022) first one via intramuscular route in the left deltoid and second one via intramuscular route in the right deltoid for prophylactic vaccination instead of PNEUMOCOCCAL 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 "Pharmacist states that an 88 year-old man came in for a flu vaccine and a pneumovax shot. He accidentally gave 2 FLUZONE HIGH-DOSE QUADRIVALENT immunizations."  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: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave 15 patients expired Flublok vaccine with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp. Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received by consumer via non healthcare professional (under Medical Information Inquiry Number- 00814633).  This case involves a 28 years old female patient who experienced gave 15 patients expired flublok vaccine with no reported adverse event (expired product administered) while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 03-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE unknown (lot QFAA2017, expiry 30-jun-2021) via intramuscular route in unknown administration site.  On 03-SEP-2021 the patient reported a gave 15 patients expired flublok vaccine with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "There were 16 patients that were administered the /expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."  Relevant lab data was not reported.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE 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: 22.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: gave expired Flublok vaccine with no reported adverse event.; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received via a consumer (under Medical Information Inquiry Number-00814642).  This case involves a 22 year old female patient who experienced gave expired flublok vaccine with no reported adverse event (expired product administered) while receiving vaccine influenza quadrivalent recombinant vaccine [flublok qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 03-Sep-2021, the patient received a dose of suspect influenza quadrivalent recombinant vaccine (lot- QFAA2017, expiration-30-jun-2021) via intramuscular route in unknown administration site.  On 03-Sep-2021 the patient reported gave expired flublok vaccine with no reported adverse event (expired product administered) following the administration of influenza quadrivalent recombinant vaccine.  It was reported "There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."  Relevant lab data was not reported.  Action taken with quadrivalent recombinant influenza vaccine 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: 8.0
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Patient received FLUBLOK QUADRIVALENT instead of the FLUZONE QUADRIVALENT with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional and physician via agency under reference number 00814649).  This case involves a 8 months old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication included a dose of Hepatitis B vaccine (lot number and expiry date and other dosing details were not reported) on an unknown date for prophylactic vaccination.  On 15-Oct-2021, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (once in total, lot UJ725AA and expiry date :30-Jun-2022) instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiration date not reported) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medical error case due to wrong vaccine administered (same day latency).  It was reported "Medical assistant calling to report that a 8 month old child received the FLUBLOK QUADRIVALENT instead of the FLUZONE QUADRIVALENT. Caller is wanting to know what to do."  No corrective treatment was provided.  At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered the expired Fluzone with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer non health care professional via Agency number: 00814651.  This case involves a 38 years old female patient who was administered an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number: QFAA2017 expiry date: 30-Jun-2021 via 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).  It was reported "The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."  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: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered with an expired vaccine, no adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professionals via Media Information (under reference number 00814661).  This case was linked to 2021SA345761, 2021SA345306, 2021SA345646 and 2021SA345109 (same reporter).  This case involves an unknown age female patient who was administered with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to patient.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Total, once, dosage form: PFS (prefilled syringe), lot QFAA2017 and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Stated that they gave 15 patients expired Flublok vaccine, and wants to know what to do.There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."   At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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: Injection site rash, Injection site swelling
Clinical narrative: rash at the injection site; swelling at the injection site; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 77-year-old female patient who had rash at the injection site (vaccination site rash) and swelling at the injection site (vaccination site swelling), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.7mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed non-serious rash at the injection site (vaccination site rash) and swelling at the injection site (vaccination site swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "Pharmacist calling on behalf of a patient that received FLUZONE HIGH-DOSE QUADRIVALENT and is reporting a potential adverse reaction of a rash and swelling at the injection site and states she was not properly administered the vaccine."  Details of laboratory were 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 both the events.  There will be no information available on the lot number for this case.
Age: 41.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, Medication error
Clinical narrative: patient received expired Flublok vaccine with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Media Information (under the reference 00814672).  This case involves a 41 years old female patient who received expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.   On 03-Sep-2021, the patient received a dose of suspect FLUBLOK QIV (0.5 ml, total, lot QFAA2017 and expiration date: 30-jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "they gave 15 patients expired Flublok vaccine, and wants to know what to do."  At time of reporting, the outcome was unknown for the reported 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: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered the expired Fluzone with no reported adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received by other healthcare professional via consumer (under Agency Inquiry Number- 00814695).  This case involves a 56 years old female patient who reported administered the expired fluzone with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 03-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE Solution for injection in pre-filled syringe (lot QFAA2017, expiry-30-Jun-2021) via intramuscular route in unknown administration site.  On 03-SEP-2021 the patient reported administered the expired fluzone with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE.  It was reported "There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available. Patient Information o Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age."  Relevant lab data was not reported.  Action taken with QUADRIVALENT INFLUENZA VACCINE 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: 48.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered with the expired Flublok, with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professionals via Media Information (under reference number 00814705).  This case was linked to 2021SA346022 , 2021SA345306 and 2021SA345043 (same reporter).  This case involves a 48 years old female patient who was administered with the expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to patient.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Total, lot QFAA2017 and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Stated that they gave 15 patients expired Flublok vaccine, and wants to know what to do.There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."   At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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: 39.0
Sex: M
Vaccine: FLUR4
Symptoms: Expired product administered, Medication error
