chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Minor attends vaccination clinic on 01/08/2024 for the administration of his 16-year-old vaccines, menveo (MCV) and trumemba (MCV B) are administered with a booster dose in 6 months. Minor arrives today 04/02/2025 for administration of the 2nd dose of trumemenba (MCV B) when validating the vaccine in the system indicates an invalidation in the area of the trumemba vaccine (MCV B) administered on 01/08/2024 since the minor received the bexsero vaccine (MCV B) in 2019. It is validated with the health department, vaccination division area and notification was received via email from doctor with the indication that Bexsero (MCV B) be administered since she was started with it. Her primary doctor and mother are notified of the event, she expresses her understanding, and the minor is vaccinated. At the time of the interview with the mother, the same verbal statement was made: "The minor has not presented any changes or symptoms."
Age: 15.0
Sex: M
Vaccine: PNC15
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: RN administered Pneumococcal vaccine to patient. Patient is out of the age range to receive it.
Age: 0.58
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient received the incorrect RSV vaccine on 1/29/25. At the time, our office was unaware that the vaccine being carried was intended for pregnant mom's only, not for infants. On 2/3/25, this writer was made aware by staff the vaccine was showing Invalid in system, this writer then proceeded to contact our rep through the County Health Dept and was made aware that the vaccine is incorrect. This writer then took the appropriate steps to ensure no vaccines are given to infants going forward, placed an order for the correct vaccines, then on the follow day 2/4/25 reached out to the parents to make them aware and got them scheduled for appointments to come in for the correct vaccine. Parent reports no side effect or adverse reaction to the vaccine at this time.
Age: 5.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child received twinrix who was 5 years old.  The age of 18+ for this vaccine was not discovered until after vaccine had been administered.
Age: 0.08
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient received the incorrect RSV vaccine on 1/10/25. At the time, our office was unaware that the vaccine being carried was intended for pregnant mom's only, not for infants. On 2/3/25, this writer was made aware by staff the vaccine was showing Invalid in database, this writer then proceeded to contact our rep through the Health Dept and was made aware that the vaccine is incorrect. This writer then took the appropriate steps to ensure no vaccines are given to infants going forward, placed an order for the correct vaccines, then on the follow day 2/4/25 reached out to the parents to make them aware and got them scheduled for appointments to come in for the correct vaccine. Parent reports no side effect or adverse reaction to the vaccine at this time.
Age: 61.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient has already received one dose of Prevnar 20 in 04/10/2023. Patient stated he has never gotten a Pneumonia vaccine in the past. The pharmacist failed to check the system and verify the clinical appropriateness of the vaccine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Red lump in right arm 2 x  2 inches that appeared after vaccines were given on area of shots on  01-27-25, area is painful only if and when pressed, no bleeding, no discharge, no warmth. he is able to move  his arm well, no fever. no chills. Start Triamcinolone Acetonide Cream, 0.1 %, 1 application sparingly to affected area, Externally, Once a day, 7 days, 30 grams, Refills 0Start Mupirocin Ointment, 2 %, 1 application to affected area small amount, Externally, Three times a day, 7 days, 22 grams, Refills 0. If rash does not improve or resolve in a few days, or if rash changes in appearance, gets worse, symptoms seem uncontrollable, or other symptoms develop, to seek medical attention immediately.. Keep area clean and practice hygiene, using running water and soap.
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient received the incorrect RSV vaccine on 1/24/25. At the time, our office was unaware that the vaccine being carried was intended for pregnant mom's only, not for infants. On 2/3/25, this writer was made aware by staff the vaccine was showing Invalid in database, this writer then proceeded to contact our rep through the Health Dept and was made aware that the vaccine is incorrect. This writer then took the appropriate steps to ensure no vaccines are given to infants going forward, placed an order for the correct vaccines, then on the follow day 2/4/25 reached out to the parents to make them aware and got them scheduled for appointments to come in for the correct vaccine. Parent reports no side effect or adverse reaction to the vaccine at this time.
