chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the vaccine and currently have the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (mild case in 20s).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the vaccine and currently have the shingles). The patient was treated with calamine. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-JUL-2025 The case was received from a patient via interactive digital media.  The patient got the vaccine and currently had the shingles. It was only on the patient's right upper arm in 3 areas and only hurt for 2 days once the areas started to blister. The patient put calamine lotion on it several times a day. It was starting to dry up now. The patient woke up Wednesday saw bumps and red areas thinking he/she was bitten by a bugs. Then it started looking like a rash the next day and the reporter realized it was the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter stated that everyone they knew, got shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had singles twice after the shot;  This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had singles twice after the shot). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-JUL-2025 This case was reported by a patient via interactive digital media. The patient had shingles twice after the Shingles shot This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HAV (Havrix) (batch number 3397T, expiry date 30-NOV-2023) for prophylaxis.   On 28-FEB-2025, the patient received Havrix. On 28-FEB-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix expired dose administration). The outcome of the expired vaccine used 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: 10-JUL-2025 A health care provider wanted to know if a dose of Havrix (lot 3397T) was expired when it was administered on 28 February 2025.  The agent confirmed that it expired on 30th November 2023, which led to expired vaccine used and offered to give the information of the recommendations in this case, but she mentioned that only wanted to receive it via email.  The presentation given was pediatric, thus the adverse event it's only for the expired dose administration. The health care professional mentioned that the vaccine could have been given in the facility.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: longer interval between doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29-NOV-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix.The patient experienced incomplete course of vaccination (Verbatim: longer interval between doses). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 15-JUL-2025 Pharmacist reported a patient received her first dose of Shingrix in 2023 and now wanted to come in to get a dose.   Patient had not yet received second dose. The lot and expiration date of 1st dose was not available from healthcare professional. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: she accidentally gave a pediatric dose of Engerix-B to an adult patient; she accidentally gave a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 53-year-old female patient who received HBV (Engerix B pediatric) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b adulto).   On 11-APR-2025, the patient received the 2nd dose of Engerix B pediatric. On 11-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: she accidentally gave a pediatric dose of Engerix-B to an adult patient) and adult use of a child product (Verbatim: she accidentally gave a pediatric dose of Engerix-B to an adult patient). The outcome of the accidental underdose and adult use of a child product 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: 15-JUL-2025 The certified medical assistant explained she accidentally gave a pediatric dose of Engerix-B to an adult patient on 11th April 2025 which led to adult use of a child product and accidental underdose. The patient got a first dose of Engerix-B on 7th March 2025, it was the usual adult dose.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Patient was given Infanrix that was 4 days expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received DTPa (Infanrix) (batch number YC239, expiry date 13-JUL-2025) for prophylaxis.   On 17-JUL-2025, the patient received Infanrix. On 17-JUL-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Patient was given Infanrix that was 4 days expired). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-JUL-2025 The reporter mentioned that a patient was given Infanrix that was 4 days expired, which led to expired vaccine used Consent to follow up granted.
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: how you have to twist the little cap, it came off and I guess the glass from the Prevnar because it broke off and it is stuck in the part where the needle goes in; The initial case was missing the following minimum criteria: Info not qualifying for AE reporting - Product Complaint: no indication that the consumer experienced an event under Product Prevnar 20. Upon receipt of follow-up information on 16Jul2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from product quality group.  This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4931, Expiration Date: 31Jul2026) for immunisation. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "how you have to twist the little cap, it came off and I guess the glass from the Prevnar because it broke off and it is stuck in the part where the needle goes in".  The reporter considered "how you have to twist the little cap, it came off and i guess the glass from the prevnar because it broke off and it is stuck in the part where the needle goes in" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "how you have to twist the little cap, it came off and i guess the glass from the prevnar because it broke off and it is stuck in the part where the needle goes in" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Follow-up (16Jul2025): This is a spontaneous follow-up report received from product quality group. Updated information: reportability assessment.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Vaccination site erythema
Clinical narrative: Redness extending around the shot but not in the area of the spot/This lasted for about 1.5 weeks after the shot; This is a spontaneous report received from an Other HCP from a sales representative.  An adult female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Jul2025 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 01Jul2025 as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 02Jul2025, outcome "recovered", described as "Redness extending around the shot but not in the area of the spot/This lasted for about 1.5 weeks after the shot". Therapeutic measures were not taken as a result of vaccination site erythema.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: blood pressure high, real high; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OZEMPIC; HUMIRA. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "blood pressure high, real high". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500086335 same patient/drug, different dose/event;
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: patient received 2nd  prevnar20 vaccine
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Aged 38 yr old rec'd the Adjuvanted flu vaccine intended for over 65yr.   Recipient picked up the wrong form, certified pharmacy technician /vaccinator did not check the age at top of form.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: recipient was under 65yr, inadvertently rec'd Adjuvanted flu vaccine.  Patient selected wrong form. Certified Pharm Tech/Vaccinator administered shot without noticing age <65yr.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Recipient was administered Flu vaccine intended for >65yr. Recipient was under 65 yr old.  Wrong form was completed, Certified Pharm Tech/Vaccinator did not notice patient age.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Diarrhoea, Haematochezia, Mucous stools
Clinical narrative: Patient was in for his well check 1 week ago. Parents report that he developed diarrhea that evening (Tuesday) that continued through Saturday w/5-6 episodes of diarrhea daily. He had a small amount of blood and mucus in 1 stool each day on Friday and Saturday. He had no associated symptoms including fever. There was no change in his diet through this time. He is breastfeeding and Mom reports no change to her diet either. His stools, mood, and appetite have been normal since Saturday. Discussed potential sources of diarrhea and bloody stools, not likely milk protein allergy with spontaneous resolution and unchanged diet. Discussed that this may be due to Rotarix vaccine. There are postmarketing reports of hematochezia, no recommendation noted for subsequent doses.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was under 65yr old but rec'd vaccine intended for >65yr.  Wrong form was completed and Certified Pharm Tech/Vaccinator did not notice age<65yr.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Complex regional pain syndrome, Joint injury, Ligament rupture
Clinical narrative: crps developed from minor ankle fix and ligament tear. no period for 8 months after injury. had regular periods prior. pain did not match injury that should have healed and went onto a pain free life.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: fatigue, weakness, decreased energy, dizziness started the following day
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC20, VARCEL
Symptoms: Abdominal mass
Clinical narrative: 1 cm raised round movable lump right groin; 1 cm round flat lump noted in left groin - parents discovered lumps today.  Vaccination occurred one week ago.  Nurse recommended infant be seen by provider in walk in.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Patient experienced  ADRs in the form of swelling, redness, warm, and pain to the touch that lasted for over 6 weeks. The pain still remains.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Fall, Loss of consciousness
Clinical narrative: patient was given both immunizations while sitting on exam table and right after patient passed out while sitting down. He fell backwards and slid down wall. Patient was then laid flat with feet elevated and regained consciousness within 30 seconds.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity
Clinical narrative: Patient has experienced prolong soreness of the arm - Administered on 6/30/2025,  Mom called 7/14/2025 to report she is still experiencing pain, advised to treat with Aleve.  7/22/2025 office called to check on patient, patient pain has improved but still present.  Due to ongoing pain, MD prescribed Medrol dose pack. Mom to call back if pain is not improved after completion.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC15, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event. Gave the wrong vaccine. Patient was supposed to get an MMR and varicella separately at 12 mos. Instead received a Proquad and Varicella. They received a double dose of varicella.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The covid vaccine's 10-week refrigerated use by date was 7/21/25. Vaccine was administered to patient on 7/22/25.
Age: 54.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right deltoid induration and redness.  Picture taken and placed in chart 7/23/25.  No systemic symptoms.
Age: 6.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was inadvertently given a Vaxelis vs just the DTap.  No reaction / side effects noted.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Skin warm
Clinical narrative: Patient came into doctors office with rash hot to touch that patient stated started on the evening of Sunday 07/20/2025.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Hyperhidrosis, Hypoaesthesia, Nasopharyngitis, Neck pain, Pain in extremity
Clinical narrative: I got a funny pain, and all of sudden i started feeling a travel pain and the pain spread up. It went up the arm and back down the arm. And it went all the way to neck and it was numbing out. And it was painful but it was numb after. It went across the side of my face and whole side of my face was numb. It was just a bad reaction that the nurse checked to see if i had a stroke at the same moment and the whole area reacted. But the face numbing i have never had happen from any other vaccine i have ever had in my life. I think that it spread with my blood as the vaccine was going throughout my body, It took 2 days for the side effects to leave. Now on the injection site there was no swelling no redness no nothing you could not even see that i had an injection and the injection site did not even bleed. Just the side of my bottom was numb but not my leg just the upper body.  On the 21st i broke into a heart sweat, every inch of my was wet including my scalp. I went and took and shower and when i went to the bathroom the toilet seat was wet, I was very careful in the shower i was in there for no more then 10 mins. I do not know if that was from the shot or from the weather. I have been more sleepy. It is possible that i have a cold, but i am just not sure if this came from the shot or not.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Somnolence
Clinical narrative: I got a funny pain, and all of sudden i started feeling a travel pain and the pain spread up. It went up the arm and back down the arm. And it went all the way to neck and it was numbing out. And it was painful but it was numb after. It went across the side of my face and whole side of my face was numb. It was just a bad reaction that the nurse checked to see if i had a stroke at the same moment and the whole area reacted. But the face numbing i have never had happen from any other vaccine i have ever had in my life. I think that it spread with my blood as the vaccine was going throughout my body, It took 2 days for the side effects to leave. Now on the injection site there was no swelling no redness no nothing you could not even see that i had an injection and the injection site did not even bleed. Just the side of my bottom was numb but not my leg just the upper body.  On the 21st i broke into a heart sweat, every inch of my was wet including my scalp. I went and took and shower and when i went to the bathroom the toilet seat was wet, I was very careful in the shower i was in there for no more then 10 mins. I do not know if that was from the shot or from the weather. I have been more sleepy. It is possible that i have a cold, but i am just not sure if this came from the shot or not.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Neck pain, Pain, Product administered at inappropriate site
Clinical narrative: Pt reported extreme radiating pain from site of shot given upwards toward neck and upper back. Pt stated she went to her personal physician and was told that a nerve was likely struck with the needle during administration, and that the shot was likely given too deeply. Pt stated she is of smaller size and the needle was very long.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid vac did not work; covid vac did not work; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid vac did not work".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administration of an expired ADACEL with no reported adverse event; Initial information received on 21-Jul-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old male patient who was administered of an expired diphtheria-2/tetanus/5 ac pertussis vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) and HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) both for prophylactic vaccination (Immunisation).  On 21-Jul-2025, the patient received an unknown dose of expired suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection (lot 2CA69C1, expiry date: 20-Jul-2025, strength: standard and frequency: once) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (Latency: same day).  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, RV5
Symptoms: Crying, Dyskinesia, Infant irritability, Muscle twitching, Myoclonus
Clinical narrative: Infant with new onset of infantile abnormal movements with upper and lower extremity tremor/jerking movements on day of immunization. she was increasingly irritable.  infant was laying on her back, alert and crying/irritable, when she developed dyssynchronous upper extremity tremor/myoclonus.  Not symmetric, not rhythmic, does not spread from 1 lateral extremity to the other, infant awake and alert throughout event.  Some myoclonic activity/twitching of lower extremities noted as well.  Did not seem significantly fatigued following this unusual movement. Has had no further events since day of vaccination.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, RV5
Symptoms: Tremor
Clinical narrative: Infant with new onset of infantile abnormal movements with upper and lower extremity tremor/jerking movements on day of immunization. she was increasingly irritable.  infant was laying on her back, alert and crying/irritable, when she developed dyssynchronous upper extremity tremor/myoclonus.  Not symmetric, not rhythmic, does not spread from 1 lateral extremity to the other, infant awake and alert throughout event.  Some myoclonic activity/twitching of lower extremities noted as well.  Did not seem significantly fatigued following this unusual movement. Has had no further events since day of vaccination.
Age: 39.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Chills, Trismus
Clinical narrative: patient came to pick up prescription on 07/23/2025 during counseling he mentioned on 05/16/2025 he got HEPLISAV AND VAQUTA . He stated he had locked jaw and severe chills from the vaccine but felt better after 24 hours
Age: 88.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: PT SITE OF INJECTION DEVELOPED RASH THAT WENT DOWN TO HER ELBOWS. PT WAS SEEN AT THE DR TO EVALUATE. NO OTHE REACTION
Age: 53.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Gave yellow fever vaccine instead of typhoid vaccine. Treatment: Informed travel clinic doctor (Dr.). Informed patient and Supervisor (RN), Cbc with Diff ordered. Patient will return next day for a typhoid vaccine with in 24 hours of receiving yellow fever vaccine as instructed by Dr. Outcome, no adverse reaction per patient at this time.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Chills, Tremor
Clinical narrative: Gardasil and MenQuadfi were administered, then labs were drawn. When the patient walked to the front office after the lab draw to check out, the patient started shivering/shaking. NP was notified immediately by MA of patient's condition and NP went immediately to assess the patient. No signs or symptoms of uticaria, swelling, lightheadedness, syncope, or shortness of breath visualized or reported by pateint. Caregivers gave patient Pedialyte and a candy bar, which the patient ingested. The patient was monitored for 15 minutes. Symptoms improved and pateint stated "I'm feeling better." Patient, Father and Aunt were counseled to go to ER if symptoms worsen, and all verbalized understanding. Patient was able to ambulate safely to his personal vehicle with his Father. 07/23/2025 @12:00PM
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine abnormal
Clinical narrative: creatinine levels went up and down for a week or two; This is a spontaneous report received from a Pharmacist from medical information team.  A male patient in his 40's received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rett's syndrome" (unspecified if ongoing), notes: on the spectrum of Rett's syndrome non-verbal spasticity the spectrum, not verbal spasticity. The patient's concomitant medications were not reported. The following information was reported: BLOOD CREATININE ABNORMAL (non-serious), outcome "recovered", described as "creatinine levels went up and down for a week or two". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller inquired about the frequency of COVID-19 booster vaccinations for their family members, including their son with specific health conditions. The caller mentioned past practices of receiving the vaccine every six months and sought confirmation on whether this schedule should continue despite being advised otherwise by a pharmacist. Patient on the spectrum of Rett's syndrome non-verbal spasticity the spectrum, not verbal spacity. Everytime patient got a booster, he got it every 6 months, and no one ever said, he could get it once a year. Additionally, he mentioned that the only time patient got a problem with the covid vaccine was on his first dose a few years back., where his creatinine levels went up and down for a week or two. But with every booster afterwards he was fine.
Age: 0.17
Vaccine: HPV9, HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AEs were reported; 2 month old patient received a dose of GARDASIL 9; This spontaneous report was received from healthcare worker and refers to a 2-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 03-Jul-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #y015599, expiration date: 10-Feb-2027) (strength, dose, frequency, and anatomical location were not reported), 1 dose, for prophylaxis (Product administered to patient of inappropriate age). No adverse event reported.   Lot # is being requested and will be submitted if received.
Age: 0.17
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; 2 month old patient received a dose of GARDASIL 9; This spontaneous report was received from healthcare worker and refers to a 2-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 03-Jul-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #y015599, expiration date: 10-Feb-2027) (strength, dose, frequency, and anatomical location were not reported), 1 dose, for prophylaxis (Product administered to patient of inappropriate age). No adverse event reported.   Lot # is being requested and will be submitted if received.
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Inadvertent Administration of a Vaccine Following Temperature Excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Boostrix, Engerix B, Havrix, Infanrix, Kinrix, Menveo and Pediarix. On an unknown date, an unknown time after receiving Boostrix, Engerix B, Havrix, Infanrix, Kinrix, Menveo and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Inadvertent Administration of a Vaccine Following Temperature Excursion). The outcome of the incorrect storage of drug 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:15-JUL-2025 Pharmacist reported that on 11th October 2024 Boostrix, Engerix-B, Havrix, Infanrix, Kinrix, Menveo (no lot number or data on presentation available) and Pediarix were exposed to a lowest temperature of 30.9F for less than 5 minutes. These vaccines have been administered to patients.  HCP is trying to determine which are the patients involved. No further information available. No further information available.  The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Epilepsy
Clinical narrative: epilepsy after taking pentacel; Initial information received on 18-Jul-2025 regarding an unsolicited valid  serious case received from a other health professional.  This case is linked to the following cases- US-SA-2025SA209738, US-SA-2025SA209950 and US-SA-2025SA209519.  This case involves a 2 months old male patient who had epilepsy after taking Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel); HIB vaccine conj (tet tox) (Act hib) and Polio vaccine inact 3v (Vero) (Ipol) for Immunisation.  On 22-Aug-2017 , the patient received 0.5mL (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot C5370AA) via intramuscular route in the left thigh , on 23-Oct-2017, he also received 0.5mL (dose 2) (lot C5374AA) and on 18-Dec-2017, he also received 0.5mL (dose 3) of vaccine (lot C5294AA) (strength standard and frequency once) (expiry date not reported) via intramuscular route in the left vastus lateralis for Immunisation.  On an unknown date in Nov-2017, the patient developed epilepsy after taking pentacel (epilepsy) (latency approximately few few days following the administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine.   Action taken was not applicable.  A corrective treatment was received for the event.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.  Seriousness criteria- The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 22-JUL-2025: This case involves a 2 months old male patient who had epilepsy after taking Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)]. Further information regarding allergic history, laboratory investigations, medical history, and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. US-SA-2025SA209738:Act-hib US-SA-2025SA209950:IPOL US-SA-2025SA209519:Daptacel
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Epilepsy
Clinical narrative: epilepsy; Initial information received on 18-Jul-2025 regarding an unsolicited valid  serious case received from a other health professional.  This case is linked with the following cases- US-SA-2025SA209950, US-SA-2025SA209738 and US-SA-2025SA209387.   This case involves a 3 months old male patient who had epilepsy after receiving Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine conj (tet tox) (Act hib), Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel) and Polio vaccine inact 3v (Vero) (Ipol) for Immunisation.  On 18-Sep-2017, the patient received 0.5mL (dose 1)  of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot C5190AA) via intramuscular route in the left thigh and on 21-Jun-2021 he also received 0.5mL (dose 2) (lot C5743AA) (strength standard and frequency once) (expiry date unknown) via intramuscular route in the right deltoid for prophylactic vaccination (Immunisation).   On an unknown date in Nov-2017, the patient developed epilepsy (epilepsy) (latency approximately two months) following the administration of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria - The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 22-JUL-2025: This case involves a 3 months old male patient who had epilepsy after receiving Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel]. Further information regarding allergic history, laboratory investigations, medical history and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. US-SA-2025SA209387:pentacel US-SA-2025SA209950:IPOL
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: she gave 0.5 mL subcutaneously instead of IM; he gave 0.5 mL subcutaneously instead of IM, she gave it in the forearm; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 20-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H4279, expiry date 30-AUG-2027) for prophylaxis.   On 15-JUL-2025, the patient received Boostrix (subcutaneous, unknown arm) .5 ml. On 15-JUL-2025, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: she gave 0.5 mL subcutaneously instead of IM) and vaccine administered at inappropriate site (Verbatim: he gave 0.5 mL subcutaneously instead of IM, she gave it in the forearm). The outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site 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: 16-JUL-2025 Practice manager reported that called because one of the nurses made an error while giving immunizations, that involved the Boostrix.  Reporter mentioned what happened if that she gave the Boostrix 0.5 ml subcutaneously instead of intramuscularly, she gave it in the forearm, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. So, reporter wanted to see potential, if being in a different location and potential for anything. The reporter said that to the second line agent that he did not give the complete dose, only 0.5, however according to package insert was the recommended dose.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Agnosia, Anxiety, Aphasia, Balance disorder, C-reactive protein increased
Clinical narrative: After her second injection she immediately stated that the arm she received the injection in started with unbearable pain, then terrible headache later that night. The next day was having breathing issues, had to call the rescue squad, told her to go to the hospital, became unresponsive, had to intubate her, stayed for several nights, then discharged her with adverse reaction to the vaccine, one doctor admitted it, after discharge fatigued, respiratory , vision started changed, got pneumonia in the hospital but they said was aspiration pneumonia, took a long time to see specialists like pulmonologist, 3 weeks Dec 4 visiting the mom, looked like having a stroke, went to the hospital, was stuttering really badly, started left face drooping, was fine that morning, out with her kids, went to put something in the garbage, lost her balance and realized she was not ok, felt dizzy, her grandma helped her then mouth started going numb, then couldn't talk or write, looked spacy, failed the test for a stroke, by the time she got to the hospital, couldn't recognize objects, they gave her TPA to flush out a blood clot, transferred to another hospital. Later that morning starting talking a little better, did an MRI and that was normal, says didn't have a stroke, they tried to discharge her before they even tried to get her to walk, realized she couldn't walk, Tuesday they brought her a walker and discharged her to home, dx'd with conversion disorder, Mom had to fight for her to get better care, due to lack of insurance coverage in spite of working for the federal government.  once they realized things changed completely, they assumed she didn't have any coverage.  Then got her PT, then stayed two more weeks, no PT though only when the requesting facility were asking for the PT notes but there were none, psychiatry came and talked to her.  She says her speech was worse so hard to advocate for herself.   After discharge saw two psychiatric doctors outside the hospital, they said she had depression and anxiety but only developed this due to the treatment, she says they never requested her previous records from when she was intubated, wasn't depressed then but now is depressed. Says then was still hopeful because she didn't understand the magnitude of what happened. The whole left side is in pain, the stuttering comes and goes but worse when anxious, angry,  or tired, doing speech therapy, learning to slow down,  Since then went to neurology who is calling it conversion disorder, has found now there are cases like hers with the same side effects. They are new to the area, found a new PCP but they never touched her after 3 visits. mom kept having to ask for help but no referrals made, the doctor only gave a few weeks off with no restrictions, doing PT, OT, ST, went to ortho who says she looks like a stroke but he felt like he couldn't go over the Neuro or PCP, needs to do EMG test prior to her next MRI.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Conversion disorder, Depression, Dizziness, Dysgraphia, Dysphemia
Clinical narrative: After her second injection she immediately stated that the arm she received the injection in started with unbearable pain, then terrible headache later that night. The next day was having breathing issues, had to call the rescue squad, told her to go to the hospital, became unresponsive, had to intubate her, stayed for several nights, then discharged her with adverse reaction to the vaccine, one doctor admitted it, after discharge fatigued, respiratory , vision started changed, got pneumonia in the hospital but they said was aspiration pneumonia, took a long time to see specialists like pulmonologist, 3 weeks Dec 4 visiting the mom, looked like having a stroke, went to the hospital, was stuttering really badly, started left face drooping, was fine that morning, out with her kids, went to put something in the garbage, lost her balance and realized she was not ok, felt dizzy, her grandma helped her then mouth started going numb, then couldn't talk or write, looked spacy, failed the test for a stroke, by the time she got to the hospital, couldn't recognize objects, they gave her TPA to flush out a blood clot, transferred to another hospital. Later that morning starting talking a little better, did an MRI and that was normal, says didn't have a stroke, they tried to discharge her before they even tried to get her to walk, realized she couldn't walk, Tuesday they brought her a walker and discharged her to home, dx'd with conversion disorder, Mom had to fight for her to get better care, due to lack of insurance coverage in spite of working for the federal government.  once they realized things changed completely, they assumed she didn't have any coverage.  Then got her PT, then stayed two more weeks, no PT though only when the requesting facility were asking for the PT notes but there were none, psychiatry came and talked to her.  She says her speech was worse so hard to advocate for herself.   After discharge saw two psychiatric doctors outside the hospital, they said she had depression and anxiety but only developed this due to the treatment, she says they never requested her previous records from when she was intubated, wasn't depressed then but now is depressed. Says then was still hopeful because she didn't understand the magnitude of what happened. The whole left side is in pain, the stuttering comes and goes but worse when anxious, angry,  or tired, doing speech therapy, learning to slow down,  Since then went to neurology who is calling it conversion disorder, has found now there are cases like hers with the same side effects. They are new to the area, found a new PCP but they never touched her after 3 visits. mom kept having to ask for help but no referrals made, the doctor only gave a few weeks off with no restrictions, doing PT, OT, ST, went to ortho who says she looks like a stroke but he felt like he couldn't go over the Neuro or PCP, needs to do EMG test prior to her next MRI.