chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: ADACEL being administered instead of PENTACEL with no reported adverse event; Initial information received on 11-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-month-old male patient who received diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel] 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 Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) and Rotavirus vaccine live oral 1v (Rotarix) for Immunisation.  On 08-Oct-2024, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot U8231AA and expiry date: 31-May-2026 via intramuscular route in unknown administration site for immunization instead of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine with no reported adverse event (wrong product administered) (latency: on same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: act-hib. the vaccine was re-constituted with a different diluent that did not come in the box and administered to a patient. instead of sodium chloride, it was mixed with a sterile water from a Merck vaccine with no ae; Initial information received on 11-Oct-2024 regarding an unsolicited valid  non-serious case received from  other health professional.  This case involves a patient (age and gender :unknown ) who received Haemophilus Type B (Hib) Vaccine[Act-Hib] which was re-constituted with a different diluent that did not come in the box and administered to a patient. Instead of sodium chloride, it was mixed with a sterile water from a Merck vaccine 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 Hib (Prp/T) Vaccine Powder and solvent for solution for injection (dose, strength, lot number, expiration date, route and administration site: unknown) which was re-constituted with a different diluent that did not come in the box and administered to a patient. Instead of sodium chloride, it was mixed with a sterile water from a merck vaccine with no reported adverse event (product preparation error) (latency: same day) for Immunization.  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: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administration of only the liquid component of PENTACEL without the powder with no reported adverse event; Initial information received on 14-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 9 weeks old female patient who had administration of only the liquid component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] without the powder 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 Nirsevimab (Beyfortus); Rotavirus vaccine for Immunisation; pneumococcal vaccine for Immunisation; and Hepatitis b vaccine for Immunisation.  On 14-Oct-2024, the patient had administration of only the liquid component of Standard dose of 0.5 ml once of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection (lot UK043AA, expiry date- 31-AUG-2025) via unknown route in unknown administration site for Immunization; without the powder with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, Medical assistant administered just the PENTACEL liquid but was not able to administer the powder part. Now, they have extra powder so they would like to know how they can order just the liquid part.   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: Incorrect dose administered, No adverse event
Clinical narrative: one of the nurses, possibly got a 10 mL syringe and drew up all 5 mL from a vial and administered 5 mL each, to 2 patients with no reported AE; Initial information received on 15-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 2 patients of an unknown age and gender and it was reported that one of the nurses, possibly got a 10 ml syringe and drew up all 5 ml from a vial and administered 5 ml each of influenza trival A-B subvirion vaccine [Fluzone], to 2 patients 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 one of the nurses, possibly got a 10 ml syringe and drew up all 5 ml from a vial and administered 5 ml each of influenza trival A-B subvirion vaccine (Suspension for injection) (lot number; strength; expiry date unknown), to 2 patients with no reported adverse event (overdose) (latency: same day) via unknown route in unknown administration site for Immunisation.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Peripheral swelling, Skin warm
Clinical narrative: the site is hot to touch; tenderness; swelling that migrated down her left arm; Initial information received on 15-Oct-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 24 years old female patient who had the site is hot to touch, tenderness and swelling that migrated down her left arm after receiving vaccine Influenza trivalent recombinant vaccine [flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine PROT. subunit (NVX COV 2373) (novavax covid-19 vaccine) for Immunization.  On 13-Oct-2024, the patient received standard dose of 0.5 ml of influenza trivalent recombinant vaccine once with lot U8447AA and unknown expiry date via unknown route in the left arm for immuization.  On an unknown date the patient developed the site is hot to touch (vaccination site warmth), tenderness and welling that migrated down her left arm (peripheral swelling)  (unknown latency) following the administration of influenza trivalent recombinant vaccine.  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 the events.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Tenderness
Clinical narrative: the site is hot to touch; tenderness; swelling that migrated down her left arm; Initial information received on 15-Oct-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 24 years old female patient who had the site is hot to touch, tenderness and swelling that migrated down her left arm after receiving vaccine Influenza trivalent recombinant vaccine [flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine PROT. subunit (NVX COV 2373) (novavax covid-19 vaccine) for Immunization.  On 13-Oct-2024, the patient received standard dose of 0.5 ml of influenza trivalent recombinant vaccine once with lot U8447AA and unknown expiry date via unknown route in the left arm for immuization.  On an unknown date the patient developed the site is hot to touch (vaccination site warmth), tenderness and welling that migrated down her left arm (peripheral swelling)  (unknown latency) following the administration of influenza trivalent recombinant vaccine.  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 the events.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administration of ACTHIB to a patient that had not been reconstituted with the ACTHIB specific diluent with no ae; Initial information received on 15-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 months old female patient who had administration of hib (prp/t) vaccine [Act-Hib] that had not been reconstituted with the acthib specific diluent 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 DTAP, VARICELLA, and FLU  On 11-Oct-2024, the patient received a dose 4 of 0.5 ml dose of suspect Powder and solvent for solution for injection of hib (prp/t) vaccine (lot UK008AA, Expiry date: 31-Dec-2024, strength: standard, frequency: once) via intramuscular route in the left thigh as immunization and it had not been reconstituted with the acthib specific diluent with no ae (product preparation error) (Latency: same day)  Caller was not aware of any adverse reactions. No treatment necessary post administration   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: refrigerator they have on site was about 40 F and when it was packed up inside, it was at 35.7/ it went down to 29.8 F with no reported adverse event; administration of FLUZONE NP which is deemed not suitable for use after a temperature excursion with no reported adverse event; Initial information received on 15-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves unknown age and gender patient who received the suspect Influenza Vaccine Trivalent [FLUZONE] was exposed to  refrigerator they had on site was about 40 Fahrenheit and when it was packed up inside, it was at 35.7, it went down to 29.8 Fahrenheit with no reported adverse event and administration of Fluzone Np which is deemed not suitable for use after a temperature 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  dose of suspect Influenza Vaccine Trivalent [FLUZONE] suspension for injection (lot U8531BA, expiry date: 30-JUN-2025) (unknown strength, dosage and route) in unknown administration site for Influenza as the refrigerator they had on site was about 40 Fahrenheit and when it was packed up inside, it was at 35.7 it went down to 29.8 Fahrenheit with no reported adverse event  (product storage error) and administration of Fluzone Np which is deemed not suitable for use after a temperature excursion with no reported adverse event (poor quality product administered) (unknown latency).   Reportedly, caller said they had a flu clinic today. He says that when they packed the cooler, the temperature of the vaccines was 35.7F.  He says that at one point, the temperature probe registered at 29.8F and may have been at that temp for 2 hours. Caller also said that the vaccine was administered to patients. Caller said that there was patient administered after but it is unknown to him at the time of the call. He said it might have been 23 patients.  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: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: vaccine was diluted with Sterile water instead of NaCl and administered with no adverse event; Initial information received on 15-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient for whom yellow fever vaccine- US [YF-VAX] was diluted with sterile water instead of nacl and administered 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 in 2024, the patient received yellow fever vaccine- US Solution for injection via unknown route in unknown administration site for Immunization (strength, dose, batch and expiry date unknown) was diluted with sterile water instead of nacl and administered with no adverse event (product preparation error) (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.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Discomfort, Pruritus, Rash
Clinical narrative: feel uncomfortable when he was trying to sleep; developed a total body rash, when he woke up on Saturday, he had rash on his chest and forearm; on Friday night he started to itch; Initial information received on 16-Oct-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional(patient).  This case involves a 70 years old male patient who had feel uncomfortable when he was trying to sleep, developed a total body rash, when he woke up on saturday, he had rash on his chest and forearm and on friday night he started to itch after receiving COVID-19 Vaccine and 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 09-Oct-2024, the patient received a  dose of 0.5 ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine lot U8499CA, Expiry date, strength was unknown via intramuscular route in the left arm for Immunization. On an unknown date, the patient received a  dose of suspect COVID-19 Vaccine not produced by Sanofi Pasteur lot number, strength, expiry date, formulation not reported via unknown route in unknown administration site for Covid-19 vaccination .  On 11-OCT-2024 the patient feel uncomfortable when he was trying to sleep (discomfort), developed a total body rash, when he woke up on saturday, he had rash on his chest and forearm (rash) and  on friday night he started to itch (pruritus) (latency : 2 days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and (unknown latency) following the administration of COVID-19 Vaccine.  Reportedly "He presumes it is from the vaccine as there were no other changes with him, including his diet. He said he received the Sanofi flu vaccine last year and he did not have a reaction. He was wondering if there were any changes with the components of this year and last years vaccine. Caller mentioned that he also received his COVID Vaccine a week or two before he got his Fluzone HD shot and was wondering what caused him to have a reaction. Caller wanted to know about if there was any change from the last year`s vaccine to this year's one. He also wanted to know what to do next year as well. Caller mentioned his symptoms are resolving."  Action taken was not applicable for both the events.  It was not reported if the patient received a corrective treatment for  all the events.  At time of reporting, the outcome was Recovering / Resolving for all the events.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Syringe issue
Clinical narrative: attached the needle and pulled it down to push in the vaccine vial, the diluent seeped out the back of the syringe barrel where the plunger comes in and got onto their hand with no reported AE; Initial information received on 16-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 63-year-old female patient and is reported RABIES (HDC) VACCINE [IMOVAX RABIES] attached the needle and pulled it down to push in the vaccine vial, the diluent seeped out the back of the syringe barrel where the plunger comes in and got onto their hand 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, RABIES (HDC) Vaccine Powder and solvent for suspension for injection of lot 768914, X1B611M and expiry date: Jul-2026 (strength, dose: not reported) via unknown route in unknown administration site for immunization and reported the needle and pulled it down to push in the vaccine vial, the diluent seeped out the back of the syringe barrel where the plunger comes in and got onto their hand with no reported ae (accidental exposure to product) (latency: on same day).  Reportedly, nurse wasted a diluent. They never punctured the vial with the IMOVAX RABIES vaccine powder. They wanted to know if they could use a different diluent instead or if they should order a whole new vaccine.  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: 55.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 55 year old patient administered fluzone hd with no adverse event; Initial information received on 16-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  The case is linked to US-SA-2024SA313845.  This case involves a 55 years old female patient who was administered Influenza  Trival A-B High Dose Subvirion Vaccine [Fluzone HD] with no adverse event.  The patient's past medical history included Immunodeficiency with she is on an immunosuppressant for psoriasis. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2024, the patient received a  dose of 0.5 ml 1x of suspect Influenza  Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot U8521AA, Expiry date: 30-Jun-2025, strength was unknown via intramuscular route in the left deltoid for Immunization and 55 year old patient administered fluzone hd with no adverse event (product administered to patient of inappropriate age) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to FLUZONE HD was administered to 2 patients under 65 years old. "   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-2024SA313845:patient 1
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 52 year old patient administered fluzone hd with no adverse event; Initial information received on 16-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  The case is linked to US-SA-2024SA313898.  This case involves a 52 years old female patient who was administered Influenza Trival A-B High Dose Subvirion Vaccine [Fluzone HD] with no adverse event.  The patient's past medical history included Immunodeficiency with she is on an immunosuppressant for psoriasis. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2024, the patient received a  dose of 0.5 ml 1x of suspect Influenza Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot U8521AA, Expiry date:30-Jun-2025, strength was unknown via intramuscular route in the left deltoid for Immunization and 52 year old patient administered fluzone hd with no adverse event (product administered to patient of inappropriate age) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to FLUZONE HD was administered to 2 patients under 65 years old."  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-2024SA313898:patient 1
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of last year's FLUZONE HD QIV with no reported adverse event; Initial information received on 16-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  The case is linked to US-SA-2024SA314652.  This case involves a 58 years old male received an expired dose of last year's INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications  and family history were not provided.   On 16-Oct-2024, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UT8131CA , Expiry date: 30-Jun-2024, (expired product administered) ,strength was unknown via intramuscular route in the 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.; Sender's Comments:  US-SA-2024SA314652:
Age: 3.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: child received vaccine which was expired by 1 month with no reported adverse event; Initial information received on 17-Oct-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 3 years old and unknown gender patient where child received diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel] which was expired by 1 month 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 4 of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (strength, lot/batch number and expiration date: not provided) for Immunisation and child received vaccine which was expired by 1 month with no reported adverse event (expired product administered) (latency- same day).  Information regarding batch number and expiration date corresponding to the one at a 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: 9.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok was given to 9-year-old patient with no reported adverse event; Initial information received on 17-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 years old male patient to whom Influenza trivalent recombinant vaccine [Flublok TIV] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2024, the 0.5 ml dose of Influenza trivalent recombinant vaccine, Solution for injection (lot TFAA2436; Expiration Date : 30-Jun-2025) via intramuscular route in unknown administration site for influenza was given to 9-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.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: patients received the first injection of ipol and developed hives and rashes on the back; patients received the first injection of ipol and developed hives and rashes on the back; low grade fever after the injection; Initial information received on 17-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 3 years old female patient who received the first injection of IPV (VERO) [IPOL] and developed hives and rashes on the back, and low grade fever.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Mar-2023, the patient received 0.5 ml of IPV (VERO) Suspension for injection (strength- standard, lot V18891M and expiry date- 01-JUN-2024) once via intramuscular route in leg for Immunization.   On an unknown date the patient developed hives and rashes on the back (urticaria) (rash) and low grade fever after the injection (pyrexia) (unknown latency) following the administration of IPV (VERO).  Reportedly, there was a doctor's office visit. This was the only vaccine administered on that date.  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: 2.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: reports that 0.7 ml of 0.4% nacl was used instead of the diluent that was supplied with no reported adverse event; Initial information received on 17-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2-year-old male patient and is reported that 0.7 ml of 0.4% NaCl was used instead of the diluent that was supplied in HIB (PRP/T) VACCINE [ACT-HIB] 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 0.5 ml dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection frequency: once and strength: standard of lot UK021AA (expiry date: not reported) via intramuscular route in the left thigh for immunization and is reported that 0.7 ml of 0.4% NaCl was used instead of the diluent that was supplied with no reported adverse event (product preparation error) (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: 55.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: administration of flublok that had undergone a temperature excursion and was no longer suitable for use with no adverse event; Initial information received on 17-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 55 years old female patient with administration of INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK TIV] that had undergone a temperature excursion and was no longer suitable for use with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Pregnancy: No  On 17-Oct-2024, the patient received 0.5 ml of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE lot U8440AA expiry-30-Apr-2025 once (Strength = standard) via intramuscular route in the right deltoid for influenza that had undergone a temperature excursion and was no longer suitable for use with no adverse event (poor quality product administered) (latency same day).  Reportedly, No adverse reactions at the time of the call. No treatment necessary post administration. The lowest temperature reached 23.5 F (approximately NEGATIVE 4 C per caller) and the total time out of range was 21 hours. Caller noted that the 21 hours consisted of 7 instances that lasted 3 hours each that the products went out of range. They were informed that the products were not suitable for use.   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: 71.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Product preparation issue
Clinical narrative: after full injection, she noticed the milky film inside completed syringe with no reported adverse event; Initial information received on 17-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 71 years old female patient who received vaccine Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] and after full injection, she noticed the milky film inside completed syringe, 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 suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection (strength: not reported) (lot: U8303AA, Expiry date: 30-Sep-2026) and after full injection, she noticed the milky film inside completed syringe, with no reported adverse event (poor quality product administered) (latency: same day) via unknown route in unknown administration site for Immunization.  Reportdely, They had a client given Tenivac by nurse. She reports she did not vigorously shake the product before administration. It was after full injection, she noticed the milky film inside completed syringe.  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: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: TENIVAC was stored at beverage/drinks cooler.Max/low temperature reached/human error/duration more than 72 hours (with no reported adverse event); TENIVAC was administered post-excursion with no reported adverse event; Initial information received on 17-Oct-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 2 patients with unknown details who received Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult that was stored at beverage/drinks cooler for max/low temperature reached/human error/duration more than 72 hours (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, the patient(s) received a dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [TENIVAC] Suspension for injection (lot number: U8207AC and expiry: 31-MAY-2026), injection (dose, strength and route: unknown), in unknown administration site for Immunization that was stored at beverage/drinks cooler for max/low temperature reached/human error/duration more than 72 hours with no reported adverse event (poor quality product administered) (latency : same day).  On an unknown date the, the patient(s) received a dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [TENIVAC] that was stored at beverage/drinks cooler for max/low temperature reached/human error/duration more than 72 hours with no reported adverse event (product storage error) (lot number: U8207AC and expiry: 31-MAY-2026).  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: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient was treated with expired  Influenza Quadrival A-B High Dose Hv Vaccine with no adverse event; Initial information received on 17-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 78 years old female patient who was treated with expired Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2024, the patient received a dose of  0.7 ml 1X (once), Influenza Quadrival A-B High Dose Hv Vaccine(lot: UT8072DA, Expiry:Jun-2024) via intramuscular route in the right arm (strength: unknown) (expired product administered) (latency: same day) 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.
Age: 0.33
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of FLUZONE NP to a 4 month old baby with no adverse event; Initial information received on 17-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who received  Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], 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, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Vaxelis) ; Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20); and Rotavirus vaccine live oral 1v (Rotarix) [all for Immunisation].  On 17-Oct-2024, the patient received 0.5ml,1X (once), Influenza Usp Trival A-B Subvirion No Preservative Vaccine ,Suspension for injection (lot UT8496JA,expiry-Jun-2025) via intramuscular route in the right thigh (strength: unknown) with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) 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: No adverse event, Poor quality product administered
Clinical narrative: one of the  vials (vial 1) containing particulates, some doses were administered to  patients yesterday with no AE; Initial information received on 18-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient who received Influenza Usp Trival A-B Subvirion Vaccine [Fluzone] as reported one of the vials (vial 1) containing particulates, some doses were administered to  patients yesterday with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-OCT-2024, the patient received a dose of suspect Influenza Usp Trival A-B Subvirion Vaccine Suspension for injection (lot U8435AA) (unknown strength, dosage, expiry date and route) in unknown administration site for Influenza vaccination and as reported one of the  vials (vial 1) containing particulates,  some doses were administered to  patients yesterday with no adverse event (poor quality product administered) (latency-same day).  Reportedly, Particulates appearance was gray particulates, size between half of a millimeter to 1 millimeter. She remarked that it was the same color as the stopper and the size of the needed gauges they used, either sizes 25 or 18. Vial was punctured multiple times for vial 1 and once on vial 2 needle gauge size: 25- and 18-gauge blunt needle. They noticed it after puncturing. particle was settling down the bottom: The particulates tend to settle at the bottom of the vials. She said that they store the vaccines at the middle of the refrigerator and when they use the MDVs, they remove it from the carton, but if unused, the vials stay inside the carton. She said that she did shake it before using the MDV. She remarked that the particulates tend to settle at the bottom of the vial after shaking.   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: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a double dose of FLUZONE HD a couple of weeks apart with no AE; Initial information received on 18-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 70 years old male patient who received a double dose of influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] a couple of weeks apart 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 Pneumococcal vaccine for Immunisation.  On 19-Sep-2024, the patient received first dose and on 11-Oct-2024, the patient received second dose of suspect Suspension for injection in pre-filled syringe 0.5 ml of influenza usp trival a-b high dose subvirion vaccine (lot UT8425BA, Expiry date: 06-Aug-2025) intramuscularly  in left arm as influenza (extra dose administered) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to the  administration of ADACEL that may not  have been suitable for use after excursion 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 is linked to US-SA-2024SA314715 (Master case).  This case involves a 11 years old male patient to whom nurse had administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] that may not  have been suitable for use after excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunisation.  On 15-Oct-2024 at 01:50 pm, the patient received a 0.5 ml (Dose 2) dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 31-May-2026 and lot U8232AA) via intramuscular route in unknown administration site (right) as immunization and administration of adacel that may not  have been suitable for use after excursion with no reported adverse event. (poor quality product administered) (latency: same day).  Reportedly: " Previous Excursion: No, Human error: 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.; Sender's Comments:  US-SA-2024SA314715:#Menquadfi