chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Viral load
Clinical narrative: unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from contactable physician. This physician reported similar events for 11 patients. This report is for 11th of 11 patients. This physician reported for a patient that:  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), dose 1 via an unspecified route of administration on 17Dec2020 and dose 2 via an unspecified route of administration in Jan2021 (Lot number: unknown), both as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after two weeks of second dose, the patient experienced unusually high number of COVID infections in fully vaccinated employees. The physician further stated they may need some kind of investigation here because they are seeing high viral loads in these individuals and symptoms. The patient was well after two weeks. The outcome of the event was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. The case will be reevaluated should additional information become available. ,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site reactions redness warm large bump; injection site reactions redness warm large bump; injection site reactions redness warm large bump; Initial information was received on 01-Apr-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves 4 child patients who experienced injection site reactions redness warm large bump (vaccination site mass, vaccination site warmth and vaccination site erythema), while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patients received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (Suspension for injection, lot C5763AA and expiration date was not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious injection site reactions redness warm large bump (vaccination site mass, vaccination site warmth and vaccination site erythema), over 48 hours following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment for the events.  It is unknown if the patients experienced any additional symptoms/events and had any concomitant disease or risk factor.  At time of reporting, the outcome was unknown for all the events.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Symptom recurrence, Vaccination site swelling
Clinical narrative: every month at the same time in the exact same place as the flu shot, it gets red, itchy and swollen/recurring every month at the same site; every month at the same time in the exact same place as the flu shot, it gets red, itchy and swollen/recurring every month at the same site; every month at the same time in the exact same place as the flu shot, it gets red, itchy and swollen/recurring every month at the same site; Initial information received on 02-Apr-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves adult and unknown gender patient who experienced every month at the same time in the exact same place as the flu shot, it gets red, itchy and swollen/recurring every month at the same site (vaccination site erythema, vaccination site pruritus and vaccination site swelling) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient had no medical history, concomitant disease or risk factor.  Past medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [pre-filled syringe,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 a non-serious event every month at the same time in the exact same place as the flu shot, it gets red, itchy and swollen/recurring every month at the same site (vaccination site erythema, vaccination site pruritus and vaccination site swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that, pediatrician called and reported that one of his patients has had a monthly recurring side effect from the flu vaccine. The mother reported that ever since her child received the flu shot in November, every month at the same time in the exact same place as the flu shot, it gets red, itchy and swollen. The mother said it happened a few weeks to a month after the flu shot but had been recurring every month at the same site. She was pretty angry when she was telling the office staff about that.   There were no lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received any corrective treatment for the events.  At the time of reporting, the event outcome reported as unknown for events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: HEP, HEPA, MMR, YF
Symptoms: Chills, Headache, Limb mass, Nodule
Clinical narrative: a golf-ball sized ball in arm; Initial information received on 05-Apr-2021 regarding an unsolicited valid  non-serious case from a non health care professional in courtesy from Pfizer.  This case involves female patient of unknown age who had a golf-ball sized ball in arm (limb mas) , after receiving YELLOW FEVER VACCINE, HEPATITIS B VACCINE ,HEPATITIS A VACCINE and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR VACCIN].  The patient has Familial Mediterranean Fever (FMF) but do not present active symptoms (Genetic asymptomatic carrier for Familial Mediterranean Fever) and also frequently suffered from migraines. Also reported that patient's immune system generally reacts strongly to all vaccines. Patient also has ongoing Allergy to Iodine. Patient reported that she shared all of this in case so as to help in documentation.  Past medical treatment(s), medical treatment(s), vaccination(s) and concomitant medication(s) was not provided.   In 2019, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer; a dose of suspect HEPATITIS A VACCINE not produced by Sanofi Pasteur ; a dose of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur and a dose of suspect MMR VACCIN not produced by Sanofi Pasteur (lot numbers and expiration dates were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  In 2019, the patient developed a non-serious strong reactions including a golf-ball sized ball in arm (limb mass), in the same year following the vaccinations and on the 3rd HepA/B dose.   It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  Steroids as a corrective treatment was received by the patient to bring down the limb mass.