chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pharyngeal swelling, SARS-CoV-2 test negative, Sinus congestion, Tenderness
Clinical narrative: I got the shot in my LT deltoid 01/05, Tuesday afternoon. Within minutes had nerve pain from LT shoulder to elbow. Resolved over 10-15 min. By that night I noticed some soreness in my axilla. Wednesday my left rib cage hurt so bad I couldn't take a deep breath for 2 days. I couldn't sit normally in a chair because I felt my insides were pushing up on my lungs and ribs. I couldn't lay flat. I had increased sinus congestion, everything tasted funny, things that weren't normally spicy were. Tested negative for covid again that Thursday night. Woke up in a pool of sweat on Friday and then the right side of my throat swelled up within minutes about 30 min after I got to work. Literally within a few minutes at work it felt like I had tonsillitis, and my right side of my throat was tender. The only reason I didn't freak out more was because I was amongst the CRNAs and was in the room across from me. Exhausted more every day from the night after getting it until I woke up from a nap Friday afternoon/evening. Everything was gone except the sore throat. That resolved on Sunday.  Noticed residual left deltoid muscle weakness 01/11 when I couldn't hold up a foot to prep. Unable to raise arm where elbow is horizontal to shoulder. Unable to lift more than a couple pounds until 2 weeks later when I could lift 5 lbs. Took 2 weeks to get motor function back to that arm.  was giving it a week before sending me to therapy in hopes of using stim therapy that they use for nerve palsy. I spoke to PA and PA and PA about it as well. Also noticed insidious onset of LT hand aching pain at the MPJ of the middle finger and RT DIPJ of the pinky (5th) finger. This pain was intermittent with movement.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tonsillitis
Clinical narrative: I got the shot in my LT deltoid 01/05, Tuesday afternoon. Within minutes had nerve pain from LT shoulder to elbow. Resolved over 10-15 min. By that night I noticed some soreness in my axilla. Wednesday my left rib cage hurt so bad I couldn't take a deep breath for 2 days. I couldn't sit normally in a chair because I felt my insides were pushing up on my lungs and ribs. I couldn't lay flat. I had increased sinus congestion, everything tasted funny, things that weren't normally spicy were. Tested negative for covid again that Thursday night. Woke up in a pool of sweat on Friday and then the right side of my throat swelled up within minutes about 30 min after I got to work. Literally within a few minutes at work it felt like I had tonsillitis, and my right side of my throat was tender. The only reason I didn't freak out more was because I was amongst the CRNAs and was in the room across from me. Exhausted more every day from the night after getting it until I woke up from a nap Friday afternoon/evening. Everything was gone except the sore throat. That resolved on Sunday.  Noticed residual left deltoid muscle weakness 01/11 when I couldn't hold up a foot to prep. Unable to raise arm where elbow is horizontal to shoulder. Unable to lift more than a couple pounds until 2 weeks later when I could lift 5 lbs. Took 2 weeks to get motor function back to that arm.  was giving it a week before sending me to therapy in hopes of using stim therapy that they use for nerve palsy. I spoke to PA and PA and PA about it as well. Also noticed insidious onset of LT hand aching pain at the MPJ of the middle finger and RT DIPJ of the pinky (5th) finger. This pain was intermittent with movement.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Laboratory test, Syncope
Clinical narrative: Syncopal episode the following morning 2/25/25
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site reaction- swelling, pain
Age: 15.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult vaccines given to a child.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: No symptoms reported
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Patient was administered a portion of the  Penatcel vaccine. Only the liquid portion (Dtap-IPV) was administered to patient. The second portion ( HIb) was not reconstituted with the liquid portion.  VFC and the Manufacture was updated on this situation. Pt's mother was made aware. The plan - VFC is looking to see if they have Sanofi brand Diluent for patient to receive the second portion (HIB) - recommended by the Manufacturer or Order HIb vaccine only to be administered.
