chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administration error
Clinical narrative: received a vaccination of fluzone high-dose quadrivalent after the physician was informed that it was no longer suitable for use/ no AE; Initial information was received on 01-OCT-2021 regarding an unsolicited valid non-serious case received from a Physician (Reference number- 00794512) and transmitted to Sanofi on 01-OCT-2021.  This case involves a 69-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] after the physician was informed that it was no longer suitable for use with no adverse event (Product administration error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 27-Sep-2021, the patient received a 0.7 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ748AA and expiry date 30-Jun-2022] via unknown route in unknown administration site for prophylactic vaccination.  It was reported "Caller states that a patient received a vaccination of FLUZONE HIGH-DOSE QUADRIVALENT on 27SEP2021 after the physician was informed that it was no longer suitable for use."  It was a case of actual medication error due to Drug administration error (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: M
Vaccine: FLU4
Symptoms: Pyrexia, Rash, SARS-CoV-2 test, Urine analysis, Vomiting
Clinical narrative: fever; rash on his face; throwing up; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a Consumer via Regulatory authority (Reference number- 00796584) and transmitted to Sanofi on 04-Oct-2021.  This case involves an 18-year-old male patient who experienced fever (pyrexia), rash on his face (rash) and throwing up (vomiting) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date the patient received dose (once) of suspect INFLUENZA QUADRIVAL A-B VACCINE (Solution for injection in pre-filled syringe) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On 02-OCT-2021 the patient developed a non-serious fever (pyrexia), rash on his face (rash) and throwing up (vomiting) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  He went to HCP on 03OCT2021 and had urine test, COVID test and was given a steroid which was not filled yet.  Product used: Used. First time product used: No.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Age: 59.0
Sex: M
Vaccine: FLUR4
Symptoms: Medication error, Product storage error
Clinical narrative: multiple excurion occured during shiping time  with no adverse event; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a nurse and non-healthcare profession and non-healthcare professional via [Regulatory authority (reference -00797286].  This case involves a 59 years old male patient who vaccinated INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] which went on multiple temperature excursions (product storage error).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  On 04-Oct-2021, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number QFAA2121 expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "Nurse practitioner reports that she received a delivery of FLUBLOK today 04OCT2021; states it was shipped 01OCT2021, and she received a message from Sanofi stating that her product was in shipment for too long and it was not viable for use. Nurse practitioner states that when she received this message, she had already administered FLUBLOK to one patient; asks if there are any recommendations after FLUBLOK is administered post-excursion."  It was a case of actual medication error due to incorrect product storage (latency was on same day).  At the time of reporting, no adverse event reported.  Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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: U
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A 2-month-old patient received an extra dose of IPOL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via consumer non-health care professional (Reference number- 00797653) and transmitted to Sanofi on 05-Oct-2021.  This case involves a two-month-old patient (unknown gender) who received an extra dose of POLIOMYELITIS VACCINE (INACTIVATED) (IPV) (IPOL) (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number: T1D482M; expiry date: 25-Jul-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to extra dose administered (latency same day).  No other adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Abnormal behaviour, Crying, Dermatitis acneiform, Erythema, Lethargy
Clinical narrative: lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples; it was like pus-like ulcers and they started to swell; was weepy and crying a lot; threw up; pale; lethargic; congestion; nose was swollen and inflamed; He (patient) was acting funny, quiet, and not himself; red welts;Initial information was received on 05-Oct-2021 regarding an unsolicited non-valid non-serious case from a Consumer via Media Information (under reference- 00798641) and transmitted to Sanofi on 05-Oct-2021.  This case involves a 11-year-old male patient who experienced He (patient) was acting funny, quiet, and not himself (Behaviour abnormal), red welts (Urticaria), was weepy and crying a lot, pale (Crying), pale (Pallor), lethargic (Lethargy), congestion (Nasal congestion), nose was swollen and inflamed (Nasal inflammation), threw up (Vomiting), lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples (Dermatitis acneiform), it was like pus-like ulcers and they started to swell (ulcer) while receiving MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 25-Aug-2021, the patient received 0.5 ml (once)dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [lot U6821AA and expiry date not reported] via unknown route left arm for prophylactic vaccination.  On 25-Aug-2021 the patient developed He (patient) was acting funny, quiet, and not himself (Behaviour abnormal), red welts (Urticaria) (latency on the same day), on 26-Aug-2021 the patient was weepy and crying a lot, pale (Crying), pale (Pallor), lethargic (Lethargy), congestion (Nasal congestion), nose was swollen and inflamed (Nasal inflammation), threw up (Vomiting) (latency 1 days) and in Sep-2021 lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples (Dermatitis acneiform), it was like pus-like ulcers and they started to swell (ulcer) (latency 2 weeks) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Other relevant tests were not reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]).  They (doctor) gave him a topical steroid. They didn't do a biopsy on the welts. They said that they would do a biopsy if they kept coming. They (lesions) left some scarring.  At the time of report the outcome of event was unknown.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Nasal congestion, Nasal inflammation, Pallor, Ulcer, Urticaria
Clinical narrative: lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples; it was like pus-like ulcers and they started to swell; was weepy and crying a lot; threw up; pale; lethargic; congestion; nose was swollen and inflamed; He (patient) was acting funny, quiet, and not himself; red welts;Initial information was received on 05-Oct-2021 regarding an unsolicited non-valid non-serious case from a Consumer via Media Information (under reference- 00798641) and transmitted to Sanofi on 05-Oct-2021.  This case involves a 11-year-old male patient who experienced He (patient) was acting funny, quiet, and not himself (Behaviour abnormal), red welts (Urticaria), was weepy and crying a lot, pale (Crying), pale (Pallor), lethargic (Lethargy), congestion (Nasal congestion), nose was swollen and inflamed (Nasal inflammation), threw up (Vomiting), lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples (Dermatitis acneiform), it was like pus-like ulcers and they started to swell (ulcer) while receiving MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 25-Aug-2021, the patient received 0.5 ml (once)dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [lot U6821AA and expiry date not reported] via unknown route left arm for prophylactic vaccination.  On 25-Aug-2021 the patient developed He (patient) was acting funny, quiet, and not himself (Behaviour abnormal), red welts (Urticaria) (latency on the same day), on 26-Aug-2021 the patient was weepy and crying a lot, pale (Crying), pale (Pallor), lethargic (Lethargy), congestion (Nasal congestion), nose was swollen and inflamed (Nasal inflammation), threw up (Vomiting) (latency 1 days) and in Sep-2021 lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples (Dermatitis acneiform), it was like pus-like ulcers and they started to swell (ulcer) (latency 2 weeks) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Other relevant tests were not reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]).  They (doctor) gave him a topical steroid. They didn't do a biopsy on the welts. They said that they would do a biopsy if they kept coming. They (lesions) left some scarring.  At the time of report the outcome of event was unknown.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples; it was like pus-like ulcers and they started to swell; was weepy and crying a lot; threw up; pale; lethargic; congestion; nose was swollen and inflamed; He (patient) was acting funny, quiet, and not himself; red welts;Initial information was received on 05-Oct-2021 regarding an unsolicited non-valid non-serious case from a Consumer via Media Information (under reference- 00798641) and transmitted to Sanofi on 05-Oct-2021.  This case involves a 11-year-old male patient who experienced He (patient) was acting funny, quiet, and not himself (Behaviour abnormal), red welts (Urticaria), was weepy and crying a lot, pale (Crying), pale (Pallor), lethargic (Lethargy), congestion (Nasal congestion), nose was swollen and inflamed (Nasal inflammation), threw up (Vomiting), lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples (Dermatitis acneiform), it was like pus-like ulcers and they started to swell (ulcer) while receiving MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 25-Aug-2021, the patient received 0.5 ml (once)dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [lot U6821AA and expiry date not reported] via unknown route left arm for prophylactic vaccination.  On 25-Aug-2021 the patient developed He (patient) was acting funny, quiet, and not himself (Behaviour abnormal), red welts (Urticaria) (latency on the same day), on 26-Aug-2021 the patient was weepy and crying a lot, pale (Crying), pale (Pallor), lethargic (Lethargy), congestion (Nasal congestion), nose was swollen and inflamed (Nasal inflammation), threw up (Vomiting) (latency 1 days) and in Sep-2021 lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples (Dermatitis acneiform), it was like pus-like ulcers and they started to swell (ulcer) (latency 2 weeks) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Other relevant tests were not reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]).  They (doctor) gave him a topical steroid. They didn't do a biopsy on the welts. They said that they would do a biopsy if they kept coming. They (lesions) left some scarring.  At the time of report the outcome of event was unknown.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Paraesthesia oral
Clinical narrative: trouble swallowing her saliva; About 10 minutes after administration, experienced tingling in her tongue, that started at the tip of tongue and then moved back towards middle of tongue, sensation continued to at least half way to the back of her tongue; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/ non health care professional (Reference number- 00798748).  This case involves a 73-year-old female patient who experienced about 10 minutes after administration, experienced tingling in her tongue, that started at the tip of tongue and then moved back towards middle of tongue, sensation continued to at least half way to the back of her tongue (paraesthesia oral) and trouble swallowing her saliva (dysphagia) after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 28-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date: not reported) (Frequency: once) via intramuscular route in the left arm  for prophylactic vaccination.  On 28-Sep-2021, the patient developed a non-serious about 10 minutes after administration, experienced tingling in her tongue, that started at the tip of tongue and then moved back towards middle of tongue, sensation continued to at least half way to the back of her tongue (paraesthesia oral) and trouble swallowing her saliva (dysphagia) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "The patient would like to know the difference between the ingredients from this years FLUZONE HD vaccine and the ingredients in the previous FLUZONE HD vaccine from 2019. "  Details of laboratory data not reported.  The patient was treated with 100 mg BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] (patient took this on her own).  At the time of reporting, the outcome of events were reported as unknown.  There will be no information available on the batch number for this case.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Product administered to patient of inappropriate age, Syringe issue
Clinical narrative: Product leaked out from the back of the barrel with no adverse event; Product leaked out from the back of the barrel onto her hands and the floor with no adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from an other health care professional (under the reference 00798927).  This case involves a 30 year old female patient who had INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] leaked out from the back of the barrel (device leakage) and onto her hands and the floor (exposure via skin contact).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 05-Oct-2021, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot UJ764AC and expiration date: 30-jun-2022) via unknown route in an unknown administration site for prophylactic vaccination  It was an actual medication error due to device leakage and exposure via skin contact (same day latency).   At time of reporting, the outcome was unknown for the reported events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 1.67
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: gave a dose of quadracel to a patient who was too young with no reported adverse event; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (MI) (reference number- 00799016).  This case involves a 20 months old patient (unknown gender) who received a dose of 15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] who was reportedly too young (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no adverse event reported.  It was reported "Nurse practitioner states they gave a dose of QUADRACEL to a patient who was too young according to the recommendations in the prescribing information."  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: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Medication error
Clinical narrative: Patient had 3 other doses of flu vaccines given in the past year / NO AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Regulatory authority (Reference number- 00799351) and transmitted to Sanofi on 05-Oct-2021.  This case involves a 73 years old male patient who administered 3 other doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in the past year (inappropriate schedule of product administration).  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing Memory impairment.  On 19-Oct-2020, 06-Feb-2021, 06-Mar-2021, 05-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ764AC and expiry date: 30-JUN-2022) via an intramuscular at an unknown administration site for prophylactic vaccination.   It was an actual medication error due to inappropriate schedule of vaccine administered (latency: same day).  It was reported "Patient was given FLUZONE HD QIV on 05Oct2021, and practice found out afterwards he has had 3 other doses of flu vaccines administered in the past year. The original dose was given by the practice on 19Oct2020, with the two following on 06Feb2021 and 06Mar2021, which were not administered by the practice."  HCP states that patient also received 2 flu vaccines in 2018.  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.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Medication error, No adverse event, Product administered at inappropriate site
Clinical narrative: All the injections were given in gluteal muscle; Initial information received on 06-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Global Media Information (GMI reference number 00800617).  This case involves a 46-year-old female patient (40 kg) who was by mistakenly administered all the injections were given in gluteal muscle, after receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (product administered at inappropriate site).  The patient's past medical history included bite was on her left forearm.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 25-Sep-2021, the patient received a second dose of suspect RABIES (HDC) VACCINE (batch number and expiry date: not reported) via unknown route in gluteal muscle for Post exposure immunization.  On 29-Sep-2021, the patient received a third dose of suspect RABIES (HDC) VACCINE (batch number and expiry date: not reported) via unknown route in gluteal muscle for Post exposure immunization.  It was an actual medication error case due to product administered at inappropriate site (latency: same day).  It was reported "The third injection is due today. She weighs 90 pounds"  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient was received expired QUADRACEL vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Medical Information (MI) (Reference number- 00800771) and transmitted to Sanofi on 06-Oct-2021.  This case involves a 5-year-old male patient who was received expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  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) for prophylactic vaccination.  On 25-Aug-2021, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5656AA, expiry: 13-Aug-2021, formulation: injection) via intramuscular route in the right thigh for prophylactic vaccination.  It was case of an actual medication error expired vaccine used (latency same day).  It was reported "Caller states that a patient received an injection of QUADRACEL in her office on 25AUG2021 that had expired on 13AUG2021. Caller states that she was unsure what the protocol was and called the number that was provided from the package containing QUADRACEL. Caller asked how she should proceed with regard to the patient."  No other adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 33.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: A patient received MENACTRA vaccine instead of MMR vaccine no reported AE; A patient received MENACTRA on 04-OCT-2021 and received a dose of MENACTRA last year as well no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Medical Information (Reference number- 00800779) and transmitted to Sanofi on 06-Oct-2021.   This case involves a 33-year-old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and the patient received a dose of MENACTRA vaccine last year as well (Extra dose administered) instead of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) (wrong product administered).  The patient's past vaccination(s) included MENACTRA for prophylactic vaccination.  The patient's medical history, medical treatment(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and INFLUENZA VACCINE for Prophylactic vaccination.  On 04-Oct-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7190AA, expiry: 16-Jan-2023, formulation: solution for injection) via intramuscular route in unknown administration site for prophylactic vaccination instead of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It was a case of an actual medication error due to Extra dose administered and wrong vaccine administered (latency same day).  It was reported "Pharmacy manager states they administered a dose of MENACTRA to a patient on 04Oct2021, and found out afterwards that the patient received a dose last year as well. Pharmacist reports that on 04oct2021, a 33-year-old, female patient, came in seeking an MMR vaccination. She received MENACTRA instead, along with Adacel and a flu shot. Pharmacist states that she's not sure how the error occurred, but the patient does not speak english fluently, so that may have been a contributing factor."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Nasal congestion
Clinical narrative: severe sweats; Lots of myalgias; headache; Felt febrile; shaking chills; prodrome to a minor respiratory illness; stuffy nose; Initial information was regarding an unsolicited valid non serious case was received from a physician (Reference number- 00800817) and transmitted to Sanofi on 06-Oct-2021.  This case involves a 59-years-old male patient who experienced serious prodrome to a minor respiratory illness (respiratory disorder), severe sweats (night sweats), myalgia, headache, felt febrile (pyrexia), shaking chills (tremor), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical treatment included TOZINAMERAN.  The patient's past vaccination(s) included INFLUENZA VACCINES and COVID-19 VACCINE.  The patient's medical history, concomitant medication and family history were not provided.   On 05-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, Suspension for injection, lot number and expiry date not reported) via an unknown route in the left deltoid for prophylactic vaccination.  On 05-Oct-2021, the patient developed non-serious prodrome to a minor respiratory illness (respiratory disorder) and stuffy nose (nasal congestion) (same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 06-Oct-2021, the patient developed non-serious severe sweats (night sweats), myalgia, headache, felt febrile (pyrexia), shaking chills (tremor) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included:  SARS-CoV-2 test (severe acute respiratory syndrome coronavirus)- On 05-Oct-2021: Negative  It was not reported if the patient received any corrective treatment for the events.  It was reported "about 6 hours after receiving his flu shot yesterday, he experienced a stuffy nose that seemed like a prodrome to a minor respiratory illness. He went to bed and woke up around 02:00 with severe sweats, shaking chills, lots of myalgias, headache, and felt febrile. He believes the symptoms are related to the flu shot, but it seems very peculiar to him since he has not experienced reactions to flu shots before now. He said, I thought that this seemed like a robust reaction to a flu vaccine. He now feels fine".  On an unknown date, the patient was recovered from the events.  There will be no information available on the batch number for this case.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Night sweats, Pyrexia, Respiratory disorder, SARS-CoV-2 antibody test negative, Tremor
Clinical narrative: severe sweats; Lots of myalgias; headache; Felt febrile; shaking chills; prodrome to a minor respiratory illness; stuffy nose; Initial information was regarding an unsolicited valid non serious case was received from a physician (Reference number- 00800817) and transmitted to Sanofi on 06-Oct-2021.  This case involves a 59-years-old male patient who experienced serious prodrome to a minor respiratory illness (respiratory disorder), severe sweats (night sweats), myalgia, headache, felt febrile (pyrexia), shaking chills (tremor), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical treatment included TOZINAMERAN.  The patient's past vaccination(s) included INFLUENZA VACCINES and COVID-19 VACCINE.  The patient's medical history, concomitant medication and family history were not provided.   On 05-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, Suspension for injection, lot number and expiry date not reported) via an unknown route in the left deltoid for prophylactic vaccination.  On 05-Oct-2021, the patient developed non-serious prodrome to a minor respiratory illness (respiratory disorder) and stuffy nose (nasal congestion) (same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 06-Oct-2021, the patient developed non-serious severe sweats (night sweats), myalgia, headache, felt febrile (pyrexia), shaking chills (tremor) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included:  SARS-CoV-2 test (severe acute respiratory syndrome coronavirus)- On 05-Oct-2021: Negative  It was not reported if the patient received any corrective treatment for the events.  It was reported "about 6 hours after receiving his flu shot yesterday, he experienced a stuffy nose that seemed like a prodrome to a minor respiratory illness. He went to bed and woke up around 02:00 with severe sweats, shaking chills, lots of myalgias, headache, and felt febrile. He believes the symptoms are related to the flu shot, but it seems very peculiar to him since he has not experienced reactions to flu shots before now. He said, I thought that this seemed like a robust reaction to a flu vaccine. He now feels fine".  On an unknown date, the patient was recovered from the events.  There will be no information available on the batch number for this case.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two FLUZONE HIGH DOSE vaccinations within few weeks with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional and consumer/non-health care professional (Reference number- 00800876) and transmitted to Sanofi on 06-Oct-2021.  This case involves a 72-year-old male patient who received two vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within few weeks one on 17-Sep-2021 and another on 06-Oct-2021 (extra dose administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 17-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [via an unknown route at an unknown administration site]. On 06-Oct-2021 he also received a dose of the same vaccine [frequency: once, strength: standard, dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin test(TB) skin test 0.7ml, lot UJ716AB, expiry date: 30-Jun-2022 via an intramuscular route at an the left arm] for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (latency: same day).  It was reported ''Patient received two FLUZONE HIGH DOSE vaccinations, one on 17Sep2021 and 06Oct2021. Caller states the wife called since he came to the doctor's office by himself and he didn't realize he had already had the vaccine. Caller states he has never had any side effects from the past vaccine and she didn't report any this time.''  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: 16 week pregnant female received Adacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician or consumer/non-health care professional via Medical Information (Reference number- 00800971) and transmitted to Sanofi on 06-Oct-2021.   This case involves a 16 week pregnant female received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (exposure during pregnancy).   Data regarding this pregnancy were received prospectively.  Patient was exposed to the vaccine at gestation period of 16 weeks.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient medical history, past medical treatment, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was the case of vaccine exposure during pregnancy (latency same day). The patient was pregnant when she received ADACEL vaccine.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  There will be no information available on the batch number for this case.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error
Clinical narrative: A patient was received expired FLUZONE HIGH-DOSE QUADRIVALENT with no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via consumer/non-health care professional via Medical Information (Reference number- 00801040) and transmitted on 06-Oct-2021.  This case is linked to case 2021SA334081 (same reporter).  This case involves a 78-year-old male patient who was received expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 06-Oct-2021, the patient received a first dose (0.7 ml) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ454AB, expiry: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Nurse calling in regards to expired FLUZONE HIGH-DOSE QUADRIVALENT (QIV HD) being administered to two patients. Caller would like to know how to proceed and if there is a safety issue."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: COVID-19, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: COVID; congestion; headache; fever; fatigue; aches; sore throat; Initial information received on 06-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non health care professional via Regulatory Authority (under the reference 00801151).  This case involves a 57 years old female patient who had covid (covid-19) [Coronavirus Disease] after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Oct-2021, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 05-OCT-2021 the patient developed a serious covid [Coronavirus Disease] (covid-19), congestion (pulmonary congestion), headache, fever (pyrexia), fatigue, aches (pain) and sore throat (oropharyngeal pain), four days later following the administration of vaccine.  This all events was assessed as medically significant.   No laboratory data reported.  The patient was treated with ACETAMINOPHEN and fluids.  At time of reporting, the outcome was unknown for the reported events.   It was reported "Caller states that symptoms started 05-oct-2021 and she went in this morning and diagnosed with rapid test she is still waiting on pcr (polymerase chain reaction) test. Caller states that she is vaccinated for covid (Coronavirus Disease)."  Batch number requested.; Sender's Comments: This case concerns a 57-year-old female patient who had covid-19 [Coronavirus Disease] after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. However, patient's medical condition at the time of vaccination and other relevant laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pulmonary congestion, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: COVID; congestion; headache; fever; fatigue; aches; sore throat; Initial information received on 06-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non health care professional via Regulatory Authority (under the reference 00801151).  This case involves a 57 years old female patient who had covid (covid-19) [Coronavirus Disease] after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Oct-2021, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 05-OCT-2021 the patient developed a serious covid [Coronavirus Disease] (covid-19), congestion (pulmonary congestion), headache, fever (pyrexia), fatigue, aches (pain) and sore throat (oropharyngeal pain), four days later following the administration of vaccine.  This all events was assessed as medically significant.   No laboratory data reported.  The patient was treated with ACETAMINOPHEN and fluids.  At time of reporting, the outcome was unknown for the reported events.   It was reported "Caller states that symptoms started 05-oct-2021 and she went in this morning and diagnosed with rapid test she is still waiting on pcr (polymerase chain reaction) test. Caller states that she is vaccinated for covid (Coronavirus Disease)."  Batch number requested.; Sender's Comments: This case concerns a 57-year-old female patient who had covid-19 [Coronavirus Disease] after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. However, patient's medical condition at the time of vaccination and other relevant laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: patient recieved diluent portion not the powdered portion with no adverse event; Initial information received on 07-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist and consumer non health care professional via Medical Information number: 00802360.  This case involves an unknown age and unknown gender patient who was recieved diluent portion not the powdered portion DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to inappropriate reconstitution technique (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.