chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 day expired Pentacel was administered to a patient with No adverse event; Initial information regarding an unsolicited valid non-serious case received on 30-Oct-2020 from a non-healthcare professional (patient's relative) via call center.  This case involves a 7 months old female patient who received Vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel] and 1 doses of 0.5 ml, 2 day expired Pentacel was administered to a patient (Expired product administered) (batch number: U6218AA UJ016AA and expiration date: 26-Oct-2020) via unknown route in the left thigh for prophylactic vaccination on 29-Oct-2020.  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: 70.0
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: arms are sore; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case is linked to case 2020SA320485 (same reporter).  This case involves a 70 years old patient of unknown gender, who experienced arms are sore (pain in extremity), while he/she received vaccine influenza quadrival a-b vaccine (Fluzone qiv).  The patient's medical history, past medical treatment(s), vaccination(s), concurrent condition and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine (formulation: unknown) Lot: LUT7007NA , Expiry: 30-Jun-2021 via unknown route at an unknown administration site for prophylactic vaccination.  On an unkowwn date, (latency unknown) after the initiation of suspect drug the patient's arms are sore (Pain in extremity), and she was asking for recommendations with that. The pharmacist was referred to the prescribing information, and to the physician for recommendations.  No lab data was reported. It was not reported if the patient received a corrective treatment. At the time of report, outcome was unknown for pain in arm.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: FLUZONE QUAD was given in the tricep area instead of deltoid area with no AE; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown demographic patient whom fluzone quad was given in the tricep area instead of deltoid area (product administered at inappropriate site), while the patient received vaccine influenza quadrival a-b vaccine [Fluzone quadrivalent].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patient started to receive influenza quadrival a-b vaccine (with an unknown formulation, strength, dose, frequency, route, lot number and expiration date) for prophylactic vaccination.  On an unknown date, (latency unknown) after the initiation of suspect drug therapy, the patients fluzone quad was given in the tricep area instead of deltoid area (product administered at inappropriate site).  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: U
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: FLUZONE QUAD was given in the tricep area instead of deltoid area and wants to know if the vaccine will still be effective or if they need to readminister; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case received from a healthcare professional via call center.  This case involves a patient of an unknown age who received quadrivalent influenza vaccine (Fluzone Quadrivalent), 450 - FLZ QIV NP in the tricep area instead of deltoid area (incorrect route of product administration) (batch number: unknown and expiration date: unknown) at an unknown dose and frequency via unknown route and 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 route of product administration (latency: unknown).  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 regarding batch number in this case.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity
Clinical narrative: her arm is still hurting; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Information (reference number: 00341583) and transmitted to Sanofi on 02-Nov-2020.  This case involved a 59-year-old female patient for whom it was reported the arm is still hurting (Pain in extremity), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included NA (sodium).  On 18-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2048, exoiration date 30-Jun-2021) via unknown route in the left arm for prophylactic vaccination.  On 18-Oct-2020, it was reported the arm is still hurting (Pain in extremity), on the same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No relevant laboratory test was reported.   The patient was treated with paracetamol (tylenol) for pain in extremity.  The patient outcome was reported as unknown.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patients who are under age 18 and received Flublok; Initial information regarding an unsolicited valid non-serious case received from a other health professional and transmitted to Sanofi on 02-Nov-2020.  This case is linked to cases 2020SA309245, 2020SA309246 and 2020SA309247.  This case involves a 16 years old female patient patients who are under age 18 and received flublok, (Product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2020, the patient received a dose 0.5 ml once of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2032 (30-JUN-2021).  The patient who are under age 18 and received flublok (Product administered to patient of inappropriate age).  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Not Applicable.  Sanofi company comment dated 18-Sep-2020: Based on the information provided by the reporter the causal role of company suspect drugs cannot be excluded for the serious unlisted event, considering the plausible temporal relationship. However more information about the medical history and concomitant medications of the patient are required for the proper assessment of the case.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired ADACEL vaccine with no adverse event; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involved a 38 year old male patient who administered an expired Adacel vaccine with no adverse event (Expired product administered), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On 30-Oct-2020, the patient received an expired a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Expired product administered) lot C5519BA.   No relevant laboratory data was provided.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Not Applicable.  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 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: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: second influenza vaccine was given after patient received one 3 or 4 weeks prior to 31-Oct-2020, with no adverse event; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case from an other healthcare professional.  This case involves an adult patient of unknown age for whom it was reported second influenza vaccine was given after patient received one 3 or 4 weeks prior to 31-oct-2020 (vaccination error), while the patient started therapy with vaccine influenza quadrival a-b multidose vaccine preserved [Fluzone Quadrivalent Multidose] at an unknown dose, once via unknown route (Batch number and expiration date were unknown) for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), concurrent conditions and family history were not provided. Concomitant medication was not reported.   Final diagnosis was a second influenza vaccine was given after patient received one 3 or 4 weeks prior to 31-oct-2020.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as not applicable.  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 the batch number.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: was given expired Pentacel, with no adverse event; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 3 months old female patient who was given expired pentacel (expired product administered), while she received vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] (batch number: UJ019AAA and expiration date: 09-Oct-2020) via unknown 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 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.
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Adacel that was given to an 11 year old instead of Daptacel with no AE; Initial information received on 03-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] (lot number: not reported, expiry date: unknown) via unknown route and site on an unknown date for prophylactic vaccination (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 the Wrong vaccine administered (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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: experienced hives; Initial information received on 03-Nov-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 8 years old patient of unknown gender who experienced hives (urticaria), while being treated with vaccine influenza quadrival a-b vaccine [Fluzone Quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date (unknown latency), after starting the suspect vaccine therapy, the patient experienced hives (urticaria).  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 unknown.
Age: 65.0
Sex: M
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: received a Tenivac injection by mistake when a shingles vaccine was intended with no adverse event; Initial information received on 03-Nov-2020 regarding an unsolicited valid non-serious case from  a nurse.  This case involves a 65-year-old male patient who received a diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] injection by mistake when a shingles vaccine was intended (wrong product administered) on 29-Oct-2020 (lot: U6669AA; expiry date 15-May-2022) at a dose of 0.5 ml once via intramuscular route to the right arm  for prophylactic vaccination.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included influenza vaccine (Flu vaccine).  This was an actual medication error case due to the event wrong vaccine 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: TDAP
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: 12 yr old got Menactra and Adacel and both these vaccines were not given in deltoid, with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a consumer (Patients grandmother) via Agency on 03-Nov-2020.  This case involved a 12 year old male patient for whom it was reported that, 12 year old got menactra and adacel and both these vaccines were not given in deltoid (Product administered at inappropriate site), with no adverse event, while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination (Product administered at inappropriate site).  Final diagnosis was Not Applicable 12 year old got Menactra and Adacel and both these vaccines were not given in deltoid, with no adverse event.   Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  There will be no information available on the batch number for this case.  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.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inadvertently pulled up 11 doses from, with no AE; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 8 years old male patient who inadvertently pulled up 11 doses from of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On 04-Nov-2020, the patient 11 doses of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ506AA) via intramuscular route in the left deltoid for prophylactic vaccination.  This was potential medication error case due to extra dose administered.  The patient did not present any adverse event.   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 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
Symptoms: Wrong product administered
Clinical narrative: patient who meets age requirement for FLUZONE HIGH DOSE QUADRIVALENT was given the FLUZONE QUADRIVALENT with no reported adverse event; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a physician via call center.  This case involves a 76-year-old female patient who met age requirement for fluzone high dose quadrivalent was given the influenza quadrival A-B vaccine (Fluzone Quadrivalent), 450 - FLZ QIV NP (wrong product administered) (batch number: UJ506AB and expiration date: 30-Jun-2021) at an unknown dose and frequency via unknown route and 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 wrong product administered (latency: unknown).  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: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: patient was administered ADACEL on 1 Oct 2020 and again  on 3 Nov 2020/ no AE.; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Agency and transmitted to Sanofi on 05-Nov-2020.  This case involves a 76 year old male patient who was administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 01-Oct-2020 via unknown route in an unknown site (lot number unknown) and again in error on 03-Nov-2020 at a dose of 0.5 ml (lot number C5655AA expiration date: 15-Aug-2021, strength- standard) via intramuscular route in the right deltoid (vaccine presentation unknown) (extra dose administered).  Medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications was reported as none.  It was a actual medication error due to extra dose administered.  The reporter wanted information on any adverse reactions that they need to be aware of  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. There will be no information on the lot number for this case.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently given Adacel for his fourth DTaP dose in the left thigh on 30Oct2020 (with no Adverse event); Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 months old male patient who was inadvertently given DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] for his fourth DTaP dose in the left thigh on 30Oct2020 with no Adverse event (Wrong vaccine administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  On 30-Oct-2020, it was reported that a 15 month old patient was inadvertently given Adacel [lot no. C5JL7; expiry date 28-Nov-2021] for his fourth DTaP dose in the left thigh via an unknown route for immunization (Wrong vaccine administered).  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: M
Vaccine: FLU4
Symptoms: No adverse event, Product packaging confusion, Wrong product administered
