chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Computerised tomogram abnormal, Contusion, Diverticulum intestinal, Effusion, Glomerular filtration rate normal
Clinical narrative: 8/29/24: This is a 72 year old male with a past medical history of A-fib s/p ablation on Xarelto, who presents to the ED today with the complaint of left arm pain s/p vaccination this morning.  Patient reports that he had a routine checkup with his PCP this morning.  He states that he received his pneumonia vaccine around 9 AM without complication.  He states that around 10 AM his arm started to get sore which he decided to ignore.  Later on in the afternoon he noticed that his arm was getting even more painful and he was now having difficulty lifting it above his head.  His wife took a look at the area and noticed that it was extremely swollen and bruised so they decided to come to the ED.  Besides the shot today, the patient denies any acute injuries or traumas he also denies any numbness, tingling, weakness, chest pain, shortness of breath, or any other complaints at this time.  Patient is on Xarelto blood thinner.  Patient's pain is pretty severe, difficulty with raising his left arm up above 90 degrees.  Initial plan was to apply compressive bandage discharge the patient.  Swelling got progressively worse here in the emergency department.  At that time we did decide to get vascular imaging and admit the patient for further monitoring of the compartment and swelling.  The imaging was otherwise unremarkable.  Patient will be observed overnight.  Patient should be able to be discharged in the morning as long as swelling does not progress.  I did explain that he should hold his dose of Xarelto tomorrow.  He does take it for A-fib. He was discharged 8/30/24 to continue monitoring at home.
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Haematoma, Injected limb mobility decreased, Injection site reaction, Muscle oedema, Pain in extremity
Clinical narrative: 8/29/24: This is a 72 year old male with a past medical history of A-fib s/p ablation on Xarelto, who presents to the ED today with the complaint of left arm pain s/p vaccination this morning.  Patient reports that he had a routine checkup with his PCP this morning.  He states that he received his pneumonia vaccine around 9 AM without complication.  He states that around 10 AM his arm started to get sore which he decided to ignore.  Later on in the afternoon he noticed that his arm was getting even more painful and he was now having difficulty lifting it above his head.  His wife took a look at the area and noticed that it was extremely swollen and bruised so they decided to come to the ED.  Besides the shot today, the patient denies any acute injuries or traumas he also denies any numbness, tingling, weakness, chest pain, shortness of breath, or any other complaints at this time.  Patient is on Xarelto blood thinner.  Patient's pain is pretty severe, difficulty with raising his left arm up above 90 degrees.  Initial plan was to apply compressive bandage discharge the patient.  Swelling got progressively worse here in the emergency department.  At that time we did decide to get vascular imaging and admit the patient for further monitoring of the compartment and swelling.  The imaging was otherwise unremarkable.  Patient will be observed overnight.  Patient should be able to be discharged in the morning as long as swelling does not progress.  I did explain that he should hold his dose of Xarelto tomorrow.  He does take it for A-fib. He was discharged 8/30/24 to continue monitoring at home.
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Peripheral arterial occlusive disease, Peripheral swelling, Scan with contrast abnormal, Skin oedema, Spinal osteoarthritis
Clinical narrative: 8/29/24: This is a 72 year old male with a past medical history of A-fib s/p ablation on Xarelto, who presents to the ED today with the complaint of left arm pain s/p vaccination this morning.  Patient reports that he had a routine checkup with his PCP this morning.  He states that he received his pneumonia vaccine around 9 AM without complication.  He states that around 10 AM his arm started to get sore which he decided to ignore.  Later on in the afternoon he noticed that his arm was getting even more painful and he was now having difficulty lifting it above his head.  His wife took a look at the area and noticed that it was extremely swollen and bruised so they decided to come to the ED.  Besides the shot today, the patient denies any acute injuries or traumas he also denies any numbness, tingling, weakness, chest pain, shortness of breath, or any other complaints at this time.  Patient is on Xarelto blood thinner.  Patient's pain is pretty severe, difficulty with raising his left arm up above 90 degrees.  Initial plan was to apply compressive bandage discharge the patient.  Swelling got progressively worse here in the emergency department.  At that time we did decide to get vascular imaging and admit the patient for further monitoring of the compartment and swelling.  The imaging was otherwise unremarkable.  Patient will be observed overnight.  Patient should be able to be discharged in the morning as long as swelling does not progress.  I did explain that he should hold his dose of Xarelto tomorrow.  He does take it for A-fib. He was discharged 8/30/24 to continue monitoring at home.
