chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dysstasia, Gait inability, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Patient started experiencing weakness in arms, legs, as well as numbness in fingertips and toes the day after vaccine was administered. The second day after vaccine, he was unable to stand due to not having any strength in his lower body. Went to the emergency room and was admitted and Diagnosed with Guillain-Barre Syndrome. He is now in the hospital, unable to walk and with very minimum strength and mobility to his upper body.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Lumbar puncture, Mobility decreased, Muscular weakness
Clinical narrative: Patient started experiencing weakness in arms, legs, as well as numbness in fingertips and toes the day after vaccine was administered. The second day after vaccine, he was unable to stand due to not having any strength in his lower body. Went to the emergency room and was admitted and Diagnosed with Guillain-Barre Syndrome. He is now in the hospital, unable to walk and with very minimum strength and mobility to his upper body.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV1
Symptoms: Expired product administered
Clinical narrative: An expired vaccine accidentally was given to a 4-month-old baby. Mother was notified and was asked to come for a follow up appointment and for the patient to receive a new valid vaccine.
Age: 56.0
Sex: F
Vaccine: HEP, PNC20, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: erythematous rash on left shoulder near the injection site, 10x10 cm ~ well demarcated with raised boarders, tender and warm.   Treatment: Local reactions can be treated with tylenol or nonsteroidal antiinflammatory drugs (NSAIDs) such as naproxen as needed if pain or swelling is troublesome.   -Cetirizine 10 mg nightly x7, can stop earlier if symptoms resolve  -Due to complains of a reactive cough and worsening local erythema, prednisone 20 mg for 5 days was also sent.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Headache, Heart rate increased, Lymphadenopathy
Clinical narrative: Per 2 phone calls to/from parent: Patient experienced swollen lymph node on neck on the side he got his shot, throat was bumpy on the inside (strep throat like), light headedness, high fever, nauseous after eating, high heart rate after eating, extreme headaches, and fatigue since 07/09, today is first day he's feeling better. She states patient developed a fever and took Tylenol. At 1800-1900, temp was 101 (with Tylenol on board). Throat was the back of the throat with white bumps. He also had nasal congestion during the time and took Claritin to help with that. Swollen lymph node was on the left side of the neck. Injection was also given in the LD.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Nasal congestion, Nausea, Pharyngeal enanthema, Pyrexia
Clinical narrative: Per 2 phone calls to/from parent: Patient experienced swollen lymph node on neck on the side he got his shot, throat was bumpy on the inside (strep throat like), light headedness, high fever, nauseous after eating, high heart rate after eating, extreme headaches, and fatigue since 07/09, today is first day he's feeling better. She states patient developed a fever and took Tylenol. At 1800-1900, temp was 101 (with Tylenol on board). Throat was the back of the throat with white bumps. He also had nasal congestion during the time and took Claritin to help with that. Swollen lymph node was on the left side of the neck. Injection was also given in the LD.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: pt recevied the vaccine went to hall way ,pt passed out .and landed on the floor.loss of conciousness couple of seconds.alos eye rolled back,and arms and legs stiffen few seconds.according to father.pt was brought in to the room.lied down couple of minutes.and rechecked blood pressure vitals after 10 minutes.pt has no more dizziness.pt head was checked for head injury.no hematoma palpated.pt discharged with er precautions.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Cold sweat, Dizziness, Pallor
Clinical narrative: after injection became dizzy, weak, pale and clammy.  Had lay down and elevated feet above head.  Monitored for 30 minutes, bp 110/70 hr 70.  Slowly recovered to a sitting position able to drink sips of water then to a standing position.  Color returned to pink, no longer felt dizzy, weak or clammy
Age: 1.08
Sex: F
Vaccine: HIBV, IPV, MMR, PNC20, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient given Polio #4 when should have received another vaccine. Pt tolerated vaccine administration well, no symptoms of adverse reaction noted after administration. Parents waited with child in lobby for 15 minutes before departing and were informed of the error.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: Patient reports a bump remaining on her arm where she received the vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Haematemesis, Nausea
