chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Runny nose; coughing; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2022 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available), administration date: 29Dec2021, when the patient was 45-year-old, for COVID-19 Immunization, reaction(s): "Coughing", "Runny nose". The following information was reported: RHINORRHOEA (non-serious), outcome "not recovered", described as "Runny nose"; COUGH (non-serious), outcome "not recovered", described as "coughing". Therapeutic measures were not taken as a result of rhinorrhoea, cough. Additional information: the patient had runny nose and coughing ever since vaccinated.  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-202300281096 same patient/event, different vaccine dose;
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Runny nose; coughing; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2021 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious), outcome "not recovered", described as "Runny nose"; COUGH (non-serious), outcome "not recovered", described as "coughing". Therapeutic measures were not taken as a result of rhinorrhoea, cough. 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-202300281087 same patient/event, different vaccine dose.;
Sex: M
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 30-year-old male 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid from 12Aug2023 to 16Aug2023 as treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: Penicillin" (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 "recovered" (18Aug2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2023) Negative; (20Aug2023) Positive, notes: rebound COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 12Aug2023 to 16Aug2023. Clinical courses: Completed taking the paxlovid on the 16th, tested negative on the 18th, and now (20Aug2023) she had tested positive for COVID again. (rebound COVID.)  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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Test: Nasal Swab, Result: Positive; Test: Nasal Swab, Result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9262), in left arm and on 16Feb2021 as dose 2, single (Lot number: EL9267) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Reaction Allergy" (unspecified if ongoing), notes: Reaction: Allergy. Concomitant medication(s) included: SERTRALINE; ZOLOFT. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "unknown" and all described as "Test: Nasal Swab, Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Received treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Aug2020 at 17:00 as dose 1, single (Lot number: 7006320001), in left arm, on 17Sep2020 at 09:00 as dose 2, single (Lot number: 7006320004), in left arm, on 17Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 8522500102), in left arm and on 13May2022 at 10:00 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2022 at 13:00, outcome "recovered"; DRUG INEFFECTIVE (medically significant), outcome "recovered", described as "Received treatment of COVID-19"; COVID-19 (medically significant), outcome "recovered", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: having flu symptoms last week; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, He has had all Pfizer shots and a couple of boosters.), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, He has had all Pfizer shots and a couple of boosters.), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Aug2023, outcome "unknown", described as "having flu symptoms last week".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300281456 same reporter and drug; different events;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: having flu symptoms last week; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, He has had all Pfizer shots and a couple of boosters.), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, He has had all Pfizer shots and a couple of boosters.), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Aug2023, outcome "unknown", described as "having flu symptoms last week".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300281456 same reporter and drug; different events;
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a 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), on 23Sep2022 as dose number unknown (booster), single (Lot number: GH9702) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "heptatis B carrier" (unspecified if ongoing), notes: other medical history: heptatis B carrier. 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 included Paxlovid from 12Aug2023 to 16Aug2023 were taken as a result of drug ineffective, covid-19.
Age: 32.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 32 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive on rapid test after testing negative; Negative, notes: tested positive on rapid test after testing negative. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN5318), in right arm and on 02Mar2021 as dose 2, single (Lot number: EN6199), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. Concomitant medication(s) included: ATENOLOL, start date: 01Aug2016. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID (Lot number: GL3649) taken from 10Aug2023 to 14Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Incorrect route of product administration, Suspected COVID-19
Clinical narrative: Inappropriate route of vaccination; caught COVID several months later; caught COVID several months later/Suspected COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all subcutaneous for covid-19 immunisation. The patient's relevant medical history included: "metastatic breast cancer" (unspecified if ongoing), notes: Consumer has metastatic breast cancer which has spread to her bones and liver; "Consumer has metastatic breast cancer which has spread to her bones" (unspecified if ongoing); "Consumer has metastatic breast cancer which has spread to her liver" (unspecified if ongoing). The patient took concomitant medications. Reporter did not remember but lots of treatments for cancer. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered", described as "caught COVID several months later"; SUSPECTED COVID-19 (medically significant), outcome "recovered", described as "caught COVID several months later/Suspected COVID-19"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination". Clinical course: Consumer had three Pfizer COVID vaccines and caught COVID several months later. She only had it for five days and felt she could have been much worse, had she not had the vaccines. She felt very protected. reporter consider event not caused by suspect product's.  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.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (DRUG INEFFECTIVE,SUSPECTED COVID-19,  and BNT162B2 and BNT162B2, BNT162B2 OMI BA.4-5.
Sex: U
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: severe headache; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious courtesy case received via consumer.  This case involves an unknown age and unknown gender patient who had severe headache after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), concomitant(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Allergy.   On an unknown date in Oct-2021, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic Vaccination (immunization).  On an unknown date in Oct-2021 the patient had an event of severe headache (headache) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  it was reported, After shot, got severe headache. Went to ER. Multiple daily headaches, ever since that day, for 2 years   it was unknown if any lab data/test results available.  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Not Recovered / Not Resolved for the event.
Age: 0.67
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: patient that more than likely got the incorrect dose of pentacel with no reported adverse event; did not receive both vials mixed with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA254858 (Cluster).  This case involves a 8 months old female patient who more than likely got the incorrect dose of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] and did not receive both vials mixed 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 patient received 0.5 mL dose of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ876AA; expiry date: 19-Mar-2024) via intramuscular route in the left thigh for Immunization, more than likely got the incorrect dose and did not receive both vials mixed with no reported adverse event (incorrect dose administered) (single component of a two-component product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 23.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration, Medication error, No adverse event, Wrong product administered
Clinical narrative: Ipol administered erroneously in lieu of Tubersol, medical assistant administered 0.1ml subdermally, but then realized that she grabbed MDV of Ipol rather than Tubersol with no reported adverse event; small amount of Ipol (0.1ml) was administered subdermally with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 23 years old female patient who was administered vaccine IPV (vero) [IPOL] erroneously in lieu of tuberculin test [Tubersol], medical assistant administered 0.1ml subdermally, but then realized that she grabbed mdv of ipol rather than tubersol with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Aug-2023, the patient received 0.1ml dose of suspect IPV (vero), suspension for injection (batch number: W1A191M; expiry date: 16-Feb-2025) via subdermal route in the forearm nos for TB skin test erroneously in lieu of tubersol (Tuberculin Test), solution for injection (with an unknown strength, batch number, expiry date), medical assistant administered 0.1ml subdermally, but then realized that she grabbed mdv of ipol rather than tubersol with no reported adverse event (wrong product administered) (incorrect route of product administration) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: did not receive both vials mixed with no reported adverse event; more than likely got the incorrect dose of PENTACEL, with no reported adverse event; Initial information was received on 16-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA254827 (CLUSTER).  This case involves an unknown age and gender patient who did not receive both vials mixed and more likely got the incorrect dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [PENTACEL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Aug-2023, the patient received 0.5 mL, total (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (batch number: UJ876AA; expiry date: 19-Mar-2024, unknown strength) via intramuscular route in unknown administration site for Immunization, more than likely got the incorrect dose and did not receive both vials mixed with no reported adverse event (incorrect dose administered) (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: 1.58
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired ACT-HIB was administered to a patient 2 days past the expiration date, with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 19-month-old and unknown gender patient, expired HIB (PRP/T) VACCINE [ACT-HIB] was administered to a patient 2 days past the expiration date, 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 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination.  On 15-Aug-2023, the patient received 0.5 ml total dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: unknown) (lot: UJ803AA) via intramuscular route in unknown administration site for Immunization and expired act-hib was administered to a patient 2 days past the expiration date, with no reported adverse event (expired product administered) (latency: same day).  It was unknown if nay lab data/test results available.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was 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 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: MEN
Symptoms: No adverse event, Product preparation error
Clinical narrative: MenQuadfi that was mistakenly diluted with sterile water with no reported adverse event; Initial information was received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was mistakenly diluted with sterile water 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 meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) lot number, expiry date, strength: unknown) via intramuscular route in unknown administration site for Immunization.  The information on the batch number was requested.  On an unknown date, Menquadfi was mistakenly diluted with sterile water with no reported adverse event (product preparation error) (unknown latency).  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: 30.0
Sex: M
Vaccine: TD
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: they have given a patient Tenivac IV instead of IM (with no reported adverse event); Initial information received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 30 years old male patient who was given diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] iv (intravenous) instead of im (intramuscularly) 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 unknown dose of suspect diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult, suspension for injection (strength, batch number, expiry date not reported) via iv nos (intravenous not otherwise specified) route in unknown administration site for Prophylactic vaccination (immunization) instead of im with no reported adverse event (incorrect route of product administration) (same day latency).  Reportedly, The Tenivac was accidentally given by a nurse via IV push in place of Morphine as the syringes/labels looked very similar. Reporting to Quality due to this. HCP did not have the brand of the Morphine syringe available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (they have given a patient Tenivac IV instead of IM (with no reported adverse event)).  At time of reporting, the outcome was Unknown for the event they have given a patient tenivac iv instead of im (with no reported adverse event).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: UNK
Symptoms: Hypersensitivity, Laboratory test, Pyrexia, Swelling face, Urticaria
Clinical narrative: fever of 101.4°F; facial swelling; hives all over the body/welts all over the body; allergic reaction with the PENTACEL; Initial information received on 18-Aug-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 1 years old female patient who experienced facial swelling, hives all over the body/welts all over the body, allergic reaction with the pentacel and fever of 101.4°f after receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2023, the patient received 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ678AA) (Strength: Standard) (Frequency: Once) (1 X) (with an unknown expiry date) via intramuscular (Left Vastus Lateralis Intramuscular) route in unknown administration site for immunization.  On 15-Aug-2023, the patient developed events of facial swelling (swelling face), hives all over the body/welts all over the body (urticaria) and allergic reaction with the pentacel (hypersensitivity) (Latency: same day).  On 16-Aug-2023, the patient developed an event of fever of 101.4°f (pyrexia) (latency: 1 day).  Relevant laboratory test results included: Body temperature - On 16-Aug-2023: 101 F  It was reported, Patient's mother reporting an adverse event on behalf of her daughter. Patient's mother reported that her daughter had a sever allergic reaction to PENTACEL. Patient's mother reported that her daughter was given PENTACEL last 15Aug2023. Patient experienced facial swelling, hives and welts all over the body 2 hours after the vaccine was given. Patient was given IBUPROFEN and BENADRYL for the fever and hives as per the advise of her nurse. On 16Aug2023, patient's full body was covered with hives and had a fever of 101.4°F. Patient was rushed to the ER as per the HCP's advice. After a few hours that the patient was the patient was sent home from the ER, the patient had the hives again and patient's mother called back their doctor and the patient was given PREDNISONE and BENADRYL. Patient's mother reported that the patient's hives will re-appear if BENADRYL's effect would run out. Patient went back to the doctor and HCP confirmed that the patient had an allergic reaction with the PENTACEL. Patient's mother reported that the patient will undergo testing as per HCPs advice. Patient's mother was asking compensation for the laboratory tests and treatment that was done on her daughter. Customer relations number was given to the patient's mother. Case number was given to the patient's mother for reference  Action taken: not applicable.  The patient was treated with PREDNISONE (PREDNISONE) for Urticaria, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Urticaria and IBUPROFEN (IBUPROFEN) for Pyrexia.  Outcome: Not Recovered / Not Resolved for the reported events
Age: 1.58
Sex: M
Vaccine: UNK
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: consumer was only given Dtap and IPV component of the pentacel Vaccine, as doctor forgot to mix the HIB component with no reported adverse event; Initial information was received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old male patient who received only dtap and ipv component of the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] as doctor forgot to mix the hib component with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Aug-2023, the patient received dtap and ipv component of the dose 4 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection at dose of 0.5 ml (lot number: UJ876AA, expiration date: 19-Mar-2024) via intramuscular route in the left thigh for immunization (immunisation) as doctor forgot to mix the hib component with no reported adverse event (product preparation error) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event consumer was only given dtap and ipv component of the pentacel vaccine, as doctor forgot to mix the hib 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 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: 9.0
Sex: F
Vaccine: HEP, HEPA, MMR, MMR, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Patient received two MMR, Parents notify.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: CLIENT RECEIVED A DOSE OF PFIZER FOR CHILDREN UNDER THE AGE OF 5. THE CHILD WAS 6 AT THE TIME OF VACCINATION.
Age: 18.0
Sex: U
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient informed me that they suffer from vasovagal syncope in the healthcare setting and "may" faint. The first vaccine was administered at 235 pm. The patient felt fine. The 2nd vaccine received by pt was Menveo. After administration of menveo pt informed pharmacist that they re light headed and may faint. Within 15 seconds pt lost consciousness for around 10 seconds. Pt was seated at the time of syncope. Pt's head was supported by pharmacist. Patient regained consciousness 10 seconds post syncope and requested water. a water bottle was given to pt. pt drank water and requested to lie down. Pt was laying in vaccination room for approximately 3 minutes before rising to chair. Pt was alert and able to confirm where they were and what happened. Pt refused for blood pressure to be taken and mention they were "ok" and that this happens with every vaccine. Around 5 minutes post syncope, pt stated they were good to leave and requested to go. I informed them I can take blood pressure and they can wait another 10-15 minutes. Pt refused and left. Pt was coherent and responsive upon leaving.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Crying, Decreased appetite, Insomnia, Pain
Clinical narrative: TOTAL OF VACCINE GIVEN 7/14/2023  Lab Work: Immunizations: Rotateq#3 Pediarix (DTaP-IPV-HepB) ActHib - Hib#3 Prevnar#3   MY 7-MONTH SON CRIED NON-STOP FOR 2 WEEKS.   HE WAS IN PAIN...TRIED GIVING MOTRIN IBUPROFEN. HE WASN'T EATING--NO APPETITE, INSOMNIA.
Age: 2.58
Sex: M
Vaccine: DTAPIPV, HEPA, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine that was given was aged for 4-6 year old, patient is 2 years 7 months. No treatment needed per HD, no signs or symptoms of reaction.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Axillary pain, Breast enlargement, Breast pain, Chest X-ray normal, Laboratory test
Clinical narrative: Around two weeks after vaccination, started to have left breast pain and left axillary pain. Symptoms worsened over the week and then noticed left breast enlargement. Presented to my office on 8/10/23 for persistent symptoms and noticeable left breast enlargement. Exam otherwise normal expect with enlargement and some mild pain with palpation. Sent for a STAT breast US and started on keflex for possible mastitis. Ultrasound completed on 8/11/23 and showed an enlarged left axillary lymph node, likely reactive, BIRADS 3 short interim follow up recommended. Has slight improvement with abx. Plan was to re-ultrasound in 4 wks. However, on Sunday 8/20 developed severe pain to left breast and some to right breast border. ER visit on 8/21/23. Had labs and a negative chest xray. Current still in pain and pending a consult with breast specialist on 8/24/23
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy, Ultrasound breast abnormal
Clinical narrative: Around two weeks after vaccination, started to have left breast pain and left axillary pain. Symptoms worsened over the week and then noticed left breast enlargement. Presented to my office on 8/10/23 for persistent symptoms and noticeable left breast enlargement. Exam otherwise normal expect with enlargement and some mild pain with palpation. Sent for a STAT breast US and started on keflex for possible mastitis. Ultrasound completed on 8/11/23 and showed an enlarged left axillary lymph node, likely reactive, BIRADS 3 short interim follow up recommended. Has slight improvement with abx. Plan was to re-ultrasound in 4 wks. However, on Sunday 8/20 developed severe pain to left breast and some to right breast border. ER visit on 8/21/23. Had labs and a negative chest xray. Current still in pain and pending a consult with breast specialist on 8/24/23
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Brain fog, Chills, Computerised tomogram head, Dizziness
Clinical narrative: 3:00 am next day severe chills 10:00 am severe fogginess in head and neck, dizziness.  Went to ER Today is 8/22 and I?m still having headaches off and on in back of my head and neck.  Just don?t feel well.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Headache, Malaise, Panic attack
Clinical narrative: 3:00 am next day severe chills 10:00 am severe fogginess in head and neck, dizziness.  Went to ER Today is 8/22 and I?m still having headaches off and on in back of my head and neck.  Just don?t feel well.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blood pressure increased, Condition aggravated, Electrocardiogram, Headache
Clinical narrative: Headache, extreme anxiety, elevated blood pressure and heart rate, palpitations. After 6 weeks pt was feeling better. Pt was in and out of the ED getting checked for vitals and palpitations.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Laboratory test, Palpitations, Scan
Clinical narrative: Headache, extreme anxiety, elevated blood pressure and heart rate, palpitations. After 6 weeks pt was feeling better. Pt was in and out of the ED getting checked for vitals and palpitations.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Periarthritis
Clinical narrative: adhesive capsulitis
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received duplicate vaccination according to staff at primary care office. provider's office states that the pt received these last year. Pt denies any adverse effects. Office notes that they do not report to system, the vaccine database, so administering pharmacist provided based on (signing guardian)'s statement that the immunizations were needed.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Formication, Pruritus, Urticaria
Clinical narrative: Hives that burned and itched. Went to many different doctors with no treatment other than being told to take Claritin, Benadryl, antacids, and Zyrtec. I was finally sent to an allergist where they said it was demographic urticaria and to take 40mg of Zyrtec a day along with Benadryl. Symptoms subsided with the high amount of Benadryl and Zyrtec, and over time became less persistent. Today I still get hives when my skin is touched every now and then, but have random numbness in left side of my body that lasts for a few minutes along with a spider sensation down my back.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt describes her arm as being red, swollen and hot. Stated her first dose was also similar nut with a 3/4 inch hard knot. Stated lasted about a week. When if the symptoms were going away she said yes.
Age: 45.0
Sex: M
Vaccine: HEPA
Symptoms: Hypertension, Hypertensive urgency, Migraine, Visual impairment
Clinical narrative: Patient received and immunization of HAVRIX 1440UNIT     INJ, on  08/19/2023,  approximately 2 hours after patient received the injection patient noted he had a bad migraine headache. On 08/20/23 patient was feeling somewhat better.  On 08/21/23 pt still had a migraine which became very severe as the afternoon and evening went on and pt developed very high blood pressure, vision abnormalities and went to the ER where he was treated for a hypertensive incident and then observed for some time before being released.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Injection site erythema, Injection site papule, Injection site rash
Clinical narrative: Patient presented with headache and lightheadedness at the 15th minute of observation. Physician notified of adverse reaction. Vitals taken (BP, HR, SpO2, Temperature). Patient was afebrile and SpO2 within normal limits. Patient's BP was 98/60 and HR 65. Patient evaluated by Physician. Physician noted erythematous papular rash on left arm 5 inches below injection site. The rash was not warm to touch. Immunization injection site had no erythema, tenderness to palpation/touch, or rash.  Physician advised patient to eat few salty chips and drink a glass of water.  Physician rechecked BP 5 minutes later. MD obtained the following vitals: 102/68 with HR 65. Patient was observed for an additional 15 minutes for a total of 30 minutes. At the end of the 30 minute observation period, vitals were rechecked by the MA. The MA obtained the following vitals: 106/70 with HR 66. At the end of observation period, patient stated lightheadedness has resolved. Patient stated headache was still present, but subsided.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest X-ray normal, Chest discomfort, Chest pain, Computerised tomogram normal
Clinical narrative: 2 days after 1st Pfizer shot:  Shortness of breath at RANDOM.  Felt like airway was restricted and chest tightened.   Also had some mild pain in center-right region of chest and on my back is same area - not often though.  Started taking my inhalers (Albuterol & Qvar) to get relief - THEY DID NOT HELP EVEN MY RESCUE INHALER.  Went to walk in clinic couple days later after it didn?t go away.  Took chest X-ray,  oxygen checked, EKG done.  All came back normal.  Slowly went away fully after about week and a half.  2nd Pfizer shot:  Same experiences.  Took Qvar and Albuterol again just because.  Saw cardiologist for another EKG - normal.  Took a month and a half to go away.   Had COVID in December 2021:  Same experiences for about a week and then it went away.  Did go on Qvar & Albuterol again.  Had blood work done January 2022 - normal.  August 24, 2022:  took a trip to Colorado and went up high altitude to hike.  Felt short of breath very badly on car ride up - almost thought I was going to pass out.  Trouble sleeping that night because I could not get enough air through.  Shortness of breath would come and go at random.  Very uncomfortable & lasted whole trip and beyond...  Went back to the doctor to get another chest x-ray to compare to a year ago - normal.  Was prescribed Advair (another inhaler) - did not make a difference.  Had a CT scan done in December of 2022 - normal.   Took months to get (a little) better.  It's been a year now and I still feel mild symptoms almost every day.  Not scary, but noticeable and irritating.  Terrified that it will come back strong again.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: 2 days after 1st Pfizer shot:  Shortness of breath at RANDOM.  Felt like airway was restricted and chest tightened.   Also had some mild pain in center-right region of chest and on my back is same area - not often though.  Started taking my inhalers (Albuterol & Qvar) to get relief - THEY DID NOT HELP EVEN MY RESCUE INHALER.  Went to walk in clinic couple days later after it didn?t go away.  Took chest X-ray,  oxygen checked, EKG done.  All came back normal.  Slowly went away fully after about week and a half.  2nd Pfizer shot:  Same experiences.  Took Qvar and Albuterol again just because.  Saw cardiologist for another EKG - normal.  Took a month and a half to go away.   Had COVID in December 2021:  Same experiences for about a week and then it went away.  Did go on Qvar & Albuterol again.  Had blood work done January 2022 - normal.  August 24, 2022:  took a trip to Colorado and went up high altitude to hike.  Felt short of breath very badly on car ride up - almost thought I was going to pass out.  Trouble sleeping that night because I could not get enough air through.  Shortness of breath would come and go at random.  Very uncomfortable & lasted whole trip and beyond...  Went back to the doctor to get another chest x-ray to compare to a year ago - normal.  Was prescribed Advair (another inhaler) - did not make a difference.  Had a CT scan done in December of 2022 - normal.   Took months to get (a little) better.  It's been a year now and I still feel mild symptoms almost every day.  Not scary, but noticeable and irritating.  Terrified that it will come back strong again.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood cholesterol increased, Chest pain, Computerised tomogram abdomen abnormal, Diarrhoea, Hepatic cyst
Clinical narrative: For Chest pain, high colesterol, prescription for Creator 10 mg at the beginning of 2023, on july the colesterol level was decreased to normal range. Diarreas symptoms, MTI and CT were performed with  finding in liver and pancreas  in 2022 and 2023, ( cysts of 1 cm) . The cysts is in monitoring every year since 2022
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lipids, Magnetic resonance imaging, Pancreatic cyst
Clinical narrative: For Chest pain, high colesterol, prescription for Creator 10 mg at the beginning of 2023, on july the colesterol level was decreased to normal range. Diarreas symptoms, MTI and CT were performed with  finding in liver and pancreas  in 2022 and 2023, ( cysts of 1 cm) . The cysts is in monitoring every year since 2022