chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pain, Pruritus, Pyrexia, Swollen tongue
Clinical narrative: 09/20/24: fever, body aches; 09/21/24: itchiness; 09/26/24: swollen tongue and diarrhea itchiness worsened
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Limb discomfort, Lymph node pain, Pruritus
Clinical narrative: Lymph node pain; Lymph node itching; Chest to arm tightness; Chest to arm tightness; This non-serious case was reported by a consumer and described the occurrence of lymph node pain in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number E3XT9) for prophylaxis.   On 10-SEP-2024, the patient received Shingrix. On 11-SEP-2024, 1 days after receiving Shingrix, the patient experienced lymph node pain (Verbatim: Lymph node pain), pruritus (Verbatim: Lymph node itching), chest tightness (Verbatim: Chest to arm tightness) and muscle tightness (Verbatim: Chest to arm tightness). The outcome of the lymph node pain, pruritus, chest tightness and muscle tightness were not resolved.   It was unknown if the reporter considered the lymph node pain, pruritus, chest tightness and muscle tightness to be related to Shingrix.     It was unknown if the company considered the lymph node pain, pruritus, chest tightness and muscle tightness to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2024 The patient self-reported this case for herself. The patient received Shingrix. The patient had lymph node pain, lymph node itching and chest to arm tightness The patient reported that the symptoms were not treated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Feeling abnormal, Nausea, Vomiting
Clinical narrative: This patient had severe nausea, vomiting, felt lousy and had labored breathing. She also felt very anxious.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered this vaccine twice 30 days apart (duplicate vaccine). Patient is showing no signs of adverse events and patient is feeling fine.
Age: 9.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain upper, Anaphylactic reaction, Discomfort, Dyspnoea
Clinical narrative: Patient was given Flu and Spikevax, parent signed both consent forms, did not mention any allergies on the consent form. Patient got anaphalactic reaction day after vaccine was given to him in the morning 9 am. Symptoms were reported to be stomch pain, discomfort and hard to breath. Parents rushed him to hospital for treatment. Now patient is in medical practioners  care and not fully recovered yet.
Age: 1.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix incorrectly administered to a patient under the age of 4
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Caretaker for patient came in to let us know that the patients arm was red, swollen and warm to the touch after the vaccinations. The went to a physican who prescribed an antibiotic  as precaution.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed a red, swollen and very hot arm just below the injection site (left deltoid) beginning 8 hours after injection to 7 days following injection.  Noted moderate arm pain at site with swelling, heat and redness more bothersome.  This was my 6th Moderna vaccine (I am a Urgent Care RN) and first time with this side effect/reaction.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED A PEDIATRIC DOSE NO ADVERSE OUTCOME
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient checked that she wanted Fluad for individuals over 65 years old instead of Flucelvax on the pharmacy consent form.  The vaccinator did not catch that she was only 63 years old until she billed the vaccine later that day.  Patient has not noticed any adverse events.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient requested Arexvy vaccine on 09/26/2024. Had already gotten 09/09/2023 and was unaware. Patient was later notified of such event and was calm and understanding about such.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue, Single component of a two-component product administered
Clinical narrative: only received the liquid adjuvant portion; only received the liquid adjuvant portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a female patient who received Herpes zoster (Shingrix) (batch number EY253, expiry date 16-JUL-2026) for prophylaxis.   On 16-SEP-2024, the patient received the 1st dose of Shingrix. On 16-SEP-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: only received the liquid adjuvant portion) and inappropriate preparation of medication (Verbatim: only received the liquid adjuvant portion). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 16-SEP-2024  The pharmacist reported that pharmacy held a vaccine clinic and she inadvertently administered Shingrix vaccine without reconstituting, so the patient only received the liquid adjuvant portion which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.  It was the first dose in series, and the patient was female.  At the time of reporting, the pharmacist did not had any further patient details aside from gender.  The Vaccine Administration Facility was the same as Primary Reporter. This case was linked with US2024114984, reported by same reporter.; Sender's Comments:  US-GSK-US2024114984:Same reporter/Different patient
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Pallor, Visual impairment
Clinical narrative: When nurse returned to room,  patient reported  feeling light headed, darker vision, and nauseous.  Patient did not appear to have any skin discoloration and denied breathing difficulties. Per mom and Patient,  symptoms started a couple minutes after vaccine administration and patient briefly became very pale. Patient refused to lay down and stating he was feeling better and that it was probably because he did not eat or drink anything prior to visit. Patient provided with snacks and water. VS @1013 BP 122/86, SPO2 97%, HR 93, RR 18. VS @ 10:28 BP 120/84, HR 76, SPO2 97%, RR 16. Mother refused EMS services. Child reported feeling well 1-2 minutes after onset of symptoms and denied any other signs or symptoms. Per mother and child, child was not anxious and child has never reacted like this before to medical procedures. Mother and Patient instructed that if Patient has any other symptoms to consult with their medical provider or call 911 if it's an emergency. Mother verbalized understanding and stated she will monitor child, that child has a dental appointment after this visit, and a Doctor's appointment on Saturday.
