chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Back pain, Hypoaesthesia, Rash, Rash papular, Vision blurred
Clinical narrative: Patient waited in waiting room for approximately 15 minutes post vaccinations when reported to front desk with c/o rash to right arm, pain in the middle of his back, blurry vision and numbness to the back of his neck.  Patient was immediately brought to the back room with a second person for evaluation.  Patient was put in a laying position on bed with ice pack and fan on.   Vitals were taken and WNL for the length of assessment.  Vitals redrawn approx. every 5-10minutes.   Patient denied hand/foot numbness; strength in bilateral hands/feet; able to vocalize concerns with interpreter (RN and front desk staff), pupils reactive to light, vitals stable, red papular rash to right arm. At discharge:  pain denies pain, numbness, vision improved, no rash present and responsive. Patient received vaccinations:  0915; evaluated between 0935-1000. Patient advised to seek immediate medical attention if symptoms return.  Patient feels comfortable leaving on his own without driver.
Age: 1.58
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event
Clinical narrative: No adverse events reported from patient.
Age: 12.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: ADMINISTRATION ERROR: Patient was not scheduled/due to receive IPV.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC20
Symptoms: Ear infection, Hand-foot-and-mouth disease, Impetigo, Perioral dermatitis, Pruritus
Clinical narrative: Patient received MMRV vaccine 07/12/24. Started with itchy red/raised rash 08/18/24. Seen at urgent care and dx with hand foot and mouth disease and ear infection. Given amoxicillin to treat. Seen by PCP 08/19/24 presenting with very itchy widespread rash. Rash located on hands, ankles, tops of feet, behind knees, back, and trunk, but mostly on face around mouth with clusters of blisters (some early stage, some crusted and scabbed). Several lesions with slight honey crusting noted. Patient very itchy in office. Patient diagnosed with post-vaccine varicella with possible secondary impetigo infection. PCP stopped amoxicillin and gave augmentin to treat impetigo.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC20
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: Patient received MMRV vaccine 07/12/24. Started with itchy red/raised rash 08/18/24. Seen at urgent care and dx with hand foot and mouth disease and ear infection. Given amoxicillin to treat. Seen by PCP 08/19/24 presenting with very itchy widespread rash. Rash located on hands, ankles, tops of feet, behind knees, back, and trunk, but mostly on face around mouth with clusters of blisters (some early stage, some crusted and scabbed). Several lesions with slight honey crusting noted. Patient very itchy in office. Patient diagnosed with post-vaccine varicella with possible secondary impetigo infection. PCP stopped amoxicillin and gave augmentin to treat impetigo.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC20
Symptoms: Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Patient received MMRV vaccine 07/12/24. Started with itchy red/raised rash 08/18/24. Seen at urgent care and dx with hand foot and mouth disease and ear infection. Given amoxicillin to treat. Seen by PCP 08/19/24 presenting with very itchy widespread rash. Rash located on hands, ankles, tops of feet, behind knees, back, and trunk, but mostly on face around mouth with clusters of blisters (some early stage, some crusted and scabbed). Several lesions with slight honey crusting noted. Patient very itchy in office. Patient diagnosed with post-vaccine varicella with possible secondary impetigo infection. PCP stopped amoxicillin and gave augmentin to treat impetigo.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Throat irritation
Clinical narrative: Itchy and redness to the area, itchy throat
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Muscle contracture, Muscle twitching, No adverse event
Clinical narrative: Fifth Moderna shot received at Pharmacy, on the morning of October 4, 2023; received SpikeVax shot in left arm. No adverse reactions to the previous 4 Moderna shots. On October 7, approximately 72 hours after receiving the Moderna SpikeVax, the left side of my forehead started twitching / having muscular contractions. This would happen anywhere from 3 times to 35 times each day.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Neck pain, Pain
Clinical narrative: Patient had some soreness at injection site later same day and into next day. Then she began developing numbness/pain in arm next day starting at injection site and radiating to back of shoulder and down to elbow. She saw her primary care provider and was diagnosed with "covid arm". She is still experiencing nerve type pain in back of shoulder and neck. She is scheduled to see an orthopedist for continued treatment. Her provider told her to notify us about this.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site of injection is swollen, red, hot and itchy.  About 1.5 inches in diameter from center of where injection was.  Was slightly red a few days ago and swollen and has increased in severity over time.   Suggested patient see MD to rule out cellulitis.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administration error, rotavirus oral medicine administered past minimum age for first dose.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Disorientation, Dizziness, Dyskinesia, Eye movement disorder, Hypotonia
Clinical narrative: PER Medical Assistant: ADMINISTERED MENQUADFI FIRST INTO LEFT DELTOID AND THEN ADMINISTERED BEXSERO INTO LEFT DELTOID. WAS PLACING BAND-AID WHEN PATIENT STATED SHE FELT LIKE SHE WAS GOING TO PASS OUT. PLACED MY HAND ON HER SHOULDER AND TOLD HER WE WOULD JUST LAY HER DOWN AND HER HEAD WENT LIMP AND WAS HANGING. AT THAT POINT PATIENT'S ARMS DREW UP TO HER CHEST AND SHE STARTED TO STIFFIN LIKE A BOARD AND I FELT 2 SMALL JERKS (AS I WAS CALLING FOR ASSISTANCE) WITH THE DOOR BEING SHUT HAD MOM OPEN DOOR TO CALL FOR HELP) , NURSE CAME IN AND HELPED TO FINISH LAYING PT DOWN ON TABLE AS SHE STARTED TO URINATE HERSELF. EYES WERE ROLLED BACK AND HER RIGHT CHEEK WAS TWITCHING AND LOSS OF COLOR TO FACE. PT CAME TO AND STATED DIDNT KNOW WHAT HAPPENED. PLACED COLD TOWEL ON FOREHEAD AND GIVEN SUCKER. COLOR STARTED TO RETURN TO PATIENT'S FACE. NURSE SPEAKING WITH PT AND AFTERWARDS HAD ME TO RECHECK VITALS. OF WHICH NO FURTHER VACCINES WERE THEN GIVEN DUE TO CIRCUMSTANCE.       Per Nurse:  Patient with loss of consciousness after administration of Menquadfi followed by Bexsero.  Upon arrival into room,  patient was laying on right side, urinated on self, eyes partially open with twitching to right cheek and lip.   Pale color to lips, no cyanosis evident.  After approximately 7-10 seconds, patient opened eyes, was disoriented and asked what happened.  Wet towel was placed on forehead, legs elevated, sucker given.   3 minutes later, mother cleaned child up and redressed her.  Patient walking, talking, neurologically at baseline.  Vital Signs: 83 HR, 99 O2 sat, 98/60 BP.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness, Muscle twitching, Musculoskeletal stiffness, Pallor, Posture abnormal
Clinical narrative: PER Medical Assistant: ADMINISTERED MENQUADFI FIRST INTO LEFT DELTOID AND THEN ADMINISTERED BEXSERO INTO LEFT DELTOID. WAS PLACING BAND-AID WHEN PATIENT STATED SHE FELT LIKE SHE WAS GOING TO PASS OUT. PLACED MY HAND ON HER SHOULDER AND TOLD HER WE WOULD JUST LAY HER DOWN AND HER HEAD WENT LIMP AND WAS HANGING. AT THAT POINT PATIENT'S ARMS DREW UP TO HER CHEST AND SHE STARTED TO STIFFIN LIKE A BOARD AND I FELT 2 SMALL JERKS (AS I WAS CALLING FOR ASSISTANCE) WITH THE DOOR BEING SHUT HAD MOM OPEN DOOR TO CALL FOR HELP) , NURSE CAME IN AND HELPED TO FINISH LAYING PT DOWN ON TABLE AS SHE STARTED TO URINATE HERSELF. EYES WERE ROLLED BACK AND HER RIGHT CHEEK WAS TWITCHING AND LOSS OF COLOR TO FACE. PT CAME TO AND STATED DIDNT KNOW WHAT HAPPENED. PLACED COLD TOWEL ON FOREHEAD AND GIVEN SUCKER. COLOR STARTED TO RETURN TO PATIENT'S FACE. NURSE SPEAKING WITH PT AND AFTERWARDS HAD ME TO RECHECK VITALS. OF WHICH NO FURTHER VACCINES WERE THEN GIVEN DUE TO CIRCUMSTANCE.       Per Nurse:  Patient with loss of consciousness after administration of Menquadfi followed by Bexsero.  Upon arrival into room,  patient was laying on right side, urinated on self, eyes partially open with twitching to right cheek and lip.   Pale color to lips, no cyanosis evident.  After approximately 7-10 seconds, patient opened eyes, was disoriented and asked what happened.  Wet towel was placed on forehead, legs elevated, sucker given.   3 minutes later, mother cleaned child up and redressed her.  Patient walking, talking, neurologically at baseline.  Vital Signs: 83 HR, 99 O2 sat, 98/60 BP.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urinary incontinence
