chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 4 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 4 years ago.).   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: 19th July 2022 Reporter's Comments: The pharmacist reported that patient received Shingrix first dose  4 years back. The reporter consented to follow up via email. Additional supportive information: Till the reporting patient did not received second dose which led incomplete course of vaccination.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 29th Oct 2020, 2nd dose 6th May 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose on 29th October 2020).   On 6th May 2022, the patient received the 2nd dose of Shingrix. On 6th 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-Jul-2022 Reporter's comment: The health care professional reported that a patient received 2nd dose later than recommended interval. No other details were available of vaccine. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose later than recommended interval, which led to lengthening of vaccine schedule.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 1st dose 23jun22, 2nd 13jul22; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 13th July 2022, the patient received the 2nd dose of Shingrix. On 13th July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 20-Jul-2022 Reporter's comment: The patient reported that she received 1st dose of Shingrix and to her mistake, she returned to the pharmacy after 2 weeks instead of 2 months to receive her 2nd dose. The patient received the 2nd dose of Shingrix earlier than recommended interval. No other symptoms were reported.  Reviewed dosing schedule as per package insert and provided medical advise disclaimer.  The patient gave permission to follow-up with health care professional. The reporter consented to follow up. Additional supportive information: The patient received the 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccine schedule.
Age: 54.0
Sex: M
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 54-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Jul-2022 Reporter's comment: The nurse reported on the day of reporting that the patient was administered a dose of Havrix, which was already expired. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Pain in extremity, Rash
Clinical narrative: sore arm; felt sick; rash; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On 19th July 2022, less than a month after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the patient experienced pain in arm and feeling unwell. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the pain in arm and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the shingles, pain in arm, feeling unwell and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comments:  The patient reported case for herself.  The patient received 1st dose of Shingrix one month ago from reporting.  She stated that she initially had a sore arm and felt sick. Both symptoms had resolved.  She also stated that she developed a rash a day before reporting which was diagnosed as Shingles on the day of reporting by her dermatologist.  The patient had started Valtrex for her Shingles.  The reporter did not consent to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: half-inch long bump below the injection site; red below the injection site; warm below the injection site; headache; fever; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 18th July 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 19th July 2022, the patient experienced local swelling, localized erythema, skin warm, headache and fever. On an unknown date, the outcome of the injection site pain, local swelling, localized erythema, skin warm, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, local swelling, localized erythema, skin warm, headache and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comment: The reporter was patient. The patient had allergy to ultrasound gel. The patient received second Shingrix dose on arm. That day patient had pain at the injection site. 1 day after receiving Shingrix, the patient noticed a half-inch long, red, warm, bump about 2 inches below the injection site. The patient had a fever and headache on next day after vaccination. On the day of reporting the bump was greater than 1 inch and redness, swelling, warm skin were not recovered. The patient had nothing else to report. Reporter consented to follow up and might follow up with physician.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: half-inch long bump below the injection site; red below the injection site; warm below the injection site; headache; fever; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 18th July 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 19th July 2022, the patient experienced local swelling, localized erythema, skin warm, headache and fever. On an unknown date, the outcome of the injection site pain, local swelling, localized erythema, skin warm, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, local swelling, localized erythema, skin warm, headache and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comment: The reporter was patient. The patient had allergy to ultrasound gel. The patient received second Shingrix dose on arm. That day patient had pain at the injection site. 1 day after receiving Shingrix, the patient noticed a half-inch long, red, warm, bump about 2 inches below the injection site. The patient had a fever and headache on next day after vaccination. On the day of reporting the bump was greater than 1 inch and redness, swelling, warm skin were not recovered. The patient had nothing else to report. Reporter consented to follow up and might follow up with physician.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles twice after I received the Shingrix vaccines/ suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced once before vaccination which was all across the waistband and back and was really bad).   