chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: administration of MENQUADFI that may not have been suitable for use as excursion lasted 3 hours and the lowest temperature reading was 1.6 C with no reported adverse event; Initial information received on 21-Oct-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 11 years old male patient who was administered meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] that may not have been suitable for use as excursion lasted 3 hours and the lowest temperature reading was 1.6 c 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 diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Immunisation.  On 15-Oct-2024, at 13:50 hours, the patient received 0.5 ml (once) dose 2 of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Suspension for injection (strength- standard) (lot- U8370AA and expiry date- 30-APR-2028) via intramuscular route in unknown administration site (left) for Immunisation that may not have been suitable for use as excursion lasted 3 hours and the lowest temperature reading was 1.6 c with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, Reason: Outreach clinic- the products were in the cooler with ice packs. The data logger was stuck on the maximum temperature reading. They didn't realize it was too cold until later. The data logger battery died. From 1:30pm to 4pm, there were no temperature readings. They didn't open the cooler until they got back to their clinic and the products have been quarantined since. Max/low temperature reached and duration: There was an excursion that lasted 3 hours and the lowest temperature reading was 1.6 C. However, there were no temperature readings from 1:30pm to 4pm for approximately 2.5 hours. Previous Excursion? No Human error? No Administered post-excursion? Yes, one person (the same person) may have received MENQUADFI and ADACEL at approximately 1:50pm, when there were no temperature readings. Does extended stability data cover the excursion? UNKNOWN    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA317755:#Menquadfi
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Contusion, Diarrhoea, Emotional distress, Product administered to patient of inappropriate age
Clinical narrative: itchiness; swelling and itchiness; product administered to patient of inappropriate age; diarrhea; yellow and purple bruising; emotional distress; anxiety; Initial information received on 21-OCT-2024 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 70 years old female patient who had emotional distress, anxiety, itchiness, swelling and itchiness, product administered to patient of inappropriate age, diarrhea and yellow and purple bruising after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-OCT-2024, the patient received a  dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (unknown strength, dosage, expiry, lot number and route) in left arm for prophylactic vaccination.  On 10-OCT-2024 the patient developed emotional distress and anxiety following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (latency-same day).  On an unknown date the patient developed itchiness (administration site induration), swelling and itchiness (swelling), product administered to patient of inappropriate age, diarrhea (diarrhoea) and yellow and purple bruising (contusion) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, the patient was not aware that the product administered to her was Adacel until on 18-OCT-2024 and stated the HCP  (health care professional) never discussed with her what she was receiving. She did see a doctor originally for the injection site reactions and was told it was a hematoma, then another doctor said it was an induration. She was also told by the doctor to do warm compresses, but then the pharmacist told her to do cold compresses, so she has been alternating between the two. She mentioned when she does a cold compress it makes the skin turn very purple, but the warm compress gets it back closer to normal. She also mentioned it is not so severe in discoloration now, than it was before, and her swelling has also gone down.   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-2024SA316185:02273644 2024SA313758:02271317 (clone case)
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Swelling
