chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose
Clinical narrative: Patient received a partial dose as the vial lose some volume while it was being administered; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult female patient who received Herpes zoster (Shingrix) (batch number 7D73A, expiry date 18th May 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.       Additional Information: GSK receipt date: 1-June-2022 Reporter's comment: The pharmacist reported that a patient received a partial dose of shingrix as the vial lose some volume while it was being administered to the patient. The reporter consented to follow up.  Additional Supportive Information: The patient received partial dose of shingrix which led to accidental underdose.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: experiencing redness at the injection site (left arm)./redness started to spread to the top of her arm over; experiencing itchiness at the injection site (left arm).; pain at the injection site (left arm).; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2022, the patient received the 1st dose of Shingrix (intramuscular). On 11th February 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-JUN-2022 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix and less than a day patient experienced redness, itchiness, and pain at the injection site into left deltoid (left arm). The patient reported that redness started to spread to the top of her arm over the next eight days and eventually retreated.  The patient reporter that all symptoms had resolved. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose on 5/19/21, and dose 6/2/22; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number MR5RK, expiry date 27th September 2023) for prophylaxis.   Previously administered products included Kinrix  (received a dose of Kinrix on 12th May 2014) and Boostrix  (received a dose of Boostrix on 19th May 2021).   On 2nd June 2022, the patient received Boostrix. On 2nd June 2022, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 02-Jun-2022 Reporter's comment: The registered nurse called to inquired that how to proceed or what to look for. The reporter reported that a Boostrix dose was administered on 19th May 2021 and then the patient was administered with a Boostrix dose on the day of reporting. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Boostrix earlier than recommended interval, which led to shortening of vaccine schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in fall of 2021; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19. Previously administered products included Shingrix (received 1st dose of Shingrix in fall of 2021) and Monoclonal antibody infusion (received Monoclonal antibody infusion one after the Shingrix vaccination for Covid-19).   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: 2-Jun-2022 Reporter's comment: Pharmacist reported that a patient received the first dose of Shingrix in fall of 2021.  In 2021, the patient received a monoclonal antibody infusion the one day after the Shingrix vaccination for COVID-19. The date of the first dose was unknown.  The monoclonal antibody was unknown as well.  The vaccine was administered elsewhere. The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got 1st dose on 10/05/2020, 2nd dose on May 31st 2022.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 5th October 2020).   On 31st May 2022, the patient received the 2nd dose of Shingrix. On 31st 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: 03-Jun-2022 Reporter's comment: The nurse reported that the patient got 2nd dose later than the recommended interval. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient got 2nd dose later than the recommended interval, which led to lengthening of vaccine schedule. The case was linked with case US2022084620, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022084620:same reporter
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient received their first dose of Twinrix in December; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-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 (1st dose received 13th December 2021).   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: 03-Jun-2022 Reporter's Comments: Pharmacist stated that a patient received their first dose of Twinrix in December. The reporter consented to follow up via postal. Additional Supportive: Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore Arm; Tiredness; Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, tiredness, headache and chills. On an unknown date, the outcome of the pain in arm, tiredness, headache and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness, headache and chills to be related to Shingrix.     Linked case(s) involving the same patient: US2022AMR088885   Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments: This case was self reported by patient. The reporter reported that she received the first dose of Shingrix vaccine and experienced chills, headache, tiredness, and a sore arm. AE (adverse event) filed. The reporter was given medical disclaimer. Referred to HCP (Health care professional). Spoke per PI (package insert) and content. Offered after call.  The reporter consented to follow up. Additional supportive information: For the tolerance of 2nd dose, refer linked case US2022AMR088885.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR088885:same report
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Stomach pain; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2022, the patient received Shingrix. On 3rd June 2022, 8 days after receiving Shingrix, the patient experienced stomach pain and vomiting. On an unknown date, the outcome of the stomach pain and vomiting were unknown.   It was unknown if the reporter considered the stomach pain and vomiting to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments: This case was self reported by patient. The patient received the dose of Shingrix vaccine last week before the day of reporting into right arm. The reporter reported that today (on the day of reporting), starting at six am, patient began to experiencing stomach pain and vomiting.  AE (adverse event) filed. The reporter consented to follow up. The reporter provided limited information. It was not disclosed if this was the first or second dose of Shingrix.  The reporter provided consent to follow up with HCP (Health care professional) (pharmacy).
