chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation error
Clinical narrative: patient in the office last week received only the liquid DTaP-IPV portion of PENTACEL and did not receive the lyophilized Hib powder portion with no ae; Initial information received on 28-Sep-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 4-month-old and unknown gender patient who was in the office last week received only the liquid dtap-ipv portion of pentacel and did not receive the lyophilized hib powder portion with while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue).   The patient medical history, medical treatment(s), vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product preparation issue [latency: on the same day].  It was reported "Pediatrician states that a patient in the office last week received only the liquid DTaP-IPV portion of PENTACEL and did not receive the lyophilized Hib powder portion. Caller asked if the patient required an additional injection of PENTACEL or if they could receive stand alone ACTHIB to account for the missing portion of PENTACEL".  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, UNK
Symptoms: Extra dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: the patient received an extra ACT-HIB and IPOL dose with no reported avderse event; patient who was supposed to receive DAPTACEL and IPOL, but instead was given PENTACEL and IPOL, with no adverse event; Initial information received on 28-Sep-2021 regarding an unsolicited valid non-serious case from a physician and consumer/ non healthcare professional via Global Media Information (under reference 00789175).  This case involves a 4 year old patient (unknown gender) who received an extra ACT-HIB and POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) dose (extra dose administered) as patient was supposed to receive DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) and POLIOMYELITIS VACCINE (INACTIVATED) (IPOL), but instead was given DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO) and POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) [wrong product administered].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect PENTACEL (VERO), dose of suspect IPOL (lot number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error due to extra dose administered and wrong vaccine administered (same day latency).  It was reported "Physician states that a 4 year old patient was supposed to receive DAPTACEL and IPOL. However he received PENTACEL and an extra dose of ACT-HIB instead. Because of this, the patient received an extra ACT-HIB and IPOL dose. The Physician asks if there will be a harmful effect from the ACT-HIB and IPOL doses. The Physician was in a hurry and did not have time to provide any AE information. He asked that we email any information and then call him back."  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. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired dose of YF-VAX, no AE; Initial information received on 28-Sep-2021 regarding an unsolicited valid non-serious case from another health professional via Medical Information (Reference number- 00789201).  This case involves patient (unknown demographics) who was vaccinated with the expired dose of suspect YELLOW FEVER VACCINE - US [YF-VAX], (expired product administered).  The patient's medical history, past medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US (vaccine lot number UJ372AA and expiry date: 22-Jul-2022, diluent lot number: U6427AA and expiry date: 20-Sep-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Caller reports that YF-VAX was received a few months ago and the actual product had a good expiration date but the diluent was short-dated and it expires Sep2021; caller requests replacement for diluent. Caller disconnected while on hold. caller further clarified that she spoke with Pasteur Customer Service and they sent a replacement diluent but she was sent sterile water. How purchased: Vaccine Shoppe, Number of units affected- 5 vaccines, Is dose not used or not available not used- not used, Whether product is available for return- diluent available for return o If the customer says no then advise them that if this happens again to retain the product for return to better assist in the investigation. If the customer states picture are available, ask to send us the picture. No broken vials or syringes with needles can be returned. Information to be gathered on the type of needle that was used by the end-user (e.g. gauge size)".  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Syringe issue, Underdose
Clinical narrative: unsure how much of the dose with no AE; good portion of the dose squirted out from the syringe with no AE;Initial information received on 28-Sep-2021 regarding an unsolicited valid non-serious case received from physician and consumer/non-healthcare professional via call center via Medical Information (Reference number- 00789259).  This case involves a 2-month-old female patient who experienced "good portion of the dose squirted out from the syringe" (syringe issue) and "unsure how much of the dose" (underdose) when received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  On 27-Sep-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ474AA and expiry date: 09-Jul-2022) via an intramuscular route in a right thigh for prophylactic vaccination.  It was reported "Caller with question on whether dose needs repeating"  This case include syringe issue and underdose (latency: same day).  It was not reported if the patient received a corrective treatment for the events.  At time of reporting no clinical adverse event reported.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received that FLUZONE HD vaccine a week before with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician and consumer/non-health care professional via Company (Reference number- 00790680) and transmitted to Sanofi on 29-Sep-2021.  