chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: landed me in hospital for a month and a half during school time; Initial information was received on 21-Sep-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional (under reference US-SA-SAC20210924000268).  This case is linked to cluster case 2021SA320957.  This case involves an adult with an unknown gender patient who was hospitalized for a month and a half during school time (hospitalisation) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not provided not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was hospitalized for a month and a half during school time (hospitalisation) (unknown latency) following the administration of INFLUENZA VACCINE.  The patient reported that he/she had not acquired the flu in 26 years. Last flu shot he/she had at 13 landed him/her in the hospital for a month and a half during school time. His/her dad said no flu shot next year and well no flu was taken that year also for next year and never again. So fast forward 26 years of no flu shots he/she had yet to catch the flu in all those years. The patient also reported that he/she too would take natural immunity over risking the higher chances of catching any disease or virus from  injections.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.; Sender's Comments: This case involves an adult with an unknown gender patient who received INFLUENZA VACCINE and was hospitalized for a month and a half. The time to onset is unknown with the event. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 55.0
Sex: U
Vaccine: FLU4
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: doctors administered Fluzone High Doses to a patient 55 years old, with no reported adverse event; doctors administered Fluzone High Doses to a patient 55 years old, with no reported adverse event; Initial information received on 22-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 55-year-old unknown gender patient who was by mistakenly given dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Product administered to patient of inappropriate age and overdose).  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine.  The patient had no medical history, concomitant disease or risk factor  At the time of the event, the patient had ongoing Diabetes mellitus.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It is unknown if there were lab data/results available.  It was an actual medication error case due to product administered to patient of inappropriate age and overdose (latency: same day).  It was reported "the doctor wanted her diabetic patient to have a higher antigen load and didn't know the age indication for High Dose. I reviewed the PI and showed him where it states the age indication for 65 plus".  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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: patient thinks the pharmacist took it out to soon and she didn't get her full dose of FLUZONE with no adverse event; Initial information was received on 17-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (under reference 00774819).  This case involves an unknown age female patient who thought that the pharmacist took the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] out to soon and she did not get her full dose (underdose).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via an unknown route in the arm (not specified) for prophylactic vaccination.  It was a case of vaccine underdose (same day latency).  It was reported "pharmacist stated that she administered an FLUZONE HD to a person with a little bit more fat tissue in her arm and it dripped back out a little bit and the patient thinks the pharmacist took it out to soon and she didn't get her full dose of FLUZONE and patient wants a second dose. Pharmacist wants to know does the patient need a second shot or not and if so what is the the time frame in between the 2 vaccines the patient can receive another dose? Pharmacist states that she gave a flu shot last week and her arm is quite large and some of the medicine came back out and she thinks she needs another flu shot. What do I need to do?"  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.  There will be no information on the batch number for this case.
Age: 0.17
Sex: U
Vaccine: DTAP, DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient was given a dose of Daptacel by mistake along with Pentacel with no adverse event; Patient was given a dose of Daptacel by mistake along with Pentacel with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00776955).  This case involved 2 months old (unknown gender) patient who was given a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] by mistake along with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered and extra dose administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX) for prophylactic vaccination.  On 20-Sep-2021, the patient received first 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot: C5743AA and expiry date: 06-Jun-2022) (Frequency: once) via unknown route in unknown administration site by mistake along with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ528AAA and expiry date: 10-Jul-2022) via intramuscular route in the deltoid for prophylactic vaccination (wrong product administered and extra dose administered).  It was reported "dose of DAPTACEL (not ordered). Patient was given a dose of Daptacel by mistake and would like to know how to proceed. Caller also had questions on if the double dose of DTaP was okay for the patient? Two siblings were getting routine childhood vaccinations first Sibling had an order for Daptacel and Sibling second had an order for Pentacel. Only Sibling second received two doses of DTaP."  This case was an actual medication error due to wrong vaccine administered and extra dose administered (latency: same day).  At the time of reporting, 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. 