chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: syringe was leaking at the connection of the needle and syringe/ NO AE; syringe was leaking at the connection of the needle and syringe/ NO AE; Initial information regarding an unsolicited valid serious case was received from a pharmacist via Medical Information (Reference number- 00812927) and transmitted to Sanofi on 14-Oct-2021.  This case was linked to case 2021SA342449 (CLUSTER).  This case involves a 68-year-old female patient who experienced syringe was leaking at the connection of the needle and syringe (device leakage)(Vaccine underdose), while received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, concomitant medication, past medical treatment, vaccination and family history were not provided.  On 14-Oct-2021, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency: once, Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test, Strength: standard except for Fluzone HD ,lot UJ743AA, expiry date: 30-Jun-2022] via an unknown route at an unknown administration site for prophylactic vaccination.  On 14-Oct-2021, the patient developed a non-serious syringe was leaking at the connection of the needle and syringe(device leakage)(Vaccine underdose), on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported"Caller requesting information regarding FLUZONE high dose (HD). Caller stated that when she went to administer the vaccine, the liquid came out around the place where you attached the needle. Caller stated that part of the liquid was still in the syringe, but she was not sure if any was entered into the patient. Caller wanted to know what to do. Agent warm transferred to MIS. Additional Description of event Adverse events: The caller stated that when she gave the vaccination of Fluzone HD Quad, some of the product leaked out of the patient's skin and a lot of it got on her pants. The syringe was leaking at the connection of the needle and syringe."  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient excursion case was accidently used on two patients even though they were no longer suitable for use / no AE; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional, physician and nurse via call center via Medical Information (Reference number- 00813237) in a specific country.  This case involves a 62-year-old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that was reported in a past excursion was accidently used (product storage error).  The patient medical history, medical treatments, vaccinations, concomitant medication, and family history were not provided.  On 11-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7315JA and expiry date: 30-Jun-2022] via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to product storage error due [Latency: on the same day].  It was reported "nurse states the FLUZONE QIV that was reported in a past excursion case was accidently used on two patients even though they were no longer suitable for use. Nurse was looking for information regarding if they need to re-vaccinate the patients and any possible adverse effects."  2 separate patients accidentally received FLUZONE QUADRIVALENT after an excursion that were aware that they were not supposed to use the FLUZONE QUADRIVALENT.  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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: patient received Pentacel instead of Tdap; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received by physician via consumer. This case involves a 34 years old and unknown gender patient who received pentacel instead of tdap (wrong product administered) while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE.  On 11-Oct-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Suspension for injection (lot UJ414AA, expiry-12-Mar-2022) via intramuscular route in unknown administration site.  On an unknown date the patient developed a patient received pentacel instead of tdap (wrong product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was reported "The site manager states that she is calling about a 32 year old and a 34 year old that received Pentacel instead of Tdap. She is requesting information on how to proceed with the patient via her e-mail address."  Relevant lab data was not reported.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Burning sensation, Urticaria
Clinical narrative: This case involves a 25-year-old female patient who had severe burning (burning sensation) and welts on arms (urticaria), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2127, expiry date: 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious severe burning (burning sensation) and welts on arms (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "Nurse reports they received 50 doses of Flublok. They administered 6 so far and stopped using the product. She reports for 4 of the 6 administered to staff they have complained of severe burning and were even "jumping" with the injection. Two of the employees have had rashes and welts on arms at injection site the size of a baseball. The welts were hot to touch and raised."  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events.
Sex: F
Vaccine: RAB
Symptoms: Needle issue, Product preparation issue
Clinical narrative: product leaked out between the tip and the needle and seemed to be pressurized.; due to the reconstituted product being foamy.; Initial information received on 18-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00816465.  This case involves an unknown age female patient who was experienced RABIES (HDC) VACCINE [IMOVAX RABIES]  (needle issue) and (product preparation issue).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On 18-Oct-2021, the patient received a 1 ml dose of suspect RABIES (HDC) VACCINE lot number: T1B813M and expiry date: 07-DEC-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to inappropriate reconstitution technique and needle leak (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: 10.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: 1 patient on 18OCT2021 has received the expired IPOL with no reported adverse event; Initial information received on 18-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00816606.  This case involves a 10 years old female patient who was administered an expired dose of  POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On 18-Oct-2021, the patient received a 0.5 ml  dose of suspect IPV (VERO) lot number: R1F971M and expiry date: 03-OCT-2021  via intramuscular route in the right deltoid for site prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluzone High-Dose Quadrivalent was given to a 61-year-old patient with no adverse event; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Medical Information  (Reference number- 00816733) and transmitted to Sanofi on 18-Oct-2021 in a specific country.  This case involves a 61-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 14-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to product administered to patient of inappropriate age (latency: same day).  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.  There will be no information available on the batch number for this case.
Age: 64.0
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT with no AE; FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT with no AE; FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT with no AE; Initial information was received on 18-Oct-2021 regarding an unsolicited valid non-serious case from other healthcare professional, consumer/non-healthcare professional and physician via call center via agency (Reference number- 00816964).  This case involves a 64-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (wrong product administered, overdose and Product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 28-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ747AB and expiry date: 30-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported).  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported "Caller/Office Manager would like to know side effects of administering FLUZONE HIGH DOSE QUADRIVALENT instead of FLUBLOK QUADRIVALENT. Caller reports that FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year-old patient received FLUBLOK QIV vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse (Reference number- 00817095) and transmitted to Sanofi on 18-Oct-2021.  This case involves a 17-year-old male patient who received a 0.5 mL (once) dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2108 and expiry date 30-May-2022) via intramuscular route in the left deltoid on 25-Sep-2021 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medication included MENINGOCOCCAL VACCINE for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (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. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Contraindicated product prescribed, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: prescription for FLUZONE HIGH DOSE but she is only 62 years old, with no reported AE; prescription for a patient that is immunocompromised (stage 3 kidney disease), with no AE; they did give it to her last year, with no reported AE; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (Reference number- 00817250)..  This case involves a 62-year-old female patient who is immunocompromised for whom the prescription of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was provided and gave it to her last year (Product prescribing issue, Contraindicated product prescribed  and product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Renal disorder and Immunodeficiency.   It was reported "her doctor has prescribed her to get the Fluzone High Dose which they plan to give her but are calling to get information that it is OK to do so. Caller states they did give it to her last year but they want information this time. States the consumer has Stage 3 kidney disease."  It was a case of potential medication error due Product prescribing issue, Contraindicated product prescribed  and product administered to patient of inappropriate age.  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient receiving an extra dose of Fluzone Quadrivalent with no reported adverse event; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Global Medical Information (GMI) (Reference number- 00817290).  This case involves a 48-year-old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], which was double dose of the vaccine (extra dose administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 18-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ705AB and expiry date: not reported) (Frequency twice) via intramuscular route in the left deltoid for prophylactic vaccination.  On 24-Sep-2021, the patient received another dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ694AA and expiry date: not reported) (Frequency twice) via intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  It was reported "he nurse was looking for any potential AE information in regards to a patient receiving an extra dose of Fluzone Quadrivalent."  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 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: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient received FLUBLOK with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via agency (Reference number- 00817382) and transmitted to Sanofi on 18-Oct-2021.  This case involves a 16-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [Product administered to patient of inappropriate age].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 18-Oct-2021, the patient received a 0.5 mL first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QSAA2136, expiry: 30-Jun-2022, 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 inappropriate age at vaccine administration (latency same day).  It was reported "Certified Medical Assistant (CMA) calling in regards to FLUBLOK. Caller would like safety information for FLUBLOK given to patients under 18 years of age. Caller would like to know if there are any adverse reactions/safety issues."  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: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: when she administered the product the medication leaked out/ no adverse event; medication leaked out on consumer's arm/ no adverse event; she only received about 0.1 ml dose of FLUZONE HIGH-DOSE QUADRIVALENT/ no adverse event; Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and physician via  Media Information  (under reference: 00818407) in a specific country.  This case involves a 71 years old female patient who when administered the product the medication leaked out on consumer's arm, that she only received about 0.1 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (syringe issue, exposure via skin contact, underdose).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included COVID-19 VACCINE for prophylactic vaccination.  On 17-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (total, once, lot number: UJ764AC and expiry date: 30-JUN-2022) via an intramuscular route in the right deltoid for prophylactic vaccination.  This case was a special situation due to (syringe leak, exposure via skin contact, vaccine underdose) (latency: same day).  It was reported "Caller stated that when she administered the product the medication leaked out on consumer's arm. She believes it came out of the glass part. She stated that she only saw about 0.1 ml was actually administered into the patient. Caller wanted to know if there was any data on if the consumer should be revaccinated."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Pentacel was adminstered with no adverse event;Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional and physician via Media Information (under reference 00818759).  This case involves a 1 years old male patient who received an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (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 (PNEUMOCOCCAL CONJUGATE VACCINE) via unknown route in an unknown administration site for prophylactic vaccination.  On 11-Oct-2021, the patient received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Total, lot UJ382AAA and expiration date: 01-Oct-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to an expired vaccine used (same day latency).  It was reported "Caller stated that expired Pentacel was adminstered to patients. Caller would like to know what to do next. She would like to know if Pentacel is considered a live vaccine."  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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient was administered with an extra dose of Menactra with no reported adverse event;Initial information regarding an unsolicited valid non-serious case was received from other health professional via a consumer/non-health care professional via Medical Information (Reference number- 00818817) and transmitted to Sanofi on 19-Oct-2021.   This case involves a 17 year old male patient who was received a third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [Extra dose administered].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for prophylactic vaccination.  On 15-Oct-2021, the patient received a 0.5 mL third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7191AA, expiry: 18-Jan-2023) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Extra dose administered (latency same day).  It was reported "Office manager calling in regards to a third dose of MENACTRA being administered to a patient. Caller would like to know if there are any implications or adverse effects they should be on the lookout for? Patient was administered an extra dose of MENACTRA at an office visit."  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: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Fluzone High Dose to a patient who is 64 years old, with no reported adverse event; administered Fluzone High Dose to a patient who is 64 years old, with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from other health professional and physician via  Medical Information (Reference number: 00812383) and transmitted to Sanofi on 19-Oct-2021 in the .  This case involved a 64-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On 18-Oct-2021, the patient received a 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test 0.7ML, Strength: standard except for fluzone HD, lot UJ759AD, expiry date: 30-Jun-2022] via an intramuscular route in the left deltoid for prophylactic vaccination  This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose.  It was reporter " Doctor calling to find out what side effects could occur from the FLUZONE HIGH DOSE QUADRIVALENT. Caller stated that he accidentally gave the vaccine to a patient that was 64 years old. Caller wanting to know comparison of flu vaccines as well."  No other vaccines.  At the time of this report the patient was fine and had no adverse events after the vaccination.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HIGH-DOSE QUADRIVALENT was administered to a 9 month old with no reported adverse event; FLUZONE HIGH-DOSE QUADRIVALENT was administered to a 9 month old with no reported adverse event; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional in the .   This case involves a 9-month-old and a 3-year-old female patient who administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] to a 9-month-old and a 3 year old [Product administered to patient of inappropriate age].   The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Prophylactic vaccination.  On 19-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Suspension for injection, lot UJ751AA and expiry date: 30-Jun-2022] via an intramuscular route in the left thigh for prophylactic vaccination.  The patient visit on 19-oct-2021.  It was a case of actual medication error due to product administered to patient of inappropriate age and overdose [Latency: on the same day].   It was reported "MD (Doctor of Medicine) and reviewed standard on children under 18 years. MD had question on what if the children experienced an adverse reaction do the parents contact Sanofi or contact them as the provider".  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction, Medication error, Overdose, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HIGH-DOSE QUADRIVALENT administered to a 3 year old with no reported AE; FLUZONE HIGH-DOSE QUADRIVALENT administered to a 3 year old with no reported AE; Initial information was received on 19-Oct-2021 regarding an unsolicited valid  non-serious case from a nurse.  This case involves a three-year-old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (overdose, product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 19-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (0.7mL, lot UJ751AA, expiry date 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to overdose and Inappropriate age at vaccine administration (latency: same day).  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  00819055:
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired vaccine was given to a patient with no adverse event; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from other health professional and consumer/ non health care professional. This case involves a male patient (unknown age) who received an expired TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient had no other vaccines as a concomitant medication(s).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 18-Oct-2021, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot RIS772M and expiration date: 18-Sep-2021) via intramuscular route in the deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "The caller stated that an expired vaccine was given to a patient. What is their next step?"  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: 0.33
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 month old male patient administered ADACEL rather than Daptacel with no adverse event; 4 month old male patient administered ADACEL with no adverse event; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional/consumer via Medical Information (MI) (Reference number- 00819220).  This case involves a four month old male patient who was administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] rather than DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 19-Oct-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported, Frequency: once) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (with respect to use of ADACEL and DAPTACEL) and inappropriate age at vaccine administration (with respect to use of ADACEL) (latency on same day).  It was reported "Caller states that today her sister took her 4 month-old son to the doctor for his 4 month immunizations, but he was given ADACEL rather than the indicated Daptacel".  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: 0.33
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 month old male patient received Adacel instead of indicated DAPTACEL with no reported AE; 4 month old male patient received Adacel with no reported AE; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional/consumer via Medical Information (MI) (Reference number- 00819249).  This case involves a four month old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 19-Oct-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported, Frequency: once) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (with respect to use of ADACEL and DAPTACEL) and inappropriate age at vaccine administration (with respect to use of ADACEL) (latency on same day).  It was reported "Caller states that today her sister took her 4 month-old son to the doctor for his 4 month immunizations, but he was given ADACEL rather than the indicated Daptacel".  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.  There will be no information available on the batch number for this case.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 21 year old female patient gave an expired ADACEL vaccine with no reported AE; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a Pharmacist via non-healthcare professional/consumer via Medical Information (MI) (Reference number- 00819294).  This case involves a 21 year old female patient who was vaccinated with the expired dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 17-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5666BA and expiry date: 17-Sep-2021, Frequency: once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: during administration, half of the medication appeared to be running down her arm with no A/E; during administration, half of the medication appeared to be running down her arm with no A/E; Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case received via a pharmacist via consumer (under Medical Information  Inquiry Number: 00819363) in a specific country.  This case involves an 18 years old female patient, while administering INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] half of the medication appeared to be running down her arm (underdose) and during administration, half of the medication appeared to be running down her arm (exposure via skin contact) with no reported adverse event.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 19-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  It was case of an actual medication error due to vaccine underdose and exposure via skin contact (latency: same day).  It was reported "However, the patient reported to the pharmacist that during administration, half of the medication appeared to be running down her arm and was not administered correctly. The Pharmacist would like to know if the dose should be counted as valid or if it should be repeated."  At the time of reporting, no adverse event was reported.  There will be no information on lot number for this case.  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: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 59 year old patient received Fluzone HD with no reported adverse event; A 59 year old patient received Fluzone HD with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via a consumer/non-health care professional via Medical Information (GMI) (Reference number- 00819379) and transmitted to Sanofi on 19-Oct-2021 in .  This case involves a 59 year old female patient who was received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 04-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry 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 and overdose (latency same day).  It was reported "The sales representative is reporting potential adverse event (AE) information she was made aware of by the Certified Medical Assistant (CMA) lead. The sales representative would like to know if there is a form she can e-mail in or is this the appropriate way to report a potential AE. The sales representative is reporting that the CMA lead reported to her that a 59-year-old female patient received Fluzone high dose (HD) on 04Oct2021. She states that she was asked a couple questions that she didn't answer but these are all the facts she was given."  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.  There will be no information available on the batch number for this case.