chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: site is a large red welt; site is a large red welt; site is a large red welt and hot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site wheal in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site wheal, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site wheal, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site wheal, injection site erythema and injection site warmth to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient's injection site was a large welt red, hot and red. The patient wanted to know if this was normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: An 18 year old patient received the 1 mL (adult dose) in error.; An 18 year old patient received the 1 mL (adult dose) in error; This case was reported by a nurse via sales rep and described the occurrence of accidental overdose in a 18-year-old female patient who received HBV (Engerix B) for prophylaxis.   On 11th May 2022, the patient received the 1st dose of Engerix B 1 ml. On 11th May 2022, unknown after receiving Engerix B, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comment: An 18 year old patient received the 1 mL (adult dose) in error.  The nurse thought that because the patient was 18 years old, the adult dose was due and recommended.  The patient did not experience any adverse events per the reporter.  Office called to get guidance for doses 2 and 3 (volume). The reporter did not consent to follow-up. Additional supportive information: 18 year old patient received 1 mL (adult dose) of Engerix B in error, which led to Inappropriate age at vaccine administration and Accidental overdose.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Mine burning since Feb; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a 91-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In February 2022, unknown after receiving Shingles vaccine, the patient experienced burning sensation. On an unknown date, the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the burning sensation to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient had burning sensation since February and now it was 18th May had all the shots and busters. Additional supportive information: Follow-up could not be possible as no contact details were available. Note: As it was stated had all shots but it was unspecified number of doses therefore conservatively single suspect was coded without dose number.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Patient was given Pediarix vs. Kinrix; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix 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: 19-MAY-2022 Reporter's Comments: The patient was given Pediarix instead of Kinrix because she needed a 3rd dose of Hepatitis. The patient did not experience any adverse reaction to the dose. Additional Supportive Information: The patient was given Pediarix instead of Kinrix because she needed a 3rd dose of Hepatitis, which led to Wrong vaccine administered.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 15 month old baby was inadvertently given Boostrix; was inadvertently given Boostrix Tdap, instead of Infanrix; This case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 22MS7, expiry date 1st April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In May 2022, the patient received Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. In May 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-May-2022 Reporter's comments: Fifteen month old patient was inadvertently given Boostrix (Tdap) at her 15 month visit this week, instead of Infanrix (DTaP). No adverse events or issues were reported after administration of the vaccine. The reporter agreed to follow up. Additional Supportive Information: The fifteen month old patient inadvertently received Boostrix instead of Infanrix, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: The first one was like burning sensation.; vaccines hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced burning sensation and pain. On an unknown date, the outcome of the burning sensation and pain were recovered/resolved.   It was unknown if the reporter considered the burning sensation and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR081833   Additional Information: GSK receipt date: 18-May-22 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient had received a dose of shingles vaccine and hurts like hell. The first one was like burning sensation. Additional Supportive Information: Follow-up could not be possible as no contact details were available. For tolerance of 2nd dose refer case US2022AMR081833.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081833:same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I got body-ache/Hurts like heck; Fever; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose of Shingles vaccine and it hurts like heck refer case US2022AMR081826).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general body pain and fever. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the general body pain and fever to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR081826   Additional Information: GSK receipt date: 18-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient received the second shingles dose and it hurts like hell. The patient got body ache and fever. The patient stated that next day like nothing happened. Additional Supportive Information: Follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081826:same patient, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: little tired; influenza like symptoms; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness and influenza-like symptoms. On an unknown date, the outcome of the tiredness and influenza-like symptoms were unknown.   It was unknown if the reporter considered the tiredness and influenza-like symptoms to be related to Shingrix.   Linked case(s) involving the same patient: US2022AMR081863   Additional Information: GSK Receipt Date:19-MAY-2022 Reporter's Comment: The case was reported by the patient.  The patient was 58 years old at the time of reporting. The patient had good health. The patient didn't recall too much other than feeling a little tired and flu like symptoms after the Shingrix 1st shot. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR081863; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081863:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever details; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingrix and experienced fever. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with sterile water instead of  saline diluent; reconstituted with sterile water instead of  saline diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: Reporter was a pharmacy intern who was reporting potential wrong solution used in reconstitution with Hiberix.  She stated that, Hiberix might have been reconstituted with sterile water instead of with the accompanying saline diluent.  The number of lyophilized vials and saline diluent did not match which led her to this conclusion.  It was unknown if dose was administered to the patient. The reporter consented to follow up. Additional supportive information: Hiberix might have been reconstituted with sterile water instead of with the accompanying saline diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 0.42
Sex: M
Vaccine: DTAP, DTAPHEPBIP, DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Patient received Pediarix doses 2 and 3 late; Patient received Pediarix doses 2 and 3 late; Patient received 1st Infanrix dose on 20-oct-21; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 5-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 14th March 2022, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 20th October 2021, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 20th October 2021, not applicable after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On 22nd December 2021, the patient experienced drug dose administration interval too long. On 14th March 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long, drug dose administration interval too long and wrong vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: The patient received 2nd and 3rd dose of Pediarix late. Healthcare professional also stated that, the patient received 1 dose of Infanrix too early.  The reporter consented to follow up. Additional supportive information: The patient received 2nd and 3rd dose of Pediarix, later than the recommended schedule, which led to lengthening of vaccination schedule and 1 dose of Infanrix, which led to wrong vaccine administered.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU4, HEP
Symptoms: Product storage error
Clinical narrative: 17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix 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-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age, Underdose
Clinical narrative: accidentally received pediatric dose; accidentally received pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included bone marrow transplant.   On an unknown date, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix pediatric and Havrix 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.     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: 17-May-2022 Reporter's comment: Registered pharmacist reported that a patient who recently had a bone marrow transplant accidentally received pediatric dose of Havrix. The reporter asked that how long this patient should wait to get the adult dose. The reporter did not provide any demographic details from patient.  The reporter stated he could not provide them. Lot number and expiration date of pediatric dose were not provided by the reporter since reporter did not had that information. The reporter did not consent to follow-up. Additional Supportive Information: The patient accidentally received pediatric dose of Havrix, which led to accidentally underdose and adult use of a child product. Note: Suspect was coded as per narrative.
Sex: F
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: received shingrix vaccine while still having shingles,  vaccine in a patient with active case of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 17th May 2022, the patient received Shingrix. On 17th May 2022, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   Additional Information: GSK receipt date: 17-May-2022 and 18-May-2022 Reporter's comment: The pharmacist submitted afterhours webform, which was retrieved by Medical Information at start of business on 18th May 2022. The reporter reported that what did he/she need to do to knew if a patient received Shingrix vaccine while still having shingles.  No further details were provided on form. The reporter submitted potential adverse event with all available details. Consented to follow-up. Additional Supportive Information: The patient received Shingrix with active  case of shingles, which led to off label use. The case US2022080583 was identified as duplicate of US2022080584. The case US2022080583 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: used incorrect diluent and administered to a patient; used incorrect diluent and administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA602A, expiry date 31st August 2022) for prophylaxis.   On 17th May 2022, the patient received Menveo. On 17th May 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information:  GSK Receipt Date: 17-MAY-2022 Reporter's Comment: Health care professional (HCP) reported, Medical Assistant (MA) used incorrect diluent and administered to a patient. The reporter consented to follow up. Additional Supportive Information: The patient received incorrect diluent of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: administered in 17May2022, expiration date 08May2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KD4D, expiry date 8th May 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 17th May 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 17th May 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: 17-MAY-2022 Reporter's Comments: Office Manager reported, that a 10 month old male patient was administered second dose in Pediarix series. It was then discovered the dose had an expiration date of 8th May 2022.   At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility is the same as Primary Reporter Reporter gave permission to contact for follow-up. The reporter consented to follow up. Additional Supportive Information: On 17th May 2022, the 10th month old patient received a dose of Peadiarix, which got expired on 8th May 2022, which led to expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 8May2018, did not receive further doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 8th May 2018).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: Pharmacist reported that a patient received the first dose of Twinrix and did not receive any further doses of the vaccine. The reporter consented to follow up. Additional Supportive Information: : Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA68AA, expiry date 31st October 2021) 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 17th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th May 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: 18-MAY-2022 Reporter's Comments: The patient received an expired Bexsero vaccine. The reporter consented to follow-up.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given an adult dose; 1 ml/20mcg; Pediatric patient was given an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old male patient who received HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) 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 May 2022, the patient received Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On 13th May 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comments: The medical assistant reported that a patient received an adult dose (1 ml or 20 mcg of Engerix B. No symptoms were reported. The reporter consented to follow up. Additional supportive information: The reporter reported that a child patient received an adult dose of Engerix B, which led to overdose and adult product administered to child.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered to a 15 day old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-day-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 7L9PZ, expiry date 24th November 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th May 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th May 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:18-May-2022 Reporter's comments: Pediarix was administered to a 15 days old patient. No reactions were reported. The consent to follow up was given. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The fifteen days old patient received Pediarix, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the adjuvant portion; administered only the adjuvant portion; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number H755H, expiry date 9th June 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date:19-May-2022 Reporter's comments: The patient was administered with only the adjuvant portion of Shingrix. The consent to follow up was given. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient was administered with only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: received first dose on july 2021,  second dose on May 2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA636A, expiry date 30th September 2022) for prophylaxis.   Previously administered products included Menveo (received 1st dose on an unknown date in July 2021).   In May 2022, the patient received the 2nd dose of Menveo. In May 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 19-MAY-2022 Reporter's comment: A nurse reported about a patient who received an early second dose of Menveo.  Additional Supportive Information: The patient received 2nd dose of Menveo, which led to extra dose administered.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Axillary pain, Fatigue, Lymphadenopathy, Pain
Clinical narrative: soreness in right armpit, sore in the armpit; fatigue, tired; body aches; high anxiety; Swollen lymph node/ lymphodenitis; This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced fatigue, general body pain, anxiety and enlargement of lymph nodes. On 19th May 2022, the patient experienced axillary pain. On an unknown date, the outcome of the axillary pain, fatigue, general body pain, anxiety and enlargement of lymph nodes were not recovered/not resolved.   It was unknown if the reporter considered the axillary pain, fatigue, general body pain, anxiety and enlargement of lymph nodes to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received Shingrix 1st dose on the day before reporting and on 19th May 2022 in morning experienced sore armpit, patient asked it was normal. The patient was experienced fatigue, tired, and body aches and had very high anxiety. The patient asked about lymphadenitis and patient said it did not sound like horrible probably just due to the injection area but was the lymphadenitis something bad or was it something that just had settle down.  The patient did talk with nurse who gave the injection and she said because we have lymph nodes everywhere and when we inject something into body lymph nodes were kind of attacking it and sent it causes pain that could what feeling
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blepharospasm
Clinical narrative: intermittent eye twitches in both of eyes; This case was reported by a consumer via call center representative and described the occurrence of blepharospasm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2022, the patient received the 2nd dose of Shingrix (intramuscular). In May 2022, less than a day after receiving Shingrix, the patient experienced blepharospasm. On an unknown date, the outcome of the blepharospasm was not recovered/not resolved.   It was unknown if the reporter considered the blepharospasm to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comments: The patient reported case for himself. On the afternoon of 17th May 2022, the patient received Shingrix dose in arm.  The next morning on 18th May 2022 he noticed intermittent eye twitches in both of his eyes. On the day of reporting the intermittent eye twitch was only in his left eye. The reporter had nothing else to report.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: administered frozen dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31st March 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 16th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving 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: 19-MAY-2022 Reporter's comment: The licensed practice nurse (LPN) reported having administered a frozen dose of Bexsero. The adverse event report contained all information provided by LPN at this time. The LPN gave consent for safety to follow up.  The reporter consented to follow up. Additional supportive information: The nurse administered a frozen dose of Bexsero, which led to incorrect storage of vaccine. This case has been linked to the case US2022081278, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081278:Same reporter
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: administered frozen dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31st March 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 18th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving 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: 19-MAY-2022 Reporter's comment: The licensed practice nurse (LPN) reported having administered a frozen dose of Bexsero. The adverse event report contained all information provided by LPN at this time. The LPN gave consent for safety to follow up.  The reporter consented to follow up. Additional supportive information: The nurse administered a frozen dose of Bexsero, which led to incorrect storage of vaccine. This case has been linked to the case US2022081277, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081277:Same reporter
Age: 24.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 4Nov2021, 3rd dose 3Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 24-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 3rd January 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd January 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-MAY-2022  Reporter's Comments: Pharmacist reported a patient received three doses of Twinrix. Did not consent to follow-up. Additional Supportive Information: The patient received 3rd dose of Twinrix, earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Many patients that received their first dose prepandemic and it has been a year or two later that they come in for their second dose.; This case was reported by a physician via sales rep and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (many patients that received their first dose pre-pandemic).   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 social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date:19-MAY-2022 Reporter's Comment: The reporter reported that, many patients that received their first dose pre-pandemic and it had been a year or two later that they came in for their second dose.  He would like to know if there was a hard and fast line in the sand where the series needs to be restarted for Shingrix. No additional information available as this was the information received by the sales representative on the healthcare professional's behalf.  HCP's email was provided in the event of follow up but unable to verify HCP's mailing address.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient who recieved 1st  dose of vaccine in 2018 never get the 2nd dose; 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 of Shingrix in 2018).   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: 19-May-2022 Reporter's comment: Called with the following inquiry in regards of Shingrix. The reporter had a patient who received one dose of vaccine in 2018, did they need to repeat the entire series. When asked for clarification details for patient and vaccination, the reporter stated she had no data available on this. The VARES details were for 1st dose. Consented to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. Note: Vaers details were added to second dose but it was related to first dose.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose in 2020, second on 14-MAY-22; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On 14th May 2022, the patient received the 2nd dose of Shingrix. On 14th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-MAY-2022 Reporters comment: The patient self-reported the case. Received call from agent to transfer caller who reported they received their first dose of Shingrix in 2020 and the second on 14th May 2022. Transfer of consumer was failed and was unable to collect further information.  No further information was available. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: fever of over 100; Aches; Nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, pain and nausea. On an unknown date, the outcome of the fever, pain and nausea were recovered/resolved.   It was unknown if the reporter considered the fever, pain and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine approximately 3 months ago and experienced fever of over 100, aches and nausea. The patient stated that all symptoms had resolved.  The patient did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted Shingrix with sterile water; reconstituted Shingrix with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAY-2022 Reporters comment: This case was reported for an unspecified number of patients.  Pharmacist reported that, one of their clinics might have reconstituted the Shingrix antigen powder reconstituted with sterile water.  An undetermined number of patients might have received this improperly reconstituted doses. The reporter consented to follow up. Additional supportive information: One of clinics might have reconstituted the Shingrix antigen powder reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case had been linked with case US2022058848, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022058848:Same reporter
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on FEB 2021 and received her 2nd dose on 20-MAY-22; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2021).   On 20th May 2022, the patient received the 2nd dose of Shingrix. On 20th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-MAY-2022 Reporters comment: The patient self-reported the case.  The patient called in for information for information on Shingrix.  She received the first dose of Shingrix in February 2021 and second dose on 20th May 2022.  Provided medical advice disclaimer and information per content on alternative dosing schedules. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.