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 26 year old received pediatric dose; 26 year old received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 26-year-old male patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   On 3rd June 2022, the patient received Engerix B pediatric. On 3rd June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 03-Jun-2022 Reporter's Comments: Medical assistant reporting that an adult patient received a pediatric dose of Engerix-B. Adverse event contains all health care professional (HCP) reported information. Health care professional (HCP) gave consent for safety to follow up.  Health care professional (HCP) did not wish to provide an email nor postal address. The reporter consented to follow up. Additional Supportive: the adult patient received received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 53.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered after expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received HAV (Havrix 1440) (batch number J95H7, expiry date 22nd 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 3rd June 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 3rd June 2022, unknown after receiving Havrix 1440 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: 03-Jun-2022 Reporter's Comments: Certified medical assistant (CMA) administered Havrix after the expiration date. The reporter consented to follow up via postal. Additional Supportive: the patient received dose of Havrix vaccine which was already expired, which led to expired vaccine used.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Infanrix instead of Boostrix; 11y/o administered Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     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: 03-Jun-2022 Reporter's Comments: Medical assistant reported 11 year old patient was administered Infanrix instead of Boostrix. The reporter consented to follow up. Additional Supportive: The patient was administered Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. This case had been linked with the case US2022088502, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022088502:Same reporter
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Infanrix instead of Boostrix; 11y/o was administered Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 31st May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     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: 3-June-2022 Reporter's comment: The medical assistant reported that 11 year old patient was administered Infanrix instead of Boostrix. The reporter consented to follow up. Additional Supportive Information: As the 11 year old patient was administered Infanrix instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The case has been linked with the case US2022088501 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022088501:Same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received both vaccines, had an outbreak of shingles/ Suspected vaccination failure; shingles on face; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   In October 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 3-Jun-2022 Reporter's comments: This case was reported by the patient. The patient received both of her Shingrix vaccines in 2019 in arm. After vaccination, the patient had an outbreak of shingles on her face. She has recovered from this episode. The consent to follow up was given. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: Patient received the vaccine and leaked on the patient arm; Patient received the vaccine and leaked on the patient arm; Patient received the vaccine and leaked on the patient arm; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) (batch number hm24h, expiry date 25th March 2023) for prophylaxis.   On 3rd November 2021, the patient received the 1st dose of Shingrix. On 3rd November 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.       Additional Information: GSK receipt date: 3-June-2022 Reporter's comment: The medical Assistance reported that patient was administrated with Shingrix and leaked on the patient arm. No adverse event was reported. The reporter was consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. No patient's identifiers provided. Additional Supportive Information: While administering shingrix to the patient it was leaked on the patient's arm which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: The vaccine was reconstituted using a sterile solution instead of the included MenCYW.; The vaccine was reconstituted using a sterile solution instead of the included MenCYW.; 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) for prophylaxis.   On 26th May 2022, the patient received Menveo. On 26th May 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: 3-June-2022 Reporter's comment: The medical assistant reported that patient was administered Menveo was reconstituted using a sterile solution instead of the included MenCYW. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo which was reconstituted using a sterile solution instead of the included MenCYW, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient received a dose but the powder containing menA was already expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date 22nd March 2022) for prophylaxis.   On 2nd June 2022, the patient received Menveo. On 2nd June 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 3-June-2022 Reporter's comment: The medical assistant reported that a patient received a dose of menveo but the powder containing menA was already expired. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of menveo but the powder containing menA was already expired which led to expired vaccine used.
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 nurse 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 2nd June 2022, the patient received Menveo. On 2nd June 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: 3-June-2022 Reporter's comment: Nurse reported that a patient received only the liquid component of Menveo. The reporter consented to follow up. Additional Supportive Information: The patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Gait disturbance
Clinical narrative: Right knee pain, that began 2 days after the vaccine, that is still sore; Right knee pain causing him to limp.; Fatigue the day after the vaccine; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 27th May 2022, 1 days after receiving Shingrix, the patient experienced fatigue. On 28th May 2022, the patient experienced knee pain and limping. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the knee pain and limping were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, knee pain and limping to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments:  The patient received his first Shingrix vaccine in the left arm.  General fatigue the day after the Shingrix vaccine, that resolved. The patient was reported right knee pain, that began 2 days after the Shingrix vaccine, that was still sore and causing him to limp. The reporter did not consent to follow-up. The reporter did not give permission to contact health care professional.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Joint swelling, Skin irritation
Clinical narrative: Right knee pain, that began 2 days after the vaccine, that is still sore; Right knee pain causing him to limp.; Fatigue the day after the vaccine; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 27th May 2022, 1 days after receiving Shingrix, the patient experienced fatigue. On 28th May 2022, the patient experienced knee pain and limping. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the knee pain and limping were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, knee pain and limping to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments:  The patient received his first Shingrix vaccine in the left arm.  General fatigue the day after the Shingrix vaccine, that resolved. The patient was reported right knee pain, that began 2 days after the Shingrix vaccine, that was still sore and causing him to limp. The reporter did not consent to follow-up. The reporter did not give permission to contact health care professional.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Gait disturbance
Clinical narrative: Still has irritation; Joint pain; Swollen knee; This case was reported by a physician via call center representative and described the occurrence of skin irritation in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced skin irritation, joint pain and swelling of knees. On an unknown date, the outcome of the skin irritation, joint pain and swelling of knees were not recovered/not resolved.   It was unknown if the reporter considered the skin irritation, joint pain and swelling of knees to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments: The patient received Shingrix and still had irritation, joint pain and a swollen knee. The reporter was consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Joint swelling, Skin irritation
Clinical narrative: Still has irritation; Joint pain; Swollen knee; This case was reported by a physician via call center representative and described the occurrence of skin irritation in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced skin irritation, joint pain and swelling of knees. On an unknown date, the outcome of the skin irritation, joint pain and swelling of knees were not recovered/not resolved.   It was unknown if the reporter considered the skin irritation, joint pain and swelling of knees to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments: The patient received Shingrix and still had irritation, joint pain and a swollen knee. The reporter was consented to follow up.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose was inadvertently administered to a patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th 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 27th May 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 27th May 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: 3-June-2022 Reporter's comment: The registered Nurse reported that expired Havrix dose was inadvertently administered to a patient. The reporter asked if there was a window, if the patient need to be revaccinated?  The reporter did not consent to follow-up. Additional Supportive Information: The expired Havrix dose was inadvertently administered to a patient which led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of engerix-b; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received HBV (Engerix B) (batch number 9p9b5, expiry date 4th February 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 27th May 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 27th May 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: 3-June-2022 Reporter's comment: The pharmacist reported that a patient received an expired dose of engerix-b. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of engerix-b which led to expired vaccine used.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccinated with 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 patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd 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: 03-JUN-2022 Reporter's Comments: The medical assistant reported that a dose of Havrix was given to the patient and it was already expired. HCP (health care professional) requested to remain anonymous.  The reporter only provided lot# and expiration date for Havrix.  The reporter consented to follow up by fax. Additional Supportive Information: The use of Havrix dose which was already expired on 22nd May 2022, which led to expired vaccine used.
Sex: U
Vaccine: DTAP, DTAP
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: missed a dose, patient is four years old; patient is four years old, dose of 3 was on 9/25/2021; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included POLIOMYELITIS VACCINE INACTIVATED (IPV (INACTIVATED POLIO VACCINE)).   On 25th September 2021, the patient received the 3rd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 25th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration and incomplete course of vaccination 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: 3-June-2022 Reporter's comment: Nurse reported that a patient missed a dose of Infanrix/ DTaP. The patient was four years old. The patient's last dose of DTaP and IPV  was on 25th September 2021. The physician heard that the patient should receive DTaP and IPV separately in this situation. The reporter did not consent to follow-up. No other information was provided.  Additional Supportive Information: The patient received 3rd dose at inappropriate age which led to inappropriate age at vaccine administration. The patient did not received 4th dose which led to incomplete course of vaccination.
Sex: F
Vaccine: MNQ
Symptoms: Intercepted product prescribing error
Clinical narrative: 70 old patient has a prescription for Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 70-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concurrent medical conditions included splenectomy.   On an unknown date, the patient did not receive Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 6-Jun-2022 Reporter's comments: The patient who had her spleen removed had a prescription for Menveo. Pharmacist had not yet administered Menveo to the patient. The consent to follow up was given. Additional Supportive Information: The patient had prescription of Menvevo, which was identified by the pharmacist and did not administered to the patient, which led to intercepted drug prescribing error.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Blistery Rash (similar to shingles); This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 56-year-old 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 blistery rash. On an unknown date, the outcome of the blistery rash was recovered/resolved.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comments: The pharmacist stated that the patient received first dose of Shingrix (unknown date) and developed a Blistery Rash (similar to shingles) in the abdominal area. The reporter stated that the patient was due for the 2nd dose, not administered yet and wanted to know if there were contraindications on receiving the 2nd dose.  The reporter stated that the patient did not had symptoms as of the day of reporting. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 4 years ago, skipped the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received his first dose of Shingrix 4 years ago from reporting).   On an unknown date, the patient did not 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: 6-JUN-2022 Reporter's Comments: The pharmacist reported the patient received his first dose of Shingrix 4 years ago and skipped the second dose. The reporter give consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expiry date was March 2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date March 2022) for prophylaxis.   On 2nd June 2022, the patient received Menveo. On 2nd June 2022, unknown after receiving Menveo, 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-JUN-2022 Reporter's comment: Medical Assistant reported a dose of Menveo was administered to a patient on and it had expired. The vaccine administration facility was same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient received Menveo which was already expired in 31st March 2022, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Facial pain, Haematoma, Herpes zoster, Nasal pruritus
Clinical narrative: EXACERBATION OF SHINGLES; itchy nose got worse; pain right side of face got worse; "hematoma" left side face; itchy nose and pain in face got worse; had shingles prior to getting Shingrix, received the vaccine; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles, nasal itching and pain localized.   On 10th May 2022, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles, nasal itching, facial pain, hematoma, condition aggravated and off label use. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, hematoma and condition aggravated were not recovered/not resolved and the outcome of the nasal itching, facial pain and off label use were unknown.   It was unknown if the reporter considered the shingles, nasal itching, facial pain, hematoma and condition aggravated to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comments: The patient self-reported this case. The patient knowingly had shingles prior to getting Shingrix. The patient stated the itchy nose and pain in the left side of his face got worse after the vaccine. The reporter stated that he went to health care professional and was diagnosed with shingle s and was given Valacyclovir to take for a week. The patient still had a hematome on left side of face. The reporter did not consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: EXACERBATION OF SHINGLES; itchy nose got worse; pain right side of face got worse; "hematoma" left side face; itchy nose and pain in face got worse; had shingles prior to getting Shingrix, received the vaccine; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles, nasal itching and pain localized.   On 10th May 2022, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles, nasal itching, facial pain, hematoma, condition aggravated and off label use. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, hematoma and condition aggravated were not recovered/not resolved and the outcome of the nasal itching, facial pain and off label use were unknown.   It was unknown if the reporter considered the shingles, nasal itching, facial pain, hematoma and condition aggravated to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comments: The patient self-reported this case. The patient knowingly had shingles prior to getting Shingrix. The patient stated the itchy nose and pain in the left side of his face got worse after the vaccine. The reporter stated that he went to health care professional and was diagnosed with shingle s and was given Valacyclovir to take for a week. The patient still had a hematome on left side of face. The reporter did not consented to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number XH2DF, expiry date 7th May 2022) for prophylaxis.   On 6th June 2022, the patient received the 2nd dose of Shingrix. On 6th June 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 6-June-2022 Reporter's comment: Nurse reported that the patient was administered an expired dose of the Shingrix vaccine. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of the Shingrix which led to expired vaccine used.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: product expired 05/22/2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 46-year-old female patient who received HAB (Twinrix) (batch number A955S, expiry date 22nd May 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 3rd June 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd June 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: 6-Jun-2022 Reporter's comment: The reporter was a medical assistant calling from a clinic on behalf of the patient.  The reporter stated that the patient received Twinrix on the day of reporting in left deltoid which was already expired on 22nd May 2022. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 6th June 2022, the patient received Havrix. On 6th 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: 06-Jun-2022 Reporter's Comments: The reporter was a medical assistant. The patient received a dose of expired Havrix. The reporter was consented to follow up. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-month-old female patient who received HBV (Engerix B pediatric) (batch number D423N, expiry date 1st June 2022) for prophylaxis.   On 6th June 2022, the patient received Engerix B pediatric. On 6th June 2022, unknown after receiving Engerix B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 6-June-2022 Reporter's comment: The reporter administered an expired dose of ENGERIX B PEDS to a patient. No symptoms reporter. Reporter did not provide prescriber information for follow up. The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered an expired dose of the Engerix B pediatric which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got the first shingrix vaccine in 2018 and the second vaccine in 1/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first Shingrix vaccine (0.5 ml) in 2018).   In January 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 mg/ml. In January 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: 6-JUN-2022 Reporter's Comments: The reporter had limited patient demographics and vaccine information. The reporter did not give consent to follow-up. Additional supportive Information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule.