chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Received 2nd Menveo shot by error / extra dose of Boostrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA640V, expiry date 30th November 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number MR5RK, expiry date 21st September 2023) for prophylaxis.   Previously administered products included Menveo (received 1st dose was on 18th August 2021 at 11 year old of age) and Boostrix (received one dose was on 18th August 2021 at 11 year old of age).   On 11th July 2022, the patient received the 2nd dose of Menveo and the 2nd dose of Boostrix. On 11th July 2022, unknown after receiving Menveo and Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: Medical assistant reported that a patient received a second dose of Menveo by error and an extra dose of Boostrix was administered on the day of reporting by accident. The reporter consented to follow-up by email. Additional supportive information: The patient received an extra dose of Menveo and Boostrix by error, which led to extra dose administered. The case US2022104953 was identified as duplicate of case US2022104945. Case US2022104953 was deleted due to being created in error. All future correspondence will be submitted to case US2022104945.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Wrong technique in product usage process
Clinical narrative: not sure if he got a full dose; syringe hit the bone; This case was reported by a consumer via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2022, the patient received the 1st dose of Shingrix. On 8th July 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered and wrong technique in product usage process. On an unknown date, the outcome of the incomplete dose administered and wrong technique in product usage process were unknown.   Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The patient reported that he was not sure if he got a full dose of his first dose of Shingrix. The patient stated that he went to get his first dose last Friday 8th July 2022 and when the given the dose, the syringe hit the bone and full dose was not administered. The adverse event filed with very limited information. The reporter did not consent to follow-up. Additional supportive information: When the dose was given to the patient, the syringe hit the bone and full dose was not administered, which led to incomplete dose administered and wrong technique in product usage process.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Fatigue, Neck pain, Pain in extremity
Clinical narrative: Vomiting; Diarrhea; Rash that started at her elbow and extended to just below the injection site; Tiredness; Pain in injection arm that went from elbow to her neck; Pain in injection arm that went from elbow to her neck; Pain in injection arm that went from elbow to her neck; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 49n3s, expiry date 24th August 2023) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th July 2022, several hours after receiving Shingrix, the patient experienced vomiting, diarrhea, rash, tiredness, neck pain, pain in elbow and pain in arm. On an unknown date, the outcome of the vomiting, diarrhea, tiredness, neck pain, pain in elbow and pain in arm were recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the vomiting, diarrhea, rash, tiredness, neck pain, pain in elbow and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-Jul-2022 Reporter's Comments: The patient received Shingrix vaccine in left arm. The patient stated that several hours after getting the vaccine, the patient started with vomiting, diarrhea, and tiredness. These symptoms had been resolved. The patient also reported that she had pain in the injection arm that went from elbow to her neck and a rash that started at her elbow and extended to just below the injection site. The pain had subsided, but the rash was still there. The consent to follow up was given.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vomiting
Clinical narrative: Vomiting; Diarrhea; Rash that started at her elbow and extended to just below the injection site; Tiredness; Pain in injection arm that went from elbow to her neck; Pain in injection arm that went from elbow to her neck; Pain in injection arm that went from elbow to her neck; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 49n3s, expiry date 24th August 2023) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th July 2022, several hours after receiving Shingrix, the patient experienced vomiting, diarrhea, rash, tiredness, neck pain, pain in elbow and pain in arm. On an unknown date, the outcome of the vomiting, diarrhea, tiredness, neck pain, pain in elbow and pain in arm were recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the vomiting, diarrhea, rash, tiredness, neck pain, pain in elbow and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-Jul-2022 Reporter's Comments: The patient received Shingrix vaccine in left arm. The patient stated that several hours after getting the vaccine, the patient started with vomiting, diarrhea, and tiredness. These symptoms had been resolved. The patient also reported that she had pain in the injection arm that went from elbow to her neck and a rash that started at her elbow and extended to just below the injection site. The pain had subsided, but the rash was still there. The consent to follow up was given.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Menveo and Menquadfi; received MenQuadfi instead of BEXSERO; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA677A, expiry date 30th April 2023) for prophylaxis.   On 11th July 2022, the patient received the 1st dose of Menveo .5 ml. On 11th July 2022, unknown after receiving Menveo, the patient experienced overdose and wrong vaccine administered. On an unknown date, the outcome of the overdose and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The health care professional reported that a patient was to receive Bexsero and Menveo. The patient received MenQuadfi in left deltoid instead of Bexsero.   The patient was administered Menveo in left deltoid as prescribed. The reporter gave consent to follow up. Additional supportive information: The patient received and a dose of 0.5 ml of Menquadfi instead of Bexsero along with Menveo, which led to overdose and wrong vaccine administered.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Injection site became painful; injection site red/blotchy; Injection site swollen; Injectio site warm to the touch; injection site red/blotchy; Blotchiness around the injection site has gotten larger; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 6th July 2022, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site rash and blotchy. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site rash and blotchy were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site rash and blotchy to be related to Shingrix.     Additional Information: GSK receipt date :12 July 2022 Reporters comment: This case was reported by the patient. The patient received first Shingrix vaccine in his left arm and soon after the injection, the injection site became painful, red/blotchy, swollen, and warm to the touch. The patient stated that the symptoms had not resolved and the blotchiness around the injection site has gotten larger in area. The reporter did not consent to follow-up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash macular
Clinical narrative: Injection site became painful; injection site red/blotchy; Injection site swollen; Injectio site warm to the touch; injection site red/blotchy; Blotchiness around the injection site has gotten larger; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 6th July 2022, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site rash and blotchy. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site rash and blotchy were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site rash and blotchy to be related to Shingrix.     Additional Information: GSK receipt date :12 July 2022 Reporters comment: This case was reported by the patient. The patient received first Shingrix vaccine in his left arm and soon after the injection, the injection site became painful, red/blotchy, swollen, and warm to the touch. The patient stated that the symptoms had not resolved and the blotchiness around the injection site has gotten larger in area. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated an expired dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number 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 12th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 12th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  GSK Receipt Date: 12-July-2022 Reporter's Comments: The patient was administrated with an expired dose of Havrix. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Havrix which was already expired on 18th June 2022, which led to expired vaccine used.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pediarix given to 15 month old  patient instead of Infanrix.; 4th dose of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th August 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 20th August 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-JUL-2022  Reporter's Comments: The registered nurse reported that the patient received a dose of Pediarix as a fourth dose of Dtap series instead of Infanrix.  The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional Supportive Information: The patient received a dose of Pediarix as a fourth dose of Dtap series instead of Infanrix, which led to extra dose administered and wrong vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administrated Menveo with another diluent; administrated Menveo with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number amva676a, expiry date 31st March 2023) for prophylaxis.   In July 2022, the patient received Menveo. In July 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: 13-JUL-2022 Reporter's Comments: The director of operation reported that the multiple patient were administrated with the powder of Menveo with another diluent between 6th July 2022 and 7th July 2022. No adverse event reported.  The reporter did not know how many patient were administrated with this lot number. No patient's identifiers provided. The reporter consented to follow up. Additional supportive information: The director of operation reported that the multiple patient were administrated with the powder of Menveo with another diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with case US2022106108, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106108:Same report, diferent lot number
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administrated Menveo with another diluent; administrated Menveo with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number amva660a, expiry date 28th February 2023) for prophylaxis.   In July 2022, the patient received Menveo. In July 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: 13-JUL-2022 Reporter's Comments: The director of operation reported that the multiple patient were administered with the powder of Menveo with another diluent between 6th July 2022 and 7th July 2022. No adverse event reported.  The reporter did not know how many patient were administrated with this lot number. No patient's identifiers provided. The reporter consented to follow up. Additional supportive information: The director of operation reported that the multiple patient were administered with the powder of Menveo with another diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with case US2022106107, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106107:Same report, diferent lot number
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling jittery, Palpitations, Throat irritation, Urticaria
Clinical narrative: Hives; Itchy Throat; Shortness of breath; Palpitations; Jitteriness; This case was reported by a nurse via call center representative and described the occurrence of hives in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number G2J53, expiry date 17th April 2023) for prophylaxis.   On 10th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th May 2022, immediately after receiving Shingrix, the patient experienced hives, itchy throat, shortness of breath, palpitations and jitteriness. The patient was treated with benadryl (nos) (Benadryl). On 10th May 2022, the outcome of the hives, itchy throat and jitteriness were recovered/resolved. On an unknown date, the outcome of the shortness of breath and palpitations were recovered/resolved.   It was unknown if the reporter considered the hives, itchy throat, shortness of breath, palpitations and jitteriness to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-JUL-2022  Reporter's Comments: The reporter was a nurse from a Medical Office. The patient received first dose of Shingrix into right deltoid and right after vaccination patient developed hives, itchy throat and shortness of breath. The patient was given Benadryl then less than a day after receiving Shingrix, the patient experienced palpitations and jitteriness. The Benadryl helped with the patients' hives, but the jitteriness and the itchy throat lasted for four hours. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated with 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 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 13th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 13th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-Jul-2022 Reporter's comment: Medical assistance reported that a patient was administrated with an expired dose of Havrix on the day of reporting. The Vaccine Administration Facility was the same as Primary Reporter. No adverse event was reported. No patient's identifiers were provided. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, TDAP, UNK
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: BOOSTRIX and TD on may 18th 2021, another on May 18th 2022; MENVEO on may 18th 2022, after a year, another; BOOSTRIX and TD on may 18th 2021; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva659, expiry date 31st January 2023) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number h4y36, expiry date 12th March 2024) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and DIPHTHERIA VACCINE TOXOID + TETANUS VACCINE TOXOID (TD VACCINE) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 18th May 2021 at 11 years old).   On 18th May 2022, the patient received the 2nd dose of Menveo and the 2nd dose of Boostrix. On 18th May 2021, the patient received the 1st dose of Boostrix and TD VACCINE. On 18th May 2021, not applicable after receiving Menveo and Boostrix and unknown after receiving Boostrix, the patient experienced overdose. On 18th May 2022, the patient experienced drug dose administration interval too short and extra dose administered. On an unknown date, the outcome of the overdose, drug dose administration interval too short and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 13-JUL-2022  Reporter's Comments: The health care professional reported that the patient received one dose of Menveo, Boostrix and TD-(unknown manufacturer) on same day and after a year the patient received another dose of Menveo and Boostrix. The reporter did not consent to follow up. Additional Supportive Information: The patient received the Boostrix dose earlier than the recommended interval, which led to shortening of vaccination schedule. The patient received another dose of Menveo, which led to extra dose administered. The patient received Boostrix and TD on same day, which led to overdose.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did bot received second dose yet (for Hepatitis B); This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female 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.   Concomitant products included HEPATITIS A VACCINE and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   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: 13-Jul-2022 Reporter's comment: The nurse wanted some guidance regarding a patient who received 1st dose of Twinrix and on the day of reporting received Hepatitis A vaccine from Merck. The patient did not receive the 2nd dose yet. The reporter was asking if they could administer Engerix as an alternative, because they did not use Twinrix.  The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose Twinrix (for Hepatitis B), which led to incomplete course of vaccination. This case was identified as duplicate of case US2022106125. All future correspondence would be added in case US2022106125, which stands as case of record for this patient and the case US2022106127 would be deleted.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administration of expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix 1440) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 13th July 2022, the patient received Havrix 1440. On 13th July 2022, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On 13th July 2022, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-Jul-2022 Reporter's Comments: HCP reported administration of expired dose of Havrix to a patient. At time of call, patient's Date of Birth was unavailable. Additional Supportive Information: The patient received vaccine on 13th July 2022 which was already expired on 18th June 2022.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Fatigue; This case was reported by a physician via call center representative and described the occurrence of fever 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 fever and fatigue. On an unknown date, the outcome of the fever and fatigue were unknown.   It was unknown if the reporter considered the fever and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-Jul-2022. Reporter's Comments: Physician had a question that how soon after receiving Shingrix vaccine does a patient develop fever and fatigue does that take 24 hours or they could develop sooner in first few hours? Physician was tried to figure out if it was the vaccine or something else. The reporter did not consent to follow up. No other details available.
Age: 15.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th June 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 16th June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JUL-2022 Reporter's Comment:  The reporter consented to follow-up. Additional Supportive Information: The 15 years old patient received a dose of Pediarix, which led to Inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received only the adjuvant portion of the vaccine/She initially stated that they had a lyophilized component vial that was left over but didn't have the adjuvant portion; patient received only the adjuvant portion of the vaccine/She initially stated that they had a lyophilized component vial that was left over but didn't have the adjuvant portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received 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 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: 13-Jul-2022 Reporter's comment: The pharmacist reported that she was not implying that the patient received only the adjuvant portion of the vaccine.  The reporter initially stated that they had a lyophilized component vial that was left over but did not had the adjuvant portion, and she believed it was either misplaced or wasted.  The reporter was not concerned that one of the adjuvant portions was administered to a patient. The reporter stated that she will tell the patient to come back for their dose and upon probing, she stated that she thought the patient might be late on their 2nd dose.  The reporter was unable to confirm this as the health care professional placed him/her on hold and then disconnected the call before confirming that the dose was indeed late. As the health care professional disconnected the call abruptly and the reporter was also unable to obtain patient information.  The reporter was also unable to confirm a mailing address or email or permission for follow up. Additional supportive information: The patient received one of the adjuvant portions, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was kept valid for the 1st dose with medication error considered that one of the adjuvant portions was administered to a patient and as it was not confirm whether the patient was indeed late for 2nd dose or not therefore 2nd dose was not considered as suspect.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 24Sep2019, forgot to get second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 24th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 13-Jul-2022 Reporter's Comments: The pharmacist reported 65-year-old female patient received first dose of Shingrix 24th September 2019 and forgot to get the second dose.  The patient presented to pharmacy 13th July 2022 requesting second dose.  The first dose was given at a different location, so reporter did not have the lot number and expiration date of the first dose. The reporter gave permission for follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Vaccinated with an expired dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 30th June 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 July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:13-JUL-2022 Reporter's Comments:  The reporter stated that, the patient administered expired dose Bexsero. The reporter consent to follow up. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used. The case had been linked with US2022106152 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106152:Same case/same reporter
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 30th June 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 July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:13-JUL-2022 Reporter's Comments:  The Registered Nurse (RN) reported that, the patient administered expired dose of Bexsero. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used. The case had been linked with US2022106151 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106151:same reporter, patient 1
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: placed it in the refrigerator unprotected from light exposure; This case was reported by a pharmacist via call center representative and described the occurrence of product storage error in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced product storage error. On an unknown date, the outcome of the product storage error was unknown.   Additional Information: GSK receipt date: 14-Jul-2022 Reporters comment: The pharmacist reported that nurse removed Menveo from its packaging and placed it in the refrigerator unprotected from light exposure. The reporter was unknown if any patients were involved. The reporter consented to follow up via email. Additional supportive information: The possible administration of unprotected vaccines to the patients, which led to incorrect storage of drug.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of Shingrix in 2019 and 2nd dose of Shingrix on May 5, 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 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 54TF4, expiry date 18th May 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019, date, lot number and expiration date was unknown).   On 5th May 2022, the patient received the 2nd dose of Shingrix. On 5th 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: 14-Jul-2022 Reporter's comment: The Doctor wanted patient to had his 3rd Shingrix vaccine.  Patient had not been administered the 3rd Shingrix vaccine at time of call.  The consent to follow-up was given. Additional Supportive Information: The patient received 1st dose of Shingrix in 2019 and 2nd dose of Shingrix on 5th May 2022, which led to lengthening of the vaccine schedule.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Kinrix instead of Pediarix; 4 months old patient received Kinrix; This case was reported by a nurse 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 8th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Kinrix and Kinrix 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: 14-Jul-2022. Reporter's Comments: Nurse reported that a 4 months patient received a Kinrix vaccine instead of Pediarix. This was a second dose of Dtap shot. The reporter consent to follow up by mail. Additional supportive information: The four months old patient was given Kinrix instead of Pediarix which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: MEN, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: patient was in 3 MenB dose schedule and the 3rd was Bexero; This case was reported by a consumer via call center representative and described the occurrence of interchange of vaccine products in a adolescent male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE for prophylaxis.   Previously administered products included Meningococcal B vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Bexsero, Bexsero Pre-Filled Syringe Device and the 2nd dose of MENINGOCOCCAL B VACCINE. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 14-JUL-2022  Reporter's Comments: The reporter was the mother of the patient. The patient received Bexsero for the third dose of their Meningococcal B vaccine, despite previous two doses being a different brand (did not provide brand of previous doses).  The reporter did not consent to follow up. Additional Supportive Information: The patient received Bexsero for the third dose of their Meningococcal B vaccine, despite previous two doses being a different brand, which led to interchange of vaccine products.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Incomplete course of vaccination, Injection site pain
Clinical narrative: Injection site soreness; COVID; Patient not received 2nd; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, covid-19 and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the covid-19 was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Jul-2022. Reporter's Comments: The patient reported that received first dose of Shingrix vaccine and had not received second dose. Patient was planning on getting it soon, but patient had Covid. She also stated that after her first injection, she experienced soreness at the injection site that had resolved. The reporter did not consented to follow up. Additional Supportive Information: The patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Accidental overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Accidental Overdose; Kinrix was inadvertently ordered and administered; Infant was administered Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2022, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 14th July 2022, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental overdose, wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose, 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: 14-Jul-2022. Reporter's Comments: The practice manager stated that an infant was administered with second dose of Pediarix and Kinrix at the same visit. The patient was supposed to get Prevnar-13, Rotateq, Hiberix, and Pediarix, but the Kinrix was inadvertently ordered and administered. The reporter consent to follow up via mail. Additional Supportive Information: The patient was given Kinrix instead of Prevnar-13, Rotateq, Hiberix, which led to wrong vaccine administered and inappropriate age at vaccine administration. On the same day, the patient received Pediarix, which led to accidental overdose.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 2020, has not received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th November 2020 in right arm with batch number E49YT and expiry date 25th March 2022).   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: 14-Jul-2022 Reporter's comment: The pharmacist reported at the time of the reporting, the patient has not yet received the 2nd dose. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue
Clinical narrative: Fatigue; Weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia and cataract. Concomitant products included fluticasone propionate (Fluticasone Nasal Spray).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fatigue and weakness. On an unknown date, the outcome of the fatigue and weakness were recovered/resolved.   It was unknown if the reporter considered the fatigue and weakness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022106747   Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's comments: The reporter was patient. The reporter stated that approximately 2 years ago patient received first dose of Shingrix. The reporter stated that after receiving Shingrix vaccine Patient experienced weakness and fatigue. The duration of weakness and fatigue was reported as one week. The patient received Fluticasone Sensimist Nasal Spray as a concomitant product. The reporter consented to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022106747 In the source document Fluticasone Sensimist Nasal Spray given which was not avalable in dictionary hence captured as Fluticasone nasal spray as concomitant drug.; Sender's Comments:  US-GSK-US2022106747:Same case/same reporter
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Nurse administered a Menveo vaccine by using different diluent than the approved; Nurse administered a Menveo vaccine by using different diluent than the approved; 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 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On 14th July 2022, the patient received Menveo. On 14th July 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: 14-July-2022 Reporter's comment: The nurse administered a Menveo vaccine by using different diluent than the approved.  The reporter consented to follow up via mail. Additional supportive information: Menveo was reconstituted with different diluent than the approved was administered to the patient, which led to wrong solution used in drug reconstitution error and Inappropriate dose of vaccine administered.