Clinical narrative: administered the expired vaccine with no AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from consumer/non-healthcare professional via call center via Medical Information (Reference number- 00814713).  This case is linked to case 2021SA345109(CLUSTER).  This case involves a 39-year-old male patient who received the expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 03-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA2017 and expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Stated that they gave 15 patients expired Flublok vaccine, and wants to know what to do."  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: 57.0
Sex: M
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received expired Flublok vaccine, with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00814720) and transmitted to Sanofi on 15-Oct-2021.  This case is linked to cases 2021SA344561, 2021SA344654, 2021SA344871, 2021SA345043, 2021SA345033, 2021SA345139, 2021SA345306, 2021SA345389, 2021SA345424, 2021SA345646, 2021SA345761, 2021SA346021, 2021SA346022 and 2021SA346023 (same reporter).  This case involves a 57-year-old male patient who was received expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s), and family history were not provided.  The patient had no other vaccine.   On 03-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2017, expiry: 30-Jun-2021, formulation: pre-filled syringe) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Stated that they gave 15 patients expired Flublok vaccine, and wants to know what to do"  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: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered with no reported adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Agency (00814725).  This case involves a 49-years old female patient who was vaccinated with expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 03-Sep-2021, the patient received 0.5 mL (total; standard) dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number QFAA2017 and expiry date 30-Jun-2021) via an intramuscular route at the left deltoid for prophylactic vaccination.  It was reported "There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 48.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave 15 patients expired Flublok vaccine with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non health care professional via Medical Information number: 00814729.  This case is linked to cases 2021SA345109, 2021SA344107, 2021SA344343, 2021SA345067,2021SA345249, 2021SA345086, 2021SA345823, 2021SA345587, 2021SA345419, 2021SA345624, 2021SA345617, 2021SA345099,  2021SA345624, 2021SA345099, 2021SA345067 and 2021SA344898 (CLUSTER).  This case involves a 48 years old female patient who was administered an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number: QFAA2017 and expiry date: 30-JUN-2021 via intramuscular route in unknown administration site 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: FLUR4
Symptoms: Expired product administered, Medication error
Clinical narrative: patient was administered with expired Flublok vaccine, with no reported AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professionals via Media Information (under reference number 00814737).  This case was linked to 2021SA345761, 2021SA346022,2021SA345646,2021SA345109 (same reporter).  This case involves a female patient of an unknown age who was administered with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to patient.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Total, once, dosage form: PFS (prefilled syringe), lot QFAA2017 and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Stated that they gave 15 patients expired Flublok vaccine, and wants to know what to do.There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."   At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired FLUBLOK QIV/ no adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Media Information (under reference number 00814739).  This case involves 56 years old female patient who was administered with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (total, once, lot QFAA2017 and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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: 70.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: accidently used before realizing the shipment was frozen with no AE; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/Non-healthcare professional via call center via Medical Information (reference number- 00814783).  This case is linked to cases 2021SA345065, 2021SA345236, 2021SA345205, 2021SA345076 and 2021SA344344(CLUSTER).  This case involves a 70-year-old male patient who accidently received frozen vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 15-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ716AA and expiry date: 30-Jun-2022) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to product storage error temperature too low.  It was reported "Can you please contact this customer re the stability of Influenza vaccines. Customer received their Influenza vaccines and a portion of the doses were frozen. They have administered some of the doses that they claim were not frozen. To Whom it May Concern, I am requesting information on how to return the flu vaccines that we received this year. We have 9 boxes of high-dose flu vaccines and 4 boxes of regular flu vaccines. They came to our office frozen, and therefore are no longer viable. We need to return these vaccines and get a refund."  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: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: possibly frozen product was administered on accident with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Medical information (under reference number - 00814790).  This case involves 52-years-old female patient who was accidently vaccinated with possibly frozen suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event (product storage error).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 16-Sep-2021, the patient received a 0.5ml {total} dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (injection, lot number UT7330LA and expiry date 30-06-2022) via intramuscular route at an unknown administration site for prophylactic vaccination (also reported as left).  It was reported "the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  It was case of an actual medication error due to product storage error temperature too low (latency was on same day)  At the time of report, no adverse event was reported.  Event 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.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: a portion of the doses were frozen/ no AE; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a Consumer via Regulatory authority (Reference number- 00814920) and transmitted to Sanofi on 15-Oct-2021.  This case involves a 50-year-old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and a portion of the doses were frozen with no adverse event (Product storage error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 20-Sep-2021, the patient received a 0.5 ml (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7330LA and expiry date not provided] via intramuscular route in left deltoid for prophylactic vaccination, a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not reported] via unknown route in unknown administration site.  It was reported "Doses of possibly frozen FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen. The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment".  It was a case of actual medication error due to Product storage error temperature too low (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number of FLUZONE HIGH-DOSE QUADRIVALENT and FLUZONE QUADRIVALENT for this case.
Age: 93.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE were administered on accidently with no reported adverse event; Initial information was regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00814928) and transmitted to Sanofi on 29-Sep-2021.  This case is linked to case 2021SA345065, 2021SA345205, 2021SA345076, 2021SA344823 and 2021SA344344 (CLUSTER).  This case involves a 93-year-old female patient who accidently received frozen dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALEN (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 15-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once, lot UJ716AA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to product storage error. (latency: same day). It was reported "doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen. The doses were accidently used before realizing the shipment was frozen".  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.
Age: 70.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen with no reported adverse event; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional via Medical Information (MI) number: 00814937.  This case involves a 79 years old male patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 15-Oct-2021 01:59, the patient received a0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ716AA and expiry date: 30-JUN-2022 via intramuscular route in unknown administration site and a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via intramuscular route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to Product storage error temperature too low (latency: same day).  It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  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.