chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTPPVHBHPB, MMRV, DTPPVHBHPB, MMRV
Symptoms: Urticaria
Clinical narrative: Patient began having hives throughout her body (Legs, back, Bottom, feet, chest, head); Product use in unapproved population (5 year old); This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2682483-1. The original narrative from the sender is the following:  Patient began having hives throughout her body (Legs, back, Bottom, feet, chest, head).  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Patient began having hives throughout her body (Legs, back, Bottom, feet, chest, head)". Due to the nature of the event, the causal relationship between Vaxelis and the event Product use in unapproved population (5 years old) was not applicable.  The case was classified as "Off Label Use" given that a 5-year-old was administered with Vaxelis.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, MMRV, DTPPVHBHPB, MMRV
Symptoms: Product use issue, Urticaria
Clinical narrative: Patient began having hives throughout her body (Legs, back, Bottom, feet, chest, head); Product use in unapproved population (5 year old); This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2682483-1. The original narrative from the sender is the following:  Patient began having hives throughout her body (Legs, back, Bottom, feet, chest, head).  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Patient began having hives throughout her body (Legs, back, Bottom, feet, chest, head)". Due to the nature of the event, the causal relationship between Vaxelis and the event Product use in unapproved population (5 years old) was not applicable.  The case was classified as "Off Label Use" given that a 5-year-old was administered with Vaxelis.  No further information is expected.
Sex: M
Vaccine: COVID19-2, DTPPVHBHPB, PNC13, RV5, COVID19-2, DTPPVHBHPB, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: We ONLY had the dark pink top Moderna 6month-5year vaccine at our center, which is what we gave; Lead and I later learned that we should have given a dark top, which lead was not even aware that that was an option and needed to be ordered.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2682525-1. The original narrative from the sender is the following:  Patient's mother requested to start the covid 10 series for patient. I spoke with and reviewed which vaccine to give with our lead pediatric nurse and covid 19 lead. We ONLY had the dark pink top Moderna 6month-5year vaccine at our center, which is what we gave. Lead and I later learned that we should have given a dark top, which lead was not even aware that that was an option and needed to be ordered. So we did not have the correct supply given to us.  Due to the nature of the event, the causal relationship between Vaxelis and the reported events "We ONLY had the dark pink top Moderna 6month-5year vaccine at our center, which is what we gave" and "Lead and I later learned that we should have given a dark top, which lead was not even aware that that was an option and needed to be ordered" was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMR, VARCEL, DTPPVHBHPB, HEPA, MMR, VARCEL
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Patient was given MMR in the left thigh, the evening of the vaccine the vaccine site got red and swollen to the size of a quarter by the next day it was swollen to baseball size; Patient was given MMR in the left thigh, the evening of the vaccine the vaccine site got red and swollen to the size of a quarter by the next day it was swollen to baseball size; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2684685-1. The original narrative from the sender is the following:  patient was given MMR in the left thigh, the evening of the vaccine the vaccine site got red and swollen to the size of a quarter by the next day it was swollen to baseball size.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Vaccination site erythema and Vaccination site swelling".   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMR, VARCEL, DTPPVHBHPB, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient was given MMR in the left thigh, the evening of the vaccine the vaccine site got red and swollen to the size of a quarter by the next day it was swollen to baseball size; Patient was given MMR in the left thigh, the evening of the vaccine the vaccine site got red and swollen to the size of a quarter by the next day it was swollen to baseball size; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2684685-1. The original narrative from the sender is the following:  patient was given MMR in the left thigh, the evening of the vaccine the vaccine site got red and swollen to the size of a quarter by the next day it was swollen to baseball size.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Vaccination site erythema and Vaccination site swelling".   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of product administration; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2686500-1. The original narrative from the sender is not provided.  Due to the nature of the event, the causal relationship between Vaxelis and " Inappropriate schedule of product administration" was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, DTPPVHBHPB, HEPA, MMRV
Symptoms: Fatigue, Urticaria
Clinical narrative: patient had developed hives around 24 hours after vaccines were administered. She noted they started on his legs and had started to spread to his arms and torso.; Mother reported patient was slightly more tired than usual, but otherwise had no other symptoms or different behaviors.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2686526-1. The original narrative from the sender is as follows:  Patient's mother called clinic >24 hours after vaccines and and notified us that the patient had developed hives around 24 hours after vaccines were administered. She noted they started on his legs and had started to spread to his arms and torso. No other symptoms were reported. Mother took patient to a local urgent care where he was treated with Benadryl and a steroid (according to mother). Within 8-12 hours hives had almost completely resolved. Mother reported patient was slightly more tired than usual, but otherwise had no other symptoms or different behaviors. Mother reported that patient has returned to normal self after all treatment.  The reporter assessed the causal relationship between Vaxelis and the event, "Urticaria" as related. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Fatigue".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site mass, Injection site nodule
Clinical narrative: Right thigh nodule/ Lump; Right thigh nodule/ Lump; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2686980-1. The original narrative from the sender is as follows:  Right thigh nodule/lump  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "injection site nodule and injection site mass".   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Immunisation reaction
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2023-09-06.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2687916-1. The original narrative from the sender is as follows:  Adverse effect of vaccines and biological substances, init on 2023-09-06.  Concomitant medication included Nystatin 100000 unit/gm ex crea.  Medical history included current illnesses atresia of bile ducts; diaper dermatitis; atresia of bile ducts, encntr for routine child health exam w/o abnormal findings; Encounter for immunization.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "Immunisation reaction".   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC13, VARCEL, DTPPVHBHPB, HEPA, MMR, PNC13, VARCEL
Symptoms: Immunisation reaction, Pyrexia, Rash
Clinical narrative: Mom reports today (9-28-23) that after receiving vaccines on 8/3/2023, child had a fever and rash all over her body; child had a fever and rash all over her body; child had a fever and rash all over her body; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2687989-1. The original narrative from the sender is as follows:  Mom reports today (9-28-23) that after receiving vaccines on 8/3/2023, child had a fever and rash all over her body and family took her to the ER around 8-4-2023. Mom says the ER doctor said it was from the vaccines. Child was not admitted to hospital, was sent home. Have not been able to get records from the hospital, have called mom to get ROI sighned but mom has not returned phone call.  The causal relationship between Vaxelis and the reported events of "Immunisation reaction, pyrexia and rash" was assessed as related.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC13, VARCEL, DTPPVHBHPB, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Mom reports today (9-28-23) that after receiving vaccines on 8/3/2023, child had a fever and rash all over her body; child had a fever and rash all over her body; child had a fever and rash all over her body; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2687989-1. The original narrative from the sender is as follows:  Mom reports today (9-28-23) that after receiving vaccines on 8/3/2023, child had a fever and rash all over her body and family took her to the ER around 8-4-2023. Mom says the ER doctor said it was from the vaccines. Child was not admitted to hospital, was sent home. Have not been able to get records from the hospital, have called mom to get ROI sighned but mom has not returned phone call.  The causal relationship between Vaxelis and the reported events of "Immunisation reaction, pyrexia and rash" was assessed as related.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, DTPPVHBHPB, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Product use in unapproved population (6 year old); This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2688023-1. The original narrative from the sender is the following:  N/A.  Due to the nature of the event, the causal relationship between Vaxelis and Product use in unapproved population (6 year old) was not applicable.  The case was classified as "Off Label Use" given that a 6 year old was administered with Vaxelis.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, DTPPVHBHPB, HEPA
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Product use in unapproved population (6 year old); This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2688023-1. The original narrative from the sender is the following:  N/A.  Due to the nature of the event, the causal relationship between Vaxelis and Product use in unapproved population (6 year old) was not applicable.  The case was classified as "Off Label Use" given that a 6 year old was administered with Vaxelis.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, PNC13, DTPPVHBHPB, HEPA, PNC13
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2688030-1. The original narrative from the sender is the following:  N/A.  Due to the nature of the event, the causal relationship between Vaxelis and the reported event "Extra dose administered" was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5, RVX
Symptoms: Peripheral swelling, Rash, Urticaria
Clinical narrative: swelling of the hands and feet at around 9pm; hives were still noted on face, arms, and legs as well and swelling to hands and feet; rash; This serious spontaneous safety report was retrieved from the Vaccines Adverse Event Reporting System (VAERS), VAERS Primary ID# 2694046-1, by a partner on 11-DEC-2023 and forwarded to Company on 14-DEC-2023 from a HCP. The original narrative from the sender is the following:  "Mom started to notice hives on the patients body and swelling of the hands and feet at around 9pm on 10/10/2023. Mom took patient to the nearest emergency department where they were given Benadryl and told to follow up with PCP. Patient was seen today 10/11/2023 and hives were still noted on face, arms, and legs as well and swelling to hands and feet. Patient advised to continue Benadryl every 8 hours and to go back to the emergency department if the rash becomes worse or patient develops any trouble breathing."  Due to the nature of the event, the causality between the events: "swelling of the hands and feet at around 9pm", "hives were still noted on face, arms, and legs as well and swelling to hands and feet", and "rash" and Vaxelis was assessed as related.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Crying, Feeling hot, Infant irritability, Productive cough, Pyrexia
Clinical narrative: Pt had extreme fussiness; screaming; He also has a runny nose; Congestion and productive cough; Congestion and productive cough; Pt was febrile on 10-9-23 thru 10-11-23 - pt felt warm; Crying starting the evening of his vaccinations (10-9-23) and up to today (10-12-23).; Pt was febrile on 10-9-23 thru 10-11-23 - pt felt warm; This spontaneous non-serious safety report, with reference number 2694821 (VAERS ID # 2694821-1) was received by the partner on 11-DEC-2023 and forwarded on 19-DEC-2023, from a health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events Pt had extreme fussiness, screaming, He also has a runny nose, Congestion and productive cough, Pt was febrile on 10-9-23 thru 10-11-23 - pt felt warm and crying starting the evening of his vaccinations (10-9-23) and up to today (10-12-23)  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Respiratory tract congestion, Rhinorrhoea, Screaming
Clinical narrative: Pt had extreme fussiness; screaming; He also has a runny nose; Congestion and productive cough; Congestion and productive cough; Pt was febrile on 10-9-23 thru 10-11-23 - pt felt warm; Crying starting the evening of his vaccinations (10-9-23) and up to today (10-12-23).; Pt was febrile on 10-9-23 thru 10-11-23 - pt felt warm; This spontaneous non-serious safety report, with reference number 2694821 (VAERS ID # 2694821-1) was received by the partner on 11-DEC-2023 and forwarded on 19-DEC-2023, from a health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events Pt had extreme fussiness, screaming, He also has a runny nose, Congestion and productive cough, Pt was febrile on 10-9-23 thru 10-11-23 - pt felt warm and crying starting the evening of his vaccinations (10-9-23) and up to today (10-12-23)  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Crying, Feeling hot, Irritability, Productive cough, Pyrexia
Clinical narrative: Pt had extreme fussiness; screaming; He also has a runny nose; Congestion and productive cough; Congestion and productive cough; Pt was febrile on 10-9-23 thru 10-11-23 - pt felt warm; Crying starting the evening of his vaccinations (10-9-23) and up to today (10-12-23).; Pt was febrile on 10-9-23 thru 10-11-23 - pt felt warm; This spontaneous non-serious safety report, with reference number 2694821 (VAERS ID # 2694821-1) was received by the partner on 11-DEC-2023 and forwarded on 19-DEC-2023, from a health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events Pt had extreme fussiness, screaming, He also has a runny nose, Congestion and productive cough, Pt was febrile on 10-9-23 thru 10-11-23 - pt felt warm and crying starting the evening of his vaccinations (10-9-23) and up to today (10-12-23)  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Hypophagia, Pallor, Sleep apnoea syndrome
Clinical narrative: Mom stated baby was sleepy for 3D; Did not eat well; Mom reported today (10/5/23) at time of 2 mo. visit after receiving vaccines all extremities turned pale; This non-serious spontaneous safety report, with ID number: 2695401(VAERS ID 2695401-1), was received by a partner on 11-DEC-2023 and forwarded on 14-DEC-2023, from a HCP. The original narrative from the sender is as following:   Mom reported today (10/5/23) at time of 2 mo. visit after receiving vaccines all extremities turned pale and stayed that way 5-10 min. Mom stated baby was sleepy for 3D and did not eat well. This incident was not documented in chart and nurse had no recollection of being notified no phone calls were received following. Mom refused vaccines at todays visit.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Mom reported today (10/5/23) at time of 2 mo. visit after receiving vaccines all extremities turned pale, Did not eat well, Mom stated baby was sleepy for 3D".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Decreased appetite, Pallor, Somnolence
Clinical narrative: Mom stated baby was sleepy for 3D; Did not eat well; Mom reported today (10/5/23) at time of 2 mo. visit after receiving vaccines all extremities turned pale; This non-serious spontaneous safety report, with ID number: 2695401(VAERS ID 2695401-1), was received by a partner on 11-DEC-2023 and forwarded on 14-DEC-2023, from a HCP. The original narrative from the sender is as following:   Mom reported today (10/5/23) at time of 2 mo. visit after receiving vaccines all extremities turned pale and stayed that way 5-10 min. Mom stated baby was sleepy for 3D and did not eat well. This incident was not documented in chart and nurse had no recollection of being notified no phone calls were received following. Mom refused vaccines at todays visit.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Mom reported today (10/5/23) at time of 2 mo. visit after receiving vaccines all extremities turned pale, Did not eat well, Mom stated baby was sleepy for 3D".  No further information is expected.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: There were no side effects, adverse outcomes, or unexpected reactions experienced by patient; TE for GARDASIL 9 (Lot #1957405 expiration: 11/11/2025) that had been administered to a patient on 11/27/2023; This spontaneous report was received from an office manager (also reported as "HBP") concerning to a 14-year-old patient of unspecified gender.   The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 18-NOV-2023, a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) underwent a temperature excursion with low temperature of 33.15 degrees Fahrenheit (F) for 1 hour, 8 minutes and 0 seconds with zero previous excursions and an evaluation outcome that was supported.  On 27-NOV-2023, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, 0.5ml/once, lot #1957405, expiration date: 11-NOV-2025 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  There were no side effects, adverse outcomes, or unexpected reactions experienced by the patient (no adverse event.)
Age: 0.58
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; inadvertently administered GARDASIL 9 instead of the influenza vaccine on 12/21/2023.; 7 and 1/2 months old; This spontaneous report was received from a consumer (the patient's grandmother) referring to a 7-and-a-half-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 21-DEC-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) inadvertently instead of the influenza vaccine by a healthcare professional for prophylaxis (wrong product administered and product administered to patient of inappropriate age). No symptoms reported. No additional adverse events (AE) were reported (no adverse event).
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: developing shingles 6 months after his second SHINGRIX vaccine/suspected vaccination Failure; Shingles; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13-JUN-2023, the patient received the 2nd dose of Shingrix (left deltoid). On an unknown date, the patient received the 1st dose of Shingrix. In DEC-2023, 6 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: developing shingles 6 months after his second SHINGRIX vaccine/suspected vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 22-DEC-2023 A reporter reported that a patient developing shingles 6 months after his second Shingrix vaccine. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles was unknown at the time of reporting.  The reporter consented to follow up.
Age: 0.33
Sex: U
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered
Clinical narrative: Nurse reported patient received ENGERIX B when a newborn (03/13/2023), at age 1 month (04/13/2023),at age 2 months (05/18/2023) and age 4 months (07/10/2023),however received one additional dose of hepatitis B vaccine in the process; Nurse reported patient received ENGERIX B when a newborn (03/13/2023), at age 1 month (04/13/2023),at age 2 months (05/18/2023) and age 4 months (07/10/2023),however received one additional dose of hepatitis B vaccine in the process; This spontaneous safety report, with reference number 02483890 (Interaction# 02483873), was received by the partner on 03-OCT-2023 and forwarded to UBC on 03-OCT-2023, from a health professional.  Due to the nature of the event, the causality between the event "Nurse reported patient received ENGERIX B when a newborn (03/13/2023), at age 1 month (04/13/2023), at age 2 months (05/18/2023) and age 4 months (07/10/2023), however received one additional dose of hepatitis B vaccine in the process" and Vaxelis is not applicable.   Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Accident at work, Skin laceration, Syringe issue, Wound
Clinical narrative: The nurse was administering the vaccine (vaxelis) and the top of the barrel broke off as she finished pushing the plunger in. The vaccine was safely administered and the Patient was not hurt; When nurse was administering the vaccine (Vaxelis) the plunger broke right at the end of push and cut her.The nurse did sustain a laceration; This spontaneous non-serious safety report, with reference number 2023SA302967 (Inquiry number 1-2831437271), was received by the partner on 03-OCT-2023 and forwarded on 05-OCT-2023. Additional information was received by the partner on 05-OCT-2023 and forwarded on 08-OCT-2023, from a health professional    Due to the nature of the event, the causality between the events "The nurse was administering the vaccine (vaxelis) and the top of the barrel broke off as she finished pushing the plunger in. The vaccine was safely administered, and the Patient was not hurt and When nurse was administering the vaccine (Vaxelis) the plunger broke right at the end of push and cut her. The nurse did sustain a laceration " and Vaxelis was not applicable.   Further information is expected.  Non-Significant follow-up information was received on 20-OCT-2023, from a health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the events "The nurse was administering the vaccine (vaxelis) and the top of the barrel broke off as she finished pushing the plunger in. The vaccine was safely administered, and the Patient was not hurt and When nurse was administering the vaccine (Vaxelis) the plunger broke right at the end of push and cut her. The nurse did sustain a laceration " and Vaxelis was not applicable.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VAXELIS was given off schedule to a patient; Varivax was ordered to be administered, and then VAXELIS was given instead.; VAXELIS was given off schedule to a patient; Varivax was ordered to be administered, and then VAXELIS was given instead.Vaxelis was given off schedule to patient; This spontaneous non-serious safety report, with reference number 2023SA305193 (Inquiry number 01793367), was received by the partner on 05-OCT-2023 and forwarded to Agency on 06-OCT-2023, from a health professional.  Due to the nature of the event, the causality between the event "VAXELIS was given off schedule to a patient; Varivax was ordered to be administered, and then VAXELIS was given instead" and Vaxelis was not applicable.  Further information is expected.  Non-significant follow up information was received by Agency on 20-OCT-2023, by email from a health professional.  The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "VAXELIS was given off schedule to a patient; Varivax was ordered to be administered, and then VAXELIS was given instead" and Vaxelis was not applicable.  Further information is not expected.
Sex: F
Vaccine: DTPPVHBHPB, VARCEL
Symptoms: Wrong product administered
Clinical narrative: HCP reported inadvertent administration of a 2nd dose of VARIVAX to a 2-year-old patient. Pt received 1st dose of VARIVAX on 05/16/2023 and was supposed to receive 1st dose of VAXELIS on 10/17/2023 instead received 2nd dose of  VARIVAX on 10/17/2023; HCP reported inadvertent administration of a 2nd dose of VARIVAX to a 2-year-old patient. Pt received 1st dose of VARIVAX on 05/16/2023 and was supposed to receive 1st dose of VAXELIS on 10/17/2023 instead received 2nd dose of  VARIVAX on 10/17/2023; This spontaneous safety report, with reference number 02492828, was received by a partner on 17-OCT-2023 and forwarded to Company on 18-OCT-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "HCP reported inadvertent administration of a 2nd dose of VARIVAX to a 2-year-old patient. Pt received 1st dose of VARIVAX on 05/16/2023 and was supposed to receive 1st dose of VAXELIS on 10/17/2023 instead received 2nd dose of  VARIVAX on 10/17/2023" was assessed as not applicable due to the nature of the event.  Further information is expected.  Non-Significant Follow-up information was received by the partner on 27-NOV-2023 and forwarded to Company on 28-NOV-2023, from a HCP. The case is maintained as non-serious.   Due to the nature of the event, the causality between the event "HCP reported inadvertent administration of a 2nd dose of VARIVAX to a 2-year-old patient. Pt received 1st dose of VARIVAX on 05/16/2023 and was supposed to receive 1st dose of VAXELIS on 10/17/2023 instead received 2nd dose of  VARIVAX on 10/17/2023" and Vaxelis was assessed as not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: VAXELIS was administered to a 28-year old patient instead of Tdap; VAXELIS was administered to a 28-year old patient instead of Tdap; This non-serious spontaneous safety report, with reference number 2023SA325943/ Inquiry# 01815498 was received by a partner on 23-OCT-2023 and forwarded on 24-OCT-2023 from a health care professional.   The case is classified as off label due to Product use in unapproved population.  Due to the nature of the event, the causality between the event "VAXELIS was administered to a 28-year-old patient instead of Tdap" and Vaxelis is not applicable.  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION was received on 08-NOV-2023 from a health care professional. The case is maintained as non-serious.   The case is classified as off label due to Product use in unapproved population.  Due to the nature of the event, the causality between the event "VAXELIS was administered to a 28-year-old patient instead of Tdap" and Vaxelis is not applicable.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Off label use, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Nurse accidentally gave vaxelis instead of Adacel (Tdap) to adult patient; Nurse accidentally gave vaxelis instead of Adacel (Tdap) to adult patient; This spontaneous non-serious safety report, with reference number 2023SA325868, was received by the partner on 23-OCT-2023 and forwarded to Company on 24-OCT-2023, from a non- health professional.  The case is classified as off label use due to Product use issue (product use in unapproved population).  The causal relationship between Vaxelis and the events "Nurse accidentally gave vaxelis instead of Adacel (Tdap) to adult patient " was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC15, RV5
Symptoms: Diarrhoea, Insomnia, Irritability, Pyrexia
Clinical narrative: patients temperature was 102.9F, day after, Sep 21, 2023, patients temperature was was 99F; trouble sleeping; diarrhea; fussy; patient had a high fever of 102.6F; This non-serious spontaneous safety report with the case reference number: 02498128 was received by a partner on 26-OCT-2023 and forwarded to RA on 26-OCT-2023, from a healthcare professional.    Due to the nature of the event, the causality between the events; "fussy", "trouble sleeping", "Diarrhea", "patient had a high fever of 102.6F", "patients' temperature was 102.9F, day after, Sep 21, 2023, patients' temperature was was 99F"  " and Vaxelis was assessed as Related.  Further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION RECEIVED ON 07-NOV-2023 was received by a partner on 07-NOV-2023 and forwarded to RA on 08-NOV-2023, from a healthcare professional.  Due to the nature of the event, the causality between the events; "fussy", "trouble sleeping", "Diarrhea", "patient had a high fever of 102.6F", "patients' temperature was 102.9F, day after, Sep 21, 2023, patients' temperature was was 99F"  " and Vaxelis was assessed as Related.   No further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION RECEIVED ON 14-NOV-2023 was sent to RA from a healthcare professional.  Due to the nature of the event, the causality between the events; "fussy", "trouble sleeping", "Diarrhea", "patient had a high fever of 102.6F", "patients temperature was 102.9F, day after, Sep 21, 2023, patients temperature was was 99F"  " and Vaxelis was assessed as Related  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, MEN
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: administered a VAXELIS vaccine to a patient over the recommended age. he is asking what needs to be done, if anything, regarding the situation.; the clinic reported that the vaccine VAXELIS was given in error to a child age 11-years old.; This non-serious spontaneous safety report, with the reference number 2023SA328111 (inquiry number: 01822668) was received by a partner on 27-OCT-2023 and forwarded to Company on 20-OCT-2023, from a healthcare professional.  This case was considered Off Label Use as an 11-year old patient was administered with Vaxelis.   Due to the nature of the event, the causal relationship between Vaxelis and "administered a VAXELIS vaccine to a patient over the recommended age. he is asking what needs to be done, if anything, regarding the situation", "the clinic reported that the vaccine VAXELIS was given in error to a child age 11-years old" was assessed as Not Applicable.  Further information is expected.  ADDITIONAL INFORMATION was received by was sent by a partner to Company on 08-NOV-2023.The case is maintained as non-serious. The report included the correct reference number/ID for the case as: 2023SA332220  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, IPV
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: VAXELIS and IPOL at the same day and at the same time on a 2-month-old patient; This spontaneous non-serious safety report, with reference number 2023SA341553 (Inquiry# 01833332), was received by the partner on 06-NOV-2023 and forwarded on 07-NOV-2023, from a health professional.     Due to the nature of the event, the causality between the events "VAXELIS and IPOL at the same day and at the same time on a 2-month-old patient" and Vaxelis was not applicable.  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION RECEIVED ON 10-NOV-2023, with reference number 2023SA341553 (Inquiry# 01836934), was received by the partner on 08-NOV-2023 and forwarded on 10-NOV-2023, from a health professional. The case is maintained as non-serious.   Due to the nature of the event, the causality between the events "VAXELIS and IPOL at the same day and at the same time on a 2-month-old patient" and Vaxelis was not applicable.  Further information is expected.  Follow-up information was received on 28-NOV-2023, from a HCP. The case is maintained as non-serious.   Due to the nature of the event, the causality between the events "VAXELIS and IPOL at the same day and at the same time on a 2-month-old patient" and Vaxelis was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: Nurse stated her child was vaccinated with VAXELIS and experienced a fever after the second and third scheduled dose; This non-serious spontaneous safety report, with reference number 02504917 (Interaction number# 02504911) was received by a partner on 08-NOV-2023 and forwarded on the same date, from a non-health professional.   The reporter did not assess the causal relationship between Vaxelis and the reported event of "Nurse stated her child was vaccinated with VAXELIS and experienced a fever after the second and third scheduled dose".  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, IPV
Symptoms: Extra dose administered
Clinical narrative: Vaxelis and Polio given at same visit; This spontaneous non-serious safety report, with reference number 2023SA347764, was received by the partner on 08-NOV-2023 and forwarded to Agency on 09-NOV-2023, from a non-HCP.  This case was considered non-valid due to no patient identifiers provided.   Due to the nature of the event, the causality between the event "Vaxelis and Polio given at same visit" and Vaxelis was not applicable.  Further information is expected.  Significant follow up information received by Agency on 20 Nov 2023 from HCP. The case is now valid because of patient identifiers are added and case is maintained as Non-Serious.  Due to the nature of the event, the causality between the event "Vaxelis and Polio given at same visit" and Vaxelis was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: multiple temperature excursion and would like to know if the vaccine is still viable for use; Max temperature reached: 8-11°C; 4 patients were involved.; multiple temperature excursion and would like to know if the vaccine is still viable for use; Max temperature reached: 8-11°C; 4 patients were involved.; This non-serious spontaneous safety report with reference number: 2023SA358554 (inquiry#: 01846529) was received by a partner on 16-NOV-2023 and forwarded on 17-NOV-2023, from a HCP.   Due to the nature of the event, the causality between the events; "multiple temperature excursion and would like to know if the vaccine is still viable for use; Max temperature reached: 8-11°C; 4 patients were involved." and Vaxelis was assessed as not applicable.   Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product dose omission issue
Clinical narrative: Missed dose; This non-serious spontaneous safety report with the reference number 02512569, was received by a partner on 27-NOV-2023 and forwarded on 27-NOV-2023, from a HCP.   Due to the nature of the event, the causality between the event " Missed dose" and Vaxelis was assessed as not applicable.   No Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: A HBP called to report a TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursio; This non-serious spontaneous safety report, with the reference number: 02513065 (interaction number: 02513010), was received by a partner on 27-NOV-2023 and forwarded on 28-NOV-2023, from a HCP.  Due to the nature of the event, the causality between the event "TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions" and Vaxelis was assessed as not applicable.   Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions; This non-serious spontaneous safety report, with the reference number: 02513116 (interaction number: 02513010), was received by a partner on 27-NOV-2023 and forwarded to Agency on 28-NOV-2023, from a HCP.  Due to the nature of the event, the causality between the event "TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions" and Vaxelis was assessed as not applicable.   Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/21/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions; This non-serious spontaneous safety report, with the reference number: 02513115 (interaction number: 02513010), was received by a partner on 27-NOV-2023 and forwarded on 28-NOV-2023, from a HCP.  Due to the nature of the event, the causality between the event "TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions" and Vaxelis was assessed as not applicable.   Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions; This non-serious spontaneous safety report, with the reference number: 02513056 (interaction number: 02513010), was received by a partner on 27-NOV-2023 and forwarded on 28-NOV-2023, from a HCP.  Due to the nature of the event, the causality between the event "TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions" and Vaxelis was assessed as not applicable.   This case shares the same event with the following companion cases: MCM-005551, MCM-005552, MCM-005554, MCM-005555, MCM-005557, MCM-005558, MCM-005559, MCM-005560, MCM-005562, and MCM-005563.   Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: report TE for VAXELIS that had been administered to patient on 11/27/2023.TE details were a low temp of 33.15F for 1 hr 8 min on 11/18/2023. There were no side effects, adverse outcomes, or unexpected reactions experienced by the patient; This spontaneous non-serious safety report, with reference number 02513060, was received by a partner on 27-NOV-2023 and forwarded on 28-NOV-2023, from a HCP.  Due to the nature of the event, the causality between the event "report TE for VAXELIS that had been administered to patient on 11/27/2023.TE details were a low temp of 33.15F for 1 hr 8 min on 11/18/2023. There were no side effects, adverse outcomes, or unexpected reactions experienced by the patient" and Vaxelis was not applicable.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions; This non-serious spontaneous safety report, with the reference number: 2513057 (interaction number: 02513010), was received by a partner on 27-NOV-2023 and forwarded on 28-NOV-2023, from a HCP.  Due to the nature of the event, the causality between the event "TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions" and Vaxelis was assessed as not applicable.   This case shares the same event with the following companion cases: MCM-005551, MCM-005552, MCM-005554, MCM-005555, MCM-005556, MCM-005557, MCM-005559, MCM-005560, MCM-005561, MCM-005562, and MCM-005563  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HBP report TE for VAXELIS that had been administered to patient on 11/20/2023.TE details were a low temp of 33.15F for 1 hr 8 min on 11/18/2023. There were no side effects, adverse outcomes, or unexpected reactions experienced by the patient; This spontaneous non-serious safety report, with reference number 02513064, was received by a partner on 27-NOV-2023 and forwarded to Agency on 28-NOV-2023, from a HCP.  Due to the nature of the event, the causality between the event "Agency report TE for VAXELIS that had been administered to patient on 11/20/2023.TE details were a low temp of 33.15F for 1 hr 8 min on 11/18/2023. There were no side effects, adverse outcomes, or unexpected reactions experienced by the patient" and Vaxelis was not applicable.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/27/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions; This non-serious spontaneous safety report, with the reference number: 02513114 (interaction number: 02513010), was received by a partner on 27-NOV-2023 and forwarded on 28-NOV-2023, from a HCP.  Due to the nature of the event, the causality between the event "TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions" and Vaxelis was assessed as not applicable.   Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions; This non-serious spontaneous safety report, with the reference number: 02513063 (interaction number: 02513010), was received by a partner on 27-NOV-2023 and forwarded to Agency on 28-NOV-2023, from a HCP.  Due to the nature of the event, the causality between the event "TE for VAXELIS (Lot #U7535AA expiration: 09/23/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions" and Vaxelis was assessed as not applicable.   This case shares the same event with the following companion cases: MCM-005551, MCM-005552, MCM-005554, MCM-005555, MCM-005556, MCM-005557, MCM-005558, MCM-005559, MCM-005560, and MCM-005562.   Further information is expected.