chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: ACT-HIB at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and was administrated post excursion with no reported adverse event; ACT-HIB at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and was administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2022SA370866, 2022SA372086, 2022SA372080, 2022SA372584, 2022SA373534, 2022SA371564, 2022SA371948, 2022SA372095, 2022SA372123, 2022SA372180, 2022SA372199, 2022SA372581, 2022SA373167 and 2022SA372581.  This case involves a 1 years old female patient who was administrated HIB (PRP/T) VACCINE [ACT-HIB] post excursion at a low of negative 5.1 C (Celsius) out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2022, the patient received 0.5 ml, total, dose 4 of suspect HIB (PRP/T) VACCINE, unknown formulation (lot UJ665AA, exp date: 11-Mar-2023) via intramuscular route in the right thigh as Immunization.  On an unknown date the HIB (PRP/T) VACCINE [ACT-HIB] at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes (product storage error) and was administrated post excursion on 31-Aug-2022 with no reported adverse event (poor quality product administered) (latency: same day).  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.; Sender's Comments:  US-SA-2022SA372080:
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: temperature excursion at negative 5.1 degree Celsius for 12 minutes and a low of 1.3 degree Celsius for 10 minutes with no reported adverse event; vaccine administered post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] post excursion which was at negative 5.1 degree Celsius for 12 minutes and a low of 1.3 degree Celsius for 10 minutes 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 meningococcal vaccine and hpv vaccine.  On an unknown date, the suspect diphtheria-2/tetanus/5 AC pertussis vaccine was exposed to a temperature excursion at negative 5.1 degree Celsius for 12 minutes and a low of 1.3 degree Celsius for 10 minutes with no reported adverse event (product storage error).  On 30-Aug-2022, the patient received a0.5 mL dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (formulation and strength not reported; lot U7461AA, expiry date: 12-Jul-2024) via intramuscular route in the right arm for prophylactic immunization.  On 30-Aug-2022, (latency: same day) the patient was administered diphtheria-2/tetanus/5 AC pertussis vaccine post excursion with no reported adverse event (poor quality product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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:  General 01266747: Daptacel 01266903: ACTHIB 01266768: ACTHIB 01266921: ACTHIB 01266924: MENACTRA 01266780: ADACEL 01266792: ADACEL 01266974: ADACEL 01266976: ADACEL  01266978: ADACEL  01266980: ADACEL  01266982: ADACEL  01266983: ADACEL  01266985:
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: a low of 1.3C out of range for 10 minutes were administrated post excursion(with no reported adverse event); Daptacel administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient and it was reported that a a low of 1.3c out of range for 10 minutes were administrated post excursion(with no reported adverse event) and daptacel administrated post excursion with no reported adverse event while 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.   On 31-Aug-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot C589388, expiration date: 21-Jun-2023, via intramuscular route in the left thigh as Immunization.  On 31-AUG-2022 the daptacel administrated post excursion with no reported adverse event (poor quality product administered) same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  On an unknown date there was a low of 1.3c out of range for 10 minutes were administrated post excursion(with no reported adverse event) (product storage error) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.No human error was there.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (a low of 1.3C out of range for 10 minutes were administrated post excursion(with no reported adverse event), Daptacel administrated post excursion with no reported adverse event).  At time of reporting, the outcome was Unknown for all.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2022SA372080:
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes with no reported adverse event; vaccine administered post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom experienced HIB (PRP/T) VACCINE [ACT-HIB] vaccine administered post excursion after low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HIB VACCINE (HIB) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 31-Aug-2022, the patient received 0.5 ml total dose of suspect HIB (PRP/T) VACCINE, (lot UJ611AA exp date: 30-Nov-2022)  via intramuscular route in the left thigh as immunization.  on unknown date low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes with no reported adverse event" (product storage error) occurs and on 31-Aug-2022 (latency: same day) the patient was administered post excursion with no reported adverse event (poor quality product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event vaccine.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2022SA370866: US-SA-2022SA371948: US-SA-2022SA372086: US-SA-2022SA372095: US-SA-2022SA372123: US-SA-2022SA372180: US-SA-2022SA372199: US-SA-2022SA372581: US-SA-2022SA373167: US-SA-2022SA373534: US-SA-2022SA371333: US-SA-2022SA372584: US-SA-2022SA371564:
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minute with no adverse event; administering dose post temperature excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 23 years old female patient who reported administering dose post temperature excursion with no reported adverse event and at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minute 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.    On 31-Aug-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE once (1X) ( lot U7461AA; expiry date: 12-JUL-2024) via intramuscular route in the right arm for immunization.  On 31-AUG-2022 the patient reported a non-serious event administering dose post temperature excursion with no reported adverse event (poor quality product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minute with no adverse event (product storage error) (unknown latency) 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 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.; Sender's Comments:  01266747: 01266903: 01266768: 01266921: 01266924: 01266780: 01266792: 01266974: 01266976: 01266978: 01266980: 01266982: 01266983: 01266985: US-SA-2022SA372080:
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Adacel at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes. with no reported ae; ADACEL (8 doses) were administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 38 years old male patient and it was reported DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] exposed at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes with no reported adverse event(AE) and adacel (8 doses) were administrated post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 29-Aug-2022, the patient received suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 0.5 ml once (lot U7461AA, expiry date: 12-Jul-2024) via intramuscular route in the right arm for immunisation.  On an unknown date the patient adacel was at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes. with no reported ae (product storage error). On 29-Aug-2022 the patient developed a non-serious adacel (8 doses) were administrated post excursion with no reported adverse event (poor quality product administered) same day latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: Not applicable.  Outcome was Unknown for the event adacel at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes. with no reported ae and was Unknown for the event adacel (8 doses) were administrated post 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.; Sender's Comments:  01266768: 01266921: 01266924: US-SA-2022SA372080:
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Adacel at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes were administrated post excursion with no AE; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from health professional. GMI number: 01266980  This case involves a 33-year-old male patient who experienced Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes were administrated post excursion with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA370866, 2022SA372086, 2022SA373534, 2022SA371564, 2022SA371948, 2022SA372095, 2022SA372180, 01266982, 2022SA372199, 2022SA373167, 2022SA372080, 2022SA372581 and 2022SA372584.    It was reported that a temperature excursion of unknown cause, reporting two excursions occurring overnight, no staff present, no human error. Caller reporting ADACEL at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes.  On 30-Aug-2022, the patient received a dose post excursion of suspect Adacel Vaccine at dose 0.5ml once via intramuscular route in the left arm (lot U7461AA, expiry date: 12-Jul-2024) for immunization with no reported adverse event (poor quality product administered) latency same day.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: ADACEL were administrated post excursion with no adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 58 years old male patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administrated post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Aug-2022, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (lot U7461AA; expiry date: 12-Jul-2024) via intramuscular route in the left arm for immunization  On 29-Aug-2022 on same day the Adacel were administrated post excursion with no adverse event (poor quality product administered).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: ADACEL was administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 65 years old male patient to whom experienced diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administrated post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient was administrated  0.5 ml dose 1 of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (lot U7461AA Exp.date: 12-JUL-2024) via intramuscular route in the right arm for immunization post excursion with no reported adverse event (poor quality product administered).  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.; Sender's Comments:  01266747: 01266903: 01266768: 01266921: 01266924: 01266780: 01266792: 01266974: 01266976: 01266978: 01266980: 01266982: 01266985: US-SA-2022SA372080:
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: ADACEL at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and was administrated post excursion with no reported adverse event; ADACEL at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and was administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2022SA370866(CLUSTER), 2022SA372086(CLUSTER), 2022SA372581(CLUSTER), 2022SA372080(CLUSTER), 2022SA372584(CLUSTER), 2022SA373534(CLUSTER), 2022SA371564(CLUSTER), 2022SA371948(CLUSTER), 2022SA372095(CLUSTER), 2022SA372123(CLUSTER), 2022SA372180(CLUSTER), 2022SA371333(CLUSTER), 2022SA372199(CLUSTER), 2022SA373167(CLUSTER) and 2022SA373167(CLUSTER).  This case involves a 79 years old female patient who was administrated DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] post excursion at a low of negative 5.1 C (Celsius) out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient received 0.5 ml, total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, unknown formulation (lot U7461A, exp date: 12-Jul-2024)  via intramuscular route in the left arm as Immunization.  On an unknown date the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes (product storage error) and was administrated post excursion on 30-Aug-2022 with no reported adverse event (poor quality product administered) (latency: same day.  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.; Sender's Comments:  US-SA-2022SA372080:
Sex: U
Vaccine: DTAPIPVHIB, HIBV, IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion to be 0.0 degrees Celsius human error and occurred for 7 hours with no adverse event; poor quality product administered; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and  gender patient who reported temperature excursion to be 0.0 degrees celsius human error and occurred for 7 hours with no adverse event and poor quality product administered while receiving vaccines IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ACT-HIB] and 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 lot number: UJ673AAA EXP: 27-04-2023) via unknown route in unknown administration site, HIB (PRP/T) VACCINE (lot number: UJ665AAA ; expiry date: 11-Mar-2023)  and  IPV (VERO) (lot number: C1AO21M; EXP: 17-02-2024) (strength, dose, formulation, route,lot number not reported) in unknown administration site all for prophylactic vaccination.  On an unknown date the patient reported a non-serious temperature excursion to be 0.0 degrees celsius human error and occurred for 7 hours with no adverse event (product storage error)and poor quality product administered  (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, HIB (PRP/T) VACCINE and IPV (VERO).    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.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: Per guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: Per guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: Per DHA IHD guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: Per guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: Per Regulatory Authority guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per Regulatory Authority guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per agency guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per Regulatory Authority guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Haematemesis, Haematochezia, Peripheral swelling, Pyrexia
Clinical narrative: Fever, back pains, swelling of arm, and blood in vomit and stool
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per Regulatory Authority guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per Regulatory Authority guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per healthcare division guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per healthcare division guidance we are to discontinue monovalent mRNA boosters> All such boosters administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine was initially stored in refrigerator on 5Aug2022 and administered on 6Sep2022; No other adverse reaction; Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.), PRODUCT STORAGE ERROR (vaccine was initially stored in refrigerator on 5Aug2022 and administered on 6Sep2022) and NO ADVERSE EVENT (No other adverse reaction) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AS1416B) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was initially stored in refrigerator on 5Aug2022 and administered on 6Sep2022) and NO ADVERSE EVENT (No other adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.), PRODUCT STORAGE ERROR (vaccine was initially stored in refrigerator on 5Aug2022 and administered on 6Sep2022) and NO ADVERSE EVENT (No other adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No other adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.) and PRODUCT STORAGE ERROR (vaccine was initially stored in refrigerator on 5Aug2022 and administered on 6Sep2022).    No concomitant drug information was provided.  Vaccine was administered on 06-Sep-2022 from  09:15 to 09:45. It was confirmed that the vial had not undergone any temperature excursion issue. No adverse events were reported post vaccination of both the Moderna doses.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-642057, US-MODERNATX, INC.-MOD-2022-642060, US-MODERNATX, INC.-MOD-2022-642052 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Follow-up received, Suspect drug information and narrative was updated. Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642060:Same reporter US-MODERNATX, INC.-MOD-2022-642057:Same reporter US-MODERNATX, INC.-MOD-2022-642052:
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient noticed rash on her arm today after getting the flu shot on September 6th. She showed me where she had the injection which was on her arm more towards the back than the deltoid. I wasn't confident to say this was an adverse reaction to the vaccine, but recommended benadryl and advil for the swelling and redness. Recommended to make a provider visit if symptoms get worse.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal swelling, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Pt recieved bivalent pfizer vaccine - about 10 min after administration, pt stated throat felt slightly swelling. pt received 1 tab of benadryl and 1 dose of epi pen. pt stated after 5 min throat swelling went from moderate to mild.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: shortness of breath-Mild, Additional Details: Per pt's father, pt started complaining about chest tightness and shortness of breath starting 3-4 days ago.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Seizure
Clinical narrative: Systemic: Seizure-Mild, Additional Details: Patient got lightheaded and then began seizing for less than 1 minute. Patient did not disclose that this had already happened to him with the covid vaccine previously. Administrator was notified after vaccine was given. 911 was called. EMTs came to check vitals (all normal after seizure). Patient said he did not want to go to hospital because this happened to him before and he was fine after.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Differential white blood cell count, Full blood count, Metabolic function test
Clinical narrative: Resident expired 9/2/2022
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Allergic Reaction; Broke out in hives.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: FEVER, AND CONGESTION.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired fluzone given to pt in clinic. Expired 6/30/22. No adverse reactions displayed. Spoke with pt's mom will repeat fluzone dose at follow up appt in 2 weeks.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Headache, Nasal congestion, Pyrexia
Clinical narrative: LGF, tactile  temp, runny nose, headache, stuffy nose, cough.  No SOB or chest pain.  Less energy and less active than normal.  All started day after vaccine and progressively gotten worse over the next couple of days.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: LGF, tactile  temp, runny nose, headache, stuffy nose, cough.  No SOB or chest pain.  Less energy and less active than normal.  All started day after vaccine and progressively gotten worse over the next couple of days.
Age: 1.58
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Patient's mother made an appt with the call center to have out of states vaccine record input into system and have needed vaccines administered at same visit. Office manager informs the mother that it would take a while to have the information put in. Mother becomes upset stating that is the reason she made an appt. The office manager input the information into system and had me check behind her. During this time the mother is in the waiting room waiting for her child to be seen. I reviewed the forms and inadvertently missed one dose of PCV being put into system. Mother informed that the child would need Hep A and PCV to be up to date and receive an UTD. She agrees to the child receiving the vaccines. Vaccines are administered and discharge/aftercare instruction given to the mother. When told that the child needs to remain for 20 minutes after vaccination per protocol to watch for adverse reactions she comments that she cannot stay 20 minutes, they had already been there over an hour as it is. They did remain for a brief period in waiting room before leaving.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Janssen 8/27/21. Positive on 9/9/22.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/24/21, 3/31/21, 12/2/21. Positive on 9/9/22.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHES
Age: 48.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case.
Age: 51.0
Sex: M
Vaccine: YF
Symptoms: Product preparation error
Clinical narrative: During a yearly audit 2 yellow fever diluents were found without the yellow fever. This had us further investigate. The last two yellow fever vaccines that were given by CMA who was questioned to figure out what happened as her patients were the last to given them and charted by her. After discussion it was found CMA gave the two patients the yellow fever vaccine with the wrong diluent. Sterile water was given instead of sodium chloride.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Pfizer EL9261 1/21/21 and EM9810 2/11/21 and boosted with Moderna Lot 012F 10/28/21.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Headache, Hot flush, Influenza like illness, Pyrexia
Clinical narrative: On 09/07/2022, donor disclosed to medical personnel that she was experiencing  a reaction following a Tetanus immunization that was administered on 09/02/2022. Donor stated the onset of the reaction occurred later that day at approximately 6pm. Donor states that she first experienced a head ache that would not resolve with hydration or eating. Donor stated that the next day (09/03/2022) around 7am, she felt fatigued and experienced some congestion accompanied by some hot flashes and a head ache. She also stated to having a 'very mild fever' with a temperature reading of approximately 99.8 degrees Fahrenheit, Donor denied being in the presence  of anyone exhibiting flu-like symptoms and denies receiving any other immunizations within the las 30 days. Donor admitted to having a history of reactions to immunizations that would provoke flu-like symptoms in the past. Donor stated signs and symptoms resolved by 09/04/2022.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Respiratory tract congestion
Clinical narrative: On 09/07/2022, donor disclosed to medical personnel that she was experiencing  a reaction following a Tetanus immunization that was administered on 09/02/2022. Donor stated the onset of the reaction occurred later that day at approximately 6pm. Donor states that she first experienced a head ache that would not resolve with hydration or eating. Donor stated that the next day (09/03/2022) around 7am, she felt fatigued and experienced some congestion accompanied by some hot flashes and a head ache. She also stated to having a 'very mild fever' with a temperature reading of approximately 99.8 degrees Fahrenheit, Donor denied being in the presence  of anyone exhibiting flu-like symptoms and denies receiving any other immunizations within the las 30 days. Donor admitted to having a history of reactions to immunizations that would provoke flu-like symptoms in the past. Donor stated signs and symptoms resolved by 09/04/2022.
Age: 52.0
Sex: F
Vaccine: YF
Symptoms: Product preparation error
Clinical narrative: During a yearly audit 2 yellow fever diluents were found without the yellow fever. This had us further investigate. The last two yellow fever vaccines that were given by CMA who was questioned to figure out what happened as her patients were the last to given them and charted by her. After discussion it was found CMA gave the two patients the yellow fever vaccine with the wrong diluent. Sterile water was given instead of sodium chloride.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Pt tested positive for COVID-19 on 09/19/2022. Deceased on 09/10/2022
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Administered monovalent booster 8 days after the monovalent vaccine authorization for boosters was revoked. At the time of administration only bivalent vaccines could be administered.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Adverse reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: The first dose of this vaccine was administered toward back of upper right shoulder. There were no adverse side effects following this. Administered on 8/5/22. Clinic then switched to administration of the vaccine subcutaneously in the bottom of the upper forearm. As a result of this form of administration, swelling at the injection site, redness, itching and some tenderness  resulted approximately 12 hours following administration. Redness has continued to increase as has minor swelling, itching and tenderness. Visually, the reaction at the injection site looks worse this morning, 9/12/22 at 10:00am than it did very early morning as indicated above. There is no fever or severe adverse reactions associated with administration. Adverse reaction is currently localized and increasing slowly at injection site.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Injection site swelling, No adverse event, Product administered at inappropriate site
Clinical narrative: The first dose of this vaccine was administered toward back of upper right shoulder. There were no adverse side effects following this. Administered on 8/5/22. Clinic then switched to administration of the vaccine subcutaneously in the bottom of the upper forearm. As a result of this form of administration, swelling at the injection site, redness, itching and some tenderness  resulted approximately 12 hours following administration. Redness has continued to increase as has minor swelling, itching and tenderness. Visually, the reaction at the injection site looks worse this morning, 9/12/22 at 10:00am than it did very early morning as indicated above. There is no fever or severe adverse reactions associated with administration. Adverse reaction is currently localized and increasing slowly at injection site.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Diarrhoea, Extra dose administered, Injection site reaction, Joint warmth
Clinical narrative: Nausea, vomiting, diarrhea, red rash at injection site, and sore hot shoulder for 3 days. The arm is better now but not the gastric issues.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Rash erythematous, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, red rash at injection site, and sore hot shoulder for 3 days. The arm is better now but not the gastric issues.
Age: 61.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: During a flu clinic on location at the patient's residence, this patient who is 61 years old was given a Fluad vaccine approved for age 65+ only. Upon discovery, I attempted to contact the patient with no answer. I contacted the patient's PCP office and was able to notify someone of the occurrence.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, Hyperaesthesia, Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: pt stated her right arm started getting hot and was hurting.  It started to swell and itch that was red that was about 4x4.  She could not get it to stop itching.  She started using Benadryl cream and a 150 mg Benadryl tablet at night.  She says it is getting  better but if she touches it again that is starts itching and it is still red and irritated around the injection site.  She did not have any complications with the other 4 Moderna vax except some mild flu like symptoms after 1st dose.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: pt stated her right arm started getting hot and was hurting.  It started to swell and itch that was red that was about 4x4.  She could not get it to stop itching.  She started using Benadryl cream and a 150 mg Benadryl tablet at night.  She says it is getting  better but if she touches it again that is starts itching and it is still red and irritated around the injection site.  She did not have any complications with the other 4 Moderna vax except some mild flu like symptoms after 1st dose.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given Moderna COVID19 vaccine on 8/31/22 that expired on 8/27/22.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was due for 3rd PFIZER 8 weeks after second dose, however received the 3rd dose early. Dose #1 was given on 8/1/22, Dose #2 was given on 8/22/22 and 3rd Dose was given on this date of 9/12/2022.  Patient was supposed to get 3rd Dose at the earliest the week of 10/17/22. Dose #3 given too early according to the guidelines. NO adverse effect noted 30 minutes post vaccination.