chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 10Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 01Jul2021 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I sincerely want to thank all of you for Saving my Life! I received my first dose of the COVID-19 vaccine as soon as it was available to me on 01Jul2021 (after returning). I received my fourth Pfizer vaccine on 10Jun2022. My wife and son were also vaccinated but he brought the virus home with him after school began in August. I have underlying health conditions including asthma so when we got Covid I used Paxlovid, Thank you and thank GOD.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Burning sensation, Death of relative, Depression, Mobility decreased
Clinical narrative: i was so stiff i couldn't move; burning in my hands, wrists, arms, legs, feet and ankles; aching in my hands, wrists, arms, legs, feet and ankles; depressed beacuse her husband passed away; Initial information received on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 70 years old female patient (162 cm and 58.967 kg) who was so stiff she couldn't move, burning in her hands, wrists, arms, legs, feet and ankles, aching in her hands, wrists, arms, legs, feet and ankles and depressed because her husband passed away while receiving vaccine INFLUENZA VACCINE.  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 Gastrooesophageal reflux disease, Osteoporosis, Hypertension and Allergies: codeine phosphate, Penicillins, Opioids (Drug hypersensitivity)  Concomitant medications included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (FEMHRT); PROPRANOLOL HYDROCHLORIDE (INDERAL); ACETYLSALICYLIC ACID, BUTALBITAL, CAFFEINE (BUTALBITAL, ASPIRIN AND CAFFEINE); MAGNESIUM (MAGNESIUM); CALCIUM (CALCIUM); and VITAMIN D3 (VITAMIN D3).  On 28-Sep-2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported in unknown administration site as Flu vaccine  On 29-SEP-2022 the patient was so stiff she couldn't move (musculoskeletal stiffness) burning in her hands, wrists, arms, legs, feet and ankles (burning sensation) aching in her hands, wrists, arms, legs, feet and ankles (pain in extremity) depressed because her husband passed away (depression)1 day following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  corrective treatment was received for the event -antidepressants for (depressed because her husband passed away). It was not reported if the patient received a corrective treatment for the events (i was so stiff i couldn't move, burning in my hands, wrists, arms, legs, feet and ankles, aching in my hands, wrists, arms, legs, feet and ankles).  At time of reporting, the outcome was not recovered for depression and Recovered / Resolved in 2022 for all others.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: i was so stiff i couldn't move; burning in my hands, wrists, arms, legs, feet and ankles; aching in my hands, wrists, arms, legs, feet and ankles; depressed beacuse her husband passed away; Initial information received on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 70 years old female patient (162 cm and 58.967 kg) who was so stiff she couldn't move, burning in her hands, wrists, arms, legs, feet and ankles, aching in her hands, wrists, arms, legs, feet and ankles and depressed because her husband passed away while receiving vaccine INFLUENZA VACCINE.  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 Gastrooesophageal reflux disease, Osteoporosis, Hypertension and Allergies: codeine phosphate, Penicillins, Opioids (Drug hypersensitivity)  Concomitant medications included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (FEMHRT); PROPRANOLOL HYDROCHLORIDE (INDERAL); ACETYLSALICYLIC ACID, BUTALBITAL, CAFFEINE (BUTALBITAL, ASPIRIN AND CAFFEINE); MAGNESIUM (MAGNESIUM); CALCIUM (CALCIUM); and VITAMIN D3 (VITAMIN D3).  On 28-Sep-2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported in unknown administration site as Flu vaccine  On 29-SEP-2022 the patient was so stiff she couldn't move (musculoskeletal stiffness) burning in her hands, wrists, arms, legs, feet and ankles (burning sensation) aching in her hands, wrists, arms, legs, feet and ankles (pain in extremity) depressed because her husband passed away (depression)1 day following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  corrective treatment was received for the event -antidepressants for (depressed because her husband passed away). It was not reported if the patient received a corrective treatment for the events (i was so stiff i couldn't move, burning in my hands, wrists, arms, legs, feet and ankles, aching in my hands, wrists, arms, legs, feet and ankles).  At time of reporting, the outcome was not recovered for depression and Recovered / Resolved in 2022 for all others.
