chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: PNC21
Symptoms: Arthralgia, Asthenia, Blood pressure fluctuation, Guillain-Barre syndrome, Hypertension
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Hypertension-Severe, Systemic: Hypotension-Severe, Systemic: Joint Pain-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Weakness-Severe, Additional Details: was diagnosed with guillam barre syndrom by medical center, nuerology team, had mri, spinal tap to confirm, has had fluctuating bp, restless leg syndrom, numbness of extremities, joint pain, has had immunotherapy and continues with physical therapy
Age: 62.0
Sex: M
Vaccine: PNC21
Symptoms: Hypoaesthesia, Hypotension, Immunoglobulin therapy, Lumbar puncture abnormal, Magnetic resonance imaging abnormal
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Hypertension-Severe, Systemic: Hypotension-Severe, Systemic: Joint Pain-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Weakness-Severe, Additional Details: was diagnosed with guillam barre syndrom by medical center, nuerology team, had mri, spinal tap to confirm, has had fluctuating bp, restless leg syndrom, numbness of extremities, joint pain, has had immunotherapy and continues with physical therapy
Age: 62.0
Sex: M
Vaccine: PNC21
Symptoms: Nervous system disorder, Pain, Restless legs syndrome
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Hypertension-Severe, Systemic: Hypotension-Severe, Systemic: Joint Pain-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Weakness-Severe, Additional Details: was diagnosed with guillam barre syndrom by medical center, nuerology team, had mri, spinal tap to confirm, has had fluctuating bp, restless leg syndrom, numbness of extremities, joint pain, has had immunotherapy and continues with physical therapy
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Shoulder and arm pain/tingling that is not well relieved by tylenol, ibuprofen, voltaren gel, or salonpas cream use over the counter that was recommneded by her primary care provider. She states the symptoms began approximately 4 days after receiving the vaccine.
Age: 67.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild
Age: 69.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Systemic: Joint Pain-Medium, Additional Details: Per patient, first 7 days she experienced left knee joint pain, then she had pain in her left toe for about 2 weeks. After 2 weeks she felt pain in her right toe for about 2 weeks
Age: 93.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: unable to move his arm-Severe, Additional Details: patient complained of abnormal pain in his arm and that the pain didnt improve with time. i advised to wait another few days and i would call him back and if pain persists or becomes severe to call his doctor or got to the Uurgent care or ER
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Additional Details: patient went to ER because she had the chills and didnt feel good, ER told her just reaction from shot, today arm got red and started swelling, warm to touch slightly painful, Other Vaccines:  VaccineTypeBrand: tetanus (boostrix); Manufacturer: GSK; LotNumber: dy3k7; Route: intramuscular; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Additional Details: patient went to ER because she had the chills and didnt feel good, ER told her just reaction from shot, today arm got red and started swelling, warm to touch slightly painful, Other Vaccines:  VaccineTypeBrand: tetanus (boostrix); Manufacturer: GSK; LotNumber: dy3k7; Route: intramuscular; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site warmth
Clinical narrative: The arm at the injection site was warm, raised and tender. It lasted about 1 week.  Patient reports currently gone and feels fine.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Rash, Rash macular
Clinical narrative: Developed a splotchy rash on her head and trunk in the office after her immunization. Her breathing remained normal.  The rash faded quickly and cleared by about 30 minutes after the immunizations were given.   She looked fine and her lungs were clear before leaving the office
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 03/20/2025 Mother of patient noted left leg swelling, redness, and hot to the touch. Mother gave child Motrin and Benadryl then brought child to our office on 03/21/2025 at 0148. Patient was diagnosed with Cellulitis of left lower limb. and treated with Cephalexin suspension, reconstituted, oral 250 mg/ 5 mL taken 8.5 mL by mouth twice a day for 7 days. Mother also told to continue Motrin and Benadryl as needed.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: Dad paged on call provider regarding arm pain, redness, swelling at injection site. Noted PT received 5 yr old vaccines yesterday (Friday) and R arm is now red, warm to touch, swollen and painful to PT. Discussed side effects of vaccines with dad and also that PT may have tensed up during administration of the vaccine causing a reaction. Encouraged to give ibuprofen and a warm compress as well as Benadryl at bedtime. PT is using R arm but favoring L one.
Age: 50.0
Sex: F
Vaccine: PNC21
Symptoms: Peripheral swelling
Clinical narrative: Patient received Pneumonia 21 vaccine on 4/11/25. Starting having swelling in and under right arm on 4/12/25. Was seen in our office on 4/14/25 for right arm swelling. Was recommended to start Benadryl.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC20, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Phone call from mother on 4/11/2025 stating that approximately two and a half hours after child received vaccines (state supplied) at health department mother noticed redness and swelling to neck going up to right side of face. Mom stated that child's behavior was normal and no change in breathing. She called 911 and child was transported to ER. Mom states child was given IV fluids, Ibuprofen, and discharged in approximately 45 minutes. Hospital instructed mom to monitor child. Mom states today, 4/11/2025, child's behavior is normal with minor swelling, but decrease in swelling from yesterday.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 mo thru age 11yo formulation administered to this pt.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: Pt had episode of vasovagal syncope following HPV injection. Face pallor followed by about 30-60 sec of unconsciousness. VSS following awakening, strong radial pulse. HR 92, pulse ox 97%, BP 130/84. Gave cheese stick and water (patient did not eat breakfast) and patient recovered well.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt had episode of vasovagal syncope following HPV injection. Face pallor followed by about 30-60 sec of unconsciousness. VSS following awakening, strong radial pulse. HR 92, pulse ox 97%, BP 130/84. Gave cheese stick and water (patient did not eat breakfast) and patient recovered well.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None reported at this time
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Thigh red and swollen, tender. Started 1 day after vaccination. Patient came in clinic to see provider today.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient was given Prevnar 20 in December of 2023 and again in April of 2025.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Contusion, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pain at the side of the injection  during the day  itchiness, next day he started showing  redness more itchiness forming a bruise firs in the left arm then continue into the right arm , child continue having less itchiness
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Influenza like illness, Injection site erythema, Injection site swelling, Magnetic resonance imaging normal
Clinical narrative: 1st Vac had prolonged flu like symptoms  2nd Vac caused redness and swelling of the injection site and Tinnitus started minimally but has now become very bad.Loud ringing is constant.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 1st Vac had prolonged flu like symptoms  2nd Vac caused redness and swelling of the injection site and Tinnitus started minimally but has now become very bad.Loud ringing is constant.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Pruritus, Respiratory disorder
Clinical narrative: Her arm swelled up bad, and was itchy and about a week later she was having issues breathing and i took her to the family doctor who referred her to the ER, Medical Hospital on 04/07/2025-04/08/2025, she is still having issues with swelling in the arm and still having issues breathing, She did get treatment for it at the hospital for breathing and we doing it also at home. At i looked it up on internet allergic reaction to RSV and that's what is sounding like is going on.
Age: 44.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test, Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient reported firm, red, swollen area on back of left arm (where Varicella was given) following vaccination.  Was seen by provider the following day who identified it as possible infection or vaccine reaction.  Patient reported that swelling and bruising travelled past the elbow on that side.  No reaction to side where MMR was given.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Tremor
Clinical narrative: Headach, vomiting for 12 hours, tremors for 2 days,  red , swollen, and sore at site of injection (began 4/11, eased up 4/14)
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: Headach, vomiting for 12 hours, tremors for 2 days,  red , swollen, and sore at site of injection (began 4/11, eased up 4/14)
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Injection site erythema, Injection site haemorrhage, Injection site pain, Nausea
Clinical narrative: Felt like fainting and throwing up , bleeding  at site burning  and redness.  No info on treatment.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Expired product administered
Clinical narrative: Quadracel dose given on 4/3/25 had expired on 3/8/25.
Age: 1.75
Sex: M
Vaccine: DTAPIPV, HIBV, PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administration error: Patient was mistakenly given DTap + IPV, when only DTap was intended. Patient was monitored for adverse reaction, but no reaction occurred.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lichen planus, Pathology test
Clinical narrative: Lichen Planus of perineum and labia
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Erythema, Hyperhidrosis, Injection site swelling, Injection site warmth
Clinical narrative: fever, chills, sweats, redness, warmth and swelling to injection site.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: fever, chills, sweats, redness, warmth and swelling to injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Full blood count normal, Pain, Rash, Rash erythematous
Clinical narrative: First two days were the usual vaccination response of soreness, redness and swelling. 3rd day at 5:30am I woke up with a red, painful rash going down from the base of my neck to under my breasts. Throat felt tight so I went to ER.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Throat tightness
Clinical narrative: First two days were the usual vaccination response of soreness, redness and swelling. 3rd day at 5:30am I woke up with a red, painful rash going down from the base of my neck to under my breasts. Throat felt tight so I went to ER.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient reports that she went to urgent care and was diagnosed with cellulitis at injection site.
Age: 74.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient was mistakenly given 2 doses of Prevnar vaccine. The first dose was given on 3/6 and the second dose was given on 4/2.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moments after giving the vaccine, it was discovered that the vaccine was expired 3/24/2025. The patient was made aware.
Age: 51.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Erythema, Injection site swelling, Pruritus, Swelling face
Clinical narrative: Patient reported to pharmacy on 4/14/25 that she had an adverse reaction to vaccines administered on 4/10/25. Patient had reported overall body itching, redness all over body, injection site swelling, and swelling of the face. Patient immediately went to emergency room where she was given a dose of Benadryl. Her symptoms quickly resolved afterwards and she was able to go back home that night.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse events occurred
Age: 39.0
Sex: M
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Patient given varicella but did not tell staff he recently had yellow fever vaccine until after given. Did not tell staff or put on his vaccination form.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Blood glucose, Cardiac arrest, Death, Pyrexia
Clinical narrative: The patient passed away on 04/07/2027 due to cardiac arrest at Hospital, five days prior to receiving the vaccines. According to the patient's parents, the night before her death, she had a fever and was acting normally. Unknown of occurred during the hours before 8am on 4/7/2025. EMS stated a possible case of SIDS (sudden infant death syndrome).
Age: 80.0
Sex: M
Vaccine: COVID19, PNC20, VARZOS
Symptoms: Amnesia, Fall
Clinical narrative: The following day, patient was doing yard work and rolled on the ground outside.  Wife came by and he could not recognized her.  He asked who she was.  He was hospitalized for 1 day.  He is ok now.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after injection was administered in office.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Patient reported severe right shoulder pain and stiffness from the evening of vaccination and continuing for 2 days.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Mobility decreased, X-ray limb
Clinical narrative: R shoulder pain and decreased ROM since a few days afterwards. Obtained R shoulder XR due to pain and difficulty w/ ROM. Impression above (no acute findings). I will refer her to PT to help with her pain and ROM improvement.
Age: 17.0
Sex: M
Vaccine: JEV1, YF
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: After administration client complained of lightheadedness. Became very pale and complained of nausea.  Elevated feet, ice pack to back of neck, water and lollipop.  BP 79/40, pulse 56, O2 98%.  Symptoms resolved in a couple of minutes. No vomiting. Skin tone returned to normal.  BP 101/65 and pulse 55. No LOC
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patients refers left arm is red and swollen at the vaccination administration site. Doctor prescribes antibiotic and for pruritus
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: PATIENT HAD BEEN A FLU VACCINE FOR THIS FLU SEASON 12/2024
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Decreased appetite, Diarrhoea, Nasal congestion, Upper respiratory tract congestion
Clinical narrative: Upper respiratory congestion, nasal congestion, cough, loose stools, loss of appetite
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Viral test
Clinical narrative: Upper respiratory congestion, nasal congestion, cough, loose stools, loss of appetite
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient forgot he got the prevnar shot and was given a second one in the same day
Age: 0.25
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine given too soon. Pt is only 3 months old. Vaccine is for 6 months and up
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Peripheral swelling
Clinical narrative: swelling from elbow to shoulder occurred day following vaccine and continued until the next saturday. Small lump remains on arm
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain, Respiratory tract congestion, Viral test
Clinical narrative: Body aches, exhaustion, dizzy, congestion
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Flushing, Hyperhidrosis, Palpitations, Pruritus, Throat irritation
Clinical narrative: I  got flushed, face got sweaty, heart raced, body and throat got itchy.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: Orders for patient vaccination were to receive MMR II vaccine. Medical Assistant prepared and administered Proquad. Patient also received a separate varicella (Varivax) vaccine. Patient reported fever following vaccination with no other symptoms.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Biopsy skin, Biopsy skin abnormal, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: After the vaccine, pt had an itchy raised bump at the site of injection. He followed up to the clinic one month later, on 10-29-2024. He was treated for possible infection of injection site and was treated with Bactrim DS 800 mg-160 mg tablet 1 tablet every 12 hours for 7 days. Lesion did not heal/resolve so he was referred to dermatologist. Biopsy was taken of the raised lesion and came back positive for squamous cell carcinoma at the injection site.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Micrographic skin surgery, Skin lesion, Squamous cell carcinoma
Clinical narrative: After the vaccine, pt had an itchy raised bump at the site of injection. He followed up to the clinic one month later, on 10-29-2024. He was treated for possible infection of injection site and was treated with Bactrim DS 800 mg-160 mg tablet 1 tablet every 12 hours for 7 days. Lesion did not heal/resolve so he was referred to dermatologist. Biopsy was taken of the raised lesion and came back positive for squamous cell carcinoma at the injection site.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: arm was sore all day, before bed started Edema of left upper arm Pt noted to have mild dema of L upper extremity after Bexsero dose #2.  Advised pt she has completed this series, no further doses are needed.  Pt with swelling of L upper bicep area.  Pt with pain/soreness in L arm and myalgias going into L side of neck.
Age: 24.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given a children's MMR vaccination. No adverse reactions occurred. Patient informed of error.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Injection site erythema, Injection site swelling, Product administered to patient of inappropriate age
Clinical narrative: Pt came in for an MA visit for vaccines and brought the pt's vaccination record. The vaccination and database was reviewed by both me and another MA. My vaccine preparation was double checked by another MA. We administered the Kinrix vaccine. Pt tolerated it without complaint. I later realized that the pt had already received 4 doses of the polio vaccine and both me and the other MA missed it when reviewing the vaccination record. The state was notified and their response was "The child should not have received Kinrix as it is only licensed through 6 years of age. However, the Dtap can be considered valid so revaccination does not need to occur. The extra IPV dose should not harm the patient but it should be reported to VAERS as an administration error. " I notified the pt's mother of the vaccine error, additional polio vaccine, the pt's mother said "thank you for letting me know" she spoke in a calm voice, expressed no concerns about the extra polio dose. She did say the pt's  arm, at the vaccine site, did have swelling and redness, she reported that she "put potatoes on it" and the pt's  arm "went back to normal on" 4/13/25. After that, pt's mother had no further questions
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: patient started having rash on hands and arm near injection site about 5 minutes after vaccination . Patient was given 2 tablets of benadryl and improved about 5-10 minutes (patient stayed in pharmacy extra 30 minutes)
Age: 24.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Erythema, Injection site pain
Clinical narrative: Localized redness at right arm, pain in right deltoid.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Muscle swelling, Skin warm
Clinical narrative: Redness, swelling, warmth of deltoid muscle aprox. within 24 hours of vaccine. Conservative treatment with cold packs and tylenol
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: Vaccine diluted with MedQuadfi (Sanofi) instead of Sterile Diluent.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: pt called stating her arm injection site was swollen and fever on Sat 4/12, but it is getting better.
Age: 85.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Gave unneeded duplicate Prevnar 20 on this date. Patient came into Pharmacy with a MD note to get it done. However, she did not mention that she had already gotten it last year. No adverse effects noted by patient due to this vaccine.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: MMRII accidentally diluted with MenQuadfi (Sanofi) instead of actual diluent.
Age: 44.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Dry throat, Feeling jittery, Palpitations, Skin warm
Clinical narrative: Pt triaged for reaction reporting hot face, palpitations, resting heart rate of 101 lasting 20 minutes, jittery feeling, throat feeling dry. Pt reports symptoms are completely resolved now.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient received both Proquad and Varivax vaccine during 12 month well child exam visit on 3/18/2025. Multiple attempts have been made to contact parents to follow-up on child's health status and ensure child had not developed any adverse effects post vaccinations. Clinical team was unsuccessful in contacting the parents despite making several attempts. Child has a scheduled appointment on June 26, 2025 for a 15 month old well child exam and team will ensure to obtain correct contact information as well as confirm if child had any adverse effects.
Age: 14.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: On 12/16/2024, Pt was to receive Meningococcal conjugate quadrivalent (MenACWY-TT) as part of routine vaccinations. However, Meningococcal B (Bexsero) vaccine was given in place of MenACWY-TT vaccine in error. Upon realizing error, clinic nurse informed nurse supervisor. Pt's guardian/parent was informed of the error and need to administer correct Meningococcal vaccine (MenACWY-TT) discussed. Pt's mother verbalized understanding. Pt was then given correct Meningococcal (MenACWY-TT) vaccine. Pt had no adverse reaction to vaccines given, VAERS report being completed due to recommendation from CDC regarding immunization error.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Client was administered two doses of newest formulation of Gardasil 9 vaccine despite having a full series of the quadrivalent formula completed with 3 doses. Quadrivalent series was administered on 04/25/2007, 07/30/2007 and 08/24/2011. Client did not and has not reported any adverse events following the two recent doses administered on 02/07/2025 and 03/12/2025. Client will not have any additional doses administered any longer as current ACIP and CDC guidelines do not advise on this.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 34.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 41.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 51.0
Sex: F
Vaccine: HEPAB, PNC21, TDAP
Symptoms: Blood pressure decreased, Palpitations
Clinical narrative: Soon after vaccination but already at home blood pressure went down and the heart started racing
Age: 52.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness and fever of 101ºF began a few hours after injection and continued for about 48 hours.  Then a 2 inch x 5 inch red, warm "rash"  about 4 inches below injection site appeared about 48 hours after injection. This "rash" does remain painful and when it gets warm begins to itch--five days post injection.  "Rash" does not appear to be spreading.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Urticaria
Clinical narrative: I received the Covid 19 Shot around 11: 00 AM on 10-31-24 and by 3:PM the same day I had large blotchy hives all over my torso front and back.  I have continuously had the same hives since then.  Sometimes they are on my legs and arms.  Most recently they have been on my legs and torso.  I have never had hives before and never had a reaction to Pfizer Covid shots until this one.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Cluster headache, Dyspnoea, Dyspnoea exertional, Fatigue, Insomnia
Clinical narrative: Onset of cluster headache, night sweats, nausea, fatigue, and insomnia approximately 1 week following vaccine and lasting about 1 month total.  Felt harder to breathe for a few weeks, different from usual asthma symptoms.  Some tachycardia and dyspnea with exertion.  Onset of rash on right hand - swollen red itchy bumps over dorsal hand first 3 digits from 2 weeks post vaccine lasting 2 weeks.  Some partially vesicular in appearance and painful to touch.  Widespread but milder rash over face, trunk, and arms starting 10 days after vaccines and lasting about 2 days.  Not itchy.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Nausea, Night sweats, Rash, Rash erythematous, Rash papular
Clinical narrative: Onset of cluster headache, night sweats, nausea, fatigue, and insomnia approximately 1 week following vaccine and lasting about 1 month total.  Felt harder to breathe for a few weeks, different from usual asthma symptoms.  Some tachycardia and dyspnea with exertion.  Onset of rash on right hand - swollen red itchy bumps over dorsal hand first 3 digits from 2 weeks post vaccine lasting 2 weeks.  Some partially vesicular in appearance and painful to touch.  Widespread but milder rash over face, trunk, and arms starting 10 days after vaccines and lasting about 2 days.  Not itchy.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Rash pruritic, Rash vesicular, Tachycardia, Tenderness
Clinical narrative: Onset of cluster headache, night sweats, nausea, fatigue, and insomnia approximately 1 week following vaccine and lasting about 1 month total.  Felt harder to breathe for a few weeks, different from usual asthma symptoms.  Some tachycardia and dyspnea with exertion.  Onset of rash on right hand - swollen red itchy bumps over dorsal hand first 3 digits from 2 weeks post vaccine lasting 2 weeks.  Some partially vesicular in appearance and painful to touch.  Widespread but milder rash over face, trunk, and arms starting 10 days after vaccines and lasting about 2 days.  Not itchy.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Joint swelling
Clinical narrative: Developed redness and swelling at injection site on the evening after. Has still been painful, swollen. Parent has noticed increasing redness on surface of skin, and area is warm to touch.
Age: 41.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Disorientation, Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itchiness, right arm, where Varicella was given a day after. Pt reports feeling disoriented 3 days after administration of vaccine.
Age: 0.75
Vaccine: RV5, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; ROTATEQ was administered to a 9 month old on 03/20/2025; This spontaneous report was received from a nurse referring to a 9-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 20-Mar-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (lot #2073367, expiration date: 26-Nov-2025), administered by Oral route as prophylaxis (dose, and strength not reported) (Product administered to patient of inappropriate age). There were no reported signs/symptoms of adverse effects (no adverse event).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Erythema, Myalgia, Nausea
Clinical narrative: Red indurated lesions like erythema on both cheeks (especially right side); generalized myalgias and weakness; pain in joints (no visible inflammation); some nausea
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Red indurated lesions like erythema on both cheeks (especially right side); generalized myalgias and weakness; pain in joints (no visible inflammation); some nausea
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Coma, Myocardial infarction, Syncope
Clinical narrative: Booster shot taken. She fainted while taking dog for a walk. Nearly died of heart attack. Was in coma for a few days.
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; ROTATEQ was administered after a temperature excursion; Information has been received from Business Partner/CRO on 21-Mar-2025.  This spontaneous report was received from a 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 17-Feb-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #X023474, expiration date: 11-Jul-2025) administered by Oral route for prophylaxis. Tis vaccine underwent temperature excursion in 52.2 degree Fahrenheit for 1 hour. No additional adverse event was reported.
Age: 14.0
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 14 year-old patient may have received less than recommend; No additional AE; This spontaneous report was received from an Other health professional and referred to a 14-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient may have received less than recommend first dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), (may have received 0.01mL of vaccine), (lot # and expiration date were not reported) for prophylaxis (underdose). No additional AE.   Lot # is being requested and will be submitted if received.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper storage of product in use; This spontaneous report was received from a/an Consumer or other non-health professional and refers to a(n) 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 21-Mar-2025, the patient was vaccinated with improper stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), formulation: injection, lot #Y011712, expiration date: 02-Jul-2026, 0.5 mL (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT).  On 29-Jan-2025, administered dose of vaccine was exposed to the temperature excursion of 14.65 degrees Fahrenheit for 13 hours and 15 minutes (product storage error). No previous temperature excursion has occurred. No additional adverse event reported (no adverse event).
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP called to report that an expired dose of VARIVAX was administered to a patient. VARIVAX expired on 3/7/2025, administered 3/24/2025. Potency of the dose was supported by the Post Expiry Memo. No symptoms reported. Consent to contact is Yes.  No a; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 24-MAR-2025, the patient was vaccinated with an expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #X006981, expiration date: 07-MAR-2025) 0.5 mL administered by unknown route (exact dose and anatomical location were not provided), which was diluted with a sterile diluent (expiration date and lot # were not reported) as prophylaxis.  No symptoms reported (no adverse event).
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: headache; Injection site erythema; Injection site pain; Injection site pruritus; Injection site inflammation; Injection site warmth; This spontaneous report was received from a Regulatory Authority and refers to a 65-year-old female patient.   The patient's medical history was headache, injection site erythema, injection site inflammation, injection site pain, injection site pruritus and injection site warmth. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 13-Jan-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Injection (lot #Y013009, expiration date: 17-Nov-2025), dose number 1, administered by Intramuscular route in Left Arm for prophylaxis.  On 16-Jan-2025, the patient experienced headache. On 16-Jan-2025, the patient experienced Injection site erythema. On 16-Jan-2025, the patient experienced Injection site pain. On 16-Jan-2025, the patient experienced Injection site pruritus. On 16-Jan-2025, the patient experienced Injection site inflammation. On 16-Jan-2025, the patient experienced Injection site warmth.   At the reporting time, the patient had not recovered from headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site inflammation and Injection site warmth.   The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable.   The causal relationship between the event of all adverse events and Pneumococcal 21-valent Conjugate Vaccine was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number :  2821300-1 , Central date : 2025-03-26 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth
Clinical narrative: headache; Injection site erythema; Injection site pain; Injection site pruritus; Injection site inflammation; Injection site warmth; This spontaneous report was received from a Regulatory Authority and refers to a 65-year-old female patient.   The patient's medical history was headache, injection site erythema, injection site inflammation, injection site pain, injection site pruritus and injection site warmth. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 13-Jan-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Injection (lot #Y013009, expiration date: 17-Nov-2025), dose number 1, administered by Intramuscular route in Left Arm for prophylaxis.  On 16-Jan-2025, the patient experienced headache. On 16-Jan-2025, the patient experienced Injection site erythema. On 16-Jan-2025, the patient experienced Injection site pain. On 16-Jan-2025, the patient experienced Injection site pruritus. On 16-Jan-2025, the patient experienced Injection site inflammation. On 16-Jan-2025, the patient experienced Injection site warmth.   At the reporting time, the patient had not recovered from headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site inflammation and Injection site warmth.   The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable.   The causal relationship between the event of all adverse events and Pneumococcal 21-valent Conjugate Vaccine was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number :  2821300-1 , Central date : 2025-03-26 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired vaccine administered; 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 21-Feb-2022, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #T025509, expiration date: 23-Jan-2022, also reported as 23-JAN-2025, discrepancy) (1 dose) reconstituted with sterile diluent (DSM STERILE DILUENT), (lot # and expiration date were not reported)(expired vaccine administered) No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Vaccine expired 02/12/2025 and administered today (03/28/2025).; This spontaneous report has been received from a medical assistant referring to a female patient of unspecified age. The patient's concurrent conditions, pertinent medical history, previous drug reactions/allergies, and concomitant therapies were not provided.  On 28-MAR-2025, the patient was vaccinated with HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (GARDASIL 9) SYRINGE with valid lot # X002626 and expiration date 12-FEB-2025 (strength, dose, frequency, route of administration, lot #, and expiration date were not provided) as prophylaxis (Expired product administered). There was confirmed no temperature excursion (TE), nor additional adverse event (AE).
Vaccine: VARCEL, VARCEL, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional aes were reported; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX (y013350   8/2/2026) Temperature: 14.92F Time frame:; Information has been received from Business Partner/CRO on 31-Mar-2025.  This spontaneous report was received from a Nurse 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 28-Mar-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), (lot #y013350, expiration date: 02-Aug-2026), dose number 1, for prophylaxis. On 28-Mar-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) for prophylaxis. This vaccine underwent temperature excursion (Product storage error).  No additional adverse event.
Vaccine: VARCEL, VARCEL, HIBV
Symptoms: Product storage error
Clinical narrative: No additional aes were reported; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX (y013350   8/2/2026) Temperature: 14.92F Time frame:; Information has been received from Business Partner/CRO on 31-Mar-2025.  This spontaneous report was received from a Nurse 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 28-Mar-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), (lot #y013350, expiration date: 02-Aug-2026), dose number 1, for prophylaxis. On 28-Mar-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) for prophylaxis. This vaccine underwent temperature excursion (Product storage error).  No additional adverse event.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician 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 medications included sterile diluent (MERCK STERILE DILUENT).  On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 05-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 5.9 degree Fahrenheit for 13 hours.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: HCP reports patient had "severe cellulitis" after receiving PNEUMOVAX 23 "years ago". Per HCP, reaction was "localized to the deltoid area". Unknown if any treatment was provided. No other information provided. No additional AE. No PQC.; This spontaneous report was received from the Health Care professional and refers to a 60-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date, reported as "years ago", the patient was administered Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) solution for injection, administered by unknown route as vaccination (dose, anatomical location, lot # and expiration date were not reported). On an unspecified date, after receiving the suspect vaccine, the patient had severe cellulitis localized to the deltoid area. Unknown if any treatment was provided. No other information provided. At the reporting time, the outcome of severe cellulitis was not known. The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not reported, but established as not applicable.   The causal relationship between the severe cellulitis and the suspect vaccine was not provided.