chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got the shot and the Flu too; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/ non-health care professional via Digital Media..  This case involves a patient of unknown gender and age who experienced got the shot and the flu too while receiving vaccine influenza vaccine.  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 influenza vaccine produced by unknown manufacturer (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date, the patient developed a non-serious event got the shot and the flu too (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event influenza.
Age: 70.0
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a 70 years unknown gender patient who had reported that I had the flu back in the very early 70's probably right about the time I had my last flu shot while receiving vaccine Influenza Vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine (form, strength, route, administration site, Batch number and expiry date: unknown) produced by unknown manufacturer for immunization.  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  Corrective treatment: not reported.  Outcome was Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 18-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.   This case involves an unknown age and unknown gender patient who experienced sick while receiving vaccine influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.     On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dose, route, batch number and expiry date) in unknown administered site for prophylactic vaccination. Information on batch number is requested  On an unknown date the patient developed "sick" (illness)  (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the events (sick).
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: unknown cause of death; Initial information received on 19-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patients died due to an unknown cause after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  It was reported that the reporter had 12 friends that took this and on an unknown date the patient died- unknown cause of death (death) (unknown latency) following the administration of Influenza Vaccine.   Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : At time of reporting, the outcome was Fatal for the event unknown cause of death. It is unknown if an autopsy was done. The cause of death was reported as Unknown cause of death.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) unknown cause of death.; Sender's Comments: Sanofi company comment dated 22-Feb-2022. This case involves Adult and unknown gender patients died due to an unknown cause after receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.; Reported Cause(s) of Death: Unknown
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media non-serious case from a Patient.  This case involves a male patient of unknown age who experienced flu while receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (dose, form, route, strength, batch number and expiry dates: unknown) in an unknown administration site for immunization. Information on batch number has been requested.  On an unknown date the patient developed  flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: TDAP
Symptoms: Immunisation reaction
Clinical narrative: reaction after Tdap but also not sure if it was Adacel or Boostrix.; Initial information received on 18-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (non health care professional).  This case involves patient with unknown demographics who had reaction after tdap but also not sure if it was adacel or boostrix. while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with unknown dose lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient had reaction after tdap but also not sure if it was adacel or boostrix. (nonspecific reaction) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (reaction after Tdap but also not sure if it was Adacel or Boostrix.).  At time of reporting, the outcome was Unknown for the event reaction after tdap but also not sure if it was adacel or boostrix.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: that's the first time I ever caught the flu; Initial information received on 18-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves patient with unknown demographics who caught the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer with unknown dosage lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient first time ever caught the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (that's the first time I ever caught the flu).  At time of reporting, the outcome was Unknown for the event that's the first time i ever caught the flu.
Sex: F
Vaccine: FLUX
Symptoms: Death, Intracardiac thrombus
Clinical narrative: patient had a blood clot in her heart and it killed her; Initial information received on 21-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had a blood clot in her heart and it killed her while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer with unknown dose lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the had a blood clot in her heart and it killed her (intracardiac thrombus) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) patient had a blood clot in her heart and it killed her.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient had a blood clot in her heart and it killed her).  At time of reporting, the outcome was Fatal for the event patient had a blood clot in her heart and it killed her. No autopsy was done. The cause of death was reported as Cardiac thrombosis.; Sender's Comments: Sanofi company comment dated 24-Feb-2022: This case involves an unknown age female patient who had a blood clot in her heart and it killed her while receiving vaccine INFLUENZA VACCINE. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.; Reported Cause(s) of Death: blood clot in her heart
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature excursion for Lantus, Toujeo, And Apidra due to human error, total time out of range is 13 hours with a maximum temperature of 48.7F reported with no reported adverse event; Initial information received on 14-Feb-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced temperature excursion for lantus, toujeo, and apidra due to human error, total time out of range is 13 hours with a maximum temperature of 48.7f reported with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] And While Treated With Insulin Glulisine [Apidra], Insulin Glargine [Lantus] And Insulin Glargine [Toujeo] via solostar.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient started taking Insulin Glulisine Unknown dosage unknown (lot - 0F789C), Insulin Glargine Unknown dosage unknown (with an unknown batch number) and  Insulin Glargine Solution for injection dosage unknown (with an unknown batch number).  On an unknown date, the patient received a  dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine lot number not reported.  On an unknown date the patient developed a non-serious event  "temperature excursion for lantus, toujeo, and apidra due to human error, total time out of range is 13 hours with a maximum temperature of 48.7f reported with no reported adverse event" (product temperature excursion issue) (unknown latency) following the first dose intake of INSULIN GLULISINE, (unknown latency) following the first dose intake of INSULIN GLARGINE of INSULIN GLARGINE and (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported "in a temperature excursion for Lantus, Toujeo, and Apidra. Excursion occurred on 12Feb2022 due to human error; total time out of range is 13 hours with a maximum temperature of 48.7F reported."  Action taken with Insulin Glulisine (Apidra), Insulin Glargine (Lantus), Insulin Glargine (Toujeo) And Meningococcal Vaccine (Menactra) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Temperature excursion for Lantus, Toujeo, And Apidra due to human error, total time out of range is 13 hours with a maximum temperature of 48.7F reported with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion for lantus, toujeo, and apidra due to human error, total time out of range is 13 hours with a maximum temperature of 48.7f reported with no reported adverse event.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: 13 year old patient received a dose of MENACTRA at the age of 11, inadvertently received an additional dose of Friday with no reported adverse event; Initial information received on 14-Feb-2022 regarding an unsolicited valid non-serious case received from the nurse.  This case involves a 13 years old female patient who received a dose of meningococcal a-c-y-w135 (d conj) vaccine [Menactra] at the age of 11, inadvertently received an additional dose of Friday with no reported adverse event.  The patient's past medical history, medical treatment(s), and family history were not provided. Concomitant medications included influenza vaccine (Flu Vaccine) for Prophylactic vaccination.  On an unknown date, the patient received meningococcal a-c-y-w135 (d conj) vaccine (strength, formulation, dosage, lot number: not provided) via unknown route of administration at unknown of site for immunization. Information on batch number was requested.  On 11-Feb-2022, the patient inadvertently received an additional dose of meningococcal a-c-y-w135 (d conj) vaccine (dose: 0.5 milliliter once) of Friday (lot number: U7207AB and expiration date 08-Feb-2023) via intramuscular route in left arm for immunization (extra dose administered) (latency: unknown). The reporter asked whether patient would require a booster at age 16 or prior to college.  No adverse event reported.  Action taken with meningococcal a-c-y-w135 (d conj) vaccine 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: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: her daughter received a dose of Daptacel on 10Nov2021 that was expired when it was administered with no reported adverse event; Initial information received on 16-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 15 months old female patient who received a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 10-Nov-2021 that was expired when it was administered 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).  On 10-Nov-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (form and strength not reported, lot number: C5643CA, expiry date: 17-Jul-2021) at a dosage of 0.5 mL via unknown route at an unknown administration site for immunization.   On 10-NOV-2021 the patient received a dose of daptacel that was expired when it was administered with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was 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: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 5 year old patient not received standard scheduled vaccines has received 1 QUADRACEL vaccine with no reported adverse event; Initial information received on 16-Feb-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 years old female patient who had not received standard scheduled vaccines , She has received 1 QUADRACEL vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine(strength, dose, formulation, route, lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination.  On an unknown date the patient had not received standard scheduled vaccines, She has received 1 diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine (quadracel)  with no reported adverse event (inappropriate schedule of product administration) (latency: unknown).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.  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: 9.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Physician is asking for safety information about QUADRACEL is mistakenly administered to a 9 year old with no reported AE; Initial information received on 16-Feb-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 9 years old patient with unknown gender in whom physician is asking for safety information about quadracel is mistakenly administered to a 9 year old with no reported AE (adverse event) while receiving vaccine Diphtheria-15/Tetanus/5 Hybrid AC Pertusis/IPV (MRC5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Feb-2022, the patient received 0.5mL dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertusis/IPV (MRC5) Vaccine suspension for injection (route, batch number and expiry dates: unknown) in an unknown administration site for immunization.  On 15-Feb-2022, physician is asking for safety information about quadracel is mistakenly administered to a 9 year old with no reported AE (product administered to patient of inappropriate age) (latency: same day) following the administration of Diphtheria-15/Tetanus/5 Hybrid AC Pertusis/IPV (MRC5) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown 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 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.; Sender's Comments:  00981348:
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given expired tdap, with no reported adverse event; Initial information received on 17-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced patient was given expired tdap, with no reported adverse event, while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE suspension for injection lot U6518AA with expiry date (11-May-2021) (unknown dose, formulation via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "patient was given expired tdap, with no reported adverse event "(expired product administered) (latency same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was given expired tdap, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient was given expired tdap, with no reported adverse event.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: an extra dose of ADACEL was administered to a patient with no ae; Initial information received on 17-Feb-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 60 years old female patient who experienced an extra dose of adacel was administered to a patient with no ae while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Jan-2022, the patient received a first  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7055BA,ED : 03-06-2023  via intramuscular route with left deltoid administration site.   On 17-Feb-2022 she also received a  second dose of the same vaccine  lot U7055BA,ED : 03-06-2023 via intramuscular route with left deltoid administration site and patient developed a non-serious event "an extra dose of adacel was administered to a patient with no adverse event" (extra dose administered) 1 month 3 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (an extra dose of ADACEL was administered to a patient with no ae).  At time of reporting, the outcome was Unknown for the event an extra dose of adacel was administered to a patient with no ae.  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: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered expired dose of MENACTRA with no reported AE; Initial information received on 17-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who administered expired dose of Menactra with no reported AE while receiving vaccine Meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for Immunisation.  On 17-Feb-2022, the patient received a dose of suspect Meningococcal a-c-y-w135 (d conj) vaccine at a dose of 0.5 ml (formulation, strength, route and expiry date: unknown) (lot U6787AB; Expiry date: 11-Aug-2021) via intramuscular route in unknown administration site for immunization.  On 17-FEB-2022 the patient had administered expired dose of Menactra with no reported adverse event (expired product administered) following the administration of Meningococcal a-c-y-w135 (d conj) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was unknown for the event expired product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a patient that got the PENTACEL vaccine but was only given the one vial of liquid (DTaP/IPV) and not the powder (ActHIB) component with no reported AE; Initial information from received on 17-Feb-2022 regarding an unsolicited valid non-serious case from other Healthcare Professional.  This case involves a patient of unknown demographics who got the pentacel vaccine but was only given the one vial of liquid (dtap/ipv) and not the powder (ACTHIB) component with no reported AE (adverse event) while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertusis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HIB Vaccine CONJ (TET TOX) (ACTHIB) for Immunization.  On an unknown date, the patient received a suspect Diphtheria/Tetanus/5 Hybrid AC Pertusis/IPV(MRC5)/HIB(PRP/T) Vaccine (dose, route, strength, batch number and expiry dates: unknown) suspension for injection in an unknown administration site for immunization.  On an unknown date, patient got the pentacel vaccine but was only given the one vial of liquid (dtap/ipv) and not the powder (Acthib) component with no reported AE (incorrect product formulation administered) (unknown latency) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertusis/IPV(MRC5)/HIB(PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event (incorrect product formulation administered).  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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose with no adverse event; Initial information received on 18-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who took expired dose with no adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  First time product used: Yes  Concomitant medications included Meningococcal Vaccine B (Meningococcal Vaccine B) ; Hpv Vaccine (Hpv Vaccine) for ; and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP) all for Immunisation.  On 17-Feb-2022, the patient received dose of 0.5 ml once a day for suspect Menactra (Batch number U6828AA expiry 09-Jan-2022) via intramuscular route in the right deltoid for immunisation.  On 17-Feb-2022, it was reported that patient was administered an expired dose with no adverse event (expired product administered) of Menactra.  Action taken was not applicable  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Single component of a two-component product administered
Clinical narrative: DTAP- IPV liquid component was administered to the patient but not the HIB component with no reported AE; Initial information received on 18-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had dtap- ipv liquid component was administered to the patient but not the hib component with no reported ae while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) 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 with unknown dose, lot number not reported via unknown route in unknown administration site. for immunization.  On an unknown date the patient had dtap- ipv liquid component was administered to the patient but not the hib component with no reported ae (single component of a two-component product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (DTAP- IPV liquid component was administered to the patient but not the HIB component with no reported AE).  At time of reporting, the outcome was Unknown for the event dtap- ipv liquid component was administered to the patient but not the hib component with no reported ae.  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: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No reaction on previous exposure to drug
Clinical narrative: gentleman who received Fluzone High dose Quadravalent today but was advised that he also received the same vaccine only four months ago with no reported adverse event; Initial information received on 18-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves a 83 years old male patient who received fluzone high dose quadravalent today(18-Feb-2022) but was advised that he also received the same vaccine only four months ago with no reported adverse event while receiving vaccine Influenza Quadrival A-B  High-Dose HV Vaccine[Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella zoster Vaccine RGE (CHO) (Shingrix) for Immunisation.  On 18-Feb-2022, the patient received a 0.5ml dose of suspect Influenza Quadrival A-B  High-Dose HV Vaccine(formulation: unknown, Strength: standard) (lot UJ775AB & expiry date:30-Jun-2022) via intramuscular route in the left deltoid for immunization.Therapy (1st therapy  patient took in Oct-2021) (dose: unknown).  On 18-FEB-2022, the patient who received fluzone high dose quadravalent today(18-Feb-2022) but was advised that he also received the same vaccine only four months ago with no reported adverse event (inappropriate schedule of product administration)(latency: unknown) following the administration of Influenza Quadrival A-B  High-Dose HV Vaccine.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.   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: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: No adverse event, Product preparation issue, Product reconstitution quality issue
Clinical narrative: mixed vaccine with sterile water instead of diluent /reconstituted ACTHIB vaccine with sterile water diluent with no reported adverse event; Initial information received on 21-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient who got mixed vaccine with sterile water instead of diluent /reconstituted acthib vaccine with sterile water diluent with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  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 Immunisation; DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 21-Feb-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE at a dose of 0.5 mL once (lot-UJ589AA,25-Oct-2022) via intramuscular route in unknown administration site for immunization.  On 21-FEB-2022 the patient developed a non-serious event "mixed vaccine with sterile water instead of diluent /reconstituted acthib vaccine with sterile water diluent with no reported adverse event" (product reconstitution quality issue)(latency-Same day) following the administration of HIB (PRP/T) VACCINE.  It was reported "reconstituted ACTHIB vaccine with sterile water diluent instead of 0.4% saline."  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event mixed vaccine with sterile water instead of diluent /reconstituted acthib vaccine with sterile water diluent with no reported adverse event.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACT-HIB reconstituted with sterile water rather than the diluent provided with no reported adverse event; Initial information received on 21-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old female patient who got act-hib reconstituted with sterile water rather than the diluent provided with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Prophylactic vaccination; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 21-Feb-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE at a dose of 0.5 mL once (lot-UJ635AAB,30-Nov-2022) via intramuscular route in the right vastus lateralis for iimunization.  On 21-FEB-2022 the patient developed a non-serious event "act-hib reconstituted with sterile water rather than the diluent provided with no reported adverse event" (product preparation error)(latency-Same day) following the administration of HIB (PRP/T) VACCINE.  It was reported "ACT-HIB vaccine was reconstituted with sterile water rather than the diluent provided with the ACT-HIB".  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event act-hib reconstituted with sterile water rather than the diluent provided 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: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RVX
Symptoms: Underdose
Clinical narrative: incomplete dose administered; Initial information received on 21-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 2 months old male patient who experienced incomplete dose administered while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  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) and rotavirus vaccine (Rotavirus vaccine) for Immunization.  On 12-Oct-2021, the patient received a first 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine lot UJ571AA via unknown route in the left thigh (dosage form, strength, formulation and expiry date: unknown). On 21-Feb-2022 he also received a second 0.5 ml dose of the same vaccine lot UJ527AA via unknown route in the left thigh (dosage form, strength, formulation and expiry date: unknown) for immunization.  On 12-OCT-2021, the patient developed a non-serious event incomplete dose administered (incorrect dose administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (incomplete dose administered).  At time of reporting, the outcome was Unknown for the event incomplete dose administered.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Product use issue
Clinical narrative: Potential AE because of use against local labelling with no AE; Initial information received on 18-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who reported potential ae because of use against local labelling with no ae while receiving vaccines DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and 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.   In 2016, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE at a dose of 1 DF(dosage form) lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "potential ae because of use against local labelling with no ae" (product use issue) (latency-Same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE) was not applicable.  At time of reporting, the outcome was Unknown for the event potential ae because of use against local labelling with no ae.   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: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of Menactra with no reported adverse event; Initial information received from on 22-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 17 years old female patient who received an expired dose of menactra with no reported adverse event, after being vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Feb-2022, the patient received a dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation: unknown) with lot u6690a; expiry date: 31-Aug-2021 via intramuscular route in the left arm as immunization ((expired product administered, onset, latency: same day).   Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received an expired dose of Menactra with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received an expired dose of menactra 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: 0.25
Sex: M
Vaccine: DTAP, HIBV, RVX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired ACTHIB vaccination with no adverse event; Initial information received on 22-Feb-2022 regarding an unsolicited valid non-serious case from patient.  This case involves a 3 months old male patient who received an expired ACT-HIB vaccination no adverse event while receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertusis vaccine acellular, Tetanus vaccine toxoid (Daptacel); and Rotavirus vaccine for Immunization.  On 22-Feb-2022, the patient received 0.5 ml dose of HIB (PRP/T) Vaccine once (lot number: UJ143AA and expiry dates: 03-May-2021)via intramuscular route in the thigh nos for immunization.  On 22-FEB-2022 the patient received an expired ACT-HIB vaccination with no adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.  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.