chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, COVID-19, Cardiac monitoring, Computerised tomogram head, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; seizure; Paroxysmal atrial fibrillation; transient ischemic attack; hematuria; This is a spontaneous report received from a Consumer or other non HCP from product quality group. Regulatory number: 2797380-1 (VAERS ID).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6204), in right arm and on 12Apr2021 as dose 2, single (Lot number: EW0150, Expiration Date: 30Jun2021), in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; DRUG INEFFECTIVE (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; ATRIAL FIBRILLATION (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered", described as "Paroxysmal atrial fibrillation"; HAEMATURIA (hospitalization, disability, life threatening) with onset 01Jul2023, outcome "not recovered", described as "hematuria"; SEIZURE (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered", described as "transient ischemic attack". The events "drug ineffective", "covid-19", "seizure", "paroxysmal atrial fibrillation", "transient ischemic attack" and "hematuria" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Cardiac monitoring: Unknonw results, notes: implantable cardiac monitor insertion; Computerised tomogram head: Unknonw results; Echocardiogram: Unknonw results; Electrocardiogram: Unknonw results; Exam: Unknonw results; labs/ Laboratory test: Unknonw results. Therapeutic measures were taken as a result of seizure, atrial fibrillation, transient ischaemic attack. Clinical course: Pfizer#01 on 17Mar2021, Pfizer#2 on 12Apr2021, developed covid 19 vaccine induced TIA with associated seizure activity, Paroxysmal atrial fibrillation, hematuria. Treated with aspirin, Eliquis, Lamictal protocol base spike Detoxification. Current Illness was reported as none. Medications at time of Vaccination was none.  No follow-up attempts are possible.  Follow-up (12Nov2024): This is a spontaneous follow-up report received from product quality group Updated information: Dose 2 details updated.  No follow-up attempts are possible.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Haematuria, Investigation, Laboratory test
Clinical narrative: Drug ineffective; COVID-19; seizure; Paroxysmal atrial fibrillation; transient ischemic attack; hematuria; This is a spontaneous report received from a Consumer or other non HCP from product quality group. Regulatory number: 2797380-1 (VAERS ID).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6204), in right arm and on 12Apr2021 as dose 2, single (Lot number: EW0150, Expiration Date: 30Jun2021), in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; DRUG INEFFECTIVE (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; ATRIAL FIBRILLATION (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered", described as "Paroxysmal atrial fibrillation"; HAEMATURIA (hospitalization, disability, life threatening) with onset 01Jul2023, outcome "not recovered", described as "hematuria"; SEIZURE (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered", described as "transient ischemic attack". The events "drug ineffective", "covid-19", "seizure", "paroxysmal atrial fibrillation", "transient ischemic attack" and "hematuria" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Cardiac monitoring: Unknonw results, notes: implantable cardiac monitor insertion; Computerised tomogram head: Unknonw results; Echocardiogram: Unknonw results; Electrocardiogram: Unknonw results; Exam: Unknonw results; labs/ Laboratory test: Unknonw results. Therapeutic measures were taken as a result of seizure, atrial fibrillation, transient ischaemic attack. Clinical course: Pfizer#01 on 17Mar2021, Pfizer#2 on 12Apr2021, developed covid 19 vaccine induced TIA with associated seizure activity, Paroxysmal atrial fibrillation, hematuria. Treated with aspirin, Eliquis, Lamictal protocol base spike Detoxification. Current Illness was reported as none. Medications at time of Vaccination was none.  No follow-up attempts are possible.  Follow-up (12Nov2024): This is a spontaneous follow-up report received from product quality group Updated information: Dose 2 details updated.  No follow-up attempts are possible.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure, Transient ischaemic attack
Clinical narrative: Drug ineffective; COVID-19; seizure; Paroxysmal atrial fibrillation; transient ischemic attack; hematuria; This is a spontaneous report received from a Consumer or other non HCP from product quality group. Regulatory number: 2797380-1 (VAERS ID).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6204), in right arm and on 12Apr2021 as dose 2, single (Lot number: EW0150, Expiration Date: 30Jun2021), in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; DRUG INEFFECTIVE (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; ATRIAL FIBRILLATION (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered", described as "Paroxysmal atrial fibrillation"; HAEMATURIA (hospitalization, disability, life threatening) with onset 01Jul2023, outcome "not recovered", described as "hematuria"; SEIZURE (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered", described as "transient ischemic attack". The events "drug ineffective", "covid-19", "seizure", "paroxysmal atrial fibrillation", "transient ischemic attack" and "hematuria" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Cardiac monitoring: Unknonw results, notes: implantable cardiac monitor insertion; Computerised tomogram head: Unknonw results; Echocardiogram: Unknonw results; Electrocardiogram: Unknonw results; Exam: Unknonw results; labs/ Laboratory test: Unknonw results. Therapeutic measures were taken as a result of seizure, atrial fibrillation, transient ischaemic attack. Clinical course: Pfizer#01 on 17Mar2021, Pfizer#2 on 12Apr2021, developed covid 19 vaccine induced TIA with associated seizure activity, Paroxysmal atrial fibrillation, hematuria. Treated with aspirin, Eliquis, Lamictal protocol base spike Detoxification. Current Illness was reported as none. Medications at time of Vaccination was none.  No follow-up attempts are possible.  Follow-up (12Nov2024): This is a spontaneous follow-up report received from product quality group Updated information: Dose 2 details updated.  No follow-up attempts are possible.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, VARCEL, COVID19, FLU3, VARCEL, COVID19, FLUX, VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: I was given the chicken pox vaccine by mistake instead of the shingles vaccine that I requested along with the COVID and flu vaccines. The nurse practitioner called the evening of the vaccine (last night) to make me aware. He said he would call me back today to let me know when I can get the shingles vaccine but haven't heard anything yet.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, VARCEL, COVID19, FLU3, VARCEL, COVID19, FLUX, VARCEL
Symptoms: Wrong product administered
Clinical narrative: I was given the chicken pox vaccine by mistake instead of the shingles vaccine that I requested along with the COVID and flu vaccines. The nurse practitioner called the evening of the vaccine (last night) to make me aware. He said he would call me back today to let me know when I can get the shingles vaccine but haven't heard anything yet.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, VARCEL, COVID19, FLU3, VARCEL, COVID19, FLUX, VARCEL
Symptoms: Ill-defined disorder, Pain, Wrong product administered
Clinical narrative: I was given the chicken pox vaccine by mistake instead of the shingles vaccine that I requested along with the COVID and flu vaccines. The nurse practitioner called the evening of the vaccine (last night) to make me aware. He said he would call me back today to let me know when I can get the shingles vaccine but haven't heard anything yet.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP calling to report patient received expired dose of VAQTA. Expiration date 10/1/2024.  No adverse effects reported. No other information provided. No additional AE. No PQC.; HCP calling to report patient received expired dose of VAQTA. Expiration date 10/1/2024.  No adverse effects reported. No other information provided. No additional AE. No PQC.; This spontaneous report was received from a registered medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-OCT-2024, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, single dose, lot #X006702, expiration date: 01-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical Assistant calling to report adverse event regarding improperly stored and administered VAQTA.; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 30-SEP-2024, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml / two dose series, administered for prophylaxis (lot #Y007585, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 31-OCT-2025; strength, and route of administration were not provided). Medical Assistant stated that the supply of hepatitis A vaccine, inactivated (VAQTA) at their facility was exposed to temperature excursions beginning in May 2024 (Product storage error). Medical Assistant confirmed the patient involved has not reported any medical concerns or symptoms after being administered the improperly stored dose of hepatitis A vaccine, inactivated (VAQTA). No additional information provided. There was no additional adverse event (AE) or product quality complaint (PQC) reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a patient was prescribed PREVNAR 20 but they were instead given an expired dose of PNEUMOVAX 23.; a patient was prescribed PREVNAR 20 but they were instead given an expired dose of PNEUMOVAX 23.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  Reporter stated that patient was prescribed with pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20). On 11-NOV-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 dose, lot #X018273, expiration date: 07-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered) instead of pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20) (Wrong product administered). No patient symptoms had been reported.
Sex: U
Vaccine: DTP, FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information received on 31-OCT-2024 regarding an unsolicited valid  non-serious case received from a patient.  This case involves an unknown age and gender patient who had sore arm after receiving INFLUENZA VACCINE and DIPHTHERIA, TETANUS AND NOS PERTUSSIS 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 DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and INFLUENZA VACCINE  produced by unknown manufacturer (unknown strength, dosage, formulation, expiry, lot number and route) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed sore arm (pain in extremity) (unknown latency) following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and INFLUENZA VACCINE.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok given to 16 years old with no reported adverse event; Initial information received on 05-NOV-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who was given INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK TIV] 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 MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Product used for unknown indication.   On 04-NOV-2024, the 16 years old patient received 0.5 ml (once) (standard) INFLUENZA TRIVALENT RECOMBINANT VACCINE (lot TFAA2447, expiry:30-JUN-2025) via intramuscular route in left armfor prophylactic vaccination with no reported adverse event (product administered to patient of inappropriate age) (latency-same day).  Reportedly, inappropriate use due to use in a pediatric patient.  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: F
Vaccine: DTAP
Symptoms: Crying, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: couldn't hardly lift my arm or doing anything normally for two weeks; Initial information received on 31-Oct-2024 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-hcp (non-healthcare professional).  This case involves an unknown age female patient who couldn't hardly lift her arm or doing anything normally for two weeks after receiving Diphtheria, Tetanus And Acellular Pertussis Vaccine (tDap).  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 diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (strength, formulation, expiry date, lot number- not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number cannot be requested corresponding to the one at time of event occurrence  On an unknown date the patient couldn't hardly lift her arm or doing anything normally for two weeks (limb discomfort) (unknown latency) following the administration of diphtheria and tetanus and acellular pertussis vaccine.  Reportedly, patient got the tDAP with her first and couldn't hardly lift my arm or doing anything normally for two weeks. She cried every time when tried to lift arm-definitely not a reaction that she would normally have. she didn't get the vaccine because she had the flu while pregnant. and the RSV (Respiratory syncytial virus) shot wasn't a thing yet. THIS time, she had 36-week appointment this week and NONE of them were mentioned. She will not be getting any this time and frankly very happy that she didn't mentioned them.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient did not receive FLUZONE HD because they were inadvertently given an expired dose of last year's FLUZONE HD QIV with no adverse event; Initial information received on 16-Oct-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 58-year-old male patient who did not receive fluzone hd because they were inadvertently given an expired dose of last year fluzone hd qiv with no adverse event while receiving vaccines Fluzone High Dose Quadrivalent instead of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received dose of  Fluzone High Dose Quadrivalent (formulation, dose, strength, lot and expiry : unknown) Vaccine in unknown administration site for Immunization, instead of Influenza Usp Trival A-B High Dose Subvirion Vaccine suspension for injection in pre-filled syringe (dose, strength, administration site, lot and expiry : unknown) for lymphoma, patient receive hd qiv with no adverse event instead of fluzone hd (inappropriate age at vaccine administration)  (latency: same day) following the administration of Fluzone High Dose Quadrivalent.   Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   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.; Sender's Comments:  US-SA-2024SA318614:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: act-hib was reconstituted with sterile water and administered to a patient with no reported adverse event; act-hib was reconstituted with sterile water and administered to a patient with no reported adverse event; Initial information received on 01-Nov-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who  was administered HIB (PRP/T) Vaccine [ACT-HIB]  which was reconstituted 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 HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UJ978AA, strength not reported and expiry date: 08-Nov-2024) via unknown route in unknown administration site as Immunization, which was reconstituted with sterile water with no reported adverse event (product preparation error) and (poor quality product administered) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 23.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: gave of IPOL to a patient who is supposed to received TUBERSOL with no reported adverse event; Initial information received on 04-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 23-year-old female patient and gave IPV (vero) [IPOL] who is supposed to received tuberculin test [Tubersol] 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 started taking TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown for Tuberculin test.  On 04-Nov-2024, the patient received a 0.1 ml dose of suspect IPV (VERO) Suspension for injection of lot W1C741M and expiry date: 17-Nov-2025 via intradermal route in unknown administration site for immunization who is supposed to received TUBERSOL (TUBERCULIN TEST) Solution for injection with no reported adverse event (wrong product administered) (latency: on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Extremely lethargic; staying in bed for approximately 24 hrs; interfered with his activities of daily living; This non-serious case was reported by a consumer via sales rep and described the occurrence of lethargy in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced lethargy (Verbatim: Extremely lethargic), bedridden (Verbatim: staying in bed for approximately 24 hrs) and activities of daily living impaired (Verbatim: interfered with his activities of daily living). The outcome of the lethargy was resolved and the outcome of the bedridden and activities of daily living impaired were resolved (duration 24 hrs).   The reporter considered the lethargy and bedridden to be related to Shingrix. It was unknown if the reporter considered the activities of daily living impaired to be related to Shingrix.     The company considered the lethargy and bedridden to be related to Shingrix. It was unknown if the company considered the activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2024 The patient received first dose. The reporter reported that he/she was attending a medical confrence and starting talking to a patient (an attendee).  The patient stated that Shingrix caused the most side effects he had ever experienced with a vaccine and he experienced lethargy that was so much that it kept him in bed and interfered with his activities of daily living for a period of 24 hours.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Vision blurred
Clinical narrative: double vision; blurry double vision; This non-serious case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2024-2025 season) for prophylaxis.   On 12-OCT-2024, the patient received Fluarix Tetra 2024-2025 season (intramuscular, right arm). On 13-OCT-2024, 1 days after receiving Fluarix Tetra 2024-2025 season, the patient experienced blurred vision (Verbatim: blurry double vision). On 15-OCT-2024, the patient experienced double vision (Verbatim: double vision). The outcome of the blurred vision and double vision were not resolved.   It was unknown if the reporter considered the blurred vision and double vision to be related to Fluarix Tetra 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the blurred vision and double vision to be related to Fluarix Tetra 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-OCT-2024 The patient's vision was really blurry when she woke up.  Her vision continued to get blurrier until it progressed to double vision and the patient went to the emergency room. The emergency room physician referred her to an eye specialist, who she saw. The eye physician stated that the Fluarix vaccine seems to have attacked the nerve in her eye. The reporter consented to follow up.