chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Nausea, Pain, Pain in extremity, Photophobia
Clinical narrative: When she was ten, patient received the three-shot course of quadrivalent HPV vaccine. Please note, it was quadrivalent, not Gardasil 9 which was not yet available at the time. She experienced severe pain in her arm and a massive headache with each shot. As middle school started in the Fall, we noticed her getting more frequent headaches and not having as much energy as usual. PE class became a struggle for her as well, and she had trouble concentrating on her homework. Patient developed feelings of anxiety. She also started to have a disordered sleep schedule, often unable to sleep at night but exhausted enough to need naps during the day to function. She started spending less and less time outside as she felt overly sensitive to the noise, direct light, and heat. She progressively spent more time in her room where it was dark and quiet. She spent much of her time in bed feeling fatigued. She started requesting to take personal days off from school because of her frequent migraines and exhaustion. She would often start to black out (lose vision and hearing, feel dizzy and nauseous, and drop to the ground) after getting up from bed. She noticed pain in her joints, especially in her shoulders, back, and lower extremities. Any time she would have to stand for more than a few minutes, her legs would get splotchy red or purple coloring and her knees would feel sore. Warm showers and baths made her feel lightheaded and would induce shooting pains in her calves and feet. She experienced gastric stasis with nausea, bloating and intermittent constipation. Eventually, she developed a hand tremor that would manifest any time she used her hands for eating, painting, drawing, or carrying things.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Posture abnormal, Skin discolouration, Sleep disorder, Syncope, Tachycardia
Clinical narrative: When she was ten, patient received the three-shot course of quadrivalent HPV vaccine. Please note, it was quadrivalent, not Gardasil 9 which was not yet available at the time. She experienced severe pain in her arm and a massive headache with each shot. As middle school started in the Fall, we noticed her getting more frequent headaches and not having as much energy as usual. PE class became a struggle for her as well, and she had trouble concentrating on her homework. Patient developed feelings of anxiety. She also started to have a disordered sleep schedule, often unable to sleep at night but exhausted enough to need naps during the day to function. She started spending less and less time outside as she felt overly sensitive to the noise, direct light, and heat. She progressively spent more time in her room where it was dark and quiet. She spent much of her time in bed feeling fatigued. She started requesting to take personal days off from school because of her frequent migraines and exhaustion. She would often start to black out (lose vision and hearing, feel dizzy and nauseous, and drop to the ground) after getting up from bed. She noticed pain in her joints, especially in her shoulders, back, and lower extremities. Any time she would have to stand for more than a few minutes, her legs would get splotchy red or purple coloring and her knees would feel sore. Warm showers and baths made her feel lightheaded and would induce shooting pains in her calves and feet. She experienced gastric stasis with nausea, bloating and intermittent constipation. Eventually, she developed a hand tremor that would manifest any time she used her hands for eating, painting, drawing, or carrying things.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Temperature intolerance, Tremor
Clinical narrative: When she was ten, patient received the three-shot course of quadrivalent HPV vaccine. Please note, it was quadrivalent, not Gardasil 9 which was not yet available at the time. She experienced severe pain in her arm and a massive headache with each shot. As middle school started in the Fall, we noticed her getting more frequent headaches and not having as much energy as usual. PE class became a struggle for her as well, and she had trouble concentrating on her homework. Patient developed feelings of anxiety. She also started to have a disordered sleep schedule, often unable to sleep at night but exhausted enough to need naps during the day to function. She started spending less and less time outside as she felt overly sensitive to the noise, direct light, and heat. She progressively spent more time in her room where it was dark and quiet. She spent much of her time in bed feeling fatigued. She started requesting to take personal days off from school because of her frequent migraines and exhaustion. She would often start to black out (lose vision and hearing, feel dizzy and nauseous, and drop to the ground) after getting up from bed. She noticed pain in her joints, especially in her shoulders, back, and lower extremities. Any time she would have to stand for more than a few minutes, her legs would get splotchy red or purple coloring and her knees would feel sore. Warm showers and baths made her feel lightheaded and would induce shooting pains in her calves and feet. She experienced gastric stasis with nausea, bloating and intermittent constipation. Eventually, she developed a hand tremor that would manifest any time she used her hands for eating, painting, drawing, or carrying things.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthma, Atrial fibrillation, Dysphagia, Mitral valve prolapse
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 2/15/2021 ASTHMA, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 2/15/2021 ATRIAL FIBRILLATION, PAROXYSMAL J96.00 ACUTE RESPIRATORY FAILURE 2/15/2021 DYSPHAGIA J96.00 ACUTE RESPIRATORY FAILURE 2/15/2021 MITRAL VALVE PROLAPSE
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Metabolic encephalopathy, Metastases to bone, Neoplasm malignant, Pneumonia
Clinical narrative: DRUG INDUCED POLYNEUROPATHY 3/27/2022 WEAKNESS  DRUG INDUCED POLYNEUROPATHY 3/27/2022 BILAT PNEUMONIA  DRUG INDUCED POLYNEUROPATHY 3/27/2022 CANCER METASTATIC TO BONE  DRUG INDUCED POLYNEUROPATHY 3/27/2022 METABOLIC ENCEPHALOPATHY
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Polyneuropathy
Clinical narrative: DRUG INDUCED POLYNEUROPATHY 3/27/2022 WEAKNESS  DRUG INDUCED POLYNEUROPATHY 3/27/2022 BILAT PNEUMONIA  DRUG INDUCED POLYNEUROPATHY 3/27/2022 CANCER METASTATIC TO BONE  DRUG INDUCED POLYNEUROPATHY 3/27/2022 METABOLIC ENCEPHALOPATHY
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: stabbing pain in upper arm
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac monitoring, Cardiac stress test, Computerised tomogram, Decreased appetite
Clinical narrative: On 06/19/2022, at 03:00PM, I had severe fatigue, heart palpitations, loss of stamina. Treatment was lots of bed rest. Eventually I was issued prescriptions. I also had severe dizziness and appetite loss. There were many CT Scans and stress tests and heart monitoring sessions, I do not know dates and details.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Mobility decreased, Palpitations
Clinical narrative: On 06/19/2022, at 03:00PM, I had severe fatigue, heart palpitations, loss of stamina. Treatment was lots of bed rest. Eventually I was issued prescriptions. I also had severe dizziness and appetite loss. There were many CT Scans and stress tests and heart monitoring sessions, I do not know dates and details.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Cardio-respiratory arrest, Rash, Urticaria
Clinical narrative: Pt received vaccine around 0950,  tolerated well. Pt and mother sent to lobby, and within approximately 10 minutes nurse was called that mother had reported patient had a rash. Immediately nurse called code blue, noticed patient in mothers arms, awake, alert in no distress. Patient mother was told to come in  to vaccine room to be assessed. Head to toe assessment was done by nurse, patient is awake and alert, no respiratory distress noted, skin warm, dry to touch. Nurse noted hives to upper and lower body excluding face. Pt  mother denied any previous allergic reaction of any sort. Pt was monitored for 30 minutes,  mother voiced she would take patient to pediatrician (Dr.) to be evaluated  today. Pt mother advised to seek medical care to E.R or call 911 if s/s worsen. Pt mother voiced understanding of all discussed. Pt was calm, in no respiratory distress, no itching noted upon leaving clinic.. Will follow up with mother.....
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse events. Explained to patient she received the dose intended for the next patient and it was not harmful nor would it have adverse effects with other travel vaccines. Patient stated she is "totally fine with it."
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Paranasal sinus hypersecretion, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: After my 4th dose of my Covid 19 vaccination which was Pfizer vaccination I developed a chronic cough, experienced fever and a sever case of sinus drainage. I visited the Urgent Care and was examined and diagnosed with Covid 19. I was then advised to follow up with my Primary Care physician 21 days later. I was prescribed Albuterol and Flovent.
Age: 38.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Headache, Injection site urticaria
Clinical narrative: severe headache and chills for 2 days, hives around the injection site
Age: 67.0
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Malaise, SARS-CoV-2 test positive
Clinical narrative: I had vaccination on 09/20/2022. I started to experience headache and feeling unwell on 02/27/2023. I tested COVID-19 positive on 02/28/2023. I was prescribed PAXLOVID. The symptoms went away really quickly.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy, Blood test, COVID-19, Cerebrovascular accident, Computerised tomogram head abnormal
Clinical narrative: On 12/27/2022, I tested myself for COVID-19 because I felt funny. When it was positive, I didn't feel too bad. Over the course of the next few days, the left side of my face felt slight tingling and numbness and I felt like I was favoring my left side when walking. I called 911 on 12/30/2023, after thinking it was sinus issues for a few days. They took me to a nearby hospital. They confirmed my positive COVID-19 results. That night, the doctor told me I had a mild stroke. They recommended that I see a neurologist. It was a holiday weekend, so I was unable to be seen. They ultimately air lifted me on 01/01/2023, to another hospital. They didn't think it was too severe, but I had very high blood pressure as well. I saw two neurologists as well as the head neurologist. They all concurred that I had a mild stroke and my blood pressure was just getting worse. I don't remember what all kind of medications they gave me. I also developed a really bad COVID-19 headache. As soon as I was diagnosed, I called my primary doctor, who recommended I take PAXLOVID. I was only able to take 9 of the 10 doses, which my doctor said was alright. I was only in that hospital for 2 days. They always considered it a mild case. Eventually the head neurologist came in and informed me that I actually did not have a stroke. His conclusion was that I had Bell's Palsy. He believed that the COVID-19 cause inflammation that affected the nerves in my brain which gave me stroke like symptoms. The morning of 01/02/2023 or 01/03/2023, they discharged me, and I've been ok since. Even today, I feel lucky because the only remaining symptom has been occasional fatigue. About every 2 weeks or so, I get extremely fatigued. Sunday, I took multiple 2-hour naps and then went to bed at 09:00PM.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Fatigue, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: On 12/27/2022, I tested myself for COVID-19 because I felt funny. When it was positive, I didn't feel too bad. Over the course of the next few days, the left side of my face felt slight tingling and numbness and I felt like I was favoring my left side when walking. I called 911 on 12/30/2023, after thinking it was sinus issues for a few days. They took me to a nearby hospital. They confirmed my positive COVID-19 results. That night, the doctor told me I had a mild stroke. They recommended that I see a neurologist. It was a holiday weekend, so I was unable to be seen. They ultimately air lifted me on 01/01/2023, to another hospital. They didn't think it was too severe, but I had very high blood pressure as well. I saw two neurologists as well as the head neurologist. They all concurred that I had a mild stroke and my blood pressure was just getting worse. I don't remember what all kind of medications they gave me. I also developed a really bad COVID-19 headache. As soon as I was diagnosed, I called my primary doctor, who recommended I take PAXLOVID. I was only able to take 9 of the 10 doses, which my doctor said was alright. I was only in that hospital for 2 days. They always considered it a mild case. Eventually the head neurologist came in and informed me that I actually did not have a stroke. His conclusion was that I had Bell's Palsy. He believed that the COVID-19 cause inflammation that affected the nerves in my brain which gave me stroke like symptoms. The morning of 01/02/2023 or 01/03/2023, they discharged me, and I've been ok since. Even today, I feel lucky because the only remaining symptom has been occasional fatigue. About every 2 weeks or so, I get extremely fatigued. Sunday, I took multiple 2-hour naps and then went to bed at 09:00PM.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypertension, Hypoaesthesia, Magnetic resonance imaging head abnormal, Neuritis, Neurological symptom
Clinical narrative: On 12/27/2022, I tested myself for COVID-19 because I felt funny. When it was positive, I didn't feel too bad. Over the course of the next few days, the left side of my face felt slight tingling and numbness and I felt like I was favoring my left side when walking. I called 911 on 12/30/2023, after thinking it was sinus issues for a few days. They took me to a nearby hospital. They confirmed my positive COVID-19 results. That night, the doctor told me I had a mild stroke. They recommended that I see a neurologist. It was a holiday weekend, so I was unable to be seen. They ultimately air lifted me on 01/01/2023, to another hospital. They didn't think it was too severe, but I had very high blood pressure as well. I saw two neurologists as well as the head neurologist. They all concurred that I had a mild stroke and my blood pressure was just getting worse. I don't remember what all kind of medications they gave me. I also developed a really bad COVID-19 headache. As soon as I was diagnosed, I called my primary doctor, who recommended I take PAXLOVID. I was only able to take 9 of the 10 doses, which my doctor said was alright. I was only in that hospital for 2 days. They always considered it a mild case. Eventually the head neurologist came in and informed me that I actually did not have a stroke. His conclusion was that I had Bell's Palsy. He believed that the COVID-19 cause inflammation that affected the nerves in my brain which gave me stroke like symptoms. The morning of 01/02/2023 or 01/03/2023, they discharged me, and I've been ok since. Even today, I feel lucky because the only remaining symptom has been occasional fatigue. About every 2 weeks or so, I get extremely fatigued. Sunday, I took multiple 2-hour naps and then went to bed at 09:00PM.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia, SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: On 12/27/2022, I tested myself for COVID-19 because I felt funny. When it was positive, I didn't feel too bad. Over the course of the next few days, the left side of my face felt slight tingling and numbness and I felt like I was favoring my left side when walking. I called 911 on 12/30/2023, after thinking it was sinus issues for a few days. They took me to a nearby hospital. They confirmed my positive COVID-19 results. That night, the doctor told me I had a mild stroke. They recommended that I see a neurologist. It was a holiday weekend, so I was unable to be seen. They ultimately air lifted me on 01/01/2023, to another hospital. They didn't think it was too severe, but I had very high blood pressure as well. I saw two neurologists as well as the head neurologist. They all concurred that I had a mild stroke and my blood pressure was just getting worse. I don't remember what all kind of medications they gave me. I also developed a really bad COVID-19 headache. As soon as I was diagnosed, I called my primary doctor, who recommended I take PAXLOVID. I was only able to take 9 of the 10 doses, which my doctor said was alright. I was only in that hospital for 2 days. They always considered it a mild case. Eventually the head neurologist came in and informed me that I actually did not have a stroke. His conclusion was that I had Bell's Palsy. He believed that the COVID-19 cause inflammation that affected the nerves in my brain which gave me stroke like symptoms. The morning of 01/02/2023 or 01/03/2023, they discharged me, and I've been ok since. Even today, I feel lucky because the only remaining symptom has been occasional fatigue. About every 2 weeks or so, I get extremely fatigued. Sunday, I took multiple 2-hour naps and then went to bed at 09:00PM.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Allergy test positive, COVID-19, Dust allergy, Eye irritation, Ocular hyperaemia
Clinical narrative: In September 2022 I got COVID-19, I called my doctor's office to let her know that I had tested positive for COVID-19. She let me know that I didn't qualify for the Paxlovid. It took days for me to get through my sore throat symptoms. Then I started feeling much better. In November I went in for my annual physical, I mentioned that my eyes were really red, I could not get it to go away. I was advised to use Zaditor, I was also advised to use Visine. I went to my optometrist in December as I still could not get any relief. She prescribed eye drops for me to use, Prednisolone Acetate Suspension. My eyes felt great when I used the drops, but I could only use the drops for seven days. I went back to the optometrist; she prescribed me a taper down drops and advised me to use extra strength Pataday. I have been taking Benadryl at night to help me sleep at night and putting Bag Balm on my eyes, I also us Loratadine during the day. I went to an ophthalmologist, who gave me a steroid cream, Lotemax, to put on my eyelids that I used for seven days. I have been referred to an allergist who did allergy testing. I did test positive for dust. She did suggest that I put my Systane eye drop vials in the refrigerator, it helps to cool the eyes when they are irritated.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: In September 2022 I got COVID-19, I called my doctor's office to let her know that I had tested positive for COVID-19. She let me know that I didn't qualify for the Paxlovid. It took days for me to get through my sore throat symptoms. Then I started feeling much better. In November I went in for my annual physical, I mentioned that my eyes were really red, I could not get it to go away. I was advised to use Zaditor, I was also advised to use Visine. I went to my optometrist in December as I still could not get any relief. She prescribed eye drops for me to use, Prednisolone Acetate Suspension. My eyes felt great when I used the drops, but I could only use the drops for seven days. I went back to the optometrist; she prescribed me a taper down drops and advised me to use extra strength Pataday. I have been taking Benadryl at night to help me sleep at night and putting Bag Balm on my eyes, I also us Loratadine during the day. I went to an ophthalmologist, who gave me a steroid cream, Lotemax, to put on my eyelids that I used for seven days. I have been referred to an allergist who did allergy testing. I did test positive for dust. She did suggest that I put my Systane eye drop vials in the refrigerator, it helps to cool the eyes when they are irritated.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Order incident and administered what was thought to be Bivalent from the pharmacy but was Monovalent.   Patient had no reaction and was notified.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Dry throat, Myalgia, Nasal congestion, Nasopharyngitis
Clinical narrative: On 01/06/2023, I tested positive for COVID-19. My symptoms began on 01/04/2023. My throat was dry and scratchy and I had post-nasal drip. It felt like a cold, with nasal congestion, muscle aches and low grade fever. I called to report it to my doctor. She prescribed PAXLOVID but I did not take it.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive, Throat irritation, Upper-airway cough syndrome
Clinical narrative: On 01/06/2023, I tested positive for COVID-19. My symptoms began on 01/04/2023. My throat was dry and scratchy and I had post-nasal drip. It felt like a cold, with nasal congestion, muscle aches and low grade fever. I called to report it to my doctor. She prescribed PAXLOVID but I did not take it.
Age: 75.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Movement disorder, Paralysis
Clinical narrative: patient states unable to move with paralysis for approximately 6 hours
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Behaviour disorder, Dementia, Neuropathy peripheral
Clinical narrative: Pfizer vaccine was administered outside of the clinic - reported by patient     NEUROPATHY 1/11/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, W OTHER BEHAVIORAL DISTURBANCE
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 COVID-19 DISEASE
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: covid pfizer grey top vaccine given 2 days after an email notice was sent out not to give the primary series vaccines. staff was not aware of the recent change  pt did not have any adverse reaction while at the clinic
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral artery occlusion, Cerebrovascular accident, Immune thrombocytopenia, Pulmonary embolism, Pyrexia
Clinical narrative: PULMONARY EMBOLISM, UNSPECIFIED. 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA ACUTE STROKE DUE TO OCCLUSION OF BILAT MIDDLE CEREBRAL ARTERIES 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA PULMONARY EMBOLISM, UNSPECIFIED. 12/1/2021 FEVER ACUTE STROKE DUE TO OCCLUSION OF BILAT MIDDLE CEREBRAL ARTERIES 12/1/2021 FEVER PULMONARY EMBOLISM, UNSPECIFIED. 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA ACUTE STROKE DUE TO OCCLUSION OF BILAT MIDDLE CEREBRAL ARTERIES 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA PULMONARY EMBOLISM, UNSPECIFIED. 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA ACUTE STROKE DUE TO OCCLUSION OF BILAT MIDDLE CEREBRAL ARTERIES 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash erythematous, Varicella, Wrong product administered
Clinical narrative: Patient received MMRV instead of MMR at 12 month well child check in addition to the varicella vaccine. Medical staff called the mother at 1624 on April 20, 2023 to check on how the family was doing and if the patient was okay. The mother stated about a week ago, one week after vaccine administration, the child has gotten the Varicella Virus and had about 30 red bumps over her body. The mother stated she had given her a breast milk bath last night, April 19th, and noted that the red bumps over the patient's body were clearing up today, April 20th.  The mother stated she called the nurse advice line this morning and the nurse advice line at the hospital recommended coming back in to visit the doctor is the rash worsened.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cerebrovascular accident, Embolic stroke, Gastrointestinal haemorrhage, Hypoxia
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/4/2021 GI HEMORRHAGE R09.02 HYPOXIA 7/30/2021 GI HEMORRHAGE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/4/2021 ACUTE STROKE DUE TO EMBOLISM OF LEFT MIDDLE CEREBRAL ARTERY R09.02 HYPOXIA 7/30/2021 ACUTE STROKE DUE TO EMBOLISM OF LEFT MIDDLE CEREBRAL ARTERY
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Notified of the close exposure on 02/18/2023.  First test was a rapid test at the urgent care, the results were positive. The doctor had him isolate for 10 days. After the 10th day, 02/28/2023, he tested negative with a COVID-19 home test. He is immunocompromised. He was A-symptomatic COVID. He had no symptoms.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: NONE COVID 19 VACCINE EXPIRES 2/8/2023 GIVEN 3/23/2023
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Obstructive sleep apnoea syndrome, Respiratory failure, Type 2 diabetes mellitus
Clinical narrative: vaccine was administered outside of source - reported by patient  G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 4/7/2022 DM 2 WO COMPLICATIONS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/1/2022 DM 2 WO COMPLICATIONS J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/19/2022 DM 2 WO COMPLICATIONS J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 4/19/2022 DM 2 WO COMPLICATIONS
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram pelvis, Cough, Dizziness, Impaired work ability, Nocturia
Clinical narrative: On the night of 9/14/2022, I got a sore throat. On the morning of 9/15/2022, I underwent a PCR test and got a positive result. The sore throat lasted for about two days, but I had persistent, nonproductive cough that lasted for about six to eight weeks. Towards the end of the six to eight weeks, when I thought I was getting better, I went out to eat one day. I developed a coughing spell that was so severe that I had to leave the restaurant. I almost passed out, and someone at the restaurant actually asked me if he needed to call the rescue squad. I never took an antiviral. I took NYQUIL and MOTRIN to manage the symptoms I had, but they weren't really effective. I work at a hospital, and I was off from work for only five days after I was diagnosed. Shortly after the coughing subsided, I began to have Nocturia in late November or early December 2022. I went to my PCP sometime in early December 2022, and he put me on tamsulosin and told me to follow up with him. Unfortunately, the Nocturia became even worse. I then saw a urologist in early January 2023, and he told me my prostate was just fine after he conducted a digital rectal exam. He then doubled my dose of tamsulosin. Two weeks later, I went to the urgent care. I underwent a urinalysis and another digital rectal exam. I was then diagnosed with prostatitis and put on doxycycline. I then followed up with my PCP. I underwent a pelvic CT scan, and the results were normal with regard to the benign prostatic hyperplasia. The Nocturia continued, though. I am currently under the care of a NP at a urologist's office. I have gone through three rounds of different antibiotics (doxycycline, ciprofloxacin, and BACTRIM). My condition has improved. I no longer have any issues with nighttime urination beyond the ordinary at this point. I am due to see the NP for a follow-up in the next month.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Prostatitis, Urine analysis abnormal
Clinical narrative: On the night of 9/14/2022, I got a sore throat. On the morning of 9/15/2022, I underwent a PCR test and got a positive result. The sore throat lasted for about two days, but I had persistent, nonproductive cough that lasted for about six to eight weeks. Towards the end of the six to eight weeks, when I thought I was getting better, I went out to eat one day. I developed a coughing spell that was so severe that I had to leave the restaurant. I almost passed out, and someone at the restaurant actually asked me if he needed to call the rescue squad. I never took an antiviral. I took NYQUIL and MOTRIN to manage the symptoms I had, but they weren't really effective. I work at a hospital, and I was off from work for only five days after I was diagnosed. Shortly after the coughing subsided, I began to have Nocturia in late November or early December 2022. I went to my PCP sometime in early December 2022, and he put me on tamsulosin and told me to follow up with him. Unfortunately, the Nocturia became even worse. I then saw a urologist in early January 2023, and he told me my prostate was just fine after he conducted a digital rectal exam. He then doubled my dose of tamsulosin. Two weeks later, I went to the urgent care. I underwent a urinalysis and another digital rectal exam. I was then diagnosed with prostatitis and put on doxycycline. I then followed up with my PCP. I underwent a pelvic CT scan, and the results were normal with regard to the benign prostatic hyperplasia. The Nocturia continued, though. I am currently under the care of a NP at a urologist's office. I have gone through three rounds of different antibiotics (doxycycline, ciprofloxacin, and BACTRIM). My condition has improved. I no longer have any issues with nighttime urination beyond the ordinary at this point. I am due to see the NP for a follow-up in the next month.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs; expired lot of PROQUAD was administered; This spontaneous report was received from a medical assistant and the vaccine provider referring to a 4-year-old male patient. The patient's medical history, concurrent conditions and drug reaction/allergies were not reported. Concomitant medication included sterile diluent (0.5 milliliter (mL), once, lot # W025272, expiration date: 20-JAN-2025).  On 21-MAR-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, 0.5 milliliter (mL), once, lot #U029295, expiration date: 19-MAR-2023, administered for prophylaxis in right arm (strength and route of administration were not provided) (expired product administered). No additional adverse events.  It was reported that staff did not confirm expiration date before administration. Expiration date was discovered when entering vaccine information. Company was contacted and the reporter was informed that vaccine was still potent (2 days after expiration date). Per healthcare professional, re-vaccination was not required. The vaccine was not available for return/evaluation and was currently in provider office. The operator of vaccine was healthcare professional who had been trained. The patient was vaccinated at health clinic/hospital. The vaccine was purchased with funds. The event of expired product administered occurred in the process of preparation and administration. There was no temperature excursion occurred.
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Injection site mass, Pain
Clinical narrative: developed a "lump" three or four days after receiving the first dose of the GARDASIL 9 vaccine in the injection site of her left arm; burning sensation; This spontaneous report has been received from a 43-year-old female patient referring to herself. The patient's concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 20-JAN-2023, the patient received her first dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot#, expiration date and route were unknown) in her left arm for prevention of human papillomavirus (HPV).  It was reported when the vaccination provider plunged the vaccine in the patient's arm, it "burned like crazy" (burning sensation) which lasted a minute or two, after then the patient was fine. When the patient questioned the nurse pertaining to the burning sensation, the nurse told the patient "this one stings". On 23-JAN-2023 (reported as three or four days after receiving the first dose of the hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine), the patient developed a lump in the injection site of her left arm (vaccination site mass), and it went away after a couple of days.  On 17-MAR-2023, the patient received the second dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, lot#, expiration date and route were unknown) in her right arm.  The reporter reported it "didn't burn". The patient questioned the nurse why the first dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) "burned like crazy" but the second dose did not, the nurse responded with "it didn't burn because it came straight out of the fridge". The patient also reported that she looked up the hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) dosing schedule to ensure she was on schedule when she read the hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine needed to be shaken before administered. Per the patient, she was not paying attention during the second dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and was unsure if the nurse shook the vile before administration, making the patient question if it was properly administered and would still be effective. The patient reported the difference between getting the first dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the second dose made her question if the second dose was administered properly.  The patient did not seek for any medical attention. It was not reported if patient received treatment, or any lab diagnostic/studies were performed. Action taken with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for the events was not applicable. The outcome of the events burning sensation and vaccination site mass was reported as recovered.   The causality assessment between the suspect vaccine and events burning sensation and vaccination site mass was not provided.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs; a 4 year old male patient inadvertently received an extra dose of PEDVAX HIB on today 03/31/2023; This spontaneous report was received from a medical assistant (also office manager) referring to a 4 years old male patient. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On an unknown date, at 15 months old, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) one time dose for prophylaxis (strength, dose and route not reported, lot #W015927 and expiration date: 15-FEB-2025).  On 31-MAR-2023, the patient inadvertently received an extra dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (extra dose administered). He was caught up on all vaccines. No adverse event was reported.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia
Clinical narrative: pins and needles of toes and feet bilaterally; This spontaneous report was received from a registered nurse referring to a 37-year-old female patient.  The patient's medical history and concurrent conditions were not reported. There was no known drug allergy. Concomitant therapies were not reported.  On 14-MAR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 mL, administered intramuscularly for prophylaxis (lot #U019413, expiration date: 01-NOV-2023; strength was not provided).  On an unknown date in 2023, the patient experienced pins and needles of toes and feet bilaterally. It happened more so when she was sitting and standing. She did not have any weakness, dizziness, discoloration, warmth or issues with hands and arms. It had been happening frequently throughout the day since a few days after vaccination. The patient was unable to provide an exact date of onset. The patient had sought medical attention. She called the nurse on 04-APR-2023 (reported as today). No treatment was given for the event. She was not hospitalized. The outcome of the event was not recovered. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was discontinued, the patient refused additional doses, she would not receive any additional hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccines.   The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired vaccine used; This spontaneous report was received from a medical assistant referred to a 41-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 11-APR-2023, the patient was vaccinated an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, lot #U036184, expiration date: 02-MAR-2023, for prophylaxis (strength, and route of administration were not provided) (Expired product administered). It was confirmed that no other adverse event occurred (no adverse event), and the product did not have any temperature excursions prior to administration.
Age: 0.08
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no other AE occurred.; VAQTA was administered to a 1 month old patient on 4/17/2023; patient was supposed to receive a hepatitis B vaccine.; This spontaneous report was received from a nurse and refers to an 1-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-APR-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, intramuscular injection, 1 dose, lot number: w028554, expiration date: 10-JUL-2024, administered for prophylaxis (exact dose, strength, and route of administration were not provided) (product administered to patient of inappropriate age). The reporter stated that the patient was supposed to receive hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (wrong product administered). No other adverse event occurred (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Migraine
Clinical narrative: she developed a migraine the morning after receiving her 3rd dose of GARDASIL 9; This spontaneous report was received from a patient referring to herself as a 40-year-old non-pregnant female. Her concurrent conditions, medical history and concomitant medications were not reported.  On 12-OCT-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 05-DEC-2022 and 14-APR-2023, she received the second and third doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), respectively. All the doses were administered intramuscularly (IM) as prevention of human papillomavirus (HPV) (doses, anatomical locations, lot/batch # and expiration dates were not reported).  On 15-APR-2023, the morning after receiving her third dose of vaccine, the patient developed a migraine. On 16-APR-2023, she recovered from the event. The patient did not sought for medical attention, nor treatment was received. However, she was concerned she might have received her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) too early.  The causal relationship between migraine and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: patient experienced "full body chicken pox like rash" 1-2 weeks after receiving initial dose; This spontaneous report was received from a certified registered nurse practitioner (CRNP) and refers to a 33 years old non-pregnant female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 24-FEB-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (dosage regimen, strength, lot #, expiry date and route of administration were not reported) for vaccination.   On an unknown day in March 2023 (also reported as 1-2 weeks after receiving initial dose of VARIVAX), the patient experienced "full body chicken pox like rash" (rash vesicular). Furthermore, it was reported that the patient did not seek medical attention and no treatment was given for the event. On 31-MAR-2023, the patient was seen for routine checkup and still had rashes on body, though not as significant, and had not been seen since. At the time of reporting, the outcome of the event of rash vesicular was not known.  The causal relationship between the event of rash vesicular and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: a child passed out post administration from GARDASIL 9; This spontaneous report was received from a physician and refers to a child patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered intramuscularly for prophylaxis (strength, dosage, vaccination scheme, anatomical site of injection, lot number, and expiration date were not reported).  On an unknown date, the patient passed out (loss of consciousness) post administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The outcome of the event was not reported.  The reporter did not provide a causal relationship between the event and the suspect vaccine.  Upon internal review, the event loss of consciousness was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Suicidal ideation
Clinical narrative: wanted to die; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suicidal ideation in a 70-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine (vaccinated 3 times, got covid, damn near died), Flu shot with an associated reaction of influenza (got 1st Flu shot and got flu, refer case US2023AMR057486) and Pneumonia shot (got 1st Pneumonia shot and got pneumonia, damn near died again).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced suicidal ideation (Verbatim: wanted to die) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the suicidal ideation and shingles were not reported.   It was unknown if the reporter considered the suicidal ideation and shingles to be related to Shingles vaccine.     It was unknown if the company considered the suicidal ideation and shingles to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR057486   Additional Information: GSK receipt date: 22-Mar-2023 The case was received form the patient's friend via interactive digital media. The reporter reported that the patient who was healthy all of his life, he recently turned 70, a very healthy person mind. The patient got his 1st shingles shot and got shingles and wanted to die. The patient asked that what did this tell you about vaccines. The patient stated that trust your own immunity. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR057486:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had that crap shingles after the shot/ suspected vaccination failure; Pain; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (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: had that crap shingles after the shot/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 3 years) and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that she received Shingles vaccine and after that experienced that crap shingles for 3 years. The patient stated that the vaccine do not work. The patient stated that the shingles was worse than childbirth because she did not known when the pain caused by shingles would end. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.