chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness; This non-serious case was reported by a nurse via sales rep and described the occurrence of dizziness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis.   On 19-OCT-2023, the patient received Shingrix and COVID 19 VACCINE. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizziness). The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix.     It was unknown if the company considered the dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2023 The patient was over age 65-year-old. The reporter stated that, the patient vaccinated with Shingrix and Covid vaccine around 6 days ago from the date of reporting and patient still experiencing dizziness.  It was unknown if the reporter considered the dizziness to be related to Covid 19 vaccine. No other information provided since vaccine administered at pharmacy. The reporter undecided if it was related to product but requested to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Pyrexia
Clinical narrative: from shoulder to elbow bruise, central part of arm lateral side bruised; Fever; Chills; This non-serious case was reported by a nurse via sales rep and described the occurrence of contusion in a 70-year-old 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 contusion (Verbatim: from shoulder to elbow bruise, central part of arm lateral side bruised), fever (Verbatim: Fever) and chills (Verbatim: Chills). The outcome of the contusion, fever and chills were not reported.   It was unknown if the reporter considered the contusion, fever and chills to be related to Shingrix.     It was unknown if the company considered the contusion, fever and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-OCT-2023 The reporter stated that, after first vaccination of Shingrix, the patient experienced bruise from shoulder to elbow, central part of arm lateral side bruised, fever and chills. The reporter did agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: FLUX, RSV
Symptoms: Injected limb mobility decreased
Clinical narrative: difficulty moving the shoulder; This non-serious case was reported by a physician via sales rep and described the occurrence of mobility decreased in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received Arexvy (intramuscular) and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Arexvy, the patient experienced mobility decreased (Verbatim: difficulty moving the shoulder). The outcome of the mobility decreased was resolved (duration 8 weeks).   It was unknown if the reporter considered the mobility decreased to be related to Arexvy.     It was unknown if the company considered the mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-OCT-2023 A GSK MSL Field Representative reported that a physician stated in his office that 3 female patients (no distinguishing factors provided), all received the Arexvy vaccine, and had difficulty moving the shoulder the vaccine was administered in for 6 to 8 weeks after administration. One of the female patients also received a flu shot (unknown product information) in her other arm at the same time as receiving the Arexvy vaccine, and had no difficulty with mobility in the flu shot arm. The GSK MSL Field Representative did not have any further information about this event, nor any information about lot/expiry or date of administration. The reporter consented to follow up. This case is linked with US2023147931, same reporter.; Sender's Comments:  US-GSK-US2023AMR149219:3rd female patient US-GSK-US2023147931:
Age: 46.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Incomplete course of vaccination; unintentionally given a SHINGRIX instead of a TWINRIX vaccine; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 46-year-old female patient who received Herpes zoster (Shingrix) (batch number Y7PP4, expiry date 07-MAY-2025) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (on an unknown date received 1st dose).   On 30-JUN-2023, the patient received Shingrix (injection, left deltoid). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On 30-JUN-2023, an unknown time after receiving Shingrix and not applicable after receiving Twinrix, the patient experienced wrong vaccine administered (Verbatim: unintentionally given a SHINGRIX instead of a TWINRIX vaccine) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and incomplete course of vaccination 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: 24-OCT-2023 Patient was given a Shingrix instead of Twinrix, it was supposed to be her 2nd dose of Twinrix.  The patient came back in for her third dose of Twinrix and the error was uncovered.  Patient was immunocompetent.  The reporter was a Licensed Practical Nurse who reported that a female patient under 50 years old received a Shingrix vaccine, which led to inappropriate age at vaccine administration. Patient was unintentionally given a Shingrix instead of a Twinrix vaccine, which led to wrong vaccine administration. The patient was late for 2nd dose for 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: did not return for second dose until today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 2nd July 2023, batch no. 2KE55 and expiry date 22nd September 2023).   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: did not return for second dose until today). 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: 24-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist reported that  the patient received 1st dose of Twinrix and did not return for 2nd dose until today (on the day of reporting), which led to incomplete course of vaccination.  The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: patient inadvertently received a dose of expired Twinrix.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 20-OCT-2023, the patient received Twinrix. On 20-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: patient inadvertently received a dose of expired Twinrix.). 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: 24-OCT-2023 The pharmacist reported that the patient inadvertently received a dose of expired Twinrix which led to expired vaccine used. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: inadvertently received a dose of expired Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 20-OCT-2023, the patient received Twinrix. On 20-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: inadvertently received a dose of expired Twinrix). 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: 24-OCT-2023 The pharmacist reported that, the patient inadvertently received a dose of expired Twinrix, which led to an expired vaccine used. The reporter consented to follow up.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: patient received a dose of FluLaval after an excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 35-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 39PF2, expiry date 30-JUN-2024) for prophylaxis.   On 24-OCT-2023, the patient received FluLaval Quadrivalent. On an unknown date, an unknown time after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug (Verbatim: patient received a dose of FluLaval after an excursion). 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: 24-OCT-2023 The pharmacist stated that a patient received a dose of FluLaval after an excursion before GSK was called for a statement of stability.  It was a high of 70 degrees Fahrenheit for 24 hours, first excursion. The vaccine administration facility was the same as primary reporter. The patient received product after temperature excursion, which led to incorrect storage of drug. The reporter consented to follow up.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: 6-year-old patient received a first dose of Kinrix and today was not intended to receive any vaccines but due to a record error received a second dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 24-OCT-2023, the patient received the 2nd dose of Kinrix. On 24-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 6-year-old patient received a first dose of Kinrix and today was not intended to receive any vaccines but due to a record error received a second dose of Kinrix). 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: 24-OCT-2023 The medical assistant called to report in March a 6-year-old patient received a first dose of Kinrix and today was not intended to receive any vaccines but due to a record error received a second dose of Kinrix. The vaccine administration facility was the same as primary reporter. Reporter stated patient was turning 7 years old on May 2024 and after error dose reported had a total of 2 doses of Dtap and IPV. The patient received Kinrix more than the age 6 years, which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received 1st dose 10/10/2024 and 2nd dose 10/24/2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number D99N7, expiry date 29-SEP-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 24-OCT-2023, the patient received the 2nd dose of Shingrix. On 24-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received 1st dose 10/10/2024 and 2nd dose 10/24/2024.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 The health care professional (HCP) reported that the patient received 1st dose and 2nd dose with in a month, which led to shortening of the vaccination schedule .  No reactions reported. The reporter consented to follow up via email
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles behind the right ear; This non-serious case was reported by a physician via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included not immunocompromised.   On 13-OCT-2023, the patient received Shingrix. In OCT-2023, 5 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles behind the right ear). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2023 The physician administered Shingrix and about 5 to 6 days after that male patient developed shingles behind the right ear. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive 2nd dose/ late 2nd dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   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: did not receive 2nd dose/ late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-OCT-2023 The sales representative submitted the query via system for a nurse practitioner. The physician was inquired that if a patient only received the first series of the Shingrix vaccine ad it was been over a year or 2, did the patient need to restart the Shingrix series over. The medical information specialist did not speak with the health care provider. The consented to follow up granted.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 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 male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in March 2023).   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: not received 2nd dose yet). 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: 24-OCT-2023 A pharmacist called to inform that a patient that received the 1st dose of Twinrix in March 2023, had not received the 2nd dose yet. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: RSV
Symptoms: Gait disturbance, Impaired driving ability, Loss of personal independence in daily activities, Neurological symptom, Walking aid user
Clinical narrative: experienced neurologic reaction; patient can not drive; he needs a walker to walk; he needs a walker to walk; This non-serious case was reported by a physician via call center representative and described the occurrence of neurologic reaction in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced neurologic reaction (Verbatim: experienced neurologic reaction), activities of daily living impaired (Verbatim: patient can not drive), walking difficulty (Verbatim: he needs a walker to walk) and walker user (Verbatim: he needs a walker to walk). The outcome of the neurologic reaction, activities of daily living impaired, walking difficulty and walker user were not resolved.   It was unknown if the reporter considered the neurologic reaction, activities of daily living impaired, walking difficulty and walker user to be related to Arexvy.     It was unknown if the company considered the neurologic reaction, activities of daily living impaired, walking difficulty and walker user to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-OCT-2023 The caller was the GlaxoSmithKline representative called to report an AE (adverse event) and she stated HCP (health care professional) reported that a patient received Arexvy and experienced neurologic reaction shortly thereafter.  The patient could not drive and he needed a walker to walk.  No other information provided. The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: only the Arexvy adjuvant was administered; only the Arexvy adjuvant was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 24-OCT-2023, the patient received Arexvy. On 24-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: only the Arexvy adjuvant was administered) and inappropriate dose of vaccine administered (Verbatim: only the Arexvy adjuvant was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-Oct-2023 No other patient details or product details were available as pharmacist was calling from home and was not at pharmacy. The reporter consented to follow-up. The patient only received Arexvy adjuvant one day before the reporting, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: developed widespread hives from head to toe; patient received Engerix B 1st dose many years ago and received the 2nd dose on 30-Aug-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of hives in a 36-year-old male patient who received HBV (Engerix B) (batch number 7B2YL, expiry date 25-FEB-2024) for prophylaxis.   Previously administered products included Engerix B (1st dose received many years ago on an unknown date).   On 30-AUG-2023, the patient received the 2nd dose of Engerix B. On 30-AUG-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: patient received Engerix B 1st dose many years ago and received the 2nd dose on 30-Aug-2023). On an unknown date, the patient experienced hives (Verbatim: developed widespread hives from head to toe). The patient was treated with antihistamine. The outcome of the hives was resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the hives to be related to Engerix B.     It was unknown if the company considered the hives to be related to Engerix B.   Additional Information: GSK Receipt Date: 25-OCT-2023 The pharmacist reported that, a patient received the 2nd dose of Engerix B late, which led to lengthening of the vaccination scheduled. After the 2nd dose, the patient developed widespread hives from head to toe in 2023. The patient took an antihistamine and the hives subsided almost immediately in 2023. The reporter consented to follow-up via email.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient received Bexsero instead of Menveo first dose; 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 12-year-old male patient who received Men B NVS (Bexsero) (batch number KL472, expiry date 30-SEP-2024) for prophylaxis.   On 24-OCT-2023, the patient received the 1st dose of Bexsero. On 24-OCT-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Patient received Bexsero instead of Menveo first dose). 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- 25-OCT-2023 The medical assistant reported that a patient received Bexsero instead of Menveo 1st dose, which led to wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she received first dose of Shingrix on December 2020 and hasn't received the second dose yet; This non-serious case was reported by a consumer 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 1st dose in December 2020).   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 received first dose of Shingrix on December 2020 and hasn't received the second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-OCT-2023 The patient had not received the second dose of Shingrix yet. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: an adult patient received a pediatric dose; Pediatric dose in an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 45-year-old female patient who received HBV (Engerix B) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   On 24-OCT-2023, the patient received the 2nd dose of Engerix B. On 24-OCT-2023, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: an adult patient received a pediatric dose) and adult use of a child product (Verbatim: Pediatric dose in an adult). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date- 25-OCT-2023 A licensed vocational nurse called in to request information about the procedure after an adult patient received a pediatric dose, which led to underdose and adult use of a child product. The reporter provided information about patient, vaccine and event. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus
Clinical narrative: her morning (fasting) blood glucose was increased; This non-serious case was reported by a consumer via call center representative and described the occurrence of blood glucose increased in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included metformin.   On 13-OCT-2023, the patient received Arexvy. On 15-OCT-2023, 2 days after receiving Arexvy, the patient experienced blood glucose increased (Verbatim: her morning (fasting) blood glucose was increased). The outcome of the blood glucose increased was not resolved.   It was unknown if the reporter considered the blood glucose increased to be related to Arexvy.     It was unknown if the company considered the blood glucose increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-OCT-2023 The patient self-reported this case. The patient was a type-2 diabetic previously well-controlled on metformin 500 mg twice a day. The patient received an Arexvy vaccine and 2 days later her morning (fasting) blood glucose was increased. Since then her fasting blood glucose had been 150-165 every morning, her normal fasting blood glucose was 120-130s. Blood glucose returned to normal (110s-120s) every afternoon. The patient consulted her physician who said the increase in blood glucose was an expected metabolic response to vaccination. The physician suggested she increased metformin by 500 mg daily. The patient had not done this and she had a follow up appointment with her doctor in about 6 weeks. Nothing else was reported. The reporter consented to follow up.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a minor child has received vaccine at age 7; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On an unknown date, the patient received Infanrix (right deltoid). On an unknown date, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a minor child has received vaccine at age 7). 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-Oct-2023 A minor patient had received Infanrix vaccine at age 7. It was not reported if patient received any other dose of the Infanrix series. However, the reporter reported that patient's parents were against vaccines due to their beliefs and were not receptive to recommended vaccination schedules.  Transferred to medical information for further guidance.  The reporter consented to follow-up. The patient received a dose of Infanrix vaccine at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased
Clinical narrative: difficulty moving the shoulder; This non-serious case was reported by a physician via sales rep and described the occurrence of mobility decreased in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced mobility decreased (Verbatim: difficulty moving the shoulder). The outcome of the mobility decreased was resolved (duration 8 weeks).   It was unknown if the reporter considered the mobility decreased to be related to Arexvy.     It was unknown if the company considered the mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-OCT-2023 A GSK MSL Field Representative reported that a physician stated in his office that patient (no distinguishing factors provided), received the Arexvy vaccine, and had difficulty moving the shoulder the vaccine was administered in for 6 to 8 weeks after administration. The GSK MSL Field Representative did not have any further information about this event, nor any information about lot/expiry or date of administration. The reporter consented to follow up. This case is linked with US2023AMR152006 and US2023147931, by same reporter.; Sender's Comments:  US-GSK-US2023147931:1st female patient US-GSK-US2023AMR152006:2nd female patient
Sex: U
Vaccine: DTP
Symptoms: Expired product administered
Clinical narrative: The CMA of my office gave to a patient, a child, on October, today,  a 2-3 months expired immunization. I think it expired on June.; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a child patient who received DTP (A or W not known) (DTP (A or W not known)) (expiry date JUN-2023) for prophylaxis.   On 25-OCT-2023, the patient received DTP (A or W not known). On 25-OCT-2023, an unknown time after receiving DTP (A or W not known), the patient experienced expired vaccine used (Verbatim: The CMA of my office gave to a patient, a child, on October, today,  a 2-3 months expired immunization. I think it expired on June.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 25-OCT-2023  A physician reported that a patient, on October, today, a 2-3 months expired immunization.  The reporter think it expired in June, what do you do. The reporter wanted to know do you repeat. HCP reported the vaccine name as "DTT" or "DPT".  MIS asked for clarification several times but unable to confirm brand name of the vaccine.  The patient received an expired dose of vaccine which led to expired vaccine used. The reporter consent to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered an adult dose of Havrix on 09Oct2023.; inadvertently administered an adult dose of Havrix on 09Oct2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-year-old male patient who received HAV (Havrix 1440 adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 09-OCT-2023, the patient received the 2nd dose of Havrix 1440 adult. On 09-OCT-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: inadvertently administered an adult dose of Havrix on 09Oct2023.) and accidental overdose (Verbatim: inadvertently administered an adult dose of Havrix on 09Oct2023). The outcome of the adult product administered to child and accidental overdose 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: 25-OCT-2023 The reporter reported that a child patient was inadvertently administered an adult dose of Havrix. The reporter reported that this was the patient's second dose in the series. The reporter consented to follow up. The reporter reported that a child patient was inadvertently administered an adult dose of Havrix, which led to adult product administered to child and accidental overdose.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: the patient received only the sterile water diluent; Inappropriate dose of vaccine administered; he administered a dose of Priorix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 39-year-old female patient who received MMR (Priorix) for an unknown indication.   On 22-OCT-2023, the patient received the 1st dose of Priorix. On 22-OCT-2023, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: the patient received only the sterile water diluent), inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered) and inappropriate age at vaccine administration (Verbatim: he administered a dose of Priorix). The outcome of the inappropriate preparation of medication, inappropriate dose of 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: 25-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist reported that a patient came in to pharmacy for MMR vaccination and administered with a dose of Priorix, but afterward realized that he did not reconstitute, so the patient only received only the sterile water diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. A 39 year old patient received Priorix, which led to inappropriate age at vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Myalgia
Clinical narrative: The patient was feeling more Myalgia.; Fatigue; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of myalgia in an unspecified number of male patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced myalgia (Verbatim: The patient was feeling more Myalgia.) and fatigue (Verbatim: Fatigue). The outcome of the myalgia and fatigue were unknown.   It was unknown if the reporter considered the myalgia and fatigue to be related to Arexvy.     It was unknown if the company considered the myalgia and fatigue to be related to Arexvy.   Additional Information: GSK receipt date-25-OCT-2023 The Health Field Representative on a GSK vaccine project reported that a pharmacist stated in the pharmacy today (on the day of reporting) that a few patients, all over 60 years of age, reported feeling more fatigue and myalgia than normal after receiving the Arexvy Vaccine. The Health Field Representative did not had any further information about these events, nor any information about lot and expiry, route of administration, date of administration, or any distinguishing factors for the patients. The reporter consent to follow up with the pharmacy vaccination facility was obtained. The case is linked with US2023147947, by same reporter.; Sender's Comments:  US-GSK-US2023147947:2 of 2 report
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Mobility decreased
Clinical narrative: flu like symptoms; bed for over 10 hours; This non-serious case was reported by a consumer via call center representative and described the occurrence of bedridden in a 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, an unknown time after receiving Shingrix, the patient experienced bedridden (Verbatim: bed for over 10 hours) and flu like symptoms (Verbatim: flu like symptoms). The outcome of the bedridden was resolved (duration 10 hrs) and the outcome of the flu like symptoms was unknown.   It was unknown if the reporter considered the bedridden and flu like symptoms to be related to Shingrix.     It was unknown if the company considered the bedridden and flu like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-OCT-2023 The consumer called today reporting that he had his first dose of Shingrix recently and he had flu like symptoms and was in bed for over 10 hours. No further information was known. The reporter did not consent to follow up. The consumer declined to provide any demographic information, consent or physician information.
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Myalgia
Clinical narrative: myalgia; fatigue; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of myalgia in an unspecified number of female patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced myalgia (Verbatim: myalgia) and fatigue (Verbatim: fatigue). The outcome of the myalgia and fatigue were unknown.   It was unknown if the reporter considered the myalgia and fatigue to be related to Arexvy.     It was unknown if the company considered the myalgia and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-OCT-2023 It was reported by Health Field Representative on a GlaxoSmithKline Vaccine that a pharmacist stated in the pharmacy on the day of reporting that a few female patients, all over 60 years of age, reported feeling more fatigue and myalgia than normal after receiving the Arexvy Vaccine. The reporter did not have any further information about these events, nor any information about lot/expiry, route of administration, date of administration, or any distinguishing factors for the patients. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023147946:1 of 2 report
Sex: F
Vaccine: RSV
Symptoms: Intercepted product prescribing error, Product prescribing issue
Clinical narrative: her pregnant daughter was recently prescribed AREXVY by her doctor; This non-serious case was reported by a consumer via call center representative and described the occurrence of intercepted drug prescribing error in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient  did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: her pregnant daughter was recently prescribed AREXVY by her doctor). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 25-OCT-2023 Reporter was the patient's mother. The reporter stated that her pregnant daughter was recently prescribed Arexvy by her doctor, which led to intercepted drug prescribing error. As per prescribing information, Arexvy was only indicated in patients who were 60 years and older. The patient has not received a dose of Arexvy yet. The reporter did not consent to follow-up.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Injection site pain, Product storage error, Swelling
Clinical narrative: pain at injection site; fatigue; swelling; vaccine administered after nonviable temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain at injection site), fatigue (Verbatim: fatigue) and swelling (Verbatim: swelling). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: vaccine administered after nonviable temperature excursion). In OCT-2023, the outcome of the injection site pain, fatigue and swelling were resolved. The outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the injection site pain, fatigue and swelling to be related to Arexvy.     It was unknown if the company considered the injection site pain, fatigue and swelling to be related to Arexvy.   Additional Information: GSK receipt date: 25-OCT-2023 The pharmacist reported that a patient received a dose of Arexvy that was found not viable after temperature excursion, which led to incorrect storage of drug. The patient had experienced swelling, pain at injection site, and fatigue.  The reporter did not know exactly when the symptoms developed or resolved and did not have the lot or expiry date. The symptoms had resolved.  The reporter did not consent to follow-up. The case had been linked to the case US2023147954, reported by the same reporter.; Sender's Comments:  US-GSK-US2023147954:2 of 2 report
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Injection site pain, Product storage error, Swelling
Clinical narrative: pain at injection site; swelling; fatigue; vaccine administered after nonviable temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-OCT-2023, the patient received Arexvy (intramuscular). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain at injection site), swelling (Verbatim: swelling) and fatigue (Verbatim: fatigue). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: vaccine administered after nonviable temperature excursion). In OCT-2023, the outcome of the injection site pain, swelling and fatigue were resolved. The outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the injection site pain, swelling and fatigue to be related to Arexvy.     It was unknown if the company considered the injection site pain, swelling and fatigue to be related to Arexvy.   Additional Information: GSK receipt date: 25-OCT-2023 The pharmacist reported that a patient received a dose of Arexvy that was found not viable after temperature excursion, which led to incorrect storage of drug. The patient had experienced swelling, pain at injection site, and fatigue.  The reporter did not know exactly when the symptoms developed or resolved and did not have the lot or expiry date. The symptoms had resolved.  The reporter did not consent to follow-up. The case had been linked to the case US2023147952, reported by the same reporter.; Sender's Comments:  US-GSK-US2023147952:1 of 2 report
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Fluarix was exposed to 31 Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 554NM, expiry date 30-JUN-2024) for prophylaxis.   On 21-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced incorrect product storage (Verbatim: Fluarix was exposed to 31 Fahrenheit). The outcome of the incorrect product storage 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-OCT-2023 The reporter stated that Fluarix was exposed to 31 Fahrenheit and administered to at least 60 patients as they had a flu vaccine clinic which led to incorrect product storage. The reporter consented to follow up via postal. The vaccine administration facility was the same as primary reporter. The reporter did not have any patient demographics at the time of reporting.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: unavailable to get the third dose for about two weeks.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received 1st dose on unknown date) and Engerix b (received 2nd dose on unknown date).   On an unknown date, the patient did not received the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: unavailable to get the third dose for about two weeks.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 25 Oct 2023 A pharmacist reported that a patient who had received the first and the second dose of Engerix-B. Today was the sixth month after the first dose. However, the patient would be unavailable to get the third dose for about two weeks, which led to incomplete course of vaccination. The HCP asked what the max interval between the second and third dose is in order to not re-start the series.