chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: CROHN'S FLARE; This is a report received from contactable reporter (Consumer or other non HCP), Program ID: (FACILITATED COLLECT). The reporter is the patient.  Report from a consumer of a female with events of and non-serious and with Single-Dose Pen, Adalimumab Solution for Injection. A 66-year-old female patient received BNT162B2, on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160836), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1; Route: Intramuscular), administration date: 01Mar2021, when the patient was 64-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2; Route: Intramuscular), administration date: 01Apr2021, when the patient was 64-year-old, for Covid-19 Immunization. The following information was reported: CROHN'S DISEASE (medically significant) with onset Aug2022, outcome "not recovered", described as "CROHN'S FLARE". It was also reported that on an unknown date, the patient experienced Humira was not working as expected. The action taken for adalimumab was unknown. Assessment Results: HUMIRA: Crohn's aggravated not reported per Non-Health Care Professional via Global Introspection, and for drug effect incomplete was probable per non-health care professional via global introspection. Pfizer Biontech covid-19 vaccine: drug effect incomplete and Crohn's aggravated were not reported per Market Authorization Holder (MAH).  The reporter's assessment of the causal relationship of "crohn's flare" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event CROHN'S FLARE Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: Patient also stated that there was a chap in another country bled to death due to brain haemorrhage due to Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MDGB22-00941 (MODERNA).  A male patient received 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: CEREBRAL HAEMORRHAGE (death), outcome "fatal", described as "Patient also stated that there was a man in another country bled to death due to brain haemorrhage due to Pfizer". The patient date of death was unknown. Reported cause of death: "Patient also stated that there was a man in another country bled to death due to brain haemorrhage due to Pfizer". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Patient also stated that there was a chap in another country bled to death due to brain haemorrhage due to Pfizer
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have been testing positive for Covid for over a month even though I had the vaccines and a booster; I have been testing positive for Covid for over a month even though I had the vaccines and a booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant), outcome "unknown" and all described as "I have been testing positive for Covid for over a month even though I had the vaccines and a booster". Clinical course: Patient takes tofacitininb citrate (XELJANZ). Patient has been testing positive for Covid for over a month even though patient had the vaccines and a booster. Asked if we have similar results from patients taking Xeljanz. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: testing positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have been testing positive for Covid for over a month even though I had the vaccines and a booster; I have been testing positive for Covid for over a month even though I had the vaccines and a booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received 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), COVID-19 (medically significant), outcome "unknown" and all described as "I have been testing positive for COVID for over a month even though I had the vaccines and a booster". The patient underwent the following laboratory tests and procedures: COVID-19 Test: Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200083052 same patient/product, different dose/.event;
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Gastrointestinal disorder, Product taste abnormal
Clinical narrative: GI issues; chills; metallic taste; metallic taste; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "hypertriglyceridemia" (unspecified if ongoing); "PMH" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "GI issues"; CHILLS (non-serious), outcome "unknown"; DYSGEUSIA (non-serious), PRODUCT TASTE ABNORMAL (non-serious), outcome "unknown" and all described as "metallic taste".  Additional information: Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient presented with herpes zoster; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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: HERPES ZOSTER (non-serious), outcome "unknown", described as "Patient presented with herpes zoster".  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: Cardiac disorder, Nerve injury
Clinical narrative: got your vaccine and developed 2 heart conditions afterwards; nerve damage to his heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the parent.  A 27-year-old male patient received 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: CARDIAC DISORDER (hospitalization), outcome "unknown", described as "got your vaccine and developed 2 heart conditions afterwards"; NERVE INJURY (hospitalization), outcome "unknown", described as "nerve damage to his heart". The events "got your vaccine and developed 2 heart conditions afterwards" and "nerve damage to his heart" required physician office visit. Therapeutic measures were taken as a result of nerve injury.  Clinical course: Reporter stated, son age 27, got your vaccine and developed 2 heart conditions afterwards. He had been seen by doctors and even hospitalized since receiving the COVID shot some time ago. Most recently, he was prescribed a medication for nerve damage to his heart. Reporter would have an attorney reach out to your organization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: shivering within 2 hours post dose/chilled; fever for 2 days; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose number unknown (booster), 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 Immunization. The following information was reported: PYREXIA (non-serious) with onset 03Oct2022, outcome "recovered" (05Oct2022), described as "fever for 2 days"; HEADACHE (non-serious) with onset 03Oct2022, outcome "unknown"; CHILLS (non-serious) with onset 03Oct2022, outcome "unknown", described as "shivering within 2 hours post dose/chilled". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, headache.  Additional information: Excedrin provides some relief but headache returns. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Still caught COVID-19; Still caught COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2022 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) all with onset Jun2022, outcome "unknown" and all described as "Still caught COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Long haul COVID symptoms; Long haul COVID symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  An adult female patient received 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 "Long haul COVID symptoms". Clinical course: The two female patients in their 30-40s were abnormally thin and they were both experiencing long haul covid symptoms after being vaccinated. The reporter stated that the patients were both so petite, they may need a child size dosage. Further stated the company should look into making doses based on weight and stated that a 90lb middle aged woman and a 190lb middle aged man probably need different size dosages. They both reacted negatively to the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201233450 same reporter/vaccine/event, different patients.;
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Patient had a terrible reaction to it; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003681.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 3 (booster), 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 (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "Patient had a terrible reaction to it".  Additional information: On 30Sep2022, it was reported that a patient started treatment on 20Sep2022 with Pfizer BioNTech Covid-19 Vaccine dose 3 for COVID-19 vaccination. It was reported the patient had a terrible reaction to it. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: he's sick from the vaccine (two doses); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male 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: ILLNESS (non-serious), outcome "unknown", described as "he's sick from the vaccine (two doses)".  Additional information: Patient mentioned that he was sick from the vaccine (two doses) and would never take the booster. He also mentioned that the vaccine killed a lot of people. No medical questions asked.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201233969 same patient/drug/event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Off label use
Clinical narrative: COPD Excerbation; (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5; 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 patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1st), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd), for Covid-19 immunization; Covid-19 vaccine (Dose: 3rd), for Covid-19 immunization; Covid-19 vaccine (Dose: 4th), for Covid-19 immunization. The following information was reported: OFF LABEL USE (hospitalization) with onset 05Oct2022, outcome "unknown", described as "3rd Booster shot"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (hospitalization) with onset 10Oct2022, outcome "unknown", described as "COPD Excerbation". The patient was hospitalized for chronic obstructive pulmonary disease, off label use (hospitalization duration: 3 day(s)).  Clinical course: The patient got Pfizer's 3rd Booster shot on 05Oct2022, had a reaction, within 5 days developed COPD Exacerbation and was hospitalized for 3 days. This would take a while to get over and feel better again. The patient was just fine before the patient got the shot. Patient got the vaccine to not have patient's underlying condition. The patient had to wait 4 weeks to get a flu shot now. The patient would not get any more boosters; enough was enough.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: son had the shot 2 days later that young man was dead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Private  A male patient received 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: DEATH (death), 2 days after the suspect product(s) administration, outcome "fatal", described as "son had the shot 2 days later that young man was dead". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  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: son had the shot 2 days later that young man was dead
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: maternal vaccine exposure with no reported adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 25 years old female patient who was exposed to vaccine influenza quadrival A-B vaccine [Fluzone QIV] in context of maternal vaccine exposure with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal vaccine exposure with no reported adverse event occurred at 17 weeks of pregnancy and the patient was exposed to influenza quadrival A-B vaccine at 17 weeks of pregnancy, during second pregnancy trimester for influenza quadrival A-B vaccine.  The date of last menstrual period was reported as 10-Jun-2022. The estimated due date is 04-Apr-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient previous pregnancy.   On 06-Oct-2022, the patient received a dose 1 of suspect influenza quadrival A-B vaccine suspension for injection at an unknown dose (lot UT7682KA, expiry date: not reported) via intramuscular route in the left deltoid for prophylactic vaccination(immunisation).  On 06-Oct-2022 the patient developed a non-serious maternal vaccine exposure with no reported adverse event (exposure during pregnancy, latency: same day).  Action taken: Not applicable.  Outcome: Unknown. Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: U
Vaccine: FLUR3
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: flublok was frozen and placed in the door of the fridge; the lowest temperature reached 33 f or it may have been slightly below that; the total excursion lasted 18 hours; administered to a patient with no reported adverse event; flublok was frozen and placed in the door of the fridge; the lowest temperature reached 33 f or it may have been slightly below that; the total excursion lasted 18 hours; administered to a patient with no reported adverse event; Initial information received 10-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient and reporter reported that flublok was frozen and placed in the door of the fridge; the lowest temperature reached 33 f or it may have been slightly below that; the total excursion lasted 18 hours; administered to a patient with no reported adverse event 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 an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant (with an unknown strength, formulation, dose, frequency, route, expiry date, batch number, administration site) for influenza.  On an unknown date the flublok was frozen and placed in the door of the fridge; the lowest temperature reached 33 f or it may have been slightly below that; the total excursion lasted 18 hours with no reported adverse event (product storage error) and administered to a patient with no reported adverse event(poor quality product administered) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  No lab data reported.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for both the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally administered expired FLUZONE HIGH DOSE vaccines from the previous year on 06OCT2022 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 2022SA417918(CLUSTER), 2022SA419905(CLUSTER) and 2022SA419905(CLUSTER).  This case involves an unknown age female patient who accidentally received last year's expired dose of fluzone high dose with no reported adverse event. (Influenza quadrival A-B high dose HV vaccine) [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s) and family history were not provided.   On 06-Oct-2022, the patient accidentally received last year's expired dose of influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml total (0.7 ml 1X)(lot number: UJ748AA; expiry date : 30-Jun-2022: strength, formulation unknown) via unknown route in left deltoid for immunization, with no reported adverse event (expired product administered) (latency : same day).  It was reported Pharmacist reporting that 3 patients accidentally received last year's expired dose of FLUZONE HIGH DOSE and requesting revaccination recommendations regarding dosing and timing of administration. A nurse practitioner (same as prescriber) accidentally administered 3 expired FLUZONE HIGH DOSE vaccines from the previous year on 06OCT2022. The pharmacist identified the administration of expired products today, 10OCT2022, stating that she did not know "why last year's formulation was in the fridge." Pharmacist inquired what the recommendations are for the timing and need for revaccination with current FLUZONE HIGH DOSE QIV. SRDs emailed to requestor. Pharmacist denied any untoward effects from the administration of the expired vaccines at this time and advised that the patients would be revaccinated with current FLUZONE HIGH DOSE QIV    Action taken with 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: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: FLUZONE PFS, that were expired was administered with no adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health care professional.  This case is linked to cases 2022SA418835(CLUSTER), 2022SA417297(CLUSTER), 2022SA419920(CLUSTER), 2022SA418873(CLUSTER), 2022SA419928(CLUSTER), 2022SA419132(CLUSTER), 2022SA419111(CLUSTER), 2022SA417976(CLUSTER), 2022SA417246(CLUSTER), 2022SA417992(CLUSTER), 2022SA417624(CLUSTER), 2022SA419912(CLUSTER), 2022SA417187(CLUSTER), 2022SA417608(CLUSTER) and 2022SA419169 (CLUSTER).  This case involves a 1 year old female patient and Fluzone QIV PFS (Influenza quadrival A-B vaccine [Fluzone QIV], that were expired was administered with no reported adverse event.   The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine for prophylactic vaccination; pneumococcal CONJ 7V (CRM197) (Prevnar) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for prophylactic vaccination.  On 07-Oct-2022, the patient had received a dose of suspect influenza quadrival A-B vaccine Suspension for injection standard at a dose of 0.5 ml total (lot UT7378MA, expiry date- 30-Jun-2022) via intramuscular route in the left vastus lateralis for immunization.  On 07-Oct-2022 the patient received fluzone pfs, that were expired was administered with no reported adverse event (expired product administered) (latency : same day) following the administration of influenza quadrival A-B vaccine.  Action taken - not applicable.  Outcome - Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Seizure like phenomena
Clinical narrative: experienced seizure like activity; Initial information received on 10-Oct-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves a 16 years old and unknown gender patient who experienced seizure like activity while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Aug, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation: injection, strength: unknown) lot U7249AA, expiration date:11-Mar-2024 in unknown administration site as immunization  On an unknown date  of 2022, the patient experienced seizure like activity (seizure) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (experienced seizure like activity).  At time of reporting, the outcome was Unknown for the event experienced seizure like activity.; Sender's Comments: Sanofi company comment dated on 13-Oct-2022:This case involves a 16 years old and unknown gender patient who experienced seizure like activity while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  Furthermore information regarding medical history, past medical treatment, vaccinations, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: fluzone pfs, that was expired was administered, with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 16-year-old female patient to whom INFLUENZA QUADRIVAL A-B VACCINE [Fluzone Qiv], that was expired was administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at a dose 0.5ml total (strength: standard; formulation: unknown), Drug Treatment Duration: not applicable (NA) (lot number: UT7378MA and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for Immunization and on the same day, fluzone pfs, that was expired was administered, with no reported adverse event (expired product administered).  This situation is reported as a medication error due to inadvertently given expired product.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: inadvertently given expired product with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA419169(CLUSTER) and 2022SA420010(CLUSTER).  This case involves a 2 years old female patient who was inadvertently given expired product 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 07-Oct-2022, the patient received 0.5 ml total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7378MA and expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On 07-Oct-2022, (latency: same day) the patient was inadvertently given expired product with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) 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.; Sender's Comments:  01314490:
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently given expired product, with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA419169(CLUSTER) and 2022SA420010(CLUSTER).  This case involves a 6 years old female patient who was inadvertently given expired product, 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, the patient received 0.5 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation and strength not reported; lot UT7378MA and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient was inadvertently given expired product, with no reported adverse event (expired product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) 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: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: fluzone pfs, that were expired was administered with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health care professional.  This case is linked to cases 2022SA418835(CLUSTER), 2022SA417297(CLUSTER), 2022SA419920(CLUSTER), 2022SA418873(CLUSTER), 2022SA419928(CLUSTER), 2022SA419132(CLUSTER), 2022SA419111(CLUSTER), 2022SA417976(CLUSTER), 2022SA417246(CLUSTER), 2022SA417992(CLUSTER), 2022SA417624(CLUSTER), 2022SA419912(CLUSTER), 2022SA417187(CLUSTER), 2022SA417608(CLUSTER) and 2022SA420010(CLUSTER).  This case involves a 1 year old male patient and fluzone pfs, that were expired was administered with no reported adverse event. (Influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine (HEPA [Hepatitis A vaccine]) for prophylactic vaccination; pneumococcal CONJ 7V (CRM197) (Prevnar) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for prophylactic vaccination.  On 07-Oct-2022, the patient received suspect influenza quadrival A-B vaccine standard at a dose of 0.5 ml once (lot UT7378MA, expiry date- 30-Jun-2022) via intramuscular route in the left vastus lateralis for immunization.  On 07-Oct-2022 the patient received fluzone pfs, that were expired was administered with no reported adverse event (expired product administered) (latency : same day) following the administration of influenza quadrival A-B vaccine.  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: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: FLUZONE PFS, that was expired was administered to patient with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case US-SA-2022SA417187(CLUSTER).  This case involves a 6 months old female patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], that was expired 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, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ), all for Immunisation.  On 07-Oct-2022, the patient was administered expired INFLUENZA QUADRIVAL A-B VACCINE with an unknown dose once (lot UT7378MA; expiry date: 30-Jun-2022; strength: standard) via intramuscular route in the left vastus lateralis for prophylactic vaccination (expired product administered)(latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: M
Vaccine: FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK being administered to pediatric patients with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 years old male patient who experienced flublok being administered to pediatric patients with no reported adverse event 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 10-Oct-2022, the patient received a  dose of suspect influenza quadrivalent recombinant vaccine at dose of 0.5 mL 1X lot QFAA223 , Expiration Date: 30-Jun-2023 via intramuscular route in the left deltoid for Flu prophylaxis,  On 10-OCT-2022 the patient developed a non-serious flublok being administered to pediatric patients with no reported adverse event (product administered to patient of inappropriate age) following the administration of influenza quadrivalent recombinant vaccine.  It was reported "Caller reported FLUBLOK was administered to 9 pediatric patients at a vaccine clinic today and is requesting validity information. Please reference FLUBLOK AE cases: 01314863, 01314917, 01314922, 01314927, 01314933, 01314938, 01314943 and 01314953 This situation is reported as a medication error due to FLUBLOK being administered to pediatric patients".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (FLUBLOK being administered to pediatric patients with no reported adverse event).  At time of reporting, the outcome was Unknown for the event flublok being administered to pediatric patients 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: 7.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok was administered to 9 pediatric patients with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA420021(CLUSTER), 2022SA419213(CLUSTER), 2022SA420025(CLUSTER) and 2022SA420094(CLUSTER).  This case involves a 7 years old male patient who was administered flublok, with no reported adverse event, after receiving vaccine influenza quadrivalent recombinant vaccine [Flublok qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2022, the patient received a dose of suspect influenza quadrivalent recombinant vaccine (form: unknown, strength: standard) (lot QFAA223 and expiration date: 30-Jun-2023) at a dose of 0.5ml once via intramuscular route in the left deltoid for immunization.  On 10-Oct-2022 (latency: same day), the patient was administered flublok with no reported adverse event (product administered to patient of inappropriate age) following the administration of vaccine.   No lab data reported.  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.
Age: 7.0
Sex: M
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was administered to pediatric patient, with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA420021(CLUSTER), 2022SA419213(CLUSTER) and 2022SA420025(CLUSTER).  This case involves a 7 years old male patient who was administered flublok, with no reported adverse event, after receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE( lot QFAA223 and expiration date: 30-Jun-2023) at a dose of 0.5ml once via intramuscular route in the left deltoid for immunization.  On 10-Oct-2022 (latency: same day), the patient was administered flublok  with no reported adverse event (product administered to patient of inappropriate age) following the administration.   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.