chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test negative, Sleep disorder, Vertigo
Clinical narrative: After each booster I have experienced dizziness/vertigo when I turn my left ear down (so, lying on my left side, leaning left out of a chair to pick something up, performing a yoga posture that leans left).  I've also have a pretty big lymph node response on that side each time.  That happened this time too, but then after a couple weeks I developed a monster of a cough and then what I would describe as the worst cold I've had as an adult.  No positive covid tests (I home tested every day for a week), but fever, cough that would not stop and did keep me awake pretty much constantly, complete loss of voice down to the tiniest whisper, total exhaustion.  We tried various cough suppressants and such, as well as oral steroids to see if it was my asthmatic lungs overreacting to things, but I was really uncomfortable and exhausted for fully 3 weeks, but then after that: my blood pressure went up and isn't interested in coming down.  This could just be an expected age-and-genetics outcome, but the timing is kind of hinky.  I'm also short of breath pretty constantly even though we added more inhaled stuff (advair) and have some some nebulizering with albuterol etc, which helps for a couple of days then reverts.  We did a chest x-ray to verify I didn't have pneumonia, although I don't know whether they carefully looked at heart things.  I'm going in for more blood pressure checks (where I expect the small dose of something that should be reducing the pressure to be increased because I don't think it's coming down based on pharmacy automated machine checks) and a stress test.  We did an EKG which looked okay, so that's promising.  I have no proof any of this has anything to do with the bivalent covid vaccine, but I also do note that there's some increase in stuff like myocarditis and so here I am telling this story.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past beyond use date (exp 1/23).
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past beyond use date (exp 1/23).
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past beyond use date (exp 1/23)
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past beyond use date (exp 1/23).
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past beyond use date (exp 1/23),
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past beyond use date (exp 1/23)
Age: 62.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD (1/23)
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: PLAN ONLY COVERS 30 OR 90 DAYS PLAN LIMITATIONS EXCEEDED (PHARMACY HELP DESK.)
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: PATIENT CAME IN REQUESTING THE UPDATED MODERNA VACCINE AND WAS ADMINITERED MODERNA BIVALENT VACCINE 02/13/2023. HOWEVER, PATIENT WAS ALREADY ADMINISTERED WITH THE MODERNA BIVALENT BACK IN 09/2022. IN TOTAL THE PATIENT DID RECEIVED 2 MODERNA BIVALENT DOSES (09/2022 AND 02/2023).
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported by patient, but vaccine was administered 5 days after the BUD of 2/8/23.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported by patient but vaccine was administered after BUD of 2/8/23
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Mobility decreased
Clinical narrative: My lower back hurt for several days, prohibiting movement. I am still feeling  some back pain.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria that developed about 15 min after vaccine administration. The family thought it was eczema and did not contact our clinic. The hives were pruritic and lasted about 2 days. They did not give an antihistamine. Now that we know, we have referred to a pediatric allergist for evaluation before going ahead with the bivalent booster. Visit to allergist was referred today - has not yet occurred.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthritis, Pain, Synovial cyst, X-ray
Clinical narrative: Severe inflammation of arthritis in right knee joint and surrounding areas/tissues, including Baker's Cyst. Physical therapy sessions (6) since then has helped, but I have not reached total pain resolution yet.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Barium enema, Enema administration, Intussusception, Poor feeding infant, Ultrasound abdomen abnormal
Clinical narrative: Patient developed acute onset of poor feeding on 1/10/23.  Started vomiting on 1/11/23 and was diagnosed with Intussusception on 1/11/23.  Intussusception was successfully reduced with barium enema in the hospital. F/U US was normal. Infant is doing well currently and feeding normally.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Patient developed acute onset of poor feeding on 1/10/23.  Started vomiting on 1/11/23 and was diagnosed with Intussusception on 1/11/23.  Intussusception was successfully reduced with barium enema in the hospital. F/U US was normal. Infant is doing well currently and feeding normally.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Amylase, Full blood count, Lipase, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Persistent vomiting for 6 days, starting the day after the vaccine was given
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Vomiting
Clinical narrative: Persistent vomiting for 6 days, starting the day after the vaccine was given
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cerebrovascular accident, Intracranial aneurysm
Clinical narrative: As stated before, pt. was forced by his employer, to get the vaccine to continue his employment. He received his first vaccine in August 21 and second one in September 21. He was a healthy guy no issues prior to this. In July 22, he suffered a brain aneurysm and stroke. Since this time, he has been incapacitated. We believe this vaccine had something to do with leading to both of these things.
