chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Right off the Shingrix website. All began 2 hours after injection.  Pain at in injection area, enough I could not lift my arm. Muscle pain through the right shoulder about 8 inches diameter from injection site. Fever 100.2 within 5 hours of injection. Shivering, it was 80 degrees out and I was overcome with shivering, I ran and but sweat on and through 2 blankets on top.  This happened 2 times 3 hours after injection and another 4 hours Later. Hot shower seemed to prevent shivers. They were incredible, worse than the club dive I did on a New Year's Day
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Headache, Injection site pain, Nausea, Oropharyngeal pain
Clinical narrative: 2 hours after injection.  Pain at injection site, sore throat, nuasea, headache, joint pain. Following day, headache, muscle pain at injection site, nausea and joint pain mostly in elbows and shoulders.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Gastrointestinal disorder, Myalgia, Rhinorrhoea, Vomiting
Clinical narrative: PATIENT REPORTS HE IS HAVING MYALGIA, SHIVERING, GI INTOLREANCE, CHILLS AND RUNNY PHLEGM. HE IS NOT SURE IF HE HAS A FEVER. HE CAN'T KEEP ANY FOOD DOWN RIGHT NOW BECAUSE OF GI INTOLERANCE.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Cerebral haemorrhage, Chills, Concussion, Decreased appetite
Clinical narrative: Had 2nd dose of SHINGRIX vaccine about 10:40 a.m. By noon I had a headache and deep shuddering, shaking shivers (much more physical than a chill). Lunch tasted off; I was not hungry. I had no appetite for dinner and what I ate tasted off. Through the night I felt fever and deep shuddering, shaking shivers. My arms and legs felt unusually heavy. I got up in the morning and did not feel well. I knew that eating breakfast would be difficult but went to the kitchen with my husband to begin making it and try to stay on schedule. I was standing at the kitchen counter slicing bananas for cereal and took one sip of orange juice when a massive wave of ill-feeling descended on me. I felt light-headed and nauseated.   I leaned over the sink to possibly vomit. I then fainted and hit my head on the cupboard knobs and the floor and was unconscious for minutes according to my husband who called 911. I was taken by ambulance to Hospital Emergency Room for treatment and diagnosis of syncope, scalp laceration, hematoma of right scalp, jaw scrape, concussion, and brain bleed (subarachnoid hemorrhage). Because of the brain bleed and possible need for brain surgery, I was transferred by ambulance to Medical Center ICU because they have neurosurgeons. Brain bleed did not worsen and brain surgery was not needed according to doctors. I still have continuous headache which varies in intensity, very sore scalp/skull, and vertigo.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Extrapyramidal disorder, Face injury, Haematoma, Head injury
Clinical narrative: Had 2nd dose of SHINGRIX vaccine about 10:40 a.m. By noon I had a headache and deep shuddering, shaking shivers (much more physical than a chill). Lunch tasted off; I was not hungry. I had no appetite for dinner and what I ate tasted off. Through the night I felt fever and deep shuddering, shaking shivers. My arms and legs felt unusually heavy. I got up in the morning and did not feel well. I knew that eating breakfast would be difficult but went to the kitchen with my husband to begin making it and try to stay on schedule. I was standing at the kitchen counter slicing bananas for cereal and took one sip of orange juice when a massive wave of ill-feeling descended on me. I felt light-headed and nauseated.   I leaned over the sink to possibly vomit. I then fainted and hit my head on the cupboard knobs and the floor and was unconscious for minutes according to my husband who called 911. I was taken by ambulance to Hospital Emergency Room for treatment and diagnosis of syncope, scalp laceration, hematoma of right scalp, jaw scrape, concussion, and brain bleed (subarachnoid hemorrhage). Because of the brain bleed and possible need for brain surgery, I was transferred by ambulance to Medical Center ICU because they have neurosurgeons. Brain bleed did not worsen and brain surgery was not needed according to doctors. I still have continuous headache which varies in intensity, very sore scalp/skull, and vertigo.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Intensive care, Limb discomfort, Loss of consciousness, Malaise
Clinical narrative: Had 2nd dose of SHINGRIX vaccine about 10:40 a.m. By noon I had a headache and deep shuddering, shaking shivers (much more physical than a chill). Lunch tasted off; I was not hungry. I had no appetite for dinner and what I ate tasted off. Through the night I felt fever and deep shuddering, shaking shivers. My arms and legs felt unusually heavy. I got up in the morning and did not feel well. I knew that eating breakfast would be difficult but went to the kitchen with my husband to begin making it and try to stay on schedule. I was standing at the kitchen counter slicing bananas for cereal and took one sip of orange juice when a massive wave of ill-feeling descended on me. I felt light-headed and nauseated.   I leaned over the sink to possibly vomit. I then fainted and hit my head on the cupboard knobs and the floor and was unconscious for minutes according to my husband who called 911. I was taken by ambulance to Hospital Emergency Room for treatment and diagnosis of syncope, scalp laceration, hematoma of right scalp, jaw scrape, concussion, and brain bleed (subarachnoid hemorrhage). Because of the brain bleed and possible need for brain surgery, I was transferred by ambulance to Medical Center ICU because they have neurosurgeons. Brain bleed did not worsen and brain surgery was not needed according to doctors. I still have continuous headache which varies in intensity, very sore scalp/skull, and vertigo.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain of skin, Pyrexia, Skin laceration, Syncope
Clinical narrative: Had 2nd dose of SHINGRIX vaccine about 10:40 a.m. By noon I had a headache and deep shuddering, shaking shivers (much more physical than a chill). Lunch tasted off; I was not hungry. I had no appetite for dinner and what I ate tasted off. Through the night I felt fever and deep shuddering, shaking shivers. My arms and legs felt unusually heavy. I got up in the morning and did not feel well. I knew that eating breakfast would be difficult but went to the kitchen with my husband to begin making it and try to stay on schedule. I was standing at the kitchen counter slicing bananas for cereal and took one sip of orange juice when a massive wave of ill-feeling descended on me. I felt light-headed and nauseated.   I leaned over the sink to possibly vomit. I then fainted and hit my head on the cupboard knobs and the floor and was unconscious for minutes according to my husband who called 911. I was taken by ambulance to Hospital Emergency Room for treatment and diagnosis of syncope, scalp laceration, hematoma of right scalp, jaw scrape, concussion, and brain bleed (subarachnoid hemorrhage). Because of the brain bleed and possible need for brain surgery, I was transferred by ambulance to Medical Center ICU because they have neurosurgeons. Brain bleed did not worsen and brain surgery was not needed according to doctors. I still have continuous headache which varies in intensity, very sore scalp/skull, and vertigo.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Taste disorder, Tremor, Vertigo
Clinical narrative: Had 2nd dose of SHINGRIX vaccine about 10:40 a.m. By noon I had a headache and deep shuddering, shaking shivers (much more physical than a chill). Lunch tasted off; I was not hungry. I had no appetite for dinner and what I ate tasted off. Through the night I felt fever and deep shuddering, shaking shivers. My arms and legs felt unusually heavy. I got up in the morning and did not feel well. I knew that eating breakfast would be difficult but went to the kitchen with my husband to begin making it and try to stay on schedule. I was standing at the kitchen counter slicing bananas for cereal and took one sip of orange juice when a massive wave of ill-feeling descended on me. I felt light-headed and nauseated.   I leaned over the sink to possibly vomit. I then fainted and hit my head on the cupboard knobs and the floor and was unconscious for minutes according to my husband who called 911. I was taken by ambulance to Hospital Emergency Room for treatment and diagnosis of syncope, scalp laceration, hematoma of right scalp, jaw scrape, concussion, and brain bleed (subarachnoid hemorrhage). Because of the brain bleed and possible need for brain surgery, I was transferred by ambulance to Medical Center ICU because they have neurosurgeons. Brain bleed did not worsen and brain surgery was not needed according to doctors. I still have continuous headache which varies in intensity, very sore scalp/skull, and vertigo.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling abnormal, Influenza like illness, Pyrexia
Clinical narrative: Feeling tired and weak; flulike achiness; fever (100.9); stuffed head sensation
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt said her arm started hurting aroung 4-5 PM on Saturday May 11th. She came into the store on Sunday May 12th when we opened at 11AM and the area on her left arm had a red, raised, swollen patch around where the vaccine had been administered. The area felt warm to the touch. She said it had not changed much since it started hurting the day before. She was recommended to take oral benadryl and use benadryl cream on the area and take Tylenol if it continued to be painful. She was also told that if it got any worse to go to the emergency room.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: C-reactive protein normal, Fatigue, Headache, Memory impairment, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Headaches, fatigue, memory difficulty, POTS.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome, Red blood cell sedimentation rate normal, Toxicologic test normal
Clinical narrative: Headaches, fatigue, memory difficulty, POTS.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Diplegia, Fall, Feeling abnormal, Gingival pain