Age: 90.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: arm became red and swollen around injection site, 2-3in in diameter, warm to touch
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came in 6 days after her vaccine with swollen, red patch on arm right under injection site. Stated it feels hot and itches. Also reported some pain there and in armpit on same arm. She stated she hadn't taken any medicine to alleviate any symptoms. Pharmacist advised her to take some Benadryl for itching/swelling, Advil or Tylenol for pain and to apply a cold compress to swollen area. Advised her to keep monitoring and if there is any worsening to seek medical attention at ER/hospital.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth
Clinical narrative: Patient came in 6 days after her vaccine with swollen, red patch on arm right under injection site. Stated it feels hot and itches. Also reported some pain there and in armpit on same arm. She stated she hadn't taken any medicine to alleviate any symptoms. Pharmacist advised her to take some Benadryl for itching/swelling, Advil or Tylenol for pain and to apply a cold compress to swollen area. Advised her to keep monitoring and if there is any worsening to seek medical attention at ER/hospital.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Electrocardiogram, Malaise, Myalgia, Pyrexia
Clinical narrative: Patient complined of malaise, fever of 101, extreme muscle  and joint pain.   He went to the ED where Tylenol and Motrin were advised.  ketorolac (TORADOL) injection 60 mg was given in the ED.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: SARS-CoV-2 test
Clinical narrative: Patient complined of malaise, fever of 101, extreme muscle  and joint pain.   He went to the ED where Tylenol and Motrin were advised.  ketorolac (TORADOL) injection 60 mg was given in the ED.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Persistant L deltoid pain 11 days post-vaccine
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Injection site haemorrhage, Injection site pain, Muscle spasms, Myalgia
Clinical narrative: Patient reports 2 days later experiencing pain at injection site and pain in the left paraspinal muscles at the T2 Level, left shoulder pain, and left elbow pain. Occasional muscle spasms of the left upper arm and left forearm. Patient evaluated 1 week after vaccine which still has an area of ecchymosis approximately 3 cm in diameter at the injection site.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Mobility decreased
Clinical narrative: Pt reports that in the evening she had sudden onset weakness and unable to move her body except she was able to talk and breathe. She had 2 episodes of this during the night and each episode lasted 10 minutes. She had no residual effects after each episode.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 6m-11y Moderna vaccine given to a 17yo, no symptoms noted afterwards
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Balance disorder, Loss of personal independence in daily activities, Mobility decreased, Polymyalgia rheumatica
Clinical narrative: within eight days I noticed sore shoulders and hips while execising.  Four days later I could not get out of bed, lost balance, couldn't dress.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Eye swelling, Peripheral swelling
Clinical narrative: Swollen eyes, swollen arms
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: First vaccine no problem.  When Ihad second vaccine rash broke.  I was given. Steroid shot& it clears up.when I the booster, it came back.  Steroid shot not effective.
Age: 90.0
Sex: F
Vaccine: RSV
Symptoms: Blood gases, Dysphagia, Dysstasia, Endotracheal intubation, Gout
Clinical narrative: Unable to stand, Unable to control hand, if she raised her hand it would automatically  fall down. Unable to move legs, then hands, become strangled when taking fluids, became paralyzed. Diagnosed with Guillain-Barre' Syndrome. Admitted to hospital, intensive care, was intubated  for 7 days.. stayed in Medical Center for approx. 3 1/2 weeks transferred to Rehab. Patient there at present. Developed Gout. Never had prior
Age: 90.0
Sex: F
Vaccine: RSV
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Laboratory test, Mobility decreased
Clinical narrative: Unable to stand, Unable to control hand, if she raised her hand it would automatically  fall down. Unable to move legs, then hands, become strangled when taking fluids, became paralyzed. Diagnosed with Guillain-Barre' Syndrome. Admitted to hospital, intensive care, was intubated  for 7 days.. stayed in Medical Center for approx. 3 1/2 weeks transferred to Rehab. Patient there at present. Developed Gout. Never had prior
Age: 90.0
Sex: F
Vaccine: RSV
Symptoms: Musculoskeletal disorder, Paralysis
Clinical narrative: Unable to stand, Unable to control hand, if she raised her hand it would automatically  fall down. Unable to move legs, then hands, become strangled when taking fluids, became paralyzed. Diagnosed with Guillain-Barre' Syndrome. Admitted to hospital, intensive care, was intubated  for 7 days.. stayed in Medical Center for approx. 3 1/2 weeks transferred to Rehab. Patient there at present. Developed Gout. Never had prior
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient was vaccinated 3/6/21 and 4/10/21, tested +ve for COVID19 on 12/5/24 and expired 2/2/25
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received vaccine when not indicated for it as they received the TDAP back on 08/23/24. Patient reported no adverse symptoms.
Age: 55.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Cough, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Patient reports congestion, cough, and a severe sore throat ("raw") developing the day after the immunization.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient was vaccinated 8/24/21 and 12/21/21, tested +ve for COVID19 on 1/5/25 and expired 2/1/25
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Immediate post-injection reaction, Increased viscosity of upper respiratory secretion, Periorbital oedema, Vomiting
Clinical narrative: Patient received MMR, Varicella and Hep A vaccines after routine blood draw. Patient was crying, had episode of milky emesis right after the first  vaccine was administered. RN proceeded to give 2nd and third vaccine back to back,  Patient  continued to have intermittent episodes of emesis with thick mucous secretions. Patient placed on SpO2 monitor and was 100%.  Remained awake and crying during event in father's arms. Mild periorbital edema and slight wheezes noted on reexamination. Epi given 0.15 mg x2 and albuterol 2.5 mg x1, remained on face mask on oxygen until EMS arrived to transport patient to ED.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Wheezing
Clinical narrative: Patient received MMR, Varicella and Hep A vaccines after routine blood draw. Patient was crying, had episode of milky emesis right after the first  vaccine was administered. RN proceeded to give 2nd and third vaccine back to back,  Patient  continued to have intermittent episodes of emesis with thick mucous secretions. Patient placed on SpO2 monitor and was 100%.  Remained awake and crying during event in father's arms. Mild periorbital edema and slight wheezes noted on reexamination. Epi given 0.15 mg x2 and albuterol 2.5 mg x1, remained on face mask on oxygen until EMS arrived to transport patient to ED.
Age: 2.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Expired product administered
Clinical narrative: Covid Vaccine was expired on 1/25/25
Age: 82.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered the Arexvy vaccine on 4/2/24 and again on 1/30/25. The patient has not experienced any negative symptoms from being administered the vaccine twice, 10 months apart.
Age: 9.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Crying, Head injury, Pain, Paraesthesia, Seizure
Clinical narrative: The patient was given the vaccines. He had seemed to have done well after the vaccine & was chuckling as both RN and mother praised him for receiving his vaccines. The RN stepped out about a minute after administering and heard screaming. RN came back in and patient had an episode of syncope that resulted in a head injury with the head making contact to the chair from the examination table. Patient seized for roughly 5 seconds with eyes closed. The patient opened his eyes startled & began to cry from the pain of the fall. The patient was then brought to the table and vitals were taken. Patient described tingling in both of his hands. The EMTs then arrived and assessed patient - RN relayed head injury and seizure activity.
Age: 9.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Syncope
Clinical narrative: The patient was given the vaccines. He had seemed to have done well after the vaccine & was chuckling as both RN and mother praised him for receiving his vaccines. The RN stepped out about a minute after administering and heard screaming. RN came back in and patient had an episode of syncope that resulted in a head injury with the head making contact to the chair from the examination table. Patient seized for roughly 5 seconds with eyes closed. The patient opened his eyes startled & began to cry from the pain of the fall. The patient was then brought to the table and vitals were taken. Patient described tingling in both of his hands. The EMTs then arrived and assessed patient - RN relayed head injury and seizure activity.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenocortical insufficiency acute, Condition aggravated, Intensive care
Clinical narrative: Adrenal Crisis with ICU care.  This patient received the Covid-19 vaccine on 11/19/24.  On 11/21/24 she went into Adrenal Crisis which resulted in an ICU stay.  The patient was in the ICU for two days and then returned to our facility.
Age: 94.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had already received RSV vaccine on 1/17/2024
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had already received a dose of RSV vaccine on 1/17/2024
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: This patient reported a swollen upper lip three days after receiving the covid-19 vaccines.  Benadryl 50mg was administered.  The swelling resolved over the course of the day following the Benadryl.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID INFECTION WITH HOSPITALIZATION AFTER VACCINATION
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Electrocardiogram abnormal, Fatigue, Myalgia
Clinical narrative: The patient was evaluated for chest pain with EKG changes. They repeated EKG and found previous EKGs which showed similar findings. Troponin was negative and not changing. Imaging including CTA chest/abdomen/pelvis was reassuring. They felt that patient's discomfort was likely musculoskeletal in etiology and recommended symptomatic measures for that. of note, patient recently had the Covid vaccine and it is possible that he is having myalgias and fatigue related to that in retrospect.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Scan with contrast normal, Troponin normal
Clinical narrative: The patient was evaluated for chest pain with EKG changes. They repeated EKG and found previous EKGs which showed similar findings. Troponin was negative and not changing. Imaging including CTA chest/abdomen/pelvis was reassuring. They felt that patient's discomfort was likely musculoskeletal in etiology and recommended symptomatic measures for that. of note, patient recently had the Covid vaccine and it is possible that he is having myalgias and fatigue related to that in retrospect.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Patient reports that he had his COVID vaccination booster (Dec 2024) and has had left arm pain at the injection site intermittently since then that began at the time of injection and has never gone away.  Rates pain as minimal, comes and goes, notices it more than once a day as an "ache." Not severe enough to limit ROM or activity, no particular inciting motions or pressure that reproduces the ache, seems to be at random. No numbness, no tingling, no radiation of symptom. Never had bruising or redness. Has not ever been painful enough that he would consider taking a pain reliever, but since it has been ongoing, he wanted to mention it.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Extra dose administered, Fatigue, Nausea
Clinical narrative: patient went to physician reporting nausea/vomiting, dizziness, rash, swelling, redness and fatigue. md discovered patient had received an unnecessary 3rd dose of shingrix.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling, Vomiting
Clinical narrative: patient went to physician reporting nausea/vomiting, dizziness, rash, swelling, redness and fatigue. md discovered patient had received an unnecessary 3rd dose of shingrix.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Child received COVID-19 vaccine,    the vaccine expired on 1/30/2025.  Manufacturer expiration date= 12/31/2025,  use by date in regards to thaw date was 1/30/2025.  No immediate adverse reaction noted .   PCP notified of incident ,pcp called and  informed parent.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Shingrix Vaccine, Headache, Exhaustion, muscle ache, weakness and swelling at site and soreness. Lasted about 5 days
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Shingrix Vaccine, Headache, Exhaustion, muscle ache, weakness and swelling at site and soreness. Lasted about 5 days
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effects noted. Patient received 2 doses of Arexvy (incorrect dosing interval) - 1st dose given 12/23/2023 and 2nd dose given 02/03/2025 .
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: My left arm is tingling and numb from the injection site through my arm all the way down to my hand. It comes and goes hundreds of times a day, every day since the injection. (about a week today)
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Headache
Clinical narrative: Headache for over a week (still present today)
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching all over (not at injection site) onset approximately 10 hours after receiving injection.  Hives noted to palms of hands the next morning at approximately 6am. Hives then began to spread over body.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed a rash that doesn't go away, the patient is unsure about the time line so the vaccine is unlikely to be the culprit but there is a possibility it was during the time after his second vaccine.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was given DTap when she should have received TD or TDap due to her age.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: lingering left deltoid soreness
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Chest pain, Injection site pain, Injection site reaction, Injection site swelling, Insomnia
Clinical narrative: Patient reports stiff swollen area at site of injection beginning day of injection and continuing to time of report. Reports pain occasionally radiating to chest, reports pain in their arm with motion. Reports difficulty sleeping due to pain from injection site. Reports fever x4 days.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient reports stiff swollen area at site of injection beginning day of injection and continuing to time of report. Reports pain occasionally radiating to chest, reports pain in their arm with motion. Reports difficulty sleeping due to pain from injection site. Reports fever x4 days.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC20, RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received the flu shot - she did not want it - no reaction or otherwise from the actual injection itself.
Age: 87.0
Sex: F
Vaccine: PNC21, RSV
Symptoms: Erythema, Hypersensitivity, Swelling
Clinical narrative: pt had severe allergic reaction, redness  and swelling . pt seen by her doctor  and got prescribed Medrol dose pack
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This vaccine was administered subcutaneously instead of Intramuscular.   There have been no adverse reactions from this administration.  Provided was consulted and the necessary follow up actions were taken.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Flushing, Immediate post-injection reaction, Urticaria
Clinical narrative: Patient presents to clinic for 12month vaccine. verified patients full name and DOB. Parents of patient stated  reactions to influenza vaccines and Prevnar 20  in the past. Stated they were seen by an allergy specialist and  determined it would be  sufficient to continue age specific vaccination process. Spoke with the pediatrician  who follows patient , here in clinic and concluded to move forward with vaccinating. Parents had prescribed EpiPen junior, and Benadryl.   The benadryl was given 5-10 minutes prior to vaccine administration. After administering the MMR, Varicella, and Hep A, I noticed immediate flush skin throughout body and hives. Notified the pediatric provider team and administered the EpiPen, monitored vitals and observed patient. Hives immediately  disappeared, vitals were stable and monitored patient in clinic for 1 hour.
Age: 81.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient's daughter (caretaker) called us on 2/4/25 to report that on 2/4/25 patient started to experience redness and itching at the injection site.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to child age 6 years.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received one dose too many due to incomplete order from 2021 that should have been closed.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP called and reported inadvertent administration of GARDASIL 9 to a patient after a temperature excursion that occurred on 02DEC2024. Vaccine was administered after the excursion on 24DEC2024.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 24-DEC-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X026668, expiration date: 10-APR-2026, administered for prophylaxis (strength, route of administration, and anatomical location were not provided) that underwent a temperature excursion that occurred on 02-DEC-2024.  The temperature excursion was 46.7 degrees Fahrenheit for the time frame of 192 hours. There was no previous temperature excursion.  No adverse event.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called and reported inadvertent administration of GARDASIL 9 to a patient after a temperature excursion that occurred on 02DEC2024. Vaccine was administered during the excursion on 07DEC2024.; This spontaneous report was received from a medical assistant 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 02-DEC-2024, a temperature excursion occurred at 46.7 F for 192 hours. Later, on 07-DEC-2024, the patient was vaccinated with a improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X026668, expiration date: 10-APR-2026, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No previous temperature excursion occurred. No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called and reported inadvertent administration of GARDASIL 9 to a patient after a temperature excursion that occurred on 02DEC2024.; This spontaneous report was received from Other Health Professional and refers to a patient of a not reported age or gender.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On 24-DEC-2024, the patient was vaccinated with  an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X026668, expiration date: 10-APR-2026, administered for prophylaxis (strength, dose description and route of administration were not provided) after a temperature excursion of 46.7 Fahrenheit for 192 hours 0 minutes 0 seconds, it was stated that no previous temperature excursion occurred. No additional adverse event occurred.
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: First Dose Heplisav-B, Second Dose Twinrix; Initial report received on 03-Jan-2025.  A pharmacist reported that a 59-year-old (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received TWINRIX as the second dose of the series.  No medical history or concomitant medications were reported.    On 24-Aug-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 943008, expiration 30-Sep-2025, NDC # 43528-0003-05) intramuscularly in the left deltoid.    On 29-Sep-2024, the patient received a dose of TWINRIX (hepatitis A/hepatitis B vaccine).    Reporter stated that no 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.
Sex: U
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: incidence of Guillian; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: incidence of Guillian) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Arexvy.     The company considered the guillain barre syndrome to be unrelated to Arexvy.   Additional Information: GSK receipt date: 24-JAN-2025 Reporter stated that patient had incidence of Gullian.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patients that have developed a skin rash; This non-serious case was reported by a physician via sales rep and described the occurrence of skin rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the  unspecified number of patients patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced skin rash (Verbatim: patients that have developed a skin rash). The outcome of the skin rash was unknown.   The reporter considered the skin rash to be related to Shingrix.     The company considered the skin rash to be related to Shingrix.   Additional Information: GSK Receipt Date:06-JAN-2025 Physician mentioned that he had patients that have developed a skin rash following a dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; you can still get it after getting the vaccine I  did but it's a much weakened version; 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 (Shingrix) for prophylaxis.   The patient's past medical history included post herpetic neuralgia (Developed Post Herpetic Neuralgia right after the Shingles cleared up), shingles (right after the Shingles cleared up) and pain. Previously administered products included Gabapentin and Codine.   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: you can still get it after getting the vaccine I  did but it's a much weakened version). 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 to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JAN-2025 This case was reported by a patient via interactive digital media. Consumer reported that they got it really bad 4 years ago.  Developed Post Herpetic Neuralgia right after the Shingles cleared up and the pain upped a few notches.  He /she couldn't stand up straight or hardly move because of it. Internal electric shocks had doubled up for almost a week until they saw a doctor (in person) and he knew what it was and got the patient on Gabapentin. Patient had gone to an urgent care, and they only gave them codine - which was did nothing for the pain. Got the vaccine as soon as possible doctor was recommended for waiting a year and he/she thoroughly recommends getting the shingles vaccine if you've ever had Chickenpox because the virus never goes away. Consumer mentioned that you can still get it after getting the vaccine as he/she did but it's was much weakened version mostly just really itchy and a few red spots in the same area. 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. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt like hell for a week-bad reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal 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 feeling abnormal (Verbatim: felt like hell for a week-bad reaction). The outcome of the feeling abnormal was resolved (duration 1 week).   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JAN-2025 This case was reported by a patient via interactive digital media. The patient reported that the vaccine was a series of 2 shots. The patient had received the 1st dose and felt like hell for a week-bad reaction, so he/she did not get the 2nd shot. But patient further reported that shingles was a way worse hell so he/she probably should have had the 2nd dose.
Sex: U
Vaccine: RSV
Symptoms: Dyspnoea
Clinical narrative: I'm having more trouble breathing since the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced difficulty breathing (Verbatim: trouble breathing). The outcome of the difficulty breathing was not reported.   It was unknown if the reporter considered the difficulty breathing to be related to Arexvy.     It was unknown if the company considered the difficulty breathing to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had more trouble breathing since the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; also had shingles several years later; within a few days, came down with 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: also had shingles several years later) and shingles (Verbatim: within a few days, came down with shingles). The outcome of the vaccination failure, shingles and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, shingles 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 and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JAN-2025 This case was reported by a patient via interactive digital media. Patient reported that he/she received the Shingles shot and within a few days, came down with Shingles. He/she also mentioned that it was horrible, and asked to keep in mind that this was a possibility. Patient also had shingles several years later. 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,  completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Product use in unapproved indication
Clinical narrative: unapproved indication; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug use for unapproved indication 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 drug use for unapproved indication (Verbatim: unapproved indication). The outcome of the drug use for unapproved indication was unknown.   Additional Information: GSK Receipt Date: 24-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient was glad to had shot when he/she came down with them, which led to Drug use for unapproved indication.
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: aask for a 8 years old patient that they don't know which vaccine can they give him; patient received 3 DTaP and last one was at 4 years and 10 months old; 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 8-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   Previously administered products included Infanrix (received 2nd dose on an unknown date) and Infanrix (received 1st dose on an unknown date).   On an unknown date, the patient received Infanrix and the 3rd dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix and not applicable after receiving Infanrix, the patient experienced incomplete course of vaccination (Verbatim: aask for a 8 years old patient that they don't know which vaccine can they give him) and inappropriate age at vaccine administration (Verbatim: patient received 3 DTaP and last one was at 4 years and 10 months old). The outcome of the incomplete course of vaccination and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-NOV-2024 The healthcare professional called to ask for a 8 years old patient that they did not know which vaccine could they give him. They could not give the Dtap, the Kinrix or the Tdap because of his age. The reporter asked which vaccine could be administered. The patient received 3 DTaP and last one was at 4 years and 10 months old which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive booster dose of Infanrix vaccine, which led to incomplete course of vaccination.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: painful lump in her left deltoid; painful lump in her left deltoid; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site lump in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-DEC-2024, the patient received Arexvy (intramuscular, left deltoid). On 06-DEC-2024, less than a day after receiving Arexvy, the patient experienced injection site lump (Verbatim: painful lump in her left deltoid) and injection site pain (Verbatim: painful lump in her left deltoid). The outcome of the injection site lump and injection site pain were not resolved.   It was unknown if the reporter considered the injection site lump and injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site lump and injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-JAN-2025 The patient self-reported this case for herself. Patient reported that she received her Arexvy vaccine and has had a painful lump in her left deltoid that has not resolved.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a patient that received the Kinrix vaccine that was 4 months old; it was the 2nd dose of DTap and IPV for the patient; 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 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 27-DEC-2024, the patient received Kinrix. On 27-DEC-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a patient that received the Kinrix vaccine that was 4 months old) and inappropriate schedule of vaccine administered (Verbatim: it was the 2nd dose of DTap and IPV for the patient). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JAN-2025 A patient that received the Kinrix vaccine that was 4 months old, which led to an inappropriate age at vaccine administration. According to reporter, it was the 2nd dose of DTap and IPV for the patient, which led to an inappropriate schedule of vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Extra dose administered, Interchange of vaccine products, Wrong patient received product
Clinical narrative: menveo was given to a patient by mistake; menveo was given to a patient by mistake; had Menactra first dose and received Menveo second dose; 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 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 7GF79, expiry date 31-DEC-2025) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA989A) for prophylaxis and Meningococcal vaccine A/C/Y/W conj (dip tox) (Menactra) for prophylaxis.   Concomitant products included HPV vaccine VLP rL1 4v (yeast) (Gardasil).   On 08-JAN-2025, the patient received the 2nd dose of Menveo. On 27-NOV-2024, the patient received the 1st dose of Menveo. On 01-MAY-2023, the patient received the 1st dose of Menactra. On 27-NOV-2024, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced interchange of vaccine products (Verbatim: had Menactra first dose and received Menveo second dose). On 08-JAN-2025, the patient experienced extra dose administered (Verbatim: menveo was given to a patient by mistake) and administered drug to incorrect patient (Verbatim: menveo was given to a patient by mistake). The outcome of the extra dose administered, administered drug to incorrect patient and interchange of vaccine products were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2025  The other health professional reported that a dose of Menveo was given to a patient by mistake, mentions patient looked similar to her sister who was supposed to be vaccinated with menveo, so the wrong patient got vaccinated which led to administered drug to incorrect patient.  The patient also received gardasil vaccine on the same clinic day. The patient had Menactra first dose and the patient received Menveo dose (2 vials presentation) which led to interchange of vaccine products. 18 year old patient received 2 doses of Menveo which led to extra dose administered.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: got Twinrix injection on 16Nov2024 and he is just now returning for 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix on 16th November 2024).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: got Twinrix injection on 16Nov2024 and he is just now returning for 2nd dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JAN-2025 The pharmacist reported that the patient got Twinrix injection and he was just returning for the 2nd dose at time of reporting. Till the time of reporting the patient did not receive the second dose of Twinrix which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received their first dose of Shingrix 5 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received their first dose of Shingrix 5 years ago ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received their first dose of Shingrix 5 years ago ). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-JAN-2025 Pharmacist called reporting a received their first dose of Shingrix 5 years ago and pharmacist was looked for recommendations for how to proceed with series.  Did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.