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.  It was also reported that at the age of 42 Years (Pregnancy: no); start Date/Time: [Pfizer] 10- Mar-2021 07:15 AM, patient received the most recent COVID-19 (coronavirus disease, Two doses) vaccine in Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and also no any other medications was received within 2 weeks of vaccination. Reported Event: For both doses: Chills for about an hour (began exactly 3 hours after the shot was administered in both doses). First dose had a hangover-type headache the day after the shot. Second dose the hangover-type headache started the same day as the shot and with much greater intensity. It was day 2 and the headache was still present but with less intensity. Some chills in the morning sporadically. Patient thanked and said let's get rid of this COVID pandemic. She did not received treatment for the adverse event;  Prior to vaccination, the patient  was not diagnosed with COVID- 19 and since the vaccination, she had not been tested for COVID-19; Vaccine Facility information available. Ethnicity information was available. Race information was available.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only the liquid portion of Pentacel with no reported adverse event; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from an other health care professional (HCP) via Medical Information (Reference number- 00542797).  This case is linked to case 2021SA110128 (same reporter).  This case involves a seven months old female patient who received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 0.5 ml third dose (batch number: UJ162AB, expiry date: 24-APR-2021, frequency: once, strength: standard) via an unknown route in unknown administration site on 25-Mar-2021 for prophylactic vaccination (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique (latency: same day).  Potential Product Technique Complain: No, Description: Stated that the liquid portion of Pentacel was given to two children and want to know what to do. HCP who reports two patients received the liquid portion of Pentacel. She stated they are unsure which patient received the incorrect dose and asks what to do about potentially giving an extra dose. Treatment: none. Emergency Room/ Doctor Visit and date: none.    At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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: 57.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product administration duration, Off label use, Product administered to patient of inappropriate age
Clinical narrative: 57 year old male patient administered Pentacel  twice 6 weeks apart, per order, but it is an off-label usage, no AE; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from a other health care professional via physician.  This case involves a 57 year old male patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (off label use).  Medical history included Bone marrow transplant.  Past vaccination included Adacel on 22-JUL-2020.  Medical treatment and family history were not provided.  Concomitant medications included on 02-Oct-2020 and 30-Nov-2020, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and on 02-Oct-2020, HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 02-Oct-2020 and 30-Nov-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to off label use in unapproved indication.  It was also reported that PENTACEL was not given in error, the physician ordered Pentacel and it was administered twice, 6 weeks apart, per order, but it is an off-label usage. He came back in for another Pentacel vaccine, but it was not administered because he just received the (COVID19) coronavirus disease 19 vaccine. He will return after the 2-week waiting period is over. Caller did not have patient chart at hand and injection site provided.  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: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient adminstered Pentacel without mixing the Hib component powder with no  AE; Initial information regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00537013) and transmitted to Sanofi on 26-Mar-2021.  This case involves a 63 days old female patient who administered 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing the Hib component (Lot U6842BA and UJ336AA expiry date 05-Jul-2021) once via Intramuscular in right thigh for prophylactic vaccination on 23-Mar-2021,(Product preparation issue).   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  Health care professional reported that patient was given Pentacel without the Hib component.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a patient received only the liquid portion of Pentacel/ No AE; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from an other health care professional (HCP) via Medical Information (Reference number- 00542797).  This case is linked to case 2021SA128613 (same reporter).  This case involves a five months old female patient who received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 0.5 ml third dose (batch number: UJ162AB, expiry date: 24-APR-2021, frequency: once, strength: standard) via an unknown route in unknown administration site on 01-Mar-2021 for prophylactic vaccination (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique (latency: same day).  Potential Product Technique Complain: No, Description: Stated that the liquid portion of Pentacel was given to two children and want to know what to do. HCP who reports two patients received the liquid portion of Pentacel. She stated they are unsure which patient received the incorrect dose and asks what to do about potentially giving an extra dose. Treatment: none. Emergency Room/ Doctor Visit and date: none. Reporter relationship: HCP. Product used: Used.   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 holders 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: 0.17
