chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: Patient received expired ACT-HIB vaccine/ NO AE; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (reference number- 00730100).  This case involves a 1-years-old female patient who administered expired vaccine (expired product administered) HIB (PRP/T) VACCINE [ACT-HIB].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On 19-Jul-2021, the patient received a 0.5 ml first dose of suspect HIB (PRP/T) vaccine (frequency: once, strength: standard, lot number: UJ183AA and expiry date: 12-Feb-2021) via an intramuscular route in the right thigh for prophylactic vaccination.  It was of actual medication error due to expired vaccine used (latency: same day).  It was reported as "patient received an expired ACTHIB vaccine; asking if patient will need to be revaccinated. Event Information -Treatment: patient did not receive treatment for this event ".  At the 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: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: daughter was given DAPTACEL on Friday, when the vaccine expired on 17Jul2021 with no reported adverse event; Initial information received on 18-Aug-2021 regarding an unsolicited valid  non-serious case received from a consumer/ Non-Healthcare Professional (mother).  This case involves an unknown age female patient who was expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 20-Jul-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported, expiry date 17-Jul-2021 via unknown route in unknown administration site.  It was a case of actual medication error due to expired product administered (latency same day).  It was reported that, "The caller stated, I find it unsettling you only provide information to providers. I don't feel safe with the provider who gave this expired vaccine to my child. Why can't you tell me if another dose should be given? I want to file a complaint. It is not good enough to talk to you, how do I file a formal complaint? Will I receive follow-up that something has changed? What is the efficacy of vaccine that is expired by a certain amount of time? Do you have that information? What is the risk of getting more than one dose of the vaccine too close together? (Agent addressed 2nd to last question by saying we do not have studies at all that look at amount of efficacy v of days expired. During hold time for research of the last question, could not reconnect to the caller after hold. Had to disconnect the call. Outbound call at 14:35 and reached voicemail. Left message apologizing for technical difficulties, instructed to call back and ask for MIS III. If I am not available, find out best time for me to call her back)."  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. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Medication error
Clinical narrative: had inadvertently been administered an expired dose of Daptacel with no reported adverse event; Initial information received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional via Consumer/ Non-Healthcare Professional..  This case involves a 5 years old (unknown gender) patient who had inadvertently been administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO) for prophylactic vaccination.  On 03-Aug-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5643BA, expiry date-17-July-2021 via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired product administered (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. 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, Medication error
Clinical narrative: patient was given expired Menactra/ NO AE; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case from a physician and non-healthcare professional via call center via Global Medical Information (Reference number- 00730324).  This case involves a patient of (unknown demographics) who administered (expired vaccine used) (expired product administered) MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  On 14-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number not reported and expiry date: 26-Jan-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency: same day).  It was reported as "The Physician asks if the Menactra needs to be revaccinated. The Physician had to get off the phone, however the Physician or a medical assistant (MA) will be calling back to provide the Pasteur adverse event (AE) questions".  At the 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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: medical assistant provided expired MENACTRA vaccine to a patient/no AE; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from a Physician via (Medical Information-00730396).  This case involves a 17 years 3 months old male patient who was vaccinated with expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 14-Aug-2021, the patient received 0.5 mL (total; standard) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6521AB and expiry date 26-Jan-2021) via an intramuscular route at the left deltoid for prophylactic vaccination.  It was reported "HCP called back to provide AE information from previous call that he had to disconnect from. Doctor reports that medical assistant provided expired MENACTRA vaccine to a patient on 14Aug2021.Doctor also asked about the most common side effects that may occur with an expired dose of MENACTRA but was unable to hold for a MIS transfer. Caller was advised on previous call that vaccine was not valid. MA got the expiration date confused and mixed up the year with the date 26-Jan-21. She thought it expired in 2026".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: practice had given 2 vaccines the MENACTRA and the TDAP that had been expired for 3 month/no AE; Initial information regarding an unsolicited valid non-serious case was received from the physician assistant via medical information (Reference number- 00730400) and transmitted to Sanofi on 18-Aug-2021.  This case involves two patients (of an unknown demographics) to whom practice had given 2 vaccines the MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE  that had been expired for 3 months (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patients received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) that had been expired for three months (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (same day).  It was reported, "calling to report their practice had given 2 vaccines the MENACTRA and the TDAP That had been expired for 3 months. She wants to know from a healthcare standpoint should they be on the watch for anything and does the patient need to be re-vaccinated. physicians assistant states the expired MENACTRA was given to 2 patients and she doesn't know what brand of Tdap was used".  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error
Clinical narrative: patient received expired quadracel with no adverse event reported; Initial information received on 18-Aug-2021 regarding an unsolicited valid  non-serious case received from a consumer/ Non-Healthcare Professional via other health professional.  This case involves a patient with unknown demographics who received expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Aug-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported, expiry date 13-Aug-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired product administered (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 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient received a yellow fever vaccine intramuscular instead of subcutaneous with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional.  This case involves patient with unknown demography who received YELLOW FEVER VACCINE - US [YF-VAX] intramuscular instead of subcutaneous (incorrect route of product administration).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US (lot UJ386AA and expiry date was not reported) via intramuscular route at an unknown administration site instead of subcutaneous route for prophylactic vaccination (incorrect route of product administration).  It was reported "Caller asked what, if anything, needed to be done".  It was an actual medication error case due to inappropriate route of vaccination (latency: same day).  At the time of reporting, the patient experienced 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: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: Expired Act-Hib was administered without any reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number- 00732188) and transmitted to Sanofi on 19-Aug-2021.  This case was linked to case - 2021SA279788.  This case involves a two year old male patient who was administered an expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) and MEASLES VACCINE LIVE, MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  On 09-Aug-2021, the patient received a dose 3 (0.5 ml) of suspect HIB (PRP/T) VACCINE (lot number: UJ398AA; expiry date: 06-Aug-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "Expired Act-Hib was administered, and she wants to know how to follow up? Expired ActHIB was given to 2 patients. Event Information o Treatment--none at this time o Dose # if series-3rd o List concomitant or "no other vaccines"- Kinrix, ProQuad o Pregnancy--NA  Last menstrual period  Due date  AE symptoms or no AE."  No adverse events were reported at the time of this report.  The 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.
Age: 5.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: :Expired Act-Hib was administered without any reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number-00732218) and transmitted to Sanofi on 19-Aug-2021.  This case is linked to case 2021SA279787(CLUSTER).  This case involves a five-year-old female patient who was administered an expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) and MEASLES VACCINE LIVE , MUMPS VACCINE LIVE , RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  On 09-Aug-2021, the patient received a second dose (0.5 ml) of suspect HIB (PRP/T) VACCINE (lot number: UJ398AA; expiry date: 06-Aug-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "Expired Act-Hib was administered, and she wants to know how to follow up? Expired ActHIB was given to 2 patients. Event Information o Treatment--none at this time o Dose # if series-3rd o List concomitant or "no other vaccines"- Kinrix, ProQuad o PregnancyNA. Last menstrual period. Due date. AE symptoms or no AE."  No adverse events were reported at the time of this report.  The 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: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received a expired dose of menactra vaccine with no reported adverse event; Initial information received on 19-Aug-2021 regarding an unsolicited valid non-serious case from a consumer via Medical Information (Reference number- 00732275) in the United States.  This case involves a patient (unknown demographics) who was vaccinated with the expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number not reported and expiry date: 30-Jul-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "caller wanted to know if there was any information if this is harmful and when is the soonest they can receive a non-expired Menactra vaccine and to report an AE (adverse event)".  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: an 11 year old was given Daptacel instead of Adacel with no adverse event; an 11 year old was given Daptacel instead of Adacel with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00732363).  This case involves a 11-year-old male patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (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 HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 18-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5743AA and expiry date: 06-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).   It was reported that "the child received Daptacel instead of Adacel and they knows "there is more in there" but wanted to know what to look for and if they should do anything?"   This was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (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. 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: RAB
Symptoms: Medication error, Needle issue, Product dose omission issue
Clinical narrative: The vaccine was leaking out of the hole the needle made to pierce the septum/ no AE; only able to get 0.7 ml out of the single dose vial initially and She was unable to give the patient her dose/ no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (Reference number- 00733317) and transmitted to Sanofi on 20-Aug-2021.  It was reported that a 30-year-old female patient while receiving RABIES (HDC) VACCINE [IMOVAX RABIES] (powder and solvent for suspension for injection) third 1 mL dose [lot T1B813M, expiry date 27-Dec-2021] via unknown route at an unknown administration site prophylactic vaccination then the vaccine was leaking out of the hole the needle made to pierce the septum (product leakage) and nurse only able to get 0.7 ml out of the single dose vial initially and was unable to give the patient her dose (product dose omission issue).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of potential medication error due to missed dose (latency was on same day).  It was reported "Caller state that she has a patient there to receive their 3rd rabies vaccine and she only able to draw up .7 ml of the vaccine instead of 1 ml of the vaccine. Caller stated that she did use sterile diluent."  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: F
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient inadvertently received a dose of PENTACEL after having already received a dose of Pediarix, with no reported adverse event; Initial information received on 20-Aug-2021 regarding an unsolicited valid  non-serious case from an other health professional and consumer/ non healthcare professional via Media information (under reference 00733710).  This case involves a 6 months old female patient who inadvertently received a dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL [VERO]) after having already received a dose of  DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) [extra dose administered].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration for prophylactic vaccination.  On 04-Aug-2021, the patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 20-Aug-2021, the patient received a 0.5 ml dose of suspect PENTACEL (lot UJ458AA and expiration date: 21-May-2022) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to extra dose administered (same day  latency).  It was reported "Caller states that a patient inadvertently received a dose of PENTACEL on 20-Aug-2021 after having already received a dose of Pediarix on 04-Aug-2021. Caller asked if the patient was at risk for any adverse events because of the close proximity of the two doses and stated that she realized that today's dose would not count as a valid dose in the series".  At time of reporting, it was unknown if the patient experienced any adverse event and the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 15-month-old male patient had inadvertently received an expired dose of Daptacel, with no reported AE; Initial information received on 20-Aug-2021 regarding an unsolicited valid non-serious case from a nurse via Medical Information (Reference number- 00733906).  This case involves a 15 month old male patient who was inadvertently vaccinated with the expired dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 19-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5624AA and expiry date: 10-Jun-2021) (Strength: Standard, Frequency: once) via an unknown route in the left thigh 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. 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, No adverse event
Clinical narrative: patient was administered an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 21-Aug-2021 from a Pharmacist via Medical Information (Reference number- 00734255) and transmitted to Sanofi on 23-Aug-2021.  This case involves a patient (unknown age and gender) who administered an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with no adverse event (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.    On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6521AB, expiry date 26-Jan-2021] via unknown route in unknown administration site for prophylactic vaccination.  It was reported, "A patient was given an expired dose of Menactra".  It was a case of actual medication error due to expired vaccine used (latency was on the same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired dose had been administered, no AE; Initial information received on 23-Aug-2021 regarding an unsolicited valid non-serious case from a nurse and physician via Media Information (under the reference 00735979).  This case involved a 2 month old male patient who was given an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant medication was given to the patient.  On 23-Aug-2021, the patient received a first  dose of suspect HIB (PRP/T) VACCINE (0.5 ml, once in total,  lot UJ266AA and expiration date: 05-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "Nurse called to report that an expired dose of ACTHIB had been administered to a patient. The caller would like to know whether the dose is valid and if it should be repeated."  No treatment was required.  At time of reporting, it was unknown where the patient had any adverse event or not and the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired powder portion of ACT-HIB/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other health professional and physician via call center via Global Medical Information (GMI) (reference number- 00736119).  This case involves a 24 months old male patient who administered expired powder portion of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 23-Aug-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (strength: standard, frequency: once) (powder: UJ357AA and expiry date: 26-JUL-2021) (diluent: lot number: U6849AA and expiry date: 22-JAN-2022)) via an intramuscular route in the left vastus lateralis for prophylactic vaccination.  It was of actual medication error due to expired vaccine used (latency: same day).  It was reported ''Stated that the vaccine was given, but the diluent portion expired on 01/22/2022, powder expired 07/26/2021 and she wants to know what the recommendations are.''  At the 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 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: 28.0
Sex: F
Vaccine: HPVX, TDAP
Symptoms: Medication error, Wrong product administered
Clinical narrative: patient was supposed to receive an HPV vaccine but they received an Adacel vaccine that was not ordered for her with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional (nurse) via Medical Information (Reference number- 00736518) and transmitted to Sanofi on 23-Aug-2021.  This case involves a 28-year-old female patient who was supposed to receive an HPV (Human papillomavirus) VACCINE but they received an HPV VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine that was not ordered for her (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Information of concomitant medications was not reported.  On 19-Aug-2021, the patient received a dose (0.5ml) of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6927AA; expiry date: 280Aug-2023) via intramuscular route in the left deltoid for prophylactic vaccination instead of suspect HPV VACCINE not produced by Sanofi Pasteur (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to wrong vaccine administered (latency: same day).  It was reported, "Nurse needs some safety information as ADACEL was administered to a patient that shouldn't have received it she states. The nurse states that the patient was supposed to receive an HPV vaccine but they received an Adacel vaccine that was not ordered for her."  No adverse event was reported at the time of this report.  The outcome of the event was reported as unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Accident, Haemorrhage
Clinical narrative: He had an incident and lost blood; He had an incident and lost blood; This spontaneous case was received on 30-Sep-2020 from a pharmacist via Med Communications (reference number: SEQW20-02629) and concerned a 73-year-old, male patient.   The patient's concurrent condition included high blood pressure. The patient's concomitant medications included unspecified high blood pressure medications.     On 21-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279791, expiry date: 28-May-2021.    On the same day, shortly after receiving Fluad Quadrivalent, the patient had an incident and lost blood, however it was not enough for a transfusion.   The outcome of events was not reported.   The reporter assessed events as not related to Fluad Quadrivalent. The pharmacist said that it was not related to the vaccine.  The event of 'blood loss of (NOS)' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Additional information received on 06-Nov-2020 with additional information received on 12-Nov-2020 (being processed together) from pharmacist: Reference number added and reporter's email address was provided. No changes in the narrative.  Case updated on 14-Dec-2020: Correction made to information received on 30-Sep-2020: Typo in company comment amended.  Company comment: The patient experienced haemorrhage and accident (reported as 'he had an incident and lost blood') after administration of Fluad Quadrivalent. The patient's concurrent condition included high blood pressure while concomitant medications included unspecified high blood pressure medications. Causality will follow the reporter's causality assessment - not related to vaccine and more likely related to mechanical/physical accident.; Reporter's Comments: The pharmacist said that it was not related to the vaccine.; Sender's Comments: The patient experienced haemorrhage and accident (reported as 'he had an incident and lost blood') after administration of Fluad Quadrivalent. The patient's concurrent condition included high blood pressure while concomitant medications included unspecified high blood pressure medications. Causality will follow the reporter's causality assessment - not related to vaccine and more likely related to mechanical/physical accident.
Sex: F
Vaccine: FLUX
Symptoms: Dehydration
Clinical narrative: Dehydration; This spontaneous case was received on 06-Aug-2021 from other non-health professional (consumer) via Agency (reference number: SEQW21-01546) and concerned a female patient of an unknown age. At the time of initial reporting, the patient was a 45-year-old.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in the past, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication, dose, anatomical location, route of administration: not reported). The batch number was not reported. The patient did not know the name of the vaccine or lot number or expiration date.  On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced severe dehydration and was admitted to hospital due to the event.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of 'dehydration' was assessed as serious due to criterion of hospitalization.  This case is linked with case 202102845 (due to the same patient).  Company Comment: A female patient developed dehydration after vaccination with the suspect product influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history and related diagnostic findings have not been provided. Due to lack of information regarding the temporal relationship, causality is unassessable.; Sender's Comments: A female patient developed dehydration after vaccination with the suspect product influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history and related diagnostic findings have not been provided. Due to lack of information regarding the temporal relationship, causality is unassessable.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy, Pregnancy
Clinical narrative: Spontaneous abortion at 11 weeks of gestation; This spontaneous case was received on 10-Aug-2021 from other health professional  and concerned a 42-year-old female patient, of body weight: 108 lbs, height: 61 inches and body mass index (BMI): 20.4.  The patient had no relevant medical history. The patient's concomitant medications included Vitafol One (ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, iron polysaccharide complex, magnesium oxide, nicotinamide, omega-3 fatty acids, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) for healthy pregnancy.  The patient's obstetrical history included two previous pregnancies, with one elective abortion and one ectopic pregnancy. The patient had no history of offspring with major congenital malformation (MCM) and no maternal or paternal history with MCMs. The patient did not use tobacco, alcohol or illicit drugs during pregnancy.   The patient's last menstrual period (LMP) date was reported as 27-Dec-2020. The type of pregnancy was singleton. The estimated delivery date (EDD) was reported as 03-Oct-2021 and corrected estimated date of delivery (CEDD) was not reported.  On 03-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose, indication, route of administration and anatomical location: not reported). The batch number reported was P100239705.  No pregnancy complications were noted, and no prenatal tests were performed.   On 14-Mar-2021, five months and 11 days after receiving Afluria Quadrivalent, at 11 weeks of gestation, the patient had spontaneous abortion.   The outcome of the event spontaneous abortion was not reported.  The reporter did not provide a causality assessment to Afluria Quadrivalent.  The event of 'spontaneous abortion' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company Comment:  Spontaneous abortion was reported in a 42-year-old female patient five months after vaccination with the suspect product Afluria Quadrivalent. No pregnancy complications were noted, and no prenatal tests were performed. Information regarding autopsy and possible aetiology for the reported event have not been provided. Patients age confounds causality since the risk of spontaneous abortions significantly increases by age. Based on implausible temporal relationship and presented confounder, causality is assessed as not related.; Sender's Comments: Spontaneous abortion was reported in a 42-year-old female patient five months after vaccination with the suspect product Afluria Quadrivalent. No pregnancy complications were noted, and no prenatal tests were performed. Information regarding autopsy and possible aetiology for the reported event have not been provided. Patients age confounds causality since the risk of spontaneous abortions significantly increases by age. Based on implausible temporal relationship and presented confounder, causality is assessed as not related.
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction, Swelling face
Clinical narrative: Had a reaction to it, including swelling in the face and other; Had a reaction to it, including swelling in the face and other; This spontaneous case was received on 14-Aug-2021 from other non-health professional (reference number: NUS2021US122701) and concerned a female patient, of an unreported age.  The patient's concurrent conditions and concomitant medications were not reported. The patient had another side effect to unspecified product prior to Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine) which resulted with the hospitalization.   On an unknown date in 2014, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; dose, route of administration, indication and anatomical location: not reported). The batch number reported was 1309501.   On an unknown date, unknown amount of time after receiving Fluvirin, the patient had a reaction to it, including swelling in the face and other.   The outcome of the events was not reported.   The reporter assessed all events as related to Fluvirin. The patient had a reaction to it.  Company Comment: A female patient experienced adverse reaction and swelling of face after vaccination with the suspect product Fluvirin. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to limited information causality is unassessable.; Sender's Comments: A female patient experienced adverse reaction and swelling of face after vaccination with the suspect product Fluvirin. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to limited information causality is unassessable.