chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient received bnt162b2 (BNT162B2), on 09Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 24 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. There were no concomitant medications. 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.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Trigeminal neuralgia
Clinical narrative: Severe left sided facial pain; Possible trigeminal neuralgia; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 13:00 as dose 1, single (Lot number: HG4633) at the age of 26 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA taken for immunisation, on 09Oct2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Unknown Manufacturer, DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (Unknown Manufacturer, Primary Immunization Series Completed), for Covid-19 immunization. No covid tested prior or post vaccination. No known allergies. No other medications in two weeks. The following information was reported: TRIGEMINAL NEURALGIA (hospitalization) with onset 12Oct2023 at 18:00, outcome "recovering", described as "Possible trigeminal neuralgia"; FACIAL PAIN (hospitalization) with onset 12Oct2023 at 18:00, outcome "recovering", described as "Severe left sided facial pain". Severe left sided facial pain that required hospitalization for pain management. Workup for possible trigeminal neuralgia. The patient was hospitalized for facial pain, trigeminal neuralgia (hospitalization duration: 5 day(s)). The events "severe left sided facial pain" and "possible trigeminal neuralgia" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of facial pain, trigeminal neuralgia. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported events and suspect BNT162B2 omi xbb.1.5cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Aug2023 as dose 6 (booster), single (Lot number: GJ3268) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 20Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESCITALOPRAM, start date: 01Jan2020; ADDERALL, start date: 01Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, 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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Walnuts and Pecans" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19 as Paxlovid from 11Oct2023 to 15Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 3 (booster), single (Lot number: GH9703) at the age of 50 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Epstein Barr infection" (unspecified if ongoing), notes: chronic post viral fatigue from Epstein Barr infection; "Allergies pineapple" (unspecified if ongoing), notes: Sulfa antibiotics, pineapple; "chronic post viral fatigue" (unspecified if ongoing); "Sulfa antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Alleve, reaction(s): "Known allergies; Alleve". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Oct2023, outcome "recovered" (25Oct2023), COVID-19 (medically significant) with onset Oct2023, outcome "recovered" (15Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Oct2023) Negative, notes: Home antigen testing; (26Oct2023) Positive, notes: Home antigen test showed clear positive on 26Oct2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment for the events from 17Oct2023 to 22Oct2023.  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: F
Vaccine: COVID19
Symptoms: Insomnia, Night sweats, Vaginal discharge
Clinical narrative: Severe Night Sweats Problems; can't Sleep more than 2-hours; Vagina Juices (Running Down My Legs); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NIGHT SWEATS (non-serious), outcome "not recovered", described as "Severe Night Sweats Problems"; INSOMNIA (non-serious), outcome "unknown", described as "can't Sleep more than 2-hours"; VAGINAL DISCHARGE (non-serious), outcome "unknown", described as "Vagina Juices (Running Down My Legs)". The events "severe night sweats problems", "can't sleep more than 2-hours" and "vagina juices (running down my legs)" required physician office visit. Therapeutic measures were taken as a result of night sweats.  Additional Information: From the first 2019 Pfizer Vaccine (as reported, possible discrepant), patient started having severe night sweats problems. She doesn't have hot flashes just night sweats. She can't sleep more than 2-hours and she wakes up sweating all over, including her hair (like she was taking a shower) and vagina juices (running down my legs) and patient is 78-years old. The patient immediately called her gynecologist and primary care physician and they have been prescribing several different medications for hot flashes and night sweats. Nothing works. Patient asks for help.   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: Heart rate, Heart rate increased
Clinical narrative: She had taken 4 of the 5 Pfizer Covid Vaccines but each time she takes it she gets a very fast heartbeat and lasts for quite a while, sometime months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing); "gluten allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, She had taken 4 of the 5 Pfizer Covid Vaccines but each time she takes it she gets a very fast heartbeat and lasts for quite a while), for Covid-19 immunization, reaction(s): "very fast heartbeat"; Bnt162b2 (DOSE 2, SINGLE, She had taken 4 of the 5 Pfizer Covid Vaccines but each time she takes it she gets a very fast heartbeat and lasts for quite a while), for Covid-19 immunization, reaction(s): "very fast heartbeat"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, She had taken 4 of the 5 Pfizer Covid Vaccines but each time she takes it she gets a very fast heartbeat and lasts for quite a while), for Covid-19 immunization, reaction(s): "very fast heartbeat". The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "She had taken 4 of the 5 Pfizer Covid Vaccines but each time she takes it she gets a very fast heartbeat and lasts for quite a while, sometime months". Relevant laboratory tests and procedures are available in the appropriate section.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352464 Same patient/vaccine/event, different dose.;US-PFIZER INC-202300352449 Same patient/vaccine/event, different dose.;US-PFIZER INC-202300352465 Same patient/vaccine/event, different dose.;
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Flank pain, Ultrasound scan
Clinical narrative: flank pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received bnt162b2 (BNT162B2), on 09Apr2021 as dose 2, 0.3 ml single (Lot number: EW0158) at the age of 34 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "typhoid", start date: 2010 (unspecified if ongoing); "two pregnancies" (unspecified if ongoing), notes: during 2011-2012 and 2015-2016. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Anatomical site of Injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: ER2613), administration date: 19Mar2021, for COVID-19 immunisation. The following information was reported: FLANK PAIN (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Many full abdominal ultrasounds and CT scans for other purposes (e.g., typhoid diagnosis in 2010, as well as two pregnancies during 2011-2012 and 2015-2016). Patient was a mother of two kids (11years and 7 years). Both the delivery was normal, and the pregnancy period was also normal. Patient did many ultrasounds during her pregnancy time. She never had any issues at that time. She had no previous kidney injury. Patient also did a complete CT scan on Abdomen in 2010 in (Withheld) due to a typhoid infection. In that report (attached) it was mentioned that both kidneys were seen clearly. No atrophy was mentioned there. Further, patient never had any flank pain before early 2022. It started after second Pfizer vaccine for COVID19 and became severe with fatigue after the third (first Booster) vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300135086 same patient/product, different dose/events;
Sex: U
Vaccine: COVID19
Symptoms: Device breakage, Device issue
Clinical narrative: when removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force/ the stopper flew off side ways; the stopper flew off side ways and cracked the screws/syringe where the needle would connect; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: HG9498, Expiration Date: 31Jan2024) for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "when removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force/ the stopper flew off side ways"; DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the stopper flew off side ways and cracked the screws/syringe where the needle would connect".  The reporter considered "when removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force/ the stopper flew off side ways" and "the stopper flew off side ways and cracked the screws/syringe where the needle would connect" not related to bnt162b2 omi xbb.1.5. Causality for "when removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force/ the stopper flew off side ways" and "the stopper flew off side ways and cracked the screws/syringe where the needle would connect" was determined associated to device constituent of bnt162b2 omi xbb.1.5 (malfunction).  Additional information: A safety hazard was encountered with the Comirnaty vaccine. When removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force. In 2 cases, the stopper flew off side ways and cracked the screws/syringe where the needle would connect. The Lot# of both doses= HG9498, with expiration date of Jan24. NDC# 00089238201. Reporter was asking for advise whether there is a method of removing the stopper that will eliminate this cracking of the syringe hub.     The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300348823 Same reporter/drug/AE, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: chose the Pfizer vax for family as the best fit/we caught Covid this summer; chose the Pfizer vax for family as the best fit/we caught Covid this summer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "chose the Pfizer vax for family as the best fit/we caught Covid this summer".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture
Clinical narrative: Fractured Hip Bone; fell out of an chair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An 85-year-old female patient received bnt162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 84 years for covid-19 immunisation; bebtelovimab (BEBTELOVIMAB), on 25Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1, Lot: EL9263), administration date: 30Jan2021, when the patient was 83-year-old, for COVID-19 immunization; bnt162b2 (Dose 2, at 3:30 PM), administration date: 20Feb2021, when the patient was 83-year-old, for COVID-19 immunization. The following information was reported: HIP FRACTURE (medically significant) with onset 09Dec2022 at 17:00, outcome "unknown", described as "Fractured Hip Bone"; FALL (medically significant) with onset 09Dec2022 at 17:00, outcome "unknown", described as "fell out of an chair". Therapeutic measures were taken as a result of hip fracture.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298831 same patient, different events and doses;US-PFIZER INC-PV202300153749 same patient, different events and doses;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 test result last Jan2022/tested positive that year; Covid-19 test result last Jan2022/tested positive that year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 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), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Covid-19 test result last Jan2022/tested positive that year". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive. Clinical course: The patient called in asking to send her Covid-19 test result last Jan2022. She mentioned that she tested positive that year and she needed proof.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: every time I get the flu shot I get 10 times sicker; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received via consumer.  This case involves an unknown age and unknown gender patient who stated every time i get the flu shot i get 10 times sicker after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had an event of every time i get the flu shot i get 10 times sicker (illness) (unknown latency) following the administration of influenza vaccine.  It was unknown if any lab data/test results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the event.
Age: 1.25
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product preparation error, Wrong technique in product usage process
Clinical narrative: stated that PENTACEL was mixed with the solution part of the ACT-HIB and was administered incorrectly with no reported adverse event; stated that PENTACEL was mixed with the solution part of the ACT-HIB and was administered incorrectly with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received via nurse.  This case involves a 1-year-old female patient and the reporter stated that diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was mixed with the solution part of the act-hib and was administered incorrectly with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination.  On 19-Oct-2023, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ859AA, 02-Apr-2024) via intramuscular route in the right thigh for Immunization and reporter stated that pentacel was mixed with the solution part of the act-hib and was administered incorrectly with no reported adverse event (product preparation error and poor quality product administered) (latency: same day)  It was reported, preparation and administration of PENTACEL that was mixed with a saline diluent of ACT-HIB.    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: 38.0
Sex: M
Vaccine: TYP, YF
Symptoms: Incorrect route of product administration, Medication error, No adverse event, Wrong product administered
Clinical narrative: patient came in for a typhoid fever vaccine but was given yf-vax intramuscularly instead of subcutaneously with no reported adverse event; patient came in for a typhoid fever vaccine but was given yf-vax intramuscularly instead of subcutaneously with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to cases 2023SA326767 and 2023SA326868.  This case involves a 38 years old male patient who came in for a Typhoid fever Vaccine but was given Yellow Fever Vaccine - [Yf-Vax] intramuscularly instead of subcutaneously 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 b vaccine (hepatitis b vaccine) for Prophylactic vaccination.  On 20-Oct-2023, the patient received 0.5 ml total (Dose 1) (1 X) of suspect Yellow Fever Vaccine - Solution for injection (lot number: UJ819AA, Expiry date: 18-Apr-2024) (Strength: standard) (Frequency: once) via intramuscular route in the arm nos (not otherwise specified) for immunisation.  On 20-Oct-2023, the patient came in for a typhoid fever vaccine but was given Yellow Fever Vaccine - [Yf-Vax] intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration) (wrong product administered) (latency: same day).  It was reported, Nurse called to advise that patient came in for a typhoid fever vaccine but was given YF-VAX intramuscularly instead of subcutaneously.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone highdose quadrivalent was administered to 5 pages of incorrect age group with no reported adverse event; fluzone highdose quadrivalent was administered to pregnant with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA330943(CLUSTER).  This case involves an unknown age female patient who was exposed to vaccine Influenza Quadrival A-B High dose HV Vaccine [Fluzone High-dose-Quadrivalent] in context of administered to incorrect age group and pregnant patient with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was unknown. The events occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On an unknown date, the pregnant patient at incorrect age group received a dose of suspect Influenza Quadrival A-B High dose HV Vaccine (lot number, strength, expiry date, dose not reported) via unknown route in unknown administration site as prophylactic vaccination with no adverse event (product administered to patient of inappropriate age) (exposure during pregnancy) (unknown latency).  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: after administration they wrote out the expiration date, but it was smudged therefore he couldn't read the month. caller reporting it was 2023 but month unknown with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age male patient and the reporter reported after administration they wrote out the expiration date, but it was smudged therefore he couldn't read the month. caller reporting it was 2023 but month unknown with no reported adverse event after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for Immunization and after administration they wrote out the expiration date, but it was smudged therefore he couldn't read the month. caller reporting it was 2023 but month unknown with no reported adverse event (expired 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: 0.33
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired pentacel was administered with no reported adverse event; Initial information was received on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient to whom expired diphtheria/tetanus/5 hybrid AC pertussis/ipv(vero)/HIB(PRP/T) vaccine [Pentacel (VERO)] 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 23-Oct-2023, the patient received a 0.5ml, once dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/ipv(vero)/HIB(PRP/T) vaccine Suspension for injection (lot UJ799AA, expiry date: 02-Oct-2023, strength: standard) via intramuscular route in the left thigh for Immunization and expired pentacel was administered with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired pentacel with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid  non-serious case received from a Physician.  This case involves a 4 months old male patient who got administered an expired diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5v (Rotateq) for Prophylactic vaccination and Vaxudence.  On 23-Oct-2023, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot UJ786AA and expiration date- 10-Dec-2023) via unknown route in unknown administration site (strength: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 64.0
Sex: F
Vaccine: YF
Symptoms: Dyspnoea
Clinical narrative: felt winded and had shortness of breath; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2023SA332246.  This case involves a 64 years old female patient who felt winded and had shortness of breath after receiving vaccine YELLOW FEVER VACCINE - [YF-VAX].  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 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) and INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for Prophylactic vaccination (Immunization).  On 13-Oct-2023, the patient received unknown dose of suspect YELLOW FEVER VACCINE - (Solution for injection) (frequency: 1X and Drug Treatment Duration: once) (lot UJ829AA and expiry date: 30-Nov-2024) via subcutaneous route in the left arm for Immunization.  On 18-Oct-2023, the patient felt winded and had shortness of breath (dyspnoea) 5 days following the administration of YELLOW FEVER VACCINE.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine 9-11-2023, dose was given with no reported adverse event; Initial information was received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 weeks old female patient to whom expired HIB (PRP/T) vaccine [ACT-HIB] 9-11-2023, dose was given 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), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix); and pneumococcal vaccine conj 13v (crm197) (Prevnar 13).  On 24-Oct-2023, the patient received an unknown dose (total, once) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number: UJ798AB, expiry date: 11-Sep-2023, strength: standard) via unknown route in the right thigh for Immunization and expired vaccine 9-11-2023, dose was given with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Single component of a two-component product administered, Vaccination error
Clinical narrative: had a vaccine error with PENTACEL and did not mix the Dtap-IPV component and gave the HIB component separately with no reported adverse event; Initial information received on 25-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter reported that nurse had a vaccine error Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] and did not mix the dtap-ipv component and gave the hib component separately 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 total (1 X) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (Strength: standard) (Frequency: once) (With an unknown expiry date, lot number) not reported via unknown route in unknown administration site.  On an unknown date, the reporter reported that nurse had a vaccine error Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] and did not mix the dtap-ipv component and gave the hib component separately with no reported adverse event (single component of a two-component product administered) (latency: same day).  It was reported, One of the nurses, had a vaccine error with PENTACEL and did not mix the Dtap-IPV component and gave the HIB component separately. Nurse on the line wanted to confirm if it's considered a valid HIB dose. Nurse did not have any information thus questionnaire is blank. Nurse called to ask if it's considered a valid HIB dose if not mixed the Dtap-IPV component of PENTACEL.   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: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Induration, Inflammation, Local reaction, Pruritus
Clinical narrative: Indurated arm; Red Arm; Arm started itching; Arm Inflamed; Warm Arm; This spontaneous case was received on 20-Oct-2023 from other health professional (Nurse, Patient) via agency (reference number: SEQW23-03616) and concerned a 71-year-old, female patient.  The patient's concurrent conditions included intestinal problems, allergy to penicillin, sulfur and dairy (milk protein). The patient's concomitant medications included Xarelto (Rivaroxaban), Calcium, unspecified vitamins, Singulair (Montelukast sodium) all used for unreported indication and low dose Ciprofloxacin used for intestinal problems.  On 18-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration, anatomical location, and indication: not reported). The batch number reported was 371640 with expiry date: 30-Jun-2024.  On the same date, five minutes after receiving Fluad Quadrivalent vaccine, the patient had a local reaction and her arm started itching. The rest of the day it started to get inflamed.  On 19-Oct-2023, the patient observed that, the arm was red and indurated.  On an unspecified date in Oct-2023, the patient's arm was warm.  On 20-Oct-2023, the patient's arm was still red however it was slightly less warm.  The outcome of the event inflammation localized, induration, erythema of extremities, localized itching was not reported.  At the time of initial reporting, on 20-Oct-2023, the patient was recovering from the event skin warm.  The reporter assessed the case as non-serious.  Company comment: A 71-year-old patient experienced localized inflammation, induration, skin warmth, arm erythema, and localized pruritus within two days after receiving the suspect product influenza vaccine. Based on suggestive temporal relationship and the absence of confounders, causality for the reported events is assessed as probably related.; Sender's Comments: A 71-year-old patient experienced localized inflammation, induration, skin warmth, arm erythema, and localized pruritus within two days after receiving the suspect product influenza vaccine. Based on suggestive temporal relationship and the absence of confounders, causality for the reported events is assessed as probably related.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Skin warm
Clinical narrative: Indurated arm; Red Arm; Arm started itching; Arm Inflamed; Warm Arm; This spontaneous case was received on 20-Oct-2023 from other health professional (Nurse, Patient) via agency (reference number: SEQW23-03616) and concerned a 71-year-old, female patient.  The patient's concurrent conditions included intestinal problems, allergy to penicillin, sulfur and dairy (milk protein). The patient's concomitant medications included Xarelto (Rivaroxaban), Calcium, unspecified vitamins, Singulair (Montelukast sodium) all used for unreported indication and low dose Ciprofloxacin used for intestinal problems.  On 18-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration, anatomical location, and indication: not reported). The batch number reported was 371640 with expiry date: 30-Jun-2024.  On the same date, five minutes after receiving Fluad Quadrivalent vaccine, the patient had a local reaction and her arm started itching. The rest of the day it started to get inflamed.  On 19-Oct-2023, the patient observed that, the arm was red and indurated.  On an unspecified date in Oct-2023, the patient's arm was warm.  On 20-Oct-2023, the patient's arm was still red however it was slightly less warm.  The outcome of the event inflammation localized, induration, erythema of extremities, localized itching was not reported.  At the time of initial reporting, on 20-Oct-2023, the patient was recovering from the event skin warm.  The reporter assessed the case as non-serious.  Company comment: A 71-year-old patient experienced localized inflammation, induration, skin warmth, arm erythema, and localized pruritus within two days after receiving the suspect product influenza vaccine. Based on suggestive temporal relationship and the absence of confounders, causality for the reported events is assessed as probably related.; Sender's Comments: A 71-year-old patient experienced localized inflammation, induration, skin warmth, arm erythema, and localized pruritus within two days after receiving the suspect product influenza vaccine. Based on suggestive temporal relationship and the absence of confounders, causality for the reported events is assessed as probably related.
Sex: F
Vaccine: FLUC3
Symptoms: Pain, Pruritus, Skin warm
Clinical narrative: Warm to touch; Painful / Increased pain due to her itching it; Very itchy; This spontaneous case was received on 24-Oct-2023 from other healthcare professional via Company (reference number: SEQW23-03707) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On 13-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, and anatomical location: not reported) as Influenza immunization. The batch number was not reported.  On an unspecified day in Oct-2023, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient reported feeling very itchy, warm to touch, and painful. As reported, the patient had no fever, and the pain probably increased due to the patient itching it. The patient's treatment included hydrocortisone cream and Benadryl itch gel (diphenhydramine hydrochloride).   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The patient was vaccinated with Flucelvax Quadrivalent vaccine. Within eleven days following vaccination, the patient experienced skin warm, pain and pruritus. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine cannot be excluded, and is assessed as possible for all events, due to chronological plausibility.; Sender's Comments: The patient was vaccinated with Flucelvax Quadrivalent vaccine. Within eleven days following vaccination, the patient experienced skin warm, pain and pruritus. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine cannot be excluded, and is assessed as possible for all events, due to chronological plausibility.