chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: An expired IPOL was given to a patient with no reported AE; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00813142).  This case involves a five-year-old female patient who was vaccinated with the expired dose of suspect vaccine IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   Concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 14-Oct-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot R1F801M and expiry date: 28-Sep-2021) (Frequency: once) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error case due to expired product administered (latency on same day).  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: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: patient accidentally received FLUZONE QUADRIVALENT after an excursion with no adverse event; Initial information was regarding an unsolicited valid non serious case was received from a nurse via Medical Information (Reference number- 00813179) and transmitted to Sanofi on 14-Oct-2021.  This case involves a 56-year-old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that was reported in a past excursion was accidently used (product storage error).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 11-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, suspension for injection, lot UT7315JA, 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 "FLUZONE QIV that was reported in a past excursion case was accidently used on two patients even though they were no longer suitable for use".  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: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Expired vaccine administered- with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from an other health care professional and non health care professional via Medical Information (MI) number: 00813275.  This case involves a 18 months old male patient who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was unknown if the patient had any additional concomitant disease or risk factor   On 14-Oct-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ405AAA and expiry date:08-OCT-2021 via intramuscular route in the left thigh for prophylactic vaccination.  It was unknown if the patient experienced any additional symptoms/ event  It was unknown if there were lab data/results available.  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.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling the size of a golf ball at injection site; redness at injection site that went down to elbow; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00813290) and transmitted to Sanofi on 14-Oct-2021.  This case involves a 62-year-old female patient who experienced swelling the size of a golf ball at injection site (vaccination site swelling) and redness at injection site that went down to elbow (erythema), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), 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 QFAA2117 and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 12-Oct-2021, the patient developed non-serious swelling the size of a golf ball at injection site (vaccination site swelling) and serious redness at injection site that went down to elbow (erythema) (on the same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Details of laboratory data reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported "patient reports swelling the size of a golf ball at injection site, redness at injection site that went down to elbow".  At time of reporting, the outcome was unknown for the event.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Headache, Pain
Clinical narrative: Severe body ache the entire night; Severe headache; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a physician and non-healthcare professional via Regulatory authority (under reference: 00814214).  This case involves a 65 years old female patient who experienced severe headache (headache) and severe body ache the entire night (pain) when received vaccines COVID-19 VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  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 dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (injection, 0.7 mL, once, total, lot number and expiry date not reported) via an unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 15-OCT-2021 the patient developed a non-serious severe headache (headache), severe body ache the entire night (pain) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and (unknown latency) following the administration of COVID-19 VACCINE.  It was reported "The caller's wife turned 65 within this past year and yesterday received FLUZONE HIGH DOSE QUADRIVALENT for the first time in her life. When the caller woke up this morning, his wife informed that she had a severe headache and severe body ache the entire night. She seems to be improving, as she had an appointment this morning and was able to leave the home to keep her appointment. The caller was unsure of which arm his wife received the injection, but believes it is likely that it was the left arm. He mentions that he and his wife both received Covid-19 vaccinations with the same brand. He had no side effects from the Covid-19 vaccine, but his wife had similar side effects that she is now having with after Fluzone High-Dose Quadrivalent."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  The patient was recovering from the events (headache, pain) at the time of reporting.  There will be no information available on the batch number for this case.
Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, Product storage error
Clinical narrative: product storage error due to refrigerator malfunction at lowest temperature of negative 26 degree celsius, no AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from other health care professional and consumer/non- health care professional via Agency (Under reference number 00814299).  This case involves a 60 years old female patient who was administered with the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] that had a product storage error due to refrigerator malfunction at lowest temperature of negative 26 degree celsius (Product storage error).  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 11-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Total, once, lot UJ725AA and expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to product storage error temperature too low.  Details of laboratory data were not provided.  It was reported "Practice Administrator calling in a temperature excursion for FLUBLOK. Excursion started on 10-Oct-2021 and ended on 11-Oct-2021, dose of the FLUBLOK was administered. Caller is inquiring if the products are still suitable for use and if not should they revaccinate?'  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: Hypersensitivity
Clinical narrative: Allergic reaction; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Agency (Reference number- 00814371) and transmitted to Sanofi on 15-Oct-2021.  This case involves a female patient (unknown age) who had allergic reaction (hypersensitivity) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  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 INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller would like to know the ingredients in FLUZONE QUAD from 2020. She states she had an allergic reaction to it. Suggested that the call go to the website My Daily Med. The caller was calling from work and in a hurry. Was not able to obtain template info."  No laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
Age: 32.0
Sex: U
Vaccine: DTAP, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Pentacel instead of Tdap with no AE; received Pentacel instead of Tdap with no AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from consumer/non-healthcare professional and physician via call center via the Regulatory Authority (Reference number- 00814410).  This case involves a 32-year-old (unknown gender) patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (wrong product administered and product administered to patient of inappropriate age)   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for prophylactic vaccination.  On 11-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ414AA and expiry date: 12-Mar-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  It was reported "She is requesting information on how to proceed with the 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: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received expired Fluzone QIV with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and physician via regulatory authority number: 00814427.  This case involves a 13 years old male patient who was administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 14-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7108MA 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 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 is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: Expired product administered
Clinical narrative: Patient received an expired FLUBLOK QIV with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional via Media information (under the reference 00814428).   This case is linked to case 2021SA345109 (CLUSTER).  This case involves a patient of (unknown demographics) who received an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product used).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT 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 due to expired vaccine used (same day).  It was reported "There were 15 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info."  At time of reporting, it was unknown whether the patient had any adverse event or not 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.  There will be no information available on the batch number for this case.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired vaccine of FLUZONE QUADRIVALENT with no adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional, physician, non-healthcare professional via Media Information (under reference: 00814496).   This case is linked to cases 2021SA344343, 2021SA344107 and 2021SA345249(CLUSTER).  This case involves a 14 years old male patient who received expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product 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 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5mL, once, total, lot UT7108MA, expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual case of medication error due to expired vaccine used (latency: same day).  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  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: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: had given an expired IPOL injection 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 00814501).  This case involves a 4 years old male patient who had given an expired IPV (VERO) [IPOL] injection (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 15-Oct-2021, the patient received a dose of suspect IPOL (0.5 ml, total, lot R1F972M and expiration date: 3-Oct-2021) via intramuscular route in the deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  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: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired vaccine of FLUZONE QUADRIVALENT with no adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional, physician, non-healthcare professional via regulatory authority (under reference: 00814513).  This case is linked to cases 2021SA344343, 2021SA344107 and 2021SA345249 (CLUSTER).  This case involves a 14 years old male patient who received expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product 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 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5mL, once, total, lot UT7108MA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual case of medication error due to expired vaccine used (latency: same day).  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  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.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received expired FLUZONE QIV NP with no reported adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional and physician via (Medical Information- 00814531).  This case involves a 13-year old female patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE 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 14-Oct-2021, the patient received a first 0.5ml dose of expired suspect INFLUENZA QUADRIVAL A-B VACCINE (FLUZONE QIV) (lot number UT7108MA and expiry date 30-Jun-2022 was reported) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine. This information is regarding the fourth of 12 patients that received expired FLUZONE QIV NP."  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: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patients have received FLUZONE QIV NP vaccines that expired; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via AGency (under the reference 00814533).  This case was linked to cases 2021SA344107, 2021SA345249, 2021SA345624, 2021SA344898, 2021SA345067, 2021SA345099, 2021SA345086, 2021SA345617, 2021SA345823, 2021SA345419 and 2021SA344343 (same reporter).  This case involves a 13 years old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that expired (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 14-Oct-2021, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, once, lot UT7108MA and expiration date: 30-Jun-2022) 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 "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  No adverse event was reported.  