chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: fever; sick; aches, pains; Vertigo She had an 8 hour episode and had to go the ER; knee replacement surgery in Jan; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EW0151) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (ongoing); "Blood pressure high" (ongoing); "Weight loss" (ongoing). Concomitant medication(s) included: ZEPBOUND taken for weight decreased (ongoing); NEVIBOLOL DCI taken for hypertension (ongoing); METHYLPHENIDATE taken for attention deficit hyperactivity disorder (ongoing). Vaccination history included: BNT162b2 (Dose 1, lot number: ER2613; in left arm, below shoulder, few inches below elbow), administration date: 17Mar2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "knee replacement surgery in Jan", "fever", "sick", "aches, pains". The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 21Jan2025, outcome "unknown", described as "knee replacement surgery in Jan"; VERTIGO (non-serious) with onset 07Mar2025, outcome "unknown", described as "Vertigo She had an 8 hour episode and had to go the ER"; PYREXIA (non-serious), outcome "recovered", described as "fever"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), outcome "unknown", described as "aches, pains". The events "vertigo she had an 8 hour episode and had to go the er" required emergency room visit. The patient underwent the following laboratory tests and procedures: Weight: loss. Therapeutic measures were taken as a result of knee arthroplasty.  Clinical course: A patient on the line reporting on Comirnaty vaccine. She said recently received booster vaccine on 28Jun2025 and every time in the past she has gotten a fever in a few hours, but this time did not. She stated she had in past aches, pain, and fever so was surprised to not experience that this time. She also mentioned she had a knee replacement in Jan. She wondering if her vaccine is effective. She also clarified every time got the vaccine, she also gets the fever and aches within 10 hours or so and it would always last for a day or less, but this time did not. She has received both the Moderna and Pfizer vaccines, and this is the first time this did not happen. While capturing details she clarified at up until Jun2025 out of the 8 covid vaccines received only 2, the first two were manufactured by Pfizer. The rest were Moderna. Then this 9th one she just received was her 9th Covid Vaccine, and 3rd Pfizer vaccine manufactured by Pfizer.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: Drug exposure during pregnancy with no reported adverse event; Initial information received on 25-Apr-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 42 years old female patient who was exposed to vaccine influenza vaccine in context of drug exposure during pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported. The estimated due date is 01-Jul-2025.  The patient's past medical history included Cholelithiasis, Cholelithiasis in AUG-2023, Caesarean section in AUG-2023, Cholecystectomy and Last menstrual period determination on 21-AUG-2024. The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy.  Concomitant medications included Drospirenone (SLYND) for Contraception.  On 21-Aug-2024, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and had drug exposure during pregnancy with no reported adverse event (exposure during pregnancy).  Relevant laboratory test results included: Pregnancy test urine - On 05-Sep-2024: Negative; on 12-Sep-2024: Negative; on 02-Oct-2024: Negative; on 27-Mar-2025: Positive  Action taken was not applicable.  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered with expired FLUZONE HD, with no reported adverse evet; Initial information received on 01-Jul-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 70 years old male patient who was administered with expired Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] 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 Elasomeran (COVID-19 vaccine Moderna),Hepatitis A Vaccine Inact, Hepatitis B Vaccine Rhbsag (Yeast) (Twinrix) and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) for Immunisation.  On 01-Jul-2025, the patient received 0.5 ml expired dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8524DA,expiry date:30-Jun-2025,frequency:once,strength:high via intramuscular route in the right deltoid for immunisation 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: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Biopsy, Lichen planus
Clinical narrative: Lichen Planus -- autoimmune
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis
Clinical narrative: Patient was seen at ER for cellulitis of the injection site.
