chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Compartment syndrome, Erythema, Injection site erosion, Injection site erythema
Clinical narrative: The patient named above was not seen by me when he developed adverse reaction. He was also not followed up by me after developing adverse reaction. Patient was given flu vaccine (lot # U6655AA) in my office on 12/11/2019 @ approx. 330 pm. Parents then took patient to Medical Center E.R. on 12/12/2019 in the evening. Please see copy enclosed with this form from Medical Center E.R. Patient was then taken to different Medical Center on 12/13/2019 where he was then admitted from 12/13/2019 - 12/17/2019. Please see copy enclosed with this form from Medical Center. Thank you.  5Y 3M old male complaining of Reaction to Flu Shot. Patient had a flu shot in the right arm yesterday at his doctor's office. This evening he presents with complaint of pain swelling redness and abrasion to the right shoulder area. He has had flu shots in the past without any reaction. There is no reports of fever. They deny that he has been scratching he area. The patient presents with rash. The onset was 1 days ago. The course/duration of symptoms is worsening. Location: Face trunk back. The character of symptoms is itching and redness. Radiating symptom(s): spreading distally. The degree of symptoms is minimal. Risk factors consist of infectious exposure. Prior episodes: none. Therapy today: none. Associated symptoms: none. Otherwise healthy vaccinated 5-year-old male presents with rash following recent hospital discharge for cellulitis compartment syndrome. Patient was discharged 5 days ago for a cellulitis following a flu shot which led to compartment syndrome requiring surgical intervention. Currently on day 7 of p.o. antibiotics. Yesterday had a popular raised erythematous rash that began on the chest and overnight spread to involve the abdomen, back, and face. Distal extremities are relatively spared. No fevers, difficulty breathing, difficulty swallowing, nausea vomiting diarrhea.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Pruritus, Rash, Rash papular
Clinical narrative: The patient named above was not seen by me when he developed adverse reaction. He was also not followed up by me after developing adverse reaction. Patient was given flu vaccine (lot # U6655AA) in my office on 12/11/2019 @ approx. 330 pm. Parents then took patient to Medical Center E.R. on 12/12/2019 in the evening. Please see copy enclosed with this form from Medical Center E.R. Patient was then taken to different Medical Center on 12/13/2019 where he was then admitted from 12/13/2019 - 12/17/2019. Please see copy enclosed with this form from Medical Center. Thank you.  5Y 3M old male complaining of Reaction to Flu Shot. Patient had a flu shot in the right arm yesterday at his doctor's office. This evening he presents with complaint of pain swelling redness and abrasion to the right shoulder area. He has had flu shots in the past without any reaction. There is no reports of fever. They deny that he has been scratching he area. The patient presents with rash. The onset was 1 days ago. The course/duration of symptoms is worsening. Location: Face trunk back. The character of symptoms is itching and redness. Radiating symptom(s): spreading distally. The degree of symptoms is minimal. Risk factors consist of infectious exposure. Prior episodes: none. Therapy today: none. Associated symptoms: none. Otherwise healthy vaccinated 5-year-old male presents with rash following recent hospital discharge for cellulitis compartment syndrome. Patient was discharged 5 days ago for a cellulitis following a flu shot which led to compartment syndrome requiring surgical intervention. Currently on day 7 of p.o. antibiotics. Yesterday had a popular raised erythematous rash that began on the chest and overnight spread to involve the abdomen, back, and face. Distal extremities are relatively spared. No fevers, difficulty breathing, difficulty swallowing, nausea vomiting diarrhea.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Surgery
Clinical narrative: The patient named above was not seen by me when he developed adverse reaction. He was also not followed up by me after developing adverse reaction. Patient was given flu vaccine (lot # U6655AA) in my office on 12/11/2019 @ approx. 330 pm. Parents then took patient to Medical Center E.R. on 12/12/2019 in the evening. Please see copy enclosed with this form from Medical Center E.R. Patient was then taken to different Medical Center on 12/13/2019 where he was then admitted from 12/13/2019 - 12/17/2019. Please see copy enclosed with this form from Medical Center. Thank you.  5Y 3M old male complaining of Reaction to Flu Shot. Patient had a flu shot in the right arm yesterday at his doctor's office. This evening he presents with complaint of pain swelling redness and abrasion to the right shoulder area. He has had flu shots in the past without any reaction. There is no reports of fever. They deny that he has been scratching he area. The patient presents with rash. The onset was 1 days ago. The course/duration of symptoms is worsening. Location: Face trunk back. The character of symptoms is itching and redness. Radiating symptom(s): spreading distally. The degree of symptoms is minimal. Risk factors consist of infectious exposure. Prior episodes: none. Therapy today: none. Associated symptoms: none. Otherwise healthy vaccinated 5-year-old male presents with rash following recent hospital discharge for cellulitis compartment syndrome. Patient was discharged 5 days ago for a cellulitis following a flu shot which led to compartment syndrome requiring surgical intervention. Currently on day 7 of p.o. antibiotics. Yesterday had a popular raised erythematous rash that began on the chest and overnight spread to involve the abdomen, back, and face. Distal extremities are relatively spared. No fevers, difficulty breathing, difficulty swallowing, nausea vomiting diarrhea.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Neuropathy peripheral, Peripheral swelling
Clinical narrative: Arm swollen & red within an hour of injection. C/O dull headache since C/O new onset neuropathy feet since
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash, Rash maculo-papular, Urticaria
Clinical narrative: Within 24 hours of IZ administration - Next morning - I noticed Full body Rash except diaper area & soles of feet. Generalized macular papular lare Hive Rash to face Torso & All 4 extremities. No itching & blanching 7mo Infant exam did not seemed to be bothered by Rash. Cannot associate Rash to vaccine, had same vaccines @ 2 & 4 months. Patient had no other signs of viral exanthem. No fever. No running nose.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash all over the body Loratadine & prednisolone Sent to ER.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Contraindication to vaccination, Exposure during pregnancy
Clinical narrative: Pt 6w pregnant was mistakenly given Flu Mist. Pt advised to go to her GYN and to call us if any symptoms occur Pt shows no signs of adverse reaction at this time.
