chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Dialysis; While in the procedure he started to feel unwell; Headache; felt hot in the back of the head; Tiredness; he felt dizzy 4 times/Dizziness; 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 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Jul2023 at 09:00 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, 1 year ago he had received another dose of the vaccine.), for COVID-19 immunisation. The following information was reported: DIALYSIS (medically significant) with onset 12Jul2023, outcome "unknown"; HEADACHE (non-serious) with onset 12Jul2023, outcome "recovering"; FATIGUE (non-serious) with onset 12Jul2023, outcome "recovering", described as "Tiredness"; MALAISE (medically significant) with onset 12Jul2023, outcome "recovering", described as "While in the procedure he started to feel unwell"; FEELING HOT (non-serious) with onset 12Jul2023, outcome "recovering", described as "felt hot in the back of the head"; DIZZINESS (non-serious) with onset 12Jul2023, outcome "recovering", described as "he felt dizzy 4 times/Dizziness". Therapeutic measures were taken as a result of malaise, headache, feeling hot, fatigue, dizziness. Clinical course: Caller explained that yesterday (11Jul2023) around 9 AM, he received the booster dose of the Pfizer-BioNTech COVID-19 vaccine. He mentioned that 1 year ago he had received another dose of the vaccine. Today (12Jul2023) around 8:30 AM he underwent dialysis. While in the procedure he started to feel unwell; he felt dizzy 4 times. About every half hour he felt dizzy again, and this was repeated 4 times. He described that he was lying down and that's why he couldn't fall, but he felt like he was going to faint. He had a headache and felt "hot" in the back of the head. He was given Tylenol at the site. All of these symptoms occurred about 24 hours after vaccination. He explained that at the time of the call he had no longer had those symptoms and that he was feeling better. He wanted to know how to treat his symptoms if it happened again.  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.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm and was achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 30-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Diagnosed pre-2020 and reporter would say maybe in 2018 patient he was undiagnosed. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "had a sore arm and was achy".  Additional Information: The patient's medical history was reported as: Hypothyroidism was diagnosed pre-2020 and reporter would say maybe in 2018 as patient was undiagnosed and after the fact he noted his hands were cold and put it together it may be the hypothyroidism and so was getting treatment by 2018 and this started to appear when the patient was in law school in 2016 and he was treated and they thought he was not just tired from law school but attributed some fatigue to being in school so was diagnosed in 2017 or 2018 for the hypothyroidism. Reporter further stated that the patient mounted a response and he had said his arms were a little sore; clarified the patient had a sore arm and was achy and was unremarkable.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300249456 same reporter/patient, different dose/ events;US-PFIZER INC-202300249539 same reporter/patient, different dose/ events;
Age: 71.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06May2023 at 10:00 as dose 6 (booster), single (Lot number: GJ6742) at the age of 71 years, in left arm 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: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 26Jun2023 to 01Jul2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300249432 same reporter/patient, different drug/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Jun2023 at 13:15 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm 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 and concomitant medications were not reported. Vaccination history included: Shingrix (Shingrix #2 vaccinations half day before original symptoms), for Herpes zoster immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treated with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300249663 same patient, different drug/event;
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose number unknown, single (Lot number: 330368D) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid Treatment from 02Jul2023 to 07Jul2023. Patient didn't had any Known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300249718 same patient, different drug/event;
Sex: M
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 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) 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: "Heart palpitations" (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 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 04Jul2023 to 08Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250291 Same patient, different drug, different event;
Age: 69.0
Sex: M
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 70-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment start date reported as 29Jun2023 and Treatment stop date reported as 04Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250325 Same patient, different drug, different event;
Sex: F
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm 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: "HBP" (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 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested positive for Covid again after four days of testing negative; (2023) Positive, notes: Tested positive for Covid again after four days of testing negative; (Jul2023) Positive, notes: Tested +10 days after first initial test of positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with paxlovid from 03Jul2023 to 07Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further informaton is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250384 Same reporter/patient, different drug/AE.;
Sex: F
Vaccine: COVID19
Symptoms: Lung neoplasm malignant
Clinical narrative: lung cancer after the shot, and she was gone within months; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: LUNG NEOPLASM MALIGNANT (death, medically significant), outcome "fatal", described as "lung cancer after the shot, and she was gone within months". The patient date of death was unknown. Reported cause of death: "lung cancer after the shot, and she was gone within months". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250402 same reporter/product, different patient/AE;; Reported Cause(s) of Death: lung cancer after the shot, and she was gone within months
Sex: F
Vaccine: COVID19
Symptoms: Lung carcinoma cell type unspecified stage IV
Clinical narrative: stage 4 lung cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV (medically significant), outcome "unknown", described as "stage 4 lung cancer". Clinical course: Reporter watched her sister's friend got lung cancer. She wasn't gone right after, but she used to walk 3 miles a day and ended up getting stage 4 lung cancer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250402 same reporter/product, different patient/AE;
Sex: F
Vaccine: COVID19
Symptoms: Lung neoplasm malignant
Clinical narrative: lung cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: LUNG NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "lung cancer". Therapeutic measures were taken as a result of lung neoplasm malignant. Clinical course: They removed something she thought.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250402 same reporter/product, different patient/AE;
Sex: F
Vaccine: COVID19
Symptoms: Uterine cancer
Clinical narrative: uterine cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A 40-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: UTERINE CANCER (medically significant), outcome "unknown". Therapeutic measures were taken as a result of uterine cancer. Clinical course: It was rapidly progressing and they removed her uterus. She saw an online video that the vaccine contains sv40 which is a cancer causing virus, and a DNA virus which causes antibiotic resistance. She listened to a gentleman from privacy that had terror in his voice about what was in the vials. That the vaccines are causing antibiotic resistance and turbo cancer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250402 same reporter/product, different patient/AE;
Sex: U
Vaccine: COVID19
Symptoms: Pathogen resistance
Clinical narrative: antibiotic resistance/second hospital said they had one other case before; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: PATHOGEN RESISTANCE (medically significant), outcome "unknown", described as "antibiotic resistance/second hospital said they had one other case before". Clinical course: Patient had antibiotic resistance. The doctor's were all stumped with no idea what to do.The second hospital said they had one other case before. Reporter did not want to provide contact details because of the government. And she just wanted to get to Medical information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250402 same reporter/product, different patient/AE;
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis; Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 19-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 Immunization. The following information was reported: MYOCARDITIS (death, medically significant), PERICARDITIS (death, medically significant), outcome "fatal" and all described as "Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis". The patient date of death was 26May2023. Reported cause of death: "Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in this case and considering a plausible drug-event temporal association, there is a reasonable possibility that the reported fatal listed events (Myocarditis and Pericarditis) are related to the suspect product BNT162b2 (COMIRNATY). However, additional information is needed to better assess this case and determine patients cause of death. This case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis; Passed away had received 2 of the vaccine shots from your company/developed Myocarditis and Pericarditis
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID on 11Jul2023; Tested positive for COVID on 11Jul2023; 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 (COMIRNATY), on 11Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) and 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 11Jul2023, outcome "unknown" and all described as "Tested positive for COVID on 11Jul2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2023) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Urticaria
Clinical narrative: hives all over my body; Chronic Idiopathic Urticaria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Lot number not provided ), for COVID-19 immunization. The following information was reported: CHRONIC SPONTANEOUS URTICARIA (non-serious) with onset May2021, outcome "unknown", described as "Chronic Idiopathic Urticaria"; URTICARIA (non-serious) with onset May2021, outcome "unknown", described as "hives all over my body". Therapeutic measures were taken as a result of urticaria.  Additional information: Patient received second covid-19 vaccine and within 1 hour patient began to have hives all over the body. These hives could not be controlled with allergy medications and ever since had been diagnosed with Chronic Idiopathic Urticaria.   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: Malaise
Clinical narrative: very sick; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP), Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: MALAISE (medically significant), outcome "unknown", described as "very sick".  Clinical course: Patient got the vaccine and each time she got it she got very sick bedridden 3 days. Side effects after the vaccine was serious. She got very sick herself and couldn't work.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the event Malaise and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: He has since been hospitalized multiple times for a heart arrhythmia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the parent.  A 21-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: ARRHYTHMIA (hospitalization), outcome "unknown", described as "He has since been hospitalized multiple times for a heart arrhythmia". Clinical Course: Their son was a healthy 21 year old who received original COVID vaccine as well as the first booster 2 years ago. He had since been hospitalized multiple times for a heart arrhythmia. He did not have any health issues prior to receiving vaccine. He might need surgery to place an internal monitor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered Pentacel to a patient, after giving shot nurse realized she was not able to reconstitute Hib component of vaccine, patient only received DTaP-IPV component with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional (nurse).  This case involves a 4 months old male patient who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] to a patient and after giving shot nurse realized she was not able to reconstitute Hib component of vaccine, patient only received DTAP-IPV component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. There were no concomitant vaccines administered.  On 07-Jul-2023, the patient only received DTAP-IPV component at a dose of 0.5ml (dose 2) of suspect Diphtheria/Tetanus/5 HYBRID AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of lot UJ843AB and expiry: 24-Feb-2024 (strength: standard and frequency: once) via unknown route in the thigh NOS for immunization and after giving shot nurse realized she was not able to reconstitute HIB component of vaccine, patient only received DTAP-IPV component with no reported adverse event (single component of a two-component product administered) (Latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event single component of a two-component product 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administration of ACTHIB that was reconstituted with a normal sterile diluent, not the ACTHIB diluent with no reported adverse event; Initial information received on 10-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 years old female patient who was administrated HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with a normal sterile diluent, not the acthib diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR); and pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) [PCV-13] for Prophylactic vaccination.  On 06-Jul-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Batch number: UJ756AAA; Expiry date: 12-Aug-2023) via intramuscular route in the left thigh for Immunization, reconstituted with a normal sterile diluent, not the acthib diluent with no reported adverse event (product preparation error) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administration of acthib that was reconstituted with a normal sterile diluent, not the acthib diluent with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Pentacel to a 6 year old with no reported adverse event; Initial information received on 10-Jul-2023  regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 years old female patient who was inadvertently administered diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past vaccination(s) included DTP on 05-Aug-2017 and 26-Apr-2022 and IPV (2). The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (OKA/merck) (Proquad); and hepatitis A vaccine (Hepatitis A) for Prophylactic vaccination.  On 07-Jul-2023, the patient received 0.5 mL dose 3 of suspect diphtheria/ tetanus/ 5 hybrid ac pertussis/ IPV(vero)/ HIB (PRP/T) vaccine, suspension for injection (batch number: UJ805AA; Expiry date: 17-Feb-2024) via intramuscular route in the right deltoid for Immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered pentacel to a 6 year old with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: only the liquid component of the vaccine was administered to a patient with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient who was administered only the liquid component of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Jul-2023, the patient was administered a dose of 0.5 ml once of the liquid component of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot: UJ843AB; expiry date: 24-Feb-2024; strength: standard) (single component of a two-component product administered) (latency: same day) via unknown route in the left thigh for Immunization. There are no adverse event(s) in this case.  It was reported, "Nurse called saying that the lyophilized component of PENTACEL wasn't reconstituted using the liquid component, so only the liquid component of the vaccine was administered to a patient. Nurse asked how many Hib's are necessary for the whole series and what should they do next? Nurse also asked if they can use a standalone Hib component to make up for the dose?"   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: administered the liquid portion of the PENTACEL, but not the powder with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from Nurse.  This case involves a 15 months old male patient who was administered the liquid portion of the diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)], but not the powder with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination.  On 11-Jul-2023, the patient received 0.5 mL dose 4 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ842AA; Expiry date: 22-Feb-2024) via intramuscular route in the left thigh for immunization, the liquid portion of the pentacel, but not the powder with no reported adverse event (product preparation error) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered the liquid portion of the pentacel, but not the powder with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: IPOL was likely to be used as one dose missing since the excursion with no reported adverse event; temperature excursion as vaccines had multiple short excursions going above 10.3 degrees C, for 50 minutes due to a reason unknown with no reported adverse event; Initial information received on 11-Jul-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 temperature excursion as vaccine had multiple short excursions going above 10.3 degrees c, for 50 minutes due to a reason unknown with no reported adverse event and  IPV (VERO) [IPOL] was likely to be used as one dose missing since the excursion with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Caller reported temperature excursion for open IPOL in JUN-2023 as vaccine had multiple short excursions going above 10.3 degrees c, for 50 minutes due to a reason unknown with no reported adverse event (product storage error) (unknown latency) and the patient received a dose of suspect IPV (VERO) Suspension for injection (lot number, strength, expiry date, dosage- not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) since the excursion with no reported adverse event (poor quality product administered) (latency- same day)  Information on the batch number was requested  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: YF-VAX administered IM instead of Subcutaneous with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient and Yellow Fever Vaccine [Yf-Vax] administered im (Intramuscularly) instead of subcutaneous 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 Yellow Fever Vaccine Solution for injection (lot number: UJ820AB, Expiry date: 28-May-2024) (with an unknown strength) via intramuscular route in unknown administration site for Immunization.  On an unknown date, the patient received Yellow Fever Vaccine -vax im (Intramuscularly) instead of subcutaneous with no reported adverse event (incorrect route of product administration) (latency: same day).  It was reported, reports YF-VAX administered IM instead of Subcutaneous. She would like to know if there are any anticipated side effects and if the pt needs to be re-immunized." The pharmacist states that she doesn't have time right now to provide additional AE information but if e-mails her a form with specific questions she would be happy to fill it out. This is all the additional information she provided at the time of her call.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion due to opening and closing the door to perform an inventory check, the highest temperature reached 9.1 C and the total excursion lasted 64 minutes with no reported adverse event; IPOL has been administered post excursion with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 5 years old male patient and reporter reported temperature excursion due to opening and closing the door to perform an inventory check, the highest temperature reached 9.1 c and the total excursion lasted 64 minutes with no reported adverse event and IPV (VERO) [IPOL] has been administered post excursion 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) for Immunisation.  Caller reported temperature excursion for IPOL due to opening and closing the door to perform an inventory check, the highest temperature reached 9.1 c and the total excursion lasted 64 minutes with no reported adverse event(product storage error) (unknown latency) and then On 10-Jul-2023, the patient received a standard total dose 1 of punctured IPV (VERO) Suspension for injection at a dose of 0.5 mL (lot V1A021M, expiry date- 17-FEB-2024) via subcutaneous route in the left arm for Immunization, post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, No previous temperature excursions to report. The possible excursion was due to human error. The caller was also not aware of any adverse reactions post administration  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 49.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Health professional gave patient Hep B pediatric vaccine rathen than an adult hep b vaccine. Patient was contacted and informed of the situation. Patient was okay with coming in to receive another dose of Hep b pediatric vaccine to count as a fully dose adult.
Age: 67.0
Sex: U
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: systemic itching
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Arterial disorder, Asthenia, Back pain, Cardiac disorder
Clinical narrative: Too many and too long to explain. Some: fever, cold, shaking, weakness, in bed a lot for at least 6 months, vomit, headaches, eye sight problems, heart & arteries DAMAGE, Left arm numbness ( blood flow restricted due to damage and blood clots from Vaccine), hair loss, hair thinning, could hardly move for months just enough to work remotely at desk, heart palpitations, could hardly breath for months, back pain, lung DAMAGE from vaccine worse than the COVID-19 virus previously had, extreme sleep problems (no sleep more than 20-50min at a time) for months
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Lung disorder, Mobility decreased
Clinical narrative: Too many and too long to explain. Some: fever, cold, shaking, weakness, in bed a lot for at least 6 months, vomit, headaches, eye sight problems, heart & arteries DAMAGE, Left arm numbness ( blood flow restricted due to damage and blood clots from Vaccine), hair loss, hair thinning, could hardly move for months just enough to work remotely at desk, heart palpitations, could hardly breath for months, back pain, lung DAMAGE from vaccine worse than the COVID-19 virus previously had, extreme sleep problems (no sleep more than 20-50min at a time) for months
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Palpitations, Peripheral vascular disorder, Pyrexia, Sleep disorder
Clinical narrative: Too many and too long to explain. Some: fever, cold, shaking, weakness, in bed a lot for at least 6 months, vomit, headaches, eye sight problems, heart & arteries DAMAGE, Left arm numbness ( blood flow restricted due to damage and blood clots from Vaccine), hair loss, hair thinning, could hardly move for months just enough to work remotely at desk, heart palpitations, could hardly breath for months, back pain, lung DAMAGE from vaccine worse than the COVID-19 virus previously had, extreme sleep problems (no sleep more than 20-50min at a time) for months
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Tremor, Visual impairment, Vomiting
Clinical narrative: Too many and too long to explain. Some: fever, cold, shaking, weakness, in bed a lot for at least 6 months, vomit, headaches, eye sight problems, heart & arteries DAMAGE, Left arm numbness ( blood flow restricted due to damage and blood clots from Vaccine), hair loss, hair thinning, could hardly move for months just enough to work remotely at desk, heart palpitations, could hardly breath for months, back pain, lung DAMAGE from vaccine worse than the COVID-19 virus previously had, extreme sleep problems (no sleep more than 20-50min at a time) for months
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient received a dose of Boostrix on 7/14/2022 and then a dose of Adacel on 7/6/2023, less than a year later.    The provider ordered an HPV vaccine and the Tdap was given in error.  There were no adverse symptoms reported by patient or parent
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: patient stated vaccine  hurt going in and then he was unable to lift his arm up and it is still very painful lost range of motion
Age: 44.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt was given the wrong vaccine. pt was to receive Shingrix but instead received menveo. supervisor, provider and patient was notified. no adverse reaction at the time of coversation. documentation was done and no treatment needed. pt was to get this vaccine in the future, it was not what the provider ordered at this time.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: No reaction or symptoms reported
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Contusion, Cough, Full blood count abnormal, Immune thrombocytopenia, Petechiae
Clinical narrative: Petechial Rash Viral Upper Respiratory tract Infection Bruising Cough CBC Data consistent with Idiopathic Thrombocypenic Papura
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Platelet count decreased, Viral upper respiratory tract infection
Clinical narrative: Petechial Rash Viral Upper Respiratory tract Infection Bruising Cough CBC Data consistent with Idiopathic Thrombocypenic Papura