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: 21-Jul-2022 Reporter's comment: The patient self-reported this case. The patient received a dose of Shingrix and experienced shingles twice. The patient stated that the 2 bouts that she had after the Shingrix was not as bad as the first time. The second episode was down at crotch and third episode was between butt cheeks which the patient described as really nasty. The patient wondered if there was any study about people who have shingles after the vaccines. The patient was wailing to participate in a study if they were going to study shingles after the vaccine. The consent to follow up was requested. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't had second shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of 1st dose of Shingrix in left arm intramuscularly on 07th October 2020 with batch number H552g and expiry date 20th September 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-Jul-2022 Reporter's comment: The pharmacist stated that she had a patient that had not the 2nd dose of Shingrix vaccine. The reporter did not consent to follow-up. Additional supportive information: Till the time reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 16.0
Sex: U
Vaccine: MEN
Symptoms: Incorrect route of product administration, Local reaction
Clinical narrative: had a local reaction; gave it SC instead of IM; This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a 16-year-old patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Meningococcal B Vaccine Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine (subcutaneous) and Meningococcal B Vaccine Pre-Filled Syringe Device. On an unknown date, unknown after receiving Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device, the patient experienced local reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the local reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the local reaction to be related to Meningococcal B vaccine and Meningococcal B Vaccine 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: 20-Jul-2022 Reporter's comment: The heath care professional reported they had a patient who was given the Meningococcal B vaccine and had a local reaction, they discovered that the medical assistant accidentally given the vaccine subcutaneously instead of intramuscular route. No additional adverse event available as the reporter was unavailable at time of return call to the office. The reporter consented to follow-up. Additional supportive information: The patient received the Meningococcal B vaccine subcutaneously instead of intramuscular route, which led to intramuscular formulation administered by other route. The suspect was coded as per narrative information and the regarding outcome and outcome date query was raised.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo was reconstituted with  non-GSK sterile diluent; Menveo with wrong diluent administered; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced 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: 21-Jul-2022 Reporter's comment: The nurse reported that a patient was administered Menveo powder after it was reconstituted with a non-GlaxoSmithKline sterile diluent. The reporter stated that the facility's office manager would had the relevant information for the adverse event report. The reporter consented to follow-up via postal.  Additional supportive information: The patient was administered Menveo powder after it was reconstituted with a non-GlaxoSmithKline sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Post herpetic neuralgia
Clinical narrative: she also has PHN; 1st dose of Shingrix on 03 Jul 2021, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 4Y2P4, expiry date 23rd January 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer. Previously administered products included Zostavax and COVID BOOSTER 2021. Concurrent medical conditions included shingles (developed shingles on 25th May 2022).   On 3rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced post herpetic neuralgia and incomplete course of vaccination. On an unknown date, the outcome of the post herpetic neuralgia was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.  Additional Information: GSK Receipt Date: 21-Jul-2022. Reporter's Comments: The case was self-reported by the patient. The patient received 1st dose of Shingrix on right arm. The patient stated that she had not yet had her second dose.  The patient stated the shingles were on the left side of her head, eye, and she also had PHN (post herpetic neuralgia). The reporter consented to follow up with HCP (pharmacy). Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. VAERS details were reported for 1st dose.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on May 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-JUL-2022 Reporter's Comments:  The pharmacist reported that, the patient was not immunocompromised that received Shingrix. During the call, reporter was not asked if he wanted the information stored in GlaxoSmithKline database, but he agreed a follow up with Safety. The reporter consented to follow-up by email.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: Muscle cramps, legs, thighs and hands; This case was reported by a consumer via call center representative and described the occurrence of muscle cramp in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 hrs after receiving Shingrix, the patient experienced muscle cramp. On an unknown date, the outcome of the muscle cramp was not recovered/not resolved.   It was unknown if the reporter considered the muscle cramp to be related to Shingrix.     Additional Information: GSK receipt date: 22-Jul-2022 Reporter comment: The patient self-reported this case. The patient received the first dose of Shingrix a few days ago. The patient reported that about 5 hours after the dose, the patient experienced muscle cramps in the back of legs and thighs, and also cramps in hands. The patient reported that symptoms had not yet resolved.  The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles/Supstected vaccination failure; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 85-year-old male patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis.   On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, unknown after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine.     Additional Information: GSK Receipt Date: 22-JUL-2022. Reporter's Comments: The patient developed shingles after receipt of a shingles vaccine. The reporter was unsure which herpes zoster vaccine the patient received. The reporter had no further details at the time of reporting, regarding date of administration or lot/expiration date. The reporter attempted to ask for consent to contact but pharmacist was rushed off the phone. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 3-NOV-2020, not yet received second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 3rd November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-Jul-2022 Reporter's comment: The patient had not yet received her second dose. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st July 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 21st July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The pharmacist reported that they had a customer (patient) who got Bexsero vaccine one day before the reporting date and after they gave the shot, they realized the vaccine was expired. The reporter did not had date of birth or lot number at time of interaction. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Achiv diluent used instead of Hiberix diluent; Achiv diluent used, administered to 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 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: 22-Jul-2022 Reporter's comment: The health care professional reported that Achiv diluent was used instead of Hiberix diluent and administered to patient.  The exact patient and date of administration unknown at time of call. The reporter consented to follow-up. Additional supportive information: The  Achiv diluent was used instead of Hiberix diluent and administered to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administrated with Infanrix instead of Boostrix; 11 years old received Infanrix; 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 (Infanrix) (batch number 7km94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th July 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 18th July 2022, unknown after receiving Infanrix and Infanrix 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: 22-Jul-2022 Reporter's comment: The health care professional that a patient was administered with Infanrix instead of Boostrix. No adverse event was reported. The reporter consented to follow-up. Additional supportive information: The patient was administered with Infanrix instead of Boostrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the adjuvant portion of the vaccine was administered; only the adjuvant portion of the vaccine was 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 patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA674A, expiry date 31st March 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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: 22-Jul-2022 Reporter's comment: Certified medical assistant stated that they had one vial of the lyophilized component for Menveo left, but not an adjuvant portion, and believe that only the adjuvant portion of the vaccine was administered to a patient.  They had not identified a patient at this time and also did not know when this occurred. The reporter consented to follow-up via postal. Additional supportive information: The patient only received the adjuvant portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: administered a dose after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced 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: 22-Jul-2022 Reporter's comment: Nurse practitioner reported that they administered a dose of Infanrix after a below temperature excursion, the vaccine reached 31.7 Fahrenheit. The reporter consented to follow-up. Additional supportive information: The vaccine was administered after a below temperature excursion, which led to incorrect storage of drug. The case was linked with case US2022110060, reported by same reporter.; Sender's Comments:  US-GSK-US2022110060:Same reporter
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: administered a dose after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB59AA, expiry date 30th September 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 18th July 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: 22-Jul-2022 Reporter's comment: Nurse practitioner reported that they administered a dose of Bexsero after a below temperature excursion, the vaccine reached 31.7 Fahrenheit. The reporter consented to follow-up. Additional supportive information: The vaccine was administered after a below temperature excursion, which led to incorrect storage of drug. The case was linked with case US2022110059, reported by same reporter.; Sender's Comments:  US-GSK-US2022110059:Same reporter
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1st dose on 23Aug2021, forgot and then received again on 13Sep2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 13th September 2021, the patient received the 2nd dose of Shingrix. On 13th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The pharmacist reported that 67 year old male patient received 1st dose of Shingrix series  at a different pharmacy, forgot he received the dose, and then came in to their facility on 13th September 2021 and received another dose.   The reporter did not had lot number / expiration date information for the 1st dose.   At the time of reporting, the patient had not received a repeat dose. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on Feb/22, 2nd on 21/Ju/22; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 21-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose in February 2022).   On 21st July 2022, the patient received the 2nd dose of Engerix B adult. On 21st July 2022, unknown after receiving Engerix B adult, 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: 22-Jul-2022 Reporter's comment: The health care professional called to report that an adult patient received 2nd dose of Engerix B adult later than recommended interval. The reporter consented to follow-up via postal or fax. Additional supportive information: The patient received 2nd dose of Engerix B adult  later than recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: dose was expired; This case was reported by a nurse 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 D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd July 2022, 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: 22-Jul-2022 Reporter's comment: The license practical nurse reported that a patient received a dose of Kinrix on the day of reporting and the dose was already expired. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Kinrix, which led to expired vaccine used.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-b expired, was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HBV (Engerix B) (batch number J7H4D, expiry date 23rd March 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In July 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. In July 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: The health care professional reported that Engerix-B was expired on 23rd March 2022 and was administered over the weekend between 23rd July 2022 and 24th July 2022.  No reactions were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email.  Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Age: 65.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 31-JAN-2022, 2nd dose on 3/22/2022; 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 65-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).   On 22nd March 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 22nd March 2022, unknown after receiving Twinrix and Twinrix 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: 25-Jul-2022 Reporter's comment: The health care professional reported that she had received the 2nd dose of Twinrix later than recommended interval. The patient asked that she will be able to get her 3rd dose now. The reporter consented to follow-up via email. Additional supportive information: The patient received 2nd dose of Twinrix later than recommended interval, which led to lengthening of vaccine schedule.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: exposed to 30F, some doses could have been given; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients 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, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Menveo and Boostrix. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Menveo and Boostrix, 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: 25-Jul-2022 Reporter's comment: The medical assistant reported that Kinrix, Pediarix, Havrix, Engerix-B, Infanrix, Bexsero, Menveo, and Boostrix were exposed to 30 Fahrenheit and some doses had been given to patients after the excursion occurred. This was currently being investigated as of the time of this call and no further details were available.  The reporter consented to follow up from safety. Additional supportive information: The  Kinrix, Pediarix, Havrix, Engerix-B, Infanrix, Bexsero, Menveo, and Boostrix were exposed to 30 Fahrenheit and some doses had been given to patients after the excursion occurred, which led to incorrect storage of drug.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: received a third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old 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.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 25th July 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 25th July 2022, unknown after receiving Bexsero and Bexsero 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: 25-Jul-2022 Reporter's comment: The medical assistant reported a patient received a third dose of Bexsero a month apart from the second dose. The permission for storing personal information was declined.  The reporter contact information was sent by email to Safety. Additional supportive information: The patient received third dose of Bexsero, which led extra dose administered.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old received the Kinrix; 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 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 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: 25-Jul-2022 Reporter's comment: The health care professional reported that a 4 month old patient received the Kinrix. The patient was due for their 2nd dose of Dtap and IPV.  The Vaccine Administration Facility was the same as Primary Reporter. No reactions were reported. The reporter consented to follow up via email.  Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccinated with an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 25th July 2022, the patient received Havrix. On 25th July 2022, 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: 25-Jul-2022 Reporter's comment: The registered pharmacist reported that on day of reporting the patient was vaccinated with an expired dose of Havrix. The reporter consented to follow-up. Additional supportive information: The patient received an expire dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Decreased immune responsiveness, Headache, Illness, Psoriasis, Skin exfoliation
Clinical narrative: PLAQUE PSORIASIS WORSENED; CONFIRMED POSSIBLE DECREASE IN IMMUNE SYSTEM; HEADACHE; SICK; SKIN PEEL; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (5 days before Christmas 2019 patient came down with the most bizarre cold-like thing patient ever had. It had none of the usual things, did not recognize it. It was very bizarre patient lost sense of taste, sense of smell and felt crappy), and spine surgeries (patient had 4 spine surgeries, rebuilt lumbar region due to a serious accident), and concurrent conditions included: plaque psoriasis. 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 for covid-19 prophylaxis. The batch number was not reported and has been requested.  Non-company suspect drugs included: apremilast ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for plaque psoriasis; tretinoin (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for plaque psoriasis; and abrocitinib (form of admin, route of admin, and batch number were not reported) 100 mg, frequency, and therapy dates were not reported for plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced plaque psoriasis worsened, confirmed possible decrease in immune system, headache, sick, and skin peel. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with apremilast, tretinoin, and abrocitinib was not reported. The patient recovered from plaque psoriasis worsened, and the outcome of confirmed possible decrease in immune system, headache, sick and skin peel was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.