chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: gave a 63 year old patient Fluarix, patient then came back and asked for another flu shot so they gave them FLUZONE QUADRIVALENT with no  AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves 63 year patient who received fluarix and then came back and asked for another flu shot so they gave them INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [batch number and expiration date not reported] via an unknown route and site for prophylactic vaccination on an unknown date (extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was a case of an actual medication error due to extra dose administered (latency unknown).  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 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.
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: prescribed to get a Tdap dose on this day but was in error given the Fluzone Quadrivalent with no AE; Consumer was prescribed to get a Tdap dose on this day but was in error given the Fluzone Quadrivalent and that this will make the second dose of flu vaccine in this flu season with no AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist  via Call Center.  This case involves a 63 year old female patient who was prescribed to get a TDAP dose on but was in error given the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UT7096KA expiration date 30-Jun-2021) and that this will make the second dose of flu vaccine in this flu season (wrong product administered and extra dose administered).  Medical history, medical treatments, concomitant medications and family history were not provided.  It was a potential medication error due to wrong product administered and extra dose administered.  The patient previously had Fluarix vaccination and asked for another flu shot so they gave her INFLUENZA QUADRIVAL A-B VACCINE, wanted to know if there are any adverse effects to doing so.   No relevant laboratory tests were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was inadvertently given an expired dose of Pentacel vaccine with no adverse event; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional via Agency (Reference number: 00328024).  This case involves an 14 months male patient who was vaccinated inadvertently with an expired 0.5 mL fourth dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] (lot number: UJ058ABA and expiration date 13-Oct-2020) via intramuscular route in the left thigh on 16-Oct-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), HEPATITIS A VACCINE and INFLUENZA VACCINE 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 reported.  Caller would like to know information regarding this incident and adverse reactions to look for.  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: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Loss of consciousness, Migraine, Nausea
Clinical narrative: went to the emergency room due to having a migraine; almost passed out; a massive bout of diarrhea; severe nausea; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 49-year-old female patient who experienced severe nausea (nausea), a massive bout of diarrhea (diarrhoea), almost passed out (loss of consciousness) and went to the emergency room due to having a migraine (migraine), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient gets the shot every ten years and has never reacted.  Medical history, medical treatment(s) and family history were not provided.  List concomitant: no other vaccines.  On 31-Aug-2020, the patient received dose of 0.5 ml suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5669AA, expiry date-09-Oct-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On 31-Aug-2020, the patient developed non-serious severe nausea (nausea) on the same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 02-Jul-2020, the patient developed non-serious a massive bout of diarrhea (diarrhoea) 2 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 03-Jul-2020, the patient developed a non-serious almost passed out (loss of consciousness) 3 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 07-Jul-2020, the patient developed non-serious went to the emergency room due to having a migraine (migraine) 7 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data were not reported.  Patient went to the emergency room due to having a migraine, corrective treatment was unknown for rest of the events.  Outcome was unknown for all the events at the time of reporting.
Age: 1.83
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Pentacel vaccine that was administered to a patient with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information (reference number: 00328227) was received from other health care professional and transmitted to Sanofi 22-Oct-2020.  This case involved 22 months old male patient who was administered with a 0.5 mL expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ021AA, expiry date: 21-Oct-2020) (expired product administered), via intramuscular route in the right thigh for prophylactic vaccination.  Relevant medical history, past medical treatment, vaccination details, concomitant medication and family history were not provided.  It was a case of an actual medication error as expired vaccine used (latency same day).  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements 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: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: he was given Fluzone quadrivalent subcutaneously with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via agency (Reference number- 00329501) and transmitted to Sanofi on 23-Oct-2020.  This case is linked to case 2020SA301398 (same reporter).  This case involves a 3 years old male patient who received 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number: UJ533AA and expiration date: 30-Jun-2021) via subcutaneous route at an unknown administration site for prophylactic vaccination on 20-Oct-2020.  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of an actual medication error due to Inappropriate route of vaccination.  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 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.  No further relevant information was reported.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: consumer is 24-weeks pregnant with no adverse event; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involved a 16 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE in context of consumer is 24-weeks pregnant with no adverse event (Maternal exposure before pregnancy). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Oct-2020, the patient received at a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number-U7012AA, Expiration date- 30-Jun-2021) via intramuscular route in the left arm while she was 24-weeks pregnant (Maternal exposure before pregnancy).  No adverse event was reported.  No laboratory test was reported.