chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo dluted with sterile water and administered; Menveo dluted with sterile water and administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) and (batch number T014300, expiry date unknown) for prophylaxis.   On 16th August 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 16th August 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: 17-AUG-2022 Reporter's comment: The reporter stated that, they accidentally diluted Menveo with sterile water and administered it to patient. The reporter consented to follow up. Additional Supportive Information: The reporter stated that, they accidentally diluted Menveo with sterile water and administered it to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 2 cases reported by the same reporter. Note: Two batch number were reported one for the liquid conjugate (AMVA710A) and other for lyophilized conjugate (T014300).; Sender's Comments:  US-GSK-US2022120204:Same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy rash on left arm; Red rash on left arm; Itchy (no rash) on legs and right arm; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 5H29x, expiry date 6th July 2023) for prophylaxis.   On 14th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th July 2022, 4 days after receiving Shingrix, the patient experienced itchy rash, red rash and pruritus. On an unknown date, the outcome of the itchy rash, red rash and pruritus were recovering/resolving.   It was unknown if the reporter considered the itchy rash, red rash and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comment: The patient stating that she got her shingrix vaccine in the left arm and then  she broke out in an itchy red rash on the left arm.   She stated the rash went from her shoulder to her elbow and then she also got itchy (with no rash) on both her legs and right arm.  The rash and itching had improved, but it isn't completely gone. The patient did not give a HCP for follow up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Half dose still PFS,unsure howmuch administered; Half dose still PFS,unsure howmuch administered; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th 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 17th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 17th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced underdose and incomplete dose administered. On an unknown date, the outcome of the underdose and incomplete dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: Nurse reported that she was administered a dose of Kinrix to patient, and the patient pulled away during administration.  The nurse stated that she was unsure how much of the dose the patient received, half of the dose was still left in the PFS, and she believed most of the part that was injected did not go into the patient.  At the time of reporting, the dose had not been repeated.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive information: The half of the dose was still left in the PFS and how much of the dose the patient received was unsure which led to Under dose and incomplete dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: having swollen nodes by the neck; This case was reported by a pharmacist via call center representative and described the occurrence of lymphadenopathy cervical 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 lymphadenopathy cervical. On an unknown date, the outcome of the lymphadenopathy cervical was not recovered/not resolved.   It was unknown if the reporter considered the lymphadenopathy cervical to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-AUG-2022.  Reporter's Comments: Afterhours webform submitted on 18th August 2022 and retrieved at start of business the same day as follows.  The reporter had someone said that they received first dose of Shingrix having swollen nodes by the neck and not went away. No further details provided. The consent to follow up was granted.
Age: 11.0
Sex: F
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 years of age patient received a dose of Twinrix; 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 11-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22nd September 2023) 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.   On 17th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 17th August 2022, unknown after receiving Twinrix and Twinrix 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 Information: GSK receipt date: 18-AUG-2022 Reporter's comments: Medical assistant reported that patient 11 years of age received a dose of Twinrix.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive information: Medical assistant reported that patient 11 years of age received a dose of Twinrix, which led to inappropriate age at vaccine administration.
Age: 62.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administrated with an expired dose of Twinirx; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received HAB (Twinrix) (batch number x239d, expiry date 7th August 2022) 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.   On 12th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 12th August 2022, unknown after receiving Twinrix and Twinrix 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: 18-AUG-2022 Reporter's comment: The manger reported that the patient was administrated with an expired dose of Twinirx. The vaccine expired on 7th August 2022. No adverse event was reported. The consent to follow up. Additional Supportive Information: The patient was administrated with an expired dose of Twinirx, which led to expired vaccine used.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: pain at injection site; fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th August 2022, several minutes after receiving Shingrix, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comments: The reporter was the patient.  The patient received dose of Shingrix and minutes after experienced pain at injection site and fatigue. No other information provided. The patient did not want to give her demographics. The patient did not want to give her demographics, nor did she give consent for HCP follow up. The reporter did not consent to follow up.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 6 month old received kinrix; Received kinrix instead of pediarix; 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 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th July 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 18th July 2022, 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 Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comment: The reporter was a Medical assistant. The reporter reported that the six month patient inadvertently received Kinrix vaccine instead of Pediarix vaccine. Reporter did not want the information stored in GlaxoSmithKline database but agreed to follow up by safety. The reporter consented to follow up. Additional supportive information: The patient received Kinrix vaccine at 5 month age which led to, Inappropriate age at vaccine administration. The reporter reported that, they were intending to administered Pediarix and inadvertently administered Kinrix instead of Pediarix, which led to wrong vaccine administered.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 30th June 2022) for prophylaxis.   On 17th August 2022, the patient received Havrix. On 17th August 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:17-AUG-2022 Reporter's comment: The  pharmacist reported that on 17th August 2022 a patient received a dose of Havrix that had expired on June 2022. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. Additional supportive information: The patient had received an expired dose of Havrix, which led to expired vaccine used. Call center's email attached confirming that the formulation was not confirmed by reporter and neither by their system. Therefore conservatively it was coded as Solution for Injection.
Age: 6.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: Administrated with the only the liquid component; Administrated with the only the liquid component; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 6-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva714a, expiry date 30th June 2023) for prophylaxis.   On 16th August 2022, the patient received Menveo. On 16th August 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- 18-Aug-2022 Reporter's comment: Nurse reported that a male patient was administrated with only the liquid component of Menveo. Adverse event was not reported. The reporter consented to follow up. Additional Supportive Information: The patient was administrated Menveo reconstituted with only the liquid component of Menveo, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose more than a year ago; This case was reported by a nurse via sales rep 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 (received first dose more than a year 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: 18-Aug-2022 Reporter's Comments: The reporter was the patient involved on this situation. Account manager reported by phone that a nurse director of clinical support needed information about Shingrix late second dose. The healthcare professional (HCP) received Shingrix first dose more than a year ago. The healthcare professional (HCP) managed several clinics. Consented to follow-up accepted by postal. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose more than a year and a half ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than a year and a half ago in a different state).   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: 18-AUG-2022 Reporter's comment: The vaccine lot number and expiration date were unknown. Exact administration date of first dose was unknown. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered on 07Jul2022, expiration date of 05Jul2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th July 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 7th July 2022, unknown after receiving Boostrix and Boostrix 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: 18-Aug-2022 Reporter's Comments: A nurse reported a patient was administered Boostrix vaccine on 7th July 2022, which had an expiration date of 5th July 2022. At the time of reporting, the dose had not been repeated.  Reporter declined to provide patient information aside from gender. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Boostrix, which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received one of the vials of Shingrix; Received one of the vials of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients 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: 18-AUG-2022 Reporter's Comments: The pharmacist believed that 20 other patients over time received one of the vials of shingrix, either adjuvant alone or antigen mixed with other diluent.  The reporter did not knew what was given. No other details was available. The reporter consented to follow up. Additional Supportive Information: The unspecified number of patients received one of the vials of shingrix, either adjuvant alone or antigen mixed with other diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Gave only vial 1 of Menveo; Gave only vial 1 of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA656A, expiry date 31st August 2023) for prophylaxis.   On 17th August 2022, the patient received the 1st dose of Menveo. On 17th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's comment: The reporter reported that at their clinic one day before the reporting date, the patient accidently received only the vial 1 of Menveo into the left deltoid.  This was her first vaccination for meningococcal. The reporter asked when could she have the full vaccine.  The reporter asked that the patient still need 2. The reporter consented to follow-up. Additional Supportive Information: The patient accidently received only the vial 1 of Menveo, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. Follow-up request was raised for facility  type clarification but meanwhile facility type was captured as clinic as per reported narrative.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: 1st dose 2019, due to the Covid-19 Pandemic, 2nd dose June 30 2022; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M39A, expiry date 28th August 2023) for prophylaxis.   Previously administered products included Shingrix (On 25th August 2019,the patient received 1st dose of Shingrix).   On 30th June 2022, 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 Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comment: The second dose of Shingrix was administered late to the patient due to the covid-19 pandemic. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The second dose of Shingrix was administered late to the patient due to the covid-19 pandemic, which led to social problem.
Sex: F
Vaccine: VARZOS
Symptoms: Immune system disorder
Clinical narrative: experiencing severe immune response, after receiving first dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of immune system disorder 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 immune system disorder. On an unknown date, the outcome of the immune system disorder was unknown.   It was unknown if the reporter considered the immune system disorder to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comments: The caller reported she had experienced severe immune response, after receiving first dose of Shingrix. The reporter did not consented to follow-up.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an 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 35-year-old female patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 18th August 2022, the patient received Havrix. On 18th August 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: 18-AUG-2022 Reporter's Comments: The health care professional reported that a patient received Havrix and was expired on 9th August 2022.  The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix on the day of reporting, which led to expired vaccine used.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received an Engerix-B expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received HBV (Engerix B) (batch number K2L79, expiry date 12th August 2022) for prophylaxis.   On 17th August 2022, the patient received the 3rd dose of Engerix B. On 17th August 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date- 18-Aug-2022 Reporter's comment: Licensed practical nurses (LPN) reported that a patient received an expired dose of Engerix-B. This was patient's third dose of Engerix-B. The reporter did not consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 month old was vaccinated with Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th 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 6th April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 6th April 2022, 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 Information: GSK receipt date: 18-Aug-2022 Reporter's Comments: The nurse reported that the 6 months old patient was vaccinated with Kinrix.  The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. As per reported information, 6 months old patient received Kinrix but in system it was auto calculated as 5 months therefore auto calculated one was captured in structured field.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Occupational exposure to product, Product complaint
Clinical narrative: Product Complaint; Liquid shot out from the vial and got on her hand; Liquid shot out from the vial and got on her hand; This case was reported by a nurse via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number NF442, expiry date 5th October 2023) for prophylaxis. This case was associated with a product complaint.   On 18th August 2022, the patient received Shingrix .5 ml. On 18th August 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via skin contact. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comment: The nurse stated that when she went to put the adjuvant into the antigen bottle, the liquid shot out from the vial and got on her hand. The reporter said about 0.1 ml left after the adjuvant was put in the antigen bottle and there was stopper pierced in the circular area dedicated to perforation. There were no air injected into the vial.  No product quality complaint report was completed. Not enough of the vaccine was left to administer.  The reporter reconstituting the Shingrix was an experienced user.  The reporter will send pictures.  The reporter asked to send a single vial dose pack for replacement and also send a return shipping label for the clinic to send back the defective dose. The reporter did not gave consent to follow up. Additional Supportive Information: The liquid shot of the vaccine out from the vial and got on reporter's hand, which led to occupational exposure while preparing product for administration and exposure via skin contact. The product complaint event was captured as local and global reference numbers were reported and for further clarification follow-up request was raised.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy rash around his waist; red rash around his waist; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than 2 weeks after receiving Shingrix, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the itchy rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-AUG-2022.  Reporter's Comments: The reporter was the wife of the patient.   The patient received his Shingrix on right arm.   The reporter stated the patient developed an itchy, red rash around his waist.   The reporter stated that her husband showed her the rash on the day of the reporting. Reporter gave consent to follow up with health care professional (HCP) (pharmacy).
Age: 5.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 year old was administered Bexsero; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received Men B NVS (Bexsero) (batch number R42C, expiry date 30th June 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 18th August 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comments: The nurse reported that patient was inadvertently administered a dose of Bexsero. The reporter was consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The 5 years old patient received bexsero inadvertently, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the liquid component; Patient received only the liquid component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 18-AUG-2022 Reporter's comments: The patient received only the liquid component of the Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions were reported.  The reporter consented to follow up via email.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Received expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   On 19th August 2022, the patient received Havrix. On 19th August 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: 19-Aug-2022 Reporter's Comments: A medical assistant reported a patient received on 19th August 2022 a dose of Havrix that had expired on 9th August 2022. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: got the Shingrix vaccine and then had an episode of A-fib; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a male 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 atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's comment: The reporter was the patient. The patient stated that he got the Shingrix vaccine and then had an episode of atrial fibrillation.  There was no information given as well concerning vaccine lot number or expiry date.  The patient did not consent to follow-up.  No healthcare professional for follow-up. The reporter had not given any demographics details or further information concerned to the adverse event.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bradycardia
Clinical narrative: her mother is now experiencing bradycardia; This case was reported by a consumer via call center representative and described the occurrence of bradycardia in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced bradycardia (serious criteria GSK medically significant). On an unknown date, the outcome of the bradycardia was not recovered/not resolved.   It was unknown if the reporter considered the bradycardia to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's comments: The case was reported by patient's daughter. The reporter stated that her mother had the first dose of Shingrix on 17th August 2022 and her mother had now experienced bradycardia and she was scheduled for a pacemaker placement. The reporter had limited information about the pharmacy and Healthcare Professional (HCP) contact information. The daughter gave the consent to contact to herself and to the consumer.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: received vaccine 6 years ago, only received one dose; shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 66-year-old female 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. In July 2022, more than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Jun-2022 Reporter's comment: The reporter was the patient, who received a shingles vaccine about 6 years ago.  She did not know which shingles vaccine it was (Zostavax or Shingrix).  She stated that this past month she had an episode of shingles.  She had also only received one dose of the shingles vaccine.  The consent to follow up was granted.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 2.5 years ago, has not received second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2.5 years ago from the date of reporting).   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: 19-AUG-2022 Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shngrix, which led to Incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Neuropathy peripheral
Clinical narrative: Neuropathy got worse; Neuropathy got worse; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (1st dose received on end of August 2021,for tolerance of first dose refer case US2022AMR121991). Concurrent medical conditions included neuropathy and celiac disease.   In October 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the outcome of the neuropathy and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the neuropathy and condition aggravated to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR121991   Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine. The reporter stated after received Shingrix vaccine patient experienced her neuropathy got worse and this is still an ongoing problem. The reporter was unsure if it was related to the vaccine. The patient did not had any further information about the vaccine. Additional Supportive Information: This case had been linked with US2022AMR121991 reported by same reporter for same patient. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2022AMR121991:Same patient
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Muscular weakness, Pyrexia
Clinical narrative: muscle weakness, hospitalized; fatigue, hospitalizaed; fever, hospitalized; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), muscle weakness (serious criteria hospitalization) and fatigue (serious criteria hospitalization). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the muscle weakness was not recovered/not resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fever, muscle weakness and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's comment: Pharmacist was the daughter of the patient. Who administered vaccines was unknown. Pharmacist reported that the patient received dose of Shingrix vaccine and after receiving the dose (exact time of development of adverse events was not communicated) experienced fever for 3 days, muscle weakness that last until today (day or reporting) and had the patient hospitalized and fatigue. The patient required emergency room visit. Pharmacist did not have lot number nor expiration date of the vaccine. The reporter consented to follow-up. This case has been linked with case US2022119657, reported by the same reporter.; Sender's Comments:  US-GSK-US2022119657:Same reporter
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; dose on February 12 2018, March 20 2018, and November, 13, 2020; dose on February 12 2018, March 20, 2018; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Chemotherapy. Concurrent medical conditions included blood dyscrasia and immunocompromised.   On 13th November 2020, the patient received the 3rd dose of Shingrix. On 20th March 2018, the patient received the 2nd dose of Shingrix. On 12th February 2018, the patient received the 1st dose of Shingrix. On 20th March 2018, not applicable after receiving Shingrix and Shingrix, unknown after receiving Shingrix and not applicable after receiving Shingrix and Shingrix, the patient experienced drug dose administration interval too short. On 13th November 2020, the patient experienced extra dose administered. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, drug dose administration interval too short and extra dose administered were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: The pharmacist reported that the patient received first and second dose of Shingrix and experienced shingles. The pharmacist reported that his patient currently recovering from shingles and patient was taking Valtrex for treatment. The pharmacist also stated that there was another date recorded for a Shingrix vaccine for this patient on 13th November 2020, but the pharmacist questioned the accuracy of this latter date. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test and time to onset confirming shingles was unknown at the time of reporting. The patient received the Shingrix dose earlier than the recommended interval, which led to shortening of vaccination schedule. The patient received a third dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Received a dose of Bexsero that had 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 female patient who received Men B NVS (Bexsero) (batch number ABXV3588, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's comments: This case was reported by a nurse. The reporter stated that a patient received a dose of Bexsero that had expired. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consented to follow up. Additional Supportive Information: The reporter stated that a patient received an expired dose of Bexsero which led to expired vaccine used.
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo inappropriately reconstituted; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA583A, expiry date 31st August 2022) for prophylaxis.   On 22nd August 2022, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The registered nurse reported that one day before the reporting date, a patient received the the powder (MenA) portion only of Menveo diluted with sterile solution and another patient received the liquid portion of Menveo (MCWY) diluted as well with sterile solution.  It was unknown which patient received each part of the vaccine. The reporter mentioned that the patients were a female and a male but it was unknown which one received the powder portion or the liquid portion. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received Menveo vaccine which was incorrectly reconstituted, which led to wrong solution used in drug reconstitution. This case is for 1 of 2 linked patients reported by same reporter.; Sender's Comments:  US-GSK-US2022122728:Same reporter