chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: inadvertedly gave a menveo vaccine that was 12 days outdated,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA956A, expiry date 31-JUL-2024) for prophylaxis.   On 12-AUG-2024, the patient received Menveo. On 12-AUG-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: inadvertedly gave a menveo vaccine that was 12 days outdated,). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 13-AUG-2024 Health Care Professional reported that they inadvertedly gave a menveo vaccine that was 12 days outdated, just wandering if there's a grace period, which led to expired vaccine used. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: RPH preparing his dose may have done it incorrectly; Inappropriate dose of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-AUG-2024, the patient received Shingrix. On 12-AUG-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: RPH preparing his dose may have done it incorrectly) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The action taken with Shingrix was unknown. The outcome of the inappropriate preparation of medication was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   Additional Information: GSK receipt date: 14-AUG-2024 The patient called to inquire about the procedure to prepare Shingrix for administration.  He was concerned that the RPH preparing his dose may have done it incorrectly.  At one point the caller said the RPH used water to dilute the dose, then he stated he had used two liquid vials. He did not see a powder vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The reporter described the correct process and he admits that he may not have understood the steps correctly while observing the preparation.  Did not consent to follow-up.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Interchange of vaccine products, Wrong product administered
Clinical narrative: Interchangeability with a Menveo vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number 2Y393, expiry date 30-APR-2027) for prophylaxis.   Previously administered products included Meningococcal vaccine (on an unknown date received).   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Interchangeability with a Menveo vaccine). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-AUG-2024 The Medical Assistant reported that a patient received a Bexsero dose instead of a Menveo vaccine, which led to wrong vaccine administered. Medical Assistant asked what should they do, should they revaccinate.  Medical Assistant specified that patient had never received a Meningococcal vaccine previously.  Patient demographics and vaccine detail requested and registered in the corresponding sections above.  No further information was provided by the healthcare provider in this call. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Underdose; Inappropriate dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 19-year-old female patient who received HAV (Havrix pediatric) (batch number 7PK53, expiry date 04-MAR-2026) for prophylaxis.   On 14-AUG-2024, the patient received Havrix pediatric. On 14-AUG-2024, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: Inappropriate dose.). The outcome of the underdose was unknown and the outcome of the adult use of a child product was not reported.   Additional Information: GSK receipt date: 14-AUG-2024 A health department worker started a web chat to inform that they had a staff member administer a peidatiric dose of Hep A to a 19 year old, which led to underdose and adult use of child product. The reporter asked could administer another pediatric dose to count it as an adult dose on the same clnic day. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered a dose of Menveo that had been reconstituted with sterile diluent instead of the liquid conjugate portion of the vaccine.; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered a dose of Menveo that had been reconstituted with sterile diluent instead of the liquid conjugate portion of the vaccine.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   Additional Information: GSK receipt date: 14-AUG-2024 Clinic manager reported someone administered a dose of Menveo that had been reconstituted with sterile diluent instead of the liquid conjugate portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered Consented to follow up.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: just the diluent was given to a patient and not the vaccine portion; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 1-year-old female patient who received MMR (Priorix) (batch number X3M3D, expiry date 01-APR-2025) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: just the diluent was given to a patient and not the vaccine portion) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-AUG-2024 The reporter called to report that the diluent was given to a patient and not the vaccine portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered Consented to follow up. The case is 1 of the 5 linked case, by same reporter.; Sender's Comments:  US-GSK-US2024101918:Same reporter, different patient US-GSK-US2024101909:Same reporter, different patient US-GSK-US2024101907:Same reporter, different patient US-GSK-US2024101892:Same reporter, different patient
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix + subcutaneous route; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number J327J, expiry date 19-JUN-2026) for prophylaxis.   On 14-AUG-2024, the patient received Shingrix (subcutaneous). On 14-AUG-2024, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Shingrix + subcutaneous route). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 15-AUG-2024 The pharmacist called to report a dose of Shingrix was administered subcutaneously, which led to incorrect route of vaccine administration. Consented to follow up.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Fatigue, Gastrointestinal disorder, Pain in extremity
Clinical narrative: Fatigue, sore arm, increased GI symptoms after vaccination
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Contusion, Fall, Loss of consciousness, Tooth fracture
Clinical narrative: After recieving the vaccinations the patient walked out of the clinic room with mom. Mom and patient went to front desk to get a school note. The patient sat in chair in waiting area and said that he needed a cup of water and stood up and walked out of clinic with mom. After the patient and mom walked out of clinic a clerk came into the clinic room and said that the patient had passed out and fell down in the hall outside the clinic. Patient was lying in hall passed out. Ammonia inhalant used to arouse patient. Legs elevated and head stabilized. Patient awake, alert, and oriented. Front teeth chipped and bruise to left cheek. Mom requested EMS be called and child was taken to hospital. Vitals below. Vitals taken at 11:20 am B/P 98/48, HR 50. Vitals at 11:25 am B/P 122/92, HR 63. Vitals taken at 11:30 am B/P 112/70, HR 60.
Age: 14.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: No adverse event occurred. Patient received a 3rd HPV dose, and only needed 2 doses due to age. Based on charting, it appears that the patient did not have an updated vaccine record with the HPV vaccines listed at the time of visit. RN charted this was the 1st HPV dose, and the 2nd HPV was due in 6 months.
Age: 39.0
Sex: M
Vaccine: MNQ, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: As reported by the patient, the injection site became red swollen and painful. The pain and swelling comes and goes. The duration approximately is 2 weeks.
Age: 5.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given incorrect vaccines for age.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Wrong patient received product
Clinical narrative: Prevnar was given to wrong patient.  Provider instructed CMA to give the vaccine to the patient in a specific exam room and provider gave wrong room number.  No adverse outcome.  Pt made aware as soon as discovered before she left the office that day.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administration error
Clinical narrative: Vaccine was given in error. Not needed at the time. No adverse reaction at the time. Patient tolerated well.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient developed a severely pruritic maculopapular rash on her right groin a few days after receiving her 1st dose of Shingrix.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Costochondritis, Echocardiogram, Electrocardiogram, Hypertensive emergency, Pain in extremity
Clinical narrative: Pt started with arm pain 8/14/24. Admitted to hospital 8/20/24 - costochondritis, pericarditis, hypertensive emergency. Discharged 8/22/24.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pericarditis, Troponin
Clinical narrative: Pt started with arm pain 8/14/24. Admitted to hospital 8/20/24 - costochondritis, pericarditis, hypertensive emergency. Discharged 8/22/24.
Age: 8.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMRV
Symptoms: Dyskinesia
Clinical narrative: Mom denies that the child has fevers or body aches but states she has noticed she has involuntary head movements.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Induration
Clinical narrative: Mother calls facility on day 3 following vaccination to report that patient's arm is red, hard and an approximate area of 7 x7 cm.  Denies area is warm.  Patient is afebrile and reports no change in patient's status.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Headache, Malaise, Nausea, Syncope
Clinical narrative: Patient came in office for his 16 year WCC with mom.  During the visit I had informed mom, patient is due for two vaccines; mom verbally agreed with vaccines. Vaccines he needed at visit were MenQuadfi and Bexsero.  Before administering vaccines, I explained to both patient and mom about possible side effects to the vaccines. Informed mom we recommend for patient to wait in office for 15 minutes for observation after vaccines are given just to be safe.   After administration of vaccines, patient and mom walked to the lobby. They did not wait 15 minutes in the room as recommended. Practice Service Rep informed me patient had collapsed in the lobby area and hit the back of his head on the ground. When I arrived at the scene, patient was lying flat on the ground. I had patient stay still and I elevated his legs higher than his heart for circulation. The doctor assisted.  While I was elevating patient's legs, me and doctor started to ask patient questions as soon as he started to feel better. He was able to answer the questions without difficulty or any slurring.  Patient does not remember how he ended on the ground. Patient stated, "I felt dizzy and lightheaded." When patient felt completely better doctor assisted me by lifting up patient slowly. Patient was able to stand and walk without difficulty. Assessed the back of his head. No noted bleeding, wound, bruising, redness or swelling. I had patient return to the room and had him lay down on the bed. Encouraged water; handed patient two cups of water. I recommended for patient to wait 15 minutes in room. I re-assessed patient 10 minutes later in room. Mom was present the entire time. Patient stated, "he felt himself again". I explained to mom to monitor for worsening symptoms after visit; concussion precautions given. To call our office and speak to Triage nurse if needed. An hour later mom called the office and asked to speak to the nurse. I spoke to Mom. Per mom patient was not feeling well. Patient developed a headache and nausea. Mom states, "patient needs to throw up." Recommended mom to take patient to ED now for further evaluation; possible concussion related to injury in office. Mom agreed with plan.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Contusion, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: He got his vaccine, he had left shoulder pain and swelling that has not resolved for 2 weeks.  Numbness on the anterior aspect of his left shoulder, and inability to raise his arm above shoulder level with continued pain and swelling about 3 cm x 3 cm in that area.  Bruising down his left arm that has now resolved.  He has applied ice and has taken Tylenol and Ibuprofen and has rested, still with the same amount of issues.  He called the nurse advice line through insurance and is a physician himself, so there is not much to offer him to try things.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: He got his vaccine, he had left shoulder pain and swelling that has not resolved for 2 weeks.  Numbness on the anterior aspect of his left shoulder, and inability to raise his arm above shoulder level with continued pain and swelling about 3 cm x 3 cm in that area.  Bruising down his left arm that has now resolved.  He has applied ice and has taken Tylenol and Ibuprofen and has rested, still with the same amount of issues.  He called the nurse advice line through insurance and is a physician himself, so there is not much to offer him to try things.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Fear, Heart rate increased, Injection site erythema
Clinical narrative: Rapid heart rate, chest pain, red swelling at injection site, caused severe anxiety onset of worry and fear because of reaction. Affected my mental health ever since receiving vaccine
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Mental disorder
Clinical narrative: Rapid heart rate, chest pain, red swelling at injection site, caused severe anxiety onset of worry and fear because of reaction. Affected my mental health ever since receiving vaccine
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Lightheaded followed by syncopal episode
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Palpitations
Clinical narrative: HEART PALPITATIONS
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: Mother reported today 8/26/24 that on 6/3/24 patient became pale and arms stiff immediately after vaccines were given. Stiffness lasted about 5 minutes per mother. Mother did not report concern when it occurred to clinic.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Pain, Pain in extremity
Clinical narrative: Pt came into the public health office for her scheduled 2nd dose of Shingrix. Pt told this nurse that her arm has been hurting ever since her first dose two months ago. Pt stated that since the first vaccine, she has had a hard lump. The hard lump is not visually recognizable, but this RN was able to palpate it. Hard lump approximately 1.5" in diameter, no redness or inflammation noted by this RN. The hard lump is about an 1.5-2" lower than the middle of the deltoid muscle. Pt states that it hurts to lift up her arm, that it is sore all the time.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Death
Clinical narrative: Patient expired on 8/25/2024.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Wrong technique in product usage process
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: ER personnel told patient that vaccine was injected into blood vessel due to "poor technique"., Other Vaccines:  VaccineTypeBrand: Fluzone High-Dose; Manufacturer: Sanofi-Pasteur; LotNumber: U8429BA; Route: Intramuscular; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Chief complaint: severe pain in shoulder, gotten worse with time. Instructed her to visit Dr immediately.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient states her arm is numb and she is unable to move it
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Headache-Mild, Additional Details: MIld redness and swelling lasting a few days at the injection site. mild transient headache consistent with vaccination, Other Vaccines:  VaccineTypeBrand: Flucelvax trivalent; Manufacturer: Seqiris; LotNumber: 946583; Route: Intramuscular; BodySite: Right Arm; Dose: ; VaxDate: UNKNOWN
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Numbness and tingling feeling radiating down left hand roughly 15 minutes after vaccination
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: BURNING REDNESS AND SWELLING AT THE INJECTION SITE. RADIATING PAIN TOWARD NECK
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Autoscopy, Confusional state, Delirium
Clinical narrative: Systemic: Confusion-Severe, Systemic: Delirium-Severe, Additional Details: Patient states she had out-of-body experience. No awareness of self, time, need to eat or drink.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Lethargy, Paralysis
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient called pharmacy from hospital inquiring about previous vaccine dates after being admitted with paralysis-like symptoms.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Additional Details: Patient developed redness under the injection site. , Other Vaccines:  VaccineTypeBrand: boostrix tdap; Manufacturer: ; LotNumber: x357e; Route: IM; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 21.0
Sex: F
Vaccine: DTAP
Symptoms: Anxiety, Blood test, Bradycardia, Chest pain, Echocardiogram
Clinical narrative: Extreme Chest pain, Bradycardia, induced severe anxiety, disruption in ability to sleep, pain.
Age: 21.0
Sex: F
Vaccine: DTAP
Symptoms: Electrocardiogram, Insomnia, Pain
Clinical narrative: Extreme Chest pain, Bradycardia, induced severe anxiety, disruption in ability to sleep, pain.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Flushing, Injection site swelling, Tenderness
Clinical narrative: Patient had increased pain and swelling over the Shringrix vaccine site. Had mild shortness of breath and flushing. Benadryl and cold packs given. Swelling did decrease slightly although still tender. Patient monitored for over an hour and no changes noted. Was discharged home. This was patient's first Shringrix vaccination. No prior allergies to meds or vaccines on file.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: He developed a large, red, and hot area greater than 6 inches in diameter around the injection site on his left leg. This reaction began shortly after receiving the booster shots and has progressively worsened.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Burning sensation, Tenderness
Clinical narrative: Constant burning sensation specially on the joint areas, burning sensation on the back area. No rash, just feeling of burning. Sensitivity to the touch, clothes, etc. Weakness.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Dyspnoea, Lip swelling, Urticaria
Clinical narrative: 20 minutes after receiving vaccines developed hives ,swollen lips and difficulty breathing ,went to ER and received Epi , Decadron , pepcid and Benadryl followed up with PCP on 8/26/24.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: C-reactive protein increased, Irritability, Joint swelling, Laboratory test normal, Pain in extremity
Clinical narrative: Child was very irritable and complained almost immediately of leg pain after vaccination.  She felt a bit warm but temperature was never taken.  Ibuprofen was given that evening due to irritability and leg pain just before nighttime sleep and also first thing the next morning due to complaints about her legs.  At about 9:30am I thoroughly examined her legs due to her complaints after ibuprofen and noticed her right knee was significantly swollen.  Another dose of ibuprofen was given around 1pm and we had a pediatrician appointment to take a look.  Pediatrician confirmed abnormal right knee swelling and ordered x-rays and bloodwork due to child's brother having Juvenile Arthritis.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Skin warm, X-ray limb normal
Clinical narrative: Child was very irritable and complained almost immediately of leg pain after vaccination.  She felt a bit warm but temperature was never taken.  Ibuprofen was given that evening due to irritability and leg pain just before nighttime sleep and also first thing the next morning due to complaints about her legs.  At about 9:30am I thoroughly examined her legs due to her complaints after ibuprofen and noticed her right knee was significantly swollen.  Another dose of ibuprofen was given around 1pm and we had a pediatrician appointment to take a look.  Pediatrician confirmed abnormal right knee swelling and ordered x-rays and bloodwork due to child's brother having Juvenile Arthritis.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client is 19 years old. She was given a dose of the adult (20 years and older) version of Engerix B.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Injection site pain, Pyrexia, Somnolence
Clinical narrative: Gave the combo vaccine DTAP/IPV and also gave the single vaccine IPV.  Spoke with the mother and she had a slight temperature, was more sleepy the next day and had soreness at the injection sites.  No other reactions were noted.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: The morning after receiving the vaccines the patient woke up with swollen hands and feet with hives scattered on extremities. By that evening the hives had mostly resolved.
Age: 11.0
Sex: F
Vaccine: DTAPIPV, HPV9, MNQ
Symptoms: Extra dose administered
Clinical narrative: Called the Health Department. They stated patient will be fine and that she just has received an extra dose of polio. Patient and parent were both informed.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Peripheral swelling, Rash
Clinical narrative: 8 hours post vaccination the 15 mo old patient developed a full body rash. The following morning she had swelling of both feet. Pt was assessed by urgent care the day of rash and OV with this NP the following morning.  Started on Benadryl 1mg/kg every 6 hours until symptoms resolved.  Per parents, pt symptoms are resolving well with Benadryl, as of 4 days later the rash is barely visible.
Age: 14.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. came back on 08/19/2024, 5 days after vaccine administration, with complaints of headache, loss of appetite, hot patchy redness on right upper arm, and small bulge 3 inches below deltoid towards the side. Right upper arm was warm to touch. Mother stated that symptoms started on 08/18/2024. Mother verbalized that pt. has tolerated vaccines in the past with no issues. Mother stated not giving any medications or intervention to pt.  Assessed pt. LOC x4. Denies any respiratory distress. Advised pt. to go to ER or urgent care for evaluation. Pt. left the clinic in a stable condition.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given a 2nd dose of Beyfortus 100mg/ml Lot # 2022831 given in Right thigh; his 1st dose was on 1/4/24. No know adverse reactions noted.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms or complications at this time.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient had redness and soreness on his arm that was spread down his arm from the shot site. The injection site was clear, but he had redness over his right bicep.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Vaccination error, Wrong product administered
Clinical narrative: At the School Vaccine clinic, patient was given Tdap instead of Dtap. Informed nurse about the incident and asked for advice if it has to be repeated. Nurse advised that it is counted towards the child's series and does not need to be repeated. Parent and School nurse will be informed of the error. No other side effect noted.
Age: 12.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave a pediarix to a 12 year old. This is outside the license age.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Muscle swelling, Myalgia, Skin warm
Clinical narrative: swollen arm muscle, warm to the touch, painful, redness which spread all the way around circumference of arm
Age: 12.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Decreased appetite, No adverse event, Wrong product administered
Clinical narrative: QUADRACEL WAS GIVEN INSTEAD OF TDAP.  NO SIDE EFFECTS REPORTED
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patients arm was red, swollen, warm to touch. Doctor told him to go home and put ice on it.
Age: 4.0
Sex: M
Vaccine: PNC20, VARCEL
Symptoms: Rash macular
Clinical narrative: Patient developed a fine macular rash. No vesicles per parent report. No fever.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: Severe headache immediately after vaccine administration
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: "extremely sore arms" per patient
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: Headache, extreme immediately after immunization given.
Age: 75.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Nausea, Pain in extremity, Vomiting
Clinical narrative: nausea with vomiting, chills, sore arm
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient states the injection site is sore and tender to the touch
Age: 0.5
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Product dispensing error
Clinical narrative: This nurse evaluated client Shots record, wrote down vaccinations to give to client. Client is currently 6 months and 1 day in age. This nurse dispensed Havrix in error to client, client should not have received Havrix vaccine until 12 months of age.  This nurse informed parents of error and apologized. Client vitals signs obtained and put in to chart. Contacted Dr. concerning this nurse error. Dr. advised this nurse to educate parents on ER precautions and s/s to monitor for. This nurse also instructed parents to contact the client's pediatrician to make them aware of the error as well.  Client monitored for 30 minutes following vaccination error. DON made aware of error.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Hordeolum, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient received vaccine on 18 Aug 2024. Reported symptoms onset 19 Aug 2024 with numbness and tingling of feet and hands, bilaterally and headache. Numbness and tingling subsided after 3 days. Patient reported sty on upper and lower eyelid developing on L eye 2 days after receiving vaccine with continued symptoms. Patient was treated at urgent care 26 Aug 2024 and given eye drops for medication treatment.
Age: 0.92
Sex: F
Vaccine: UNK
Symptoms: Product use issue
Clinical narrative: child was on a steroid (Dupixent) and received MMR and Varivax
Sex: F
Vaccine: HPV9
Symptoms: Heavy menstrual bleeding
Clinical narrative: side effects (mild and transient)/ Period was previously regular but has now had it for 18 days and has concerns that it might be vaccine-related; This spontaneous report was received from a Company Employee who referred to a personal friend, 35-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not provided.  On 10-APR-2024, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided), and on 24-MAY-2024, she received the second dose (no administration details).  On an unknown date in July 2024, the patient experienced possible mild side effects from the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (mild and transient); previously she had regular period, but now she had it for 18 days and had concerns that it might be vaccine-related. The patient sought medical attention. At the time of reporting, the patient had not recovered from the event (discrepancy, as also present status was reported as unknown).  The reporter considered the event to be possibly related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events were reported; PROQUAD was inadvertently administered to an 18 year old patient on 8/5/2024; This spontaneous report was received from a nurse referring to an 18-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 05-AUG-2024, product measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter, (lot #x023877, has been verified to be a valid lot number, expiration date reported as 07-MAR-2025, but upon internal validation established as 27-MAR-2025) was inadvertently administered to the 18-year-old patient (Product administered to patient of inappropriate age) for prophylaxis (strength, and route of administration were not provided). No adverse events were reported. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Age: 32.0
Sex: F
Vaccine: MEN, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No signs/symptoms of adverse events were reported; PROQUAD was inadvertently administered to 32 yo patient today. Patient needed an MMR II and a VARICELLA. No signs/symptoms of adverse events were reported. Limited information was provided. Permission to contact HCP was; This spontaneous report was received from a licensed practical nurse and refers to a 32-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-AUG-2024, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, valid lot #X018814, expiration date reported and confirmed as 07-JAN-2025, administered as prophylaxis in the left deltoid by a medical assistant (strength, dose, and route of administration were not provided), but she needed  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection and varicella virus vaccine live (oka/merck) (VARIVAX) injection as prophylaxis (strengths, lot numbers, expiry dates, and routes of administration were not provided). On the same day, the patient was vaccinated with meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), batch #: U8193AB, expiration date: 30-SEP-2027, administered in the right deltoid (strength, formulation, dose, route of administration, and indication were not provided). No signs/symptoms of adverse events were reported (no adverse event).  No further information available.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: No additional AE; a pediatric dose of VAQTA inadvertently administered to a 19 year old adult patient; This spontaneous report as received from a Licensed Practical Nurse referring to a 19-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 16-JUL-2024, the patient was inadvertently vaccinated with a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) 0.5 mL/second dose of the series, for prophylaxis (strength, route of administration, anatomical location, lot # and expiration date were not reported) (incorrect dose administered). No symptoms and no additional adverse event (AE) were reported.
Age: 1.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Product administered to patient of inappropriate age
Clinical narrative: Redness on his cheeks; 1-year-old was given the GARDASIL 9 vaccine.; This spontaneous report was received from the patient's mother via company representative and refers to a 1-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 20-AUG-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age) and the reporter wanted to know what side effects she should look out.   On that same day (20-AUG-2024), the patient experienced redness on his cheeks (erythema). No treatment was given for the event. At the time of reporting, the patient had not recovered from the event of erythema. No other side effects reported.  The causal relationship between the event of erythema and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reported patient administered VAXNEUVANCE after product experienced a T/E.  T/E filed: 02659842. No symptoms reported. This case also related to AE cases: 02659845, 02659886, 02659889 and 02659891.  Consent to correspond was granted. No additiona; No adverse event; This spontaneous report was received from medical assistant and refers to patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with expired dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #X022475, expiration date: 23-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse event was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Pyrexia
Clinical narrative: shivering; 101.5 temp,; This non-serious case was reported by a consumer and described the occurrence of shivering in a 83-year-old male patient who received Herpes zoster (Shingles vaccine) (batch number 4835H) for prophylaxis.   Concomitant products included rosuvastatin.   On 15-AUG-2024, the patient received Shingles vaccine .5 ml. On 16-AUG-2024, 1 days after receiving Shingles vaccine, the patient experienced shivering (Verbatim: shivering) and fever (Verbatim: 101.5 temp,). The outcome of the shivering and fever were not resolved.   It was unknown if the reporter considered the shivering and fever to be related to Shingles vaccine.     It was unknown if the company considered the shivering and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-AUG-2024 The patient experienced 101.5 temperature and shivering. On 16-AUG-2024, the patient was woken up at 2:40 am with feeling very hot and shivering. The patient needs to know if should take ibuprofen or Tynenol? The symptoms were not treated.
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: Kinrix (DTaP/IPV) vaccine was maladministered as her 4th dose of DTaP and her 3rd dose of IPV.; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate schedule of vaccine administered in a 2-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Previously administered products included tetanus vaccine (received on November 2023) and polio vaccine (received on September 2023).   On 30-JUL-2024, the patient received Kinrix (unknown arm). On 30-JUL-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrix (DTaP/IPV) vaccine was maladministered as her 4th dose of DTaP and her 3rd dose of IPV.). The outcome of the inappropriate schedule of vaccine administered was unknown.   Additional Information: GSK Receipt date: 16-AUG-2024 A reporter reported that adverse drug reaction was a maladministration of Kinrix to a 2-year-old patient (patient was not up to date on vaccines and not consistent with appointments made for catch up of vaccines).  Kinrix (DTaP/IPV) vaccine was maladministered as her 4th dose of DTaP and her 3rd dose of IPV which led to Inappropriate schedule of vaccine administered. Last previous tetanus vaccine received was in November 2023 and last polio vaccine received was in September 2023.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: administration of an adult dose of Engerix-B to an 18-year-old patient.; overdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 18-year-old patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced adult product administered to child (Verbatim: administration of an adult dose of Engerix-B to an 18-year-old patient.) and overdose (Verbatim: overdose). The outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-AUG-2024 A nurse manager called to inform about the administration of an adult dose of Engerix-B to an 18-year-old patient, which led adult product administered to child and overdose. According to the reporter, this was a booster dose for the patient.
Age: 0.17
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A nurse accidently gave a T-dap (Boostrix) instead of a D-tap (Infanrix) to a 2 months old; A nurse accidently gave a T-dap (Boostrix) instead of a D-tap (Infanrix) to a 2 months old; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: A nurse accidently gave a T-dap (Boostrix) instead of a D-tap (Infanrix) to a 2 months old) and inappropriate age at vaccine administration (Verbatim: A nurse accidently gave a T-dap (Boostrix) instead of a D-tap (Infanrix) to a 2 months old). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-AUG-2024 The physician reported that a nurse accidently gave a T-dap (Boostrix) instead of a D-tap (Infanrix) to a patient of an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter was wondering and asked do they need to get an extra vaccine or do they just continue as normal as they would. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: female patient received an EXTRA DOSE of AREXVY; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number t5232, expiry date 18-AUG-2025) for prophylaxis.   Previously administered products included Arexvy (received arexvy on 22 Feb 2024).   On 15-AUG-2024, the patient received Arexvy. On 15-AUG-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: female patient received an EXTRA DOSE of AREXVY). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date 15 August 2024: HCP  was the reporter. The patient received an extra dose of Arexvy.   The extra dose was administered on 15-AUG-2024. The reporter consented to follow up. This case has been linked with case US2024101929 reported by same reporter.; Sender's Comments:  US-GSK-US2024101929:Same reporter
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient were accidentally administered with pediatric doses of Engerix-B/wrong dose; adult patient were accidentally administered with pediatric doses of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a male patient who received HBV (Engerix B pediatric) (batch number 29RN7, expiry date 25-FEB-2024) and (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   On 15-DEC-2023, the patient received the 3rd dose of Engerix B pediatric. On 15-DEC-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient were accidentally administered with pediatric doses of Engerix-B/wrong dose) and adult use of a child product (Verbatim: adult patient were accidentally administered with pediatric doses of Engerix-B). The outcome of the underdose was unknown and the outcome of the adult use of a child product was not reported.   Additional Information: GSK Receipt date: 15-AUG-2024 An HCP reported that a patient are accidentally administered with pediatric doses of Engerix-B which led to Underdose and Adult use of child product. This is 1 of 3 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR105807:Different patient US-GSK-US2024AMR105818:Different patient