chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Wrong technique in product usage process
Clinical narrative: gave the liquid portion of the Pentacel without mixing it with the powder with no AE; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from the other health professional via phone at call center as Agency inquiry (reference number: 00316061).  This case involved a five month old male patient for whom it was reported that they gave the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing it with the powder with no adverse event (Wrong technique in product usage process).  It was an actual medication error due to wrong technique in product usage process.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 09-Oct-2020, the patient received second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ227AAA, expiry date: 23-Apr-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was reported that only part was of Pentacel vaccine was administered and reporter was wanting to know more information regarding issues and what 2 parts (liquid/powder) contain. Further it was reported that they gave the liquid portion of the Pentacel and not the powder portion (Wrong technique in product usage process).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001-83-EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4, IPV, TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: received vaccine Fluzone High Dose(unopened), that was not suitable for use post a temperature excursion with Thyphim (unopened), Ipol (Opened, unopened) and Tubersol(unopened)at -17C degrees for 63 hour and 45 minutes due to unknown cause with no ae; Initial information regarding this unsolicited valid non-serious case was received from a other health care professional and transmitted to Sanofi on 14-Oct-2020.  This case involved a 79 year old female patient who was administered with a 0.7 mL dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (unopened) (lot UJ450AA) via unknown route in the left deltoid for prophylactic vaccination, on 09-Oct-2020, that was not suitable for use post a temperature excursion with IPV (VERO) [IPOL] (opened, unopened), TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM] (unopened) and INFLUENZA and TUBERCULIN TEST [TUBERSOL] (unopened) at -17 degrees Celsius for 63 hour and 45 minutes due to unknown cause.  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.    It was an actual medication error case due to product storage error temperature too low.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: FLU4, HIBV, IPV, TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: Lowest temperature was -17C degrees. Total excursion time was for 63 hour and 45 minutes with no AE; Initial information regarding this unsolicited valid non-serious case via The Agency (reference number: 00316318)was received from a nurse and transmitted to Sanofi 14-Oct-2020.  This case involves a 66 years old female patient who received a 0.7 ml dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]  (lot: UJ450AA, expiry date: 30-Jun-2021), via unknown route in the left deloid, on 06-Oct-2020 for prophylactic vaccination. Along with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], also IPV (VERO) [IPOL], TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM], HIB (PRP/T) VACCINE [ACT-HIB] and TUBERCULIN TEST [TUBERSOL] (unknown lot numberand expiration number) reached lowest temperature of -17 C degrees. Total excursion time was for 63 hour and 45 minutes (product storage error).  The patient's medical history, medical treatments, vaccinations, family history and concomitant medication were not provided.  It was an actual medication error due to the Product storage error temperature too low (latency same day for INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE).   At the time of reporting, the 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: 67.0
Sex: F
Vaccine: FLU4, HIBV, IPV, TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: Lowest temperature was -17C degrees.  Total excursion time was for 63 hour and  45 minutes with no AE; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA288477, 2020SA288422 and 2020SA290005.  This case involves a 67 years old female patient who received a 0.7 ml dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]  (lot: UJ450AA, expiry date: 30-Jun-2021), via unknown route in the left deloid, on 05-Oct-2020. Along with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], also IPV (VERO) [IPOL], TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM], HIB (PRP/T) VACCINE [ACT-HIB] and TUBERCULIN TEST [TUBERSOL] reached lowest temperature of -17 C degrees. Total excursion time was for 63 hour and 45 minutes (product storage error).  The patient's medical history, medical treatments, vaccinations, family history and concomitant medication were not provided.  It was an actual medication error due to the Product storage error temperature too low.   At the time of reporting, the 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: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: given a second dose of Adacel with no adverse event; pregnant female was "unexpectedly, in error" given a second dose of Adacel; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case from the other health professional.  