chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Maladministration of pediatric dose on adult patient; Adult use of child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient) and adult use of a child product (Verbatim: Adult use of child product). The outcome of the accidental underdose and adult use of a child product were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050566:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050558:same reporter/different patient US-GSK-US2025050556:same reporter/different patient
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Maladministration of pediatric dose on adult patient) and accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2025050551:same reporter/different patient US-GSK-US2025050553:same reporter/different patient US-GSK-US2025050556:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050558:same reporter/different patient US-GSK-US2025050559:same reporter/different patient US-GSK-US2025050561:same reporter/different patient US-GSK-US2025050563:same reporter/different patient US-GSK-US2025050566:same reporter/different patient
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Maladministration of pediatric dose on adult patient) and accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050559:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050553:same reporter/different patient US-GSK-US2025050551:same reporter/different patient US-GSK-US2025050556:same reporter/different patient US-GSK-US2025050561:same reporter/different patient US-GSK-US2025050563:same reporter/different patient US-GSK-US2025050566:same reporter/different patient
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Maladministration of pediatric dose on adult patient) and accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050559:same reporter/different patient
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Maladministration of pediatric dose on adult patient; Adult use of a child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the accidental underdose and adult use of a child product were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050558:same reporter/different patient US-GSK-US2025050566:same reporter/different patient US-GSK-US2025050556:same reporter/different patient
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Borrelia test negative, Facial paralysis, Herpes simplex test negative, Magnetic resonance imaging head normal
Clinical narrative: February 12, 2022 R sided facial droop and sensation changes, forehead muscle paralysis, presented to this same facility's ER , diagnosed with Bell's Palsy and sent with antiviral, steroids, about 1 month out had near resolution of facial droop.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Sore throat and coughing to the point have to leave the room when talking to people starting the next day after the shot. She was healthy and not sick before the shot. She wen tot he urgent care and they said to not take cough syrup but to go to pharmacy to ask what hey recommend. Sore throat has gone away.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given vaccine dose that had exceeded its BUD
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given vaccine dose that had exceeded its BUD
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Skin discolouration
Clinical narrative: Patient's husband reported larg red marks that appeared on patient's thighs 3-4 days after the vaccine. No fever, no pain, only minor itching.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Rash, Skin lesion, Vomiting
Clinical narrative: MOM REPORTED SHE BROKE OUT IN A RASH ON 4/11/25.  SHE WAS SEEN IN OFFICE ON 04/22/2025, RASH HAD RESOLVED BUT SHE HAD SWOLLEN LYPM NODE IN NECK AND HAD VOMITED ONCE.  DEVELOPED A HIGH FEVER, 104 F, DAY 12 AFTER MMR THEN ON DAY 13 BROKE OUT IN RASH THAT STARTED AT HARILINE, SPREAD DOWN FACE AND ONTO TRUNK WITH SORES INSIDE OF MOUTH . THEY WERE SORE CIRCULAR LESIONS INSIDE HER CHEEK WITH A SLIGHT WHITE TINGE. AT TIME OF APPOINTMENT WITH DOCTOR THEY WERE ALREADY RESOLVING.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Patient received MCV4 & TDap. Patient stared at the wall, became pale, then fainted while sitting in chair. Patient leaned towards nurse on right side. Noted skin warm and clammy. Patient awoke in approximately 30 seconds, he stated he could not see or hear, then stated he hears weird noises. Laid patient on a mat on his left side after complaints of dizziness. Asked nurse to assist with next patient and obtained an ice pack from Nurse. This nurse obtained VS, placed cool towel on back of neck, ice pack on forehead, later provided water. Patient returned to baseline at 1604, he denied dizziness and stated he felt like his normal self. Color normal for ethnicuty, gait steady. Mom stated this has never happened before but has been complaining of dizziness and light-headedness for a few weeks. Provided resource list of clinics and encouraged to follow up with PCP. Vital signs % 1553: 108/60, HR-51, 94% RA, RR-18. 1556: HR-62, 98% RA. 1604: 110162, HR-67, 97%-RA, RR-18.
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Maladministration of pediatric dose on adult patient; Adult use of a child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the accidental underdose and adult use of a child product were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050566:same reporter/different patient US-GSK-US2025050556:same reporter/different patient US-GSK-US2025050558:same reporter/different patient
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: PT SAID SHE STARTED TO EXPERIENCE REDNESS, ITCHING,  SWELLING AND PAIN RADIATING DOWN THE ARM AND  IS GETTING WORSE. SHE HAS BEEN APPLYING COLD PACKS FOR 15 MINUTES A T A TIME, BUT THIS IS NOT HELPING.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired upon administration. Exp date 04/19/2025
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased
Clinical narrative: Patient is unable to raise their arm over 90 degrees
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine past its beyond use date. Patient reports no symptoms or issues. Patient at this moment has chosen not to re-vaccinate.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: patient passed out for less than 30 seconds
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Maladministration of pediatric dose on adult patient; Adult use of a child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the accidental underdose and adult use of a child product were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050566:same reporter/different patient US-GSK-US2025050556:same reporter/different patient US-GSK-US2025050558:same reporter/different patient
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dyspnoea, Headache, Neck pain, Pain in extremity
Clinical narrative: Patient provided information: Difficulty breathing, back pain, arm pain, head ache, neck pain. As of writing this the patient is at the ED.
Age: 19.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose was given 1 month too soon.  Due 5/25/25
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Cardiac assistance device user, Cardioversion, Implantable defibrillator insertion, Laboratory test normal
Clinical narrative: I am writing to report a serious cardiac event that occurred in August 2024. At that time, my heart stopped, and I required defibrillation via an automated external defibrillator (AED). I regained consciousness en route to the hospital. Subsequent extensive testing has not identified a cause for this event, and I have since had an internal defibrillator implanted.  I received the Moderna COVID-19 vaccine prior to this event and am concerned about a potential correlation between the vaccination and my cardiac arrest, particularly given discussions regarding potential cardiac issues in men my age following mRNA vaccines.  I urge the FDA to investigate potential links between COVID-19 vaccines and unexplained cardiac events. I am available to provide further details about my experience if needed.  Thank you for your time and attention to this important matter.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: I am writing to report a serious cardiac event that occurred in August 2024. At that time, my heart stopped, and I required defibrillation via an automated external defibrillator (AED). I regained consciousness en route to the hospital. Subsequent extensive testing has not identified a cause for this event, and I have since had an internal defibrillator implanted.  I received the Moderna COVID-19 vaccine prior to this event and am concerned about a potential correlation between the vaccination and my cardiac arrest, particularly given discussions regarding potential cardiac issues in men my age following mRNA vaccines.  I urge the FDA to investigate potential links between COVID-19 vaccines and unexplained cardiac events. I am available to provide further details about my experience if needed.  Thank you for your time and attention to this important matter.
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: swollen, redness, painful injection site and fever  a day after the administration.  patient reported possible cellulitis and treatment at urgent care with an injection of steroid or antibiotic.   Patient is not sure if patient recieved antibiotic or steroid injection at urgent care but it help reduce injection site reaction.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given 3 days beyond expiration date. No adverse reactions reports.
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: Palpitations, Peripheral swelling, Rash, Vision blurred
Clinical narrative: 5 days after vaccine, pt had heart palpitations and blurred vision. The next day she had swelling and rash in the arm. @ days after that it was gone.
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Face injury, Fall, Laboratory test normal, Loss of consciousness
Clinical narrative: As the patient was receiving his oversea shots at 8:57 am he passed out and fell face flat into the ground in front of him from the sitting position. We proceeded to sternum rub him and pick him up to lay him down on the gurney. where he woke up after being out for 3 seconds at 8:58 am, He was seen by a provider and cleared of any TBI.
Age: 0.75
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Hives on face, arm, leg and buttocks within 5 minutes of receiving vaccine. Benadryl 3/4 tsp, decadron 4mg administered orally in office and topical steroid applied. Patient observed for 40 minutes in the office and cleared to leave by Dr.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Genital herpes, Headache, Herpes simplex
Clinical narrative: Chronic low grade to moderate fatigue. A increase in headaches and now having migraines. Muscle soreness. An increase in herpes outbreaks (3+ times a year now) as well as the herpes sores presenting in a different location both on my lip and genital region. A possibility that I have heavier bleeding during my menstrual cycle since the immunization, however I  am not positive that is resulting from the shot.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Oral herpes, SARS-CoV-2 antibody test positive
Clinical narrative: Chronic low grade to moderate fatigue. A increase in headaches and now having migraines. Muscle soreness. An increase in herpes outbreaks (3+ times a year now) as well as the herpes sores presenting in a different location both on my lip and genital region. A possibility that I have heavier bleeding during my menstrual cycle since the immunization, however I  am not positive that is resulting from the shot.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient's wife called on 4/30/25 to report patient's reaction to his Shingrix shot given on 4/28/25. He has ~2 inch diameter red, raised, hard area where the vaccine was injected (right deltoid). No difficulties breathing, no rash/hives.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Vision blurred
Clinical narrative: The patient has experienced loss of vision in their right eye.  She describes it as white, fuzzy, or lines through it.  She's seen an eye doctor who says it isn't retinal, but they are going to explore more concerns.  With post market reporting for the vaccine showing optical adverse events, I thought there's a chance this could be related to the Comirnaty injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: chills   headache  muscular pain and fatigue. no energy and pain at the injection site, some nausea
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: chills   headache  muscular pain and fatigue. no energy and pain at the injection site, some nausea
Age: 11.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine given 14 days too soon.  No adverse reaction.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Asthma, Condition aggravated
Clinical narrative: Child developed an asthma exacerbation the day after the vaccine administration and was seen in the ER, prescribed albuterol. Parent reports a history of asthma flare ups after vaccine administration when she was an infant as well.
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Maladministration of pediatric dose on adult patient) and accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050557:same reporter/different patient US-GSK-US2025050563:same reporter/different patient US-GSK-US2025050561:same reporter/different patient US-GSK-US2025050559:same reporter/different patient US-GSK-US2025050556:same reporter/different patient US-GSK-US2025050553:same reporter/different patient US-GSK-US2025050551:same reporter/different patient US-GSK-US2025050558:same reporter/different patient
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Given too soon
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Diarrhoea, Injection site inflammation, Injection site rash, Pyrexia
Clinical narrative: Patient developed a rash after the injection below site. Rash was described as very red and inflamed. Patient also experienced chills, fever, and diarrhea.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Rash erythematous
Clinical narrative: Patient developed a rash after the injection below site. Rash was described as very red and inflamed. Patient also experienced chills, fever, and diarrhea.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Brain fog, Chronic obstructive pulmonary disease, Computerised tomogram abnormal, Computerised tomogram head
Clinical narrative: Skin issue, difficulty breathing, joint pain, generalized edema, fatigue brain fog, sinusitis, wheezing, COPD, Insulin dependent diabetes
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Generalised oedema, Paranasal sinus polypectomy, Sinuplasty
Clinical narrative: Skin issue, difficulty breathing, joint pain, generalized edema, fatigue brain fog, sinusitis, wheezing, COPD, Insulin dependent diabetes
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus polyp, Sinusitis, Skin disorder, Type 1 diabetes mellitus, Wheezing
Clinical narrative: Skin issue, difficulty breathing, joint pain, generalized edema, fatigue brain fog, sinusitis, wheezing, COPD, Insulin dependent diabetes
Age: 0.58
Sex: M
Vaccine: RV1, RV1
Symptoms: Extra dose administered
Clinical narrative: patient was given a third dose of rotovirus in error
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Cellulitis, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Patient developed vomiting and increased temp, was transferred to hospital r/t acute change in condition and tested positive for covid at the hospital
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Patient developed vomiting and increased temp, was transferred to hospital r/t acute change in condition and tested positive for covid at the hospital
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Chronic Fatigue; Lack of energy; Dizziness. No treatments given or recommended.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Computerised tomogram, Deafness unilateral
Clinical narrative: Loss of hearing left ear
Age: 66.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Injected limb mobility decreased, Injection site nerve damage, Muscular weakness
Clinical narrative: Patient states that when vaccine was administered the needle "hit a nerve" and consequently she has had issues with mobility and strength in her left arm.
Age: 65.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Evening of vaccination, her left arm became red and swollen from the shoulder through the wrist. The next day it was itchy as well. Came into clinic 4/30/2025 to show RN/MD. It has been improving since then, but there remains areas of raised, red, pruritic rash.  Areas include the left deltoid area, posterior to shoulder, anterior upper arm, and an area in the back right lateral to the spine and medial to the shoulder.  Reports no fevers and no other symptoms.  Feeling fine otherwise.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient was having fever the night after having the vaccines and it was gone by the time patient reports the adverse events. It was a localized red patch around the injection and then it get bigger and bigger but not just remained localized around the injection site. Patient also reports some pain. Recommended Bendery, hydrocortisone cream and if not getting better or the redness radiate to the rest of body or the other arm, recommend to ER to urgent care for some prednisone but not SOB reported.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atelectasis, Back pain, Chest X-ray normal, Chest discomfort, Computerised tomogram thorax abnormal
Clinical narrative: After my second injection my shortness of breath really increased, had to be put on home oxygen, I also developed tachycardia. I had made 3 trips to the ER Because I was so short of breath. At approximately 6/25/21 I had developed a 100 degree fever with pain in my lower back rt side. I also felt bubbling and rubbing in my lower lungs. It was so painful that I could only sleep on my side. I felt that something was really wrong. I messaged my Dr twice. All she did was order a plain Xray of my chest in her office, it was normal. She didn't do any more, I was disappointed and worried. By 11 pm 7/1/21 I was so sick, coughing alot too, I drove myself to the ER.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Cough, Dyspnoea, Malaise, Pulmonary embolism
Clinical narrative: After my second injection my shortness of breath really increased, had to be put on home oxygen, I also developed tachycardia. I had made 3 trips to the ER Because I was so short of breath. At approximately 6/25/21 I had developed a 100 degree fever with pain in my lower back rt side. I also felt bubbling and rubbing in my lower lungs. It was so painful that I could only sleep on my side. I felt that something was really wrong. I messaged my Dr twice. All she did was order a plain Xray of my chest in her office, it was normal. She didn't do any more, I was disappointed and worried. By 11 pm 7/1/21 I was so sick, coughing alot too, I drove myself to the ER.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast abnormal, Sleep disorder, Tachycardia
Clinical narrative: After my second injection my shortness of breath really increased, had to be put on home oxygen, I also developed tachycardia. I had made 3 trips to the ER Because I was so short of breath. At approximately 6/25/21 I had developed a 100 degree fever with pain in my lower back rt side. I also felt bubbling and rubbing in my lower lungs. It was so painful that I could only sleep on my side. I felt that something was really wrong. I messaged my Dr twice. All she did was order a plain Xray of my chest in her office, it was normal. She didn't do any more, I was disappointed and worried. By 11 pm 7/1/21 I was so sick, coughing alot too, I drove myself to the ER.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC20, RV1
Symptoms: Crying, Discomfort, Encephalitis, Pain
Clinical narrative: At roughly 3 hours after the shot, our child began showing signs of discomfort. The child began to intensely cry uncontrollable for 3+ hours. We were unable to calm her down due to encephalitis. We called our primary care provider, and they recommend Tylenol. This medicine knocked her out for about 6 hours until she woke up crying again. We had to administer additional tylenol to control the pain for the child.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Cyanosis, Staring, Vomiting projectile
Clinical narrative: Per patient's mother at 1955 patient was taking her famotidine and projectile vomited. Following that patient's lips and around mouth were a bluish/purple color. Patient then began to have bubbles come out of her mouth and had a "blank stare." Per mother reported that patient then was not tracking or responding for approximately 2 minutes following episode.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Arthralgia, Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: I pain in arms a little after 24 muscle joint area pain, and began to spread towards my elbow today and i went to open a door and i noticed it was painful which was my left which i got the Covid and flu shot in.  Yesterday i couldn't use the other arm so it changed sides. Today as well i am having issues with neck
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event. Vaccine administered was 3 days beyond the beyond use date.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Patient complains of severe pain in both arms, her right arm shows signs of injection site reaction with mild redness that was reportedly much more swollen, red, and hot a couple of days previous to today. She says that she is still experiencing fever at night. She was referred to her pcp for follow up.
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: seems that they may use the Shingrix diluent for the Priorix lyoph powder; vaccines where given without the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in specified number of patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: seems that they may use the Shingrix diluent for the Priorix lyoph powder) and inappropriate dose of vaccine administered (Verbatim: vaccines where given without the diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-APR-2025 Other HCP reported that they had 2 situation which the diluent was not use to diluent the injection. Reporter stated that they had in the inventory 2 Priorix diluents left alone, so that's why they assume the Priorix vaccines were given without the diluent. Also, indicated that they also had the Shingrix vaccine, so due to this, it seems that they may use the Shingrix diluent for the Priorix lyoph. powder, HCP did not confirmed this. Priorix reconstituted with diluent of Shingrix instead of the supplied liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Maladministration of Adult Dose on an Pediatric Patient; Adult Dose on an Pediatric Patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 17-year-old female patient who received HBV (Engerix B) (batch number T5P73, expiry date 10-APR-2027) for prophylaxis.   On 20-MAR-2025, the patient received Engerix B. On 20-MAR-2025, an unknown time after receiving Engerix B, the patient experienced adult product administered to child (Verbatim: Maladministration of Adult Dose on an Pediatric Patient) and overdose (Verbatim: Adult Dose on an Pediatric Patient). The outcome of the adult product administered to child and overdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-APR-2025 The pharmacist called to ask about guidance/safety concerns because a pediatric patient seventeen year old was administered with an adult dose, which led to adult product administered to child and overdose. The Vaccine Administration Facility is the same as Primary Reporter.
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Menveo - Only diluent administered; Menveo - Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) 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: Menveo - Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Menveo - Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 28-APR-2025 The pharmacist stated that they had found a vial of the A component of Menveo (2 vials) in their fridge.  As a result, they assumed that one of the five patients had only received the diluent portion of the vaccine, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The pharmacist mentioned that a physician had been considering re-vaccinating all five patients, but the pharmacist had been uncertain about this decision.  The pharmacist had inquired about how soon the dose could be repeated.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7349L, expiry date 25-MAR-2027) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in December 2021) and Shingrix (received second dose of Shingrix in February 2022).   On 28-APR-2025, the patient received the 3rd dose of Shingrix. On 28-APR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered.). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 28-APR-2025 The nurse reported that he/she just gave a patient a Shingrix vaccine, however it was her third one which led ot extra dose administered, the other one was given in December of 2021, the second (dose) was on February of 2022..
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered an expired COVID-19 Comirnaty vaccine; This is a spontaneous report received from an Other HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "administered an expired COVID-19 Comirnaty vaccine". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, C-reactive protein increased, Cardiac monitoring, Chest pain, Complement factor C3 increased
Clinical narrative: COMIRNATY 2024-25(12Y UP) SYRG PFIZER US PHARM LN0588 ,  FLUCELVAX TRIVAL 2024-2025 SYR  SEQIRUS, INC. Lot # 946621  48 hour onset of symptoms tachycardia, exercise intolerance, excessive fatigue, brain fog, insomnia, headache, nausea and dizziness.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram normal, Electrocardiogram abnormal, Exercise tolerance decreased, Fatigue
Clinical narrative: COMIRNATY 2024-25(12Y UP) SYRG PFIZER US PHARM LN0588 ,  FLUCELVAX TRIVAL 2024-2025 SYR  SEQIRUS, INC. Lot # 946621  48 hour onset of symptoms tachycardia, exercise intolerance, excessive fatigue, brain fog, insomnia, headache, nausea and dizziness.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nausea, Neurological symptom, Red blood cell sedimentation rate increased
Clinical narrative: COMIRNATY 2024-25(12Y UP) SYRG PFIZER US PHARM LN0588 ,  FLUCELVAX TRIVAL 2024-2025 SYR  SEQIRUS, INC. Lot # 946621  48 hour onset of symptoms tachycardia, exercise intolerance, excessive fatigue, brain fog, insomnia, headache, nausea and dizziness.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus tachycardia, Tachycardia
Clinical narrative: COMIRNATY 2024-25(12Y UP) SYRG PFIZER US PHARM LN0588 ,  FLUCELVAX TRIVAL 2024-2025 SYR  SEQIRUS, INC. Lot # 946621  48 hour onset of symptoms tachycardia, exercise intolerance, excessive fatigue, brain fog, insomnia, headache, nausea and dizziness.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash. That spread down the dermatome, Diagnosed by dermatology as singles. Given Acyclovir (parents believe). Rash is now resolved and did resolve after a few weeks.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Diarrhoea, Headache
Clinical narrative: PT HAD DIARRHEA AFTER 2 DAYS OF VACCINATION.  SHE ALSO HAD HEADACHE AND COUGHING.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Debilitatimg chronic fatigue, contnuing to worsen in 2025.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Debilitatimg chronic fatigue, contnuing to worsen in 2025.
Age: 25.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Migraine, Pain in extremity
Clinical narrative: Redness the size of my palm, very noticeable and  arm getting more sore days later. Migraine yesterday
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood test, Cognitive disorder, Magnetic resonance imaging
Clinical narrative: In July of 2024 I began having cognitive decline, with memory loss.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Basal cell carcinoma, Invasive ductal breast carcinoma
Clinical narrative: Breathing, basal cell carcinoma on my left cheek, and invasive ductal carcinoma, right breast cancer
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient reported full body rash within 24 hours of vaccine
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Cold sweat, Lethargy, Presyncope, Somnolence, Tinnitus
Clinical narrative: After vaccine was given, patient was alert and oriented. Patient stood up, walked out of vaccination room to lobby and sat down. Patient's mother came to get pharmacist to say patient almost fainted. Upon viewing patient, she exhibited signs of lethargy, cold clammy skin, continuous yawning, and difficulty keeping eyes open. Patient also stated she had constant ear ringing. Offered to call 911 and ambulance, but patient's mother declined and wanted to take patient to hospital herself. Helped patient walk to vehicle and watched as party left parking lot heading to hospital. Called for welfare check 2 days later but received no answer. Left voicemail for call back.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Yawning
Clinical narrative: After vaccine was given, patient was alert and oriented. Patient stood up, walked out of vaccination room to lobby and sat down. Patient's mother came to get pharmacist to say patient almost fainted. Upon viewing patient, she exhibited signs of lethargy, cold clammy skin, continuous yawning, and difficulty keeping eyes open. Patient also stated she had constant ear ringing. Offered to call 911 and ambulance, but patient's mother declined and wanted to take patient to hospital herself. Helped patient walk to vehicle and watched as party left parking lot heading to hospital. Called for welfare check 2 days later but received no answer. Left voicemail for call back.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported by patient.  This reporting is due to finding that patient had previously received Arexvy RSV vaccine at another facility approx. 1 year prior (08/15/2023)