Clinical narrative: PER Medical Assistant: ADMINISTERED MENQUADFI FIRST INTO LEFT DELTOID AND THEN ADMINISTERED BEXSERO INTO LEFT DELTOID. WAS PLACING BAND-AID WHEN PATIENT STATED SHE FELT LIKE SHE WAS GOING TO PASS OUT. PLACED MY HAND ON HER SHOULDER AND TOLD HER WE WOULD JUST LAY HER DOWN AND HER HEAD WENT LIMP AND WAS HANGING. AT THAT POINT PATIENT'S ARMS DREW UP TO HER CHEST AND SHE STARTED TO STIFFIN LIKE A BOARD AND I FELT 2 SMALL JERKS (AS I WAS CALLING FOR ASSISTANCE) WITH THE DOOR BEING SHUT HAD MOM OPEN DOOR TO CALL FOR HELP) , NURSE CAME IN AND HELPED TO FINISH LAYING PT DOWN ON TABLE AS SHE STARTED TO URINATE HERSELF. EYES WERE ROLLED BACK AND HER RIGHT CHEEK WAS TWITCHING AND LOSS OF COLOR TO FACE. PT CAME TO AND STATED DIDNT KNOW WHAT HAPPENED. PLACED COLD TOWEL ON FOREHEAD AND GIVEN SUCKER. COLOR STARTED TO RETURN TO PATIENT'S FACE. NURSE SPEAKING WITH PT AND AFTERWARDS HAD ME TO RECHECK VITALS. OF WHICH NO FURTHER VACCINES WERE THEN GIVEN DUE TO CIRCUMSTANCE.       Per Nurse:  Patient with loss of consciousness after administration of Menquadfi followed by Bexsero.  Upon arrival into room,  patient was laying on right side, urinated on self, eyes partially open with twitching to right cheek and lip.   Pale color to lips, no cyanosis evident.  After approximately 7-10 seconds, patient opened eyes, was disoriented and asked what happened.  Wet towel was placed on forehead, legs elevated, sucker given.   3 minutes later, mother cleaned child up and redressed her.  Patient walking, talking, neurologically at baseline.  Vital Signs: 83 HR, 99 O2 sat, 98/60 BP.
Age: 1.5
Sex: F
Vaccine: HEPA, PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Hepatitis A vaccine too early for the second time. First dose was given 2/12/24. Second dose was given 4/29/24, only 3 months after last dose. Dr. ordered another dose to be given on 7/29/24, which still was not 6 months after original dose. Patient needs to return in 6 months to receive second valid dose.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received first dose of Shingrix on 8/9/24 and second dose on 8/22/24
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Hep B Birth Dose was deferred by parents initially, was later administered at first appointment on 8/22/2024 after educating parent.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: High fever 103-103.5 despite acetaminophen and ibuprofen for 42 hours. Lethargy and lack of appetite for 72 hours.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Additional 3rd dose given when not needed.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Power outage in clinic due to storm, fridge outside recommended temperature.  It was initially reported by head clinic pharmacist that vaccines were deemed viable on 7/10/24. It was determined the vaccines were not viable  on 7/17/24.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Product quality issue, Product storage error
Clinical narrative: Power outage in clinic due to large storm, fridge outside recommended temperature.  It was initially reported by head clinic pharmacist that vaccines were deemed viable on 7/10/24. It was determined the vaccines were not viable  on 7/17/24.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Injection site pain, Pain
Clinical narrative: There was soreness at the injection site and pain in her arm. The next day she had problems breathing and was winded. She was unable to drink or eat anything for over twenty four hours without vomiting. She vomited over twenty times and was just vomiting bile. She was shivering and sweating at the same time. She stated that everything in her body hurt.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Vomiting
Clinical narrative: There was soreness at the injection site and pain in her arm. The next day she had problems breathing and was winded. She was unable to drink or eat anything for over twenty four hours without vomiting. She vomited over twenty times and was just vomiting bile. She was shivering and sweating at the same time. She stated that everything in her body hurt.
