chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: patient received the Fluzone NP vaccine instead of Adacel With no reported advers event; patient is pregnant with no reported adverse event; Initial information received on 22-OCT-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 29 years old female patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] instead of adacel with no reported advers event and patient is pregnant with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The estimated due date is 12-JAN-2025.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  List concomitant- ''no other vaccines''.  On 22-OCT-2024, the patient received a 0.5ml standard dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE 1x (once) (lot UT8496NA) (unknown expiry) via intramuscular route in the right deltoid for influenza instead of adacel with no reported advers event (wrong product administered) and patient is pregnant with no reported adverse event (exposure during pregnancy).  Reportedly, the patient got her 1st Fluzone shot on 23-SEP-2024 but unfortunately, she receive the same vaccine today. The patient is pregnant and doesn't have any reaction nor complaints.   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: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: ADACEL administered to a patient instead of DAPTACEL with no adverse event; Initial information received on 23-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was vaccinated with Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of being vaccinated with Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] 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 received 0.5ml, 1X (once) of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number: U8252AA an d expiry 31-May-2026) (strength: unknown) instead of  Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection with no adverse event (wrong product administered) (latency: same day) via intramuscular route In left deltoid 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.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: bad arm swelling; huge red welts; huge red welts; Initial information received on 23-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case was linked to US-SA-2024SA314806  This case involves 68 years old female patient who had bad arm swelling, and huge red welts after receiving influenza 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 an unknown dose of suspect influenza 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 was requested corresponding to the one at time of event occurrence  On an unknown date the patient developed bad arm swelling (peripheral swelling), huge red welts (urticaria) (erythema) (unknown latency) following the administration of influenza vaccine.  Reportedly, Patient mentioned that they usually experience bad arm swelling and huge red welts with flu vaccines since they were 40.   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 Unknown for all the events.; Sender's Comments:  US-SA-2024SA314806:02276602 (FLUZONE HD)
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received FLUZONE HD twice in 2 months, with no adverse event; Initial information received on 23-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age female patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]twice in 2 months, 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 patient received a  dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (unknown: dose, strength, lot and route) (Lot UT8454AA expiry 30-Jun-2025) twice in 2 months, with no adverse event (extra dose administered) (latency same day) in unknown administration site for Influenza.  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: Extra dose administered, No adverse event
Clinical narrative: patient received a FLUZONE HD in one arm and a FLUZONE NP on the other arm. Both were given the same day, with no adverse event; patient received a FLUZONE HD in one arm and a FLUZONE NP on the other arm. Both were given the same day, with no adverse event; Initial information received on 23-Oct-2024 regarding an unsolicited valid  on-serious case received from a other health professional.  This case involves Adult and unknown gender patient who received a Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] in one arm  and a fluzone np on the other arm both were given the same day, 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 patient received Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe via unknown route in the arm  nos and on same day received fluzone NP  on the other arm (strength, dose, batch and expiry date unknown) both were given the same day, with no adverse event (extra dose administered) (Product administered to patient of inappropriate age) (same day latency).  Information on batch number and 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.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received a FLUZONE HD in one arm and a FLUZONE NP on the other arm/Both were given the same day, with no reported adverse event; Initial information received on 23-Oct-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves an unknown age and unknown gender patient and reporter stated that received a influenza USP trival A-B high dose subvirion vaccine [fluzone HD] in one arm and a influenza USP trival A-B subvirion NO preservative vaccine [fluzone NP] on the other arm/both were given the same day, 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 an unknown date the patient received unknown dose of  influenza USP trival A-B high dose subvirion vaccine (unknown strength, formulation, lot and expiry date) via unknown route in the arm NOS (Not otherwise specified) in one arm and a influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (unknown strength, lot and expiry date) via unknown route in the arm NOS on the other arm/both were given the same day, 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: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: medication error due to administration to an 8-year-old patient with no adverse event; Initial information received on 23-Oct-2024 regarding an unsolicited valid non-serious case received from  other health professional.  