chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Given 2 Doses of Heplisav-B; Initial Report Received on 03-Nov-2021  A nurse reported that a 60 year-old male (race and ethnicity not provided) was accidentally given two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 03-Nov-2021, the patient received two doses of HEPLISAV-B (Lot # 934973, expiration date 24-Jul-2022m NDC # 43528-003-05 and serial number 492972497336.). One injection was given in the right deltoid and the other injection was given in the left deltoid. It was reported that this error happened when trying to give HEPLISAV-B with the adjuvant and another vaccine with recombinant, hence the reason for the double dose of HEPLISAV-B.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: year and a half since first dose/ before the COVID outbreak; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The was reported by the patient. The age at vaccination were not applicable for this report. It's been probably a year and a half since then the patient did not get the second dose of Shingrix.  The patient asked if it was too late to get second shot. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in January 2021; This case was reported by a other health professional via interactive digital media 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 on an unknown date in January 2021).   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 information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter enquired if it was too late to get the second dose.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: second shot a month ago / still geting shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she received 2nd Shingles shot a month ago and still getting shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shots but also the shingles\ 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots but also the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 5 weeks after the first; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The case was self-reported by patient. The age at vaccination was not reported. The patient received 2nd dose 5 weeks after the first dose earlier than the recommended interval, which led to shortening of vaccine schedule. The patient enquired was that okay.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had my second shot a month ago / shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had 2nd Shingles shot a month ago and still getting shingles. The patient he/she asked when could expect to be shingles free. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: nerve pain at her mid section.; This case was reported by a consumer and described the occurrence of nerve pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve pain. The patient was treated with gabapentin. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The patient had the shingles vaccine and now had terrible nerve pain at her mid-section.  The physician prescribed Gabapentin. The reporter asked was there any other options out there.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles 11 times. Also got both shots/ Suspected vaccination failure; Had shingles 11 times; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles 11 times and also got both Shingles shots. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot /I got the shingles/ 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, less than 2 years 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot years ago and this year he/she got the shingles. The patient stated need the new shots he/she could not had the shingles shot till March. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pneumonia, Vaccination failure
Clinical narrative: been vaccinated and had shingles/Suspected vaccination failure; pneumonia; shingles; This case was reported by a consumer via 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), pneumonia (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and pneumonia were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, pneumonia and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had been vaccinated and had shingles twice been sick with pneumonia and had shingles now. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Shingles on face and eye. I did get a vaccination/ Suspected vaccination failure; Have shingles on my eye; Have shingles on my face; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received a dose of Shingles vaccine several years ago and now had shingles on his/her face and eye. The patient did get a vaccination several years ago therefore his/her case was not severe because of that.  The patient's PCP told him/her that the vaccinations would not guarantee prevention of the disease but would much lessen the severity.  The patient planned to take this newer vaccine as soon as he/she could. The patient could not imagine and  dealing with anything worse than what he/she had already experienced. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got first Shingrix vaccine in early 2018. The patient stated that vaccine gave him/her shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingrix vaccine and experienced rash following the shot.
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 2-7/13/2021, Dose 3-8/12/2021; second dose of 11 days apart; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received HBV (Engerix B adult) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 13th July 2021, the patient received the 2nd dose of Engerix B adult (intramuscular) 1 ml and Engerix B Pre-Filled Syringe Device. On 12th August 2021, the patient received the 3rd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 13th July 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, not applicable after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device and an unknown time after receiving ENGERIX B ADULT, the patient experienced drug dose administration interval too short. On 12th August 2021, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too short 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 details were provided as follows: The age at vaccination was not reported. The patient received 2nd and 3rd dose early than the recommended time interval, which led to shortening of vaccination schedule. The reporter ststed that, the patient received 2nd dose 11 days apart, instead of 4 weeks apart. The reporter gave a consent to follow-up with herself.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: few people come back for the 2nd shot; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a unspecified number of patients who received Hepatitis B vaccine for prophylaxis.   Previously administered products included HEPATITIS B VACCINE (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, 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 The reporter said that, the pharmacist who administered the shots to her mentioned that, very few people (patients) come back for the 2nd shot and till the time of reporting, the patients did not receive 2nd dose, which led to incomplete course of vaccination The reporter did not want to provide her mailing address. The reporter provided limited information. The case had been linked with US2021AMR225939, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR225939:same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2019 / 2ND DOSE NOT RECEIVED; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   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. The action taken with Shingrix was unknown. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the pharmacy technician. The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The consent to follow up was denied by the patient.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: was administered two doses as a first dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number E344C, expiry date 1st April 2023) for an unknown indication.   Co-suspect products included Herpes zoster (Shingrix) (batch number E344C, expiry date 1st April 2023) for an unknown indication.   On 29th October 2021, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 29th October 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   It was unknown if the reporter considered the overdose to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient had received two doses of Shingrix as a first dose, which led to overdose. The reporter wanted any information if a patient received an extra dose of Shingrix. The patient had granted consent for follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Headache
Clinical narrative: upset stomach; headaches off and on; Dizziness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included macular degeneration (has macular degeneration that could caused weird ocular effects) and heart disorder.   On 1st October 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced upset stomach, headache, dizziness and tiredness. On an unknown date, the outcome of the upset stomach was recovered/resolved and the outcome of the headache, dizziness and tiredness were not recovered/not resolved.   The reporter considered the upset stomach to be unrelated to Shingrix. It was unknown if the reporter considered the headache, dizziness and tiredness to be related to Shingrix.  Additional details were provided are as follows: The patient received a shot of Shingrix and had disturbing dizziness off and on, headache off and on, but thought they were related to the dizziness. The patient was unsure if the dizziness was related to the vaccine as she also has had macular degeneration that can cause weird ocular effects and stated that she was also experiencing tiredness, but thought this was more related to her heart issues and lifestyle. The patient also had an upset stomach post vaccine. The patient was unsure exactly when these symptoms started post vaccine. Medical information number to her health care professional. Spoken as per content and gave medical disclaimer. The patient stated she was going to follow-up with her health care professional. No health care professional provided. The reporter did not consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter reported that the patient experienced flu like symptoms after receiving the dose of Shingrix. The report did not clarify what the flu like symptoms were. The reporter had limited information. The reporter did not consent to follow-up. The case has been linked with case US2021225705 and US2021225709, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021225705:same reporter US-GLAXOSMITHKLINE-US2021225709:same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received Shingrix . Developed shingles/Suspected Vaccination Failure; mild case of shingles.; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 2nd dose of Shingrix. In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix in December 2018 and 2nd dose in March 2019. The patient recently developed a mild case of shingles.  The patient inquired if it was possible to receive a third dose of Shingrix.  The reporter did not consent to follow up. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix over 2 yeas ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received over 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 reported as follows: The age at vaccination was not applicable for this report. At the time of reporting the patient was over 70 years age. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The VAERS details were reported for 1st dose of Shingrix. The reporter consented to follow up. The healthcare professional did not have any more information. This case had been linked to the case US2021226681, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021226681:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet gotten the second shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose, 0.5 ml intramuscularly in left arm).   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 not recovered/not resolved.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient asked about financial assistance with her second shingrix vaccine. She got the first shot 2 to 3 yrs ago, but had not yet gotten the second shot, which led to incomplete course of vaccination.  She was instructed to get 2nd dose as soon as possible and that she did not need to restart the series. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
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 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA72AA, expiry date 31st October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd November 2021, unknown after receiving Bexsero and Bexsero 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 patient received an expired dose of Bexsero, it expired on 31st October 2021 and was administered on the same day as reported it, which led to expired vaccine used. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received just the adjuvant; received just the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number J7J4X, expiry date 31st January 2023) for prophylaxis.   On 2nd November 2021, the patient received the 1st dose of Shingrix. On 2nd November 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 medical assistant reported that, the patient received just the Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only gave one component; only gave one component; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 3rd November 2021, the patient received Menveo. On 3rd November 2021, unknown after receiving Menveo, 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 age at vaccination was not reported. The reporter stated that, medical assistant (MA) only gave one component that is liquid portion of Menveo was administered without being reconstituted with the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No information provided regarding patient, date of administration of Menveo/date of onset of adverse event.  The reporter reported that, she was calling on behalf of the nurse (data listed under HCP details) and had no additional details about the adverse event. The reporter did not have patient permission to provide additional details and she did not have the lot number available. She did consent to follow up from safety via email.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA462A, expiry date 31st October 2021) for prophylaxis.   On 2nd November 2021, the patient received Menveo. On 2nd November 2021, 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 provided as follows: Nurse Manager called in to report:  They inadvertently administered an expired dose of Menevo to the patient, which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: missed her 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 25-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 2nd May 2018) and Twinrix (2nd dose received on 5th June 2018).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, 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 details were provided as follows: The age at vaccination was not applicable for this report. The patient missed her 3rd dose of Twinrix by a couple of years and still not received it, which led to incomplete course of vaccination. No lot available or expiration dates when asked. The reporter consented to follow up.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose administered to an adult; pediatric dose administered to an adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HBV (Engerix B pediatric) (batch number P49XZ, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 details were provided as follows: The pediatric dose of the Engerix-B vaccine was administered to an adult, which led to underdose and adult use of a child product. No additional information was provided by the reporter. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose a year ago, 2nd dose has not been administered yet; This case was reported by a pharmacist 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 1st dose on 11th November 2020).   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. The patient received the first dose of Shingrix a year ago and the 2nd dose has not been administered yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose at week 6; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. Patient was administered with second dose of Shingrix at week 6 from the first dose instead of 8 weeks apart, which was shorter than the recommended interval, leading to shortening of vaccination schedule. The reporter claimed that he had no information to provide about the vaccination schedule and or the patients. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2020 and is late for the 2nd.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 22nd January 2020).   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 information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 60-year-old male patient who received HBV (Engerix B pediatric) (batch number 53YL7, expiry date 22nd December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2021, the patient received Engerix B pediatric 10 mcg and Engerix B Pre-Filled Syringe Device. On 2nd November 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 details were provided as follows: The adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.
Age: 55.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 2nd dose on 10Dec2014, has not received a 3rd dose; received a 0.5 mL dose on 10Nov2014; Received a 0.5 mL dose on 10Nov2014; This case was reported by a consumer via call center representative and described the occurrence of underdose in a 62-year-old male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   On 10th November 2014, the patient received the 1st dose of Hepatitis B vaccine .5 ml. On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine. On 10th November 2014, unknown after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced underdose and adult use of a child product. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the underdose, adult use of a child product and incomplete course of vaccination were unknown.  Additional details were provided as follows: The reporter was the patient. The patient received 1st dose in the left arm. The patient received 0.5 mL of 1st dose of Hepatitis B vaccine, which led to underdose and adult use of a child product. Till the time of reporting, the patient did not receive 3rd dose of Hepatitis B vaccine, which led to incomplete course of vaccination. The reporter believed it was Engerix B but was not sure. No symptoms reported. The patient did not want to give his real birthdate but the year was correct. He was able to provide his vaccination info from an app from his doctor's office. The reporter consented to follow up.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received a pediatric dose; adult patient received a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HAV (Havrix pediatric) (batch number Y4FL4, expiry date 28th January 2022) for prophylaxis.   On 3rd November 2021, the patient received the 1st dose of Havrix pediatric. On 3rd November 2021, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The medical assistant reported that, an adult female patient who received a pediatric dose of Havrix, which led to underdose and adult use of a child product. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: adult patient received pediatric dose; adult patient received pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 51-year-old male patient who received HAV (Havrix) (batch number Y4SL4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th November 2021, the patient received the 2nd dose of Havrix .5 ml and Havrix Pre-Filled Syringe Device. On 4th November 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 details were provided as follows: The adult male patient received a pediatric 0.5ml dose of Havrix, which led to underdose and adult use of a child product. No symptoms reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd dose not given within the 2-6 months window; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.  Additional details were provided as follows: The patient did not receive 2nd dose of Shingrix withn the 2 to 6 months window. The reporter stated that, when asked for more clarifications if the 2nd dose was administered before or beyond 2 to 6 months interval, health care professional ended chat, which led to inappropriate schedule of vaccine administered. No other adverse event details provided. No Consent to follow up asked as health care professional ended chat.