Age: 6.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Rash
Clinical narrative: The day after his vaccines were given, he developed a rash on his legs that quickly spread to include his trunk and arms. The rash initially looked nonspecific. The following day, it was more consistent in appearance with urticaria multiforme. The rash improved with a dose of Children's Claritin.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: THE ADULT RECEIVED A PEDIATRIC DOSE, WITH NO ADVERSE OUTCOME
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Patient reported to pharmacy 9/26 and said she had pain in left arm, went to see her doctor, and doctor told her she had bursitis possibly from the flu shot she received 8/25.  She was prescribed prednisone on 9/23 and said she was feeling better
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Red raised patchy rash to lower back
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PATIENT 10 YO RECIEVED COVID-19 VACCINE FOR 12YO AND OLDER. NO ADVERSE REACTION
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Inflammation, Injection site pain
Clinical narrative: Patient received HPV #2 on 8/29/24. On 9/7/24, the patient called the office with complaints of increasing arm pain at the injection site. Denied any other symptoms except for the pain. Stated pain had improved as of the morning of 9/7/24, took Tylenol but provider that spoke to her that morning, advised Ibuprofen to reduce inflammation. Recommended ice and heat alternating and to call back if no improvement within 24-48hrs.
Age: 7.0
Sex: M
Vaccine: RAB
Symptoms: Incorrect dose administered
Clinical narrative: patient received 6.25 units/2.5ml, not 2.5 units/ml.  Vaccine manufacturer was contacted and has no data on pediatric overdose.  Tele-toxicology was consulted and has no additional information for this situation.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV
Symptoms: Injection site nodule, Pain
Clinical narrative: Pt developed painful knots at immunizations sites.  Pain has persisted 3 weeks post-immunization.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: PATIENT WAS ADMINISTERED HIGH DOSE FLU SHOT AND ALSO THE RSV VACCINE IN THE RIGHT ARM.  HE HAD RECEIVED A SECONDARY DOSE OF THE RSV VACCINE.  ONE DOSE WAS ADMINISTERED 12/11/2023 AND 2ND DOSE 9/16/2024. HE CONTACTED PHARMACY 9/26/24.  ADVERSE EVENTS IS STILL ARM ACHE.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE REACTION
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I forgot to recieve 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10-OCT-2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I forgot to recieve 2nd dose). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 16-SEP-2024 The patient forgot to receive 2nd dose of Shingrix. The patient asked, did he/she need to get 2 more doses or one dose. The patient just need the generic answer and did not want to disclose too much about himself/herself. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE REACTION
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE REACTION
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: right vaccine given schedule discrepancy
Age: 80.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Balance disorder, Muscle disorder, Musculoskeletal disorder
Clinical narrative: Patient described loss of muscle use in legs, unsteady moving around which onset about 30 minutes post vaccine and last until 1am in the morning.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Clinic staff checked system, indicated 2nd Hep A shot needed, consistent with CDC guidelines checked by CRNP.  Did not know there was a 2nd vaccination record which indicated 2nd Hep A was already given, 2nd record not discovered until after shot given.
Age: 82.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Anal incontinence, Defaecation urgency, Faeces soft, Headache, Visual impairment
Clinical narrative: He got 2 vaccines, and could rarely feeling them, they did not sting or anything.  She then felt fine, and when he was being taken home, there was a lot of traffic and had medicine put in his eyes also and lights did not look right.  He was riding in the vehicle and had the sudden feeling that he needed to use the bathroom.  He got home, and felt that he could make it to the bathroom, and opened the door and could feel it coming out and most of it went on the floor, not diarrhea, but soft.  He had to clean it up and was a real big mess.  He is feeling fine now and does not have the urge to go at this point.  He has a mild headache.  He feels that all his medicines and the combination with the new vaccine and both together had something to do with his reaction.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site rash, Paraesthesia
Clinical narrative: Patient received Prevnar 20 , IM , right deltoid on 09/21/24. She stated she noticed rash, redness and soreness in the area of immunization on 09/24/24. She also had tingling and numbness in the left  portion of her face and jaw.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE REACTION
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE REACTION
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE REACTION
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient experienced pain and swelling at the site of injections. Patient advised to apply ice and to follow up with PCP if not resolves
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Pruritus, Rash erythematous, Swelling
Clinical narrative: large red rash, swelling and itching
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE REACTION
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient was given the pediatric dose.
Age: 77.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt was given fluad on 8/21/24 and 9/25/24. Pt reported no symptoms.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: RASHES ON NECK AND CHEST AREA
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, Product expiration date issue
Clinical narrative: administered a dose of Shingrix that was 2 weeks past expiration; 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 patient who received Herpes zoster (Shingrix) (batch number 3N743, expiry date 20-AUG-2024) for prophylaxis.   In AUG-2024, the patient received the 1st dose of Shingrix. In AUG-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Shingrix that was 2 weeks past expiration). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2024 Healthcare professional reported a patient was administered a dose of Shingrix that was 2 weeks past expiration. Their facility puts their own labels on the vaccines, and the label the facility placed on the vaccine had the incorrect expiration date which led to expired vaccine used. This was the patient's first dose in the series.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site erythema, Administration site pruritus, Administration site rash
Clinical narrative: RED, ITCHY RASH NEAR SITE OF ADMIN, BUT NOT AT SITE OF ADMIN
Age: 41.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Dizziness, Refusal of treatment by patient
Clinical narrative: PT RECEIVED FLUZONE 2024-25 AND PREVNAR 20 AND SHE LEFT THE IMZ AREA. SHE FELT DIZZY AND SHE WAS FOUND ON THE FLOOR.  WHEN PT WAS APPROARCHED BY RPH PT WAS CONSCIOUS AND FEELING FINE TO GO HOME. PT STATES THAT SHE HAD NO BREAKFAST IN THE MORNING AND SHE FELT DIZZY. PT DECLINED EMS ACTIVATION. HER BP WAS MEAURED AND IT WAS 73/39 AND PT DECLINED EMS ACTIVATION OR ANY OTHER TREATMENT. SHE KEPT HAVING SIPS OF WATER AND THEN SHE ASKED FOR SUGAR AND SHE TOOK ONE 4 GM GLUCOSE TABLET. HER BP WAS RETAKEN AND IT WAS 99/73. PT STATED THAT HER BP USUALLY RUNS AROUND 100.
Age: 5.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized redness and swelling in right thigh
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Pain in jaw, Peripheral swelling
Clinical narrative: swelling and pain in arm neck and shoulder and pain in jaw. Nurse recommended benadryl if it looked rashy, and due to pain in shoulder and jaw did recommend going to an er.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling and pain in arm neck and shoulder and pain in jaw. Nurse recommended benadryl if it looked rashy, and due to pain in shoulder and jaw did recommend going to an er.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Ear discomfort, Rash, Rash pruritic
Clinical narrative: pruritic rash to chest, neck and bilateral arms within hours of injection, ear fullness, reports of shortness of air.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site mass, Limb mass
Clinical narrative: lump in both thighs
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pruritus, Rash erythematous
Clinical narrative: Itching within 24 hours and continues; day two myalgia over whole body; day three red rash neck under chin, left shoulder and upper back
Age: 0.75
Sex: M
Vaccine: FLUN3
Symptoms: Underdose, Wrong product administered
Clinical narrative: Patient was given wrong medication, was given half dose of the flumist into left nostril.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Urticaria
Clinical narrative: Patient phoned call center within 1 hour of receiving vaccine complaining of severe headache and hives to wrists and hands bilaterally.  Nurse followed up with phone call to patient about 1 hour 15 minutes after receiving vaccine.  The patient stated hives were beginning to diminish at that time.  The patient denied SOB, Lightheadedness, rash, nausea, vomiting, difficulty swallowing, facial swelling, nasal congestion.  There were no signs of distress noted.  The patient stated they were currently at work and declined to go to ER.   The patient was encouraged to take Benadryl, monitor symptoms, and go to the ER if symptoms worsen.  The patient was contacted again via phone 2.5 hours following injection.  He stated the hives and headache were dissipating and that he had no further issues or concerns.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Crying, Dysphagia, Ear pain
Clinical narrative: fever, chills, hot flush, myalgia. drowsiness, fatigue, abnormal crying , chest pain, tachycardia, facial swelling, sweating, night sweats, oropharyngeal pain, swelling of tongue, dysphagia, flu-like symptoms, myalgia, shivering, muscle ache,  vertigo,  eye redness, ear pain, photophobia, rhinorrhea, nasal congestion.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Hot flush, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: fever, chills, hot flush, myalgia. drowsiness, fatigue, abnormal crying , chest pain, tachycardia, facial swelling, sweating, night sweats, oropharyngeal pain, swelling of tongue, dysphagia, flu-like symptoms, myalgia, shivering, muscle ache,  vertigo,  eye redness, ear pain, photophobia, rhinorrhea, nasal congestion.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Night sweats, Ocular hyperaemia, Oropharyngeal pain, Photophobia
Clinical narrative: fever, chills, hot flush, myalgia. drowsiness, fatigue, abnormal crying , chest pain, tachycardia, facial swelling, sweating, night sweats, oropharyngeal pain, swelling of tongue, dysphagia, flu-like symptoms, myalgia, shivering, muscle ache,  vertigo,  eye redness, ear pain, photophobia, rhinorrhea, nasal congestion.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea, Somnolence, Swelling face, Swollen tongue
Clinical narrative: fever, chills, hot flush, myalgia. drowsiness, fatigue, abnormal crying , chest pain, tachycardia, facial swelling, sweating, night sweats, oropharyngeal pain, swelling of tongue, dysphagia, flu-like symptoms, myalgia, shivering, muscle ache,  vertigo,  eye redness, ear pain, photophobia, rhinorrhea, nasal congestion.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, Vertigo
Clinical narrative: fever, chills, hot flush, myalgia. drowsiness, fatigue, abnormal crying , chest pain, tachycardia, facial swelling, sweating, night sweats, oropharyngeal pain, swelling of tongue, dysphagia, flu-like symptoms, myalgia, shivering, muscle ache,  vertigo,  eye redness, ear pain, photophobia, rhinorrhea, nasal congestion.
Age: 79.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: Hypertension
Clinical narrative: High blood pressure
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was given 2 doses of Covid Vaccine (Moderna) One in each deltoid and same day at same time.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Feeling cold, Headache, Nausea, Pyrexia
Clinical narrative: 3 hours after the  Meningococcal vaccination (MenQuadfi, NDC#49281-590-10), my son started to have chili,  he was cold and shaking,  He started to have a headache. At night he had nausea, a bad headache, and a chill. The next day he had a fever and all previous symptoms. The same symptoms repeated at night and today on day 3 after the vaccine. I must give him Motrin every 6 hours to help him feel better.  He was seen yesterday by nerse practitioner, and checked for strep, it was negative.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Streptococcus test negative, Symptom recurrence, Tremor
Clinical narrative: 3 hours after the  Meningococcal vaccination (MenQuadfi, NDC#49281-590-10), my son started to have chili,  he was cold and shaking,  He started to have a headache. At night he had nausea, a bad headache, and a chill. The next day he had a fever and all previous symptoms. The same symptoms repeated at night and today on day 3 after the vaccine. I must give him Motrin every 6 hours to help him feel better.  He was seen yesterday by nerse practitioner, and checked for strep, it was negative.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Back pain, Headache
Clinical narrative: Patient started experiencing a severe headache, upset stomach, and back pain. She received the shot at about 1:20 pm and the symptoms started at 5:00 pm and lasted almost two days.  She said the symptoms were very severe, unlike anything she has experienced before.
Age: 42.0
Sex: M
Vaccine: HEPAB
Symptoms: Wrong product administered
Clinical narrative: Patient was given incorrect vaccine (Twinrix) instead of a second dose of Havrix
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 2 inch induration, swelling, pain around injection site of the RVL. 1 inch induration swelling, pain around injection site of LVL
Age: 1.25
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt inadvertently administered ACTHIB and PEDVAX vaccine same day. No adverse side effects noted. Physician/Parent aware.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient technically had no reaction.  Patient asked for a vaccination for RSV even though he had one in November 2023.  I was instructed by my company to inform you that he received this twice.  Patient and doctors office has been advised.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: Patient came in requesting a RSV vaccination. He'd been at our location earlier in the day and received a Covid and  a high dose flu shot.  He came back claiming he just wanted to get the vaccinations over with and had returned to get his RSV shot.  Our technician entered the shot but did not look to see that a previous RSV vaccine given at our location 279 days ago.  The patient made the comment to the vaccinating tech (different from entering tech) as she was giving the shot that he had a previous dose about a year ago and wanted to complete the series.  The vaccinating tech came immediately out from releasing the patient and alerted me there was a possible problem. I contacted my superiors looking for guidance, then contacted the patient at approximately 7:30pm.  I told him that he should has only received 1 RSV and that the 2nd dose was unncessary. He replied that he felt just fine. He'd exercised and mowed the lawn after he returned from receiving the additional vaccine.  He was understanding of the mistake on our part and said he would let me know if anything changed.  The next morning his primary care physician was notified.  The doctor noted it in his chart and had no concerns regarding this.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash erythematous, Rash papular, Urticaria
Clinical narrative: Rash: pink, raised, itchy welts on the side vaccine was administered. around 10 welts total.
Sex: U
Vaccine: MMR
Symptoms: Intercepted product preparation error, Product appearance confusion
Clinical narrative: sterile water product and the diluent for PRIORIX look the same; they did not administer the vaccine to a patient, they realize about the error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of product appearance confusion in a patient who received MMR (Priorix) (batch number 43G92) and (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis.   On an unknown date, the patient did not receive Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced product appearance confusion (Verbatim: sterile water product and the diluent for PRIORIX look the same) and intercepted product preparation error (Verbatim: they did not administer the vaccine to a patient, they realize about the error). The outcome of the product appearance confusion and intercepted product preparation error 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: 16-SEP-2024  The pharmacist reported that they had a nurse that just gave a Priorix to a client, they use the vaccine component, but instead of using the diluent that comes with the Priorix, they use a different sterile water diluent, that comes with the MMR. The pharmacist reported that they got confused because the sterile water from the Priorix vaccine and MMR vaccine are very similar. Due to the pharmacist forgot to asked the vaccination date and number of dose, they called back to get more information. The pharmacist confirming that they did not administer the vaccine to a patient, they realize about the error and they would probably discarded the vaccine which led to intercepted product preparation error. The pharmacist reports that a nurse inadvertantly reconstituted the Priorix vaccine with another manufacturers diluent.  The diluent used was sterile water (prefilled syringe).  The pharmacist stated that the reconstituted product was not administered to the patient.  The reporter states that the sterile water product and the diluent for Priorix look the same which led to product appearance confusion. The pharmacist also states that when they 1st started using Priorix, one of the components was not administered to the patient.  The pharmacist could not remember any further details about the event.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered
Clinical narrative: On May 14, 2024, my two month old daughter received a Rotavirus vaccine at clinic. The vaccine?s lot number was flagged as invalid in the State Shots database. According to State Shots, the lot number was marked as expired.  I returned to clinic to address the issue, and the staff insisted that the vaccine was not expired, claiming the expiration date had been incorrectly entered into the system. To "correct" the issue, they re-entered a new lot number into the State Shots database. However, this was done without showing me the records.  When I requested the paper records for my daughter?s vaccination, both the signed form and the office?s logbook listed the original lot number, which was indeed expired on the day of vaccination. I have copies of these records showing the expired lot number.  Despite this, the office claimed the paper records were wrong and assured me that my daughter had not received an expired vaccine. They then altered the logbook to show a different lot number, effectively falsifying the records to reflect a different vaccine batch.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received an RSV vaccine 10/10/23 then received a second RSV 9/20/24. No adverse effects.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling
Clinical narrative: Eyes swollen bilaterally, primarily the right eye.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Crying, Vomiting
Clinical narrative: Patient began vomiting once he returned home. Per mom, patient cried for a coupe minutes after the flu shot and then was okay. He was playing on the drive home with no side effects noted. Once home, he had three episodes of vomiting in a ten minute period. He has recovered since the adverse event.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Loss of consciousness, Nausea, Pallor, Paraesthesia
Clinical narrative: Patient passed out in room with nurses. No injuries obtained when passing out, she was caught by a nurse. She was transferred to a wheelchair and taken to a room with a bed. Prior to transfer she was  alert and oriented x4. She was placed on the bed with her legs bent. Her color started to return. Mom was at the bedside. Patient monitored for over 30 minutes. Complained of headache, nausea, and tingling. She drank a apple juice and a water and ate a pack of peanut butter crackers.  Her blood pressure upon discharge was 94/62, heart rate 65. They refused transport to ER. I notified the patient and mother to go to the ED for evaluation if she had anything other than a local reaction to the vaccine that lasted longer than 6 hours. MSN, RN
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: only received the diluent portion; only received the diluent portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4F45Z, expiry date 31-OCT-2025) for prophylaxis.   On 15-SEP-2024, the patient received Arexvy. On 15-SEP-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate dose of vaccine administered (Verbatim: only received the diluent portion) and inappropriate preparation of medication (Verbatim: only received the diluent portion). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 16-SEP-2024 The pharmacist reported that they administered 2 patients with Arexvy but one of them (they do not know which patient) only received the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  This case was linked with US2024114976, reported by same reporter.; Sender's Comments:  US-GSK-US2024114976:Same reporter/Diffrent patient
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: received the diluent portion; received the diluent portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4F45Z, expiry date 31-OCT-2025) for prophylaxis.   On 15-SEP-2024, the patient received Arexvy. On 15-SEP-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate dose of vaccine administered (Verbatim: received the diluent portion) and inappropriate preparation of medication (Verbatim: received the diluent portion). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 16-SEP-2024 The pharmacist reported that they administered 2 patients with Arexvy but one of them (they do not know which patient) only received the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  This case was linked with US2024114962, reported by same reporter.; Sender's Comments:  US-GSK-US2024114962:Same reporter/Diffrent patient
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product administration duration
Clinical narrative: Administration after the maximum interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug administration duration too long in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number KR4HY, expiry date 04-NOV-2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug administration duration too long (Verbatim: Administration after the maximum interval). The outcome of the drug administration duration too long was unknown.   Additional Information: GSK Receipt Date: 16-SEP-2024 A pharmacist contacted GSK to request data about the administration of Shingrix 2 years after the first dose. They stated the patient was 81 years of age when they received the first dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Product dose omission issue
Clinical narrative: never received the 2nd dose for Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (1st dose received in 2019) and Shingrix (1st dose received in November 2018). Concurrent medical conditions included immunocompromised.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received the 2nd dose for Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-SEP-2024 Caller reported that one of their patients received a 1st dose of Shingrix in Nov 2018, and latter on 2019, they received a Zoster vaccine from another brand (caller said that it was probably the Merck vaccine). This patient never received the 2nd dose for Shingrix and they need to know if they can administer another dose to complete the vaccination schedule. HCP reported to coworker that this patient received the 1st Shingrix dose at 45 year old due to the patient was immunocompromised. The HCP said that the Zoster vaccine was probably from Merck. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administration of the second dose before the 1 month interval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number A2JX7, expiry date 31-OCT-2026) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On 08-JUL-2024, the patient received the 2nd dose of Bexsero. On 08-JUL-2024, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Administration of the second dose before the 1 month interval). The outcome of the drug dose administration interval too short 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: 16-SEP-2024 The patient received 2nd dose of Bexsero earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered Shingrix second dose adjuvant alone without the powder; administered Shingrix second dose adjuvant alone without the powder; 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 54-year-old female patient who received Herpes zoster (Shingrix) (batch number BT59B, expiry date 10-AUG-2026) for prophylaxis.   On 10-SEP-2024, the patient received the 2nd dose of Shingrix. On 10-SEP-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered Shingrix second dose adjuvant alone without the powder) and inappropriate dose of vaccine administered (Verbatim: administered Shingrix second dose adjuvant alone without the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-SEP-2024 Medical Assistant reported that a colleague administered Shingrix second dose adjuvant alone without the powder to a 54 year-old patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Miosis, Product preparation issue, Single component of a two-component product administered, Swollen tongue
Clinical narrative: one of them only received the adjuvant portion of the vaccine and they do not know which one it is; one of them only received the adjuvant portion of the vaccine and they do not know which one it is; Pin point pupils; her tongue was swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of pupils pinpoint in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included pneumonectomy (approximately 16 months post lung resection).   On 02-AUG-2024, the patient received Arexvy. On 02-AUG-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: one of them only received the adjuvant portion of the vaccine and they do not know which one it is) and inappropriate dose of vaccine administered (Verbatim: one of them only received the adjuvant portion of the vaccine and they do not know which one it is). In AUG-2024, the patient experienced pupils pinpoint (Verbatim: Pin point pupils) and swollen tongue (Verbatim: her tongue was swollen). In AUG-2024, the outcome of the pupils pinpoint and swollen tongue were resolved (duration 4 hrs). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pupils pinpoint and swollen tongue to be related to Arexvy.     It was unknown if the company considered the pupils pinpoint and swollen tongue to be related to Arexvy.  Additional Information: GSK Receipt Date: 16-SEP-2024 The reporter was the patient who reported for herself. The patient and her husband went to the pharmacy to get the RSV vaccine.  The reporter did not had any identifying numbers for either of the suspect RSV vaccines.  The patient was told on the telephone by a pharmacist that the RSV vaccine was GSK brand.  The reporter stated that when she went home she received a call from the pharmacist. The pharmacist told her that one of them only received the adjuvant portion of the vaccine and they did not know which one it was, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient stated that a half hour after receiving the suspect vaccine she had pin point pupils and her tongue was swollen. Her symptoms resolved in 4 hours. The patient reports that she reported this adverse event to Vaccine Adverse Event Reporting System (VAERS). This case had been link with US2024114974, reported by the same reporter.; Sender's Comments:  US-GSK-US2024114974:Same reporter/Husband case
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Fatigue
Clinical narrative: very fatigued for 24 hours; Extra Dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) and (batch number KD424, expiry date 27-JAN-2025) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis and Influenza vaccine for prophylaxis.   Previously administered products included Arexvy (received Arexvy on 21st September 2023).   On 08-SEP-2024, the patient received Arexvy (intramuscular). In SEP-2024, the patient received COVID-19 vaccine and Influenza vaccine. On 08-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Extra Dose administered). On 09-SEP-2024, the patient experienced fatigue (Verbatim: very fatigued for 24 hours). On 10-SEP-2024, the outcome of the fatigue was resolved (duration 24 hrs). The outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the fatigue to be related to Arexvy.     It was unknown if the company considered the fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-SEP-2024 and 17-SEP-2024 The pharmacist reported the administration of a 2nd dose of Arexvy to patient. The patient was administered Arexvy and another dose was administered. The pharmacist reported that she and the patient were leaving to go out of the country and the pharmacy told them to go ahead and get the Covid Vaccine, Arexvy vaccine and the flu vaccine.  The patient's wife reported after the licensed pharmacy technician gave the 3 vaccines the reporter realized she and her husband had the Arexvy Vaccine already which led to extra dose administered. The patient's wife reported that the only thing that changed was they were both being very fatigued for 24 hours.  This adverse event did subside after 48 hours. It was unknown if the reporter considered the fatigue to be related to COVID-19 vaccine and Influenza vaccine  This case was linked with US2024114967, reported by same reporter.; Sender's Comments:  US-GSK-US2024114967:Same reporter,Different patient
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient missed 2nd dose window; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient missed 2nd dose window). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-SEP-2024 A pharmacist that administered Shingrix, need guidance on how to proceed with a patient that had missed the 2nd dose window of 6 months. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only received the liquid adjuvant portion; only received the liquid adjuvant portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a female patient who received Herpes zoster (Shingrix) (batch number EY253, expiry date 16-JUL-2026) for prophylaxis.   On 16-SEP-2024, the patient received the 1st dose of Shingrix. On 16-SEP-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: only received the liquid adjuvant portion) and inappropriate preparation of medication (Verbatim: only received the liquid adjuvant portion). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 16-SEP-2024  The pharmacist reported that pharmacy held a vaccine clinic and she inadvertently administered Shingrix vaccine without reconstituting, so the patient only received the liquid adjuvant portion which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.  It was the first dose in series, and the patient was female.  At the time of reporting, the pharmacist did not had any further patient details aside from gender.  The Vaccine Administration Facility was the same as Primary Reporter. This case was linked with US2024AMR115288, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR115288:Same reporter/Different patient