Clinical narrative: itchiness; swelling and itchiness; product administered to patient of inappropriate age; diarrhea; yellow and purple bruising; emotional distress; anxiety; Initial information received on 21-OCT-2024 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 70 years old female patient who had emotional distress, anxiety, itchiness, swelling and itchiness, product administered to patient of inappropriate age, diarrhea and yellow and purple bruising after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-OCT-2024, the patient received a  dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (unknown strength, dosage, expiry, lot number and route) in left arm for prophylactic vaccination.  On 10-OCT-2024 the patient developed emotional distress and anxiety following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (latency-same day).  On an unknown date the patient developed itchiness (administration site induration), swelling and itchiness (swelling), product administered to patient of inappropriate age, diarrhea (diarrhoea) and yellow and purple bruising (contusion) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, the patient was not aware that the product administered to her was Adacel until on 18-OCT-2024 and stated the HCP  (health care professional) never discussed with her what she was receiving. She did see a doctor originally for the injection site reactions and was told it was a hematoma, then another doctor said it was an induration. She was also told by the doctor to do warm compresses, but then the pharmacist told her to do cold compresses, so she has been alternating between the two. She mentioned when she does a cold compress it makes the skin turn very purple, but the warm compress gets it back closer to normal. She also mentioned it is not so severe in discoloration now, than it was before, and her swelling has also gone down.   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-2024SA316185:02273644 2024SA313758:02271317 (clone case)
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: administration of FLUZONE NP to a patient after it had been exposed to a period of time of no temperature recordings 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 to whom influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] had been exposed to a period of time of no temperature recordings 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 October 2024, the patient had been exposed an unknown dose of suspect influenza usp trival a-b high dose subvirion vaccine (Suspension for injection in pre-filled syringe) to a period of time of no temperature recordings with no reported adverse event (poor quality product administered) (latency: same day) (lot UT8470AA and expiry date: 30-Jun-2025) via unknown route in unknown administration site for Influenza.  Reportedly, due to lack of information regarding administration of FLUZONE NP. Nurse reported 4 hours of time where no temperatures were recorded for their products. The Microsoft system for recording temperatures went down. They do not believe there was a temperature excursion. However, they are unable to prove that there was no temperature excursion during that time. The products have been used since this occurred on Friday. Caller stated that the FLUZONE has been administered, but she was not sure about the remaining products. Caller was not sure at the time of the call who has received the FLUZONE and was unable to provide patient specific information.   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, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: DAPTACEL was given to an adult patient instead of ADACEL with no adverse event; Daptacel was administered to adult patient with no adverse event; Initial information received on 21-Oct-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves Adult (unknown age, gender) patient who was vaccinated with Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine[Daptacel]  instead of being vaccinated with Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine,Suspension for injection [lot number, expiration date, dose, strength, route, administration site : unknown], with no adverse event (wrong product administered) (Product administered to patient of inappropriate age) ( latency: same day) for prophylactic vaccination.   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: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; Initial information received on 21-Oct-2024 regarding an unsolicited valid non-serious case received from a patient.  This case involves a 73 years old male patient who experienced shortness of breath after receiving influenza usp trival a-b high dose subvirion vaccine [Fluzone HD].  The patient's past medical history included Atrial fibrillation, Pacemaker placed 4 weeks ago, Shortness of breath in the past thought probable side effect of an anti-arrhythmic medication, discontinued medication and started a new anti-arrhythmic medication, COVID vaccine 2 weeks ago and has had FLUZONE HD in the past with no adverse effect.   List concomitant or "other vaccines": No other vaccines.  On 17-Oct-2024, the patient received unknown dose of suspect influenza usp trival a-b high dose subvirion vaccine (suspension for injection in pre-filled syringe) (Frequency: once) (lot number and expiry date not reported) via unknown route in the left arm for Immunization.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   On 17-Oct-2024, the patient developed a non-serious shortness of breath (dyspnoea) (latency: 36 hours) following the administration of influenza usp trival a-b high dose subvirion vaccine.  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 Not Recovered / Not Resolved for the event shortness of breath.
Age: 68.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered YF-VAX that is mixed with sterile water instead of Sodium Chloride, with no 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 a 68 years old male patient who was administered yellow fever vaccine- US [YF-VAX] that was mixed with sterile water instead of sodium chloride, 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 0.5 ml dose of suspect yellow fever vaccine- US Solution for injection (strength unknown, lot UK118AA , Expiration Date: 30-Sep-2025) via subcutaneous route in the right arm for Immunization, that was mixed with sterile water instead of sodium chloride, with no adverse event (product preparation error) (same day latency).  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: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: potential excursions of ipol with no reported adverse event; only ipol was administered post excursion 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 a patient of unknown age and gender to whom administered IPV (VERO) [IPOL] after 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, the patient received a unknown dose of suspect IPV (VERO) suspension for injection (strength: unknown, expiry date: 21-Nov-2025 and lot W1C831M via unknown route in unknown administration site as immunization (poor quality product administered) (same day latency) and potential excursions of ipol with no reported adverse event (product storage error) (unknown latency).  Reportedly: "Max/low temperature reached: 33.2F 26 hrs cumulative and 208 cumulative hrs with high of 62.37F Reason: Unknown Malfunction, Human error: No, the 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: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: received a Fluzone Trivalent SDV via IV today with no adverse event; Initial information received on 21-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 49 years old male patient who experienced received a Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] via IV today with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Oct-2024, the patient received a unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (strength: unknown, expiry date: 30-JUN-2025 and lot UT8415LA) via iv nos (intravenous not otherwise specified) route in unknown administration site as immunization instead of intramuscular route with no 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: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic, Sleep disorder
Clinical narrative: administered the vaccine on "my right upper arm about 6 inches below my shoulder and I could not sleep that night on my right side as I normally do; when I woke up I had a red, itchy rash that emanated from the injection spot half way down my back and up to my right ear; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 79 years old male patient who had administered the vaccine on "my right upper arm about 6 inches below my shoulder and i could not sleep that night on my right side as i normally do and when i woke up i had a red, itchy rash that emanated from the injection spot half way down my back and up to my right ear after receiving vaccine influenza USP trival A-B high dose subvirion vaccine [fluzone HD].  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.  Concomitant medications included Hydrocortisone valerate (Cortisone); and Levocetirizine dihydrochloride (Xyzal).  On 14-Oct-2024, the patient received unknown 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 the right arm influenza.  On an unknown date in Oct-2024 the patient stated that administered the vaccine on "my right upper arm about 6 inches below my shoulder and i could not sleep that night on my right side as i normally do (limb discomfort) and when i woke up i had a red, itchy rash that emanated from the injection spot half way down my back and up to my right ear (rash erythematous) (unknown latency) following the administration of influenza USP trival A-B high dose subvirion vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, On Monday, 14Oct2024 he was administered the vaccine on my right upper arm about 6 inches below my shoulder and I could not sleep that night on my right side as I normally do, when I woke up I had a red, itchy rash that emanated from the injection spot half way down my back and up to my right ear.  Caller denies any fever or headache. Consumer states he took Xyzal and used cortisone cream on the rash. He states that there is just a residual area that is where he was scratching.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Recovering / Resolving for both the events.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: medication error/an inappropriate use  due toCaller stated they administered  FLUZONE HD to some adults under 65  and to some children as well with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA317985 (master case)  This case involves a 48-year-old female patient who 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 04-Oct-2024, the patient received 0.5 ml 1x (once) Influenza USP Trival A-B high dose subvirion vaccine (strength high dose) Suspension for injection in pre-filled syringe lot:UT8473CA and expiry-30-Jun-2025 via unknown route in the right arm for Immunization due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) (latency same day).   This situation is pre-assessed as a medication error/an inappropriate use due to Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well  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-2024SA318981:Cluster case US-SA-2024SA314219:02274696 US-SA-2024SA318876: US-SA-2024SA317985:Master case US-SA-2024SA318712: US-SA-2024SA318878:Master case US-SA-2024SA314804:Cluster case US-SA-2024SA318727:02274696 US-SA-2024SA319049:Cluster case US-SA-2024SA319375:Cluster case
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 36 years old patient using fluzone hd with no reported adverse event; Initial information received on 22-OCT-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 36 years old female patient who had 36 years old patient using fluzone hd with no reported adverse event 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 04-OCT-2024, the patient received a 0.5ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (once) Suspension for injection in pre-filled syringe (lot UT8473CA, expiry:30-JUN-2025) (unknown route) in the right arm for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency-same day).  Reportedly, Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well.  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-2024SA313311:02274696
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 52-years received FLUZONE HD due to a medication error during flu clinics and not paying attention, with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA317985 (master case)  This case involves a 52-year-old male patient who 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 04-Oct-2024, the patient received 0.5 ml 1x (once) Influenza USP Trival A-B high dose subvirion vaccine (strength high dose) Suspension for injection in pre-filled syringe lotUT8473CA  expiry-30-Jun-2025 via unknown route in the right arm for Immunization due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) (latency same day).   This situation is pre-assessed as a medication error/an inappropriate use due to Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well  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:
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 59-years old received FLUZONE HD due to a medication error during flu clinics and not paying attention, with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 59 years old male patient who 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 reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the 59 years old patient received (0.5 ml) dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (strength: not reported) (lot: UT8473CA, Expiry date: 30-Jun-2025) due to a medication error during flu clinics and not paying attention, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) via unknown route in the right arm 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: 52.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 52 yr old patient 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 health professional.  This case is linked to 2024SA313313 (clone case), 2024SA318876 and 2024SA318712.  This case involves a 52 years old male patient who  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.  List concomitant: no other vaccines.   On 04-OCT-2024, the patient received a 0.5ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot UT8473CA, expiry: 30-JUN-2025) via unknown route in the left arm for immunization due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) (latency-same day).  Reportedly, Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well and no events were 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-2024SA318712: US-SA-2024SA318876: 2024SA317985: US-SA-2024SA313313:02274696 (clone case)
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered FLUZONE HD to some adults under 65 due to medication error during flu clinics and not paying attention with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to US-SA-2024SA313311 (cluster case).  This case involves a 45 years old male patient who was under the age of 65-years received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to medication error due to medication error during flu clinics and not paying attention with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-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 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 due to medication error during flu clinics and not paying attention with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, 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-2024SA313311:Cluster case
Age: 7.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was administered DAPTACEL instead of ADACEL with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA318256.  This case involves a 7 years old male patient was administered Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] 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 (Hepatitis A) for Immunisation; and Influenza vaccine inact split 3v (Flulaval) for Immunisation.  On 25-Sep-2024, the patient received a dose 5 of 0.5 ml 1x suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine (Suspension for injection) lot 3CA25C1, Expiry date: 30-Apr-2026, strength was unknown via intramuscular route in the right deltoid for Immunization instead of adacel with no reported adverse event (wrong 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.; Sender's Comments:  US-SA-2024SA318256:
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: people under the age of 65-years received FLUZONE HD due to a medication error during flu clinics and not paying attention with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to US-SA-2024SA313311 (cluster case).  This case involves a 46 years old female patient who was under the age of 65-years received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to medication error during flu clinics and not paying attention with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-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 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 due to medication error during flu clinics and not paying attention with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, 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-2024SA313311:Cluster case
Age: 7.0
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: One TYPHIM VI has been administered post excursion with no adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.   This case involves a 7 years old male patient who received Typhoid Vi Polysaccharide Vaccine [TYPHIM VI] post temperature excursion with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza vaccine.  On 21-Oct-2024, the patient received 0.5ml 1X (once), Typhoid Vi Polysaccharide Vaccine Solution for injection (lot :W1A991M ) expiry and strength: unknown) via intramuscular in right deltoid for immunization (post temperature  excursion (poor quality product administered) (latency same day).  Reportedly-Max/low temperature reached: 11.0 C ,Duration: 1 hour and 33 minutes  HCP Product used : Used  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: 52.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 52-years 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 health professional.  This case is linked to cases- US-SA-2024SA313311, US-SA-2024SA314786, US-SA-2024SA317011, US-SA-2024SA314254, US-SA-2024SA319049, US-SA-2020SA320383, US-SA-2024SA313313, US-SA-2024SA315389, US-SA-2024SA313312, US-SA-2024SA319070, US-SA-2024SA318876, US-SA-2024SA313309, US-SA-2024SA318981, US-SA-2024SA318878, US-SA-2024SA317025, US-SA-2024SA314805, US-SA-2024SA318712, US-SA-2024SA314787, US-SA-2024SA318875, US-SA-2024SA314087, US-SA-2024SA317152, US-SA-2024SA317108, US-SA-2024SA314219, US-SA-2024SA314219, US-SA-2024SA314804  This case involves a 52 years old male patient who 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 04-Oct-2024, the patient received 0.5 ml 1x (once) INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (strength high dose) Suspension for injection in pre-filled syringe lot UT8473CA expiry-30-Jun-2025 via unknown route in the left arm for Immunization due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) (latency same day).   This situation is pre-assessed as a medication error/an inappropriate use due to Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well  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-2024SA313311: US-SA-2024SA314786: US-SA-2024SA317011: US-SA-2024SA314254: US-SA-2024SA319049: US-SA-2020SA320383: US-SA-2024SA313313: US-SA-2024SA315389: US-SA-2024SA313312: US-SA-2024SA319070: US-SA-2024SA318876: US-SA-2024SA313309: US-SA-2024SA318981: US-SA-2024SA317025: US-SA-2024SA314805: US-SA-2024SA318712: US-SA-2024SA314787: US-SA-2024SA318875: US-SA-2024SA314087: US-SA-2024SA317152: US-SA-2024SA317108: US-SA-2024SA314219: US-SA-2024SA314191:
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 57-years 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 health professional.  This case is linked to cases- US-SA-2024SA313311, US-SA-2024SA314786, US-SA-2024SA317011, US-SA-2024SA314254, US-SA-2024SA319049, US-SA-2020SA320383, US-SA-2024SA313313, US-SA-2024SA315389, US-SA-2024SA313312, US-SA-2024SA319070, US-SA-2024SA318876, US-SA-2024SA313309, US-SA-2024SA318981, US-SA-2024SA318878, US-SA-2024SA317025, US-SA-2024SA314805, US-SA-2024SA318712, US-SA-2024SA314787, US-SA-2024SA318875, US-SA-2024SA314087, US-SA-2024SA317152, US-SA-2024SA317108, US-SA-2024SA314219, US-SA-2024SA314219, US-SA-2024SA314804.  This case involves a 57 years old male patient who 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 04-Oct-2024, the patient received 0.5 ml 1x (once) INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (strength high dose) Suspension for injection in pre-filled syringe lot UT8473CA expiry-30-Jun-2025 via unknown route in the left arm for Immunization due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) (latency same day).   This situation is pre-assessed as a medication error/an inappropriate use due to Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well.  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-2024SA314786: US-SA-2024SA317011: US-SA-2024SA314254: US-SA-2024SA319049: US-SA-2020SA320383: US-SA-2024SA313313: US-SA-2024SA315389: US-SA-2024SA313312: US-SA-2024SA319070: US-SA-2024SA318876: US-SA-2024SA313309: US-SA-2024SA318981: US-SA-2024SA318878: US-SA-2024SA317025: US-SA-2024SA314805: US-SA-2024SA314787: US-SA-2024SA318875: US-SA-2024SA314087: US-SA-2024SA317152: US-SA-2024SA317108: US-SA-2024SA314219: US-SA-2024SA313313:
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 45-years old patient received FLUZONE HD, with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case US-SA-2024SA313311 (Master Case).            This case involves a 45 years old female patient who received 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 04-Oct-2024, the 45 years old female patient received 0.5 mL dose of suspect  influenza usp trival a-b high dose subvirion vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) (Suspension for injection in pre-filled syringe) (Frequency: once), (strength: high dose), (lot UT8473CA and expiry date: 30-Jun-2025) via unknown route in the right arm for Immunization.  Reportedly, The clinic reported that 29 people under the age of 65-years received FLUZONE HD due to a medication error during flu clinics and not paying attention.   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-2024SA313311:Master Case