chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (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), 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: "Arthritis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Aug2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2023) Positive; (26Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient used Paxlovid from 17Aug2023 to 21Aug2023 as treatment.  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: COVID19-2
Symptoms: COVID-19, Vaccination failure
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 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim", notes: known allergies: Bactrim. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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), 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 had no relevant medical history. 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 which included Paxlovid received from 15Aug2023 to 19Aug2023.  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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16Jul2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. No known allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Patient started paxlovid for COVID 19 Treatment from 14Aug2023 to 19Aug2023. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose: 1, 2, 3. 4 Moderna/Dose 5 Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Feb2021 at 13:00 as dose 1, single (Lot number: 031L20A), in left arm, on 15Mar2021 at 13:00 as dose 2, single (Lot number: 045A21A), in right arm, on 15Nov2021 at 13:00 as dose 3 (booster), single (Lot number: 012F21A), in right arm and on 05May2022 at 13:00 as dose 4 (booster), single (Lot number: 045L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mechanical Aortic Valve" (unspecified if ongoing); "Aortic Aneurysm" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN, start date: 09Jul1996; PANTOPRAZOLE, start date: 01Feb2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022 at 13:00, outcome "unknown", described as "Dose: 1, 2, 3. 4 Moderna/Dose 5 Pfizer"; 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. Treatment was Paxlovid.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "celiac disease" (unspecified if ongoing); "known allergies: Gluten" (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 "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 12Aug2023 to 16Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19-2
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 59-year-old male patient 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 11Aug2023 and 15Aug2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
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 a non-contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 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 included: "GERD" (unspecified if ongoing); "Migraines" (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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days; (Aug2023) Positive, notes: testing positive for the last 7 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 60.0
Sex: M
Vaccine: COVID19-2
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 60 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment included Paxlovid from 18Aug2023 to 22Aug2023.
Sex: U
Vaccine: PNC20
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: difficulty walking; vertigo; dizziness; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking"; VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown".  Additional information: The patient had the same reaction as the reporter after receiving Prevnar 20.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300287168 same reporter/drug/event, different patients;
Sex: M
Vaccine: PNC20
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: difficulty walking; vertigo; dizziness; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking"; VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300287162 same reporter/drug/event, different patients;US-PFIZER INC-202300285647 same reporter/drug/event, different patients;
Sex: U
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Headache, Nausea, Oropharyngeal pain
Clinical narrative: I did get Covid; I did get Covid; headache; fever; nausea; aches; sore throat; hacking cough. I am left with the cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 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 Sep2022, outcome "unknown" and all described as "I did get Covid"; PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "aches"; PYREXIA (non-serious) with onset Sep2022, outcome "unknown", described as "fever"; COUGH (non-serious) with onset Sep2022, outcome "not recovered", described as "hacking cough. I am left with the cough"; HEADACHE (non-serious) with onset Sep2022, outcome "unknown"; NAUSEA (non-serious) with onset Sep2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "sore throat ".  Clinical course: The patient have had all but the latest Pfizer vaccines for Covid. The patient  tried to get the latest one, however, the drugstores did not have it. For some reason, they were  only using Moderna boosters. The patient asked to provide the  places that carry Pfizer booster. The patient did get Covid Sep2022. It hit with headache, fever, nausea, aches, sore throat and a hacking cough. The patient was left with the cough and reported it was not good.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Suspected COVID-19
Clinical narrative: I did get Covid; I did get Covid; headache; fever; nausea; aches; sore throat; hacking cough. I am left with the cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 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 Sep2022, outcome "unknown" and all described as "I did get Covid"; PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "aches"; PYREXIA (non-serious) with onset Sep2022, outcome "unknown", described as "fever"; COUGH (non-serious) with onset Sep2022, outcome "not recovered", described as "hacking cough. I am left with the cough"; HEADACHE (non-serious) with onset Sep2022, outcome "unknown"; NAUSEA (non-serious) with onset Sep2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "sore throat ".  Clinical course: The patient have had all but the latest Pfizer vaccines for Covid. The patient  tried to get the latest one, however, the drugstores did not have it. For some reason, they were  only using Moderna boosters. The patient asked to provide the  places that carry Pfizer booster. The patient did get Covid Sep2022. It hit with headache, fever, nausea, aches, sore throat and a hacking cough. The patient was left with the cough and reported it was not good.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