This case involves a 77-year-old male patient who experienced received that INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] vaccine a week before (inappropriate schedule of product administration)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 20-Sep-2021, the patient received first 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and on 28-Sep-2021 he also received same second dose of the same vaccine (lot: UJ716AC and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination (inappropriate schedule of product administration).  It was reported "Patient who received two doses of FLUZONE HD within 8 days of each other. First dose was 20Sep2021 and second dose was 28Sep2021. Caller wants to know if there is anything they should do or watch for. The patient did not realize that he received that FLUZONE HD vaccine a week before and the HCP (health care professional) giving the second dose did not see the documentation of the first FLUZONE HD vaccine".  This case was an actual medication error due to inappropriate schedule of vaccine administered (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: 12.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 12 year old patient received FLUBLOK QUADRIVALENT vaccine with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other-healthcare professional via consumer/non-health care professional via Medical Information (Reference number- 00790998) and transmitted to Sanofi on 29-Sep-2021.  This case involves a 12-year-old male patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), and family history were not provided.  The patient had no other vaccine.   On 25-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2109, expiry: 31-May-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  No other adverse event was reported.  It was reported "reporting that she administered FLUBLOK QUADRIVALENT to a 12-year-old patient. she monitored the child for 20 minutes post injection, she states that the child is showing no adverse reactions and that his weight is the weight of an adult, she is also questioning if another flu vaccine should be administered to the patient"   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 61 year old male patient received dose of FLUZONE HD QIV vaccine with  no AE; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (Reference number- 00791077).  This case involves a 61 year old male patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 28-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ749AA and expiry date: 30-Jun-2022) (frequency: Once) via an intramuscular route in the left for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency on same day).  It was reported "office manager calling about the administration of FLUZONE HD QIV to a patient younger than 65. Caller would like to know how to proceed?"  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 59 year old female patient received dose of FLUZONE HD QIV vaccine with  no AE; 59 year old female patient received dose of FLUZONE HD QIV vaccine with  no AE; 59 year old immunocompromised female patient received dose of FLUZONE HD QIV vaccine with  no AE; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case from a Pharmacist via Medical Information (Reference number- 00791205).  This case involves a 59 year old immunocompromised female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age, overdose and contraindication to vaccination).  The patient's past medical history included Organ transplant with immunocompromised.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  On 20-Nov-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ482AA and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration and Overdose (latency on same day).  It was also case of contraindication to vaccination (latency on same day).  It was reported "Consumer is 59 Pharmacist states the consumer received the Fluzone High Dose last year on 20Nov2020 and is asking to receive it again this year since she is a transplant patient but she hasn't given it yet. Pharmacist is very busy and limited information provided also consumer received it at a different location last year".  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: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was inadvertently administered the Fluzone High-Dose Quadrivalent vaccine, rather than the Fluzone Quadrivalent vaccine, with no reported adverse event; FLUZONE HIGH DOSE QUADRIVALENT was given to a consumer under 65 with no adverse event; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist and consumer/ non healthcare professional via Media Information (under reference 00791217).  This case is linked to case 2021SA326021 (CLUSTER).  This case involves a 63 years old female patient who was inadvertently administered the QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), rather than the QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) [wrong product administered and product administered to patient of inappropriate age].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a 0.7 mL dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (Total, lot UJ733AA and expiration date: 30-Jun-2022) via intramuscular route to the left deltoid for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (same day latency).  It was reported "HCP (Healthcare Professional) stated FLUZONE HIGH DOSE QUADRIVALENT was given to a consumer under 65 and wanted to know if there was any data? pharmacist stated that two patients under age 65 had inadvertently been administered the Fluzone High-Dose Quadrivalent vaccine. Pharmacist reported that the patient is not experiencing any adverse effects so far."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was supposed to receive PENTACEL, however received QUADRACEL instead/ NO AE; 15 month old patient received QUADRACEL vaccine/ NO AE;Initial information regarding an unsolicited valid non-serious case was received from another health care professional via Medical Information (Reference number- 00792516) and transmitted to Sanofi on 30-Sep-2021. This case involves a 15 months old male patient who received a was supposed to receive DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] however received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead (wrong product administered and product administered to patient of inappropriate age).  Medical history, concomitant medication, past medical treatment, vaccination and family history were not provided.  On 30-Sep-2021, the patient received 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength: standard, frequency: once, lot number: C5916AA, expiry date: 06-Jul-2023 via an intramuscular rote in the left thigh) instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) for prophylactic vaccination.  no other vaccines.  It was reported '' Caller stated nurse gave a 15 month old QUADRACEL. Wants to know about redosing? Is this sufficient as a dtap dose,. Call transferred. Nurse states that a 15 month old patient was supposed to receive PENTACEL, however received QUADRACEL instead. Nurse asks if if the QUADRACEL is a valid dose and if the patient just needs the ACT-HIB dose now. She also asks if the QUADRACEL will harm the patient since he is only 15 months old. Nurse states that the patient did not experience any adverse events (AE's) as a result of this. Compared components of QUADRACEL and PENTACEL. Explained the only missing component would be the ACT-HIB. Referred to healthcare professional (HCP). Additional Description of event Adverse events: Caller stated nurse gave a 15 month old QUADRACEL. Wants to know about re-dosing. Is this sufficient as a dtap dose.''  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Incorrect route of product administration, Injection site haemorrhage, Medication error
Clinical narrative: Noticed blood on her skin after they removed the needle; IMOVAX should not be injected into a blood vessel; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non health care professional via Information (under the reference 00792602).  This case involves a female patient (unknown age) who had noticed blood on her skin after they removed the needle (vaccination site haemorrhage) after receiving RABIES (HDC) VACCINE [IMOVAX RABIES] and while treated with HUMAN RABIES IMMUNOGLOBULIN [IMOGAM RABIES-HT] (incorrect route of product administration).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect IMOVAX RABIES (lot number and expiration date not provided) via unknown route in the left arm for unknown indication and a dose of suspect IMOGAM RABIES-HT (Solution for injection dosage, lot number and expiration date not provided) via unknown route in left thigh for unknown indication.  On an unknown date the patient noticed blood on her skin after they removed the needle (vaccination site haemorrhage, non serious) (unknown latency) following the administration of HUMAN RABIES IMMUNOGLOBULIN and IMOVAX RABIES.  It was an actual medication error due to incorrect route of vaccine administration (latency same day).  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the events.  It was reported "she received IMOVAX and IMOGAM at an emergency room. Caller states after receiving IMOVAX and IMOGAM, everything has been "fine". Caller states she was researching what she should and should not do after receiving these products. Caller states in her research, it was mentioned that IMOVAX should not be injected into a blood vessel; states after she received IMOVAX, she noticed blood on her skin after they removed the needle; states she did not note blood or discoloration in syringe; caller asks if this is okay."  There will be no information on the batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 74.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: they received a shipment of FLUZONE HIGH DOSE that has been in transit for a few days. It was supposed to have been returned but it wasn't and three doses were administered, no AE; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist via regulatory authority (under reference 00792823).  This case involves a 74 year old male patient who was administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] of which the shipment was delivered too late and it was supposed to have been returned but it was not, and three doses were administered (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 29-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ763AC and expiry date: 30-Jun-2022, Frequency: once) via an intramuscular route in the left upper arm for prophylactic vaccination.  It was an actual case of medication error due to incorrect product storage.  It was reported "pharmacist/manager states a shipment of FLUZONE HIGH DOSE (HD) Quadrivalent (QIV) (522 - FLZ HD HV QIV) was delivered too late and caller had already spoken to Pasteur CS. However, 3 of the vaccines in the shipment were administered to patients so Pasteur CS transferred her to us to get more information about how to move forward. Call transferred from Pasteur agent Caller states that they received a shipment of FLUZONE HIGH DOSE that has been in transit for a few days. It was supposed to have been returned but it was not, and three doses were administered."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Muscle spasms, Musculoskeletal stiffness, Pain, Upper limb fracture
Clinical narrative: feels like a cramp; fell and broke her left arm; stiffness that comes and goes and rotates from her right arm, shoulders, hips, legs and feet; pain; fell and broke her left arm; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00792710) and transmitted to Sanofi on 30-Sep-2021. This case involves a 65 years old female patient who fell (fall) and broke her left arm (upper limb fracture), feels like a cramp (muscle spasms), pain and stiffness (musculoskeletal stiffness), while received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, concomitant medication, past medical treatment, vaccination and family history were not provided. Patient had ongoing metal allergy like cobalt, thimerosal and knows it was probably the aluminum and 2-phenoxethanol that is causing her the issues with the vaccine.  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [oral solution, lot number: LU6922AA, expiry date: 22-Jan-2023], via an intramuscular route in right deltoid for prophylactic vaccination.  On 26-Sep-2021, the patient fell (fall) and broke her left arm (upper limb fracture) and went to the emergency room (suggested that she had the vaccine), pain and stiffness (musculoskeletal stiffness) that comes and goes and rotates from her right arm, shoulders, hips, legs and feet bu she wouldn't know about her left arm since it is casted and broken same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On an unknown date the patient developed a non-serious doesn't have cramps but feels like a cramp (muscle spasms) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported ''Paperwork states Adacel doesn't have a preservative but the list is incorrect because those are preservatives.''  Other relevant laboratory test were not provided.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was recovering from all the reported events.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: a shipment of FLUZONE HD QIV was delivered too late and caller had already spoken. However, 3 of the vaccines in the shipment were administered to patients, no AE; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via Agency inbound (reference number- 00792822) and transmitted to Sanofi on 30-Sep-2021.  This case involves INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] whose shipment was delivered too late, However, the vaccines in the shipment was administered to an 86 year old female patient (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On 29-Sep-2021, the patient received a dose (0.7ml) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ763AC; expiry date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was case of actual medication error due to incorrect product storage (latency: unknown).  It was reported "Pharmacist states a shipment of FLUZONE HD QIV was delivered too late and caller had already spoken. However, 3 of the vaccines in the shipment were administered to patients."  Also, the reporter mentioned that the shipment had been in transit for a few days. It was supposed to have been returned but it was not.  No adverse events were reported at the time of this report.  At the time of this report, the outcome of the event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 72.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: shipment of FLUZONE HD QIV was delivered too late. It was supposed to have been returned but it wasn't / no reported AE; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist via regulatory authority (under reference 00792823).  This case involves a 72-year-old female patient who was administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] of which the shipment was delivered too late and it was supposed to have been returned but it was not, and three doses were administered (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 29-Sep-2021, the patient received a dose of 0.7mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ763AC, expiry date 30-Jun-2022 ) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual case of medication error due to incorrect product storage.  It was reported "pharmacist/manager states a shipment of FLUZONE HIGH DOSE (HD) Quadrivalent (QIV) (522 - FLZ HD HV QIV) was delivered too late and caller had already spoken to Pasteur CS. However, 3 of the vaccines in the shipment were administered to patients so Pasteur CS transferred her to us to get more information about how to move forward. Call transferred from Pasteur agent Caller states that they received a shipment of FLUZONE HIGH DOSE that has been in transit for a few days. It was supposed to have been returned but it was not, and three doses were administered."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: HIB portion of Pentacel was reconstituted with sterile water and she did not mix it with the DTAP-IPV vaccine/no AE; Initial information regarding an unsolicited valid non-serious case was received on 30-Sep-2021 from Nurse and Consumer/non-health care professional via Medical Information (Reference number- 00792982) and transmitted to Sanofi on 30-Sep-2021.  This case involves a patient (unknown age and gender) who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received (once) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [strength: standard; lot number and expiry date was not reported] not reported via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported "Nurse states that when she administered PENTACEL to a patient, she only administered the HIB portion in the blue vial; she did not mix it with the DTAP-IPV vaccine in the green vial. Nurse states the she reconstituted HIB portion with 2 mL of sterile water. Nurse asks if this would be considered a valid HIB vaccine. This agent referred nurse to the PENTACEL".  This agent asked nurse to provide information for an AE (adverse event)/safety report; Therapy Date, Patient Information (patient age less than 1 year enter as 2 month , 4 month, etc. Many pediatric vaccines need month for age), route and site, dose, event information and treatment, concomitant medication - nurse stated she was not allowed to provide all these information.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency on the same day of vaccination).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the lot number for this case.
Age: 12.0
Sex: M
Vaccine: DTAP, HPVX, MNQ
Symptoms: Underdose
Clinical narrative: Patient missed HPV and Tdap vaccine/ NO AE; Patient received only half of the MENACTRA dosage/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from the consumer or non-healthcare professional via Medical Information (Reference number: 00793014).  This case involves 12-year-old male patient who jump away/ jerked and run off when he was trying to receive a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] about only half the dosage was administered (underdose) and dad was supposed to bring him back but he missed his appointment. He was supposed to get his DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and HPV VACCINE but missed those (product dose omission issue).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 21-Sep-2021, the patient received a total dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin skin test, strength: standard, lot number: U7087AA, expiry date: 05-Oct-2022] via an intramuscular route at an right deltoid for prophylactic vaccination.  It was an actual medication error case due to Vaccine underdose and missed dose (latency: same day).  No other vaccines.  It was reported " Office manager states they had a patient jump away and run off while they were trying to administer a dose of MENACTRA to the patient. Caller states about only half the dosage was administered. Caller states he was supposed to get his human papilloma virus (HPV) and combined tetanus, diphtheria and acellular pertussis (Tdap) but missed those".   Caller would like to know if they need to fully revaccinate or if there is another way to move forward.  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. 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: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 year old child recevied fluzone HD QIV/no AE; Overdose; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and consumer/non-healthcare professional via call center via Agency (Reference number- 00793015).  This case is linked to case 2021SA328195(CLUSTER).  This case involves a 7-year-old (unknown gender) patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 25-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ747AA and expiry date not reported) via an intramuscular route at a the left thigh for prophylactic vaccination.  It was an actual medication error case due to overdose and inappropriate age at vaccine administration (latency: same day).  It was reported "Nurse manager reports that two of their patients; a 9 year-old child and a 7 year-old child, received a FLUZONE HIGH-DOSE QUADRIVALENT. She is seeking information to provide to the children's mother."  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 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: 9.0
Sex: U
Vaccine: FLU4
Symptoms: Diarrhoea, Medication error, Overdose, Product administered to patient of inappropriate age
Clinical narrative: diarrhoea; 9 years patient received FLUZONE HIGH-DOSE QUADRIVALENT; 9 years patient received FLUZONE HIGH-DOSE QUADRIVALENT; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from nurse and consumer/non-healthcare professional via call center via Regulatory authority (Reference number- 00793047).  This case is linked to case 2021SA328686 (CLUSTER).  This case involves a 9-year-old patient (unknown gender) who experienced diarrhoea, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age, overdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  On 25-Sep-2021, the patient received a 0.7mL {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (solution for injection, lot number: UJ747AA and expiry date not reported) via an intramuscular route at a the left thigh for prophylactic vaccination.  On an unknown date, the patient developed a non-serious diarrhoea (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was also a case of actual medication error due to Inappropriate age at vaccine administration and overdose. (latency was on same day).  It was reported "Nurse manager reports that two of their patients; a 9 year-old child and a 7 year-old child, received a FLUZONE HIGH-DOSE QUADRIVALENT. She is seeking information to provide to the children's mother."  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the event (diarrhoea).  At time of reporting, outcome of the events was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.08
Sex: M
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: ACT-HIB reconstituted with sterile water instead of 0.4% NaCl saline diluent with no reported adverse event; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional via the [Reference Information (MI) - 00793063].  This case involves a 13 month-old male patient who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] which reconstituted with sterile water instead of 0.4% NaCl saline diluent (Product preparation error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and HEPATITIS A VACCINE  for prophylactic vaccination.  On 29-Sep-2021, the patient received first dose 0.5 mL suspect HIB (PRP/T) VACCINE  (strength: standard; lot UJ383ABA and expiry date 11-Oct-2021) via an intramuscular route in the right vastus lateralis for prophylactic vaccination.  It was reported "Caller reports that a patient was administered ACT-HIB; states ACT-HIB was reconstituted with sterile water instead of the provided 0.4% NaCl saline diluent. Caller asks if this dose would be considered valid. Caller also asks, since ACT-HIB would not be considered valid, if patient should be revaccinated right away or if there is a waiting period. Caller states that patient did not receive treatment for adverse events related to ACTHIB".  It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.