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: given Menactra on accident due to prescriber in error ordering the dose and the child not getting the Haemophilus Influenzae type B vaccine with no adverse event; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 02-month-old female patient who was given meningococcal a-c-y-w135 (d conj) vaccine [Menactra] on accident due to prescriber in error ordering the dose and the child not getting the haemophilus influenzae type b vaccine (product prescribing error) on 24-Aug-2020 (formulation and strebgth was unknown) (lot number: U6575AB and expiry date: 08-May-2021) via intramuscular route in the left thigh for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included Pedia RX, pneumococcal vaccine conj (PCV-13) and rotavirus vaccine (Rotavirus).  This was an actual medication error case due to product prescribing error (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 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.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient received a second dose of FLUZONE HD/ his first dose was administered one week ago and the patient received a second dose today; Initial information regarding an unsolicited valid non-serious case was received from a nurse via agency (Reference number- 00331139) and transmitted to Sanofi on 26-Oct-2020.  This case involves an 80-year-old male patient who was vaccinated with QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (suspension for injection), (batch number: UJ468AA and expiry date: 30-Jun-2021), (on right deltoid via intramuscular route the vaccine was administered) (Inappropriate schedule of product administration) on 26-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 was not reported.  It was an actual medication error case due to inappropriate schedule of vaccine administered (latency: same day). His first dose of the vaccine was administered one week ago and the patient received a second dose today.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received Adacel and they are over the age of 65 (with no adverse event); Initial information regarding an unsolicited valid non-serious case was received from a consumer/ non health care professional via Agency (Reference number- 00331149) and transmitted to Sanofi on 26-Oct-2020.  This case involves a female patient of more than 65 year old who was vaccinated with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] (suspension for injection), (batch number, expiry date not reported, it was not known on which arm the vaccine was administered) (Product administered to patient of inappropriate age) on an unspecified date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication of the patient was not reported.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Cough, Dizziness, Lethargy
Clinical narrative: dry cough; lethargy; dizziness; confusion; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from an other health professional (nurse).  This case involves a 70-year-old male patient who developed a dry cough (cough), lethargy (Lethargy), dizziness (dizziness) and confusion (confusional state), while received influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent].  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2020, the patient received influenza quadrival a-b high dose hv vaccine (formulation, strength (High-Dose) was unknown) (batch number: UJ511AA and expiration date: 30-Jun-2020) at vaccinated with 0.7 ml (once) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date in Oct-2020, same month after starting the suspect vaccine therapy patient has developed a dry cough, lethargy, dizziness and confusion.  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 events were unknown.  No further relevant information was reported.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Pain, Swelling
Clinical narrative: pain; localized reaction of redness; swelling of over the size of a golf ball; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involved a 67 years old female patient who experienced pain (vaccination site pain), localized reaction of redness (vaccination site erythema) and swelling of over the size of a golf ball (vaccination site swelling), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2020, the patient received a dose 0.7 ml once of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ483AB (expiration date-30-JUN-2021) via intramuscular route.  On 22-Oct-2020, on same day, after received a 0.7mL dose of Fluzone High Dose Quadrivalent and it immediately caused a localized reaction of redness (vaccination site erythema), swelling of over the size of a golf ball (vaccination site swelling), and pain (vaccination site pain).    The patient was held on observation, no breathing or any other issues were reported, so she was discharged the same day of the vaccine.    No lab data was reported.  Final diagnosis was swelling of over the size of a golf ball, localized reaction of redness and pain.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for all events.
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: stated she gave an expired Tenivac vaccine to a patient today with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a nurse on 27-Oct-2020.  This case involves an 87 years old male patient who received an expired dose of vaccine (expired product administered) DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6091AA, Exp date:12-Oct-2020 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Patient jolted during injection causing the needle to come out and half of the vaccine went into the patient and the other half went on the leg with no adverse event; Patient jolted during injection causing the needle to come out and half of the vaccine went into the patient and the other half went on the leg with no adverse event; Initial information was received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from a other health care professional via call center.  This case involved a 3 years old male patient for whom reported that patient jolted during injection causing the needle to come out and half of the vaccine went into the patient and the other half went on the leg (Incorrect dose administered and Exposure via skin contact), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2020, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number-UJ533AB, Expiration date- 30-Jun-2021) via intramuscular route in the right vastus lateralis for prophylactic vaccination.   On 24-Oct-2020, It was reported that patient jolted during injection causing the needle to come out and half of the vaccine went into the patient and the other half went on the leg (Incorrect dose administered and Exposure via skin contact).   No adverse event was reported.  No laboratory test 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 medication error out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: she wiggled and part of the vaccine squirted out instead of going into her with no adverse event; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from a physician via the Agency (Reference number- 00334083).  This case involves a 2-year-old female patient for whom it was reported wiggled and part of the vaccine squirted out instead of going into her with no adverse event (Incorrect dose administered), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2020, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number: UJ477AB, expiration date: 30-Jun2021) once via intramuscular route in the right thigh for Prophylactic vaccination.  On the same day, it was reported that the patient wiggled and part of the vaccine squirted out instead of going into her (incorrect dose administered) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  It was also reported that she moved her leg and the medication came out. No adverse event was reported.  Details of laboratory data not reported.  Final diagnoses was incorrect dose administered.  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: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Irritability postvaccinal, Ocular hyperaemia, Paraesthesia, Rash
