chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: No adverse event, Product lot number issue
Clinical narrative: No additional AE; HCP called to report a GARDASIL 9 box was labeled with a separate lot number than what was listed on the products inside. Caller states the box has a lot of X024727 EXP: 05/15/2026 but the syringes inside are labeled Y007322 exp: 08/18/202 for one co; Poor quality vaccine administered; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The reporter informed that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection box was labeled with a separate lot number than what was listed on the products inside. The box had the valid lot number X024727, expiration date reported and confirmed as 15-MAY-2026 but the syringes inside were labeled with the valid lot number Y007322 expiration date reported and confirmed as 18-AUG-2026 for one container (3 doses were administered on unknown day to the patients as prophylaxis [dose: 0.5ml; strength, route of administration, and anatomical location were not provided]) (Product lot number issue/Poor quality product administered) and the second container had the correct lot and corresponding syringes inside with a matching lot number. In total, caller states 5 pre-filled syringes out of the 10 had the incorrect lot according to the product package and the other 5 were correct.   In addition, the reporter verified no damages to package upon current inspection but was not the one who opened the package upon product arrival to the facility and could not verify if any other damages or issues were noted upon receipt of product. It was also informed that the suspect vaccine was store in the fridge and in its original carton; multiple people had access to the product and it was not verified if they could have inadvertently caused the mix. No additional adverse events (no adverse event).  This is a non-valid case due to unspecified number of patients and lack of patients' identifiers.  Follow up information was received from the medical assistant on 18-NOV-2024.  The case referred to a 12 year old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 29-OCT-2024, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # Y007322, expiration date: 18-AUG-2026, administered intramuscular in the right arm. It was reported that the lot # did not match with the one in the box (lot # X024727). This discrepancy was noted during weekly immunization Audit.  This case was previously considered as non-valid since there was not patients' identifiers, upon follow up information patient's identifiers were received.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Product lot number issue
Clinical narrative: No additional AE; HCP called to report a GARDASIL 9 box was labeled with a separate lot number than what was listed on the products inside. Caller states the box has a lot of X024727 EXP: 05/15/2026 but the syringes inside are labeled Y007322 exp: 08/18/202 for one co; Poor quality vaccine administered; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The reporter informed that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection box was labeled with a separate lot number than what was listed on the products inside. The box had the valid lot number X024727, expiration date reported and confirmed as 15-MAY-2026 but the syringes inside were labeled with the valid lot number Y007322 expiration date reported and confirmed as 18-AUG-2026 for one container (3 doses were administered on unknown day to the patients as prophylaxis [dose: 0.5ml; strength, route of administration, and anatomical location were not provided]) (Product lot number issue/Poor quality product administered) and the second container had the correct lot and corresponding syringes inside with a matching lot number. In total, caller states 5 pre-filled syringes out of the 10 had the incorrect lot according to the product package and the other 5 were correct.   In addition, the reporter verified no damages to package upon current inspection but was not the one who opened the package upon product arrival to the facility and could not verify if any other damages or issues were noted upon receipt of product. It was also informed that the suspect vaccine was store in the fridge and in its original carton; multiple people had access to the product and it was not verified if they could have inadvertently caused the mix. No additional adverse events (no adverse event).  This is a non-valid case due to unspecified number of patients and lack of patients' identifiers.  Follow up information was received from the medical assistant on 18-NOV-2024.  The case referred to a 12 year old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. His historical vaccines included influenza seasonal vaccine. It was reported that the patient was taking over the counter dexmethylphedinate (FOCALIN). On 25-OCT-2024, the patient was vaccinated with the  second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # Y007322, expiration date: 18-AUG-2026, administered intramuscular in the left arm. It was reported that the lot # did not match with the one in the box (lot # X024727). This discrepancy was noted during weekly immunization Audit.  This case was previously considered as non-valid since there was not patients' identifiers, upon follow up information patient's identifiers were provided.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: No adverse event, Product label issue
Clinical narrative: No additional AE; HCP called to report a GARDASIL 9 box was labeled with a separate lot number than what was listed on the products inside. Caller states the box has a lot of X024727 EXP: 05/15/2026 but the syringes inside are labeled Y007322 exp: 08/18/202 for one co; Poor quality vaccine administered; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The reporter informed that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection box was labeled with a separate lot number than what was listed on the products inside. The box had the valid lot number X024727, expiration date reported and confirmed as 15-MAY-2026 but the syringes inside were labeled with the valid lot number Y007322 expiration date reported and confirmed as 18-AUG-2026 for one container (3 doses were administered on unknown day to the patients as prophylaxis [dose: 0.5ml; strength, route of administration, and anatomical location were not provided]) (Product lot number issue/Poor quality product administered) and the second container had the correct lot and corresponding syringes inside with a matching lot number. In total, caller states 5 pre-filled syringes out of the 10 had the incorrect lot according to the product package and the other 5 were correct.   In addition, the reporter verified no damages to package upon current inspection but was not the one who opened the package upon product arrival to the facility and could not verify if any other damages or issues were noted upon receipt of product. It was also informed that the suspect vaccine was store in the fridge and in its original carton; multiple people had access to the product and it was not verified if they could have inadvertently caused the mix. No additional adverse events (no adverse event).  This is a non-valid case due to unspecified number of patients and lack of patients' identifiers.  Follow up information was received from the medical assistant on 18-NOV-2024.  The case referred to a 12 year old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. His historical vaccines included influenza seasonal vaccine. It was reported that the patient was taking over the counter dexmethylphedinate (FOCALIN). On 25-OCT-2024, the patient was vaccinated with the  second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # Y007322, expiration date: 18-AUG-2026, administered intramuscular in the left arm. It was reported that the lot # did not match with the one in the box (lot # X024727). This discrepancy was noted during weekly immunization Audit.  This case was previously considered as non-valid since there was not patients' identifiers, upon follow up information patient's identifiers were provided.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Product lot number issue
Clinical narrative: No additional AE; HCP called to report a GARDASIL 9 box was labeled with a separate lot number than what was listed on the products inside. Caller states the box has a lot of X024727 EXP: 05/15/2026 but the syringes inside are labeled Y007322 exp: 08/18/202 for one co; Poor quality vaccine administered; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The reporter informed that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection box was labeled with a separate lot number than what was listed on the products inside. The box had the valid lot number X024727, expiration date reported and confirmed as 15-MAY-2026 but the syringes inside were labeled with the valid lot number Y007322 expiration date reported and confirmed as 18-AUG-2026 for one container (3 doses were administered on unknown day to the patients as prophylaxis [dose: 0.5ml; strength, route of administration, and anatomical location were not provided]) (Product lot number issue/Poor quality product administered) and the second container had the correct lot and corresponding syringes inside with a matching lot number. In total, caller states 5 pre-filled syringes out of the 10 had the incorrect lot according to the product package and the other 5 were correct.   In addition, the reporter verified no damages to package upon current inspection but was not the one who opened the package upon product arrival to the facility and could not verify if any other damages or issues were noted upon receipt of product. It was also informed that the suspect vaccine was store in the fridge and in its original carton; multiple people had access to the product and it was not verified if they could have inadvertently caused the mix. No additional adverse events (no adverse event).  This is a non-valid case due to unspecified number of patients and lack of patients' identifiers.  Follow up information was received from the medical assistant on 18-NOV-2024.  The case referred to a 16 year old non-pregnant female patient. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. His historical vaccines included influenza seasonal vaccine. Concomitant vaccines included pneumococcal conjugated vaccine. It was reported that the patient was taking over the counter sertraline (ZOLOFT). On 25-OCT-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # Y007322, expiration date: 18-AUG-2026, administered intramuscular in the left arm. It was reported that the lot # did not match with the one in the box (lot # X024727). This discrepancy was noted during weekly immunization Audit.  This case was previously considered as non-valid since there was not patients' identifiers, upon follow up information patient's identifiers were provided.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: No adverse event, Product label issue
Clinical narrative: No additional AE; HCP called to report a GARDASIL 9 box was labeled with a separate lot number than what was listed on the products inside. Caller states the box has a lot of X024727 EXP: 05/15/2026 but the syringes inside are labeled Y007322 exp: 08/18/202 for one co; Poor quality vaccine administered; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The reporter informed that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection box was labeled with a separate lot number than what was listed on the products inside. The box had the valid lot number X024727, expiration date reported and confirmed as 15-MAY-2026 but the syringes inside were labeled with the valid lot number Y007322 expiration date reported and confirmed as 18-AUG-2026 for one container (3 doses were administered on unknown day to the patients as prophylaxis [dose: 0.5ml; strength, route of administration, and anatomical location were not provided]) (Product lot number issue/Poor quality product administered) and the second container had the correct lot and corresponding syringes inside with a matching lot number. In total, caller states 5 pre-filled syringes out of the 10 had the incorrect lot according to the product package and the other 5 were correct.   In addition, the reporter verified no damages to package upon current inspection but was not the one who opened the package upon product arrival to the facility and could not verify if any other damages or issues were noted upon receipt of product. It was also informed that the suspect vaccine was store in the fridge and in its original carton; multiple people had access to the product and it was not verified if they could have inadvertently caused the mix. No additional adverse events (no adverse event).  