Age: 65.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Headache, Hypoaesthesia, Myalgia, Neck pain
Clinical narrative: Reports that approximately a couple weeks after getting the vaccines completed on 3/29/24 began to have pain in the muscles.  Originally it started in the Left arm with numbness and then changed to the right arm. Now has been having numbness in the right arm and occasionally in the left. Reports that also had some fever and a headache. Currently as of 8/5/24 reports having all over body muscle pain and problems. reports pain in neck, shoulder and hands. That when goes to stand up has to stand for a second before moving and states that her buttocks feels as if she had done aerobic exercise but has not worked out. Has been consistently taking ibuprofen for pain. Saw Dr. the week prior to leaving for trip on June 16th and at that time Dr. was offering a steroid. Has been to the chiropractor numerous times without relief.
Age: 65.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Reports that approximately a couple weeks after getting the vaccines completed on 3/29/24 began to have pain in the muscles.  Originally it started in the Left arm with numbness and then changed to the right arm. Now has been having numbness in the right arm and occasionally in the left. Reports that also had some fever and a headache. Currently as of 8/5/24 reports having all over body muscle pain and problems. reports pain in neck, shoulder and hands. That when goes to stand up has to stand for a second before moving and states that her buttocks feels as if she had done aerobic exercise but has not worked out. Has been consistently taking ibuprofen for pain. Saw Dr. the week prior to leaving for trip on June 16th and at that time Dr. was offering a steroid. Has been to the chiropractor numerous times without relief.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Power outage in clinic due to Hurrican, fridge outside recommended temperature.  It was initially reported by head clinic pharmacist that vaccines were deemed viable on 7/10/24. It was determined the vaccines were not viable  on 7/17/24.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Power outage in clinic due to Hurrican, fridge outside recommended temperature.  It was initially reported by head clinic pharmacist that vaccines were deemed viable on 7/10/24. It was determined the vaccines were not viable  on 7/17/24.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Power outage in clinic due to Hurrican, fridge outside recommended temperature.  It was initially reported by head clinic pharmacist that vaccines were deemed viable on 7/10/24. It was determined the vaccines were not viable  on 7/17/24.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: The patient had redness and swelling at the injection site and complained of itching occurring within 24 hours of receiving the injection on 8/18/2024. She stated she took a Benadryl the night of the injection and the itching and swelling resolved. Donor returned to center on 8/22/2024 where staff observed a large red area of left shoulder.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Dermatitis, Papule, Pruritus
Clinical narrative: Patient experienced dermatitis with pruritus, small red papules.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Clonus, Dizziness, Loss of consciousness, Urinary incontinence
Clinical narrative: Patient had already had a capillary blood stick for lipis screening, had just finished asministration of vaccines when he felt dizzy. Nurse had him lay down, after which he passed out had brief ( 3 beat) clonus followed by loss of bladder control.  No other prodrome was noted, awoke quickly (15 seconds) without post ictal state - father reports mother has had similar reaction in the past.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: 8/20/2024 WAS GIVEN KINRIX IN UPPER DELTOID AND VARIVAX IN RIGHT ARM TOWARDS BACK OF ARM. GIVEN MMR IN LEFT ARM. RIGHT ARM WAS RED ABOUT SIZE OF HALF DOLLAR THIS MORNING, 8/22/2024,  AND ARM WAS SORE WHERE THE VARIVAX WAS GIVEN ON RIGHT ARM 8/20/2024. WHEN SEEN IN OUR OFFICE TODAY 8/22/24 THE AREA ON RIGHT ARM WAS RED AND HAD TINY BLISTERS IN RED AREA.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Headache, Induration, Pain, Peripheral swelling
Clinical narrative: left arm swelling, headache and pain after receiving vaccine. left arm with 7x 12cm area of erythema, warmth, slight induration, mildly tender to palpation, good ROM left arm/shoulder. Treatment:  cold compress to the injection site, diclofenac as needed for pain. Take Benadryl if itching or swelling.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm, Tenderness
Clinical narrative: left arm swelling, headache and pain after receiving vaccine. left arm with 7x 12cm area of erythema, warmth, slight induration, mildly tender to palpation, good ROM left arm/shoulder. Treatment:  cold compress to the injection site, diclofenac as needed for pain. Take Benadryl if itching or swelling.
