chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from legal division.  An adult female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 04Mar2021, outcome "unknown", described as "stroke". Clinical course: On or about (date) 03Mar2021, 09Sep2021 plaintiff was injured by the following product. On 03Mar2021, Decedent (Name withheld) received a dose of Defendants Pfizer/Pharmacia SARS-Covid2 for protection Covid-19 and (Name withheld) had multiple strokes thereafter. First, on 04Mar2021 just a day after the 03Mar2021 vaccine; then (Name withheld) received another dose on 09Sep2021 (also reported as 09Sep2020) and she had more strokes shortly after in Sept, Oct and Nov2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body height, Illness
Clinical narrative: I got sick with every single shot (Pfizer COVID-19 Vaccine); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (ongoing), notes: Synthroid is what I take for my thyroid and I have been taking that for years. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got sick with every single shot (Pfizer COVID-19 Vaccine)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported patient had the first two dose during Covid then had the booster then just had the last booster that was offered the one that just came out and patient got sick with every single shot (Pfizer COVID-19 Vaccine). Patient took some vitamins.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer COVID 19 vaccine that is not working.; Pfizer COVID 19 vaccine that is not working.; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer COVID 19 vaccine that is not working.".  Clinical information: HCP calling in regard to controlant of Pfizer COVID 19 vaccine that is not working. She also mentioned that the call got disconnected and wants to speak to him. Any medical questions addressed by this program forwarded/referred to Medical Information was reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events drug ineffective, COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke".  Clinical information: It was reported that the patient's wife of was unwilling to receive a COVID-19 vaccine because she stated that her husband (age unknown) had a stroke after getting his vaccine and now she had to care for him as he could no longer work. This anecdotal report was made to navigator during a call on RN. This was a patient of her sister, a nurse practitioner and did not know if it had been reported already. RN agreed to get additional details as she agreed to having Pfizer contact her. The event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported event cerebrovascular accident. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious), outcome "not recovered", described as "high blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: U
Vaccine: MEN
Symptoms: Loss of consciousness, Seizure
Clinical narrative: passed out 3 times; 3 seizures; Initial information received on 09-Mar-2023 regarding an unsolicited valid serious case received from a Non-Healthcare Professional.  This case involves a 16-year-old and unknown gender patient who passed out 3 times and had 3 seizures after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength, expiry date, lot number: not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient developed serious events of passed out 3 times (loss of consciousness) and 3 seizures (seizure) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. These events were assessed as medically significant.  It was reported, the pediatrician shrugged it off. It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the events (passed out 3 times, 3 seizures).  At time of reporting, the outcome was Unknown for the event passed out 3 times and was Unknown for the event 3 seizures.; Sender's Comments: Sanofi company comment dated 14-Mar-2023: This case involves a 16-year-old and unknown gender patient who passed out 3 times and had 3 seizures after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. Based upon the reported information, the role of vaccine cannot be assessed. Additional information regarding additional risk factor, medical treatment, family history, concomitant medications, medical history excluding other predisposing etiologies would be needed for complete assessment of the case.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Adacel was administered after being improperly stored with no reported adverse event; Initial information received on 13-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered after being improperly stored with no reported adverse event.  The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection at an unknown dose total (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date, adacel was administered after being improperly stored with no reported adverse event (poor quality product administered) (same day latency).  Action taken: Not applicable.  Outcome: 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: lowest temperature it reached was 1.4C and the highest temperature it reached was 9.0C for a total duration out of range of 1 hour and 54 minutes,with no reported adverse event; post administration to patients without reported adverse event; Initial information received on 04-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves vaccine IPV (VERO) [IPOL] where temperature reached was 1.4c and the highest temperature it reached was 9.0c for a total duration out of range of 1 hour and 54 minutes and was post administration to 2 years old male patient without reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor  On an unknown date the reporter reported that the lowest temperature it reached was 1.4c and the highest temperature it reached was 9.0c for a total duration out of range of 1 hour and 54 minutes,with no reported adverse event (product storage error) and post administration to patients without reported adverse event (poor quality product administered)  (unknown latency) following the administration of IPV (VERO) (Suspension for injection) (strength: 5 mg) (lot number: V1A024M and expiry date: 17-feb-2024) via intramuscular route in unknown administration site for Immunization.  It was reported "MA reporting a temperature excursion due to a refrigerator malfunction at their facility. The lowest temperature it reached was 1.4C and the highest temperature it reached was 9.0C for a total duration out of range of 1 hour and 54 minutes. The products open was IPOL. MA calling for stability information. Extended stability data does not cover open IPOL. MA requests for stability information be emailed. Submitting to PV due to post administration to patients."  Action taken: not applicable.  Outcome was Unknown for both the events.   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.  Additional information was received on 08-Mar-2023 via other health professional: case was updated from non-valid to valid case. Patient's demographics were added, strength was added, narrative amended accordingly.
Age: 57.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was administered the product IPOL but the patient was suppose to get 10units of insulin with no reported adverse event; Initial information received on 28-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 57-year-old male patient who experienced patient was administered the product IPV (VERO) [IMOVAX POLIO] but the patient was suppose to get 10units of INSULIN ASPART (Novolog) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 28-Feb-2023, the patient received suspect IPV (VERO) suspension for injection at a dose of 10 U (lot V1A022M, expiry date: 17-Feb-2024 via subcutaneous route in the right arm for immunisation.  On 28-Feb-2023 the patient was administered the product IPOL but the patient was suppose to get 10units of insulin with no reported adverse event (wrong product administered) (same day latency).  Action taken: Not applicable.  Outcome: 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 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: U
Vaccine: DTAPIPV
Symptoms: Injection site rash
Clinical narrative: developed a rash at the injection site after receiving quadracel; Initial information was received on 03-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an 5 patients with unknown demographics who developed rash at the injection site after receiving diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient's had received a unknown dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) Vaccine suspension for injection (route and frequency: unknown) ( batch number: U7526AA and expiry date: 09-Jul-2024) in unknown administration site for prophylactic vaccination.   It was reported that 5 patient's had received a vaccine with same lot number and had developed a rash at the injection site after receiving vaccine (vaccination site rash) (onset: Jan-2023 and latency: unknown) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5). Further, the caller had requested to return 3 remaining doses of the vaccine as the physician does not feel comfortable using the remaining 3 doses from this same lot.   Action taken: not applicable  Corrective treatment: not reported  Outcome: Recovered / Resolved in 2023
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered the Adacel to a patient on Saturday, but after they left, noticed that the vaccine was expired with no reported adverse event; Initial information received on 06-Mar-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age /gender patient who was administered the Diphtheria-2/tetanus/5 ac pertussis vaccine [ADACEL] on saturday, but after they left, noticed that the vaccine was expired with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 04-Mar-2023, the patient received suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection at dose of 0.5 milligram (mg) total (lot U6968AA and expiry date-07-Feb-2023) via intramuscular route in the left deltoid for immunisation but after they left, noticed that the vaccine was expired with no reported adverse event (expired product administered) (latency-same day).  Action taken was not applicable.  it was reported that Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: First dose of DAPTACEL given at 18 months of age with no reported adverse event; Initial information received on 06-Mar-2023 regarding an unsolicited valid  non-serious case received from a mother of patient.  This case involves a 1 years old male patient who had first dose of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel]  given at 18 months of age with no reported adverse event.   The patient's past medical history included Heart murmur and Neutropenia. The patient's family history included risk for seizures. The patient's past medical treatment(s), vaccination(s) was not provided.   On 08-Feb-2023, the patient received 0.5ml dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.   On 08-Feb-2023 the patient developed a non-serious event of first dose of daptacel given at 18 months of age with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day). It was due to health issues that pat8ent had in first year of life. Reporter was asking safety and efficacy of Daptacel in patients that have taken their doses later than what was recommended in the Prescribing Information. Reporter asked what was done for babies that have cancer and cannot take their Daptacel during the recommended age windows. Reporter was very concerned that something may happen to her child because he received his first dose of Daptacel outside of the age recommendations of the Prescribing information and would like to speak with someone additionally regarding this situation.  Action taken : not applicable.  Outcome: 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine was administered with no reported adverse event; Initial information received on 06-Mar-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient to whom expired hib (prp/t) vaccine [Act-Hib] vaccine was administered with no reported adverse event.  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On 06-Mar-2023, the patient received an unknown dose of suspect hib (prp/t) vaccine (lot UJ647AAB and expiry date: 05-Mar-2023) Powder and solvent for solution for injection via unknown route in unknown administration site for prophylactic vaccination.  On 06-Mar-2023 the patient developed a non-serious event of expired vaccine was administered with no reported adverse event (expired product administered) (Latency: same day) following the administration of hib (prp/t) vaccine.  Action taken : not applicable.  Outcome: 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: 67.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of TENIVAC was administered to a patient, with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 67 years old male patient who received an expired dose of diphtheria-2/tetanus-5 adsorbed toxoid no preservative adult [Tenivac], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CNJ 20V (CRM197) (PREVNAR 20).  On 07-Mar-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoid no preservative adult, Suspension for injection (strength - standard, frequency - once, lot - U6922AA, expiry date - 22-Jan-2023) via intramuscular route in the right deltoid for immunization.  On 07-Mar-2023 the patient received expired dose of tenivac with no reported adverse event (expired product administered) (latency: same day)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.58
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ACTHIB was administered with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who reported expired dose of HIB (PRP/T) vaccine [ACT-HIB] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Mar-2023, the patient received a 0.5ml dose (dose 3) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection of lot UJ646AAA and expiry: 05-Mar-2023 via intramuscular route in the left thigh for immunization.  On 07-Mar-2023, the patient developed a non-serious event expired dose of ACTHIB was administered with no reported adverse event (expired product administered) (same day) following the administration of HIB (PRP/T) vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of ACTHIB was administered with no reported 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: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: ADACEL was administered today that expired 04-mar-2023 with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 43 years old female patient to whom Diphtheria-2/tetanus/5 ac pertussis vaccine [ADACEL] was administered today that expired 04-mar-2023 with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Mar-2023, the patient received suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection at dose of 0.5 milligram (mg) total (lot U6969AB and expiry date-04-Mar-2023) via intramuscular route in the right arm for immunization today that expired 04-mar-2023 with no reported adverse event (expired product administered) (latency-same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ACTHIB was administered with no reported adverse events; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient to whom expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was administered with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 07-Mar-2023, the patient received suspect HIB (PRP/T) VACCINE powder and solvent for solution for injection at a dose of 0.5 ml once (lot number not reported, expiry date: 05-Mar-2023, 01-Apr-2023) via unknown route in unknown administration site for immunization.  On 07-Mar-2023 expired dose of acthib was administered with no reported adverse events (expired product administered) same day latency following the administration of HIB (PRP/T) VACCINE.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: 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: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired daptacel being administered to a patient with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who was administered expired Diphtheria-15/Tetanus/5 AC Pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Mar-2023, the patient received 0.5ml, 1x dose (dose 1) of suspect Diphtheria-15/Tetanus/5 AC Pertussis vaccine Suspension for injection of standard strength, lot C5774CA and expiry: 18-09-2022 via intramuscular route in the right thigh for immunization.  On 07-Mar-2023, the patient developed a non-serious event expired daptacel being administered to a patient with no reported adverse event (expired product administered) (same day) following the administration of Diphtheria-15/Tetanus/5 AC Pertussis vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired daptacel being administered to a patient with no reported 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: 18.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Menquadfi was administered to a patient with a 0.5 inch TB needle instead of the recommended 5/8 to 1 inch length needle, with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid non-serious case from a nurse.  This case involves 18 years old male patient to whom meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered to a patient with a 0.5 inch tb needle instead of the recommended 5/8 to 1 inch length needle, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 24-Feb-2023, the patient received suspect meningococcal A-C-Y-W135 (T CONJ) vaccine at a dose of 0.5 ml lot W006721 via unknown route in the right deltoid for immunization.  On 24-Feb-2023, menquadfi was administered to a patient with a 0.5 inch tb needle instead of the recommended 5/8 to 1 inch length needle, with no reported adverse event (wrong technique in product usage process) same day latency following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  It was reported "Caller unsure if the injection was given subcutaneous or intramuscularly. Wanting to know next steps to take."  Action taken: Not applicable.  Outcome: 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: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally given daptacel on 07Mar2023 that expired on 01Mar2023 with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who accidentally received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] on 07-Mar-2023 that expired on 01-Mar-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination; and HIB vaccine CONJ (TET TOX) (ACTHIB) for Prophylactic vaccination.  On 07-Mar-2023, the patient accidently received a 0.5 mL dose of expired suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection, (strength - standard, frequency - once (1x), lot - C5829AA and expiry date - 01-Mar-2023) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: QUADRACEL being administered to a patient 2 years of age with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid non-serious case received from via health professional. GMI number: 01523514.  This case involves 2 months old female patient who was administered vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunization; and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunization.  On 02-Dec-2022, the 2 years patient received a first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE Suspension for injection at dose 0.5 ml once (lot: C5862BA, Expiration: 01-Apr-2023) via intramuscular route in the left thigh for Immunization with no reported adverse event (product administered to patient of inappropriate age) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Recovered on an unknown date for the event product administered to patient of inappropriate age.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.08
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4-week-old patient mistakenly received the FLUZONE QIV-PFS with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 weeks old male patient who had mistakenly received the influenza quadrival a-b vaccine [Fluzone Qiv] with no reported adverse event while receiving vaccine   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 07-Mar-2023, the patient received 0.5ml dose of suspect influenza quadrival a-b vaccine Suspension for injection(strength, lot number not reported via unknown route in unknown administration site for Immunization.  On 07-Mar-2023 the patient developed a non-serious event of 4-week-old patient mistakenly received the fluzone qiv-pfs with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day) following the administration of influenza quadrival a-b vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: 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: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: was administered an expired daptacel with no adverse event reported; Initial information was received on 08-Mar-2023 regarding an unsolicited valid  non-serious case received from a consumer  This case involves a 1 years old female patient who was administered an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine for Prophylactic vaccination.  On 03-Mar-2023, the patient had received a suspect diphtheria-15/tetanus/5 AC pertussis vaccine suspension for injection at the dose of 0.5 ml once (1x) (batch number: C5829BA, expiry date: 01-Mar-2023) via intramuscular route in the left thigh for prophylactic vaccination.  On 03-MAR-2023 the patient was administered an expired Vaccine with no adverse event reported (expired product administered) (latency: same day) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketig authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an IPOL vaccination that had expired with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid non-serious case received via Licensed Practical Nurse (LPN).  This case involves 5 years old male patient who was administered an IPV (VERO) [IPOL] vaccination that had expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jan-2023, the patient received fifth dose of suspect IPV (VERO) Suspension for injection at dose 0.5ml once (lot TIE871M, expiry date: 10-OCT-2022) via subcutaneous route in the left arm for immunization that had expired with no reported adverse event (expired product administered) same day latency.  LPN inquired if that would count as a valid dose or if the patient would need to be re-vaccinated?   Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was administered an IPOL vaccination that had expired with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient was administered an ipol vaccination that had expired with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: acthib was given with normal saline instead of being reconstituted with the diluent provided with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient to whom hib (prp/t) vaccine [Act-Hib]  was given with sodium chloride [Normal Saline] instead of being reconstituted with the diluent provided with no reported adverse event while receiving vaccine and while treated with   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (Hepatitis A), pneumococcal vaccine conj 13v (crm197) (Prevnar 13)  and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Prophylactic vaccination.  On 08-Mar-2023 the patient developed a non-serious event of acthib Powder and solvent for solution for injection (strength was unknown,dose:0.5ml, intramuscular in Left thigh, lot: UJ648AB and expiry date: 16-Mar-2023 for Immunization) was given with normal saline instead of being reconstituted with the diluent provided with no reported adverse event (product preparation error) (Latency: same day).   Action taken : not applicable.  Outcome: 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 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: U
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 11th dose of IPOL being administered with no reported adverse event; Initial information received on 09-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves an unknown age and gender patient who reported 11th dose of poliomyelitis vaccine (inactivated) (IPOL) IPV (VERO) being administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Mar-2023, the patient received 0.5 mL dose of suspect IPV (VERO), Suspension for injection, (strength, lot number and expiry date: not reported) via unknown route in unknown administration site for immunization.  On 09-Mar-2023 the patient was 11th dose of ipol being administered with no reported adverse event (inappropriate schedule of product administration) (same day latency) following the administration of IPV (VERO).  It was reported as Caller reported that a provider that she is calling on behalf of administered an 11th dose of IPOL and is requesting validity information.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.92
Sex: M
Vaccine: MEN
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 month old patient received a dose of menquadfi with no adverse event reported; Initial information received on 09-Mar-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 11 months old male patient who received a dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine (HIB) for Immunisation.  On 30-Nov-2022, the patient received 0.5 ml (milliliter) (1x) (once) of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (lot U7576AC, expiry date: 28-Feb-2025) via intramuscular route in right thigh for immunization.  On 30-Nov-2022 the reporter reported that 11 month old patient received a dose of menquadfi with no adverse event reported (product administered to patient of inappropriate age) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an 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.