Age: 74.0
Sex: M
Vaccine: PNC20
Symptoms: Joint swelling
Clinical narrative: Swelling of the left elbow
Age: 57.0
Sex: M
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: Left Arm Pain
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Cellulitis, Injection site irritation, Injection site rash
Clinical narrative: Patient received Boostrix and Shingrix (dose one of two) on April 18, 2025 at approximately 4pm.  Patient developed rash and irritation in the injection site area five days later on April 23, 2025. She sought care from her provider on April 25, 2025 and was diagnosed with cellulitis and received antibiotics.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Fatigue, Muscle spasms, Paraesthesia, Pyrexia
Clinical narrative: TINGLING ON HANDS, FATIGUE, FEVER, CHILLS, MUSCLE SPASMS ON ARMS (FOR ABOUT 2 WEEKS)
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash, Skin warm
Clinical narrative: Local allergic reaction  Erythematous, warm, tender rash. No systemic symptoms. Claritin recommended over Allegra. Prednisone prescribed to prevent delayed reaction. - Prescribe Claritin 10 mg once daily in the morning. - Advise Benadryl every six hours if itching persists. - Prescribe topical steroid cream twice daily. - Prescribe Pepcid every evening until rash resolves. - Prescribe prednisone, two tablets daily for five days, with food in the morning. - Advise ice application to reduce inflammation. - Suggest baking soda paste or Aveeno oatmeal bath for relief.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Tenderness
Clinical narrative: Local allergic reaction  Erythematous, warm, tender rash. No systemic symptoms. Claritin recommended over Allegra. Prednisone prescribed to prevent delayed reaction. - Prescribe Claritin 10 mg once daily in the morning. - Advise Benadryl every six hours if itching persists. - Prescribe topical steroid cream twice daily. - Prescribe Pepcid every evening until rash resolves. - Prescribe prednisone, two tablets daily for five days, with food in the morning. - Advise ice application to reduce inflammation. - Suggest baking soda paste or Aveeno oatmeal bath for relief.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lichen planopilaris, Pruritus, Scalp biopsy, Skin exfoliation
Clinical narrative: Shortly after the vaccine (March 24, 2021) I noted scalp issues including itching; shedding; etc.  I scheduled an appointment with a dermatologist for June 1, 2021.  (I had to wait several weeks to obtain an appointment.)  The dermatologist diagnosed lichen planopilaris (an auto-immune disease resulting in permanent hair loss).  I have been in treatment for over fours years including doxycycline, clobetasol, kenalog steroid injections, plaquenil, cell crept, myfortic.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dosage of Heplisav-B 26 days after her first dosage. ACIP Guidelines state that patients should receive 2nd dosage of Heplisav-B at least 28 days after 1st dosage.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dry skin, Increased tendency to bruise, Joint swelling, Lymphadenopathy
Clinical narrative: Day 1: immediate itching, sandpaper skin reaction. Day 2 morning: Left arm stiffnesss, all over joint pain, especially left thumb. Day 2 afternoon: Nausea Day 2 evening: fever, shooting pain in joints, neck pain, nausea Day 3: Lymph node above left collar bone swollen and visibly protruding, joint pain, skin on hand very flaky. Day 4: swollen joints in hands, easy bruising. Ongoing approx one month: joint pain
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Nausea, Neck pain, Pain, Pruritus
Clinical narrative: Day 1: immediate itching, sandpaper skin reaction. Day 2 morning: Left arm stiffnesss, all over joint pain, especially left thumb. Day 2 afternoon: Nausea Day 2 evening: fever, shooting pain in joints, neck pain, nausea Day 3: Lymph node above left collar bone swollen and visibly protruding, joint pain, skin on hand very flaky. Day 4: swollen joints in hands, easy bruising. Ongoing approx one month: joint pain
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin exfoliation
Clinical narrative: Day 1: immediate itching, sandpaper skin reaction. Day 2 morning: Left arm stiffnesss, all over joint pain, especially left thumb. Day 2 afternoon: Nausea Day 2 evening: fever, shooting pain in joints, neck pain, nausea Day 3: Lymph node above left collar bone swollen and visibly protruding, joint pain, skin on hand very flaky. Day 4: swollen joints in hands, easy bruising. Ongoing approx one month: joint pain
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Swelling
Clinical narrative: Patient reported itching and swelling  3 days after  receiving vaccine
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Musculoskeletal disorder, Posture abnormal, Urinary tract infection
Clinical narrative: Per Nurses documentation on 6/11/25 patient could not sit up straight on the side of the bed, R arm limp loss of control of R arm, R foot curled in.  Resident sent to Medical Center where he was admitted and dx'd with CVA & UTI. He was hospitalized until 6/17/25 then he was discharged back to the retirement center.