Age: 8.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Mild fever and measle like rash on the left arm
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever of 102.1, administered Motrin. Fever came down during the day then spiked at bed time again to 103. Came down 2 degrees with Motrin.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Influenza virus test negative
Clinical narrative: Headache, body aches, temperature between 99.4 - 100.8, chills, fatigue.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Headache, body aches, temperature between 99.4 - 100.8, chills, fatigue.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disorientation, Headache, Pain, Pyrexia
Clinical narrative: 103 degree fever, headache, body aches, chills, disorientation
Age: 83.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Back pain, Biopsy artery abnormal, Blood iron decreased, Headache
Clinical narrative: About 7-10 days after injection patient started with a headache and pain behind knees.  The pain went to lower back, shoulders and jaw.  When pain behind knee and lower back began he went to a chiropractor.  Pain did not get better.  His foot doctor suggested him go to a neurologist where they sent him for x-rays and MRI's and sent him to physical therapy, which did not help and he was released.  He returned to chiropractor and still did not get better. He saw his primary care physician and he sent patient for blood work.  The blood work came back showing patient had very low iron. His primary sent him to Dr.  She sent him for a biopsy of the Temporal artery, which came back positive for an autoimmune disease called temporal arteritis.  He was treated with prednisone and slowly began feeling better.
Age: 83.0
Sex: M
Vaccine: FLUA3
Symptoms: Magnetic resonance imaging, Musculoskeletal pain, Pain in jaw, Temporal arteritis, X-ray
Clinical narrative: About 7-10 days after injection patient started with a headache and pain behind knees.  The pain went to lower back, shoulders and jaw.  When pain behind knee and lower back began he went to a chiropractor.  Pain did not get better.  His foot doctor suggested him go to a neurologist where they sent him for x-rays and MRI's and sent him to physical therapy, which did not help and he was released.  He returned to chiropractor and still did not get better. He saw his primary care physician and he sent patient for blood work.  The blood work came back showing patient had very low iron. His primary sent him to Dr.  She sent him for a biopsy of the Temporal artery, which came back positive for an autoimmune disease called temporal arteritis.  He was treated with prednisone and slowly began feeling better.
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: Patient was given flu shot. Doctor would not give patient any information. Doctor says flu shot did not cause his issues, it was a good shot. Patient began with pain behind knees again 7 days after flu shot. Same occurrence that had happened to him from the flu shot in 2018.  Patient went back to Dr. to tell her the same events were occurring as what happened to him last year and she said it had nothing to do with the shot.  She asked him if he was still taking the prednisone and he said, no that she had weaned him off.  She said to patient you are still to be taking the prednisone and prescribed it again for him.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea, fever, headache, tiredness, muscle pain
Age: 1.5
Sex: M
Vaccine: PNC13
Symptoms: Abdominal X-ray, Abdominal distension, Diarrhoea, Influenza, Influenza virus test
Clinical narrative: Within 24 hours of the injection, healthy and well (aside from pre-existing reflux condition being managed holistically)Patient suffered from persistent and SEVERE diarrhea (profuse 3-5 times daily complete lose and watery bowels) for 10 days consecutive, without resolve at any point. Taken to the Emergency Room 3/11/2019 for severe bloated hard abdomen. ER diagnosed with influenza A, and found no obstruction with GI (Test:XR ABDOMEN 2V ROUTINE SUPINE W UPRIGHT/DECUB/CTL). 3/12/2019 office visit with pediatrics to follow up- The b.r.a.t. diet was recommended and implemented, diarrhea persisted for at least 4-5 more days, then subsided naturally.
