chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of shingrix in 2019; 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 (received 1st dose in 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 Information: GSK Receipt Date:06-APR-2022 Additional Supportive Information:The patient did not receive the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The case had been linked to US2022061071, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061071:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2019, hasn't received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 2nd April 2019, Batch Number :4257F,Expiry date:11th September 2021).   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: 06-APR-2022 Reporter's Comment: The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix , which led to incomplete course of vaccination. The case had been linked to US2022061067, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061067:Same reporter
Age: 42.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, Product administered to patient of inappropriate age, Product use in unapproved indication
Clinical narrative: bexsero expired 1/31/22, administered; 42 year old received bexsero; bexsero administered as part of post splenectomy series; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used, inappropriate age at vaccine administration and drug use for unapproved indication. On an unknown date, the outcome of the expired vaccine used, inappropriate age at vaccine administration and drug use for unapproved indication 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: 06-APR-2022 Reporter's Comment: The reporter stated that expired Bexsero vaccine that was accidentally administered to a patient as part of a post splenectomy vaccine series and wanted to know what recommendation was for repeating the vaccine. The reporter did not confirm with the healthcare professional that the series was a repeat but coded it as possible extra dose/repeat series since HCP stated that it was part of a post splenectomy vaccine series.  The reporter consented to follow up via postal. Additional Supportive Information: A 42 years patient accidentally received Bexsero vaccine that was already expired on 31st January 2022 as part of a post splenectomy vaccine series, which led to expired vaccine used, inappropriate age at vaccine administration and drug use for unapproved indication.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR061753:Possibly same patient
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: was administrated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 9-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 23yl4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Pediarix and Pediarix 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.   Linked case(s) involving the same patient:  US2022062600   Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The reporter stated that the patient was administrated with an expired dose of Pediarix. No adverse event was reported. The vaccine administration facility is the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: The patient was administrated with an expired dose of Pediarix, which led to expired vaccine used. This case had been linked to US2022062600, reported for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022062600:Same patient
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Pediarix (exp:4/4/22) dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 67-day-old patient who received DTPa-HBV-IPV (Pediarix) (batch number 23YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Pediarix and Pediarix 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: 07-APR-2022 Reporter's Comment: The reporter was clinical coordinator. The reporter called in to inquire that should the patient be revaccinated as they inadvertently administered an expired Pediarix dose to a patient. The reporter declined follow-up from safety team. Additional Supportive Information: The patient received Pediarix, which was expired on 4th April 2022, which led to expired vaccine used.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose in March 2019, second dose in January 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 57-year-old male patient who received Herpes zoster (Shingrix) (batch number T29Y2, expiry date 8th April 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2019).   In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The patient received second dose of Shingrix in January 2022 and wanted to know if the patient needed a 3rd dose or how to proceed in this situation. The reporter consented to follow up via fax. Additional Supportive Information: The patient received delayed second dose of Shingrix, which led to lengthening of vaccination schedule.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Accidental underdose, Adult failure to thrive
Clinical narrative: adult patient inadvertently received a pediatric dose of Engerix-B; adult patient inadvertently received a pediatric dose of Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 52-year-old male patient who received HBV (Engerix B pediatric) (batch number F22EZ, expiry date 3rd June 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th April 2022, the patient received Engerix B pediatric 10 µg. On an unknown date, the patient started Engerix B Pre-Filled Syringe Device. On 7th April 2022, unknown after receiving Engerix B pediatric and an unknown time after starting Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   It was unknown if the reporter considered the accidental underdose and adult use of a child product to be related to Engerix B 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 Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The reporter stated that an adult patient inadvertently received a pediatric dose of Engerix-B. The reporter consented to follow up. Additional Supportive Information: The patient was administered pediatric dose of Engerix B, which led to accidental underdose and adult use of a child product.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental underdose
Clinical narrative: patient did not receive the full dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number N3755, expiry date 26th June 2023) for prophylaxis.   On 7th April 2022, the patient received Shingrix (intramuscular) .5 ml. On 7th April 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The reporter stated that while administering the Shingrix vaccine there was an issue with the syringe and the patient did not receive the full dose of Shingrix. The reorter did not have patient's Healthcare professionals information. The reporter did not consent to follow-up. Additional Supportive Information: The patient did not receive the full dose of Shingrix, which led to accidental underdose.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Hives; body rash; mild temperature; This case was reported by a nurse via call center representative and described the occurrence of hives in a 6-month-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) (batch number 7E4F4, expiry date 30th June 2019) 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 Influenza vaccine Quadrivalent 2018-2019 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than 4 months after receiving Influenza vaccine Quadrivalent 2018-2019 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced hives, generalized rash and slight temperature. On an unknown date, the outcome of the hives, generalized rash and slight temperature were recovered/resolved.   It was unknown if the reporter considered the hives, generalized rash and slight temperature to be related to Influenza vaccine Quadrivalent 2018-2019 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.   Linked case(s) involving the same patient:  US2022AMR062248   Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The reporter stated that the patient reacted to Influenza vaccine quadrivalent, was this Fluarix or Flulaval was not sure but it was in 2018. The patient developed hives, body rash and mild temperature. The reporter wanted to resume vaccinations. The reporter was unable to provide exact date of vaccine or additional details as the vaccines were administered at a different facility The reporter consented to follow up via post. Additional Supportive Information: For tolerance to 2nd dose, refer case US2022AMR062248.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR062248:same reporter
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 3-year-old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number Y297N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The reporter stated that a 3-year-old patient received Kinrix.  The reporter consented to follow-up. Additional Supportive Information: The reporter stated that a 3-year-old patient received Kinrix, which led to inappropriate age at vaccine administration.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial spasm, Influenza like illness, Nasal congestion, Nasopharyngitis, Sneezing
Clinical narrative: Facial spasms; cold and flu symptoms; flu symptoms (congestion); flu symptoms (congestion); flu symptoms (sneezing, congestion); This case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2022, the patient received the 2nd dose of Shingrix. On 2nd March 2022, less than a day after receiving Shingrix, the patient experienced cold symptoms, influenza-like symptoms, nasal congestion and sneezing. On an unknown date, the patient experienced facial spasm. On an unknown date, the outcome of the cold symptoms, influenza-like symptoms, nasal congestion and sneezing were recovered/resolved and the outcome of the facial spasm was not recovered/not resolved.   It was unknown if the reporter considered the cold symptoms, influenza-like symptoms, nasal congestion, sneezing and facial spasm to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The patient self-reported this case. The patient reported side effects of Shingrix. The patient received her second dose of Shingrix and that same day after receiving the vaccine she experienced cold and flu symptoms (sneezing, congestion). This resolved after two weeks but then she noted she started having facial spasms on the left side of her face which had yet to resolve. The reporter consented to follow up.
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidentally received a dose of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix 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: 07-Apr-2022 Reporter's Comments: The reporter stated that the patient accidentally received a dose of Infanrix, Infanrix was indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the 7th birthday).  The reporter consented to follow up. Additional Supportive Information: The patient accidentally received a dose of Infanrix, which led to inappropriate age at vaccine administration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Menveo to a patient yesterday; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA467A, expiry date 31st March 2022) for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Menveo. On 6th April 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Linked case(s) involving the same patient:  US2022061853   Additional Information: GSK receipt date: 08-Apr-2022 Reporter's comment: Certified medical assistant administered an expired dose of Menveo to a patient a day before of reporting day (yesterday). Lot number did not identify as a GlaxoSmithKline vaccine, but it was confirmed with health care professional by repeating back twice. Consented to follow-up via postal. Additional Supportive Information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In May 2021,1st dose received intramuscularly in left arm).   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: 7-Apr-2022 Reporter's comments: This case was reported by the patient. After receiving 1st dose of Shingrix, the patient was not told that she was supposed to get two doses by her healthcare professional. As of the date of reporting she had not received her second dose. The reporter did not consent to follow-up. The reporter did not give consent to contact the healthcare professional.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. VAERS details for 1st dose was provided.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 23YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 7th April 2022, unknown after receiving Pediarix and Pediarix 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: 7-April-2022 Reporter's Comments: Clinic manager reported that patient was administered a dose of Pediarix which was expired. The reporter did not consent to follow-up.  Additional Supportive Information: The patient received dose of Pediarix that was already got expired which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Been longer than 6 months since 1st dose; This case was reported by a physician 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 more than 6 months before the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: Doctor of medicine reported that it had been longer than 6 months since the patient got first dose of Shingrix and wanted to get 2nd dose. The reporter asked did this patient had to restart the series. The healthcare professional did not know exactly when the first dose was given. Only that it had been more than 6 months. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEP, HEPA, MENB, TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: Administered frozen vaccines from 03/07/2022 to present; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of the patients who received HBV (Engerix B) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis, HAV (Havrix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B, Boostrix, Shingrix, Havrix, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B, Boostrix, Shingrix, Havrix, Bexsero and Bexsero 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: GSK Receipt Date: 7-Apr-2022 Reporter's comments: Nurse reported administration of frozen vaccines to the patients from 7th March 2022 to the date of reporting. Vaccines were Engerix-B, Boostrix, Shingrix, Bexsero, and Havrix. Chat was disconnected before additional details were provided. The consent to follow up was given. Additional Supportive Information: Frozen vaccines were administered to the patients which led incorrect storage of drug. There were total 43 patients. For 10 patients 10 cases were created. For rest patients this case was considered as master case. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Nurse administered frozen vaccine; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Nurse administered frozen vaccine; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Overdose
Clinical narrative: Two doses administered on same day; This case was reported by a physician via sales rep and described the occurrence of overdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2022, the patient received Shingrix and Shingrix. On 7th April 2022, unknown after receiving Shingrix and Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The doctor reported that two doses of Shingrix was administered to the patient on the same day. Additional Supportive Information: The patient received two doses of Shingrix on the same day, which led to overdose.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Nurse administered frozen Shingrix; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administered frozen Shingrix; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter US-GLAXOSMITHKLINE-US2022061871:Same reporter US-GLAXOSMITHKLINE-US2022061872:Same reporter US-GLAXOSMITHKLINE-US2022061873:Same reporter US-GLAXOSMITHKLINE-US2022061874:Same reporter US-GLAXOSMITHKLINE-US2022061875:Same reporter
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administered frozen Shingrix; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administered frozen Shingrix; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administered frozen Shingrix.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administered frozen Shingrix; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administered frozen Shingrix.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administered frozen Shingrix.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter.
Age: 0.83
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: received HAVRIX instead PEDIARIX; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 10-month-old female patient who received HAV (Havrix pediatric) (batch number 4CY9H, expiry date 28th April 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th April 2022, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 7th April 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 7-APR-2022 Reporter's Comment: The patient received dose Havrix instead of the intended Pediarix. The patient spoke per PI (Package insert) and content.  The reporter provided outside phone number for GSK Medical Information given for future reference and warm transfer provided. The reporter consented to follow-up. Additional supportive information: The patient received dose Havrix instead of the intended Pediarix, which led to Wrong vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: vaccinated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA82AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th April 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: 7-APR-2022 Reporter's Comment: The patient received an expired dose of Bexsero. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Bexsero which was already expired on 31st January 2022, which led to expired vaccine used.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: was administered only the diluent portion of Rotarix; was administered only the diluent portion of Rotarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L4HN3, expiry date 8th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 6th April 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 6th April 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.   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: 8-Apr-2022 Reporter's comments: Certified medical assistant reported that the patient was administered with only the diluent portion of Rotarix, without being reconstituted. The consent to follow up was given. Additional Supportive Information: The patient received only the diluent portion of Rotarix without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid adjuvant; administered only the liquid adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number ANXA656A, expiry date 30th August 2023) for prophylaxis.   On 8th April 2022, the patient received the 1st dose of Menveo. On 8th April 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 8-Apr-2022 Reporter's comments: The patient was administered with only the liquid adjuvant of the Menveo vaccine. The consent to follow-up was given. Additional Supportive Information: The patient received only liquid adjuvant of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown