chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: HEPAB
Symptoms: Chills, Fatigue, Injection site rash, Pruritus
Clinical narrative: rash at injection site; itching; chill; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 25-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (Patient received first dose on an unknown date) and Twinrix (Patient received second dose on an unknown date).   On 24-FEB-2025, the patient received the 3rd dose of Twinrix. On 25-FEB-2025, 1 days after receiving Twinrix, the patient experienced injection site rash (Verbatim: rash at injection site), pruritus (Verbatim: itching), chills (Verbatim: chill) and fatigue (Verbatim: fatigue). On 26-FEB-2025, the outcome of the chills and fatigue were resolved (duration 1 day). The outcome of the injection site rash and pruritus were not resolved.   It was unknown if the reporter considered the injection site rash, pruritus, chills and fatigue to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site rash, pruritus, chills and fatigue to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-FEB-2025 Patient who stated that from previous ones (Twinrix), he never had any issues but with his last vaccine for Twinrix, he started to develop a rash on his arm, and it was itching, and started having some other symptoms that he was kind of concerned about.  Patient had a telehealth that night and he was told that everything was fine and he was okay.  He received the vaccine on Monday, 24-FEB-2025, and Tuesday night when he got home around 7, he noticed he had a rash at the injection site (left shoulder), and chills. He stated he felt off throughout the day with fatigue and when asked if the symptoms had resolved, he stated the rash was still there, but the other symptoms were gone in the morning when he woke up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product preparation issue
Clinical narrative: Nurse explained that they administered just the diluent portion without reconstituting of a Shingrix vaccine to a patient; Nurse explained that they administered just the diluent portion without reconstituting of a Shingrix vaccine to a patient; Patient received first dose of Shingrix on March 6th 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number X5J23, expiry date 25-JAN-2026) and (batch number N77J2, expiry date 23-OCT-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix on 06th March 2024).   On 03-MAR-2025, the patient received the 2nd dose of Shingrix. On 03-MAR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Nurse explained that they administered just the diluent portion without reconstituting of a Shingrix vaccine to a patient), inappropriate dose of vaccine administered (Verbatim: Nurse explained that they administered just the diluent portion without reconstituting of a Shingrix vaccine to a patient) and drug dose administration interval too long (Verbatim: Patient received first dose of Shingrix on March 6th 2024). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and drug dose administration interval too long were not applicable.   Additional Information: GSK Receipt Date : 03-MAR-2025 Licensed Practical Nurse explained that they administered just the diluent portion without reconstituting of a Shingrix vaccine to a patient on March 3rd 2025 which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. Patient received first dose of Shingrix on March 6th 2024. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse Reaction noted yet.
Age: 1.08
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Contusion, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count abnormal, Rash
Clinical narrative: MMR given 1/29/25; returned to clinic on 2/18/25 for rash and bruising. MD called Hematologist who advised transfer to ER to transfer for admission for tx. Pt was seen and dc'd from hospital. He was given a single course of IVIG with iomprovement and stabilization of platelet number
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Head injury, Presyncope
Clinical narrative: patient had vasovagal event within 5 minutes of vaccine administration. Patient was not sitting, but leaning against exam table and slid down table to ground hitting head on ground. No LOC from hitting head. awake immediately and with sitting down for 10-15 minutes recovered without concerns
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Decreased appetite, Pruritus, Pyrexia, Rash
Clinical narrative: slight fever, chills, loss of appetite and a big red rash with itch on arm
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Body temperature increased, Diarrhoea, Frequent bowel movements
Clinical narrative: Mom called on 3/6/2025 with concerns that patient had a temp of 101.7 at 1900 on 3/5/2025. Mom said that the temp at 0925 on 3/6/2025 was 100.1.  Mom said patient had an increased amount of stools as well. Mom described them as "runny, almost like water."
Age: 0.58
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: N/A given for travel
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: 5 minutes after given injection pt states that his arm was itching at injection site. Pt denies any SOB or swelling in face. Site was not red, hot to touch, rash or swelling. Otherwise, pt states that he is feeling fine. Dr. examined pt and took band aid off. Vitals were obtained and pt sat for another 10 mins.  Dr.  examined pt again. Pt states that itching was gone. Pt instructed of itching comes back, redness or swelling at site, SOB to call our office. Pt verbalized understanding.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Leg rash at site of injection. Exam shows localized swelling, erythema of U/L LE that appears consistent with injection site reaction, most likely to Proquad.  Recommended conservative measures at this time with ice, analgesics if febrile, and antihistamine for pruritus.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy thyroid gland, Biopsy thyroid gland normal, Blood thyroid stimulating hormone decreased, Computerised tomogram, Poorly differentiated thyroid carcinoma
Clinical narrative: Nodule on thyroid developed and had grown significantly in size by April, lab work was completed and TSH was 0.69 and T4 was 1.01. Us was done in May and found a 4.7cmx1.7x3.9 nodule on thyroid. FNA biopsy completed by the ENT was negative. Recommendation by ENT based on US presentation and the nodule having continued to grow on repeat US in a short time frame was for removal. Nodule was removed with thyroidectomy and diagnosed as poorly differentiated thyroid carcinoma. Radioactive iodine was performed. Continuous monitoring has been completed by MD for lymph nodes in thyroid bed.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Radioactive iodine therapy, Thyroid mass, Thyroidectomy, Thyroxine, Ultrasound thyroid abnormal
Clinical narrative: Nodule on thyroid developed and had grown significantly in size by April, lab work was completed and TSH was 0.69 and T4 was 1.01. Us was done in May and found a 4.7cmx1.7x3.9 nodule on thyroid. FNA biopsy completed by the ENT was negative. Recommendation by ENT based on US presentation and the nodule having continued to grow on repeat US in a short time frame was for removal. Nodule was removed with thyroidectomy and diagnosed as poorly differentiated thyroid carcinoma. Radioactive iodine was performed. Continuous monitoring has been completed by MD for lymph nodes in thyroid bed.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Whole body scan
Clinical narrative: Nodule on thyroid developed and had grown significantly in size by April, lab work was completed and TSH was 0.69 and T4 was 1.01. Us was done in May and found a 4.7cmx1.7x3.9 nodule on thyroid. FNA biopsy completed by the ENT was negative. Recommendation by ENT based on US presentation and the nodule having continued to grow on repeat US in a short time frame was for removal. Nodule was removed with thyroidectomy and diagnosed as poorly differentiated thyroid carcinoma. Radioactive iodine was performed. Continuous monitoring has been completed by MD for lymph nodes in thyroid bed.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Patient reported paralyzing weakness
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Non febrile seizure on 3/1/25 and also on 3/6/25. Both were Tonic clonic seizures lasting 5 minutes on 3/1/25 and 7 minutes on 3/6/25. No family history of epilepsy on either maternal or paternal side.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: Nothing has been said of any signs of adverse.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal monitoring abnormal, Loss of consciousness, Ultrasound antenatal screen
Clinical narrative: Patient was given the TDAP vaccine 0853 - when she went to check out she passed out at the front desk. Per witnesses, she did not fall straight to floor, pivoted and then went down to side. Vitals WNL - patient take back to room. Patient to go to triage when her mom picks her up. Patient reports good fetal movement. Left clinic at 0946 ambulatory. -OB Triage Discharge Summary   Presenting Complaint: Syncopal episode at OB appointment while checking out  Presenting time:1000 Discharge Diagnosis:S/P Syncopal episode Discharge time: 11:16 AM    HPI: 18 y.o. female G1P0000 at 30w1d who presents to triage with the c/o gentle fall to floor following syncopal episode at OB appointment. Pt does not believe she hit her abdomen.    She denies VB or LOF. She reports active fetal movement. States she feels fine    Pregnancy Complicated by: Chlamydia on initial labs, TOC positive, retreated 1/29 GBS UTI on initial labs, allergy to PCN and cephalosporin, tx with nitrofurantoin per Up to Date, will need TOC Anatomy - 12/10 - 23% overall, 8%AC for 21w2d, all details visualized, will rpt with MFM or direct to US for poss IUGR, Rpt - 01/02 - 38% overall for 24w4d, 16% AC, rpt as clinically indicated, consider 3rd trim growth. Observational course/ Follow up Examination(s) Pt resting in bed in no acute distress. She reports active FM throughout monitoring/time in triage   Fetal monitoring: NST: baseline 130 with moderate variability, present accelerations,  NST reactive : yes TOCO: few mild irregular contractions every 10-15 minutes  Plan:  DC home Kick counts reviewed Reviewed importance of hydration and nutrition Labor precautions given
Age: 71.0
Sex: F
Vaccine: PNC21
Symptoms: Confusional state, Impaired driving ability
Clinical narrative: Starting wednesday had confusion. placed uncooked food in bed to eat and then didn't eat. Did not realize until morning. Friends reported when speaking to the patient that they were concerned she was having a stroke. The next day while driving patient got lost despite having gps map guidance open. Was able to make it home ok, but without the gps she would not have.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: The night after the shot my arm was extremely sore but it went away after two days. But my arm at the site became tender and puffy and pain on movement after 8 days.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted; Patient received Boostrix in 3/6/2025 and Boostrix on 7/29/2024 .
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions noted. Client inadvertently received 1 cc ( adult dose) of Hepatitis A vaccine. 11 year old should have received a 0.5 cc dose of Havrix
Age: 67.0
Sex: M
Vaccine: COVID19, FLU3, PNC20, TDAP
Symptoms: Wrong patient
Clinical narrative: This RN roomed a patient for PCP visit. Chart opened and confirmed birthday with patient.  Patient advised due for 4 vaccinations, pt agreed to all 4.   This RN went back into patient room, reopened chart and proceeded to give the 4 due vaccinations.  Upon speaking to PCP, it was realized that vaccinations were given to incorrect patient.  System showed patients being in incorrect rooms (i.e pt in room 27 actually in room 26).  Patients also had same first name and same birth year.  Patient notified by PCP, and had actually been due for 3 of 4 vaccinations.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pruritus
Clinical narrative: redness, itching, bruise feeling
Age: 34.0
Sex: M
Vaccine: HPV9
Symptoms: Musculoskeletal stiffness, Syncope
Clinical narrative: No contraindications or precautions on screening prior to vaccination. Following administration of vaccine in seated position, client reported feeling lightheaded. Client placed in supine position. This nurse called health department nurse manager to the room. Client appeared to experience syncopal episode with muscle stiffening. Client s legs elevated. Client returned to consciousness within seconds. Vital signs monitored. Client declined emergency medical services contact. Client provided cool water and candy which were tolerated well. Client declined cool cloth or cool pack. Client alert and oriented to person, place, time, and situation. Client denied previous reactions to vaccines in the past. Continued to monitor client with stable vital signs in supine, sitting, and standing positions. Regional medical director notified. Client encouraged to follow up with personal medical provider. Client voiced understanding. Client encouraged to notify providers of reaction following receipt of vaccine  prior to any future injections or procedures. Client voiced understanding. Client informed that per regional medical director client cannot receive any further doses of HPV vaccine from  clinics.  Client voiced understanding. Vital signs stable. Client ambulatory with steady gait without assistance. No symptoms present at time of discharge from clinic. Regional immunization program manager notified.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Patient as vaccinated on 02/13/2025 and vaccine were drawn up by another MA named and I gave the patient his vaccine and had them verify by an RN named. I was informed at my eval on 03/05 that the vaccines for a 6-month-old child only received the sterile saline used to mix with the hib vaccine meaning he has not been vaccinated for Hib and will need to return to the clinic to be re-vaccinated. I call the mother and notify her of the situation, and to see if the patient had any vaccine reaction, or she had any questions?  Mother of the patient stated we are all human and make mistake and no symptoms and that the patient is doing fine and will come into the clinic to be revaccinated again.
Age: 79.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient was given two Prevnar 20 vaccines which is over the maximum number of doses that should be given for this vaccine. The first was given on 04/25/24 and second was given on 03/06/25.
Age: 16.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Pt. arrived at Clinic to receive immunizations for school. He was given 3 vaccines in his left deltoid one inch apart (Tdap,MCV4,Polio). He was given Hep A IM in the right deltoid and upon administering the vaccine he had a reaction. His parent was at his side as we tried to arouse him. Patient started turning pale, his head turn to the right side with feet extended. Help was called and Providers came to assist and started talking with patient. I. started talking with parents. Vitals were taken on patient with first set @10:25am BP-115/66 HR-85, O2Sats 96% T-97.7 R-20. Patient started responding to verbal command with color to skin. At 14:27 BP-118/69,P-64, O2sats @100% R-22. Patient transported into jeri chair with assistance. Given some water and a sugar snack. No problems with swallowing. Parents at patient side. Patient communicating and alert @1445 BP-110/71, P-68, O2sats @100%. Mother refused Ambulance service. Unable to finish immunizations on this visit and parent advised to take patient to pediatrician for other immunizations. Mother verbalized understanding. Pt. alert and talking. Monitored for another 45 minutes until end of visit. Pt. ambulated with a steady gait out the clinic.
Age: 27.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient inadvertently vaccinated with duplicate Fluzone and Moderna vaccines.
Age: 0.08
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Mother was notified
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness
Clinical narrative: PATIENT GOT DIZZY AND LIGHT HEADED
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Myalgia
Clinical narrative: pt says she developed a fever after getting the vaccine. Next day she started feeling worse. She had headache, shivering, congestion, upset stomach, fatigue, muscle pain, and her fever was 101.9. She took day time and night time Nyquil for her symptoms. She continues to have all of these symptoms after seven days but is feeling a little better. Fever still comes and goes. The pain from the shot in the arm lasted about 2 days. She contacted the nurse with her insurance and was told to follow up with doctor or go to an urgent care. She will contact her pharmacy and PCP if needed.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: pt says she developed a fever after getting the vaccine. Next day she started feeling worse. She had headache, shivering, congestion, upset stomach, fatigue, muscle pain, and her fever was 101.9. She took day time and night time Nyquil for her symptoms. She continues to have all of these symptoms after seven days but is feeling a little better. Fever still comes and goes. The pain from the shot in the arm lasted about 2 days. She contacted the nurse with her insurance and was told to follow up with doctor or go to an urgent care. She will contact her pharmacy and PCP if needed.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Salivary hypersecretion, Trismus
Clinical narrative: After 3 mins of vaccine application pt. started with uncontrolled movements of lower jar and increased saliva production.  No loss of conscious.  No sounds.  No other movements. VS in normal limit.  Except HR 142. After 30 minutes Pt. is stable.  Given instruction to mother to go to PMD if any other changes.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: Patient presented with loss or displacement of Adipose tissue on right arm approximately 3 inches below injection site. Occurrence within same day as injection on same arm. Displacement not found on opposite arm which appears normal.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered before his 4th birthday due to miscalculation of age. No adverse effects were noted.
Age: 49.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient was given Prevnar-20 for a second (duplicate) time. The previous PCV-20 was on 5/3/2022. The database did not specify which PCV was administered, and it has the words "Not Valid" next to the shot, leading the pharmacist to believe the patient had not received the vaccine. The patient experienced zero ADRs and has no complaints.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal discomfort, Dizziness, Erythema, Headache, Pain in extremity
Clinical narrative: When i woke up i was feeling sore my arm was feeling sore, kinda warm. Once i got up i looked at it, it was kinda red, I was feeling dizzy and my stomach was kinda icky and i had a slight headache. ( Unclear which type o the vaccines i got )
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Skin warm
Clinical narrative: When i woke up i was feeling sore my arm was feeling sore, kinda warm. Once i got up i looked at it, it was kinda red, I was feeling dizzy and my stomach was kinda icky and i had a slight headache. ( Unclear which type o the vaccines i got )
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Breech presentation, Caesarean section, Exposure during pregnancy, Premature labour
Clinical narrative: I went into preterm labor about a week after receiving the vaccine. Baby was breached and I had to receive a C-section to deliver the baby. The baby weighed 7lbs 13.2 oz and spent almost two weeks in the Nicu. My due date was January 25.
Age: 0.33
Sex: M
Vaccine: FLU3
Symptoms: Crying, Infant irritability, Injection site erythema, Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: Patient received influenza vaccine at 4 months of age rather than at 6 months of age, so vaccine was given 2 months too early. Nursing staff spoke with patient's father. Per patient's father, patient had redness and pain at injection site and was cranky/crying more than usual following vaccination. Patient's father reported no other concerns, and patient did not receive any medical treatment. Patient's father also reports that patient is now back to normal.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Arrhythmia, Chest pain
Clinical narrative: chest pain and arrhythmia-like symptoms were reported. Patient reported that they began to feel better on the day they reported to the pharmacy,  Patient was recommended to take benadryl for any other allergy-like symptoms and told to continue monitoring for exacerbations.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Fall, Hypotension, Seizure like phenomena, Syncope
Clinical narrative: Pt received a hepatitis A and a meningococcal vaccine in the left deltoid at 1:30pm. Approximately 30 seconds after administration, she stated "I feel dizzy" and fell over into the chair beside her. Pt experienced a syncopal episode with some convulsion-like behavior. She came to within 30 seconds and was alert and oriented to person, place, and time. Pt had a second episode of similar behavior (syncope/ convulsion) a few seconds after the first. She came to within about 30 seconds. Vital signs showed pt as hypotensive (70's/40's), normal hr, and O2 sats mid to upper 90's. Pt reports she had not eaten anything that day prior to the vaccine. Pt's mom reports that she has experienced a similar episode before during a venipuncture procedure but it "wasn't as bad as this."
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Sluggishness
Clinical narrative: after administered vaccine, patient said she felt  sluggish and scared to drive.  patient waited at lobby 1 hour still feels same . she wants to report to about the vaccine.   now patient said feels better
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Delivery, Exposure during pregnancy, High risk pregnancy, No adverse event
Clinical narrative: Patient did not exhibit an adverse affect 15 post administration. Patient  was a high risk teen pregnancy in 2nd Trimister.  Patient delivered 11.XX.2024
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: Patient was VFC eligible and received a private dose of HPV vaccine instead of a state-supplied dose. No adverse reaction.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient called to state she received all her shots this day in the same arm (5 total) and afterwards her arm was more sore than normal.  She had mobility issues since then and is now going to see the MD.  She thinks maybe the shot was given in the wrong place.  She is seeing her MD for the pain and mobility issues this week.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Rash, Urticaria
Clinical narrative: around 3 hours after the vaccines given, mom called the office and stated he had broke out in  a rash that could be hives on his face only. Mom also noted that they had just walked through polled right right before the rash started. He had been acting normal otherwise, was happy and smiling at mom, and no reported coughing or breathing struggles. Mom was advised to give 2.5mL  benadryl and she said she gave it while on the phone. Advised to watch for worsening symptoms, progression of rash, or struggling to breath and to call office back. No further calls received
Age: 66.0
Sex: F
Vaccine: COVID19, MMR
Symptoms: Injection site pruritus, Mouth swelling
Clinical narrative: Itchiness at ejection site of MMR injection. Funny feeling (swelling?) in mouth (but not throat). I did just have a takeout sandwich and brownie.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU3, HPV9, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered Moderna covid vaccine for ages 12+ .  Patient should have had Moderna covid vaccine for 6 months to 11 years.  Patient and family were educated on vaccine, potential side effects, and  adverse effects to be aware of and monitor.  Talked with mother of patient who states that patient only has a sore arm.  no other side effects or concerns at this time.  Primary care provider was updated along with supervising staff per protocol.  Manufacturer updated and discussed potential side effects.  Dose will not be readministered. No change in treatment for this patient.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: weakness or a burning, numbness, or tingling feeling
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: No adverse event
Clinical narrative: Patient received two courses of 2 month vaccines.  The two month vaccines administered were PedvaxHIB, Prevnar and Pediarix.  All doses were the same lot number on administration on 2/21/25 and 3/5/25.  The patient tolerated the vaccines well and did not demonstrates signs or symptoms of a reaction.  Patient was discharged from NICU on 3/6/25.
Age: 9.0
Sex: F
Vaccine: COVID19, FLU3, HEPA, VARCEL
Symptoms: Eye pruritus, Swelling face, Swelling of eyelid
Clinical narrative: Mother reported that adverse symptoms began roughly 3 hours after vaccination. Symptoms began with pruritic eyes and eyelid swelling. Mom gave eye drops and oral benadryl and tylenol, per the box dosing instructions. 5-10 minutes post-medication, the eyelid swelling was reduced, but not gone. Mom continued to give benadryl and tylenol around the clock as symptoms were not resolved. In the evening, the facial swelling increased but mom denied shortness of breath, rash, or fever. Patient describes swelling as "puffy bunny face." Symptoms were resolved after the first night (ie, no symptoms since 3/4/25).   Of note, Mom denied that patient was exposed to any new items. Mom denied any similar occurrence with prior vaccines. Patient was not treated at a medical facility for symptoms.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received dose 2 of Shingrix before recommended interval of 8 weeks from first dose. Patient was not harmed but informed their 2nd dose would be invalid according to CDC guidelines. Patient agreed to come 8 weeks from invalid dose to receive valid second dose of Shringrix.
Age: 49.0
Sex: F
Vaccine: PNC21
Symptoms: No adverse event
Clinical narrative: no adverse event
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Lip swelling, Oral discomfort, Pruritus, Rash
Clinical narrative: My daughter received the vaccine, and less than 24 hours later, she began experiencing intense itchiness all over her body, including behind her ears and on her back. The next day, the rash was still present on her back, arms, and extremities. While the rash temporarily subsided, the itching persisted. The following Monday, the rash returned, even worse than before. By Wednesday morning, she was dealing with the same issues: itching, a rash, swollen lips, and discomfort in her mouth,  and the itching became unbearable. As soon as we noticed her symptoms worsening, we took her to the ER. The ER doctor confirmed that it was an adverse reaction to the vaccine, as there had been no changes in her diet or any other new medications. She was treated with prednisone and Benadryl at the hospital, and we were given a prescription for both medications to continue for five days.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Visual impairment
Clinical narrative: I administered the covid and flu vaccine and about 1 minute after she was standing Infront of me and said she saw red cells and told her to sit down and when she was about to sit mom and I heard a sound and mom and I ran to her and helped her up and checked her blood pressure, she immediately woke up and was ok.
Age: 40.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Impaired work ability, Pruritus, Rash
Clinical narrative: Per EE,  Had an adverse reaction on 03/06/25 @ 1700.  Adverse  Reaction started on left posterior side of her neck and was itchy and bumpy, and continued to her back and arms and woke up this morning 03/07/25 with itchiness all over body. Per EE, spoke to her local pharmacy and they told her to take benadryl and see provider.  Per EE, she told them she couldn't because she was coming into work and benadryl will cause her to be unsafe because of drowsiness and she does not have a provider. Advised EE to seek medical attention as well, but she declined at this time.  EE states she took an oatmeal bath and applied Desitin to her underarms for itchiness last night, but has not taken any over-the-counter medication for adverse reaction.  Per EE, no hx of adverse reaction to vaccinations, however she had a flu shot one time and became ill.  Advised EE that if she would like to receive medical attention with workers comp, she will need to fill out forms and we will refer her to Occ Health.  Per EE, she spoke to her manager and will take the day off and will self monitor instead of seeking medical attention at this time and will let us know if she needs anything.  Per EE, does not have any respiratory issues at this time and will seek medical attention as needed.
Sex: F
Vaccine: COVID19, FLU3, UNK
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: an itchy, red, hot, and swollen arm that went down to her elbow; an itchy, red, hot, and swollen arm that went down to her elbow; itchy, red, hot, and swollen arm that went down to her elbow; itchy, red, hot, and swollen arm that went down to her elbow; This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2232179. The previous case ID: 2412USA004213.  Information has been received from FDA on 11-DEC-2024, regarding an 82-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-OCT-2024, the patient was vaccinated with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection (lot #Y011819 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 01-OCT-2025) intramuscularly in the left arm (strength and dose was not provided), tozinameran (PFIZER BIONTECH COVID-19 VACCINE) intramuscularly in the left arm (lot# LM2211, strength, formulation and expiry date were not provided) and influenza vaccine inact split 3v (FLUZONE HIGH DOSE) intramuscularly in the right arm (lot # U8515EA, strength, formulation and expiry date were not provided) all for prophylaxis.  On 11-OCT-2024, the patient experienced an itchy, red, hot, and swollen arm that went down to her elbow. The patient called the doctor and they told her to go to urgent care and she was given an antibiotic and steroid to help. She also used cold compresses all weekend to help. She was told if it got worse, she was to go to the emergency room (ER) but that never happened. Outcome of all the events was recovered on an unknown date in 2024. Causality assessment was not provided.  This is one of several reports from the same reporter.   Executive Summary:  Investigation summary for CAPVAXIVE Batch/Lot# Y011819  Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of CAPVAXIVE Batch number 0001774623 material number 2017970 at MSD which could have impacted on product quality.  No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch.  Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications.  Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product.  There have been no additional requests for information or additional testing relating to this Adverse Event.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, PNC20, UNK
Symptoms: Pyrexia
Clinical narrative: still running a fever; he is also cutting a tooth this week; This spontaneous report was received from a Nurse and refers to a 1-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 03-FEB-2025 (also reported as 03-FEB-2024, discrepancy), the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), used along with sterile diluent (no details), 1 dosage form, lot #Y013073, expiration date: 29-JUL-2026, for prophylaxis (anatomical location and route of administration were not provided); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), used along with sterile diluent (no details), 1 dosage form, lot #Y008592, expiration date: 30-APR-2026, for prophylaxis (anatomical location and route of administration were not provided);  Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20), for prophylaxis (dose, lot #, expiration date, anatomical location and route of administration were not reported); and Influenza vaccine inact sAg 3v (FLUCELVAX), for prophylaxis (dose, lot #, expiration date, anatomical location and route of administration were not reported). Starting on an unspecified date in February 2025 (discrepancy, as also provided as 03-FEB-2024 or "10-FEB"), the patient was displaying a fever, which was expected, however as of 07-FEB-2025 (also reported as "today") he was still running a fever (103.3F unmedicated). Tests were also performed by his pediatrician to ensure that he did not have another infection, and all results came back negative. He was also cutting a tooth that week. No further information was available. At the reporting time, the patient had not recovered from the events. The action taken with suspect products was not reported but established as not applicable.   The causal relationship between the events and the suspect products were not provided.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Antibody test negative
Clinical narrative: Patient is 30 year old female with a history of 2 VARIVAX doses. HCP believes the titers are low but is not sure; This spontaneous report was received from a registered nurse regarding a 30-year-old female patient. The patient's medical history, historical drugs, and concomitant therapies were not reported. Her concurrent conditions included a fish allergy.   On an unknown date, the patient was vaccinated with the first and second doses of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection (strengths, doses, lot #, expiration dates, anatomical location, and routes of administrations were not reported), both diluted with sterile diluent (MERCK STERILE DILUENT) solution for injection (strengths, doses, lot #, expiration dates, anatomical location, and routes of administrations were not reported), as prophylaxis.  The health care professional stated that in an unknown date, believed that her titers were low but was not sure (Antibody test negative). The HCP additionally inquired whether the suspect vaccine contained fish given the patient's allergy, and the medical information request (MIR) she received only discussed fish oil.  At the reporting time, the outcome of the event had not been provided.   The causal relationship between the event and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) plus sterile diluent (MERCK STERILE DILUENT) was not provided.   Lot # is being requested and will be submitted if received.
Age: 1.0
Vaccine: VARCEL, VARCEL, VARCEL, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event; HCP called to report a patient received their first does of VARIVAX at 12 months of age and was administered a second dose just 3 months later at 15- months of age. Caller states no side effects or symptoms have been reported. HCP does not have the l; Information has been received from a Registered Nurse  on 12-FEB-2025 regarding to an 1-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.   It was reported that the patient received their first dose of Varicella Virus Vaccine Live (Oka-Merck) at 12 months of age on 03-NOV-2024 (dose, lot #and expiration date was not reported) and it was administered a second dose, reported as just 3 months later at 15- months of age on 03-FEB-2025 (dose: 0.5 milliliter,  lot #Y015101, expiration date: 06-SEP-2026) (Inappropriate schedule of product administration) for prophylaxis. It was reported that no side effects or symptoms had been reported.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: no adverse event; vaccine exposure during pregnancy; Wrong vaccine administered; This spontaneous Prospective pregnancy report was received from a Physician and refers to a 35-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  The patient became pregnant with the date of last menstrual period of 20-Jul-2024. The pregnancy due date was estimated as 26-Apr-2025. This pregnancy involved 1 fetus. The pregnancy outcome and fetal outcome were unknown. On 12-Feb-2025, at gestational age 29 weeks and 4 days the patient was accidentaly given Human Papillomavirus 9-valent Vaccine, Recombinant Injection (lot #X024251, expiration date: 15-May-2026), dose number 1, 0.5 mL (0.5 mL, deltoid), instead of Tetanus, Diphtheria, and Pertussis (TDAP) (Wrong vaccine administered, vaccine exposure during pregnancy). No adverse event was reported.
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose increased, Condition aggravated, Hyperglycaemia
Clinical narrative: Hyperglycemia; This spontaneous report was received from a Nurse Practitioner regarding a 42-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions included Insulin dependent diabetes. Historical drugs included Insulin. Concomitant therapies, past drug reactions and allergies were not reported.   On 18-Feb-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection administered intramuscularly for prophylaxis (dose, vaccination scheme frequency, lot number, expiration date and anatomical site of injection were not reported).  It was reported that on that same date, prior to the vaccination, the patient's blood sugar was 80 (units not provided) and approximately two hours after administering the vaccine, after the patient left the office, they called the HCP to report that her blood sugar had spike to 400 (units not provided) (Blood glucose increased). The reporter stated that no medical treatment was needed, and the patient just gave herself a bolus of insulin at home to bring the number down.   At the time of the report, the patient was recovering from the event of Blood glucose increased.  The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.   Follow up information was received from a nurse practitioner. Concomitant therapy included cabergoline, insulin pump, lexapro, metformin and levonorgestrel (MIRENA). Current conditions included also situsitis. Lot # of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was Y014059, espiry date was 01-NOV-2025, site was right deltoid. The event term was changed to hyperglycemia, it occurred two hours after vaccination. The patient received increased exogenous insulin and it was reported that the event was controlled.  In approximately February 2025, the patient recovered from hyperglicemia. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was changed to possibly related.; Sender's Comments: Priority : 4 , Is case serious : No , Index user :  , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : US-009507513-2256278 , Central date : 2025-02-24 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inappropriate schedule of product administration; No adverse event; Information has been received from Business Partner/CRO on 18-Feb-2025.  This spontaneous report was received from a/an Consumer or other non health professional and refers to a(n) Child 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 started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (indication, expiration date, and lot # were not reported).  On an unknown date, the patient experienced Inappropriate schedule of product administration. On an unknown date, the patient experienced No adverse event.   At the reporting time, the outcome of Inappropriate schedule of product administration and No adverse event was unknown.
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE/PQC reported; the office inadvertently administered PROQUAD to a 20 year old patient; This spontaneous report was received from a nurse and refers to a 20-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 07-Jun-2024, the 20-year-old patient (product administered to a patient of inappropriate age) was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Solution for injection (lot #Y003880, expiration date: 05-Aug-2025) for prophylaxis.  No other adverse event was reported.
Sex: F
Vaccine: MMRV
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: vaccine leaked out onto her gloved hand during administration; HCP reports vaccine leaked out onto her gloved hand during administration.; HCP reports vaccine leaked out onto her gloved hand during administration.; HCP reports vaccine leaked out onto her gloved hand during administration.; This spontaneous report was received from a physician and refers to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 20-Feb-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for prophylaxis (lot #Y009348, expiration date: 11-Nov-2025). On 20-Feb-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot #1973529, expiration date: 03-Mar-2026 which was estimated to be non-valid) for an unknown indication.  On 20-Feb-2025, the patient experienced vaccine leaked out onto her gloved hand during administration (accidental exposure to product, occupational exposure to product, syringe leak and vaccination error). The patient recovered from the events on unknown date. The action taken with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and sterile diluent was reported as not applicable.
Age: 0.17
Vaccine: DTPPVHBHPB, VARCEL, DTPPVHBHPB, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No reported signs or symptoms of adverse effects have been reported; VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered; This spontaneous report was received from a nurse and refers to a2-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-FEB-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) as prophylaxis, the vaccine was reconstituted using a diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus (VAXELIS) pre-filled syringe rather than the sterile diluent (product preparation error) (exact dose, strength, vaccination site, route of administration, lot number and expiration were not reported). No reported signs or symptoms of adverse effects have been reported.   Lot # is being requested and will be submitted if received.;
Age: 0.17
Vaccine: DTPPVHBHPB, VARCEL, DTPPVHBHPB, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No reported signs or symptoms of adverse effects have been reported; VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered; This spontaneous report was received from a nurse and refers to a2-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-FEB-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) as prophylaxis, the vaccine was reconstituted using a diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus (VAXELIS) pre-filled syringe rather than the sterile diluent (product preparation error) (exact dose, strength, vaccination site, route of administration, lot number and expiration were not reported). No reported signs or symptoms of adverse effects have been reported.   Lot # is being requested and will be submitted if received.;