chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Seizure
Clinical narrative: neurological issues having seizures/stroke post COVID vaccine; neurological issues having seizures/stroke post COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team and a sales representative.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Neurological issues" (unspecified if ongoing), notes: Neurological issues. The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown" and all described as "neurological issues having seizures/stroke post COVID vaccine".  Clinical info: Please contact, to provide information/advise on the following: Patient w/neurological issues having seizures/stroke post COVID vaccine..  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events seizure, cerebrovascular accident and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 103 F fever; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "103 F fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After every Pfizer COVID vaccine he gets 103 F fever and was out from work for 2 days. After 2 days, the patient returned to baseline. The event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Diplopia, Dizziness
Clinical narrative: double vision; balance issue; dizziness; This is a spontaneous report received from contactable reporter(s) (Physician).  A 41-year-old female 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: COVID-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: DIPLOPIA (non-serious), outcome "unknown", described as "double vision"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance issue"; DIZZINESS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hypersensitivity, Swollen tongue
Clinical narrative: anaphylactic reaction; the patient's tongue started swelling; allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000004032 (Novavax).  A female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant), outcome "recovered"; SWOLLEN TONGUE (hospitalization), outcome "unknown", described as "the patient's tongue started swelling"; HYPERSENSITIVITY (hospitalization), outcome "unknown", described as "allergic reaction". Therapeutic measures were taken as a result of anaphylactic reaction, swollen tongue, hypersensitivity.  Clinical course: "On 28Oct2022"(as reported), it was reported that a patient started treatment on an unspecified date in Jan2021 with Pfizer BioNTech COVID-19 Vaccine at dose 1 for COVID-19 immunization. It was reported the patient experienced an anaphylactic reaction to the vaccine. The patient waited 30 minutes instead of 15 minutes. Within the waiting time, the patient's tongue started swelling. The patient went to the hospital for observation after she was given the medication for the allergic reaction, but she reported she was okay.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Upper respiratory tract congestion
Clinical narrative: throat congestion; She developed a sore throat; with possible low grade fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (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), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 10Nov2022, outcome "not recovered", described as "She developed a sore throat"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 11Nov2022, outcome "not recovered", described as "throat congestion"; PYREXIA (non-serious) with onset Nov2022, outcome "not recovered", described as "with possible low grade fever". The events "she developed a sore throat", "throat congestion" and "with possible low grade fever" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Approximately 59-year-old female had Comirnaty bivalent booster around 3-4 weeks ago. Her primary and 2 earlier boosters were also Pfizer vaccines. She developed a sore throat on 10Nov2022 with negative rapid antigen COVID test at that time. Continued to had sore throat and throat congestion on the day of reporting, with possible low-grade fever. Took another COVID rapid antigen test which was positive. She had been evaluated by her primary care physician and was following his recommendations. This is being reported as a breakthrough infection following the Comirnaty bivalent booster vaccine. Event took place after use of product.  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-202201296516 Same patient/vaccine, different dose/event;US-PFIZER INC-PV202200102748 Same reporter/vaccine, similar event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac flutter
Clinical narrative: Afib; Developed heart flutter; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Afib"; CARDIAC FLUTTER (medically significant), outcome "unknown", described as "Developed heart flutter". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Collapsed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization) with onset 2022, outcome "unknown", described as "Collapsed". The patient was hospitalized for loss of consciousness (hospitalization duration: 8 day(s)). Clinical course included the patient administered Pfizer booster vaccine and collapsed in their house for three days and been hospitalized for 8 days, wanted to know the adverse reaction information since the doctors have no clue to what happened   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Blood test abnormal
Clinical narrative: I had blood work yesterday and it's like in the eight hundreds, it was nine hundred and something last month; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (086396). The reporter is the patient.  A 74-year-old female patient received palbociclib (IBRANCE), at 125 mg; 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: Covid-19 vaccine (Primary immunization series complete, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: BLOOD TEST ABNORMAL (non-serious), outcome "unknown", described as "I had blood work yesterday and it's like in the eight hundreds, it was nine hundred and something last month". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for palbociclib was temporarily withdrawn.  Additional information: Patient stated "I've been on Ibrance for three months now. I had blood work yesterday and it's like in the eight hundreds, it was nine hundred and something last month. So my physician is thinking that it might be the Ibrance. And so I'm off of it until the 21st. I'm supposed to start Ibrance again on the 22nd. So I'm going in on the 21st to get more bloodwork. I'm gonna be off Ibrance for 11 days instead of 7. And I just had my Pfizer covid booster a couple of days before this."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: keeps getting Covid; keeps getting Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "keeps getting Covid". It was reported that patient has had bad impacts of and keeps getting Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Chest X-ray, Chills, Electrocardiogram, Fatigue, Immobile
Clinical narrative: side effects worsen and begin to lose mobility; complete loss of mobility; vomiting; fever; tiredness; chills; Initial information received on 02-Nov-2022 regarding an unsolicited valid  courtest serious case received from a consumer/non-hcp via GSK.  This case involves a 76 years old male patient who had side effects worsen and begin to lose mobility; complete loss of mobility, tiredness, chills, vomiting and fever after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On 29-Sep-2022, the patient received an unknown dose at 10:00am of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 29-Sep-2022 the patient developed a non-serious event of tiredness (fatigue), chills at 6:30pm (Latency: same day) following the administration of INFLUENZA VACCINE.  On 30-Sep-2022 the patient developed a serious event of side effects worsen and begin to lose mobility; complete loss of mobility (immobile) 1 day following the administration of INFLUENZA VACCINE. respiratory, temperature Regained mobility  at 4:30am and released at 5:00am.  On 30-Sep-2022 at9:00pm the patient developed a non-serious event of vomiting, fever (pyrexia)  1 day following the administration of INFLUENZA VACCINE.  Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  No result provided Chest X-ray - On an unknown date:  no final diagnosis Electrocardiogram - On an unknown date:  No final diagnosis SARS-CoV-2 test - On an unknown date:  Not result provided  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: recovered on 30-Sep-2022 for immobile and Unknown for other events.  Seriousness criteria: Medically significant and was leading to disability for immobile; Sender's Comments: Sanofi company comment dated 15-Nov-2022: This case involves a 76 years old male patient who had side effects worsen and begin to lose mobility; complete loss of mobility, tiredness, chills, vomiting and fever after receiving vaccine INFLUENZA VACCINE. Further patient's individual information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the few reported information, the role of the suspect vaccine cannot be assessed.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: side effects worsen and begin to lose mobility; complete loss of mobility; vomiting; fever; tiredness; chills; Initial information received on 02-Nov-2022 regarding an unsolicited valid  courtest serious case received from a consumer/non-hcp via GSK.  This case involves a 76 years old male patient who had side effects worsen and begin to lose mobility; complete loss of mobility, tiredness, chills, vomiting and fever after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On 29-Sep-2022, the patient received an unknown dose at 10:00am of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 29-Sep-2022 the patient developed a non-serious event of tiredness (fatigue), chills at 6:30pm (Latency: same day) following the administration of INFLUENZA VACCINE.  On 30-Sep-2022 the patient developed a serious event of side effects worsen and begin to lose mobility; complete loss of mobility (immobile) 1 day following the administration of INFLUENZA VACCINE. respiratory, temperature Regained mobility  at 4:30am and released at 5:00am.  On 30-Sep-2022 at9:00pm the patient developed a non-serious event of vomiting, fever (pyrexia)  1 day following the administration of INFLUENZA VACCINE.  Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  No result provided Chest X-ray - On an unknown date:  no final diagnosis Electrocardiogram - On an unknown date:  No final diagnosis SARS-CoV-2 test - On an unknown date:  Not result provided  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: recovered on 30-Sep-2022 for immobile and Unknown for other events.  Seriousness criteria: Medically significant and was leading to disability for immobile; Sender's Comments: Sanofi company comment dated 15-Nov-2022: This case involves a 76 years old male patient who had side effects worsen and begin to lose mobility; complete loss of mobility, tiredness, chills, vomiting and fever after receiving vaccine INFLUENZA VACCINE. Further patient's individual information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the few reported information, the role of the suspect vaccine cannot be assessed.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Exposure to communicable disease, Inappropriate schedule of product administration
Clinical narrative: In JUL2022 I had a minor exposure to rabies and had the Imovax vaccine. I then had a second exposure to rabies, and got a booster dose on 04SEP2022 and 07SEP2022; Initial information received on 04-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 64 years old female patient who was first time administered vaccine IPV (VERO) [IMOVAX] in Jul 2022 and received the booster dose on 04 Sep 2022 and 07 Sep 2022 for her exposure to rabies 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 Rabies Vaccine (RABIES VACCINE); Tetanus Vaccine (TETANUS VACCINE) and Rabies Vaccine INACT (CHICK EMBRYO) (RABAVERT) for Immunisation.  In July 2022, the patient received a dose 1 of suspect IPV (VERO) (with batch lot number, strength, dose: not reported) via unknown route in unknown administration site for prophylaxis.   On 04-Sep-2022 she also received a dose 2 of the same vaccine with (batch lot number, strength, dose: not reported) via unknown route in unknown administration site for prophylaxis.   On 07-Sep-2022 she also received a dose 3 dose of the same vaccine  with (batch lot number, strength, dose: not reported) via unknown route in unknown administration site for prophylaxis.  In JUL-2022 the patient reported a non-serious event of in jul2022 i had a minor exposure to rabies and had the imovax vaccine. i then had a second exposure to rabies, and got a booster dose on 04sep2022 and 07sep2022 (inappropriate schedule of product administration).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IMOVAX) was not applicable.  At time of reporting, the outcome was Unknown for the event in jul2022 i had a minor exposure to rabies and had the imovax vaccine. i then had a second exposure to rabies, and got a booster dose on 04sep2022 and 07sep2022.     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: COVID19, FLUX
Symptoms: Illness
Clinical narrative: sick, very sick; Initial information received on 05-Nov-2022 regarding non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who experienced sick, very sick after receiving vaccines influenza vaccine and covid-19 vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine by unknown manufacturer (lot, expiry date and strength was unknown) via unknown route and unknown administration site as flu vaccination and on same day patient also received Booster dose of covid-19 vaccine not produced by Sanofi Pasteur (dose, expiry date and strength was unknown) via unknown route and unknown administration site as Covid-19 vaccination.  On an unknown date the patient developed sick, very sick (illness) (unknown latency) following the administration of influenza vaccine and covid-19 vaccine.  It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: aches; sore arm; low grade fever; had a bad rash all over her arm; Initial information was received on 07-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had a bad rash all over her arm, sore arm, aches and low grade fever while receiving vaccine influenza usp trival a-b high dose subvirion vaccine [Fluzone high dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe of unknown frequency via unknown route in unknown administration site (with an unknown strength, batch number and expiry date) for immunization.   On an unknown date the patient had a non-serious event had a bad rash all over her arm (rash), sore arm (pain in extremity), aches (pain) and low grade fever (pyrexia) (unknown latency) following the administration of influenza usp trival a-b high dose subvirion vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Pain in extremity
Clinical narrative: sore arm; illness; Initial information received on 09-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced sore arm and illness after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed sore arm (pain in extremity) and illness(unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (sore arm, illness).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event sore arm and was Unknown for the event illness.
Age: 0.75
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: they received a second dose instead of waiting for 30 days or more with no reported adverse event; Initial information received on 03-Nov-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 9 months old patient of unknown gender who received a second dose of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] instead of waiting for 30 days or more 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 a dose 2 of suspect of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Suspension for injection) (lot: UT7744NA ) (expiry date: 30-JUN-2023) (strength was unknown) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient received a second dose of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] instead of waiting for 30 days or more with no reported adverse event (inappropriate schedule of product administration) (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: 61.0
Sex: F
Vaccine: FLUR3
Symptoms: Accidental exposure to product, Expired product administered, Medication error, No adverse event, Syringe issue
Clinical narrative: an exposure took place described as due to the vaccine leaking from the syringe the consumer had a lot of fluid to drip down the arm with no adverse event; expired vaccine used with no adverse event; Initial information received on 07-Nov-2022 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 61 year old female patient who had an exposure to the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] leaking from the syringe the consumer had a lot of fluid to drip down the arm with no adverse event and expired vaccine used with no adverse event.     The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 20-Oct-2022, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE  at a dose of 0.5 ml once (lot UJ888AA, expiry date: 09-Jun-2022) via intramuscular route in left arm for Immunization.  On 20-Oct-2022, an exposure took place described as due to the vaccine leaking from the syringe the consumer had a lot of fluid to drip down the arm with no adverse event (accidental exposure to product) and expired vaccine used with no adverse event (expired product administered) (same day latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported When she administered the flu vaccine to the patient and she started to inject, the medicine started to come out of the back of the syringe. Nurse would like to know if she needs to revaccinate because she is not sure how much the patient received. A Nurse reporting a partial dose due to having 1-FLUBLOK syringe to leak from the back of the syringe; that it is unknown to the caller the exact location of the leak; that the syringe has been disposed of in the SHARPS container; that there was no known defect to the syringe or the carton; and that an exposure took place described as due to the vaccine leaking from the syringe the consumer had a lot of fluid to drip down the arm.  Action taken: not applicable.  Outcome: 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: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired ACT-HIB to a 6-month-old patient with no reported adverse event; Initial information received on 07-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient whom had was administered with an expired haemophilus type B (HIB) Vaccine [ACT-HIB] to a 6-month-old patient 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 Ipol polio vaccine [Polio vaccine inact 3v (vero)]  On 27-Oct-2022, the patient received a  dose of suspect haemophilus type B (HIB) Vaccine Powder and solvent for solution for injection dose 0.5 ml lot UJ600AAB, expiry date: 20-Oct-2022 via intramuscular route in the right thigh for immunization, the patient had administered an expired act-hib to a 6-month-old patient with no reported adverse event (expired product administered) on the same day  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired act-hib to a 6-month-old patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site rash, Vaccination site inflammation
Clinical narrative: developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed.; developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed.; Initial information received on 07-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 54 years old female patient who had developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed. After receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 02-Nov-2022, the patient received 0.5ml, 1X(once)total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 02-Nov-2022 the patient developed a non-serious event of developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed. (vaccination site rash, inflammation) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. She states most of it has cleared up but there is some residual redness left.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: recovering
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site rash
Clinical narrative: developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed.; developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed.; Initial information received on 07-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 54 years old female patient who had developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed. After receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 02-Nov-2022, the patient received 0.5ml, 1X(once)total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 02-Nov-2022 the patient developed a non-serious event of developed a circular rash the size of a grapefruit around the injection site and that it was sensitive and inflamed. (vaccination site rash, inflammation) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. She states most of it has cleared up but there is some residual redness left.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: recovering
Age: 73.0
Sex: M
Vaccine: 6VAX-F, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient inadvertently received a dose of VAXELIS, nurse accidentally pulled and administered VAXELIS, instead of the ordered FLUZONE HIGH DOSE QIV, with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 73-year-old male patient who inadvertently received a dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE (Vaxelis), nurse accidentally pulled and administered vaxelis, instead of the ordered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], 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 suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Immunization and suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE produced by unknown manufacturer (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation) and patient inadvertently received a dose of vaxelis, nurse accidentally pulled and administered vaxelis, instead of the ordered fluzone high dose qiv, with no reported adverse event (wrong product administered) (unknown latency).  It was reported, ordering physicians ordered FLUZONE HIGH DOSE QIV for both patients. This situation is reported as a medication error due to a missed dose of FLUZONE HIGH DOSE QIV.  As patient did not receive dose of ordered FLUZONE HIGH DOSE QIV on 07NOV2022. No further information provided by the reporter.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) and DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE (DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE) 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired dose of menactra with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old male patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with no reported adverse event.  The patient's past medical history, vaccination(s) and family history were not provided.Patient had no medical treatment and no concomitant medication.   On 07-Nov-2022, the patient received a  0.5ml, 1 X(once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7140AA and expiry date:04-Nov-2022) via intramuscular route in unknown administration site for Immunization.  On 07-Nov-2022 the patient developed a non-serious event of patient received an expired dose of menactra with no reported adverse event (expired product administered) (Latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: topical reaction/ rash; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 80 years old female patient who had topical reaction/ rash after receiving vaccine Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Nov-2022, the patient received a dose of suspect Influenza Quadrival A-B high dose HV vaccine at a dose of 0.25 mL to 2 mL Total (1x) (strength, formulation, lot number and expiry date: not reported) via unknown route in unknown administration site as Immunisation.  On 08-Nov-2022, the patient developed a non-serious event of topical reaction/ rash (rash) (same day) following the administration of Influenza Quadrival A-B high dose HV vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (topical reaction/ rash).  At time of reporting, the outcome was Unknown for the event topical reaction/ rash.; Sender's Comments:  01358051:
Age: 4.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: inadvertently administered tenivac instead of daptacel with no reported AE; administered dose of TENIVAC was expired with no reported AE; Initial information was received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 4 years old female patient who stated inadvertently administered tenivac instead of daptacel with no reported ae and administered dose of tenivac was expired with no reported ae while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine INACT SPLIT 4V (Fluzone QUADRIVALENT) for Prophylactic vaccination; POLIO VACCINE INACT 3V (VERO) (Ipol POLIO VACCINE) for Prophylactic vaccination; measles vaccine, MUMPS VACCINE, rubella vaccine (MMR) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACC.) for Prophylactic vaccination.  On 08-Nov-2022, the patient received suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT Suspension for injection at a dosage of 0.5 ml once (lot C5779AA, expiry date - 02-Oct-2022) via intramuscular route in the left thigh for immunisation.  On 08-Nov-2022 the patient developed non-serious events of inadvertently administered tenivac instead of daptacel with no reported ae (wrong product administered), administered dose of tenivac was expired with no reported ae (expired product administered) (latency: same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered tenivac instead of daptacel with no reported ae and was Unknown for the event administered dose of tenivac was expired with no reported ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: a patient inadvertently received a dose of MENQUADFI instead of TRUMEMBA with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient inadvertently received a dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] instead of trumemba with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 08-Nov-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE  (lot U7450AA; 10-OCT-2024)  via intramuscular route in the left arm for prophylactic vaccination.  On 08-NOV-2022 the patient reported a non-serious event a patient inadvertently received a dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE instead of trumemba with no reported adverse event (wrong product administered).  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 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.; Sender's Comments:  01358281:
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: inadvertently received a dose of MENQUADFI instead of TRUMEMBA With no reported adverse event; Initial information was received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 17 years old male patient who stated inadvertently received a dose of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] instead of trumemba 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 suspect meningococcal a-c-y-w135 (t conj) vaccine solution for injection lot number not reported via unknown route in unknown administration site (strength, dosage, frequency, expiry date: unknown) for immunisation.  On an unknown date the patient developed a non-serious event of inadvertently received a dose of menquadfi instead of trumemba with no reported adverse event (wrong product administered) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently received a dose of menquadfi instead of trumemba 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.