chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: FLUR4
Symptoms: Fatigue, Headache
Clinical narrative: headache; fatigue; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (hcp) via Regulatory authority (under reference number 00793253).  This case involves a 21-year-old female patient who experienced headache and fatigue, after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines were given to the patient.  On 30-Sep-2021, the patient received a dose of 0.5mL suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2106, expiry date 28-May-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 30-Sep-2021, the patient developed a non-serious headache and fatigue (on the same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "caller states she received a flu shot at a flu vaccine clinic and she believes she received FLUZONE HIGH DOSE; states she is 21 years old; asks if there are any dangers to a 21 year old receiving FLUZONE HIGH DOSE. Caller states she is experiencing headache and fatigue, asks if this is normal. While completing AE/safety report, caller states according to information she was provided at flu vaccine clinic, she actually received FLUBLOK; caller states she did not receive FLUZONE HIGH DOSE QUADRIVALENT. Caller asks if FLUBLOK is okay for a 21 year old."  Details of laboratory were not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the both the reported events.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of the FLUZONE HIGH-DOSE QUADRIVALENT, with no adverse event; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a other health professional and consumer or non-healthcare professional via call center via Company (Reference number- 00793324).  This case involves a patient of (unknown demographics) who received an expired vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ499AB and expiry date: 30-JUN-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: M
Vaccine: FLUR4, HPVX, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 13 years old patient received FLUBLOK QIV vaccine/ No AE; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from a physician via consumers via regulatory authority number: 00793359.  This case involves a 13 year old male patient who received a dose of  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and Human papillomavirus (HPV) VACCINE for prophylactic vaccinations.  On 30-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (pre-filled syringe, lot number: UJ725AA, expiry date: 30-Jun-2022, frequency: once, strength: standard) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "Office Manager stated FLUBLOK was given to a child and wanted to know what needed to be done. States the child received the product yesterday and they notified the mom who did not report any issues."  Product used: Used and First time product used: Yes.   Adverse event (AE) symptoms or no AE.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: a patient received an expired dose of FLUZONE QUADRIVALENT vaccine/ No AE; a pregnant patient received an dose of FLUZONE QUADRIVALENT vaccine/ No AE; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a other health care professional via consumer via phone via regulatory authority number: 00794278.   This case involves a 25 year old female pregnant patient who was exposed to an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] at 32 weeks of pregnancy during third pregnancy trimester (expired product administered and exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e., before pregnancy outcome was known.   The date of last menstrual period was reported as 18-Feb-2021.  The estimated due date is 25-Nov-2021.  It was not reported if patient had previous pregnancy.   The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant Medication: None.  On 30-Sep-2021, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe lot number: UT7073NA, expiry date: 30-Jun-2021, frequency: once, strength: standard via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy and also a case of actual medication error due to expired vaccine used (latency: same day).  It was reported "Caller states that a patient received an injection of FLUZONE QIV No Preservative (NP) from a prefilled syringe on 30SEP2021 that had expired on 30JUN2021. Caller asked if this was considered a valid dose or if it would have to be repeated. Caller asked for information on how to proceed."  Product used: used and still using product: no.   Adverse event (AE) symptoms: No AE.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of Adacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Medical Information (MI) (Reference number- 00794447) and transmitted to Sanofi on 01-Oct-2021.  This case involves Adult female patient who was received an expired dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 30-Sep-2021, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5666BNA, expiry: 17-Sep-2021) via intramuscular route in the right arm for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "A Pharmacist reporting that a consumer received an expired dose of ADACEL, on 30Sep2021. The caller reported that the vaccine expired on 17Sep2021 and the dose was given on 30Sep2021 and that the consumer is between the age of 30 to 40 years old."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: flublok Quadrivalent vaccine was administered to a 13 year old (male), with no adverse event; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.   This case involves 13-year-old male patient who administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 30-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication due to product administered to patient of inappropriate age [Latency: on the same day].   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 3.0
Sex: U
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ADACEL was given to 3 years old child patient/ no AE; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (MI) (Reference number- 00794567).  This case involves a 3 years old patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] product administered to patient of inappropriate age.  The patient's medical history, past medical treatment, vaccination, concomitant medication 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration (latency: same day)  At the time of reporting, no adverse event reported.  It was reported "Caller is requesting information regarding administration of ADACEL to a patient under the age of 10years; caller verified the age of patient is 3 years of age; caller would like to know what precautions and adverse reactions to look out for as well as when to administer the age appropriate DAPTACEL if necessary".  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLU4
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: Vaccine leaked out of the syringe where the needle and syringe meet with no reported adverse event; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age male patient for it was reported vaccine leaked out of the syringe where the needle and syringe meet (underdose) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 01-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Oral solution ,pre filled syringe,lot UJ763AC and expiry date: 30-Jun-2022] via an intramuscular route in unknown administration site for prophylactic vaccination.  It was reported "FLUZONE HIGH DOSE QUADRIVALENT to a patient today and noted that some of the vaccine leaked out of the syringe where the needle and syringe meet. Leaking (gather as much info as possible)-syringe looked like it was connected-some got out of injection o where is it leaking from? (use vial & syringe guides). Clear location of the leakage (under the Luer-Lok adaptor, out of the vial stopper puncture mark)- leur lok where needed is inserted o When did the leakage occur (e.g. when removing unit from the box, when attaching needle, when injecting diluent into powder vial, when administering the dose)-leaking occurred during injection. leak (e.g. only a few droplets or half the dose)-1/2 Amount o Diluent or vaccine leaking."  No other vaccines were reported.   It was case of actual medication error due to underdose [Latency: on the same day].   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of FLUZONE HIGH-DOSE QUADRIVALENT/no adverse event; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional via call center via regulatory authority (reference number- 00794775).  This case involves a 77 years old female patient who received an expired vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On 01-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ482AA and expiry date: 30-JUN-2021) via an intramuscular route in the arm nos for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: comes with sodium chloride diluent and it was reconstituted with sterile water instead with no reported adverse event; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional and non-healthcare professional via the [Medical information under reference number- 00794785].   This case involves a patient of (unknown demographics) who was vaccinated with YELLOW FEVER VACCINE - US [YF-VAX] that was reconstituted with sterile water instead sodium chloride diluent (Product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day).   It was reported "she had Yellow Fever (YF) vaccine which comes with sodium chloride diluent and it was reconstituted with sterile water instead. Caller stated the vaccine was administered to a patient. Caller said she read research that says the vaccine is not going to work and has to be redone. Caller wants to know what should be done. Caller requested call back because she was busy and could not wait to be warm transferred."  At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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 batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: unopened prefilled syringes of FLUZONE HIGH-DOSE QUADRIVALENT from last year which expired on 30-JUN-2021 was accidentally left in the refrigerator and administered to 4 patients on 30-SEP-2021 with no reported adverse event; Initial information was regarding an unsolicited valid serious case was received from a consumer/non-health care professional via regulatory authority (Reference number- 00794818) and transmitted to Sanofi on 01-Oct-2021.    This case involves an unknown demographic patient (unknown age and unknown gender) who had INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] unopened prefilled syringes from last year which expired on 30-Jun-2021 was accidentally left in the refrigerator and administered to 4 patients on 30-Sep-2021 (expired product administered).  Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 30-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ500AA, expiry date-30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired product administered (latency: same day).  It was reported "box containing unopened prefilled syringes of FLUZONE HIGH-DOSE QUADRIVALENT from last year which expired on 30-Jun-2021 was accidentally left in the refrigerator and administered to 4 patients on 30-Sep-2021".  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurse gave 3 separate patient's an expired FLUZONE HD Quadrivalent vaccine, with no reported adverse event; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/Non-Healthcare Professional and physician via Regulatory authority (under reference 00794848).  This case is linked to case 2021SA327336 (same reporter).  This case involves a 68 years old male patient who accidentally received an expired dose of QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) [expired product administered].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Oct-2021, the patient received a 0.7 mL dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (Prefilled Syringe, TOTAL, lot UJ482AA, expiration date: 30-Jun-2021) via intramuscular route in the upper arm for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Practicing manager with provider's office is reporting they gave a patient an expired FLUZONE HD Quadrivalent vaccine. What shall we do from here? Caller repeated the above question. 2 HCP states that she saved back one box of FLUZONE HIGH DOSE because it had 1 month before it expired and the nurse accidentally pulled 3 prefilled syringes of FLUZONE HIGH DOSE from that box and gave them to 3 separate patients today 01-Oct-2021"  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave a patient an expired FLUZONE HD Quadrivalent vaccine (with no reported adverse event); Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a physician via regulatory authority (under reference 00794859).  This case is linked to case 2021SA327336 and 2021SA328514 (same reporter).  This case involves a 91 years old female patient who received an expired dose of QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Oct-2021, the patient received a 0.7 mL dose (total) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Prefilled Syringe, lot UJ482AA, expiration date: 30-Jun-2021) via intramuscular route in the upper arm for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Practicing manager with provider's office is reporting they gave a patient an expired FLUZONE HD Quadrivalent vaccine. What shall we do from here? Caller repeated the above question. 2 HCP states that she saved back one box of FLUZONE HIGH DOSE because it had 1 month before it expired and the nurse accidentally pulled 3 prefilled syringes of FLUZONE HIGH DOSE from that box and gave them to 3 separate patients today 01-Oct-2021"  At time of reporting, no adverse event was reported.  The outcome of the event was reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient recieved expired vaccine with no reported adverse event; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Regulatory authority (00794863).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ565AB and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported "Caller stated they administered vaccine to two patients and realized the vaccine expired 30Jun2021. Caller asking if there any safety issues and should the patients receive the updated version vaccine for this year? Caller declined to provide email."  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: Wrong product administered
Clinical narrative: patient who was scheduled to receive FLUZONE HIGH-DOSE QUADRAVALENT was immunized with FLUZONE QUADRIVALENT with no adverse event; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional and non-healthcare professional via Regulatory authority (reference number -00794873).  This case involves a 65-year-old male patient who was accidentally vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of FLUZONE HIGH-DOSE QUADRAVALENT with no adverse event (Wrong product administered).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 01-Oct-2021, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (oral solution, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination (Wrong product administered).  There were no laboratory data/results available.  It was case of an actual medication error due to wrong vaccine administered (latency was on same day).  It was reported "the patient is asking to be vaccinated with the High-dose, the nurse was told by the pharmacy that an additional flu vaccine can be given, she is seeking clarity she stated that the patient is very entitled and wants to know how long he must wait until he can get the high-dose vaccine."  At the time of report, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: gave only the powder HIB portion/ DTaP-IPV portion of Pentacel was not administered, with no reported adverse event; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via consumer via phone (under Medical Information Inquiry Number: 00794918).  This case involves a two-month-old female patient who was given only the powder hib portion/ dtap-ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was not administered (product preparation error).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  On 01-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot UJ529AAA and expiry date: 22-Jul-2022 via unknown route in the left thigh for prophylactic vaccination.  It was an actual medication error due to wrong diluent used (same day).  It was reported "Caller reported giving PENTACEL to a child and only used the HIB portion with a diluent. Caller was asking what to do from here. A Medical Assistant gave only the powder HIB portion. The diluent that was used was sterile water. The DTaP-IPV portion of Pentacel was not administered. The caller asked what should be done. Was there any adverse effect of giving the HIB portion diluted with sterile water. Later, another Medical Assistant went to the vaccination supply and found that there was an extra Pentacel diluent by itself in there without the powder, and that was how the error was discovered."  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was administered FLUZONE QUADRIVALENT sryinge which were not supposed to be used because of temperature excursion /No AE; shipment of pre-filled syringe FLUZONE QUADRIVALENT arrived late/ No AE; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a Pharmacy technician via consumer via phone via regulatory authority number: 00794935.   This case is linked to case 2021SA310171(CLUSTER).  This case involves a 60 years old male patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] syringe which were not supposed to be used because of temperature excursion and shipment of these pre-filled syringe arrived late (product storage error and product distribution issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for prophylactic vaccination.  On 30-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Injection lot number: UT7376LA, expiry date: 30-Jun-2022, frequency: once, strength: standard via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage and product shipment delay (latency: same day).  It was reported "Pharmacy technician called stating they had a shipment of pre-filled syringes FLUZONE QUADRIVALENT arrive late, after a temperature excursion was reported and it was determined that the syringes should not be used, 2 patients were accidentally given these vaccines. She asks if the vaccines were valid or if these patient's should be revaccinated. Caller states they had already reached to Pasteur Company Sanofi to find out if the vaccines were suitable, which they were told they were not and they were set to return them. Upon going to pack and return the shipment, caller realized one of the boxes set aside was incorrect, and the box that was supposed to be returned had been opened and two syringes used on patients."  Product used: Used, first time product used: no, still using product: no and was device used: yes.   No additional adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, Vaccination complication
Clinical narrative: Patient received expired dose of ADACEL/ with no adverse event; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and non-healthcare professional via call center via Medical Information (MI) (reference number- 00796310).  This case involves a patient of (unknown demographics) who received patient vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On 03-Oct-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported and expiry date: 17-SEP-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was of actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: 3x3 inch reaction around the injection site that was inflamed; injection site that was reddened; injection site that was hot; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via regulatory authority (under the reference 00796451).  This case involves an 8 years old male patient who had 3x3 inch reaction around the injection site that was inflamed (vaccination site inflammation) after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), Concomitant medication(s) and family history were not provided.  Patient had no other vaccines.  On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, total, lot UT7315MA and expiration date 30-jun-2022) via intramuscular route in the deltoid for prophylactic vaccination.  On an unknown date the patient developed a non-serious 3x3 inch reaction around the injection site that was inflamed (vaccination site inflammation), injection site that was reddened (vaccination site erythema) and injection site that was hot (vaccination site warmth) (unknown latency) following the administration of vaccine.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The patient recovering from the reported events.  The reported assessed the causality of the suspect with the events as related.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, UNK
Symptoms: Extra dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: Patient was suppose to receive DAPTACEL, ACTHIB, and PREVNAR 13, but instead received PENTACEL, ACTHIB, and PREVNAR 13, with no reported adverse event; received two doses of ACTHIB and an extra dose of IPV component, with no adverse event; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case from nurse, consumer/non-healthcare professional and physician via Media Information (under reference 00796837).  This case involves a 17 months old female patient who was suppose to receive DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL), HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), but instead received DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)], ACT-HIB and PREVNAR 13 (wrong product administered) and received two doses of ACT-HIB and an extra dose of ipv component [extra dose administered].  The patient's past vaccination(s) included IPV (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. The IPV series was completed in September 2020.  The patient's medical history, past medical treatment(s) and family history were not provided.  On 04-Oct-2021, the patient received concomitant medication, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On 04-Oct-2021, the patient received a 0.5 mL fourth dose of suspect PENTACEL (VERO) (Total, lot UJ416AAA and expiration date: 12-Mar-2022) via intramuscular route in the right thigh and on the same day, she received a dose of suspect ACT-HIB (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered and extra dose administered (same day latency).  It was reported "Nurse would like safety information of receiving extra doses and would like to know how this affects the patients booster dose of IPOL?"  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for the suspects DAPTACEL and ACT-HIB.
Sex: U
Vaccine: UNK
Symptoms: Medication error, Product preparation issue
Clinical narrative: patient received the DTap-IPV portion of PENTACEL only without reconstituting with the Hib component, with no reported adverse event; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case from a nurse and consumer/ non-healthcare professional via Media Information (under reference 00796883).  This case involves a patient (unknown age and gender) who received the dtap-ipv portion of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] only without reconstituting with the hib component (product preparation issue).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 04-Oct-2021, the patient received a 0.5 mL dose of suspect [PENTACEL (VERO)] (Total, lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique (same day latency).  It was reported "Caller states that she is the vaccine coordinator/nurse at her practice and that she is currently working from home. Caller states that she was contacted by a nurse at her practice and told that a patient received the DTap-IPV portion of PENTACEL only without reconstituting with the Hib component on 04OCT2021. Caller asked if she can use a standalone ACTHIB vaccine to count as the Hib portion that was not administered. Caller states that the nurse should know this and doesn't understand why she is asking. Caller states that she will call the nurse back and let her know how to proceed. Caller asked for the name of the organization used in the standard regarding PENTACEL reconstitution. Caller states that she does not have any information available on the patient or lot numbers for products because she is working from home."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 43.0
Sex: F
Vaccine: DTP, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient accidentally received PENTACEL instead of their TDap vaccine in the office with no adverse event; 43 year old patient accidentally received PENTACEL instead of their TDap vaccine, with no adverse event; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case from a physician and consumer/ non-healthcare professional via Media Information (under reference 00796958).  This case involves a 43 years old female patient who accidentally received DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] instead of their DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE in the office (wrong product administered and product administered to patient of inappropriate age).  Patient did not receive other concomitant vaccines.  The patient's medical history, past medical treatment(s), past vaccination (s) and family history were not provided.  On 04-Oct-2021, the patient received a 0.5 mL dose of suspect PENTACEL (VERO) (Total, lot UJ440AA and expiration date: 29-May-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration (same day latency).  It was reported "Doctor states that a 43 year old patient accidentally received PENTACEL instead of their TDap vaccine in the office on 04OCT2021 and asked for recommendations on how to proceed. Doctor states that she could not find any information online other than for children that inadvertently received the vaccine. Doctor states that no Adverse Events have occurred and that they will continue to monitor the patient."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.