chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered dose reconstituted with a non-supplied diluent; administered dose reconstituted with a non-supplied diluent; 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 patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA673A, expiry date 31st March 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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 Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comments: The medical assistant reported that the clinic staff discovered that box of Menveo vaccines had an extra vial of diluent, so they believe a patient was administered a dose that was reconstituted with a non-supplied diluent. At the time of reporting, the reporter only knew that it was a pediatric patient, but were not sure yet which patient it was, or what date it was administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient received Menveo that was reconstituted with a non-supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 24.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 24-year-old male patient who received HAV (Havrix) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   On 5th July 2022, the patient received the 1st dose of Havrix. On 5th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's comment: The patient received an expired dose of Havrix vaccine. The reporter asked was it still effective. The reporter consented to follow up. Additional Supportive Information:  The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Rotarix was administered intramuscularly rather than orally; This case was reported by a physician via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 5th July 2022, the patient received the 2nd dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 5th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's comment: Physician reported that the Rotarix was administered intramuscularly rather than orally to the patient. The reporter did not have the lot or expiration date of vaccine at the time of the call. The reporter consented to follow-up. Additional Supportive Information: The patient received Rotarix intramuscularly rather than orally, which led to Inappropriate route of vaccination.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix 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 Information: GSK Receipt Date: 06-JULY-2022   Reporter's Comments:  The reporter stated that patient received an expired dose of Havrix adult. Additional supportive information: The reporter consented to follow up. The patient received Havrix which was already expired in 20th May 2022 which led to expired dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 31Oct2019, ate 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 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st October 2019).   On an unknown date, the patient did not receive 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: GSK receipt date: 6-Jul-2022 Reporter's comment: The pharmacist reported that the patient was late for the 2nd dose. The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Engerix B and Engerix B 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 Information: GSK receipt date: 6-Jul-2022 Reporter's comment: The office manager stated that one of their employees received an expired dose of Engerix-B. The health care professional did not had patient's initials or date of birth at time of call.  The reporter also did not had the lot or expiry date, but stated that he believed it expired at the end of May.  The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 18Jun2021, did not return for subsequent dosing; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male 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 (received 1st dose on 18th June 2021, batch number DK23D expiration date 08 February 2022).   On an unknown date, the patient did not receive the 2nd 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 Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comments: The pharmacist reported that the patient did not return for subsequent dosing. At the time of reporting, the patient was not yet received further doses.  The reporter consent to follow-up. The reporter gave permission for follow up but declined to provide email address. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of Twinrix which led to incomplete course of vaccination.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Social problem
Clinical narrative: 1st dose in APR-2019, received 2nd dose 7/6/2022  due to the pandemic; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (as received 1st dose of Shingrix in April 2019).   On 6th July 2022, the patient received the 2nd dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the pain in arm and social problem were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's comments: The patient had received the 2nd dose one day before the reporting date (yesterday), however, the 2nd dose was received late due to the pandemic. The patient also reported that she had experienced a sore arm. The patient had asked if could take Tylenol. The patient also wanted to know if they need to take the 3rd dose. Spoken as per the content and provided medical disclaimer and was referred to Healthcare professional (HCP). The reporter consented to follow-up. As it was not clearly after which dose patient had experienced sore arm, therefore as per processing convention it was considered that the event was occurred after the latest dose.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: she developed a shingles rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2022, the patient received the 1st dose of Shingrix (intramuscular). In July 2022, 7 days after receiving Shingrix, the patient experienced shingles. The patient was treated with famciclovir. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK receipt date: 07 July 2022 Reporters comment: The patient self-reported this case. The patient received Shingrix dose in left arm and experienced shingles rash on her left arm. Her doctor prescribed famciclovir to treat the shingles. The reporter did not consent for follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: pain in his ankles; This case was reported by a pharmacist via call center representative and described the occurrence of pain ankle in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th May 2022, less than a day after receiving Shingrix, the patient experienced pain ankle. On an unknown date, the outcome of the pain ankle was not recovered/not resolved.   It was unknown if the reporter considered the pain ankle to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's Comments: The patient on that day he developed pain in his ankles. The pain persisted, was nothing else to report. The reporter consented to follow up with health care professional.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: gave dose that was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received HAV (Havrix) (batch number X989B, expiry date 14th June 2020) for prophylaxis.   On 30th June 2022, the patient received Havrix. On 30th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 7-Jul-2022 Reporter's comment: Nurse reported that a staff member gave a dose of Havrix to a patient which was already expired. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email.  Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered a dose on 07Jul2022, which had an expiration date of 28May2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix.   On 7th July 2022, the patient received the 5th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 7th July 2022, 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 Information: GSK receipt date: 7-Jul-2022 Reporter's comment: The nurse practitioner reported that the patient was administered a dose of Infanrix, which had an expiration date of 28th May 2022. This was the patient's fifth dose in the series. At the time of reporting, the dose has not been repeated.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional supportive information: The patient had received an expired dose of Infanrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 10/11/2019 and 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 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix on 11th October 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 Information: GSK Receipt Date: 07-JUL-2022 Reporter's comment: The pharmacist reported that the patient (husband) had not been administered 2nd dose yet. The Vaccine administration facility was the same as primary reporter. The Healthcare Professional (HCP) did not had lot number or expiration date of Shingrix first dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was linked with case US2022103850 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103850:Same reporter
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient received expired Boostrixdose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 7th July 2022, the patient received Boostrix. On 7th July 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 7-Jul-2022 Reporter's comment: The nurse reported that the patient received an expired dose of Boostrix vaccine in left deltoid. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Boostrix, which led to expired vaccine used.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received a dose of Engerix B already expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th May 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 7th July 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 7th July 2022, unknown after receiving Engerix B and Engerix B 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 Information: GSK receipt date: 7-Jul-2022 Reporter's comment: The registered nurse reported that on the day reporting the patient received a dose of Engerix B which was already expired on 6th April 2022. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Engerix B, which led to expired vaccine used. Suspect was coded as per reported information.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered adjuvant only portion; administered adjuvant only portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Shingrix. On 6th July 2022, 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 Information: GSK Receipt Date: 07-JUL-2022 Reporter's comment: Medical assistant reported that the patient was administered only the adjuvant portion of Shingrix. The adjuvant was not reconstituted with the lyophilized powder portion. The reporter did not have the lot number or expiration date information available at the time of call. The dose had not been repeated at the time of reporting. The reporter consented to follow-up. Additional Supportive Information: The patient was administered only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case US2022104536 was identified as duplicate of this case. The case US2022104536 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: gave Shingrix diluent only without mixing it with powder; gave Shingrix diluent only without mixing it with powder; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication 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 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 Information: GSK Receipt Date: 07 July 2022 Reporter's Comments:  Nurse reported nursing staff gave Shingrix diluent only without mixing it with powder. The reporter declined to answer any further questions when asked for consent to follow-up refused to answer the question. Additional supportive information As patient received only Shingrix diluent only without mixing it with powder which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: adjuvant was not reconstituted iwith the lyophilized vial.; Administration of adjuvant only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adult 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 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 Information: GSK Receipt Date: 07-JUL-2022 Reporter's comment: Nurse reported that a patient was administered the Shingrix adjuvant only without reconstituting it with the lyophilized vial. The vaccine administration facility was the same as primary reporter. The reporter did not have lot number or expiration date at time of call, she said she could provide if GlaxoSmithKline follow-up via email. The reporter consented to follow-up. Additional Supportive Information: The patient was administered the Shingrix adjuvant only without reconstituting it with the lyophilized vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administration of Havrix expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th July 2022, the patient received Havrix (intramuscular) and Havrix Pre-Filled Syringe Device. On 5th July 2022, unknown after receiving Havrix and Havrix 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 Information: GSK receipt date: 7-Jul-2022 Reporter's comment: The pharmacist reported that the patient was administered a dose of Havrix in left arm which was expired on 14th June 2022. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used. This was 2 out of 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103864:Same reporter. Patient 1
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: unapproved diluent used; unapproved diluent used; 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 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA5928, expiry date 21st August 2022) for prophylaxis.   On 29th June 2022, the patient received Menveo. On 29th June 2022, 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 Information: GSK Receipt Date: 07-Jul-2022 Reporter's Comments: The reporter was medical assistant. The patient received a Menveo vaccine that was reconstituted by using an unapproved diluent. The reporter consented to follow up via email. Additional Supportive Information: The patient received a Menveo vaccine that was reconstituted by using an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Social problem, Vaccination failure
Clinical narrative: belief they are in the early stages of a shingles; belief they are in the early stages of a shingles; Itching; receiving first dose in November of 2019 and second dose in 2021, due to COVID; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix. In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and social problem. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and social problem were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 7-July-2022 Reporter's Comment: The reporter was the patient. The patient received first dose in November of 2019 and second dose of Shingrix more than 6 months after the first dose, in 2021, due to COVID. The reporter reported that she belief that she was in the early stages of a Shingles outbreak. The patient was experiencing itching in the same area of previous Shingles outbreak. The reporter did not consent to follow-up. Additional supportive information: The patient received the 2nd dose more than 6 month after the 1st dose due to COVID, Social problem. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose recieved after 11 months of first; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received 1st dose of Shingrix in June 2021).   In May 2022, the patient received the 2nd dose of Shingrix. In May 2022, 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 Information: GSK Receipt Date: 08-Jul-2022 Reporter's Comment: The case was reported by the patient. The reporter did not consent to follow up. Additional Supportive information: The patient received second dose of Shingrix after 11 months after receiving first dose, which led to lengthening of vaccination schedule.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received a dose that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 75F27, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th July 2022, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 7th July 2022, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comment: Nurse reported that a patient received dose of Fluarix that had expired on 30th June 2022.  The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Fluarix which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expiration date of 05Jul2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 92-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 7th July 2022, the patient received Boostrix. On 7th July 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's comment: The pharmacist reported that the patient received dose of Boostrix which had expired on 5th July 2022. At the time of reporting, repeat dose had not been administered.  The vaccine administration facility was the same as primary reporter. The reporter did not have patient initials available at time of call. The reporter did not consent to follow-up. Additional Supportive Information:  The patient received a dose of Boostrix which was already expired, which led to expired vaccine used.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 month was administrated with Kinrix; Kinrix was the patient's 4th dose of DTaP; was to have hep a and mmrv, received Kinrix by mistake; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received DTPa-IPV (Kinrix) (batch number h99j7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th July 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered 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 Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comments: The patient was administrated with Kinrix as 4th dose of DTaP and 4th dose of IPV. The patient was to have received a Hepatitis A and MMRV but received Kinrix by mistake. No adverse event was reported. The reporter did not consent to follow-up. Additional Supportive Information:  The patient received Kinrix as 4th dose of DTaP and 4th dose of IPV at 12 months of age and the patient was to have received a Hepatitis A and MMR vaccine, which led to inappropriate age at vaccine administration, inappropriate schedule of vaccine administered, and wrong vaccine administered.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Rash vesicular
Clinical narrative: blistery rash underneath her right breast; soreness at the injection site; right sided numbness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th June 2022, the patient received the 1st dose of Shingrix .5 ml. On 30th June 2022, immediately after receiving Shingrix, the patient experienced injection site pain and numbness. On 8th July 2022, the patient experienced blistery rash. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the numbness and blistery rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, numbness and blistery rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comments: The patient got her Shingrix vaccine on the left arm.  Shortly after the vaccine, she had soreness at the injection site which was since resolved. Later in the evening post her injection, she stated that she began with right sided numbness that was progressed down to her foot and was not resolved.  The patient also reported that on the day of reporting she started with a blistery rash underneath her right breast.  The patient did not have any further information about the vaccine. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose administered June 2019, 2nd on Nov 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 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on 6th June 2019 ).   On 14th November 2021, the patient received the 2nd dose of Shingrix. On 14th November 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 Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comment: The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow up. Vaccine expiration date not recorded by health care professional. Additional supportive information The second dose was administered late which led to lengthening of vaccination schedule.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: forgot she received series, got new dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th April 2018) and Shingrix (received 2nd dose on 22nd June 2018).   On 8th July 2022, the patient received the 3rd dose of Shingrix. On 8th July 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's comments: The case was reported by the patient who was the nurse. The patient received the first and second dose of Shingrix and patient forgot that patient had received the series and got another dose.  The reporter did not have the lot number or expiration date information for any of the doses received. The reporter consented to follow up. Additional supportive information: The patient reported that the patient received another dose, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site vesicles, Vaccination failure
Clinical narrative: Shingrix vaccine which triggered Shingles Outbreak; shingles; vesicles on her hands and knees/ Vesicles appeared around the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included immunosuppressants nos (Immunosuppressive Therapy (Nos)).   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), shingles and vesicles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and vesicles were recovered/resolved.   The reporter considered the vaccination failure, shingles and vesicles to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Jul-2022 and 11-Jul-2022 Reporter's Comments:  The patient reported that she received her Shingrix vaccine which triggered a Shingles Outbreak. Patient was certain that this was an outbreak of shingles as she had experienced it previously.  Vesicles appeared around the injection site, on her hands, and knees.  The patient was successfully treated with a ten days course of Valtrex.  The reporter reported that, also patient was on immunosuppressive therapy. The reporter consented to follow up. No further details provided on web form. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with sterile diluent not accompanying diluent; reconstituted with sterile diluent not accompanying diluent; 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 patient who received Hib (Hiberix) (batch number Y772R, expiry date 25th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, 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 Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The reporter reported that HIberix was reconstituted with sterile diluent not accompanying diluent. The reporter consented to follow-up. Additional supportive information: The Hiberix was reconstituted with sterile diluent not accompanying diluent, which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered 11Jul2022, expiration date 05Jul2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 11th July 2022, the patient received Boostrix. On 11th July 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The nurse reported that the patient was administered a dose of Boostrix on the day of reporting, which had an expiration date of 5th July 2022. At the time of reporting, dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Boostrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix vaccine over 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first Shingrix vaccine intramuscularly over 2 years ago).   On an unknown date, the patient did not receive 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: GSK receipt date: 11-Jul-2022 Reporter's comment: The healthcare professional called to report about the second dose of Shingrix for one of his patients. The reporter reported that the patient did not receive the second dose of Shingrix. No other information was available. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose has not been administered.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th October 2020).   On an unknown date, the patient did not receive 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: GSK receipt date: 11-Jul-2022 Reporter's comment: The pharmacist reported that the second dose has not yet been administered to the patient. The reporter declined follow-up from Safety for now due to wanting to ask if the patient if it was okay first. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: experienced headache; experienced body aches; This case was reported by a consumer via call center representative and described the occurrence of headache in a female 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 headache and general body pain. On an unknown date, the outcome of the headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the headache and general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-July-2022 Reporter's comment: The reporter was the patient who stated after dose of the Shingrix vaccine, the patient experienced body aches and headache which lasted for several days. The reporter did not consent to follow up. Additional supportive information: This case had been linked with US2022105572 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022105572:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling; Injection site redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling and injection site redness. On an unknown date, the outcome of the injection site swelling and injection site redness were unknown.   It was unknown if the reporter considered the injection site swelling and injection site redness to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-July-2022 Reporter's comment: The patient received the first dose of the shingrix vaccine 2 months ago from the date of reporting and experienced injection site redness and swelling.