Age: 1.25
Sex: M
Vaccine: UNK, UNK
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Within hours of vaccination, patient developed high fever, vomiting and diarrhea.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: I now have slow onset, constant, significant tinnitus that has limited my hearing permanently. It's onset was about 1 month after the booster and has been constant ever since. I did not realize it could be associated with the vaccine or I would have reported it sooner.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer Bivalent Vaccine, however did not complete primary series. Hospital reported patient received monovalent series to restart. Patient did not report any signs or symptoms of adverse event.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Asthenia, Burning sensation, Confusional state
Clinical narrative: Joint pain, fatigue, weakness, blurry vision, sciatic nerve pain, migraines, sensitivity to sound and light,, neck pain, tingling arms and legs, confusion, memory loss,  nausea,  unexplained bruising,  sensitivity to temperature?either sweating or freezing. General unwell feeling, feels like bones and muscles are burning and aching, loss of mobility
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Feeling cold, Hyperacusis, Hyperhidrosis
Clinical narrative: Joint pain, fatigue, weakness, blurry vision, sciatic nerve pain, migraines, sensitivity to sound and light,, neck pain, tingling arms and legs, confusion, memory loss,  nausea,  unexplained bruising,  sensitivity to temperature?either sweating or freezing. General unwell feeling, feels like bones and muscles are burning and aching, loss of mobility
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Mobility decreased, Myalgia, Nausea
Clinical narrative: Joint pain, fatigue, weakness, blurry vision, sciatic nerve pain, migraines, sensitivity to sound and light,, neck pain, tingling arms and legs, confusion, memory loss,  nausea,  unexplained bruising,  sensitivity to temperature?either sweating or freezing. General unwell feeling, feels like bones and muscles are burning and aching, loss of mobility
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Paraesthesia, Photophobia, Sciatica, Temperature intolerance
Clinical narrative: Joint pain, fatigue, weakness, blurry vision, sciatic nerve pain, migraines, sensitivity to sound and light,, neck pain, tingling arms and legs, confusion, memory loss,  nausea,  unexplained bruising,  sensitivity to temperature?either sweating or freezing. General unwell feeling, feels like bones and muscles are burning and aching, loss of mobility
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Joint pain, fatigue, weakness, blurry vision, sciatic nerve pain, migraines, sensitivity to sound and light,, neck pain, tingling arms and legs, confusion, memory loss,  nausea,  unexplained bruising,  sensitivity to temperature?either sweating or freezing. General unwell feeling, feels like bones and muscles are burning and aching, loss of mobility
Age: 9.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site itching, redness, swelling, hot to the touch beginning 22-36h after vaccination. Swelling lessened after 2 days; itching and redness in area 4x5? in size remained on third day after vaccination
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Antibody test, Antinuclear antibody, Blood folate, Blood thyroid stimulating hormone, Dysarthria
Clinical narrative: 4-6 wks after vaccine started with dysphagia, dysarthria, facial weakness, twitching
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Dysphagia, Facial paresis, Full blood count, Laboratory test, Metabolic function test
Clinical narrative: 4-6 wks after vaccine started with dysphagia, dysarthria, facial weakness, twitching
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Muscle twitching, Red blood cell sedimentation rate, Vitamin B12
Clinical narrative: 4-6 wks after vaccine started with dysphagia, dysarthria, facial weakness, twitching
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Blood test, Clostridium difficile infection, Death
Clinical narrative: 4-6 wks after vaccine started with dysphagia, dysarthria, facial weakness, twitching
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Dysphagia, Eating disorder, Gastrostomy, Magnetic resonance imaging, Mechanical ventilation
Clinical narrative: 4-6 wks after vaccine started with dysphagia, dysarthria, facial weakness, twitching
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Muscle twitching, Nerve conduction studies, Slow speech, Speech disorder, Weight decreased
Clinical narrative: 4-6 wks after vaccine started with dysphagia, dysarthria, facial weakness, twitching
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysarthria, Magnetic resonance imaging head abnormal, Scan with contrast abnormal, Transient ischaemic attack
Clinical narrative: I and my husband had Pfizer covid-19 shot the same time and within the same week we both was labeled with having a stroke. Mine was a T.I.A. 3 days after my shot I had slurred speech that lasted about 30 minutes. After that time everything was O.K. with me. The store I had my shot is pharmacy.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging abnormal
Clinical narrative: Husband and wife had a adverse re-action to the Pfizer covid-19 shot given all within the same week. We was both labeled with having a stroke. Mine was a stroke in hospital for 2 days. Had a MRI done and said to have been a stroke. The store I had my covid-19 shot is pharmacy.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Asthenia, Back pain, Dizziness, Feeling abnormal
Clinical narrative: My symtoms Began in about 2022=Dizzy, Anxious & then progressed to rash (comes & goes) (small knodules, red, itchy) muscle aches in shoulder & hand Headache, Heart pounding. Doesn't want to go away (now 2-9:23) & I still have this I'm experiencing an ache in my Back on my Left side - also along w/ the other symptoms on prvious page I'm very Anxious - I don't feel like myself. I wish these symtoms would go away. They just want to stay - I eat very good - Fiber, Vegetables, fruits - oils. Place where I got vaccine isn't there anymore & I don't know where they are I Don't feel At Ease. I need medical tests to determine All of my symptoms. And also what can be done for me to get rid of these symptoms. My whole Body feels weak My muscles feel weak! I also have the sniffles blowing my nose all times!
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscular weakness, Myalgia, Nodule, Palpitations
Clinical narrative: My symtoms Began in about 2022=Dizzy, Anxious & then progressed to rash (comes & goes) (small knodules, red, itchy) muscle aches in shoulder & hand Headache, Heart pounding. Doesn't want to go away (now 2-9:23) & I still have this I'm experiencing an ache in my Back on my Left side - also along w/ the other symptoms on prvious page I'm very Anxious - I don't feel like myself. I wish these symtoms would go away. They just want to stay - I eat very good - Fiber, Vegetables, fruits - oils. Place where I got vaccine isn't there anymore & I don't know where they are I Don't feel At Ease. I need medical tests to determine All of my symptoms. And also what can be done for me to get rid of these symptoms. My whole Body feels weak My muscles feel weak! I also have the sniffles blowing my nose all times!
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Rhinorrhoea
Clinical narrative: My symtoms Began in about 2022=Dizzy, Anxious & then progressed to rash (comes & goes) (small knodules, red, itchy) muscle aches in shoulder & hand Headache, Heart pounding. Doesn't want to go away (now 2-9:23) & I still have this I'm experiencing an ache in my Back on my Left side - also along w/ the other symptoms on prvious page I'm very Anxious - I don't feel like myself. I wish these symtoms would go away. They just want to stay - I eat very good - Fiber, Vegetables, fruits - oils. Place where I got vaccine isn't there anymore & I don't know where they are I Don't feel At Ease. I need medical tests to determine All of my symptoms. And also what can be done for me to get rid of these symptoms. My whole Body feels weak My muscles feel weak! I also have the sniffles blowing my nose all times!
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Aspergillus infection, COVID-19, Condition aggravated, Hypervolaemia
Clinical narrative: Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "65-year-old female with SLE, I LD, chronic hypoxic respiratory failure on 5 L, HFpEF, phechromocytoma, dm 2, coronary artery disease admitted 12/2 for acute on chronic hypoxic respiratory failure which was multifactorial the concern for acute on chronic I will be, recent COVID, fluid overload, community-acquired pneumonia, aspergillus infection requiring BiPAP therapy transition to high-flow nasal cannula before being very slowly weaned down.  Patient treated broadly with antibiotics for community-acquired pneumonia as well as given IV Lasix for concern for fluid overload.  Pulmonology consulted and initially recommended bronchoscopy, patient decided not to proceed with this procedure.  Id consulted for concern for Aspergillus pneumonia and recommended 12 week course of micafungin 100 mg IV daily through 3/4/2023. .  Pulmonology treated patient stayed higher dose steroids and slowly over time patient's oxygen needs improved such that by the time of discharge patient was able to maintain at rest on 5 L although any minimal exertion required non-rebreather.  Should be noted that pulmonology goal SpO2 goal is 82-85%.  Patient on 20 mg steroids for 2 weeks to be followed by 10 mg daily until seen by pulmonology."
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Positive airway pressure therapy, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "65-year-old female with SLE, I LD, chronic hypoxic respiratory failure on 5 L, HFpEF, phechromocytoma, dm 2, coronary artery disease admitted 12/2 for acute on chronic hypoxic respiratory failure which was multifactorial the concern for acute on chronic I will be, recent COVID, fluid overload, community-acquired pneumonia, aspergillus infection requiring BiPAP therapy transition to high-flow nasal cannula before being very slowly weaned down.  Patient treated broadly with antibiotics for community-acquired pneumonia as well as given IV Lasix for concern for fluid overload.  Pulmonology consulted and initially recommended bronchoscopy, patient decided not to proceed with this procedure.  Id consulted for concern for Aspergillus pneumonia and recommended 12 week course of micafungin 100 mg IV daily through 3/4/2023. .  Pulmonology treated patient stayed higher dose steroids and slowly over time patient's oxygen needs improved such that by the time of discharge patient was able to maintain at rest on 5 L although any minimal exertion required non-rebreather.  Should be noted that pulmonology goal SpO2 goal is 82-85%.  Patient on 20 mg steroids for 2 weeks to be followed by 10 mg daily until seen by pulmonology."
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Autonomic nervous system imbalance, Dizziness, Dyspnoea, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Patient has episodes of rapid heart rate , SOB, light headedness and fatigue. Patient was seen by her PCP and a Cardiologist within the first week of symptoms which began 10/02/2023. She has had 3 EKG's worn a holter monitor and is scheduled for an echocardiogram. She was diagnosed today by Dr. from Cardiac Electrophysiology with dysautonomia/Postural Orthostatic Tachycardia Syndrome. She was seen by MD as well a Cardiovascular Specialist
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Heart rate increased, Laboratory test, Postural orthostatic tachycardia syndrome
Clinical narrative: Patient has episodes of rapid heart rate , SOB, light headedness and fatigue. Patient was seen by her PCP and a Cardiologist within the first week of symptoms which began 10/02/2023. She has had 3 EKG's worn a holter monitor and is scheduled for an echocardiogram. She was diagnosed today by Dr. from Cardiac Electrophysiology with dysautonomia/Postural Orthostatic Tachycardia Syndrome. She was seen by MD as well a Cardiovascular Specialist
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Aprox. 30 minutes after vaccination pt complained of pain radiating down into her fingers. Shot give at 7:55, took ibuprofen, and started ice pack at 8:45am. at 9:25 she described pain as: sore at site of injection, a bit tingely in fingers and some tingling in left forearm. She has seen some improvement but symptoms persist.
Age: 15.0
Sex: F
Vaccine: COVID19-2, HPV9
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: COVID booster was administered first in left arm, then HPV administered in right arm.  Immediately after the HPV vaccine, looked pale and sweaty and said she felt like she was going to "pass out".  I laid her back and put ice pack on head and gave her a cup of water.    She rested for about 20 min, then was back to her usual self.  Ate a popsicle, was talking and smiling and walked out of clinic independently.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Biopsy, Computerised tomogram, Memory impairment, Mental disorder
Clinical narrative: Rapidly developed tumors on thyroid 6.8cm within 6 months.  Severe reduction in memory, mental capacity, energy and muscle mass beginning within days and still present. .
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle atrophy, Surgery, Thyroid neoplasm, Ultrasound scan, X-ray
Clinical narrative: Rapidly developed tumors on thyroid 6.8cm within 6 months.  Severe reduction in memory, mental capacity, energy and muscle mass beginning within days and still present. .
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, RV5
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase normal, Ascites, Aspartate aminotransferase normal, Bilirubin conjugated
Clinical narrative: 2/4  upset at bedtime which was unusual 2/5 slept longer during night, didn't wake up until 5 am, usually up at 3 am,  only took 1 oz, usually 4 oz,  2/6 dec intake, only 1 oz per feeding, q 3-4 hrs, projectile vomiting, sleeping more, when awake lethargic, cold hand and feet, purple, spit bubbles around mouth,  More spit up than nl, color same,  Dec UO, stool dec, Dark brown, not normal color Didn't notice abd distention was more than usual  2/7 talked to triage nurse, went to ER in the afternoon,Transferred to hosp ER overnight.    Received 1x NS bolus.  Extensive work up in ED including CBC, CRP, ESR, CMP, coags, UA, hepatitis panel, CT head, and US pylorus which were all unremarkable except for ascites noted on US.   + rhinovirus/enterovirus, coronavirus, rest of respiratory panel neg including covid 19, flu, RSV abd U/S: Likely ileocolic intussusception seen in the right hemiabdomen, reduced with contrast enema,  Pt immediately better, happy, po nl, UO and stool nl  D/c home later same day 2/8
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, RV5
Symptoms: Blood bilirubin, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood potassium normal
Clinical narrative: 2/4  upset at bedtime which was unusual 2/5 slept longer during night, didn't wake up until 5 am, usually up at 3 am,  only took 1 oz, usually 4 oz,  2/6 dec intake, only 1 oz per feeding, q 3-4 hrs, projectile vomiting, sleeping more, when awake lethargic, cold hand and feet, purple, spit bubbles around mouth,  More spit up than nl, color same,  Dec UO, stool dec, Dark brown, not normal color Didn't notice abd distention was more than usual  2/7 talked to triage nurse, went to ER in the afternoon,Transferred to hosp ER overnight.    Received 1x NS bolus.  Extensive work up in ED including CBC, CRP, ESR, CMP, coags, UA, hepatitis panel, CT head, and US pylorus which were all unremarkable except for ascites noted on US.   + rhinovirus/enterovirus, coronavirus, rest of respiratory panel neg including covid 19, flu, RSV abd U/S: Likely ileocolic intussusception seen in the right hemiabdomen, reduced with contrast enema,  Pt immediately better, happy, po nl, UO and stool nl  D/c home later same day 2/8
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, RV5
Symptoms: Blood sodium normal, C-reactive protein normal, Carbon dioxide normal, Coagulation test abnormal, Computerised tomogram head normal
Clinical narrative: 2/4  upset at bedtime which was unusual 2/5 slept longer during night, didn't wake up until 5 am, usually up at 3 am,  only took 1 oz, usually 4 oz,  2/6 dec intake, only 1 oz per feeding, q 3-4 hrs, projectile vomiting, sleeping more, when awake lethargic, cold hand and feet, purple, spit bubbles around mouth,  More spit up than nl, color same,  Dec UO, stool dec, Dark brown, not normal color Didn't notice abd distention was more than usual  2/7 talked to triage nurse, went to ER in the afternoon,Transferred to hosp ER overnight.    Received 1x NS bolus.  Extensive work up in ED including CBC, CRP, ESR, CMP, coags, UA, hepatitis panel, CT head, and US pylorus which were all unremarkable except for ascites noted on US.   + rhinovirus/enterovirus, coronavirus, rest of respiratory panel neg including covid 19, flu, RSV abd U/S: Likely ileocolic intussusception seen in the right hemiabdomen, reduced with contrast enema,  Pt immediately better, happy, po nl, UO and stool nl  D/c home later same day 2/8
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, RV5
Symptoms: Enema administration, Enterovirus test positive, Faeces discoloured, Full blood count normal, Gamma-glutamyltransferase normal
Clinical narrative: 2/4  upset at bedtime which was unusual 2/5 slept longer during night, didn't wake up until 5 am, usually up at 3 am,  only took 1 oz, usually 4 oz,  2/6 dec intake, only 1 oz per feeding, q 3-4 hrs, projectile vomiting, sleeping more, when awake lethargic, cold hand and feet, purple, spit bubbles around mouth,  More spit up than nl, color same,  Dec UO, stool dec, Dark brown, not normal color Didn't notice abd distention was more than usual  2/7 talked to triage nurse, went to ER in the afternoon,Transferred to hosp ER overnight.    Received 1x NS bolus.  Extensive work up in ED including CBC, CRP, ESR, CMP, coags, UA, hepatitis panel, CT head, and US pylorus which were all unremarkable except for ascites noted on US.   + rhinovirus/enterovirus, coronavirus, rest of respiratory panel neg including covid 19, flu, RSV abd U/S: Likely ileocolic intussusception seen in the right hemiabdomen, reduced with contrast enema,  Pt immediately better, happy, po nl, UO and stool nl  D/c home later same day 2/8
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, RV5
Symptoms: Haemoglobin normal, Hepatitis A antibody negative, Hepatitis B core antibody negative, Hepatitis B surface antigen negative, Hepatitis C antibody negative
Clinical narrative: 2/4  upset at bedtime which was unusual 2/5 slept longer during night, didn't wake up until 5 am, usually up at 3 am,  only took 1 oz, usually 4 oz,  2/6 dec intake, only 1 oz per feeding, q 3-4 hrs, projectile vomiting, sleeping more, when awake lethargic, cold hand and feet, purple, spit bubbles around mouth,  More spit up than nl, color same,  Dec UO, stool dec, Dark brown, not normal color Didn't notice abd distention was more than usual  2/7 talked to triage nurse, went to ER in the afternoon,Transferred to hosp ER overnight.    Received 1x NS bolus.  Extensive work up in ED including CBC, CRP, ESR, CMP, coags, UA, hepatitis panel, CT head, and US pylorus which were all unremarkable except for ascites noted on US.   + rhinovirus/enterovirus, coronavirus, rest of respiratory panel neg including covid 19, flu, RSV abd U/S: Likely ileocolic intussusception seen in the right hemiabdomen, reduced with contrast enema,  Pt immediately better, happy, po nl, UO and stool nl  D/c home later same day 2/8
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, RV5
Symptoms: Human rhinovirus test positive, Hypersomnia, Hypophagia, Infant irritability, Infantile spitting up
Clinical narrative: 2/4  upset at bedtime which was unusual 2/5 slept longer during night, didn't wake up until 5 am, usually up at 3 am,  only took 1 oz, usually 4 oz,  2/6 dec intake, only 1 oz per feeding, q 3-4 hrs, projectile vomiting, sleeping more, when awake lethargic, cold hand and feet, purple, spit bubbles around mouth,  More spit up than nl, color same,  Dec UO, stool dec, Dark brown, not normal color Didn't notice abd distention was more than usual  2/7 talked to triage nurse, went to ER in the afternoon,Transferred to hosp ER overnight.    Received 1x NS bolus.  Extensive work up in ED including CBC, CRP, ESR, CMP, coags, UA, hepatitis panel, CT head, and US pylorus which were all unremarkable except for ascites noted on US.   + rhinovirus/enterovirus, coronavirus, rest of respiratory panel neg including covid 19, flu, RSV abd U/S: Likely ileocolic intussusception seen in the right hemiabdomen, reduced with contrast enema,  Pt immediately better, happy, po nl, UO and stool nl  D/c home later same day 2/8
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, RV5
Symptoms: Influenza virus test negative, Infrequent bowel movements, International normalised ratio increased, Intussusception, Large intestinal obstruction reduction
Clinical narrative: 2/4  upset at bedtime which was unusual 2/5 slept longer during night, didn't wake up until 5 am, usually up at 3 am,  only took 1 oz, usually 4 oz,  2/6 dec intake, only 1 oz per feeding, q 3-4 hrs, projectile vomiting, sleeping more, when awake lethargic, cold hand and feet, purple, spit bubbles around mouth,  More spit up than nl, color same,  Dec UO, stool dec, Dark brown, not normal color Didn't notice abd distention was more than usual  2/7 talked to triage nurse, went to ER in the afternoon,Transferred to hosp ER overnight.    Received 1x NS bolus.  Extensive work up in ED including CBC, CRP, ESR, CMP, coags, UA, hepatitis panel, CT head, and US pylorus which were all unremarkable except for ascites noted on US.   + rhinovirus/enterovirus, coronavirus, rest of respiratory panel neg including covid 19, flu, RSV abd U/S: Likely ileocolic intussusception seen in the right hemiabdomen, reduced with contrast enema,  Pt immediately better, happy, po nl, UO and stool nl  D/c home later same day 2/8
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, RV5
Symptoms: Lethargy, Metabolic function test normal, Peripheral coldness, Platelet count normal, Prothrombin time normal
Clinical narrative: 2/4  upset at bedtime which was unusual 2/5 slept longer during night, didn't wake up until 5 am, usually up at 3 am,  only took 1 oz, usually 4 oz,  2/6 dec intake, only 1 oz per feeding, q 3-4 hrs, projectile vomiting, sleeping more, when awake lethargic, cold hand and feet, purple, spit bubbles around mouth,  More spit up than nl, color same,  Dec UO, stool dec, Dark brown, not normal color Didn't notice abd distention was more than usual  2/7 talked to triage nurse, went to ER in the afternoon,Transferred to hosp ER overnight.    Received 1x NS bolus.  Extensive work up in ED including CBC, CRP, ESR, CMP, coags, UA, hepatitis panel, CT head, and US pylorus which were all unremarkable except for ascites noted on US.   + rhinovirus/enterovirus, coronavirus, rest of respiratory panel neg including covid 19, flu, RSV abd U/S: Likely ileocolic intussusception seen in the right hemiabdomen, reduced with contrast enema,  Pt immediately better, happy, po nl, UO and stool nl  D/c home later same day 2/8
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, RV5
Symptoms: Red blood cell sedimentation rate normal, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Skin discolouration, Ultrasound abdomen abnormal
Clinical narrative: 2/4  upset at bedtime which was unusual 2/5 slept longer during night, didn't wake up until 5 am, usually up at 3 am,  only took 1 oz, usually 4 oz,  2/6 dec intake, only 1 oz per feeding, q 3-4 hrs, projectile vomiting, sleeping more, when awake lethargic, cold hand and feet, purple, spit bubbles around mouth,  More spit up than nl, color same,  Dec UO, stool dec, Dark brown, not normal color Didn't notice abd distention was more than usual  2/7 talked to triage nurse, went to ER in the afternoon,Transferred to hosp ER overnight.    Received 1x NS bolus.  Extensive work up in ED including CBC, CRP, ESR, CMP, coags, UA, hepatitis panel, CT head, and US pylorus which were all unremarkable except for ascites noted on US.   + rhinovirus/enterovirus, coronavirus, rest of respiratory panel neg including covid 19, flu, RSV abd U/S: Likely ileocolic intussusception seen in the right hemiabdomen, reduced with contrast enema,  Pt immediately better, happy, po nl, UO and stool nl  D/c home later same day 2/8
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, RV5
Symptoms: Urine analysis normal, Urine output decreased, Vomiting projectile, White blood cell count normal
Clinical narrative: 2/4  upset at bedtime which was unusual 2/5 slept longer during night, didn't wake up until 5 am, usually up at 3 am,  only took 1 oz, usually 4 oz,  2/6 dec intake, only 1 oz per feeding, q 3-4 hrs, projectile vomiting, sleeping more, when awake lethargic, cold hand and feet, purple, spit bubbles around mouth,  More spit up than nl, color same,  Dec UO, stool dec, Dark brown, not normal color Didn't notice abd distention was more than usual  2/7 talked to triage nurse, went to ER in the afternoon,Transferred to hosp ER overnight.    Received 1x NS bolus.  Extensive work up in ED including CBC, CRP, ESR, CMP, coags, UA, hepatitis panel, CT head, and US pylorus which were all unremarkable except for ascites noted on US.   + rhinovirus/enterovirus, coronavirus, rest of respiratory panel neg including covid 19, flu, RSV abd U/S: Likely ileocolic intussusception seen in the right hemiabdomen, reduced with contrast enema,  Pt immediately better, happy, po nl, UO and stool nl  D/c home later same day 2/8
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Myalgia, Pain, Tremor
Clinical narrative: Intense sharp shoulder pain around joints of left should and constant pain in deltoid muscle.i cannot lift left arm15 degrees above shoulder without pain. I feel great pain lifting left arm 30 degrees above shoulder. Unable to lift arm more than 45 degrees above shoulder. Any movement of left arm up, down, forward, back caused great pain. Cannot rest elbow on chair arm without great pain. Cannot lie on left shoulder in bed without great pain. Cannot hold objects in left hand without hand shaking perfumery. Symptoms worsening. Visit to Healthcare facility and scheduled visit to orthopedic.
Age: 67.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal
Clinical narrative: Previously asymptomatic. Severe vertigo/dizziness immediately 1 day post injection. Also with nausea, vision changes, diaphoretic. ED visit at 3 days with blood labs, EKG, CXR and CT with contrast (all results negative).  Discharged with referral to MRI for unrelated suspicious area. Follow-up with PCP prescribed Meclizine 25 Mg with no improvement. Follow-up MRI with contrast and consult with neurosurgeon showed no connection to vertigo symptoms. Symptoms very slowly improved by early January. As of early February symptoms have resolved.
Age: 67.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Hyperhidrosis, Magnetic resonance imaging normal, Nausea, Scan with contrast normal, Vertigo
Clinical narrative: Previously asymptomatic. Severe vertigo/dizziness immediately 1 day post injection. Also with nausea, vision changes, diaphoretic. ED visit at 3 days with blood labs, EKG, CXR and CT with contrast (all results negative).  Discharged with referral to MRI for unrelated suspicious area. Follow-up with PCP prescribed Meclizine 25 Mg with no improvement. Follow-up MRI with contrast and consult with neurosurgeon showed no connection to vertigo symptoms. Symptoms very slowly improved by early January. As of early February symptoms have resolved.
Age: 67.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Visual impairment
Clinical narrative: Previously asymptomatic. Severe vertigo/dizziness immediately 1 day post injection. Also with nausea, vision changes, diaphoretic. ED visit at 3 days with blood labs, EKG, CXR and CT with contrast (all results negative).  Discharged with referral to MRI for unrelated suspicious area. Follow-up with PCP prescribed Meclizine 25 Mg with no improvement. Follow-up MRI with contrast and consult with neurosurgeon showed no connection to vertigo symptoms. Symptoms very slowly improved by early January. As of early February symptoms have resolved.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Renal cancer, Renal surgery
Clinical narrative: Kidney cancer surgically removed.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; HBP reported a dose of VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from an office manager, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 18-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliter (ml), lot #W020540, expiration date reported as 29-JUN-2024, but upon internal validation, established as 28-JUN-2024 (route of administration and anatomical location were not provided), administered for prophylaxis after a temperature excursion of 41.4 degrees Fahrenheits (F) with a time frame of 1 hour (h) and 58 minutes (min) (product storage error).   No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA008103:02321653 US-009507513-2301USA007926:02321654
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported; VARIVAX was administered to a patient after a temperature excursion; This spontaneous report was received from a licensed vocational nurse (LVN) and refers to a patient of unknown age and gender. The pertinent  patient's medical history, drug reactions and allergies and concomitant therapies were not reported.  On 15-NOV-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W005206, expiration date: 14-FEB-2024, administered for prophylaxis (anatomical location and route of administration were not provided), after the vaccine underwent a temperature excursion in a temperature of -13.7 Celsius degrees for a time frame of 5 hours and 15 minutes (Product storage error). There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) reported (No adverse event).
Age: 0.17
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temp excursion 47.9 degrees; This spontaneous report was received from a certified medical assistant and refers to a 2-month-old female. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported.  On 19-DEC-2022, the patient was vaccinated with the first doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly in the left tight (dose was not provided) and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally (dose was not provided); both for prophylaxis. On 01-DEC-2022, the vaccines underwent a temperature excursion of 47.9 Celsius degrees for 47 minutes (Product storage error). Data logger was involved. The medication error occurred at storage in practice. No additional adverse event (AE) reported.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion of 47.9 F for 47 min on Dec 1st 2022; This spontaneous report was received from a certified medical assistant and refers to a 7-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-DEC-2022, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and exact dose were not provided).  The vaccine underwent temperature excursion of 47.9 degrees Fahrenheit for 47 min (incorrect product storage) in clinical Practice on 01-DEC-2022. Data Logger was involved. No additional adverse event (AE) was reported. There was no product quality complaint (PQC).
Age: 14.0
Sex: U
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: 14 year old patient with pulmonary disease was supposed to receive Pneumovax 23 but in error was given Prevnar 20; This spontaneous report was received from a nurse and refers to a 14-year-old patient of unknown gender. The patient's concurrent conditions included lung disorder. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated in error with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, vaccination schedule, lot #, expiry date, site and route of administration were not provided) instead of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (strength, dose, vaccination schedule, formulation, lot #, expiry date, route of administration, and indication were not provided) (Wrong product administered).
Sex: F
Vaccine: HEP, HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: No other adverse events reported; pregnant patient received a dose of GARDASIL 9 as a result of user error; that RECOMBIVAX HB was intended; This prospective pregnancy spontaneous report was received from a registered nurse and refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant therapies were not reported.  The patient became pregnant with the last menstrual period (LMP) on 31-MAY-2022 and estimated date of delivery (EDD) on 07-MAR-2023. At the time of this report, her gestation was 36 weeks and 1 day.  On 08-FEB-2023, the patient received a dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, pre-filled syringe, 1 dose in a right arm, lot #U039529, expiration date: 09-AUG-2024 (strength, and route of administration were not provided) as a result of user error (wrong product administered). The nurse reported that hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was intended and there was not anything in regards to packaging or labeling that contributed to the error. The patient did receive the intended vaccine hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 dose in the left arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No other adverse events were reported. No product quality complaints. The pregnancy outcome was outcome pending and the fetal outcome was unknown (exposure during pregnancy).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Medical assistant reported that an expired VAQTA was given to patient; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 09-FEB-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter (ml), (lot # u012007, has been verified to be a valid lot number for hepatitis a vaccine, inactivated [VAQTA], expiration date reported and upon internal validation established as 18-JAN-2023) (anatomical location and route of administration were not reported) (Expired product administered).  No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details were provided; patient was administered a dose of PNEUMOVAX 23 after it expired.; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-FEB-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter, lot #U026796, expiration date: 28-JAN-2023 (strength, anatomical location, and route of administration were not provided) administered as prophylaxis (Expired product administered). No adverse events were reported.
Age: 42.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient was 42 years old when he received his first dose of GARDASIL 9. The patient is now 44 years old and never received the third dose of GARDASIL 9; No additional adverse event (AE) reported; This spontaneous report has been received from a nurse, concerning a currently 44-year-old male patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 28-DEC-2021, when the patient was 42-year-old, he was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9); followed by a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered on 20-JUL-2022 (exact doses, lot numbers, expiration dates, routes of administration, and anatomical locations were not provided) as prophylaxis.  At the reporting time (reported as "now"), the patient was 44-year-old and never received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration). No additional adverse event (AE) was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; have shingles right now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 03-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shots of shingles vaccine. The patient had shingles right now. Additional Supportive Information: The follow up would not possible, as no contact, details were available. 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 were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and got shingles/Suspected vaccination failure; Got shingles, got them worse; This 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 08-FEB-2023 Reporter comment: This case was reported by a patient via interactive digital media. The patient received the Shingles shot and got shingles after and stated them as worse. The reporter thought that the event might had been related to the drug. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.