chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: QUADRACEL was administered to an 11 year old patient for catch-up immunizations with no reported adverse event; Initial information received on 08-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 was administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (Quadracel) for catch-up immunizations 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 B Vaccine (Hepatitis B Vaccine) for Prophylactic vaccination; Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination; and Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 05-Jan-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength: unknown) lot C5862BA, expiration: 01-Apr-2023, via intramuscular route in the left deltoid.  On 05-JAN-2022 the Quadracel was administered to an 11-year-old patient for catch-up immunizations with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  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 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: M
Vaccine: MNQ
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with no reported adverse event; Patient received MENQUADFI after the temperature excursion occurred with no reported adverse event; Initial information received on 08-Feb-2022 regarding an unsolicited valid non-serious case was received from an other health professional.  This case involves a 10 year old male patient who received meningococcal a-c-y-w135 (t conj) vaccine (Menquadfi) after the temperature excursion occurred 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 diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) as prophylactic vaccination.  On 02-Feb-2022, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine at 0.5 ml, once (lot U6824AA, expiry date: unknown) via intramuscular route in the left arm as prophylactic vaccination.  It was reported that on 02-Feb-2022 the patient received meningococcal a-c-y-w135 (t conj) vaccine after the temperature excursion occurred (Product temperature excursion issue) with no reported adverse event (poor quality product administered, latency: same day).  Action taken with meningococcal vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (Patient received MENQUADFI after the temperature excursion occurred with no reported adverse event, temperature excursion with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received menquadfi after the temperature excursion occurred with no reported adverse event and was Unknown for the event temperature excursion 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: 16.0
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received Ipol at 2 months 4 months and early at 6 months and earlier than 4 at 3 years 4 months with no reported adverse event; Initial information received on 09-Feb-2022 regarding an unsolicited valid  non-serious case received from a pharmacist via call center.  This case involves a 16 years old male patient who received Ipol at 2 months 4months and early at 6 months and earlier than 4 at 3 years 4 months with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect IPV (VERO) vaccine (formulation, dose, route, batch number and expiry date unknown ) in unknown administration site for immunization. Information on batch number was requested.  On an unknown date, the patient developed a non-serious event received Ipol at 2 months 4months and early at 6 months and earlier than 4 at 3 years 4 months with no reported adverse event  (inappropriate schedule of product administration) (unknown latency) following the administration of IPV (VERO).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (received Ipol at 2 months 4months and early at 6 months and earlier than 4 at 3 years 4 months with no reported adverse event ).  At time of reporting, the outcome was Unknown for the event received Ipol at 2 months 4months and early at 6 months and earlier than 4 at 3 years 4 months 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: 0.75
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received their 4th dose of acthib 3 months early on 8feb2022; would not be due for their 4th and final dose until 12 months of age with no reported adverse event; Initial information received on 09-Feb-2022 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 9 months old female patient who received their 4th dose of acthib 3 months early on 8feb2022; would not be due for their 4th and final dose until 12 months of age with no reported adverse event, after 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 Prophylactic vaccination; 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; and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 08-Feb-2022, the patient received dose 4 of suspect HIB (PRP/T) VACCINE (strength, dose, formulation: unknown) with lot UJ456AA via unknown route in the left thigh as immunization.  It was reported that patient received their 4th dose of acthib 3 months early on 8-Feb-2022; patient received their 3rd dose on 22-Nov-2021 at 6 months of age and would not be due for their 4th and final dose until 12 months of age (inappropriate schedule of product administration) following the administration of HIB (PRP/T) VACCINE. No adverse event was reported.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event      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: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received the Adacel vaccine instead of the Daptacel with no reported adverse event; Initial information received on 09-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old male patient who received the adacel vaccine instead of the daptacel 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.  Concomitant medications included HEPATITIS A VACCINE (HEPA [HEPATITIS A VACCINE]) for Prophylactic vaccination; HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Prophylactic vaccination.  On 22-Nov-2021, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.25 mL to 2 mL 1x(Once) lot C5921AA via intramuscular route in the left deltoid for immunization. First time product used : Yes  On 22-NOV-2021 the patient developed a non-serious event "received the adacel vaccine instead of the daptacel with no reported adverse event" (wrong 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.  At time of reporting, the outcome was Unknown for the event received the adacel vaccine instead of the daptacel 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: 12.0
