chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Nov2023 as dose 1, single (Lot number: HF9300) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gerd" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "osteoporosis prediabtetes" (unspecified if ongoing); "hx of depression" (unspecified if ongoing); "Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gabapentin, reaction(s): "Allergies: Gabapentin"; Zoledronic acid, reaction(s): "Allergies: zoledronic acid". Vaccination history included: BNT162b2 (Vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=02Mar2021,, Vaccine lot number=EN6202,, Vaccine lot unknown=False,, Vaccine dose number=1,, Vaccine dose number unknown=False,, Vaccine location=Left arm), administration date: 02Mar2021, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (Vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=23Mar2021,, Vaccine lot number=EP7534,, Vaccine lot unknown=False,, Vaccine dose number=2,, Vaccine dose number unknown=False,, Vaccine location=Left arm,), administration date: 23Mar2021, when the patient was 70-year-old, for COVID-19 immunization; moderna (Vaccine brand=Other,, Vaccine brand other=Moderna,, Vaccine brand unknown=False,, Vaccine administration date=27Nov2021,, Vaccine lot number=018F21A,, Vaccine lot unknown=False,, Vaccine dose number=3,, Vaccine dose number unknown=False,, Vaccine location=Left arm,), administration date: 27Nov2021, when the patient was 71-year-old, for Covid-19 immunization; moderna (Vaccine brand=Other,, Vaccine brand other=Moderna,, Vaccine brand unknown=False,, Vaccine administration date=17May2022,, Vaccine lot number=056A22A,, Vaccine lot unknown=False,, Vaccine dose number=4,, Covid vaccine details, Vaccine dose number=4,, Vaccine dose number unknown=False,, Vaccine location=Left arm,), administration date: 17May2022, when the patient was 71-year-old, for Covid-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (Vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=01Nov2022,, Vaccine lot number=GJ6665,, Vaccine lot unknown=False,, Vaccine dose number=5,, Vaccine dose number unknown=False,, Vaccine location=Left arm,), administration date: 01Nov2022, when the patient was 72-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 19Feb2024 to 24Feb2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: first Pfizer Covid vaccine made her dizzy; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL3249) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "first Pfizer Covid vaccine made her dizzy".
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 30-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from23Feb2024 to 27Feb2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 26-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Lot number: HF9275) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Vitamin D deficiency", start date: Nov2021 (unspecified if ongoing); "Type 1 diabetes", start date: Mar2005 (unspecified if ongoing), notes: well-managed. Concomitant medication(s) included: NOVOLOG, start date: 05Mar2005; VITAMIN D3, start date: 01Dec2022. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose 5 (booster), single, Batch/Lot No: GJ3275, Location of injection: Arm Right), administration date: 28Oct2022, when the patient was 25-year-old, for COVID-19 Immunization; BNT162b2 (Dose 4 (booster), single, Batch/Lot No: FK9893, Location of injection: Arm Left), administration date: 18Apr2022, when the patient was 24-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3 (booster), single, Batch/Lot No: 320308D, Location of injection: Arm Left), administration date: 28Oct2021, when the patient was 24-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, single, Batch/Lot No: ER2613, Location of injection: Arm Right), administration date: 22Mar2021, when the patient was 23-year-old, for COVID-19 Immunization; BNT162b2 (Dose 1, single, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 26Feb2021, when the patient was 23-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2024) Negative; (04Mar2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19: the patient received treatment with Paxlovid from 24Feb2024 to 28Feb2024 (lot number HL1196). The patient first tested negative for COVID on 28Feb2024, her final day of taking Paxlovid. Symptoms returned on 04Mar2024, when she tested positive again.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 as dose 1, single (Lot number: HG2282) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3 (booster), single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (dose 4 (booster), single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (dose 5 (booster), single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (dose 6 (booster), single, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19: the patient received treatment with Paxlovid from 25Feb2024 to 29Feb2024.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: having the exact same issue/Feeling pressure and ringing in both ears; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient 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: EAR DISCOMFORT (non-serious), outcome "unknown", described as "having the exact same issue/Feeling pressure and ringing in both ears".  Batch/lot number is not provided, and it cannot be obtained.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Dyspnoea
Clinical narrative: chest pain; heart complications; shortness of breath; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 19-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), (Batch/Lot number: unknown) at the age of 19 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart complications"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.  Additional information: The patient mentioned that he got 1 dose of our vaccine when he was only 19, he have had chest pains heart complications and shortness of breath ever since getting the shot. The patient would like his life back.
