chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: FLU3, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions observed at the time of the vaccine administration. Student was given a  MMR on Feb 11, 2025 that expired Feb 8, 2025.
Age: 1.08
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Wrong diluent was used to mix the act Hib, diluent used was sterile water prefilled syringe  for MMR/varicella. Patient had no adverse reactions.
Age: 16.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Antibody test negative, Blood glucose increased, Diabetic ketoacidosis, Fatigue, Intensive care
Clinical narrative: He began to feel fatigue on 1/7/2025. He began vomiting on 1/8/2025 and I thought it was norovirus,  but now realize it was probably diabetic ketoacidosis. He went to ER on 1/9/2025 in diabetic ketoacidosis with a blood sugar over 600mg/dL and was emergency transferred to PICU. His test results show the absence antibodies which generally occur at onset of type 1 diabetes.
Age: 16.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Vomiting
Clinical narrative: He began to feel fatigue on 1/7/2025. He began vomiting on 1/8/2025 and I thought it was norovirus,  but now realize it was probably diabetic ketoacidosis. He went to ER on 1/9/2025 in diabetic ketoacidosis with a blood sugar over 600mg/dL and was emergency transferred to PICU. His test results show the absence antibodies which generally occur at onset of type 1 diabetes.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: 2 days after receiving IM vaccine patient reports severe right arm pain and inability to move arm.  was hospitalized for 3 days. Patient has been unable to lift arm up since. Is receiving care by ortho specialist
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, IPV, PNC15, RV5
Symptoms: Emotional poverty, Feeling abnormal, Infant irritability, Mental status changes
Clinical narrative: Parents report 2-3 days of altered mental status ("zoned out", no emotion) followed by 2 days of extreme irritability.
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness in fingers in same side as vaccination.
Age: 18.0
Sex: M
Vaccine: HEPAB, IPV, MMR, TDAP
Symptoms: Dreamy state, Fatigue, Gaze palsy, Head injury, Hypoaesthesia
Clinical narrative: After receiving final injection, I was putting bandage on patient's arm and patient went pale and started to faint and slump forward in chair, his grandmother who was present and looking at him head on reports that his eyes rolled back. I tried to support patient to the ground but I believe he hit the side of his head on the desk when he slumped over patient came to his knees with my support but kind of nose dived and his head landed on the ground. I helped him to roll to his side and he started having uncontrolled seizure like movements for about 5-6 seconds then he sat up and asked what happened. Unsure if patient had seizure or vasovagal response. Patient was alert and oriented, able to answer all questions....after this incident but laid down for about 20-30 minutes after the incident. He reported some numbness in his left arm and his arms felt a little heavy/weird where the shots were given. The numbness in his arm resolved after a few minutes. He does not have a previous hx of seizures, but grandmother reports that patient's mother has had seizures after a TBI in 2016. Patient reports he had eaten breakfast before appt. Per report from patient's perspective he reports that he got the feeling like before he goes to bed and couldn't keep his head up anymore and then he felt like he was dreaming. The entire incident was about 10-15 seconds. Patient was monitored for about 30 minutes afterwards and reports he was feeling well but tired before leaving. He was given juice and a granola bar. Recommended patient follow up with provider regarding the incident and recommended patient lay down for future vaccines -LSW, RN.