Age: 63.0
Sex: M
Vaccine: MMR, YF
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/PQC reported.; Email received in email to case que on 6/17/2025 11:29 AM with a scanned document from SANOFI; This spontaneous report was received from other healthcare professional and refers to a 63-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), reconstituted with sterile diluent (MERCK STERILE DILUENT), administered for prophylaxis (dose, route of administration, anatomical site of injection, lot # and expiration date were not provided).  On an unknown date (reported as two weeks after the patient received the MMR II vaccine), the patient was vaccinated with the yellow fever vaccine (trade name not provided), lot #UK134AA (dose, route of administration, anatomical site of injection, indication and expiration date were not reported) (Inappropriate administration interval between different vaccines). The patient did not experience any adverse effects from the vaccination (no adverse events).  Follow up information has been received from the nurse on 27-JUN-2025.  The patient was vaccinated on 15-APR-2025, with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number Y010372 has been verified to be valid, expiration date reported as 05-JUN-2026).  On that same day, he also received hepatitis B vaccine (recombinant) suspension for injection (RECOMBIVAX HB) (lot number Y018229, has been verified to be valid, expiration date reported as 31-MAY-2027), Pneumococcal vaccine conj 20v (other manufacturer) (lot number LJ5283, expiration date 31-MAY-2026), and Diphtheria vaccine toxoid (+) Pertussis vaccine acellular 5-component  (+) Tetanus vaccine toxoid (TDAP) (other manufacturer) (lot number U8352AA, expiration date 31-DEC-2026). The vaccines were administered from a vaccine provider and vaccinated at public health clinic/hospital and purchased with private funds. The operator of device was a health professional. The adverse event was previously reported to health department and to manufacturer. Moreover, it was reported that the patient was aware that he will need to complete a blood test or receive a second yellow fever vaccine to ensure he have adequate immunity against yellow fever.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02823591-02823541 , CLIC number : , ESTAR number : , IRMS number : 500UW00000dWnIlYAK|30062025230049|1867 , Central date : 2025-07-01 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2297631 , MNSC case number : 02823591 , MNSC interaction number : 02823541 , Integration log UniqueID : 500UW00000dWnIlYAK|30062025230049|1867 , Service cloud CaseID : 500UW00000dWnIlYAK
Vaccine: VARZOS, VARZOS
Symptoms: Accidental overdose
Clinical narrative: Double dose of Shingrix by mistake; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of accidental overdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix and Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced accidental overdose (Verbatim: Double dose of Shingrix by mistake). The outcome of the accidental overdose was not applicable.   Additional Information: GSK Receipt date:25-JUN-2025 This case was reported by a consumer via (shingrix GRC Chatbot) interactive digital media. The patient had been given two doses of Shingrix together by mistake, he/she wanted to know possible adverse effects, which led to accidental overdose.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral abnormal, Aphasia, Disturbance in attention, Dizziness, Dysarthria
Clinical narrative: 40 minutes after receiving the vaccine, I started with severe head pressure, dizziness, tunnel vision.  I was told headache was expected and could last 3 days.  I saw my pcp office 3 days later when it had not subsided.  I continued with symptoms that were severe, called pcp again 3 days later and was told to be seen again.  I was seen 2 days after that.  Had imaging performed and was negative.  I started with bilateral leg weakness 8 days after the vaccine.  10 days after the vaccine, my right leg started to drag.  I was seen by my pcp 3 days later as that continued to progress.  Reflexes were decreased and I was hospitalized at (withheld) General Hospital for 5 days.  I was told it was similar to Guillain Barre but not Guillain barre.  I was told it was a severe immune response to the covid vaccine.  My condition continued to worsen despite treatment.  My left leg became so weak and was dragging as well, I was wheelchair bound from January 10, 2022 until January 15, 2025.  I was told I was paralyzed from my belly button down.  I also started having seizures April 2022 which continued to worsen as many as 5 per day.  I also experienced severe sound sensitivity, light sensitivity, memory and concentration problems, ringing in my ears, vision changes.  I had a couple stroke like episodes where my entire left side would become paralyzed, had slurred speech and once had aphasia.  I was living in (withheld state) at the time, but have since moved to (withheld state) to be treated by Dr. (withheld) for my covid vaccine injury.  I have been found to have severe micro clots, severe iliac vein compression, stenosis of the Left sinus which was filled with blood clots, mast cell activation syndrome.  I am no longer paralyzed and have not had any further seizures since March 2025.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Head discomfort, Hemiplegia, Hyperacusis, Hyporeflexia
Clinical narrative: 40 minutes after receiving the vaccine, I started with severe head pressure, dizziness, tunnel vision.  I was told headache was expected and could last 3 days.  I saw my pcp office 3 days later when it had not subsided.  I continued with symptoms that were severe, called pcp again 3 days later and was told to be seen again.  I was seen 2 days after that.  Had imaging performed and was negative.  I started with bilateral leg weakness 8 days after the vaccine.  10 days after the vaccine, my right leg started to drag.  I was seen by my pcp 3 days later as that continued to progress.  Reflexes were decreased and I was hospitalized at (withheld) General Hospital for 5 days.  I was told it was similar to Guillain Barre but not Guillain barre.  I was told it was a severe immune response to the covid vaccine.  My condition continued to worsen despite treatment.  My left leg became so weak and was dragging as well, I was wheelchair bound from January 10, 2022 until January 15, 2025.  I was told I was paralyzed from my belly button down.  I also started having seizures April 2022 which continued to worsen as many as 5 per day.  I also experienced severe sound sensitivity, light sensitivity, memory and concentration problems, ringing in my ears, vision changes.  I had a couple stroke like episodes where my entire left side would become paralyzed, had slurred speech and once had aphasia.  I was living in (withheld state) at the time, but have since moved to (withheld state) to be treated by Dr. (withheld) for my covid vaccine injury.  I have been found to have severe micro clots, severe iliac vein compression, stenosis of the Left sinus which was filled with blood clots, mast cell activation syndrome.  I am no longer paralyzed and have not had any further seizures since March 2025.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Intracranial venous sinus stenosis, Laboratory test abnormal, Lumbar puncture normal, Magnetic resonance imaging abdominal abnormal, Magnetic resonance imaging head normal
Clinical narrative: 40 minutes after receiving the vaccine, I started with severe head pressure, dizziness, tunnel vision.  I was told headache was expected and could last 3 days.  I saw my pcp office 3 days later when it had not subsided.  I continued with symptoms that were severe, called pcp again 3 days later and was told to be seen again.  I was seen 2 days after that.  Had imaging performed and was negative.  I started with bilateral leg weakness 8 days after the vaccine.  10 days after the vaccine, my right leg started to drag.  I was seen by my pcp 3 days later as that continued to progress.  Reflexes were decreased and I was hospitalized at (withheld) General Hospital for 5 days.  I was told it was similar to Guillain Barre but not Guillain barre.  I was told it was a severe immune response to the covid vaccine.  My condition continued to worsen despite treatment.  My left leg became so weak and was dragging as well, I was wheelchair bound from January 10, 2022 until January 15, 2025.  I was told I was paralyzed from my belly button down.  I also started having seizures April 2022 which continued to worsen as many as 5 per day.  I also experienced severe sound sensitivity, light sensitivity, memory and concentration problems, ringing in my ears, vision changes.  I had a couple stroke like episodes where my entire left side would become paralyzed, had slurred speech and once had aphasia.  I was living in (withheld state) at the time, but have since moved to (withheld state) to be treated by Dr. (withheld) for my covid vaccine injury.  I have been found to have severe micro clots, severe iliac vein compression, stenosis of the Left sinus which was filled with blood clots, mast cell activation syndrome.  I am no longer paralyzed and have not had any further seizures since March 2025.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Mast cell activation syndrome, May-Thurner syndrome, Memory impairment, Muscular weakness, Neurological symptom
Clinical narrative: 40 minutes after receiving the vaccine, I started with severe head pressure, dizziness, tunnel vision.  I was told headache was expected and could last 3 days.  I saw my pcp office 3 days later when it had not subsided.  I continued with symptoms that were severe, called pcp again 3 days later and was told to be seen again.  I was seen 2 days after that.  Had imaging performed and was negative.  I started with bilateral leg weakness 8 days after the vaccine.  10 days after the vaccine, my right leg started to drag.  I was seen by my pcp 3 days later as that continued to progress.  Reflexes were decreased and I was hospitalized at (withheld) General Hospital for 5 days.  I was told it was similar to Guillain Barre but not Guillain barre.  I was told it was a severe immune response to the covid vaccine.  My condition continued to worsen despite treatment.  My left leg became so weak and was dragging as well, I was wheelchair bound from January 10, 2022 until January 15, 2025.  I was told I was paralyzed from my belly button down.  I also started having seizures April 2022 which continued to worsen as many as 5 per day.  I also experienced severe sound sensitivity, light sensitivity, memory and concentration problems, ringing in my ears, vision changes.  I had a couple stroke like episodes where my entire left side would become paralyzed, had slurred speech and once had aphasia.  I was living in (withheld state) at the time, but have since moved to (withheld state) to be treated by Dr. (withheld) for my covid vaccine injury.  I have been found to have severe micro clots, severe iliac vein compression, stenosis of the Left sinus which was filled with blood clots, mast cell activation syndrome.  I am no longer paralyzed and have not had any further seizures since March 2025.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraplegia, Photophobia, Seizure, Thrombosis, Tinnitus
Clinical narrative: 40 minutes after receiving the vaccine, I started with severe head pressure, dizziness, tunnel vision.  I was told headache was expected and could last 3 days.  I saw my pcp office 3 days later when it had not subsided.  I continued with symptoms that were severe, called pcp again 3 days later and was told to be seen again.  I was seen 2 days after that.  Had imaging performed and was negative.  I started with bilateral leg weakness 8 days after the vaccine.  10 days after the vaccine, my right leg started to drag.  I was seen by my pcp 3 days later as that continued to progress.  Reflexes were decreased and I was hospitalized at (withheld) General Hospital for 5 days.  I was told it was similar to Guillain Barre but not Guillain barre.  I was told it was a severe immune response to the covid vaccine.  My condition continued to worsen despite treatment.  My left leg became so weak and was dragging as well, I was wheelchair bound from January 10, 2022 until January 15, 2025.  I was told I was paralyzed from my belly button down.  I also started having seizures April 2022 which continued to worsen as many as 5 per day.  I also experienced severe sound sensitivity, light sensitivity, memory and concentration problems, ringing in my ears, vision changes.  I had a couple stroke like episodes where my entire left side would become paralyzed, had slurred speech and once had aphasia.  I was living in (withheld state) at the time, but have since moved to (withheld state) to be treated by Dr. (withheld) for my covid vaccine injury.  I have been found to have severe micro clots, severe iliac vein compression, stenosis of the Left sinus which was filled with blood clots, mast cell activation syndrome.  I am no longer paralyzed and have not had any further seizures since March 2025.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tunnel vision, Visual impairment, Wheelchair user
Clinical narrative: 40 minutes after receiving the vaccine, I started with severe head pressure, dizziness, tunnel vision.  I was told headache was expected and could last 3 days.  I saw my pcp office 3 days later when it had not subsided.  I continued with symptoms that were severe, called pcp again 3 days later and was told to be seen again.  I was seen 2 days after that.  Had imaging performed and was negative.  I started with bilateral leg weakness 8 days after the vaccine.  10 days after the vaccine, my right leg started to drag.  I was seen by my pcp 3 days later as that continued to progress.  Reflexes were decreased and I was hospitalized at (withheld) General Hospital for 5 days.  I was told it was similar to Guillain Barre but not Guillain barre.  