chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; got the shingles; they are very painful; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by the patient herself/himself. The age at vaccination was not reported. The patient stated that he/she got the Shingles vaccine and got the shingles been would be a year the 27th of reported month and shingles was very painful. The patient knew how someone felt. 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: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles / Not as bad; shingles shot 3x; 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case reported by the patient herself/himself. The age at vaccination was not reported. The patient stated that he/she got the Shingles shot three times and still got shingles. The patient received the 3rd dose of Shingles vaccine, which led to extra dose administered. The patient stated that the shingles was not as bad as the first time The reporter stated that he/she still recommended getting the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; shingles several times plus right now; 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 1st dose of Shingles vaccine and the 2nd 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 was unknown and the outcome of the shingles was not recovered/not resolved.   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: The case reported by the patient herself/himself. The age at vaccination was not reported. The patient stated that he/she got the Shingles vaccine twice and had shingles several times, plus right at the time of reporting. The patient stated vaccines did not work and stated be honest. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st Shingrix vaccine 3 years ago.Never rec'd the 2nd.; This case was reported by a consumer 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 1st dose 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 to this report. The patient never received 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked if it was too late to get the 2nd dose. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspect vaccination failure; I did get both shots./Caught it early bit did get a mild case recently; 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 1st dose of Shingles vaccine and the 2nd 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: The case reported by the patient herself/himself. The age at vaccination was not reported. The patient stated that he/she got the both shot of Shingles vaccine and had shingles. The patient stated that guess what he/she caught it early bit and did get a mild case recently. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: sores in his mouth; This case was reported by a consumer via interactive digital media and described the occurrence of sores mouth in a 81-year-old male 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 sores mouth. On an unknown date, the outcome of the sores mouth was recovered/resolved.   It was unknown if the reporter considered the sores mouth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sores in his mouth for 3 weeks. The reporter asked should the patient take the second dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: blister on the arm that the shot was given in; This case was reported by a consumer via interactive digital media and described the occurrence of blister 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 blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister 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 received 1st dose of Shingrix and experienced blister on the arm. The patients doctor said the reaction would be worse with the second dose. The patient asked what could he/she expect that time.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got his first Shingrix 14 months ago; This case was reported by a other health professional via media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 14th months 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: Age at vaccination was not applicable to this report. The reporter reported that the patient received his 1st dose 14th months ago, which led to incomplete course of vaccination. The reporter asked did he just get his second shot now and the series was complete or did he need to start over again because of the time lapsed.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product dose omission issue
Clinical narrative: supposed to receive a "booster dose" 6 months after the first dose but never made the appointment; This case was reported by a consumer via other manufacturer and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October or 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 case details were reported as follows: The case was reported by the patient. Age at vaccination was not applicable for this report. The patient reported missed dose adverse event (AE) for SHINGRIX during a call regarding a SHINGRIX medical information inquiry.  The patient received a dose of SHNGRIX and was supposed to receive a booster dose (it should be 2nd dose) 6 months after the 1st dose but never made the appointment for the booster dose (2nd dose) which led to incomplete course of vaccination. No further AE information and no product quality complaint (PQC) was reported. Physician information was unknown. No contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: 1st shingles vaccine / 11/29/19 / Covid 19 restrictions and lockdowns / 2nd shot until 6/9/2021; 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 (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on 29th November 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided are as follows: The age at vaccination was not applicable for this report. The patient did not receive 2nd shot until 9th June 2021 due to Covid-19 restrictions and lockdown. The reporter asked did he/she need another 4 to 6 months. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient here now with first Shingrix 8/28/20 - can I give second even though;; 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 (1st dose received on 28th August 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 to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked could he/she give 2nd dose even though 6 months interval passed. The follow up would not be possible as no contact details were available.
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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving 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.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient reported that, he or she got shingles after receiving the Shingrix vaccine. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure during pregnancy
Clinical narrative: accidental eye exposure with the adjuvant portion  / happened / to one of their employees/ Inadvertent exposure to vaccine; accidental eye exposure with the adjuvant portion; exposed person was female and 18 weeks pregnant; This prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of accidental occupational exposure to product in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2021, the patient received Shingrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Shingrix at an unknown time during the pregnancy. On 14th July 2021, unknown after receiving Shingrix, the patient experienced accidental occupational exposure to product, exposure via eye contact and vaccine exposure during pregnancy. On an unknown date, the outcome of the accidental occupational exposure to product, exposure via eye contact and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported, the accidental eye exposure with the adjuvant portion of the Shingrix vaccine on the same day of reporting to one of the employees, which led to accidental occupational exposure to product and exposure via eye contact. The exposed person was female and 18 weeks pregnant, which led to vaccine exposure during pregnancy. No further events or details about the event were clarified. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Product packaging confusion
Clinical narrative: the expiration date of the box was different than the vials inside; Based on the expiration date on the box, it was not expired at the time, however the vials did; received an expired dose of Menveo which expired on Nov 30, 2020; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA207A, expiry date 30th November 2020) for prophylaxis. This case was associated with a product complaint.   On 16th May 2021, the patient received Menveo. On 16th May 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the patient experienced product packaging confusion and product expiration date issue. On an unknown date, the outcome of the expired vaccine used, product packaging confusion and product expiration date issue were unknown.  Additional details were provided as follows: The patient received expired dose of Menveo which expired on 30th November 2020 which led to expired vaccine used.  Healthcare professional mentioned that, the expiration date of the box was different than the vials inside which led to product packaging confusion.  Based on the expiration date on the box, it was not expired at the time, however the vials did, which led to product expiration date issue. The reporter consented to follow up.  This was 1 of 3 linked cases reported by the same reporter.  Note: Date of vaccination was captured as 16th May 2021, as the clarification was raised for the same but no response was received yet.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152087:Same reporter US-GLAXOSMITHKLINE-US2021152086:Same reporter
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Administrated / an expired dose of Infanrix /  expired on October 23 2020; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received DTPa (Infanrix) (batch number cx59c, expiry date 23rd October 2020) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 14th July 2021, unknown after receiving Infanrix and Infanrix 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 manager reported that, the patient administrated with an expired dose of Infanrix, which led to expired vaccine used. The vaccine expired on 23rd October 2020. No adverse event was reported. The reporter consented to follow up.
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 9 month male patient was administrated with Kinrix instead of Pediarix; administrated with Kinrix instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number hb717, expiry date 1st September 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The nurse manager reported that 9 months old patient was administrated with Kinrix instead of Pediarix which led to inappropriate age at vaccine administration and wrong vaccine administered.  No adverse event was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: doctors office sent it to her/and/had it laying around for 4 months /took it to the doctors office and had it injected; This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a female 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 incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. Caller stated that her pharmacy sent the shingrix vaccine for her to the doctor, then the doctors office sent it to her house and the patient just had it laying around for 4 months before she took it to the doctors office and had it injected which led to incorrect storage of drug.  She refused to give any contact information or additional information for herself or the office or pharmacy or the vaccine. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: didn´t received the second dose of Havrix/ first dose was given during 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 37-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix 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 reporter stated that, a patient did not received the second dose of Havrix at time, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: it has been over six months since / patient received her first dose (11/4/2020) / due to Covid-19; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th November 2020, in left deltoid, batch number 52F7X, expiry date 31st october 2021).   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 provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient did not receive 2nd dose of Shingrix, due to covid 19. The pharmacist's plan was to gave dose 2 to the patient on the day of reporting. The VAERS details were provided for 1st dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose / on 12-Aug-2019 / has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 12th August 2019).   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 case details were reported as follows: The case was reported by the patient. Age at vaccination was not applicable for this report. The patient had not received 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up. The case had been linked with US2021153988 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021153988:Same reporter
Age: 32.0
Sex: F
Vaccine: MENB
Symptoms: Haemolytic uraemic syndrome, Product administered to patient of inappropriate age
Clinical narrative: Now hospitalized with a hemolytic uremic syndrome diagnosis; Administration / to a / 32 year old patient / first dose / on 5/14/2021; This case was reported by a physician via call center representative and described the occurrence of hemolytic uremic syndrome in a 32-year-old female patient who received Men B NVS (Bexsero) 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.   Concurrent medical conditions included hemolytic uremic syndrome.   On 14th May 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 14th May 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced hemolytic uremic syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the hemolytic uremic syndrome and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the hemolytic uremic syndrome to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The patient received 1st dose of Bexsero at the age of 32 years, which led to inappropriate age at vaccine administration and was hospitalized with a hemolytic uremic syndrome diagnosis during the time of reporting. The reporter did not clarify if there was a correlation between the administration of the vaccine and the current condition.  The reporter did not report any further events. The physician agreed to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had her first shot / in January 2020 / not yet received her second shot.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 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 details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient did not want to answer any further questions. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got / shot 1 / about a year and a couple months ago / has not yet received dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose intramuscularly a year and couple months ago of the 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: This case was reported by patient himself. The age at vaccination was not applicable for this report.. Till the time of reporting, the patient not yet received dose 2 of Shingrix vaccine, which led to incomplete course of vaccination. The patient received dose 1 intramuscularly and did not have exact date and did not have the lot number or expiration date. The reporter did not consent to follow up. The patient did not want to share his MD contact information.
Age: 22.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Shingrix instead of the varicella vaccine; A 22 year old patient received Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 22-year-old male patient who received Herpes zoster (Shingrix) (batch number TP943, expiry date 28th January 2023) for prophylaxis.   On 25th June 2021, the patient received Shingrix. On 25th June 2021, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided are as follows: Certified Medical Assistant (CMA) stated that 22 year old patient received Shingrix instead of Varicella vaccine which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow-up vis mail.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: baby received Havrix adult dose by error; baby received Havrix adult dose by error; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 1-year-old male patient who received HAV (Havrix adult) (batch number 299X2, expiry date 24th 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 19th July 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 19th July 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and accidental overdose. On an unknown date, the outcome of the adult product administered to child and accidental overdose 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 are as follows: Nurse supervisor called to report that a baby received Havrix adult dose by error as his Havrix dose which led to adult product administered to child and accidental overdose. The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: On 29Aug2019 / received the first /dose / did not return within the recommended time frame to receive the second dose; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 29th August 2019).   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 return within the recommended time frame to receive second dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient under 4 years old was administrated with Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number h9y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 provided were as follows: The manager reported that a 2-years-old patient received Kinrix vaccine, which led to inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow-up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received dose 1 / a half year ago /dose 2/ administered on July 15th 2021.; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number K2CG4, expiry date 11th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received 1 and a half year ago).   On 15th July 2021, the patient received the 2nd dose of Shingrix. On 15th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 1 dose of Shingrix 1 and a half year ago and dose 2 was administered on 15th July 2021, which led to lengthening of vaccine schedule. The reporter consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a nurse via call center representative and described the occurrence of hives in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 75XA2, expiry date 28th January 2023) for prophylaxis.   Concurrent medical conditions included drug allergy (thimerosal).   On 13th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The NDC number was provided  as 58160-828-03. The patient received dose of Shingrix and  2 or 3 days later started with hives and patient was still with this symptom. The patient allergist doctor realized that patient was very allergic to thimerosal but they were trying to discover if Shingrix caused this reaction on this patient. The reporter consent to follow up via personal email.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: administered the shingrix vaccine/ subcutaneous; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15th November 2022) 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 were provided as follows: The age at vaccination was not reported. The medical assistant reported that she administered the shingrix vaccine to a female patient subcutaneously, which led to intramuscular formulation administered by other route.  The patient did not reported any symptoms to the health care professional.  No other information was reported The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on 5/4/2018 / not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 4th May 2018).   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. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No further events were reported.  The health care professional agreed to be contacted for follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: partial administration of only the adjuvant portion; partial administration of only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number DE9L4R, expiry date 27th January 2023) for prophylaxis.   On 20th July 2021, the patient received Shingrix. On 20th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details provided were as follows: The reporter informed that the partial administration of only the adjuvant portion of Shingrix to the patient, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter consented to follow-up by email.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received a shingles vaccine and subsequently had a Shingles outbreak/Suspect vaccination failure; received a shingles vaccine and subsequently had a Shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male 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 reported as follows: The age at vaccination was not reported. The reporter was in the general public, not a patient.  The reporter inquired about Shingrix and vaccine hesitancy in general.  The reporter stated that people she knows have received a shingles vaccine and subsequently had a Shingles outbreak.  When asked for more details about the patients the reporter cited just a guy at my church. The reporter did not know the year the conversation with the patient occurred or which vaccine he received and she did want to provide additional details and ended the call. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/on 09/15/2018/never received one; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th September 2018 on left arm into the muscle).   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 provided were as follows: The reporter was the patient herself. The age at vaccination was not applicable for this report. The patient received her 1st dose of Shingrix and did not know about the second dose of Shingrix to complete the series, so till the time of reporting she did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not have lot number and expiration date for Shingrix. She had national drug code number (58160-0819-12). VAERS details for 1st dose was reported. The reporter gave a consent to follow-up with health care professional. However, she did not have a fax number or an email address. The reporter consented to follow up. This case has been linked with US2021156427, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021156427:Same reporter. Husband case.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/on 09/15/2018/never received one; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th September 2018 on left arm into the muscle).   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 provided were as follows: The age at vaccination was not applicable for this report. The reporter was the patient's wife. The patient received his 1st dose of Shingrix and did not know about the 2nd dose of Shingrix to complete the series, so till the time of reporting he did not receive the 2nd dose which led to incomplete course of vaccination. The reporter did not have lot number and expiration date for Shingrix. She had national drug code number (58160-0819-12). The reporter gave a consent to follow-up with health care professional. However, she did not have a fax number or an email address. The reporter consented to follow-up. This case had been linked with US2021156426, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021156426:Same reporter. Wife case.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: HCP used saline to reconstitute Menveo/ instead of using liquid conjugate component; HCP used saline to reconstitute Menveo/ instead of using liquid conjugate component; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA419A, expiry date 31st October 2021) for prophylaxis.   On 19th July 2021, the patient received Menveo (intramuscular) .5 ml. On 19th July 2021, unknown after receiving Menveo, 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 are as follows: The case was reported by medical assistant from the doctor's office. The reporter reported that the patient had been given a Menveo 0.5 ml intramuscularly in the left arm that a mixed incorrectly at the doctor's office.  The reporter stated that the health care professional used saline to reconstitute Menveo (powder form orange top vial lyophilized conjugate component) instead of using liquid conjugate component (gray top vial), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter provided lot/expiry date from the Menveo box but did not had lot/expiry date from the vials lyophilized (orange top vial) and liquid conjugate (gray vial).  The reporter gave a consent to follow-up with health care professional. The reporter consented to follow-up.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: on Jul-20-2021 / patient was administered an expired dose / (expiration date: 5/14/2021); This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number 9PL5A, expiry date 14th May 2021) for prophylaxis.   On 20th July 2021, the patient received Havrix. On 20th July 2021, unknown after receiving Havrix and Havrix, 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: Age at vaccination was not reported. Nurse reported that a patient received an expired dose of havrix. She did not have information about the patient. Consented to follow-up was by phone/mail