This is a non-valid case due to unspecified number of patients and lack of patients' identifiers.  Follow up information was received from the medical assistant on 18-NOV-2024.  The case referred to a 16 year old non-pregnant female patient. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. His historical vaccines included influenza seasonal vaccine. Concomitant vaccines included pneumococcal conjugated vaccine. It was reported that the patient was taking over the counter sertraline (ZOLOFT). On 25-OCT-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # Y007322, expiration date: 18-AUG-2026, administered intramuscular in the left arm. It was reported that the lot # did not match with the one in the box (lot # X024727). This discrepancy was noted during weekly immunization Audit.  This case was previously considered as non-valid since there was not patients' identifiers, upon follow up information patient's identifiers were provided.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dysphonia, Influenza virus test, Musculoskeletal discomfort, Nasal congestion, Nasopharyngitis
Clinical narrative: Effecting her voice; A little darkening of skin in the area; uncomfortable,  warm to touch, at the injection site; uncomfortable,  warm to touch, at the injection site; cold; congestion; Discomfort in her shoulder; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "Effecting her voice"; VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown", described as "A little darkening of skin in the area"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown" and all described as "uncomfortable,  warm to touch, at the injection site"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "recovered", described as "Discomfort in her shoulder". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter stated that she probably had a reaction, a little darkening of skin in the area, uncomfortable, and warm to touch, at the injection site. The patient also has cold symptoms. She was testing because she wanted to see if she is safe for going out this weekend. The patient has had the COVID-19 flu and home test. The patient was feeling well, but with some congestion the last day or two and it was effecting her voice. She also reported that the discomfort in her shoulder has passed.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: SARS-CoV-2 test, Vaccination site discolouration, Vaccination site discomfort, Vaccination site warmth
Clinical narrative: Effecting her voice; A little darkening of skin in the area; uncomfortable,  warm to touch, at the injection site; uncomfortable,  warm to touch, at the injection site; cold; congestion; Discomfort in her shoulder; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "Effecting her voice"; VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown", described as "A little darkening of skin in the area"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown" and all described as "uncomfortable,  warm to touch, at the injection site"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "recovered", described as "Discomfort in her shoulder". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter stated that she probably had a reaction, a little darkening of skin in the area, uncomfortable, and warm to touch, at the injection site. The patient also has cold symptoms. She was testing because she wanted to see if she is safe for going out this weekend. The patient has had the COVID-19 flu and home test. The patient was feeling well, but with some congestion the last day or two and it was effecting her voice. She also reported that the discomfort in her shoulder has passed.  Batch/lot number is not provided, and it cannot be obtained.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD was administered instead of the intended FLUZONE NP with no reported adverse event; Initial information received on 07-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 34 years old male patient to whom Influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] was administered instead of the intended influenza USP trival A-B subvirion no preservative vaccine [Fluzone NP] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Nov-2024, the patient was administered 0.5 ml dose (once) of suspect Influenza USP trival A-B high dose subvirion vaccine, Suspension for injection in pre-filled syringe (strength; not reported), (lot UT8437AA; Expiration Date :30-Jun-2025) via intramuscular route in the left deltoid for Influenza instead of the intended Fluzone NP with no reported adverse event (wrong product administered) (latency: same day)  Reporter asked if there's any reaction that the patient will have and what should they expect.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok dose was given in error to a person who is only 16-years of age with no adverse event; Initial information received on 15-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Influenza trivalent recombinant vaccine [Flublok TIV] dose was given in error to a person who is only 16-years of age Male with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Oct-2024, the 0.5 ml dose of suspect  Influenza trivalent recombinant vaccine, Solution for injection (strength not reported) (lot TFAA2422 expiry date: 31-May-2025) via unknown route in the left arm for Immunization was given in error to a person who is only 16-years of age with no adverse event (product administered to patient of inappropriate age) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone hd was inadvertently administered to a patient for whom it was not indicated with no reported adverse event; Initial information received on 07-Nov-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 43 year old male patient who had influenza USP trival A-B high dose subvirion vaccine [FLUZONE HD] was inadvertently administered to a patient for whom it was not indicated 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 tozinameran (comirnaty) for Immunisation.  On 11-Jun-2024, the patient received 0.5 ml of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe standard (Unknown strength) once with lot UT8425BA and expiry date 30-Jun-2025 via intramuscular route in the left deltoid for Influenza was inadvertently administered to a patient for whom it was not indicated 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: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was provided with the DTAP-IPV component without HIB with no reported adverse event; Initial information received on 07-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 15 months old male patient who was provided with the DTAP-IPV component without HIB with no reported adverse event for Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Nov-2024, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection once (lot UK044AA, expiry date- 31-AUG-2025) via intramuscular route in unknown administration site for Immunization; with the DTAP-IPV component without HIB with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, Caller asked if the DTAP-IPV component of PENTACEL would count as a valid. No adverse events occurred.  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: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: act-hib vaccine reconstituted with sterile water instead of 0.4% sodium chloride with no reported adverse event; Initial information received on 08-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who may have received HIB (PRP/T) VACCINE [ACT-HIB] reconstituted with sterile water instead of 0.4% sodium chloride 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, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 08-Nov-2024, the patient may have received 0.5 ml dose once of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (strength not reported) (lot UK168AC; Expiration Date :31-Oct-2025) via unknown route in unknown administration site for Immunization which was reconstituted with sterile water instead of 0.4% sodium chloride with no reported adverse event (product preparation error) (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: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: second dose of fluzone hd was given to a patient with no reported adverse event; Initial information received on 08-Nov-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72-year-old female patient whom second dose of influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] was given 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 Tozinameran (Comirnaty); and Varicella zoster vaccine rgE (CHO) (Shingrix) for Immunisation.  On 06-Nov-2024, the patient received a 0.5 ml dose (dose 2) of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe frequency: once and strength: standard of lot UT8419AA and expiry date: 30-Jun-2025 via intramuscular route in the right deltoid and previously On 26-Oct-2024 she also received a 0.5 ml dose (dose 1) of vaccine with an unknown batch number via intramuscular route in the right deltoid for Influenza with no reported adverse event (extra dose administered) (latency: on same day of second dose).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Max/Low temperature reached: 1.6°C and Duration out of labelled range: 6 Hours and 21 Minutes; patients that received the IPOL; Initial information received on 11-Nov-2024 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] that exposed to max/low temperature reached: 1.6°c and duration out of labelled range: 6 hours and 21 minutes and patients that received the ipol.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the suspect IPV (VERO) Suspension for injection (unknown strength, lot and expiry date) for prophylactic vaccination (immunization) exposed to max/low temperature reached: 1.6°c and duration out of labelled range: 6 hours and 21 minutes (product storage error).  On an unknown date the patient received the IPV (VERO) Suspension for injection (unknown strength, lot and expiry date) for prophylactic vaccination (immunization) (poor quality product administered) (latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Reporter statetd that We had a temperature excursion on our vaccine refrigerator and based on the stability calculator, they were not stable. We have 3 patients that received the IPOL and we did not know about the temperature excursion, so I need to find out what steps to take   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 62 years old administered fluzone with no reported adverse event; Initial information received on 12-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 62 years old female patient who administered influenza usp trival a-b high dose subvirion vaccine [fluzone HD] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Nov-2024, the patient received 0.5 ml dose of suspect Suspension for injection in pre-filled syringe of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UT8437AA, Expiry date: 30-Jun-2025, Strength: high, frequency: once) via intramuscular route in the left deltoid for influenza (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: 12.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 12 years old patient received fluzone with no reported adverse event; Initial information received on 12-Nov-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to US-SA-2024SA334730 and US-SA-2024SA334990  This case involves a 12 years old male 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 an unknown date, the patient received a dose of suspect Suspension for injection in pre-filled syringe of influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] (lot U8429CA, Expiry date: 30-Jun-2025) (dose, strength, route, administration site was unknown) as influenza (product administered to patient of inappropriate age) (Latency: same day)   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA334730:linked case US-SA-2024SA334990:linked case
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Underdose
Clinical narrative: received half of the vaccine with no reported adverse event; Initial information received on 12-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who received half of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  Concomitant medications included rotavirus vaccine and pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) both for Immunisation.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Nov-2024, the patient received 0.5 ml dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength- standard, expiry date- 30-Apr-2025, lot UK023AA) once via intramuscular route in leg and received half of it with no reported adverse event (incorrect dose administered) (latency- same day).  Reportedly, it was the green cap part which was administered after being diluted with sterile water.  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: 31.0
Sex: F
Vaccine: UNK
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: They believed the patient received a partial dose with no adverse event; The product that leaked out of the syringes did come in contact with the patient's skin with no adverse event; The product that leaked out of the syringes did come in contact with the patient's skin with no adverse event; Initial information received on 13-Nov-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 31 years old female patient and reporter stated that they believed the patient received a partial dose of influenza trivalent recombinant vaccine [flublok TIV] with no adverse event and the product that leaked out of the syringes did come in contact with the patients skin with no adverse event.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On 12-Nov-2024, the patient received 0.5 ml of suspect Influenza trivalent recombinant vaccine Solution for injection standard with lot TFAA2439 and expiry date 29-Jun-2025 once via intramuscular route in the right deltoid for immunization.  On 12-Nov-2024 the patient received a partial dose of 0.5 ml of suspect Influenza trivalent recombinant vaccine Solution for injection standard with lot TFAA2439 and expiry date 29-Jun-2025 once via intramuscular route in the right deltoid for immunization with no adverse event (incorrect dose administered) (latency same day) and the product that leaked out of the syringes did come in contact with the patient's skin with no adverse event (accidental exposure to product) (exposure via skin contact) (Latency same day).  Reportedly, A phlebotomist made two attempts to administer flublok to a patient. The product exploded out of the first syringe and none of the product was administered to the patient. During the second attempt, some of the product leaked out, but not as much. They believed the patient received a partial dose. The product that leaked out of the syringes did come in contact with the patients skin.   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: Expired product administered, No adverse event
Clinical narrative: receive an expired dose with no reported adverse event; Initial information received on 13-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown demographics who receive an expired dose of 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 13-Nov-2024, the patient received an unknown expired dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection of lot UJ977AA and expiry date: 08-Nov-2024 (strength: not reported) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency: on same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event
Clinical narrative: patient was administered PENTACEL with a diluent of sterile water with no adverse event; Initial information received on 13-Nov-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an 8-month-old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] in which a diluent of sterile water was used with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Nov-2024, the patient received 0.5 ml (dose 3) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot UJ984AA; Expiration Date : 12-MAR-2025) via intramuscular route in the right thigh for Immunization in which a diluent of sterile water was used with no adverse event (product preparation error) (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: 1.25
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: PENTACEL vaccine due a medication error with PENTACEL described as the two components were not mixed together but only the DTAP-IPV portion was given to the patient with no reported adverse event; Initial information received on 14-Nov-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 1 years old and unknown gender patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] due a medication error with pentacel described as the two components were not mixed together but only the dtap-ipv portion was given to the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Prevnar 20 for Immunization.   On 16-Oct-2024, the patient received a  dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) lot UJ985AA, Expiry date:14- Feb-2025, strength was unknown via unknown route in the right thigh for Immunziation and pentacel vaccine due a medication error with pentacel described as the two components were not mixed together but only the dtap-ipv portion was given to the patient with no reported adverse event (product preparation error) (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: 70.0
Sex: M
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: given the FLUBLOK vaccine by mistake.She said they meant to give the FLUZONE HD; Initial information received on 14-Nov-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 the influenza trivalent recombinant vaccine [Flublok TIV] by mistake as they meant to give the influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Nov-2024, the patient received an unknown dose of influenza trivalent recombinant vaccine Solution for injection (strength- standard, expiry date and lot number not reported) once via subcutaneous route in the arm NOS (not otherwise specified) for Influenza by mistake as they meant to give the influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, lot and expiry date not reported) (wrong product administered) (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.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given a 13-day old expired PENTACEL vaccine with no reported adverse event; Initial information received on 14-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 months old female patient who was given a 13-day old expired 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.   On 14-Nov-2024, the patient received a expired dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) (lot UJ970AA, Expiry date: 03-Nov-2024, strength: standard, frequency: once, dose, route, administration site was unknown) as immunization (expired 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.