I was told it was a severe immune response to the covid vaccine.  My condition continued to worsen despite treatment.  My left leg became so weak and was dragging as well, I was wheelchair bound from January 10, 2022 until January 15, 2025.  I was told I was paralyzed from my belly button down.  I also started having seizures April 2022 which continued to worsen as many as 5 per day.  I also experienced severe sound sensitivity, light sensitivity, memory and concentration problems, ringing in my ears, vision changes.  I had a couple stroke like episodes where my entire left side would become paralyzed, had slurred speech and once had aphasia.  I was living in (withheld state) at the time, but have since moved to (withheld state) to be treated by Dr. (withheld) for my covid vaccine injury.  I have been found to have severe micro clots, severe iliac vein compression, stenosis of the Left sinus which was filled with blood clots, mast cell activation syndrome.  I am no longer paralyzed and have not had any further seizures since March 2025.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; developed Shingles last year, and again this year; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed Shingles last year, and again this year). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 30-JUN-2025 The patient received 2 doses of Shingrix 4 years ago. The patient developed shingles last year, and again this year. This case was considered as suspected vaccination failure as details regarding 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 vaccines Shingrix.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Syringe issue
Clinical narrative: started leaking on the side of it, and the needle and everything was attached correctly; Pharmaceutical product complaint; half of it, not sure, probably more; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 67-year-old male patient who received HBV (Engerix B) (batch number N733B, expiry date 27-AUG-2027) for prophylaxis. This case was associated with a product complaint.   On 20-JUN-2025, the patient received Engerix B. On 20-JUN-2025, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: half of it, not sure, probably more). On an unknown date, the patient experienced syringe leak (Verbatim: started leaking on the side of it, and the needle and everything was attached correctly) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the underdose, syringe leak and pharmaceutical product complaint were not applicable.   It was unknown if the reporter considered the syringe leak to be related to Engerix B and Engerix B Pre-Filled Syringe Device.     It was unknown if the company considered the syringe leak to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-JUN-2025 Other HCP was giving Engerix-B vaccine on 20th June 2025 on Friday, and then as reporter was administering the vaccine half of it or they were not sure, probably more, just started leaking on the side of it, and the needle and everything was attached correctly. Reporter stated that liquid leaked out from the syringe, not from the site of injection.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: Vaccine reconstituted with unapproved diluent; Vaccine reconstituted with unapproved diluent;  This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 46-year-old female patient who received MMR (Priorix) (batch number J942L, expiry date 08-NOV-2026) for prophylaxis.   On 23-JUN-2025, the patient received Priorix. On 23-JUN-2025, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Vaccine reconstituted with unapproved diluent) and inappropriate dose of vaccine administered (Verbatim: Vaccine reconstituted with unapproved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JUN-2025 The Nurse Practitioner explained that on 23rd June 2025, patient had been vaccinated with Priorix doses that had been accidentally reconstituted with sterile water from Merck Sharp & Dohme vaccines instead of the Priorix corresponding diluent that had been provided by Glaxo Smith Kline, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: pharmacist reports that a staff member administered the yf-vax (yellow fever) but used a different diluent solution with no reported adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered Yellow Fever Vaccine - [Yf-Vax] but a different diluent solution was used with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection, lot UK137AA (unknown strength and expiry date) via unknown route in unknown administration site for Immunization but a different diluent solution was used with no reported adverse event (product preparation error) (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.
