chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 12 year old female patient who was supposed to receive adacel but administered quadracel with no reported adverse event; 12 year old female patient who was supposed to receive adacel but administered quadracel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (reference number: 00706278) and transmitted to Sanofi on 02-Aug-2021.  This case involves a 12-year-old female patient who was supposed to receive DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] but administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] [(wrong product administered) and (Product administered to patient of inappropriate age)].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) on an unknown date for prophylactic vaccination.  On 02-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number: C5656AA; expiry date: 13-Aug-2021) via intramuscular route in the right deltoid for prophylactic vaccination instead of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported).  It was case of actual vaccination error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  It was reported, "Nurse practitioner reports that the incorrect vaccine was given to a patient; the patient was supposed to receive ADACEL but the nurse administered QUADRACEL instead."  No adverse events were reported at the time of this report.   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: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: product was frozen for 48 hours; Initial information was received on 02-Aug-2021 regarding an unsolicited valid non-serious case from pharmacist via call center via Global Medical Information (reference number- 00706346).  This case involves a patient of (unknown demographics) who received suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was frozen for 48 hours by thawed it (product storage error).  The patient's past medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to product storage error temperature too low.  It was reported that, "HCP requests to know if we have any efficacy information"  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.  There will be no information available on the batch number for this case.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: the patient technically got half a Menactra dose because the patient received 0.5 mL of the diluted solution/no AE; accidentally diluted Menactra with the sterile diluent that was used with the MMR and Varicella/no AE; Initial information was received on 02-Aug-2021 regarding an unsolicited valid  non-serious case received from a Nurse via the [Global Medical Information (GMI) under reference-00706608].  This case involves a 12 year-old male patient who accidentally got half of the  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (0.5 mL of the diluted solution) which was diluted with the sterile diluent that was used with the MMR and Varicella (underdose) (product preparation error).  The patient's past 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 (TDAP) for prophylactic vaccination.  On 31-Jul-2021, the patient received 0.5 mL (of diluted vaccine) [once; standard] dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6952AA and expiry date 09-Jun-2022)  via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose (latency was on same day).  It was a also a case of inappropriate reconstitution technique.  It was reported that "NP asking if they need to repeat the MENACTRA dose. NP states that the patient technically got half a MENACTRA dose because the patient received 0.5 mL of the diluted solution (MENACTRA). NP asking if they re-administer the dose if it would be another full dose or if they would give a half of a dose. NP asking if there are certain potential side effects to watch out for since the patient will be receiving a dose and a half total".  The patient was fine and there was no type of adverse event.  outcome of the event was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Occupational exposure to product, Product physical issue
Clinical narrative: 2 Pentacel vaccines that were broken and nurse was trying to draw out the vaccine for a patient and realized her hand was wet /No AE; Two Pentacel vaccines were broken and other vial had a crack in it as well/ No AE; Initial information was received on 02-Aug-2021 regarding an unsolicited valid non-serious case received from an other health care professional via phone (under Global Information Number Inquiry Number: 00706640).  This case involves an unknown age female patient (nurse).  This case involves two DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was broken and nurse was trying to draw out the vaccine for a patient and realized her hand was wet and other vial had a crack in it as well (occupational exposure to product and product physical issue) lot number: UJ542AAA and expiry date: 10-JUL-2022, indication: prophylactic vaccination.  The patient's medical history, past medical treatments, concomitant medications vaccinations and family history were not provided.  It was a case of occupational exposure via skin contact with product and cracked product (latency: same day).  It was reported "Caller stated receiving two PENTACEL vaccines that were broken. Caller stated a nurse was trying to draw out the vaccine for a patient and realized her hand was wet. Caller stated the nurse noticed the bottom of the bottle was in the box and not attached to the vial. Caller stated the other vial had a crack in it as well. Caller reported she receives her shipments via FEDEX. Caller was requesting for a replacement of two PENTACEL vaccines. Resent due to possible Adverse Event (AE) vaccine got on a hand. Product used: Not Used, Still using product: No. Was Device Used: No, Product Technique Complain assessment medical/ Physical: Physical."  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 holders 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: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired MENACTRA was given yesterday with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Global Medical Information (GMI) (Reference number- 00707969) and transmitted to Sanofi on 03-Aug-2021.  This case involves a 12-year-old female patient who was given expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] yesterday (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 02-Aug-2021, the patient received 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot: U6641AB and expiry date: 31-Jul-2021) (Frequency = once) (Strength = standard) via unknown route in the right deltoid for prophylactic vaccination (expired product administered)  This was an actual medication error case due to expired vaccine used (latency same day)  At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements 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: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: reconstituted ACTHIB with sterile water/no AE; Initial information was received on 03-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional and physician via call center via Global Medical Information (GMI) (Reference number- 00708161).  This case involves a 4-year-old female patient who received HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with sterile water (product preparation error).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (QUADRACEL) for prophylactic vaccination.  On 30-Jul-2021, the patient received a fourth dose of 0.5 mL of suspect HIB (PRP/T) VACCINE (lot number: UJ526AAA and expiry date: 30-Jun-2022) via unknown route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  It was reported that, "Caller reports that a nurse administered ACTHIB to a patient without reconstituting with proper ACTHIB diluent."  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: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse gave an injection of expired DAPTACEL to a child, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Medical Information (Reference number- 00708308).  This case involves a three-year-old male patient who was given an injection of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], no adverse event (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant vaccines was received by the patient.  On 02-Aug-2021, the patient received a 0.5ml dose (dose 4) of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5624AA; expiry date: 10-Jun-2021) via intramuscular route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "Office manager reports that a nurse gave an injection of expired DAPTACEL to a child; asking if this child would need to receive another dose of DAPTACEL. DAPTACEL had expired 10JUN2021."  No adverse events were reported at the time of reporting.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB, IPV, MNQ, TDAP, UNK
Symptoms: Product storage error
Clinical narrative: product were exposed to -0.5 degrees celsius for 45 minutes/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from other Health Care Professional via Global Medical Information (GMI) (Reference number- 00708327) and transmitted to Sanofi on 03-Aug-2021.  This case involves MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL] that were exposed to -0.5 degree Celsius for 45 minutes and a patient received a dose of received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (UJ542AA and expiry date: 10-JUL-2022), DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (C5863AA and expiry date: 13-APR-2023), TUBERSOL (TUBERCULIN TEST) (lot C65751AA and expiry date: 19-Sep-2022), MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (06920AA and expiry date: 15-APR-2022) and IPV (VERO) (lot R1F973M and expiry date:30-Oct-2021) exposed to -0.5 degree Celsius for 45 minutes.  On 02-Aug-2021, the patient received as dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE via unknown route at an unknown administration site for prophylactic vaccination.  This was potential medication error case due to product storage error temperature too low (on same day).  It was reported that "the refrigerator temperature went down and Caller states that excursion was caused by the door being left open."  It was not reported if patient experienced any 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 by the regulatory authority. 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: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a dose of MENACTRA post temperature excursion, temperature went down to 31.1F for 45 minutes, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Global Medical Information (GMI) (Reference number- 00708386) and transmitted to Sanofi on 03-Aug-2021.  This case involves a patient of unknown demographics who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] post temperature excursion, temperature went down to 31.1F (Fahrenheit) for 45 minutes, no adverse (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 02-Aug-2021, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: 06920AA; expiry date: 15-Apr-2022 via unknown route in unknown administration site.  It was case of actual medication error due to product storage error temperature too low (latency: unknown).  It was reported, "caller states that she had a case from a temperature excursion call made on 02AUG2021. Caller states that the information given on that case was inaccurate and that the refrigerator temperature went down to 31.1F for 45 minutes. Caller also states that a patient received a dose of MENACTRA on 02AUG2021 in the office post temperature excursion. Caller states that excursion was caused by the door being left open."  At the time of reporting, no adverse events were reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB, IPV, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine exposed to -0.5 degree Celsius for 45 minutes with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Care Professional via Medical Information (Reference number- 00708411) and transmitted to Sanofi on 03-Aug-2021.  This case involves MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL] that were exposed to -0.5 degree Celsius for 45 minutes and a patient received a dose of received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, TUBERSOL (TUBERCULIN TEST), MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and IPV (VERO) (lot R1F973M and expiry date:30-Oct-2021) exposed to -0.5 degree Celsius for 45 minutes.  On 02-Aug-2021, the patient received as dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  This was potential medication error case due to product storage error temperature too low (on same day).  It was reported that "the refrigerator temperature went down and Caller states that excursion was caused by the door being left open."  It was not reported if patient experienced any 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.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient was received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from physician via Global Medical Information (Reference number- 00708509) and transmitted to Sanofi on 03-Aug-2021.  This case involves a patient (unknown demographics) who received an expired IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 20-Jul-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) (lot R1D972M and expiry date: 17-Jul-2021) via an unknown route in an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "The caller did not have patient information or demographics but stated that there was no report of any adverse reaction or treatment required afterwards. Caller would like to know if the dose is valid and whether it should be repeated?"  This was a case of actual medication error due to Expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: recevied expired a dtap vaccine/ no AE;Initial information was received on 03-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional and physician via call center via Medical Information (Reference number- 00708519).  This case involves a 4-year-old male patient who was vaccinated with an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered).  The patient's past medical history, medical treatments, vaccinations, concomitant vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE, MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3), PROQUAD; HEPATITIS A VACCINE; and PNEUMOCOCCAL 13 VALENT VACCINE for prophylactic vaccination.  On 03-Aug-2021, the patient received a third dose of 0.5mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (diluent lot number: U6842BA, powder lot number: UJ335AA and expiry date: 05-Jul-2021) via intramuscular route in the right arm for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported that, "I gave a dtap vaccine but it expired last month. Does the person have to come and redo it?."  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: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Patient received only liquid DTAP-IPV portion of PENTACEL with no AE; Initial information regarding an unsolicited non-valid non-serious case was received from other Health Care Professional via Global Medical Information (GMI) (Reference number- 00708617) and transmitted to Sanofi on 03-Aug-2021 in United States.  This case involves an 1 years old female patient who received liquid DTAP-IPV portion without reconstituting with powder ACTHIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, past medical treatment, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 03-Aug-2021, the patient received a 0.5 mL dose of received liquid DTAP-IPV portion without reconstituting with powder ACTHIB portion suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Oral solution, DTAP-IPV: lot UJ440AA, ACTHIB: lot UJ502AA and expiry date: 29-MAY-2022) via intramuscular route in the left vastus lateralis for prophylactic vaccination.  This was an actual medication error case due to inappropriate reconstitution technique (on same day).  It was reported that "Nurse asking how she should proceed."  It was not reported whether any patient had received the product and experienced any 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: nurse gave a child ACT-HIB vaccine that was two weeks expired. with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via  Medical Information (Reference number- 00708642 and 00708732) and transmitted to Sanofi on 803-Aug-2021 in United States.  This case involved 4-month-old male patient gave HIB (PRP/T) VACCINE [ACT-HIB] that was two weeks expired (expired product administered)  The patient's past vaccination(s) included ACT-HIB on an unknown date in May-2021 with last dose.  Relevant medical history, medical treatment(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for prophylactic vaccination  On 02-Aug-2021, the patient received second 0.5ml dose of suspect HIB (PRP/T) VACCINE [lot: UJ354ABA and expiry date: (two weeks expired) 18-Jul-2021] (Frequency = once) (Strength = standard) (Form: solution) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered)  It was reported that, "Caller wanted to know if there was any time after an expired vaccine so that they do not have to repeat the vaccine".   This was an actual medication error due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements 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: Conjunctivitis, Eye swelling, Lip swelling, Ocular hyperaemia, Swelling face
Clinical narrative: Had red eyes; extreme facial swelling; eyes swollen shut; lip swelling; Initial information was received on 03-Aug-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 48-year-old female patient who experienced red eyes (ocular hyperaemia), extreme facial swelling (swelling face), eyes swollen shut (eye swelling) and lip swelling, after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included FLU in 2015 which resulted in bilateral pink eyes.  At the time of the event, the patient had ongoing Cancer.   The patient's past medical treatment(s), concomitant medications and family history were not provided.  On 14-Dec-2016 at 6:00 pm, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot A4VN37333PAW3UX and expiry date was not reported) via an unknown route probably in left arm for prophylactic vaccination.  On 14-Dec-2016, the patient developed a non-serious red eye (ocular hyperaemia) (within an hour), at (11:30 pm) she had extreme facial swelling (swelling face), eyes swollen shut (eye swelling), lip swelling (Five hour 30 minutes) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, that "call received from Patient reporting an adverse reaction to a flu shot received in 2015 (unknown which vaccine) as well as a reaction to FLUZONE QUADRIVALENT received in 2016. Patient reporting she has a history of cancer and had always gotten her flu shots at her oncologist without any adverse reactions until 2015. Caller reporting the flu shot in 2015 resulted in bilateral pink eyes which resolved on their own. Reporting she received the vaccine at pharmacy. Caller reporting in 2016 she received the FLUZONE QUADRIVALENT at 6:00pm and within an hour she had red eyes, and by 11:30pm she had extreme facial swelling, eyes swollen shut, and lip swelling. Caller with concerns on whether she should get the COVID vaccine based on her reaction to the flu vaccine. Caller with question on ingredients in the 2016 FLUZONE QUADRIVALENT to research whether she can receive a COVID vaccine."  Details of laboratory data were not reported.  The patient was treated with two ACRIVASTINE (BENADRYL [ACRIVASTINE]) and applied ice to affected areas, the doctor told that no further treatment required, patient was referred to allergist who recommended not to get the flu shot in the future.  On an unknown date, the patient was recovered from all the events.
Age: 39.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from physician via Global Medical Information (GMI) (Reference number- 00708715) and transmitted to Sanofi on 03-Aug-2021.  This case involves a 39-year-old female patient who received an expired TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 26-Jul-2021, the patient received a 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R2A25 and expiry date: 11-May-2021) via an intramuscular route in the right deltoid for prophylactic vaccination (expired product administered).  It was reported that "Caller wanted to know how soon she could give the patient a new vaccine. Call transferred from MIA Provider calling to get guidance on an expired Typhim dose."  This was a case of actual medication error due to Expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave expired dose of ACT-HIB to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician via Medical Information (Reference number- 00708771) and transmitted to Sanofi on 03-Aug-2021.  This case involved 3-month-old male patient gave expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered)  Relevant 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 (DAPTACEL) for prophylactic vaccination.  On 30-Jul-2021, the patient received first dose of suspect HIB (PRP/T) VACCINE (lot: UU357AAB and expiry date: 26-Jul-2021) (Frequency = once) (Strength = standard) (Form: solution for injection) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered)  It was reported that, "doctor is calling to see what they need to do and reported the event".   This was an actual medication error due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements 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: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event
Clinical narrative: patient received only the solution portion of the Pentacel/no AE; Initial information was received on 03-Aug-2021 regarding an unsolicited valid non-serious case received from an other health professional via the Medical Information under reference number - 00708879.   This case involves a 3 month-old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], but only with solution portion (Act-HIB) (Product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  On 22-Jul-2021, the patient received first dose 0.5 mL (standard; total) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ458ABA and expiry date 21-May-2022) via an intramuscular route at the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency was on same day).   It was reported that "HCP (Healthcare Professional) stated PENTACEL come with two components and she didn't combine both. HCP stated she gave the solution, Act-HIB and wanted to know how she can fix the error. HCP wanted to know if she can reconstitute the powder with saline and give that or redo the PENTACEL shot. Caller states that she administered a Pentacel and she may have be rushed or was distracted but she only gave the solution portion of the vaccine".  At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority 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: 58.0
Sex: M
Vaccine: RAB
Symptoms: Animal bite, Incorrect route of product administration, No adverse event
Clinical narrative: administered IMOVAX subcutaneously in the wound, instead of intramuscularly with no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist Global Medical Information (Reference number- 00710123) and transmitted to Sanofi on 04-Aug-2021.  This case involves a 58 year old male patient who experienced administered imovax subcutaneously in the wound, instead of intramuscularly [incorrect route of product administration] while receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 04-Aug-2021, the patient received a 1 mL dose of suspect RABIES (HDC) VACCINE [lot T1C662M and expiry: 17-Jun-2022] via a subcutaneous route in unknown administration site (hand (reporter unsure if it was left or right hand) for prophylactic vaccination.  It was a case of actual medication error due to incorrect route of product administration [Latency: on the same day].  It was reported that, "Caller reports that a patient came in with animal bites and a nurse administered IMOVAX subcutaneously in the wound, instead of intramuscularly".  No laboratory test was reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event administered imovax subcutaneously in the wound, instead of intramuscularly.   At the time of report no adverse event was reported.  The reporter assessed the causal relationship with suspect vaccines as: related for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received a expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare professional via Medical Information (Reference number- 00710323) and transmitted to Sanofi on 04-Aug-2021.  This case involves a one-year-old male patient who received an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 28-Jul-2021, the patient received a 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE (solution, lot UJ54ABA and expiry date: 18-Jul-2021) via an unknown route in an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "Medical office manager reporting that an expired ACTHIB vaccine was given to a patient on 28Jul2021, she is inquiring if the dose is valid."  This was a case of actual medication error due to Expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare professional via Global Medical Information (GMI) (Reference number- 00710335) and transmitted to Sanofi on 04-Aug-2021.  This case involves a 11-year-old female patient received an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE for prophylactic vaccination.  On 29-Jul-2021, the patient received a dose of expired suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6521AA and expiry date: 26-Jan-2021) via an unknown route in the right deltoid for prophylactic vaccination (expired product administered).  It was reported that "It was realized afterwards that the Menactra dose had expired on 26-Jan-2021. The pharmacist had incorrectly entered the expiry in the facility's electronic system as 21-Jan-2026, and that is why their system did not alert that the product should not have been used. The nurse stated that despite the pharmacist's error, the nurse who administered Menactra should have checked the label at the time, but that was not done and therefore the fact that the product was expired was overlooked prior to administration."  This was a case of actual medication error due to Expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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: MNQ
Symptoms: Expired product administered
Clinical narrative: accidentally administered expired Menactra to 4 patients with no reported adverse event; Initial information received on 04-Aug-2021 regarding an unsolicited valid non-serious case from a nurse via Global Media information (under reference 00710627).  This case involved 4 patients (unknown age and unknown gender) who accidentally received an expired dose of MENINGOCOCCAL VACCINE (MENACTRA) [expired product administered].  The past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patients received a 0.5 mL dose of suspect MENACTRA (lot U65218A, total, once and expiration date: 26-Jan-2021) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported that "She said that they had read the expiration date wrong. She is looking for information on next steps. Outbound call placed on 04-Aug-2021 at 02:15 pm. the dates being entered into the system with the expiration date transposed with the year in the day spot and the day in the year spot. The caller reported that some of the patients recently received the expired Menactra and that at the time of this call the Patient Information and Administering physicians are unknown due to not having the information pulled up at the time of the call".  At the time of reporting, it was unknown whether the patients had any adverse event or not.  At time of reporting, the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.