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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: MENACTRA was expired and administered to a patient, with no reported adverse event; Initial information was received on 22-Sep-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 17- years old male patient who experienced menactra was expired and administered to a patient, with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  This case involves a 17 years old male patient who received an expired  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   On 22-Sep-2021, the patient received a 0.5 mL dose of suspect MENACTRA (lot number: U6690AA and expiration date: 23-Aug-2021) via intramuscular route in the arm for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "What do we need to do next office manager asking if there is any grace period. Reporter was not sure if the patient had MENACTRA in the past or not. That was a new patient to them. Office manager stated that the patient may have gotten the flu vaccine as well that day, but she was not sure."  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: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Medication error, Product preparation issue
Clinical narrative: ACTHIB was prepared using sterile water with no reported adverse event; Initial information received on 22-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demographics who received HIB (PRP/T) VACCINE [ACT-HIB] which was prepared using sterile water instead of normal diluent.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product preparation error (latency 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.  There will be no information available on the batch number for this case.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error
Clinical narrative: nurse accidentally gave an expired fluzone high dose quadrivalent with no reported adverse event; Initial information was received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a other-health care professional and consumer via Agency - 00782322].  This case involves 72 years old male patient who was accidentally vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ512AB and expiry date 30-Jun-2021) via intramuscular route in the left deltoid, for prophylactic vaccination.  It was reported "Nurse Manager states that the last year's stock of FLUZONE HIGH DOSE QUADRIVALENT did not get pulled and as a result a nurse accidentally gave an expired FLUZONE HIGH DOSE QUADRIVALENT to a patient in error. She asks if the dose was valid or if it needs to be readministered".  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.   Outcome of event 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: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine being administered to a patient with no adverse event; Initial information was received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a Nurse and consumer or non-health care professional via Medical Information - 00782397.   This case involves 67 years old male patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2021, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ499AB and expiry date 30-Jun-2021) via intramuscular route in the right deltoid, for prophylactic vaccination.  It was reported "Nurse calling in regards to expired FLUZONE HD PFS being administered to a patient. Caller would like to know if the patient needs to be revaccinated, if so when and if it would cause a problem".  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.   Outcome of event 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: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: she accidentally administered a dose of FLUZONE HIGH-DOSE QUADRIVALENT to a patient from a box that was in the refrigerator from last year, with no adverse event; Initial information received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a nurse via Agency Inquiry Number: 00782410).  This case involves a 71- years old female patient who received an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 23-Sep-2021, the patient received a first 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ552AA and expiry date not provided via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "Nurse stated that she accidentally administered a dose of FLUZONE HIGH-DOSE QUADRIVALENT to a patient from a box that was in the refrigerator from last year. Caller asked how to proceed and whether or not she could have the patient come back in today to be revaccinated."  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: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: received the DTaP-IPV liquid component of pentacel but not the HIB lyophilized powder component; pentacel was not reconstituted with no reported adverse event; Initial information received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional via Medical Information number: 00782515.  This case involves a Four months old male patient who was received the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 23-Sep-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ529AA and expiry date: 22-JUL-2022 via intramuscular route in the left thigh Prophylactic vaccination respectively.  It was case of an actual medication error due to product preparation issue (latency: same day).  It was reported that "Office Manager reports that a 4-month old patient received the DTaP-IPV liquid component of PENTACEL but not the HIB lyophilized powder component; PENTACEL was not reconstituted. Caller would like to know if the patient can receive ACTHIB separately. Caller was encouraged to view the PENTACEL Reconstitution video".  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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient recieved expired vaccine with no reported adverse event; Initial information was received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a other healthcare professional and non-healthcare professional via MI (Medical Information- 00782588).  This case involves a 1-years old female patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 22-Sep-2021, the patient received a 0.5ml fourth {total} dose of suspect HIB (PRP/T) VACCINE (lot number LUJ401AA and expiry date 23-Aug-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was reported "they would like to know if they need to revaccinate or can that vaccine count towards the series of shots for the patient?"  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.