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: sterile water was used as a diluent, confirmed that the incorrectly reconstituted YF VAX was administered with no reported adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received Yellow Fever Vaccine - [YF-Vax] which was reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization which was reconstituted with sterile water with no reported adverse event (product preparation error) (Latency Same day).  Information regarding batch number corresponding to the one at time of event occurrence will not be available.  Reportedly, Sterile water was used as diluent in reconstitution of vaccine.  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.  No routine follow up possible as reporter did not consent to be contacted.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Carotid artery aneurysm, Cervical spinal stenosis, Computerised tomogram, Diarrhoea, Hemiplegia
Clinical narrative: Nausea, Vomiting, Muscle Cramps, Diarhea, Uncontrolable Muscle Spasms, Right side Paralysis temporay, Weakness lower body and Right Arm x 9 days . on the 10th day Paralysis right side and weakness no sensation lower body and  syncope
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Magnetic resonance imaging, Muscle spasms, Muscular weakness, Myelitis transverse, Nausea
Clinical narrative: Nausea, Vomiting, Muscle Cramps, Diarhea, Uncontrolable Muscle Spasms, Right side Paralysis temporay, Weakness lower body and Right Arm x 9 days . on the 10th day Paralysis right side and weakness no sensation lower body and  syncope
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Scan with contrast, Sensory loss, Syncope, Vomiting
Clinical narrative: Nausea, Vomiting, Muscle Cramps, Diarhea, Uncontrolable Muscle Spasms, Right side Paralysis temporay, Weakness lower body and Right Arm x 9 days . on the 10th day Paralysis right side and weakness no sensation lower body and  syncope
Age: 59.0
Sex: F
Vaccine: HPV9
Symptoms: Pollakiuria
Clinical narrative: Consumer advised she is 59 years old; she received the GARDIL 9 vaccine and Felt like she had to use the bathroom frequently and had a urge to go number one after a couple of weeks of getting the vaccine; she received the GARDIL 9 vaccine and Felt like she had to use the bathroom frequently and had a urge to go number one after a couple of weeks of getting the vaccine; This spontaneous report was received from a 59-year-old female patient, who refers to herself. Her medical history included 4 screws and metal plate in her back. The patient's concurrent conditions was latex allergy. Concomitant therapies were not reported.   On 12-MAY-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) suspension for injection, administered by unknown route (dose, strength, anatomical location, lot # and expiration date were not reported) as prophylaxis.  On an unspecified date in 2025, the patient felt like she had to use the bathroom frequently and had an urge to go number one after a couple of weeks of getting the vaccine. The patient recovered from both events. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported but established as not applicable.   The causal relationship between the events of feeling like she had to use the bathroom frequently and having urge to go number one and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIl9) was not provided.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Urticaria
Clinical narrative: Voice message received from SRP mailbox on 26JUN2025 at 703PM with following message verbatim:  "Hi Good afternoon my name is {REDACTED} calling from REDACTED} our phone number is (REDACTED) again this is {REDACTED}from {REDACTED} our hum; low grad fever; This spontaneous report was received from other health professional and refers to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), dose number 1, (lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced low grade fever and hives (pyrexia and urticaria).   At the reporting time, the outcome of the events was unknown.   The causal relationship between the events and the vaccine was not provided.   Lot # is being requested and will be submitted if received.
Age: 50.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Feeling cold, Feeling hot, Injection site erythema, Injection site swelling, Nasopharyngitis
Clinical narrative: "small bump" on her right arm; a fever and feeling chilly, cold, and warm; having redness and swelling on her right arm; having redness and swelling on her right arm; This spontaneous report has been received from a pharmacist, regarding to a 50-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 26-JUN-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine, administered intramuscularly (IM) in the right arm, lot number Y019158, expiration date 20-MAY-2026 as routine administration (dosage, route of administration, and vaccination scheme frequency), on the same date, the patient received Boostrix (Diphtheria vaccine toxoid; Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) (dose, route of administration, anatomical site of injection, vaccination scheme frequency, lot number, indication, and expiration date were not reported) .  On 27-JUN-2025, the patient experienced a fever and feeling chilly, cold, and warm (Pyrexia), on the same date, the patient developed small bump (Vaccination site mass) on her right arm, also, she had redness and swelling (Vaccination site swelling and Vaccination site erythema). On an unknown date in 2025, the patient recovered from pyrexia. At the time of the report, the patient had not recovered from Vaccination site mass and Vaccination site erythema. The outcome of Vaccination site swelling was not provided.  The causal relationship between the aforementioned events and the suspect vaccines was not provided.
Age: 50.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Pyrexia
Clinical narrative: "small bump" on her right arm; a fever and feeling chilly, cold, and warm; having redness and swelling on her right arm; having redness and swelling on her right arm; This spontaneous report has been received from a pharmacist, regarding to a 50-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 26-JUN-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine, administered intramuscularly (IM) in the right arm, lot number Y019158, expiration date 20-MAY-2026 as routine administration (dosage, route of administration, and vaccination scheme frequency), on the same date, the patient received Boostrix (Diphtheria vaccine toxoid; Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) (dose, route of administration, anatomical site of injection, vaccination scheme frequency, lot number, indication, and expiration date were not reported) .  On 27-JUN-2025, the patient experienced a fever and feeling chilly, cold, and warm (Pyrexia), on the same date, the patient developed small bump (Vaccination site mass) on her right arm, also, she had redness and swelling (Vaccination site swelling and Vaccination site erythema). On an unknown date in 2025, the patient recovered from pyrexia. At the time of the report, the patient had not recovered from Vaccination site mass and Vaccination site erythema. The outcome of Vaccination site swelling was not provided.  The causal relationship between the aforementioned events and the suspect vaccines was not provided.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No side effects reported; HCP is calling report  an AE for a patient  that received fourth dosage of GARDASIL 9 on 04/28/2025. No side effects reported. No additional details provided. No additional AE/PQC reported.; This spontaneous report was received from a Registered Nurse and refers to a 19-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-Apr-2025, the patient was vaccinated with a fourth dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y015179, expiration date: 28-Jan-2027), dose number 1 for prophylaxis (extra dose administered). No adverse event was reported.
Sex: M
Vaccine: RVX
Symptoms: Death
Clinical narrative: died 2 days after the shot;  This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, 2 days after receiving RSV vaccine, the patient experienced unknown cause of death (Verbatim: died 2 days after the shot) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to RSV vaccine.     The company considered the unknown cause of death to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 30-JUN-2025 This case was reported by a consumer via interactive digital media. The reporter husband died 2 days after the shot.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK RSV vaccine.; Reported Cause(s) of Death: Unknown cause of death
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Eye pain, Headache, Influenza
Clinical narrative: arm pain; Fever; Chills/Shivering; Eye pain; Jaw pain; Flu symptoms; redness in her face; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included parathyroid tumor (Parathyroid tumor).   On 20-JUN-2025, the patient received the 1st dose of Shingrix. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm pain), fever (Verbatim: Fever), chills (Verbatim: Chills/Shivering), eye pain (Verbatim: Eye pain), jaw pain (Verbatim: Jaw pain), flu symptoms (Verbatim: Flu symptoms), red face (Verbatim: redness in her face) and headache (Verbatim: Headache). The outcome of the pain in arm, fever, chills, eye pain, jaw pain, flu symptoms, red face and headache were unknown.   It was unknown if the reporter considered the pain in arm, fever, chills, eye pain, jaw pain, flu symptoms, red face and headache to be related to Shingrix.     It was unknown if the company considered the pain in arm, fever, chills, eye pain, jaw pain, flu symptoms, red face and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2025 The reporter was the patient who received her first dose of Shingrix on June 20th. The reporter reported that arm pain, redness in her face, flu symptoms, fever, chills, headache, eye pain, shivering, and jaw pain. The reporter was going to get a nuclear CT on Tuesday to check for a parathyroid tumor.