Age: 7.0
Sex: F
Vaccine: FLUR3
Symptoms: Oropharyngeal pain, Product use issue
Clinical narrative: sore throat; Flublok given to 7 yr; Initial information was received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves 7 years old female patient who experienced sore throat while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Sep-2022, the patient received suspect influenza quadrivalent recombinant vaccine (lot UJ887AA) (strength, form, dose, frequency, expiry date: unknown) via intramuscular route in unknown administration site for influenza and experienced sore throat (oropharyngeal pain) and (product use issue) (latency: same day).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered on 21-Sep-2022 for the event sore throat and was Unknown for the event flublok given to 7 yr.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: accidental administration of expired FLUZONE HIGH DOSE vaccine by an HCP with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA419905(CLUSTER) and 2022SA420369(CLUSTER).  This case involves a 65 years old female patient who had accidental administration of expired fluzone high dose vaccine by an health care professional(hcp) with no reported adverse event , after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2022, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE ( lot UJ748AA and expiration date: 30-Jun-2022) at a dose of 0.7ml once  via intramuscular route in the left deltoid for immunization.  On 06-Oct-2022(latency: same day), the patient had accidental administration of expired fluzone high dose vaccine by an hcp 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 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: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: used the diluent from the Acthib and put it into the powder of the Pentacel and vaccinated the patient with no AE; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was vaccinated with powder of the Diptheria / Tetanus / 5 Hybrid AC Pertussis / IPV (MRC) / HB (PRP/T) (Pentacel VERO) powder diluted with ACT HIB and experienced no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC 5)/HIB(PRP/T) vaccine (with an unknown expiry date, lot number) powder form diluted with ACT HIB (product preparation error) via unknown route in unknown administration site for prophylaxis.  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 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: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: have administered an expired IPOL to a patient with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old male patient who experienced have administered an expired ipol to a patient 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.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap); measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3) (mmrvaxpro); and hepatitis b vaccine (hepatitis b [hepatitis b vaccine]).  On 11-Oct-2022, the patient received a  dose of suspect ipv (vero) at dose of 0.5 ml (lot T1E871M, expiry date:10-Oct-2022  via subcutaneous route in the left arm. for Immunization.  On 11-OCT-2022 the patient developed a non-serious have administered an expired ipol to a patient with no reported adverse event (expired product administered)(latency same day) following the administration of ipv (vero).  It was reported "Nurse is calling to get some guidance as they have administered an expired IPOL to a patient. Nurse also wants to know if they need to revaccinate the patient and what to do moving forward".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (have administered an expired IPOL to a patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event have administered an expired ipol 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 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: 59.0
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion that exceeded the stability data with No adverse event; administered to patients post excursion with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 59 years old and unknown gender patient who was administered influenza quadrival A-B multidose vaccine preserved [Fluzone Quadrivalent Multidose] post excursion with no adverse event and temperature excursion that exceeded the stability data with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 23-Sep-2022, the patient received suspect influenza quadrival A-B multidose vaccine preserved at an unknown dose (lot UJ899AA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On 23-Sep-2022 there was temperature excursion that exceeded the stability data with no adverse event (product storage error) and administered to patients post excursion with no adverse event (poor quality product administered) same day latency following the administration of influenza quadrival A-B multidose vaccine preserved.  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 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: 59.0
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 59 years old and unknown gender patient and it was reported that this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and administered to patient 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.   On an unknown date, this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error)   On 22-Sep-2022 the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength, route: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as Immunization.  On 22-SEP-2022 the vaccine was administered to patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event, administered to patient with no reported adverse event).  At time of reporting, the outcome was Unknown for all.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 58 years old and unknown gender patient who experienced temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and administered to patient with no reported adverse event while receiving vaccine 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 an unknown date there was a temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error).  On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as immunization.  On 22-SEP-2022 the vaccine was administered to the patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data; administered to patients with no reported adverse event, vaccine was adminstered to the patient with no reported adverse event).  At time of reporting, the outcome was Unknown for all  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 34 years old and unknown gender patient and it was reported that  this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and  administered to patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error)  On 29-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (formulation, strength, route: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as Immunization    On 29-SEP-2022 the vaccine was  administered to patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event,  administered to patient with no reported adverse event).  At time of reporting, the outcome was Unknown for all.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, Memory impairment
Clinical narrative: received FLUZONE HIGH DOSE QUADRIVALENT on 18SEP2022 then received another dose of it today; forgotten; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced received fluzone high dose quadrivalent on 18sep2022 then received another dose of it today and forgotten while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Sep-2022, the patient received a 2  dose of suspect influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent]  lot UT7718BA Expiration Date: 30-Jun-2023  via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious received fluzone high dose quadrivalent on 18-sep-2022 then received another dose of it today (extra dose administered) and non-serious forgotten (memory impairment) (unknown latency) following the administration of vaccine influenza quadrival a-b high dose hv vaccine.  It was reported "MA reporting that a patient received FLUZONE HIGH DOSE QUADRIVALENT on 18SEP2022 then received another dose of it today. MA said the patient must have forgotten that they already received the vaccine. MA requesting for guidance moving forward".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event received fluzone high dose quadrivalent on 18sep2022 then received another dose of it today and was Unknown for the event forgotten.   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: DTAPIPVHIB
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: the patient did not receive the full dose with no reported adverse event; Initial and live follow up information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who did not receive the full dose with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 11-Oct-2022, the patient received a  dose of 0.25 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot UJ663AAA, expiration date: 04-May-2023, via intramuscular route in unknown administration site as Immunization.  On 11-OCT-2022 the patient did not receive the full dose with no reported adverse event (incorrect dose administered) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The caller reported the needle was displaced and the medication squirted out. The caller inquired does the patient need to be revaccinated. The patient may have gotten a partial dose but they were not positive. This situation was reported as a medication error due to not securing the needle properly for the injection.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (the patient did not receive the full dose 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: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ACTHIB was given today with the sterile diluent from the box that expired on 17SEP2022 with no adverse event.; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient to whom HIB (PRP/T) VACCINE [ACT-HIB] was given today with the sterile diluent from the box that expired on 17-Sep-2022 with no 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, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 12-Oct-2022, the patient received today 0.5 ml dose 3 of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UJ581AAA; Expiration: 17-SEP-2022) via intramuscular route in the left thigh for Immunization with the sterile diluent from the box that expired on 17-Sep-2022 with no adverse event (expired product administered).  Action taken : not applicable.  Outcome :  Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: menactra was mixed wrong , it is a powder substance that was accidently mixed with saline solution with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 16 years old male patient for whom meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] was mixed wrong, it is a powder substance that was accidently mixed with saline solution 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 INFLUENZA VACCINE (INFLUENZA) for Immunisation.  On 12-Oct-2022, the patient received suspect meningococcal A-C-Y-W135 (D CONJ) vaccine at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination(immunisation).  On 12-Oct-2022 the menactra was mixed wrong, it is a powder substance that was accidently mixed with saline solution with no reported adverse event (product preparation error, latency: same day). Caller wanted to find out if it was safe to give menactra to her son again right away, or do they need to wait 4 weeks  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: M
Vaccine: FLU4
Symptoms: Immunisation reaction, No adverse event, Product storage error
Clinical narrative: Product was left out of refrigeration for 15 hours, temperature reached is 75 F for 15 hours with no adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age male patient and it was reported product was left out of refrigeration for 15 hours, temperature reached is 75 Fahrenheit (F)  for 15 hours with no adverse event, it involved vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the product was left out of refrigeration for 15 hours, temperature reached is 75 F for 15 hours with no adverse event (product storage error) (latency: unknown) and it involved vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED, (lot: UT7680L ; expiry date: 30-Jun-2023). The product was to be used for prophylactic vaccination (immunization)   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: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: received a /2 to 1/3 of vaccine dose with no adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 76 years old male patient who received a 1/2 to 1/3 of vaccine dose with no adverse event while receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 13-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a 1/2 to 1/3 of vaccine dose (0.7 ml) (lot UJ882AB, expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for Immunization.  On 13-Oct-2022 the patient developed a non-serious received a 1/2 to 1/3 of vaccine dose with no adverse event (incorrect dose administered) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV 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: 16.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL - administered to a patient post excursion with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old male patient who was administered ipol post excursion 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 hepatitis a vaccine (hepatitis a vaccine) for Prophylactic vaccination; hepatitis b vaccine (hepatitis b vaccine) for Prophylactic vaccination; measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 03-Oct-2022, the patient received a dose of suspect ipv (vero) Suspension for injection 0.5 ml (milliliter) Once (lot V1A024M, expiry date 17-Feb-2024) (strength: unknown) via intramuscular route in unknown administration site for Immunization.   On 03-Oct-2022 the patient was administered ipol post excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data reported.  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: 59.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 59 years old patient who was accidentally administered a high dose flu shot instead of a normal flu shot, with no reported adverse event; 59 years old patient who was accidentally administered a high dose flu shot instead of a normal flu shot, with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 59 years old female patient who was accidentally administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] instead of a normal flu shot (INFLUENZA VACCINE), with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 13-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.5 ml (lot UT7743CA, expiry date: 30-Jun-2023) via intramuscular route in the left arm for immunisation.  On 13-Oct-2022, 59 years old patient administered high dose flu shot instead of a normal flu shot, with no reported adverse event (product administered to patient of inappropriate age, wrong product administered, latency: same day).  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 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: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: fluzone high dose qiv was inadvertently administered to a 6 month old infant with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received via health professional. Agency number: 01321030  This case involves a 6-month-old female patient to whom vaccine Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] 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. Concomitant medications included Diphtheria Vaccine Toxoid, HIB vaccine CONJ (TET TOX), Pertussis Vaccine Acellular 5-Component, Polio Vaccine INACT 3V (MRC 5), Tetanus Vaccine Toxoid (Pentacel) for Prophylactic vaccination; ROTAVIRUS VACCINE for Prophylactic vaccination; and Pneumococcal Vaccine 13V for Prophylactic vaccination.  On 13-Oct-2022, the 6-month female patient inadvertently administered Fluzone High-Dose Quadrivalent vaccine at dose 0.7 ml once via intramuscular route in the right thigh (lot: UT7718CA, expiry date: 30-Jun-2022) for immunization with no reported adverse event (product administered to patient of inappropriate age) at same day latency. The reported inquired what they should look out for; asks if it will cause harm to the infant?  Action taken: Not applicable. No corrective treatment was received for the event.  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: UNK
Symptoms: Medication error, No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: mistakenly mixed the powder component (ActHib) of Pentacel with sterile saline and failed to use the DTaP/IPV portion with no reported adverse event; mistakenly mixed the powder component (ActHib) of Pentacel with sterile saline and failed to use the DTaP/IPV portion with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reported that mistakenly mixed the powder component (Acthib) of Pentacel with sterile saline and failed to use the Dtap/Ipv portion with no reported adverse event , it involved vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  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 , with an unknown formulation and strength, (lot: UJ660AAA ; expiry date: 25-Feb-2023) via unknown route in unknown administration site for immunization.  On an unknown date the reporter mistakenly mixed the powder component (Acthib) of Pentacel with sterile saline and failed to use the Dtap/Ipv portion with no reported adverse event (product preparation error)  (single component of a two-component 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: 27.0
Sex: F
Vaccine: FLUX, IPV, MMR
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired IPOL to a patient with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 27 years old female patient who was administered an 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.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 14-Oct-2022, the patient received expired 0.5 ml, once dose of suspect IPV (VERO) (lot T1E87, exp date: 10-Oct-2022) (standard strength) via intramuscular route in the left deltoid for immunization 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.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired ADACEL vaccine was given with no adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who experienced an expired adacel vaccine was given with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient reported a non-serious event an expired adacel vaccine was given with no adverse event (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.