Sex: M
Vaccine: FLU4, HPV4, TDAP
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received two doses of ADACEL two weeks apart with no adverse event; Initial information was received on 09-Feb-2022 regarding an unsolicited valid non-serious case from a other health professional via call center.  This case involves a 12 years old male patient who received two doses of adacel two weeks apart with no 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.  Concomitant medications included Influenza vaccine inact split 4v (Fluzone quadrivalent) and althaea officinalis root, cinnamomum camphora essential oil, citrus aurantium oil, eucalyptus globulus leaf essential oil, mentha x piperita essential oil (Gardisil).  On 12-JAN-2022, the patient received a first dose of suspect Diphtheria-2/tetanus/5 ac pertussis vaccine (strength, formulation, dose and frequency: unknown) (batch number: U6767AA, expiry date: unknown)  via intramuscular route in unknown administration site. On 26-Jan-2022, the patient received second dose of vaccine (strength, formulation, dose, batch number and expiry date: unknown) via intramuscular route in unknown administration site for immunization.  On 26-JAN-2022, the patient had received two doses of adacel two weeks apart with no adverse event (inappropriate schedule of product administration) (latency: 14 days) following the administration of Diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event patient received two doses of adacel two weeks apart with no adverse event.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: The vaccine was received after more or less 24 hours after delivery and noted the box is still cold but the gauge is beginning to turn red with no reported adverse event; Initial information received on 10-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced the vaccine was received after more or less 24 hours after delivery and noted the box is still cold but the gauge is beginning to turn red 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 (strength, dose and formulation: unknown) with lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious "the vaccine was received after more or less 24 hours after delivery and noted the the box is still cold but the gauge is beginning to turn red with no reported adverse event (intercepted product storage error)" (unknown latency) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  It was reported that "client called to check viability of vaccine as he was told the vaccine was ordered 31/Jan/2022 and arrived 01/Feb/2022 not even within 24 hours after it was ordered. The vaccine was received after more or less 24 hours after delivery and noted the the box is still cold but the gauge is beginning to turn red. Account manager cannot provide information on the worst case lowest or highest temperature and duration of the excursion".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (The vaccine was received after more or less 24 hours after delivery and noted the the box is still cold but the gauge is beginning to turn red with no reported adverse event).  At time of reporting, the outcome was Unknown for the event the vaccine was received after more or less 24 hours after delivery and noted the the box is still cold but the gauge is beginning to turn red 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: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: pregnant female received expired Fluzone with no reported adverse event.; pregnant female received expired Fluzone with no reported adverse event.; Initial information received on 10-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 21 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] in and pregnant female received expired fluzone with no reported adverse event at unknown gestation period<<the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On an unknown date of February 2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (lot UT7065MA and expiration date: 30-Jun-2021) once via unknown route in unknown administration site a prophylactic vaccination.  In FEB-2022, the patient developed a non-serious event "pregnant female received expired fluzone with no reported adverse event" (exposure during pregnancy)(expired product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the events (pregnant female received expired Fluzone with no reported adverse event., pregnant female received expired Fluzone with no reported adverse event.).  At time of reporting, the outcome was Unknown for the event pregnant female received expired fluzone with no reported adverse event. and was Unknown for the event pregnant female received expired fluzone with no reported adverse event.. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 69.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Product storage error
Clinical narrative: Nurse reported 2 temperature excursions; nurse administered fluzone quadrivalent  from the punctured multi dose vial to a patient after 1 week following the excursion.; Initial information received on 10-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 69 years old male patient who experienced nurse reported 2 temperature excursions and nurse administered Fluzone quadrivalent  from the punctured multi dose vial to a patient after 1 week following the excursion while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Feb-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B vaccine suspension for injection (lot number: UJ694AB and expiry date: 30-Jun-2022) once via intramuscular route in the right deltoid for immunization and TUBERSOL (TUBERCULIN TEST) 0.1 mL solution for injection (lot details, route, frequency: unknown) in an unknown administration site for tuberculin test. .  On 09-FEB-2022 the patient developed nurse reported 2 temperature excursions  (product temperature excursion issue) and nurse administered fluzone quadrivalent  from the punctured multi dose vial to a patient after 1 week following the excursion. (wrong technique in product usage process) (latency: same day) following the first dose intake of TUBERCULIN TEST and INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (product temperature excursion issue).  At time of reporting, the outcome was Unknown for the event product temperature excursion issue and wrong technique in product usage process.   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: DTAPIPV
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: inadvertently administered to a patient SC rather than IM with no reported adverse event; Initial information received on 11-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves  patient with unknown demographics who inadvertently administered to a patient sc rather than im with no reported adverse event while receiving vaccine 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 11-Feb-2022, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE with the dose of 0.5ml lot number not reported via unknown route in unknown administration site.  On 11-FEB-2022 the patient inadvertently administered to a patient sc rather than im with no reported adverse event (incorrect route of product administration) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inadvertently administered to a patient SC rather than IM with no reported adverse event).  At time of reporting, the outcome was Unknown for the event inadvertently administered to a patient sc rather than im 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event
Clinical narrative: Hib portion of pentacel was reconstituted with sterile water and administered, Dtap-IPV portion was not administered with no adverse event; Initial information received on 11-Feb-2022 regarding an unsolicited valid non-serious case was received from a pharmacist.  This case involves an unknown age and unknown gender patient who received hib portion of diptheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel) which was reconstituted with sterile water and administered, dtap-ipv portion was not administered with no 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/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (dose, frequency, formulation, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. There will be no information regarding the batch number for this case.  It was reported that the hib portion of pentacel was reconstituted with sterile water and administered, dtap-ipv portion was not administered with no adverse event (single component of a two-component product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The pharmacist was enquiring if the hib portion of the vaccine would be invalid and if they would need to re-administer the whole Pentacel vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Hib portion of pentacel was reconstituted with sterile water and administered, Dtap-IPV portion was not administered with no adverse event).  At time of reporting, the outcome was Unknown for the event hib portion of pentacel was reconstituted with sterile water and administered, dtap-ipv portion was not administered with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: DTAPIPVHIB
Symptoms: Pyrexia
Clinical narrative: highest temperature reached was 8.7C and the total amount of time that the temperature was out of range for all 5 excursions was 40 minutes with no reported adverse event; Initial information received on 11-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient with unknown demographics who had highest temperature reached was 8.7c and the total amount of time that the temperature was out of range for all 5 excursions was 40 minutes with no reported adverse event 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 dosing lot UJ393AAA via unknown route in unknown administration site for immunization.  On 24-AUG-2021 the patient had highest temperature reached was 8.7c and the total amount of time that the temperature was out of range for all 5 excursions was 40 minutes with no reported adverse event (intercepted medication error) (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 (highest temperature reached was 8.7C and the total amount of time that the temperature was out of range for all 5 excursions was 40 minutes with no reported adverse event).  At time of reporting, the outcome was Unknown for the event highest temperature reached was 8.7c and the total amount of time that the temperature was out of range for all 5 excursions was 40 minutes 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: 13.0
Sex: F
Vaccine: DTAP
Symptoms: Incorrect product formulation administered
Clinical narrative: was scheduled to receive their third dose of ADACEL was accidentally given DAPTACEL instead with no adverse event; Initial information received on 11-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 years old female patient who was scheduled to receive their third dose of adacel was accidentally given daptacel instead with no adverse event, on receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IODINATED GLYCEROL (IPOL [IODINATED GLYCEROL]) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation.  On 10-Feb-2022, the patient received a dose of 0.5 ml suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation: unknown) with lot C5816AA via intramuscular route in the left deltoid asimmunization. The nurse practitioner stated that the patient that was scheduled to receive their third dose of ADACEL in the office on 10-FEB-2022 was accidentally given DAPTACEL instead (wrong product administered). Caller wanted to know if that vaccine would count as a valid Tdap dose or if the patient needed to be revaccinated with ADACEL. No adverse event was reported. Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event      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: 31.0
Sex: M
Vaccine: YF
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: administered YF-Vax reflected IM administration instead of the labelled SQ route,with no reported adverse event; Initial information was received on 11-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 31 years old male patient who was administered vaccine yellow fever vaccine -us [YF-VAX] reflected IM (Intramuscular) administration instead of the labelled SQ (subcutaneous) route, with no reported adverse event while receiving   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jan-2022, the patient received a d suspect yellow fever vaccine -us at the dose of 0.5 ml total via intramuscular route (batch number: UJ371AB; expiry date: 21-Jul-2022) in unknown administration site for Immunization.  On 19-Jan-2022, the patient was administered yf-vax reflected IM administration instead of the labelled SQ route, with no reported adverse event (incorrect route of product administration) (latency: same day). Further reported that the nurse caller asked the patient if he had a card from the vaccination. The patient was not given a care from that other facility and nurse caller told him  that she could update the card she would create with the YF-Vax that he received elsewhere, but she needed him  to obtain all the information about the YF-Vax from  the other facility. Patient returned to the nurse caller on 11-Feb-2022 with the information. The documentation from the facility who administered YF-Vax reflected IM administration instead of the labelled SQ route. The nurse called the outside facility and was told by facility personnel that the notation of "IM" was only a documentation error and that the patient actually received the dose of YF-Vax as a SQ injection. The nurse asked the patient his impressions of the dose. To him it seemed the same as all the other IM vaccines he had received. The nurse has no way to know for sure whether YF-Vax was given to the patient by IM or SQ route. The nurse did not have any records of additional vaccines given on the same day as the YF-Vax. Also, the nurse administered other travel vaccines, but not on the same date as YF-Vax.   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: DTAP, DTAPIPV, DTAPIPVHIB, HIBV, IPV, TDAP
Symptoms: Product storage error
Clinical narrative: temperature excursion; Initial information received on 14-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 temperature excursion while receiving vaccines [ADACEL], [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and HIB (PRP/T) VACCINE [ACT-HIB] and while treated with TUBERCULIN TEST [TUBERSOL].  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 TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown (lot - C582AA) for Product used for unknown indication.  On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot UJ603AAA via unknown route in unknown administration site for immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C59700A via unknown route in unknown administration site immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ597AAA via unknown route in unknown administration site immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5816AA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect IPV (VERO) lot V1A011M via unknown route in unknown administration site immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7093AA via unknown route in unknown administration site immunization.  On an unknown date the patient had temperature excursion (product temperature excursion issue) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion).  At time of reporting, the outcome was Unknown for the event temperature excursion.
Sex: U
Vaccine: MNQ
Symptoms: Product temperature excursion issue
Clinical narrative: Excursion occurred total time out of range is 3 hours and 45 minutes with a maximum temperature of 51.7F reported with no reported adverse event; Initial information received on 14-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 excursion occurred total time out of range is 3 hours and 45 minutes with a maximum temperature of 51.7f reported with no reported adverse event while 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 a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE with unknown dosing lot U6821AA via unknown route in unknown administration site for immunization.  On 11-FEB-2022 the patient had excursion occurred total time out of range is 3 hours and 45 minutes with a maximum temperature of 51.7f reported with no reported adverse event (product temperature excursion issue) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Excursion occurred total time out of range is 3 hours and 45 minutes with a maximum temperature of 51.7F reported with no reported adverse event).  At time of reporting, the outcome was Unknown for the event excursion occurred total time out of range is 3 hours and 45 minutes with a maximum temperature of 51.7f reported with no reported adverse event.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Mobility decreased
Clinical narrative: was bed ridden for 2 days afterwards; may have received the high-dose; Initial information received from on 14-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an adult female patient who was bed ridden for 2 days afterwards and may have received the high-dose, after receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].     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 USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (strength, dose, formulation: unknown) with lot UT7347LA via unknown route in unknown administration site as prophylactic vaccination. It was reported that patient was bed ridden for 2 days afterwards, so she was concerned she may have received the high-dose ((extra dose administered). Patient was asking whether the lot of UT7347LA a FLUZONE was, or FLUZONE HIGH-DOSE VACCINE. Caller reported her clinic stated they administered FLUZONE VACCINE. Advised caller to contact clinic to gather NDC. Marked as potential to submit to Quality team to see if they were able to look up that information. Caller was frustrated that she could not locate the product via the lot number only, therefore, caller disconnected and said she had call back another time.  Action taken with INFLUENZA VACCINE TRIVALENT (FLUZONE HIGH DOSE) was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for 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.
Sex: U
Vaccine: DTAP, FLU4, HIBV, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: a temperature excursion due to unknown reasons Temperature reached 1.7C for 6 minutes with no reported adverse event; Initial information received on 14-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 a temperature excursion due to unknown reasons temperature reached 1.7c for 6 minutes with no reported adverse event while receiving vaccines[ACT-HIB].  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 HIB (PRP/T) VACCINE with unknown dose lot UJ581AAB via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with unknown dose lot C5788BA via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE with unknown dose  lot C5829BA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U7191AA via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE with unknown dose lot UJ776AA ,UT7347MA via unknown route in unknown administration site.  On an unknown date the patient had a temperature excursion due to unknown reasons temperature reached 1.7c for 6 minutes with no reported adverse event (product storage error) (unknown latency) following the administration of HIB.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event (a temperature excursion due to unknown reasons Temperature reached 1.7C for 6 minutes with no reported adverse event).  At time of reporting, the outcome was Unknown for the event a temperature excursion due to unknown reasons temperature reached 1.7c for 6 minutes 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: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Discomfort, Feeling abnormal, Irritability, Medication error, Product use issue
Clinical narrative: uncomfortable; fussy; patient under the age of 4 was inadvertently given a dose of QUADRACEL; Initial information received on 14-Feb-2022 regarding an unsolicited valid  non-serious case from a physician.  This case involves a 4 months old female patient whom under the age of 4 was inadvertently given a dose of quadracel, experienced uncomfortable and fussy while 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 23-Sep-2021, the patient received a dose of suspect Diphtheria-15/Tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine once (strength, lot and batch number: unknown) via intramuscular route in an unknown administration site for immunization. Information on batch number has been requested.  Concomitant medications included Rotavirus vaccine; Hepatitis B vaccine; Pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 23-SEP-2021 the patient under the age of 4 was inadvertently given a dose of Quadracel (product use issue), had been uncomfortable (discomfort), fussy (irritability) (latency: same day) following the administration of Diphtheria-15/Tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (product se issue, uncomfortable, fussy).  At time of reporting, the outcome was Unknown for the events product use issue and fussy, was Recovered / Resolved on an unknown date for the event uncomfortable.  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: 83.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: ACUTE RESPIRATORY FAILURE; ENDOTRACHEAL INTUBATION; INTENSIVE CARE; SARS-COV-2 TEST POSITIVE; COVID-19; PULMONARY EMBOLISM; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2055433) on 04-FEB-2022 and concerned an 83 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: anxiety, Benign prostatic hyperplasia (BPH) with obstruction, depression, dysphagia, hypertension, Gastrooesophageal reflux disease (GERD) and paroxysmal atrial fibrillation no anticoagulation. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: unknown) dose was not reported, 1 total administered on left arm on 11-MAR-2021 for unspecified indication. Drug start period was 307 days. Concomitant medications included acetylsalicylic acid, clonazepam, duloxetine, finasteride, guaifenesin, mecobalamin, metoprolol, mirtazapine, olanzapine, pantoprazole, paracetamol, sennoside a+b, tamsulosin, tramadol, and trazodone. On 12-JAN-2022, the patient tested positive for COVID (sars-cov-2 test positive) and was hospitalized (date unspecified). The patient was admitted to inpatient (intensive care) intubated (endotracheal intubation) with acute hypoxemic respiratory failure due to COVID-19 and pulmonary embolism. The patient was hospitalized for 9 days. As of 21-JAN-2022, the patient was still in hospital.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute respiratory failure, endotracheal intubation, intensive care, pulmonary embolism, sars-cov-2 test positive and covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged).  This report was associated with product quality complaint: 90000216455. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 11-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.This updated information does not alter the causality of previously reported events. 20220213293- covid-19 vaccine ad26.cov2.s- acute respiratory failure,pulmonary embolism, endotracheal intubation, intensive care,  sars-cov-2 test positive and covid-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission; occurred after 2nd vaccine
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 3rd vaccine; breakthrough case admission