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Product quality issue, Product storage error
Clinical narrative: Power outage in clinic due to storm, fridge outside recommended temperature.  It was initially reported by head clinic pharmacist that vaccines were deemed viable on 7/10/24. It was determined the vaccines were not viable  on 7/17/24.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given Kinrix vaccine instead of individual dtap and polio vaccines. Kinrix is only for ages 4-6. Contacted the state who states vaccines are valid and will not need to be revaccinated.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19-2
Symptoms: Death
Clinical narrative: Patient expired 8/21/2024.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Power outage in clinic due to Hurrican, fridge outside recommended temperature.  It was initially reported by head clinic pharmacist that vaccines were deemed viable on 7/10/24. It was determined the vaccines were not viable  on 7/17/24.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Headache
Clinical narrative: Vaccine recipient reported a mild headache approximately 5 minutes after receiving 2nd dose of vaccine. No other complaints voiced.
Age: 20.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Disorientation, Fall, Feeling abnormal, Head injury, Loss of consciousness
Clinical narrative: Patient was seated near the edge of the seat in a vaccine administration.  Men ACWY was administered first in the left deltoid and the HPV was administered second in the right deltoid.  Patient was leaned over a clip board completing paperwork for a medical appointment at a facility next door.  RN exited the room to complete charting of vaccines and heard a noise.  Shortly after the noise patient then opened the exam room door and said "Hello".  Both RNs on duty responded to noise in exam room and patient standing in hallway.  Patient stated she didn't know what had happened.  She woke up lying on the floor in the exam and did not know where she was.  Patient was unconscious for 1 minute.  Patient reported feeling as though she was "falling asleep" and fell out of the chair, and onto the floor hitting her head on the stool or counter in the exam room.  Patient was returned to the vaccine chair and placed in a reclined position and instructed to remain until she was examined by a health care professional.
Age: 20.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Neurological examination
Clinical narrative: Patient was seated near the edge of the seat in a vaccine administration.  Men ACWY was administered first in the left deltoid and the HPV was administered second in the right deltoid.  Patient was leaned over a clip board completing paperwork for a medical appointment at a facility next door.  RN exited the room to complete charting of vaccines and heard a noise.  Shortly after the noise patient then opened the exam room door and said "Hello".  Both RNs on duty responded to noise in exam room and patient standing in hallway.  Patient stated she didn't know what had happened.  She woke up lying on the floor in the exam and did not know where she was.  Patient was unconscious for 1 minute.  Patient reported feeling as though she was "falling asleep" and fell out of the chair, and onto the floor hitting her head on the stool or counter in the exam room.  Patient was returned to the vaccine chair and placed in a reclined position and instructed to remain until she was examined by a health care professional.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient is over the age of 7 years old, should have received TD instead of Dtap, she aged out of the dose given
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Pt received duplicate immunization on 8/22/24 (received first one on 1/2/24)
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, pain, warmer skin
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Nonviable vaccine given to pt. Vaccine temp out of rage during hurricane. Vaccines were deemed viable on 7/10, then not viable om 7/17.
Age: 0.33
Sex: F
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 month child received wrong vaccines.  Varicella, MMR and Hep A were given too early.  no adverse event to date
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Crying, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: The nurses assistant initially injected the vaccine intermuscular but withdrew the needle early while still injecting the vaccine and it ended up under the skin. My daughter was in severe pain and crying because it hurt so much. They provided a hot compress which helped a bit. A week later the injection site became a very noticeable bump and was red and sore to the touch (my daughter said it felt like it was pulsing). Another visit to the doctor and they didn't provide much help other than to say to use the compress. It has now been 3 weeks since the vaccine and there is a very noticeable subcutaneous nodule that is sore to the touch and is not going away. We don't know what to do to make it go down and be less sensitive.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Sensitive skin, Skin mass, Wrong technique in product usage process
Clinical narrative: The nurses assistant initially injected the vaccine intermuscular but withdrew the needle early while still injecting the vaccine and it ended up under the skin. My daughter was in severe pain and crying because it hurt so much. They provided a hot compress which helped a bit. A week later the injection site became a very noticeable bump and was red and sore to the touch (my daughter said it felt like it was pulsing). Another visit to the doctor and they didn't provide much help other than to say to use the compress. It has now been 3 weeks since the vaccine and there is a very noticeable subcutaneous nodule that is sore to the touch and is not going away. We don't know what to do to make it go down and be less sensitive.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Nausea, Retching, Tinnitus, Vomiting
Clinical narrative: Patient almost immediately after receiving second immunization felt lightheaded and just a bit nauseous.  I asked if she would like to have some water to drink.  I left to get the water and came back about 30 seconds later to find the mom holding a trashcan in front of the patient.  She felt nauseous and proceeded to vomit a small amount after gagging a couple of times.  Afterward she said that she had ringing in her ears.  I asked if she wanted to lay on the exam table instead of sitting in my vaccination chair.  She did not want to move.  She also did not want the crackers I offered to her.  Her mother had stated that she was in a motor vehicle accident  about a year ago that resulted in a Traumatic Brain Injury and treatments. She also has regular headaches and has gotten Botox injections for them.  She has had trouble with needles and blood draws and IVs since.   She was very nervous before receiving the vaccines but they both said she had never vomited afterward before.  She sat and rested for several minutes and ambulated beside her mother at 4:11.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Pt received Heplisav B instead  of Hepatis 3 dose series vaccine as ordered
Sex: M
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Seizure like phenomena
Clinical narrative: Patient received Hepatitis B Vaccine without consent; Seizure-like activity observed several hours later and treated with phenobarbital
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Kinrix inadvertently given as dose #2 of Dtap and IPV instead of Pediarix.  No adverse reactions noted.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Immunization was given at month 1 instead of month 2 as recommended by ACIP.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Blood creatine phosphokinase, Rhabdomyolysis
Clinical narrative: Rhabdomyolysis, required treatment for 5 days in the hospital. Had also possibly had  a concurrent viral infection and did weight lifting involving his upper extremities following
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: The Proquad vaccine  recommended not to be given while taking Dupixent.  He tolerated vaccine well.
Age: 17.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient came in for vaccination in order to return back to school. MA was forming together the vaccinations and did not notice the age verification from the school order and patient report. Patient is feeling good after vaccination & no further actions towards the vaccine.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Gait disturbance, Paraesthesia
Clinical narrative: Tingling on Right side of arm and legs, after 3 days tingling and limping of right leg resolved and tingling of right arm getting better
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site swelling
Clinical narrative: Left arm - swelling and bruised near armpit. The patient complained that it was hard to lift her left arm and found a baseball sized swell at home. Came to pharmacy 10 days after vaccination, bruised still visible.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Mom gave me what she said was copies of the patient's vaccine records and a copy of the school letter showing what vaccination was needed and their record of what vaccines he had been given prior.  I started with the copy of the shots from the doctor.  I was done entering them into the state immunization record when I saw that the dates on some of the vaccines were before his date of birth.  It was then that I looked closer at the records and found only half of a page of shot records was his.  The other records were from his brother.  So I gave the records back to his mother and cancelled the information I had been putting into the system.  I then took the school letter and put those vaccinations into the system and asked the mother to have the doctor's office pull his records from their other older computer system so we have the whole shot record and fax them to our fax line.  When done, I talked over the vaccinations that I saw that was needed.  I noticed the date on the Varicella was 8 days after the MMR and told her that he needed the vaccine repeated.  After the patient and his mother left, I saw that the doctor had faxed the records.  On the 21st of August I entered the vaccines into the system and at that point noticed I had incorrectly entered the date of his second Varicella and that it was in fact given on the same day as the MMR and he did not require a revaccination of the Varicella after all.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Expired vaccine administered; This spontaneous report was received from Pharmacist and refers to a patient of an unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 18-JUN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, valid lot #X012185, expiration date: 03-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered).  No additional adverse event (AE) was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; HCP calling to report that 14 year old patient received PROQUAD instead of MMR II.; This spontaneous report was received from a technician, referring to a 14-year-old patient.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 10-AUG-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, single dose, lot # X026597, expiration date: 11-MAY-2025, administered for prophylaxis by health professional (strength, dose, and route of administration were not provided); instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (wrong product administered). No adverse effects were reported (no adverse event).
Age: 12.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Product lot number issue, Product storage error
Clinical narrative: Product Lot number issue; No aditional AE; Multiple current below excursions where products were administered.; This spontaneous report was received from a medical assistant referring to a 12-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies was not reported.   On 13-AUG-2024, the patient was vaccinated with an improperly stored dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 mL for prophylaxis (strength, vaccination scheme, route of administration and anatomical site of injection were not reported) (Product storage error). Reporter reported quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) with lot # X024251; expiration date: 31-MAY-2026), which was not valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). However, lot # X024251 is valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Product lot number issue).  The administered dose was stored at a temperature of 0.9 degrees Celsius (C) during a time frame of 24 hours and 40 minutes, and -1.1 degrees (C) during a time frame of 20 minutes (both reported as current temperatures). There were no previous excursions.  No adverse event occurred with the administration of the vaccine (No adverse event).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No side effects or symptoms reported; Medical Assistant called to inquire about revaccination recommendations for a smaller dose than recommended of VARIVAX administered to a patient.the patient received less than the recommended dose; Medical assistant pulled the syringe out too soon while administering VARIVAX; This spontaneous report has been received by a medical assistant regarding a 12-month-old female patient. The patients' medical history, concurrent conditions, concomitant medications were not provided.  On 14-AUG-2024, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (strength, dose, frequency, route of administration, vaccination scheme, and site of administration were not provided; lot # y002062, which has been verified to be a valid number, and expiration date reported and validated as 09-JAN-2026) as prophylaxis.   However, the medical assistant pulled the syringe out to soon while administrating the vaccine (wrong technique in product usage process). Therefore, the patient received less than the recommended dose (smaller dose) (accidental underdose). Revaccination recommendation was requested. No side effects or symptoms were reported.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Crying, Irritability, Pyrexia, Rash
Clinical narrative: the patient is very fussy, inconsolable, and just not himself.; the patient is very fussy, inconsolable, and just not himself.; the patient is very fussy, inconsolable, and just not himself.; the patient developed bumps / a rash on his body; the patient started to develop a fever that eventually went up to 102.5 degree Fahrenheit; This spontaneous report was received from the patient's mother, referring to a 15-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-AUG-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, route of administration: vaccination, administered for prophylaxis of measles, mumps, and rubella (dose, strength, lot # and expiry date were not provided).  On 13-AUG-2024, the patient started to develop a fever that eventually went up to 102.5-degree Fahrenheit (Pyrexia). On 15-AUG-2024, the patient developed bumps/a rash on his body (Rash popular). The reporter took the patient to the doctor who said that the rash should go away but that it should be monitored. On 16-AUG-2024, the rash had gotten worse, and that the patient was very fussy, inconsolable, and just not himself (Irritability, Emotional distress, Abnormal behaviour). Treatment was not given for the events. The outcome of all events was reported as not recovered.  The causal relationship between all events and suspect vaccine was not provided.  Lot# is being requested and will be submitted if received.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: female patient who received her first GARDASIL 9 dose on 12/20/2023 and second dose 5/20/2024; No additional AE; This spontaneous report was received from a pharmacist and refers to a 29-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-DEC-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis.  On 20-MAY-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis (inappropriate schedule of product administration). The pharmacist was calling to request information on vaccination guidelines for the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine. No additional adverse event (AE) and no product quality complaint (PQC) was noted. No additional information was provided.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 12 month old patient who had been administered VARIVAX and PROQUAD concomitantly.; No additional AE; This spontaneous report was received from a pharmacist and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated concomitantly with varicella virus vaccine live (oka/merck) (VARIVAX) injection and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection both administered as prophylaxis (strengths, doses, vaccination schemes, lot #s, expiry dates, anatomical locations and routes of administration were not provided) (overdose). There was no additional adverse event (AE) and no Product Quality Complaints (PQC).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no side effects or symptoms reported; HBP reported the following: VARIVAX which expired on 08/10/2024 was inadvertently administered on 08/21/2024.  Instructed HBP to transfer to HCP in order to provide Post Expiry memo information.  Provided to information to HCP.  HCP granted permissio; This spontaneous report was received from an Office Manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not provided.  On 21-AUG-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection for prophylaxis (strength, vaccination scheme, route of administration and site of vaccination were not provided, lot number W025277, expiration date was reported and validates as 10-AGU-2024) (expired product administered). No side effects or symptoms reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; HBP called to report inadvertent administration of expired MMR-II to a patient. Vaccine expired on 14AUG2024 and was administered on 19AUG2024. Limited patient demographics provided. No additional AE/PQC.; This spontaneous report has been received from a health business professional (HBP) (also reporter as other) regarding a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant medication, past drug reactions or allergies were not reported.  On 19-AUG-2024, the patient was vaccinated inadvertently with an expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II), injection, administered as prophylaxis (lot number W025567 has been verified to be a valid lot number for measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II), expiration date reported and established as 14-AUG-2024) (expired product administered) (strength, dose number, dose quantity, route of administration, vaccination scheme frequency and anatomical site of application were not provided). No additional adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Abdominal pain, Arthralgia, Back pain, Headache
Clinical narrative: Chills; Pain in lower back, knees, and shoulders; Pain in lower back, knees, and shoulders; Pain in lower back, knees, and shoulders; Abdominal pain; Headache; Initial report received on 05-Aug-2024.  A consumer reported that a 56-year-old gender (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has received their second dose.  Medical history and concomitant medications at the time of vaccination were not reported. The patient has an allergy to cipro (hives).  On 01-Jul-2024, the patient received the first dose of HEPLISAV-B (lot #, expiration date, and NDC # and route and site not reported).   On 01-Aug-2024, 31 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (lot#, expiration date, NDC# 43528-002-01, not reported) intramuscularly in the left upper arm. One day after having been vaccinated with the second dose of HEPLISAV-B the patient woke up with abdominal pain in his lower back, knees, and shoulders, and he had a headache. The patient stated that most of the symptoms have resolved, except some residual belly aches.  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingle; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (for the last 7 years).   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), shingles (Verbatim: shingle) and pain (Verbatim: pain). The outcome of the vaccination failure was not reported and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-AUG-2024 The patient got shingles shot and still came with shingles and pain was relentless. There were no medications work nor did nerve blocks. 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 is considered related to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Product use in unapproved indication
Clinical narrative: of Shingrix vaccine administered according to the non-approved indication; This non-serious case was reported by a other health professional and described the occurrence of drug use for unapproved indication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: of Shingrix vaccine administered according to the non-approved indication). The outcome of the drug use for unapproved indication was not reported.   Additional Information: GSK Receipt Date: 12-AUG-2024 Th reporter reported, the Shingrix vaccine administered according to the non-approved indication, which led drug use for unapproved indication.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: a vaccine (Engerix-B) was given, but it was expired,; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis.   On 08-AUG-2024, the patient received the 1st dose of Engerix B. On 08-AUG-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: a vaccine (Engerix-B) was given, but it was 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: 09-AUG-2024 The reporter was calling because yesterday a vaccine (Engerix-B) was given, but it was expired, so was tried to see how far outside of the expiration day window, was still good. The reporter asked if they need to be revaccinated. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.