Clinical narrative: experiencing: red spots over her body, a warm tingling feeling in both feet and these symptoms are driving me crazy; experiencing: red spots over her body, a warm tingling feeling in both feet and these symptoms are driving me crazy; eyes also look red; Initial information regarding an unsolicited valid non-serious case from was received from a consumer (patient) via Agency (Inquiry number: 00334215) and transmitted to Sanofi on 27-Oct-2020.  This case involved a 82 yearsold female patient who was experiencing: red spots over her body (rash macular), a warm tingling feeling in both feet (paraesthesia) and these symptoms were driving the patient crazy and eyes also look red (ocular hyperaemia), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medications and family history, were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in the left arm  for prophylactic vaccination.  On an unknown date, the patient developed non-serious red spots over her body (rash macular), a warm tingling feeling in both feet (paraesthesia) and these symptoms were driving the patient crazy and eyes also look red (ocular hyperaemia), unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Mentioned that the patient's symptoms started a couple of days after the injection and she went to the hospital where they gave her a lot of medication and they believe along with her doctor that this was a result of the flu shot. Stated her symptoms were no better and did not get any other vaccines that visit.  Final diagnosis was eyes also look red, experiencing: red spots over her body, a warm tingling feeling in both feet and these symptoms are driving me crazy.  No relevant laboratory tests were reported.  The patient was treated with Methylprednisolone 4 mg.  The event outcome was reported as unknown for all the events, at the time of reporting.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: that ADACEL was given to a 6 year old patient with no adverse event; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received (reference number: US-SANOFI-00335397) via other health professional.  This case involves a 6-year-old patient for whom vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was given.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the 6-year-old patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Product administered to patient of inappropriate age) (lot number: not known) via an unknown route for prophylactic vaccination.  Final diagnosis was Not Applicable that adacel was given to a 6 year old patient with no adverse event.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was not applicable for the event at the time of reporting.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Flublok vaccine was held in transition for to long. They did not received the email until the end of the day and 2 doses had already been with no adverse event; 2 doses had already been administered with no adverse event; Flublok vaccine was held in transition for to long. They did not received the email until the end of the day and 2 doses had already been with no adverse event; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case involves a 33 year old female patient for whom it was reported that INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] was held in transition for too long and they did not received the email until the end of the day and 2 doses was administered of 0.5 mL (Extra dose administered, Product storage error and Product distribution issue) (lot number UJ509AA expiration date 05-Oct-2021) via intramuscular route in the left deltoid indication: prophylactic vaccination.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was a potential medication error due to incorrect product storage and Extra dose administered.  At the time of this 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: expired dose; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional via call center.  This case involves of unknown demographics patient who had expired dose of pentacel (Expired product administered), while he/she received vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel) via unknown route (batch number : UJ059AA and expiry date :04-Oct-2020) for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event Expired vaccine used (latency: unknown).  At the time of reporting, no adverse event was reported.  No 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.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Caller states Daptacel was given instead of Adacel; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 11 year old male patient who was administered diphtheria-15/tetanus/5 ac pertussis vaccine (Daptacel)  instead of diphtheria, tetanus, and acellular pertussis (Adacel) (wrong product administered) on 26-Oct-2020, (lot: C5621AA, expiry date unknown) at a dose of 0.5 ml (dose series:5) via via intramuscular route in left deltoid for prophylactic vaccination.  Concomitant medications included meningococcal vaccine a/c/y/w conj (DIP TOX) (Menactra); and Hpv Vaccine.  This was an actual medication error case due to the wrong product administered (latency: same day).  At the time of reporting, no adverse event was reported.  No 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.
Sex: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event, Underdose
Clinical narrative: vaccine spill from the injection site of the thigh after the injection,with no adverse event; vaccine spill from the injection site of the thigh after the injection,with no adverse event; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional. Agency Inquiry Number: 00336435).  This case involves a 7-year-old male patient for whom vaccine spill from the injection site of the thigh after the injection, with no adverse event (Underdose and Exposure via skin contact) was reported, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.  On 19-Oct-2020 , patient received a 0.5 mL of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ430AB) via unknown route in the thigh NOS for prophylactic vaccination.  19-Oct-2020, on same day  it was reported that vaccine spill from the injection site of the thigh after the injection, with no adverse event (Underdose and Exposure via skin contact). Nurse reported that the mother is requesting repeat dose and that the vaccine dripped down the injection site of the thigh.  Details of laboratory data not reported.  Final diagnosis was vaccine spill from the injection site of the thigh after the injection, with no adverse event.   It was not reported if the patient received a corrective treatment.  The outcome was not applicable for both the events.
Age: 8.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: an 8 year-old patient  received FLUBLOK QUADRIVALENT with no adverse event; Initial information regarding this unsolicited valid non-serious case via agency (reference number: 00337219) was received from other health care professional and transmitted to Sanofi 29-Oct-2020.  This case involved a 8 years old patient of unknown demoghraphics who was vaccinated  with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2010; expiry date: 30-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report, patient had not experienced any adverse 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.; Sender's Comments:  US-SA-2020SA306627:8 years old patient US-SA-2020SA306627:8 years old patient
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: child was supposed to receive Daptacel and Acthib but received Daptacel and Pentacel instead with no AE; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4 months old male patient who was supposed to receive daptacel and acthib but received daptacel and pentacel instead (wrong product administered), while he received vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria, tetanus, ac pertussis, ipv and hib vaccine (Pentacel) for prophylactic vaccination.  On 29-Oct-2020, the patient received suspect diphtheria-15/tetanus/5 ac pertussis vaccine at a dose of 0.5 ML once daily via intramascular route and in the anatomical location thigh (lot number: C5624AA and expiration date: 06-Jun-2021) for prophylactic vaccination  On an unknown date, (latency unknown) it was reported that the child was supposed to receive daptacel and acthib but received daptacel and pentacel instead (wrong product administered). Nurse would like to know if there are any side effects that they should be aware of for this vaccination There were no adverse reactions to report at the time of the call. No further information was provided.  No laboratory tests were reported.  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.
Sex: M
Vaccine: DTAP
Symptoms: Product preparation issue, Underdose
Clinical narrative: A nurse wanting to know can a dose of Daptacel be counted as valid after it was reconstituted with and diluted with sterile water and administered to an 8-month-old child; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from healthcare professional (nurse).  This case involves an 8-month-old male patient for whom nurse wanted to know could a dose of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] be counted as valid after it was reconstituted with and diluted with sterile water and administered to an 8-month-old child (unevaluable event).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were none.  On 23-Sep-2020, the patient received a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (lot number: C5643CA and expiration date: 16-July-2021) 0.5 ml once via intramuscular route in the left thigh for prophylactic vaccination.  On 23-Sep-2020, on the same day nurse wanted to know a dose of diphtheria-15/tetanus/5 ac pertussis vaccine be counted as valid after it was reconstituted with and diluted with sterile water and administered to an 8-month-old child (unevaluable event).  No laboratory data was not reported. It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was not resolved.
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Pain in extremity
Clinical narrative: pain in her arm was severe; Patient states that she has a 3 inch by 2 inch black mark where the shot was given and it started black and blue but now it just went black; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a 67 years old female patient who experienced pain in her arm was severe (Injection site pain) and patient states that she has a 3 inch by 2 inch black mark where the shot was given and it started black and blue but now it just went black (Injection site reaction), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient the suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number- UJ482AB) (other dosing details were unknown) for Prophylactic vaccination.  On an unknown date (unknown latency) after the first dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, the patient experienced pain in her arm was severe (Injection site pain) and patient states that she has a 3 inch by 2 inch black mark where the shot was given and it started black and blue but now it just went black (Injection site reaction).  No laboratory test was reported.  It was unknown if the patient received any corrective treatment.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: was inadvertently administered a dose of Tenivac lot#U6091AA lot#12Oct2020 today with no AE; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient of unknown age who was inadvertently administered a dose of Tenivac lot#U6091AA lot#12Oct2020 (Expired product administered) while she received vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] at a dose of 0.5 ml daily (batch number: :U6091AA and expiration date: 12-Oct-2020) via intramuscular route in unknown administration site for prophylactic vaccination.   Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   This was an actual medication error case due to the event incorrect product storage (latency: unknown).   At the time of reporting, no adverse event was reported.   No 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
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used with no adverse event; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from the other health professional (Agency inbound US-SANOFI-00338223).  This case involves Adult male patient who had received expired HIB (PRP/T) VACCINE [ACT-HIB] Powder and solvent for solution for injection at a dose of 0.5 ml (lot number UI974AAA) via intramuscular route in the right thigh.  Medical history, medical treatments, concomitant medications and family history were not provided. It was a potential medication error due to Expired product administered.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA), MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) and INFLUENZA VACCINE (FLU) for Immunisation.  at the time of this report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently given to a patient that was only 62 years with no adverse event; Initial information received on 30-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a patient for whom reported inadvertently given vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] that was only 62 years old (product administered to patient of inappropriate age). No adverse event was reported.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 28-Oct-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ537AB, Expiration date: 30-Jun-2021) via intramuscular route for prophylactic vaccination, inadvertently given to a patient that was only 62 years old (product administered to patient of inappropriate age)  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements 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 other relevant information was reported.