Sex: M
Vaccine: COVID19
Symptoms: Ventricular fibrillation
Clinical narrative: VFib; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose numer 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: VENTRICULAR FIBRILLATION (death, medically significant) with onset Feb2024, outcome "fatal", described as "VFib". The patient date of death was Feb2024. Reported cause of death: "VFib". It was not reported if an autopsy was performed. Additional information: Reporter stated to have lost two more friends from the Pfizer shots.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: VFib
Sex: F
Vaccine: COVID19
Symptoms: Ventricular fibrillation
Clinical narrative: VFib; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female 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: VENTRICULAR FIBRILLATION (death, medically significant), outcome "fatal", described as "VFib". The patient date of death was unknown. Reported cause of death: "VFib". It was not reported if an autopsy was performed. Additional information: Reporter stated to have lost two more friends from the Pfizer shots.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: VFib
Sex: F
Vaccine: FLUX
Symptoms: Impaired quality of life, Pain, Pyrexia
Clinical narrative: Low grade fever; achy; disease symptoms somewhat affect quality of life; Initial information received on 22-Feb-2024 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Adult female patient who had low grade fever, achy and disease symptoms somewhat affect quality of life after receiving INFLUENZA VACCINE.  The patient's past medical history included Eosinophilic oesophagitis, Anxiety disorder, Vertigo and Breast cancer female. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Dermatitis atopic and Drug hypersensitivity.  Concomitant medications included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR); ESCITALOPRAM (ESCITALOPRAM); IBUPROFEN (IBUPROFEN); ESCITALOPRAM OXALATE (LEXAPRO); LEVOTHYROXINE SODIUM (SYNTHROID); VARENICLINE TARTRATE (TYRVAYA); LEVOTHYROXINE (LEVOTHYROXINE); and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB).  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer  for immunization (route, administration site, strength, dose, batch and expiry- unknown). Information on the batch number was requested  On an unknown date the patient had low grade fever (pyrexia), achy (pain) and disease symptoms somewhat affect quality of life (impaired quality of life) (unknown latency).  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 the events
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose was being used on 1 or 2 patients younger than 65 years of age with no reported adverse event; Initial information received on 29-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves male patient of an unknown age and it was reported influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] was being used on 1 or 2 patients younger than 65 years of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (formulation: Suspension for injection) (lot number; strength; expiry date unknown) which was being used on patient younger than 65 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Information regarding batch number will be requested in this case.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient was given their second dose of IMOVAX subcutaneously instead of intramuscularly with no adverse event; Initial information received  on 29-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 21 years old female patient who was given their second dose of rabies (HDC) vaccine [Imovax Rabies] subcutaneously instead of intramuscularly with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List of concomitant: No other vaccines   On 28-Feb-2024, the patient received a standard dose 2 (0.5 ml) total of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (strength unknown) (lot W1C931M, expiry date- 31-OCT-2025) via subcutaneous route in unknown administration site for  Immunization/Pre-exposure (Immunization).  On 28-FEB-2024 the patient was given their second dose of Rabies (Hdc) Vaccine subcutaneously instead of intramuscularly with no adverse event (incorrect route of product administration) (latency- same day).  Reportedly, Caller stated that the patient was given the first dose, and everything went well. Caller wanted to know the next steps after a patient was given their second dose of IMOVAX subcutaneously instead of intramuscularly.   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: 5.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Adacel was given accidentally to a 5 year old with no reported AE; Initial information received on 29-Feb-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5-year-old male patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was given accidentally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR Vaccine) for Prophylactic vaccination (immunization).  On 29-Feb-2024, the patient accidently received 0.5 mL dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (lot number: U7948BA; expiry date: 29-Nov-2025) via intramuscular route in unknown administration site for Immunization with no reported adverse event (wrong product administered) (same day latency).  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: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: received the IPV after the temperature excursion with no reported adverse event; Initial information received on 29-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2024SA071065(CLUSTER), 2024SA070984(CLUSTER), 2024SA071451(CLUSTER) and 2024SA071311(CLUSTER).  This case involves 4 years old and unknown gender patient who received the IPV (VERO) [IPOL] after the temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Feb-2024, the patient received a dose of suspect IPV (VERO) Suspension for injection (lot W1C831M, expiry date- 21-NOV-2025) via intramuscular route in the right arm for Prophylactic Vaccination (Immunisation) after the temperature excursion with no reported adverse event (poor quality product administered) (latency- same day).   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: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received the IPV after the temperature excursion with no reported adverse event; Initial information received on 29-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2024SA070984(CLUSTER), 2024SA071451(CLUSTER) and 2024SA071065(CLUSTER).  This case involves a 6 months old patient of an unknown gender who received the IPV (VERO) [IPOL] after the temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Feb-2024, the patient received an unknown dose of suspect IPV (VERO) (Suspension for injection) (strength unknown) (lot number: W1C831M; expiry date: 21-Nov-2025) via intramuscular route in right thigh for Immunization.  On 26-Feb-2024 the patient received the IPV (VERO) after the temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  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: 1.67
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: nurse only gave the lyophilized component of the pentacel. it is unknown what diluent was used, if the pentacel diluent or a diluent of a different vaccine was used with no reported ae; Initial information received on 01-Mar-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 20 months old female patient and nurse had gave the lyophilized component of the diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine [Pentacel (Vero)] it is unknown what diluent was used, if the pentacel diluent or a diluent of a different vaccine was used 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; Pneumococcal Vaccine Conj 15v (Crm197) (Pneumococcal Vaccine Conj 15v (Crm197)); And Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 27-Feb-2024, the patient received a dose 4 at a dose of 0.5 ml suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine Suspension for injection (Frequency: once, strength: standard, expiry date: 03-NOV-2024 and lot UJ970AA) via intramuscular route in the right thigh as Immunization and nurse only gave the lyophilized component of the pentacel. it is unknown what diluent was used, if the pentacel diluent or a diluent of a different vaccine was used with no reported ae (single component of a two-component product administered) (same day latency).   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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ACTHIB was administered to a patient but it was expired with no adverse event; Initial information received on 01-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who was administered Haemophilus Type B (Hib) Vaccine (ACT-HIB) but it was expired with no 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 (hepatitis a) for prophylactic vaccination; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (daptacel) for prophylactic vaccination; pneumococcal vaccine polysacch 23v (pneumovax) for prophylactic vaccination; and influenza vaccine (influenza) for Prophylactic vaccination.  On 29-Feb-2024, the patient received 0.5 ml of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot UJ870AB) (expiry date: 23-Feb-2024) (frequency: once) (strength: standard) via unknown route in the left thigh for immunization.  On 29-FEB-2024 the patient was administered Haemophilus Type B (Hib) Vaccine but it was expired with no adverse event (expired product administered) (latency: same day).  It was reported, Practice Supervisor reports that an ACTHIB was administered to a patient but it was expired. This situation is pre-assessed as a medication error/an inappropriate use due to an expired dose of a product being administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: 2-month-old patient was given only the liquid vaccine component (DTaP-IPV component) and not with the lyophilized vaccine component (ActHIB vaccine) with no reported adverse event; Initial information received on 01-Mar-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [pentacel (vero)] where reporter reported 2-month-old patient was given only the liquid vaccine component (dtap-ipv component) and not with the lyophilized vaccine component (acthib vaccine) 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 and rotavirus vaccine for Prophylactic vaccination.  On 01-Mar-2024, the patient received 0.5 ml dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot UJ858AA via intramuscular route in the right thigh (right vastus lateralis) (strength and expiration date: not provided) for Immunisation (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Dizziness, Fatigue, Hot flush
Clinical narrative: fatigue; hot flashes; dizziness; Initial information received on 01-Mar-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp via call center.  This case involves a 17 years old male patient who experienced fatigue, hot flashes and dizziness after receiving Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] and Meningococcal Vaccine B RFHBP/NADA/NHBA OMV [Bexsero].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient had received (dose and units: unknown) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) Vaccine (lot number, strength, expiration date not reported) via unknown route in the arm NOS (not otherwise specified) and on an unknown date patient also received (dose and units: unknown) of suspect Bexsero not produced by Sanofi Pasteur (lot number, formulation, strength, expiration date not reported) via unknown route in Unknown administration site; both for prophylactic vaccination.  On an unknown date (unknown latency) the patient had developed fatigue, hot flashes (hot flush) and dizziness following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) Vaccine and Bexsero.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: patient called 3/6/24 complaining of a red lump at injection site that is hot to the touch. Advised patient to follow up with provider to be examined for cellulitis
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: COVID Moderna 12yrs and older 0.5mL administered instead of ordered dose of COVID Moderna 6mos to 11yrs 0.25ml
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Inflammation, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: 15 y/o female brought into clinic by mother on 03/01/24 for annual well child exam. The provider ordered Menveo vaccine for the patient. The medical assistant administered the vaccine and documented the route as intramuscular. The patient came back to clinic on Monday 03/04/24 with c/o a rash to her right arm that occurred 2 days after administration of Menveo. The parent describes the rash as warm, pruritic, raised, and erythematous oval shape that progressively worsened in pain and size. Patients mother called the nurse hotline, and they advised her to measure the rash which was 3 inches in length and 1.5 inches in width, since then, the rash has increased in length to about 4 inches and the pain has progressed. Per the vaccine's website, local reactions/rash to vaccines occur in 1% of patients so it is rare but not ordinary. Mother was concerned about vaccine injection site; per provider it appears the vaccine was administered ventral to deltoid muscle, however the location it was placed in has a thin fat pad which may still be intramuscular. Management Recommendations:  a. Medications are currently recommended to start:PO Ibuprofen Q 6 hours for pain and inflammation, PO Benadryl TID PNR itchiness, Topical Hydrocortisone in affected area. b. Labs: are not recommended. c. Referral: is not recommended. d. Imaging: is not recommended. Doctor's note not requested. -Follow-up: for in 48 hours to reevaluate symptoms.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Skin warm
Clinical narrative: 15 y/o female brought into clinic by mother on 03/01/24 for annual well child exam. The provider ordered Menveo vaccine for the patient. The medical assistant administered the vaccine and documented the route as intramuscular. The patient came back to clinic on Monday 03/04/24 with c/o a rash to her right arm that occurred 2 days after administration of Menveo. The parent describes the rash as warm, pruritic, raised, and erythematous oval shape that progressively worsened in pain and size. Patients mother called the nurse hotline, and they advised her to measure the rash which was 3 inches in length and 1.5 inches in width, since then, the rash has increased in length to about 4 inches and the pain has progressed. Per the vaccine's website, local reactions/rash to vaccines occur in 1% of patients so it is rare but not ordinary. Mother was concerned about vaccine injection site; per provider it appears the vaccine was administered ventral to deltoid muscle, however the location it was placed in has a thin fat pad which may still be intramuscular. Management Recommendations:  a. Medications are currently recommended to start:PO Ibuprofen Q 6 hours for pain and inflammation, PO Benadryl TID PNR itchiness, Topical Hydrocortisone in affected area. b. Labs: are not recommended. c. Referral: is not recommended. d. Imaging: is not recommended. Doctor's note not requested. -Follow-up: for in 48 hours to reevaluate symptoms.
Age: 1.25
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: gardasil given to 15 month old child - vaccine not indicated, no symptoms immediately after and for 5 months afterwards
Age: 11.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired ipol vaccine was inadvertently administered with no reported adverse event; Initial information was received on 01-Mar-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 11 years old female patient who received expired IPV (VERO) [IPOL]vaccine inadvertently with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL),  MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMR II) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Prophylactic vaccination.  On 28-Feb-2024, the patient received expired 0.5 ml of suspect IPV (VERO), suspension for injection (lot V1A011M and expiry 10-02-24) ( strength: unknown) ((expired product administered, latency same day) via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  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: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Fatigue, Impaired work ability, Injection site reaction
Clinical narrative: The patient states that the reaction started about 12 hours after the vaccination and lasted for about 2 days.  She said that it really "knocked her down".  She reported extreme fatigue and weakness, extreme body aches, nausea and diarrhea.  She also had a red, itchy rash several inches in diameter at the injection site.  She reported that she called off of work a day because she felt so weak and tired.  She treated with Tylenol and rest.  Today she reported feeling better except for the rash that is still on her arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Rash erythematous, Rash pruritic
Clinical narrative: The patient states that the reaction started about 12 hours after the vaccination and lasted for about 2 days.  She said that it really "knocked her down".  She reported extreme fatigue and weakness, extreme body aches, nausea and diarrhea.  She also had a red, itchy rash several inches in diameter at the injection site.  She reported that she called off of work a day because she felt so weak and tired.  She treated with Tylenol and rest.  Today she reported feeling better except for the rash that is still on her arm.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine given past BUD.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Guillain-Barre syndrome, treated at outside hospital from 2/29 - 3/2/24. Patient with back pain, b/l lower extremity weakness, and paresthesias of whole body. During clinic visit on 3/6/24, patient still experiencing whole body numbness/tingling; however, this is mostly affecting hands/feet. Walks with assistance of walker. Still feels weakness in both arms and legs, but lower extremity weakness is worse than upper extremity weakness. No significant improvement in weakness since hospital discharge, but not worsening.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Walking aid user
Clinical narrative: Guillain-Barre syndrome, treated at outside hospital from 2/29 - 3/2/24. Patient with back pain, b/l lower extremity weakness, and paresthesias of whole body. During clinic visit on 3/6/24, patient still experiencing whole body numbness/tingling; however, this is mostly affecting hands/feet. Walks with assistance of walker. Still feels weakness in both arms and legs, but lower extremity weakness is worse than upper extremity weakness. No significant improvement in weakness since hospital discharge, but not worsening.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Angioedema, Erythema multiforme
Clinical narrative: Erythema multiforme. Angiodema
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states that she noticed right away that the vaccine "really hurt". She states that it hurt to drive her car home afterward.  She went to a regularly scheduled appointment with a PA at her PCP's office on 3/5/24 in the afternoon (unsure of time)and her PA asked what happened because it was red, swollen,warm, and bruised. The provider told her that she felt that vaccine was administered too low. Patient was advised by PA to use tylenol and put ice on it.  Patient states that pain has gotten a little better but still red, warm etc.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Product administered at inappropriate site
Clinical narrative: Patient states that she noticed right away that the vaccine "really hurt". She states that it hurt to drive her car home afterward.  She went to a regularly scheduled appointment with a PA at her PCP's office on 3/5/24 in the afternoon (unsure of time)and her PA asked what happened because it was red, swollen,warm, and bruised. The provider told her that she felt that vaccine was administered too low. Patient was advised by PA to use tylenol and put ice on it.  Patient states that pain has gotten a little better but still red, warm etc.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child given Hep-A adult dose, contact health officer, spoke with pediatrician, no concern. Called and spoke with guardian to inform of vaccine.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Dyspepsia, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red & swelling at injection site which spread to a large rash about 3 inch circumference which itched for 5 days. Indigestion which still exists at day 6 after the vaccination.
Age: 35.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The client was vaccinated at a special vaccination event on 2/24/2024. He received a dose of Fluzone 0.5ML Quadrivalent influenza vaccine (lot U8200CA) and a Havrix Hepatitis A 1ML vaccine (Lot T9TL9) to the L deltoid at 1636. He was screened for precautions, contraindications, and previous vaccination history by vaccinator and no concerns were noted. MA indicates that the client did not have any vaccination records with him to review and that all communication was conducted via a interpreter.  The vaccination team was unable to use computers due to the conditions at the event, so his vaccination and screening were recorded on a downtime form until the team could return to the fixed site to document his vaccination electronically. This was done on the next working day (2/27/28), at which point the team saw that his account in system indicates that he had already received a flu vaccine on 11/7/2023 (Fluzone Quadrivalent, Lot number UT8129LA, given by RN with the Mobile Van).  This writer conducted a documentation review and noted that the client does not appear to have an account in system, but both vaccinations do appear in record and there is a visit note describing the 11/7/2023 vaccination in detail.  This writer spoke with Dr on 2/29/2024 regarding the situation. She reports ?no concerns with this revaccination?.  This writer also spoke with the client through an interpreter on 2/29/2024 to explain the situation, the physician?s response, and the reporting process. The client verbalized understanding and reported that he has felt ?fine? since his vaccination and has had ?no side effects?. The client had been unaware that the flu vaccine is typically only given once per season, so this writer provided education to explain the flu standard vaccination schedule, the client verbalized understanding.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Paranasal sinus discomfort, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: Coughing, sinus irritation, post nasal drip. NO FEVER.  Tested positive for COVID19 one week after the vaccination.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient is 7 years and 1 month old, but was given the wrong COVID vaccine based on age. Patient was given Pfizer Biontech Covid vaccine for 6 months to 4 years, when he should have received the Pfizer Biontech Covid vaccine for 5-11 years old. Health care provider was notified. Manufacturer was called for consultation. Healthcare provider determined that manufacturer and CDC all recommended patient be revaccinated with the correct vaccine in 2 months.
Age: 90.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: very bad pain in the back where the booster was shot. Also caller's left arm, shoulder; hardly move left arm; The initial case was missing the following minimum criteria: [Unspecified product]. Upon receipt of follow-up information on [05Mar2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single at the age of 90 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, made by Baylor), for COVID-19 immunisation. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "very bad pain in the back where the booster was shot. Also caller's left arm, shoulder"; VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious), outcome "unknown", described as "hardly move left arm". Additional information: Patient called about side effect of booster number three for Covid 19. Patient stated he was in dire need of help. Patient had a very bad side effect of the Pfizer Booster. He had been suffering. Patient had pain where the needle was in the back shoulder, the left shoulder. Caller can hardly move left arm. Caller stated he is 91 years old. Patient was feeling pains again in arms and back. Had first and second Covid vaccine and the booster for the Covid vaccine. Patient didn't sleep all night. Patient was injected on 05Oct2022 and started having the side effects a month before that but he did not bother about it because patient thought it was just a little bit longer for the pain to disappear.
Age: 90.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, Vaccination site joint movement impairment
Clinical narrative: very bad pain in the back where the booster was shot. Also caller's left arm, shoulder; hardly move left arm; The initial case was missing the following minimum criteria: [Unspecified product]. Upon receipt of follow-up information on [05Mar2024], this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single at the age of 90 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, made by Baylor), for COVID-19 immunisation. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "very bad pain in the back where the booster was shot. Also caller's left arm, shoulder"; VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious), outcome "unknown", described as "hardly move left arm". Additional information: Patient called about side effect of booster number three for Covid 19. Patient stated he was in dire need of help. Patient had a very bad side effect of the Pfizer Booster. He had been suffering. Patient had pain where the needle was in the back shoulder, the left shoulder. Caller can hardly move left arm. Caller stated he is 91 years old. Patient was feeling pains again in arms and back. Had first and second Covid vaccine and the booster for the Covid vaccine. Patient didn't sleep all night. Patient was injected on 05Oct2022 and started having the side effects a month before that but he did not bother about it because patient thought it was just a little bit longer for the pain to disappear.