chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Dizziness, Dyskinesia, Loss of consciousness, Presyncope
Clinical narrative: orders placed for patient to receive GARDASIL 9 VACCINE. Vaccine obtained and dual verified with LPN prior to administration, vaccination given per provider order. Pre-vaccination counseling provided and patient agreeable to vaccination administration. Verbal consent and confirmation obtained. Patient and father present both deny previous adverse reactions to vaccination administration and patient denies contraindications to vaccination. Vaccine provided via IM route to R deltoid w/o complication, patient tolerated well and conversational with her father and RN during administration. During post-vaccination observation patient noted to become pale and while seated began to experience a suspected vasovagal response, patient began jerking arms and legs and lost consciousness for ~3 seconds before recovering. On waking, patient reported no recollection of event. Pallor improved after event. GCS of 15, responds appropriately to all commands, pupils equal and reactive. Patient passed Neuro Exam w/o issue. PCP notified and in room to assess patient, similar findings. Patient provided with 8oz of juice and crackers and vitals rechecked. No further events. Vitals rechecked after 15 minutes and WDL. Patient reports no further feeling of lightheadedness and reports resolution of symptoms.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Blood glucose normal, Brief resolved unexplained event, Crying, Cyanosis, Electroencephalogram normal
Clinical narrative: At  approximately 10:30pm on 4/16 she was being held by grandma with her owelette  sock in place. The owelette alarmed for low oxygen. The infant became pale, then  blue then let out a weak cry and stopped. She was not breathing for about 15-20  seconds then she regained color and 30 seconds later this occurred again. Mom  reports this continued for 15-20 minutes. During these episodes she had a blank  stare. She was taken via private vehicle to ER after EMS was called. It was  determined it would be quicker to take her than to wait for EMS. When they  arrived at ER she started to come out of it, but had a couple of more  episodes while there. She was transferred by ambulance to Hospital. She had  another couple of episodes while there. EEG was performed and it was normal.  Blood glucose was reportedly normal per mom. No other labs or tests were performed. She was admitted for observation for 24 hours then released with diagnosis of Brief Resolved Unexplained Event.  Mom reports earlier on the day this occurred she would scream and arch her back in an extreme way while lying on her tummy or side causing her to roll over to her back. She had  not done this previously and reports she did it 13 times that day. She has not  done it since.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Infantile apnoea, Infantile back arching, Oxygen saturation decreased, Pallor, Screaming
Clinical narrative: At  approximately 10:30pm on 4/16 she was being held by grandma with her owelette  sock in place. The owelette alarmed for low oxygen. The infant became pale, then  blue then let out a weak cry and stopped. She was not breathing for about 15-20  seconds then she regained color and 30 seconds later this occurred again. Mom  reports this continued for 15-20 minutes. During these episodes she had a blank  stare. She was taken via private vehicle to ER after EMS was called. It was  determined it would be quicker to take her than to wait for EMS. When they  arrived at ER she started to come out of it, but had a couple of more  episodes while there. She was transferred by ambulance to Hospital. She had  another couple of episodes while there. EEG was performed and it was normal.  Blood glucose was reportedly normal per mom. No other labs or tests were performed. She was admitted for observation for 24 hours then released with diagnosis of Brief Resolved Unexplained Event.  Mom reports earlier on the day this occurred she would scream and arch her back in an extreme way while lying on her tummy or side causing her to roll over to her back. She had  not done this previously and reports she did it 13 times that day. She has not  done it since.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Staring
Clinical narrative: At  approximately 10:30pm on 4/16 she was being held by grandma with her owelette  sock in place. The owelette alarmed for low oxygen. The infant became pale, then  blue then let out a weak cry and stopped. She was not breathing for about 15-20  seconds then she regained color and 30 seconds later this occurred again. Mom  reports this continued for 15-20 minutes. During these episodes she had a blank  stare. She was taken via private vehicle to ER after EMS was called. It was  determined it would be quicker to take her than to wait for EMS. When they  arrived at ER she started to come out of it, but had a couple of more  episodes while there. She was transferred by ambulance to Hospital. She had  another couple of episodes while there. EEG was performed and it was normal.  Blood glucose was reportedly normal per mom. No other labs or tests were performed. She was admitted for observation for 24 hours then released with diagnosis of Brief Resolved Unexplained Event.  Mom reports earlier on the day this occurred she would scream and arch her back in an extreme way while lying on her tummy or side causing her to roll over to her back. She had  not done this previously and reports she did it 13 times that day. She has not  done it since.
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site warmth, Muscle twitching, Rash macular
Clinical narrative: Redness and blotching down left arm. Left arm is sore. The redness and blotching are not at the injection site but more distal. 4-23-25 was warm to the touch.  Pt is also having muscle twitching in left arm.   NP encourage the the pt to apply ice, take ibu/tylenol for pain, and take an antihistamine. Discussed red flag symptoms and when to seek further evaluation.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Nerve compression, Skin discolouration
Clinical narrative: Given fluvarix vaccine on 4/21/25 in right deltoid muscle.  Patient called office on Tuesday 4/22/25 to note swelling at site and redness.  Patient called office again on Wednesday 4/23/25 to report "being unable to move right arm, sensitivity to touch, discoloration in comparison to other arm, pain that feels like pin and needles" Patient directed to ER and did not go on 4/23/25.  Patient walked into office on Thursday 4/24/25 got examined by physician and instructed to go to ER.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Chief Complaint  In office 4/22 for 18 mo WB; Hep A vaccine given (early am). Around 1430 developed hives on R outside thigh around vaccine injection site Hives progressed on torso and taken to facility. Never respiratory symptoms Dose of Benadry given and sent home temp 99-100 Discharged home with instructions for Benadryl Q 6-8 and Zyrtec once daily No further rash since last night
Age: 62.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Asthenia, Back pain, Eye pain, Gait inability, Neurological symptom
Clinical narrative: Patient reported GBS symptoms.  She said she had pain in her eyes, arms, back, legs.  She had tingling and weakness.  She could not walk.  She went to hospital.  She had to have plasma treatments to repair her nerve endings.  She was in an inpatient rehab and is currently doing out patient rehab.
Age: 62.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient reported GBS symptoms.  She said she had pain in her eyes, arms, back, legs.  She had tingling and weakness.  She could not walk.  She went to hospital.  She had to have plasma treatments to repair her nerve endings.  She was in an inpatient rehab and is currently doing out patient rehab.
Age: 63.0
Sex: M
Vaccine: DTAP
Symptoms: Discomfort, Injected limb mobility decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Vaccination in upper left arm. First day, some noticeable discomfort, but common to this type of vaccine. second day discomfort became slightly more noticeable, and by day three it had become a deeper more intense pain.  Called the physicians office on day five,  as pain increased and mobility of the left arm lessened and became more pronounced. Advised to use ice, ibuprofen and acetaminophen  (alternating) every 3 to 6 hours. Lateral motion of the arm very difficult and painful. Sleeping (any position) is difficult. Pain radiates upward into the neck and downward toward the elbow. some pain also in the mid to upper scapula.
Age: 63.0
Sex: M
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: Vaccination in upper left arm. First day, some noticeable discomfort, but common to this type of vaccine. second day discomfort became slightly more noticeable, and by day three it had become a deeper more intense pain.  Called the physicians office on day five,  as pain increased and mobility of the left arm lessened and became more pronounced. Advised to use ice, ibuprofen and acetaminophen  (alternating) every 3 to 6 hours. Lateral motion of the arm very difficult and painful. Sleeping (any position) is difficult. Pain radiates upward into the neck and downward toward the elbow. some pain also in the mid to upper scapula.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, Malaise, Pyrexia, Tremor, Vomiting
Clinical narrative: Wrong Vaccine was given at age 11, when it should have been the Tdap. They gave her the Meninggoccocal B vaccine which is due when she is 16. She was very sick that night after the vaccine. Shaking, dizzy, fever, throwing up.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Wrong Vaccine was given at age 11, when it should have been the Tdap. They gave her the Meninggoccocal B vaccine which is due when she is 16. She was very sick that night after the vaccine. Shaking, dizzy, fever, throwing up.
Age: 49.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Chest discomfort, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Patient began experiencing an adverse reaction the day following vaccination (04/22/2025). She presented to our clinic an additional day following (04/23/2025). Patient had a swollen, red area about 4 inches in length and 2 inches in width at the site of the varicella vaccine (back of left arm). The area was red with small, raised bumps. Patient stated that the area was painful and pulsating. She stated that she experienced a fever the day following the vaccine but was unable to report her exact temperature. She also experienced fatigue, headache, and tightness in her chest. Patient has a history of asthma, but did not feel the need to use her inhaler. At the time she presented to our clinic (04/23/2025 at 4:10pm) she was still experiencing tightness in her chest, fatigue, and pain, but stated that symptoms were starting to feel better. Patient had not had the varicella vaccine before but stated she had the chickenpox as a child. At that time her vitals were as follows: Temperature 97.5F, Blood Pressure 112/81, Pulse 79 bpm, O2 sat on right arm 99%. Patient was instructed to go to urgent care and was given a note explaining what has been stated above, which vaccines she received and where they were given, and vital signs at 4:10pm that she could take to urgent care.
Age: 49.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Pyrexia, Rash papular
Clinical narrative: Patient began experiencing an adverse reaction the day following vaccination (04/22/2025). She presented to our clinic an additional day following (04/23/2025). Patient had a swollen, red area about 4 inches in length and 2 inches in width at the site of the varicella vaccine (back of left arm). The area was red with small, raised bumps. Patient stated that the area was painful and pulsating. She stated that she experienced a fever the day following the vaccine but was unable to report her exact temperature. She also experienced fatigue, headache, and tightness in her chest. Patient has a history of asthma, but did not feel the need to use her inhaler. At the time she presented to our clinic (04/23/2025 at 4:10pm) she was still experiencing tightness in her chest, fatigue, and pain, but stated that symptoms were starting to feel better. Patient had not had the varicella vaccine before but stated she had the chickenpox as a child. At that time her vitals were as follows: Temperature 97.5F, Blood Pressure 112/81, Pulse 79 bpm, O2 sat on right arm 99%. Patient was instructed to go to urgent care and was given a note explaining what has been stated above, which vaccines she received and where they were given, and vital signs at 4:10pm that she could take to urgent care.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Client called in stating she was experiencing soreness, redness, and swelling at the injection site and found it difficult to raise her arm. Client stated the symptoms began the day after receiving her Tdap booster and have not improved. Client stated she will continue to apply ice to the injection site and has found relief with over the counter pain relievers. Client shared she will continue to monitor and seek medical attention if symptoms don't improve or worsen.
Age: 6.0
Sex: M
Vaccine: DTAP, DTAP, HEPA, HEPA, MMR, MMR
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Pts mother noted patient scratching at his right Deltoid on 04/23/25. Pts mother noted a large wheal approx 3 inches across under injection site. Initially hot to the touch ,today at office visit, redness till present but no swelling noted. MOP states it has improved.   No treatment necessary
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Invalid dose. Vaccine had 2 temp excursions.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site urticaria
Clinical narrative: Roughly 3 days after receiving first dose of HPV and Meningicoccal vaccine given in Left deltoid, patient started developing hives on L arm surrounding injection sites that continued to spread with antihistamines
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt given cov vaccine 7 days past BUD of vaccine. Grace period post-BUD is 2 days. Vaccine not otherwise expired. Vaccine info: Pfizer Sars-Cov-2 VACCINE 10mcg/0.2mL 5y-11y. Lot:LN7302 BUD:3/20/2025 Exp:01/31/2026. NDC:59267-4438-1
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: No adverse event
Clinical narrative: none at the time of the visit
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt given cov vaccine 7 days past BUD of vaccine. Vaccine not otherwise expired. Vaccine info: Pfizer Sars-Cov-2 VACCINE 10mcg/0.2mL 5y-11y. Lot:LN7302 BUD:3/20/2025 Exp:01/31/2026. NDC:59267-4438-1
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood sodium decreased, Differential white blood cell count
Clinical narrative: Vaccinations administered 04/23/2025, on the morning of 04/24/2025, the person c/o being lightheaded and almost vomited at school, father took daughter to the Local ER for evaluation and treatment, after treatment daughter was discharged to home. Case was diagnosed with #1 - myalgias, #2 - Nausea. While in the ER - she was given 1 liter of fluid before being discharged home
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Full blood count, Metabolic function test, Myalgia, Nausea
Clinical narrative: Vaccinations administered 04/23/2025, on the morning of 04/24/2025, the person c/o being lightheaded and almost vomited at school, father took daughter to the Local ER for evaluation and treatment, after treatment daughter was discharged to home. Case was diagnosed with #1 - myalgias, #2 - Nausea. While in the ER - she was given 1 liter of fluid before being discharged home
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Pregnancy test negative, Protein total abnormal, Urine analysis, Vomiting
Clinical narrative: Vaccinations administered 04/23/2025, on the morning of 04/24/2025, the person c/o being lightheaded and almost vomited at school, father took daughter to the Local ER for evaluation and treatment, after treatment daughter was discharged to home. Case was diagnosed with #1 - myalgias, #2 - Nausea. While in the ER - she was given 1 liter of fluid before being discharged home
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Got Shingrix at pharmacy
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no sx's but Covid 12+ was given instead of 5-11 age COVID
Age: 69.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Erythema, Hypersensitivity, Incontinence, Peripheral swelling
Clinical narrative: 04/14/2025-"Patient called in and stated after receiving the shingles vaccine she had an allergic reaction. I asked patient if she had called us to report the allergic reaction, patient stated she did not and "would let it take it's course". Patient stated she was experiencing redness, arm swelling, caused incontinence that causes her to wake up 3-4 times a night x10 days. Patient stated she was not experiencing any symptoms today." Pt is scheduled to f/u for her reaction today at 2:15pm
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Dizziness, Headache
Clinical narrative: strong abdominal pain, headache, dizziness reported via Mychart on 4/24
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Conjunctival haemorrhage, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient started about 14 hours after his vaccines with significant nausea and vomiting; he forcefully vomited at least 6 times and had to be seen in an urgent care for SL Zofran. No LOC or other SE's. His vomiting cause bilateral subconjunctival hemorrhages. He had no other symptoms of anaphylaxis. He had no diarrhea or other symptoms of gastroenteritis. He did have a fever 101.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site nodule, Injection site pain, Injection site reaction, Rash papular
Clinical narrative: mother states that the day after receiving vaccines, child woke up with rash, raised area, with knot on the left arm at injection site.  Was taken to PCP due to area worsening and was prescribed antibiotics to rule out infection.  Site was marked and mother advised to return if area worsens or spreads.  Mother returned child to PCP the next day d/t area worsening.  Was prescribed another antibiotic and dx with cellulitis.  Mother denies child running a fever or complaining of itching.  Mother states the only pain felt by child is pain/soreness at the actual injection site.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt given cov vaccine 8 days past BUD of vaccine. Grace period post-BUD is 2 days. Vaccine not otherwise expired. Vaccine info: Pfizer Sars-Cov-2 VACCINE 10mcg/0.2mL 5y-11y. Lot:LN7302 BUD:3/20/2025 Exp:01/31/2026. NDC:59267-4438-1
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the DTAP/HEPB/IPV Vaccine second dose too early.  The dose was received at 17 months.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt given cov vaccine 7 days past BUD of vaccine. Vaccine not otherwise expired. Vaccine info: Pfizer Sars-Cov-2 VACCINE 10mcg/0.2mL 5y-11y. Lot:LN7302 BUD:3/20/2025 Exp:01/31/2026. NDC:59267-4438-1
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: PATIENT HAS HAD A VERY SORE ARM SINCE THE TIME OF INJECTION.  2ND SHINGRIX VACCINE IN THE LEFT DELTOID DID NOT CAUSE ANY ISSUES.  PATIENT REPORTS HAVING HAD A VACCINE PREVIOUSLY AT ANOTHER CLINIC IN THE RIGHT DELTOID THAT REQUIRED PHYSICAL THERAPY.  PATIENT WAS NOT IN PT AT THE TIME OF THIS INJECTION.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: patient presented to pharmacy 4/23 with what looked like cellulitis confirmed by ER.  Patient is currently on antibiotics for treatment
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, PNC20
Symptoms: Expired product administered, No adverse event
Clinical narrative: EXPIRED MMR DOSE INADVERTENTLY GIVEN TO PATIENT. DOSE EXPIRED ON 4/19/2025. DOSE WAS GIVEN TO PATIENT ON 4/23/2025. PATIENT'S MOTHER NOTIFIED ON 4/24/2025. PATIENT DOES NOT HAVE ANY ADVERSE REACTIONS. MOTHER NOTIFIED THAT PATIENT WILL RECEIVE AN ADDITIONAL DOSE OF MMR AT NEXT APPOINTMENT IN JUNE.
Age: 86.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Pt reported adverse reaction to our office on the afternoon of 04/24/25.  He reported that his arm got red, swollen and itched the following day after getting this immunization on 04/15/25.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: itchy, red and swollen
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dehydration, Dizziness, Hyperhidrosis, Pallor, Skin warm
Clinical narrative: 1:32pm- Administered vaccine into left deltoid. Monitored pt for any adverse effects, appeared well, denied any dizziness. Patient stood up and denied any adverse effects. LPN escorted patient and mother into waiting room to speak with PSR about scheduling appt and paperwork for when pt turns 18 years old in 2 days.  1:40pm- While standing in front of PSR desk, pt stated she was starting to feel dizzy. Moved pt to sit in chair. Pt appeared very pale and diaphoretic. Body felt hot to touch. Pt reported dizziness was worsening and vision was blurry. LPN immediately alerted RN and Dr. 1:43pm- Moved pt from chair into wheelchair then moved to chair in lactation room and elevated feet. Hooked up to Dinamap, blood pressure cuff applied to right arm along with pulse ox. RN and Dr. present. 1:45pm- Bp 67/28, pulse 53, pulse ox 100%. Gave pt juice box and cheez its, drank entire juice box and ate a few cheez its. Repeated manual blood pressure on left arm, 70/38. Gave pt another juice box and a water bottle. RN and LPN continued to monitor pt. 1:50pm- pt drank all of 2nd juice box and started drinking water. Pt reported dizziness and blurry vision was resolving. RN and LPN continued to monitor pt. 1:55pm- Repeated blood pressure on right arm, 105/72, pulse 72, pulse ox 100%. Dr. made aware. Pt reports she was feeling better, all sx resolved. No longer appeared to be diaphoretic or pale, color returned. Dr. gave verbal permission for pt to go home, advised sx were due to adverse reaction from vaccine, also dehydration. Mother was present for entire time and expressed understanding and felt comfortable taking pt home. RN reviewed proper hydration with pt and encouraged increase hydration and protein before sports practices and games. Pt admits she usually doesn't drink too much. RN and LPN escorted pt and mother to their car.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Vision blurred
Clinical narrative: 1:32pm- Administered vaccine into left deltoid. Monitored pt for any adverse effects, appeared well, denied any dizziness. Patient stood up and denied any adverse effects. LPN escorted patient and mother into waiting room to speak with PSR about scheduling appt and paperwork for when pt turns 18 years old in 2 days.  1:40pm- While standing in front of PSR desk, pt stated she was starting to feel dizzy. Moved pt to sit in chair. Pt appeared very pale and diaphoretic. Body felt hot to touch. Pt reported dizziness was worsening and vision was blurry. LPN immediately alerted RN and Dr. 1:43pm- Moved pt from chair into wheelchair then moved to chair in lactation room and elevated feet. Hooked up to Dinamap, blood pressure cuff applied to right arm along with pulse ox. RN and Dr. present. 1:45pm- Bp 67/28, pulse 53, pulse ox 100%. Gave pt juice box and cheez its, drank entire juice box and ate a few cheez its. Repeated manual blood pressure on left arm, 70/38. Gave pt another juice box and a water bottle. RN and LPN continued to monitor pt. 1:50pm- pt drank all of 2nd juice box and started drinking water. Pt reported dizziness and blurry vision was resolving. RN and LPN continued to monitor pt. 1:55pm- Repeated blood pressure on right arm, 105/72, pulse 72, pulse ox 100%. Dr. made aware. Pt reports she was feeling better, all sx resolved. No longer appeared to be diaphoretic or pale, color returned. Dr. gave verbal permission for pt to go home, advised sx were due to adverse reaction from vaccine, also dehydration. Mother was present for entire time and expressed understanding and felt comfortable taking pt home. RN reviewed proper hydration with pt and encouraged increase hydration and protein before sports practices and games. Pt admits she usually doesn't drink too much. RN and LPN escorted pt and mother to their car.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient stated shoulder/arm pain was 'excruciating', fingers were tingling.  Pain was bad enough that patient had to visit an urgent care.  Patient was prescribed muscle relaxer (tizanidine) and methylprednisolone dose pack.  Patient stated symptoms improved but then got worse again.  Had pain on entire right side of body, needed to use a walker and wheelchair as pain made it difficult to walk.  Said these symptoms continued for about a month before she had improvement.  Patient discussed with her primary care provider however pharmacy was not contacted.  Pharmacy first learned of her reaction when contacted to schedule 2nd dose.  Pharmacist recommended patient not to received 2nd dose due to severity of reaction after 1st dose.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: Patient stated shoulder/arm pain was 'excruciating', fingers were tingling.  Pain was bad enough that patient had to visit an urgent care.  Patient was prescribed muscle relaxer (tizanidine) and methylprednisolone dose pack.  Patient stated symptoms improved but then got worse again.  Had pain on entire right side of body, needed to use a walker and wheelchair as pain made it difficult to walk.  Said these symptoms continued for about a month before she had improvement.  Patient discussed with her primary care provider however pharmacy was not contacted.  Pharmacy first learned of her reaction when contacted to schedule 2nd dose.  Pharmacist recommended patient not to received 2nd dose due to severity of reaction after 1st dose.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: The MA reconstituted the vaccine with the incorrect sterile diluent she used sterile water.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site reaction, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint
Clinical narrative: Left arm pain that radiates to hand and fingers. She is experiencing numbness in the arm and has some difficulty using the arm. She was evaluated by an Emergency Department physician as well as a Neurologist and Pain specialist.  The Gabapentin and steroids that were prescribed do not seem to be effective.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Magnetic resonance imaging spinal normal, Muscle oedema, Pain, Pain in extremity, Ultrasound scan normal
Clinical narrative: Left arm pain that radiates to hand and fingers. She is experiencing numbness in the arm and has some difficulty using the arm. She was evaluated by an Emergency Department physician as well as a Neurologist and Pain specialist.  The Gabapentin and steroids that were prescribed do not seem to be effective.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Rash on chest 2 hours post-vaccination
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired COVID vaccine on 4/17/25. The vaccine expired on 4/10/25. There were no adverse effects. Patient notified.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia
Clinical narrative: Patient reports a soreness in shoulder that she received a prevanr-20 vaccine. The pain started follwoing the vaccination and has continued for 2 months.
Age: 61.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Cough, Fatigue, Pain, Pyrexia
Clinical narrative: Patient complains of fatigue, bodyache, mild fever, and cough.
Age: 41.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; patient was accidently given 3 doses of  GARDASIL-9 over a two week period.; This spontaneous report was received from a nurse referring to a 41-year-old female patient.  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 31-MAR-2025, 07-APR-2025 and 14-APR-2025, over a two-week period, the patient received respectively the first, second and third dose of human papillomavirus (GARDASIL 9) injection, as a dose of 0.5 ml for prophylaxis (route of administration, anatomical location was not reported, lot number Y014059 with an expiration date on 20-NOV-2026). (Inappropriate schedule of product administration). There was no adverse effect reported.
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: the patient involved has not experienced any medical concerns or symptoms after being administered the expired VARIVAX; Medical Assistant calling to report an adverse event regarding an expired administration of VARIVAX.  Medical Assistant stated that a dose of VARIVAX with a labeled expiration date of 4/11/2025 was administered to a patient today, 4/17/2025.  Medical; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 17-Apr-2025, the patient was vaccinated with an expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #X010523, expiration date: 11-Apr-2025, 0.5 mL (0.5 mL / Two dose series) (strength, route, and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (details not provided). Medical Assistant confirmed the patient involved has not experienced any medical concerns or symptoms after being administered the expired Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX).
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: BEXSERO dose was given to patient on 11-apr 2025 they intended to administer is MenQuadfi; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On 11-APR-2025, the patient received Bexsero (intramuscular) .5 ml. On an unknown date, the patient received Menquadfi. On 11-APR-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: BEXSERO dose was given to patient on 11-apr 2025 they intended to administer is MenQuadfi). The outcome of the wrong vaccine administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-APR-2025 The nurse reported that a Bexsero dose was given to a patient and stated that the medication they intended to administer was Menquadfi, which led to wrong vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received his second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26-JUN-2021, in left arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received his second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 17-APR-2025 The patient self-reported this case. The patient received his first dose of Shingrix vaccine and never received his second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: the patient received the orange topped lyophilized powder diluted with sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAB030A) for prophylaxis.   On 11-APR-2025, the patient received Menveo. On 11-APR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: the patient received the orange topped lyophilized powder diluted with sterile water). The outcome of the wrong solution used in drug reconstitution was not applicable.   Additional Information: GSK Receipt Date: 15-APR-2025 The pharmacist asked could tell if both vials of Menveo (2 vial kit) were not administered does the dose need to be repeated. The patient received the orange topped lyophilized powder diluted with sterile water, which led wrong solution used in drug reconstitution. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: When opened box, one vial was broken it the box; This is a spontaneous report received from a Nurse from product quality group.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT CONTAINER ISSUE (non-serious) with onset 15Apr2025, outcome "unknown", described as "When opened box, one vial was broken it the box".  Additional information: The nurse confirmed no patient involvement. She was taking the vaccine out to use and that was when she realized that the pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) was broken.  Causality for "when opened box, one vial was broken it the box" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction).  The lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein), was not provided and will be requested during follow up.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Incorrect vaccine administered for patient's age
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Dairy intolerance, Eczema, Poor feeding infant, Screaming
Clinical narrative: On day after receiving the vaccine in the evening ( about 36 hours after administration) the infant cried "like we have never heard before". It was hours of uncontrollable crying. Parents were close to going to ER. They administered Tylenol and it did not help. Went on from 9 PM until 3 AM. Baby would not nurse. Baby just screamed for hours. Baby now exhibits eczema and milk protein intolerance
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Cough, Measles antibody positive, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Pt. developed a fever on 3/27/25, on 3/29/25, pt developed a maculopapular rash at the hairline on his forehead, and it progressed down his trunk and out to his extremities. Pt also experienced cough and coryza. He was seen in the pediatric ED and suspected of having measles by the clinician.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Rhinitis
Clinical narrative: Pt. developed a fever on 3/27/25, on 3/29/25, pt developed a maculopapular rash at the hairline on his forehead, and it progressed down his trunk and out to his extremities. Pt also experienced cough and coryza. He was seen in the pediatric ED and suspected of having measles by the clinician.
Sex: F
Vaccine: PNC20
Symptoms: Eczema, Milk allergy
Clinical narrative: Eczema and dairy intolerance
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Injection site swelling
Clinical narrative: Diarrhea all day on the day after the shot (4/25/25) Swelling ad soreness at injection site, ongoing
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20
Symptoms: Condition aggravated, Metabolic function test, Renal impairment, Renal tubular acidosis
Clinical narrative: Kidney function worsened requiring increased doses of Bicitra
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Metabolic function test, Renal tubular acidosis, Thyroid function test, Urine analysis, Weight decreased
Clinical narrative: Began to lose weight noted at 9 month visit and continued to drop. Was referred and diagnosed with Renal Tubular Acidosis at 11 months
Age: 15.0
Sex: M
Vaccine: UNK
Symptoms: Syncope
Clinical narrative: After administering a vaccine, patient had a syncope.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Bronchiolitis, Infant irritability, Pyrexia
Clinical narrative: Fever of 103.  Irritable for 3 days. Bronchiolitis non RSV on 12/22/2021
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC20, RV5
Symptoms: Crying, Infant irritability, Poor feeding infant
Clinical narrative: Irritable and cried for many days afterward. Was fussy and not eating well for 2 weeks after the vaccine. Went to hospital and examined and told ok
Age: 0.58
Sex: M
Vaccine: FLU3, PNC20
Symptoms: Infant irritability, Pyrexia
Clinical narrative: Very fussy. Fever of 101.7 for 24 hours
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash, Urticaria
Clinical narrative: A red welt developed on day two, at the site of injection, about 2 inches in diameter. On day 7, a rash developed down the leg in which the injection was received, across the low back, and partially down the other leg.
Age: 4.0
Sex: F
Vaccine: COVID19, HEPA, MMRV
Symptoms: Cough, Dermatitis exfoliative generalised, Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: Child had coughing, redness of injection site followed by itching and erythroderma of face, trunk, less on extremities with some nausea and fatigue within 5 minutes of vaccination. Coughing resolved spontaneously. No wheezing on exam.  Benadryl 12.5mg given and epinephrine .015 mg given with improvement of skin redness and itching. Child previously received MMR and Varivax separately without reaction.  Vaccine was given in conjunction with first dose of Hepatitis A and COVID.
Age: 4.0
Sex: F
Vaccine: COVID19, HEPA, MMRV
Symptoms: Nausea
Clinical narrative: Child had coughing, redness of injection site followed by itching and erythroderma of face, trunk, less on extremities with some nausea and fatigue within 5 minutes of vaccination. Coughing resolved spontaneously. No wheezing on exam.  Benadryl 12.5mg given and epinephrine .015 mg given with improvement of skin redness and itching. Child previously received MMR and Varivax separately without reaction.  Vaccine was given in conjunction with first dose of Hepatitis A and COVID.
Age: 65.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash on arm, itchiness (Rt) arm. Pt was prescribed Hydrocortisone.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal, Hypoaesthesia, Laboratory test normal, Mobility decreased
Clinical narrative: Pt began to experience numbness & tingling in R feet 45 minutes after the vaccine. In evening fingers in R hand got stuck. Numbness & tingling in R feet has now progressed to pain in R leg.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pt began to experience numbness & tingling in R feet 45 minutes after the vaccine. In evening fingers in R hand got stuck. Numbness & tingling in R feet has now progressed to pain in R leg.
Age: 57.0
Sex: F
Vaccine: PNC21, TDAP, VARZOS, UNK, UNK, VARZOS
Symptoms: Incoherent, Syncope
Clinical narrative: After the 3rd vaccine (order was shingrix, capvaxive, adacel) patient incoherent then fainted. I administered one dose of epinephrine  0.3mg.; After the 3rd vaccine (order was shingrix, capvaxive, adacel) patient incoherent then fainted. I administered one dose of epinephrine  0.3mg.; Information has been received from the Health Authority via VAERS (VAERS ID: 2828448-1).  This spontaneous report was received from a Regulatory Authority and refers to a(n) 57-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies included citalopram 40 mg.  On 26-Feb-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # as reported 013009, administered by Intramuscular route in Left Arm (strength, dose, dose number, vaccination scheme, and expiration date were not reported), as prophylaxis. On 26-Feb-2025, the patient started therapy with Diphtheria vaccine toxoid;Pertussis vaccine acellular 5-component;Tetanus vaccine toxoid (ADACEL) lot #U8115AA, administered by Intramuscular route in the left arm (strength, dose, dose number, vaccination scheme, and expiration date was not reported), as prophylaxis. On 26-Feb-2025, the patient started therapy with Varicella zoster vaccine rgE (CHO) (SHINGRIX) lot #4H79Y, administered by Intramuscular route in the right arm (strength, dose, dose number, vaccination scheme, and expiration date were not reported), as prophylaxis. On 26-Feb-2025, after the 3rd vaccine (order was shingrix, capvaxive, adacel) patient became incoherent then fainted; then, it was administered one dose of epinephrine 0.3mg.  On 26-Feb-2025, the patient recovered from the events. The reporter did not assess the causal relationship between the events and the suspect vaccines.  Upon internal review syncope was determined to be important medical event.
Vaccine: VARCEL, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reported PEDVAX HIB was administered after a temperature excursion.  No other information provided.  No PQC reported; This spontaneous report was received from an Other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 26-MAR-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (lot #X022981, expiration date: 21-May-2026) 0.5 mL, administered by Intramuscular route for prophylaxis. It was reported that the vaccine was administered after a temperature excursion (Product storage error). Temperature excursion was reported as 54.19 F for the time frame of 2 hours 45 minutes. No other information was provided.
Vaccine: VARCEL, HIBV
Symptoms: Product storage error
Clinical narrative: Caller reported PEDVAX HIB was administered after a temperature excursion.  No other information provided.  No PQC reported; This spontaneous report was received from an Other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 26-MAR-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (lot #X022981, expiration date: 21-May-2026) 0.5 mL, administered by Intramuscular route for prophylaxis. It was reported that the vaccine was administered after a temperature excursion (Product storage error). Temperature excursion was reported as 54.19 F for the time frame of 2 hours 45 minutes. No other information was provided.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information provided. No additional AE/PQC reported; Nurse calling to report inadvertently administering a dose of PROQUAD outside of time frame in the Prescribing Information. Caller stated dose was administered 40 minutes after reconstitution. Caller stated patient reported no symptoms and permission; This spontaneous report was received from nurse and refers to a patient of unknown age and gender.   The patient's medical history, current conditions and concomitant medications were not reported.   On 31-MAR-2025, the patient was vaccinated with a outside of time frame of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD), (lot #Y009347 who had been verified to be a valid lot number, expiration date reported and validated as 11-NOV-2025); and sterile diluent (BAXTER STERILE DILUENT), (lot # and expiration date were not reported) as prophylaxis (product storage error). The reporter stated that, dose was administered 40 minutes after reconstitution.   No additional adverse events.
Age: 27.0
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Pharmacist reported that a patient missed his second dose of GARDASIL 9. Product information attached is related to first dose that was administered on 10/22/2024. No additional information available. No additional AE/no PQC.; No adverse event; This spontaneous report was received from a Pharmacist and refers to a 28-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 22-OCT-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y010656, expiration date: 29-Nov-2026), dose number 1, 0.5 mL administered by Unknown route for Prophylaxis.  On an unknown date, the patient missed his second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Product dose omission issue) No additional adverse event was reported.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report TE's for GARDASIL 9 advised the vaccine was administered to a patient on 03/20/2025.; This spontaneous report was received from a medical assistant and refers to a 16-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-Jan-2025, Human Papillomavirus 9-valent Vaccine, Recombinant (GRADASIL 9) (lot #1957404, expiration date: 05-Oct-2025) underwent a temperature excursion with a temperature of 35.8 F and on 30-Jan-2025, 35.6 F during 15 minutes and 10 minutes respectively. On 20-Mar-2025, the patient was vaccinated with this improperly stored vaccine, administered by unknown route as prophylaxis (Product storage error). No additional adverse event (AE).