Age: 18.0
Sex: M
Vaccine: HEPAB, IPV, MMR, TDAP
Symptoms: Injection site discomfort, Limb discomfort, Pallor, Seizure like phenomena, Syncope
Clinical narrative: After receiving final injection, I was putting bandage on patient's arm and patient went pale and started to faint and slump forward in chair, his grandmother who was present and looking at him head on reports that his eyes rolled back. I tried to support patient to the ground but I believe he hit the side of his head on the desk when he slumped over patient came to his knees with my support but kind of nose dived and his head landed on the ground. I helped him to roll to his side and he started having uncontrolled seizure like movements for about 5-6 seconds then he sat up and asked what happened. Unsure if patient had seizure or vasovagal response. Patient was alert and oriented, able to answer all questions....after this incident but laid down for about 20-30 minutes after the incident. He reported some numbness in his left arm and his arms felt a little heavy/weird where the shots were given. The numbness in his arm resolved after a few minutes. He does not have a previous hx of seizures, but grandmother reports that patient's mother has had seizures after a TBI in 2016. Patient reports he had eaten breakfast before appt. Per report from patient's perspective he reports that he got the feeling like before he goes to bed and couldn't keep his head up anymore and then he felt like he was dreaming. The entire incident was about 10-15 seconds. Patient was monitored for about 30 minutes afterwards and reports he was feeling well but tired before leaving. He was given juice and a granola bar. Recommended patient follow up with provider regarding the incident and recommended patient lay down for future vaccines -LSW, RN.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Headache, Heart rate increased, Injection site erythema, Injection site pain
Clinical narrative: 2/11/25 -2/1325 Head Ache, Pain at Inj site.  2/12/25-2/13/25 redness at inj sight and scattered redness on her chest, low grade fever today 99.1. Has felt that her HR has been fast for starting 2/11/25.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: 2/11/25 -2/1325 Head Ache, Pain at Inj site.  2/12/25-2/13/25 redness at inj sight and scattered redness on her chest, low grade fever today 99.1. Has felt that her HR has been fast for starting 2/11/25.
Age: 53.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MenA vaccine was administered  to soon based on guidelines. 1st dose administered on  03/30/2023; 2nd dose administered on 05/29/2023. Notified pharmacist and they will reach out to the MD office to notify them .
Age: 45.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Deafness unilateral, Urticaria
Clinical narrative: Patient stated one month after the vaccine he devolped hives on his arms and upper chest and had a temporary loss of hearing in his left ear. Patient took Benadryl and is now ok. He stated this exact reaction happened after his second Moderna Vaccine.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Tdap vaccine was administered on 1/6/2025. Dad called office 2/13/2025 @ 11:12am to reports that she has been c/o arm pain x 3 days. Upon further questioning, Dad reports that she "has been complaining of arm pain weekly".  Dad will be bringing child in for eval of arm on Fri 2/14/2025.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Electromyogram, Guillain-Barre syndrome, Laboratory test, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Patient developed guillane barre syndrome shortly after recieving  RSV vaccine
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy, Breast pain, HIV test negative, Hepatitis B test negative, Hepatitis C test negative
Clinical narrative: Red rash / bumps that started out with several and more came out all over body as month went on. These red bumps did not itch but did "feel" them when a new spot came out, felt like a slinter, once that "head" was removed I didn't feel them. This rash was not contagious. Was prescribed prednisone  on Nov 6th when seen PCP, spots were better then when prednisone was done, more red spots came out, Seen Dermatologist on Nov 19th had biopsy done, blood work ordered.  Left breast started hurting. Had mammogram on dec 16th. Seen dermatologist again on Dec 18th, referral was placed to rheumatologist. Rash caused internal inflammation through out body
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Mammogram normal, Metabolic function test normal, Rash erythematous, Treponema test negative
Clinical narrative: Red rash / bumps that started out with several and more came out all over body as month went on. These red bumps did not itch but did "feel" them when a new spot came out, felt like a slinter, once that "head" was removed I didn't feel them. This rash was not contagious. Was prescribed prednisone  on Nov 6th when seen PCP, spots were better then when prednisone was done, more red spots came out, Seen Dermatologist on Nov 19th had biopsy done, blood work ordered.  Left breast started hurting. Had mammogram on dec 16th. Seen dermatologist again on Dec 18th, referral was placed to rheumatologist. Rash caused internal inflammation through out body
Age: 55.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Product preparation error
Clinical narrative: nurse administered a Shingrix vaccine that was diluted with the sterile diluent provided for Merck live vaccines, did not use adjuvant suspension component in reconstitution
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: Debilitating back spasms
Age: 34.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd Dose Given Too Early;  No physical adverse symptoms reported/observed by patient
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Large area of urticaria involving 70% of anterior thigh
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came to counter requesting a flu shot and stated she did not get one this season because she missed her annual clinic that she goes to. High dose fluzone was given to the patient by pharmacist and later patient's relative (sister) called to let us know she already received the flu shot this season. After verifying with insurance, patient received flu shot in October 28,2024 and then came to the counter and got another shot in February 10,2025, so there was a duplication of vaccine administration in the same season. No adverse reactions were reported by patient or relative, just a duplication.
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: vaccination failure; Developed Influenze A; This serious case was reported by a medical representative via sales rep and described the occurrence of vaccination failure in a adult male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) for prophylaxis.   In SEP-2024, the patient received the 1st dose of FluLaval Quadrivalent 2024-2025 season. In JAN-2025, between 4 and 5 months after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced vaccination failure (Verbatim: vaccination failure) (serious criteria GSK medically significant) and influenza a virus infection (Verbatim: Developed Influenze A). The outcome of the vaccination failure was not reported and the outcome of the influenza a virus infection was not resolved.   It was unknown if the reporter considered the vaccination failure and influenza a virus infection to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the vaccination failure and influenza a virus infection to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JAN-2025 The reporter stated that the patient received FluLaval Quadrivalent vaccine. The patient had a purchased rapid test that showed he had developed Influenza A on January 2025. The reporter was not his doctor.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description) is considered unrelated to GSK vaccine FluLaval Quadrivalent 2024-2025 season and FluLaval Tetra PRE-FILLED SYRINGE DEVICE.  Influenza is a listed event which, due to the following criteria (insufficient information provided about the clinical description) is considered unrelated to GSK vaccine FluLaval Quadrivalent 2024-2025 season and FluLaval Tetra PRE-FILLED SYRINGE DEVICE.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Flu like symtoms/fever; This non-serious case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-JAN-2025, the patient received Shingrix (right arm). On 17-JAN-2025, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symtoms/fever). The outcome of the influenza-like symptoms was unknown.   The reporter considered the influenza-like symptoms to be related to Shingrix.     The company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-JAN-2025 Patient received Shingrix and experienced fever of 101.2 and flu like symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Mobility decreased, Vaccine positive rechallenge
Clinical narrative: also felt sick for; wiped me out; couldnt move my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of mobility decreased (received 1st dose on an unknown date, experienced feeling unwell and fatigue, For tolerance to 1st dose, refer case US2025AMR008461).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced mobility decreased (Verbatim: couldnt move my arm), feeling unwell (Verbatim: also felt sick for) and fatigue (Verbatim: wiped me out). Rechallenge with Shingles vaccine was positive. The outcome of the mobility decreased was resolved (duration 1 week) and the outcome of the feeling unwell and fatigue were not reported.   It was unknown if the reporter considered the mobility decreased, feeling unwell and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the mobility decreased, feeling unwell and fatigue to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2025AMR008461   Additional Information: GSK Receipt Date: 16-JAN-2025 This case was reported by a patient via interactive digital media. The patient received shingles vaccine and it was wiped out, could not move arm for a week and also felt sick for that same period of time. The patient said it was a piece of cake compared to getting shingles, get vaccinated.; Sender's Comments:  US-GSK-US2025AMR008461:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the shot and had the Shingles anyway. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Surgery, Vaccination failure
Clinical narrative: Suspected vaccination failure; Surgery; I've had the vaccination and just got them again/ Three weeks later I go to my PCP and she tells me that I have shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (worst) and pain (painful shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), surgery (Verbatim: Surgery) (serious criteria clinically significant/intervention required) and shingles (Verbatim: I've had the vaccination and just got them again/ Three weeks later I go to my PCP and she tells me that I have shingles). The outcome of the vaccination failure, surgery and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, surgery and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and surgery to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt Date: 01-FEB-2025 This case was reported by a patient via interactive digital media. The patient had shingles three times. The first time was the worst.  The patient had the vaccination and just got shingles again. He/she thought that they injured his/her back during surgery.  Three weeks later, the patient went to the PCP (primary care physician) and she told the patient that he/she had shingles. It was not nearly as painful as the first time.  The patient guessed that was why the patient just thought it was sciatica. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Surgery is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: RVX
Symptoms: Cough, Sleep disorder
Clinical narrative: Cough sometimes for 20 minutes; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: Cough sometimes for 20 minutes). The outcome of the cough was not reported.   It was unknown if the reporter considered the cough to be related to RSV vaccine.     It was unknown if the company considered the cough to be related to RSV vaccine.   Additional Information: GSK receipt Date: 04-FEB-2025. This case was reported by a patient via interactive digital media. The coughing spells were so brutal that you felt like your brains and gut was going to explode because you cough sometimes for 20 minutes straight and you can't stop.  It keeps you awake all night.  The patient got over it and caught it again back to back. The patient  had the vaccine ahead of time ,but it failed the patient big time.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not received 2nd dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose ??-JUN-2024).   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 received 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-FEB-2025 The reporter reported that if it has been 8 months since first dose, do you give 2nd dose or start over. Till the time of reporting the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; l have just now had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: l have just now had shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix.   Additional Information: GSK receipt date: 10-FEB-2025 This case was reported by a patient via interactive digital media. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: white blood count is elevated; This non-serious case was reported by a consumer via call center representative and described the occurrence of white blood cell count increased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced white blood cell count increased (Verbatim: white blood count is elevated). The outcome of the white blood cell count increased was unknown.   It was unknown if the reporter considered the white blood cell count increased to be related to Shingles vaccine.     It was unknown if the company considered the white blood cell count increased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-FEB-2025 The reporter reported that he/she just got first dose shingles vaccine and had a blood test done. The patient white blood count was elevated. The patient asked could the vaccine cause this.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: vaccine administered reconstituted with non-approved diluent; vaccine administered reconstituted with non-approved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 15-JAN-2025, the patient received the 1st dose of Menveo. On 15-JAN-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: vaccine administered reconstituted with non-approved diluent) and inappropriate dose of vaccine administered (Verbatim: vaccine administered reconstituted with non-approved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-JAN-2025 The pharmacy Intern reported that they administered Menveo (2-vial) but the powder was reconstituted with sterile water instead of the liquid component vial, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not had any patient demographics, lot number or expiration date for the vaccine.  This was the first dose of Menveo for this patient. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrixout of recommended storage temperatures for more than 6 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Shingrixout of recommended storage temperatures for more than 6 hours). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 16-JAN-2025 The reporter called to report leaving Shingrix vaccine out of recommended storage temperatures for more than 6 hours which led to, incorrect storage of drug.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age
Clinical narrative: received a MMR vaccine intramuscularly; 45 years patient received Priorix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 45-year-old female patient who received MMR (Priorix) (batch number A2J35, expiry date 01-SEP-2025) for prophylaxis.   On 14-JAN-2025, the patient received Priorix (intramuscular, unknown deltoid). On 14-JAN-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: received a MMR vaccine intramuscularly) and inappropriate age at vaccine administration (Verbatim: 45 years patient received Priorix vaccine). The outcome of the subcutaneous injection formulation administered by other route 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: 16-JAN-2025 The nurse practitioner reported that they had a patient who received a MMR vaccine (Priorix) two days ago and she received that yesterday. The reporter asked it was a live vaccine and was that correct and she received a MMR vaccine intramuscularly and she got it in the deltoid, which led to subcutaneous injection formulation administered by other route The reporter was told that it was not a live vaccine and she received it on the deltoid and was needing her varicella today which she could not give her if she received the MMR two days ago.  The reporter asked that something that they need to repeat whether subcutaneously. The reporter asked do she need to wait and what was it that they need to do at that point, since it was administered incorrectly The patient received Priorix at inappropriate age which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: TDap vaccine (Boostrix) was inadvertently given to a newborn baby; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a neonate patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16-JAN-2025, the patient received Boostrix. On 16-JAN-2025, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: TDap vaccine (Boostrix) was inadvertently given to a newborn baby). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-JAN-2025 The physician reported that on the day of reporting a TDap vaccine (Boostrix) was inadvertently given to a newborn baby which led to, inappropriate age at vaccine administration.  According to reporter, the patient was not even one-day old. The reporter did not agree additional details on the patient when asked. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: administration of another dose of Kinrix administered on today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number Y498Z, expiry date 17-MAY-2026) for prophylaxis.   Concomitant products included Kinrix.   On 16-JAN-2025, the patient received the 2nd dose of Kinrix. On 16-JAN-2025, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: administration of another dose of Kinrix administered on today). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JAN-2025 The other health professional reported administration of Kinrix as 5th dose in series and another dose of Kinrix administered on the day of reporting which led to extra dose administered.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 20-year-old female received an Engerix B Pediatric/Adolescent Vaccine dose; 20-year-old female received an Engerix B Pediatric/Adolescent Vaccine dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number C2Y9B, expiry date 15-JUL-2026) for prophylaxis.   On 08-JAN-2025, the patient received Engerix B pediatric (right arm) .5 ml. On 08-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 20-year-old female received an Engerix B Pediatric/Adolescent Vaccine dose) and adult use of a child product (Verbatim: 20-year-old female received an Engerix B Pediatric/Adolescent Vaccine dose). 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: 17-JAN-2025  The other health professional reported that a 20-year-old female patient received an Engerix B Pediatric/Adolescent vaccine dose instead of Engerix B 20 adult dose by error which led to underdose and adult use of child product.  The other health professional stated that the vaccine was administered on the right arm.  No additional information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Spinal stenosis
Clinical narrative: has stenosis in his spine and it was caused by the zoster virus/nerve pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of spinal stenosis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose in 2020). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. In OCT-2024, an unknown time after receiving Shingrix and SHINGRIX, the patient experienced spinal stenosis (Verbatim: has stenosis in his spine and it was caused by the zoster virus/nerve pain). The outcome of the spinal stenosis was not reported.   The reporter considered the spinal stenosis to be related to Shingrix.     The company considered the spinal stenosis to be related to Shingrix.   Additional Information: GSK receipt date: 16-JAN-2025 The reporter was the patient. Patient stated that he had the complete series of Shingrix administer with the first dose in 2020 and the second dose in 2021. the patient stated he started experiencing nerve pain in October 2024. Also, states his doctor said he had stenosis in his spine and it was caused by the zoster virus. Consumer denied having been diagnosis with shingles. No further information was known including dates of administration of Shingrix, demographics of consumer.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received hepatitis B dosing with Heplisav-B in April 2024 and June 2024 and the patient then received Twinrix in August 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a adult female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) and Hepatitis b vaccine rHBsAg (yeast) (Heplisav b).   In AUG-2024, the patient received Twinrix. In AUG-2024, an unknown time after receiving Twinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: received hepatitis B dosing with Heplisav-B in April 2024 and June 2024 and the patient then received Twinrix in August 2024). The outcome of the inappropriate schedule of 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: 17-JAN-2025 The pharmacy intern reported that the patient that received hepatitis B dosing with Heplisav-B in April 2024 and June 2024 and the patient then received Twinrix, which led to Inappropriate schedule of vaccine administered. The reporter asked how to complete the hepatitis A series for this patient and at the time of call, no additional dosing had been administered. The Vaccine Administration Facility was the same as Primary Reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product preparation issue
Clinical narrative: 2nd dose was given 7 months later, 1 month more than recommended; reconstituted with two vials of the diluent; reconstituted with two vials of the diluent; 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 male patient who received Herpes zoster (Shingrix) (batch number FH9A7, expiry date 16-JUL-2026) for prophylaxis.   Previously administered products included Shingrix (First dose received on 07-June-2024).   On 17-JAN-2025, the patient received the 2nd dose of Shingrix. On 17-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose was given 7 months later, 1 month more than recommended), inappropriate preparation of medication (Verbatim: reconstituted with two vials of the diluent) and inappropriate dose of vaccine administered (Verbatim: reconstituted with two vials of the diluent). The outcome of the drug dose administration interval too long, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-JAN-2025 The patient was older than 50 years old. The pharmacist had a patient who was getting a shingles vaccine, it was his second dose and had a vial of the powder that was reconstituted with two vials of the diluent and then administered, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was reported if dose been a little more diluted so, reporter asked if that would be sufficient or there was just kind of manufacturer's guidance or if needed to, recommended him to come back and to get like a third dose to make sure a third dose, a standardized dose. The patient received 2nd dose was given 7 months later, 1 month 10 days more than recommended which led to lengthening of vaccination schedule. Pharmacist was transferred to second line specialist, after which he stated he/she knew during Covid there were patients that missed the interval for Shingrix and had late second doses. No further context or details provided, The reporter did not consent to follow-up. This case was linked with case US2019236811 reported by the same reporter, for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019236811:same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: patient wanted to get a late second dose.; she ended up getting shingles,; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) (batch number TP2N2, expiry date 10-FEB-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 05-OCT-2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In JUL-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: she ended up getting shingles,). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: patient wanted to get a late second dose.). The outcome of the shingles and incomplete course of vaccination were 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: 17-JAN-2025 The pharmacist reported that a patient received the first dose of Shingrix and then patient decided she did not want the second dose.  About 6 months ago she ended up getting shingles, and now patient wanted to get a late second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 31-year-old patient received a pediatric dose of Engerix B; underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 31-year-old male patient who received HBV (Engerix B pediatric) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis.   On 16-JAN-2025, the patient received the 3rd dose of Engerix B pediatric. On 16-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 31-year-old patient received a pediatric dose of Engerix B) and underdose (Verbatim: underdose). The outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-JAN-2025 Vaccine Coordinator stated a 31-year-old patient received a pediatric dose of Engerix-B, which led to adult use of a child product and underdose.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 4 months old patient received a dose of Kinrix.; 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 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 4 months old patient received a 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: 22-JAN-2025 The pharmacist reported that a patient of an inappropriate age received a dose of Kinrix, which led to inappropriate age at vaccine administration The reporter asked was it harmful for the patient and was there a problem or was just not recommended. The reporter said that he did not had more information about the patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: received Shingrix diluent alone; received Shingrix diluent alone; 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 61-year-old female patient who received Herpes zoster (Shingrix) (batch number N77J2, expiry date 23-OCT-2026) for prophylaxis.   On 28-JAN-2024, the patient received the 2nd dose of Shingrix. On 28-JAN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received Shingrix diluent alone) and inappropriate dose of vaccine administered (Verbatim: received Shingrix diluent alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JAN-2025 The office manager reported that a patient received second dose of Shingrix diluent alone without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Coma, Herpes zoster, Incomplete course of vaccination
Clinical narrative: 4 days in a coma; and got SHINGLES 4 years later.; Symptomatic - Did Not Receive the 2nd vaccination; This serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31-JAN-2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient  did not received the 2nd dose of Shingrix. On 08-JAN-2025, 1438 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: and got SHINGLES 4 years later.) (serious criteria hospitalization). On an unknown date, the patient experienced coma (Verbatim: 4 days in a coma) (serious criteria hospitalization and GSK medically significant) and incomplete course of vaccination (Verbatim: Symptomatic - Did Not Receive the 2nd vaccination). The outcome of the shingles and incomplete course of vaccination were unknown and the outcome of the coma was resolved (duration 4 days).   It was unknown if the reporter considered the shingles and coma to be related to Shingrix.     The company considered the shingles and coma to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 30-JAN-2025 Consumer stated no one told him he needed a 2nd dose of Shingrix. The patient was proceeded to get SHINGLES 4 years after first dose and was hospitalized for 16 days, 4 days in a coma. Patient would like to be contacted and would like to send pictures and be a spokesperson.  Consumer stated he doesn't believe commercial presents itself as to how serious shingles can be and the commercial needs to stated 2 shots are to be given.  The reporter Consented to follow up. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.; Sender's Comments: Herpes zoster and Coma are unlisted events which are considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient received a first dose of Shingrix and has not received the second 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 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (1st dose received in September 2023).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim:  a patient received a first dose of Shingrix and has not received the second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2025 The reporter called report in September 2023 a patient received a first dose of Shingrix and has not received the second dose yet. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.