chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Periodic limb movement disorder, Sleep study normal
Clinical narrative: I have previously had sleep apnea symptoms, but after receiving the fourth dose of Moderna, I started to experience the symptoms again. I would wake up not being able to breathe. I also experience moderate fatigue, memory loss, brain fog and not being able to focus or concentrate. I went to a sleep clinic and was scheduled for a sleep study. During the sleep study, I did not meet the diagnostic sleep criteria, so I was not diagnosed with sleep apnea. I was told that I have severe periodic limb movement, which is a neurological condition. I was put on MIRAPEX, but I couldn't handle the side effects that it caused. I have a follow up appointment with them in a couple of weeks and I will decide if I want to take any medication.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, Acute respiratory failure, COVID-19, Condition aggravated, Death
Clinical narrative: This is an instance of COVID-19 breakthrough disease after which death occurred. The individual was vaccinated with the Pfizer product on 01/21/2021, 02/11/2021, 09/28/2021, and 04/30/2022. They presented to emergency department on 08/24/2022 and were discharged after evaluation but then presented again later the same day due to acute delirium. The individual was admitted to hospital. They were diagnosed with complications of acute hypoxic respiratory failure and acute respiratory distress syndrome. It is not well known if the individual experienced COVID-19 symptoms due to poor historian (dementia). They tested positive for COVID-19 on 08/24/2022. Their health continued to decline and they remained hospitalized until their death on 08/27/2022.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Delirium, General physical health deterioration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: This is an instance of COVID-19 breakthrough disease after which death occurred. The individual was vaccinated with the Pfizer product on 01/21/2021, 02/11/2021, 09/28/2021, and 04/30/2022. They presented to emergency department on 08/24/2022 and were discharged after evaluation but then presented again later the same day due to acute delirium. The individual was admitted to hospital. They were diagnosed with complications of acute hypoxic respiratory failure and acute respiratory distress syndrome. It is not well known if the individual experienced COVID-19 symptoms due to poor historian (dementia). They tested positive for COVID-19 on 08/24/2022. Their health continued to decline and they remained hospitalized until their death on 08/27/2022.
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Injection site discolouration, Injection site pain, Injection site rash, Injection site swelling, Rash
Clinical narrative: I had swelling and pain and rash at the sight of the injection early on, I thought it was just a minor reaction and I had a flu vaccine at the same time and it was in both arms, but it was in the left arm first, and then I took BENADRYL because the rash had spread over every inch of my body for over the last 4 weeks. It is red and raised and it's a lot, I went to the Dr. office and the gave me cetirizine, and famotidine, to help with the symptoms and it helps some but it is still going on.  It is still going on and there is puncture mark where they did the injection it's like a dark spot on my arm like it is scared.  There have been a consult to my allergist but I have not seen anyone yet due to them believing that I am having an allergic reaction to a different medication that I am taking.
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Rash erythematous, Rash papular
Clinical narrative: I had swelling and pain and rash at the sight of the injection early on, I thought it was just a minor reaction and I had a flu vaccine at the same time and it was in both arms, but it was in the left arm first, and then I took BENADRYL because the rash had spread over every inch of my body for over the last 4 weeks. It is red and raised and it's a lot, I went to the Dr. office and the gave me cetirizine, and famotidine, to help with the symptoms and it helps some but it is still going on.  It is still going on and there is puncture mark where they did the injection it's like a dark spot on my arm like it is scared.  There have been a consult to my allergist but I have not seen anyone yet due to them believing that I am having an allergic reaction to a different medication that I am taking.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered Pfizer Bivalent instead of Pfizer Primary.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye pain, Magnetic resonance imaging head abnormal, Myelin oligodendrocyte glycoprotein antibody-associated disease, Ophthalmological examination abnormal, Optic neuritis
Clinical narrative: I had vaccination on 10/01/2022. On 10/29/2022 I was having eye pain. This continued for a week and my vision started to become blurry. I went to my ophthalmologist on 11/07/2022 Optic Nerve was inflamed and had edema. I had a brain MRI on 11/10/2022 and was diagnosed with Optic Neuritis. I was hospitalized high dose IV steroid treatment and was in patient for 3 days and 2 days outpatient. I am currently on an oral taper. Mild antibody disease. I am waiting for plasm exchange for the myelin oligodendrocyte glycoprotein.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Papilloedema, Vision blurred
Clinical narrative: I had vaccination on 10/01/2022. On 10/29/2022 I was having eye pain. This continued for a week and my vision started to become blurry. I went to my ophthalmologist on 11/07/2022 Optic Nerve was inflamed and had edema. I had a brain MRI on 11/10/2022 and was diagnosed with Optic Neuritis. I was hospitalized high dose IV steroid treatment and was in patient for 3 days and 2 days outpatient. I am currently on an oral taper. Mild antibody disease. I am waiting for plasm exchange for the myelin oligodendrocyte glycoprotein.
Age: 0.33
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Both Pediarix (containing Hep B vaccine) and Engerix were inadvertently administered on the same day when provider only intended to give routine 4-month vaccines. No noted adverse events to date, though patient did receive 1 extra injection that was not needed.
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: no adverse events
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pharyngeal swelling, Pruritus, Urticaria
Clinical narrative: Patient received Fluzone vaccine at pharmacy. Approximately 15 minutes later, pt returned to pharmacy stating that her throat felt swollen, and she had redness on her neck/upper chest area. RPh gave her 50mg diphenhydramine, and she sat in the consult room for 15 minutes for observation. Pt said her throat swelling had improved and she felt okay to go home. RPh talked to pt on the phone approx 50 minutes later (to follow up after pt got home). Pt said that she felt itchy, the redness on neck and chest had spread and was looking like hives. She has prednisone on hand at home which she was going to take. She also has an epi-pen at home if she should need it. RPh recommended pt to take another dose of benadryl at home around 6:30pm and at bedtime today, then re-assess tomorrow. RPh also advised her to use the epi-pen and/or go to the ER if symptoms continue to escalate and she agreed.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dysphagia, Erythema, Odynophagia, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: Patient received Fluzone vaccine at pharmacy. Approximately 15 minutes later, pt returned to pharmacy stating that her throat felt swollen, and she had redness on her neck/upper chest area. RPh gave her 50mg diphenhydramine, and she sat in the consult room for 15 minutes for observation. Pt said her throat swelling had improved and she felt okay to go home. RPh talked to pt on the phone approx 50 minutes later (to follow up after pt got home). Pt said that she felt itchy, the redness on neck and chest had spread and was looking like hives. She has prednisone on hand at home which she was going to take. She also has an epi-pen at home if she should need it. RPh recommended pt to take another dose of benadryl at home around 6:30pm and at bedtime today, then re-assess tomorrow. RPh also advised her to use the epi-pen and/or go to the ER if symptoms continue to escalate and she agreed.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Skin warm, Swelling face, Throat tightness, Urticaria
Clinical narrative: Patient received Fluzone vaccine at pharmacy. Approximately 15 minutes later, pt returned to pharmacy stating that her throat felt swollen, and she had redness on her neck/upper chest area. RPh gave her 50mg diphenhydramine, and she sat in the consult room for 15 minutes for observation. Pt said her throat swelling had improved and she felt okay to go home. RPh talked to pt on the phone approx 50 minutes later (to follow up after pt got home). Pt said that she felt itchy, the redness on neck and chest had spread and was looking like hives. She has prednisone on hand at home which she was going to take. She also has an epi-pen at home if she should need it. RPh recommended pt to take another dose of benadryl at home around 6:30pm and at bedtime today, then re-assess tomorrow. RPh also advised her to use the epi-pen and/or go to the ER if symptoms continue to escalate and she agreed.
Age: 41.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Chest discomfort, Dizziness postural, Dyspnoea, Fatigue, Palpitations
Clinical narrative: Recurrence of post-acute sequelae from Covid-19. Shortness of breath & racing heart rate (120-130bpm) on standing and with minimal exertion. Debilitating fatigue. Dizziness on standing. Tightness in chest. Intermittent tinnitus.   This is persisting & has not resolved.
Age: 41.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Post-acute COVID-19 syndrome, Tinnitus
Clinical narrative: Recurrence of post-acute sequelae from Covid-19. Shortness of breath & racing heart rate (120-130bpm) on standing and with minimal exertion. Debilitating fatigue. Dizziness on standing. Tightness in chest. Intermittent tinnitus.   This is persisting & has not resolved.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Blood test normal, Chest discomfort, Chest pain, Computerised tomogram normal
Clinical narrative: On November 20, 2022, this was the next day I had chest discomfort. It was pressure and fullness and a bit achy. It persisted and a few days and my doctor. It was pressure. I woke up that morning and I had odd foot pain and numbness. I was unable to stand or walk on it. It was almost like my put was put into a vice. It was contracting my toes and ankles.  I was worried about clotting. My doctor sent me to the ER, and they did a CT, X-Ray and look at my results. I had a vein blow out during getting my blood drawn. The doctor says I seemed to be dehydrated and could be having muscle problems. I am achy in the left side of my chest under my chest, and it moves to the right side. It kind of shoots straight through to my back and then the front of my chest. Today it was a little painful to walk on, but it feels fine today.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dehydration, Dysstasia, Electrocardiogram normal, Gait inability, Hypoaesthesia
Clinical narrative: On November 20, 2022, this was the next day I had chest discomfort. It was pressure and fullness and a bit achy. It persisted and a few days and my doctor. It was pressure. I woke up that morning and I had odd foot pain and numbness. I was unable to stand or walk on it. It was almost like my put was put into a vice. It was contracting my toes and ankles.  I was worried about clotting. My doctor sent me to the ER, and they did a CT, X-Ray and look at my results. I had a vein blow out during getting my blood drawn. The doctor says I seemed to be dehydrated and could be having muscle problems. I am achy in the left side of my chest under my chest, and it moves to the right side. It kind of shoots straight through to my back and then the front of my chest. Today it was a little painful to walk on, but it feels fine today.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle contractions involuntary, Pain, Pain in extremity, Scan with contrast normal, Vein rupture
Clinical narrative: On November 20, 2022, this was the next day I had chest discomfort. It was pressure and fullness and a bit achy. It persisted and a few days and my doctor. It was pressure. I woke up that morning and I had odd foot pain and numbness. I was unable to stand or walk on it. It was almost like my put was put into a vice. It was contracting my toes and ankles.  I was worried about clotting. My doctor sent me to the ER, and they did a CT, X-Ray and look at my results. I had a vein blow out during getting my blood drawn. The doctor says I seemed to be dehydrated and could be having muscle problems. I am achy in the left side of my chest under my chest, and it moves to the right side. It kind of shoots straight through to my back and then the front of my chest. Today it was a little painful to walk on, but it feels fine today.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: X-ray limb normal
Clinical narrative: On November 20, 2022, this was the next day I had chest discomfort. It was pressure and fullness and a bit achy. It persisted and a few days and my doctor. It was pressure. I woke up that morning and I had odd foot pain and numbness. I was unable to stand or walk on it. It was almost like my put was put into a vice. It was contracting my toes and ankles.  I was worried about clotting. My doctor sent me to the ER, and they did a CT, X-Ray and look at my results. I had a vein blow out during getting my blood drawn. The doctor says I seemed to be dehydrated and could be having muscle problems. I am achy in the left side of my chest under my chest, and it moves to the right side. It kind of shoots straight through to my back and then the front of my chest. Today it was a little painful to walk on, but it feels fine today.
Age: 50.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient said she has had a hard time moving her right arm since she received the flu vaccine.
Age: 52.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Headache
Clinical narrative: I have had chronic headaches since receiving the vaccine. Combining ibuprofen and acetaminophen provides temporary relief.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose normal, Chest X-ray normal, Computerised tomogram head normal, Differential white blood cell count normal, Dizziness
Clinical narrative: 4 days after receiving the vaccine - I went to dinner with my family. While eating a cookie for dessert, I became lightheaded and knew I could not stand unaided. My daughter said my head was bobbing and my speech was slurred. I had had no alcohol. She called 911. The paramedics got me into the ambulance and I was taken to the hospital ER. Enroute they asked if I had any allergies - I said yes, but could not tell them what because of my speech. At the hospital, I was tested for Chest X-ray (normal); CT of head W/O contrast (normal); CBC w/ differential (all normal range); Comp. Metabolic panel (all normal except Glucose 165 - which they thought was high because of just finishing a heavy meal; Electrocardiagram -  Abnormal due to an extra beat; and Troponin T count of 19 (tested twice at 9:12pm and 11:25) In the end they decided I could go home - I had not fainted and my tests were not bad enough. They called it possible Vasovagel Syncope
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysarthria, Dysstasia, Electrocardiogram abnormal, Full blood count normal, Heart rate irregular
Clinical narrative: 4 days after receiving the vaccine - I went to dinner with my family. While eating a cookie for dessert, I became lightheaded and knew I could not stand unaided. My daughter said my head was bobbing and my speech was slurred. I had had no alcohol. She called 911. The paramedics got me into the ambulance and I was taken to the hospital ER. Enroute they asked if I had any allergies - I said yes, but could not tell them what because of my speech. At the hospital, I was tested for Chest X-ray (normal); CT of head W/O contrast (normal); CBC w/ differential (all normal range); Comp. Metabolic panel (all normal except Glucose 165 - which they thought was high because of just finishing a heavy meal; Electrocardiagram -  Abnormal due to an extra beat; and Troponin T count of 19 (tested twice at 9:12pm and 11:25) In the end they decided I could go home - I had not fainted and my tests were not bad enough. They called it possible Vasovagel Syncope
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Metabolic function test normal, Posture abnormal, Troponin increased
Clinical narrative: 4 days after receiving the vaccine - I went to dinner with my family. While eating a cookie for dessert, I became lightheaded and knew I could not stand unaided. My daughter said my head was bobbing and my speech was slurred. I had had no alcohol. She called 911. The paramedics got me into the ambulance and I was taken to the hospital ER. Enroute they asked if I had any allergies - I said yes, but could not tell them what because of my speech. At the hospital, I was tested for Chest X-ray (normal); CT of head W/O contrast (normal); CBC w/ differential (all normal range); Comp. Metabolic panel (all normal except Glucose 165 - which they thought was high because of just finishing a heavy meal; Electrocardiagram -  Abnormal due to an extra beat; and Troponin T count of 19 (tested twice at 9:12pm and 11:25) In the end they decided I could go home - I had not fainted and my tests were not bad enough. They called it possible Vasovagel Syncope
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Tongue discomfort
Clinical narrative: Within 5 minutes of the first vaccine I started to have a burning sensation on my tongue (similar to when you burn it from hot foods).   After the second vaccine this increased.    This has never improved or gone away since the initial vaccine (now over one year ago).
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Insomnia, Pain in extremity
Clinical narrative: I had pretty severe pain in my left arm a few hours after the vaccine. I started to take TYLENOL and it did not relieve the pain immediately. I ended up not sleeping at all. I continued taking the TYLENOL and it started to get better. My arm remained sore about a week. I have completely recovered from the pain at this time.
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Dizziness, Heart rate increased, Vomiting
Clinical narrative: about 3 hrs later threw up 3 times, and has elevated pulse of 116, its usually 78, next morning woke up feeling a bit weak and light headed.  We are thinking maybe its a combination of the vaccine plus that he ate tamales that evening that may have prompted the vomiting.  Seems a bit better today, no vomitting but feels weak and pulse is high.  Tried to make an appt tp see  hisDr but they wont see him for 14 days cause he thre up. He is 92 and can not do a virual appt.!!!
Age: 1.42
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a dose of dtap+IPV, he was only supposed to get a Dtap vaccine.  patient had no reaction to vaccine.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: On August 28th, 2022-I was having breakfast at home with my wife and all of a sudden I had this LOUD ringing in my right ear. I am hearing impaired and wear a hearing aid on my right ear. I had (very mild) ringing in the past but it would go away within hours. As of today, (11/28)-I still have loud ringing and I think it is now permanent. It sounds like music (Drumming) or the sound of a plane's engine. I must point out that I just purchased a new hearing aid a month before I got this ringing in my ear. I am deaf in my left ear so I don't wear a hearing aid on that ear. Last month, I went for my (updated) second booster shot. I also went for my annual flu shot. Last December, when I went for my first booster shot-I
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Abdominal pain lower, Computerised tomogram abnormal, Diverticulitis, Nausea
Clinical narrative: Woke up on 11/23/22  around 8:30 am with abdominal cramps at the lower left abdomen. At around 11:45 pm Entered ER on  the evening of 11/23/2022 with severe lower left side abdominal pain and nausea. After CT scan it was confirmed I had diverticulitis - was prescibed Cipro, Metronidazole and Norco for pain. All liquid diet the. A low residue diet until better. 10 day course of antibiotics.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Headache, Nasal congestion
Clinical narrative: I received the Moderna Bivalent booster for COVID-19 on 10/16/2022. On 11/19/2022, I developed a cough and nasal congestion in the afternoon. On 11/20/2022, I took a home antigen test and got a negative result. The symptoms remained about the same, though I also developed some chest congestion. On the evening of 11/21/2022, I felt more fatigued, though it wasn't major. I still had cough and congestion at this point. I took another home antigen test on 11/22/2022 and got a positive result. I then self-isolated and began masking while at home to protect my children. I had a telehealth visit with my doctor that day, and I was prescribed PAXLOVID. I began taking PAXLOVID on 11/23/2022. In addition to the aforementioned symptoms, I also had headaches. I took some ibuprofen for the headache and MUCINEX to help with the cough and congestion. The MUCINEX and ibuprofen helped with my symptoms, and I felt better afterwards. I took another home antigen test on 11/27/2022 and got another positive result. At the time of this writing, I feel fine and am able to work from home. My only complaint at this point is that I have a bitter aftertaste from the Paxlovid and a loss of my sense of smell.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: I received the Moderna Bivalent booster for COVID-19 on 10/16/2022. On 11/19/2022, I developed a cough and nasal congestion in the afternoon. On 11/20/2022, I took a home antigen test and got a negative result. The symptoms remained about the same, though I also developed some chest congestion. On the evening of 11/21/2022, I felt more fatigued, though it wasn't major. I still had cough and congestion at this point. I took another home antigen test on 11/22/2022 and got a positive result. I then self-isolated and began masking while at home to protect my children. I had a telehealth visit with my doctor that day, and I was prescribed PAXLOVID. I began taking PAXLOVID on 11/23/2022. In addition to the aforementioned symptoms, I also had headaches. I took some ibuprofen for the headache and MUCINEX to help with the cough and congestion. The MUCINEX and ibuprofen helped with my symptoms, and I felt better afterwards. I took another home antigen test on 11/27/2022 and got another positive result. At the time of this writing, I feel fine and am able to work from home. My only complaint at this point is that I have a bitter aftertaste from the Paxlovid and a loss of my sense of smell.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Back pain, Biopsy liver normal, Blood alkaline phosphatase increased
Clinical narrative: Received the Moderna Booster 5/3/2022. Presented to ER with left-sided chest/back pain on 5/23. This resolved with pain medication and he was ruled out for MI. However, liver enzymes were markedly abnormal with alk phos 1029, AST 156, and ALT 296. Previous liver tests were normal in 3/2022.  Extensive work-up (including U/S, MRCP, liver biopsy which didn't have sufficient tissue and labs) showed no underlying etiology. Liver tests have improved with ursodiol. Pattern and history are most consistent with drug-induced liver injury. There were no new medications prior to the event and patient denied herbal or supplement use.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Drug-induced liver injury, Hepatic enzyme abnormal, Laboratory test normal, Liver function test abnormal
Clinical narrative: Received the Moderna Booster 5/3/2022. Presented to ER with left-sided chest/back pain on 5/23. This resolved with pain medication and he was ruled out for MI. However, liver enzymes were markedly abnormal with alk phos 1029, AST 156, and ALT 296. Previous liver tests were normal in 3/2022.  Extensive work-up (including U/S, MRCP, liver biopsy which didn't have sufficient tissue and labs) showed no underlying etiology. Liver tests have improved with ursodiol. Pattern and history are most consistent with drug-induced liver injury. There were no new medications prior to the event and patient denied herbal or supplement use.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance cholangiopancreatography, Ultrasound scan normal
Clinical narrative: Received the Moderna Booster 5/3/2022. Presented to ER with left-sided chest/back pain on 5/23. This resolved with pain medication and he was ruled out for MI. However, liver enzymes were markedly abnormal with alk phos 1029, AST 156, and ALT 296. Previous liver tests were normal in 3/2022.  Extensive work-up (including U/S, MRCP, liver biopsy which didn't have sufficient tissue and labs) showed no underlying etiology. Liver tests have improved with ursodiol. Pattern and history are most consistent with drug-induced liver injury. There were no new medications prior to the event and patient denied herbal or supplement use.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Eye movement disorder, Muscle twitching
Clinical narrative: Patient was given a Gardasil vaccine and a flu vaccine during his appointment today. Patient was given the Gardasil while sitting on the exam table. Patient then stood up and went over to his chair. When he went over to his chair, his mother was reading the VIS to him. The patient's mother reported that the patient's eyes rolled back in his head and he had twitching. Patient's mother came out of exam room and alerted the staff that "there is something wrong". Patient had slid of the chair in the exam room as I was entering the exam room. It took several seconds for patient to be able to focus on the providers. PA-C and Dr. responded. Patient was moved to the exam table. A cool compress was applied to his forehead and neck. Dr. and PA-C checked patient's heart rate several times. They then applied a pulse oximeter for continuous monitoring of his pulse. Patient did eat a pack of animal crackers and drank a small cup of water.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Arthritis, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: arthritis; pain in hands;pain in feet; swelling in hands;swelling in feet; This spontaneous report was received from a female patient of unknown age who is a medical assistant, regarding herself. Patient's concurrent conditions and relevant medical history was not reported. On 17-JUN-2014 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter once (lot number, expiration date and route of administration were not provided) administered for prophylaxis. Concomitant medications were not reported. On an unknown date in 2014, after vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), the patient experienced pain and swelling in elbows, feet, hands and shoulders. The outcome of the events was reported as not recovered/not resolved. The causality of the events with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported. All the data provided was reconfirmed by the reporter.  Follow-up information has been received from the medical assistant (consumer) on 21-NOV-2022. On an unknown date in 2014 (reported as about 2 and a half weeks after vaccination), the patient developed arthritis and arthralgia that lasted for 2 years. The patient stated she reported these symptoms to her doctor, but he was concerned and did not want to prescribe steroids since it was a result of a vaccination. The outcome of the events was unknown. The causality of the events with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reported as related. The reporter considered arthritis and arthralgia to be disability.; Sender's Comments: , MERCK1411USA001395:Mfr number
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: no additional adverse event; HCP reported an adverse event for VARIVAX. Caller explained the VARIVAX was administered after the expiry date. Caller said the VARIVAX had a prior temperature excursion. No additional AE or PQC reported. No additional information provided.  Name of; prior temperature excursion; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 31-OCT-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #T035268, expiration date: 15-OCT-2022, administered as prophylaxis (strength, and route of administration were not provided) (Expired product administered). Additionally, it was reported that on 20-OCT-2021, the vaccine had a prior temperature excursion at a temperature of 3 Celsius degrees (C) for 13 hours (Product storage error). No additional adverse events were reported.
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Patients that were administered products after they were involved in a temperature excursion / Temp excursion freeze was unplugged merck OK to use; This spontaneous report was received from a register nurse referring to a 4-year-old male patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  On 13-NOV-2022, freezer became unplugged from unit (Cord came unplugged from unit); and the vaccines were moved to the pharmacy freezer.   On 14-NOV-2022, 2 doses were given, the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot number W026315 and expiration date of 18-FEB-2024, subcutaneously on the right leg and the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot number W018837 expiration date of 14-JUN-2024, subcutaneously on the left leg both for prophylaxis. The medication error occurred in storage in clinical practice. No additional adverse events were reported.  The vaccine was exposed to a temperature excursion of 30.6°F with a time frame of 2 hours. There was no previous temperature excursion. It was unknown whether the vaccine was used according to the instruction leaflet.  A call was placed to the manufacturer and to state who advice vaccines could be given.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of RECOMBIVAX HB was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided.   On 21-NOV-2022, the patient was vaccinated with a expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, at dose 0.5 milliliter, administered intramuscularly for prophylaxis (lot number T036814 was verified to be a valid number, expiration date reported and established as 12-NOV-2022) (strength, anatomical injection site and vaccination scheme were not reported) (expired product administered). No additional adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient was administered an expired dose of RECOMBIVAX HB on 11/21/2022.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On 21-NOV-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) thimerosal-free, vial (RECOMBIVAX HB) intramuscular injection, lot #T032918, expiration date: 12-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional information was provided. No additional adverse event or product quality complaint was reported.
Sex: F
Vaccine: HPV9
Symptoms: Off label use, Product use issue
Clinical narrative: her doctor administered GARDASIL 9 because she has seen "success with GARDASIL 9 in suppressing more and more skin cancer"/Consumer is also over the age of 45; Consumer is also over the age of 45; This spontaneous report was received from a female consumer who is over 45-year-old and was reporting on herself. The patient's pertinent medical history included leukemia. Her drug allergies or reactions, and concomitant medications were not reported.  On unknown dates, the patient who was over 45-year-old was vaccinated with 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were unknown by the reporter) (product use in unapproved population). All the vaccines doses were given for skin cancer since the patient's doctor had seen "success with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in suppressing more and more skin cancer" (off label use in unapproved indication) ( drug effective for unapproved indication (capture in MARRS# 2211USA008787)).
Sex: U
Vaccine: UNK, UNK
Symptoms: Product storage error
Clinical narrative: VACCINE WITH AN OUT OF RANGE TEMPERATURE EXCURSION  AND WAS ADMINISTERED; DURING TRANSPORT THE REFRIGERATOR HAD A TEMPERATURE EXCURSION OF ONE DEGREE C FOR FIVE MINUTES; vaccine with an out of range temperature excursion  and was administered; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent #dose1 (influenza vaccine live reassort 4v) (batch number PJ3267) (expiration date 26-DEC-2022) once/single administration, via nasal route, on 03-NOV-2022. The patient received Flumist Quadrivalent #dose2 (influenza vaccine live reassort 4v) once/single administration, via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT #DOSE2.   No malfunction has been reported for FLUMIST QUADRIVALENT #DOSE1.    The report described a medication error for Flumist Quadrivalent #dose1. The reported term was vaccine with an out of range temperature excursion  and was administered (Preferred term: Product storage error). The report described a product issue. The reported term was during transport the refrigerator had a temperature excursion of one degree c for five minutes (Preferred term: Product temperature excursion issue).     The outcome of the event(s) of vaccine with an out of range temperature excursion  and was administered and during transport the refrigerator had a temperature excursion of one degree c for five minutes was unknown.     The events were considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent #dose1 and the following event: vaccine with an out of range temperature excursion  and was administered.   The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent #dose2 and the following event: vaccine with an out of range temperature excursion  and was administered.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT #DOSE2  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST QUADRIVALENT #DOSE1  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Age: 82.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after my 1st shot; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2022, the patient received the 1st dose of Shingrix. In September 2022, between 2 and 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-NOV-2022  Reporter's Comments: This case was reported by a consumer via interactive digital media  The patient received first dose of Shingrix vaccine and had shingles before receiving the 2nd dose.  The patient asked when he/she should receive the 2nd shot of Shingrix vaccine. The reporter just wanted to know GlaxoSmithKline recommendations.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, VARZOS, VARZOS
Symptoms: Product administered at inappropriate site, Rotator cuff syndrome, Tendon injury
Clinical narrative: Destroyed bicep tendon and cuff, 2 surgeries; Destroyed bicep tendon and cuff, 2 surgeries; 2 Shingrix destroyed biceps tendon and cuff; This case was reported by a other health professional via other manufacturer and described the occurrence of rotator cuff injury in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis, TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis, TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis and TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix, the 4th dose of COVID 19 VACCINE PFIZER, the 3rd dose of COVID 19 VACCINE PFIZER, the 2nd dose of COVID 19 VACCINE PFIZER and the 1st dose of COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced rotator cuff injury, tendon injury and vaccine administered at inappropriate site. On an unknown date, the outcome of the rotator cuff injury, tendon injury and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the rotator cuff injury and tendon injury to be related to Shingrix and Shingrix.     Additional Information:  Receipt Date: 18-NOV-2022 Reporter's Comment: The reporter stated that she had a patient who was also a physical therapist who received the Pfizer BioNTech Covid19 vaccine adult bivalent booster and it was administered in the quadricep muscle and received it yesterday and wanted to report some side effects.  The patient had her a lot of information for the side effects she reported and stated the patient got the vaccine in her quadricep and she did this because she has had two surgeries in the past three months on her right shoulder and because she had four covid vaccines already in the right shoulder and two Shingrix vaccines in the same right shoulder. The reporter stated it had just destroyed her bicep tendon and cuff and the injection site where she got the vaccine yesterday, it was sore to the touch, and sore when she walks. The patient had swelling distal to the injection site and stated overall she was having a lot of pain, soreness and swelling. The full report details not able to be obtained due to caller disconnected the line prior to transfer. It was unknown if the reporter considered the rotator cuff injury and tendon injury to be related to Covid-19 vaccine.  Additional Supportive Information: The patient received Shingrix on her right shoulder, which led to vaccine administered at inappropriate site.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: had a fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male 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 fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient had reported that her husband had got the vaccine and had a fever, Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot hurt like hell, worse; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included covid vaccine with an associated reaction of pain (received 2 shots on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comments: The reporter reported the case via  interactive digital media. The reporter stated that he/ she got this done but let him/ her tell that the shots hurt like hell.  The reporter stated that worse than that stupid covid 2 shots. Additional Supportive Information:The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: heat at the injection site; pain at the injection site; swelling at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced injection site warmth, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site warmth, injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site pain and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient had reported that he/she had got the Shingrix vaccine on Tuesday and at the time of reporting he/she still had the pain, swelling and heat at the injection site.  The reporter had asked that for how much longer will this last. Additional supportive information: Follow-up would not possible as no contact details were available.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: My salad tasted like metallic; This case was reported by a consumer via call center representative and described the occurrence of taste metallic in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2022, the patient received Shingrix. On 18th November 2022, 3 days after receiving Shingrix, the patient experienced taste metallic. On an unknown date, the outcome of the taste metallic was not recovered/not resolved.   It was unknown if the reporter considered the taste metallic to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the vaccine on Tuesday and today on the day of reporting he/she had salad which had tasted like a metallic. The patient had metallic taste. The reporter requested consent to follow-up.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect dose administered, Needle issue, Wrong technique in product usage process
Clinical narrative: Got only partial dose due to administration technique; Got only partial dose due to administration technique; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number HFZYA, expiry date 15th July 2023) for prophylaxis.   On 17th November 2022, the patient received the 1st dose of Boostrix. On 17th November 2022, unknown after receiving Boostrix, the patient experienced incomplete dose administered and incorrect vaccine administration technique. On an unknown date, the outcome of the incomplete dose administered and incorrect vaccine administration technique were unknown.   Additional Information: GSK receipt date: 18-Nov-2022 Reporter's comment: The reporter did not exactly mentioned that the needle broke or there was not skin expose. The reporter mentioned that did not know if there was a skin exposure. No product quality complaint was confirmed. No patient details were available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient got only partial dose of vaccine due to administration technique, which led to incomplete dose administered and incorrect vaccine administration technique.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: ankle pain; This case was reported by a consumer via call center representative and described the occurrence of pain ankle in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced pain ankle. On an unknown date, the outcome of the pain ankle was unknown.   It was unknown if the reporter considered the pain ankle to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comment: The reporter was the friend of the patient and reporting if ankle pain after a Shingrix vaccine was common. The reporter spoke per Shingrix. The reporter acknowledged the understanding and minimum to file, caller would share no demographics of patient or caller.  The was no permission for GSK to contact HCP. The reporter did not consent to follow up.