chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient administered an expired vaccine by mistake. Vaccine (MMR) administered to patient in Right Deltoid on 10/23/24 at 12:56 pm and expiration of vaccine dated as 10/21/24.  Pt. notified and educated on re-administration and error. Advised patient to follow up in 28 days in the clinic before another dose of MMR can be administered. Pt. verbalized an understanding of the plan of care.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Dyskinesia, Dyspnoea, Fatigue, Headache
Clinical narrative: After drinking a cup of coffee in our den, my husband stood up to take my cup and get us a refill.  As I raised my arm to give my cup to him, I lost my breath. He turned  to walk to our kitchen which is less than 15 feet away with no walls to where we were sitting as I had regained my breath and turned my head toward the right and the room disappeared from my vision.  I could tell my left arm was jerking back and forth and it was as if I was dreaming of trying to reach a rope.  He was back in less than 1.5-2 minutes.  I thought I called his name but he said I never said anything and he did not hear a sound.  From the time I turned my head after the brief loss of breath, went through the left arm jerking back and forth was just a fraction of time.  This appears to fit a seizure description of which I have never had before.  I have taken each Covid vaccine originally starting with the J&J then once we could get a booster, I went with Phizer and have stayed with them ever since not missing a dose.  This makes my second annual dose.   I immediately checked all of my senses afterwards to be sure there wasn t anything signaling a stroke, body and mind were fine but a horrific headache.   The rest of the day yesterday I just felt worn out.  I still have tingling sensation in my head that is aggravating and bothersome as well as a headache.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: After drinking a cup of coffee in our den, my husband stood up to take my cup and get us a refill.  As I raised my arm to give my cup to him, I lost my breath. He turned  to walk to our kitchen which is less than 15 feet away with no walls to where we were sitting as I had regained my breath and turned my head toward the right and the room disappeared from my vision.  I could tell my left arm was jerking back and forth and it was as if I was dreaming of trying to reach a rope.  He was back in less than 1.5-2 minutes.  I thought I called his name but he said I never said anything and he did not hear a sound.  From the time I turned my head after the brief loss of breath, went through the left arm jerking back and forth was just a fraction of time.  This appears to fit a seizure description of which I have never had before.  I have taken each Covid vaccine originally starting with the J&J then once we could get a booster, I went with Phizer and have stayed with them ever since not missing a dose.  This makes my second annual dose.   I immediately checked all of my senses afterwards to be sure there wasn t anything signaling a stroke, body and mind were fine but a horrific headache.   The rest of the day yesterday I just felt worn out.  I still have tingling sensation in my head that is aggravating and bothersome as well as a headache.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Patient reports flu-like symptoms for 2 weeks after receiving vaccine. She reports fatigue, chills and fever.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blepharospasm, Erythema, Pain in extremity, Pruritus
Clinical narrative: Patient reported experiencing itching almost immediately then the next day 11/7 swelling, redness, pain in arm, right eye twitching, left elbow pain and hand pain
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient reported experiencing itching almost immediately then the next day 11/7 swelling, redness, pain in arm, right eye twitching, left elbow pain and hand pain
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: My left arm became red, and when touched it was very hot and tender. It became very swollen, hard to move. I had a high fever especially on Saturday and Sunday and could not move my left arm. I saw online that this maybe an Arthus reaction. Yesterday, it was tender and the upper arm turned red again, at the injection site if you press on it - it is hard size of a half dollar and a cylinder of hard tissue depth and is black.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: My left arm became red, and when touched it was very hot and tender. It became very swollen, hard to move. I had a high fever especially on Saturday and Sunday and could not move my left arm. I saw online that this maybe an Arthus reaction. Yesterday, it was tender and the upper arm turned red again, at the injection site if you press on it - it is hard size of a half dollar and a cylinder of hard tissue depth and is black.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Inflammation, Palpitations