This Case Involves A 8-Year-Old Female Patient Who Received Diphtheria, Tetanus, Ac Pertussis And Ipv Vaccine [Quadracel] Vaccine with No Adverse Event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2024, the patient received a dose of Diphtheria, Tetanus, Ac Pertussis And Ipv Vaccine Suspension for injection (dose, strength, route: unknown) with lot number: U7838AA and expiry: 25-JUL-2025 in unknown administration site for Immunization (product administered to patient of inappropriate age) (latency: same day) with no adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: patient was given adacel vaccine while pregnant with no reported adverse event; Initial information received on 23-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was pregnant and exposed to vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] while pregnant with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported event occurred at 28 Weeks of pregnancy. The date of last menstrual period was not reported. The estimated due date was approximately Nov-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 04-Mar-2024, the patient received a dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection and On 28-Aug-2024, she also received a  dose of same vaccine (strength, dose, expiry date, lot number- not reported) via unknown route in unknown administration site for Immunization.  Information on the batch number was requested corresponding to the one at time of event occurrence.  On 28-AUG-2024 the patient was given Diphtheria-2/Tetanus/5 Ac Pertussis vaccine while pregnant with no reported adverse event (exposure during pregnancy) (latency- same day).  Relevant prenatal testing after exposure was not reported.  Reportedly, the patient received ADACEL on 04-MAR-2024, before they were pregnant and another on 28-AUG-2024 at 28 weeks age of gestation. They wanted to know if that was okay and if there are any recommendations available.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired product administered with no reported adverse event; Initial information received on 24-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 1-year-old female patient whom expired HIB (PRP/T) vaccine [ACT-HIB] administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine INACT (VAQTA); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix) for Immunisation.  On 24-Oct-2024, the patient received an unknown dose of expired suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection of lot UJ852AB and expiry date: 13-Apr-2024 via intramuscular route in lateral (frequency: once, strength: standard) for immunization with no reported adverse event (expired 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
Age: 14.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: given an extra dose with no reported adverse event; Initial information received on 24-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14-year-old female patient who was given an extra dose of IPV (VERO) [IPOL] 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 Rabivax [Rabies Vaccine]; and Hepatitis A Vaccine for Immunisation.  On 22-Oct-2024, the patient received a 0.5 ml dose of suspect IPV (VERO) Suspension for injection frequency: twice and strength: standard (expiry date, lot number not reported) via unknown route in unknown administration site for Immunization was given an extra dose with no reported adverse event (extra dose administered) (latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence is 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: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to device use error, Exposure via skin contact, No adverse event, Underdose
Clinical narrative: vaccine leaked out of patient's skin is because the puncture was not deep and the patient moved or bent her knee, with no reported adverse event; vaccine leaked out of patient's skin is because the puncture was not deep and the patient moved or bent her knee, with no reported adverse event; vaccine leaked out of patient's skin is because the puncture was not deep and the patient moved or bent her knee, with no reported adverse event; Initial information received on 24-Oct-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 years old female patient who was exposed to Influenza usp trival a-b subvirion vaccine [Fluzone] vaccine leaked out of patient's skin is because the puncture was not deep and the patient moved or bent her knee, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2024, the patient received an unknown dose of suspect influenza usp trival a-b subvirion vaccine Suspension for injection (lot- U8442AA and expiration date- 30-JUN-2025) via intramuscular route in the left thigh (dose, strength: not provided) for Influenza and vaccine leaked out of patient's skin is because the puncture was not deep and the patient moved or bent her knee, with no reported adverse event (occupational exposure to product), (incorrect dose administered) and (exposure via skin contact) (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: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: door left open temperature reached 31.5° fahrenheit for 1 hour with no reported adverse event; quadracel and pentacel administered to patients following the temperature excursion with no reported adverse event; Initial information received on 24-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case- US-SA-2024SA320321  This case involves an unknown age and unknown gender patient to whom Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] And Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] administered following the temperature excursion and door left open temperature reached 31.5° fahrenheit for 1 hour 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 Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine Suspension for injection and Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection dosage 0.5 ml 1x (once) via unknown route in unknown administration site for immunization (strength, batch and expiry date unknown) following the temperature excursion with no reported adverse event (poor quality product administered) (latency same day). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested  On an unknown date door left open temperature reached 31.5° fahrenheit for 1 hour with no reported adverse event (product storage error) (unknown latency).  Cause- Human error   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-2024SA320321:
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: gave extra doses of IPOL to a patient, with no reported adverse event; Initial information received on 24-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who received extra doses of Ipv (Vero) [Ipol], 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 Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for and Varicella Zoster Vaccine for Immunisation.  On 13-Feb-2024, the patient received a dose of suspect Ipv (Vero), Suspension for injection (strength: not reported) (lot: W1C831M, Expiry date: 21-Nov-2025) via intramuscular route in the left thigh for Immunization. On 24-Oct-2024, he also received extra dose of same vaccine via intramuscular route in the left thigh, 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.; Sender's Comments:  US-SA-2024SA314955:
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: gave extra doses of daptacel to a patient, with no reported adverse event; Initial information received on 24-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to US-SA-2024SA314929.   This case involves a 4 years old male patient who received extra doses of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], 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 Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for and Varicella Zoster Vaccine for Immunisation.  On 13-Feb-2024, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength: not reported) (lot: 3CA03C3, Expiry date: 30-Sep-2025) via intramuscular route in the left thigh for Immunization. On 24-Oct-2024, he also received extra dose of same vaccine via intramuscular route in the left thigh, 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.; Sender's Comments:  US-SA-2024SA314929:
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Max/low temperature reached: highest 5.2 C, lowest -2.5 C Duration: 20 minutes with no reported adverse event; Max/low temperature reached: highest 5.2 C, lowest -2.5 C Duration: 20 minutes with no reported adverse event; Initial information received on 24-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who received diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] which was exposed temperature excursion and max/low temperature reached: highest 5.2 c, lowest -2.5 c duration: 20 minutes 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 received 0.5 ml of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection with standard strength (lot U8232AA and expiry date- 31-May-2026) once via intramuscular route in the right deltoid as Immunization was exposed to temperature excursion whose max/low temperature reached: highest 5.2 c, lowest -2.5 c duration: 20 minutes with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency- same day).  Reportedly, there was no previous excursion. Human error was unknown. Product was administered post excursion.  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, DTAPIPV, DTAPIPVHIB, HIBV, MEN, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion at 31.5 degrees f but then reported it as 0.278 degrees c. : negative disposition with human error, while administered with no adverse event.; temperature excursion at 31.5 degrees f but then reported it as 0.278 degrees c. : negative disposition with human error, while administered with no adverse event.; Initial information received on 25-Oct-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves patient (unknown age and gender) who received  Hib (Prp/T) Vaccine [Act-Hib], Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel], Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] And Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)],post  excursion 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 patient received Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine, Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine,  Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Meningococcal A-C-Y-W135 (T Conj) Vaccine, Hib (Prp/T) Vaccine, And Suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (lot number, expiry, strength, route, administration site: unknown ), post temperature excursion occur at 31.5 degrees f but then reported it as 0.278 degrees c.: negative disposition with human error, while administered with no adverse event (poor quality product administered) (latency: same day) for Immunisation.  On an unknown date the patient received Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine, Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine,  Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Meningococcal A-C-Y-W135 (T Conj) Vaccine, Hib (Prp/T) Vaccine, And Suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, temperature excursion occur at 31.5 degrees f but then reported it as 0.278 degrees c. with no adverse event (product storage error).  Information on 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: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 7-year-old patient who was given with FLUBLOK instead of the Fluzone NP Qiv with no adverse event; 7-year-old patient who was given with FLUBLOK instead of the Fluzone NP Qiv with no adverse event; Initial information received on 25-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7-year-old patient male who was given with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] instead of the fluzone np qiv (INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]) with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Oct-2024, the patient received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE 1x (once) via unknown route in unknown administration site for influenza (strength, dose, batch and expiry date unknown) instead of the fluzone np qiv with no adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency same day).  Information on batch number and 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: 80.0
Sex: M
Vaccine: FLU3
Symptoms: COVID-19, Pain of skin, Pruritus
Clinical narrative: COVID 19; sore skin; SEVERE ITCHING; Initial information received on 25-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional with live follow-up processed together.  This case involves a 80 years old male patient who experienced covid 19, sore skin and severe itching after receiving influenza usp trival a-b high dose subvirion vaccine [Fluzone HD].  Patient taken flu shots just about every year since forever with no more reaction than mild soreness at the injection site. He have been extremely sensitive to ALPHA GAL (alpha-galactose) and avoid red meat and dairy since 1995.   On 22-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) (lot number and expiry date not reported) via unknown route in unknown administration site for Immunization.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On 24-Oct-2024, the patient developed a non-serious covid 19 (covid-19), sore skin (pain of skin) and severe itching (pruritus) (latency: 2 days) following the administration of influenza usp trival a-b high dose subvirion vaccine.  Reportedly, By the end of that day he started to feel like patient MIGHT be getting sick. By Wednesday evening he was exhausted. By Thursday he tested positive for Covid 19 and, he also had very intense, very severe itching and "sore skin" which continued Through Friday morning and has only started to let up today (Friday). He did NOT have difficulty in swallowing or breathing. In the absence of a recent Flu Shot and a Covid-19 infection I would characterize this event as a moderate to moderate+ exposure to red meat but short of a trip to the ER (emergency room). There are vegetable food products such as Carrageenan that have a molecule that triggers an Alpha GAL response. Patient have typical reactions to airborne pollens etc. So, the obvious question was: Have he developed a sensitivity to common flu shots? He would hate to panic and stop getting flu shots in the future. Caller states that once he had a very severe reaction to a food and the emergency medical staff told him that as soon as he feels any sign of a hypersensitivity reaction, he should take a Benadryll, wait a short time, then take another Benadryll. He states that he has used this intervention to halt other incidents of hypersensitivity since then.   Relevant laboratory test results included: COVID-19 - On 24-Oct-2024: Positive  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 60 years of patient administered FLUZONE HD TIV with no reported adverse event; Initial information received on 25-Oct-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case was linked with US-SA-2024SA317763.  This case involves a 60 years old female patient who was administered 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.   On 25-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 (lot- U8515EA and expiration date- 30-JUN-2025) via intramuscular route in the left deltoid (strength: not provided) for Immunisation and 62 years of patient was administered fluzone hd tiv with no reported 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.; Sender's Comments:  US-SA-2024SA317763:
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL was placed at 48.2° Fahrenheit for 12 minutes as door was left open with no reported adverse event; IPOL was administered to patient post excursion with no reported adverse event; Initial information received on 25-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 13 years old female patient who was administered IPV (VERO) [IPOL] post excursion as the same was placed at 48.2° fahrenheit for 12 minutes as door was left open 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, (latency- same day), the IPV (VERO) Suspension for injection (strength- standard) (lot- X1C891M and expiry date- 01-OCT-2026) was placed at 48.2° fahrenheit for 12 minutes as door was left open (product storage error) and the patient received 0.5 ml (once) dose of the suspect via intramuscular route in the left deltoid for Immunisation post excursion with no reported adverse event (poor quality product administered)   Reportedly, Did it occur due to a human error? YES Does extended stability data cover the excursion: 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: 62.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 62 years of patient was administered FLUZONE HD TIV with no reported adverse event; Initial information received on 25-Oct-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case was linked with US-SA-2024SA317769.  This case involves a 62 years old female patient who was administered 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.   On 25-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 (lot- U8515EA and expiration date- 30-JUN-2025) via intramuscular route in the left deltoid (strength: not provided) for Immunisation and 62 years of patient was administered fluzone hd tiv with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, Product used : Used, First time product used : Yes.  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-2024SA317769:
Age: 10.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL  was administered to patient post excursion with no reported adverse event; IPOL was placed at 48.2 f for 12 minutes as was door left open with no reported adverse event; Initial information received on 25-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 10 years old male patient where reporter reported that IPV (VERO) [IPOL] was placed at 48.2 f for 12 minutes as was door left open with no reported adverse event and ipol  was administered to patient post excursion 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 in 2024, the patient received 0.5 ml (once) dose of suspect IPV (VERO) Suspension for injection (strength- standard) (lot- X1C891M and expiry date- 01-OCT-2026) via intramuscular route in the left deltoid for Immunisation and ipol was placed at 48.2 f for 12 minutes as was door left open with no reported adverse event (product storage error).  On 03-Oct-2024, ipol was administered to patient post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Products involved? IPOL MDV (opened) Product activated/prepared? YES Ask how the situation occurred? DOOR LEFT OPEN Max/Low Temperature reached? 48.2° FAHRENHEIT How long did the excursion last?  12 MINUTES Did it occur due to a human error? YES Does extended stability data cover the excursion: NO And in case of negative advice: Was the product used by/ administered to the patient: YES   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: 15.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: DOOR LEFT OPENMax/Low Temperature reached? 48.2° FAHRENHEITHow long did the excursion last? 12 MINUTES. Did it occur due to a human error? YES with no reported adverse event; product used by/ administered to the patient: YES with no reported adverse event; Initial information received on 25-Oct-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a 15 years old male patient who received IPV (VERO) [IMOVAX POLIO] had door left openmax/low temperature reached? 48.2° fahrenheithow long did the excursion last? 12 minutes. did it occur due to a human error? yes with no reported adverse event and product used by/ administered to the patient: yes 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 22-Oct-2024, the patient received a  dose of 0.5 ml 1x of suspect IPV (VERO)(suspension for injection) lot X1C891M, Expiry date: 01-Jan-2026, strength was unknown via intramuscular route in the left deltoid for Immunization and door left openmax/low temperature reached? 48.2° fahrenheithow long did the excursion last? 12 minutes. did it occur due to a human error? yes with no reported adverse event (product storage error) (unknown latency) and product used by/ administered to the patient: yes with no reported adverse event (poor quality product administered) (latency : same day).  Reportedly "Does extended stability data cover the excursion: NO. And in case of negative advice: Was the product used by/ administered to the patient: YES. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data."   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: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a third dose of MENQUADFI was administered , even though did not require it with no reported adverse event; Initial information received on 25-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old male patient who received third dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered, even though did not require it 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 HPV vaccine VLP RL1 4V (yeast) (Gardasil) and  for Immunisation and Tremenba   On 25-Oct-2024, the patient received a 0.5 ml dose (dose 3) of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection of lot U8256AD and expiry date: 31-Oct-2027 via intramuscular route in the right arm (frequency: once, strength: standard) even though did not require it with no reported adverse event (extra dose 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.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was administered to a 14-year-old patient with no reported adverse event; Initial information received on 28-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an Influenza Trivalent Recombinant Vaccine [Flublok TIV] was administered to a 14-year-old patient 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 26-Oct-2024, the patient received a dose of 0.5 ml of suspect Influenza Trivalent Recombinant Vaccine (Solution for injection) lot TFAA2423 , Expiry date: 31-Mar-2025, strength was unknown via intramuscular route in the left deltoid for Immunization and flublok was administered to a 14-year-old patient with no reported 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.