chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: temperature excursion range from 31.7F to 52.4F for 300 hours due to a refrigerator malfunction; vaccine administration  post excusrion; medication error due to administration post excursion vaccine with no adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced medication error due to administration post excursion vaccine with no adverse event, temperature excursion range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction and vaccine administration  post excusrion while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL).  On 19-Jul-2022, the patient received a  0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE once  (lot U7268AA; expiry date: 22-Apr-2023)  via intramuscular route in the right deltoid for immunization.  On 19-JUL-2022 the patient developed a non-serious medication error due to administration post excursion vaccine with no adverse event (medication error),   vaccine administration  post excusrion (poor quality product administered) and On an unknown date the patient developed a non-serious temperature excursion range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction (product storage error) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.   Action taken: not applicable.    At time of reporting, the outcome was Unknown for the event medication error,poor quality product administered, product storage error    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: UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: pentacel was given inappropriately, states only the diluent was administered and not the powder with no reported adverse event; pentacel was given inappropriately, states only the diluent was administered and not the powder with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was given inappropriately, stated only the diluent was administered and not the powder with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot U7013AA.  On an unknown date,  Pentacel was given inappropriately, stated only the diluent was administered and not the powder with no reported adverse event (product preparation error) (single component of a two-component product administered)  (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  The reporter stated that all the diluents they had were either sterile water or 0.9% normal saline , so they wanted to know how they would obtain the proper diluent (0.4% NaCl saline solution) .  Action taken : not applicable.  Outcome: unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Adacel temperature excursion range from 31.7F to 52.4F for 300 hours due to a refrigerator malfunction with no reported adverse event; Adacel administered after temperature excursion with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2022SA302671.  This case involves a 13 years old female patient it was reported diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] had temperature excursion range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction with no reported adverse event and Adacel administered after temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that adacel had temperature excursion range from 31.7f to 52.4f for 300 hours due to a refrigerator malfunction with no reported adverse event (product storage error).  On 11-Jul-2022, the patient received a  dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (strength: unknown) (lot U6923AA and expiry date: 21-Jan-2023) via intramuscular route in the left deltoid for immunization was administered after temperature excursion with no reported adverse event (poor quality product administered)( latency : same day).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menactra was grabbed as mistake and administered to the patient, 12 yo patient who was given a second dose of Menactra. The first dose was given at age 11 with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient by whom Menactra was grabbed as mistake and administered to the patient, 12 yo patient who was given a second dose of Menactra. The first dose was given at age 11 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 0.5 ml (once) dose of suspect Meningococcal A-C-Y-135 (D Conj) Vaccine (lot U7273BB, expiry date; 24-Apr-2023, formulation, strength: unknown) via intramuscular route at administration site left (unspecified) for immunization or Tuberculin skin test.  On an unknown onset and latency, It was reported Menactra was grabbed as mistake and administered to the patient, 12 yo patient who was given a second dose of Menactra. The first dose was given at age 11 with no reported adverse event (wrong 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: a patient came in for a booster dose and was administered an expired dose by mistake, with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a patient of unknown age and gender who came in for a booster dose and was administered an expired dose of HIB (PRP/T) Vaccine [ACT-HIB] by mistake, 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 an unknown dose of suspect HIB (PRP/T) VACCINE (expiry date: 29-May-2022; lot number; strength; frequency not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was reported that, a patient came in for a booster dose and was administered an expired dose by mistake, with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) Vaccine.  It was unknown if there were lab data/results available.  Action taken: Not applicable  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.83
Sex: F
Vaccine: FLUR4
Symptoms: Off label use, Wrong product administered
Clinical narrative: report of under-age usage of Flublok in clinic- with no reported adverse event; Fluzone was ordered but Flublok was sent.; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 10 months old female patient who report of under-age usage of flublok in clinic- with no reported adverse event and fluzone was ordered but flublok was sent. while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 04-Apr-2022, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2155; expiry date: 30-june-2022)  via unknown route in the left thigh for immunization.  On 04-APR-2022 the patient developed a non-serious report of under-age usage of flublok in clinic- with no reported adverse event (off label use) and fluzone was ordered but flublok was sent. (wrong product administered)following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken:not applicable.   At time of reporting, the outcome was Unknown for the event wrong product administered, off label use.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: one year old received Flublok with no adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 1 years old male patient who experienced one year old received flublok with no adverse event while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 06-Apr-2022, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE  once  (strength, formulation (lot QFAA2155; expiry date: 30-Jun-2022) via intramuscular route in the right thigh for immunization.  On 06-APR-2022 the patient reported one year old received flublok with no adverse event (off label use) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event off label use.; Sender's Comments:  01196930:
Age: 1.0
Sex: M
Vaccine: FLUR4
Symptoms: Product dispensing error, Wrong product administered
Clinical narrative: reports our agency sent her Flublok when Fluzone was ordered with no reported advere event; reports 1 year old was administered Flublok. She reports our agency sent her Flublok when Fluzone was ordered. with no reported advere event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 1 years old male patient who experienced reports our agency sent her flublok when fluzone was ordered with no reported advere event  and reports 1 year old was administered flublok. she reports our agency sent her flublok when fluzone was ordered. with no reported advere event while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 15-Apr-2022, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE  (lot QFAA2155) (strength, formulation: unknown)  via intramuscular route in the left thig for immunization.  On 15-Apr-2022 the patient developed a non-serious reports our agency sent her flublok when fluzone was ordered with no reported advere event (product dispensing error)(unknown latency) and  year old was administered flublok. she reports our agency sent her flublok when fluzone was ordered. with no reported advere event (wrong product administered) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product dispensing error and wrong 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: 21.0
Sex: F
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Imovax that expired 17June2022 was given to a patient with no reported adverse event; Initial information was received on 24-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional via call center.   This case involves a 21 years old female patient who experienced imovax that expired 17june2022 was given to a patient with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 23-Jul-2022, the patient received 0.25 ml of suspect RABIES (HDC) VACCINE (lot T1C663M, expiry 17-jun-22) (strength: unknown) via intramuscular route in unknown administration site for Immunization.    On 23-JUL-2022 the patient developed a non-serious imovax that expired 17june2022 was given to a patient with no reported adverse event (expired product administered) (latency same day) following the administration of RABIES (HDC) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event imovax that expired 17june2022 was given to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A fifteen year old was administered a Menactra booster a year too soon. His last injection was 3 years ago with no adverse event; Initial information received on 25-Jul-2022 and live follow-up received on same day (processed together) regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old male patient who was administered a menactra booster a year too soon. his last injection was 3 years ago with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Jul-2019, the patient received a 0.5ml 1 X(once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation was unknown, lot U7208AA and expiry date: 20-Feb-2023) via unknown route in unknown administration site for Immunization.  On 21-Jul-2022 the patient developed a non-serious event of a fifteen year old was administered a menactra booster a year too soon. his last injection was 3 years ago with no adverse event (inappropriate schedule of product administration) (Latency:  3 years) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: receiving ACT-HIB that was reconstituted with sterile diluent (with no reported adverse event); Initial information received on 25-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 year old female patient who was receiving act-hib (HIB (PRP/T) VACCINE) that was reconstituted with sterile diluent (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, TETANUS VACCINE TOXOID (DTAP); ELASOMERAN (MODERNA COVID-19 VACCINE); and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) all for Prophylactic vaccination.  On 21-Jul-2022, the patient received a  dose of 0.25 ml (0.25 mL to 2 mL ) of suspect HIB (PRP/T) VACCINE lot UJ646AAA, expiration date: 05-Mar-2023, via intramuscular route in the left deltoid as Immunization.  On 21-JUL-2022 the patient was receiving act-hib that was reconstituted with sterile diluent (with no reported adverse event) (product preparation error) same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (receiving ACT-HIB that was reconstituted with sterile diluent (with no reported adverse event)).  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired dose of Daptacel, had expired on 06 Jun 2022 with no reported adverse event; Initial information received on 26-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 years old male patient who was administered an expired dose of daptacel, had expired on 06 jun 2022 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.  Concomitant medications included polio vaccine for Prophylactic vaccination.  On 26-Jul-2022 at 11:14, the patient received suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml (lot C5743AA, expiry date: 06-Jun-2022) via intramuscular route in left deltoid.  On 26-Jul-2022 the patient developed a non-serious patient was administered an expired dose of daptacel, had expired on 06-Jun-2022 with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: Not applicable.  Outcome: Unknown for the event patient was administered an expired dose of daptacel, had expired on 06 jun 2022 with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: PENTACEL was administered to a patient after the expiration date with no reported adverse event; Initial information received on 26-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 6 months old female patient who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (Hepatitis B [Hepatitis B Vaccine)]; Pneumococcal Vaccine Conj 13V (CRM197) (Prevnar 13) and Rotavirus Vaccine (Rotavirus Vaccine) for Immunisation.  On 25-Jul-2022, the patient received a 0.5 ml dose once total (dose 3) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (lot: UJ527AAA; expiry date: 22-Jul-2022) via intramuscular route in the left thigh for Immunisation.  On 25-JUL-2022 the patient was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/HIB(PRP/T) Vaccine after the expiration date with no reported adverse event (expired product administered) (latency: same day).  It was unknown if there were lab data/results available.  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: 35.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion due to the refrigerator door being left opened with no reported adverse event; patients administered TUBERSOL post excursion with no reported adverse event; Initial information received on 26-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 35 years old female patient who had temperature excursion due to the refrigerator door being left opened of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] and Tuberculin test [Tubersol] with no reported adverse event and was administered Tuberculin Test [Tubersol] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The suspect diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] Suspension for injection pertains to batch number: unknown (strength, dosage, route of administration, expiry date and administration site: unknown) for prophylactic vaccination. The batch number is requested.  On 26-Jul-2022, the patient received a dose of Tubersol (tuberculin test) Solution for injection with lot number: C5841AB and expiry date: 17-Jun-2023 at a dose of 0.1 mL total via intradermal route on Left Forearm for (strength: unknown) Tuberculin test.  On 26-Jul-2022, the diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] and Tuberculin test [Tubersol] were exposed to temperature at a high of 21.2C out of range for 8 hours (temperature excursion) due to the refrigerator door being left opened with no reported adverse event (product storage error) (Latency: Same day).  On 26-Jul-2022, the patient received a dose of tubersol post excursion with no reported adverse event (poor quality product administered) (Latency: Same Day) following the first dose intake of Tuberculin Test.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: was given expired ipol with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves patient of an unknown age and gender who was given expired IPV (Vero) [Ipol] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Jul-2022, the patient received an unknown dose once (total) of suspect IPV (Vero) (Suspension for injection; strength: standard) (lot: T1D482N; expiry date: 25-Jul-2022) via unknown route in unknown administration site for immunization.  On 27-JUL-2022 the patient was given expired IPV (Vero)with no reported adverse event (expired product administered) (latency: same day).  It was unknown if there were lab data/results available.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: patient received ADACEL last year and was mistakenly given another dose of vaccine with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 12 years old female patient who received Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] last year and was mistakenly given another dose of vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Jul-2022, the patient received a 2nd dose 0.5 ML (once) of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (lot U7266AA, expiry date;11-Jan-2024, strength; standard, formulation: unknown) via intramuscular route at Left deltoid for immunization.  It was reported, the patient received adacel last year and was mistakenly given another dose of vaccine with no reported adverse event (extra dose administered) (onset 14-Jul-2022, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: 07/25/22 Pt. came in for a 2 year physical and received 2 vaccines DTP on the left thigh and Hep A on the right thigh   07/27/22 Pt. came in for a sick visit for a swollen left thigh  Diagnosis: Cellulites  Medication: Clindamycin 75ml/5ml (8.5 ml TID x 10 days)  Pt. is scheduled on 08/01/22 for a follow up appointment
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Lymphadenopathy, Pruritus, Rash, Urticaria
Clinical narrative: Approximately 10-14 days after injection, I developed hives all over my body that change location daily, are itchy, and my skin is very inflamed. I have many swollen lymphnodes and the rashes migrate but always end up on my neck daily at some point. It?s been nearly 3 weeks since this began with no improvement, and benadryl only gets rid of the itchiness but nothing more.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Malaise, SARS-CoV-2 test positive
Clinical narrative: I started having COVID symptoms on 07/20/22, and my PCR test was positive for SARS COV 2 on 07/21/2022. I encountered COVID when I was out of country.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood test, Computerised tomogram, Condition aggravated, Dyspnoea
Clinical narrative: I stared getting respiratory issues that turned into pneumonia and from that I have developed severe asthma and constant shortness of breath. I tire easily and can?t even talk for long periods of time. My fibromyalgia pain is much worse and my brain fog is also much worse. I have more numbness and tingling.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Fibromyalgia, Hypoaesthesia, Laboratory test
Clinical narrative: I stared getting respiratory issues that turned into pneumonia and from that I have developed severe asthma and constant shortness of breath. I tire easily and can?t even talk for long periods of time. My fibromyalgia pain is much worse and my brain fog is also much worse. I have more numbness and tingling.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain, Paraesthesia, Pneumonia, Respiratory disorder
Clinical narrative: I stared getting respiratory issues that turned into pneumonia and from that I have developed severe asthma and constant shortness of breath. I tire easily and can?t even talk for long periods of time. My fibromyalgia pain is much worse and my brain fog is also much worse. I have more numbness and tingling.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: I stared getting respiratory issues that turned into pneumonia and from that I have developed severe asthma and constant shortness of breath. I tire easily and can?t even talk for long periods of time. My fibromyalgia pain is much worse and my brain fog is also much worse. I have more numbness and tingling.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Medication error
Clinical narrative: inadvertently administered a YF-VAX to a severely immunocompromised patient with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves a 56 years old female patient who was inadvertently administered a yf-vax vaccine to a severely immunocompromised patient, while receiving vaccine YELLOW FEVER VACCINE - [YF-VAX].  At the time of event , the patient had an ongoing history of severely immunocompromised. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation; HEPATITIS A VACCINE INACT (HAVRIX) for Immunisation; and TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) for Immunisation.  On 26-Jul-2022, the patient received a  dose of suspect YELLOW FEVER VACCINE ( lot UJ412AB and expiration date: 25-Nov-2022) at a dose of 0.5ml once via unknown route at unknown administration site for immunization.  On 26-Jul-2022 (latency: same day), the patient inadvertently administered a yf-vax ( Contraindicated product administered) to a severely immunocompromised patient that currently receives IV immune therapy following the administration of YELLOW FEVER VACCINE.  Action taken: not applicable  Outcome: 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: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse side effects reported; an expired dose of PNEUMOVAX 23 (pre-filled syringe) was accidently administered to a patient today; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender, whose medical history, concurrent conditions, previous adverse drug reaction, or family adverse drug reactions were not provided.  On 18-JUL-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliter (ml), 1 dose, administered intramuscularly for prophylaxis (strength, anatomical location, and vaccine scheme were not reported; lot number T031820 was determined to be a valid lot number and expiration date: 10-MAY-2022). There were no adverse side effects reported. The administered expired vaccine has no temperature excursions.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes, Pain in extremity
Clinical narrative: experiencing arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of oral herpes (1st dose received on 18th May 2018, refer case US2022111778) and Shingles vaccine with an associated reaction of oral herpes (received in 2004).   On 19th October 2018, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Linked case(s) involving the same patient: US2022111778, US2022AMR112249.  Additional Information: GSK Receipt Date: 27-Jul-2022. Reporter's Comments: The case was self reported by the patient. The patient received Shingrix in the left upper arm (left deltoid). The reporter reported that he was experiencing fever blisters prior to getting a different, earlier Shingles vaccine that only required one dose (caller was unsure of the name of earlier vaccine received) in what they believe was 2004. The patient experienced arm soreness after receipt of Shingrix.  The reporter consented to follow up with health care professional.; Sender's Comments:  US-GSK-US2022111778:Same patient, different dose US-GSK-US2022AMR112249:Same patient, split case
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: received 1st dose of Twinrix and Havrix as the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 56-year-old female patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 22nd July 2022, the patient received the 2nd dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 22nd July 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-JUL-2022 Reporter's comments: The pharmacist stated that the patient received her 1st dose of Twinrix on 23rd June 2022 and received Havrix as the 2nd dose.  The consented to follow up was granted via postal. Additional Supportive Information: The patient received 2nd dose as Havrix instead of Twinrix, which led to wrong vaccine administered.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bradycardia, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient had vasovagal event after COVID vaccine. No hx of fainting in the past, but "got close" per mother. Patient fainted twice after vaccine. Was bradycardic and hypotensive, but responsive. Activated EMS to transport to ED for further evaluation since patient remained pale, diaphoretic and lethargic 30-40 minutes after vaccine. Airway remained patent. Mother agreed with plan of care for patient.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Lethargy, Pallor, Presyncope, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient had vasovagal event after COVID vaccine. No hx of fainting in the past, but "got close" per mother. Patient fainted twice after vaccine. Was bradycardic and hypotensive, but responsive. Activated EMS to transport to ED for further evaluation since patient remained pale, diaphoretic and lethargic 30-40 minutes after vaccine. Airway remained patent. Mother agreed with plan of care for patient.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient had vasovagal event after COVID vaccine. No hx of fainting in the past, but "got close" per mother. Patient fainted twice after vaccine. Was bradycardic and hypotensive, but responsive. Activated EMS to transport to ED for further evaluation since patient remained pale, diaphoretic and lethargic 30-40 minutes after vaccine. Airway remained patent. Mother agreed with plan of care for patient.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Patient called regarding new onset of chest pain and was referred to get evaluated. He is currently at Hospital.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Severe, Additional Details: patient developed large bump on his bicep after vaccine administration. bump has since decreased in size but is presently about 2.5 inches in diameter. patient is experiencing pain but no other symptoms.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Administered expired product.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy bone marrow abnormal, Biopsy lymph gland abnormal, Lymphadenectomy, Lymphadenopathy, Lymphoma
Clinical narrative: Mammogram after booster showed enlarged lymph nodes on right side. Then three months later a biospsy indicated they were lymphoma. Then petscan and surgically remove two nodes two months later confirmed. Then  a month later bone marrow indication lymphoma 3a.
Sex: U
Vaccine: COVID19
Symptoms: Mammogram abnormal, Positron emission tomogram abnormal
Clinical narrative: Mammogram after booster showed enlarged lymph nodes on right side. Then three months later a biospsy indicated they were lymphoma. Then petscan and surgically remove two nodes two months later confirmed. Then  a month later bone marrow indication lymphoma 3a.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Diabetes mellitus, Fatigue, Headache
Clinical narrative: Long covid(still in going after 1 year) lock jaw( 4 months post vaccine) chronic fatigue(still on going one year post vaccine) headaches/migraines (9 months post vaccine) diabetes ( 11 months after vaccine found out I had diabetes)  , aching feet and legs ( symptom of diabetes) joint ache ( still on going 1 year post vaccine)
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Post-acute COVID-19 syndrome, Trismus
Clinical narrative: Long covid(still in going after 1 year) lock jaw( 4 months post vaccine) chronic fatigue(still on going one year post vaccine) headaches/migraines (9 months post vaccine) diabetes ( 11 months after vaccine found out I had diabetes)  , aching feet and legs ( symptom of diabetes) joint ache ( still on going 1 year post vaccine)
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Flushing, Hyperhidrosis, Injection site pain, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: EMS WAS CALLED PATIENT WAS CLEARED-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: CHILD GOT A BOOSTRIX (TDAP) AND MENACTRA AT THE SAME TIME PATIENT FAINTED LEAVING THE PHARMACY EMS WAS CALLED AND PATIENT GOT CHECK AND WAS SENT HOME
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: EMS WAS CALLED PATIENT WAS CLEARED-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: CHILD GOT A BOOSTRIX (TDAP) AND MENACTRA AT THE SAME TIME PATIENT FAINTED LEAVING THE PHARMACY EMS WAS CALLED AND PATIENT GOT CHECK AND WAS SENT HOME
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Head injury, Seizure
Clinical narrative: Systemic: Seizure-Mild, Additional Details: short episode with sudden change of awareness followed by convulsions. patient griped onto pharmacist's arm fimly and knocked head against wall. Patient broke his glasses. Parmacist called out to tech for assistance. Patient monitored for 5 mins. EMS offered but declined. follow up calls made at 2pm and 7pm . messages left. no return call received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: patient waited for few minutes after getting vaccinated while her husband got his vaccine, then they both left immunization area to shop the store
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness/Lightheadedness-Mild.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Swelling, Swelling face
Clinical narrative: Systemic: swelling around face/neck per patient-Mild, Systemic: Weakness-Mild, Additional Details: Pt states she started having swollen face/neck since 7/27/22 and saw a doctor for the adverse reaction. She was not prescribed anything or treated at doctor's office. She was told to wait for a couple of days and return to officec if not getting better. She came to pharmacy on 7/28/22 around 10 am to have us report this adverse reaction. She did not have severe swelling nor breathing difficulty, she appeared otherwise healthy. She insisted on filing the vaers to be followed up.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Chest X-ray, Chest pain, Computerised tomogram
Clinical narrative: Systemic: swelling around face/neck per patient-Mild, Systemic: Weakness-Mild, Additional Details: Pt states she started having swollen face/neck since 7/27/22 and saw a doctor for the adverse reaction. She was not prescribed anything or treated at doctor's office. She was told to wait for a couple of days and return to officec if not getting better. She came to pharmacy on 7/28/22 around 10 am to have us report this adverse reaction. She did not have severe swelling nor breathing difficulty, she appeared otherwise healthy. She insisted on filing the vaers to be followed up.