chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fall, Head injury, Headache, Loss of consciousness
Clinical narrative: Client walking in lobby post vaccination and leans toward the wall with arm while turning pale and falls hitting left side of head reported by witness. Client passed out. Upon awakening client reports., "Feeling dizzy and going toward chair remembered falling". Client reports that she does not remember hitting the floor or head. Area on left side of head with a feeling of soreness when questioned by nurse. Client observed in laying position on lobby floor. Client mother in lobby at time of fall declines EMS. VS  within normal limits for client taken by RN and observation provided with cool compress to neck and head. Mother (post vaccination incident) reports of two times of passing out that are non vaccine related.  7/22/19 client vaccinated at 16:45, fell in lobby at 1656 and recovered and left building at 1720 escorted by mother.  Follow up call to client at 1015  on 7/23/19 reports small bump on left side of head and no other symptoms after leaving clinic. & no evidence of bump today. Client rested at home the  evening and returned to work the next day (7/23/19).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pallor
Clinical narrative: Client walking in lobby post vaccination and leans toward the wall with arm while turning pale and falls hitting left side of head reported by witness. Client passed out. Upon awakening client reports., "Feeling dizzy and going toward chair remembered falling". Client reports that she does not remember hitting the floor or head. Area on left side of head with a feeling of soreness when questioned by nurse. Client observed in laying position on lobby floor. Client mother in lobby at time of fall declines EMS. VS  within normal limits for client taken by RN and observation provided with cool compress to neck and head. Mother (post vaccination incident) reports of two times of passing out that are non vaccine related.  7/22/19 client vaccinated at 16:45, fell in lobby at 1656 and recovered and left building at 1720 escorted by mother.  Follow up call to client at 1015  on 7/23/19 reports small bump on left side of head and no other symptoms after leaving clinic. & no evidence of bump today. Client rested at home the  evening and returned to work the next day (7/23/19).
Age: 72.0
Sex: U
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Asthenia, Blood pressure decreased, Blood pressure increased, Decreased appetite, Fatigue
Clinical narrative: With in 8 hours experienced loss of appetite, tiredness;  At night symptoms included muscle aches, nausea, fever: Upon awakening in the morning and being upright, I became increasingly nauseated and fainted. My blood pressure initially dropped but then became elevated compared to my usual readings.  48 hours after the injection, I still feel tired, weakened and continue to monitor blood pressure.  Blood Pressure still more elevated than usual; monitoring.
Age: 72.0
Sex: U
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Syncope
Clinical narrative: With in 8 hours experienced loss of appetite, tiredness;  At night symptoms included muscle aches, nausea, fever: Upon awakening in the morning and being upright, I became increasingly nauseated and fainted. My blood pressure initially dropped but then became elevated compared to my usual readings.  48 hours after the injection, I still feel tired, weakened and continue to monitor blood pressure.  Blood Pressure still more elevated than usual; monitoring.
Age: 72.0
Sex: U
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Chills, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: With in 8 hours experienced loss of appetite, tiredness;  At night symptoms included muscle aches, nausea, fever: Upon awakening in the morning and being upright, I became increasingly nauseated and fainted. My blood pressure initially dropped but then became elevated compared to my usual readings.  48 hours after the injection, I still feel tired, weakened and continue to monitor blood pressure.  Blood Pressure still more elevated than usual; monitoring.
Age: 72.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Asthenia, Blood pressure decreased, Blood pressure increased, Decreased appetite, Fatigue
Clinical narrative: Fever at night, chills, nausea, : Next morning at 7am while having breakfast patient passed out.
Age: 72.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Syncope
Clinical narrative: Fever at night, chills, nausea, : Next morning at 7am while having breakfast patient passed out.
Age: 72.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Chills, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: Fever at night, chills, nausea, : Next morning at 7am while having breakfast patient passed out.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Aphasia, Electroencephalogram normal, Myoclonus, Sleep study abnormal, Tic
Clinical narrative: mother report hypnic jerks at night, tic disorder and difficulty with word finding
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Fever - 100.1, erythema/pruritus/bruising/swelling around injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Vomiting
Clinical narrative: Flu-like symptoms, vomiting within 3 hours of administration. One episode of vomiting following morning, symptoms began to resolve late that morning into early afternoon.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: On Sunday morning July 14th I woke up w/  L upper arm itching redness and an approx 3  inch circ well defined hive . I treated it with topical aloe and 1-2 x topical Hydrocortisone. The hive decreased after day one. The itching  lasted for several days. All sx are now resolved.
Age: 44.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: After leaving the clinic and sitting down at his desk, patient says he felt dizzy and his hands started feeling tingly/numb.  He had someone drive him back over here and waited for a provider. At 1:59 BP 153/100, rechecked at 155/97, O2 98%, 94bpm. Lungs clear, no rash, no swelling. After about 2 hours the dizziness stopped and he left.  Pt had multiple vaccines including 1st rabies dose on 6/1/19, said he had the same reaction. Dizziness was gone same day but tingling in hands lasted 2 days.  7/18/19 he received the 2nd MMR with no reaction.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Injection site swelling
Clinical narrative: swelling at location of injection
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Swelling
Clinical narrative: Patient reports that approximately 1 hour after receiving Pneumovax 23 his right deltoid started swelling until at around 10 PM his shoulder was swollen to the size of a grapefruit and he had swelling in his arm and clear into his shoulder blade with decreased ability to move his arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Myalgia, Nausea
Clinical narrative: Flu-like symptoms: muscle aches, fatigue, mild nausea. Pain at injection site
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Syncopal episode about 10 min after administration of vaccine.  Pt fainted in the lobby.  Regained consciousness quickly- all symptoms resolved within 5 minutes.  Observed patient in office - complete resolution of symptoms prior to discharge
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient stated: Developed a rash a couple days after vaccine on the right side and continued to get worse and went to the physician office where he was diagnosed with Shingles.  Dr. ordered Valtrex, Medrol Dos Pak, and Acyclovir cream.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: He spiked a high fever to over 103 degrees. His temperature has since come down.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Bone pain, Injection site reaction, Injection site swelling, Pain, Pyrexia
Clinical narrative: PATIENT STARTED NOTICING PAINFUL SYMPTOMS RIGHT AWAY, SHE FELT BONE PAIN AROUND THE INJECTION SITE, FELT FEVERISH, AND THE RASH SIZE OF A FIST STARTED FORMING 2 DAYS AFTER. ALSO NOTICED SWELLING ON THE INJECTION SITE. Told the patient to apply cortisone cream and take benadryl, if symptoms persist told her to go seek medical attention.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: PATIENT STARTED NOTICING PAINFUL SYMPTOMS RIGHT AWAY, SHE FELT BONE PAIN AROUND THE INJECTION SITE, FELT FEVERISH, AND THE RASH SIZE OF A FIST STARTED FORMING 2 DAYS AFTER. ALSO NOTICED SWELLING ON THE INJECTION SITE. Told the patient to apply cortisone cream and take benadryl, if symptoms persist told her to go seek medical attention.
Age: 81.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Injection site bruising, Peripheral swelling, Skin warm
Clinical narrative: Swollen and  red along left arm, hot to the touch, with dark bruises above the joint of elbow. The patient stated taking Benadryl and the reaction cleared up slightly. She had taken it at onset of the reaction.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: NAUSEA WHICH WENT AWAY THE NEXT DAY / PAIN, WAS TOLD THAT IT MAY LAST FOR 7 TO 10 DAYS AND TO TAKE TYLENOL/ RASH , WAS TOLD TO USE BENADRYL  CREAM
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives- on all extremities, coming and going
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Influenza, Influenza like illness, Loss of consciousness
Clinical narrative: Patient received second dose of Shingrix on 7/8/19 and then came down with a flu-like illness over a week later. Patient said she passed out and then had classic symptoms of flu, such as nausea, fatigue, weakness, inability to get out of bed, aches, etc that lasted for a week. She was wondering if this could be an adverse reaction to getting the shingrix, even though she had no issues after the first dose in the series.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Pain
Clinical narrative: Patient received second dose of Shingrix on 7/8/19 and then came down with a flu-like illness over a week later. Patient said she passed out and then had classic symptoms of flu, such as nausea, fatigue, weakness, inability to get out of bed, aches, etc that lasted for a week. She was wondering if this could be an adverse reaction to getting the shingrix, even though she had no issues after the first dose in the series.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swelling, hot to the touch, pain, redness at injection site 5 days later
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Diarrhoea, Feeling abnormal, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Adacel was given in the right upper arm, Shingrix in the left.  Within about 12 hours, she was at the movies with her sons, started feeling general malaise and some nausea.  Went to bed, developed some fever and general malaise, did not sleep well.  Over the next 48 hours had some diarrhea, malaise, ongoing intermittent fever.  Developed significant soreness in the left upper arm.  Lots of heat in the area.  Now it is turning more red.  The right upper arm did not turn red or feel near as hot.  Overall feeling better today than she was a couple days ago, no more fever, appetite is better.  Now has redness and a firm feeling in the left upper arm. Ambulating independently. Left upper arm: 3 to 4 cm area of erythema, about 2 cm of mild induration around the vaccine site over the deltoid.  No motor deficits.  Mildly tender in the area as well. Right upper arm: No erythema, induration, only mild tenderness. Probably a reaction to the shin Grix. This was her first dose. Because she felt so poorly, we agreed to hold off on the second dose indefinitely.  Reviewed the benefits and risks of skipping the second dose. Reviewed home care of this, symptoms should resolve spontaneously over the next week or so. Call or return any time for new concerns.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site warmth, Malaise, Nausea, Poor quality sleep, Pyrexia
Clinical narrative: Adacel was given in the right upper arm, Shingrix in the left.  Within about 12 hours, she was at the movies with her sons, started feeling general malaise and some nausea.  Went to bed, developed some fever and general malaise, did not sleep well.  Over the next 48 hours had some diarrhea, malaise, ongoing intermittent fever.  Developed significant soreness in the left upper arm.  Lots of heat in the area.  Now it is turning more red.  The right upper arm did not turn red or feel near as hot.  Overall feeling better today than she was a couple days ago, no more fever, appetite is better.  Now has redness and a firm feeling in the left upper arm. Ambulating independently. Left upper arm: 3 to 4 cm area of erythema, about 2 cm of mild induration around the vaccine site over the deltoid.  No motor deficits.  Mildly tender in the area as well. Right upper arm: No erythema, induration, only mild tenderness. Probably a reaction to the shin Grix. This was her first dose. Because she felt so poorly, we agreed to hold off on the second dose indefinitely.  Reviewed the benefits and risks of skipping the second dose. Reviewed home care of this, symptoms should resolve spontaneously over the next week or so. Call or return any time for new concerns.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Vaccination complication
Clinical narrative: Adacel was given in the right upper arm, Shingrix in the left.  Within about 12 hours, she was at the movies with her sons, started feeling general malaise and some nausea.  Went to bed, developed some fever and general malaise, did not sleep well.  Over the next 48 hours had some diarrhea, malaise, ongoing intermittent fever.  Developed significant soreness in the left upper arm.  Lots of heat in the area.  Now it is turning more red.  The right upper arm did not turn red or feel near as hot.  Overall feeling better today than she was a couple days ago, no more fever, appetite is better.  Now has redness and a firm feeling in the left upper arm. Ambulating independently. Left upper arm: 3 to 4 cm area of erythema, about 2 cm of mild induration around the vaccine site over the deltoid.  No motor deficits.  Mildly tender in the area as well. Right upper arm: No erythema, induration, only mild tenderness. Probably a reaction to the shin Grix. This was her first dose. Because she felt so poorly, we agreed to hold off on the second dose indefinitely.  Reviewed the benefits and risks of skipping the second dose. Reviewed home care of this, symptoms should resolve spontaneously over the next week or so. Call or return any time for new concerns.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: per pat-experienced arm turning bright red and warm to touch from injection site to wrist, tooks weeks to dissipate
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Insomnia
Clinical narrative: Pain at injection site,  Redness around injection site,  Headache,  Insomnia,  fatigue,
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Dysarthria, Mobility decreased, Muscle spasms, Nausea, Paraesthesia
Clinical narrative: Fingers unable to move well, arms cramping, slurred speech, vomiting, nausea, tingling sensation in arms and legs
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Fingers unable to move well, arms cramping, slurred speech, vomiting, nausea, tingling sensation in arms and legs
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Patient woke up day after vaccination with chickenpox-like spots all over her legs, said they itched prettty bad, and reminded her of chicken pox. She stated she felt otherwise fine, no fever, etc.  She said she was putting an "itch cream" on her legs. I counseled her to keep an eye on the spots, use cortisone cream/benadryl, and to let me or her doctor know if it worsens.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Feeling abnormal, Pyrexia
Clinical narrative: PATIENT CAREGIVER CALLED AND REPORTED THAT FEVER, CHILLS, UPSET STOMACH, AND GENERAL UNPLEASANT FEELING WAS EXPERIENCED WHEN NO ADVERSE EVENTS WERE EXPERIENCED WITH THE FIRST DOSE.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Dizziness, Dyspnoea, Hypersensitivity
Clinical narrative: Pt. reported allergic type symptoms within 1 minute of receiving dose. SOB, faintness. Pt. was seated. Emergency kit was obtained. He provided his own Epinephrine auto-injected and I administered in right thigh. Oral diphenhydramine  was given. His blood pressure was obtained and was appropriate. Pulse was ten and remained strong. No frank tachycardia or bradycardia noted.  Emergency service had been contacted and arrived shortly and assumed care and transported patient to the ER.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Patient states she woke up Saturday 07/20/19, and her vision was blurry in both eyes. She said it was difficult to see close at first. Throughout the day it became harder to see further away. Eventually all aspects of her vision were blurry.  She never lost her sight completely. Each day her vision has improved she said. However as of 07/23/19 her vision is still not back to normal.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Lethargy
Clinical narrative: Headache, lethargy, chills
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Patient complains of fever, chills and headache for the last 3 days
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient was fine after injection.  She was talking, laughing, and walking around.  Suddenly about 5-10 minutes later, she passed out for a few seconds then came back around and was fine again
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Pain
Clinical narrative: within an hour pt experienced body aches, head ache, fatigue, wheezing, lump in throat and eventually a red, tender arm at the injection site
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensation of foreign body, Wheezing
Clinical narrative: within an hour pt experienced body aches, head ache, fatigue, wheezing, lump in throat and eventually a red, tender arm at the injection site
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: 103 fever, violent shaking, extreme nausea, body ache, headache. Lasted 3 days
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Body temperature decreased, Chest X-ray normal, Dyspnoea, Nasopharyngitis, Respiratory rate increased
Clinical narrative: Patient developed rapid breathing and lower body temperature after receiving the vaccines.  He was seen at the office on the next day and noted to have tachypnea and cold symptoms.  He continued to have difficulty with heavy breathing and shortness of breath.  He went to the Emergency Department for shortness of breath with a normal chest X-ray.  He was seen by a pulmonologist and cardiologist.  He was placed on Montelukast and Budesonide breathing treatments.  He continues to have tachypnea chronically and has developed intermittent wheezing.  His breathing has never normalized since the vaccines.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Tachypnoea, Wheezing
Clinical narrative: Patient developed rapid breathing and lower body temperature after receiving the vaccines.  He was seen at the office on the next day and noted to have tachypnea and cold symptoms.  He continued to have difficulty with heavy breathing and shortness of breath.  He went to the Emergency Department for shortness of breath with a normal chest X-ray.  He was seen by a pulmonologist and cardiologist.  He was placed on Montelukast and Budesonide breathing treatments.  He continues to have tachypnea chronically and has developed intermittent wheezing.  His breathing has never normalized since the vaccines.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain in extremity
Clinical narrative: The injection was painful and my arm was sore all night. That evening I was super sleepy. The next morning my arm was only a little sore and not red or swollen as for warned. Instead I continued to experience fatigue and a sort of out of body feeling. Then came the waves of nausea which were followed by more fatigue and a head ache. Tylenol and sleep help.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: The injection was painful and my arm was sore all night. That evening I was super sleepy. The next morning my arm was only a little sore and not red or swollen as for warned. Instead I continued to experience fatigue and a sort of out of body feeling. Then came the waves of nausea which were followed by more fatigue and a head ache. Tylenol and sleep help.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: 9:15am-Client experienced syncope incident approx 10min after administration of vaccines. MOC stated
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, TDAP
Symptoms: Confusional state, Dizziness, Feeling abnormal, Injection site reaction, Loss of consciousness
Clinical narrative: Pt given Tdap at 9:30, states feels ticklish, in Right deltoid; then HPV given and Hep A in Left deltoid. At 9:33 Pt states she feels dizzy and by 9:35 pt Is passing out, slumped to the Left side. Approximately 20 seconds later patient woke up and states what happened I fell asleep, skin was pale and she wasn't sure about where she was at that moment. 9:38 patient states she was going to be sick and proceeded to vomit. Asked patient if she ate today and she replied no not yet. After sitting and sipping water, color returned to face and states she felt much better. Pt left office after 10 minutes, to front lobby, walking on her own unassisted. Patient sat in lobby for another 10 minutes and states felt better. Grandmother and patient proceeded to leave building, without problem. Called grandmother at 11:00AM and spoke to patient who was eating lunch and looking forward to going skating.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, TDAP
Symptoms: Malaise, Pallor, Posture abnormal, Vomiting
Clinical narrative: Pt given Tdap at 9:30, states feels ticklish, in Right deltoid; then HPV given and Hep A in Left deltoid. At 9:33 Pt states she feels dizzy and by 9:35 pt Is passing out, slumped to the Left side. Approximately 20 seconds later patient woke up and states what happened I fell asleep, skin was pale and she wasn't sure about where she was at that moment. 9:38 patient states she was going to be sick and proceeded to vomit. Asked patient if she ate today and she replied no not yet. After sitting and sipping water, color returned to face and states she felt much better. Pt left office after 10 minutes, to front lobby, walking on her own unassisted. Patient sat in lobby for another 10 minutes and states felt better. Grandmother and patient proceeded to leave building, without problem. Called grandmother at 11:00AM and spoke to patient who was eating lunch and looking forward to going skating.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, burning sensation @ site. Flu like symptoms
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Malaise, Nausea
Clinical narrative: Nausea Low grade fever Headache Weakness Malaise Received Shingrix injection around 1pm on 7/3/2019 Around 9pm began having a headache. Throughout the night, headache worsened and low grade fever / chills began. By morning, experienced weakness, nausea, body aches, etc Symptoms lasted approx 36-48 hr.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Nausea Low grade fever Headache Weakness Malaise Received Shingrix injection around 1pm on 7/3/2019 Around 9pm began having a headache. Throughout the night, headache worsened and low grade fever / chills began. By morning, experienced weakness, nausea, body aches, etc Symptoms lasted approx 36-48 hr.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Laboratory test normal, Neck pain, Nerve injury, Sensory loss
Clinical narrative: Onset of nerve damage after receiving the vaccine. Currently, a year later, increasing numbness in center back, arms, legs and feet. No pain. Complete numbness. I am loosing the sensation of touch on all parts of my body. Numerous testing is all negative. I am at my wits end. May be effecting my vision and now the onset of neck pain.
Age: 57.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Blood test normal, Grip strength decreased, Hypersensitivity, Inflammation
Clinical narrative: Date is approximate. I received a flu shot as well as shingles vaccination (1 of 2 expected) during my annual physical. Have never had either before. A few days later I started experiencing joint pain over my whole body. All blood tests have been negative. Hand XR and ultrasound showed inflammation and I was started on Prednisone (worked well) and Plaquenil to which I developed a severe allergic reaction (known and treated successfully). Rheumatology restarted investigation as to cause of joint pain (worsening). Still not resolved, but tentative plan is to start me on Methotrexate (in spite of negative blood test results for RA factor or anything else). I am reporting as I am highly suspicious of the timing compared to the immunizations and the rapid deterioration. I had some joint stiffness previously, but never any pain. I also have some known osteoarthritis (I am 56) but this has been a very rapid change and pain and swelling are not minor (Sometimes I have trouble holding a pen, or lifting a cup of coffee). It may be that this has nothing to do with the shots, but I wanted to report in case there is a link. Thank you!
Age: 57.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rheumatoid factor negative, Swelling, Ultrasound scan abnormal, X-ray limb abnormal
Clinical narrative: Date is approximate. I received a flu shot as well as shingles vaccination (1 of 2 expected) during my annual physical. Have never had either before. A few days later I started experiencing joint pain over my whole body. All blood tests have been negative. Hand XR and ultrasound showed inflammation and I was started on Prednisone (worked well) and Plaquenil to which I developed a severe allergic reaction (known and treated successfully). Rheumatology restarted investigation as to cause of joint pain (worsening). Still not resolved, but tentative plan is to start me on Methotrexate (in spite of negative blood test results for RA factor or anything else). I am reporting as I am highly suspicious of the timing compared to the immunizations and the rapid deterioration. I had some joint stiffness previously, but never any pain. I also have some known osteoarthritis (I am 56) but this has been a very rapid change and pain and swelling are not minor (Sometimes I have trouble holding a pen, or lifting a cup of coffee). It may be that this has nothing to do with the shots, but I wanted to report in case there is a link. Thank you!
Sex: F
Vaccine: HEP
Symptoms: Cholecystectomy, Pain in extremity, Taste disorder
Clinical narrative: I am just trying to find out why I have pain in my calves and taste problems - food doesn't taste good and I have a bad taste in my mouth all the time. Could this be side effects of Hep b antibodies or vaccine? Or Truvada/Tivicay? Or some other drugs I may have been given in the hospital. I had my gallbladder removed and one piece of equipment hadn't been cauterized so I was put on a protocol for HIV/Hep. Ever since then I have had these issues.
Sex: F
Vaccine: HEPA
Symptoms: Allergy test, Menorrhagia, Pain of skin, Skin burning sensation, Skin warm
Clinical narrative: menstrual period that lasted 30 days; she developed a hot and painful burn mark on her left side of her abdomen; she developed a hot and painful burn mark on her left side of her abdomen; This spontaneous report was received from a 68-year-old female patient referring to herself. There was no information about her concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2000, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscularly, lot # reported as 0313K (upon an internal verification, lot number 0313K was assessed as not valid for hepatitis a vaccine, inactivated (VAQTA))(exact dose, injection site and expiration date were not reported) for prophylaxis. On an unknown date, her menstrual period lasted 30 days. On an unknown date (reported as about 30 days after the vaccination), the patient developed a hot and painful burn mark on her left side of her abdomen. The patient sought medical attention. Allergy puncture test was performed (result not provided). As a treatment she received valacyclovir hydrochloride (VALTREX) for pain of skin and skin burning sensation (time frame unspecified) and unspecified contraceptive pill to make the bleeding stop (time frame unspecified). The outcome of the events was reported as recovered on unknown dates. The relatedness between the events and the suspect therapy was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster disseminated, Ophthalmic herpes zoster
Clinical narrative: shingles in eye; shingles on his scalp, ears and face; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix last fall. Less than a week later, he developed shingles on his scalp, eyes, ears and face.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Grip strength decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient's daugter states that the doctor has confirmed  the shot caused nerve damage, carpal tunnel in both hands, and pain at the injection site, neck pain, and swollen hands which all resulted in surgery.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Patient's daugter states that the doctor has confirmed  the shot caused nerve damage, carpal tunnel in both hands, and pain at the injection site, neck pain, and swollen hands which all resulted in surgery.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, X-ray
Clinical narrative: Patient's daugter states that the doctor has confirmed  the shot caused nerve damage, carpal tunnel in both hands, and pain at the injection site, neck pain, and swollen hands which all resulted in surgery.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Carpal tunnel syndrome, Injection site pain, Neck pain, Nerve injury, Peripheral swelling
Clinical narrative: Patient's daugter states that the doctor has confirmed  the shot caused nerve damage, carpal tunnel in both hands, and pain at the injection site, neck pain, and swollen hands which all resulted in surgery.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Surgery
Clinical narrative: Patient's daugter states that the doctor has confirmed  the shot caused nerve damage, carpal tunnel in both hands, and pain at the injection site, neck pain, and swollen hands which all resulted in surgery.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Flu-like symptoms; Headache; Stomach hurts; Weakness; Tired; Shivering; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering. On an unknown date, the outcome of the influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering to be related to Shingrix.  Additional details were provided as follows: Later that same day, the patient experience flu-like symptoms, headache, general weakness, tired, and stomach hurt. The patient also experienced a little shivering.  All symptoms resolved within two days.  The reporter did not consent to follow-up. This case was linked with case US2019115910 (2nd dose case), reported by the sane reporter for the same patient.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Pain, Vaccine positive rechallenge
Clinical narrative: Flu-like symptoms; Headache; Stomach hurts; Weakness; Tired; Shivering; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering. On an unknown date, the outcome of the influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering to be related to Shingrix.  Additional details were provided as follows: Later that same day, the patient experience flu-like symptoms, headache, general weakness, tired, and stomach hurt. The patient also experienced a little shivering.  All symptoms resolved within two days.  The reporter did not consent to follow-up. This case was linked with case US2019115910 (2nd dose case), reported by the sane reporter for the same patient.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; Headache; Stomach hurts; Weakness; Tired; Shivering; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering. On an unknown date, the outcome of the influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering to be related to Shingrix.  Additional details were provided as follows: Later that same day, the patient experience flu-like symptoms, headache, general weakness, tired, and stomach hurt. The patient also experienced a little shivering.  All symptoms resolved within two days.  The reporter did not consent to follow-up. This case was linked with case US2019115910 (2nd dose case), reported by the sane reporter for the same patient.
Age: 1.5
Sex: M
Vaccine: JEV1
Symptoms: Incorrect dose administered
Clinical narrative: 0.5ML was administered when 0.25 should of been administered.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Lethargy, Nausea, Vaccination site induration
Clinical narrative: Patient felt extremely lethargic, could not get out of bed and very nauseated to 24 hours. She had a large red, hardened, itchy area approximately 1 inch below the vaccination puncture, I was shown this 3 days later and still very visible. Red area is approximately 3 inches long and 1.5 inches wide. It subsided around day 5  lightening up but still visible.
Age: 35.0
Sex: F
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no adverse event; a 35-year-old patient was administered a dose of PROQUAD; due for next VARIVAX, but was also due for an M-M-R II dose. Because of this, it was decided to give PROQUAD; due for next VARIVAX, but was also due for an M-M-R II dose. Because of this, it was decided to give PROQUAD; This spontaneous report has been received from a medical assistant referring to a 35 year old female patient. Information about pertinent medical history and drug reactions/allergies was not provided. Concomitant therapies included sterile diluent.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported). On 24-MAY-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (lot# R013568, expiration date 13-MAY-2020; dose detail, anatomical location and route of administration were not reported). On 24-JUN-2019, the patient was accidentally vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant Human albumin)) (PROQUAD) for prophylaxis (lot # R026362, expiration date 15-MAR-2020; dose detail, anatomical location and route of administration were not reported).  On 24-JUN-2019, the patient was due for next varicella virus vaccine live (oka/merck)(VARIVAX), but was also due for an measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose. Because of this, it was decided to give measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant Human albumin))(PROQUAD) (product administered to patient of inappropriate age, wrong product administered and interchange of vaccine products). It was only after the fact that they noticed that this was not indicated for patients that was 35 years of age. The patient had complained of no adverse events thus far.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: negative for the measles disease, but positve for the mumps and rubella disease/ the serology test was "under 25" for measles immunity; Information has been received from a nurse referring to a non-pregnant 33-year-old female patient. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.  The patient received two doses measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R001658 (expiration date: 17-JAN-2020) (additional dosage regimen information was not reported) for prophylaxis on 12-NOV-2018 and 22-MAR-2019 respectively.  On 20-JUN-2019, the patient was tested for serology, which resulted negative for measles disease, but positive for the mumps and rubella disease. The serology test was under 25 (units were not specified) for measles immunity. There was no treatment given for the event. At the time of the report, the outcome of measles antibody negative was reported as not recovered. The causality between the event and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1906USA011300:
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Was administered a dose of imporperly stored vaccines; This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 09-JUL-2019, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # S007769 expiration date on 24-JUL-2020 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  recombinant human albumin (rHA) (M-M-R II) lot # R031681 expiration date on 01-NOV-2020 (route of vaccination, strength and dose number were not provided) for prophylaxis.  It was stated that, the Hepatitis A Vaccine, Inactivated (VAQTA) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II), were exposed to a temperature excursion of above 47°F (92.3°F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. The vaccines were not involved in any previous temperature excursion, and report was made due to a data logger. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA012634: US-009507513-1907USA012634: US-009507513-1907USA012635: US-009507513-1907USA012632:
Sex: U
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Three unspecified patients between the ages of 12 through 14 years experienced syncope after receiving GARDASIL 9 vaccine/ the patient passed out/ black out for a couple of seconds; This spontaneous report was received from a nurse via company representative concerning 3 adolescent patients between the ages of 12 through 14 years old of unknown gender. Information regarding the patients' pertinent medical history, concomitant medications or drug reactions/allergies was unknown by reporter. On an unspecified day in July 2019 (reported as in the last couple of days), the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as recommended by age (strength and route of administration was not provided; dose, lot number and date of expiration were unknown by reporter). On that day, the patients experienced syncope after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The nurse reported that, for one patient, this was the second dose administered and the patient tolerated the first dose just fine. For the other two patients it was unspecified which dose was administered. One patient was sitting down. When the patient stood up, the patient passed out for a couple of seconds. The patient was asked to stay seated for "15 minutes", but it could not be clarified if the patient tried to stand prior to waiting 15 minutes. The other two patients were "laying down on a table and blacked out for a couple of seconds" (syncope). One patient was asked if they had eaten anything that day and the patient replied (s)he had not eaten anything that day. It was unspecified if the other two patients had eaten anything that day.  The patients sought medical attention, and all three patients were in the healthcare provider's office. However they did not receive treatment for the adverse event. It was unknown by reporter if laboratory diagnostics/studies were performed. It was reported that therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not discontinued.  On the same date as the injection, the patients recovered from the syncope event. The causal relationship between the event and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. Upon internal review the event syncope was considered to be medically significant.
Sex: M
Vaccine: HPV9
Symptoms: Anaphylactic reaction, Dyspnoea, Eye swelling, Inappropriate schedule of product administration, Lip swelling
Clinical narrative: anaphylaxis/The patient experienced swollen eyes, swollen lips, developed hives and shortness of breath; The patient received the first dose of GARDASIL 9 on 15-MAY-2018 and received the second dose on 16-JUN-2019; This spontaneous report was received from a physician (also reported as a director of quality) via a field employee referring to a 12 years old male patient. The patient's pertinent medical history included history of Guillain-barre syndrome folloing influenza vaccination. Information about drug reactions/allergies and concomitant medication was unknown.  On 15-MAY-2018, the patient was vaccinated the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, route, lot # and expiration date were unknown) for prophylaxis (reported as recommended for 11 and 12 year olds).  On 16-JUN-2019, the patient was vaccinated with the second dose in the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1602281has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 21-JUL-2021, dose detail, route were unknown) for prophylaxis (reported as recommended for 11 and 12 year olds) and the patient did not receive any other vaccinations at that day (inappropriate schedule of product administration).  On 19-JUN-2019, the patient experienced anaphylaxis, swollen eyes, swollen lips, developed hives and shortness of breath. The patient was hospitalized for an unknown amount of time. Information about treatment given, lab diagnostics/studies was unknown by the reporter. The outcome of event was reported as recovered. The causality assessment between anaphylaxis and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was determined as related.   Upon internal review, the event of anaphylaxis was determined to be medically significant.