Clinical narrative: heart palpitations, excessive sweating, shortness of breath, inflammation
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: This child was accidently given 2 Fluzone injections
Age: 62.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Chills, Pain in extremity, Product preparation issue, Pyrexia
Clinical narrative: Pt was to receive 3 vaccines. Shingrix, Arexvy and Flu. The diluent for shingrix was used to mix the Arexvy vaccine and pt was given just the the Arexvy diluent on its own and was given to the patient. Pt only reported fever, chills and a sore arm the next day
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Dermatitis contact, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Patient developed contact dermatitis spreading from the injection site across his thigh with redness and swelling.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Erythema, Pain
Clinical narrative: I woke with a very sore red hot itchy right arm. Soon followed by chills 100 degrees fever and body aches all day. The next day Nov.10 I had stomach pains along with my joints still hurt and rash is still there even today. 11-11-24. I took Tylenol for the fever and stayed in bed all day.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia, Rash, Skin warm
Clinical narrative: I woke with a very sore red hot itchy right arm. Soon followed by chills 100 degrees fever and body aches all day. The next day Nov.10 I had stomach pains along with my joints still hurt and rash is still there even today. 11-11-24. I took Tylenol for the fever and stayed in bed all day.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site paraesthesia
Clinical narrative: Dates, or shifts missed, due to this injury:0 Concern/Data: Received varicella vaccine, subcutaneously in the back of my right arm, on Thursday November 7, at approximately 2pm. Friday, 11/8, I began feeling ill (nausea, increased stomach upset, low-grade fever). Later in the day I noticed a raised red area at the injection site. The area was warm to the touch and painful. By Saturday morning, 11/9, the area had grown to about 2-3x the size it was on Friday. The area was extremely painful, hot to the touch, and tingling down into my fingers. I went to Urgent care and gave them a description of the events that had occurred. The nurse practitioner came in to see me. She looked at the area and examined and determined I had gotten cellulitis. She started me on a 7 day course of Cephalexin 1,000mg twice a day. The area is still painful with lots of bruising and some redness in the area, as of 11/11. Action/Intervention: Reviewed online injury report. Recommended self care instructions to include: Continues antibiotics, as prescribed and OTC med of choice. No medical provider referral at this time. Provided written information on Workers  Compensation, including contacts, medical services information, work status information, first fill document for initial prescriptions, Health Care Provider Report form and mileage log. Physician choice form discussed and completed. Area is less reddened and warm since initiation of cephalexin, but employee continues to report that area is painful to touch. using Tylenol, as needed, for pain with good effect. Response: Verbalizes understanding of instructions. Evaluation/Plan: Self care instructions. Return to work with no restrictions. Contact Workers  Compensation case manager if medical provider appointment is indicated. -RN
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Paraesthesia
Clinical narrative: Dates, or shifts missed, due to this injury:0 Concern/Data: Received varicella vaccine, subcutaneously in the back of my right arm, on Thursday November 7, at approximately 2pm. Friday, 11/8, I began feeling ill (nausea, increased stomach upset, low-grade fever). Later in the day I noticed a raised red area at the injection site. The area was warm to the touch and painful. By Saturday morning, 11/9, the area had grown to about 2-3x the size it was on Friday. The area was extremely painful, hot to the touch, and tingling down into my fingers. I went to Urgent care and gave them a description of the events that had occurred. The nurse practitioner came in to see me. She looked at the area and examined and determined I had gotten cellulitis. She started me on a 7 day course of Cephalexin 1,000mg twice a day. The area is still painful with lots of bruising and some redness in the area, as of 11/11. Action/Intervention: Reviewed online injury report. Recommended self care instructions to include: Continues antibiotics, as prescribed and OTC med of choice. No medical provider referral at this time. Provided written information on Workers  Compensation, including contacts, medical services information, work status information, first fill document for initial prescriptions, Health Care Provider Report form and mileage log. Physician choice form discussed and completed. Area is less reddened and warm since initiation of cephalexin, but employee continues to report that area is painful to touch. using Tylenol, as needed, for pain with good effect. Response: Verbalizes understanding of instructions. Evaluation/Plan: Self care instructions. Return to work with no restrictions. Contact Workers  Compensation case manager if medical provider appointment is indicated. -RN
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Vomiting
Clinical narrative: MUCUS/BLOODY DIARRHEA STOOLS, VOMITING
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMBNESS IN LEFT ARM AND LEFT SIDE OF FACE
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I spoke with the patient, administered the second dose of RSV vaccine, and pt stated no adverse reaction following the dose.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Injection site pruritus
Clinical narrative: Covid arm, itchy like crazy (at injection site only) ever since vaccine was given.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Dysphonia
Clinical narrative: pt states he a stuffy and runny nose. His voice is hoarse and he is hacking up phlem.  He developed severe diarrhea with sweating and chills. He was feeling very weak and dizzy.  He continues to have the weakness and fatigue.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Nasal congestion, Productive cough, Rhinorrhoea
Clinical narrative: pt states he a stuffy and runny nose. His voice is hoarse and he is hacking up phlem.  He developed severe diarrhea with sweating and chills. He was feeling very weak and dizzy.  He continues to have the weakness and fatigue.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: fever, body aches
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness with sensation radiating down my arm to my fingertips.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site mass, Injection site rash, Nausea, Pain
Clinical narrative: Patients wife states patient began getting lump and rash at injection site followed by nausea, vomiting, fever, chills, and body aches
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patients wife states patient began getting lump and rash at injection site followed by nausea, vomiting, fever, chills, and body aches
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching, Neuropathy peripheral, Paraesthesia
Clinical narrative: PATIENT IS SAYING THAT THE DAY AFTER THE VACCINE WAS GIVEN HE STARTED TO SHOW SIDE EFFECTS OF NUMBNESS, TINGLING, NUEROPATHY IN THE FACE, ITCHING IN THE FACE. SYPTOMS HAVE PERSISTED SINCE, THEY HAVE NOT WORSEN SINCE BUT HAVE NOT SUBSIDED. PATIENT WENT TO SEE DR AND THE VERIFIED THAT IT WAS A SIDE EFFECT. IT IS POSSIBLE THAT PATIENT COULD HAVE BELLS PALSEY DUE TO VACCINE. PHARMACIST CALLED THE PROVIDER TO LET THEM KNOW PATIENT IS HAVING REACTIONS.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Connective tissue disorder, Ligament disorder, Ligament sprain, Mobility decreased, Muscular weakness
Clinical narrative: Mother reports patient's connective tissue does not work right causing patient to keep spraining wrists. Unable to straighten her fingers. Mom reports patient has damage to her DNA and muscle weakness.    Patient reports she has weak ligaments and has been diagnosed with a small amount of uterine cancer.  Patient has been advised by our office to submit a VAERS report in order to document her symptoms since receiving two HPV vaccines. Second HPV was received on 2/23/2021 Lot # 1687291.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Uterine cancer, X-ray
Clinical narrative: Mother reports patient's connective tissue does not work right causing patient to keep spraining wrists. Unable to straighten her fingers. Mom reports patient has damage to her DNA and muscle weakness.    Patient reports she has weak ligaments and has been diagnosed with a small amount of uterine cancer.  Patient has been advised by our office to submit a VAERS report in order to document her symptoms since receiving two HPV vaccines. Second HPV was received on 2/23/2021 Lot # 1687291.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Unable to reach patient after multiple attempts
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Patient was given a moderna 6m-11yr vaccine when based on age should have received a moderna spikevax which is double the dose. To correct the issue, a second moderna 6m-11yr was given.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: none from the vaccine.  Bronchitis was probably from international travel.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pfizer Comirnaty 30mcg/0.3ml. NDC #00069-2432-10. Severe pain in upper left arm and left knee. Pain in left arm resolved. Pain in left knee continues.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine Expired 11/2/24. No adverse reactions.
