chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Infanrix booster dose to 12 month old patient; 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 12-month-old male patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB VACCINE).   On 28-AUG-2023, the patient received Infanrix. On 28-AUG-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix booster dose to 12 month old patient).  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: 28-AUG-2023 A medical assistant called to inform that earlier that day, a 12-month-old received a dose of Infanrix. Such dose was supposed to be administered in November. Which led to Inappropriate age at vaccine administration.  Also, the reported said that it was administered along with ACTHib vaccine. The reporter did not consent to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Myalgia, Paraesthesia
Clinical narrative: The patient received the second dose of SHINGRIX on August 18, 2023 (AE - Inappropriate schedule of vaccine).; pins and needle sensation in the right leg.; the patient has been experiencing itching in the right leg; Muscle soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pins and needles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included clot blood (left foot) and intervertebral disc protrusion. Previously administered products included Zyrtec. Concurrent medical conditions included shellfish allergy. Additional patient notes included Undefined procedure to improve blood flow. Concomitant products included COVID-19 VACCINE (COVID 19 BOOSTER), VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX), hydrocodone and neosporin (nos) (Neosporin).   On 18-AUG-2023, the patient received the 2nd dose of Shingrix (right arm). In AUG-2023, an unknown time after receiving Shingrix, the patient experienced pins and needles (Verbatim: pins and needle sensation in the right leg.), itchy legs (Verbatim: the patient has been experiencing itching in the right leg) and muscle soreness (Verbatim: Muscle soreness). On 18-AUG-2023, the patient experienced drug dose administration interval too short (Verbatim: The patient received the second dose of SHINGRIX on August 18, 2023 (AE - Inappropriate schedule of vaccine).).  The patient was treated with gabapentin. The outcome of the pins and needles, itchy legs and muscle soreness were not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pins and needles, itchy legs and muscle soreness to be related to Shingrix.     It was unknown if the company considered the pins and needles, itchy legs and muscle soreness to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter was the patient.  The patient has been using Neosporin, Hydrocortisone, Gold Bond Powder, washing with Ivory Soap (3-4 times daily). The patient received the first dose of Shingrix on June 23, 2023.  The patient also received another shot at the same time, which the patient believes to be a COVID booster.  The patient received the second dose of Shingrix on 18th August 2023, which led to shortening of vaccinations schedule. The patient states the Shingrix vaccine was administered in the right shoulder on both dates.  It is unclear which site the COVID vaccine was administered.   Since receiving the second dose of Shingrix, the patient had been experiencing itching, muscle soreness, and a pins and needle sensation in the right leg.  The patient was prescribed gabapentin for the symptoms.   The patient gave consent to follow up with HCP (pharmacy).
Age: 72.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Third dose Aug 26th 2023; 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 72-year-old male patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 26-AUG-2023, the patient received the 3rd dose of Twinrix. On 26-AUG-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: Third dose Aug 26th 2023).  The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-AUG-2023 Pharmacist had a patient who received Twinrix third dose 10 days after the second dose. There had been none side effects reported. The reporter consented to follow up via email. The patient received the 3rd dose of Twinrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received Kinrix instead of Boostrix.; inappropriate age at vaccine administration; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 51-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 24-AUG-2023, the patient received Kinrix. On 24-AUG-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: patient received Kinrix instead of Boostrix.) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration).  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 28 Aug 2023: The nurse informed that a 51 years old patient received Kinrix instead of Boostrix.  No side effects reported in the email. The consent to contact reporter was not provided in the email.  51 years old patient received Kinrix instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 18-month-old patient that was supposed to receive Infanrix, received Pediarix instead; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 473YA, expiry date 04-APR-2025) for prophylaxis.   On 28-AUG-2023, the patient received Pediarix. On 28-AUG-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: 18-month-old patient that was supposed to receive Infanrix, received Pediarix instead).  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: 28 Aug 2023. A nurse called to inform that earlier that day, an 18-month-old patient that was supposed to receive Infanrix, received Pediarix instead, which led to wrong vaccine administered.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration
Clinical narrative: given to a customer subcutaneously instead of intermuscular; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GX45D) for prophylaxis.   On an unknown date, the patient received Arexvy (subcutaneous, left deltoid). On an unknown date, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: given to a customer subcutaneously instead of intermuscular).The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2023 The reporter reported that an Arexvy vaccine was given to a customer subcutaneously instead of intermuscular, which led to intramuscular formulation administered by other route. The reporter called for guidance from medical information. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Somnolence
Clinical narrative: Extreme Fatigue; Fever; deep intense muscle pain all over her body; Headache; Slept for 2 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7) for prophylaxis.   On 22-AUG-2023, the patient received Boostrix (intramuscular, left deltoid). On 22-AUG-2023, an unknown time after receiving Boostrix, the patient experienced headache (Verbatim: Headache). On 23-AUG-2023, the patient experienced fatigue (Verbatim: Extreme Fatigue), fever (Verbatim: Fever), muscle pain (Verbatim: deep intense muscle pain all over her body) and sleepiness (Verbatim: Slept for 2 days).  On 23-AUG-2023, the outcome of the fever and headache were resolved.  On 27-AUG-2023, the outcome of the fatigue and muscle pain were resolved (duration 4 days). The outcome of the sleepiness was resolved (duration 2 days).   It was unknown if the reporter considered the fatigue, fever, headache, muscle pain and sleepiness to be related to Boostrix.     It was unknown if the company considered the fatigue, fever, headache, muscle pain and sleepiness to be related to Boostrix.   Additional Information: GSK Receipt Date: 29-AUG-2023 The patient was self-reported this case. The reporter reported that she received Boostrix Vaccine. On the evening of the 23rd August 2023 patient experienced headache that lasted through the night and also had a fever as high as 100 degrees Fahrenheit, event was resolved.  On 23rd August 2023 patient started with deep intense muscle pain all over her body and also she experienced extreme fatigue and slept for 2 days.  The reporter stated that all events resolved.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: patient recieved an expired dose of shingrix on Aug 29th 2023 and it was expired on 8/28/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received Herpes zoster (Shingrix) (expiry date 28-AUG-2023) for prophylaxis.   On 29-AUG-2023, the patient received the 2nd dose of Shingrix. On 29-AUG-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: patient recieved an expired dose of shingrix on Aug 29th 2023 and it was expired on 8/28/2023).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 29-Aug-2023 The reporter consented to follow-up. The patient received an expire dose of Shingrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Incomplete course of vaccination, Influenza like illness, Lethargy, Pruritus
Clinical narrative: the itching sensation lasts for a minimum of 3-4 days; patient has not yet received the second dose; Lethargy; Chills; Fever; Flu-like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm) and the 2nd dose of Shingrix. On an unknown date, 1 month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pruritus (Verbatim: the itching sensation lasts for a minimum of 3-4 days), lethargy (Verbatim: Lethargy), chills (Verbatim: Chills), fever (Verbatim: Fever), influenza-like symptoms (Verbatim: Flu-like symptoms) and incomplete course of vaccination (Verbatim: patient has not yet received the second dose).  The outcome of the pruritus was not resolved and the outcome of the lethargy, chills, fever and influenza-like symptoms were resolved (duration 3 days) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pruritus, lethargy, chills, fever and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the pruritus, lethargy, chills, fever and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt date: 29-AUG-2023 The patient reported that he received the first dose of Shingrix about 1 year ago from reporting.  The patient had not yet received the second dose and after receiving the first dose of Shingrix, the patient experienced flu like symptoms, fever, chills, and lethargy which last about 2 - 3 days.  About 1 month after receiving Shingrix, the patient experiences itching sensations on the back, in the area of the right shoulder blade.  This itching sensation comes and goes, with an interval of a few weeks, and the itching sensation lasts for a minimum of 3-4 days.  Till the time of reporting, the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. This case was linked with case US2023118062 same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023118062:1st report
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: the itching sensation lasts for a minimum of 3-4 days; patient has not yet received the second dose; Lethargy; Chills; Fever; Flu-like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm) and the 2nd dose of Shingrix. On an unknown date, 1 month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pruritus (Verbatim: the itching sensation lasts for a minimum of 3-4 days), lethargy (Verbatim: Lethargy), chills (Verbatim: Chills), fever (Verbatim: Fever), influenza-like symptoms (Verbatim: Flu-like symptoms) and incomplete course of vaccination (Verbatim: patient has not yet received the second dose).  The outcome of the pruritus was not resolved and the outcome of the lethargy, chills, fever and influenza-like symptoms were resolved (duration 3 days) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pruritus, lethargy, chills, fever and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the pruritus, lethargy, chills, fever and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt date: 29-AUG-2023 The patient reported that he received the first dose of Shingrix about 1 year ago from reporting.  The patient had not yet received the second dose and after receiving the first dose of Shingrix, the patient experienced flu like symptoms, fever, chills, and lethargy which last about 2 - 3 days.  About 1 month after receiving Shingrix, the patient experiences itching sensations on the back, in the area of the right shoulder blade.  This itching sensation comes and goes, with an interval of a few weeks, and the itching sensation lasts for a minimum of 3-4 days.  Till the time of reporting, the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. This case was linked with case US2023118062 same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023118062:1st report
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: an early second dose of Shingrix was administered to a patient; 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 58-year-old male patient who received Herpes zoster (Shingrix) (batch number LC757, expiry date 21-AUG-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 29-AUG-2023, the patient received the 2nd dose of Shingrix. On 29-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: an early second dose of Shingrix was administered to a patient).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 29-AUG-2023 The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up via email.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid CWY component of Menveo; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via sales rep 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 AMVA957A, expiry date 30-SEP-2024) for prophylaxis.   On 29-AUG-2023, the patient received Menveo. On 29-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received only the liquid CWY component of Menveo) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 30-Aug-2023 The patient had been given only the grey top vial (Liquid Conjugate Component) of Menveo. A nurse reported that a patient received only the liquid CWY component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health acre professional (HCP) consented to follow up via email; Sender's Comments:  US-GSK-US2023118684:same reporter US-GSK-US2023118682:same reporter US-GSK-US2023118666:same reporter US-GSK-US2023118665:same reporter
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect route of product administration
Clinical narrative: he received the Arexvy Vaccine, as a SC injection by his pharmacist, instead of an IM injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 77-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-AUG-2023, the patient received Arexvy (subcutaneous). On 27-AUG-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: he received the Arexvy Vaccine, as a SC injection by his pharmacist, instead of an IM injection).  The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 30-Aug-2023 The reporter was the wife of the patient. The reporter had no further information available about this event. Consent to follow up with health care professional was not asked as the patient was not there. This is report 2 of 2 reported by same reporter.  The patient received Arexvy vaccine 3 pm as a subcutaneous injection by his pharmacist, instead of an intramuscular injection, which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GSK-US2023118662:1st report
Sex: U
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: Patient possibly received only the diluent component of Priorix; Patient possibly received only the diluent component of Priorix; 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 patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Patient possibly received only the diluent component of Priorix) and inappropriate dose of vaccine administered (Verbatim: Patient possibly received only the diluent component of Priorix).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-AUG-2023 The reporter was a medical assistant. The reporter reported that the patient possibly received only the diluent component of Priorix which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not provided any details about patient and stated that paperwork was not available at the moment of the call. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Drug dose administration interval too long; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number AS7168B) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th April 2019 with lot number 477Z7).   On 16-MAR-2023, the patient received the 2nd dose of Shingrix. On 16-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 30-Aug-2023 The nurse reported he patient had their initial Shingrix vaccine on11 April 2019 then completed the series on 16 March 2023, which led to lengthening of vaccination schedule. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Rotarix was administered via nasogastric tube; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a infant patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On 29-AUG-2023, the patient received Rotarix lyophilized formulation. On 29-AUG-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination (Verbatim: Rotarix was administered via nasogastric tube).  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: 30-AUG-2023 The reporter reported that the patient received Rotarix vaccine administered via nasogastric tube in the critical care unit, which led to Inappropriate route of vaccination. The reporter did not had specific information about the patients or lot number of the reported vaccine. The reporter mentioned that in their facility they were vaccinated with rotarix vaccine between 2 and 4 months old. The reporter did consent to follow up via email. This US2023AMR118810 case has been linked to the case reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR118810:same reporter
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the grey top vial liquid conjugate component of Menveo; Patient received only the grey top vial liquid conjugate component of Menveo; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA957A, expiry date 30-SEP-2024) for prophylaxis.   On 29-AUG-2023, the patient received Menveo. On 29-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Patient received only the grey top vial liquid conjugate component of Menveo) and inappropriate dose of vaccine administered (Verbatim: Patient received only the grey top vial liquid conjugate component of Menveo).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-AUG-2023 The reporter reported that the vaccine clinic discovered this morning that two of three children had been received only the grey top vial liquid conjugate component of Menveo vaccine.  The reporter did not know which two of the three children patient identified actually who received only the grey vial. Only adjuvant of Menveo administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This US2023118668 case has been linked to the case reported by the same reporter.; Sender's Comments:  US-GSK-US2023118668:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix a couple years ago and wants to know if it's okay to send them back for the second shot; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a couple 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: first dose of Shingrix a couple years ago and wants to know if it's okay to send them back for the second shot).The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-AUG-2023 The reporter had some patients that got the first dose of Shingrix a couple years ago and wanted to know if it was okay to send them back for the second shot after more than 6 months has passed or if they need to restart the series. No additional information was available and unknown if follow up was permissible. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid CWY; received only the liquid CWY; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA957A, expiry date 30-SEP-2024) for prophylaxis.   On 29-AUG-2023, the patient received Menveo. On 29-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received only the liquid CWY) and inappropriate dose of vaccine administered (Verbatim: received only the liquid CWY).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-AUG-2023 A nurse reported that a male patient received only the liquid CWY component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2023118668 and US2023118665, same reporter.; Sender's Comments:  US-GSK-US2023118668:same reporter
Age: 66.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo (2 vials) + administered 66 yo patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 66-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA9388, expiry date 31-MAY-2025) for prophylaxis.   On 29-AUG-2023, the patient received Menveo. On 29-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo (2 vials) + administered 66 yo patient).  The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 30-AUG-2023 The patient was working as nurse and teaching. The vaccine administration facility was the same as primary reporter.    The reporter did not consent to follow-up. 66 years old patient received Menveo (2 vials), which led to inappropriate age at vaccine administration.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a patient 3 months before the 4-years-old minimum recommended age; 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 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 30-AUG-2023, the patient received Kinrix. On 30-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a patient 3 months before the 4-years-old minimum recommended age).  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: 30-AUG-2023 The medical assistant called to report Kinrix was administered to a patient 3 months before the 4th years old minimum recommended age.  The facility was planning on administering Dtap alone and patient had 3 doses of Dtap and IPV before today´s (on the day of reporting) dose. The vaccine administration facility was the same as primary reporter The patient received Kinrix below the scheduled age, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 2nd June 2023 and 2nd dose 31 August 2023; 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 56-year-old male patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 2nd June 2023).   On 31-AUG-2023, the patient received the 2nd dose of Twinrix. On 31-AUG-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 2nd June 2023 and 2nd dose 31 August 2023).  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: 31-AUG-2023 The pharmacist called to report a late second dose was administered to a patient. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration
Clinical narrative: subcutaneous administration of Arexvy to a patient; This non-serious case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-AUG-2023, the patient received Arexvy (subcutaneous). On 28-AUG-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: subcutaneous administration of Arexvy to a patient).  The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 31-Aug-2023 A doctor of medicine asked how to proceed with this patient. The reporter did not provide information about Arexvy dose (lot number, expiration day). During the call permission to follow up was not requested. The patient received a dose of Arexvy vaccine subcutaneous which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient got 1st dose of Twinrix on  Dec 2022  dint complete the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 23-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in December 2022).   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: patient got 1st dose of Twinrix on  Dec 2022  dint complete the series).  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: 31-Aug-2023 The pharmacist reported that the patient did not complete the series. The reporter asked need to restart. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: International normalised ratio increased
Clinical narrative: She received Arexvy yesterday and today the patient's INR came back elevated at 5.4; This non-serious case was reported by a nurse via call center representative and described the occurrence of international normalized ratio increased in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included warfarin.   On 30-AUG-2023, the patient received Arexvy. On 31-AUG-2023, 1 days after receiving Arexvy, the patient experienced international normalized ratio increased (Verbatim: She received Arexvy yesterday and today the patient's INR came back elevated at 5.4).  The outcome of the international normalized ratio increased was unknown.   It was unknown if the reporter considered the international normalized ratio increased to be related to Arexvy.     It was unknown if the company considered the international normalized ratio increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-AUG-2023 The licensed practical nurse (LPN) stated that a patient took Warfarin daily and had been on it for a while.  She received Arexvy yesterday (day before reporting) and today (on the day of vaccination) the patient's INR came back elevated at 5.4. The vaccine administration facility was the same as primary reporter. The health care professional (HCP) declined to provide patient's date of birth and did not had the lot number for the Arexvy. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeling hot, Pain in extremity, Paraesthesia
Clinical narrative: she was tired all day and her arm was aching; she was tired all day; on her arm that was 3 inches in diameter that is red, feels hot, and tingly; on her arm that was 3 inches in diameter that is red, feels hot, and tingly; on her arm that was 3 inches in diameter that is red, feels hot, and tingly; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-AUG-2023, the patient received the 1st dose of Shingrix (left arm). In AUG-2023, an unknown time after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: on her arm that was 3 inches in diameter that is red, feels hot, and tingly), extremities hot feeling of (Verbatim: on her arm that was 3 inches in diameter that is red, feels hot, and tingly) and erythema of extremities (Verbatim: on her arm that was 3 inches in diameter that is red, feels hot, and tingly). On 29-AUG-2023, the patient experienced pain in arm (Verbatim: she was tired all day and her arm was aching) and tiredness (Verbatim: she was tired all day).The outcome of the pain in arm, tiredness, tingling of extremity, extremities hot feeling of and erythema of extremities were unknown.   It was unknown if the reporter considered the pain in arm, tiredness, tingling of extremity, extremities hot feeling of and erythema of extremities to be related to Shingrix.   It was unknown if the company considered the pain in arm, tiredness, tingling of extremity, extremities hot feeling of and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-AUG-2023 The reporter was the patient who received Shingrix on Monday. She stated that on Tuesday, she was tired all day and her arm was aching.  On Wednesday, her arm was still aching.  At the time of reporting, she noticed an area on her arm that was 3 inches in diameter that was red, felt hot and tingly. The reporter did not consent to follow-up.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered a pediatric dose of Engerix-B; inadvertently administered a pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 54-year-old female patient who received HBV (Engerix B pediatric) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis.   On 30-AUG-2023, the patient received the 1st dose of Engerix B pediatric. On 30-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: inadvertently administered a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: inadvertently administered a pediatric dose of Engerix-B). 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: 31-Aug-2023 Nurse reported that at the time of reporting, no additional doses have been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. An adult patient received a pediatric dose of Engerix-B (10 mcg), which led to underdose and adult use of a child product.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Accidental underdose
Clinical narrative: 21 year patient inadvertentaly received pediatric dose of Engerix-B; 21 year patient inadvertentaly received pediatric dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 31-JAN-2024) for prophylaxis.   On 31-AUG-2023, the patient received Engerix B pediatric. On 31-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: 21 year patient inadvertentaly received pediatric dose of Engerix-B) and adult use of a child product (Verbatim: 21 year patient inadvertentaly received pediatric dose of Engerix-B).  The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2023 The reporter was a medical assistant. The reporter reported that the 21 years old patient inadvertently received pediatric dose of Engerix-B in the office, which led accidental underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The medical assistant intended to gave another pediatric dose according to guidance.  No further details provided on call. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose before Covid and never came back for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date the several patients received 1st dose,).   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: 1st dose before Covid and never came back for the 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-AUG-2023 The pharmacist had an inquiry on restarting the series or not for patients who got 1st dose and missed the 2nd dose of Shingrix.  He had several patients inquiring since they got the 1st dose before Covid and never came back for the 2nd dose. The health care professional did not provide other details. Till the time of reporting the several patient did not received the 2nd dose, which led to incomplete course of vaccination. The HCP did not consent to follow-up.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Syringe issue, Underdose
Clinical narrative: because leur-lock and needle disconnected from PFS; Pharmaceutical product complaint; Underdose/did not get full dose of vaccine; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental underdose in a 4-year-old male patient who received MMR (Priorix) (batch number GX27P, expiry date 11-MAY-2024) and (batch number N94P2, expiry date 12-DEC-2025) for prophylaxis. This case was associated with a product complaint.   On 31-AUG-2023, the patient received Priorix. On 31-AUG-2023, an unknown time after receiving Priorix, the patient experienced accidental underdose (Verbatim: Underdose/did not get full dose of vaccine). On an unknown date, the patient experienced syringe issue (Verbatim: because leur-lock and needle disconnected from PFS) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint).The outcome of the accidental underdose, syringe issue and pharmaceutical product complaint 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: 31-AUG-2023 The reporter requested data on re-vaccination of Priorix after patient received an underdose of Priorix, which led to accidental underdose. PQC (Pharmaceutical product complaint) filed because leur-lock and needle disconnected from PFS as nurse was administering the Priorix dose to patient and patient did not get full dose of vaccine. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was administered the ASO1B adjuvant of the Shingrix vaccine alone inadvertently; Patient was administered the ASO1B adjuvant of the Shingrix vaccine alone inadvertently; 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 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 2A54M, expiry date 21-MAY-2024) for prophylaxis.   On 22-AUG-2023, the patient received the 1st dose of Shingrix. On 22-AUG-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Patient was administered the ASO1B adjuvant of the Shingrix vaccine alone inadvertently) and inappropriate dose of vaccine administered (Verbatim: Patient was administered the ASO1B adjuvant of the Shingrix vaccine alone inadvertently).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2023 The reporter was a medical assistant. The reporter reported that the patient inadvertently received ASO1B adjuvant of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.