chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Extra dose administered
Clinical narrative: Patient went to five different free Flu shot providers and got the flu shot; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via social media.   This case involves a patient (unknown age and gender patient) who went to five different free flu shot providers and got the INFLUENZA VACCINE (extra dose 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 five doses of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (same day latency).  It was reported "I went to five different free Flu shot providers yesterday and got the shot. My doctor told me NOT to get more than one shot but also told me it was 100% safe. So 5 is better than 1. 5 times the protection."   At time of reporting, the 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: FLUX
Symptoms: Illness
Clinical narrative: they always made my mother so sick; Initial information was received on 08-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media (under reference number US1-SA-SAC20211116000758).  This case involves adult female patient who experienced so sick (illness) when received vaccine INFLUENZA VACCINE.  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 VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious so sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (illness).  There will be no information available on the batch number for this case.; Sender's Comments:  US-SA-2021SA379655:
Sex: U
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Influenza
Clinical narrative: flu; covid; Initial information was received on 09-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media. This case involves an unknown age and gender patient who experienced flu (influenza) and covid (COVID-19) (corona virus disease-2019) while receiving COVID-19 VACCINE and INFLUENZA VACCINE. Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.On an unknown date the patient developed a non-serious flu (influenza) and covid (COVID-19) (corona virus disease-2019) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.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 events.At time of reporting, the outcome was unknown for both events.There will be no information available on the batch number for this case.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Injection site bruising, Injection site erythema, Injection site mass
Clinical narrative: lump at the injection site; injection site bruise; injection site redness; patient got a subcutaneous injection instead of intramuscular route; needle that was on the syringe did not go all the way in; Initial information received on 11-Nov-2021 regarding an unsolicited valid non-serious case received from a non-healthcare professional (under reference: US-SA-SAC20211116001392).  This case involves adult female patient who experienced lump at the injection site (vaccination site mass), injection site bruise (vaccination site bruising), injection site redness (vaccination site erythema) also got a subcutaneous injection instead of intramuscular route (incorrect route of product administration) and needle that was on the syringe did not go all the way in (wrong technique in product usage process) when received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 21-Oct-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, lot number: U6846AA and expiry date: 16-OCT-2022) via subcutaneous route in deltoid muscle of the arm for prophylactic vaccination.  It was an actual medication error due to inappropriate route of vaccination and wrong technique in product usage process (same day).  On an unknown date the patient developed a non-serious lump at the injection site (vaccination site mass), injection site bruise (vaccination site bruising), injection site redness (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  The patient believes that the needle did not go into the muscle.  It was reported "The caller would like to know if they need to repeat the injection. The caller also would like advice regarding how to treat the lump at the injection site."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome was unknown for all the events.  The reporter assessed the causal relationship for events (vaccination site mass, vaccination site bruising, vaccination site erythema, incorrect route of product administration) with the ADACEL as not 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: FLUX
Symptoms: Illness
Clinical narrative: patient got sick; Initial information received on 08-Nov-2021 regarding an unsolicited valid social media non-serious case from a consumer/non-non health care professional.   This case involves a patient (unknown demographics) who got sick (illness) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, 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 expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient got sick (illness, non-serious) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  It was reported "Yeah, they do their best to package what flu viruses they anticipate being prevalent that year, but there are so many flu viruses sometimes you can get sick from one they did not expect. Happened to me, too. Still got my shot."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was administered wrong vaccine/ no AE; Initial information was received on 10-Nov-2021 regarding an unsolicited valid non-serious case received from a Physician.  This case involves an adult patient (unknown age and gender) who received wrong INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED [FLUZONE UNSP] with no adverse event (Wrong product administered).  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 USP TRIVAL A-B VACCINE - UNSPECIFIED [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was reported "She ordered Fluzone standard dose & received Fluzone High Dose. Dr then mentioned that she gave Fluzone High Dose to 2 separate patients (both 15 months of age) before realizing it was the wrong vaccine".  It was a case of actual medication error due Wrong vaccine administered (latency was on the same day).  It is unknown if the patient experienced any additional symptoms/events.  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Flu vaccine killed the patient/died; Initial information was received on 14-Nov-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media  This case involves a female patient (age unspecified) who died (death) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor  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 VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  The reported stated that  Flu vaccine killed the Grandma years ago.  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 before death  It is unknown if an autopsy was done.  Information on batch number was requested for this case; Sender's Comments: This poorly documented case from social media concerns a female patient who died after vaccination with INFLUENZA, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: Flu vaccine killed the patient
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: made me sick; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/ non-health care professional.  This case involves a patient (unknown age and gender) who was sick (illness), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   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 VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Took it once made me sick. Never again. Do they really think celebrities make us want to take these stupid shots."  It was unknown if the patient experienced any additional symptoms/ events.   It was unknown if there were laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient inadvertently received FLUZONE HIGH-DOSE QUADRIVALENT instead of the pneumonia vaccine with no adverse event; patient has already received a high-dose flu vaccine this season with no AE reported; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case from another health professional via Medical Information (Reference number- 00847913).   This case involves Elderly and unknown gender who was by mistake given dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE instead of pneumococcal vaccination (extra dose administered and wrong product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 08-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ745AC and expiry date: 30-Jun-2022, Frequency once) (Suspension for injection) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to extra dose administered and Wrong vaccine administered (latency on 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: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: administered expired ACTHIB to a 15-month old patient with no reported adverse event; Initial information received on 09-Nov-2021 regarding an unsolicited valid non-serious case received from another health professional and physician via Medical Information number: 00849826.   This case involves a 15 months old female patient who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE  [ACT-HIB].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 09-Nov-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ404AAA and expiry date: 04-OCT-2021 via intramuscular route in the left thigh for prophylactic vaccination. It was reported that the patient did not receive treatment after expired vaccine administration.   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: 1.25
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A patient received FLUZONE HD  instead of FLUZONE QUADRIVALENT no AE; A patient under 65 years old received FLUZONE HD no AE; A patient under 65 years old received before realized it was FLUZONE HD no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number- 00850044) and transmitted to Sanofi on 09-Nov-2021.    This case is linked to cases 2021SA378207 and 2021SA376763 (same reporter).  This case involves a 15 month old patient (unknown gender) who was received before realized INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and accidental overdose) instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered).   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DIPHTHERIA TETANUS ACELLULAR PERTUSSIS) and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX) for prophylactic vaccination   On an unknown date, the patient received a 0.7 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number: UJ773AC and expiry not reported, form: solution) via intramuscular route in left thigh for prophylactic vaccination instead of FLUZONE QUADRIVALENT.  It was a case a case of actual medication error due to Wrong vaccine administered, Inappropriate age at vaccine administration and accidental overdose (latency same day).  It was reported "Physician called to report that she ordered FLUZONE QUADRIVALENT but was sent FLUZONE HD instead. The FLUZONE HD was administered to three patients under 65 years old before she realized it was FLUZONE HD. Adverse events (AEs) were reported for all three patients with as much information as the caller was able to provide. The caller was in a hurry to obtain/provide information and return back to her practice."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, Needle issue, Underdose
Clinical narrative: had issues with the needle they used on the syringe, causing some of the vaccine to leak out with no AE; about 1/4 to 1/2 of the Flublok leaked out onto the patient's arm  with no AE; about 1/4 to 1/2 of the Flublok leaked out onto the patient's arm with no AE; patient who is 33 weeks pregnant was administered Flublok with no AE;Initial information received on 09-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (under the reference 00850145).   This case involves a 30-years-old female patient who was exposed to vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and had issues with the needle they used on the syringe, causing some of the vaccine to leak out onto the arm (needle issue, underdose, exposure via skin contact and maternal exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  The gestation period at onset 33 weeks.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient past medical history, medical treatment, vaccination and family history were not provided.  The patient had unknown previous pregnancy.  On 09-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2117 and expiry date: 30-Jun-2022, Injection) via intramuscular route in Deltoid not otherwise specified (nos) for prophylactic vaccination.  It was a case of actual medication error due to needle issue, underdose, exposure via skin contact (latency same day).  It was also the case of vaccine exposure during pregnancy (latency same day).   At the time of reporting, no adverse event was reported.   Pregnancy outcome was unknown at the time of report.
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 7 year-old girl received ADACEL on 02-Aug-2021 and accidently received another dose on 02-Sep-2021/ no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (MI) (Reference number- 00850312) and transmitted to Sanofi on 09-Nov-2021.  This case involves a seven-year-old female patient who vaccinated with a 0.5 mL (once) dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6964AA) via intramuscular route in the left thigh on 02-Aug-2021 and accidentally received another 0.5 mL (once) dose of the same vaccine (lot U6900AA) via intramuscular route in the left thigh on 02-Sep-2021 (expiry date not reported for both doses) for prophylactic vaccination (extra dose administered).  Medical history, past medical treatment, past 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 as per second dose).  It was reported "Nurse states they had an error with administration of ADACEL to a patient. They administered a dose on 02Aug2021, and then accidentally gave the same patient another dose on 02Sep2021. Nurse is looking for information on possible adverse effects and what to inform the patient."  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.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Injury associated with device, Needle issue, Syringe issue
Clinical narrative: The needle stuck the patient in the arm; Tried to cover the needle with the cap and the end of the glass syringe broke off; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case from other healthcare professional and a consumer/ non health care professional via Medical Information (under reference number 00851878).   This case involves a 69 years old male patient who after administration of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], while pulling the needle out of the patient, they tried to cover the needle with the cap and the end of the glass syringe broke off (needle issue) and the needle stuck the patient in the arm (injury associated with device).  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 a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ773AB and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient after administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], while pulling the needle out of the patient, they tried to cover the needle with the cap and the end of the glass syringe broke off (needle issue) and the needle stuck the patient in the arm (injury associated with device)(unknown latency).  It was reported "Caller stated that they was an incident when administering FLUZONE High Dose (HD) to a patient. Caller stated that after administering the injection and pulling the needle out of the patient, they tried to cover the needle with the cap and the end of the glass syringe broke off and projected the needle through the air and the needle stuck the patient in the arm again."   Details of laboratory data were not provided.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received dose of expired IPOL with no reported adverse event; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case from a other health care professional and physician via Global Medical Information (Reference number- 00852217) in the United States  This case involves a 12-year-old male patient received an expired dose of IPV (VERO) [IPOL] (expired product administered).  The patient medical history, past medical treatments, vaccinations concomitant medication and family history were not provided.  On 10-Nov-2021, the patient received 0.5ml total dose of suspect IPV (VERO) (lot number: : R1F972M and expiry date: 03-Oct-2021) (Frequency: once, Strength: standard, Drug Interval Dosage: (1x) once) 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).  It was reported "Caller/ Practice Site Manager reports that patient received dose of expired IPOL on 10Nov2021, they did not catch the expiration date when product was administered, safety report will be completed. Caller would like to know if dose needs to be repeated since expiration date of 03Oct2021 was fairly close to administration date. "  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 set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally received an expired dose of ACTHIB with no adverse event reported; Initial information received on 10-Nov-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non-healthcare professional via (Medical Information- 00852604).  This case involves a 4-months old male patient who was accidently vaccinated with expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (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 09-Nov-2021, the patient received a second 0.5ml {total} dose of suspect HIB (PRP/T) VACCINE (lot number not reported and expiry date Oct-2021) via intramuscular route at an unknown administration site for prophylactic vaccination (also reported as administration site was thigh).  It was reported "Doctor asked if the dose should count as valid or if the patient should be re-vaccinated. Doctor states that he does not have the lot number or expiration date for the ACTHIB available because the nurse that administered the expired ACTHIB has left for the day. Doctor states that he will contact Medical Information tomorrow if he is able to obtain that information. Doctor also states that he may be contacted for the information if needed."  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.
Sex: M
Vaccine: TYP
Symptoms: Device defective, No adverse event
Clinical narrative: syringe had been activated with a needle attached for 40 minutes prior to administration of the dose/ no AE; Initial information was received on 11-Nov-2021 regarding an unsolicited valid non-serious case from an Other healthcare professional via Media Information (under reference- 00853459) and transmitted to Sanofi on 11-Nov-2021.   This case involves a male patient (unknown age) while receiving TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] syringe had been activated with a needle attached for 40 minutes prior to administration of the dose with no adverse event (Device defective).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  On 09-Nov-2021, the patient received once dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was a case of Device defective (latency was on same day).  It was reported "Two days ago, Typhim Vi was administered to a patient from a manufacturer's prefilled syringes. It was not realized until after it was administered that the syringe had been activated with a needle attached for 40 minutes prior to administration of the dose".  Product used: Used. Still using product: No.  At the time of reporting, patient had no adverse event.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given double dose of FLUZONE HD with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a pharmacist via Medical Information (Reference number- 00853740) and transmitted to Sanofi on 11-Nov-2021.  This case involves a 67-year-old male patient who received double dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 11-Nov-2021, the patient received a 0.75 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AC, expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to extra dose administered. (latency: same day).  It was reported "He would like to find out about likely side effects and next steps."  