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient had first dose of pentacel after age 3 to 4 months, who was started late on the vaccine with no reported adverse event; Initial information received on 05-NOV-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Infant and unknown gender patient who had first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] after age 3 to 4 months, who was started late on the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-NOV-2024, the patient received  (dose 1) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (unknown strength, dosage, formulation, expiry, lot number and route) in unknown administration site for prophylactic vaccination after age 3 to 4 months, who was started late on the vaccine with no reported adverse event (inappropriate schedule of product administration).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, caller said the patient who was started late on the vaccine. Normally it is given at 2 months, 4 months, 6 months, and 15-18 months.   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: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACTHIB was administered after being diluted with the sterile water instead of the provided diluent with no reported adverse event; Initial information received on 05-Nov-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age / gender patient who received HIB (PRP/T) vaccine [ACT-HIB] after being diluted with the sterile water instead of the provided diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Nov-2024, the patient received 0.5 ml of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization after being diluted with the sterile water instead of the provided diluent with no reported adverse event (product preparation error) (latency- same day).   Information on the batch number cannot be requested corresponding to the one at time of event occurrence.  Caller did not have much information at the time of the call. Reporter cannot be contacted by Sanofi.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: UNK
Symptoms: Disorientation, Hiccups
Clinical narrative: Had  the hiccups for the past 3 days; Disoriented; This spontaneous case initially received on 28-Oct-2024, was reported by a non health professional and concerns an elderly male patient.  At the time of the event the patient had Diabetes, Muscle relaxer 'knoked him out'.  Administration of company suspect drug(s): On an unknown date in Oct-2024, the patient received Fluad (TIV) for Influenza prophylaxis., Dose regimen: Not reported, Route of Administration: Not Reported, Anatomical location: Not reported, Lot number: Not reported, would not be obtained due to no follow-up consent provided  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date in Oct-2024, the patient experienced Had the hiccups for the past 3 days (outcome: Not recovered / Not resolved), Disoriented (outcome: Not recovered / Not resolved).  Consumer stated that her friend, who is diabetic, has had the hiccups for the past 3 days. Her friend went to his doctor, who prescribed a muscle relaxant to him. Consumer stated that the muscle relaxer "knocked him out" and counteracted with his diabetes. Consumer reports that the muscle relaxer also made her friend disorientated and he got lost on the road and ended up in another city. Consumer would like to know what could be causing the hiccups and if there is anything they can do about it.  Consumer was asked if her friend had received a flu vaccine and she replied that he received one around the same time that she did - about 10 days previous the date of report. Consumer stated she had no issues after receiving her flu vaccine. Consumer believed that her friend received a pneumonia shot along with his flu vaccine. Consumer was not sure which influenza vaccine her friend had received, but it was the "old age oneo since he was 88 years old. Consumer states that she got the number for Seqirus Medical Information out of a review. No additional information known. Adverse event was being filed in the event that FLUAD was the vaccine consumer's friend had received.  Fluad (TIV) action taken: Not Applicable Treatment medication: Unspecified muscle relaxer  Reporter's assessment: The reporter consider event as non-serious and causality assessment was not provided.; Reporter's Comments: Company causality: Hiccups assessed as Related and Disorientation as not related.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Tremor
Clinical narrative: PATIENT'S SON CAME DURING THIS WEEK AND SAID HE FATHER GOT VACCINATED AND PRESENTED UNCONTRORABLE SHAKING, ALSO THAT HE HAD NEUROLOGICAL PROBLEMS PREVIOUS TO THE VACCINE
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction reported, patient had forgotten his doctor gave him a flu shot 1 month ago. This was his second shot for this flu shot season.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Depression, Dizziness, Fatigue, Headache, Irritability