Age: 47.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness
Clinical narrative: PATIENT RECEIVED HER  VACCINATIONS AND WHEN WALKING, SHE BECAME VERY LIGHT HEADED AND DIZZY.  SHE IMMEDIATELY SAT DOWN.   WE GOT HER TO A SAFE PLACE AND HAD HER LIE DOWN AND DRINK WATER UNTIL SHE FELT BETTER.  SHE REFUSED 911 SERVICES AND A SNACK AS SHE HAD JUST HAD LUNCH.  SHE WAS VERY NERVOUS PRIOR TO INJECTION AND STATED SHE HAS BEEN UNDER A LOT OF STRESS LATELY.  WE CALLED HER PHYSICIAN, AND THEY WANTED HER TO REMAIN LYING DOWN UNTIL SHE FELT BETTER BUT NO OTHER NECESSARY ACTIONS.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Erectile dysfunction, Laboratory test normal
Clinical narrative: HELLO, IT IS MY BELEIVE THAT THE COVID 19 VACCINE HAS SOMETHING TO DO WITH MY ISSUE.  SINCE I GOT THE FIRST DOSE O THE VACCINE MY SEXUAL FUNTION BEGAN TO DRECREASE SUBTANTIALLY, BY THE TIME I GOT MY I GOT MY 6 DOSES OF THE REFORCE VACCINE, ALL MODERNA MY SEXUAL ACTIVITY DECREASE TO ZERO.   EVEN AFTER USING VIAGRA, CIALIS AND VARDENAFIL DO NOT GET AN ERECTION.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash
Clinical narrative: PT HAD SHOT ON WED 11/6 SUNDAY 11/10 RASH APPEARED AT SIGHT OF INJECTION AND ANOTHER RASH 3 INCHES BELOW
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired 10/31/24, no post symptoms or side effects reported.  Patient repeating vaccine.
Age: 68.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Pt's son reported pt had high fever of 102F, significant headache, chills, body aches, and sweating. Began around 2-3 hrs after administration and continued for most of night until the morning. Has mostly resolved as of this moment.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Novavax expired 10/31/24.  Patient reported no post events and will repeat in 8 weeks
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Swelling face
Clinical narrative: Symptoms began a few hours after vaccine administration. Facial swelling, dyspnea, localized redness and swelling at site of administration.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Novavax expired 10/31/24.  Patient reported no adverse events and plans to repeat in 8 weeks
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Extra dose administered, Headache
Clinical narrative: Patient received fluzone while in office. Patient called 11/11/2024 asking why it was given when he received fluzone from Pharmacy in Sept. That vaccination is not in system. Only vaccine documented in system from 09/20/2024 is RSV. Communication from Pharmacy sent to clinic on 09/22/2024 states he received Fluzone lot#u8507da on 09/20/2024, but again was not listed in System. Patient states the night of vaccination he began to cough and have HA. Advised those symptoms are consistent with normal side effects of vaccine. No CP, SOB or weakness.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Novavax expired 10/31/24.  Patient reported no adverse events and plans to repeat in 8 weeks
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Spikevax given to patient under 12 years old
Age: 1.33
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Received an extra fluzone flu vaccine in 2024
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Received one extra flu vaccine in 2024-2025 season
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aggression, Asthenia, Breath holding, Crying
Clinical narrative: Approximately 8-10 days after vaccination, child began to have loss of appetite, decreased speech/vocabulary, random small skin rashes throughout arms, torso, and thighs,  loss of energy , severe behavioral changes(uncontrolled tantrums),  seemingly discomfort in head(when crying would randomly hold the back of his head) ,and difficulty sleeping
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Head discomfort, Insomnia, Rash, Speech disorder
Clinical narrative: Approximately 8-10 days after vaccination, child began to have loss of appetite, decreased speech/vocabulary, random small skin rashes throughout arms, torso, and thighs,  loss of energy , severe behavioral changes(uncontrolled tantrums),  seemingly discomfort in head(when crying would randomly hold the back of his head) ,and difficulty sleeping
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swollen and itchy arm at and around the injection site. It was swollen to three times the size of his regular arm for 36 hours and then started to get better. After 2.5 days, it is still about 1.5 times as big as his regular arm.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Hyperhidrosis, Irritability, Mental status changes, Pallor
Clinical narrative: Patient was fussy afterwards, crying, sweaty, pale, seemed altered. Lasted for a few minutes, up to 5-10 minutes.. Patient vitals retaken, examination completed. Given apple juice and cheez-its. Self resolved
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Patient reported on 11/7/2024 that she developed bruising at injection site. We have attempted to reach out to follow up with symptoms with no response. No treatment has been given at this time.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Neuropathy peripheral, Sleep disorder
Clinical narrative: Sharp increase in severity of existing peripheral neuropathy,  Especially noticeable inn hands and face (lower left side). Disrupts sleep for th first time.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Dizziness, Muscle spasms, Urinary tract infection, Urine analysis
Clinical narrative: Severe sudden onset of UTI with blood in the urine. This has never happened to me before. I have only had one or two minor uti in 56 years.  Severe cramping and almost passed out.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient came in stating that she needed a covid vaccine when asked if she had any vaccines in the past 4 weeks patient stated that she had her flu vaccine last week. Performed the shot and when I went to enter it into the computer noticed that the patient had the covid shot the week before not the flu. Patient was called no answer and left message also spoke with Dr. for course of action. Unknown effects at this time.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Spikevax given to child under 12 years old
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: as of now there has been no adverse event, patient was given flublok for ages 18 years of age and older and pt is only 9 years old
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Aplastic anaemia, Laboratory test
Clinical narrative: My daughter got a very severe a plastic aneima two weeks after vaccine.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse event as of now, Just gave the pt flublok for pts 18 years of age and older instead of fluzone
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pain, Pyrexia
Clinical narrative: I got fever body aches from the vaccine I missed work one day it only last 1 day on a Friday
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest pain, Feeling of body temperature change, Pruritus, Pyrexia, Urticaria
Clinical narrative: I got the initial 2 covid shots back in 2021 (march 25, and Apr 22), had a follow up Apr 15 of 2022. I only got a flu shot in 2023. I have never reacted to the flu shot; not even a headache or mild fever. Other than being sick for week after the previous COVID shots, I never reacted like this. The night I received the shots, I came down with a fever, and hot/cold shakes (my chest and head felt on fire, while my extremities were freezing). The next night (Friday, Nov 1st) I started becoming uncontrollably itchy. I realized I had broken out in hives. (I get hives from grass, but I hadn't been in grass, nor had I changed my sensitive skin soaps or anything). The hives were localized on my thighs, and Benadryl took care of the itching. By the next morning they had spread, and I needed more Benadryl. I have been taking Benadryl like clockwork, The hives have spread to a majority of my body, though in some places they have 'healed' if that's the right term, or disappeared. My thighs have not gone away. The hives spread up my stomach and chest (mostly gone now), they've been on my arms, and side (come and go), They spread to the side of my thighs, and knees/back of knees. I went to the Dr Friday, Nov 8th. I was prescribed a 5 day dose of Prednisone. The Pred doesn't really seem to be helping the itchiness, or the appearance of hives.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia totalis, Echocardiogram, Electrocardiogram, Laboratory test, Myopericarditis
Clinical narrative: MODERNA #1 4/14/2021 MODERNA #2 10/24/2021  DEVELOPED VACCINE SUBCLINICAL MYOPERICARDITIS AND ALOPECIA TOTALIS.  TREATED WITH COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION
Age: 76.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Abdominal discomfort, Asthenia, Fear, Hyperhidrosis
Clinical narrative: Two days after I received my COVID and Flu shot I got my usual allergy shots.  After getting my allergy shots I urinated and then sat down.  Almost immediately after sitting down my face and head began to sweat and my stomach was upset.  I also felt weak.  I continued to sit for 10 minutes before seeing the nurse.  She took my blood pressure etc. and had me continue to sit.  The doctor gave me a low dose antihistamine.  30 minutes later I was feeling better and went home.  My stomach was upset for the following week.  I have never had a reaction to my allergy shots.  However, I have always waited 2 weeks after my COVID and Flu shot to get me allergy shots.  I got my allergy shots two weeks later with not reaction.  They reduced my dose and gave me an antihistamine.  Feeling fine now.  Was a little scary when it happened.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Peripheral swelling
Clinical narrative: Leg swelling and sciatica pain
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site swelling
Clinical narrative: Vaccine injection site got swollen for a few days after receiving. Patient was having trouble lifting arm up and placing behind back. It has slowly been getting better over time
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: PT CAME TO OUR RURAL HEALTH CLINIC TO GET A FLUAD AND COVID SHOT AT A FLU CLINIC. AFTER SHE GOT THE SHOT I WAS GOING THROUGH MY INVENTORY AND RECOGNIZED HER NAME FROM THE PREVIOUS WEEK. I LOOKED INTO OUR CLINIC RECORDS, AND SHE HAD BEEN THERE ON 10/14/2024 AND GOT A TDAP AND A FLUAD OUT THERE ALSO. PT HAS BEEN DIAGNOSED WITH DEMENTIA. SHE DID NOT REMEMBER GETTING A SHOT THE WEEK BEFORE. THERE WAS A REPORT MADE OUT ON THIS EVENT AND CONTACTED HER DR. NO SIDE EFFECTS HAPPENED DUE TO THIS EVENT.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Blood test, Computerised tomogram, Condition aggravated
Clinical narrative: debilitating headache, high blood pressure over 190, nausea, lightheaded, unsteady
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Headache, Nausea
Clinical narrative: debilitating headache, high blood pressure over 190, nausea, lightheaded, unsteady
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Muscle swelling, Swelling
Clinical narrative: My knees, back, neck and muscles have been swollen Flu shot was the week before
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain
Clinical narrative: Patient reports expected injection site pain after the vaccine, but also pain that returned and has been increasing daily starting about 2 weeks ago. Patient took Advil but has not experienced relief from it.
Age: 40.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Malaise, Vomiting
Clinical narrative: During eligibility verification patient stated that she has fainted in the past with vaccines but it has not happened for over 2 decades.  After consulting with two other pharmacist on duty, it was determined that since the fainting episodes had not happen for over 2 decades it was ok to proceed with the vaccines.  Covid and Flu vaccines were administered around 12:30pm.  I asked the patient to wait in the consultation area while I prepared and completed some paperwork for her 6-year old daughters vaccines who was waiting outside of the pharmacy area.  While we were discussing that her daughter is very nervous about getting her vaccines, patient stated she did not feel well.  Immediately after stated that she passed out.  She was sitting and did not fall off out of the chair.  I managed to grab a hold of her head before it hit the table.  I immediately called the other two pharmacist for assistance.  I also started tapping the patient to see if she responded.  She reposted as soon as I started tapping her.  We got her some water and she laid on the floor with her feet elevated.  She was there for a few minutes and asked for a garbage can and proceeded to vomit.  Once she vomit she sat up and stated she felt better.  She sat in the consultation area for a few more minutes and then we proceed while we gave her daughter her vaccines.  Once they were done we asked the patient to sit near the pharmacy for anothe r30min
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: pt reported developing shingles a few days after receiving the vaccine.
Age: 82.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site which seemed normal.  Soreness never went away and continues which doe not seem normal.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received 2 doses
Age: 84.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Rash macular
Clinical narrative: Patient call the pharmacy to report her arm is blotchy down to the elbow,  The shot were given yesterday. Patient advise to take benadryl and could use an ice pack.  Also advised pt to follow up with her doctor.
Age: 12.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired vaccine due to storage guidelines of a 60 day expiration date from move date to the refrigerator.
Age: 13.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm to touch, redness at injection site
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: No additional AE/PQC.; Caller reported AE on behalf of a patient who was inadvertently concomitantly administered PROQUAD and VARIVAX on 10/28/2024. Patient was intended to received PRIORIX (manufacturer: GlaxoSmithKline Biologicals) instead of PROQUAD. Patient was also ad; Patient was intended to received PRIORIX (manufacturer: GlaxoSmithKline Biologicals) instead of PROQUAD; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant vaccinations included hepatitis a vaccine inact (HAVRIX) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE).  On 28-OCT-2024, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/dose, lot# Y00455 - verified as not valid, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5ml/dose, lot #Y002100, expiration date: 09-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided); instead of measles vaccine live (schwartz), mumps vaccine live (rit 4385), rubella vaccine live (wistar ra 27/3) (PRIORIX) (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided) (Wrong product administered, Accidental overdose).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose of GARDASIL-9 expired on 20OCT2024 and was administered on 05NOV2024; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-NOV-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W026151 (confirmed to be valid), expiration date: 20-OCT-2024 (Expired product administered), administered for prophylaxis (exact dose, strength, anatomical location and route of administration were not provided). It was reported that the product had no temperature excursions through date of administration. No additional adverse event were reported (No adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; patient received first dose of GARDASIL 9 on Aug 22, 2023 and then patient received a second dose of GARDASIL 9 on Oct 16, 2024; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-AUG-2023, the patient was vaccinated wit hthe first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).    On 16-OCT-2024, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No further information provided. No additional advere event (AE) reported (No adverse event).
Age: 40.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: CRT transfered pharmacist who is requesting information on dosing for a 40 year old male patient who missed his second dose in a 3 dose series of GARDASIL 9. She states his first dose was "8 months ago" and plans on getting his second dose today, 11/; no additional adverse event was reported; This spontaneous report was received from Pharmacist and refers to a 40-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in March 2024 (also reported as 8 months ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). There are plans to vaccinate the patient with second dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 07-NOV-2024 (Inappropriate schedule of product administration). No additional adverse information was reported.
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Palpitations, Rash, Rash papular
Clinical narrative: Felt Hot; Heart Palpitations; Small, Raised Skin-Colored Areas that Broke Out On Abdomen Area, Legs and Chest; Itchy; Felt Dizzy; Initial report received on 30-Oct-2024.  A consumer reported that a 20-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient reported heart palpitations, raised skin-colored areas that "broke out" and were itchy on the abdomen area, legs, and chest. The patient also felt hot and dizzy.  No medical history or concomitant medications were reported.  On an unspecified date in Jun-2023, the patient received dose 1 of a hepatitis B vaccine (HEPLISAV-B) (lot number 941588 and NDC number 43528-002-01; expiration date not provided) intramuscularly in the left arm.  On an unspecified date, after having been vaccinated with HEPLISAV-B, the patient reported heart palpitations and small, raised skin-colored areas that "broke out" and were itchy on her abdomen area, legs, and chest. The patient also felt hot and dizzy. The patient is noted to have gone to the emergency room (ER) and that "no treatment was received." The patient had an electrocardiogram (EKG) and was sent home on rest instructions. The dose was received in June of 2023 and was a requirement for schooling. The injection was received at an unspecified Pharmacy.   No other information was available.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Rash pruritic
Clinical narrative: Felt Hot; Heart Palpitations; Small, Raised Skin-Colored Areas that Broke Out On Abdomen Area, Legs and Chest; Itchy; Felt Dizzy; Initial report received on 30-Oct-2024.  A consumer reported that a 20-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient reported heart palpitations, raised skin-colored areas that "broke out" and were itchy on the abdomen area, legs, and chest. The patient also felt hot and dizzy.  No medical history or concomitant medications were reported.  On an unspecified date in Jun-2023, the patient received dose 1 of a hepatitis B vaccine (HEPLISAV-B) (lot number 941588 and NDC number 43528-002-01; expiration date not provided) intramuscularly in the left arm.  On an unspecified date, after having been vaccinated with HEPLISAV-B, the patient reported heart palpitations and small, raised skin-colored areas that "broke out" and were itchy on her abdomen area, legs, and chest. The patient also felt hot and dizzy. The patient is noted to have gone to the emergency room (ER) and that "no treatment was received." The patient had an electrocardiogram (EKG) and was sent home on rest instructions. The dose was received in June of 2023 and was a requirement for schooling. The injection was received at an unspecified Pharmacy.   No other information was available.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Nerve injury, Pain
Clinical narrative: pain; nerve damage; she got GBS 1 month later spent 3; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In SEP-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: she got GBS 1 month later spent 3) (serious criteria GSK medically significant), pain (Verbatim: pain) (serious criteria hospitalization) and nerve damage (Verbatim: nerve damage) (serious criteria hospitalization). The outcome of the guillain barre syndrome, pain and nerve damage were not reported.   It was unknown if the reporter considered the guillain barre syndrome, pain and nerve damage to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome, pain and nerve damage to be related to Shingles vaccine.   Additional Information: GSK receipt date: 02-NOV-2024 This case was reported by the patient's husband via interactive digital media. The reporter reported that, know your risk, his wife got her shot last September 2023 and she got guillain barre syndrome, 1 month later spent 3 months in hospital were live with the pain and nerve damage for the rest of her life, if they had knew they would never got the shot.; Sender's Comments: Guillain-Barre syndrome, Pain and Nerve injury  are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; It's just another jab it doesn't work I know 2 people that got the Shingles jab and still got 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: It's just another jab it doesn't work I know 2 people that got the Shingles jab and still got 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 1-NOV-2024 This case was reported by a patient via interactive digital media. Consumer reported that, It is just another jab it doesn't work .He/she  know 2 people that got the Shingles jab and still got shingles. The follow-up could not be possible as no contact details were available. 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, 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.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: He forgot to get the second Shingrix dose; he developed a stabbing pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not received the 1st dose of Shingrix and the 2nd dose of Shingrix. In NOV-2024, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain (Verbatim: he developed a stabbing pain). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: He forgot to get the second Shingrix dose). The outcome of the pain was resolving and the outcome of the incomplete course of vaccination was unknown.   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: 03-NOV-2024. The reporter was the patient. He received his first Shingrix dose about three years ago, in 2021. He forgot to get the second Shingrix dose.  Patient stated shingles reactivated on him and he was hit by it. Patient questioned was it possible that he could had all symptoms was pain, but rashes. He developed a stabbing pain that felt like shingles pain.  He visited his physician but there was no rash and shingles was not diagnosed.  The patient pain with an unknown pain reliever. The pain continued but was lessened. Nothing else was reported. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, MNQ, TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: Administration after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number X7R4Z, expiry date 30-SEP-2025) and (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis, Herpes zoster (Shingrix) (batch number 94ST2, expiry date 09-AUG-2026) for prophylaxis, HAV (Havrix) (batch number MZ474, expiry date 24-APR-2026) for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 333SK, expiry date 28-SEP-2025) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Infanrix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 11-OCT-2024, the patient received Bexsero, Kinrix and Menveo. On 11-OCT-2024, the patient received Shingrix, Havrix and Boostrix. On an unknown date, the patient received Engerix B, Infanrix and Pediarix. On an unknown date, an unknown time after receiving Bexsero, Kinrix, Menveo, Shingrix, Havrix, Boostrix, Engerix B, Infanrix and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Administration after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-OCT-2024 The reporter reported that the Bexsero, Boostrix, Engerix-B, Havrix, Infanrix, Kinrix, Menveo one vial presentation, Pediarix and Shingrix vaccines suffered a temperature excursion on 10th November 2024, with a lowest temperature of 1.9 degree Celsius for a total time of 1 hr and 33 minutes which led to, incorrect storage of drug. HCP (Healthcare professional) stated that the vaccines were not frozen. There was no patient's information available. The vaccine administration facility was the same as Primary Reporter.