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: 2.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublok was accidentally given to a 2 year old child, no AE;Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Medical Information (Reference number- 00855256) and transmitted to Sanofi on 12-Nov-2021.  This case involves a 2 year old patient (gender unknown) who was accidentally vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient accidentally received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE produced by Sanofi Pasteur (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  It was reported "Caller stated Flublok was accidentally given to 2 children and caller is looking for guidance. The caller would like to know what the follow-up and side effects would be from giving two patients under 18 years old the FLUBLOCK vaccine? The only info the caller has is that a Flublock vaccination was given to a 2 year old and 3 year old"  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: 3.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: three year old patient accidentally given Flublok vaccine with no reported adverse event;Initial information received on 12-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via non-healthcare professional via Medical Information (Reference number- 00855276).  This case involves a three-year-old patient (unknown gender) who accidentally received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], (product administered to patient of inappropriate age).  The patient's medical history, 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 a case of actual medication error due to inappropriate age at vaccine administration (latency on same day).   It was reported "Caller stated Flublok was accidentally given to 2 children and caller is looking for guidance. The caller would like to know what the follow-up and side effects would be from giving two patients under 18 years old the FLUBLOCK vaccine? See the additional event details field for more info. Additional Description of event Adverse events: The only info the caller has is that a Flublock vaccination was given to a 2 year old and 3 year old".  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.  There will be no information available on the batch number for this case.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 month old female patient administered QUADRACEL vaccine, no AE; Initial information received on 12-Nov-2021 regarding an unsolicited valid non-serious case from a Physician via non-healthcare professional via Medical Information (Reference number- 00855626).  This case involves a 15-month-old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], (product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLU) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 12-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5763AA and expiry date: 26-Aug-2022) (Frequency: once) via an intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency on same day).    It was reported "Caller stated that they administered QUADRACEL to a 15 month old. Caller said that when she put the QUADRACEL in the Florida shots, it shows that the polio counts as a dose and the dtap counts a dose, but she wants to double check that the QUADRACEL is okay or if they need to revaccinate with DAPTACEL. A clinic reporting a 15-month-old female received Quadracel and not the prescribed DAPTACEL. The caller reported that the Practitioner order was correct, but a staff member used the incorrect vaccine".  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 4-year-old patient received expired IPOL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00855797) and transmitted to Sanofi on 12-Nov-2021.  This case involves a four-year-old male patient who vaccinated with third 0.5 mL (once) dose of expired IPV (VERO) [IPOL] (lot R1F973M and expiry date 03-Oct-2021) via intramuscular route at an unknown administration site on 12-Nov-2021 for prophylactic vaccination (expired product administered).  Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  It was reported "caller states that a patient (male/4years) was given a vaccine that expired on 03OCT2021; caller would like counseling on revaccination step and adverse effects."  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: F
Vaccine: DTAP, DTAPIPV
Symptoms: Medication error, Wrong product administered
Clinical narrative: 15-month old received Quadracel and not the prescribed Daptacel with no reported adverse event; Initial information received on 12-Nov-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 15-month-old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and not the prescribed DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient 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 DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to wrong product administered [Latency: on the same day].  It was reported "Caller said that when she put the QUADRACEL in the Florida shots, it shows that the polio counts as a dose and the dtap counts a dose, but she wants to double check that the QUADRACEL is okay or if they need to revaccinate with DAPTACEL".  At time of reporting, the outcome was unknown for the event.  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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: MENACTRA WAS inadvertently given subcutaneous instead of the recommended intramuscular route with no reported adverse event; Initial information received on 12-Nov-2021 regarding an unsolicited valid non-serious case from a Pharmacist via non-healthcare professional via Agency (Reference number- 00856094).  This case involves adult female patient (unknown age) who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] via subcutaneous route (incorrect route of product administration).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 12-Nov-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7191AA and expiry date: 18-Jan-2023) (Frequency: once) via subcutaneous route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate route of vaccination (same day latency).  It was reported "Pharmacist reporting that MENACTRA was inadvertently given subcutaneous instead of the recommended intramuscular route, she is questioning if the dose is valid".   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Chills, Dyspnoea
Clinical narrative: This was after receiving the Moderna Booster:   Chest pain (feeling of constant tightness, lasted approx 24 hours), increased heart rate (between 89 - 125), shortness of breath, reduced oxygen level (between 88-93), extensive joint pain where it hurt to walk, muscles aches, headache, tiredness, severe chills and could not get warm (house was 75/76 degrees and I had on full pj's, furry robe and blanket and couldn't get warm)
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Heart rate increased, Myalgia
Clinical narrative: This was after receiving the Moderna Booster:   Chest pain (feeling of constant tightness, lasted approx 24 hours), increased heart rate (between 89 - 125), shortness of breath, reduced oxygen level (between 88-93), extensive joint pain where it hurt to walk, muscles aches, headache, tiredness, severe chills and could not get warm (house was 75/76 degrees and I had on full pj's, furry robe and blanket and couldn't get warm)