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Subclavian arteriosclerosis, Swelling, Vascular imaging
Clinical narrative: 8/29/24: This is a 72 year old male with a past medical history of A-fib s/p ablation on Xarelto, who presents to the ED today with the complaint of left arm pain s/p vaccination this morning.  Patient reports that he had a routine checkup with his PCP this morning.  He states that he received his pneumonia vaccine around 9 AM without complication.  He states that around 10 AM his arm started to get sore which he decided to ignore.  Later on in the afternoon he noticed that his arm was getting even more painful and he was now having difficulty lifting it above his head.  His wife took a look at the area and noticed that it was extremely swollen and bruised so they decided to come to the ED.  Besides the shot today, the patient denies any acute injuries or traumas he also denies any numbness, tingling, weakness, chest pain, shortness of breath, or any other complaints at this time.  Patient is on Xarelto blood thinner.  Patient's pain is pretty severe, difficulty with raising his left arm up above 90 degrees.  Initial plan was to apply compressive bandage discharge the patient.  Swelling got progressively worse here in the emergency department.  At that time we did decide to get vascular imaging and admit the patient for further monitoring of the compartment and swelling.  The imaging was otherwise unremarkable.  Patient will be observed overnight.  Patient should be able to be discharged in the morning as long as swelling does not progress.  I did explain that he should hold his dose of Xarelto tomorrow.  He does take it for A-fib. He was discharged 8/30/24 to continue monitoring at home.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Swelling face
Clinical narrative: Metallic taste immediately lasting 3-4 hours  and puffy lips for one hour
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: This patient was 32 weeks and 5 days when she received the Arevxy RSV vaccine that is not currently approved for use during pregnancy. She is currently 33 weeks and 6 days. Patient was made aware and plans to report to Pediatrician as well.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Contusion, Facial paralysis
Clinical narrative: I asked the pharmcy if I could get them at the same tome ans he said she could. I got the my first Moderna Covid vaccines all pre COVID vaccine were Pfizer vaccines. All my Pfizer vaccines were minimmul reations. After these shots I was on my butt for 36 hourswith severe fatigue, . Next eveing about 7 p I noticed I had a slight brusing between the corner of my eye and my nose, I went to bed and the next morning I had brusing from the left side of my eye to the right eye and down the left side of my face and I had not fallen, I had a crooker smile, I went to my doctors office until I was seen by the PA and got a full exam, I was run through physical riggers and they recommended the ER where I had more test, MRI, CAT, radiology and other test, then seen by a Nuerologist by video call and was diagnosied with bells palsy. DATE OF SERVICE 8/28/2024 at  Hospital.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Laboratory test, Magnetic resonance imaging, X-ray
Clinical narrative: I asked the pharmcy if I could get them at the same tome ans he said she could. I got the my first Moderna Covid vaccines all pre COVID vaccine were Pfizer vaccines. All my Pfizer vaccines were minimmul reations. After these shots I was on my butt for 36 hourswith severe fatigue, . Next eveing about 7 p I noticed I had a slight brusing between the corner of my eye and my nose, I went to bed and the next morning I had brusing from the left side of my eye to the right eye and down the left side of my face and I had not fallen, I had a crooker smile, I went to my doctors office until I was seen by the PA and got a full exam, I was run through physical riggers and they recommended the ER where I had more test, MRI, CAT, radiology and other test, then seen by a Nuerologist by video call and was diagnosied with bells palsy. DATE OF SERVICE 8/28/2024 at  Hospital.
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injection site reaction, Peripheral swelling, Tenderness
Clinical narrative: 24 hours following vaccination administration patient experienced left arm swelling, tenderness, erythema. She applied ice to site, took advil with some improvement. she presents to Clinic for concerns of side effects. She states symptoms are overall improving.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Congestion, rhinorrhea, mild cough, fevers
Age: 26.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Patient is a G8P1 with a history of miscarriage x6. She received the Arexvy vaccine at 35 weeks of pregnancy and this vaccine is not currently approved for use during pregnancy. Patient has been made aware.
Age: 24.0
Sex: F
Vaccine: DTPPVHBHPB, TDAP
Symptoms: No adverse event, Vaccination error, Wrong product administered
Clinical narrative: Vaxelis was given by mistake. Patient informed of vaccine error by provider and assessed. No signs or symptoms noted by of adverse effects.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Rash
Clinical narrative: generalized rash and joint pain, rash on whole body (torso, arms, legs)
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Pt received an extra dose of DTaP as previous dose was not reflecting on medical records chart.
Age: 22.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Presyncope, Seizure
Clinical narrative: AFTER THE PATIENT WAS GIVEN VACCINATIONS, SHE TOLD ME ABOUT HER HISTORY OF PASSING OUT BEFORE. I RECOMMENDED HER TO WAIT IN THE PHARMACY WAITING AREA FOR 15 MINUTES. AFTER ABOUT 5 MINUTES, SHE STARTED SEIZING AND SHE ALMOST PASSED OUT. PHARMACY TEAM CALLED 911 AND BOTH THE PHARMACIST WERE WITH PATIENT THE WHOLE TIME UNTIL EMS ARRIVED. WE CHECKED FOR HER PULSE AND SHE WAS RECOVERING WELL. WE WERE TALKING TO THE PATIENT AND SHE WAS REPONDING TO OUR QUESTIONS SO SHE DID NOT LOOK LIKE SHE WAS CONFUSED OR DISORIENTED. EMS TOOK CARE FROM THERE ON. PATIENT'S MOM ARRIEVED RIGHT AWAY AND SHE TOOK HER TO THE DOCTOR'S OFFICE FOR CHECK UP.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Chills, Computerised tomogram abnormal, Computerised tomogram limb, Culture tissue specimen, Culture wound
Clinical narrative: Pt developed a local reaction at the site of the MMR vaccine (Left arm) 1-2 days after administration. This led to cellulitis of upper left arm. Symptoms: redness, swelling, pain, and fever. She started Cephalexin 500mg Every 6 hours x 10 days and Prednisone 20mg daily x 5 days on 8/11/2024. After starting Cephalexin and the steroid, the redness and swelling increased. She developed body aches, fever and chills. Added Bactrim DS 800/160mg Twice a day x 5 days on the morning of 8/13/2024. Pt went to the ER that night due to the worsening of redness, swelling, and fever. Had CT Scan of left arm to rule out abscess, it showed cellulitis but no abscess. She completed all antibiotics, but still had a hard purple area at the site of the MMR vaccination that was painful to the touch. No fevers at that this time. On 8/27/2024, the area opened up and started to drain. Area/Drainage cultured, results pending. Patient had appointment with wound specialist on 8/30/2024 for wound care and to get an updated treatment plan. The specialist did another culture as well.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Injection site cellulitis, Local reaction, Pain, Pyrexia
Clinical narrative: Pt developed a local reaction at the site of the MMR vaccine (Left arm) 1-2 days after administration. This led to cellulitis of upper left arm. Symptoms: redness, swelling, pain, and fever. She started Cephalexin 500mg Every 6 hours x 10 days and Prednisone 20mg daily x 5 days on 8/11/2024. After starting Cephalexin and the steroid, the redness and swelling increased. She developed body aches, fever and chills. Added Bactrim DS 800/160mg Twice a day x 5 days on the morning of 8/13/2024. Pt went to the ER that night due to the worsening of redness, swelling, and fever. Had CT Scan of left arm to rule out abscess, it showed cellulitis but no abscess. She completed all antibiotics, but still had a hard purple area at the site of the MMR vaccination that was painful to the touch. No fevers at that this time. On 8/27/2024, the area opened up and started to drain. Area/Drainage cultured, results pending. Patient had appointment with wound specialist on 8/30/2024 for wound care and to get an updated treatment plan. The specialist did another culture as well.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Swelling, Vaccination site discharge, Vaccination site discolouration, Vaccination site induration, Vaccination site pain
Clinical narrative: Pt developed a local reaction at the site of the MMR vaccine (Left arm) 1-2 days after administration. This led to cellulitis of upper left arm. Symptoms: redness, swelling, pain, and fever. She started Cephalexin 500mg Every 6 hours x 10 days and Prednisone 20mg daily x 5 days on 8/11/2024. After starting Cephalexin and the steroid, the redness and swelling increased. She developed body aches, fever and chills. Added Bactrim DS 800/160mg Twice a day x 5 days on the morning of 8/13/2024. Pt went to the ER that night due to the worsening of redness, swelling, and fever. Had CT Scan of left arm to rule out abscess, it showed cellulitis but no abscess. She completed all antibiotics, but still had a hard purple area at the site of the MMR vaccination that was painful to the touch. No fevers at that this time. On 8/27/2024, the area opened up and started to drain. Area/Drainage cultured, results pending. Patient had appointment with wound specialist on 8/30/2024 for wound care and to get an updated treatment plan. The specialist did another culture as well.
Age: 20.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Vaccination site reaction, Wound
Clinical narrative: Pt developed a local reaction at the site of the MMR vaccine (Left arm) 1-2 days after administration. This led to cellulitis of upper left arm. Symptoms: redness, swelling, pain, and fever. She started Cephalexin 500mg Every 6 hours x 10 days and Prednisone 20mg daily x 5 days on 8/11/2024. After starting Cephalexin and the steroid, the redness and swelling increased. She developed body aches, fever and chills. Added Bactrim DS 800/160mg Twice a day x 5 days on the morning of 8/13/2024. Pt went to the ER that night due to the worsening of redness, swelling, and fever. Had CT Scan of left arm to rule out abscess, it showed cellulitis but no abscess. She completed all antibiotics, but still had a hard purple area at the site of the MMR vaccination that was painful to the touch. No fevers at that this time. On 8/27/2024, the area opened up and started to drain. Area/Drainage cultured, results pending. Patient had appointment with wound specialist on 8/30/2024 for wound care and to get an updated treatment plan. The specialist did another culture as well.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema
Clinical narrative: Giant red circle 3 inches in diameter. Appeared 2 says after the shot. First time using a Pfizer vaccine. The other 5 were Moderna.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Aphonia, Asthenia, Delirium, Diarrhoea, Dizziness
Clinical narrative: Patient reported on 03 SEP 2024 (5 days after receiving the vaccine) "Within 30 minutes of taking the vaccine, I got really dizzy and started feeling sick. It just escalated from there. I have been running 103 to 104 fevers all weekend, severe body aches, vomiting, diarrhea, my throat hurts so much, my neck is swollen, it hurts to swallow. I have felt delirious. I'm have slept mostly since Thursday. I don't have a voice. I feel extremely weak and shaky. "
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Hypersomnia, Malaise, Nervousness, Odynophagia, Oropharyngeal pain
Clinical narrative: Patient reported on 03 SEP 2024 (5 days after receiving the vaccine) "Within 30 minutes of taking the vaccine, I got really dizzy and started feeling sick. It just escalated from there. I have been running 103 to 104 fevers all weekend, severe body aches, vomiting, diarrhea, my throat hurts so much, my neck is swollen, it hurts to swallow. I have felt delirious. I'm have slept mostly since Thursday. I don't have a voice. I feel extremely weak and shaky. "
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia, Swelling, Vomiting
Clinical narrative: Patient reported on 03 SEP 2024 (5 days after receiving the vaccine) "Within 30 minutes of taking the vaccine, I got really dizzy and started feeling sick. It just escalated from there. I have been running 103 to 104 fevers all weekend, severe body aches, vomiting, diarrhea, my throat hurts so much, my neck is swollen, it hurts to swallow. I have felt delirious. I'm have slept mostly since Thursday. I don't have a voice. I feel extremely weak and shaky. "
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 2 Flu vaccines were administered into different arms, no Adverse Events Reported.
Age: 23.0
Sex: F
Vaccine: COVID19, RSV, UNK
Symptoms: Product administered at inappropriate site, Pyrexia, Urticaria, Vaccination site reaction
Clinical narrative: Immunizations reported to be have given too low. Patient is currently reporting a 2x3 inch welt from where the influenza vaccine was given and that she had hives in the same are but the hives have resolved within an hour of the vaccine. She is currently using ice packs to treat the welt and does express concern that is it growing larger. After speaking with patient and reviewing her record, it does not appear that she has received a recombinant influenza vaccine (Flublok) before and only remembers receiving inactive influenza vaccines in the past. She reported developing a fever yesterday (9/2/24) and this has resolved with Tylenol. She reports that she normally gets fevers with the COVID vaccine and does not express concern. She was instructed to continue to use ice and Tylenol as needed and to follow up with her provider if symptoms do not resolve.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Malaise, Nausea
Clinical narrative: I started feeling fatigued, very sleepy, slept for hours and then developed extreme debilitating dizziness, each time I open my eyes I see the room spinning; developed nausea and vomiting throughout the hours of 2-4 am and this morning just feeling unwell.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vertigo, Vomiting
Clinical narrative: I started feeling fatigued, very sleepy, slept for hours and then developed extreme debilitating dizziness, each time I open my eyes I see the room spinning; developed nausea and vomiting throughout the hours of 2-4 am and this morning just feeling unwell.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram heart, Echocardiogram, Electrocardiogram, Headache, Immunisation reaction
Clinical narrative: PFIZER #1 3/22/2021 PFIZER #2 4/12/2021 PATIENT DEVELOPED SUBCLINICAL VACCINE MYOPERICARDITIS, SMALL FIBER NEUROPATHY, POST-EXERTIONAL MALAISE, AND HEADACHE.  SLOWLY IMPROVED OVER ONE YEAR ON PROTOCOL BASE SPIKE DETOXIFICATION AND LATER ADDED COLCHICINE 0.6 MG A DAY AND NICOTINE PATCH 7 MG A DAY.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Malaise, Myopericarditis, Scan myocardial perfusion, Small fibre neuropathy
Clinical narrative: PFIZER #1 3/22/2021 PFIZER #2 4/12/2021 PATIENT DEVELOPED SUBCLINICAL VACCINE MYOPERICARDITIS, SMALL FIBER NEUROPATHY, POST-EXERTIONAL MALAISE, AND HEADACHE.  SLOWLY IMPROVED OVER ONE YEAR ON PROTOCOL BASE SPIKE DETOXIFICATION AND LATER ADDED COLCHICINE 0.6 MG A DAY AND NICOTINE PATCH 7 MG A DAY.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Insulin therapy, Oesophageal carcinoma
Clinical narrative: Death
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Starting 14 hours after vaccine: temperature up to 101.6, chills, nausea, severe headache, body aches (mostly hips, legs and lower back), fatigue, injection site pain.     Symptoms lasted for 24 hours after onset. Took acetaminophen then ibuprofen, cold packs to forehead. Gingerale was the only food/liquid I could tolerate. By 48 hours after vaccine I felt back to normal.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Starting 14 hours after vaccine: temperature up to 101.6, chills, nausea, severe headache, body aches (mostly hips, legs and lower back), fatigue, injection site pain.     Symptoms lasted for 24 hours after onset. Took acetaminophen then ibuprofen, cold packs to forehead. Gingerale was the only food/liquid I could tolerate. By 48 hours after vaccine I felt back to normal.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2
Symptoms: Death
Clinical narrative: Patient expired on 8/31/2024.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Nerve conduction studies, Radiculitis brachial
Clinical narrative: Patient reports both COVID and influenza vaccinations; patient diagnosed with brachial neuritis without known cause, thought due to recent influenza or COVID vaccinations though unsure of details surrounding vaccine specifics
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Brain natriuretic peptide increased, Pain, Red blood cell sedimentation rate increased
Clinical narrative: Resident received RSV vaccine 8/29/24 in afternoon. Resident sent to Emergency Department 8/30/24 in the afternoon for increased pain, fever - 99.7 deg F, and abnormal lab results -- BNP 3,075, ESR 107.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Muscle disorder, Myalgia, Nodule, Pain
Clinical narrative: Red, swollen, painful, itching localized area 5 inches by 3 inches with severe pain and large knot in the muscle. Patient went to urgent care and received a steroid shot and a prescription for benadryl. She states now, 5 days later, that symptoms are resolving.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Red, swollen, painful, itching localized area 5 inches by 3 inches with severe pain and large knot in the muscle. Patient went to urgent care and received a steroid shot and a prescription for benadryl. She states now, 5 days later, that symptoms are resolving.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dyskinesia, Feeling abnormal, Malaise, Pallor, Posture abnormal
Clinical narrative: Public Health Nurse (PHN) was giving immunization, client went pale, stated ?I don?t feel so well? closed eyes and slumped backwards in chair, client had jerking motion along with perspiration. This PHN was able to stabilize client in chair while mom pushed red emergency button phone. Client opened eyes seconds later. Another PHN was able to respond. BP taken 1732 80/48.  This nurse was able to talk to patient. Patient was able to tell me her name but stated she still, ?felt funny.? Client stayed in chair, food and juice given. BP retaken 88/50, color came back into clients face and client sat for another 10 minutes and was able to stand up and walk with steady gate and stated no dizziness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Incorrect dose administered, Medication error
Clinical narrative: This is a medication error report. The pediatric patient received the adult dose of Hep B( Engerix-B) 20mcg/hep b vaccine. The error was found during our end of month count. The provider was notified, patient's family was called and notified. Per patient's mother child had no adverse reaction following vaccine, no changes in status and is doing fine, states playing as usual and has not been sick.  A corrective action plan has been put in place to prevent this from happening again.                                                                                                     Corrective action plan for vaccine administration error  1. All personnel that administer vaccines will have to review the videos offered.    2. The refrigeration set up for immunization has been review and the following changes made to decrease the possibility of medication error when administering vaccines. ?  The adult vaccines are currently on the top shelf of the refrigeration unit and they will remain on top shelf but will be enclosed in a separate container all together. All individual doses will remain in shipping box; however, all doses will be label ADULT. This will help in identifying the vaccine so that it cannot be mistaken for a pediatric dose.  ? Pediatric doses will remain in the second and third shelf of refrigeration unit, they will also remain in their shipped box and will have a yellow label indicating pediatric dose.  3. The 5 rights of medication administration are currently used and we have reviewed the process to see how the mistake took place. After further review, we have decided to add an extra step to the verification process. All immunizations will now have a two-point verification process in addition to the 5 rights of medication administration.  the first verification process will be done by staff administering immunization. They will verify 5 rights and inspect the vaccines physically for accuracy, as in Pediatric or Adult dose. The second verification process will be done by the primary or secondary vaccine coordinator, they will reverify the 5 rights and correct dose Pediatric or Adult before being administered to the patient.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Rotateq given on 7.11.24 at 4months of age. Rotateq not to be given after 14 weeks 6 days. No patient symptoms or events as of 9.3.24. Error caught on 8/22/24.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Laboratory test, Muscle contracture, Pallor
Clinical narrative: No contraindications noted. Child does have history of fainting during medical procedures as follows: fainting after blood draw at age 5-6, and fainting after COVID vaccination in 2022.  Mother described that child fainted with "seizure like shaking" in the Doctor's office without any medical procedure; child went to the Emergency Room via ambulance and was in the ER for 6 hours were ?many? studies/tests were completed and seizures were ruled out. Two other Doctors have ruled out seizures. Child has and upcoming referral with a neurologist. After speaking with other medical providers including therapist, mother believes it is related to anxiety. Child highly anxious and encouraged to engage her coping skills to lower anxiety. Child listened to music, and had sensory tools. Vital signs taken @1030 before vaccine administration and as follows: BP 116/78, HR 95, O2 98%, and RR 20; per mother, baseline BP is 96/66 or 98/60.  Immunizations given with child sitting and supported by mom; mother denied having child lay down on the ground for vaccine administration. Immediately after vaccine administration, Child fainted into mother?s arm with muscles contracting in the legs and arms a few times. Child recovered within 10 seconds of onset, alert and oriented X4; patient face color pale but no paleness noted in the extremities. Patient stated only feeling dizzy and denied feeling any other sign or symptom immediately before event, during event, and after event. Patient encouraged to lay down with mother providing support. Patient encouraged to drink water and eat snacks. Vital signs @1040 BP 92/60, HR 74, O2 97%, RR 20. Vital signs @1045 BP 94/66, HR 70, O2 100%, RR 18. Vital signs @1055 BP 96/72, HR 83, O2 99%, RR 16. VS @ 1115 BP 98/74, HR 88, O2 98%, RR 16. Child stated feeling ?good? and no longer pale. Recommended going to the ER. Mother stated she did not want to go to the ER and will follow up with her provider. Supervisor notified. Copy of vaccine record given, next vaccine discussed. After-shot cared reviewed. Mother and Patient instructed to call emergency services and follow up with her Provider if child displays any other signs or symptoms. Mother verbalized understanding.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Seizure like phenomena, Syncope, Tremor
Clinical narrative: No contraindications noted. Child does have history of fainting during medical procedures as follows: fainting after blood draw at age 5-6, and fainting after COVID vaccination in 2022.  Mother described that child fainted with "seizure like shaking" in the Doctor's office without any medical procedure; child went to the Emergency Room via ambulance and was in the ER for 6 hours were ?many? studies/tests were completed and seizures were ruled out. Two other Doctors have ruled out seizures. Child has and upcoming referral with a neurologist. After speaking with other medical providers including therapist, mother believes it is related to anxiety. Child highly anxious and encouraged to engage her coping skills to lower anxiety. Child listened to music, and had sensory tools. Vital signs taken @1030 before vaccine administration and as follows: BP 116/78, HR 95, O2 98%, and RR 20; per mother, baseline BP is 96/66 or 98/60.  Immunizations given with child sitting and supported by mom; mother denied having child lay down on the ground for vaccine administration. Immediately after vaccine administration, Child fainted into mother?s arm with muscles contracting in the legs and arms a few times. Child recovered within 10 seconds of onset, alert and oriented X4; patient face color pale but no paleness noted in the extremities. Patient stated only feeling dizzy and denied feeling any other sign or symptom immediately before event, during event, and after event. Patient encouraged to lay down with mother providing support. Patient encouraged to drink water and eat snacks. Vital signs @1040 BP 92/60, HR 74, O2 97%, RR 20. Vital signs @1045 BP 94/66, HR 70, O2 100%, RR 18. Vital signs @1055 BP 96/72, HR 83, O2 99%, RR 16. VS @ 1115 BP 98/74, HR 88, O2 98%, RR 16. Child stated feeling ?good? and no longer pale. Recommended going to the ER. Mother stated she did not want to go to the ER and will follow up with her provider. Supervisor notified. Copy of vaccine record given, next vaccine discussed. After-shot cared reviewed. Mother and Patient instructed to call emergency services and follow up with her Provider if child displays any other signs or symptoms. Mother verbalized understanding.
Age: 6.0
Sex: M
Vaccine: DTAPIPVHIB, HEPAB, MMRV, PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms. Mom said he was fine. We gave the adult Twinrix
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Allergy to vaccine, Diarrhoea, Hypersensitivity, Pyrexia, Rash
Clinical narrative: Summary of emergency room view Hospital... What... per skin rash. ... ... of pediatric Dr indicates that you have a high fever 40 C ...diarrhea x3 and urticaria generalizes... who received treatment in the emergency room at the Hospital with Benadryl and Solumedrol. Document attached. ... Vaccination here reported that the child ... indicated presented allergic reaction to vaccination of 4 months on 8/26/24 ... ... high... of 40 C. 12 ... diarrhea due to 3 episodes and generalized urticaria in the body. Received... in the hospital .. Benadryl and Solumedrol... Registered today 8/28/24. Sincerely, Dr.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Urticaria
Clinical narrative: Summary of emergency room view Hospital... What... per skin rash. ... ... of pediatric Dr indicates that you have a high fever 40 C ...diarrhea x3 and urticaria generalizes... who received treatment in the emergency room at the Hospital with Benadryl and Solumedrol. Document attached. ... Vaccination here reported that the child ... indicated presented allergic reaction to vaccination of 4 months on 8/26/24 ... ... high... of 40 C. 12 ... diarrhea due to 3 episodes and generalized urticaria in the body. Received... in the hospital .. Benadryl and Solumedrol... Registered today 8/28/24. Sincerely, Dr.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Decreased appetite, Dizziness, Gastritis, Malaise
Clinical narrative: First day (two days after injection): sore arm, stomach bloating, gastritis, dizziness, general malaise. Subsequent days: General malaise, dizziness, loss of appetite. Antacid (Tums) and Pepto-Bismol, aspirin, ibuprofen helped to alleciate symptoms. Sept 2nd: started to feel better.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First day (two days after injection): sore arm, stomach bloating, gastritis, dizziness, general malaise. Subsequent days: General malaise, dizziness, loss of appetite. Antacid (Tums) and Pepto-Bismol, aspirin, ibuprofen helped to alleciate symptoms. Sept 2nd: started to feel better.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no side effects or symptoms; expired PNEUMOVAX23 was administered today; This spontaneous report was received from a Medical Assistant and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 14-AUG-2024, the patient received pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0,5ml/once, lot #w025084, expiration date: 12-AUG-2024, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) (Expired product administered) by a Health Professional. No side effects or symptoms (no adverse event). No previous temperature excursions.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Accidental underdose
Clinical narrative: No additional AE information available; A patient did not receive a full dose of VARIVAX today 8/14/2024; The Medical Assistant delivering the vaccine did not connect the needle to the syringe completely; This spontaneous report was received from a nurse and refers to an 1-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #Y003891, expiration date: 06-FEB-2026, administered for prophylaxis (strength, dose and route of administration were not provided). The Medical Assistant delivering the vaccine did not connect the needle to the syringe completely, therefore the vaccine in the syringe sprayed out of the needle and the patient did not receive a full dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Accidental underdose). The Nurse reports that the Syringe that was used to deliver the varicella virus vaccine live (oka/merck) (VARIVAX) to the patient was not the Pre-Filled Syringes that comes with the Diluent but was a 1ML syringe BD brand and BD brand needle 25G by 5/8th.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE; a 17 year old patient was inadvertently administered a PROQUAD dose; This spontaneous report has been received from a medical assistant referring to a 17-year-old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were unknown. The patient's prior vaccination history was unknown.  On 09-AUG-2024, the patient was inadvertently administered a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) dose by a health professional for prophylaxis (lot # Y004996, expiration date 26-AUG-2025; strength, dose and route of administration were not reported) (Product administered to patient of inappropriate age). The office had not followed up with the patient since the administration took place. No additional details were provided. No product quality complaint (PQC) or other adverse event (AE) was reported (No adverse event).
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Infant irritability
Clinical narrative: a 2-month-old female patient who experienced fussiness after receiving Pentacel, Prevnar, and ROTATEQ; This spontaneous report was received from a physician referring to a 2-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 21-MAR-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for immunisation (strength, dose, lot #, and expiry date were not provided); diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), administered intramuscularly for immunisation (lot # UK015AA, expiry date, strength, formulation, and dose were not provided); and pneumococcal vaccine conj 7v (crm197) (PREVNAR), administered for immunisation (strength, formulation, dose, lot #, expiry date, and route of administration were not provided).   On 21-MAR-2024, the patient experienced fussiness (Irritability) after receiving suspect vaccines above. On 22-MAR-2024, the patient recovered from the event of irritability. The action taken with all suspect vaccines regarding irritability was considered as not applicable.   The causal relationship between irritability and all suspect vaccines was not provided.
Sex: U
Vaccine: FLUN3, FLUN3
Symptoms: Unevaluable event
Clinical narrative: PATIENT IS ON THE AUTISM SPECTRUM; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v) (batch number Unknown) once/single administration, via nasal route, on an unknown date. The patient received Flumist (influenza vaccine live reassort 3v) (batch number Unknown) once/single administration, via nasal route, on an unknown date.     A UNKNOWN administered FLUMIST. No malfunction has been reported for this combination product.   A UNKNOWN administered FLUMIST. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced patient is on the autism spectrum (preferred term: Autism spectrum disorder).    Action taken with suspect flumist was not applicable.     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a specified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-AUG-2024 This case was reported by a consumer via interactive digital media. The reporter asked, who and why were they promoting the shingles shot. 2 siblings ago got the shot, got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; people still get shingles/get Shingles a couple weeks later; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: people still get shingles/get Shingles a couple weeks later). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 The case was received from the consumer via interactive digital media. The reporter reported that many people still got shingles after getting vaccinated with Shingrix. The reporter asked not to get the vaccination as many still got it after the shot. The reporter reported that you could still got shingles after shingles vaccination and that the vaccination did not lessen the severity of shingles. The reporter reported sadly, this was true, many had gotten the Shingles vaccination and got Shingles a couple weeks later and the shot did not lessen the severity.  The reporter asked everyone to do their research, a paid doctor, was not your best recommendation. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles 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 vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; had pain and issues; back pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), pain (Verbatim: had pain and issues) and back pain (Verbatim: back pain). The outcome of the vaccination failure and back pain were not reported and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and back pain to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix. It was unknown if the company considered the shingles, pain and back pain to be related to Shingrix.   Additional Information: GSK receipt date: 28-AUG-2024 This case was reported by a patient via interactive digital media. The reporter reported that a friend had a shingles vaccine upon her doctor's recommendation and ended up shingles and still dealing with the pain and issues from it.  The reporter thought it was not worth it. The reporter believed people should make their own decision. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles infection were unknown at the time of reporting; Sender's Comments: Vaccination failure  is a listed event which is considered related to GSK vaccine  Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received first dose on 03-DEC-2020 with batch number XG52X and expiration date 28-NOV-2021).   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: has not yet received a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2024 The pharmacist had a patient that received first dose of Shingrix and had has not yet received a second dose. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Reporter gave permission for follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination.