chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's reported; Improperly Stored; Administered; This spontaneous report was received from a registered nurse (also reported as a certified medical assistant) and refers to a 12-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 13-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) one dose, lot # U002394 was confirmed to be valid, expiration date 22-JAN-2023, for prophylaxis (dose, route and site of administration were not reported). The administered dose was exposed to the temperature from -10 degrees Celsius (C) to 8 C (4 C) for 20 minutes on 07-SEP-2021 and from -10 C to 8 C (4 C) for 20 minutes 09-SEP-2021 (both during transport). There was also previous temperature excursion reported as from -10 C to 8 C for 7 hours and 30 minutes. No additional adverse event was reported; Sender's Comments:  US-009507513-2109USA005628:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; Inadvertently administered post expiration; This spontaneous repot was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported.  On 22-SEP-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, once,  lot # S019581 was confirmed to be valid, expiration date 25-JUN-2021, for prophylaxis (route and site of administration were not reported). No additional adverse event was reported.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's reported; temperature excursion for VARlVAX / have been administered to patients; This spontaneous report was received from a registered nurse (also reported as a certified medical assistant) and refers to a 5-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 13-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) one dose, lot # U002394 was confirmed to be valid, expiration date 22-JAN-2023, for prophylaxis (dose, route and site of administration were not reported). The administered dose was exposed to the temperature from -10 degrees Celsius (C) to 8 C (4 C) for 20 minutes on 07-SEP-2021 and from -10 C to 8 C (4 C) for 20 minutes 09-SEP-2021 (both during transport). There was also previous temperature excursion reported as from -10 C to 8 C for 7 hours and 30 minutes. No additional adverse event was reported; Sender's Comments:  US-009507513-2109USA005628:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AEs or PQC reported.; expired dose of PNEUMOV AX 23 was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported.  On 22-SEP-2021, the patient was vaccinated with an expired dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, subcutaneously, lot # S024808 was confirmed to be valid, expiration date 02-JUN-2021, for prophylaxis (site of administration was not reported). No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Doses of PEDVAXHIB had been administered following a temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 12-AUG-2021, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (route of administration was not reported), lot # T026961 and expiration date 02-APR-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion below 2 degree celsius (°C) (-40°C) and above of 8°C (9.6°C) for 15 minutes and 1 hour respectively on an unknown date; no previous temperature excursions were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA007655: US-009507513-2108USA007711: US-009507513-2109USA006020: US-009507513-2109USA006021: US-009507513-2109USA006022: US-009507513-2109USA006023:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Doses of PEDVAXHIB had been administered following a temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 16-AUG-2021, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (route of administration was not reported), lot # T026961 and expiration date 02-APR-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion below 2 degree celsius (°C) (-40°C) and above of 8°C (9.6°C) for 15 minutes and 1 hour respectively on an unknown date; no previous temperature excursions were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA007655: US-009507513-2108USA007711: US-009507513-2109USA006019: US-009507513-2109USA006021: US-009507513-2109USA006022: US-009507513-2109USA006023:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Doses of PEDVAXHIB had been administered following a temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 20-AUG-2021, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (route of administration was not reported), lot # T026961 and expiration date 02-APR-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion below 2 degree celsius (°C) (-40°C) and above of 8°C (9.6°C) for 15 minutes and 1 hour respectively on an unknown date; no previous temperature excursions were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA007655: US-009507513-2108USA007711: US-009507513-2109USA006019: US-009507513-2109USA006020: US-009507513-2109USA006022: US-009507513-2109USA006023:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Doses of PEDVAXHIB had been administered following a temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 20-AUG-2021, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (route of administration was not reported), lot # T026961 and expiration date 02-APR-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion below 2 degree celsius (°C) (-40°C) and above of 8°C (9.6°C) for 15 minutes and 1 hour respectively on an unknown date; no previous temperature excursions were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA007655: US-009507513-2108USA007711: US-009507513-2109USA006019: US-009507513-2109USA006020: US-009507513-2109USA006021: US-009507513-2109USA006023:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Doses of PEDVAXHIB had been administered following a temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 20-AUG-2021, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (route of administration was not reported), lot # T026961 and expiration date 02-APR-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion below 2 degree celsius (°C) (-40°C) and above of 8°C (9.6°C) for 15 minutes and 1 hour respectively on an unknown date; no previous temperature excursions were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA007655: US-009507513-2108USA007711: US-009507513-2109USA006019: US-009507513-2109USA006020: US-009507513-2109USA006021: US-009507513-2109USA006022:
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the liquid component of Menveo was administered; Only the liquid component of Menveo was administered; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that currently the clinic was trying to identify the patient and date of the error. It was unknown which patient only received a partial vaccine dose.  The error was found during an inventory audit.  The clinic was running a report in an attempt to identify the patient. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a health care professional and concerned multiple patients of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients died of unknown cause of death after receiving Janssen vaccine. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210940869-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous (non-serious) report received from a consumer, concerned a male of unspecified age. The patient's height and weight not reported. No past medical history, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, batch/lot# and expiry: unknown), route of admin and dose not reported, administered Apr 2021, for immunization. On an unspecified date, patient experienced headache; with outcome of not reported. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. Per procedure, no follow-up will be requested for this case. This case, from the same reporter is linked to 20210946745.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: RECEIVED EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced received expired vaccine. On 23-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the received expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210946670.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous (non-serious) report received from a patient, concerned a female of unspecified age. The patient's height and weight not reported. No past medical history, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, batch/lot# and expiry: unknown), route of admin and dose not reported, administered Apr 2021, for immunization. On an unspecified date, patient experienced headache; with outcome of not reported. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. Per procedure, no follow-up will be requested for this case. This case, from the same reporter is linked to 20210946560.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Heart rate, Heart rate increased
Clinical narrative: FAST HEART RATE, WHICH LASTED ABOUT 10 MINUTES; ABDOMINAL PAIN IMPROVED AFTER 25 MINUTES FROM TAKING IBUPROFEN, IT WENT AWAY AFTER 40 MINUTES; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included: reacted to iron injection, and concurrent conditions included: non smoker, abstains from alcohol, wheat, nut and sea food allergy, rhythm issues, and tachycardia, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 19-OCT-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. Concomitant medications included flecainide for tachycardia.  On 22-SEP-2021, the patient experienced fast heart rate, which lasted about 10 minutes. On 22-SEP-2021, the patient experienced abdominal pain improved after 25 minutes from taking ibuprofen, it went away after 40 minutes. Laboratory data included: Heart rate (NR: not provided) 117-120 beats per minute. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart rate, which lasted about 10 minutes, and abdominal pain improved after 25 minutes from taking ibuprofen, it went away after 40 minutes on 22-SEP-2021. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus
Clinical narrative: ITCHING ALL OVER BODY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, from 13-MAY-2021 for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 2021, the patient experienced itching all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of itching all over body was not reported. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-SEP-2021, the patient experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: UNKNOWN) dose was not reported, administered on 23-SEP-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: your vaccine is injuring people; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (your vaccine is injuring people) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (your vaccine is injuring people). At the time of the report, VACCINATION COMPLICATION (your vaccine is injuring people) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details not provided.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: a pregnant patient was administered Fluzone, with no reported adverse event; Initial information received on 15-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health professional.  This case involves a 28 years old female pregnant patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [exposure during pregnancy].   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 31 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] at 31 weeks of pregnancy, during third pregnancy trimester for the vaccine.  The date of last menstrual period was reported as 14-Feb-2021.  The estimated due date was 08-Nov-2021.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 15-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7325QA; expiry date: 30-Jun-2021; Form: suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  At time of reporting, the outcome was unknown for the reported event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: vaccine is to be administered with a dosage of one part liquid and 1 part powder but infant was only administered the liquid with no adverse event; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involved a 2 months old (unknown gender) patient who had DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with a dosage of one part liquid and 1 part powder but infant was only administered the liquid (Product preparation issue).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was actual an medication error due to inappropriate reconstitution technique.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  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 reported "The vaccine is to be administered with a dosage of one part liquid and 1 part powder. The infant was only administered the liquid. Patient wanted to know the best way to proceed in regards to assuring that the infant receives the proper dosage. I placed them on hold while contacting medical facility for medical advice. . I made contact. I briefed them on the situation and told them that I would send a copy of the Safety Data Sheet (SDS) by email. I conferenced them in with the caller before leaving the line for privacy".  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: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: A 6 month old patient was vaccinated with Fluzone High dose quadrivalent, with no AE; A 6 month old patient was vaccinated with Fluzone High dose quadrivalent, with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via consumer/non-health care professional via Medical Information (Reference number- 00772888) and transmitted to Sanofi on 16-Sep-2021.  This case involves a 6-month-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and Accidental overdose).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 16-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ733AB, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and Overdose accidental (latency same day).  It was reported "Caller reported by accident, a FLUZONE HIGH-DOSE VACCINE was given to a 6 month old child. Caller wanted to know what she should do from here. Caller states that FLUZONE HIGH DOSE QUADRIVALENT 21-22was given to a six month old at a different location. "What should we watch for safety and side effects?"   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: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: supposed to vaccinate a patient with Adacel, however vaccinated her with Influrix instead, with no reported adverse event; Initial information received on 16-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non- health care professional via Medical Information (Reference number- 00773258).  This case involves a 51 years old female patient who was supposed to vaccinate a patient with adacel, however vaccinated her with influrix instead, with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On 01-Jul-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to 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 holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: He received his day three dose, a day late and his day seven dose on 16sep2021, with no adverse event; nitial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non healthcare professional via Information (under reference 00774476).  This case involves a male patient (unknown age) who received his day three dose of RABIES VACCINE (IMOVAX RABIES), a day late and his day seven dose on 16sep2021(inappropriate schedule of product administration).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  The patient received first, second and third dose of the suspect IMOVAX RABIES (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination on 09-Sep-2021, 13-Sep-2021 and 16sep2021 respectively.  It was a case of an actual medication error due to Inappropriate schedule of product administered.  It was reported "Pharmacist reports a male patient, receiving post-exposure vaccination, was administered his day 0 dose on 09sep2021, he then received his day 3 dose, a day late, on 13sep2021. He came in for his day 7 dose on 16sep2021, which would have been the day it was due, if he hadn't received his day 3 dose late, but is now a day early, per interval guidelines.. The dose was administered and they have now received an order for him to receive his day 14 dose on 23sep2021. Pharmacist is asking if these interval irregularities will affect efficacy."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: ACT-HIB was administered to a 2 year old but it was expired as of June of this year.- with no reported adverse event; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from a other health care professional and consumer non health care professional via Global Medical Information number: 00774839. This case involves a 2 years old female patient who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE VACCINE [ACT-HIB] (wrong product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 17- SEP -2021, the patient received a 0.50 mL dose of suspect HIB (PRP/T) VACCINE batch number: UJ327AA and expiry date: 30-SEP-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  IT was reported that "The Medical Information agent confirmed the spelling of demographics with the caller for accuracy".  At time of reporting, the patient was not recovered 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.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently given a dose of Fluzone Quadrivalent instead of Fluzone High-Dose with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Pharmacist via Medical Information (Reference number- 00774841) and transmitted to Sanofi on 17-Sep-2021.  This case involves a 65 years old female patient who was inadvertently given a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a 0.5 mL (once, total) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date were not reported) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE via unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  It was reported "He inquired whether the patient could receive a dose of Fluzone HD. Second: He requested the stability letter for Fluzone Quadrivalent, Fluzone High-Dose and Flublok."  It was an actual medication error case due to wrong vaccine administered (latency: same day).  At the time of reporting, the patient experienced 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 on the batch number for this case.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect dose administered
Clinical narrative: a patient was administered a 1 ml dose of IPOL vaccine/ No AE; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician via consumer via phone via Agency number: 00775098.    This case is linked to cases 2021SA311330, 2021SA312326, 2021SA314197 and 2021SA314182 (same reporter)  This case involved 4-year-old female patient was administered a 1 ml dose of IPV (VERO) [IPOL] vaccine (overdose)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received 1ml total dose of suspect IPV (VERO) (lot: U1A452M and expiry date: 20-Feb-2023) frequency: once, strength: standard via unknown route in unknown administration site for prophylactic vaccination (overdose).  It was a case of overdose (latency: same day).   It was reported " Caller/ Medical Assistant reports that IPOL was administered to 5 patients, caller states that she does not know if patients received a 1 mL dose or a 0.5 mL dose, caller requests information on possible adverse effects from a 1 mL dose of IPOL. Caller states she does not have time to look through all patient charts for adverse event information, she will call back at a less busy time."  At time of reporting, no adverse event was reported.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered
Clinical narrative: a patient was administered a 1 ml dose of IPOL vaccine/ No AE; Initial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case received from another health care professional via physician via consumer via phone via Medical Information number: 00775110.    This case is linked to cases 2021SA311330, 2021SA312326, 2021SA314197 and 2021SA312255 (same reporter)  This case involved 5-year-old male patient was administered a 1 ml dose of IPV (VERO) [IPOL] vaccine (overdose)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received 1ml total dose of suspect IPV (VERO) (lot: U1A452M and expiry date: 20-Feb-2023) frequency: once, strength: standard via unknown route in unknown administration site for prophylactic vaccination (overdose).  It was a case of overdose (latency: same day).   It was reported " Caller/ Medical Assistant reports that IPOL was administered to 5 patients, caller states that she does not know if patients received a 1 mL dose or a 0.5 mL dose, caller requests information on possible adverse effects from a 1 mL dose of IPOL. Caller states she does not have time to look through all patient charts for adverse event information, she will call back at a less busy time."  At time of reporting, no adverse event was reported.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: an expired dose of ADACEL that was administered/no AE; Initial information received on 20-Sep-2021 regarding an unsolicited valid non-serious case received from an other healthcare professional and consumer/non-healthcare professional via call center via Global Medical Information (Reference number- 00776414).  This case involves an 11-year-old male patient who received an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 20-Sep-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5666BA and expiry date: 17-Sep-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Office gave ADACEL to a patient that was 3 days expired."  The Medical Information agent confirmed the spelling of demographics with the caller for accuracy. Confirmed with Medical Assistant that she is calling about an expired dose of ADACEL that was administered, and the office would like to know what to do from here.  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.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Syringe issue, Underdose
Clinical narrative: The caller stated that most of the medication came out of the syringe and did not go into the patient, with no adverse event; the medication came out of the syringe with no adverse event; Initial information received on 20-Sep-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non healthcare professional via Media Information (under reference 00776928).  This case involves a patient (unknown age and gender) who was vaccinated with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), but most of the medication came out of the syringe and did not go into the patient (underdose and syringe issue).  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 FLUZONE HIGH-DOSE QUADRIVALENT (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to vaccine underdose and syringe leak (same day latency).  It was reported "The caller stated that a call back on 21 SEP 2021 is okay as she is ending her shift for today. The caller stated that she administered a FLUZONE HIGH DOSE QUADRIVALENT injection to a patient today. The caller stated that most of the medication came out of the syringe and did not go into the patient. The caller would like to know if the patient must be revaccinated."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.  There will be no information available 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 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: inadvertently administered just the liquid DTaP-IPV component of the Pentacel vaccine, and not the lyophilized Hib component  with no AE; Initial information received on 20-Sep-2021 regarding an unsolicited valid  non-serious case received from a pharmacist.   This case involves an unknown age and unknown gender patient who experienced inadvertently administered just the liquid dtap-ipv component of the pentacel vaccine, and not the lyophilized hib component while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient medical history, medical treatment(s), vaccination(s) , concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/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 "The caller reported a patient only received the Dtap portion of Pentacel. The caller wanted to know what to do now for the patient. pharmacist stated that a patient early last week was inadvertently administered just the liquid DTaP-IPV component of the Pentacel vaccine, and not the lyophilized Hib component. Pharmacist asked it is a valid dose for DTap-IPV and also whether the left-over lyophilized Hib component could be administered and if so, how should it be reconstituted, or should they use a separate commercially available Hib-only vaccine. Pharmacist asked whether the dose of Hib in Pentacel was the same as the Hib dose in ActHib. Pharmacist stated that a patient early last week (the week beginning Monday, 13 Sep 2021) was inadvertently administered just the liquid DTaP-IPV component of the Pentacel vaccine, and not the lyophilized Hib component"  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: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient administered expired dose of ADACEL vaccine, with no adverse event; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist and non-healthcare professional via Medical Information (Reference number- 00778177).  This case involves a 26-year-old female patient who was vaccinated with the expired dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 20-Sep-2021, the patient received a 0.5ml {total} dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number C5655AA and expiry date: 15-Aug-2021) via at an unknown route in the left arm for prophylactic vaccination.  It was reported "Is there any extended time that an ADACEL (306 - ADACEL) can be used beyond the expiration date? His pharmacy gave a dose of ADACEL that was expired at the time of administration".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.