Sex: U
Vaccine: PNC20
Symptoms: Device breakage
Clinical narrative: she was flicking with her finger to get the air bubbles out like she typically do and then the syringe just broke in half.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT6700, Expiration Date: 31Oct2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "she was flicking with her finger to get the air bubbles out like she typically do and then the syringe just broke in half.".  Additional information: A syringe broken for Prevnar 20. She had taken a picture of that it occurred earlier but she said she was just tapping it to get the air out in the syringe with her finger not like tapping 'with anything'. The needle of the syringe not exactly and little bit of the syringe left and 'damaged' in 2 separate parts. The one that administers the vaccines and prepare them for administration, and she said that she had a syringe of Prevnar 20 that she was flicking with her finger to get the air bubbles out like she typically do and then the syringe just broke in half. A portion broke off with the needle attached and some of the syringe attached and then there was another portion that contain the plunger at the other end. She was not trying to administer it; she was just preparing it to administration. No patient was affected. She was getting the air bubbles out of it.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Vaccination failure
Clinical narrative: covid; covid; covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "covid"; DISEASE RECURRENCE (medically significant) with onset Sep2022, outcome "recovered", described as "covid". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid in May2022. Therapeutic measures were not taken as a result of disease recurrence. Symptoms in Sep2022 was a nuisance but not serious enough to warrant meds. There was no other products that were taken together with those indicated above.  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-PV202300132731 same patient/reporter/product, different dose/event;
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: Patient was administered only 1 vial of pentacel/Nurse did not reconstitute (with no reported adverse event); Initial information received on 24-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender who was administered only 1 vial of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)]/nurse did not reconstitute (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Aug-2023, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (with an unknown strength, expiry date and lot number) via intramuscular route in unknown administration site for Routine vaccination (Immunisation).  On 23-Aug-2023, the patient was administered only 1 vial of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine/nurse did not reconstitute (with no reported adverse event) (product preparation error) (Latency: same day).  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 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: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered PENTACEL to a patient but only the liquid, not the powder component with no reported adverse event; Initial information received on 24-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] to a patient but only the liquid, not the powder component 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); pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine); and rotavirus vaccine live reassort oral 5V (Rotateq) for Prophylactic vaccination (immunization).  On 23-Aug-2023, the patient received a dose 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection lot UJ844AB expiry date: 02-Mar-2024 via intramuscular route in the right thigh for immunization.  On 23-AUG-2023 the patient administered pentacel to a patient but only the liquid, not the powder component with no reported adverse event (incorrect dose administered) on the same day following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine.  Reportedly, Medical assistant states that they administered PENTACEL to a patient yesterday but only the liquid, not the powder component. The patient is in the clinic today for their repeat dose. Caller wants to know if it will be ok. They also asked what would be the possible issues regarding extra dose of DTAP-IPV.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered pentacel to a patient but only the liquid, not the powder component 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: F
Vaccine: YF
Symptoms: Visual impairment
Clinical narrative: visual disturbance; Initial information received on 24-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age female patient who had visual disturbance after receiving yellow fever vaccine - [YF-VAX].  The patient's past medical history included Ophthalmic migraine. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Patient does not have any other history of anything and is not currently on any other medications.  On 24-Aug-2023 at 11:30 A.M., the patient received unknown dose of suspect yellow fever vaccine, solution for injection (strength, batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  Information on the batch number was requested.  On 24-Aug-2023 (at around 1:30 P.M.) the patient had visual disturbance (visual impairment) (same day latency) following the administration of yellow fever vaccine.  Patient reported the visual disturbance lasted about an hour. Reporter stated the patient was on the way to the ophthalmologist for an evaluation, but the visual disturbance was already resolving. Patient also did not experience any reactions at the injection site or system related reactions.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (visual disturbance).  At time of reporting, the outcome was Recovered / Resolved on 24-Aug-2023 for the event visual disturbance.  No additional details.
Age: 22.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: injected a patient over 7 years of age with a daptacel instead of a boostrix by accident with no reported adverse event; injected a patient over 7 years of age with a daptacel instead of a boostrix by accident with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 years old female patient who was injected with a diphtheria-15/tetanus/5 AC pertussis vaccine (Daptacel) instead of a boostrix by accident patient over 7 years of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Aug-2023, the suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection lot C'6013AA expiry date: 05-Jul-2024 via unknown route in unknown administration site for prophylactic vaccination (strength, dose: unknown), was injected a patient over 7 years of age with a daptacel instead of a boostrix by accident with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events (wrong product administered and product administered to patient of inappropriate age).  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: 40.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: reporting that a dose of pentacel was inadvertently administered to a patient who was not age appropriate with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 40 years old male patient who took dose of diphtheria/tetanus/5 Hybrid AC Pertussis/IPV(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] inadvertently and who was not age appropriate with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Aug-2023, the 40 years old male patient received a 0.5 mL dose of suspect diphtheria/tetanus/5 Hybrid AC Pertussis/IPV(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot UJ8418A, Expiry date: 09-Feb-2024, Strength: standard, Frequency: once) via intramuscular route in the left deltoid as Immunization and (product administered to patient of inappropriate age) (Latency: same day).  First time product used : No Still using product : Yes   Action taken was not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 0.17
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: Medical Assistants only gave solution that has blue top (Dtap/IPV) but not powder (Hib) so it wasn't mixed together with no reported adverse event; Initial information was received on 25-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient to whom medical assistants only gave solution that has blue top of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but not powder (hib) so it wasn't mixed together with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Aug-2023, the patient received a 0.5 ml, (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot number, expiry date: unknown, strength: standard) via unknown route in unknown administration site for Immunization.  On 09-Aug-2023, medical assistants only gave solution that has blue top (dtap/ipv) but not powder (hib) so it wasn't mixed together with no reported adverse event (single component of a two-component 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: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Product administration error, Product preparation error, Single component of a two-component product administered
Clinical narrative: administration error; powder was not injected only sterile solution
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered vaccine to patient below recommended age for the combination vaccine when should have administered vaccines separately, will be calling parent to notify and schedule follow up visit with provider.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MMRV was given to a 15 year old patient. Family to be notified and doses repeated if needed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Extra dose administered
Clinical narrative: an additional dose of Hep A (Havrix) administered to the patient
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Fall, Head injury, Immunisation reaction, Laboratory test
Clinical narrative: Patient was nauseous, got up to get glass of water and fainted. Fell on bottom and then hit head. Went to Urgent Care and was referred to ER. Full evaluation and sent home. ER attributed reaction to Shingrix vaccine
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Syncope
Clinical narrative: Patient was nauseous, got up to get glass of water and fainted. Fell on bottom and then hit head. Went to Urgent Care and was referred to ER. Full evaluation and sent home. ER attributed reaction to Shingrix vaccine
Age: 13.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MMRV given to a 13 year old. Family to be notified.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Loss of consciousness, Mass, Nausea
Clinical narrative: About 3:30 in the morning, I had terrible side effects. I got up to go to the bathroom, felt fine, went to the bathroom, stood up, suddenly felt very dizzy, and then ... I woke up on the floor, my head and shoulders in my shower. The dizziness was gone, but I had a lump on the back of my head. For a short while there was a buzzing in my ears. I felt feverish and stayed where I was because the floor was cool. When I finally felt able to get up, I walked to the kitchen for a bowl in case I vomited. I started writing a note about what happened in case I didn't make it through the night. As I was writing, I started vomiting, which lasted for several minutes. When I went back to bed, I had the chills for a while.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tinnitus, Vomiting
