chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: fist dose October 15 2021 / second dose  January 20 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 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.   Previously administered products included Twinrix (received 1st dose on 15th October 2021).   On 20th January 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 20th January 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter that a patient received a second dose of Twinrix outside recommended schedule, which led to lengthening of vaccine schedule. No know side effect were reported. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Ear pain
Clinical narrative: Ear Pain; This case was reported by a consumer via interactive digital media and described the occurrence of ear pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced ear pain. On an unknown date, the outcome of the ear pain was unknown.   It was unknown if the reporter considered the ear pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had ear pain.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Arm was always tender; My arm was swollen; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st shot on an unknown date and was fine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got new Shingles shots and they were 2 shots and supposedly lasted a life time. The patient stated 1st shot was fine but the 2nd one was horrible. The patient had arm swollen for almost 2 months and was always tender. The follow-up could not be possible as no contact details were available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: administrated only the diluent portion of the vaccine; administrated only the diluent portion of the vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 99e53, expiry date 9th April 2023) for prophylaxis.   On 26th October 2021, the patient received Shingrix. On 26th October 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was inadvertently administrated only the diluent portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No further events were reported. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. This case has been linked to the case US2022016942 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022016942:same reporter
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: first dose 16-NOV-21, second 30-NOV-21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 58-year-old male patient who received HBV (Engerix B) (batch number 39tz2, expiry date 7th September 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 30th November 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 30th November 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the 2nd dose of Engerix-B earlier than the recommended interval, which led to shortening of vaccination schedule. No known side effect was reported. The reporter consented to follow up.
Age: 19.0
Sex: M
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 19-year-old male patient who received HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th January 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 24th January 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 details were provided as follows: The reporter reported that a patient received an expired dose of Havrix, which led to expired vaccine used. The reporter gave consent to follow up.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered a dose of expired Infanrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-month-old female patient who received DTPa (Infanrix) (batch number 9BC23, expiry date 30th January 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 31st January 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated they inadvertently administered a dose of expired Infanrix, which led to expired vaccine used. The reporter called in to inquire and report that the dose was valid and they should revaccinate. The reporter did not consent to follow-up.
Age: 0.58
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: did not received the full dose, partial dose was administered; 7 months old was administered Pediarix; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 7-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st and 2nd dose on an unknown date).   On 28th January 2022, the patient received the 3rd dose of Pediarix (intramuscular) and Pediarix Pre-Filled Syringe Device. On 28th January 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose 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 details were provided as follows: Reporter was a nurse manager at the health care facility. The nurse reported that, the patient did not receive the full dose of their Pediarix injection, which led to underdose. The partial dose that was administered was the 3rd dose in the Pediarix series and was administered into the right thigh. The nurse also reported the seven months old patient received dose of Pediarix, which led to inappropriate age at vaccine administration. The reporter consented to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Headache
Clinical narrative: abdominal pain/abdominal cramps; diarrhea; headache; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st January 2022 11:30, the patient received the 1st dose of Shingrix. On 31st January 2022, 4 hrs after receiving Shingrix, the patient experienced abdominal pain, diarrhea and headache. On an unknown date, the outcome of the abdominal pain and headache were not recovered/not resolved and the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the abdominal pain, diarrhea and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. About four hours later the patient developed a headache . The patient had one episode of diarrhea and had abdominal cramps.  The patient had nothing else to report. The reporter did not have email.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: administrated a third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 88-year-old male patient who received Herpes zoster (Shingrix) (batch number zaa27, expiry date 31st January 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 5th November 2021, the patient received the 3rd dose of Shingrix. On 5th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient was inadvertently administrated a third dose of Shingrix, which led to extra dose administered. The reporter had not reported further events.  The reporter agreed to be contacted for follow-up. The case has been linked to US2022016975,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022016975:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: administrated third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number zaa27, expiry date 31st January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date).   On 5th November 2021, the patient received the 3rd dose of Shingrix. On 5th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient inadvertently received a third dose of Shingrix, which led to extra dose administered. No further events were reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. This case had been linked with case US2022016973, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022016973:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on JUL-2021, not received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on 16th July 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable to this report. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was requesting information regarding the recommendation for patients who had waited longer than 6 months for their second dose. The reporter provided medical advice disclaimer. Spoke from Shingrix FAQs content. The patient declined to provide address, date of birth date and consent to contact her health care professional. The reporter did not consent to follow-up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: soreness at injection site; Shivering; Fever; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2022, the patient received the 2nd dose of Shingrix. On 30th January 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, shivering, fever and pain in arm. On an unknown date, the outcome of the injection site pain, fever and pain in arm were not recovered/not resolved and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the injection site pain, shivering, fever and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received second dose of Shingrix and same night 6 to 8 hours later experienced shivering, injection site pain, fever and pain in arm.  Shivering was recovered but other events were not recovered at the time of reporting. The patient's body temperature at the time of reporting was 99.1 F. Consent to follow up was granted.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose in 2020, second in 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2020).   In January 2022, the patient received the 2nd dose of Shingrix. 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 details were provided as follows: The case was self-reported by the patient for himself. The age at vaccination was not reported. The patient stated that he received first dose of Shingrix in 2020 and second dose in January 2022, which led to lengthening of vaccination schedule. The reporter provided very limited information. The reporter disconnected the call and therefore agent could not ask caller's mailing address, consent for follow-up, Health Care Professional contact information, lot/ expiry date of the shot, and date/route of administration.
Age: 1.75
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated 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 21-month-old male patient who received HAV (Havrix) (batch number i4sl4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 31st January 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 details were reported as follows: The Health Care Professional reported that, the patient was inadvertently administrated an expired dose of Havrix which led to expired vaccine used. The reported said no further events were reported. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: her age did not fit with the Vaccine Schedule/Kinrix maladministration; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-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 1st February 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 1st February 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 details were reported as follows: Nurse reported that a patient received her first Kinrix dose by error as her age did not fit with the vaccine schedule, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: was given an adult dose; an 18 year old female was given an adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HAV (Havrix adult) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2022, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 1st February 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the 18 years old patient was given an adult dose of Havrix, which led to overdose and adult product administered to child. No symptoms were reported. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second shot "about a year later; This case was reported by a consumer 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 (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient did not get the second dose of Shingrix within 6 months, she received the second shot about a year later, which led to lengthening of vaccination schedule. The patient wanted information on alternative dosing for Shingrix and wanted to know if she had to take another to restart the series or not. The patient did not provide further information. The reporter did not consent to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: was given their first dose / subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 57ex2, expiry date 26th March 2022) for prophylaxis.   On 24th January 2022, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 24th January 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The reporter was the patient's health care professional. The medical assistant stated that the patient was given a dose of Shingrix in left arm subcutaneously, which led to intramuscular formulation administered by other route. The reporter's call was transferred to medical informer for information on how to proceed. The reporter considered the wrong route of administration to be related to Shingrix The reporter did not consent to follow-up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 20th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that, the patient received a 5 days expired dose of Kinrix which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Administration of 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 Men B NVS (Bexsero) (batch number unknown, expiry date 31st January 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 1st February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st February 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 details were provided as follows: The age at vaccination was not reported. On 1st February 2022, the patient received Bexsero which was already expired on 31st January 2022, which led to expired vaccine used. The reporter asked if they had any information on extended expiry dates or recommendations for the next steps. This report was received afterhours via web. No additional information was provided in web. The reporter consented to follow-up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired dose used ( BEXSERO); This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA82AA, expiry date 31st January 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 2nd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd February 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 details were provided as follows: The patient received expired dose of Bexsero, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patients didnt get their 2nd shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of vaccination, the patients did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked restart series, or just gave the 2nd dose if it had been over the year mark. The reporter did not probe any further but health care professional did give permission for follow up via postal. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Sore arm; Patient may have only received the adjuvant; Patient may have only received the adjuvant; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain in arm, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient. The age at vaccination was not reported. The reporter stated that, the patient only received the adjuvant, instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient had sore arm after vaccination with Shingrix. The reporter did not consent to follow up.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine Administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 28-year-old female patient who received HAV (Havrix) (batch number N39BM, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 2nd February 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 detaails were provided as follows: The patient received expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 05Sep2020, 2nd dose 22Aug2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 4th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th September 2020, batch number T2CS3, expiry date 1st December 2021).   On 22nd August 2021, the patient received the 2nd dose of Shingrix. On 22nd August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter stated that, the patient said, they were not told to come in for second dose in appropriate time frame. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 07-JAN-2022. 2nd dose 28-JAN-2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 42CM4, expiry date 11th June 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 28th January 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 28th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter reported for herself. The patient received 1st dose of Shingrix on 7th January 2022. The patient received 2nd dose on an unknown arm. The patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 31st January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date).   In December 2021, the patient received the 3rd dose of Shingrix. In December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient did not inform to the pharmacist that two previous doses were administered.  The pharmacist reported that the patient received 3rd dose of Shingrix, which led to extra dose administered. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022019047:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 30th January 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   In December 2021, the patient received the 3rd dose of Shingrix. In December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was unknown. The patient did not informed the pharmacist that two previous doses were administered. The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter did not consent to follow up. This case was linked with case US2022019042, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022019042:Same reporter
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HAV (Havrix) (batch number N39BM, expiry date 31st January 2022) for prophylaxis.   On 2nd February 2022, the patient received Havrix. On 2nd February 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 details were provided as follows: The patient received expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow up.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: received extra dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 14-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number xk524, expiry date 8th October 2022) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 1st February 2022, the patient received the 2nd dose of Boostrix (intramuscular) .5 ml. On 1st February 2022, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 2nd dose of Boostrix in left deltoid. The patient received an extra dose of Boostrix accidently, which led to extra dose administered. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered 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 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 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 2nd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd February 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 details were provided as follows: The reporter reported that she inadvertently administered an expired dose of Bexsero to a patient, which led to expired vaccine used. At the time of reporting, the patient had not been re-dosed. The reporter consented to follow up. The healthcare professional gave permission for follow-up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Product dispensing error, Wrong product administered
Clinical narrative: Patient got KINRIX instead of PEDIARIX; Kinrix to a 4 month old patient; Drug dispensing error; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and drug dispensing error. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant at clinic who called in to advise that, a staff member administered the incorrect vaccine to a 4 month old patient instead of pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration and drug dispensing error. The reporter wanted to know how they could proceed after this administration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient got only one injection 2 years ago; This case was reported by a other health professional 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 years prior to the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter asked how they proceed with additional vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 3-5 years ago, 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 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 to 5 years prior to the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix, 3 to 5 years ago from the date of reporting, according to the patients claim. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.  No further events were reported. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 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 2nd February 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd February 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 details were provided as follows: A nurse reported that a patient received a dose of Bexsero which was already expired on 31st January 2022.  No other symptoms were reported. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 04Feb2021, 2nd dose 04Feb2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number E344C, expiry date 1st April 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th February 2021, (batch number G537F, expiry date 14th march 2022)).   On 4th February 2022, the patient received the 2nd dose of Shingrix. On 4th February 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 details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. Pharmacist stated that the dosing delay was not due to supply issue.  The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot 2 years ago 2nd dose not given yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the patient received 1st Shingrix shot 2 years ago and now was back to receive 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional (HCP) declined to provide any patient´s details . The HCP declined to have her personal contact information on our database. The reporter did not consent to follow
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 20th January 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 4th February 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 4th February 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 details were reported as follows: The nurse reported that the patient received dose of Bexsero that was already expired on 20th January 2022, which led to expired vaccine used. The reporter consented to follow up.