chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.42
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was due for Flu , Covid and Dtap vaccine, went to go get vaccines ready.  Got Covid vaccine ready for patient but notice the one we had was not the correct one patient needed. left covid vaccine and just got Flu and Dtap. I was a little rushed due to being behind with the providers schedule. Did confirm the flu vaccines for patient and it was the correct one. when I graved the Dtap I did not double check if it was the correct one just saw it was pulled from the Dtap container we have from the fridge. Went into the room, finished what I had to do with patient,  gave parents the VIS of the vaccines.  Parents had already answered the questions before I gave vaccines. Once I was ready I administered only FLU and Dtap Vaccines on patient right Vastus Lateralis without any complications. As I was entering the vaccines into patient chart, while patient and parents still in the room. I had realized that the vaccine I gave was the Kinrix instead of just the Dtap it self.  I let parents know right away what had happen and gave them the information and what to look out for. Also let them know if they wanted to talk to the provider or to a manager, the parents understood with what had happen and had no concerns or questions. Also understood with what to look out with patient and when to go into the ER if needed. I also let the patient provider know with what had happen and provider stated patient will be okay, no follow up needed at the moment. Also let my manager know and that is when I summitted the report.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside "Best By" date. Patient notified. No reaction stated.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: DEVELOPED RASH ON BODY
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Pain in extremity, Posture abnormal, Unresponsive to stimuli
Clinical narrative: After administering the vaccine the patient noted how it was more painful than other vaccines and said she felt like her entire arm hurt immediately post vaccine. Patient asked if she could remain sitting for a moment and sat for about 2-3 minutes. Patient then stood up and was going to pick up her belongings but then decided to sit back down, stating she knew her limitations. Patient sat for another 2-3 minutes, leaned forward to attempt to put her head between her knees for a moment then sat back up. She sat for another few minutes and requested I get her a water, I left the room to grab her a water,  was only gone for about 15 seconds and upon return the patient was slumped in the chair, her eyes were open but she was not responding. EMT's were alerted. Patient then sat up straighter but was still not responding to questions or seemingly aware. Once office first arrived, patient was more alert and oriented. EMT's arrived and patient was alert and aware, they took her blood pressure then transported to local emergency room for further assessment.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Peripheral swelling, Swollen tongue
Clinical narrative: Patient called complaining of swollen arm and tongue. Also redness at the injection site.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: COVID-19 vaccine formulated for individuals 12 years and older was administered to pt. No known adverse s/s.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "best by" date. Patient notified. No reaction stated
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "best by" date. Patient notified. No reaction stated.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Flushing, Heart rate increased, Tremor
Clinical narrative: Staff member/patient became very flushed, light headed, and shaky.  Both her pulse rate and blood pressure were elevated.  Dr. examined her and administered Benedryl and Tylenol.  We continued to monitor her blood pressure.  She started feeling better and left for home around 3:30.  Her spouse was notified of the incident.  This was the flu vaccine administered to staff in the physician office.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear congestion
Clinical narrative: AE of hearing loss occurred since receiving COVID vaccine (almost 3 weeks after receiving vaccine). I don't believe hearing loss, ear congestion are related to COVID vaccine. IF they are related to anything,  I believe it is the restasis eye drops (rare occurrence of eustachian tube dysfunction noted with restasis).
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Incorrect dose administered, No adverse event
Clinical narrative: Patient was seen for visit with NP on 10/7/2024. At the time of that visit Covid (Moderna) 25mcg vaccine was ordered for patient to receive. However, patient was given Covid (Moderna) 50mcg vaccine instead. No adverse reactions were noted after vaccine administration. Mother reports increased fatigue but patient had received 3 other vaccines at the time of the visit (Boostrix/Tdap, Fluzone, and Gardasil 9).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient claims evening of vaccine should and arm was sore. Next day no range of motion for should at all with severe pain to joint. Two days after vaccine, patient reported to pharmacy and going to PCP for further care due to severe pain in shoulder joint and still no range of motion.  Patient states that vaccine was administered properly and correct site and unsure for this reaction.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "best by" date. Patient notified. No reaction stated.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: EE received Flu vaccine at Employee health Clinic.  Approx 45 minutes after receiving vaccine began to experience numbness/tingling  in tips of fingers on rt hand.  Symptoms have persisted.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "best by" date. Patient notified. No reaction stated.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Cerebrovascular accident, Chest X-ray, Computerised tomogram, Facial paralysis, Impaired work ability
Clinical narrative: On 17th Sep after taking the vaccine was not feeling well & went to bed early. Next day was having sore arm the place of vaccination got up late went to work and came early. Same feeling was on Sep. 19th. & Sep 20th slight temp. On Sep 21st stayed at home. Sep 22 felt some swelling on the right side of face. By late evening felt weakness in rt leg and had a restless night. By morning of 23rd right leg & arm felt more weakness and rt eye and rt side of lips drooped. Went to Hospital and they diagnosed a stroke. Discharged on Sep 26th evening with a permanent loop recorder under the skin on left side just above the hear.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Implantable cardiac monitor insertion, Injection site pain, Laboratory test, Magnetic resonance imaging head, Malaise
Clinical narrative: On 17th Sep after taking the vaccine was not feeling well & went to bed early. Next day was having sore arm the place of vaccination got up late went to work and came early. Same feeling was on Sep. 19th. & Sep 20th slight temp. On Sep 21st stayed at home. Sep 22 felt some swelling on the right side of face. By late evening felt weakness in rt leg and had a restless night. By morning of 23rd right leg & arm felt more weakness and rt eye and rt side of lips drooped. Went to Hospital and they diagnosed a stroke. Discharged on Sep 26th evening with a permanent loop recorder under the skin on left side just above the hear.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Muscular weakness, Poor quality sleep, Pyrexia, Swelling face
Clinical narrative: On 17th Sep after taking the vaccine was not feeling well & went to bed early. Next day was having sore arm the place of vaccination got up late went to work and came early. Same feeling was on Sep. 19th. & Sep 20th slight temp. On Sep 21st stayed at home. Sep 22 felt some swelling on the right side of face. By late evening felt weakness in rt leg and had a restless night. By morning of 23rd right leg & arm felt more weakness and rt eye and rt side of lips drooped. Went to Hospital and they diagnosed a stroke. Discharged on Sep 26th evening with a permanent loop recorder under the skin on left side just above the hear.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: 7X12 CM ERYTHEMA  AREA
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Na
Age: 11.0
Sex: F
Vaccine: COVID19, FLUN3, HEP, HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Chest discomfort, Dizziness, Extremity contracture, Eye movement disorder, Headache
Clinical narrative: Client vaccinated at 11:50AM, while vaccinating clients sibling around 12PM RN & Interpreter  saw the client having arm/hand contractures while her eyes were rolled to the back of her head. RN  was able to hold the client in her chair until she was able to become responsive. Once the client was responsive RN  & RN were able to help the client to the floor to lay on the mat. Client talking normal, no slurring or vision changes noted. Vitals were initially taken at 12:05PM - BP 102/62 HR 61 & O2 99%. After laying on the mat for about 10 minutes client was able to sit up and drank a juice box with goldfish crackers. Client was able to stand back up around 12:20PM and was prompted to sit in the chair. Around 12:25PM client stated that she was feeling lightheaded again and her head was starting to hurt. Client was prompted to lay back on the floor with her feet up, vitals taken - BP 100/62 HR 62 O2 95%. Client talking normal, no slurring noted. After client was laying down she stated her head pain was increasing and her vision was going between blurry and clear. Client also stated she was feeling pressure in her chest. MOC was given the option for us to call 911, MOC initially declined and stated she will take her to get seen. MOC agreed to have 911 called around 12:32PM and ambulance arrived around 12:50PM. Client was released to paramedics for transfer to Hospital  at 12:55PM.
Age: 11.0
Sex: F
Vaccine: COVID19, FLUN3, HEP, HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Joint contracture, Unresponsive to stimuli, Vision blurred
Clinical narrative: Client vaccinated at 11:50AM, while vaccinating clients sibling around 12PM RN & Interpreter  saw the client having arm/hand contractures while her eyes were rolled to the back of her head. RN  was able to hold the client in her chair until she was able to become responsive. Once the client was responsive RN  & RN were able to help the client to the floor to lay on the mat. Client talking normal, no slurring or vision changes noted. Vitals were initially taken at 12:05PM - BP 102/62 HR 61 & O2 99%. After laying on the mat for about 10 minutes client was able to sit up and drank a juice box with goldfish crackers. Client was able to stand back up around 12:20PM and was prompted to sit in the chair. Around 12:25PM client stated that she was feeling lightheaded again and her head was starting to hurt. Client was prompted to lay back on the floor with her feet up, vitals taken - BP 100/62 HR 62 O2 95%. Client talking normal, no slurring noted. After client was laying down she stated her head pain was increasing and her vision was going between blurry and clear. Client also stated she was feeling pressure in her chest. MOC was given the option for us to call 911, MOC initially declined and stated she will take her to get seen. MOC agreed to have 911 called around 12:32PM and ambulance arrived around 12:50PM. Client was released to paramedics for transfer to Hospital  at 12:55PM.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "best by" date. Patient notified. No reaction stated.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient had declined recommendation to get flu vaccine. The order was active on his record. Vaccine was inadvertently given by clinical assistant. Provider and patient made aware. Provider discussed with patient. Patient was not upset. This was more of a medication error versus an adverse reaction.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site reaction, Rash, Rash papular, Skin warm
Clinical narrative: PATIENT CALLED TO REPORT RAISED RASH AT INJECTION SITE THAT SHE BELIEVES IS TRAVELLING TO INSIDE OF ARM, ALSO THAT AREA FEELS "HOT" TO TOUCH.  ADVISED PATIENT TO CONTACT HER PCP.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Heart disease congenital, Hypertension
Clinical narrative: High Blood Pressure in both wife and husband exactly 3 day after. Neither one had high blood pressure before.  Husband also had cardiac anomalies after shots. Which he had NEVER had before.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This morning, he came to my office at 0750. The site was swollen, red, and hot to the touch. You could visibly see the induration. His aunt made  a doctor's appointment and taking him to it today.
Age: 20.0
Sex: M
Vaccine: TDAP, YF
Symptoms: Abdominal pain, Dyspnoea, Pharyngeal swelling, Pruritus
Clinical narrative: 45 minutes after receiving the Yellow fever and Tdap vaccine, patient started to complain of SOB, throat swelling, itchy skin and abdominal pain. He took Benadryl and his albuterol inhaler. He symptoms started to worsen so he went to the Emergency Room. He was administer additional 25 mg of Benadryl, Solumedrol 125 mg injection, Famotidine 20 mg injection along with 30ml of Maalox and 15ml oral suspension of Bismuth Subsalicylate. He was treated , recovered and discharged from the hospital.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Erythema, Pain in extremity, Pruritus
Clinical narrative: Pateint woke up with pain and blisters up and down the arm that the flu shot was given. The area was red and slightly itchy.  He did not report any itching in the throat.  He came to pharmacy  today and showed me the arm, the blisters were gone, but the redness was still there. Pateint reported pain is gone too.
Age: 15.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMRV, MNQ, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was accidentally given both MMRV (Proquad) and Varicella (Varivax) vaccines at the same time, meaning she got double to dose of Varicella. No immediate adverse reaction noted at this time.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best by" date. Patient notified. No reaction stated.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Hep A vaccine
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 3 years of age at the time the vaccine was given.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Device connection issue, Syringe issue
Clinical narrative: faulty needle, part of vaccine came out from where the needle and syringe are connected
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea
Clinical narrative: patient reported a COVID-19 vaccine reaction of shortness of breath. no other additional information available in the chart.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: SWELLING AND VERY PAINFUL LYMPH NODES IN THE LEFT BREAST, SYMPTOMS STARTED DAY OF VACCINATION, 10/02/2024, AND CONTINUED AND HAVE NOT RESOLVED YET, PATIENT WAS EXAMINED BY HER PRIMARY DOCTOR, ON 10/09/2024, WAS TOLD IT WAS A REACTION TO THE VACCINE AND IT SHOULD RESOLVE
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Shortness of breath, hives
Age: 1.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered double the dose of the season flu vaccine by accident. Spoke with parents and informed of what happened, parents understood.No adverse reactions were reported at this time. We will continue to monitor and communicate with parents.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immediate post-injection reaction, Joint range of motion decreased, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Instant pain at time of immunization.  Felt like it was going into the bone of the shoulder.  once soreness went away couldn't move arm to dress.  About a month later went to the dr because still having pain and limited motion.  They gave cortisone shot and it helped about 75%.  No more dr visits. Range of motion is much improved but not normal.  No more pain (years later) but still limited range of motion
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain in extremity
Clinical narrative: erythema (NOT normal for me) with upper arm pain (normal for me), headache ( NOT normal for me)
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC20
Symptoms: No adverse event
Clinical narrative: Patient received all vaccines on 10/4. Initial RSV (Beyfortus) 0.5mL was given on 2/20/24 (Lot AZ230080, exp 4/29/25; manufacturer: Sanofi Pasteur. Patient was advised to wait for 15 minutes after administration and no reports of adverse effects at this time.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea exertional, Exercise tolerance decreased
Clinical narrative: 1) Intermittent substernal chest pain for about six months.   2) Decreased exercise tolerance that has persisted to include increased shortness of breath with light to moderate activity including climbing stairs.
Age: 86.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arrhythmia, Back pain, Blood pressure increased, Dizziness, Electrocardiogram abnormal
Clinical narrative: Prior to vaccination patient appeared anxious due to an alarm going off within the store. Shortly after vaccination (within 5 minutes) patient reported feeling "dizzy/shaky." after, seating patient complained of severe pain in back and neck. Denied symptoms of anaphylaxis. 911 was called. Emergency responders evaluated patient reporting elevated blood pressure (number unknown to me at this time) and performed EKG. Emergency responder reported abnormal heart rhythm (specifics unknown to me at time of report). Patient was taken to the hospital.
Age: 86.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Neck pain, Nervousness
Clinical narrative: Prior to vaccination patient appeared anxious due to an alarm going off within the store. Shortly after vaccination (within 5 minutes) patient reported feeling "dizzy/shaky." after, seating patient complained of severe pain in back and neck. Denied symptoms of anaphylaxis. 911 was called. Emergency responders evaluated patient reporting elevated blood pressure (number unknown to me at this time) and performed EKG. Emergency responder reported abnormal heart rhythm (specifics unknown to me at time of report). Patient was taken to the hospital.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Pharyngeal swelling, Throat clearing, Throat irritation
Clinical narrative: STARTED TO HAVE DIFFICULTY SWALLOWING, SCRATCHY THROAT.    COUGHING AND CLEARING THROAT TO HELP SWALLOW. FELT LIKE THROAT WAS SWOLLEN.   TOOK 25MG BENADRYL, AND WITHIN 30 MINUTES I FELT IMPROVEMENT. ALSO TOOK 50MG LATER THAT EVENING AND ANOTHER DOSE BEFORE BED.
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported red, swollen arm at injection site, roughly the size of a playing card. The reaction was not itchy or painful to the patient, but it is warm to the touch. The reaction started 2-3 days after receiving the vaccine and is still present 9 days after receiving the vaccine (7 days since the reaction started), however it is subsiding now with minimal swelling but still warm to the touch.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Palpitations, Presyncope, Ventricular extrasystoles
Clinical narrative: About 30 seconds after the meningitis vaccine injection. I started getting light headed and my heart felt like it was doing backflips inside my chest. I almost passed out and had to sit in a chair in the waiting room for a few minutes. I realize this report is 17 years late but I don't know if my pediatrician reported it to this website and I didn't know this website existed until recently. Since this reaction I have had PVCs which I believe to be caused by a reaction to eating gluten. But I have no way of knowing. They subside when I don't eat gluten. I also don't know exactly which meningitis vaccine I received I made an educated guess, there is probably a record of it somewhere.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Pain in jaw, Pruritus
Clinical narrative: Patient had increased lymph nodes causing pain in her jaw and joints and itching in her neck.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event. Vaccine administration error. Pt was given Fluad instead of Flucelvax
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: patient was given Flublok instead of Fluzone on 10/05/24 at 5:10pm.  immediately upon realizing I called the parent and discussed with mom.  I told mom to call us if patient experienced any adverse reactions.  We followed up with mom on 10/6/24 and mom stated that patient did not experience any different reactions out of the ordinary for him.  Mom stated that patient usually experiences chills/slight fever with any vaccine he receives and this is what he experienced with this.  Mom has no concerns and said patient was feeling fine.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Condition aggravated, Seizure
Clinical narrative: patient received 3 vaccines and after the administration of all vaccines, he started having a seizure. I made sure patient had a pulse and was in a secure position. I asked an employee to call EMS and the other pharmacist came into the room to check the patient with me. Patient was  breathing and started to respond indicating he is ok. He mentioned he had an episode of a seizure this morning and he does not take any medication for his seizure due to side effects of the medications and has not seen a doctor for it. Paramedics came and checked patient, he seemed to be okay and refused to go to the hospital.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Electrocardiogram abnormal, Fall
Clinical narrative: presented to hospital after falling and weakness in atrial fibrillation
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 10 year old received Pfizer (Comirnaty) 12+
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Ear pain, Erythema, Pain, Palpitations
Clinical narrative: * Symptoms appeared by Saturday evening. Most acute Sunday thru Tuesday. All still present today, Wednesday * Puffy and redness, predominantly on left side of face  * Left arm redness spread to be a very large circle and down then down the arm, now itchy too. * Severe bodily aches, deep muscle back and right thigh  * Occasional brief but acute shooting pain in deep inner ear on right side * Occasional heart racing but lasts only for a few minute * Mouth  (roof) feeling a bit raw  Treatment:  Daily allergy med-Allegra and Naproxen 2x 200mg each day, sometimes with an additional needed late afternoon, waiting and monitoring only
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin swelling, Stomatitis
Clinical narrative: * Symptoms appeared by Saturday evening. Most acute Sunday thru Tuesday. All still present today, Wednesday * Puffy and redness, predominantly on left side of face  * Left arm redness spread to be a very large circle and down then down the arm, now itchy too. * Severe bodily aches, deep muscle back and right thigh  * Occasional brief but acute shooting pain in deep inner ear on right side * Occasional heart racing but lasts only for a few minute * Mouth  (roof) feeling a bit raw  Treatment:  Daily allergy med-Allegra and Naproxen 2x 200mg each day, sometimes with an additional needed late afternoon, waiting and monitoring only
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: syringe has a manufacture defect , which is discovered after injecting patient, so it had to be done again with another/new prefilled syringe
Age: 19.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site discolouration, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: SEP 29, 2024@12:36:05     large tennis sized ball, raised, red and blue, warm to the touch, painful      welt to right upper arm. patient states its not getting better and she      would like to never get that vaccine again. EGA: 36 4/7  (Sep 27, 2024@13:15)  Due date by Ultrasound: 10/21/2024 Definitive EDD: 10/21/2024   Baby born 10/x/2024, weight on 10/x/24 6.063 pounds
Age: 19.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth, Ultrasound antenatal screen, Urticaria
Clinical narrative: SEP 29, 2024@12:36:05     large tennis sized ball, raised, red and blue, warm to the touch, painful      welt to right upper arm. patient states its not getting better and she      would like to never get that vaccine again. EGA: 36 4/7  (Sep 27, 2024@13:15)  Due date by Ultrasound: 10/21/2024 Definitive EDD: 10/21/2024   Baby born 10/x/2024, weight on 10/x/24 6.063 pounds
Age: 68.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient reported severe arm and shoulder pain at times radiating up to neck that started about a week after the vaccine was given. She came in to show us where the shot was given and it was in the correct area not too high. No swelling reported and pain still there upon reporting. Pain is alleviated with ibuprofen.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a combination vaccine of Dtap and Polio (Kinrix). Patient should have been given these 2 vaccines separately. This dose still counts as a valid dose and does not have to be repeated.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 11y8mo patient was given .5 mL of Moderna COVID vaccine for 12 years and older. Patient stayed in the clinic for 15 minutes after administration and no adverse reactions were noted. Error was realized after the patient left the clinic and was reported to Department of Health.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Administered after expiriencing a temperature excursion; No additional AE/no PQC.; This spontaneous report as received from a nurse and refers to a 15-month-old male patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On an unknown date the patient was vaccinated with third dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # Y003146 and expiration date 12-SEP-2026, intramuscularly in the left thigh for prophylaxis (exact dose was not provided). The excursion lasted for 4 minutes and 45 seconds in temperature of 8.8 Celsius degrees (product storage error). No additional adverse events reported (no adverse event).; Sender's Comments:  US-009507513-2408USA009052:
Age: 5.0
Sex: F
Vaccine: PNC15, PPV
Symptoms: Vaccination failure
Clinical narrative: lowered vaccine response for pneumococci; Literature Report.  This literature marketed report has been received from the authors in a published literature article, entitled as stated above and referred to a 5-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On an unknown date, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (manufacture unknown) injection or pneumococcal 23v polysaccharide vaccine (manufacture unknown) injection, administered for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023, immune check-up showing immunoglobulin assays within the norms of a normal lymphocytic typing, however showing lowered vaccine response for pneumococci (vaccination failure). As a result, she received pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (reported as pneumothorax 23) in March 2023. The outcome of vaccination failure was not reported. The action taken with pneumococcal 15v conj vaccine (crm197) (manufacture unknown) or pneumococcal 23v polysaccharide vaccine (manufacture unknown) was not applicable.  The causality between vaccination failure and the pneumococcal 15v conj vaccine (crm197) (manufacture unknown) or pneumococcal 23v polysaccharide vaccine (manufacture unknown) was assessed as related.   A copy of the published article is attached as further documentation of the patient's experience.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: pain) (serious criteria hospitalization). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     The company considered the pain to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 03-OCT-2024 This case was reported by a patient via interactive digital media. The podcast host noted on an local podcast, they had a couple of patients who got the shingles vaccination, and had pain was so severe that they had to admitted to the hospital. The host still received shingles vaccine.; Sender's Comments: Pain is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GSK-US2024AMR123533:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Skin warm
Clinical narrative: hard area at injection site; 8 cm reddened area at injection site; warm to the touch; This non-serious case was reported by a consumer and described the occurrence of injection site induration in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-SEP-2024, the patient received Shingrix. In SEP-2024, an unknown time after receiving Shingrix, the patient experienced skin warm (Verbatim: warm to the touch). On 27-SEP-2024, the patient experienced injection site induration (Verbatim: hard area at injection site) and injection site erythema (Verbatim: 8 cm reddened area at injection site). The outcome of the injection site induration and injection site erythema were not resolved and the outcome of the skin warm was not reported.   It was unknown if the reporter considered the injection site induration, injection site erythema and skin warm to be related to Shingrix.     It was unknown if the company considered the injection site induration, injection site erythema and skin warm to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-SEP-2024 The reporter asked that was it still possible to do the booster. The reporter reported that the patient had 8 cm reddened and hard area at injection site. It was about 4 cm a day before day of reporting and 8 cm on the day of reporting and warm to the touch. If it continues to grow larger, the patient would probably go in for treatment for cellulitis.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: worst physical pain; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: worst physical pain). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-SEP-2024 Reporter stated that it was odd enough that vaccine gave him the worst physical pain and side effects of any vaccine, but according to him it was well worth it.
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Injection site pain, Product quality issue, Syncope
Clinical narrative: fainted; Experienced extreme pain upon administration; 15 weeks pregnant; Product complaint; This serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of fainting in a adult female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced fainting (Verbatim: fainted) (serious criteria GSK medically significant), injection site pain (Verbatim: Experienced extreme pain upon administration), vaccine exposure during pregnancy (Verbatim: 15 weeks pregnant) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the fainting and injection site pain were not reported and the outcome of the vaccine exposure during pregnancy and pharmaceutical product complaint were unknown.   The reporter considered the fainting to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The reporter considered the injection site pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the fainting to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the injection site pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   Pregnancy exposure: Pregnancy Exposure (Fluarix 2024-2025 season): To mother in second trimester Pregnancy Outcome: Pregnancy was ongoing   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: 02-OCT-2024 The pharmacist stated that the health care professional who received Fluarix and experienced extreme pain upon administration. There were 5 patients and so painful that each of them swore, one wanted to swing out at someone, and one almost fainted. The medical director of the clinic believed that a quality issue was causing the extreme pain. The reporter was not able to identify which of the patients almost fainted, but it was one of the pregnant patients. This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments: Syncope is a listed event which, due to the following criteria (Injection site pain and pregnancy) is considered unrelated to GSK vaccine Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE. US-GSK-US2024AMR121803:same reporter, different patient US-GSK-US2024121099:same reporter, different patient US-GSK-US2024121112:same reporter, different patient US-GSK-US2024AMR121777:same reporter, different patient
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Injection site pain, Product quality issue, Syncope
Clinical narrative: fainted; Experienced extreme pain upon administration; 21 weeks pregnant patient received Fluarix; Product complaint; This serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of fainting in a 29-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced fainting (Verbatim: fainted) (serious criteria GSK medically significant), injection site pain (Verbatim: Experienced extreme pain upon administration), vaccine exposure during pregnancy (Verbatim: 21 weeks pregnant patient received Fluarix) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the fainting and injection site pain were not reported and the outcome of the vaccine exposure during pregnancy and pharmaceutical product complaint were unknown.   The reporter considered the fainting to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The reporter considered the injection site pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the fainting to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the injection site pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   Pregnancy exposure: Gestation time at first exposure (Fluarix 2024-2025 season): 21 Weeks Pregnancy Exposure (Fluarix 2024-2025 season): To mother in second trimester Pregnancy Outcome: Pregnancy was ongoing   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: 02-OCT-2024 The pharmacist stated that the health care professional who received Fluarix and experienced extreme pain upon administration. There were 5 patients and so painful that each of them swore, one wanted to swing out at someone, and one almost fainted. The medical director of the clinic believed that a quality issue was causing the extreme pain. The reporter was not able to identify which of the patients almost fainted, but it was one of the pregnant patients. This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments: Syncope is a listed event which, due to the following criteria (Injection site pain and pregnancy) is considered unrelated to GSK vaccine Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE. US-GSK-US2024121112:same reporter, different patient US-GSK-US2024121099:same reporter, different patient US-GSK-US2024AMR121777:same reporter, different patient US-GSK-US2024AMR121802:same reporter, different patient
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: the 1st dose of the vaccine hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: the 1st dose of the vaccine hurt). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-SEP-2024 This case was reported by the patient via interactive digital media. The patient received the 1st dose of Shingrix vaccine and vaccine was hurt.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; diagnosed with shingles on my face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: diagnosed with shingles on my face). The outcome of the vaccination failure and facial herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-OCT-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine about four years ago and this week (before the day of reporting) was diagnosed with Shingles on his/her face in 2024. The reporter stated that supposedly vaccine only good for 45 years. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: had a second dose administered inadvertently one year later.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 18-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (on an unknown date received 1st dose).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: had a second dose administered inadvertently one year later.). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 11-SEP-2024 The patient received a dose of Menveo and had a second dose administered inadvertently one year later, which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injury associated with device, Product complaint
Clinical narrative: Product Complaint; Needle remained in patient after injection; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental needle stick in a 6-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 33G3M, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On 11-SEP-2024, the patient received FluLaval 2024-2025 season (intramuscular). On 11-SEP-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental needle stick (Verbatim: Needle remained in patient after injection). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental needle stick and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the accidental needle stick to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the accidental needle stick to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-SEP-2024 The reporter was a clinical supervisor from a medical center.  Medical Assistant, informed 41that after administering flu shot, she was withdrawing needle, and it came off and remained in patient.  Confirmed that she did not twist or rotate the vial in any way the physician witnessed this as he was assisting with holding patient during injection administration.  She would let them know if/when this occur again.  The Full dose was given to the patient. The Vaccine Administration Facility was the same as Primary Reporter
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Maladministration of expired dose; 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 MMR (Priorix) (expiry date 01-AUG-2024) for prophylaxis.   On 16-AUG-2024, the patient received Priorix. On 16-AUG-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Maladministration of expired dose). The outcome of the expired vaccine used 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: 19-SEP-2024 The clinical coordinator asked about the maladministration of three expired doses in three different patients. Vaccination date of patient three of three was 16th August 2024 which led to expired vaccine used. This was report of patient three of three. No further detail about vaccine detail neither patient demographics were provided from the clinical coordinator end. No further information was obtained during this call. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024116635:Same reporter/Diffrent patient US-GSK-US2024116631:Same reporter/Diffrent patient