chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:Same Reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:Same Reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th September 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:Same Reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Immunisation
Clinical narrative: received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and got shingles\ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shot and 6 months later got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reported that he/she was had shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  The reporter was patient. The age at vaccination was not reported. The reported that he/she was had shingles vaccine and later experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Accidental exposure to product, Accidental underdose, Needle issue, Syringe issue, Underdose
Clinical narrative: Underdose due to vaccine leakage; dose dripped over the patients arm; Inadvertent exposure to vaccine; This case was reported by a nurseand described the occurrence of accidental underdose in a 39-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 34yn4, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 4th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine 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 provided as follows: Nurse reported that the patient received underdose of the vaccine due to vaccine leakage, which led to accidental underdose. The reporter claimed that the needle was not properly attached to the prefilled syringe. They were not sure how much of the vaccine was administrated but claimed most of the dose dripped to the floor and the patients arm, which led to exposure via skin contact and inadvertent exposure to vaccine. No further events were reported. The reporter consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered with only the AS01B adjuvant of Shingrix.; administered with only the AS01B adjuvant of Shingrix.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7C483, expiry date 14th November 2022) for prophylaxis.   On 24th September 2021, the patient received Shingrix. On 24th September 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 information was provided as follows: The nurse practitioner reported that a female patient was administered with only the AS01B adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206993:same reporter US-GLAXOSMITHKLINE-US2021206991:same reporter US-GLAXOSMITHKLINE-US2021206990:same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: dose reconstituted with saline solution; received dose with saline solution; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date 4th June 2022) for prophylaxis.   On 28th September 2021, the patient received Shingrix. On 28th September 2021, unknown after receiving Shingrix, 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 was provided as follows: The patient who might have received a dose of Shingrix reconstituted with saline solution instead the approved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter was not completely sure but was asking for information about this. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received Hib (Hiberix) (batch number TF4EB, expiry date 26th September 2021) for prophylaxis.   On 1st October 2021, the patient received the 4th dose of Hiberix. On 1st October 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information was provided as follows: This case was reported by clinical Supervisor. The patient received an expired dose of Hiberix vaccine. The reporter consented to follow up. The case was linked with the case US2021207018, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021207018:Same reporter
Age: 43.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Off label use
Clinical narrative: Incomplete course of vaccination; administered Shingrix to a 43 year old patient; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 43-year-old female patient who received Herpes zoster (Shingrix) (batch number 9K4T4, expiry date 8th October 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had two cases of shingles in last 18 months, before vaccination).   On 30th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 30th March 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced off label use. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the off label use and incomplete course of vaccination were unknown.  Additional details were provided as follows: It was reported that the patient didn't have a prescription for Shingrix. The patient was not immunocompromised but has had two cases of shingles in last 18 months and received Shingrix vaccine at the age of 43 year.  This was caught when she presented for a second dose. At the time of report it was unknown if the patient received 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose was 10/08/2019; 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 on 10th August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was recovered/resolved.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the consumer was in the pharmacy on the day of reporting to get his second dose of Shingrix.  Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received second dose 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 (1st dose received about 2 years before reporting).   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 was provided as follows: The age at vaccination was not applicable. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. The case was linked with the case US2021207616, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021207616:same reporter
Age: 0.08
Sex: F
Vaccine: HEP
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-week-old female patient who received HBV (Engerix B) (batch number HN2CC, expiry date 1st October 2021) for prophylaxis.   On 5th October 2021, the patient received the 2nd dose of Engerix B. On 5th October 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information was provided as follows: Nurse reported that female patient received an expired dose of Engerix B. The reporter stated that this was supposed to be her 2nd dose. The reporter consented to follow up.
Sex: M
Vaccine: UNK
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy; This case was reported by a consumer via call center representative and described the occurrence of lymphadenopathy in a male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2021, the patient received FluLaval Tetra 2021-2022 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. On 4th October 2021, 1 days after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was not recovered/not resolved.   It was unknown if the reporter considered the lymphadenopathy to be related to FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. 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 case was reported by the patient. The age at vaccination was not reported. The reporter stated that he had the vaccine and the next day started experiencing lymphadenopathy in his left armpit.  The reporter was referred to health care professional. The reporter gave limited pharmacy information. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: were left out of the refrigerator, might have been administered; This case was reported by a other health professional and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 5Z4R7, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 was provided as follows: The age at vaccination was not applicable for this report. Occupational health specialist reported that they received a new shipment of Flulaval and the vaccines were left out of the refrigerator for about 5 days, the vaccines might have been administered after this excursion, although was not completely sure and had no registration of any patients at the moment, which led to incorrect storage of drug. The reporter consented to follow up.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Boostrix expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43e4t, expiry date 1st October 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 6th October 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was vaccinated with a Boostrix expired dose, which led to expired vaccine used. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st and 2nd doses two weeks apart; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 75BA4, expiry date 5th February 2023) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 4th October 2021, the patient received the 2nd dose of Shingrix. On 4th October 2021, 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 reported as follows: This case was reported by the nurse. The nurse reported that the patient was administered his 1st and 2nd doses of Shingrix two weeks apart, which led to drug dose administration interval too short. The nurse consented to follow- up.
Sex: U
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: attempted to inject but most of the medication leaked out; This case was reported by a physician via sales rep and described the occurrence of wrong route of administration in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 5th October 2021, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 5th October 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of 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: This case was reported by the physician. The age at vaccination was not reported. The physician stated that nurse at the office attempted to inject Rotarix into a patient, most of the medication leaked out instead of the oral route, which led to wrong route of administration. The physician also stated that it was unknown whether any was successfully injected into the patient. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose three years ago/Inappropriate Schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received, 3 years ago of 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 provided as follows: The age at vaccination was not applicable for this report. Till the time e of reporting, the patient did not receive the second dose of the Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: is currently pregnant; This prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2020-2021 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   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 case was reported by patient herself who was also the physician. The patient received a dose of Fluarix during pregnancy, which led to vaccine exposure during pregnancy. The patient was not sure whether the dose given was expired or not and wanted to confirm for the season of the dose she received. The dose was confirmed as 2020-2021 and the patient was currently pregnant wanted to know if she could receive a second dose. Since no information was available patient did not confirm she would get another dose of the Fluarix vaccine.
Age: 13.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Engerix-B -Inappropriate Schedule/ 3rd dose received in Oct 2021; Engerix-B -Inappropriate Schedule/ 2nd dose received in Sep 2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 13-year-old female patient who received HBV (Engerix B) (batch number F22EZ, expiry date 3rd June 2023) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received in 2008).   On 5th October 2021, the patient received the 3rd dose of Engerix B. In September 2021, the patient received the 2nd dose of Engerix B. In September 2021, not applicable after receiving Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On 5th October 2021, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.  Additional details were provided as follows: The Nurse Practitioner reported that, the patient began the Engerix-B series in 2008, received the second dose was on September2021, which led to lengthening of vaccination schedule. The patient received the third dose on the day before reporting date, which was earlier from 2nd dose and led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: given expired doses; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received HAV (Havrix) (batch number 3HR79, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 6th October 2021, 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 patient had been given expired doses of the Havrix vaccine, which led to expired vaccine used. The patient consented to follow up by email. This case has been linked to US2021208268, reported by the sane reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021208268:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 2019/Inappropriate schedule ofvaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received their first dose of Shingrix on at a different facility. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. The reporter declined to provide additional information, both due to time constraints and lack of additional information.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7YO patient vaccinated with Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 31st July 2021, unknown after receiving Boostrix and Boostrix 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 provided as follows: The 7 year old patient was vaccinated with Boostrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: MMRV, MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with live virus of varicella and MMR diluent; administered with live virus of varicella and MMR diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA584A, expiry date 31st August 2022) for prophylaxis.   Co-suspect products included MMRV for prophylaxis.   On 6th October 2021, the patient received Menveo and MMRV. On 6th October 2021, 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 details were provided as follows: Medical Assistant stated that, the Menveo Lyophilized component was reconstituted with a live virus of varicella and MMR diluent then inadvertently administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Fatigue, Feeling hot, Heart rate increased, Muscle tightness
Clinical narrative: Extreme weakness; pins and needles tingling sensation in both hands; Increased heartrate; tightness between the neck and both shoulders; warm sensation around the spinal cord/ warm feeling has now progressed to both legs; fatigue; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 45-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2021 11:00, the patient received Fluarix Quadrivalent 2021-2022 season. On 6th October 2021, the patient started Fluarix Tetra Pre-Filled Syringe Device. On 6th October 2021 19:30, 8 hrs 30 min after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced weakness, pins and needles, heart rate increased, muscle tightness, feeling of warmth and fatigue. On an unknown date, the outcome of the weakness, pins and needles, heart rate increased, muscle tightness, feeling of warmth and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the weakness, pins and needles, heart rate increased, muscle tightness, feeling of warmth and fatigue to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.   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 case was reported by the patient. The patient received Fluarix on 6th October 2021, at approximately 11 am, the patient beginning to experience symptoms at approximately 7:30 pm, on the same day.  The patient first experienced a pins and needles tingling sensation in both hands, next experienced an increased heartrate, developing a warm sensation around the spinal cord.  The patient also experienced extreme weakness that was beyond what they would consider normal fatigue.  The patient also developing a tightness between the neck and both shoulders.  The warm feeling had now progressed to both legs, which began early on the day of reporting on 7th October 2021. The patient reported all symptoms were ongoing and seem to be getting progressively worse. The reporter consented to follow up.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Paraesthesia
Clinical narrative: Extreme weakness; pins and needles tingling sensation in both hands; Increased heartrate; tightness between the neck and both shoulders; warm sensation around the spinal cord/ warm feeling has now progressed to both legs; fatigue; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 45-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2021 11:00, the patient received Fluarix Quadrivalent 2021-2022 season. On 6th October 2021, the patient started Fluarix Tetra Pre-Filled Syringe Device. On 6th October 2021 19:30, 8 hrs 30 min after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced weakness, pins and needles, heart rate increased, muscle tightness, feeling of warmth and fatigue. On an unknown date, the outcome of the weakness, pins and needles, heart rate increased, muscle tightness, feeling of warmth and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the weakness, pins and needles, heart rate increased, muscle tightness, feeling of warmth and fatigue to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.   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 case was reported by the patient. The patient received Fluarix on 6th October 2021, at approximately 11 am, the patient beginning to experience symptoms at approximately 7:30 pm, on the same day.  The patient first experienced a pins and needles tingling sensation in both hands, next experienced an increased heartrate, developing a warm sensation around the spinal cord.  The patient also experienced extreme weakness that was beyond what they would consider normal fatigue.  The patient also developing a tightness between the neck and both shoulders.  The warm feeling had now progressed to both legs, which began early on the day of reporting on 7th October 2021. The patient reported all symptoms were ongoing and seem to be getting progressively worse. The reporter consented to follow up.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: vaccinated with expired Engerix-B; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HBV (Engerix B) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2021, the patient received Engerix B .5 ml and Engerix B Pre-Filled Syringe Device. On 6th October 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired dose of Engerix B in right deltoid, which led to expired vaccine used.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 years-old patient was administered INFANRIX; administered INFANRIX instead of BOOSTRIX; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Infanrix (intramuscular) .5 ml and Infanrix Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter called from physician's office. The 12 years old patient received dose of Infanrix in right deltoid instead of Boostrix, inappropriate age at vaccine administration and wrong vaccine administered. The reporter gave a consent to follow-up with herself.