Clinical narrative: Patient reported dizziness, nausea, and vomiting happened at home few hours after vaccination.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Head injury, Syncope, Vomiting
Clinical narrative: pt syncopized after her 4th immunization - recovered quickly, goose-egg on forehead but otherwise alright - zofran given after pt vomited
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Crying, Cyanosis, Hypotonia, Screaming
Clinical narrative: Infant was at home and woke up from nap crying and then became limp for 25 minutes with some cyanosis around the mouth, symptoms spontaneously resolved. Parents called 911 and patient was taken to the ER. He was found to be anemic at ER. He was discharged and followed up with his PCP. He has been referred to Cardiology.  Dr. History Report: History of Present Illness The patient presents for evaluation of a brief resolved unexplained event (BRUE) and anemia. He is accompanied by his parents.  Pale, limp event - About 2 hrs after receiving his vaccinations 2 days ago, he had a contact nap for approximately 1 hour and 20 minutes, which is typical for his afternoon rest. - Upon waking, he was screaming with his eyes closed. - His mother attempted to soothe him but noticed that he had turned pale and was limp.  - His breathing was slow, and his lips had turned blue. - Mom tried to sit him up on her hip but couldn't, he was so limp.  - She tried lying him down as if for a diaper change.  He would normally grab his feet.  Just limp.  No eye contact but eyes at times open, lids at times droopy as if falling asleep.  Not interacting but eyes not rolled back or deviated. - No stiffening movements. - This episode lasted about 25 minutes. - Called EMS. By the time the fire department arrived, his color had slightly improved, but his oxygen levels were low and he was crying faintly like a moan. - He was taken to the hospital where tests revealed severe anemia.  Parents noted HR when crying was over 200.  ED documented HR 153.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given Men B instead of MCV4. No reaction reported.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site rash, Skin warm
Clinical narrative: Patient reported a 2 inch circular rash which was warm to touch and hard under the skin about 2 days after injection
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reported a 2 inch circular rash which was warm to touch and hard under the skin about 2 days after injection
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Swelling
Clinical narrative: 07/04/25 large amount of swelling - about size of hand - very red, severe itching and burning. This lasted for at least 4 days. As of 07/17/25 still about palm of hand sized swelling - not itching or burning now.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Dermatitis, Erythema, Fatigue, Gait disturbance, Myalgia
Clinical narrative: Muscle Aches, Fatigue, Drowsiness, Slow Speech, Shuffled Feet on Tuesday 07/15/2025, has improved. Slight swelling, redness, warm to the touch, Dermatitis on set today 07/17/2025.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm, Slow speech, Somnolence, Swelling
Clinical narrative: Muscle Aches, Fatigue, Drowsiness, Slow Speech, Shuffled Feet on Tuesday 07/15/2025, has improved. Slight swelling, redness, warm to the touch, Dermatitis on set today 07/17/2025.
Age: 80.0
Sex: M
Vaccine: PNC21, TDAP
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Large local swelling that appeared 6 days after the injection with itching, erythma and induration
Age: 73.0
Sex: F
Vaccine: MNQ
Symptoms: Myalgia, Pruritus, Rash
Clinical narrative: Patient have pain in the deltoid area, topical rash and itching  24 hour after administration
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure 12 hours after administration. Resolved in 2 minutes.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Eczema
Clinical narrative: Severe eczema that has lasted for years.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pneumonia vaccine was received on 07/11/25. The next day the patient experienced swelling at the injection site as well as skin feeling hot. Treatment was prescribed.  Keflex for a 7 day supply for four times a day if symptoms persist were to be taken.
Age: 52.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Areflexia, Blood test, Fall, Fatigue, Guillain-Barre syndrome
Clinical narrative: On 4/20/2025 I started to develop fatigue and muscle aches that worsened through the week which was followed by muscles weakness, numbness and tingling and ultimately a fall due to weakness with led being hospitalized and diagnosed Guillain Barre Syndrome at Hospital on 4/25/2025.
Age: 52.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging spinal, Muscular weakness, Myalgia
Clinical narrative: On 4/20/2025 I started to develop fatigue and muscle aches that worsened through the week which was followed by muscles weakness, numbness and tingling and ultimately a fall due to weakness with led being hospitalized and diagnosed Guillain Barre Syndrome at Hospital on 4/25/2025.
Age: 52.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Paraesthesia
Clinical narrative: On 4/20/2025 I started to develop fatigue and muscle aches that worsened through the week which was followed by muscles weakness, numbness and tingling and ultimately a fall due to weakness with led being hospitalized and diagnosed Guillain Barre Syndrome at Hospital on 4/25/2025.
Vaccine: MMR
Symptoms: Device connection issue, Exposure via skin contact
Clinical narrative: the needle hub became loose and began leaking between the plastic hub and the syringe itself; HCP also reports that some of the liquid came in contact with the patients skin.; HCP also reports that some of the liquid came in contact with the patients skin.; the needle hub became loose and began leaking between the plastic hub and the syringe itself; HCP reports she is unsure if patient received the entire  dose; needle hub/luer lock Adaptor (syringe hub) became loose; This spontaneous report was received from a nurse and refers to a(n) patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 03-Jul-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #Y015995, expiration date: 24-Sep-2026 (information established upon internal review, also reported as 25-Sep-2026), 0.5 mL administered by intramuscular route (anatomical location was not provided)) for prophylaxis (reported as: immunization against MMR). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT).   On the same date, while administering reconstituted Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) using sterile diluent (MERCK STERILE DILUENT) syringe, the needle hub became loose and began leaking between the plastic hub and the syringe itself. It was confirmed that the luer lock Adaptor (syringe hub) became loose (Device connection loose, Syringe leak, Poor quality device used). HCP reported no issues with sterile diluent (MERCK STERILE DILUENT) syringe during preparation of dose. HCP reported that she was unsure if patient received the entire dose (Accidental underdose). HCP also reported that some of the liquid came in contact with the patient's skin (Accidental exposure to product, Exposure via skin contact). HCP was wearing gloves and therefore no contact was made with her skin. No symptoms report by patient at this time. HCP stated she has discarded the sterile diluent (MERCK STERILE DILUENT) syringe and was unable to provide photos. At the reporting time, the outcome of the events was unknown.  The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was not applicable.
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; HCP reported administration of GARDASIL 9 that experienced two temperature excursions; This spontaneous report was received from a Registered medical assistant 15-Jul-2025 and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 14-Jul-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (lot #Y015179, expiration date: 28-Jan-2027) prefilled syringe, dose: 0.5 mL (dose number, route and anatomical location was not reported) for prophylaxis (Product storage error).  The administered dose of the vaccine experienced a temperature excursion of 47.3 Fahrenheit for 50 minutes and 24 seconds. Previous excursion was not reported as 47.5 Fahrenheit for 36 minutes and 51 seconds. There was no adverse effect reported. No product quality complaint was involved.  This is one of several reports from the same source.
Sex: M
Vaccine: HEP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Accidentally Gave the HEPLISAV-B SubQ Instead of IM; Initial report received on 01-Jul-2025.  A pharmacist reported that a 26-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization subcutaneously instead of intramuscularly.  No medical history or concomitant medications were reported.  On 30-May-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)].   On 30-Jun-2025, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot number 946062, expiration date 18-May-2027, and NDC number 43528-003-05)] subcutaneously in the right arm. No side effects were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Yellow skin
Clinical narrative: Arm is Yellow on the Underside Both Above the Elbow and Bellow the Elbow; Initial report received on 03-Jul-2025.  A pharmacist reported that a female patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient's underside of her arm both above and below the elbow was yellow.   No medical history or concomitant medications were reported.  On 02-Jul-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 945665, expiration date 03-Jan-2027, and NDC number 43528-0003-05; site not available) intramuscularly.   On 03-Jul-2025, 1 day after receiving HEPLISAV-B, the patient reported her arm is yellow on the underside both above and below the elbow. No other adverse effects were reported.   No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Received First Dose And It Has Been More Than One Month; Initial report received on 03-Jul-2025.  A pharmacist reported that a patient  received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the next dose  more than one month later.  No medical history or concomitant medications were reported.  On 28-May-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)].   On 03-Jul-2025, 37 days after receiving the first dose of HEPLISAV-B, the reporter noted that more than one month had passed since the patient's first injection.  No adverse reactions were reported.  The reporter declined to provide further information.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: vaccinated on 7 JUL 2025 in the left arm with SHINGRIX/product expired 30 MAY 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 73pp9, expiry date 30-MAY-2024) for prophylaxis.   On 07-JUL-2025, the patient received Shingrix (intramuscular, left arm) .5 ml. On 07-JUL-2025, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: vaccinated on 7 JUL 2025 in the left arm with SHINGRIX/product expired 30 MAY 2024). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK receipt date: 07-JUL-2025 HCP was the reporter.  Stated that a patient was vaccinated on 7th July 2025 in the left arm with Shingrix. HCP stated that the product expired on 30th May 2024, which led to expired vaccine used. No further information was provided/obtained.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose of Shingrix in 2023 and has not yet had 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received intramuscularly in 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: received first dose of Shingrix in 2023 and has not yet had 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 08-JUL-2025 The patient received his first dose of Shingrix in 2023 and had not yet had his 2nd dose which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pain
Clinical narrative: flu like symptoms; malaise; ache/ Pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-JUN-2025, the patient received the 1st dose of Shingrix. In JUN-2025, 12 hrs after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms), malaise (Verbatim: malaise) and pain (Verbatim: ache/ Pain). The outcome of the influenza-like symptoms, malaise and pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, malaise and pain to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms, malaise and pain to be related to Shingrix.   Additional Information: GSK receipt date: 15-JUL-2025 The reporter was the patient who received her first dose of Shingrix and 12 hours after the dose, she experienced flu like symptoms, malaise, aches and pain. She wished to remain anonymous.
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered priorix (in error) 1 year after receiving a dose of priorix; This non-serious case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 5-year-old patient who received MMR (Priorix) for prophylaxis.   Previously administered products included Priorix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered priorix (in error) 1 year after receiving a dose of priorix). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 09-JUL-2025 The nurse reported that she was seeking some literature to provide to her corporate team about the potential side effects to a patient 5 years old who was administered Priorix vaccine in error 1 year after receiving a dose of Priorix, which led to inappropriate age at vaccine administration.
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Herpes zoster, Vaccination failure, Vertigo
Clinical narrative: Suspected vaccination failure; vertigo; weakness; still contracted the shingles / Mine was on my scalp, neck and chin;  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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still contracted the shingles / Mine was on my scalp, neck and chin), vertigo (Verbatim: vertigo) and weakness (Verbatim: weakness). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 13 weeks) and the outcome of the vertigo and weakness were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, vertigo and weakness to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, vertigo and weakness to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUL-2025 This case was reported by a patient via interactive digital media. The patient did get all the vaccines and still contracted the shingles which was located on the scalp, neck and chin and it lasted about thirteen weeks and the patient still having aftereffects. The patient would like to hear from anyone else that has experienced a similar situation. The patient went through two rounds of Valtrex, and I'm still having problems with vertigo and weakness. This case was considered as suspected vaccination failure as details regarding 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 completion of primary vaccination schedule, time to onset and regarding laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2).
Age: 1.0
Vaccine: HEPA
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: adult dose of Harvix to a 19-Month-Old pediatric patient; adult dose of Harvix to a 19-Month-Old pediatric patient; patient received 3 doses of Harvix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 18-month-old patient who received HAV (Havrix 1440 adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis.   Previously administered products included Havrix (Upon review two other doses were also given (1st on unknown date)) and Havrix (Upon review two other doses were also given (2nd on unknown date)).   On 20-JUN-2025, the patient received Havrix 1440 adult. On 20-JUN-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: adult dose of Harvix to a 19-Month-Old pediatric patient), overdose (Verbatim: adult dose of Harvix to a 19-Month-Old pediatric patient) and extra dose administered (Verbatim: patient received 3 doses of Harvix). The outcome of the adult product administered to child, overdose and extra dose administered were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 07-JUL-2025 Other HCP reported that they gave an adult dose (Harvix) to a pediatric patient (19-Month-Old) which led to adult product administered to child and overdose and extra dose administered. Also asked if that dose was valid or not.  Any side effects need to advise the parents of as well. Upon review two other doses were also given. This case is 1 of 3 cases reported by same reporter.; Sender's Comments:  US-GSK-US2025087636:Same reporter/Diffrent patient GSK-US2025087634:Same reporter/Diffrent patient
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: doctor did the titer to see how it took, it revealed he didn't take it; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in an adult male patient who received MMR (Priorix) (batch number 955E2, expiry date 13-SEP-2026) for prophylaxis.   On 02-MAY-2025, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced therapy non-responder (Verbatim: doctor did the titer to see how it took, it revealed he didn't take it). The outcome of the therapy non-responder was not applicable.   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: 09-JUL-2025 Pharmacist reported that he had an adult patient who got a vaccine, the Priorix back in May and when the doctor did the titer to see how it took. it revealed he didn't take it, and the patient wanted to know if they can get another vaccine. The reporter was trying to look at up in the literature and it did not really address, giving a second dose of this. And as a rule, you can, you know, usually an extra immunization is usually fine, but the reporter couldn't find out spelled out in the literature; no one had specifically asked him/her about this scenario, so, wondered if you that made the product, was there any unforeseen issues with doing that.
Age: 2.0
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered adult Havrix to 2-year-old; administered adult Havrix to 2-year-old; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 2-year-old patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: administered adult Havrix to 2-year-old) and overdose (Verbatim: administered adult Havrix to 2-year-old). The outcome of the adult product administered to child and overdose were not applicable.   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: 18-OCT-2023 The nurse reported that they administered adult Havrix vaccine to 2-year-old, which led to adult product administered to child and overdose.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot in 2021; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st shot in 2021). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 18-JAN-2024 The patient had 1st shot in 2021 and asked if she need to restart series. No other information provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who got 1st dose in May 2021, then 2nd dose in Oct 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2021).   In OCT-2023, the patient received the 2nd dose of Shingrix. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient who got 1st dose in May 2021, then 2nd dose in Oct 2023). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 24-APR-2024 The reporter reported that the patient who got 1st dose in May 2021, then 2nd dose in October 2023. The patient thought that she needed to get a new series, but registered pharmacist did not think she needed one. The patient received the 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Shingrix third dose administered; This non-serious case was reported by a consumer via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2 doses in 2019).   On 14-JUL-2025, the patient received the 3rd dose of Shingrix. On 14-JUL-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Shingrix third dose administered). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 14-JUL-2025 The reporter reported that a patient completed 2 doses of Shingrix in 2019 and vaccine coordinator accidentally gave patient 3rd dose of Shingrix today, which led to extra dose administered.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Patient was seen for an immunization appointment. After receiving the HPV vaccine and band-aid  application, patient had a syncopy event that lasted approximately less than 60 seconds. RN was immediately called for assistance. Patient was easily aroused by verbal command. Vitals  signs were obtained and observed as follows: BP-78/46, HR- 46, 02-97,T-98.4, Resp-18, Pain-0, Wt-111 .  Vital signs were captured every 5 minutes for three cycles. An EMS call was initiated. Upon arrival at  approximately, 11:25am, EMS determined patient had a syncopy event, and was stable, however, mom  requested patient be taken to the hospital for further evaluation. Patient was transported to Hospita
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Electrocardiogram abnormal, Myocardial infarction, Myocardial injury
Clinical narrative: Patient had her initial vaccination on 2-25-2021.  She had her second (booster) vaccination on 3-10-2025 at approximately 1:00 pm.  By 10:00 pm that evening she was having noticeable difficulty breathing which continued through the night.  At approximately 6:00 a.m. on 3-11-2025 she was admitted to ER with an active myocardial infarction.  Due to the damage in her heart, the only option for recovery was the insertion of a stent. The operation to insert the stent could not be completed and she had a second MI on 4-25-2021 and died on 4-26-2021.  For her age, she was in excellent health and actively cared for both herself and two family members who lived with her.  She had no cognitive issues and the only chronic condition she suffered from was atherosclerosis.  I am finally reporting this event as I believe that, while she was at clear risk for an MI, the booster shot likely triggered the event, especially when the booster was givien in such close proximity to the original vaccination (14 days).
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin abnormal
Clinical narrative: Patient had her initial vaccination on 2-25-2021.  She had her second (booster) vaccination on 3-10-2025 at approximately 1:00 pm.  By 10:00 pm that evening she was having noticeable difficulty breathing which continued through the night.  At approximately 6:00 a.m. on 3-11-2025 she was admitted to ER with an active myocardial infarction.  Due to the damage in her heart, the only option for recovery was the insertion of a stent. The operation to insert the stent could not be completed and she had a second MI on 4-25-2021 and died on 4-26-2021.  For her age, she was in excellent health and actively cared for both herself and two family members who lived with her.  She had no cognitive issues and the only chronic condition she suffered from was atherosclerosis.  I am finally reporting this event as I believe that, while she was at clear risk for an MI, the booster shot likely triggered the event, especially when the booster was givien in such close proximity to the original vaccination (14 days).
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: NO ADVERSE REACTIONS NOTED TO.
Age: 56.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Alanine aminotransferase increased, Asthenia, Basophil count decreased, Basophil percentage decreased, Blood albumin normal
Clinical narrative: Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an hour later her L arm started feeling hot/heavy and then right before lunch time started feeling nauseated. Started throwing up that evening. Had chest pain and SOB but this was after the vomiting. Had a fever, felt sweaty, but not sure what temp. Got constipation for three days after. In the ER got IVF and nausea medication. Had to miss 3 days of work. Has never had this type of reaction to vaccines before. Had PPSV23 in 2011 and tolerated well. This was the first time she had had hepatitis A/B that she knows of. Is now 8 days out and chest pain gone, energy mostly better, still nauseated but better than before. Bms back to normal (had gotten constipated from dehydration). Urine is normal. No one was sick at home. Hadn't eaten anything unusual that day. Has now gone back to work on Friday. Repeat lab a few days after discharge showed marked reduction in her LFTs though still mildly abnormal.
Age: 56.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride increased, Blood creatinine normal
Clinical narrative: Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an hour later her L arm started feeling hot/heavy and then right before lunch time started feeling nauseated. Started throwing up that evening. Had chest pain and SOB but this was after the vomiting. Had a fever, felt sweaty, but not sure what temp. Got constipation for three days after. In the ER got IVF and nausea medication. Had to miss 3 days of work. Has never had this type of reaction to vaccines before. Had PPSV23 in 2011 and tolerated well. This was the first time she had had hepatitis A/B that she knows of. Is now 8 days out and chest pain gone, energy mostly better, still nauseated but better than before. Bms back to normal (had gotten constipated from dehydration). Urine is normal. No one was sick at home. Hadn't eaten anything unusual that day. Has now gone back to work on Friday. Repeat lab a few days after discharge showed marked reduction in her LFTs though still mildly abnormal.
Age: 56.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Blood glucose normal, Blood lactic acid, Blood potassium normal, Blood sodium decreased, Blood urea normal
Clinical narrative: Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an hour later her L arm started feeling hot/heavy and then right before lunch time started feeling nauseated. Started throwing up that evening. Had chest pain and SOB but this was after the vomiting. Had a fever, felt sweaty, but not sure what temp. Got constipation for three days after. In the ER got IVF and nausea medication. Had to miss 3 days of work. Has never had this type of reaction to vaccines before. Had PPSV23 in 2011 and tolerated well. This was the first time she had had hepatitis A/B that she knows of. Is now 8 days out and chest pain gone, energy mostly better, still nauseated but better than before. Bms back to normal (had gotten constipated from dehydration). Urine is normal. No one was sick at home. Hadn't eaten anything unusual that day. Has now gone back to work on Friday. Repeat lab a few days after discharge showed marked reduction in her LFTs though still mildly abnormal.
Age: 56.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Carbon dioxide decreased, Carbon dioxide normal, Chest X-ray normal, Chest pain, Constipation
Clinical narrative: Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an hour later her L arm started feeling hot/heavy and then right before lunch time started feeling nauseated. Started throwing up that evening. Had chest pain and SOB but this was after the vomiting. Had a fever, felt sweaty, but not sure what temp. Got constipation for three days after. In the ER got IVF and nausea medication. Had to miss 3 days of work. Has never had this type of reaction to vaccines before. Had PPSV23 in 2011 and tolerated well. This was the first time she had had hepatitis A/B that she knows of. Is now 8 days out and chest pain gone, energy mostly better, still nauseated but better than before. Bms back to normal (had gotten constipated from dehydration). Urine is normal. No one was sick at home. Hadn't eaten anything unusual that day. Has now gone back to work on Friday. Repeat lab a few days after discharge showed marked reduction in her LFTs though still mildly abnormal.
Age: 56.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Dehydration, Dyspnoea, Eosinophil percentage decreased, Feeling hot, Haematocrit normal
Clinical narrative: Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an hour later her L arm started feeling hot/heavy and then right before lunch time started feeling nauseated. Started throwing up that evening. Had chest pain and SOB but this was after the vomiting. Had a fever, felt sweaty, but not sure what temp. Got constipation for three days after. In the ER got IVF and nausea medication. Had to miss 3 days of work. Has never had this type of reaction to vaccines before. Had PPSV23 in 2011 and tolerated well. This was the first time she had had hepatitis A/B that she knows of. Is now 8 days out and chest pain gone, energy mostly better, still nauseated but better than before. Bms back to normal (had gotten constipated from dehydration). Urine is normal. No one was sick at home. Hadn't eaten anything unusual that day. Has now gone back to work on Friday. Repeat lab a few days after discharge showed marked reduction in her LFTs though still mildly abnormal.
Age: 56.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Haemoglobin normal, Hyperhidrosis, Immature granulocyte count, Impaired work ability, Limb discomfort
Clinical narrative: Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an hour later her L arm started feeling hot/heavy and then right before lunch time started feeling nauseated. Started throwing up that evening. Had chest pain and SOB but this was after the vomiting. Had a fever, felt sweaty, but not sure what temp. Got constipation for three days after. In the ER got IVF and nausea medication. Had to miss 3 days of work. Has never had this type of reaction to vaccines before. Had PPSV23 in 2011 and tolerated well. This was the first time she had had hepatitis A/B that she knows of. Is now 8 days out and chest pain gone, energy mostly better, still nauseated but better than before. Bms back to normal (had gotten constipated from dehydration). Urine is normal. No one was sick at home. Hadn't eaten anything unusual that day. Has now gone back to work on Friday. Repeat lab a few days after discharge showed marked reduction in her LFTs though still mildly abnormal.
Age: 56.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Lymphocyte count normal, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an hour later her L arm started feeling hot/heavy and then right before lunch time started feeling nauseated. Started throwing up that evening. Had chest pain and SOB but this was after the vomiting. Had a fever, felt sweaty, but not sure what temp. Got constipation for three days after. In the ER got IVF and nausea medication. Had to miss 3 days of work. Has never had this type of reaction to vaccines before. Had PPSV23 in 2011 and tolerated well. This was the first time she had had hepatitis A/B that she knows of. Is now 8 days out and chest pain gone, energy mostly better, still nauseated but better than before. Bms back to normal (had gotten constipated from dehydration). Urine is normal. No one was sick at home. Hadn't eaten anything unusual that day. Has now gone back to work on Friday. Repeat lab a few days after discharge showed marked reduction in her LFTs though still mildly abnormal.
Age: 56.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Monocyte count normal, Monocyte percentage, Nausea, Neutrophil count increased, Neutrophil percentage increased
Clinical narrative: Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an hour later her L arm started feeling hot/heavy and then right before lunch time started feeling nauseated. Started throwing up that evening. Had chest pain and SOB but this was after the vomiting. Had a fever, felt sweaty, but not sure what temp. Got constipation for three days after. In the ER got IVF and nausea medication. Had to miss 3 days of work. Has never had this type of reaction to vaccines before. Had PPSV23 in 2011 and tolerated well. This was the first time she had had hepatitis A/B that she knows of. Is now 8 days out and chest pain gone, energy mostly better, still nauseated but better than before. Bms back to normal (had gotten constipated from dehydration). Urine is normal. No one was sick at home. Hadn't eaten anything unusual that day. Has now gone back to work on Friday. Repeat lab a few days after discharge showed marked reduction in her LFTs though still mildly abnormal.
Age: 56.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: PCO2, Platelet count normal, Protein total normal, Pyrexia, Red blood cell count normal
Clinical narrative: Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an hour later her L arm started feeling hot/heavy and then right before lunch time started feeling nauseated. Started throwing up that evening. Had chest pain and SOB but this was after the vomiting. Had a fever, felt sweaty, but not sure what temp. Got constipation for three days after. In the ER got IVF and nausea medication. Had to miss 3 days of work. Has never had this type of reaction to vaccines before. Had PPSV23 in 2011 and tolerated well. This was the first time she had had hepatitis A/B that she knows of. Is now 8 days out and chest pain gone, energy mostly better, still nauseated but better than before. Bms back to normal (had gotten constipated from dehydration). Urine is normal. No one was sick at home. Hadn't eaten anything unusual that day. Has now gone back to work on Friday. Repeat lab a few days after discharge showed marked reduction in her LFTs though still mildly abnormal.
Age: 56.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Red cell distribution width normal, Vomiting, White blood cell count increased, pH body fluid
Clinical narrative: Received the Twinrix and PCV20 in the L arm at last visit. Got her vaccines in the morning and an hour later her L arm started feeling hot/heavy and then right before lunch time started feeling nauseated. Started throwing up that evening. Had chest pain and SOB but this was after the vomiting. Had a fever, felt sweaty, but not sure what temp. Got constipation for three days after. In the ER got IVF and nausea medication. Had to miss 3 days of work. Has never had this type of reaction to vaccines before. Had PPSV23 in 2011 and tolerated well. This was the first time she had had hepatitis A/B that she knows of. Is now 8 days out and chest pain gone, energy mostly better, still nauseated but better than before. Bms back to normal (had gotten constipated from dehydration). Urine is normal. No one was sick at home. Hadn't eaten anything unusual that day. Has now gone back to work on Friday. Repeat lab a few days after discharge showed marked reduction in her LFTs though still mildly abnormal.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Contracted Shingles July 15, 2025. Treating with antivirals.
Vaccine: PNC21, PNC21
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: heavy fatigue; painful raised welt approx 2 x 4 inches centered on left deltoid injection site with 1 inch diameter rash; painful raised welt approx 2 x 4 inches centered on left deltoid injection site; This spontaneous report was received from a Patient on 02-Jul-2025 concerning his/herself of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-Jul-2025, the patient was vaccinated with a Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y019158, expiration date: 20-May-2026) (1 time), administered by Intramuscular route in the left deltoid for prophylaxis. On 02-Jul-2025, the patient experienced heavy fatigue, painful raised welt approximately 2 x 4 inches (Vaccination site urticaria, Vaccination site pain) centered on left deltoid injection site with 1 inch diameter rash on upper edge of armpit.   The patient recovered from the events approximately on 07-Jul-2025, reported as lasted for lasted for 4-5 days. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown.