chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller reported patient received first dose of GARDASIL on 19-AUG-2011 at 13 years old and second dose on 28-OCT-2014.; no additional AEs; This spontaneous report was received form a medical assistant and refers to a patient of unknown gender who would be 23-years-old at the reporting time. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 19-AUG-2011 at the age of 13-years-old, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), and on 28-OCT-2014, the patient received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE reported; Caller reports that an adult patient received an expired dose of VAQTA today; This spontaneous report was received from a pharmacist and refers to an Adult patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 13-OCT-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated(VAQTA), 1 milliliter, lot number S037821, expiration date reported as 17-JAN-2021 but upon internal validation established as 07-JAN-2021 (Expired product administered). No additional adverse event reported.
Sex: F
Vaccine: ANTH
Symptoms: Vaccination complication
Clinical narrative: Bad reaction to anthrax vaccine; On 27SEP2021, a spontaneous report was received from a consumer via another pharmaceutical company.  On 16SEP2021, a female consumer of unknown age called a pharmaceutical company inquiring about a vaccine and stated that after receiving the "anthrax vaccine," BioThrax (anthrax vaccine adsorbed) she experienced a "bad reaction (PT: Adverse event)." On 29SEP2021, a follow-up was received from the reporter stating that there was no additional information available with regards to this event. The outcome of the event is unknown.  The patient's medical history and concomitant medication use was not reported.  No additional information was provided.  Company Comment:  The company considers the event is not assessable, there is not enough information to assess.; Sender's Comments: The company considers the event is not assessable, there is not enough information to assess.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR212309:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212282:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212283:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212310:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212311:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212284:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212285:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212312:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212313:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212286:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212314:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212315:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212287:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212288:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212316:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212289:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212290:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212317:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212318:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212291:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212292:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR212319:Original Case : US2021AMR211145 US-GLAXOSMITHKLINE-US2021AMR201274:Same Reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Immunisation, Interchange of vaccine products
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter. US-GLAXOSMITHKLINE-US2021AMR211145:Original Case : US2021AMR211145,same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he or she got the Shingle shot and also got shingles later. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 8 patients received the adjuvant solution; 8 patients received the adjuvant solution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 17th September 2021, the patient received Shingrix. On 17th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Other health professional reported they had given 2 appropriate doses of Shingrix to 2 patient out of the box of 10 and the 8 remaining doses they gave just the adjuvant solution so they do not remember which of the 10 patient got the full dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions was reported for any patient (as reported). The reporter did not consent to follow-up. Sales representative stated that the health care professional declined follow up the case. This case was one of 9 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209458:Same reporter. US-GLAXOSMITHKLINE-US2021209462:Same reporter. US-GLAXOSMITHKLINE-US2021209478:Same reporter. US-GLAXOSMITHKLINE-US2021209482:Same reporter. US-GLAXOSMITHKLINE-US2021209483:Same reporter. US-GLAXOSMITHKLINE-US2021209470:Same reporter. US-GLAXOSMITHKLINE-US2021209468:Same reporter. US-GLAXOSMITHKLINE-US2021209467:Same reporter.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received the adjuvant solution; patient received the adjuvant solution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 5th October 2021, the patient received Shingrix. On 5th October 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Other health professional reported they had given 2 appropriate doses of Shingrix to 2 patient out of the box of 10 and the 8 remaining doses they gave just the adjuvant solution so they do not remember which of the 10 patient got the full dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions was reported for any patient (as reported). Sales representative stated that the health care professional declined follow up the case. This case was one of the 9 cases reported by the same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209458:Same reporter. US-GLAXOSMITHKLINE-US2021209462:Same reporter. US-GLAXOSMITHKLINE-US2021209463:Same reporter. US-GLAXOSMITHKLINE-US2021209468:Same reporter. US-GLAXOSMITHKLINE-US2021209470:Same reporter. US-GLAXOSMITHKLINE-US2021209478:Same reporter. US-GLAXOSMITHKLINE-US2021209482:Same reporter. US-GLAXOSMITHKLINE-US2021209483:Same reporter.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 8 patients received the adjuvant solution; 8 patients received the adjuvant solution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 14th September 2021, the patient received Shingrix. On 14th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was an office manager. The reporter reported that the patient could receive just the adjuvant solution of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not remember which of the patient got the full dose. The reporter did not consent to follow-up.  This was 1 of 9 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209467:Same reporter. US-GLAXOSMITHKLINE-US2021209458:same reporter US-GLAXOSMITHKLINE-US2021209462:Same reporter. US-GLAXOSMITHKLINE-US2021209463:Same reporter. US-GLAXOSMITHKLINE-US2021209483:Same reporter. US-GLAXOSMITHKLINE-US2021209482:Same reporter. US-GLAXOSMITHKLINE-US2021209470:Same reporter. US-GLAXOSMITHKLINE-US2021209478:Same reporter.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 8 patients received the adjuvant solution; 8 patients received the adjuvant solution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 1st October 2021, the patient received Shingrix. On 1st October 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Other health professional reported that they had given 2 appropriate doses of Shingrix to 2 patient out of the box of 10 and the 8 remaining doses they gave just the adjuvant solution so they do not remember which of the 10 patient got the full dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions was reported for any patient (as reported). Sales representative stated that the health care professional declined follow up the case. The reporter did not consent to follow-up. This case was one of the 9 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209462:Same reporter. US-GLAXOSMITHKLINE-US2021209458:same reporter US-GLAXOSMITHKLINE-US2021209468:Same reporter. US-GLAXOSMITHKLINE-US2021209463:Same reporter. US-GLAXOSMITHKLINE-US2021209467:Same reporter. US-GLAXOSMITHKLINE-US2021209478:Same reporter. US-GLAXOSMITHKLINE-US2021209482:Same reporter. US-GLAXOSMITHKLINE-US2021209483:Same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: gave just the adjuvant; gave just the adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 20th September 2021, the patient received Shingrix. On 20th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was an office manager. The reporter reported that the patient could receive just the adjuvant solution of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not remember which of the patient got the full dose. The reporter did not consent to follow-up.  This was 1 of 9 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209463:Same reporter. US-GLAXOSMITHKLINE-US2021209468:Same reporter. US-GLAXOSMITHKLINE-US2021209467:Same reporter. US-GLAXOSMITHKLINE-US2021209470:Same reporter. US-GLAXOSMITHKLINE-US2021209462:Same reporter. US-GLAXOSMITHKLINE-US2021209458:same reporter US-GLAXOSMITHKLINE-US2021209482:Same reporter US-GLAXOSMITHKLINE-US2021209483:Same reporter
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered adjuvant suspension only; administered adjuvant suspension only; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 22nd September 2021, the patient received Shingrix. On 22nd September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: The case was reported by sales representative. The office manager was called and said that they have given 2 appropriate doses of Shingrix to 2 patient out of the box of 10 and the 8 remaining doses they gave just the adjuvant solution which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. They do not remember which of the 10 patient got the full dose. The reporter did not consented to follow-up. Sales representative stated that the health care professional declined to follow up the case. This case is 1 of 9 case linked, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209458:same reporter US-GLAXOSMITHKLINE-US2021209462:Same reporter. US-GLAXOSMITHKLINE-US2021209467:Same reporter. US-GLAXOSMITHKLINE-US2021209470:Same reporter. US-GLAXOSMITHKLINE-US2021209463:Same reporter. US-GLAXOSMITHKLINE-US2021209483:Same reporter US-GLAXOSMITHKLINE-US2021209468:Same reporter. US-GLAXOSMITHKLINE-US2021209478:Sam reporter
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: gave just the adjuvant; gave just the adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 27th September 2021, the patient received Shingrix. On 27th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional details were provided as follows: Other health professional reported they had given 2 appropriate doses of Shingrix to 2 patients out of the box of 10 and the 8 remaining doses they gave just the adjuvant solution so they do not remember which of the 10 patient got the full dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions were reported for any patient (as reported). The reporter did not consent to follow-up. Sales representative stated that the health care professional declined follow up the case. This case was one of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209458:same reporter US-GLAXOSMITHKLINE-US2021209462:Same reporter. US-GLAXOSMITHKLINE-US2021209467:Same reporter. US-GLAXOSMITHKLINE-US2021209470:Same reporter. US-GLAXOSMITHKLINE-US2021209463:Same reporter. US-GLAXOSMITHKLINE-US2021209468:Same reporter. US-GLAXOSMITHKLINE-US2021209482:Same reporter US-GLAXOSMITHKLINE-US2021209478:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patients were vaccinated with Fluarix after being out of range; This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LZ4N2, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue 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 details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that 300 patients were vaccinated with Fluarix after being out of range for 2 weeks.  The reporter did not consent to follow-up.  The health care professional provided limited information since didn't have expiration date of the vaccine, or any other demographic details from vaccinated.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA414A, expiry date 30th September 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: Age at vaccination was not reported. Nurse reported that a patient received an expired dose of Menveo. No further details were provided at the time of the call. The reporter consented to follow up by phone.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vx reconstituted with sterile water; Vx reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number PG35Z, expiry date unknown) for prophylaxis.   On 5th October 2021, the patient received Shingrix. On 5th October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that the patient received the Shingrix after it was reconstituted with sterile water instead of the GlaxoSmithKline supplied adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. It was unknown whether or not it was the first or second dose. The reporter consented to follow up. This case has been linked with the case US2021209469 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209469:Same reporter. Patient 2 of 2.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Vx reconstituted with sterile water; Vx reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number PG35Z, expiry date unknown) for prophylaxis.   On 6th October 2021, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received Shingrix after it was reconstituted with sterile water instead of the supplied adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. It was unknown weather the dose was first dose or second dose. The reporter consented to follow up via email. This case has been linked to US2021209465, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209465:Same reporter. Patient 1 of 2.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Patient believes got a partial 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: Age at vaccination was not reported. The pharmacist reported that the patient believed that she received partial 1st dose of Shingrix, which led to incomplete dose administered. The dose was administered in October 2021 exact date was unknown. The health care professional did not know the patient's initial, date of birth, vaccination dates and lot number. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired(June 30,2021) dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a child patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number unknown, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The patient was administered with Flulaval quadrivalent vaccine which was expired 30th June 2021. The patient had no effects at the time of reporting. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, did not get the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received the first dose of shingrix on an unknown date, 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The pharmacist was unable to provide vaccine details. The reporter enquired if the patient need to start over with series. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has been unable to receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose (0.5 ml) received intramuscularly on unknown deltoid 2 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient self-reported this case. The patient had been unable to receive her 2nd dose till the time of reporting (resolution unknown), which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: administered subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number J7J4X, expiry date 31st January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details provided were as follows: The age at vaccination was not reported. The pharmacist reported that the patient received a dose of Shingrix subcutaneously which led to intramuscular formulation administered by other route. The reporter consented to follow-up. The case was linked with case US2021209477 and US2021AMR210335, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209477:Same reporter US-GLAXOSMITHKLINE-US2021AMR210335:Same reporter
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: not received third dose; Recombivax on 19Oct2017, Engerix-B on 28Nov2017; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old female patient who received HBV (Engerix B) (batch number 4795H, expiry date 14th July 2020) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (RECOMBIVAX).   On 28th November 2017, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received the 3rd dose of Engerix B. On 28th November 2017, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   Additional details were reported as follows: This case was reported by the pharmacist. The pharmacist reported that patient received Recombivax vaccine on and then received Engerix-B , which led to drug dose administration interval too long. The pharmacist also reported that the patient had not yet received a third dose of Hepatitis B vaccine till the time of reporting, which led to incomplete course of vaccination. The pharmacist consented to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: develops shingles; first Shingrix vaccination a few years ago; This case was reported by a physician via call center representative and described the occurrence of shingles in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, several years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the 1st dose of Shingrix vaccination a few years ago and now developed shingles. The reporter enquired if there was a value in getting a booster Shingrix shot. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination.  No further details provided via web form. The reporter consented to follow up.