Clinical narrative: About 3:30 in the morning, I had terrible side effects. I got up to go to the bathroom, felt fine, went to the bathroom, stood up, suddenly felt very dizzy, and then ... I woke up on the floor, my head and shoulders in my shower. The dizziness was gone, but I had a lump on the back of my head. For a short while there was a buzzing in my ears. I felt feverish and stayed where I was because the floor was cool. When I finally felt able to get up, I walked to the kitchen for a bowl in case I vomited. I started writing a note about what happened in case I didn't make it through the night. As I was writing, I started vomiting, which lasted for several minutes. When I went back to bed, I had the chills for a while.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: The patient did not have any reaction to vaccine. She was inadvertantly given the Monovalent vaccine, when she should have received the Bivalent vaccine.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: 4 days after receiving the vaccine, pt reported soreness of arm and a patch of red skin surrounding the injection site. they reported this to the pharmacy 1 day after the adverse event took place. While being counseled, pt concluded she did not feel the need to seek medical attention.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the BUD
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: patient got a red swollen arm at site of injection she noticed 4 days. Painful and swollen, hot to the touch. was advised to see primary care to determine if it was cellulitis or allergic reaction. Primary care doctor diagnosed allergic reaction and prescribed prednisone 5mg daily for 5 day, then every other day for 5 more doses
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Swelling
Clinical narrative: patient got a red swollen arm at site of injection she noticed 4 days. Painful and swollen, hot to the touch. was advised to see primary care to determine if it was cellulitis or allergic reaction. Primary care doctor diagnosed allergic reaction and prescribed prednisone 5mg daily for 5 day, then every other day for 5 more doses
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the BUD.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient developed itchy rash all over his body about one hour after receiving Kinrix vaccine
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Laboratory test normal, Neuralgia, Ocular hyperaemia, Pain
Clinical narrative: SEVERE REDNESS OF THE EYES, DARK FLAT PATCH ON THE NECK WHICH WAS ITCHING FOR AT LEAST 2 WEEKS, AS WELL AS BURNING NERVE PAIN ON HER BACK STARTING 1 WEEK AFTER THE IMMUNIZATION.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: SEVERE REDNESS OF THE EYES, DARK FLAT PATCH ON THE NECK WHICH WAS ITCHING FOR AT LEAST 2 WEEKS, AS WELL AS BURNING NERVE PAIN ON HER BACK STARTING 1 WEEK AFTER THE IMMUNIZATION.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial septal defect, Blood test, Cardiac imaging procedure normal, Catheterisation cardiac abnormal
Clinical narrative: 10/06/2021, I suffered several strokes with no history or risk. I was admitted to the hospital the following day and received multiple tests. I have confirmed tests offering no evidence or explanation for multiple thrombus generation, other than the Pfizer COVID vaccine. I have no blood clot disorders, neither genetic or otherwise. I have zero atrial fibrillation events, confirmed via lync loop recorder since Oct 2021. Due to multiple tests, doctors discovered I have a PFO. In Dec 2021, PFO occluder was successfully inserted via heart catheterization. I was started on heavy blood thinners in Oct of 2021. In May of 2022, doctors confirmed the final thrombus noted in my lower heart chamber was gone via cardiac MRI.  All blood thinners medications were stopped in May of 2022, however I continue ?baby? aspirin as a safety precaution due to my new medical history. My language processing was severely adversely affected by the strokes, as well as fine motor skills, such as handwriting. I work as a professional Sign Language interpreter, and I am nationally certified. Due to language processing affects of the strokes, work is extremely difficult and ability and effective language processing is unpredictable at best. Some days are just ?bad? and nothing makes sense.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysgraphia, Echocardiogram, Fine motor skill dysfunction, Impaired work ability
Clinical narrative: 10/06/2021, I suffered several strokes with no history or risk. I was admitted to the hospital the following day and received multiple tests. I have confirmed tests offering no evidence or explanation for multiple thrombus generation, other than the Pfizer COVID vaccine. I have no blood clot disorders, neither genetic or otherwise. I have zero atrial fibrillation events, confirmed via lync loop recorder since Oct 2021. Due to multiple tests, doctors discovered I have a PFO. In Dec 2021, PFO occluder was successfully inserted via heart catheterization. I was started on heavy blood thinners in Oct of 2021. In May of 2022, doctors confirmed the final thrombus noted in my lower heart chamber was gone via cardiac MRI.  All blood thinners medications were stopped in May of 2022, however I continue ?baby? aspirin as a safety precaution due to my new medical history. My language processing was severely adversely affected by the strokes, as well as fine motor skills, such as handwriting. I work as a professional Sign Language interpreter, and I am nationally certified. Due to language processing affects of the strokes, work is extremely difficult and ability and effective language processing is unpredictable at best. Some days are just ?bad? and nothing makes sense.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Implantable cardiac monitor insertion, Intracardiac thrombus, Laboratory test, Language disorder, Magnetic resonance imaging
Clinical narrative: 10/06/2021, I suffered several strokes with no history or risk. I was admitted to the hospital the following day and received multiple tests. I have confirmed tests offering no evidence or explanation for multiple thrombus generation, other than the Pfizer COVID vaccine. I have no blood clot disorders, neither genetic or otherwise. I have zero atrial fibrillation events, confirmed via lync loop recorder since Oct 2021. Due to multiple tests, doctors discovered I have a PFO. In Dec 2021, PFO occluder was successfully inserted via heart catheterization. I was started on heavy blood thinners in Oct of 2021. In May of 2022, doctors confirmed the final thrombus noted in my lower heart chamber was gone via cardiac MRI.  All blood thinners medications were stopped in May of 2022, however I continue ?baby? aspirin as a safety precaution due to my new medical history. My language processing was severely adversely affected by the strokes, as well as fine motor skills, such as handwriting. I work as a professional Sign Language interpreter, and I am nationally certified. Due to language processing affects of the strokes, work is extremely difficult and ability and effective language processing is unpredictable at best. Some days are just ?bad? and nothing makes sense.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 10/06/2021, I suffered several strokes with no history or risk. I was admitted to the hospital the following day and received multiple tests. I have confirmed tests offering no evidence or explanation for multiple thrombus generation, other than the Pfizer COVID vaccine. I have no blood clot disorders, neither genetic or otherwise. I have zero atrial fibrillation events, confirmed via lync loop recorder since Oct 2021. Due to multiple tests, doctors discovered I have a PFO. In Dec 2021, PFO occluder was successfully inserted via heart catheterization. I was started on heavy blood thinners in Oct of 2021. In May of 2022, doctors confirmed the final thrombus noted in my lower heart chamber was gone via cardiac MRI.  All blood thinners medications were stopped in May of 2022, however I continue ?baby? aspirin as a safety precaution due to my new medical history. My language processing was severely adversely affected by the strokes, as well as fine motor skills, such as handwriting. I work as a professional Sign Language interpreter, and I am nationally certified. Due to language processing affects of the strokes, work is extremely difficult and ability and effective language processing is unpredictable at best. Some days are just ?bad? and nothing makes sense.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Pain in extremity
Clinical narrative: Patient is stating that she still has arm pain and hardness at the injection site 7 months after the Shingrix injection. We recommended that patient uses lidocaine cream and/or diclofenac gel over the counter. If problem continues, patient should contact her primary care provider.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Red and painful site in OPPPOSITE arm.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Flank pain, Gastritis
Clinical narrative: Started having bad flank pain the morning after her vaccination. She ended up going to hospital where a CT was done. Diagnosed with gastritis.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Haemorrhage, Syncope
Clinical narrative: My Wife was on her period when having the flu shot. She had hard periods before but it was cured . it affected her in a Bad way and started Bleeding in a way that she fainted . Had to call EMS . I don't know the type of the flu shot.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Induration, Pyrexia, Skin warm
Clinical narrative: Fever and chills the first night. Then, a large (half dollar coin sized) hard bump formed under the skin. It was red and warm to the touch for two weeks.   We had to treat with doctor prescribed antibiotics and cream.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Fever and chills the first night. Then, a large (half dollar coin sized) hard bump formed under the skin. It was red and warm to the touch for two weeks.   We had to treat with doctor prescribed antibiotics and cream.