chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Overdose
Clinical narrative: Expired Fluzone QIV was administered to 4 patients, no AE; The patients received 5 ml of vaccine, no AE; Initial information was received on 07-Sep-2021 regarding an unsolicited valid non-serious case from a physician via other health care professional.  This case involves 4 patients (unknown demographics) who were administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Expired product administered and overdose).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patients received a 5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported, Suspension for injection) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used and overdose (latency same day).  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 ne no information available on batch number for this case.
Age: 6.0
Sex: M
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received MENQUADFI vaccine within one year of age/ NO AE; Initial information regarding an unsolicited valid non serious case was received from other health care professional via the regulatory authority (Reference number: 00748364) and transmitted to Sanofi on 31-Aug-2021.  This case involves a 16-year-old male patient who was given MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] too soon after his last dose (inappropriate schedule of product administration).  Medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  No other vaccines.  On 30-Aug-2021, the patient received 0.5 mL total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [strength: standard, frequency: once lot U7218AA, expiry date: 22-Feb-2024] via an intramuscular route in left deltoid site for prophylactic vaccination.  It was reported ''The caller wants to know if we have any recommendations for a patient who was given a MENQUADIFI too early? See the additional event details field for more info. Additional Description of event Adverse events: Patient given a dose of MENQUADFI too soon after his last dose.'' Patient age less than 1 year enter as 2 month and 4 month, etc. Many pediatric vaccines need month for age. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.5mL strength: standard except for Fluzone HD. Vaccine was not used for first time.  This was actual medication error case due to drug dose administration interval too short.  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: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant patient receive the vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 31-Aug-2021 from a Physician via Medical Information (Reference number- 00748401) and transmitted to Sanofi on 31-Aug-2021.  This case involves a 35-year-old female patient who had taken INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was pregnant (Maternal exposure during pregnancy) with no adverse event.  Gestation period at onset was not reported.  Data regarding this pregnancy were received prospectively for example before pregnancy outcome was unknown.   The date of last menstrual period was not reported.  The estimated due date is 29-Aug-2021.  The medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On 31-Aug-2021, the patient received a 0.5 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ686AA, expiry date 30-Jun-2022] via intramuscular route in the left arm for prophylactic vaccination.  It was a case of Maternal exposure during pregnancy as patient was pregnant when she received vaccine (latency on the same day).  It is unknown if the patient experienced any additional symptoms/events.  Relevant prenatal testing after exposure was not reported.  It was not reported if the patient received any corrective treatment. . At the time of report, the outcome of event was unknown.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Product preparation issue
Clinical narrative: one of the medical assistants gave the Ipol and dtap portion of the pentacel vaccine without giving the hib portion with no reported adverse event; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2-month-old male patient whom  "one of the medical assistants gave the IPOL and DTAP portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] vaccine without giving the HIB portion" (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 31-Aug-2021, the patient received a dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6899AA, expiry date 05-Feb-2022 via intramuscular route in the left thigh for prophylactic vaccination.  It was reported, "Caller stated that a 2-month-old patient was given the Ipol and dtap portion of product and not the Acthib. Caller wanted to know if the ActHIB can be given separately. She also wanted to know if there was any concerns of not given the product with acthib."  It was a case of actual medication error due to inappropriate reconstitution technique (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.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired DAPTACEL was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse and physician via Medical Information (Reference number- 00748869) and transmitted to Sanofi on 31-Aug-2021.  This case is linked to case 2021SA290049 (same reporter).  This case involved 5-year-old female patient who administered expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination.  On 12-Aug-2021, the patient received second 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot: C5643AA and expiry date: 17-Jul-2021) (Frequency: Once) (Strength: Standard) via intramuscular route in the right thigh for prophylactic vaccination (expired product administered).  It was reported,"Nurse asks if there are any recommendations for when expired DAPTACEL is administered".   This case was an actual medication error due to (expired vaccine used) (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.
Age: 1.92
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered with an expired act-hib vaccine with no A/E; Initial information received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from an other Health Care Professional via consumer Reference number: 00750051).  This case involves a 23-months old male patient who was administered with an expired HIB (PRP/T) VACCINE [ACT-HIB] with no adverse event (Expired product administered).  Concomitant medications included DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) and hepatitis for prophylactic vaccination.  On 31-Aug-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ356AA and expiry date: 25-Jul-2021 via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency: same day).  It was reported "The caller is requesting recommendations for a patient that had received an expired ACT HIB vaccination. Emergency Room/Doctor's visit and date 8/31/2021."  Frequency: once.  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: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: seven year old patient received a QUADRACEL vaccination with no A/E; Initial information received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer via physician. Inquiry Number: 00750368).  This case involves a seven-years old female patient who received a quadracel vaccination with no adverse event (Product administered to patient of inappropriate age) DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  On 30-Aug-2021, the patient received a fifth 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number: C5851AA and expiry date: 25-Mar-2023 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 "Caller states that a 7- years old patient received a QUADRACEL vaccination in the office on 30-Aug-2021 and asked what the protocol was in this situation. Caller states that the patient was new from another practice and that this would have been their fifth dose of DTAP."  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: 12.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient accidentally received DAPTACEL instead of ADACEL in the office; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from physician and other health care professional via Medical information (under reference number - 00750742).  This case involves a 12-year-old male patient who was accidentally vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] with no adverse event (Wrong product administered).  The patient's past vaccination(s) included DTAP VACCINE with Patient has already received 4 DTAP vaccinations.  The patient's past medical treatments, concomitant therapy and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  On 21-Jul-2021, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number U6628AA and expiry date 04-Apr-2022) via intramuscular route in the deltoid NOS 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)  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.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: over half of dose came out due to defect with syringe with no AE; over half of dose came out due to defect with syringe with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via the regulatory authority (Reference number- 00750752) and transmitted to Sanofi on 01-Sep-2021.  This case involves a 16 year old male patient for whom it was reported over half of dose came out due to defect with syringe while receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (under dose and syringe issue).  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 01-Sep-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an intramuscular route in the left deltoid for prophylactic vaccination.  It was case of actual medication error due to syringe issue and vaccine under dose (Latency: on the same day).   It was reported "nurse states that she went to administer a Menactra vaccine to a 16 year old, and after the needle went in some of the Menactra went in, but then the rest of vaccine came out around the hub of the syringe. The nurse did not notice any breaks or cracks in the syringe. She asked how much she should reinject".  Details of laboratory data not reported.  No adverse reactions were 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 events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: One patient may have received IPOL post-excursion at minus 0.7 degree Celsius with no A/E; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer (under Inquiry Number: 00751004) .  This case is linked to case Id: 2021SA292867(CLUSTER).  This case involves a patient of (unknown demographics) who had received IPOL post-excursion at minus 0.7 degree Celsius with no adverse event (Product storage error) IPV (VERO) [IPOL].  On an unknown date, the patient received a dose of suspect IPV(VERO) lot number: U1A452M and expiry date: 02-Feb-2023 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to Product storage error temperature too low (latency: same day).  It was reported "Caller stated that a temperature excursion of unknown origin occurred on 25-Aug-2021. The low temperature was Negative 0.7C and the excursion lasted for 5 minutes before the products were transferred to a different refrigerator. The products involved were a punctured MDV of IPOL as well as unopened ACTHIB and MENACTRA. Caller also stated that 16 patients received the ACTHIB post-excursion, 9 patients received the MENACTRA post-excursion and 1 patient may have received the IPOL post-excursion. Caller stated that she did not had any patient information available at that time, but she can be contacted in the future if it is needed. Caller had asked for stability information for these products."  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: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Non case: No stability data available in temperature excursion case no adverse event with no medication error case.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Menactra was given to a patient at an earlier interval than it should have been with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via regulatory agency (Reference number- 00752061) and transmitted to Sanofi on 02-Sep-2021.  This case involves a 13 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] at an earlier interval than it should have been (inappropriate schedule of product administration).  The patient's past vaccination(s) included MENACTRA primary dose injection on 23-AUG-2019.  The patient's medical history, past medical treatment(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  On 02-Sep-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Injection, lot U6921AA and expiry date was not reported) via intramuscular route in the left deltoid for prophylactic vaccination (inappropriate schedule of product administration).  It was a case of actual medication error due to inappropriate schedule of vaccine administered (latency: same day).  It was reported "patient received primary MENACTRA injection on 23AUG2019; clinic did not have the documentation of the primary shot and administered second primary shot today, 02SEP2021."  "Asked if there were any side effects to be concerned about."  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: 1.67
Sex: F
Vaccine: DTAPIPV, UNK
Symptoms: No adverse event, Product administered at inappropriate site, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 20-month-old patient was inadvertently administered Quadracel, rather that the intended Pentacel, with no reported adverse event; 20-month-old patient was inadvertently administered Quadracel, with no reported adverse event; 20-month-old patient was inadvertently administered Quadracel intramuscularly in the right thigh, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00752068) and transmitted to Sanofi on 02-Sep-2021.  This case involves a 20 month old female patient who was inadvertently administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] intramuscularly in the right thigh today, rather that the intended DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (wrong product administered, product administered to patient of inappropriate age and product administered at inappropriate site).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 02-Sep-2021, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5772BA and expiry date: 17-Sep-2022, once) via an intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (with respect to use of PENTACEL (VERO) and QUADRACEL) and inappropriate age at vaccine administration and Vaccine administered at inappropriate site (with respect to use of QUADRACEL) (latency on same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 0.42
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was administered too early/ no AE; Initial information was received on 02-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (Reference number- 00752429) and transmitted to Sanofi on 02-Sep-2021.  This case involves a five-month-old female patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] too early with no adverse event (Inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided  On 30-Jul-2021, the patient received a 0.5 mL (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ575AA and expiry date not provided] via intramuscular route in unknown administration site for prophylactic vaccination.  It was reported, "Caller calling regarding dosing schedule of ACT-HIB. Caller than placed MD on the phone for more information. Dr. stated she is requesting to know when to give the next shot due to the child getting the shot too early Dr. stated the child got the first shot on 6/30/21 and the next dose on 7/30/21. Caller is wanting to know if a repeated dose needs to be given. Doctor did not provide all info needed due to just wanting the answer to the question she had. MD was provided information on dosing too early."  Product used: Used. First time product used: Yes. Still using product: No.  It was a case of actual medication error due to Drug dose administration interval too short (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 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: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Accidentally gave an 11 year old patient an Adacel dose on 01-Sep-2021 that expired on 15-Aug-2021 with no reported adverse event; Initial information received on 02-Sep-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 11 year old male patient for who accidentally gave an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] dose on 01-Sep-2021 that expired on 15-aug-2021 [expired product administered].  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA); and HPV VACCINE (HPV VACCINE).  On 01-Sep-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot C5655AA and expiry date: 15-Aug-2021] via an intramuscular route in the right arm.  It was a case of actual medication error due to expired product administered [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 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: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired MENACTRA was given to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and non-health care professional/consumer via Medical Information (Reference number- 00752479) and transmitted to Sanofi on 02-Sep-2021.  This case involved 16-year-old male patient was given expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 30-Aug-2021, the patient received second 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot: U6691AB and expiry date: 21-Aug-2021) (Frequency = once) (Strength = standard) via intramuscular route in the left deltoid for prophylactic vaccination (expired product administered).  It was reported,"caller states that for some reason the vaccine was put back into rotation, caller also inquiring when a repeated Menactra vaccine can be administered. Management of Adverse Events and Product Technical Complaints Pasteur AE (adverse event) Reporting Refunds/Credits will not be issued due to adverse events".  This case was an actual medication error due to expired vaccine used (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 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: 0.25
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was administered with an expired PENTACEL vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via consumer/non-health care professional via Medical Information (Reference number- 00752586) and transmitted to Sanofi on 02-Sep-2021.  This case involves a 3-month-old patient (gender unspecified) who was administered an expired DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] [Expired product administered].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE for prophylactic vaccination.  On 02-Sep-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] (lot UJ215AAA, expiry: 30-Apr-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  No adverse event was reported.  It was reported, "Stated that they injected an expired Pentacel and want to know what to do. Lot UJ215AAA Exp 04/30/2021. Call transferred from Manufacturing Authorization (MIA). Physician Assistant (PA) states that a patient was injected with Pentacel on 02Sep2021 that expired on 4/30/2021. The PA asks if the expired Pentacel dose is valid and needs to reinjected. The PA reports an AE. The patient did not experience any adverse events as a result of this.   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: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue, Product storage error
Clinical narrative: the ACTHIB portion was not administered and the caller was just administered the diluent portion of the vaccine with no adverse event; the vaccine when left out on the counter is still viable and if it can be mixed with saline. Room temperature was 71.0 Fahrenheit and left out for 18 hours with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00753871) and transmitted to Sanofi on 03-Sep-2021.  This case involved 6-month-old male patient was just administered the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] their diluent portion of the vaccine and acthib portion was not administered (product preparation issue) and the vaccine when left out on the counter is still viable and if it can be mixed with saline room temperature was 71.0 fahrenheit and left out for 18 hours (product storage error).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) reported as ROTOTEK for prophylactic vaccination.  On 01-Sep-2021, the patient received a dose DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ52AA and expiry date: not reported) (Frequency = once) (Strength = standard) via unknown route in unknown administration site for prophylactic vaccination their diluent portion of the vaccine and acthib portion was not administered (product preparation issue) and the vaccine when left out on the counter is still viable and if it can be mixed with saline room temperature was 71.0 fahrenheit and left out for 18 hours (product storage error).  It was reported,"Materials Manager states patient received un-reconstituted PENTACEL".  This case was an actual medication error due to inappropriate reconstitution technique and incorrect product storage (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 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: 1.5
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given the liquid portion only of Pentacel in the left thigh the powder portion was not given with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and consumer/non-health care professional via the Regulatory Authority (Reference number- 00754655) and transmitted to Sanofi on 03-Sep-2021.  This case involves 18-month-old male patient who was given the liquid portion only of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] in the left thigh the powder portion was not given (product preparation issue).  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 03-Sep-2021, the patient received the liquid portion only of a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ413AA and expiry date: 09-Oct-2021) via unknown route in the left thigh for prophylactic vaccination the powder portion was not given (product preparation issue).  It was reported,"MA (Marketing authorization) states that only the liquid from the PENTACEL was given, MA did not know of the powder. Physician requests on behalf of the MA, to know if there are any AE's (adverse event) that they should be aware about. Does the DTaP and IPV count? What should we do about getting the Hib dose? The caller was referred to the reconstitution guide."  This case was an actual medication error due to inappropriate reconstitution technique (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.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Off label use, Overdose, Respiratory disorder
Clinical narrative: respiratory illnesses; Patient has an immune disorder for which her immunologist wants her to have the Fluzone High-Dose instead of a vaccine indicated for her age/ recommends Fluzone High Dose and not FluAd; Patient has an immune disorder for which her immunologist wants her to have the Fluzone High-Dose instead of a vaccine indicated for her age/ recommends Fluzone High Dose and not FluAd; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-health care professional via Medical Information (Reference number- 00757759) and transmitted to Sanofi on 07-Sep-2021.  This case involves a 63-year-old female patient who experienced respiratory illnesses, patient has an immune disorder for which her immunologist wants her to have the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of a vaccine indicated for her age/ recommends fluzone high dose and not fluad [Off label use and overdose].  The patient medical history included immune disorder (NOS) (not otherwise specified) and respiratory disorder NOS.  The patient medical treatment(s), vaccination(s), concomitant medication 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 and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious respiratory illnesses (respiratory disorder) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was a case of actual medication error due to off label use in unapproved age group and overdose [Latency: on the same day].   Caller stated that she was immune compromised and has to get the vaccine. Since in her 40s, she had received high-dose Fluzone as prescribed by her immunologist. She had an immune disorder for which her immunologist wants her to have the Fluzone High-Dose instead of a vaccine indicated for her age. Her doctor specifically recommends Fluzone High Dose and not FluAd. She gets a lot of respiratory illnesses in general. She says she must be vaccinated for the flu in September, or else she would get a bad flu in October.  Details of laboratory data 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 events.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Feeling abnormal, Weight decreased
Clinical narrative: Loss of energy; Loss 15% of body weight; Loss of appetite; Brain fog; This spontaneous case was received on 31-Aug-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-01847) and concerned a male patient of unknown age.  The patient's medical history and concomitant medications were not reported.  On an unknown date in 2019, the patient was vaccinated with Afluria (TIV) (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.  On an unknown date in 2019, an unknown amount of time after receiving Afluria (TIV), the patient experienced 15% of body weight loss and loss of energy, brain fog and loss of appetite. It was unknown if the patient received any corrective treatment.  At the time of initial reporting on 31-Aug-2021, the patient had not recovered from the events as the symptoms were still ongoing.  The reporter did not provide a causality assessment.  Company comment: A patient of unknown age was vaccinated with Afluria (TIV). On an unknown date in 2019, an unknown amount of time after receiving Afluria (TIV), the patient experienced 15% of body weight loss, loss of energy, brain fog and loss of appetite. The patient's medical history and concomitant medications were not reported. Causality is unassessable for all events, due to lack of information regarding diagnostic findings.; Sender's Comments: A patient of unknown age was vaccinated with Afluria (TIV). On an unknown date in 2019, an unknown amount of time after receiving Afluria (TIV), the patient experienced 15% of body weight loss, loss of energy, brain fog and loss of appetite. The patient's medical history and concomitant medications were not reported. Causality is unassessable for all events, due to lack of information regarding diagnostic findings.
Age: 66.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Back pain, Pain in extremity, Paraesthesia, Pelvic pain
Clinical narrative: Pelvic pain; Sore arm; Achy on shoulders and back; Achy on shoulders and back; Feeling like needles were poking her in the left side of her head; This spontaneous case was received on 02-Sep-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-01919) and concerned a 66-year-old female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 31-Aug-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid and route of administration: not reported) for influenza prophylaxis. The batch number was not reported.  On 01-Sep-2021, one day after receiving Flucelvax Quadrivalent, the patient started feeling like needles were poking her in the left side of her head. In addition, the patient experienced pelvic pain, her arm became sore and the patient felt achy on shoulders and back. The patient did not receive any corrective treatment for the events.  At the time of initial reporting on 02-Sep-2021, the patient had not recovered from the events.  The reporter did not provide a causality assessment.   Company comment: A 66-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient started feeling like needles were poking her in the left side of her head. In addition, the patient experienced pelvic pain, her arm became sore and the patient felt achy on shoulders and back. The patient had no relevant medical history and was not taking any concomitant medications. Considering plausible chronology and no alternative aetiology provided, causality is assessed as possibly related for pain in extremity, back pain, pelvic pain, arthralgia and paraesthesia.; Sender's Comments: ompany comment: A 66-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient started feeling like needles were poking her in the left side of her head. In addition, the patient experienced pelvic pain, her arm became sore and the patient felt achy on shoulders and back. The patient had no relevant medical history and was not taking any concomitant medications. Considering plausible chronology and no alternative aetiology provided, causality is assessed as possibly related for pain in extremity, back pain, pelvic pain, arthralgia and paraesthesia.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Urticaria
Clinical narrative: Hives, rash
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspnoea, Headache, Nausea
Clinical narrative: Trouble breathing, extreme headache, nausea & pain in abdomen.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I noticed a significant increase in ear ringing (Tinnitus) after the shot (about 1 day after). I spoke with my my ENT about 2.5-3 weeks later to see if it would go away or if it was normal. He stated that multiple patients had similar events, but some resolved after several weeks. Unfortunately, it has been over 4 months and mine has not subsided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Left side of face numb, tingling..best way to describe it
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF pressure increased, Dyspnoea, Feeling abnormal, Idiopathic intracranial hypertension, Lumbar puncture abnormal
Clinical narrative: Increased optic nerve pressure, papilladema, intracranial hypertension  First prescribed acetazolamide 250mg 4x/daily for 10 days - could not tolerate medication side effects Dosage dropped to 250mg 2X/daily - side effects lessened but had constant shortness of breath Neurologist switched medication to topiramate 25mg 2X/day - tried for 7 days and could not function effectively with brain fog Now taking Trokendi XR 50mg 1x/daily
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal, Ophthalmological examination abnormal, Optic nerve disorder, Papilloedema, Visual field defect
Clinical narrative: Increased optic nerve pressure, papilladema, intracranial hypertension  First prescribed acetazolamide 250mg 4x/daily for 10 days - could not tolerate medication side effects Dosage dropped to 250mg 2X/daily - side effects lessened but had constant shortness of breath Neurologist switched medication to topiramate 25mg 2X/day - tried for 7 days and could not function effectively with brain fog Now taking Trokendi XR 50mg 1x/daily
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Lip swelling, Swelling face
Clinical narrative: Evening of the second shot, swelling to the lips and face and injection site.  No difficulty with breathing
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Sunday at 6pm 6/20/21 I has sever pain in my abdomen- demobilization pain all over torso - nothing helped the pain - came on suddenly and lasted thru the night continuously -in the morning it was better - made an appointment with doctor but cancelled it because I could get in for a couple days
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral, Pruritus
Clinical narrative: 10-15 minutes after tingling lips then numb, 10-15 minutes after feet tingling like pins and needs numb then hands too. Called provider within one hour and took two hydroxoxine  palmonate 25 mg. One and a half hours later feet snd mouth were still numb but not tingling as much, then developed hives on back and was itching on head, back and legs. It took three hours for itching to stop and then by 7:30pm most symptoms stopped but lips still numb and felt swollen but did not look swollen. Took loratadine over night also per primary care recommendation. Woke up at 7am on 9/11/21, lips still numb feeling, chest is tight and heavy, but no wheezing and arms and back itch slightly.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Urticaria
Clinical narrative: 10-15 minutes after tingling lips then numb, 10-15 minutes after feet tingling like pins and needs numb then hands too. Called provider within one hour and took two hydroxoxine  palmonate 25 mg. One and a half hours later feet snd mouth were still numb but not tingling as much, then developed hives on back and was itching on head, back and legs. It took three hours for itching to stop and then by 7:30pm most symptoms stopped but lips still numb and felt swollen but did not look swollen. Took loratadine over night also per primary care recommendation. Woke up at 7am on 9/11/21, lips still numb feeling, chest is tight and heavy, but no wheezing and arms and back itch slightly.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Severe arm swelling and redness even after 5 days.