chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Mobility decreased, Pain
Clinical narrative: had them; they hurt; Joint pain/ knees elbows all my joints killed; lack of hand movement/ couldn't even move my hands; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: had them), pain (Verbatim: they hurt ), joint pain (Verbatim: Joint pain/ knees elbows all my joints killed) and mobility decreased (Verbatim: lack of hand movement/ couldn't even move my hands ). The outcome of the shingles, pain, joint pain and mobility decreased were not reported.   It was unknown if the reporter considered the shingles, pain, joint pain and mobility decreased to be related to Shingrix.     It was unknown if the company considered the shingles, pain, joint pain and mobility decreased to be related to Shingrix.   Additional Information: GSK receipt date: 8-Aug-2023 The case was received from the patient via interactive digital media. The patient stated that he had them, they hurt and could not even move his hands. The patient mentioned that knees, elbows all his joints killed.
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Feeling abnormal, Hypopnoea, Loss of personal independence in daily activities, Nausea
Clinical narrative: Fever; Arm pain/arm hurt; nausea; vomiting; Visual changes; Labored breathing; almost hypopnea RR: 9; Arm pain that shoots down arm interfering with daily activities and sleep; Arm pain that shoots down arm interfering with daily activities and sleep; Stridor; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number J52PN) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Bexsero (left deltoid). In JUN-2023, 1 hr after receiving Bexsero, the patient experienced fever (Verbatim: Fever), pain in arm (Verbatim: Arm pain/arm hurt), nausea (Verbatim: nausea), vomiting (Verbatim: vomiting), visual disturbance (Verbatim: Visual changes), labored breathing (Verbatim: Labored breathing), hypopnea (Verbatim: almost hypopnea RR: 9), activities of daily living impaired (Verbatim: Arm pain that shoots down arm interfering with daily activities and sleep), sleep disturbance (Verbatim: Arm pain that shoots down arm interfering with daily activities and sleep) and stridor (Verbatim: Stridor). The outcome of the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor were not reported.   It was unknown if the reporter considered the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 09-AUG-2023 A physician reported that patient received 1st dose of Bexsero and immediately following dose, patient complained that arm hurt and went home and slept.  Within an hour patient experienced nausea, vomiting, fever, visual changes (saw rings in field of vision) Stridor, labored breathing, almost hypopnea RR: 9. No rash or tongue swelling, patient says she just felt "out of it", lasted about 6 hours, did not need to go to ER. Arm pain that shoots down arm interfering with daily activities and sleep. Revisit with physician 6 days later due to persistent arm pain, patient had full range of motion, no redness, swelling or erythemia, Physician and patient agree to not receive Dose 2. The reporter agrees to follow up.
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Pyrexia, Sleep disorder, Stridor
Clinical narrative: Fever; Arm pain/arm hurt; nausea; vomiting; Visual changes; Labored breathing; almost hypopnea RR: 9; Arm pain that shoots down arm interfering with daily activities and sleep; Arm pain that shoots down arm interfering with daily activities and sleep; Stridor; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number J52PN) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Bexsero (left deltoid). In JUN-2023, 1 hr after receiving Bexsero, the patient experienced fever (Verbatim: Fever), pain in arm (Verbatim: Arm pain/arm hurt), nausea (Verbatim: nausea), vomiting (Verbatim: vomiting), visual disturbance (Verbatim: Visual changes), labored breathing (Verbatim: Labored breathing), hypopnea (Verbatim: almost hypopnea RR: 9), activities of daily living impaired (Verbatim: Arm pain that shoots down arm interfering with daily activities and sleep), sleep disturbance (Verbatim: Arm pain that shoots down arm interfering with daily activities and sleep) and stridor (Verbatim: Stridor). The outcome of the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor were not reported.   It was unknown if the reporter considered the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 09-AUG-2023 A physician reported that patient received 1st dose of Bexsero and immediately following dose, patient complained that arm hurt and went home and slept.  Within an hour patient experienced nausea, vomiting, fever, visual changes (saw rings in field of vision) Stridor, labored breathing, almost hypopnea RR: 9. No rash or tongue swelling, patient says she just felt "out of it", lasted about 6 hours, did not need to go to ER. Arm pain that shoots down arm interfering with daily activities and sleep. Revisit with physician 6 days later due to persistent arm pain, patient had full range of motion, no redness, swelling or erythemia, Physician and patient agree to not receive Dose 2. The reporter agrees to follow up.
Sex: F
Vaccine: MENB
Symptoms: Visual impairment, Vomiting
Clinical narrative: Fever; Arm pain/arm hurt; nausea; vomiting; Visual changes; Labored breathing; almost hypopnea RR: 9; Arm pain that shoots down arm interfering with daily activities and sleep; Arm pain that shoots down arm interfering with daily activities and sleep; Stridor; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number J52PN) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Bexsero (left deltoid). In JUN-2023, 1 hr after receiving Bexsero, the patient experienced fever (Verbatim: Fever), pain in arm (Verbatim: Arm pain/arm hurt), nausea (Verbatim: nausea), vomiting (Verbatim: vomiting), visual disturbance (Verbatim: Visual changes), labored breathing (Verbatim: Labored breathing), hypopnea (Verbatim: almost hypopnea RR: 9), activities of daily living impaired (Verbatim: Arm pain that shoots down arm interfering with daily activities and sleep), sleep disturbance (Verbatim: Arm pain that shoots down arm interfering with daily activities and sleep) and stridor (Verbatim: Stridor). The outcome of the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor were not reported.   It was unknown if the reporter considered the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 09-AUG-2023 A physician reported that patient received 1st dose of Bexsero and immediately following dose, patient complained that arm hurt and went home and slept.  Within an hour patient experienced nausea, vomiting, fever, visual changes (saw rings in field of vision) Stridor, labored breathing, almost hypopnea RR: 9. No rash or tongue swelling, patient says she just felt "out of it", lasted about 6 hours, did not need to go to ER. Arm pain that shoots down arm interfering with daily activities and sleep. Revisit with physician 6 days later due to persistent arm pain, patient had full range of motion, no redness, swelling or erythemia, Physician and patient agree to not receive Dose 2. The reporter agrees to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Had shingrix two years ago/do i get second shot or start over; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Had shingrix two years ago/do i get second shot or start over). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 8-Aug-2023 The patient asked that he or she get second shot or start over. The centers for disease control and prevention (CDC) had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible; patients did not need to restart the vaccine series. The follow-up could not be possible as no contact details were available. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.42
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: exposed to a low temperature of 31.5 degrees Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old female patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt date: 3-AUG-2023 The reporter reported that the Havrix vaccines exposed to a low temperature of 31.5 degrees Fahrenheit on 15th June 2023 was administered between 15th June 2023 and 21st June 2023. Reporter did not have specific date of administration for each patient. The reporter reported that at the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter reported that the administered Havrix vaccines exposed to a low temperature of 31.5 degrees Fahrenheit, which led to incorrect storage of drug. This case was 1 of 9 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023105916:same reporter US-GSK-US2023105926:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105917:same reporter US-GSK-US2023105923:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105928:same reporter US-GSK-US2023105927:same reporter
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: exposed to a low temperature of 31.5 degrees Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 7-year-old female patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 3-AUG-2023 Nurse reported Havrix vaccines from lot number PB5JA exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023.  Reporter did not have specific date of administration for each patient.  At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up. This is 1 of the 9 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023105928:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105926:same reporter US-GSK-US2023105927:same reporter
Age: 1.42
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 3-AUG-2023 Nurse reported Havrix vaccines from lot number PB5JA exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023.  Reporter did not have specific date of administration for each patient.  At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up. This is 1 of the 9 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023105916:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105928:same reporter US-GSK-US2023105926:same reporter US-GSK-US2023105923:same reporter US-GSK-US2023105917:same reporter
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   In JUN-2023, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-AUG-2023 Nurse reported Bexsero vaccines was exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023.  Reporter did not have specific date of administration for each patient.  At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up. This is 1 of the 4 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023105930:same reporter US-GSK-US2023105935:same reporter US-GSK-US2023105936:same reporter
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Accidental underdose, Regurgitation
Clinical narrative: patient spit up 5 to 10 minutes after the administration; patient spit up 5 to 10 minutes after the administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of regurgitation of medication in a 1-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number YL9YN, expiry date 20-APR-2025) for prophylaxis.   On 03-AUG-2023, the patient received Rotarix lyophilized formulation. On 03-AUG-2023, 5 min after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: patient spit up 5 to 10 minutes after the administration) and accidental underdose (Verbatim: patient spit up 5 to 10 minutes after the administration). The outcome of the regurgitation of medication and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 03-AUG-2023 A nurse reported that they administered the Rotarix(Liquid presentation) today on 03 August 2023 to a pediatric patient but the patient spit up 5 to 10 minutes after the administration. Nurse wanted to know if any recommendations re dosing for Rotarix(Liquid). The patient spit up 5 to 10 minutes after the administration which led to accidental underdose. The reporter did not consent to follow-up.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient was administered a dose of Pediarix on 25Jul2023, instead of a plain DTaP dose.  Therefore the patient received extra IPV and Hepatitis b dosing; received extra IPV and Hepatitis b dosing.; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number HS4F9, expiry date 11-APR-2025) for prophylaxis.   Previously administered products included DTaP (recent dose prior to this dose was on 15th November 2022).   On 25-JUL-2023, the patient received Pediarix. On 25-JUL-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: patient was administered a dose of Pediarix on 25Jul2023, instead of a plain DTaP dose.  Therefore the patient received extra IPV and Hepatitis b dosing) and extra dose administered (Verbatim: received extra IPV and Hepatitis b dosing.). The outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2023 Doctor reported that a patient was administered a dose of Pediarix instead of a plain DTaP dose.   Therefore the patient received extra IPV and Hepatitis b dosing.   The Pediarix was the patient's fourth dose of IPV, DTaP, and Hepatitis B.   The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The patient received a dose of Pediarix as fourth dose of IPV, DTaP, and Hepatitis B instead of a plain DTaP, which led to wrong vaccine administered and extra dose administered.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 41-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 9th January 2012 batch number AHABB207BA).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-AUG-2023 The pharmacist reported that a patient received one dose of Twinrix, and never received any further dosing but now would like to continue the series.  The dose was administered by a clinic.  At the time of reporting, no additional doses had yet been administered. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: lower mouth, cheeks around the sides of her mouth, down to her chin all feel numb; lower mouth, lower lip, her cheeks around the sides of her mouth, down to her chin all feel tingly; lower mouth swollen; lower lip swollen; cheeks around the sides of her mouth, down to her chin swollen; cheeks around the sides of her mouth, down to her chin all feel numb; This non-serious case was reported by a consumer via call center representative and described the occurrence of numbness oral in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (on an unknown date received 1st dose.).   On 04-AUG-2023 10:30, the patient received the 2nd dose of Shingrix (intramuscular, right arm). On 04-AUG-2023 11:10, 40 min after receiving Shingrix, the patient experienced numbness oral (Verbatim: lower mouth, cheeks around the sides of her mouth, down to her chin all feel numb), tingling mouth (Verbatim: lower mouth, lower lip, her cheeks around the sides of her mouth, down to her chin all feel tingly), swollen mouth (Verbatim: lower mouth swollen), lip swelling (Verbatim: lower lip swollen), cheek swelling (Verbatim: cheeks around the sides of her mouth, down to her chin swollen) and numbness facial (Verbatim: cheeks around the sides of her mouth, down to her chin all feel numb). The outcome of the numbness oral, tingling mouth, swollen mouth, lip swelling, cheek swelling and numbness facial were not resolved.   It was unknown if the reporter considered the numbness oral, tingling mouth, swollen mouth, lip swelling, cheek swelling and numbness facial to be related to Shingrix.     It was unknown if the company considered the numbness oral, tingling mouth, swollen mouth, lip swelling, cheek swelling and numbness facial to be related to Shingrix.   Additional Information: GSK Receipt date: 04-AUG-2023 A reporter reported about herself she received her 2nd dose of Shingrix around 10:30 AM today, 4-AUG-2023, and reports that about 40 minutes after receiving the vaccine, her lower mouth, lower lip, her cheeks around the sides of her mouth, down to her chin all feel numb, swollen and tingly like anesthesia wearing off at the dentist, and she is still feeling all of this now still at 1:42 PM 4-AUG-2023. The patient reported that the area does not look swollen, and she can eat and swallow with no problem, it did not involve her tongue or her neck or below her chin area.  Patient reported that she had no problem with the 1st dose of Shingrix.  The reporter consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a second dose of Shingrix at less than the recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 33A2Z, expiry date 25-OCT-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29 June 2023).   On 02-AUG-2023, the patient received the 2nd dose of Shingrix. On 02-AUG-2023, 34 days after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received a second dose of Shingrix at less than the recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 07-AUG-2023 The reporter stated that patient accidentally received second shot of Shingrix less than the recommended interval. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule. The reporter consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Underdose
Clinical narrative: 1 dose of pediatric Engerix-; Inappropriate Dose Administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 25-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 1 dose of pediatric Engerix-) and adult use of a child product (Verbatim: Inappropriate Dose Administered). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 07-AUG-2023 Health care professional (HCP) did not have any details regarding administration date or patient demographics for adverse event.  No additional data available. Licensed practice nurse (LPN) reported the administration of 1 dose pediatric Engerix-B to an adult patient, which led to underdose and adult use of a child product. The reporter consented to follow up.
Sex: U
Vaccine: RV1
Symptoms: Accidental underdose, Regurgitation
Clinical narrative: concerned that the taste of the newer ROTARIX  more infants" are spitting it out; concerned that the taste of the newer ROTARIX  more infants" are spitting it out; This non-serious case was reported by a other health professional via sales rep and described the occurrence of regurgitation of medication in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.  On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: concerned that the taste of the newer ROTARIX  more infants" are spitting it out) and accidental underdose (Verbatim: concerned that the taste of the newer ROTARIX  more infants" are spitting it out). The outcome of the regurgitation of medication and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-AUG-2023 The vaccine contract manager reported that customer reported concern about the taste of the newer Rotarix oral formulation. The customer stated that there might be changed flavors as more infants were spitting it out. No other information was provided. The infants split it out which led to regurgitation of medication and accidental underdoes. The reporter denied the consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: received Shingrix on 29-JAN-2019 and 31-MAR-2019 had shingles/ Suspected vaccination faliure; shingles; painful; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31-MAR-2019, the patient received the 2nd dose of Shingrix. On 29-JAN-2019, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: received Shingrix on 29-JAN-2019 and 31-MAR-2019 had shingles/ Suspected vaccination faliure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: painful). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 07-AUG-2023 The reporter was a patient. The reporter stated that she administered both doses of Shingrix and has had shingles four times since then on her bikini line. The reporter reported that it was usually resolves within five days and her physician prescribes Valacyclovir. The reporter reported that it was the size of a quarter and painful. The reporter stated that it would be okay to follow up with doctor. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did consent to follow up.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: administered a dose of Kinrix to a 3 year old patient; fourth DTaP dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 27 July 2020), Pediarix (received 2nd dose on 22 September 2020) and Pediarix (received 3rd dose on 24 November 2020).   On 31-JUL-2023, the patient received the 4th dose of Kinrix. On 31-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered a dose of Kinrix to a 3 year old patient) and inappropriate schedule of vaccine administered (Verbatim: fourth DTaP dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-AUG-2023 Supervisor reported that a nurse at their clinic administered a dose of Kinrix to a patient. The patient had previously had three Pediarix doses (27 July 2020, 22 September 2020, and 24 November 2020), so this was their fourth IPV and DTaP dose. The vaccine administration facility was the same as primary reporter. A 3 year old patient received Kinrix, which led to inappropriate age at vaccine administration. The patient received Kinrix as a 4th dose of DTaP dose, which led to inappropriate schedule of vaccine administered of DTaP. The reporter consented to follow up.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 39-year-old female patient who received HBV (Engerix B) (batch number F73DG, expiry date 03-JUL-2023) for prophylaxis.   On 03-AUG-2023, the patient received the 3rd dose of Engerix B. On 03-AUG-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Engerix-B). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-AUG-2023 The reporter administered an expired dose of Engerix-B to a patient, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Age: 2.0
Sex: F
Vaccine: DTPPVHBHPB, HEP, DTPPVHBHPB, HEP
Symptoms: Extra dose administered
Clinical narrative: inadvertently received Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 2-year-old female patient who received HBV (Engerix B) (batch number Zp72s) for prophylaxis.   Co-suspect products included VAXELIS for prophylaxis.   On 07-AUG-2023, the patient received Engerix B. On an unknown date, the patient received VAXELIS. On 07-AUG-2023, an unknown time after receiving Engerix B, the patient experienced accidental overdose (Verbatim: inadvertently received Engerix-B). The outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 07-AUG-2023 The reporter stated that on the reporting day a patient inadvertently received Engerix-B right after receiving PCV-15 and Vaxelis (Which had a hep b component). The reporter did consent to follow up. On the reporting day a patient inadvertently received Engerix-B right after receiving PCV-15 and Vaxelis (Which had a hep b component), which lead to accidental overdose.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product administration error
Clinical narrative: a Shingrix adjuvant vial was mistakenly used in November 2022 to reconstitute a Pfizer Bivalent Covid vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug administration error in a patient who received Herpes zoster (Shingrix) (batch number 4B3RH, expiry date 25-SEP-2023) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted drug administration error (Verbatim: a Shingrix adjuvant vial was mistakenly used in November 2022 to reconstitute a Pfizer Bivalent Covid vaccine). The outcome of the intercepted drug administration error was unknown.   Additional Information: GSK receipt date: 7-AUG-2023 Reporter was a pharmacist calling to report that a Shingrix adjuvant vial was mistakenly used in November 2022 to reconstitute a Pfizer Bivalent Covid vaccine NDC: 59267-0304-02. There was no patient involvement. The reporter did not ask for consent to follow up with HCP.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 51 year old female patient received a pediatric dose of Engerix-B; 51 year old female patient received a pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 51-year-old female patient who received HBV (Engerix B pediatric) (batch number KR3XD, expiry date 17-FEB-2025) for prophylaxis.   On 27-JUN-2023, the patient received the 1st dose of Engerix B pediatric. On 27-JUN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 51 year old female patient received a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: 51 year old female patient received a pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 8-Aug-2023 The nurse reported that at the time of reporting, no additional dose had been administered. On 1st August 2023, the patient received adult dose of Engerix-B of lot number 39TZ2 and expiration date 7th September 2023. The vaccine administration facility was the same as primry reporter. The reporter gave permission for follow-up. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: the Shingrix vaccine in the freezer exposed to -5 Fahrenheit for 6 days. The vaccine is frozen.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: the Shingrix vaccine in the freezer exposed to -5 Fahrenheit for 6 days. The vaccine is frozen.). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 8-Aug-2023 The pharmacist called to check stability of vaccine. The vaccine was frozen. The reporter did not consent to follow-up. The Shingrix vaccine was placed in the freezer and vaccine was exposed to minus 5 Fahrenheit for 6 days, which led to incorrect storage of drug.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received by error Infanrix instead of Boostrix; 11 year old female patient received by error Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7hm5j, expiry date 13-SEP-2024) for prophylaxis.   On 08-AUG-2023, the patient received the 2nd dose of Infanrix. On 08-AUG-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: patient received by error Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: 11 year old female patient received by error Infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-AUG-2023 This Dtap vaccine was the second on the series. A 11 year old patient received by error Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age of vaccine administration. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid component of Menveo yesterday; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa938a) for prophylaxis.   On 07-AUG-2023, the patient received Menveo. On 07-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered only the liquid component of Menveo yesterday) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-AUG-2023 The pharmacist stated that another staff member administered only the liquid component of Menveo yesterday (the day before reporting), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo was reconstituted with sterile water and administered to a patient; Menveo was reconstituted with sterile water and administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA927A, expiry date 31-MAY-2024) for prophylaxis.   On 04-AUG-2023, the patient received Menveo. On 04-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo was reconstituted with sterile water and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: Menveo was reconstituted with sterile water and administered to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 08-AUG-2023 The nurse reported Menveo was reconstituted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter The reporter consented to follow up.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Nurse reports an adult male patient was administered a dose of Engerix-B on 08Aug2023 from lot number F73DG, which had an expiration date of 03Jul2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 25-year-old male patient who received HBV (Engerix B) (batch number F73DG, expiry date 03-JUL-2023) for prophylaxis.   On 08-AUG-2023, the patient received the 1st dose of Engerix B. On 08-AUG-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Nurse reports an adult male patient was administered a dose of Engerix-B on 08Aug2023 from lot number F73DG, which had an expiration date of 03Jul2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-AUG-2023 At the time of reporting, a repeat dose had not been administered of Engerix-B. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that a patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received their first dose of Shingrix 2 years ago and never received the second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Received their first dose of Shingrix 2 years ago and never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-AUG-2023 The reporter wanted to know if the patient need to restart the two dose series or administer only the 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did consent to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: powder component of Menveo mixed with sterile water instead of the provided diluent; the diluent that had not been used to reconstitute the powder component was administered to the patient alone (without powder component); This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA926A, expiry date 31-MAY-2024) for prophylaxis.   On 08-AUG-2023, the patient received Menveo. On 08-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: powder component of Menveo mixed with sterile water instead of the provided diluent) and inappropriate dose of vaccine administered (Verbatim: the diluent that had not been used to reconstitute the powder component was administered to the patient alone (without powder component)). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-AUG-2023 The nurse informed that the patient received the powder component of Menveo mixed with sterile water instead of the provided diluent, which led to wrong solution used in drug reconstitution.  After that, the diluent that had not been used to reconstitute the powder component was administered to the patient alone, without powder component, which led to inappropriate dose of vaccine administered. The reporter consented to follow up.