chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient who was 2 1/2 years old received quadracel yesterday with no reported adverse event; Initial information received on 02-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 1/2 years old male patient who received diphtheria-15/ tetanus/ 5 hybrid AC pertussis/ IPV (MRC5) vaccine [Quadracel] yesterday with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Aug-2023, the 2 1/2 years old patient received 0.5 mL dose of suspect diphtheria-15/ tetanus/ 5 hybrid AC pertussis/ IPV (MRC5) vaccine, suspension for injection (batch number: C6002BA) (expiry date unknown) via intramuscular route in the left thigh for Immunisation with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient who was 2 1/2 years old received quadracel yesterday 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: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired MENACTRA vaccine to a patient with no reported adverse event; Initial information received on 02-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient who got administered an expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] vaccine to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml (TOTAL) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Strength = Standard) Solution for injection (lot U7273BA) (expiration date- 24-Apr-2023) (expired product administered) (latency- same day)via unknown route in unknown administration site for Immunization.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: IPV
Symptoms: Product storage error
Clinical narrative: they had a vial of punctured IPOL that was exposed to temperature beyond 8C with no reported adverse event; the 4 doses of IPOL were administered to 4 patients with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 patients of unknown age and gender patient who   had a vial of punctured IPV (VERO) [IPOL] that was exposed to temperature beyond 8c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Reportedly from 26-Jun-2023 to 29-Jun-2023, the patients received a 0.5 ml dose, once of suspect IPV (VERO) (Suspension for injection) (Lot number, expiry date: not reported, Strength; standard via unknown route in unknown administration site for Immunization (poor quality product administered) (Latency: same day).  The information on the batch number was requested.  On an unknown date the patient had a vial of punctured ipol that was exposed to temperature beyond 8c with no reported adverse event (product storage error).  Action taken: not applicable.  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: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired Fluzone QIV-HD to a patient (expiry date: 30 June 2023) with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was administered an expired fluzone qiv-hd to a patient (expiry date: 30 june 2023) with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Aug-2023, 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine expiry date: 30-Jun-2023 via unknown route in unknown administration site for immunization (strength, formulation, batch: unknown), patient administered an expired fluzone qiv-hd to a patient (expiry date: 30 june 2023) with no reported adverse event (expired product administered) (latency same day). Information on the batch number was requested  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.
Age: 13.0
Sex: M
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Menquadfi stored at 31.5F upto 2 hours 45 minutes with no reported adverse event; vaccines were administered to the patients after post excursion with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13-year-old male patient, MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] stored at 31.5f upto 2 hours 45 minutes with no reported adverse event and vaccines were administered to the patient after post excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation.  On an unknown date, the patient received 0.5 ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength, lot number, expiry date: unknown) via intramuscular route in unknown administration site for immunization and menquadfi stored at 31.5f upto 2 hours 45 minutes with no reported adverse event (product storage error) (latency: unknown). Information on batch number and expiry date was requested.  On an unknown date the patient had an event of vaccines were administered to the patients after post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) 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: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion that exceeded the stability vaccines were administered with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 years old male patient who was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] post temperature excursion that exceeded the stability vaccines were administered 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 0.5 mL dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (batch number, expiry date unknown) via intramuscular route in unknown administration site for Immunization post temperature excursion that exceeded the stability with no reported adverse event (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that excursion occurred due to potential mechanical issue with the refrigerator; Max/Low Temperature reached: 31.5° fahrenheit for 2 hours 45 minutes (human error: no)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion that exceeded the stability vaccines were administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: ipol excursion was for 3 hours to a maximum temperature of 12.6°C with no reported adverse event; received ipol after the punctured vial was exposed to the excursion with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA239251 and 2023SA239621(CLUSTER).  This case involves a 11 years old male patient who received ipol after the punctured vial was exposed to the excursion for 3 hours to a maximum temperature of 12.6°c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Jun-2023, 0.5 ml(TOTAL) dose of suspect IPV (VERO), Suspension for injection lot W1A101M expiry date- 10-Feb-2025 via unknown route in unknown administration site for Immunization (strength: unknown), patient received ipol after the punctured vial was exposed to the excursion with no reported adverse event (poor quality product administered) (latency same day).  On an unknown date ipol excursion was for 3 hours to a maximum temperature of 12.6°c with no reported adverse event (product storage error) (latency unknown).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product storage error and poor quality 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: IPV, UNK
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: patient was administered PENTACEL and also had IPV vaccine instead of pneumococcal vaccine with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient of unknown age and gender who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and also had poliomyelitis vaccine (inactivated) vaccine instead of pneumococcal 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 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] (Suspension for injection) (strength, lot number; expiry date not reported) and an unknown dose of suspect poliomyelitis vaccine (inactivated) produced by unknown manufacturer (strength, formulation; lot number; expiry date not reported) via unknown route in unknown administration site for Immunization. Information regarding batch number was requested in the case.  On an unknown date the patient was administered pentacel and also had IPV vaccine instead of pneumococcal vaccine with no reported adverse event (wrong product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   Nurse declined to provide additional information  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: M
Vaccine: MEN, TDAP
Symptoms: Product storage error
Clinical narrative: Adacel, menquadfi were administered to patients after excursion with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who were administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] And Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] after excursion 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 in Jun-2023, the patient received a unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (suspension for injection) and Meningococcal A-C-Y-W135 (T Conj) Vaccine (solution for injection) (expiry date and lot number: not reported) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) and  temperature excursion at 31.5° fahrenheit for 2 hours 45 minutes with no reported adverse event (Poor quality product administered) (latency: same day). Information regarding batch number was requested in the case.   It was reported, "Adacel, Daptacel, IPOL, Menquadfi, Pentacel, Quadracel, Tenivac, Vaxelis. Product activated/prepared? NO Due to a human error: NO and Does extended stability data cover the excursion: NO These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 4.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Product storage error
Clinical narrative: Adacel, menquadfi administered to patient after temperature excursion at 31.5° Fahrenheit for 2 hours 45 minutes due to potential mechanical issue with the refrigerator with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who was administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], and Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] after temperature excursion at 31.5° fahrenheit for 2 hours 45 minutes 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 in Jun-2023, the patient received a dose of 0.5 ml suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (suspension for injection) and Meningococcal A-C-Y-W135 (T Conj) Vaccine (solution for injection) (lot number; strength; expiry date unknown) after temperature excursion at 31.5° fahrenheit for 2 hours 45 minutes with no reported adverse event (Poor quality product administered) (latency: same day). Information regarding batch number was requested in the case.   It was reported, "Adacel, Daptacel, IPOL, Menquadfi, Pentacel, Quadracel, Tenivac, Vaxelis. Product activated/prepared? NO Due to a human error: NO and Does extended stability data cover the excursion: NO These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: adacel, menquadfi administered, after a temperature excursion for 2 hours 45 minutes at 31.5° fahrenheit due to potential mechanical issue with the refrigerator, with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 11 years old female patient who was administered meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], after a temperature excursion for 2 hours 45 minutes at 31.5° fahrenheit due to potential mechanical issue with the refrigerator, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On an unknown date, the patient received unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection and meningococcal A-C-Y-W135 (T conj) vaccine, Solution for injection (batch number, expiry date unknown) not reported via intramuscular route in unknown administration site for Immunization after a temperature excursion for 2 hours 45 minutes at 31.5° fahrenheit due to potential mechanical issue with the refrigerator, with no reported adverse event (poor quality product administered) (same day latency). Information on the batch number was requested.  Human error: no  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event adacel, menquadfi administered, after a temperature excursion for 2 hours 45 minutes at 31.5° fahrenheit due to potential mechanical issue with the refrigerator, 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.; Sender's Comments:  US-SA-2023SA239548: US-SA-2023SA239679: US-SA-2023SA239960:
Age: 1.5
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event, Product preparation error
Clinical narrative: administered only diluent (DTaP-IPV) at first/diluent not mixed with powder/physician then instructed MA to give a complete Pentacel by mixing a powder with another Pentacel DTaP-IPV diluent/received extra DTaP-IPV with no reported adverse event; administered only diluent (DTaP-IPV) at first/diluent not mixed with powder/physician then instructed MA to give a complete Pentacel by mixing a powder with another Pentacel DTaP-IPV diluent/received extra DTaP-IPV with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 months old male patient who was administered only diluent (dtap-ipv) at first/diluent not mixed with powder/physician then instructed ma to give a complete pentacel by mixing a powder with another Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] dtap-ipv diluent/received extra dtap-ipv with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Aug-2023, the patient received a dose 4 with dosage 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ843AB, Expiry date: 24-Feb-2024 with unknown strength) via unknown route at unknown site as Immunization.  On 03-Aug-2023 the patient was administered only diluent (dtap-ipv) at first/diluent not mixed with powder/physician then instructed ma to give a complete pentacel by mixing a powder with another pentacel dtap-ipv diluent/received extra dtap-ipv with no reported adverse event (product preparation error) and (extra dose administered) same day following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine.  It was reported "the patient received extra DTaP-IPV. The record shows the injection site as the left thigh. It does not specify which dose or if both were given in the left thigh. No other vaccines were administered to the patient today."  Action taken: not applicable.  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 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: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: QUADRACEL was given to a 7-year-old patient with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 7 years old male patient who was given diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Jun-2023, 7-year-old patient received a total dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine Suspension for injection (lot number, dosage, strength, expiry date-  not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Information on the batch number was not available.  Reportedly, A medical assistant asks for safety information regarding administration of QUADRACEL to inappropriate age group and reports that they have a 7-year-old patient who was given QUADRACEL on 27Jun2023; caller states the patient has not been seen in the office since 05Aug2020, the vaccination records don't get reviewed by a nurse due to the patient is a home school child, inadvertently, quadracel was given to the patient even though he is 7 years old.  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.  No follow-up is possible as Reporter cannot be contacted by Sanofi.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccine temperature execursion at 31.5° fahrenheit for 2 hours 45 minutes was administered to the patient with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 11-year-old female patient, vaccine temperature execursion at 31.5° fahrenheit for 2 hours 45 minutes was administered to the patient with no reported adverse event with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for Immunization and an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious vaccine temperature execursion at 31.5° fahrenheit for 2 hours 45 minutes was administered to the patient with no reported adverse event (poor quality product administered) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was unknown if any lab data/test results available.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) 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: 11.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccines were exposed to 31.5f for 2 hours 45 minutes and menquadfi were administered to patients after excursion with no reported adverse event; Initial information was received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced vaccines were exposed to 31.5f for 2 hours 45 minutes and menquadfi were administered to patients after excursion 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.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Prophylactic vaccination (Immunisation).  On an unknown date, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection at dose of 0.5 ml (strength, lot number, expiration date: Unknown) via intramuscular route in unknown administration site for Immunization (immunization) was exposed to 31.5 f for 2 hours 45 minutes and menquadfi were administered to patients after excursion with no reported adverse event (poor quality product administered) (latency: same day). Information on the batch number was requested.  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event vaccines were exposed to 31.5f for 2 hours 45 minutes and menquadfi were administered to patients after 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: 11.0
Sex: M
Vaccine: MEN
Symptoms: Product storage error
Clinical narrative: Vaccines were exposed to 31.5f upto 2 hours 45 minutes and These vaccines were administered to 40 patients over a span of 1 week with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 11 years old male patient where MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] vaccines were exposed to 31.5f upto 2 hours 45 minutes and these vaccines were administered to 40 patients over a span of 1 week 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) for Prophylactic vaccination.  On 15-Jun-2023, the patient received 0.5 ml dose of suspect meningococcal A-C-Y-W135 (t conj) vaccine Solution for injection lot number not reported via unknown route in unknown administration site (strength and expiration date: not provided) for immunization and (poor quality product administered) (latency- same day). Information on the batch number was requested.  Products involved? ADACEL, DAPTACEL, IPOL, MENQUADFI, PENTACEL, QUADRACEL, TENIVAC, VAXELIS Product activated/prepared? NO Ask how the situation occurred? POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached? 31.5° FAHRENHEIT How long did the excursion last? 2 HOURS 45 MINUTES Did it occur due to a human error? NO Does extended stability data cover the excursion: NO And in case of negative advice: Was the product used by/ administered to the patient: YES. First time product used : No Still using product : Yes  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: patient was given adacel instead of daptacel with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 4-year-old female patient was given adacel instead of 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), concomitant(s) and family history were not provided.   On 04-Aug-2023, the patient received a dose 5 of 0.5 ml total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength: unknown) (lot: U7837AA, expiry date: 07-Jul-2025) via intramuscular route in the right thigh for Immunization.  On 04-Aug-2023 the patient was given adacel instead of daptacel with no reported adverse event (wrong product administered) (latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was unknown if any lab data/test results available.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: they gave a 5 year old child an expired QUADRACEL with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female child patient who received expired diphtheria-15/tetanus/5 Hybrid AC Pertussis/Ipv (Mrc5) Vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jul-2023, the 5 year old child patient received a dose 1 at a dose of 0.5 ml (TOTAL) of suspect diphtheria-15/tetanus/5 Hybrid AC Pertussis/Ipv (Mrc5) Vaccine suspension for injection (Frequency: once, Strength: standard, expiry date: 06-Jul-2023 and lot C5916AA) via unknown route in unknown administration site for immunization and (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient recieved kinrix instead of individual vaccinations polio and dtap.
Age: 0.5
Sex: M
Vaccine: COVID19-2, DTAPHEPBIP, HIBV, PNC13
Symptoms: Product preparation issue
Clinical narrative: Covid-19 vaccination diluted with sterile saline for injection not normal saline.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Pt received less than recommended dose due to the patient pulling away from RN before receiving all vaccine. RN unable to determine how much vaccine patient received as the liquid was on patients leg with nothing left in the syringe. After seeing the amount of liquid on patient's leg, RN assessed it is likely that the patient received less than half of the vaccine
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Magnetic resonance imaging head abnormal, Scan with contrast abnormal, Thrombosis
Clinical narrative: I passed a blood clot and was hospitalized for 3 days. I had extreme vertigo and vomiting.  I had the vaccines on 12/28 and the stroke on 12/30.  I had a CT and then a MRI and was diagnosed with a stroke.  I was in the hospital for three days.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: I passed a blood clot and was hospitalized for 3 days. I had extreme vertigo and vomiting.  I had the vaccines on 12/28 and the stroke on 12/30.  I had a CT and then a MRI and was diagnosed with a stroke.  I was in the hospital for three days.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Crying, Grunting, Pallor, Rash, Rash macular
Clinical narrative: PATIENT CRYING AND GRUNTING. BREATH SOUNDS NORMAL WITHOUT WHEEZING. SPLOTCHY BLANCHING RASH ON FOREHEAD THAT FADED AFTER 20MINS (AFTER TYLENOL GIVEN)
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Paraesthesia
Clinical narrative: ADVERSE EVENT: PATIENT STARTED FEELING LIGHT HEADED AND TINGLING SENSATION IN THE FEET, HE WAS FEELING DIZZY AND STARTED PASSING OUT. HE WAS NOT ABLE TO COMMUNICATE. TREATMENT: PATIENT WAS ASKED TO LEAN BACK, RELAX AND TAKE DEEP BREATHS, CALLED AMBULANCE IN THE MEAN TIME. SLOWLY HE STARTED FEELING BETTER BY THE TIME AMBULANCE WAS HERE. HIS BLOOD PRESSURE MEASURED 110/60. HE REFUSED TO GO TO HOSPITAL AND HE SAID HE WAS FEELING FINE AND BETTER. MOM TRIED TO CONTACT PCP AND INFORM.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: Covid-19 5yr-11 dose diluted with sterile water for injection not normal saline for injection.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: Covid-19 vaccination diluted with sterile water for injection not normal saline for injection.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Biopsy, Blister, Borrelia test, Pruritus, Rash
Clinical narrative: broke out in rash, started itching, on cest, lower back, blisters on leg, scalp itches
Age: 1.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Gave Moderna 6mo - <6y BIV 10mg/0.2ml instead of Moderna BIV 25mcg/0.25ml
Age: 81.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash the extends down arm and on side outside of vaccination area.
Age: 68.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Contusion, Injection site haematoma
Clinical narrative: Patient came in on 8.6.23 to pick up medication. He wanted to let us know and showed me his arm. He said he developed a hematoma at the injection site which went down bust still had bruising that went down the arm. He was okay but wanted to let us know about the event.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Glucose urine present, Glycosylated haemoglobin increased, Pancreatic failure, Type 1 diabetes mellitus, Urine ketone body present
Clinical narrative: 9 months after his two first Pfizer vaccines, he developed type 1 diabetes. There was no other major viral illness. Per endocrinologist, his pancreas had been failing for 6-12 months. This lines up with his COVID vaccines.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Administered vaccine subcutaneously. In the past you could administer either subcutaneous or intramuscularly
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Endotracheal intubation, Febrile convulsion
Clinical narrative: Complex febrile seizure which required intubation and a 3 day hospital stay.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Joint instability, Magnetic resonance imaging abnormal, Pain
Clinical narrative: I had the first shot in January. I didn't really notice any thing yet. I had the second shot in Feb and started noticing shoulder pain. Since I already had neck issues, I didn't connect the vaccine to the shoulder. The pain got to where I could not lift my shoulder I then got the booster in Nov 2021. Almost immediately the other shoulder (each injection site?) was in pain and I could not lift the shoulder Seeing doctors for two years, getting treatment. Slowly shoulder has been getting better, but not all the way yer=t.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: I had the first shot in January. I didn't really notice any thing yet. I had the second shot in Feb and started noticing shoulder pain. Since I already had neck issues, I didn't connect the vaccine to the shoulder. The pain got to where I could not lift my shoulder I then got the booster in Nov 2021. Almost immediately the other shoulder (each injection site?) was in pain and I could not lift the shoulder Seeing doctors for two years, getting treatment. Slowly shoulder has been getting better, but not all the way yer=t.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mechanical urticaria
Clinical narrative: I have Moderna bivalent booster dose induced Dermatographia since 01/06/2023
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Dyspnoea, Gait disturbance, Headache, Hyperhidrosis, Mobility decreased
Clinical narrative: Came to me complaining of extreme body pain and discomfort. He laid down on the couch curled up with legs to chest rocking back and forth. His teeth clenched and breathing heavy.  Breathing so heavy that spit was coming out of his teeth as they were clenched. He has a severe headache  and was sweaty.  His pain was so intense he was groaning and yelling out in pain.  We gave him 2 motrin initially with no relief and 45 minutes later gave him another with still no relief.  We wanted to take him to the ER but was in so much pain he could barely walk and just wanted to lay down and rock side to side.  After about 3 hrs his pain came down to about a 5  and  then he began throwing up over and over until all he could do was dry heave.  He also had extreme arm pain in the arm it was administered in so much so he couldn't lift it or move it or even touch it.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Retching, Vomiting
Clinical narrative: Came to me complaining of extreme body pain and discomfort. He laid down on the couch curled up with legs to chest rocking back and forth. His teeth clenched and breathing heavy.  Breathing so heavy that spit was coming out of his teeth as they were clenched. He has a severe headache  and was sweaty.  His pain was so intense he was groaning and yelling out in pain.  We gave him 2 motrin initially with no relief and 45 minutes later gave him another with still no relief.  We wanted to take him to the ER but was in so much pain he could barely walk and just wanted to lay down and rock side to side.  After about 3 hrs his pain came down to about a 5  and  then he began throwing up over and over until all he could do was dry heave.  He also had extreme arm pain in the arm it was administered in so much so he couldn't lift it or move it or even touch it.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after beyond use date
Age: 0.5
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID vaccine after beyond use date.
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVD shots after beyond use date.
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after beyond use date.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Carotid artery occlusion, Carotid endarterectomy, Cerebrovascular accident, Speech disorder
Clinical narrative: 7:45pm I had a stroke. speech at home was difficult. An ambulance transported me to the hospital. My right carotid artery had a blockage. The blockage was removed. Four days later was sent home. I am now having a right carotid stint placed soon. this Covid-19 vaccination was my 5th I had vaccinationson, 02/28/2021, 04/01/2021,12/20/2021 07/12/2022, 07/18/2023.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after beyond use date.
Age: 0.33
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID vaccine after beyond use date.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after beyond use date.
Age: 2.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID short after beyond use date.