chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.67
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: The patient was administered an expired ACTHIB with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via physician via Global Medical Information (Reference number- 00718353) and transmitted to Sanofi on 10-Aug-2020.  This case involves a 1-year-old patient (unknown gender) who was administered an expired HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR;POLIO VACCINE INACT;TETANUS VACCINE TOXOID for prophylactic vaccination.  On 10-Aug-2021, the patient received a 0.5 ml fourth dose of suspect HIB (PRP/T) VACCINE (lot UJ3581AA, expiry date: 09-Aug-2021) via intramuscular route in left vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  It was reported "Caller reports that today she administered ACTHIB to a patient, ACTHIB expired yesterday, 09AUG2021. Caller asking if patient needs to have another dose of ACTHIB"  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired vaccine/ no AE; Initial information was received on 10-Aug-2021 regarding an unsolicited valid non-serious case received from an Other health professional.  This case involves a 16-month-old female patient reported that patient was given an expired 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.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for prophylactic vaccination.  On 10-Aug-2021, the patient received a 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ357AA, expiry date 26-Jul-2021] via intramuscular route in the right thigh for prophylactic vaccination.  It was reported that, "Caller wanted to know if consumer needed to be re-vaccinated".  It was a case of actual medication error due to expired vaccine used (latency was on 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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menactra vaccine was accidentally given with no reported adverse event; Initial information received on 11-Aug-2021 regarding an unsolicited valid non-serious case from a other health care professional via Global Medical Information (Reference number- 00719410).  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 10-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6576AA and expiry date: 04-Apr-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 that "Caller with provider office stated that an expired Menactra vaccine was accidentally given yesterday. Caller asked if there are any concerns or what should be done next. She would like to know if they should wait a week before administering a second vaccine. She would like to know if there might be any side effects expected by giving two vaccines".   At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 1 year old patient received an injection of QUADRACEL, no AE; Initial information received on 11-Aug-2021 regarding an unsolicited valid non-serious case from a other health professional and consumer/ non health care professional via Global Media Information (under reference 00719583).  This case involves a 1 years old male patient who received an injection of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included a dose of MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 04-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (total, lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration (same day latency).   It was reported that "Caller states that a fifteen month old patient received an injection of QUADRACEL in her office on 04-Aug-2021. Caller asked what Sanofi's recommendation was in this situation."  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.  There will be no information on the batch number for this case.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient was administered expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 11-Aug-2021 from an Other health professional via Global Medical Information (GMI) (Reference number- 00719846) and transmitted to Sanofi on 11-Aug-2021.  This case involves a four-month-old male patient reported that patient was administered expired HIB (PRP/T) VACCINE [ACT-HIB] with no adverse event (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(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) for prophylactic vaccination and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 10-Aug-2021, the patient received 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ398AA, U6872AA and expiry date 06-Aug-2021, 01-Feb-2022] via intramuscular route in right thigh for prophylactic vaccination.  It was reported that, "Medical assistant reports patient was administered expired vaccine on 10AUG2021. It expired 06AUG2021".  It was a case of actual medication error due to expired vaccine used (latency was on 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 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: F
Vaccine: FLU4
Symptoms: Alopecia, Arthropod sting, Burning sensation, Fall, Pain
Clinical narrative: burning; lost half of her hair; experiencing a bee sting and that it stinging; fall; severe itching; Initial information received on 12-Aug-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a elderly female patient who experienced severe itching (pruritus), burning (burning sensation), lost half of her hair (alopecia), bee sting and that it stinging (pain)and fall, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included influenza vaccine and no adverse event reported for prophylactic vaccination.  The patient's past medical history, medical treatment(s) and family history were not provided.  At the time of the event, the patient had Osteoporosis.  On an unknown date in 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious severe itching (pruritus), burning (burning sensation), lost half of her hair (alopecia), bee sting and that it stinging (pain) and fall (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that "Caller stated she called a couple of months ago because she had a severe reaction to the FLUZONE HIGH DOSE VACCINE. Caller stated she is still sufferings from it with sever itching and burning. Caller stated she wanted her primary care doctor to give her an exemption card for the COVID-19 shot because they told her if she had a bad reaction to FLUZONE HIGH-DOSE, her COVID-19 reaction would be way worse. Caller is asking what ingredient could cause severe itching and burning in the vaccine. She would like to know who, is it someone at our company, chooses the strains of the inactivated split influenza virus that is in the vaccine. She wants to know if the strains are all from another country. She states that she is miserable and that it is "all over her body". She states that she did not eat anything different so she knows it was the flu shot. She states that she also lost half of her hair and it is not just because of her age and that she knows it was the flu shot. She mentions that she was born in 1934. She states that she can't have anything that would make you dizzy because she "can't handle another fall" and she states that she has osteoporosis. She states that she has no choice and she can not have another vaccine ever again and that she can't even get a tetanus shot. The caller states that she has had an "absolutely miserable year".  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At time of reporting, patient had not recovered from any of the events.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: burning; lost half of her hair; experiencing a bee sting and that it stinging; fall; severe itching; Initial information received on 12-Aug-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a elderly female patient who experienced severe itching (pruritus), burning (burning sensation), lost half of her hair (alopecia), bee sting and that it stinging (pain)and fall, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included influenza vaccine and no adverse event reported for prophylactic vaccination.  The patient's past medical history, medical treatment(s) and family history were not provided.  At the time of the event, the patient had Osteoporosis.  On an unknown date in 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious severe itching (pruritus), burning (burning sensation), lost half of her hair (alopecia), bee sting and that it stinging (pain) and fall (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that "Caller stated she called a couple of months ago because she had a severe reaction to the FLUZONE HIGH DOSE VACCINE. Caller stated she is still sufferings from it with sever itching and burning. Caller stated she wanted her primary care doctor to give her an exemption card for the COVID-19 shot because they told her if she had a bad reaction to FLUZONE HIGH-DOSE, her COVID-19 reaction would be way worse. Caller is asking what ingredient could cause severe itching and burning in the vaccine. She would like to know who, is it someone at our company, chooses the strains of the inactivated split influenza virus that is in the vaccine. She wants to know if the strains are all from another country. She states that she is miserable and that it is "all over her body". She states that she did not eat anything different so she knows it was the flu shot. She states that she also lost half of her hair and it is not just because of her age and that she knows it was the flu shot. She mentions that she was born in 1934. She states that she can't have anything that would make you dizzy because she "can't handle another fall" and she states that she has osteoporosis. She states that she has no choice and she can not have another vaccine ever again and that she can't even get a tetanus shot. The caller states that she has had an "absolutely miserable year".  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At time of reporting, patient had not recovered from any of the events.  There will be no information available on batch number for this case.
Age: 0.42
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient had been inadvertently vaccinated with an expired dose of 05ml of ActHib with no adverse event; patient had been inadvertently vaccinated with an expired dose of 05ml of ActHib with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via Global Medical Information (Reference number: 00721637) and transmitted to Sanofi on 12-Aug-2021.  This case involves a 05-months old female patient had been inadvertently vaccinated with an expired dose of 05 ml of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered and overdose).  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 10-Aug-2021, the patient received 05 ml (once) dose of suspect HIB (PRP/T) VACCINE (lot number: UJ351AA and expiration date: 09-Aug-2021) via unknown route in the unknown site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used and overdose (latency: same day).  No adverse events were reported at the time of this report.  At the time of this report, 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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Medication error, Product preparation issue
Clinical narrative: they mixed the ACT-HIB with sterile saline instead of using the diluent provided with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and a consumer via Global Medical Information (Reference number: 00721749) and transmitted to Sanofi on 12-Aug-2021.  This case involves a 12-months old female patient for whom it was reported that they mixed the HIB (PRP/T) VACCINE [ACT-HIB] with sterile saline instead of using the diluent provided (product preparation issue).  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) for and concomitant medication PARACETAMOL (HEPA [PARACETAMOL]).  On an unknown date, the patient received 0.5 ml total dose of suspect HIB (PRP/T) VACCINE (lot number: UJ522AAA and expiration date: 06-Aug-2022) via intramuscular route in right thigh for prophylactic vaccination.  It was case of potential medication error due to inappropriate preparation of medication (latency: same day).  No adverse events were reported at the time of this report.  At the time of this report, 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: 1.5
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Medication error, Wrong product administered
Clinical narrative: mistakenly given an Adacel vaccination instead of Daptacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number- 00721986).  This case involves an 18-month-old female patient who mistakenly given a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination, family history and concomitant medications were not provided.  On 12-Aug-2021, the patient mistakenly received a 0.5 mL first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot C5757AA, 22-Jul-2022] via an intramuscular route at the right thigh for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number, expiry date and other dosing details not applicable] (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered to patient.  It was reported that, "caller asked if it was alright to administer the DAPTACEL or if the ADACEL would be sufficient. Caller also asked if there is anything that she should be watching for with regard to administering the incorrect vaccine".  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. 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: FLU4
Symptoms: Chest discomfort, Dizziness, Electrocardiogram, Fatigue, Headache
Clinical narrative: nausea; tightness in the chest; lightheadedness; headache; fatigue; body aches; Initial information regarding an unsolicited valid non-serious case was received from a Consumer/non-hcp (Healthcare professional) via Medical Information (Reference number- 00722010) and transmitted to Sanofi on 12-Aug-2021.  This case involves a female patient who experienced body aches (pain), nausea, tightness in the chest (chest discomfort), headache, fatigue and lightheadedness (dizziness), after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Exposure to SARS-CoV-2 on 08-AUG-2021. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 09-Aug-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On 10-AUG-2021 the patient developed a non-serious body aches (pain), headache, and fatigue, next day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 11-AUG-2021 the patient developed a non-serious nausea, tightness in the chest (chest discomfort) and lightheadedness (dizziness) 2 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that I'm wondering if the symptoms I'm experiencing are normal? I'm most concerned about the tightness in my chest.  Relevant laboratory test results included: Electrocardiogram - On an unknown date with unknown result. SARS-CoV-2 antibody test - On 09-Aug-2021: Negative  The patient was given inhaler.  At time of reporting, the patient was not recovered from the events.
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, SARS-CoV-2 test negative
Clinical narrative: nausea; tightness in the chest; lightheadedness; headache; fatigue; body aches; Initial information regarding an unsolicited valid non-serious case was received from a Consumer/non-hcp (Healthcare professional) via Medical Information (Reference number- 00722010) and transmitted to Sanofi on 12-Aug-2021.  This case involves a female patient who experienced body aches (pain), nausea, tightness in the chest (chest discomfort), headache, fatigue and lightheadedness (dizziness), after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Exposure to SARS-CoV-2 on 08-AUG-2021. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 09-Aug-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On 10-AUG-2021 the patient developed a non-serious body aches (pain), headache, and fatigue, next day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 11-AUG-2021 the patient developed a non-serious nausea, tightness in the chest (chest discomfort) and lightheadedness (dizziness) 2 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that I'm wondering if the symptoms I'm experiencing are normal? I'm most concerned about the tightness in my chest.  Relevant laboratory test results included: Electrocardiogram - On an unknown date with unknown result. SARS-CoV-2 antibody test - On 09-Aug-2021: Negative  The patient was given inhaler.  At time of reporting, the patient was not recovered from the events.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Expired product administered
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (GMI) (Reference number- 00722319) and transmitted to Sanofi on 12-Aug-2021.  This case involves a two-month-old female patient who received an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 11-Aug-2021, the patient received 0.5 mL dose of expired suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ359AAA and expiry date: 11-Jul-2021) via an intramuscular route in the left thigh for prophylactic vaccination (expired product administered).  On an unknown date, the patient received 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination (expired product administered).  It was reported, "Caller states that 2 patients received expired doses of PENTACEL in the practice on 10AUG2021 and 11AUG2021 respectively. Caller asked about how to proceed after administering expired doses to these patients. Caller also revealed that the patient who was treated on 11AUG2021 received an expired ACTHIB vaccine as well."  It 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: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: received expired dose of Pentacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Medical Information (Reference number- 00722325) and transmitted to Sanofi on 12-Aug-2021.  This case was linked to case-2021SA270105 (cluster).  This case involves a four-month-old female patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 10-Aug-2021, the patient received a second dose (0.5ml) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ325AA; expiry date: 13-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "Caller states that 2 patients received expired doses of PENTACEL in the practice on 10AUG2021 and 11AUG2021 respectively. Caller asked about how to proceed after administering expired doses to these patients."  No adverse events were reported at the time of this report.  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: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: patients were given expired PENTACEL with no reported adverse event; Initial information was received on 13-Aug-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (Reference number- 00723367).  This case involves a 6 months old female patient who administered expired (expired product administered) DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (lot number and expiration not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 03-Aug-2021, the patient received a third dose 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (frequency: Once, Strength: standard, lot number: UJ343ABA and expiry date: 22-Jun-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 "Caller reported that 2 patients were given expired PENTACEL. Caller requesting a copy of AE (adverse event) report be forwarded to her email".  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: FLU4
Symptoms: Malaise
Clinical narrative: patient did not feel well; Initial information received on 12-Aug-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves elderly female patient (over 65 years) who did not feel well (malaise), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient did not feel well (malaise) [unknown latency] following the administration vaccine.  It was reported that " Hi, my name is (redacted) and, you know, I placed an order for vaccine and I just couldn't follow if I have the right order in because I was placed on a wait list for another vaccine. So, if you could call me back, I would appreciate it. My name is (redacted). My phone number is (redacted) and first name (spells first name), last name (spells last name).Also reported that physician mentions she has a female patient over 65 that every year she has to write a letter for her to get the Fluzone Quadrivalent because she has reactions to the Fluzone High Dose. Caller states she cannot remember what kind of reaction but for the last few years when she got it she didn't feel well. No other information available."  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: patient was given expired PENTACEL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician, other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00580819) and transmitted to Sanofi on 13-Aug-2021.  This case is linked to case 2021SA270589 (same reporter).  This case involved 6-month-old male patient was given expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 12-Aug-2021, the patient received third 0.5ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: UJ343ABA and expiry date: 22-Jun-2021) (Form: Solution for injection) (Frequency=once) (Strength: standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered)  This case 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation issue
Clinical narrative: She states that she does not know for sure if a Pentacel was reconstituted with a Merck sterile water and then given to a patient with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00723451) and transmitted to Sanofi on 13-Aug-2021.  This case involved (unknown age and gender) patient it was reported that she does not know for sure if a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was reconstituted with a merck sterile water and then given to a patient (product preparation issue)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, it was reported that she does not know for sure if a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: lot UJ543AAA and expiry date: 10-Jul-2022) (dosing details unknown) via unknown route in unknown administration site for prophylactic vaccination was reconstituted with a merck sterile water and then given to a patient (product preparation issue)  It was reported that,"Caller stated that it comes with the 2 vials, (Powder, Diluent). Stated that in the box was an extra diluent in the box, and she thinks it was mixed likely with sterile water. What are the recommendations. She would also like to know what the safety concerns are of a patient getting a second Pentacel vaccine. She states that they will try and figure out which of the four kids this happen to and maybe they can narrow it down to two patients. She was asked for the initials and dates of birth of the potential patient, but she states that she does not have that available at this time".  This was an actual medication error case due to inappropriate reconstitution technique (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.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received her first and second dose of IMOVAX RABIES but third dose (day 21 dose) will be received by the patient on day 24 / No AE; Initial information was received on 13-Aug-2021 regarding an unsolicited valid non-serious case received from a nurse via phone via Global Medical Information Inquiry Number: 00723480.    This case involves an unknown age female patient who received her first and second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] but third dose (day 21) will be received by the patient on day 24 (inappropriate schedule of product administration).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On an unknown date, the patient received first and second dose of suspect RABIES (HDC) VACCINE Solution lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination respectively(pre-exposure rabies).  It was case of an actual medication error due to inappropriate schedule of vaccine administered (latency: same day).  It was reported". The caller states that they were treating a patient for pre-exposure rabies. The patient had already received dose 1 and 2. Today was day 21 (13-AUG-2021) and the patient would miss the appointment. The caller would like to know if they may proceed on Monday, 16-AUG-2021 with giving the next dose. Nurse wants to know since the consumer cannot come today which is day 21 is it ok if she comes on day 24 instead of day 28 to get her dose. Nurse states the consumer missed her third prophylactic dose today but will come one Monday to take it. Product used: Used, First time product used: No, Still using product: No."  It was unknown if patient received the vaccine or not.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the  lot number for this case.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error
Clinical narrative: patient was given an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 13-Aug-2021 from a Pharmacist via Global Medical Information (Reference number- 00723727) and transmitted to Sanofi on 13-Aug-2021.  This case involves a 17-year-old male patient reported that he was given an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 13-Aug-2021, the patient received 0.5 ml (total) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6594AA, expiry date 21-May-2021] via intramuscular route in deltoid (left or right) for prophylactic vaccination.  It was reported that, "Pharmacist states that expired MENACTRA was given to a patient. Pharmacist states that a medical assistant was trying to scan MENACTRA into their system, but it would not let him; becoming frustrated, the medical assistant administered the MENACTRA to patient without first scanning MENACTRA into their system. After administering MENACTRA, the medical assistant went back to try to scan MENACTRA into their system again; the pharmacist tried to help him and realized that the system would not let him scan the MENACTRA because the MENACTRA had expired".  It was a case of actual medication error due to expired vaccine used (latency was on 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: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, Medication error
Clinical narrative: First vaccination was given on July 29th and the second was given on August 5th with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Global Medical Information (Reference number- 00723783) and transmitted to Sanofi on 13-Aug-2021.  This case involves 12-year-old (unknown gender) patient who was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] first vaccination on july 29th and the second was given on august 5th (extra dose administered)   Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 29-Jul-2021, the patient received first 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U7087AA and expiry date was not provided) and on 05-Aug-2021, the patient received second dose of 0.5ml of same vaccine (lot number: U6920AB and expiry date: 15-Apr-2022) via unknown route in unknown administration site for prophylactic vaccination (extra dose administered)  It was reported that,"Medical assistant stated that they had a set of twins to come in and that one of the twins was over vaccinated with Menactra. MA (Marketing authorization) is calling to see if there is any concern or what should be done at this point because they want to be certain that the patient is going to be ok. Spoke with office staff who states she is in another office and unable to transfer me to that office but will take a number to have her contact us back. Informed office staff information would be emailed to assist with answering the question".  This case was an actual medication error due to extra dose administered (latency: same day)  At the time of reporting, no adverse event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements 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: 7.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Medication error
Clinical narrative: patient gave an expired dose of IPOL with no 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- 00725597) and transmitted to Sanofi on 16-Aug-2021.  This case involved 7-year-old female patient gave an expired dose of IPV (VERO) [IPOL] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and MMR VARICELLA COMBINATION for prophylactic vaccination.  On 02-Aug-2021, the patient received fourth 0.5ml dose of suspect IPV (VERO) (lot: R1D97 and expiry date: 17-Jul-2021) (Frequency=once) (Strength=standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered)  This case 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.