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: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had received Fluzone QIV NP vaccines that expired on 30-Jun-2021 with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional consumer non-healthcare professional via Agency number: 00814542  This case is linked to cases 2021SA344343, 2021SA344107 and 2021SA345249(CLUSTER).  This case involves a 14 years old female patient who was administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 14-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number: UT7108MA and expiry number: 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.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received FLUZONE QIV NP vaccine that expired on 30JUN2021 with no AE; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a nurse via Agency (under reference:00814554).  This case involves a 30-year-old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] vaccine that expired on 30-Jun-2021 (expired product administered).   The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 14-Oct-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5mL, once, Total, lot UT7108MA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual case of medication error due to expired vaccine used (latency: same day).  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine. See inquiries associated with this contact for additional patient information. This information is regarding the seventh of 12 patients that received expired FLUZONE QIV NP."  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: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patient received FLUZONE QIV NP from 14OCT2021 to 15OCT2021 that expired on 30JUN2021 with no AE; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a nurse via regulatory authority (under reference: ).  This case is linked to cases 2021SA344107, 2021SA344343, 2021SA344898, 2021SA345067, 2021SA345099, 2021SA345086, 2021SA345249, 2021SA345617,2021SA345624,2021SA345823,2021SA345419,2021SA345587(same reporter).    This case involves a 10-year-old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 14oct2021 that expired on 30-Jun-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 14-Oct-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5mL, once, total, lot UT7108MA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual case of medication error due to expired vaccine used (latency: same day).  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine. See inquiries associated with this contact for additional patient information. This information is regarding the seventh of 12 patients that received expired FLUZONE QIV NP."  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: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received expired FLUZONE QIV NP with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via Agency (under the reference 00814563).  This case is linked to cases 2021SA344343, 2021SA344107, 2021SA345249, 2021SA345624, 2021SA345587, 2021SA344898, 2021SA345067, 2021SA345099, 2021SA345086, 2021SA345823 and 2021SA345419 (same reporter).  This case involves a 48 years old female patient who received expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.  On 14-Oct-2021, the patient received a dose of suspect FLUZONE QIV (0.5 ml, total, once, lot UT7108MA 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 product administered (same day latency).  No adverse event was reported.  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  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: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patients received expired FLUZONE QIV NP with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional via Agency (under the reference 00814567).  This case involves a 18 years old female patient who received expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE 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 14-Oct-2021, the patient received a dose of suspect FLUZONE QIV (0.5 ml, lot UT7108MA 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 "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14-OCT-2021 to 15-OCT-2021 that expired on 30-JUN-2021.Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  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: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired FLUZONE QIV with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a nurse practitioner via non health care professional/ consumer via physician via regulatory authority (under reference number 00814573).  This case is linked to cases 2021SA345624, 2021SA344107, 2021SA345249, 2021SA345067, 2021SA345086, 2021SA344898, 2021SA345823, 2021SA345617 , 2021SA345419, 2021SA345587 and 2021SA345099 (same reporter).  This case involves a 62 years old female patient who received an expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication and additional medications was given to patient.  On 15-Oct-2021, the patient received a 0.5 ml first dose of 2021 of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, lot UT7108MA and expiration 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 "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event (non-clinical).   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: Expired product administered, No adverse event
Clinical narrative: this information is regarding the twelfth of 12 patients that received expired FLUZONE QIV NP with no reported adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received by nurse via other healthcare professional via physician (under Agency Inquiry Number-00814579).  This case involves a 70 years old male patient who reported this information is regarding the twelfth of 12 patients that received expired fluzone qiv np with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 15-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7108MA, expiry- 30-jun-2021) via intramuscular route in unknown administration site.  On 15-OCT-2021 the patient reported a this information is regarding the twelfth of 12 patients that received expired fluzone qiv np with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine. See inquiries associated with this contact for additional patient information."  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: 14.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Wrong product administered
Clinical narrative: 14 year old female was given Tenivac instead of Boostrix, with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00814581).  This case involves a 14-years-old female patient who was by mistake given dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [BOOSTRIX].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   Concomitant medications included HPV VACCINE (HPV VACCINE) for and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO) for prophylactic vaccination.  On 12-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6922AA and expiry date:22-Jan-2023) (Frequency: once) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (latency on same day).  It was reported caller would like to know how long to wait before administering the proper vaccine for patient's age range. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml.  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.
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered
Clinical narrative: administered the expired Fluzone; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received by non-healthcare professional via consumer (under Agency Inquiry Number-00814605) .  This case involves an unknown age female patient who administered the expired fluzone (expired product administered) while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 03-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2017, expiry-30-jun-2021) via unknown route in unknown administration site.  On 03-Sep-2021 the patient administered the expired fluzone (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 (administered the expired Fluzone).  At time of reporting, the outcome was Unknown for the event administered the expired fluzone.  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.