chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 months 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, 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: 01-MAR-2023 Reporter's Comment: A reporter reported that a 4 months old patient received a Kinrix dose. The reporter consented to follow up. Additional Supportive Information: A reporter reported that a 4 months old patient received a Kinrix dose, which led to inappropriate age at vaccine administration.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received unreconstituted diluent only; received unreconstituted diluent only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMZA756A, expiry date 31st October 2023) for prophylaxis.   On 1st March 2023, the patient received the 1st dose of Menveo. On 1st March 2023, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's comments: A nurse reported that a patient received a dose of unreconstituted diluent only Menveo on 1st March 2023. The reporter had consented to follow-up via email. Additional supportive information: The patient had received the diluent portion of the Menveo vaccine only without reconstituting it, which had led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix 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 male patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2023, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-Mar-2023 Reporter's Comments:  Medical assistants (MA) reports a patient received an expired dose of Havrix on the day of reporting.  Vaccine expired on 6th February 2023. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix after expiration date, which led to expired vaccine used.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st December 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 28th February 2023, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 28th February 2023, 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: 01-Mar-2023 Reporter's Comments:  Licensed vocational nurse (LVN) states that an expired dose of Bexsero was administered to a patient yesterday. The health care professional (HCP) did not have lot number at the time of call but should have it for follow up. The reporter consented to follow up via postal. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received Bexsero after expiration date, which led to expired vaccine used.
Age: 0.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 5-month-old; Kinrix was 2nd dose of dtap and ipv; 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 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule 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: 1-Mar-2023 Reporter's Comments:  A clinic manager reported that a 5-month-old male patient received a dose of Kinrix on 20th February 2023.  No symptoms reported. Health care professional (HCP) reported, to the 2nd line agent, that Kinrix was patients 2nd dose of dtap and ipv and HCP was not sure what the intention was to give or timing of previous doses. The reporter consented to follow up via email. Additional Supportive Information: the patient received Kinrix as 2nd dose of Dtap and IPV vaccine, which led to inappropriate age at vaccine administration, inappropriate schedule of vaccine administered.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 1st March 2023, the patient received Havrix. On 1st March 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-Mar-2023 Reporter's Comments:  A medical assistant called in to report the administration of an expired Havrix dose to a 59 year-old female patient.  The reporter asked how to proceed with this patient. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received Havrix after expiration date, which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received HAV (Havrix) (batch number U016222, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comments: The reporter consented to follow-up via email. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 1st March 2023, the patient received Havrix. On 1st March 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comment: The reporter declined to provide patient's date of birth.  The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-Mar-2023 Reporter's comments: The reporter asked if the patient had to be revaccinated.  The reporter consented to follow up. Additional supportive information: The patient received an expired dose of Kinrix, which led to expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: had 2 Twinrix doses, missed 3rd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (received 1st dose on unknown date) and Twinrix adult (received 2nd dose on unknown date).   On an unknown date, the patient did not receive the 3rd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's comment: The patient self-reported this case. The patient had 2 doses of Twinrix vaccine in the correct time and the 3rd dose was missed at 6 months.  The patient enquired if she could get the 3rd dose now.  The lot and expiration dates were not provided.  The date of vaccination were unknown reporter disconnected abruptly. No additional information could be collected for adverse event. The consent for follow up was not provided. Additional supportive information: Till the time of reporting, the patient did not receive 3rd dose of Twinrix adult, which led to incomplete course of vaccination.
Age: 1.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Received extra dose of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 21-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number E9Y29, expiry date 26th October 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (had already finished the scheme of Pediarix).   On 1st March 2023, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose 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: 01-MAR-2023 Reporter's comment: The nurse called to report  that earlier that day (on the day of reporting) a patient that had already finished the scheme of Pediarix received an extra dose of such vaccine.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient had received the 4th dose of Pediarix, which had led to extra dose administered.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st March 2023, 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: 01-MAR-2023 Reporter's Comments: The reporter enquired if the patient should be revaccinated. The reporter was unable to provide any patient details The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero vaccine, which had led to expired vaccine used.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received expired dose of HAvrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix pediatric) (batch number Ep47e, expiry date 6th February 2023) for prophylaxis.   On 21st February 2023, the patient received Havrix pediatric. On 21st February 2023, unknown after receiving Havrix pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comments: The caller opted out of providing additional information The reporter did not consent to follow-up.  Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: 4th dose Engerix-B administered to a 3 year old; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 3-year-old male patient who received HBV (Engerix B) (batch number ZT72F, expiry date 15th December 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2023, the patient received the 4th dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose 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: 01-MAR-2023 Reporter's comment: The reporter consented to follow up. Additional supportive information: A 4th dose of Engerix B was administered to a patient, which led to extra dose administered.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given to an adult; Pediatric dose given to an adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number EM9E4, expiry date 17th February 2025) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th February 2023, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 13th February 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   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: 02-Mar-2023. Reporter's Comment: It was stated that a pediatric dose of Engerix-B was given to an adult patient. The reporter consent to follow up. Patient´s initials were asked and caller look for information but did not have it so it was declined. Additional Supportive Information: An adult patient received pediatric dose of Engerix-B, which led to adult use of a child product and underdose.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA824A, expiry date February 2025) for prophylaxis.   On 1st March 2023, the patient received Menveo. On 1st March 2023, 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: 02-MAR-2023 Reporter comment: The reporter reported that, the male patient received only the diluent component of Menveo (2 vials presentation) without being properly reconstituted. The health care practitioner declined to provide patient´s details. The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow up Additional Supportive Information: The patient received only the diluent component of Menveo (2 vials presentation) without being properly reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received liquid component only; Received liquid component only; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 1st March 2023, the patient received Menveo. On 1st March 2023, 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: 02-Mar-2023 Reporter comment: The physician reported that a patient received the Menveo liquid component only, without reconstituting with lyophilized component.  The healthcare professional did not have the patient's information of gender, date of birth and the lot or expiration at the time of report.  The healthcare professional declined to store name and phone number but consented to follow-up via email. Additional supportive information: The patient received the Menveo liquid component only, without reconstituting with lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pediarix given instead of Boostrix; Pediarix given to a 14-year-old; Extra dose of DTaP, Hepatitis B and IPV; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15th April 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (received dose in 2014), Pediarix (received dose in 2008), Pentacel (received dose in 2009), Dtap vaccine (received dose in 2009), Dtap vaccine (received dose in 2011), Polio vaccine (received 4 doses) and hepatitis B vaccine (received 3 doses).   On 1st March 2023, the patient received Pediarix. On an unknown date, the patient started Pediarix Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 2-Mar-2023 Reporter's Comments:  HCP called in to report that a 14-year-old patient was incorrectly given a dose of Pediarix when they were scheduled for a dose of Boostrix.  The healthcare provider gave information about the dose and patient. They accepted to be escalated to second line.  Previous vaccination mentioned were Kinrix 2014, Pediarix 2008, Pentacel 2009, 2 Dtap in 2009 and 2011, being a total of 5 Dtap.  Other vaccines include 4 doses Polio and 3 hepatitis B. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patients received Pediarix vaccine, which led to wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered.; Sender's Comments:  US-GSK-US2023034000:Same reporter
Age: 11.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pediarix given instead of Boostrix; Pediarix given to an 11-years-old; Extra dose of DTaP, Hepatitis B and IPV; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15th April 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (received 1 dose in 2017), Pediarix (received 1 dose in 2012), Pentacel (received 2 doses in 2012), Pentacel (received 1 dose in 2013), Dtap vaccine (received 4 doses on an unknown date), IPV vaccine (received 3 dose on an unknown date) and hepatitis B vaccine.   On 1st March 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 2-Mar-2023 Reporter's Comments:  HCP called in to report that a 11-year-old patient was incorrectly given a dose of Pediarix when they were scheduled for a dose of Boostrix.  The healthcare provider gave information about the dose and patient.  They accepted to be escalated to second line.  Previous vaccination include 1 Kinrix 2017, 1 Pediarix 2012, 2 Pentacel 2012 and 1 Dtap 2013. Other vaccines include 4 doses of IPV and 3 doses of hepatitis B. the reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patients received Pediarix vaccine, which led to wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered.; Sender's Comments:  US-GSK-US2023033996:Same reporter
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Received 1st Bexsero then  Trumenba; This case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 02-FEB-2023 Reporter's comment: The registered pharmacist reported that patient received the first dose of Bexsero then received a non-GSK Trumenba dose as a second dose. The pharmacist wanted to know about how to proceed with Bexsero series. The reporter unable to provide any additional details on vaccines. The reporter did not consent to follow up. Additional Supportive Information: The patient received Trumenba vaccine instead of Bexsero, which led to interchange of vaccine products.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: was given Boostrix instead of Infanrix; was given Boostrix, is 15 months old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 34FR4, expiry date 23rd September 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd March 2023, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 2nd March 2023, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-Mar-2023 Reporter's comments:  The health care professional (HCP) reported that patient was given Boostrix instead of Infanrix, on the day of reporting. The patient was doing well. The reporter consented to follow up. Additional supportive information: 15 months and 15 days old patient received a dose of Boostrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site rash, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: rash at the injection site; 4 month old patient received a dose of Kinrix; Received  Kinrix instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced injection site rash, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the injection site rash, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   It was unknown if the reporter considered the injection site rash to be related to Kinrix and Kinrix 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: 02-MAR-2023 and 06-MAR-2023 Reporter's comment: The nurse asked further questions and mentioned that the patient developed rash at the injection site after the administration of Kinrix. The vaccine was administered at unknown place.  The reporter received the call from a parent and did not had patient details, other than age, or any vaccination details (date, lot, expiry date, etc). The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional supportive information: The patient received a dose of Kinrix instead of Pediarix at an inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered.; Sender's Comments:  US-GSK-US2023035536: - same reporter
Age: 69.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2006, 2nd 02Mar2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received HAV (Havrix 1440 adult) (batch number 3J9G4, expiry date 30th August 2025) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 adult  (1st dose received in 2006).   On 2nd March 2023, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 2nd March 2023, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's comment: No further information about the first dose was available. The consent to follow up with healthcare professional was not asked. Additional supportive information: The patient received 2nd dose of Havrix in left arm later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Rotarix not reconstituted; Diluent given  without  reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, 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: 02-Mar-2023 Reporter's comments: The nurse reported that the administration of Rotarix diluent to a patient without previous reconstitution of the lyophilized powder portion. The reporter mentioned that one of three patients received only the liquid portion, but they were unable to identify this patient. The reporter asked if the patient who received only the diluent had to receive a properly reconstituted dose. Since they did not know which patient received only the diluent portion, the reporter asked about the safety of giving an extra dose to all three patients. The reporter did not provide any information about the patients involved in this case.  Vaccine information (lot number/expiry date) was not shared by the health care professional. The reporter consented to follow up. Additional supportive information: The patient received diluent portion of Rotarix without reconstitution with the lyophilized powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received Vx then shingles were re-activated/suspected vaccination failure; shingles reactivated; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a history of shingles).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's Comment: The reporter stated that her friend's mother who had a history of shingles received the Shingrix vaccine and her shingles were re- activated after Shingrix.  She thought that it might have already been reported, this was a while ago.  She did not want to provide any additional information. Limited information was reported. The reporter did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 68.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: Administered diluent only; Administered diluent only; Inappropriate age at vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 68-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 3rd March 2023, the patient received Menveo. On 3rd March 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 03-MAR-2023 Reporter's comment: The pharmacist called to report that the administration of the Menveo diluent without previous reconstitution of the lyophilized conjugate vaccine component to a patient. The reporter asked for recommendations about patients re vaccination The reporter did not provide lot number and expiration date of Menveo vaccine. The reporter consent to follow up. Additional Supportive Information: The patients received Menveo diluent without previous reconstitution of the lyophilized conjugate vaccine component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. 68 years old patient received Menveo vaccine, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Renal impairment
Clinical narrative: LOST LEFT KIDNEY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lost left kidney and almost lost life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lost left kidney was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230308677- lost left kidney. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple patients (unspecified number of patients) of an unspecified age, sex. The patients weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced blood clots. It was reported that, the reporter had friends, who had blood clots after getting their Janssen covid shots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221162412 and 20221162364.; Sender's Comments: V0: 20230321709- blood clots. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: recently came in contact with a friend who had the Moderna vaccine she was also getting frozen shoulder; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIARTHRITIS (recently came in contact with a friend who had the Moderna vaccine she was also getting frozen shoulder) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIARTHRITIS (recently came in contact with a friend who had the Moderna vaccine she was also getting frozen shoulder). At the time of the report, PERIARTHRITIS (recently came in contact with a friend who had the Moderna vaccine she was also getting frozen shoulder) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication not reported. Treatment medication not reported.  Company comment.  This spontaneous case concerns a female patient (unknown age), with no medical history reported, who received a dose of mRNA  1273 original vaccine and experienced the unexpected, non  serious AESI of periarthritis. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. No information about patient´s immunisation schedule was disclosed. The report stated that the patient experienced frozen shoulder and that "she has been dealing with an arm that has not worked for over a year". The outcome of the event was unknown. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714274, US-MODERNATX, INC.-MOD-2023-714276 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714276:(Case 30 Peoples) US-MODERNATX, INC.-MOD-2023-714274:(Tracking only case for Repoter))
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient had syncope; This spontaneous case was reported by a pharmacist and describes the occurrence of SYNCOPE (Patient had syncope) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Patient had syncope) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Patient had syncope) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had syncope that was momentary and came back, and vitals were ok. It was reported that EMS (emergency medical service) was called and everything was fine, and they transferred the patient.   No treatment medication was reported.  Company comment: This is a spontaneous case reported by a pharmacist regarding a patient of an unknown age and gender, with no reported medical history, who experienced unexpected and medically significant event of syncope after receiving mRNA-1273 vaccine (dose number unknown). Vaccination date and onset date of the event were not provided, latency cannot be assessed. Patient experienced syncope and came back to his senses and vitals were ok. It was reported that EMS (emergency medical service) was called and everything was fine, and they transferred the patient. It is unknown if patient was transferred to hospital or if any diagnostic tests/intervention/treatment was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-714400 (  Linked Report).; Sender's Comments:  MOD-2023-714400:Pfizer vaccine case