chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: male patient may potentially receive two doses of Fluzone High-Dose a month apart; Initial information received on 17-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  The case is linked to US-SA-2024SA315750.  This case involves an unknown age male patient may potentially receive two doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] a month apart.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a dose 2 of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Suspension for injection in pre-filled syringe) strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and male patient may potentially receive two doses of fluzone high-dose a month apart (inappropriate schedule of product administration) (latency: same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.   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-2024SA315750:Patient 2
Sex: U
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received 3 meningitis vaccines with no reported adverse event; Initial information received on 21-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received 3 meningitis vaccines (meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]) 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 3 doses of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (with lot U7140BB, U4597AB and AMAA058Z) via unknown route in unknown administration site (strength, dose and expiry date unknown) for prophylactic vaccination with no reported adverse event (extra dose administered) (latency: same day)  Information on expiry 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.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 45-year old received FLUZONE HD due to a medication error during flu clinics and not paying attention, with no adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case was linked to US-SA-2024SA313311 (cluster case).  This case involves a 45 year old female patient and reporter stated that 45-year old received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to a medication error during flu clinics and not paying attention, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Oct-2024, the patient received 0.5 ml of influenza trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with strength- high dose (lot UT8473CA and expiry date- 30-Jun-2025) once via unknown route in the left arm for Immunization due to medication error with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, vaccines were administered due to a medication error during flu clinics and not paying attention. There had been no events reported related to the administration of the vaccines.  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-2024SA317985: US-SA-2024SA313313: US-SA-2024SA313311:02274696 US-SA-2024SA318712: US-SA-2024SA318876:
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: dose of FLUZONE HD was inadvertently administered in the bicep instead of the deltoid with no reported adverse event; Initial information received on 29-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 69 years old female patient to whom dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] was inadvertently administered in the bicep instead of the deltoid with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Oct-2024, the patient was inadvertently administered INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe dose 0.5 ml Frequency = once lot U8527AA expiry-30-Jun-2025 via unknown route in left bicep for Immunization (strength unknown) instead of the deltoid with no reported adverse event (incorrect route of product administration) (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: 65.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient inadvertently received a regular fluzone np instead of the intended fluzone hd with no reported adverse event; Initial information received on 29-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 65 years old female patient who was inadvertently received a regular Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] instead of the intended Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  List concomitant: No other vaccines  On 11-Oct-2024, the patient inadvertently received a standard dose of 0.5 ml once of suspect influenza USP trival A-B subvirion no preservative vaccine Suspension for injection (lot UT8415MA, expiry date- 30-JUN-2025) via intramuscular route in the right deltoid for Immunization instead of the intended Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot number, expiry date- not reported), with no reported adverse event (wrong product administered) (latency- same day).   Reportedly, No treatment was received.   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: 76.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: administered ADACEL to 76 years patient, with no reported adverse event; vaccine had been in transit for too long and was no longer viable and administered to patient with no reported adverse event; Initial information received on 29-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 76 years old male patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] and vaccine had been in transit for too long and was no longer viable and administered to 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 Influenza vaccine inact split 3v (Fluzone high dose) for Immunisation; and tozinameran (Comirnaty) for Immunisation.  On 29-Oct-2024, the patient of 76 years received a dose of 0.5 ml once of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: U7999AA; expiry date: 08-Feb-2026; strength: standard) via intramuscular route in the right arm for Immunisation (product administered to patient of inappropriate age) (latency: same day) and vaccine had been in transit for too long and was no longer viable and administered to patient with no reported adverse event (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.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of flublok, Max/low temperature reached: 10.8FDuration: 5 hours with no reported adverse event; Initial information received on 30-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves temperature excursion of flublok, max/low temperature reached: 10.8fduration: 5 hours with no reported adverse event  It was reported that  suspect Influenza Quadrivalent Recombinant Vaccine (lot number: TFAA2409 and expiration date: 31-May-2025) had temperature excursion of flublok, max/low temperature reached: 10.8fduration: 5 hours with no reported adverse event (product storage error) (unknown latency).  Human error: Yes  Does extended stability data cover the excursion: No  Was the product administered/dispensed to a patient:  No  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: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Malaise, Mobility decreased, Pyrexia
Clinical narrative: quite ill; extreme fatigue; general malaise/felt terrible; did not regain strength/could hardly get up out of bed; fever for 3 days; Initial information received on 30-Oct-2024 regarding an unsolicited valid  non-serious case received from a patient.  This case involves a 73 years old female patient who experienced quite ill, fever for 3 days, extreme fatigue, general malaise/felt terrible and did not regain strength/could hardly get up out of bed after receiving  Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd].  The patient's past vaccination(s) included COVID-19 vaccine and Influenza vaccine with Past reactions after a flu vaccine were mild and only lasted a day.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 21-Oct-2024, the patient received 0.5ml (1X) once, Influenza Usp Trival A-B High Dose Subvirion Vaccine,Suspension for injection in pre-filled syringe via intramuscular route (lot, expiry, strength, administration site: unknown) for immunization.  On an unknown date, the patient developed quite ill (illness), fever for 3 days (pyrexia),extreme fatigue (fatigue),general malaise/felt terrible (malaise),did not regain strength/could hardly get up out of bed (asthenia) (unknown latency:) after receiving  Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Relevant laboratory test results included: Body temperature - On an unknown date: 100.6 F  Information regarding batch number  corresponding to the one at time of event occurrence was requested.  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 Recovered / Resolved  for the event fever for 3 days, was Unknown for all other events .
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally given FLUBLOK, with no reported adverse event; Initial information received on 30-Oct-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case was linked with US-SA-2024SA327597, US-SA-2024SA323465 and US-SA-2024SA321979.  This case involves a 11 years old female patient who was accidentally given Influenza quadrivalent recombinant vaccine [Flublok QIV], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Oct-2024, the patient accidentally received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (strength- standard, frequency- once) (lot- TFAA2408) via unknown route in unknown administration site (route, formulation and expiration date: not provided) for Immunisation (product administered to patient of inappropriate age) (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.; Sender's Comments:  US-SA-2024SA327597: US-SA-2024SA323465: US-SA-2024SA321979:
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Vision blurred
Clinical narrative: right eye blurriness; unusual tiredness; Initial information received on 30-Oct-2024 regarding an unsolicited valid non-serious case received from a Patient.  This case involves a 69-year-old male patient who experienced unusual tiredness and right eye blurriness after receiving 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 28-Oct-2024, the patient received an unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (strength, dose, lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.  Information regarding batch number corresponding to the one at time of event occurrence is requested.  On an unknown date in OCT-2024 the patient developed unusual tiredness (fatigue) and right eye blurriness (vision blurred) (latency: approximately same or 1 day).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for the events.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patients younger than 18 have received FLUBLOK  with no reported adverse event; Initial information received on 30-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16-year-old female patient younger than 18 have received 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.  On 22-Oct-2024, the patient younger than 18 received a 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection of lot TFAA2408 and expiry date: 31-May-2025 frequency; once and strength: standard via intramuscular route in unknown administration site for immunization with no reported adverse event (product administered to patient of inappropriate age) (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: U
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient who was given two injections of Flublok trivalent instead of one with no reported adverse event; Initial information received on 30-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age /gender patient who received two injections of influenza trivalent recombinant vaccine [Flublok TIV] instead of one 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 influenza trivalent recombinant vaccine Solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization) who was given two injections of influenza trivalent recombinant vaccine instead of one with no reported adverse event (extra dose administered) (latency- same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.    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: 14.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidental administration of flublok to 14y old with no adverse event; Initial information received on 31-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 14 years old female patient who had accidental administration of Influenza Trivalent Recombinant Vaccine [Flublok TIV] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the 14 year old patient accidentally received a dose of suspect Influenza Trivalent Recombinant Vaccine (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as immunization with no adverse event (product administered to patient of inappropriate age) (latency: same day). 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.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received 2 adacel injections in the same arm with no reported adverse event; Initial information received on 31-Oct-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 50 year old male patient who received 2 diphtheria-2/tetanus/5 AC pertussis vaccine [adacel] injections in the same arm 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 COVID-19 vaccine.  On 31-OCT-2024 the patient received 2 diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (unknown strength) with lot 2CA56C1 and expiry date 12-may-2025 via intramuscular route in the left arm for immunization with no reported adverse event (extra dose 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: 16.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: menquadfi was administered post temperature excursion with no adverse event; Initial information received on 31-Oct-2024 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves a 16 years old male patient and reporter stated that meningococcal A-C-Y-W135 (T CONJ) vaccine [menquadfi] was administered post temperature excursion with no adverse event.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On 30-Oct-2024, standard dose of 0.5 ml of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection once with lot U8361AA and expiry date 31-Mar-2028 via intramuscular route in the left deltoid for immunization was administered post temperature excursion with no adverse event (poor quality product administered) (Latency same day).  Reportedly, Temperature excursion of vaccine due to Refrigerator malfunction Max/low temperature: 26.8 F and time of excursion: 21 minutes. Human error not involved.  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: FLU3
Symptoms: Drug hypersensitivity
Clinical narrative: thimerosal allergy; Initial information received on 31-Oct-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves an unknown age female patient who had thimerosal allergy after receiving vaccine influenza USP TRIVAL A-B subvirion vaccine [fluzone].  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza USP TRIVAL A-B subvirion vaccine Suspension for injection (unknown strength, lot and expiry date) unknown route in unknown administration site for Influenza.  On an unknown date the patient developed thimerosal allergy (hypersensitivity) (unknown latency) following the administration of influenza USP TRIVAL A-B subvirion vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.   Reportedly, director of pharmacy, stated she has a staff member that cites a thimerosal allergy. Caller stated she does not know if the staff member has ever received fluzone, that she dis not t know if the staff member had ever received a multi-dose fluzone and had a reaction, that she did not know if the staff member has been specifically tested for the thimerosal allergy. Caller stated the staff member stated it was anaphylaxis. Caller stated she recommended to the staff member that she needed to follow up with her physician on that and  maybe get it in a controlled setting. Caller stated that what the staff member experienced maybe was some other component of the vaccine itself but caller did not know if the staff member had ever even gotten fluzone.  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: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: the medication leaked out the side of syringe and down the arm of the patient with no reported adverse event; the medication leaked out the side of syringe and down the arm of the patient with no reported adverse event; may have received half the dose with no reported adverse event; Initial information received on 31-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 58 years old female patient who received the influenza USP TRIVAL A-B subvirion NO preservative vaccine [Fluzone] which leaked out the side of syringe and down the arm of the patient, and may have received half the dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 31-Oct-2024, the patient received 0.5 ml influenza USP TRIVAL A-B subvirion NO preservative vaccine Suspension for injection with standard strength (lot U8523AA and expiry date- 30-JUN-2025 ) once via unknown route in unknown administration site as Immunization which was leaked out the side of syringe and down the arm of the patient with no reported adverse event (accidental exposure to product) (exposure via skin contact) and  patient may have received half the dose with no reported adverse event (incorrect dose administered) (latency- same day).  Reportedly, this was now the second time reporter had to call about this issue. Reporter stated she called about a week earlier for another syringe. Reporter was looking for reimbursement of three syringe products.  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-2024SA315540:Previous report
Age: 56.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nurse mistakenly gave Fluzone HD to a redacted year old with no reported adverse event; Initial information received on 31-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 56 years old and unknown gender patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] that the nurse mistakenly gave fluzone hd to a redacted year old 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  Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in a pre-filled syringe (lot number, expiry, dose, strength, route, administration site: unknown) that nurse mistakenly gave fluzone hd to a redacted year old with no reported adverse event (product administered to patient of inappropriate age) ( latency: same day) for influenza.  Information regarding batch number 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.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received the FLUZONE HD who is below 65 years old with no adverse event; Initial information received on 31-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 30 years old male patient who received the influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Elasomeran (COVID-19 vaccine Moderna); Aesculus hippocastanum (Varivax; Meningococcal vaccine A/C/Y/W conj (CRM197) (Menveo); Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR); and influenza vaccine (Fluzone No Preservative) all for Immunisation.  On 31-Oct-2024, the patient received 0.5 ml of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- high dose, lot UT8409CA and expiry date- 30-Jun-2025) via intramuscular route in the left deltoid for Influenza who is below 65 years old with no adverse event (product administered to patient of inappropriate age) (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.
Sex: U
Vaccine: DTAP
Symptoms: Hypersensitivity
Clinical narrative: an allergic reaction with Tdap; Initial information received on 01-Nov-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and  gender patient who experienced an allergic reaction with tdap while receiving Diphtheria, Tetanus And Acellular 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 Diphtheria, Tetanus And Acellular Pertussis Vaccine(strength, formulation, dose ,route, administration site: unknown) produced by unknown manufacturer (lot number,expiry: unknown).   On an unknown date the patient developed an allergic reaction with tdap (allergy to vaccine) (unknown latency) after receiving Diphtheria, Tetanus And Acellular Pertussis Vaccine.  Information regarding batch number corresponding to the one at time of event occurrence was requested.  Action taken -not applicable.  It was not reported if the patient received a corrective treatment for the event (an allergic reaction with Tdap).  At time of reporting, the outcome was Unknown for the event .; Sender's Comments:  US-SA-2024SA324736:
Age: 19.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 19 year old was administered a FLUZONE HD, with no reported adverse event; Initial information received on 01-Nov-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case was linked to other case US-SA-2024SA326097.  This case involves a 19-year-old and unknown gender patient who was administered a influenza USP trival A-B high dose subvirion vaccine [fluzone HD] with no reported adverse event.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On 30-Oct-2024, the patient received 0.5 ml dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (unknown strength, lot and expiry date) via unknown route in unknown administration site for immunization.  On 30-Oct-2024, 19-year-old was administered a influenza USP trival A-B high dose subvirion vaccine, with no reported adverse event (product administered to patient of inappropriate age) (Latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence   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-2024SA326097:02289330
Age: 15.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15-year-old was given FLUBLOK 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 is linked to US-SA-2024SA324913.  This case involves a 15 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.   On 01-Nov-2024,15-year-old was given flublok (Solution for injection) (lot: TFAA2424; expiry date: 30-Jun-2025; frequency: once; strength: standard) with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) via unknown route in an unknown administration site for Immunization.   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-2024SA324913:
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Product administered to patient of inappropriate age
Clinical narrative: had mild flu-like symptoms after receiving a flu shot dose; 19 year old was administered a fluzone hd; Initial information received on 01-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA322843.  This case involves a 19 years old male patient who had mild flu-like symptoms after receiving a Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] shot dose.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medictaions and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) (product administered to patient of inappropriate age) (latency : same day) strength, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (Immunization). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On an unknown date the patient had mild flu-like symptoms after receiving a flu shot dose (influenza like illness) (unknown latency) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Reportedly, This situation is pre-assessed as a medication error/an inappropriate use due to administering Fluzone HD to a patient under the age of 65.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (had mild flu-like symptoms after receiving a flu shot dose).  At time of reporting, the outcome was Unknown for the event had mild flu-like symptoms after receiving a flu shot dose.  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-2024SA322843:
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok was administered to 12-year-old with no ae; Initial information received on 01-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA324272.  This case involves a 12 years old male patient to whom influenza trivalent recombinant vaccine [Flublok TIV] was administered  with no adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Nov-2024, the 12 years old male patient received 0.5 mL dose of suspect influenza trivalent recombinant vaccine (Solution for injection) with no adverse event (product administered to patient of inappropriate age) (latency: same day) (lot TFAA2424 and expiry date: 30-Jun-2025) (frequency: once) (strength: standard) via intramuscular route in unknown administration site for immunization.  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: 4.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 years old patient administarted adacel 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 a 4 years old and unknown gender patient who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 01-Nov-2024, the patient received a  dose of 0.5 ml (frequency : once) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (suspension for injection) lot U8274AA, Expiry date: 31-Aug-2026, strength was unknown via unknown route in unknown administration site for Immunization and 4 years old patient administarted adacel with no reported adverse event (product administered to patient of inappropriate age)(latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administration for patient out of indicated age range."   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: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Off label use
Clinical narrative: off-label use as per local labelling due to use for primary vaccination; Initial information received on 01-Nov-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 18 years old male patient who had  diphtheria-2/tetanus/5 AC pertussis vaccine [adacel] and reporter stated it as off-label use as per local labelling due to use for primary vaccination.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunization and reporter stated it as off-label use as per local labelling due to use for primary vaccination (off label use) (Latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, she has a patient that is from out of the country.his records have been lost so she is starting his vaccines over.She has already administered an ADACEL to the patient, but is asking if he will need another dose. The physician administered a dose of Adacel to an 18 year old patient. She plans to use Adacel according to the CDC catch up schedule for all three of his catch up doses.
Sex: U
Vaccine: RAB
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: nurses only give 2 doses of IMOVAX RABIES for pre-exposure, and they were worried that the patients were not getting what they're supposed to get with no reported adverse event; Initial information received on 04-Nov-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who stated that nurses only give 2 doses of RABIES (HDC) VACCINE [IMOVAX RABIES] for pre-exposure, and they were worried that the patients were not getting what they're supposed to get with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On an unknown date, the patient received a dose 2 of suspect RABIES (HDC) VACCINE (Powder and solvent for suspension for injection) strength, expiry date, lot number not reported via unknown route in unknown administration site for pre-exposure immunization (Immunization) and nurses only give 2 doses of imovax rabies for pre-exposure, and they were worried that the patients were not getting what they're supposed to get with no reported adverse event (incorrect dose administered) (latency: same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  Reportedly ,This situation is pre-assessed as an off-label use as per local labelling due to 2-dosing series being practiced in another county. HCP has a question about the IMOVAX RABIES vaccine. She was reading the literature for the vaccine and is asking why it is recommended for some patients to only receive 2 doses, versus the standard 3 doses.   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.