Age: 52.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events occured.  PT was given COVID vaccine 02/21 when it expired 02/18.  Pfizer contacted for recommendations.
Age: 49.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Pyrexia
Clinical narrative: fever
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Body temperature increased, Cough, Wrong product administered
Clinical narrative: Patient's parent requested HPV (Gardasil 9) vaccine to NOT be given during well child appointment for further investigation of ingredients due to possible sensitivity or reaction. Patient was to be given the TDAP (Boostrix) and  Meningococcal (Menveo) for his 11 year vaccines. Patient was given TDAP and then given the HPV instead of the Meningococcal. The Patient has had an elevated temperature ranging from 101 to 102 since 7:30am on 2/25/2025. Patient also has a cough.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Pt received 2nd dose of vaccine in error
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC20, VARCEL
Symptoms: Culture throat, Pyrexia, Rash, Rash papular, Streptococcus test negative
Clinical narrative: Papular Rash of legs day after receiving vaccines and localized rash of left thigh; papular rash spread to abdomen - prescribed topical steroid and oral antihistamine. Parent reports child felt feverish as well day after receiving vaccines but no other suspected fever after that. Denies: vomiting, angioedema, difficulty breathing, diarrhea, lethargy.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Laboratory test, Muscular weakness, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Developed chronic polyneuropathy of both feet and right hand with seronegative arthritis. Loss of function in both feet and some of right hand. Unable to grip or close right hand with painful swelling to hand. Was seen by multiple rheumatologist and admitted by Neurologist in Sept 2024 for difficulty walking. Has been under the care of Neurologist and rheumatologist. After not being able to find a cause, was referred to clinic and currently under the care of Dr. and Dr. Also, being cared for by Pain Management Dr.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Polyneuropathy chronic, Seronegative arthritis
Clinical narrative: Developed chronic polyneuropathy of both feet and right hand with seronegative arthritis. Loss of function in both feet and some of right hand. Unable to grip or close right hand with painful swelling to hand. Was seen by multiple rheumatologist and admitted by Neurologist in Sept 2024 for difficulty walking. Has been under the care of Neurologist and rheumatologist. After not being able to find a cause, was referred to clinic and currently under the care of Dr. and Dr. Also, being cared for by Pain Management Dr.
Age: 72.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site ulcer, Injection site vesicles
Clinical narrative: Patient came back to report adverse event at the site of Shingrix vaccine.  Patient reported that a small bubble developed at the site of the injection, the bubble later pupped and patient had an open soar.  Patient reported not scratching the area.  Patient applied bacitracin and covered the area with bandage.  When patient came to pharmacy on 5/24, the area did not feel warm to touch.  After visiting the pharmacy patient went to see his doctor.  No other medications were prescribed, the doctor told him to keep an eye on it and report any changes, especially if area started to redden
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported the day after receiving vaccine (2/12/25) that She had a temperature of 101 all day associated with a headache. Vaccine injection site was swollen and warm. Patient also reported having pounding headaches on 2/14/25
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired 02/08/2025. I need clarification if patient needs to be vaccinated again. No reaction noted after patient waited 15 min.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Brain fog, Chronic fatigue syndrome, Exercise tolerance decreased, Malaise
Clinical narrative: Diagnosed with ME/CFS after the second vaccination. Symptoms: exercise intolerance, chronic fatigue, post exertional malaise, brainfog, muscle and joint pain
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Diagnosed with ME/CFS after the second vaccination. Symptoms: exercise intolerance, chronic fatigue, post exertional malaise, brainfog, muscle and joint pain
Age: 70.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Feeling hot, Hypersomnia, Pain, Somnolence
Clinical narrative: She felt a lot of pain and heat. No redness visible. Also felt very sleepy. Went to bed that day at 8PM and could not wake up until late the next afternoon. The following day felt very sleepy as well. Pain and heat still present one week later when reported to us.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Crying, Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient had an appointment for HPV vaccine at 10:00 AM. I talked to patient prior to the vaccine to verify that she had the 2 previous shots of HPV. When I called her name for the vaccine, I asked her name and birthdate too verify her info. I told her she was receiving her HPV 3rd dose as I always do. The minute I injected her with vaccine, she started crying and said it hurts a lot. I said I'm sorry that it did and I told her to ice it or take Tylenol for the pain. I said I'm, sorry again and I told her to ice it again. She said she never felt this pain before and left. She ended up calling our pharmacy to explain again that she was in pain and crying a lot and also spoke to the store manager about her pain and vaccine experience,
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Balance disorder, Cognitive disorder, Computerised tomogram
Clinical narrative: Initially he complained of pain in his head and all over his body, and increasing weakness. COVID Booster given 10-5-23 and he began to feel unwell the following day. By 10-15-23 he was very unsteady on his feet and had double vision, and his L vocal chord became paralyzed and he was unable to void/retaining urine. By 10/16/23 he was unable to walk, and had no bladder or bowel control. He had been retaining urine and leaking urine/unable to void when he presented with double vision/paralyzed eye and vocal chord and pain all over his body. He remains unable to walk and is wheelchair bound. He was eventually diagnosed with  disseminated VZV which was reactivated by his COVID Booster. The VZV attacked his CNS and spine and cranial nerves.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Delirium, Diplopia, Disseminated varicella zoster virus infection, Encephalitis, Gait inability
Clinical narrative: Initially he complained of pain in his head and all over his body, and increasing weakness. COVID Booster given 10-5-23 and he began to feel unwell the following day. By 10-15-23 he was very unsteady on his feet and had double vision, and his L vocal chord became paralyzed and he was unable to void/retaining urine. By 10/16/23 he was unable to walk, and had no bladder or bowel control. He had been retaining urine and leaking urine/unable to void when he presented with double vision/paralyzed eye and vocal chord and pain all over his body. He remains unable to walk and is wheelchair bound. He was eventually diagnosed with  disseminated VZV which was reactivated by his COVID Booster. The VZV attacked his CNS and spine and cranial nerves.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lumbar puncture, Magnetic resonance imaging, Magnetic resonance imaging spinal abnormal, Malaise
Clinical narrative: Initially he complained of pain in his head and all over his body, and increasing weakness. COVID Booster given 10-5-23 and he began to feel unwell the following day. By 10-15-23 he was very unsteady on his feet and had double vision, and his L vocal chord became paralyzed and he was unable to void/retaining urine. By 10/16/23 he was unable to walk, and had no bladder or bowel control. He had been retaining urine and leaking urine/unable to void when he presented with double vision/paralyzed eye and vocal chord and pain all over his body. He remains unable to walk and is wheelchair bound. He was eventually diagnosed with  disseminated VZV which was reactivated by his COVID Booster. The VZV attacked his CNS and spine and cranial nerves.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Myelitis, Ophthalmoplegia, Pain, Polyneuropathy, Urinary incontinence
Clinical narrative: Initially he complained of pain in his head and all over his body, and increasing weakness. COVID Booster given 10-5-23 and he began to feel unwell the following day. By 10-15-23 he was very unsteady on his feet and had double vision, and his L vocal chord became paralyzed and he was unable to void/retaining urine. By 10/16/23 he was unable to walk, and had no bladder or bowel control. He had been retaining urine and leaking urine/unable to void when he presented with double vision/paralyzed eye and vocal chord and pain all over his body. He remains unable to walk and is wheelchair bound. He was eventually diagnosed with  disseminated VZV which was reactivated by his COVID Booster. The VZV attacked his CNS and spine and cranial nerves.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary retention, Vocal cord paralysis, Wheelchair user
Clinical narrative: Initially he complained of pain in his head and all over his body, and increasing weakness. COVID Booster given 10-5-23 and he began to feel unwell the following day. By 10-15-23 he was very unsteady on his feet and had double vision, and his L vocal chord became paralyzed and he was unable to void/retaining urine. By 10/16/23 he was unable to walk, and had no bladder or bowel control. He had been retaining urine and leaking urine/unable to void when he presented with double vision/paralyzed eye and vocal chord and pain all over his body. He remains unable to walk and is wheelchair bound. He was eventually diagnosed with  disseminated VZV which was reactivated by his COVID Booster. The VZV attacked his CNS and spine and cranial nerves.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: 19 Y/O G1 P0 Pregnant 13 weeks. and 6 days on 2/24/2025. EDD 8/26/2025.Hepatitis B vaccine given outside of age guidelines.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 65.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: injection site reaction (sore arm, red, hot to touch, pain), vomiting at least once, headache, "horrible pain" which caused pt to be unable to sleep, apap/ibu did not work
Age: 65.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Sleep disorder, Vomiting
Clinical narrative: injection site reaction (sore arm, red, hot to touch, pain), vomiting at least once, headache, "horrible pain" which caused pt to be unable to sleep, apap/ibu did not work
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT EXPERIENCE IMMEDIATE SWELLING REDNESS AND WARMTH AT INJECTION SITE.  OVER THE MONTHS FOLLOWING VACCINATION SHE EXPERIENCED NODULAR AREAS OF SWELLING FROM THE RIGHT SHOULDER TO THE RIGHT HAND.  THESE ARE NOT RESOLVING AS OF THIS REPORT DATE.  SHE IS ALSO EXPERIENCING PAIN IN THE RIGHT ARM  , WRIST AND HAND .
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT EXPERIENCE IMMEDIATE SWELLING REDNESS AND WARMTH AT INJECTION SITE.  OVER THE MONTHS FOLLOWING VACCINATION SHE EXPERIENCED NODULAR AREAS OF SWELLING FROM THE RIGHT SHOULDER TO THE RIGHT HAND.  THESE ARE NOT RESOLVING AS OF THIS REPORT DATE.  SHE IS ALSO EXPERIENCING PAIN IN THE RIGHT ARM  , WRIST AND HAND .
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cyanosis, Dizziness, Eye movement disorder, Malaise, Pallor
Clinical narrative: About 30-40 minutes after vaccination patient stood up and while walking started feeling dizzy and sick, threw up, and almost passed out. She was immediately picked up and put in trendelenburg, her face/lips turned pale and was green/blue around her mouth, eyes rolling into the back of her head, but did not entirely lose consciousness. About 10-15 minutes after the event she felt better. She ate a full breakfast an hour before her appointment and has never passed out from vaccines in the past. Her doctor?s office was notified and said this was a ?very common adrenaline reaction,? which seems inaccurate as it did not occur immediately after vaccination, and should not be a common reaction. I want to make sure the reaction is reported accurately.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Presyncope, Vomiting
Clinical narrative: About 30-40 minutes after vaccination patient stood up and while walking started feeling dizzy and sick, threw up, and almost passed out. She was immediately picked up and put in trendelenburg, her face/lips turned pale and was green/blue around her mouth, eyes rolling into the back of her head, but did not entirely lose consciousness. About 10-15 minutes after the event she felt better. She ate a full breakfast an hour before her appointment and has never passed out from vaccines in the past. Her doctor?s office was notified and said this was a ?very common adrenaline reaction,? which seems inaccurate as it did not occur immediately after vaccination, and should not be a common reaction. I want to make sure the reaction is reported accurately.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. Patient is pregnant with EDD of 6/20/2025
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 1.33
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Accidental third dose of Influenza (flulaval) IZ administered to pt. No adverse reaction occured - did call mother of patient followind day, 02/25/2025 and ask how patient was doing, MOC (speaking) notified that pt was doing well and had no side effects or adverse reaction. Did speak with provider of visit and supervisors of incident day of (02/24/2025) - notified by supvervisor to report incident.
Age: 1.0
Sex: M
Vaccine: DTPPVHBHPB, MMR
Symptoms: Rash
Clinical narrative: Rash beginning day after vaccine administration.  Resolved over next few days.   Per nursing note "Mom called to clinic stating child had a well check on 2/19. At appt he received two vaccines (MMR and vaxelis). The next day mom noted a rash and by Friday rash seemed worse. Improved over the weekend and has completely resolved today."
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.  Patient is pregnant and EDD is 4/10/25
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. Patient is pregnant and EDD is 4/10/25
Age: 32.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Circumstance or information capable of leading to medication error, Skin abrasion, Skin haemorrhage
Clinical narrative: Vaccine administered by LPN and when vaccine was administered, needle was removed but patient moved his leg and needle did hit his upper left knee leaving a small abrasion. Bleeding was controlled and bandaid was applied
Age: 31.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. Patient is pregnant EDD is 3/9/25
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 5.0
Sex: F
Vaccine: HEPAB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt was given twinrex instead of hep a hep b separately...no symptoms
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Pallor, Syncope
Clinical narrative: Following administration of vaccines, client slid from chair onto floor. Client s father was seated on chair beside client. Client appeared pale and experienced a brief period of syncope. Client placed in supine position with legs elevated. Vital signs monitored. Client returned to consciousness within a few seconds. Vital signs stable and pupils equal, round, reactive, to light and accommodation. Father voiced concern for possible allergic reaction. Client s shirt removed, cool cloths and fan provided and tolerated well. Client s skin tone returned to baseline coloration within minutes. Continued to monitor client and vital signs. No symptoms of localized or anaphylactic reaction present. Within minutes client stated no dizziness, nausea, or other symptoms. No vomiting present. Client denied pain. Cool water provided and tolerated well; snack offered but declined. Continued to monitor client who was able to sit, stand, and walk around room without difficulty. Vital signs stable, activity and water tolerated well. Two small areas of redness present to intact skin of nose. Client denied pain and tenderness; no injury or bleeding present. Client s father denied concerns and declined emergency medical response. Client denied symptoms. Father encouraged to have client follow up with primary medical provider and to seek medical attention for client with concerns or changes in condition. Father voiced understanding. Client and parent encouraged to notify providers of syncopal episode prior to future injections or procedures. Client and parent voiced understanding. Regional medical director notified by telephone. Per regional medical director no further intervention indicated, no orders received. Regional immunization program manager notified by telephone. Client ambulatory with steady gait without assistance, accompanied by father. No symptoms or distress present at time of discharge from clinic.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 25.0
Sex: F
Vaccine: FLU3, RSV, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pruritus, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Per the 02/19/2025 triage note from RN, "After 20 minutes, sight of shot displayed redness and mild swelling and itchiness. Dr. checked spot with patient and advised that is possible natural reaction from the injection given in the subcutaneous tissue of the lower forearm and stated benadryl would be prescribed for symptomatic relief and patient and mother acknowledged information." Patient and patient's mother left the medical office before receiving the benadryl from the Health Center pharmacy. Later that evening, the patient's parents took the patient to the Hospital emergency room.   Per provider encounter note on 02/21/2025, "here to follow up ER visit. seen at facility 2 days ago after local reaction to the varicella vaccine. doing better, redness is smaller and not itchy, but hurts a lot. note reviewed, got benadryl, has been taking 25 mg every  hours." "Current Medications Discontinued Benadryl Allergy 12.5 MG/5ML Liquid 5 ml Orally every 6 hrs prn , stop date 03/12/2025  Treatment 1. Acute urticaria Start diphenhydrAMINE HCl Capsule, 25 MG, 1 capsule, Orally, every 6 hours As needed, 7 days, 28 Capsule, Refills 1 Start predniSONE Tablet, 5 MG, 1 tablet, Orally, Once a day, 3 days, 3 Tablet, Refills 0  Notes: Nursing supervisor spoke with manufacturer and advised will need to repeat the dose due to not being given IM or SQ and to wait 30 days. will have patient return to see me after 30 days and update all vaccines and repeat the varicella.   2. Others Start Ibuprofen Tablet, 200 MG, 2 tablets, Orally, every 8 hours As needed, 7 days, 42 Tablet, Refills 1  On 02/20/2025, RN "Spoke to Merck Sharp & Dohme LLC. Spoke with representative. Case #02756830. Per Merck and CDC vaccine is invalid because there are no studies on vaccine efficacy when given in forearm. Per Merck, titers may be drawn to determine immunity. Based on results of titers, provider may decide to offer additional dose of Varivax. Merck states that immunity cannot be guaranteed with current second dose. Per Merck, should wait at least 28 days prior to administering additional dose. Reaction reported to Merck (Merck stated that they report all reactions to VAERS)".
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Per the 02/19/2025 triage note from RN, "After 20 minutes, sight of shot displayed redness and mild swelling and itchiness. Dr. checked spot with patient and advised that is possible natural reaction from the injection given in the subcutaneous tissue of the lower forearm and stated benadryl would be prescribed for symptomatic relief and patient and mother acknowledged information." Patient and patient's mother left the medical office before receiving the benadryl from the Health Center pharmacy. Later that evening, the patient's parents took the patient to the Hospital emergency room.   Per provider encounter note on 02/21/2025, "here to follow up ER visit. seen at facility 2 days ago after local reaction to the varicella vaccine. doing better, redness is smaller and not itchy, but hurts a lot. note reviewed, got benadryl, has been taking 25 mg every  hours." "Current Medications Discontinued Benadryl Allergy 12.5 MG/5ML Liquid 5 ml Orally every 6 hrs prn , stop date 03/12/2025  Treatment 1. Acute urticaria Start diphenhydrAMINE HCl Capsule, 25 MG, 1 capsule, Orally, every 6 hours As needed, 7 days, 28 Capsule, Refills 1 Start predniSONE Tablet, 5 MG, 1 tablet, Orally, Once a day, 3 days, 3 Tablet, Refills 0  Notes: Nursing supervisor spoke with manufacturer and advised will need to repeat the dose due to not being given IM or SQ and to wait 30 days. will have patient return to see me after 30 days and update all vaccines and repeat the varicella.   2. Others Start Ibuprofen Tablet, 200 MG, 2 tablets, Orally, every 8 hours As needed, 7 days, 42 Tablet, Refills 1  On 02/20/2025, RN "Spoke to Merck Sharp & Dohme LLC. Spoke with representative. Case #02756830. Per Merck and CDC vaccine is invalid because there are no studies on vaccine efficacy when given in forearm. Per Merck, titers may be drawn to determine immunity. Based on results of titers, provider may decide to offer additional dose of Varivax. Merck states that immunity cannot be guaranteed with current second dose. Per Merck, should wait at least 28 days prior to administering additional dose. Reaction reported to Merck (Merck stated that they report all reactions to VAERS)".
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Paraesthesia oral
Clinical narrative: Patient said she had tingling of the tongue/mouth area that started about 5 to 10 minutes after the vaccine. Symptoms resolved within about 30 minutes. No medical care sought
Age: 21.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, IPV, PNC20
Symptoms: Extra dose administered
Clinical narrative: Dtap-Hib-IPV administered at the same time as single antigen IPV.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss 2 months post vaccination. No personal history and No family history of alopecia or male pattern baldness. Episodes have come in waves over the last 3-4 years. Always patchy and different areas of body. permanent hair loss on crown of head
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: Nurse didn't realize the child had an egg allergy until after giving the vaccine. Parnts and child waiting in clinic 10 minutes before leaving. No reaction was noted.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Oral pruritus, Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Pt describes feeling  itchiness around mouth within 1 hour of vaccine administration. Within next 3 hours complained of facial itching and also facial redness, rash and blotchiness. Returned to clinic within 5 hours to get evaluated and noted to have facial itchiness with rash and redness/warmth, without any respiratory or other complaints. Received oral Prednisone 20 mL (15 mg/mL) suspension and oral Children's Allegra Allergy liquid 25 ml. Within 1 hour itchiness decreased and facial rash noticeably less reddened. Was sent home on oral Prednisone 40 mg 2x's/day x 5 days and also Allegra Allergy liquid. Per patient next day 2/25/25 reports facial complaints improved, slight itchiness, no increased redness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm
Clinical narrative: Pt describes feeling  itchiness around mouth within 1 hour of vaccine administration. Within next 3 hours complained of facial itching and also facial redness, rash and blotchiness. Returned to clinic within 5 hours to get evaluated and noted to have facial itchiness with rash and redness/warmth, without any respiratory or other complaints. Received oral Prednisone 20 mL (15 mg/mL) suspension and oral Children's Allegra Allergy liquid 25 ml. Within 1 hour itchiness decreased and facial rash noticeably less reddened. Was sent home on oral Prednisone 40 mg 2x's/day x 5 days and also Allegra Allergy liquid. Per patient next day 2/25/25 reports facial complaints improved, slight itchiness, no increased redness.
Age: 0.83
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past manufacturer expiration date. Printed expiration date lists 02/16/2025. Vaccine administered to patient on 02/25/2025
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood creatinine increased, Blood immunoglobulin G decreased, Blood immunoglobulin M normal, Cardiac failure congestive
Clinical narrative: Developed mononucleosis, atrial fibrillation and congestive heart failure.  Hospitalized for 11 days.  Major mono symptoms lasted about 2 weeks, and included painful headaches, body aches, chills, sweats and fatigue.   Today (six weeks later) the fatigue is still severe.  Heart failure was treated with diuretics.  Also developed under-performing kidneys, possibly from diuretics.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Epstein-Barr virus antibody, Fatigue, Glomerular filtration rate decreased, Headache
Clinical narrative: Developed mononucleosis, atrial fibrillation and congestive heart failure.  Hospitalized for 11 days.  Major mono symptoms lasted about 2 weeks, and included painful headaches, body aches, chills, sweats and fatigue.   Today (six weeks later) the fatigue is still severe.  Heart failure was treated with diuretics.  Also developed under-performing kidneys, possibly from diuretics.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Infectious mononucleosis, Pain, Renal impairment
Clinical narrative: Developed mononucleosis, atrial fibrillation and congestive heart failure.  Hospitalized for 11 days.  Major mono symptoms lasted about 2 weeks, and included painful headaches, body aches, chills, sweats and fatigue.   Today (six weeks later) the fatigue is still severe.  Heart failure was treated with diuretics.  Also developed under-performing kidneys, possibly from diuretics.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: There was no adverse reaction. The patient received this vaccine diluted with the wrong diluent. Sterile water was used instead of the supplied diluent of 0.4% sodium chloride.
Age: 23.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Mobility decreased, Pain
Clinical narrative: Complains of 3 weeks of intermittent radiating pain originating in left shoulder with limited mobility that started after the COVID vaccine. Reported it lasted 2 days after administration, resolved, and then returned.  Complains of episodes of right hand limited mobility over 3 weeks since flu vaccine administration. 3 weeks later he reported "my right hand still hurts at the wrist".  Client wanted to see if symptoms improved after completion of course of antibiotics.
Sex: F
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: patient vaccinated with the fourth dose of pneumococcal vaccine on 17-FEB-2006 at the age reported as 1y0mo; patient vaccinated with the fourth dose of pneumococcal vaccine on 17-FEB-2006 at the age reported as 1y0mo; patient vaccinated with the third dose pneumococcal vaccine on 16-AUG-2005 at the age reported as 6m3do; patient vaccinated with the third dose pneumococcal vaccine on 16-AUG-2005 at the age reported as 6m3do; patient vaccinated with the second dose of pneumococcal vaccine on 14-JUN-2005 at the age reported as 4m1do; patient vaccinated with the second dose of pneumococcal vaccine on 14-JUN-2005 at the age reported as 4m1do; patient vaccinated with the first dose of pneumococcal vaccine on 12-APR-2005 at the age reported as 1m30do; This spontaneous report, which is a split case from a case in litigation for human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (case ID in previous safety database: 2501USA003441; current case ID: 2249222), has been received via medical records from a physician and refers to a 1-month-old female patient. The patient's medical history, current conditions and concomitant therapies have already been reported in the above-mentioned case in litigation.  On 12-Apr-2005, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) solution for injection, provided as "pneumococcal" vaccine (exact dose, lot #, expiration date, route of administration and anatomical location not reported), for prophylaxis, at the age reported as "1m30do" (Inappropriate age at vaccine administration).  On 14-Jun-2005, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) solution for injection (exact dose, lot #, expiration date, route of administration and anatomical location not reported), for prophylaxis, at the age reported as "4m1do" (Inappropriate age at vaccine administration, Extra dose administered).  On 16-Aug-2005, the patient was vaccinated with the third dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) solution for injection (exact dose, lot #, expiration date, route of administration and anatomical location not reported), for prophylaxis, at the age reported as "6m3do" (Inappropriate age at vaccine administration, Extra dose administered).  On 17-Feb-2006, the patient was vaccinated with the fourth dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) solution for injection (exact dose, lot #, expiration date, route of administration and anatomical location not reported), for prophylaxis, at the age reported as "1y0mo" (Inappropriate age at vaccine administration, Extra dose administered).  This is one of several reports pertaining to the same patient (cross-referenced with case # US-009507513-2501USA003441).  All available medical records will be provided upon request.
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: 3-month-old child was admitted with Rotavirus 2/7/2025. Child was supposed to receive ROTATEQ today, but did not; This spontaneous report was received from a Nurse and refers to a 3-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral solution, reported as "ROTATEQ VIAL 2", administered by oral route for prophylaxis (lot # and expiration date were not reported).  On 07-FEB-2025, the patient was admitted due to Rotavirus, diagnosed on 20-FEB-2025. Child was supposed to receive Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) that day, but did not.  At the reporting time, the outcome of Rotavirus was not known. The action taken with the suspect vaccine regarding the event was not reported but established as not applicable.   The causal relationship between the event of Rotavirus and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: A patient experienced a nodule at the injection site after receiving their second dose of GARDASIL 9 that lasted approximately a week.; After the nodule went away, the patient has still been experiencing arm pain; This spontaneous report was received from a Physician regarding a 45-year-old female patient.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter.    On an unknown date in November 2024 (reported as at the end of November), the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection, 0.5 mL, administered Intramuscularly for vaccination (lot number, expiration date and anatomical site of injection were not reported). After receiving the mentioned dose, the patient experienced a nodule at the injection site (Vaccination site nodule) that lasted approximately a week. After the patient recovered from the vaccination site nodule on an unknown date in November 2024 (reported as after the nodule went away), the patient has still been experiencing arm pain (Pain in extremity). The reporter stated that due to the event of Vaccination site nodule, they decided not to administer the third dose of the vaccine.   At the time of the report, the patient was recovered from the event of Vaccination site nodule and was not recovered from the event of Pain in extremity.   The action taken with the suspect vaccine regarding the events was reported as drug withdrawn. Dechallenge and rechallenge were not applicable.   The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient had received two shots of Shingrix, but they were more; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 24M7E, expiry date 02-APR-2026) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22-NOV-2021).   On 03-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid). On 03-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient had received two shots of Shingrix, but they were more). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 21-FEB-2025 Reporter did not had access saw this in registry first dose was not administered at their pharmacy. The reporter stated that although the pharmacy has email it was for internal use only.   She reported to the GRC on 21 February 2025 that a patient had received a shots of Shingrix, but they were more than 6 months apart.  Reporter did not have access to the lot number for dose #1 which was given at a different facility in 2021. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.