Clinical narrative: given quadrivalent Fluzone Standard Dose by mistake; Initial information was received on 06-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) (email received in inbox).  This case involves a 77 years old male patient who was given quadrivalent fluzone standard dose by mistake (wrong product administered), while he received vaccine influenza quadrival a-b vaccine [Fluzone quadrivalent].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patient received influenza quadrival a-b vaccine (with an unknown formulation, strength, dose, frequency, route, lot number and expiration date) for prophylactic vaccination.  Patient was prescribed with quadrivalent Fluzone High Dose flu vaccine for elderly, but was given quadrivalent Fluzone Standard Dose by mistake. Obviously when dealing with drug stores to administer vaccines, you need to better distinguish the different vaccines on the carton/syringe. A druggist was not a doctor or nurse, but rather a clerk dealing with a long line of anxious customers. Note, except for the third word in the four-word name of the vaccines, all the other words are exactly the same. Perhaps, if you put on the cartons "for elderly use" and "for under 65 use"; note one has the word "elderly' and the other has a number "65" then even a clerk can distinguish them.  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.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza virus test positive, Lethargy, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: fever; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 25-month-old male patient who had fever (pyrexia), while he received vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s) were not provided whereas family history included the father could not get vaccinated as he got Guillen Barre. And the mother was pregnant. The father was really at risk here and he would have to leave and had already been exposed to child for a week.  Concomitant medications were none.  On 30-Oct-2020, the patient received a dose of suspect influenza quadrival A-B vaccine (prefilled syringe) (lot number: unknown and expiration date: unknown) at 0.5 ml once via intramuscular route in the right thigh for prophylactic vaccination.  On 30-Oct-2020, within 24 hours on the same day of starting the suspect vaccine therapy, patient had a fever of 103 fahrenheit (pyrexia).   since then he had been fine and again on 06-Nov-2020 (this morning) he spiked a fever of 103. the pediatrician did a fast-rapid flu test and it came back positive. the child he otherwise not sick or lethargic much, only a little were he wants to sleep.The patient was tested for COVID and came back negative.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: child was 7 and a half and they sent the child to get the TD but they gave him an ADACEL instead; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 7-year-old male for whom it was reported that child was 7 and a half and they sent the child to get the TD but they gave him an ADACEL instead (DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE) (lot U6807BB, expiry date 10-Sep-2022), (PT: Wrong product administered)  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the wrong product administered. It was reported that the a child who just came from country to clinic to get the TD (Tdap vaccine) but was given Adacel instead. Nurse stated the child was 7 and a half years old  almost. Given dose intramuscularly in the right deltoid. Lot number was U6807BB exp: 10-Sep-2022. It was reported that they do have an 8 year old that the school needed the injection but do not want to send that child if they are going to give Adacel which was not recommended at this age.  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: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Lowest temperature reached 34 degrees Fahrenheit/ Stated last temperature taken was 2:14, with no adverse event; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional. This case involves a patient of unknown demographics who reported the suspect drug lowest temperature reached 34 degrees fahrenheit/ stated last temperature taken was 2:14 (product storage error), while treated with vaccine influenza quadrival a-b vaccine [Fluzone QIV] (batch number: uj506aa and expiration date: 30-Jun-2021), via unknown 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 improper storage of unused product (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: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was given to a 17 year old patient/no AE; Initial information regarding this unsolicited valid non-serious case via Medical Information (MI) (Reference number- 00351502) was received from the other healthcare professional and transmitted to Sanofi on 09-Nov-2020.  This case involved a 17 year old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Relevant medical history, medical treatment, vaccination and family history were not provided.  No concomitant medication was reported.  On 09-Nov-2020, the patient received a dose of 0.5 ml once of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ509AA and expiry date: 05-Oct-2021) via intramuscular route in the left arm for prophylactic vaccination (product administered to patient of inappropriate age as 17 year old female patient received vaccine) (latency same day).  It was reported that the vaccine was grabbed by mistake from the refrigerator and the provider wanted to double check if they needed to watch out for anything in particular since it was given too early.  No adverse event was reported at the time of reporting.  Details of laboratory data not reported.    It was a case of actual medical error as the vaccine was given to a 17 year old 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: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone HD that was left outside of the refrigerator and exposed to 60-65F for 2 days; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age who Fluzone HD that was left outside of the refrigerator and exposed to 60-65F for 2 days (product storage error) while treated with vaccine while he/she received vaccine influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] (batch number: : UJ567AA and expiration date 30-Jun-2020) via an unknown 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: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: sore arm 3 weeks after immunization; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 71 years old female patient who experienced sore arm 3 weeks after immunization (pain in extremity), while she received vaccine Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s), concurrent condition and family history were not provided.  Concomitant medication was unknown.  On 16-Oct-2020, the patient received a dose of suspect 0.7 mL influenza Quadrival A-B High Dose HV Vaccine (formulation: unknown) (batch number: UJ499AB and expiry date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date of 2020, 3 weeks after the initiation of suspect drug, reporter stated that patient's arm was still sore. She stated that there was no swelling or redness. Pharmacist stated that she had never had someone complaint that their arm was still sore 3 weeks after immunization (pain in extremity).  No laboratory data was reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Tenivac was administered after it expired on 23Oct2020, with no AE; Initial information received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 50 years old male patient who was administered DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (TENIVAC) after it expired (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On 10-Nov-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number, administration route was unknown and expiry date: 23-Oct-2020) for prophylactic vaccination.  This was potential medication error case due to expired vaccine used (same day).  The patient did not present any 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.  There will be no information available on the batch number for this case
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: patient was administered IPOL on 10 Nov 2020 that expired the day before with no AE; Initial information regarding an unsolicited non-valid serious case was received from a pharmacist via Agency and transmitted to Sanofi on 10-Nov-2020.  This case involves a 49 years old male patient who was administered ipv (vero) [Ipol] at a dose of 0.5 ml once in left deltoid (lot number: P1E701M and expiration date: 09-Nov-2020) for prophylactic vaccination on 10-Nov-2020 that expired the day before (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine polysacch vi (Typhim Vi); and pneumococcal vaccine conj 13v (crm197) (Prevnar 13).  This was an actual medication error case due to the event expired vaccine used.  At the time of report, no adverse event was reported.  No laboratory data 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.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Tremor
Clinical narrative: patient now complaining of fatigue; tremors began in the left arm the evening; Initial information received on 10-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 78 years old female patient who experienced tremors began in the left arm the evening and patient now complaining of fatigue, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history included Vaccination site nerve damage. The patient's past medical treatment(s), vaccination(s) and family history were not provided.    On 08-Nov-2020, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7096NA) via intramuscular route in the right arm for prophylactic vaccination.  On 09-Nov-2020, the patient developed a non-serious tremors in the left arm the evening (tremor) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious patient now complaining of fatigue (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was not reported if the patient received a corrective treatment. The outcome was reported as unknown for both events.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: gave a 4 month old child an expired Pentacel today with no adverse event; Initial information received on 10-Nov-2020 regarding an unsolicited valid non-serious case received from a healthcare professional (medical Assistant).  This case involves a 4-month-old female patient who received today expired diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel], 242 -pentacel  (expired product administered) (batch number: UJ074AB and expiration date: 13-Oct-2020) at doss of 0.5 ml once via intramuscular route in the right thigh 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 product administered (latency: same day)  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: F
Vaccine: FLU3
Symptoms: Arthritis, Bursitis, Fungal infection, Injected limb mobility decreased, Injection site pain
Clinical narrative: yeast infection with her shoulder; left shoulder has arthritis; bursitis; Initial information regarding an unsolicited valid non-serious case was received from a Patient via agency (Reference number- 00354717) and transmitted to Sanofi on 11-Nov-2020.  This case involves a 74 year old female patient who experienced yeast infection with her shoulder (Fungal infection), left shoulder has arthritis (Arthritis) and bursitis while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  Medical history, concurrent conditions, vaccination(s) and family history were not provided. Concomitant medication was unknown.  In October 2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE in her left arm and that the was injection was given, "at the highest point on her arm, close to the bone in her shoulder, (lot number: UJ236AA) via unknown route at an unknown administration site as prophylactic vaccination.    On an unknown date, she could not tell exactly where they gave the shot, but it was not like her previous shots. She recalled the staff who administered the injection was "on her 2nd day". The next day she could not move or lift her left arm, she stated she continues to have issues and it was still sore. She also experienced a yeast infection and said, " I thought my insides were coming out." Consumer reported she never had a yeast infection or issues with her shoulder before receiving the FLUZONE HIGH DOSE vaccine. Also reported that her doctor did not tell her it was a different shot than the ones she received in the past, or what the possible side effects are. X Rays were taken and her doctor said her left shoulder has arthritis and bursitis and one more condition the consumer could not recall. Consumer stated she will never get any kind of shot from this experience. She requested an anatomical shoulder image to be included in the letter. This way she can mark where the injection was given because she feels it was given too high.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for all events.