chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 (Vaccination failure); COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 62 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 08Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 31Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9393), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to wasp venom" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "COVID 19 (Vaccination failure)"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID), from 07Oct2023 to 11Oct2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: has Covid; has Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 89-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "has Covid". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course was reported as follows: Caller states she currently has Covid and is on a different antiviral (not Paxlovid) that she finished taking today. She has has 6 or 7 Pfizer shots, those when first available and then the boosters. Caller states she got her last booster in June, she was scheduled for the new shot but then she came down with Covid. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331404 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot
Clinical narrative: I received the latest Pzifer covid vaccine and now I have chills or I feel extremely hot all the time- almost like menopause; I feel extremely hot all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "I received the latest Pzifer covid vaccine and now I have chills or I feel extremely hot all the time- almost like menopause"; FEELING HOT (non-serious), outcome "unknown", described as "I feel extremely hot all the time".  Follow-up attempts are completed, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: performed a molecular COVID test. The result was Positive.; performed a molecular COVID test. The result was Positive.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "performed a molecular COVID test. The result was Positive.". 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: Patient just completed (PRIVACY) training and then experienced an event that patient thought was supposed to report. Patient received the new Pfizer monovalent booster on 30Sep2023, at a [pharmacy name withheld] (Mailing address withheld). This morning patient woke up with a mild sore throat and performed a molecular COVID test. The result was Positive. Patient's symptoms remain mild and patient had started treatment with an oral antiviral. Patient was traveling right now but could provide the lot number for patient's vaccine dose if needed. Thanks.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had an allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001243 (Novavax).  A female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "had an allergic reaction".  Clinical information: On 29Sep2023, it was reported that a patient started treatment on an unreported date with Pfizer BioNTech COVID-19 vaccine dose 1 for an unreported indication. It was reported the patient had an allergic reaction on an unreported date, so she could not take Pfizer or Moderna. The individual had J&J for dose 2 of her primary series, then 1 as a booster (dose 3) on unreported dates.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Renal cancer
Clinical narrative: ever since receiving your COVID vaccination, I now have some minor Cardiac issues & I have Kidney Cancer; ever since receiving your COVID vaccination, I now have some minor Cardiac issues & I have Kidney Cancer; shortness of breath; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "a slow heart beat" (unspecified if ongoing), notes: a slow heart beat. The patient's concomitant medications were not reported. The following information was reported: RENAL CANCER (medically significant), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "ever since receiving your COVID vaccination, I now have some minor Cardiac issues & I have Kidney Cancer"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". Clinical course: since receiving your COVID vaccination, the patient have some minor Cardiac issues & have Kidney Cancer. The patient have never had any issues with patient's heart (other than a slow heart beat). The lower half of the patient heart has been damaged slightly. Enough to cause shortness of breath. Again, the patient have never had any Kidney issues.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: He died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "He died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: the patient have taken the Pfizer vaccine since the outbreak of covid but died.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: He died
Sex: M
Vaccine: FLUX
Symptoms: Cough
Clinical narrative: cough remain ongoing; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves Child male patient who experienced cough remain ongoing after receiving vaccine Influenza vaccine.  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 influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation. Information on the batch number was requested.  On an unknown date the patient developed cough remain ongoing (cough) (unknown latency) following the administration of influenza vaccine.  Patient's mom reports new symptoms of cough remain ongoing. cough started over the weekend. around that same time (over the weekend) patient received a flu shot.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event (cough remain ongoing).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Coma, Confusional state, Depressed mood, Dizziness
Clinical narrative: comatose; having suicidal thoughts; depressed; confused; tired; weak; fatigued; dizzy; Initial information was received on 10-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-health-care professional (Patient).  This case involves an unknown age male patient who experienced comatose, having suicidal thoughts, confused, tired, depressed, weak, fatigued and dizzy after receiving 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 an unknown date, the patient received a unknown dose of suspect influenza quadrival a-b high dose hv vaccine (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the patient developed comatose (coma), having suicidal thoughts (suicidal ideation) ,confused (confusional state) ,tired (fatigue), depressed (depression), weak (asthenia) ,fatigued (fatigue) and dizzy (dizziness) (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine.  Reportedly "Consumer states that: "I got this flu shot 4 days ago. sanofi advertisers on TV how wonderful it is to get a flu shot and that everyone should get one and you might just have a little bit of a sore arm after the injection. What you don't advertise is that people such as myself, after getting the injection, spent 3 days. "  Action taken with QUADRIVALENT influenza vaccine (Fluzone HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (comatose, confused, tired, depressed, having suicidal thoughts, weak, fatigued, dizzy).  At time of reporting, the outcome was Unknown for all the events.  Seriousness criteria : Medically significant for comatose and suicidal thoughts.; Sender's Comments: Sanofi Company Comment dated 13-Oct-2023 : This case involves an unknown age male patient who experienced comatose, having suicidal thoughts, after receiving influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Suicidal ideation
Clinical narrative: comatose; having suicidal thoughts; depressed; confused; tired; weak; fatigued; dizzy; Initial information was received on 10-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-health-care professional (Patient).  This case involves an unknown age male patient who experienced comatose, having suicidal thoughts, confused, tired, depressed, weak, fatigued and dizzy after receiving 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 an unknown date, the patient received a unknown dose of suspect influenza quadrival a-b high dose hv vaccine (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the patient developed comatose (coma), having suicidal thoughts (suicidal ideation) ,confused (confusional state) ,tired (fatigue), depressed (depression), weak (asthenia) ,fatigued (fatigue) and dizzy (dizziness) (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine.  Reportedly "Consumer states that: "I got this flu shot 4 days ago. sanofi advertisers on TV how wonderful it is to get a flu shot and that everyone should get one and you might just have a little bit of a sore arm after the injection. What you don't advertise is that people such as myself, after getting the injection, spent 3 days. "  Action taken with QUADRIVALENT influenza vaccine (Fluzone HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (comatose, confused, tired, depressed, having suicidal thoughts, weak, fatigued, dizzy).  At time of reporting, the outcome was Unknown for all the events.  Seriousness criteria : Medically significant for comatose and suicidal thoughts.; Sender's Comments: Sanofi Company Comment dated 13-Oct-2023 : This case involves an unknown age male patient who experienced comatose, having suicidal thoughts, after receiving influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Immunisation reaction
Clinical narrative: allergic reaction to "regular" flu shots; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from consumer/non-hcp.  This case involves an unknown age female patient who had allergic reaction to "regular" flu shots after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, batch number, expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient had allergic reaction to "regular" flu shots (hypersensitivity) (unknown latency) following the administration of influenza vaccine.  Reportedly, Consumer states that she has allergic reaction to "regular" flu shots. She does not know which flu vaccine she received when she had the reactions.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (allergic reaction to "regular" flu shots).  At time of reporting, the outcome was Unknown for the event allergic reaction to "regular" flu shots.
Age: 58.0
Sex: F
Vaccine: FLUR4, FLUX
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administered the wrong influenza vaccine with no adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case is linked to case 2023SA312971 (CLUSTER).  This case involves a 58 years old female patient where reporter reported two years ago she was at the doctor's office to receive a dose of influenza quadrivalent recombinant vaccine [Flublok QIV], but was administered a different Influenza vaccine instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine and influenza vaccine lot number not reported via unknown route in unknown administration site (dose, frequency, route, formulation, strength and expiration date: not provided) for Immunisation (wrong product administered). Information on the batch number was requested.  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: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Feeling abnormal, Immunodeficiency, Malaise
Clinical narrative: immunocompromised; general malaise; feeling bad; Initial information was received on 10-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-health-care professional.  This case is linked to case 2023SA310485.  This case involves 66 years old female patient who experienced immunocompromised, general malaise and feeling bad after receiving influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of 0.5 ml of suspect influenza quadrivalent recombinant vaccine (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization. The information on batch number was requested.  On an unknown date the patient developed immunocompromised (immunodeficiency), general malaise and feeling bad (feeling abnormal) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Reportedly "See inquiry 01795947 Consumer states that she had a bad reaction to a non-Sanofi influenza vaccine 3 years ago. See inquiry 01796949. But she has taken FLUBLOK "for many years" without any "bad side effects". She states that she has experienced general malaise and feeling bad after receiving FLUBLOK, but it wasn't a problem, compared to the experience she had a few years ago with the other vaccine. Consumer has questions about comparison of the different flu vaccines and which one she should take. MIS discussed comparison and referred to HCP."  Action taken with QUADRIVALENT RECOMBINANT influenza vaccine (Flublok QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the events (general malaise, feeling bad, immunocompromised).  At time of reporting, the outcome was Unknown for the event general malaise, feeling bad and immunocompromised.  Seriousness criteria : Medically significant for immunocompromised.; Sender's Comments: Sanofi Company Comment dated 13-Oct-2023 : This case involves 66-year-old female patient who experienced immunocompromised after receiving influenza quadrivalent recombinant vaccine [Flublok QIV].Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Administration site wound, Blister, Impaired healing, Injection site mass, Vaccination site vesicles
Clinical narrative: Blister; Wound; wound that will not heal; lump at the injection site; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 72-years-old male patient who had blister, wound and lump at the injection site and wound that will not heal after receiving 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. Patient is not a diabetic and has never had any type of healing problems prior to the shot. Concomitant: no other vaccines.  On 27-Aug-2023, the patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine, injection (Frequency: once) (batch number, expiry date: not reported) via unknown route in the right arm for Immunization.  On 27-Aug-2023 the patient had lump at the injection site (vaccination site mass) (same day latency) following the administration of influenza quadrival A-B high dose HV vaccine.  On an unknown date the patient had blister (vaccination site vesicles), wound (administration site wound) and wound that will not heal (impaired healing) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Patient states that when he received the shot there was a lump at the injection site. The lump since became a blister and is now a wound that will not heal. He states that this situation is very stressful and he is fearful that the product may have contained bacteria that got into his bones. He mentioned that he is not a diabetic and has never had any type of healing problems prior to the shot. He did call a specialist and will be going for a medical exam. Patient does not have any lot or expiration information at this time.  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 Not Recovered / Not Resolved for all the events.   No additional details.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: separate administration of the PENTACEL components with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2023SA314333.  This case involves a 3 years old male patient and reporter reported separate administration of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] components 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 heparin sodium (heparin [heparin sodium]); measles vaccine, mumps vaccine, rubella vaccine (mmr) for immunisation; and varicella zoster vaccine (varicella vaccine) for immunisation.  On 09-Oct-2023, the patient received Dose 1 of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ869AA, Expiry date: 23-Mar-2024) (Strength: standard, Frequency: once) via intramuscular route in the right deltoid for immunisation.  On 09-Oct-2023, it was reported separate administration of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine components with no reported adverse event (single component of a two-component product administered) (latency: same day).  It was reported, Nurse called to report about the administration of the PENTACEL components to 2 patients. Nurse wanted to know if the dose given would be valid. Please see case 01799136. This situation is reported as a medication error due to separate administration of the PENTACEL components.   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: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of PENTACEL which had expired 5 days prior to use with no reported adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4-years-old female patient who was administered diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] which had expired 5 days prior to use 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 live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Prophylactic vaccination.  On 14-Sep-2023, the patient received 0.5 mL Booster dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, Suspension for injection (Strength: standard; Frequency: once) (batch number: UJ7578A; expiry date: 09-Sep-2023) via intramuscular route in the left thigh for immunization which had expired 5 days prior to use with no reported adverse event (expired product administered) (same day latency).  Reportedly, Medical assistant called to know if the administered PENTACEL would still count as a valid dose even though it had expired 5 days prior to use. Caller mentioned that no adverse reaction was experienced by the patient. (Treatment : Immunization)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired pentacel has been administered to a patient with no reported adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient and reporter reported that patient has been administered expired diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepa [Hepatitis A Vaccine]); Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) And Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination.  On 11-Oct-2023, the patient received a expired unknown (dose 2) dose of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 08-Oct-2023 and lot UJ7948B) via intramuscular route in the right thigh as immunization (expired product administered) (same day latency).  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: 3.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion which lasted for a total duration of 44 minutes opened ipol refrigerator door was left open temperature reached: sep 22: 1.3c for 19 min sep 30 1.7c for 14 min oct 9: 1.8c for 11 minutes with no ae; after temperature excursion opened ipol.if was the product administered with no reported adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3-years-old female patient who was administered vaccine IPV (vero) [IPOL] after temperature excursion which lasted for a total duration of 44 minutes as refrigerator door was left open temperature reached: sep 22: 1.3c for 19 min sep 30 1.7c for 14 min oct 9: 1.8c for 11 minutes 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, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP); Influenza Vaccine; and pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination.  On 03-Oct-2023, the patient received 0.5 mL dose 1 of suspect IPV (VERO), Suspension for injection (batch number: W1A191M; expiry date: 16-Feb-2025) via intramuscular route in left thigh for immunization after temperature excursion which lasted for a total duration of 44 minutes as refrigerator door was left open temperature reached: sep 22: 1.3c for 19 min sep 30 1.7c for 14 min oct 9: 1.8c for 11 minutes with no adverse event (poor quality product administered) (same day latency) (product storage error) (unknown latency).  Human error: Yes  Action taken: not applicable.  Treatment: None  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 and Regulatory Authority 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: 8.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone HD was administered to children age 8 year old without any reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 8-years-old female patient who administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] without any reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant(s): no other vaccines  On 11-Oct-2023, patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (Frequency: Once; Strength: Standard) (batch number: U8138CA; expiry date: 30-Jun-2024) via intramuscular route in the right deltoid for Immunization, to children age 8 year old without any reported adverse event (product administered to patient of inappropriate age) (same day latency).  Action taken: not applicable.  Treatment: None  At time of reporting, the outcome was Unknown for the event.  No additional information at the time of the report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA317312:01802208
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Temperature: 10.3 C Time of excursion: 15 minutes with no reported adverse event; was the product administered to a patient? Yes with no adverse event; Initial information was received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom IPV (VERO) [Ipol] was administered after temperature: 10.3 c time of excursion: 15 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received an unknown dose of suspect IPV (VERO) (Suspension for injection) (lot W1A191M, expiry date: 16-Feb-2025, strength: unknown) via unknown route in unknown administration site for Immunisation (poor quality product administered) (Latency: same day).  On an unknown date, temperature: 10.3 c time of excursion: 15 minutes with no reported adverse event (product storage error) (unknown latency).  This situation is due to human error. Reason: while moving the rack to accommodate the FLUZONE vaccines, and the not the data logger did not register it   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: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: nurses administered ADACEL to a patient IV instead of IM with no reported adverse event; Initial information was received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 24 years old female patient who reported that nurses administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] to a patient IV instead of IM of with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (lot 2CA61C1, Expiry date : 06-Jun-2025, strength was unknown) via intravenous not otherwise specified route in unknown administration site for Immunization.  On an unknown date the nurses administered adacel to a patient IV instead of IM with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event nurses administered adacel to a patient iv instead of im with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of ACT-HIB with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 4 years old male patient who received an expired dose of haemophilus type B (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 measles vaccine live (enders-edmonston), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Immunisation; and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (Quadracel) for Immunisation.  On 11-Oct-2023, the patient received a standard expired dose 3 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml (lot UJ798AA) (with an unknown strength and expiry date) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller asked Is the dose okay or do it need to be repeated?  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: 54.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired vaccine with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 54-year-old male patient and the reporter stated administration of an expired vaccine diphtheria-2/tetanus-5 adsorbed toxoids No preservative adult [Tenivac]with no reported adverse event.  The patient's past medical history included Injury NOS. The patient's past medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 12-Oct-2023, the patient received a 0.5 ml total dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids No preservative adult, Suspension for injection (strength: unknown) (lot: U7183AA, expiry date: 24-Sep-2023) via intramuscular route in the left deltoid for immunization and administration of an expired vaccine with no reported adverse event (expired product administered) (latency: same day).  Action taken with diphtheria and tetanus toxoids (Tenivac) was not applicable.  Outcome: unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: patients were administered with an expired pentacel with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who were administered with an expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 10-Oct-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ785AA, expiry date: 09-Oct-2023 with unknown strength) via intramuscular route in the left thigh as prophylactic vaccination.  On 10-Oct-2023 the patient was administered with an expired /Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine with no reported adverse event (expired 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 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: 23.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Expired Tenivac administered, with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 23 years old female patient who got expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection lot number (expiration date- 24-Sep-2023) not reported via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (expired product administered) (latency- same day).Information on the batch number was requested.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   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: 0.25
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: patients were administered with an expired pentacel with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 3 months old female patient where patients were administered with an expired diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (prevnar) and rotavirus vaccine live reassort oral 5v (rotateq) for Immunisation.  On 10-Oct-2023, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot- UJ785AA and expiration date- 09-Oct-2023) via intramuscular route in the left thigh (strength: not provided) for Immunisation (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.