Clinical narrative: About 6 hours after receiving the vaccination I developed a fever, headache and body aches. I had trouble sleeping. When I arose to go to the toilet about 6AM I had tunnel vision and my arms and legs became paralyzed. I fell on my way back to bed. Several minutes later I woke up with pains in my chest, even my gums hurt. I made it back into bed and slept for the remainder of the day and night. 24 hours later I was able to walk unaided and remained headachy and foggy. My vision was slightly blurry. I missed an entire day of work due to this shot, and lost approx 1000.00. This was the scariest episode I have ever experienced and I was given no warning. My PCP's office did not seem to know how to help me except to suggest I go to the ER. I did not, because I had someone with me watching me all day and night and I felt I could not tolerate the trip nor the ER wait given the severity of my condition. It was a nightmare. My husband called Galaxo Smith Kline and they said my physician would have to talk to them directly. My physician refused and referred me to her nurse practioner. She suggested I take tylenol. My husband called HIS PCP who suggested I take advil. The lack of information as to how to treat an averse reaction to this vaccination is unconscionable. People MUST be informed. Not to do so is unethical at the very least.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Insomnia, Pain, Pyrexia
Clinical narrative: About 6 hours after receiving the vaccination I developed a fever, headache and body aches. I had trouble sleeping. When I arose to go to the toilet about 6AM I had tunnel vision and my arms and legs became paralyzed. I fell on my way back to bed. Several minutes later I woke up with pains in my chest, even my gums hurt. I made it back into bed and slept for the remainder of the day and night. 24 hours later I was able to walk unaided and remained headachy and foggy. My vision was slightly blurry. I missed an entire day of work due to this shot, and lost approx 1000.00. This was the scariest episode I have ever experienced and I was given no warning. My PCP's office did not seem to know how to help me except to suggest I go to the ER. I did not, because I had someone with me watching me all day and night and I felt I could not tolerate the trip nor the ER wait given the severity of my condition. It was a nightmare. My husband called Galaxo Smith Kline and they said my physician would have to talk to them directly. My physician refused and referred me to her nurse practioner. She suggested I take tylenol. My husband called HIS PCP who suggested I take advil. The lack of information as to how to treat an averse reaction to this vaccination is unconscionable. People MUST be informed. Not to do so is unethical at the very least.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tunnel vision, Vision blurred
Clinical narrative: About 6 hours after receiving the vaccination I developed a fever, headache and body aches. I had trouble sleeping. When I arose to go to the toilet about 6AM I had tunnel vision and my arms and legs became paralyzed. I fell on my way back to bed. Several minutes later I woke up with pains in my chest, even my gums hurt. I made it back into bed and slept for the remainder of the day and night. 24 hours later I was able to walk unaided and remained headachy and foggy. My vision was slightly blurry. I missed an entire day of work due to this shot, and lost approx 1000.00. This was the scariest episode I have ever experienced and I was given no warning. My PCP's office did not seem to know how to help me except to suggest I go to the ER. I did not, because I had someone with me watching me all day and night and I felt I could not tolerate the trip nor the ER wait given the severity of my condition. It was a nightmare. My husband called Galaxo Smith Kline and they said my physician would have to talk to them directly. My physician refused and referred me to her nurse practioner. She suggested I take tylenol. My husband called HIS PCP who suggested I take advil. The lack of information as to how to treat an averse reaction to this vaccination is unconscionable. People MUST be informed. Not to do so is unethical at the very least.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Myalgia, Pain, Pyrexia
Clinical narrative: Severe muscle and body pain, fever, chills, sweating.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Whole body rash/ started 4 hours after vaccination and has persisted up and through the report being sent right now.  Patient has pictures available upon contact.  Patient has previously received the Zostavax (live vaccine) without problem, but first dose of the Shingrix resulted in this experience.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Concussion, Dizziness, Feeling abnormal, Impaired driving ability
Clinical narrative: On  Saturday 5/11/19, when I was driving in my car, I became extremely lightheaded. I felt similar to had a concussion 2.5 years ago. I got my haircut and then I drove home and I still felt lightheaded. My dad and I went to visit my mom?s grave and I wasn?t able to drive I felt so lightheaded and dazed. My vision will sometimes seem slightly blurry.  My dad drove.   I developed a headache and mild tinnitus. I feel weak today, Sunday 5/11/19 and still lightheaded. I feel better when I rest or do quiet activities.  My temperature has been 98.2-99.3. Blood pressure 100?s over 60?s. My respirations are non-labored.
Age: 41.0
Sex: M
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injection site swelling, Musculoskeletal pain
Clinical narrative: **Patient verbatim statement**  Immediately following injection the area of treatment swelled up. On Friday, I woke up with severe pain in the left shoulder. I could not pin point the exact location as it was throughout the entire shoulder. I did see my local doctor in March and was issued an anti inflammatory which has reduced the pain significantly and helped the healing process. As of 12 May 2019 the pain is declining but still exists. Will continue to monitor.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypoaesthesia, Injection site abscess, Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Numbness and tingling through both shoulders and down back.  Every major muscle in body hurts.  In the morning, started getting very dizzy
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Numbness and tingling through both shoulders and down back.  Every major muscle in body hurts.  In the morning, started getting very dizzy
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Dizziness, Nasal congestion, Nausea
Clinical narrative: Patient called pharmacy late in day in 5/11 stating  she got her shot on 4/29 and sore arm few days after shot and then on 5/1 (wed) she developed 101 fever and chills that lasted until 5/3 (fri). She says fever resolved but she then got dizziness and nausea on 5/4 to 5/6.   She says then she developed body aches, nasal congestion, coughing, low grade feverof 100 on thurs 5/9 up until she called sat 5/11.  We told her to call MD or see MD since she started having fever again. She said she is going to call MD Monday and try to see her if she is not better. She said if she felt worse on Sunday she would go to immediate care.  We told her we would follow up with her Monday to see how she feels. We told her normal side effects include sore arm, fever, headache, muscle aches, fatigue.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient called pharmacy late in day in 5/11 stating  she got her shot on 4/29 and sore arm few days after shot and then on 5/1 (wed) she developed 101 fever and chills that lasted until 5/3 (fri). She says fever resolved but she then got dizziness and nausea on 5/4 to 5/6.   She says then she developed body aches, nasal congestion, coughing, low grade feverof 100 on thurs 5/9 up until she called sat 5/11.  We told her to call MD or see MD since she started having fever again. She said she is going to call MD Monday and try to see her if she is not better. She said if she felt worse on Sunday she would go to immediate care.  We told her we would follow up with her Monday to see how she feels. We told her normal side effects include sore arm, fever, headache, muscle aches, fatigue.
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Epistaxis
Clinical narrative: Per wife states husband complained of a nose bleed around 8:30pm.  Nose bleed did not stop so they went to ER around 9pm. While at hospital, BP was 227/128. Pt was given several doses of Clonidine to stabalize BP.  Eventually nose bleed did reduce and pt was discharged home with a rx for Clonidine and Amoxil.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Impaired work ability, Musculoskeletal pain, Pain
Clinical narrative: April 30: Got vaccine in left arm. May3:Rash started on right arm, right shoulder pain. Called pharmacist said keep eye on it. It didn't make sense that you would get a rash from a dead virus. May 6: Blister started & rash was spreading. Stopped by and let pharmacist look at it. Still told me to keep eye on it. May 8:Rash & blisters spreading & more whelped up. Hand swollen, couldn't make a fist. May 9:My hand was more swollen, couldn't hardly bend fingers. Blisters & rash were more sensitive and spreading. Went to dr. He said he didn't know what it was and would be rare if I got the shingles form the vaccine since it was dead. Prescribed steroids. They didn't help at all. May11: Got up and in horrible pain. When my was down straight down it was throbbing.  I had to get a sling to keep my arm up. Went to the ER because I was in so much pain. Was seen first by an infectious disease nurse. She knew immediately it was shingles. When the doctor came in also knew immediately it was shingles. They were very worried about my well being because it was so bad. The doctor prescribed me lortab, gabapentin 300 mg, valacyclovir hcl 1 gram. Because of this I'm unable to work.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash, Urticaria
Clinical narrative: April 30: Got vaccine in left arm. May3:Rash started on right arm, right shoulder pain. Called pharmacist said keep eye on it. It didn't make sense that you would get a rash from a dead virus. May 6: Blister started & rash was spreading. Stopped by and let pharmacist look at it. Still told me to keep eye on it. May 8:Rash & blisters spreading & more whelped up. Hand swollen, couldn't make a fist. May 9:My hand was more swollen, couldn't hardly bend fingers. Blisters & rash were more sensitive and spreading. Went to dr. He said he didn't know what it was and would be rare if I got the shingles form the vaccine since it was dead. Prescribed steroids. They didn't help at all. May11: Got up and in horrible pain. When my was down straight down it was throbbing.  I had to get a sling to keep my arm up. Went to the ER because I was in so much pain. Was seen first by an infectious disease nurse. She knew immediately it was shingles. When the doctor came in also knew immediately it was shingles. They were very worried about my well being because it was so bad. The doctor prescribed me lortab, gabapentin 300 mg, valacyclovir hcl 1 gram. Because of this I'm unable to work.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Symptoms flu like, very tired, aches,,24 hours, and my arm at injection site became very red huge area the next day.  It was very warm and itchy,  I was able to work with it. Still very red today. I read that this could happen. I took photos of it yesterday, I wasn?t worried about it, but other people said I should report it.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Symptoms flu like, very tired, aches,,24 hours, and my arm at injection site became very red huge area the next day.  It was very warm and itchy,  I was able to work with it. Still very red today. I read that this could happen. I took photos of it yesterday, I wasn?t worried about it, but other people said I should report it.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Vaccination site pain, Vaccination site swelling
Clinical narrative: 4/23/19 About 3-4 hrs post vaccine redness, swelling and pain down the upper arm on (L) side came in on 4/24/19 and showed me her arm. Her right arm had limited motion due to injury approximately 7 weeks prior. Pt was given Shingrix and Pneumovax 23 vaccines in the (L) arm. 4-24-19 - Pt presented to pharmacy around 1-130pm to show me her (L) arm, Redness, swelling, warm, pain and rash on the upper arm down to her elbow. I reviewed her meds with her that she provided, listed below. I advised her to take Benadryl 50mg q 6-8 for two doses to see if improvement and to continue with 25mg. Called her primary care MD, spoke with staff and notified them of the incident. Advised her to call Dr. if no improvement. If no improvement to follow-up with her primary care physician. Called her at the end of my shift (approximately 3:00pm) to see if there was improvement, she stated, yes. 4/25 - 5:28pm - spoke with pt, her primary care, prescribed Medrol ds pak - she is to start. 5/9 approximately 3:15pm followed up with pt, no further tx was required.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: Approx 1 hr after receiving 1st dose-I fainted. I went to bed with fever and stayed in bed all day the next day. After 2nd shot I also felt faint, but did not, but stayed in bed 24 hrs. with fever.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Rash, Throat irritation
Clinical narrative: Approx 1 hr after receiving 1st dose-I fainted. I went to bed with fever and stayed in bed all day the next day. After 2nd shot I also felt faint, but did not, but stayed in bed 24 hrs. with fever.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Syncope
Clinical narrative: Approx 1 hr after receiving 1st dose-I fainted. I went to bed with fever and stayed in bed all day the next day. After 2nd shot I also felt faint, but did not, but stayed in bed 24 hrs. with fever.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Ultrasound therapy
Clinical narrative: PATIENT CAME IN 4/30/2019 AT THE PHARMACY AND SAID THAT SHE WAS DIAGNOSED WITH SIRVA AFTER HER SECOND SHINGRIX INJECTION. ALSO STATED THAT DUE TO SIRVA DIAGNOSIS THEY FOUND THAT SHE HAD A TORN ROTATOR CUFF.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rotator cuff syndrome, Shoulder injury related to vaccine administration
Clinical narrative: PATIENT CAME IN 4/30/2019 AT THE PHARMACY AND SAID THAT SHE WAS DIAGNOSED WITH SIRVA AFTER HER SECOND SHINGRIX INJECTION. ALSO STATED THAT DUE TO SIRVA DIAGNOSIS THEY FOUND THAT SHE HAD A TORN ROTATOR CUFF.
Age: 10.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: chronic regional pain syndrome in the (unspecified) vaccinated arm; Pain to right deltoin (injection site); This spontaneous report has been received from a registered nurse via a field representative referring to a 10 year old (currently 11 year old) female patient. The patient had a sister. Information about concomitant medication was not provided. There was none illness at time of vaccination. There was none known pre-existing physician-diagnosed allergies, birth defects or medical conditions. There was none known adverse event following a prior vaccination.  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) dose 1 for prophylaxis (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported). On 01-DEC-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R024264 dose 2, intramuscular in the right deltoid (Lot No. R024264 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 29-OCT-2019).  On 01-DEC-2018 (also reported as since had second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)), the patient experienced pain to right deltoid (injection site). Prescription drug treatment for the experience was not required. On 29-APR-2019, the patient was presenting with chronic regional pain syndrome in the vaccinated arm (unspecified). The patient had visited a physician. A temperature excursion didn't occur as a result of a reading from a digital data logger.  The outcome of chronic regional pain syndrome was unknown. The outcome of pain to right deltoid (injection site) was reported as not recovered.  No causality assessment was provided.
Age: 10.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Complex regional pain syndrome, Injection site pain
Clinical narrative: chronic regional pain syndrome in the (unspecified) vaccinated arm; Pain to right deltoin (injection site); This spontaneous report has been received from a registered nurse via a field representative referring to a 10 year old (currently 11 year old) female patient. The patient had a sister. Information about concomitant medication was not provided. There was none illness at time of vaccination. There was none known pre-existing physician-diagnosed allergies, birth defects or medical conditions. There was none known adverse event following a prior vaccination.  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) dose 1 for prophylaxis (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported). On 01-DEC-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R024264 dose 2, intramuscular in the right deltoid (Lot No. R024264 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 29-OCT-2019).  On 01-DEC-2018 (also reported as since had second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)), the patient experienced pain to right deltoid (injection site). Prescription drug treatment for the experience was not required. On 29-APR-2019, the patient was presenting with chronic regional pain syndrome in the vaccinated arm (unspecified). The patient had visited a physician. A temperature excursion didn't occur as a result of a reading from a digital data logger.  The outcome of chronic regional pain syndrome was unknown. The outcome of pain to right deltoid (injection site) was reported as not recovered.  No causality assessment was provided.
Age: 10.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site pain
Clinical narrative: chronic regional pain syndrome in the (unspecified) vaccinated arm; Pain to right deltoin (injection site); This spontaneous report has been received from a registered nurse via a field representative referring to a 10 year old (currently 11 year old) female patient. The patient had a sister. Information about concomitant medication was not provided. There was none illness at time of vaccination. There was none known pre-existing physician-diagnosed allergies, birth defects or medical conditions. There was none known adverse event following a prior vaccination.  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) dose 1 for prophylaxis (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported). On 01-DEC-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R024264 dose 2, intramuscular in the right deltoid (Lot No. R024264 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 29-OCT-2019).  On 01-DEC-2018 (also reported as since had second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)), the patient experienced pain to right deltoid (injection site). Prescription drug treatment for the experience was not required. On 29-APR-2019, the patient was presenting with chronic regional pain syndrome in the vaccinated arm (unspecified). The patient had visited a physician. A temperature excursion didn't occur as a result of a reading from a digital data logger.  The outcome of chronic regional pain syndrome was unknown. The outcome of pain to right deltoid (injection site) was reported as not recovered.  No causality assessment was provided.
Age: 27.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: No adverse effects were reported.; patient received a dose of GARDASIL 9 on 3/18/2019 while "34 weeks pregnant."; the patient, who is pregnant, was inadvertenly administered a dose of GARDASIL 9 instead of a dose of a influenza vaccine / the patient was supposed to be administered the influenza vaccine to prevent the flu, but was adminsitered GARDASIL 9.; This spontaneous prospective pregnancy report as received from a nurse refers to a 27-year-old pregnant female patient. No information regarding the patients pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 18-MAR-2019, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1581027, expiration date: 03-JUN-2021, intramuscularly (dose, frequency and strength were not reported) for prophylaxis instead of a dose of a influenza vaccine (manufacturer unspecified) (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported). The reporter considered that this was not product confusion. No adverse effects were reported. The patient became pregnant with last menstrual period (LMP) calculated to be on 23-JUL-2018 and estimated date of delivery (EDD) of 29-APR-2019. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 34 weeks of pregnancy.  The pregnancy outcome was pending.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash macular, Swelling
Clinical narrative: Pain at injection site; yellowish, purplish, with red splotches in center, 1.5'' in diameter; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 23rd April 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site rash and pruritus. The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site rash and pruritus were unknown.   It was unknown if the reporter considered the injection site pain, injection site rash and pruritus to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix and complained of pain, yellowish purplish, red splotches in center, 1.5 inches in diameter , itching. The patient saw her physician and was told to take antihistamine. According to the global sale data sheet, the batch number was updated to F3D7H from F307H.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Yellow skin
Clinical narrative: Pain at injection site; yellowish, purplish, with red splotches in center, 1.5'' in diameter; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 23rd April 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site rash and pruritus. The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site rash and pruritus were unknown.   It was unknown if the reporter considered the injection site pain, injection site rash and pruritus to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix and complained of pain, yellowish purplish, red splotches in center, 1.5 inches in diameter , itching. The patient saw her physician and was told to take antihistamine. According to the global sale data sheet, the batch number was updated to F3D7H from F307H.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site pain, Injection site rash, Injection site reaction, Pruritus
Clinical narrative: Pain at injection site; yellowish, purplish, with red splotches in center, 1.5'' in diameter; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 23rd April 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site rash and pruritus. The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site rash and pruritus were unknown.   It was unknown if the reporter considered the injection site pain, injection site rash and pruritus to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix and complained of pain, yellowish purplish, red splotches in center, 1.5 inches in diameter , itching. The patient saw her physician and was told to take antihistamine. According to the global sale data sheet, the batch number was updated to F3D7H from F307H.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular
Clinical narrative: Pain at injection site; yellowish, purplish, with red splotches in center, 1.5'' in diameter; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 23rd April 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site rash and pruritus. The patient was treated with antihistamine. On an unknown date, the outcome of the injection site pain, injection site rash and pruritus were unknown.   It was unknown if the reporter considered the injection site pain, injection site rash and pruritus to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix and complained of pain, yellowish purplish, red splotches in center, 1.5 inches in diameter , itching. The patient saw her physician and was told to take antihistamine. According to the global sale data sheet, the batch number was updated to F3D7H from F307H.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Antinuclear antibody increased, Arthralgia, Asthenia, Blast cells present, Blood creatinine abnormal
Clinical narrative: Woke up the day following the vaccination (Saturday, 16 March 2019) with exacerbation of joint pain, exhaustion, malaise, lack of appetite. By afternoon developed fever of 103.2 degrees (could not control fever with acetaminophen). Went to Emergency Department (high/urgent severity) in the evening and once there developed, nausea, vomiting and numbness in arms. Received normal saline and ondansetron IV, continued vomiting and received IV COMPAZINE. Was discharged at 6:30 AM on Sunday, 17 March 2019, and went home. Once home around 12:00 PM (noon) fever returned with maximum of 101.9, while dosing with acetaminophen and ibuprofen. That evening (Sunday 17 March 2019) from 16:00 PM to 4:30 AM the next day, experienced extreme nausea, with violent vomiting, rigor, chills, and delirium. At 09:00 AM on Monday 18 March 2019 returned to Emergency Department with exacerbation of fever, nausea, chills, shortness of breath, joint pain and malaise and was admitted to hospital. In the hospital between Monday 18th to Thursday 21st March continued to experience fever, nausea, chills and rigors, and sweating that worsened throughout the evening and into the night, as well as joint pain and swelling, lack of appetite, weakness, dizziness, fatigue and malaise which were treated with hydromorphone, acetaminophen, ondansetron, COMPAZINE, diclofenac, and tramadol. Started prednisone 20 mg QD on Thursday, 21 March 2019. Abnormal labs tests for serum creatinine and urine protein led to Nephrology consult and recommendation for kidney biopsy. Abnormal CBC and differential lab tests showed blasts in peripheral blood led to Hematology consult and additional flow cytometric analyses and recommendation for bone marrow biopsy. All laboratory testing during Emergency Department visits on 16-17 March and on 18 March then throughout the 5 days of hospitalization suggested cytokine release syndrome and RBC lyses and hemoglobin drop. Laboratory test also identified elevated C-reactive protein, sedimentation rate, circulating immune complexes, and extreme elevations in anti-nuclear antibody titers and complement depletion.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: C-reactive protein increased, Chills, Complement factor decreased, Cytokine release syndrome, Decreased appetite
Clinical narrative: Woke up the day following the vaccination (Saturday, 16 March 2019) with exacerbation of joint pain, exhaustion, malaise, lack of appetite. By afternoon developed fever of 103.2 degrees (could not control fever with acetaminophen). Went to Emergency Department (high/urgent severity) in the evening and once there developed, nausea, vomiting and numbness in arms. Received normal saline and ondansetron IV, continued vomiting and received IV COMPAZINE. Was discharged at 6:30 AM on Sunday, 17 March 2019, and went home. Once home around 12:00 PM (noon) fever returned with maximum of 101.9, while dosing with acetaminophen and ibuprofen. That evening (Sunday 17 March 2019) from 16:00 PM to 4:30 AM the next day, experienced extreme nausea, with violent vomiting, rigor, chills, and delirium. At 09:00 AM on Monday 18 March 2019 returned to Emergency Department with exacerbation of fever, nausea, chills, shortness of breath, joint pain and malaise and was admitted to hospital. In the hospital between Monday 18th to Thursday 21st March continued to experience fever, nausea, chills and rigors, and sweating that worsened throughout the evening and into the night, as well as joint pain and swelling, lack of appetite, weakness, dizziness, fatigue and malaise which were treated with hydromorphone, acetaminophen, ondansetron, COMPAZINE, diclofenac, and tramadol. Started prednisone 20 mg QD on Thursday, 21 March 2019. Abnormal labs tests for serum creatinine and urine protein led to Nephrology consult and recommendation for kidney biopsy. Abnormal CBC and differential lab tests showed blasts in peripheral blood led to Hematology consult and additional flow cytometric analyses and recommendation for bone marrow biopsy. All laboratory testing during Emergency Department visits on 16-17 March and on 18 March then throughout the 5 days of hospitalization suggested cytokine release syndrome and RBC lyses and hemoglobin drop. Laboratory test also identified elevated C-reactive protein, sedimentation rate, circulating immune complexes, and extreme elevations in anti-nuclear antibody titers and complement depletion.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Delirium, Differential white blood cell count abnormal, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Woke up the day following the vaccination (Saturday, 16 March 2019) with exacerbation of joint pain, exhaustion, malaise, lack of appetite. By afternoon developed fever of 103.2 degrees (could not control fever with acetaminophen). Went to Emergency Department (high/urgent severity) in the evening and once there developed, nausea, vomiting and numbness in arms. Received normal saline and ondansetron IV, continued vomiting and received IV COMPAZINE. Was discharged at 6:30 AM on Sunday, 17 March 2019, and went home. Once home around 12:00 PM (noon) fever returned with maximum of 101.9, while dosing with acetaminophen and ibuprofen. That evening (Sunday 17 March 2019) from 16:00 PM to 4:30 AM the next day, experienced extreme nausea, with violent vomiting, rigor, chills, and delirium. At 09:00 AM on Monday 18 March 2019 returned to Emergency Department with exacerbation of fever, nausea, chills, shortness of breath, joint pain and malaise and was admitted to hospital. In the hospital between Monday 18th to Thursday 21st March continued to experience fever, nausea, chills and rigors, and sweating that worsened throughout the evening and into the night, as well as joint pain and swelling, lack of appetite, weakness, dizziness, fatigue and malaise which were treated with hydromorphone, acetaminophen, ondansetron, COMPAZINE, diclofenac, and tramadol. Started prednisone 20 mg QD on Thursday, 21 March 2019. Abnormal labs tests for serum creatinine and urine protein led to Nephrology consult and recommendation for kidney biopsy. Abnormal CBC and differential lab tests showed blasts in peripheral blood led to Hematology consult and additional flow cytometric analyses and recommendation for bone marrow biopsy. All laboratory testing during Emergency Department visits on 16-17 March and on 18 March then throughout the 5 days of hospitalization suggested cytokine release syndrome and RBC lyses and hemoglobin drop. Laboratory test also identified elevated C-reactive protein, sedimentation rate, circulating immune complexes, and extreme elevations in anti-nuclear antibody titers and complement depletion.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Flow cytometry, Full blood count abnormal, Haemoglobin decreased, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Woke up the day following the vaccination (Saturday, 16 March 2019) with exacerbation of joint pain, exhaustion, malaise, lack of appetite. By afternoon developed fever of 103.2 degrees (could not control fever with acetaminophen). Went to Emergency Department (high/urgent severity) in the evening and once there developed, nausea, vomiting and numbness in arms. Received normal saline and ondansetron IV, continued vomiting and received IV COMPAZINE. Was discharged at 6:30 AM on Sunday, 17 March 2019, and went home. Once home around 12:00 PM (noon) fever returned with maximum of 101.9, while dosing with acetaminophen and ibuprofen. That evening (Sunday 17 March 2019) from 16:00 PM to 4:30 AM the next day, experienced extreme nausea, with violent vomiting, rigor, chills, and delirium. At 09:00 AM on Monday 18 March 2019 returned to Emergency Department with exacerbation of fever, nausea, chills, shortness of breath, joint pain and malaise and was admitted to hospital. In the hospital between Monday 18th to Thursday 21st March continued to experience fever, nausea, chills and rigors, and sweating that worsened throughout the evening and into the night, as well as joint pain and swelling, lack of appetite, weakness, dizziness, fatigue and malaise which were treated with hydromorphone, acetaminophen, ondansetron, COMPAZINE, diclofenac, and tramadol. Started prednisone 20 mg QD on Thursday, 21 March 2019. Abnormal labs tests for serum creatinine and urine protein led to Nephrology consult and recommendation for kidney biopsy. Abnormal CBC and differential lab tests showed blasts in peripheral blood led to Hematology consult and additional flow cytometric analyses and recommendation for bone marrow biopsy. All laboratory testing during Emergency Department visits on 16-17 March and on 18 March then throughout the 5 days of hospitalization suggested cytokine release syndrome and RBC lyses and hemoglobin drop. Laboratory test also identified elevated C-reactive protein, sedimentation rate, circulating immune complexes, and extreme elevations in anti-nuclear antibody titers and complement depletion.