Clinical narrative: Sore throat, headache, dizziness, exhaustion, depression, irritation, sinus congestion
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Oropharyngeal pain, Sinus congestion, Streptococcus test negative
Clinical narrative: Sore throat, headache, dizziness, exhaustion, depression, irritation, sinus congestion
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse the patient is 7 and the vaccine is indicated for under 6 years old.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Burning sensation, Injection site pain
Clinical narrative: off and on burning sensation, mainly left side, ear, neck, trapezius, outer left arm: near injection site but also forearm, left upper chest,  collarbone, sometimes shoulder blade to shoulder blade, chin, lips -- started two days after vaccination, has continued as of this report 2-1/2 weeks
Age: 1.67
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 10/3/2024, Patient received 6m - 4 yrs multidose Pfizer vaccine which contained 9mcg in the vial. The whole vial contains 3 doses. The whole vial was drawn up by the Medical Assistant, without diluent, and given to the Patient. The Patient was only supposed to receive 3 mcg of this vaccine. The error was noticed a few weeks later when vaccine counts were being completed. During that time, we did not receive any communication from the Parents regarding any adverse event.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Arteriosclerosis coronary artery, Asthenia, Balance disorder, COVID-19
Clinical narrative: Admit date: 11/4/2024   Discharge date: Nov 6, 2024   Attending Physician at the Time of Discharge: MD  Reason for Admission: This is a 76 y.o. male with h/o CAD, MI, HTN, tachy/brady syndrome s/p pacemaker, COPD, BPH, HLD, hearing loss and tinnitus presenting to the ED for evaluation of difficulty breathing.   Patient reports thathe has fallen twice this week last time was two days ago. Both occasions he "lost his balance". States he knew he was falling tried to grab onto things but could not prevent it. Denies loss of consciousness. First fall he fell on his back and second fall (2 days ago) he fell on his right side and the pain has continued which prompted him to visit the ED. Also reports some generalized weakness, dizziness and body aches with SOB and "chest tightness". As well as cough with minimal sputum production. He denies fever, dysuria, blood in stool or urine and nausea or vomiting.    Brief Summary of Hospital Stay:  Principal Problem:   Weakness, falls, - suspect form COVID myopathy.CT head - no acute abnormality - CT spine and thorax - no acute traumatic injury - CT thorax - Bibasilar atelectatic changes. Right lung apex atelectatic changes/scarring with associated groundglass opacities.  - has HX vertigo - no vertiginous Sx now. .   - no treatment needed for COViD. No hypoxia. Lungs clear. Slight cough.  Tessalon for cough. Sats good on RA today.    PT, OT to eval. PT cleared pt for home Dc. Will arrange homecare.    Elevated troponin (non-ST elevated myocardial infarction) (HCC) - troponin elevation - 142 - 160 and trending down now. Suspect demand ischemia. No CP at present. No acute ST changes. Hx CAD, with stent May 2024. . On ASA, plavix. Cardiology consulted - suspect demand ischemia. . ECHO - EF normral. Given IV heparin for 48 hrs.  Active Problems:   COPD (chronic obstructive pulmonary disease) (HCC) - stable. Not on home O2. Lungs clear. Albuterol Prn.    Coronary artery disease involving native coronary artery of native heart without angina pectoris - Hx stents   Essential hypertension, benign - stable. On BB.     Tachy-brady syndrome (HCC) - has PPM.    Chronic vertigo   Irritable bowel syndrome - IBS-D.    Nephrolithiasis - sees at facility. Abdo soft, NT.   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home Health Care
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chronic obstructive pulmonary disease, Computerised tomogram head normal, Computerised tomogram spine normal, Computerised tomogram thorax abnormal
Clinical narrative: Admit date: 11/4/2024   Discharge date: Nov 6, 2024   Attending Physician at the Time of Discharge: MD  Reason for Admission: This is a 76 y.o. male with h/o CAD, MI, HTN, tachy/brady syndrome s/p pacemaker, COPD, BPH, HLD, hearing loss and tinnitus presenting to the ED for evaluation of difficulty breathing.   Patient reports thathe has fallen twice this week last time was two days ago. Both occasions he "lost his balance". States he knew he was falling tried to grab onto things but could not prevent it. Denies loss of consciousness. First fall he fell on his back and second fall (2 days ago) he fell on his right side and the pain has continued which prompted him to visit the ED. Also reports some generalized weakness, dizziness and body aches with SOB and "chest tightness". As well as cough with minimal sputum production. He denies fever, dysuria, blood in stool or urine and nausea or vomiting.    Brief Summary of Hospital Stay:  Principal Problem:   Weakness, falls, - suspect form COVID myopathy.CT head - no acute abnormality - CT spine and thorax - no acute traumatic injury - CT thorax - Bibasilar atelectatic changes. Right lung apex atelectatic changes/scarring with associated groundglass opacities.  - has HX vertigo - no vertiginous Sx now. .   - no treatment needed for COViD. No hypoxia. Lungs clear. Slight cough.  Tessalon for cough. Sats good on RA today.    PT, OT to eval. PT cleared pt for home Dc. Will arrange homecare.    Elevated troponin (non-ST elevated myocardial infarction) (HCC) - troponin elevation - 142 - 160 and trending down now. Suspect demand ischemia. No CP at present. No acute ST changes. Hx CAD, with stent May 2024. . On ASA, plavix. Cardiology consulted - suspect demand ischemia. . ECHO - EF normral. Given IV heparin for 48 hrs.  Active Problems:   COPD (chronic obstructive pulmonary disease) (HCC) - stable. Not on home O2. Lungs clear. Albuterol Prn.    Coronary artery disease involving native coronary artery of native heart without angina pectoris - Hx stents   Essential hypertension, benign - stable. On BB.     Tachy-brady syndrome (HCC) - has PPM.    Chronic vertigo   Irritable bowel syndrome - IBS-D.    Nephrolithiasis - sees at facility. Abdo soft, NT.   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home Health Care
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Echocardiogram normal, Ejection fraction normal, Fall
Clinical narrative: Admit date: 11/4/2024   Discharge date: Nov 6, 2024   Attending Physician at the Time of Discharge: MD  Reason for Admission: This is a 76 y.o. male with h/o CAD, MI, HTN, tachy/brady syndrome s/p pacemaker, COPD, BPH, HLD, hearing loss and tinnitus presenting to the ED for evaluation of difficulty breathing.   Patient reports thathe has fallen twice this week last time was two days ago. Both occasions he "lost his balance". States he knew he was falling tried to grab onto things but could not prevent it. Denies loss of consciousness. First fall he fell on his back and second fall (2 days ago) he fell on his right side and the pain has continued which prompted him to visit the ED. Also reports some generalized weakness, dizziness and body aches with SOB and "chest tightness". As well as cough with minimal sputum production. He denies fever, dysuria, blood in stool or urine and nausea or vomiting.    Brief Summary of Hospital Stay:  Principal Problem:   Weakness, falls, - suspect form COVID myopathy.CT head - no acute abnormality - CT spine and thorax - no acute traumatic injury - CT thorax - Bibasilar atelectatic changes. Right lung apex atelectatic changes/scarring with associated groundglass opacities.  - has HX vertigo - no vertiginous Sx now. .   - no treatment needed for COViD. No hypoxia. Lungs clear. Slight cough.  Tessalon for cough. Sats good on RA today.    PT, OT to eval. PT cleared pt for home Dc. Will arrange homecare.    Elevated troponin (non-ST elevated myocardial infarction) (HCC) - troponin elevation - 142 - 160 and trending down now. Suspect demand ischemia. No CP at present. No acute ST changes. Hx CAD, with stent May 2024. . On ASA, plavix. Cardiology consulted - suspect demand ischemia. . ECHO - EF normral. Given IV heparin for 48 hrs.  Active Problems:   COPD (chronic obstructive pulmonary disease) (HCC) - stable. Not on home O2. Lungs clear. Albuterol Prn.    Coronary artery disease involving native coronary artery of native heart without angina pectoris - Hx stents   Essential hypertension, benign - stable. On BB.     Tachy-brady syndrome (HCC) - has PPM.    Chronic vertigo   Irritable bowel syndrome - IBS-D.    Nephrolithiasis - sees at facility. Abdo soft, NT.   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home Health Care
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Lung opacity, Myocardial ischaemia, Myopathy, Nephrolithiasis
Clinical narrative: Admit date: 11/4/2024   Discharge date: Nov 6, 2024   Attending Physician at the Time of Discharge: MD  Reason for Admission: This is a 76 y.o. male with h/o CAD, MI, HTN, tachy/brady syndrome s/p pacemaker, COPD, BPH, HLD, hearing loss and tinnitus presenting to the ED for evaluation of difficulty breathing.   Patient reports thathe has fallen twice this week last time was two days ago. Both occasions he "lost his balance". States he knew he was falling tried to grab onto things but could not prevent it. Denies loss of consciousness. First fall he fell on his back and second fall (2 days ago) he fell on his right side and the pain has continued which prompted him to visit the ED. Also reports some generalized weakness, dizziness and body aches with SOB and "chest tightness". As well as cough with minimal sputum production. He denies fever, dysuria, blood in stool or urine and nausea or vomiting.    Brief Summary of Hospital Stay:  Principal Problem:   Weakness, falls, - suspect form COVID myopathy.CT head - no acute abnormality - CT spine and thorax - no acute traumatic injury - CT thorax - Bibasilar atelectatic changes. Right lung apex atelectatic changes/scarring with associated groundglass opacities.  - has HX vertigo - no vertiginous Sx now. .   - no treatment needed for COViD. No hypoxia. Lungs clear. Slight cough.  Tessalon for cough. Sats good on RA today.    PT, OT to eval. PT cleared pt for home Dc. Will arrange homecare.    Elevated troponin (non-ST elevated myocardial infarction) (HCC) - troponin elevation - 142 - 160 and trending down now. Suspect demand ischemia. No CP at present. No acute ST changes. Hx CAD, with stent May 2024. . On ASA, plavix. Cardiology consulted - suspect demand ischemia. . ECHO - EF normral. Given IV heparin for 48 hrs.  Active Problems:   COPD (chronic obstructive pulmonary disease) (HCC) - stable. Not on home O2. Lungs clear. Albuterol Prn.    Coronary artery disease involving native coronary artery of native heart without angina pectoris - Hx stents   Essential hypertension, benign - stable. On BB.     Tachy-brady syndrome (HCC) - has PPM.    Chronic vertigo   Irritable bowel syndrome - IBS-D.    Nephrolithiasis - sees at facility. Abdo soft, NT.   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home Health Care
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Productive cough, Troponin increased
Clinical narrative: Admit date: 11/4/2024   Discharge date: Nov 6, 2024   Attending Physician at the Time of Discharge: MD  Reason for Admission: This is a 76 y.o. male with h/o CAD, MI, HTN, tachy/brady syndrome s/p pacemaker, COPD, BPH, HLD, hearing loss and tinnitus presenting to the ED for evaluation of difficulty breathing.   Patient reports thathe has fallen twice this week last time was two days ago. Both occasions he "lost his balance". States he knew he was falling tried to grab onto things but could not prevent it. Denies loss of consciousness. First fall he fell on his back and second fall (2 days ago) he fell on his right side and the pain has continued which prompted him to visit the ED. Also reports some generalized weakness, dizziness and body aches with SOB and "chest tightness". As well as cough with minimal sputum production. He denies fever, dysuria, blood in stool or urine and nausea or vomiting.    Brief Summary of Hospital Stay:  Principal Problem:   Weakness, falls, - suspect form COVID myopathy.CT head - no acute abnormality - CT spine and thorax - no acute traumatic injury - CT thorax - Bibasilar atelectatic changes. Right lung apex atelectatic changes/scarring with associated groundglass opacities.  - has HX vertigo - no vertiginous Sx now. .   - no treatment needed for COViD. No hypoxia. Lungs clear. Slight cough.  Tessalon for cough. Sats good on RA today.    PT, OT to eval. PT cleared pt for home Dc. Will arrange homecare.    Elevated troponin (non-ST elevated myocardial infarction) (HCC) - troponin elevation - 142 - 160 and trending down now. Suspect demand ischemia. No CP at present. No acute ST changes. Hx CAD, with stent May 2024. . On ASA, plavix. Cardiology consulted - suspect demand ischemia. . ECHO - EF normral. Given IV heparin for 48 hrs.  Active Problems:   COPD (chronic obstructive pulmonary disease) (HCC) - stable. Not on home O2. Lungs clear. Albuterol Prn.    Coronary artery disease involving native coronary artery of native heart without angina pectoris - Hx stents   Essential hypertension, benign - stable. On BB.     Tachy-brady syndrome (HCC) - has PPM.    Chronic vertigo   Irritable bowel syndrome - IBS-D.    Nephrolithiasis - sees at facility. Abdo soft, NT.   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home Health Care