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered expired IPOL (On: 13-Mar-2021) vaccine with no reported AE.; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information  (Reference number- 00544725) and transmitted to Sanofi on 01-Apr-2021.  This case involves a 2-month-old male patient who administered expired IPV (VERO) [IPOL] vaccine on 01-Apr-2021 [Expired product administered].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 01-Apr-2021, the patient received a dose of suspect IPV (VERO) [lot R1B252M and expiry date: 13-Mar-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: on the same day].  It was reported that, the caller would like to know if the patient must be revaccinated and if there would be any adverse effects. The caller stated that a patient was administered IPOL today, 01-Apr-2021, less than 1 hour ago.   Details of laboratory data not 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: 53.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, Wrong product administered
Clinical narrative: Patient was administered with Pentacel vaccine which was expired with no reported AE; instead of Adacel patient administered Pentacel with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00544726) and transmitted to Sanofi on 01-Apr-2021.  This case involves a 53 year old female patient who instead of adacel administered pentacel (Wrong product administered) and also was administered with pentacel vaccine which was expired (Expired product administered), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Patient received no concomitant vaccines.  Medical history, medical treatment, vaccination and family history were not provided.   On 01-Apr-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot U6615AB and expiry date: 29-Mar-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported that, they intended to administer Adacel (Tdap) to the patient today (01-Apr-2021), but instead Pentacel, but only the DTaP-IPV component and not the Hib component, was inadvertently administered intramuscularly to the patient. In addition to that, the DTaP-IPV component of the Pentacel had expired on 29-Mar-2021. Facility was planning to re-vaccinate patient with Adacel. Reporter did not know the injection/administration site on the body where the vaccine was administered.  Product used : Used. First time product used: Yes  Still using product: No  It was a case actual medication error due wrong product administered and expired product administered. [latency: at the same time of vaccination] .  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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Neck pain, Pain, Paraesthesia, Pruritus
Clinical narrative: stinging all over is the same, especially with the back of her neck; rash; Felt like needles sticking; itchy skin; Initial information received on 05-Apr-2021 regarding an unsolicited valid  non-serious case from a non health care professional via Media Information (inquiry number 00547585).  This case involves female patient of unknown age who experienced stinging all over is the same, especially with the back of her neck (pain), rash, felt like needles sticking (paraesthesia) and itchy skin (pruritus), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   In 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious stinging all over is the same, especially with the back of her neck (pain), rash, felt like needles sticking (paraesthesia) and itchy skin (pruritus) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that caller stated she had the 2020 FLUZONE HIGH DOSE and had a terrible reaction that the company warns about. Caller stated she called several weeks ago and reported adverse reactions. Caller wanted to know what was in part 2 of the flu shot. Caller request the exact name.The caller wants to know the ingredients of the Fluzone HD Quad and said that she had called about having an extreme reaction to the second part of the Fluzone HD Quad injection. She stated during the call that the stinging all over was the same, especially with the back of her neck. She wanted to know what in the Fluzone HD Quad was she allergic to.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the patient did not recover  from the event pain , while the outcomes were unknown for rest of the events.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Rash, Vaccination complication
Clinical narrative: stinging all over is the same, especially with the back of her neck; rash; Felt like needles sticking; itchy skin; Initial information received on 05-Apr-2021 regarding an unsolicited valid  non-serious case from a non health care professional via Media Information (inquiry number 00547585).  This case involves female patient of unknown age who experienced stinging all over is the same, especially with the back of her neck (pain), rash, felt like needles sticking (paraesthesia) and itchy skin (pruritus), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   In 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious stinging all over is the same, especially with the back of her neck (pain), rash, felt like needles sticking (paraesthesia) and itchy skin (pruritus) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that caller stated she had the 2020 FLUZONE HIGH DOSE and had a terrible reaction that the company warns about. Caller stated she called several weeks ago and reported adverse reactions. Caller wanted to know what was in part 2 of the flu shot. Caller request the exact name.The caller wants to know the ingredients of the Fluzone HD Quad and said that she had called about having an extreme reaction to the second part of the Fluzone HD Quad injection. She stated during the call that the stinging all over was the same, especially with the back of her neck. She wanted to know what in the Fluzone HD Quad was she allergic to.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the patient did not recover  from the event pain , while the outcomes were unknown for rest of the events.  There will be no information on the batch number for this case.
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A 13-year old female received an expired dose of Ipol with no reported adverse event; Initial information regarding an unsolicited valid serious case was received from the other health professional (Reference number- US-SANOFI-00550189) and transmitted to Sanofi on 06-Apr-2021.  This case involves a 13 year old female patient who received an 0.5 mL expired dose of suspect IPV (VERO) [IPOL] [lot number: not reported, expiry date: 13-Mar-2021] via an intramuscular route at the left deltoid, on 05-Apr-2021 for prophylactic vaccination (expired product administered) (latency : on the same day).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was a case of actual medication error due to expired vaccine used. At the time of reporting, reporter would like to know if the patient needs to be revaccinated if received an expired IPOL vaccine.   It was also reported that the lot number was unknown due to the lot number not being documented and the vial discarded.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HIBV, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: products reached 8.5 degrees Celsius for 30 minutes and the excursion cause was unknown with no reported adverse event; Human error involved, stability data of vaccine was not reported, and vaccine was not administered hence it is a non case.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Product preparation issue
Clinical narrative: patient received ACT-HIB which was reconstituted with expired diluent/no adverse event; Initial information regarding an unsolicited valid non-serious case was received on 06-Apr-2021 from a health care professional (medical assistant) (Reference number- 00550125) and transmitted to Sanofi on 07-Apr-2021.  This case involves a 6 month-old male patient who was vaccinated with 0.5 mL HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with expired diluent (batch number UJ143AA; expiry date 03-May-2021 and expiry date of diluent 22-Mar-2021) via an unknown route at an unknown administration site on 07-Apr-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was also reported that "MA(medical assistant) also asked if all of the Act-HIB vaccines they had in that box with the expired diluent would also be considered not viable. MA confirmed that the Act-HIB and diluent were from the same brand new box, and vial used was the first vial taken from the box. MA was requesting letter stating different expiration dates should be expected for the Act-HIB and the diluent. MA suddenly had to go saying they had patients in the middle of the call. Attempted to call back MA for AE(adverse event) information but the front desk stated that she was still assisting patients and just asked a number she can call back". Additional description of event Adverse events: "MA explained that the expiration date for the Act-HIB itself and the diluent were different. The expiration date for Act-HIB in the vial was 03-May-2021 and the expiration date for diluent was 22-Mar-2021. Initial Response: It was discussed with MA that it was not atypical for the expiration dates to differ. It was discussed, dose administered was not considered valid as Act-HIB was reconstituted with expired diluent. MA also asked if having the expired diluent means all Act-HIB vaccines in the same box were no longer viable for use and use of alternate diluent was discussed. MA requested to her information that it was not atypical for the expirations to differ".  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event information was obtained from the consumer who received the vaccine.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Information (Reference number- 00550239).  This case involves a female patient (age not reported) who had allergic reaction (hypersensitivity) while receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number not reported via unknown route in unknown administration site.  In 2017 (date not reported), the patient developed a non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  The reporter were trying to find the components to what was in this vaccine so they could do further allergy testing, but they were struggling to do so online.  The details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Age: 1.33
Sex: M
Vaccine: DTAP, DTAPIPV
Symptoms: Medication error, Wrong product administered
Clinical narrative: inadvertently administered QUADRACEL instead of DAPTACEL, no AE; Initial information received on 06-Apr-2021 regarding an unsolicited valid  non-serious case from a nurse.  This case involves a 16 months old male who was inadvertently administered with 0.5 ml first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot O5763AA and expiration date 26-Aug-2022) via intramuscular route in the right thigh for prophylactic vaccination on 06-Apr-2021 (wrong product administered) instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE).  It was an actual medication error due to wrong vaccine administered (same day latency).   Also reported that the caller with questions on whether dose counts as valid dose of DTAP. Spoken with nurse supervisor, she had questions on if patient has already had 3 previous doses of IPV, does this extra dose of IPV pose any health risks?  It was not reported whether the patient had 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. 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: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00552062).  This case involves a 20-month-old male patient who received an expired 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5611BA and expiry date: 03-Apr-2021) via an unknown route in the right thigh (vastus lateralis) for prophylactic vaccination on 07-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and HIB VACCINE CONJ (OMPC) (PEDVAXHIB) for prophylactic vaccination.  This was a case of actual medication error due to expired vaccine used (latency 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 holders compliance with the requirements. 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: Expired product administered, Medication error
Clinical narrative: inadvertently administered an expired dose of ACT-HIB, no AE; formatting of the expiration date was confusing; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Agency (reference number- 00553490 and 00552458) and transmitted to Sanofi on 07-Apr-2021.  This case involves a HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date not reported) whose diluent was expired on 22-Mar-2021, and a 0.5ml dose was inadvertently administered to a five month old female patient via unknown route in unknown administration site for prophylactic vaccination on 07-Apr-2021 (expired product administered) and the formatting of the expiration date was confusing (Product label confusion).  Medical history, medical treatment(s), past vaccination(s), and family history were not provided.  Concomitant vaccines included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for prophylactic vaccination.   It was a case of an actual medication error due to expired vaccine used and Expiration date format confusion (latency same day).  The reporter stated that the patient was inadvertently administered an expired dose of ACT-HIB. Further, the reporter explained that the diluent of vaccine had expired on 22-Mar-2021. The contributing factor to the error was the format of the expiration date on the box which was "22 Mar 21." The healthcare professional (HCP) at the clinic interpreted this as "21-Mar-2022" rather that the correct expiration date was 22-Mar-2021. Also, it was reported that there was no actual damage or defect for the ACT-HIB, just the formatting of the expiration date was confusing.  At the time of this report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired 0.5ml dose of Menactra in the left deltoid, with no AE; Initial information received on 08-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17-year-old female patient who received an expired 0.5ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6576AB,  expiry date- 04-Apr-2021) in the left deltoid via an unknown route for prophylactic vaccination on 08-Apr-2021 (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported that, the Physician Assistant wanted to know if there is a grace period on the expiration date of a Menactra vaccine given? or do they need to call the patient back to revaccinate?  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: MNQ
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired Menactra vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Global Medical Information (GMI) (Reference number- 00555170) and transmitted to Sanofi on 09-Apr-2021.  This case involves a patient (demographics unknown) who was administered an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6565AA, expiry date: 28-Mar-2021) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (Expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day)  At the time of report, no adverse event was reported  The reporter had an incident where a patient was given an expired Menactra vaccine in one of the clinics. They were looking for documentation on whether or not the patient needs to be revaccinated..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired on 03Apr2021 was given with no reported adverse event; Initial information was received on 09-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional. (Inquiry number: 00555611).  It was reported that DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5611BA) (Suspension For Injection) was expired on 03-Apr-2021 and it was administered to a two-year-old male patient on 09-Apr-2021 for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  Concomitant medications included HEPATITIS A VACCINE, HEPATITIS B VACCINE and FLUZONE [FLUCONAZOLE].  At the time of report, 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. 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: TD, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a 12 years old patient received TENIVAC instead of ADACEL/ No AE; Initial information received on 12-Apr-2021 regarding an unsolicited valid non-serious case received from a nurse via (Reference number: 00557053).  This case involves a 12 years old male patient who received a 0.5 ml first dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] batch number: U6265AA, Frequency: once, Strength: Standard, Expiry date: 19-Apr-2021 via intramuscular route in the left deltoid on 10-Apr-2021 for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered).  The patient's past vaccination included Diphtheria, Tetanus, and Acellular Pertussis (DTAP) for which patient had completed five doses.  The patient's medical history, medical treatments and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered (latency: same day).  Potential Product Technique Complain: No. Caller with question on whether dose of ADACEL needs to be administered.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received his Pediarix vaccine and was prescribed a HIB vaccine as well, but was instead administered a Pentacel vaccine, with no reported adverse event; Initial information was received on 12-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional ( Inquiry number: 00557376).  It was reported that vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: S006471 ) (Suspension For Injection) was administered to a six-year-old male patient instead of HIB vaccine on 09-Apr-2021 via intramuscular route at right thigh for prophylactic vaccination (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered.  On an unknown date, the patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur.  At the time of report, 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 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.