chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Hypersomnia, Myalgia, Pyrexia, Somnolence
Clinical narrative: running a high fever with the shakes; running a high fever with the shakes/ slight fever; very sore joints; very sore muscles; sleep 16.5 hours; Initial information received on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a patient.  This case involves a 65 years old male patient who had very sore muscles, running a high fever with the shakes, running a high fever with the shakes/ slight fever, very sore joints and sleep 16.5 hours , after receiving vaccine MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE [H1N1 FLU VACCINE PACKAGED BY ].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On 14-Sep-2022, the patient received an unknown dose of suspect MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE, (with an unknown strength, lot number and expiry date) , given as topical injection in an unknown administration for prophylactic vaccination (immunization). Information regarding batch number has been requested.  On 15-Sep-2022, the patient woke up at 2:30AM and had running a high fever with the shakes (tremor) (pyrexia) , The patient also had very sore muscles/joints (myalgia), (arthralgia) ,  1 day following the administration of MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. The patient went to work and left at Lunch, went home and sleep 16.5 hours (somnolence) , 1 day following the administration of MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. Then, the fever finally broke around 11:30AM, and a slight fever came back and then was over with morning of the 16-Sep-2022. Patient did not experience any additional symptoms/events. There were no lab data/results available  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (very sore muscles, running a high fever with the shakes, running a high fever with the shakes/ slight fever, very sore joints, sleep 16.5 hours).  Outcome: Recovered / Resolved on 15-Sep-2022 for all the events.
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Tremor
Clinical narrative: running a high fever with the shakes; running a high fever with the shakes/ slight fever; very sore joints; very sore muscles; sleep 16.5 hours; Initial information received on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a patient.  This case involves a 65 years old male patient who had very sore muscles, running a high fever with the shakes, running a high fever with the shakes/ slight fever, very sore joints and sleep 16.5 hours , after receiving vaccine MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE [H1N1 FLU VACCINE PACKAGED BY ].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On 14-Sep-2022, the patient received an unknown dose of suspect MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE, (with an unknown strength, lot number and expiry date) , given as topical injection in an unknown administration for prophylactic vaccination (immunization). Information regarding batch number has been requested.  On 15-Sep-2022, the patient woke up at 2:30AM and had running a high fever with the shakes (tremor) (pyrexia) , The patient also had very sore muscles/joints (myalgia), (arthralgia) ,  1 day following the administration of MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. The patient went to work and left at Lunch, went home and sleep 16.5 hours (somnolence) , 1 day following the administration of MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. Then, the fever finally broke around 11:30AM, and a slight fever came back and then was over with morning of the 16-Sep-2022. Patient did not experience any additional symptoms/events. There were no lab data/results available  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (very sore muscles, running a high fever with the shakes, running a high fever with the shakes/ slight fever, very sore joints, sleep 16.5 hours).  Outcome: Recovered / Resolved on 15-Sep-2022 for all the events.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient received fluzone QV vaccine with no reported adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid non-serious case received from health professional.  This case involves a 32-year-old female patient who was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone QIV] in context of pregnant patient received fluzone qv vaccine with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e., before pregnancy outcome was known. The reported Pregnant patient received fluzone QV vaccine with no reported adverse event occurred at 37 weeks of pregnancy and during pregnancy trimester.   The date of last menstrual period was reported as 27-Dec-2021. The estimated due date is 03-Oct-2022. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if patient had previous pregnancy.    On 14-Sep-2022, the pregnant patient received of suspect Fluzone QIV Suspension for injection at dose 1 DF (dosage form) via intramuscular route in the left deltoid (lot: UT7682KA) for prophylactic vaccination with no reported adverse event (exposure during pregnancy) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event exposure during pregnancy. Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 14.0
Sex: U
Vaccine: FLUR4
Symptoms: Product use issue
Clinical narrative: Flublok out of indication was administered to a 14 year old patient with no reported adverse event; Initial information was received on 22-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 years old patient with unknown demographics who had experienced an event influenza quadrivalent recombinant vaccine [Flublok QIV] was administered out of indication to a 14 year old patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Sep-2022, the patient received a dose of suspect influenza quadrivalent recombinant vaccine (strength, formulation, dose, route, batch number and expiry date: unknown) via intramuscular route for Annual flu shot. Information on batch number was requested.  On 22-SEP-2022 the patient was administered influenza quadrivalent recombinant vaccine out of indication to a 14 year old patient with no reported adverse event (product use issue) (latency: same day).   No lab data was reported  Action taken: not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: they were to get PENTACEL and they gave the DTaP-IPV portion but not the ACTHIB with no reported AE; they were to get PENTACEL and they gave the DTaP-IPV portion but not the ACTHIB with no reported AE; Initial information received on 25-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11 months old female patient was to get pentacel and they gave the dtap-ipv portion but not the acthib with no reported adverse event(ae), while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 10-Aug-2022, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at an unknown dose once (lot number, expiry date: not reported) via unknown route at an unknown administration site.  On 10-Aug-2022 the patient was to get pentacel and they gave the dtap-ipv portion but not the acthib with no reported ae (single component of a two-component product administered) (product preparation error) same day latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: Not applicable.  Outcome: 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.
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Intercepted product administration error
Clinical narrative: getting 2-half doses of 0.25 mL a week apart doses are split with no adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid non-serious case received from health professional. Agency number: 01282437   This case involves a 90-year-old female patient who would be getting 2-half doses of 0.25 ml a week apart split doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no adverse event.    The patient's past medical history of history of getting reactions to the flu shots (Drug allergy) with arm has gotten red after getting the flu vaccine (Injection site erythema). At the time of the event, the patient had ongoing Rheumatoid arthritis.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA388219.    On an unknown date, the patient would be getting suspect Fluzone QUADRIVALENT Multi-dose vial at dose 2-half doses of 0.25 ml a week apart doses are split with (unknown strength, form, lot, route, administration site) for prophylactic vaccination with no adverse event (intercepted product administration error).  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 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: 39.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of TYPHIM VI given with no reported adverse event; Initial information received  on 16-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 39 years old male patient who had expired dose of typhim vi given with no reported adverse event after receiving vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE).  On 16-Sep-2022, the patient received 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot T1E371M and 14-Sep-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On 16-Sep-2022, (latency: same day) the patient had expired dose of typhim vi given with no reported adverse event (expired product administered) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  It was reported, "expired dose of TYPHIM VI given. This situation is reported as a medication error due to an expired dose of TYPHIM VI being administered to a patient".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: Accidental exposure to product, Needle issue, No adverse event, Underdose
Clinical narrative: a lot of the medication was leaked out from the sides of the needle resulting in an under dose,as an occupational/accidental exposure with no reported adverse event; Initial information (received on 19-Sep-2022 processed as non-case) with additional information 19-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist. Agency number: 01284280.  This case involves a 63-year-old and unknown gender patient who experienced a lot of the medication was leaked out from the sides of the needle resulting in an under dose, as an occupational/accidental exposure with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 17-Sep-2022, the patient received suspect FLUZONE QIV NP at dose 0.5ml once via intramuscular route in the left deltoid (lot: UT7701MA, expiry date: 30-Aug-2022) for Influenza immunization. The patient used the product first time.    On 17-SEP-2022, the patient developed a non-serious a lot of the medication was leaked out from the sides of the needle resulting in an under dose, as an occupational/accidental exposure with no reported adverse event (accidental exposure to product) at same day latency.  Pharmacist calling to inquire about a FLUZONE QIV NP, a patient was receiving vaccination on 17Sep2022, the needle they used was damaged and a lot of the medication was leaked out from the sides of the needle resulting in an under dose. They are seeking guidance on how to handle this situation. This situation is reported as an occupational/accidental exposure.   Action taken: Not applicable. The patient was still using product.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 siblings received IPOL vaccinations, that had expired with no reported adverse event; Initial information received on 19-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 2 patients of an unknown demographics who received ipol vaccinations, that had expired with no reported adverse event, after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Sep-2022, the patient received a total dose of suspect IPV (VERO) (lot T1D482M  and expiration date: 25-Jul-2022) at a dose of 0.5ml via unknown route in unknown administration site for immunization.   On 16-Sep-2022(Latency: same day),  the reporter stated 2 siblings received ipol vaccinations, that had expired with no reported adverse event (expired product administered).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   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: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: giving half doses of HD Fluzone and having the patient return a week later for the second half ; problematic on many fronts because the vaccine is only good for 24 hrs with no reported adverse event; Initial information received on 19-Sep-2022 regarding an unsolicited valid non-serious case via health professional. Agency number: 01284655  This case involves patient of unspecified demographics who experienced giving half doses of Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] and having the patient return a week later for the second half; problematic on many fronts because the vaccine is only good for 24 hrs 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 suspect Fluzone High-Dose Quadrivalent half dose (lot number, route in unknown administration site) for prophylactic vaccination and having the patient return a week later for the second half; problematic on many fronts because the vaccine is only good for 24 hrs. with no reported adverse event (incorrect dose administered) at unknown latency. The reported enquired, if the patient returns should they receive another half dose and discard the rest or should they receive a second full dose?   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 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: 73.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: patient not receiving the full dose of FLUZONE HIGH DOSE QIV due to the vaccine leaking out with no reported adverse event; Initial information received on 19-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 73 years old female patient who did not received the full dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] due to the vaccine leaking out with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Sep-2022, the patient received 0.5 ml  dose of suspect influenza quadrival A-B high dose HV vaccine (strength and formulation not reported) (lot UJ900AA; Expiry Date 30-Jun-2023) via intramuscular route in Right deltoid administration site for prophylactic vaccination.  On 19-Sep-2022 the patient did not received the full dose of influenza quadrival A-B high dose HV vaccine due to the vaccine leaking out with no reported adverse event (incorrect dose administered). It was stated that she attached the needle to the pre-filled syringe and when she went to immunize the patient the vaccine started leaking out of the prefilled syringe and she does not know how much of the vaccine actually went into the patient. It was asked if patient needs to be revaccinated or if she can give the rest of the vaccine left in the pre-filled syringe. Patient was still in the office and was able to get a full dose of the vaccine and she doesn't see any damage to the syringe and states the needle was attached properly, the syringe itself was leaking out the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion and products were determined to be not suitable to use with no reported adverse event; another physician used the products and administered them to patients post excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2022SA391393, 2022SA390948, 2022SA392234, 2022SA392303 and 2022SA392531.  This case involves a 10 months old female patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] after temperature excursion and products were determined to be not suitable to use with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Caller states she previously reported a temperature excursion (product storage error) and products were determined to be not suitable to use and the product was still placed back in the refrigerator. Caller states that on 19-Sep-2022 another physician used the INFLUENZA QUADRIVAL A-B VACCINE and administered them to patients post excursion 0.5 ml dose once of suspect  (lot UT7695JA, exp date: 30-Jun-2023) via intramuscular route in the left thigh for Immunization (poor quality product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccine was administered post excursion to patient with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to cases 2022SA390611(CLUSTER), 2022SA390948(CLUSTER), 2022SA391393(CLUSTER), 2022SA392234(CLUSTER) and 2022SA392531(CLUSTER).  This case involves a 38 years old male patient to whom vaccine was administered post excursion with no reported adverse event for Influenza quadrival A-B vaccine [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Sep-2022, the patient received 0.5 ml dose of suspect Influenza quadrival A-B vaccine, suspension for injection (lot UT7695JA: strength and expiry date not reported) via intramuscular route in the right arm for Immunization.  It was reported that vaccine was administered post excursion to patient 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 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: 1.92
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine exposed to a temperature excursion and products were determined to be not suitable to use with no reported adverse event; Vaccine was administered after it was not suitable to use post temperature excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2022SA390611(CLUSTER).  This case involves a 23 months old female patient who was administered vaccine after it was not suitable to use post temperature excursion with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  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).  On an unknown date, the INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion and products were determined to be not suitable to use with no reported adverse event (product storage error).  On 19-Sep-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation and strength not reported; lot UT7695JA and expiry date: 30-Jun-2022) via intramuscular route in the left thigh for prophylactic vaccination.  On 19-Sep-2022, (latency: same day) the patient was administered vaccine after it was not suitable to use post temperature excursion with no reported adverse event (poor quality product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  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 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:  01286160: 01286040: 01286171: 01286178: 01286213:
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: FLUZONE QIV NP to 6 patients after it was not suitable to use post temperature excursion with no reported adverse event; FLUZONE QIV NP to 6 patients after it was not suitable to use post temperature excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to cases 2022SA390611, 2022SA390948, 2022SA392303 and 2022SA392234.  This case involves a 17 years old male patient who was given  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] after it was not suitable to use post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Sep-2022, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7695JA exp date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization.  On 19-Sep-2022 the patient developed a non-serious event "fluzone qiv np to 6 patients after it was not suitable to use post temperature excursion with no reported adverse event (product temperature excursion issue) (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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: consumer received MENQUADFI instead of Bexsero with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient who received menquadfi (MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE) instead of bexsero with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received a dose of 0.5 ml of  suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U7450AB, expiration date: 10-Oct-2024 via intramuscular route in the right upper arm as immunization.  On 15-SEP-2022 the patient received menquadfi instead of bexsero with no reported adverse event (wrong product administered) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. Caller reported that the consumer has already had their booster Meningococcal (Groups A, C, Y, W) Conjugate Vaccine with MENACTRA back, on 27Jul2022  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (consumer received MENQUADFI instead of Bexsero 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.
Sex: F
Vaccine: DTAP
Symptoms: Abdominal distension
Clinical narrative: bloating; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who experienced bloating after receiving vaccine Diphtheria, tetanus and acellular pertussis vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In June 2011, the patient received a dose of suspect Diphtheria, tetanus and acellular pertussis vaccine(dose, strength, formulation, lot details: unknown) produced by unknown manufacturer via unknown route in unknown administration site for immunization.  Pharmacist calling in asking if Adacel contains any eggs or gluten. Pharmacist reports patient experienced bloating (abdominal distension) following the Tdap (Diphtheria, tetanus and acellular pertussis vaccine) vaccine in June 2011 and patient asked if she should go to the emergency room for evaluation. Pharmacist confirms patient was not admitted in the hospital at this time. Outbound call made to reporter to verify if patient had a Tdap AE from ADACEL. Pharmacist states patient did not receive the mentioned Tdap vaccine at the in June 2011, states information she is seeing in the system is pulling from an outside source and unable to verify if patient had a AE from ADACEL or another Tdap vaccine manufactured by another company.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (bloating).  At time of reporting, the outcome was Unknown for the event bloating.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dosing of imovax, using pre-exposure schedule instead of post-exposure unvaccinated schedule and giving 3 doses with a booster instead of 5 doses for post-exposure unvaccinated with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics who had dosing of imovax, using pre-exposure schedule instead of post-exposure unvaccinated schedule and giving 3 doses with a booster instead of 5 doses for post-exposure unvaccinated 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 09-Sep-2022, the patient received a first dose of suspect RABIES (HDC) VACCINE (formulation, strength, route: unknown)  lot number not reported in unknown administration site as Immunization  On 09-SEP-2022 the patient had dosing of imovax, using pre-exposure schedule instead of post-exposure unvaccinated schedule and giving 3 doses with a booster instead of 5 doses for post-exposure unvaccinated with no reported adverse event (inappropriate schedule of product administration) same day following the administration of RABIES (HDC) VACCINE.  On 12-Sep-2022 he/she also received a second dose of the same vaccine  with an unknown batch number in unknown administration site. On 20-Sep-2022 he/she also received a third dose of the same vaccine  with an unknown batch number in unknown administration site as Immunization, where the 3rd was supposed to be on 16sep2022.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (dosing of imovax, using pre-exposure schedule instead of post-exposure unvaccinated schedule and giving 3 doses with a booster instead of 5 doses for post-exposure unvaccinated 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 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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received menquadfi instead of bexsero,with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] instead of Bexsero,with no reported adverse event.  The patient's past vaccination(s)has already had their booster Meningococcal (Groups A, C, Y, W) Conjugate Vaccine (MENACTRA) back, on 27-Jul-2022. The patient's past medical history, medical treatment(s) and family history were not provided.   On 15-Sep-2022, the patient received 0.5ml  dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (lot U7450AB; Expiration Date 10-OCT-2024) via intramuscular route in the right arm for immunization instead of bexsero,with no reported adverse event (wrong product administered) (latency: on 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: temperature excursion at 1 degree C for 43 minutes due to unknown reasons with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received via Lab manager. number: 01286865   This case reports temperature excursion of vaccine IPV (VERO) [IPOL] at 1 degree c for 43 minutes due to unknown reasons with no reported adverse event.  This case is linked to cases 2022SA391587 and 2022SA391920.   On an unknown date, Lab manager reported temperature excursion of Ipol (Lot: V1B901M, expiry: 03-Jun-2024, lot: V1A022M, expiry: 17-Jun-2024, Lot: V1A121M, expiry: 15-Jun-2024) at 1 degree c for 43 minutes due to unknown reasons with no reported adverse event (product storage error) at unknown latency. Caller verified none were used post excursion.  This situation is reported as a temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data and is due to unknown reasons.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ACT-HIB was administered with an expired diluent with no adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics and it was reported that act-hib (HIB (PRP/T) VACCINE) was administered with an expired diluent with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Immunization. Batch/lot number requested.  On an unknown date the act-hib was administered with an expired diluent with no adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE. The reporter asked does it have to be reconstituted with that diluent?  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (ACT-HIB was administered with an expired diluent with no 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 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: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administration of expired acthib and daptacel with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Healthcare professional).  This case is linked to case 2022SA391400.  This case involves a 2 years old male patient who was administration expired HIB (PRP/T) vaccine [ACT-HIB] 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 (daptacel) for Immunisation.  On 20-Sep-2022, the patient received 0.5 ml dose of suspect HIB (PRP/T) vaccine (formulation, strength, expiry date : unknown) lot UJ583ABA via intramuscular route in the left deltoid for immunization.  On 20-Sep-2022 the patient administered of expired ACT-HIB and Daptacel with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Temperature excursion at 48.3 Fahrenheit for 2 hours due to a power outage with no reported adverse event; Vaccine administered post excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was administered vaccine post temperature excursion at 48.3 Fahrenheit for 2 hours due to a power outage with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the IPV (VERO) was exposed to a temperature excursion at 48.3 Fahrenheit for 2 hours due to a power outage with no reported adverse event (product storage error).  On 19-Sep-2022, the patient received 0.5 mL dose of suspect IPV (VERO) (formulation and strength not reported; lot V1A121M and expiry date: 15-Feb-2024) via intramuscular route in the right thigh for prophylactic immunization.  On 19-Sep-2022, (latency: same day) the patient was administered vaccine post excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of ACTHIB was inadvertently administered with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult female patient to whom  expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Immunosuppression.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOCOCCAL VACCINE POLYSACCH 23V) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 20-Sep-2022, the patient received an expired dose 0.5 ml (dose 1) of suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection, strength not reported  (lot U6999AB; expiry date: 23-Jul-2022) via intramuscular route in the left arm for immunization with no reported adverse event (expired product administered) (latency: on 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 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.