Sex: M
Vaccine: FLU4
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: A patient under the age of 65 years received FLUZONE HIGH-DOSE QUADRIVALENT with no AE; A patient under the age of 65 years received FLUZONE HIGH-DOSE QUADRIVALENT with no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via pharmacist via consumer/non-health care professional via Medical Information (Reference number- 00782671) and transmitted to Sanofi on 23-Sep-2021.  This case involves a male patient (unknown age) who was under the age of 65-year-old received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age) (accidental overdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 23-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry not reported) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and Overdose accidental (latency same day).  It was reported "Caller wants to know if there are any adverse events regarding the FLUZONE high dose (HD). Pharmacist asks what adverse reactions can occur as a result of a patient under 65 years of age receiving FLUZONE QUADRIVALENT HIGH DOSE. Pharmacist reports an adverse event (AE). Pharmacist states that a male patient either aged 48 or 53 (she could not remember) received the FLUZONE QUADRIVALENT HIGH-DOSE vaccine in error due to an unknown reason."  No additional adverse events (AE's) were reported.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: pregnant female accidentally received a dose of FLUZONE QIV NP from a prefilled syringe in the office on 22SEP2021 that had expired on 30JUN2021 (with no reported adverse event); accidentally received a dose of FLUZONE QIV NP from a prefilled syringe in the office on 22SEP2021 that had expired on 30JUN2021 (with no reported adverse event); Initial information received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/ Non-Healthcare Professional.  This case involves a 25 years old female patient who received expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], while she was 36 weeks pregnant (during third pregnancy trimester).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was reported as 14-Jan-2021.  The estimated due date is 10-Nov-2021.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 22-Sep-2021, the patient received (first dose in 2021) a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7041NA, expiry date- 30-06-2021 via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired product administered (latency same day).  It was also the case of vaccine exposure during pregnancy.  It was reported "Caller states that a patient accidentally received a dose of FLUZONE QIV from a prefilled syringe in the office. Caller asked if there was anything additionally that needed to be done on her end. Caller states that she is aware of a 28 day waiting period to re-administer live vaccines and asked what the guidelines were for this situation."  At time of reporting, no adverse event was reported.  Additionally, at time of reporting, the outcome of the pregnancy is 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: 37.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 37 year old was given FLUZONE HIGH DOSE QUADRIVALENT in error by one of her nurses with no reported adverse event; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional and physician via Agency number: 00784104.  This case involves a 37 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 24-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ73180 and expiry date: 30-JUN-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "that Nurse manager repeated the above question. She asks if the FLUZONE HIGH DOSE QUADRIVALENT vaccine is valid or should be repeated with a different flu vaccine and what AE's they should look out for".  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: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Photopsia
Clinical narrative: stiff neck on the left side; photopsia in the left eye; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from pharmacist and consumer/non-healthcare professional via call center via Agency (Reference number- 00784117).  This case involves a 65-year-old male patient who experienced stiff neck on the left side (musculoskeletal stiffness) and photopsia in the left eye (photopsia) when received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 23-Sep-2021, the patient received a 0.5mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7376JA and expiry date: 30-Jun-2022) via an intramuscular route at a the left deltoid for prophylactic vaccination.  On 23-Sep-2021, the patient developed a non-serious stiff neck on the left side (musculoskeletal stiffness) and photopsia in the left eye (photopsia) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Pharmacist would like to know if photopsia is a reported adverse effect of the vaccine or if there have been any cases of photopsia reported?"  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  The event outcome was unknown for all the events.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient recieved a expired vaccine with no reported adverse event; Initial information was received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist and non-healthcare professional via Agency (00784201).  This case involves an unknown age of female patient who was vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Expired product administered).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 23-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  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.  There will be no information available on batch number for this case.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: A patient was administered with an expired dose of FLUZONE HIGH-DOSE QUADRIVALENT with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Medical Information (Reference number- 00784366) and transmitted to Sanofi on 24-Sep-2021.  This case involves a 71-year-old male patient who was administered with an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 22-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ483AB, expiry: 30-Jun-2021, formulation: solution for injection in pre-filled syringe) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  No adverse event was reported.  It was reported "Caller stated that her office started giving this seasons FLUZONE high dose (HD) vaccines but a vaccine from last season was given of the 2020-2021 FLUZONE HD and she would like to know if the patients need to be revaccinated or what the process is now? Caller states Fluzone HD was given from last season, expired dose. She asks for follow-up. She clarifies, so it can be given again immediately."  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: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Act-hib component with sterile diluent; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional and consumer non health care professional via Medical Information number: 00784569.  This case involves an unknown age female patient who was received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ422AA and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to Inappropriate reconstitution technique (latency: same day).  It was reported that nurse who states she doesn't have any information other than what was provided in initial contact. Caller isn't sure what diluent the medical assistant mixed the Act-HIB powder with. Caller states it "like what comes with Varicella" and informed her that is not our product.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: No adverse event; Non case: No stability data available in temperature excursion case no adverse event with no medication error case
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: A patient was administered with a dose of PENTACEL vaccine without reconstituting with diluent with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Agency (Reference number- 00784846) and transmitted to Sanofi on 24-Sep-2021.  This case involves a 4-month-old male patient who was administered with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] without reconstituting with diluent (Product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 24-Sep-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6945AA, expiry: 09-Jul-2022) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  It was reported "Caller stating they administered a patient a dose of PENTACEL without reconstituting with diluent. Caller wanting to know if they can administer the diluent separately. Caller clarifies that the DAPTACEL/IPOL portion of the PENTACEL vaccine was administered, however they forgot to administer the powdered ACT-HIB portion. She asks what diluent can be used with the ACT-HIB portion of the PENTACEL vaccine so it can be administered."  No additional adverse event (AE) 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: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: product excursion occured during shipment with no adverse event; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer non health care professional via Medical Information number: 00785004.  This case involves an unknown age and unknown gender patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product temperature excursion issue).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ759AC and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to product temperature excursion issue (latency: same day).  It was reported that Receptionist states she already spoke to customer service and is having products replaced. Receptionist states she was told to call medical information because they did administer FLUZONE HIGH DOSE to 11 patients before they were notified that their products would not be suitable for use. Receptions asks what they should do in this situation. Receptionist states she does not have information to complete AE/safety report for the 11 patients at this time. Additional Description of event Adverse events :Receptionist states they received a notification that their shipment of FLUZONE HIGH DOSE took more than 2 days in shipping and the product is not suitable for use. Receptionist states she already spoke to customer service and is having products replaced. Receptionist states she was told to call medical information because they did administer FLUZONE HIGH DOSE to 11 patients before they were notified that their products would not be suitable for use. Receptionist asks what they should do in this situation. Receptionist states she does not have information to complete AE/safety report for the 11 patients at this time. Receptionist states they will begin gathering information for AE/safety report and agrees that they can be contacted by Sanofi.  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: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: 12 years old patient received expired FLUZONE QUAD with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00786871) and transmitted to Sanofi on 27-Sep-2021.  This case involves a 12-year-old female patient who vaccinated with a 0.5 mL (total, once) dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (lot UJ560AC, expiry date 30-Jun-2021) via intramuscular route in the left deltoid on 23-Sep-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, 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.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inadvertently administered 2 FLUZONE QUADRIVALENT vaccines instead of a PENTACEL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Physician via Medical Information (Reference number- 00786914) and transmitted to Sanofi on 27-Sep-2021.  This case involves an unknown demographic patient who received 2 doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] inadvertently (lot number and expiry date not reported) via unknown route at an unknown administration site on an unknown date for prophylactic vaccination (extra dose administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to extra dose administered (latency was on same day).  It was reported "Sales rep states the he was told by Dr that she intended to administer a FLUZONE QUADRIVALENT and a PENTACEL vaccine, but inadvertently administered 2 FLUZONE QUADRIVALENT vaccines instead."  At the time of report, 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.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Medication error
Clinical narrative: administered one dose of the expired vaccine with no adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case from other health professional, consumer/non-healthcare professional and physician via Agency (under reference 00786940).  This case involves a patient (unknown age and gender) who received one dose of the expired QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) [expired product administered].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received 0.7 mL dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (Total, lot UJ764AA and expiration date: 30-Jun-2021) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Caller states that they received a shipment of vaccines on 27Sep2021 at 9am, and received an email later that day that the vaccines may have been expired due to being in shipping for too long. The caller states that they have already administered one dose of the vaccine by the time they received the email. Caller informed they have already spoken with customer service and were transferred over to medical information. Caller would like to know how to proceed after administering the expired dose? Caller was unable to provide patient information at this time since they do not have access, they were able to provide vaccine information, administering nurse, and prescribing physician information which is listed below."  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.