chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was received an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 16-Aug-2021 from a Physician via Global Medical Information (Reference number- 00725599) and transmitted to Sanofi on 16-Aug-2021.  This case involves a nine-year-old female patient reported that patient was gave an expired IPV (VERO) [IPOL] with no adverse event (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 02-Aug-2021, the patient received 0.5 mL (total) dose of suspect IPV (VERO) (Oral solution) [lot R1D97, expiry date 17-Jul-2021] via intramuscular route in the right deltoid for prophylactic vaccination.  It was reported that, 'Caller stated they gave an expired dose of IPOL to two children. Caller is wanting to know if the doses will need to be repeated. Both children received the dose on 8/2/21."  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ACTHIB was administered to a patient, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Global Medical Information (GMI) (Reference number- 00725700) and transmitted to Sanofi on 16-Aug-2021.  This case involves a one-year-old female patient who was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination.  On 16-Aug-2021, the patient received a fourth dose (0.5ml) of suspect HIB (PRP/T) VACCINE (lot number: UJ351AAB; expiry date: 09-Aug-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "Caller states that an expired dose of ACT-HIB was administered to a patient on 16AUG2021 and needed to report it. Caller sought information on how to proceed."  No adverse events were reported at the time of this report.  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 by the regulatory authority. 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: Erythema, Malaise, Pain in extremity, Pyrexia
Clinical narrative: pain in her calf and thought it was in part to her sciatica but she has experienced pain bilaterally in her calves; some redness in a circular pattern a few inches below the injection site; pain in her calf and thought it was in part to her sciatica but she has experienced pain bilaterally in her calves; malaise; low grade fever 99.2 degrees; Initial information received on 16-Aug-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional.  This case involved a 65 years old female patient who had pain in her calf and thought it was in part to her sciatica but she has experienced pain bilaterally in her calves (sciatica) (pain in extremity), some redness in a circular pattern a few inches below the injection site (erythema), malaise and low grade fever 99.2 degrees (pyrexia), after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past vaccinations included pneumonia (pneumococcal vaccine), shingles vaccine (varicella zoster) and flu vaccine (influenza vaccine) previously and had experienced cramping in her calf.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided   On 10-Aug-2021, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 10-Aug-2021, the patient developed a non-serious malaise and low grade fever 99.2 degrees (pyrexia), on the same day following the administration of the vaccine.  On an unknown date, the patient developed a non-serious pain in her calf and thought it was in part to her sciatica but she has experienced pain bilaterally in her calves (sciatica) (pain in extremity), some redness in a circular pattern a few inches below the injection site (erythema), (unknown latency) following the administration of the vaccine.  It was reported that "she has no physician information as she received her vaccine at pharmacy."  Other relevant laboratory test results were not reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for all the reported event.  There will be no information on the batch number for this case.
Age: 0.5
Sex: F
Vaccine: MNQ, PNC
Symptoms: Medication error, Wrong product administered
Clinical narrative: patient was supposed to receive Prevnar and was given MENACTRA by mistake, no AE; Initial information received on 16-Aug-2021 regarding an unsolicited valid  non-serious case received from a physician via Global Media Information (under the reference 00726178).  This case involved a 6 months old female patient who was supposed to receive PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR)and was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Menactra) by mistake (wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and HIB VACCINE CONJ (OMPC) (PEDVAXHIB) (lot number and expiration date not reported) via unknown route in an unknown site for prophylactic vaccination.  On 16-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6921AA and expiration date :17-Apr-2022) via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered (same day latency).  It was reported that "nurse supervisor asking if there are any adverse events reported in 6 month olds who are given MENACTRA, and how they should proceed".  At time of reporting, the outcome was unknown for the reported 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 by the regulatory authority. 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: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; Initial information received on 16-Aug-2021 regarding an unsolicited valid serious case from a pharmacist via Agency (Reference number- 00726317).  This case involves a patient (unknown demographics) who experienced anaphylactic reaction, while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date (2017-2018), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UI883AB and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (2017-2018), the patient developed a serious anaphylactic reaction (unknown latency), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a patient (unknown demographics) who had anaphylactic reaction, after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of the events, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: The patient was administrated with an expired Act-hib vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via  consumer/non-healthcare professional via Global Medical Information (Reference number- 00726333) and transmitted to Sanofi on 16-Aug-2020.  This case involves a 3-year-old female patient who was administered an expired HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 16-Aug-2021, the patient received a first dose of suspect HIB (PRP/T) VACCINE (lot UJ327AAB, expiry: 28-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  It was reported "stated that an expired ACT-HIB was given and wants to know what the recommendations would be on the vaccine. stated that she does not have that information"  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.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event, Product storage error
Clinical narrative: two patients received ADACEL Adult vaccine which was stored in a fridge that had a temperature excursion that reached 34 degrees Fahrenheit (or 1.11 degrees Celsius) over the weekend/ No AE; Initial information was received on 17-Aug-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer under Global Medical Information Inquiry Number:00727607.  This case involves two patients with an unknown age and gender who were administered with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] that was stored in a fridge that had a temperature excursion that reached 34 degrees Fahrenheit (or 1.11 degrees Celsius) over the weekend (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On an unknown date, the patients received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: U6964AA and expiry date not provided via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to incorrect product storage (latency: same day).  It was reported" We currently have ADACEL TDAP (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE) Adult vaccine stored in a fridge that had a temperature excursion. The refrigerator reached 34 degrees Fahrenheit (or 1.11 degrees Celsius) over the weekend, we do not know when the excursion began. It was noted yesterday. The refrigerator has since been reset and is at it normal temperature of 40 degrees Fahrenheit (or 4.44 degrees Celsius). The vaccine was administered to two patients. We need to know if the vaccine was safe to use."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: An expired dose was given with no reported adverse event; Initial information received on 13-Aug-2021 regarding an unsolicited valid non-serious case from an other health professional and consumer/ non health care professional via Global Media Information (Under reference 00727701).  This case involves a patient (unknown age and gender) who received an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) [expired product administered].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 10-Aug-2021, the patient received a dose of suspect ACT-HIB (lot number: not reported and expiration date: 25-Jul-2021) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported that "We would like to know if there is a significant degradation in potency for the vaccine if it was roughly 2 weeks past its expiration date. Please advise".  At time of reporting, the outcome was unknown for the reported 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 on the batch number for this case.
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: chills; myalgias; fever; progressively worsening swelling at injection site; Initial information received on 17-Aug-2021 regarding an unsolicited valid  non-serious case (under reference number : 00727839) from a physician. This case involves a 34 years old female patient who experienced chills, myalgias (myalgia), fever (pyrexia) and progressively worsening swelling at injection site (vaccination site swelling), after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 13-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Solution for injection, once, total, lot U6831AA and expiration date :08-Oct-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 13-Aug-2021, the patient developed a non-serious chills, myalgias (myalgia), fever and progressively worsening swelling at injection site (vaccination site swelling), on the same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  It was reported as " Physician reported that a patient received TENIVAC on 13AUG2021. She returned to office on 17AUG2021 with complaints of progressively worsening swelling at injection site, fever, chills, and myalgias. Physician asking if there are any recommendations on how to proceed, and the ingredients of TENIVAC. Physician was unable to provide all information for AE report at time of call. Physician given case number and states he will call back when he has all information to complete AE report. Physician declined to provide email." No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for all the reported events.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, Product administered at inappropriate site
Clinical narrative: four month old male patient administered QUADRACEL vaccine in the thigh left with no reported AE; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case from a other health care professional via Medical Information (Reference number- 00727886).  This case involves a four month old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] at the left thigh (product administered at inappropriate site).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 16-Aug-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5763AA and expiry date: 26-Aug-2022) (Frequency: once) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to Vaccine administered at inappropriate site (latency on 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 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: FLUR4
Symptoms: Confusional state, Inappropriate schedule of product administration
Clinical narrative: Flublok was administered outside the 2 day window/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 17-Aug-2021 from a Nurse (Reference number- 00727907) and transmitted on 17-Aug-2021.  This case involves a patient (unknown age and gender) who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] outside the two- day window, with no adverse event (Inappropriate schedule of product administration).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 16-Aug-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to Inappropriate schedule of product administration (latency was on the same day).  It was reported that, "Flublok was received and administered to a patient outside the 2 day window. The nurse practitioner states that the Flublok was received yesterday from facility to the clinic and there was a message left with one of the nurses over the weekend that due to an error it was sent outside of the two day window. She states that when she received the shipment yesterday, she gave one to a patient which was "not good" and "very upsetting" to her that she did that. She said she didn't get the message until today that since it was sent outside of the two-day window that it needed to be quarantined and sent back. She states that nothing looked out of the ordinary. She states that she is confused as to what she needs to do with the patient. She wants to know if she is going to be receiving a return shipping label and if so will it be mailed or e-mailed to her".  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on batch number for this case.
Age: 15.0
Sex: F
Vaccine: IPV
Symptoms: Incomplete course of vaccination, Medication error
Clinical narrative: patient received 3 doses of Ipol as a baby, but never received the fourth dose with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional and consumer/non-health care professional via Global Medical Information (Reference number- 00727955) and transmitted to Sanofi on 17-Aug-2021.  This case involved 15-year-old female patient received 3 doses of IPV (VERO) [IPOL] as a baby, but never received the fourth dose (incomplete course of vaccination)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received 3 doses of suspect IPV (VERO) as a baby (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination but never received the fourth dose (incomplete course of vaccination)  It was reported that,"Now, should she receive a single dose? Start the series over? or, because of her age, no dose is necessary"?   This was an actual medication error due to incomplete course of vaccination (latency: same day)  At the time of reporting, 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 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: 34.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site pain, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: aches and pains; patient has decreased range of motion of left arm; joint stiffness; chills; myalgia; fever; progressively worsening swelling at injection site; patient was positive for 3 centimeter raised injection site reaction that is tender to palpation; patient was positive for 3 centimeter raised injection site reaction that is warm to touch; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case from a physician via Medical Information (Reference number- 00727956).  This case involves a 34 year old female patient who experienced myalgia, fever (pyrexia), chills, joint stiffness, aches and pains, (pain), decreased range of motion of left arm (mobility decreased), progressively worsening swelling at injection site (vaccination site swelling), patient was positive for 3 centimeter raised injection site reaction that is tender to palpation and warm to touch (vaccination site pain) and (vaccination site warmth), while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 13-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6831AA and expiry date: 08-Oct-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  On 13-Aug-2021, the patient developed a non-serious event "She returned to office on 17-Aug-2021 with complaints of progressively worsening swelling at injection site" (vaccination site swelling), myalgia, fever (pyrexia), "physician states on physical exam patient was positive for 3 centimeter raised injection site reaction that is tender to palpation and warm to touch" (vaccination site pain) and (vaccination site warmth), on same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  On an unknown date, the patient developed a non-serious decreased range of motion of left arm (mobility decreased), joint stiffness and aches and pains (pain), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Physician reports patient has no hives or urticaria, no airway compromise, and no shortness of breath.   It was reported that "Physician states patient is not pregnant -Last menstrual period: 30-Jul-2021. Due date AE (adverse event) symptoms or no AE. If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug administration) requirement".  Details of laboratory data not reported.  Physician also states he recommended Ibuprofen, Tylenol (Paracetamol) and rest.  At the time of reporting, the patient had not recovered from the all events.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Joint stiffness, Myalgia, Pain, Pyrexia
Clinical narrative: aches and pains; patient has decreased range of motion of left arm; joint stiffness; chills; myalgia; fever; progressively worsening swelling at injection site; patient was positive for 3 centimeter raised injection site reaction that is tender to palpation; patient was positive for 3 centimeter raised injection site reaction that is warm to touch; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case from a physician via Medical Information (Reference number- 00727956).  This case involves a 34 year old female patient who experienced myalgia, fever (pyrexia), chills, joint stiffness, aches and pains, (pain), decreased range of motion of left arm (mobility decreased), progressively worsening swelling at injection site (vaccination site swelling), patient was positive for 3 centimeter raised injection site reaction that is tender to palpation and warm to touch (vaccination site pain) and (vaccination site warmth), while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 13-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6831AA and expiry date: 08-Oct-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  On 13-Aug-2021, the patient developed a non-serious event "She returned to office on 17-Aug-2021 with complaints of progressively worsening swelling at injection site" (vaccination site swelling), myalgia, fever (pyrexia), "physician states on physical exam patient was positive for 3 centimeter raised injection site reaction that is tender to palpation and warm to touch" (vaccination site pain) and (vaccination site warmth), on same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  On an unknown date, the patient developed a non-serious decreased range of motion of left arm (mobility decreased), joint stiffness and aches and pains (pain), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Physician reports patient has no hives or urticaria, no airway compromise, and no shortness of breath.   It was reported that "Physician states patient is not pregnant -Last menstrual period: 30-Jul-2021. Due date AE (adverse event) symptoms or no AE. If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug administration) requirement".  Details of laboratory data not reported.  Physician also states he recommended Ibuprofen, Tylenol (Paracetamol) and rest.  At the time of reporting, the patient had not recovered from the all events.
Sex: U
Vaccine: MNQ
Symptoms: Medication error, Product storage error
Clinical narrative: 5 patient received Menactra vaccine which was store at minus 8 degrees Celsius for 7 hours and 24 minutes/ No AE; Initial information was received on 17-Aug-2021 regarding an unsolicited valid non-serious case received from another health professional via consumer (under Medical Information Inquiry Number:00727996).  This case is linked to case 2021SA275306 (Same reporter).  This case involves five patients with an unknown age and gender who were administered dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that had stored at minus eight degrees Celsius for seven hours and 24 minutes (product storage error).  The patients medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On an unknown date, the patients received dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution lot number: U6921AB, U7087AA and expiry date:17-Apr-2022, 05-Oct-2022 via an unknown route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to product storage error temperature too low (latency: same day).  It was reported "Nurse calling back to ask specifically about MENACTRA and IPOL that was administered yesterday after temperature. Is re-vaccination needed and if so, when should it be given. Caller states they do not think they had a real temperature excursion but had a faulty data logger because none of the other vaccines were frozen. States he provided minus eight degrees Celsius for seven hours and 24 minutes. Caller states 1 patient had received the IPOL. Caller thinks he had 5 patients between the two lots for the Menactra but is looking through his computer now to gather all the information. Product used."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram abnormal, Epstein-Barr virus infection, Neurological symptom
Clinical narrative: Epstein Barr diagnosis; experienced some weird neurological symptoms; Initial information regarding an unsolicited valid non serious case was received from a pharmacist via Medical Information (Reference number- 00728247).  This case involves an unknown age female patient who had Epstein Barr diagnosis and some weird neurological symptoms (Epstein-Barr virus infection), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date in last year, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious Epstein Barr diagnosis and some weird neurological symptoms (Epstein-Barr virus infection) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, "pharmacist stated that a female patient received the Fluzone Quadrivalent flu shot last year and is experiencing some weird neurological symptoms and has had CT scans and other tests and the only thing showing is Epstein Barr diagnosis. Pharmacist stated the flu shot was the only thing different the patient had done".  Relevant laboratory test results included: Computerized tomogram (CT) scans and other tests and the only thing showed was Epstein Barr diagnosis.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the lot number for this case.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error
Clinical narrative: patient was given an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 17-Aug-2021 from a Physician via Global Medical Information (GMI) (Reference number- 00728357) and transmitted to Sanofi on 16-Aug-2021.  This case involves an 11-year-old male patient who was administered with an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine with no adverse event (Expired product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  On an unknown date, the patient received a 0.5ml (total) (once) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: U6401AA and expiry date: 26-Jul-2021] via intramuscular route in the left deltoid (also reported as left arm) for prophylactic vaccination.  It was reported that, "she gave an expired ADACEL vaccine. She states that the vaccine was expired and she gave it to the patient intramuscularly in the left arm, she asked how soon the patient could be revaccinated". Emergency Room/Dr. visit and date 17Aug2021. First time product used: No. Still using product : Yes. Was Device Used : No.  It was case of an actual medication error due to expired vaccine used (latency was on the same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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, Medication error
Clinical narrative: expired ADACEL was given with no reported adverse event; Initial information received on 17-Aug-2021 regarding an unsolicited valid  non-serious case received from a other health professional via Media information (under the reference 00728465).  This case involved a 30 years old female patient who was vaccinated with an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication were given to the patient.   On 17-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, total, 1X(once), 0.5ml, lot U6214AA and expiration date: 14-mar-2021) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported, "HCP (Healthcare Professional) stated expired ADACEL was given and wanted to know what needed to be done. Attempted transfer to MIS-No answer. Placed in proxy for a call back. HCP request to be called on the mobile number on file. She would be leaving out the office in the next 25 minutes."  At time of reporting, no adverse event was reported and the outcome was unknown for reported 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.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error
Clinical narrative: Patient received expired QUADRACEL with no AE; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Global Medical Information (Reference number- 00728548) and transmitted to Sanofi on 17-Aug-2021.  This case involves a patient with unknown gender who received expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 16-Aug-2021, the patient received a dose of expired suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number was not reported and expiry date: 13-Aug-2021) via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used (latency: on same day).  It was reported that "Caller did not have any other AE reporting information to provide and is only inquiring about if this dose is valid or if re-vaccination is needed and if so, how soon?"  It was not reported if the patient experienced 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error
Clinical narrative: ADACEL expired 2 days ago was administered with no reported adverse event; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case from a pharmacist and non-healthcare professional via call center via Medical Information (Reference number- 00729455).  This case involves an adult male patient in his 30's administered expired vaccine (expired product administered) DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On 17-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported and expiry date: 15-Aug-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case 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.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error
Clinical narrative: Patient was inadvertently administered an expired dose of Quadracel with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Global Medical Information (GMI) (Reference number- 00729642) and transmitted to Sanofi on 18-Aug-2021..  This case involves a 6-year-old male patient who experienced patient was inadvertently administered an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 17-Aug-2021, the patient received an expired second dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5656AA and expiry date: 13-Aug-2021) via intramuscular route in the right deltoid for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used (latency: on same day).  It was not reported if the patient experienced 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 by the regulatory authority. 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: MNQ
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event, Underdose
Clinical narrative: patient did not receive a full dose due to the patient squirming during injection/ no AE; the vaccine did visibly leak down the patient's arm./ no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00730052) and transmitted to Sanofi on 18-Aug-2021.  This case involves an unknown age and gender patient while received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] then reported patient did not received a full dose due to the patient squirming during injection (underdose) and the vaccine did visibly leak down the patient's arm (exposure via skin contact).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 17-Aug-2021, the patient received a 0.5 mL (total) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (solution for injection) [lot U7140AA, expiry date 04-Nov-2022] via unknown route at an unknown administration site for prophylactic vaccination and reported (latency was on same day) patient did not received a full dose due to the patient squirming during injection (underdose) and the vaccine did visibly leak down the patient's arm (exposure via skin contact).  Details of laboratory data not reported.  It is unknown if the patient experienced any additional symptoms/events.  No adverse event was reported.  It was not reported if the patient received any corrective treatment.  The outcome was unknown for both the events.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Patient received an expired QUADRACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Care Professional via Medical Information (Reference number- 00730061) and transmitted to Sanofi on 18-Aug-2021.  This case involves a patient with unknown demography who received a dose of expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 16-Aug-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number was not reported and expiry date: 13-Aug-2021) via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "Medical assistant supervisor asked if patient should be revaccinated or is there a grace period. Medical assistant supervisor does not have the patient's information on hand. She agreed to call us back if she has obtained the patient's information."  It was a case of actual medication error due to expired vaccine used (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.