chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received today an expired dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 82-year-old female patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 27-JAN-2025, the patient received Havrix. On 27-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient received today an expired dose of Havrix). 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: 27-JAN-2025 Other HCP reported that a patient received an expired dose of Havrix, which led to expired vaccine used. The vaccine expired on 13th December, 2024. The HCP asked if the dose is considered valid.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she had not received her second dose; This non-serious case was reported by a consumer 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 (patient received her first dose of Shingrix before the Covid-19 pandemic).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she had not received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-JAN-2025 Reporter was the patient who received her first dose of Shingrix before the Covid 19 pandemic. She has not received her second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: pt got 1st shot 3 years ago; This non-serious case was reported by a other health professional 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 (patient got 1st shot 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: pt got 1st shot 3 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-JAN-2025 HCP reported that a patient got 1st shot 3 years ago. Also asked if they need to restart or finish up with 2nd dose. Till the time of reporting patient did not receive 2nd dose of shingrix which led to incomplete course of vaccination.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the first dose was administered on June 28th 2024 and the 2nd dose on December 4th 2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 35-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (Received 1st dose on 28 June 2024).   On 04-DEC-2024, the patient received the 2nd dose of Engerix B. On 04-DEC-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: the first dose was administered on June 28th 2024 and the 2nd dose on December 4th 2024.). 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: 30-JAN-2025 The reporter reported that a patient that came to receive the 3 dose of Engerix B, the first dose was administered on 28 June 2024 and the 2nd dose on 4 December 2024 which led to drug dose administration interval too long. The reporter want to know when the 3rd dose should be administered.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain on injection site/patient that experienced a lot of pain in the deltoid muscle; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain on injection site/patient that experienced a lot of pain in the deltoid muscle). The outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK receipt date: 06-FEB-2025 The registered Nurse reported that they had a patient that experienced a lot of pain in the deltoid muscle. The reporter had a question can they administer the vaccine in the ventral gluteal area. No vaccination date, vaccine detail or patient demographics were provided from the registered nurse.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received a second dose yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 38-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received 1st dose of vaccine in 2016).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: has not received a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-FEB-2025 Reporter called to report in 2016 a patient received a first dose of Engerix-B and has not received a second dose yet. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric dose of Engerix-B was administered to adult patient; Accidental underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 43-year-old female patient who received HBV (Engerix B pediatric) (batch number K4JHJ) for prophylaxis.   On 06-FEB-2025, the patient received Engerix B pediatric. On 06-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose of Engerix-B was administered to adult patient) and accidental underdose (Verbatim: Accidental underdose). The outcome of the adult use of a child product and accidental underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-FEB-2025 The reporter called to report that they accidentally administered a pediatric dose of Engerix-B to a female adult patient who is 43 years old which led to adult use of child product and underdose.  The reporter enquired does the patient needs another dose for 20 years and older
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: patient had a negative titer test; This non-serious case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a adolescent male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced therapy non-responder (Verbatim: patient had a negative titer test). The outcome of the therapy non-responder was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-FEB-2025 The patient had a negative titer test, so the physician asked us what was the appropriate booster volume dose for Engerix-B. During the call the health care professional informed that the patient complete their Engerix-B vaccine scheme as a child, but due to the titer negative test, they were looking for the appropriate Engerix-B booster volume dose.  Health care professional mentioned that the patient had the titer test in 02-Oct-2024. We report this as an adverse event because the patient had a titer negative test, so can consider this as vaccine failure.
Age: 11.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 1st Infanrix dose when she was 19 months and 29 days; 11-year-old a Dtap, the Infanrix, she should have gotten the Boostrix; This non-serious case was reported by a nurse 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 M52GG, expiry date 07-SEP-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 06-FEB-2025, the patient received Infanrix. On an unknown date, the patient received the 1st dose of Infanrix and Boostrix. On 06-FEB-2025, an unknown time after receiving Infanrix and not applicable after receiving Infanrix and Boostrix, the patient experienced wrong vaccine administered (Verbatim: 11-year-old a Dtap, the Infanrix, she should have gotten the Boostrix). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: 1st Infanrix dose when she was 19 months and 29 days). 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: 07-FEB-2025 The health care professional mentioned that the patient received the 1st Infanrix dose when she was 19 months and 29 days, which led inappropriate age at vaccine administration. The nurse reported the patient received Dtap, the Infanrix, she should have gotten the Boostrix the Tdap, which led wrong vaccine administered. The reporter needs to know if she needs to be revaccinated or what recommendations. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Felt Horrible; This non-serious case was reported by a consumer via call center representative and described the occurrence of feels awful in a elderly 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, an unknown time after receiving Shingrix, the patient experienced feels awful (Verbatim: Felt Horrible). The outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.     It was unknown if the company considered the feels awful to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-FEB-2025 This case was reported by patient itself.  The patient felt horrible after receiving Shingrix.  The patient could not elaborate on what she experienced as she could not remember but remembers only that she felt horrible.  The patient could not remember when the first dose was given, but was schedule for the second dose on this day (07-February-2025).
Sex: U
Vaccine: RSV, VARZOS
Symptoms: Product preparation error
Clinical narrative: Arexvy reconstituted with a different diluent; Shingrix reconstituted with a different diluent; This non-serious 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 RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Arexvy and Shingrix. On an unknown date, an unknown time after receiving Arexvy and not applicable after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Arexvy reconstituted with a different diluent) and wrong solution used in drug reconstitution (Verbatim: Shingrix reconstituted with a different diluent). The outcome of the wrong solution used in drug reconstitution and wrong solution used in drug reconstitution were unknown.   Additional Information: GSK Receipt Date: 07-FEB-2025 Nurse reported that she realized that her staff has been using other diluents to reconstitute Shingrix and Arexvy vaccines, probably sterile water, which led wrong solution used in drug reconstitution.  At the moment of the call, there was no patient information available.  The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who received her first dose of Shingrix in November 2023 and second dose in December 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in November 2023).   In DEC-2024, the patient received the 2nd dose of Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient who received her first dose of Shingrix in November 2023 and second dose in December 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 12-FEB-2025 The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patients received only adjuvant; patients received only adjuvant; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patients received only adjuvant) and inappropriate dose of vaccine administered (Verbatim: patients received only adjuvant ). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-FEB-2025 Reporter stated that 3 doses of Shingrix were given in office without being reconstituted and wanted to know how to get adjuvant for their remaining 3 vials of Shingrix. The 3 patients received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Injection site reaction, Muscle twitching, Paraesthesia
Clinical narrative: Following immunization, my arm was more sore than usual than with other immunizations, I felt very light headed, and then a few days later started getting tingling in my feet and hands as well as muscle twitching at the site of injection as well as throughout my lower extremities.  I plan to go see my provider.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received only first dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (patient received the first dose of Twinrix on October 9, 2017 with batch no. L5SH5).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received only first dose of Twinrix). 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: 21-JAN-2025 Other HCP reported that a 46 years old male patient received the first dose of Twinrix on October 9th, 2017. Reporter asked if the patient need to start over the series. Till the time of reporting patient did not receive 2nd dose of Twinrix which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea
Clinical narrative: Chills; Nausea; Headache; This non-serious case was reported by a physician via call center representative and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Chills), nausea (Verbatim: Nausea) and headache (Verbatim: Headache). The outcome of the chills, nausea and headache were unknown.   It was unknown if the reporter considered the chills, nausea and headache to be related to Shingrix.     It was unknown if the company considered the chills, nausea and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JAN-2025 The reporter reported that the patient had adverse reactions to 1st dose of Shingrix and the symptoms included headache, nausea, and chills and wanted to knew if patient should be given the second dose
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: the patient had not received the 2nd dose yet.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020 batch number 5SB37 and expiry date 19-jun-22).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: the patient had not received the 2nd dose yet.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-FEB-2025 The patient received one dose of Shingrix. VAERS details reported for 1st dose of Shingrix. The reporter asked question did they need to restart it? Reporter mentioned that at the time of reporting, the patient had not received the 2nd dose yet, which led incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: my arm is still sore; itchy; red pattern; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: my arm is still sore), itchy upper limbs (Verbatim: itchy) and erythema (Verbatim: red pattern). The outcome of the pain in arm, itchy upper limbs and erythema were not resolved.   It was unknown if the reporter considered the pain in arm, itchy upper limbs and erythema to be related to Shingrix.     It was unknown if the company considered the pain in arm, itchy upper limbs and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JAN-2025 Reporter reported that he/she could not believed his/her arm was still sore and itchy after shingles vaccination.  It had been 12 days now.  It was not swollen but he/she could see the red pattern when he/she came out of the shower.
Sex: U
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: My white blood count is elevated; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of white blood cell count increased 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, an unknown time after receiving Shingles vaccine, the patient experienced white blood cell count increased (Verbatim: My white blood count is elevated). The outcome of the white blood cell count increased was not reported.   It was unknown if the reporter considered the white blood cell count increased to be related to Shingles vaccine.     It was unknown if the company considered the white blood cell count increased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-FEB-2025 This case was reported by a patient via interactive digital media. The patient  just got first dose shingles vaccine and had a blood test done and white blood count was elevated.  The reporter wanted to ask if the vaccine could cause this or not.
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: a patient received an extra MemB (Bexsero); This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 20-NOV-2027) for prophylaxis.   Previously administered products included Bexsero (received 1st dose of Bexsero vaccine on 15-MAR-2023) and Bexsero (received 2nd dose of Bexsero vaccine on 18-APR-2023).   On 08-JAN-2025, the patient received the 3rd dose of Bexsero. On 08-JAN-2025, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: a patient received an extra MemB (Bexsero)). 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: 21-JAN-2025 The reporter reported that a patient received an extra dose of Bexsero vaccine, which led to extra dose administered. The Vaccine Administration Facility is the same as Primary Reporter. The 1st dose was received on 15-Mar-2023, 2nd dose was received on 18-Apr-2023 and 3rd dose was received on 08-Jan-2025.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Wrong Vaccine Administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Engerix B (received a dose of Engerix B vaccine on 02-SEP-2024).   On 06-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not receive Pediarix. On 06-JAN-2025, an unknown time after receiving Kinrix and Pediarix, the patient experienced wrong vaccine administered (Verbatim: Wrong Vaccine Administered). 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: 21-JAN-2025 The Healthcare professional reported that a 4 month old patient was administered Kinrix instead of Pediarix on January 6, 2025, which led to wrong vaccine administered. The patient was administered Engerix-B at birth.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: She experienced itchiness; redness; burning on the left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (received 1st dose of shingrix on an unknown date).   In JAN-2025, the patient received the 2nd dose of Shingrix (left arm). In JAN-2025, 24 hrs after receiving Shingrix, the patient experienced pruritus (Verbatim: She experienced itchiness), erythema (Verbatim: redness) and burning sensation (Verbatim: burning on the left arm). The patient was treated with acrivastine (Benadryl). (Dechallenge was positive). Rechallenge with Shingrix was positive. The outcome of the pruritus was resolved and the outcome of the erythema and burning sensation were not resolved.   It was unknown if the reporter considered the pruritus, erythema and burning sensation to be related to Shingrix.     It was unknown if the company considered the pruritus, erythema and burning sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JAN-2025 Reporter was the patient who received her second dose of SHINGRIX about 2 and a half days ago.  She experienced itchiness, redness, and burning on the left arm.  Patient received the dose on her left arm as well.  The itching started about 24 hours after the dose and had resolved.  The redness started within 48 hours and was still present.  It was about 5 inches by 1 inches long.  She took one dose of Benadryl last night.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Wrong administration route; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate route of vaccination in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On 16-JAN-2025, the patient received Rotarix lyophilized formulation. On 16-JAN-2025, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination (Verbatim: Wrong administration route). The outcome of the inappropriate route 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: 21-JAN-2025 A medical assistant called and reported that they gave out a Rotarix lyophilized to a 2 month old baby, instead of an oral administration, they injected the medication which led to inappropriate route of vaccination. It was given in the left thigh, instead of oral. The vaccine administration facility is the same as primary reporter. During the call, the healthcare professional did not provide any lot number nor expiry date, however, she said that this was the Rotarix lyophilized version.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got second dose prior to the recommended six months; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 5-year-old male patient who received HAV (Havrix) (batch number DN273, expiry date 28-AUG-2026) for prophylaxis.   Previously administered products included Havrix (recived 1st dose on 29-JUL-2024 with batch number: LM99N and expiry date: 04-MAR-2026).   On 17-JAN-2025, the patient received the 2nd dose of Havrix. On 17-JAN-2025, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: got second dose prior to the recommended six months). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 21-JAN-2025 The licensed practitioner nurse reported that they administered to a Havrix vaccine, then 4 years old child, who was now 5 years old, roughly 10 days prior to the six months, prior to the recommended six months. The reporter had a question for second dose, and she just wanted to know was that an issue and did the patient need to be revaccinated. The patient received 2nd dose of Havrix vaccine earlier than the recommended interval, which led to shortening of the vaccination scheduled.
Age: 0.17
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Flulaval to a 2 month old baby; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number AE2J7, expiry date 16-JUN-2025) for prophylaxis.   On 20-JAN-2025, the patient received FluLaval 2024-2025 season. On 20-JAN-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Flulaval to a 2 month old baby). 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: 21-JAN-2025 A nurse called to report the administration of Flulaval to a 2 month old patient which led inappropriate age at vaccine administration.  The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Cancer surgery
Clinical narrative: just have surgery to remove cancer; This serious case was reported by a pharmacist via call center representative and described the occurrence of cancer surgery in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On 18-SEP-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cancer surgery (Verbatim: just have surgery to remove cancer) (serious criteria clinically significant/intervention required). The outcome of the cancer surgery was not reported.   It was unknown if the reporter considered the cancer surgery to be related to Arexvy.     The company considered the cancer surgery to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 03-FEB-2025 The registered pharmacist reported that they had a patient that was severely immunocompromised on radiation and chemotherapy and just had surgery to remove cancer and had her 1st dose for Arexvy back in 2023.  The reporter asked could she get another dose and stated that she was not sure that at the moment of the 1st dose if the patient was already immunocompromised  The reporter requested for the information to see if the patient was eligible for a 2nd dose. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: Cancer surgery is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: U
Vaccine: VARZOS
Symptoms: Mycobacterium avium complex infection
Clinical narrative: she has been just diagnosed with MAC; This serious case was reported by a pharmacist via call center representative and described the occurrence of mycobacterium avium complex infection in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced mycobacterium avium complex infection (Verbatim: she has been just diagnosed with MAC) (serious criteria GSK medically significant). The patient was treated with rifampin and ethambutol. The outcome of the mycobacterium avium complex infection was unknown.   It was unknown if the reporter considered the mycobacterium avium complex infection to be related to Shingrix.     It was unknown if the company considered the mycobacterium avium complex infection to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-FEB-2025 The reporter had a patient who wanted to take Shingrix but had just been diagnosed with mycobacterium avium complex infection and was on rifampin and ethambutol.  They didn't know if it was a good idea since this had just started. This was to be the second dose. She had received the first dose in October 2024. During the chat, the HCP asked if it was possible to administer the second Shingrix dose to the patient. The HCP mentioned that the first dose was in October 2024 but did not specify the date. They set this as 01-Oct-2024 because the system does not allow setting only the month and year.; Sender's Comments: Mycobacterium avium complex infection is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received his second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on an unknown date).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received his second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-FEB-2025 The primary reporter was the Health Care Professional (pharmacist) who stated that a patient received his first dose of shingrix vaccine more than 6 months ago and never received his second dose, which led to incomplete course of vaccination. This case is linked with US2025015904 reported by the same reporter.; Sender's Comments:  US-GSK-US2025015904:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration before the recommended age for a booster; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 4293K, expiry date 31-JUL-2025) for prophylaxis.   Previously administered products included Menveo (received 1st dose on an unknown date).   On 08-AUG-2024, the patient received the 2nd dose of Menveo. On 08-AUG-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration before the recommended age for a booster). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 11-FEB-2025 A registered nurse contacted GSK to request data about the administration of a second dose of Menveo to a 12 year old male patient which took place on 8th August 2024, months after the initial dose which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: DTAP, DTAPIPV, HIBV, MNQ, RV1
Symptoms: Product storage error
Clinical narrative: RN requests stability data for Menveo (1-vial), Kinrix, Infanrix, Hiberix, Rotarix (liq) stored; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, Hib (Hiberix) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis.   On an unknown date, the patient received Menveo, Kinrix, Infanrix, Hiberix and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Menveo, Kinrix, Infanrix, Hiberix and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: RN requests stability data for Menveo (1-vial), Kinrix, Infanrix, Hiberix, Rotarix (liq) stored). 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: 11-FEB-2025 The register nurse requested stability data for Menveo (1-vial), Kinrix, Infanrix, Hiberix, Rotarix (liq) stored at negative 17 degree Fahrenheit for 30 days which led to incorrect storage of drug. The vaccines had been used in patients during this time as they were not frozen. The patient data was not available at time of call.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: administration of the diluent portion only of Menveo (2-vial) vaccine; administration of the diluent portion only of Menveo (2-vial) vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXB056A, expiry date 31-DEC-2026) for prophylaxis.   On 12-FEB-2025, the patient received Menveo. On 12-FEB-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administration of the diluent portion only of Menveo (2-vial) vaccine) and inappropriate dose of vaccine administered (Verbatim: administration of the diluent portion only of Menveo (2-vial) vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-FEB-2025 The health care professional reported that the inadvertent administration of the diluent portion only of Menveo (2-vial) vaccine to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received an extra 3rd dose of Shingrix by accident back on February 8th 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number YZ9CY) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28-FEB-2022 with batch number TM449) and Shingrix (received 2nd dose on 29-APR-2022 with batch number 445XD).   On 08-FEB-2025, the patient received the 3rd dose of Shingrix. On 08-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient received an extra 3rd dose of Shingrix by accident back on February 8th 2025). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 13-FEB-2025 The pharmacist mentioned that a patient received an extra 3rd dose of Shingrix by accident back on 8th February 2025 which led to extra dose administration. The patient received 2 prior Shingrix doses on 29th April 2022 and 28th February 2022. Expiration dates were unknown by reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose; This non-serious 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30-MAY-2023).   On 07-DEC-2024, the patient received the 2nd dose of Shingrix. On 07-DEC-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-FEB-2025 The health care professional reported that a patient that was came in for their second dose of shingrix.  No further details were obtained from the chatter, only what is shown here in this report. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: the lowest temperature the vaccine reached was thirty-four point six degrees Fahrenheit.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: the lowest temperature the vaccine reached was thirty-four point six degrees Fahrenheit.). 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: 13-FEB-2025 The reporter reported that Boostrix vaccine was administered to a patient and afterwards they realized the lowest storage temperature of this vaccine was thirty-five point four degrees Fahrenheit.  Afterwards during the same call, Nurse Practitioner confirmed the lowest temperature the vaccine reached was thirty-four point six degrees Fahrenheit, which led to incorrect storage of drug.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Patient administered Bexsero/Improper Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number FH443, expiry date 30-SEP-2027) for prophylaxis.   On 21-JAN-2025, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Patient administered Bexsero/Improper Storage Error). 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: 13-FEB-2025 The reporter requested a stability data on Bexsero, Havrix, Kinrix, Infanrix, Engerix-B, Rotarix (liq) stored at 1st on 07th January 2025 at 46,7 Fahrenheit in to 30 mins and 2nd on 21st January 2025 at 49.4 Fahrenheit in to 2hrs 30mins. The reporter mentioned that the patient administered Bexsero vaccine which led to, incorrect storage of drug.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Exposure during pregnancy, Swelling
Clinical narrative: pregnant women recived Boostrix vaccine; mentioned that they began to present swelling that exceeded the 50 mm; mentioned that they began to present redness that exceeded the 50 mm; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC, expiry date 19-MAR-2027) for prophylaxis.   On 11-FEB-2025, the patient received Boostrix. On 11-FEB-2025, less than a day after receiving Boostrix, the patient experienced erythema (Verbatim: mentioned that they began to present redness that exceeded the 50 mm). On 12-FEB-2025, the patient experienced swelling (Verbatim: mentioned that they began to present swelling that exceeded the 50 mm). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant women recived Boostrix vaccine). The outcome of the erythema, swelling and vaccine exposure during pregnancy were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the erythema and swelling to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   Pregnancy exposure: Gestation time at first exposure (Boostrix): 36 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Estimated Delivery/Due date: 27-FEB-2025 Pregnancy Outcome: Pregnancy was ongoing   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-FEB-2025 The pharmacist contacted GlaxoSmithKline to request data on how long grade 3 swelling and redness lasted before they resolved, mentioning that a patient 36 weeks pregnant received a dose of Boostrix. However, they mentioned that they began to present swelling and redness that "exceeded the 50 mm" described in the prescribing information. They wished to know if they had data on how long it took for the symptoms to resolve.   The Vaccine Administration Facility is the same as Primary Reporter.