This case involves a 30 year old female patient who was pregnant and was unexpectedly, in error, given a second dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (extra dose administered and Vaccine exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. It was reported that the patient was exposed to the vaccine at 29 weeks of pregnancy and had given a second dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE on 34 weeks of pregnancy.  The date of the last menstrual period was reported as 15-Feb-2020.  The estimated due date is 21-Nov-2020.  Medical history, medical treatments, vaccinations and family history were not provided. It was a potential medication error due to an extra dose being administered. Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for immunisation.  On 31-Aug-2020, the patient received 1 dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number U6676AA expiration date 16-May-2022) via intramuscular route in the right deltoid muscle for immunization during the 29 weeks of pregnancy (vaccine exposure during pregnancy).   On 13-Oct-2020, 1 month 15 days after the first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE unexpectedly, in error, the patient was given the second dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and asked if there were any possible side effects or concerns that they should look out for.   The healthcare professional stated that the 30 year old pregnant female patient was given a second DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE dose on 13-Oct-2020. The patient's first dose of vaccine was given on 31-Aug-2020. The physician, did not realize that the patient had already received the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and wrote a prescription for patient to receive vaccination on 13-Oct-2020.   It was discovered after DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE that this was actually the second DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as not applicable for both the events.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Swelling
Clinical narrative: she developed a red rash and swelling there; she developed a red rash and swelling there; she developed a red rash and swelling there; she developed a red rash and swelling there; Initial information regarding this unsolicited non-valid non-serious case via The Agency (reference number: 00317925) was received from other health care professional on behalf of a consumer and transmitted to Sanofi 15-Oct-2020.  This case involved a 79 years old female patient who developed a red rash and swelling there (vaccination site inflammation associated with vaccination site rash, vaccination site erythema and vaccination site swelling), where she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included hydroxyzine hydrochloride and medrol.  On 12-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ510AA, expiry date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious (vaccination site inflammation associated with vaccination site rash, vaccination site erythema and vaccination site swelling), unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was she developed a red rash and swelling there.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given regular Fluzone QIV vaccine instead of the Fluzone High Dose with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via agency (Reference number- 00318089) and transmitted to Sanofi on 15-Oct-2020  This case involves a 76 year old female patient who was vaccinated with a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (batch number UJ477AA and expiration date 30-Jun-2021) via an intramuscular route in the left arm instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in error on 15-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other vaccine concomitantly.  This was an actual medication error case due to wrong vaccine administered (latency: same day). Nurse Practitioner reporting a medication error described a consumer in error got the Fluzone Quadrivalent Standard dose and not the prescribed Fluzone Quadrivalent Standard High Dose. The patient was concerned she did not get the high dose. The nurse wanted to know if there were any exceptions about revaccination.  At the time of reporting, no adverse reported for the patient.  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: Extra dose administered, No adverse event
Clinical narrative: Patient was inadvertently administered the Fluzone High-Dose vaccine twice with no AE; Initial information regarding an unsolicited valid Non-serious case was received from a other health professional via Medical Information (Reference number-00319148) and transmitted to Sanofi on 16-Oct-2020.  It was reported that a 73-year old male patient inadvertently administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT twice (extra dose administered), first received on 16-Sep-2020 (lot number: unknown, expiry date: unknown, Route and injection site was unknown) and second dose received on 06-Oct-2020 (lot number: unknown, expiry date: unknown, Route: unknown and injection site was left deltoid).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to an inadvertently administered product twice (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 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: DTAPIPVHIB
Symptoms: Incorrect dose administered, Incorrect route of product administration
Clinical narrative: reporting on behalf of a 6-month old male that received a medication error with Pentacel described as only receiving the DTap-IPV portion and not the Hib portion of the vaccine; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Agency (Reference number- 00319832) and transmitted to Sanofi on 16-Oct-2020.  This case involves a 6-months-old male patient who was vaccinated with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] (suspension for injection), (batch number: UJ207ABA/ UJ207AB and expiry date: 30-Apr-2021) (on the left thigh via intramuscular route the vaccine was administered) (incorrect route of product administration) on 16-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication of the patient included hepatitis B vaccine, influenza vaccine, pneumococcal vaccine conj (Pneumococcal conjugate vaccine) and rotavirus vaccine.  It was an actual medication error case due to Incomplete dose administered (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2-months old patient was given the Fluzone Quadrivalent,no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (patient's mother) via The Agency (Reference number- 00319850) and transmitted to Sanofi on 16-Oct-2020.  This case involves a 2 month old female patient was given 0.5ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ533AB and expiry date: 30-Jun-2021) once (strength = standard) via unknown route in unknown administration site for prophylactic vaccination on 16-Oct-2020 (product administered to patient of inappropriate age).  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no other vaccines.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: received a FLUZONE HIGH-DOSE QUADRIVALENT on 13 Oct 2020 and also received another FLUZONE HIGH-DOSE QUADRIVALENT on 19 Oct 2020 on accident with no adverse event; The patient was scheduled to receive a pneumonia vaccine on 19-Oct-2020 but was accidentally administered a flu vaccine instead with no adverse event; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from an other health professional (office manager) via call center .  This case involves a 66 year old female patient who received a fluzone high-dose quadrivalent on 13-Oct-2020 and also received another influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] on 19-Oct-2020 on accident (extra dose administered) and was scheduled to receive a pneumonia vaccine on 19-Oct-2020 but was accidentally administered a flu vaccine instead (wrong product administered).  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2020, the patient received on influenza quadrival a-b high dose hv vaccine (formulation, strength, batch number, expiration date, dose, frequency, route of administration was unknown) for prophylactic vaccination.  On 19-Oct-2020, 6 days after starting the suspect vaccine therapy patient received an influenza quadrival a-b high dose hv vaccine on 13-Oct-2020 and received another influenza quadrival a-b high dose hv vaccine on 19-Oct-2020 on accident (extra dose administered). The patient was scheduled to receive a pneumonia vaccine on 19-Oct-2020 but was accidentally administered a flu vaccine instead (wrong product administered). Patient had not reported any side effects at this time.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not applicable.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding batch number in this case.  No further relevant information was reported.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was administered Fluzone High Dose on 09SEP2020 and 17OCT2020 with No AE; Initial information regarding an unsolicited valid Non-serious case was received from a pharmacist via Agency (Reference number-00322320) and transmitted on 19-Oct-2020.  It was reported that a 81-year old female patient was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT twice (extra dose administration), the first dose received on 09-Sep-2020 (lot number: UJ546AA, expiry date: 30-Jun-2021, Route: Intramscular at an unknown administration site) and 17-Oct-2020 (lot number: unknown, expiry date: unknown, Route: intramuscular in the left arm). It was reported that the patient did not know they received 2 doses.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to extra dose administration (latency same day).  At the time of reporting, no adverse event was reported.  Disclaimer: 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: 61.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired vaccine with no adverse event; Initial information regarding an unsolicited valid serious case was received from other health professional via Agency (Reference number- 00322432) and transmitted to Sanofi on 19-Oct-2020.  This case involves an 61-year-old male patient who was vaccinated with 0.5 ml dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] on 19-Oct-2020 (lot U5854AA, expired on 25-Jan-2020 ) via intramuscular route in the right deltoid for prophylactic vaccination (expired vaccine used).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired product administered (unknown latency).  At the time of report, patient had not experienced any adverse events.  Disclaimer: 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.  No further relevant information was reported.
Age: 80.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Body temperature increased, Chills, Influenza virus test negative, Laboratory test abnormal, Nausea
Clinical narrative: Woke up on Tuesday Morning after shot on 11.21.20. Woke up on 11.24.20, was nauseous. Husband took temp and it was 100.6 temp. Was having violent chills. Husband called the ambulance and went to ER. ER stated that pneumonia was present. Was admitted to hospital. Tests for flu and Covid test was done and negative results.
Age: 80.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pneumonia, SARS-CoV-2 test negative
Clinical narrative: Woke up on Tuesday Morning after shot on 11.21.20. Woke up on 11.24.20, was nauseous. Husband took temp and it was 100.6 temp. Was having violent chills. Husband called the ambulance and went to ER. ER stated that pneumonia was present. Was admitted to hospital. Tests for flu and Covid test was done and negative results.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Increased fussiness and fever - had rectal temp of 101.8
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received Pentacel on 02-Oct-2020 and 19-Oct-2020 with no adverse event; Pentacel administered 2 weeks before reaching age requirement with no adverse event; Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient with unknown demographic received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number and expiration date unknown) via unknown route in unknown administration site on 02-Oct-2020 and 19-Oct-2020 (Inappropriate schedule of product administration) for prophylactic vaccination and reported Pentacel administered 2 weeks before reaching age requirement (Product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (Latency: Same day) and Inappropriate schedule of vaccine administered (Latency: 17 days from first dose).  At the time of reporting no adverse event was reported.  Reporter wanted know that if their any possibility to find any adverse event.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 59.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I experienced fever like symptoms and body aches which lasted approximately 12 hours  Shingles vaccine was given at the same time as the influenza vaccine
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Pentacel was given to a patient with no adverse event; Initial information was received regarding this unsolicited valid non-serious case from other health professional via Medical Information (Reference number- 00323656) and transmitted to Sanofi on 20-Oct-2020.  This case involved a 10 weeks old female patient who received an expired 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number UI992AA and expiration date 30-Sep-2020) (Expired product administered) via intramuscular route in the right thigh on 19-Oct-2020 for prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant vaccine included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was a case of actual medication error as patient received an expired vaccine (Latency: Same day)  No relevant laboratory data was reported.  Disclaimer: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.  No further relevant information was reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Tremor
Clinical narrative: I woke up because I started shaking violently. I calmed down but every time I moved I started shaking again. This lasted for about a half hour. I also had a headache which lasted until later that day even though I took Tylenol. The first Shingrix shot resulted in a fever and chills and feeling awful for 3 days. While this time the shaking was very bad and my head felt like it wanted to explode, the recovery from the effects was quicker. I felt fine after one day of resting.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient had been given an expired Tenivac vaccination with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Agency (Reference number- 00323975) and transmitted to Sanofi on 20-Oct-2020.  This case involves a 31 year old male patient who received an 0.5 ml expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U6021AA, expiry date: 22-Jul-2020) via Intramuscular route in the right deltoid site on 20-Oct-2020  for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to the expired vaccine used (same day).  At the time of report, no adverse event was reported.  Disclaimer: 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.  No further relevant information was reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia, Sleep disorder
Clinical narrative: Fever, chills, body aches, inability to sleep, teeth hurt, severe headache
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Toothache
Clinical narrative: Fever, chills, body aches, inability to sleep, teeth hurt, severe headache
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported swelling around the left arm near the injection site and was first noticed the morning after the injection.  Was slightly painful to the touch and warm.  Patient advised to treat with ibuprofen and cold compress and if worsened to seek medical attention.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 70 year old male received two doses of the Fluzone Quadrivalent High Dose in the same flu season with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Information (Reference number- 00324036) and transmitted to Sanofi on 20-Oct-2020.  This case involves a 70 years old male patient who received two doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in the same flu season on 13-Oct-2020 [batch number, expiration date not reported] via an unknown route and site and on 20-Oct-2020 [batch number-UJ510AA and expiration date 30-Jun-2021, 0.7 ml, frequency- twice] via an intramuscular route at left deltoid for prophylactic vaccination(extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), family history were not provided.  Concomitant medication includes Shingles vaccine (VARICELLA ZOSTER VACCINE).  It was a case of an actual medication error due to extra dose administered (latency 7 days from 1st dose and on same day of 2nd dose).  At the time of report, no adverse event was reported.  The nurse reported that their clinic has a database that was checked to see if a flu vaccine had been given and the database showed no flu vaccine given this season, however the patient  realized he got another flu vaccine when he was reviewing his paper work. The original injection on 13-Oct-2020 took place at a local pharmacy. Nurse wanted information on any reactions regarding this occurrence which could be conveyed to patient.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case for first dose.
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal
Clinical narrative: got Fluzone yesterday and felt bad; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves female patient of unknown age who got INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] yesterday and felt bad (feeling abnormal).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number not reported and expiration date unknown] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient felt bad (feeling abnormal) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was feeling abnormal.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was  reported as Unknown.  There will be no information available on the batch number for this case.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was administered Adacel and was supposed to be administered with Pentacel with no AE; 5 years patient was administered Adacel and was supposed to be administered with Pentacel with no AE; Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who administered 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6706AA, expiry date: 09-Jul-2022) via un unknown route on left deltoid on an 12-Oct-2020 for prophylactic vaccination and was supposed to be administered with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration (latency same day).  At the time of report no adverse event was reported.  Disclaimer: 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.  No further relevant information was reported.
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: the plastic syringe broke and the vaccine leaked out; upon pushing syringe plunger down to administer vaccine, the entire contents sprayed out onto the floor of the exam room out of the syringe; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves female patient for whom it was reported as needle was advanced into muscle and upon pushing syringe plunger down to administer vaccine, the entire contents sprayed out onto the floor of the exam room out of the syringe (Product leakage) and the plastic syringe broke and the vaccine leaked out (syringe issue), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, it was reported that as needle of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (dosing details unknown) was advanced into muscle and upon pushing syringe plunger down to administer vaccine, the entire contents sprayed out onto the floor of the exam room out of the syringe (Product leakage) and the plastic syringe broke and the vaccine leaked out (syringe issue),  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Not Applicable for both events.
Sex: M
Vaccine: TDAP
Symptoms: Incorrect dose administered by device, No adverse event, Syringe issue
Clinical narrative: plunger stopped at a certain point and would not push all 5ml with no AE; plunger stopped at a certain point and would not push all 5ml with no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 27 years old male patient who received partial dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6321AA, expiry date: 07-Jun-2021) via unknown route and on an unknown date for prophylactic vaccination whose plunger stopped at a certain point and would not push all 5ml with (incorrect dose administered by device and device issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant medication was given to the patient.  It was an actual medication error due to device component issue and Partial dose delivery by device.  At the time of report, no adverse event was reported.  Disclaimer :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: 83.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: the shipment had been in transit to long with no AE; FLUZONE HIGH DOSE QUADRIVLAENT administered after the vaccine was in transit to long with no AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 83 years old female patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ546AA, expiry date: 30-Jun-2021) via intramuscular route in the left arm on an 19-Oct-2020 for prophylactic vaccination. It was also reported that shipment had been in transit to long (product storage error and product distribution issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant medication was given to the patient.  It was an actual medication error due incorrect product storage.  It was a case of product shipment delay.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The patient was administered the vaccine which was in transit to long/no AE; The vaccine was in transit to long/no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00325681) and transmitted to Sanofi on 21-Oct-2020..  This case involves a 71 year old male patient who was administered 0.7 ml INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ546AA, expiry date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination on 19-Oct-2020 (product storage error and product distribution issue)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Quadracel was given on accident to a 3 years old and not the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) that was ordered/ No AE; Quadracel was given on accident to a 3 years old/ No AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional (Medical assistant).  This case involves a three years old male patient who received 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5688AA, expiry date: 26-Nov-2021) via intramuscular route in the left thigh on 19-Oct-2020 for prophylactic vaccination instead of DIP HTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP] that was ordered (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and HEPATITIS A VACCINE (HEPATITIS A).  It was a case of an actual medication error due to the wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  Reporter can be contacted by Sanofi: Yes. Potential product technical complaint (PTC): No. Treatment: The clinic calling the manufacturer. Product was used. First time product used: Yes. Still using product: No.  At the time of report, no adverse event was reported.  Disclaimer: 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: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Quadracel was administered to a patient inadvertently, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via  Medical Information (Reference number- 00326236) and transmitted to Sanofi on 21-Oct-2020.  This case involves a 5 year old male patient who was administered a 0.5 ml first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5532AA, expiry date: 09-Oct-2020) via intramuscular route in the left thigh for prophylactic vaccination on 20-Oct-2020 (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.