Age: 1.5
Sex: M
Vaccine: PNC13
Symptoms: Polymerase chain reaction, Respiratory syncytial virus test, X-ray normal
Clinical narrative: Within 24 hours of the injection, healthy and well (aside from pre-existing reflux condition being managed holistically)Patient suffered from persistent and SEVERE diarrhea (profuse 3-5 times daily complete lose and watery bowels) for 10 days consecutive, without resolve at any point. Taken to the Emergency Room 3/11/2019 for severe bloated hard abdomen. ER diagnosed with influenza A, and found no obstruction with GI (Test:XR ABDOMEN 2V ROUTINE SUPINE W UPRIGHT/DECUB/CTL). 3/12/2019 office visit with pediatrics to follow up- The b.r.a.t. diet was recommended and implemented, diarrhea persisted for at least 4-5 more days, then subsided naturally.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: 4 hours after recieving vaccine, patient had vomiting, chills and a low grade fever. His wife was worried due to his current cancer diagnosis and took him to the ER. They gave him anti-emetics and fluids, kept him for a couple hours but not overnight. He said he had a similar reaction to a flu shot forty years ago, but his oncologist wanted him to get one now and patient was comfortable trying it again.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: LIGHTHEADEDNESS/DIZZINESS
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dehydration, Dizziness, Fatigue
Clinical narrative: Severe chills, shivering, fever, sweats, exhaustion, headache, nausea, dizziness, fast heartbeat, weakness, difficulty walking, dehydrated, and passed out.  Severe symptoms began 1:00 A.M. on 1/8/2020 and lasted until 9:00 A.M. Still was weak and had headache until 5:00 P.M. on 1/8/2020.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Heart rate increased, Hyperhidrosis, Loss of consciousness
Clinical narrative: Severe chills, shivering, fever, sweats, exhaustion, headache, nausea, dizziness, fast heartbeat, weakness, difficulty walking, dehydrated, and passed out.  Severe symptoms began 1:00 A.M. on 1/8/2020 and lasted until 9:00 A.M. Still was weak and had headache until 5:00 P.M. on 1/8/2020.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Severe chills, shivering, fever, sweats, exhaustion, headache, nausea, dizziness, fast heartbeat, weakness, difficulty walking, dehydrated, and passed out.  Severe symptoms began 1:00 A.M. on 1/8/2020 and lasted until 9:00 A.M. Still was weak and had headache until 5:00 P.M. on 1/8/2020.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Gait disturbance, Laboratory test, Myalgia, Pyrexia
Clinical narrative: Patient states she had no immediate soreness or fever.  She states week of 11/11 & 11/18 she had 3 days each week where she felt feverish with a duration of 4 hours but the thermometer didn't reflect fever.  Patient states she developed difficulty walking and extreme muscle pain that got progressively worse.  Patient visited the ER and had an overnight stay.  The patient states she was seen by neurology and rheumatology and had numerous tests.   The patient was treated with steroids.  Patient states the steroids were ineffective.  She got progressively worse and was admitted to the hospital 12/11-14.  She has had to have occupational and physical therapy.  She is improving.  Patient reported to pharmacy on 1/10/20.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Huge red, itchy, swollen, hard, puffy, hot to the touch area on skin at site of injection. Injection may have also been administered in wrong area of the arm. Possible local reaction or skin infection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cold sweat, Contusion, Diarrhoea, Dizziness
Clinical narrative: light headed, clammy, fainted, nausea, diarrhea.  Passed out to the floor resulting in sore knee, bruised toe/foot, bumped head.  Saw family doctor next day
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Head injury, Loss of consciousness, Nausea, Syncope
Clinical narrative: light headed, clammy, fainted, nausea, diarrhea.  Passed out to the floor resulting in sore knee, bruised toe/foot, bumped head.  Saw family doctor next day
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Paraesthesia, Pruritus
Clinical narrative: Donor immediately had a reaction after the injection of Tdap left deltoid. Donor complained of tingling and itching  in arm and back immediately. EMS called and arrived at center at 9:45am. EMS and Handout given. Donor agreed to be transported By EMS for treatment.
Age: 89.0
Sex: F
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: second dose was administered too early (first dose: 12/17/2019, second dose: 1/6/2020)  - second dose needs to be at least 4 weeks a part from first  - patient did not report any adverse reactions and will be revaccinated 2 months from 1/6/2020
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dizziness, Flushing
Clinical narrative: pt reported feeling light headed, chest pain, flushed face one to two minutes after administration.  Paramedics contacted, who provided oxygen (sat99 hr 60), and transport to local hospital for eval at pt request.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: SWEATING, DIZZINESS, TIRED
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: chills, sore muscles, headache,  extreme fatigue day after
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood test normal, Fatigue, Gait disturbance, Hypersomnia
Clinical narrative: Weakness and pain in arms and legs, especially knees and shoulders (cannot raise arms or legs) Unable to get out of bed without assistance, or rise unassisted from sitting position Walking with great difficulty Unable to get clothing on and off without assistance General weakness and extremely tired-sleeping a lot
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Weakness and pain in arms and legs, especially knees and shoulders (cannot raise arms or legs) Unable to get out of bed without assistance, or rise unassisted from sitting position Walking with great difficulty Unable to get clothing on and off without assistance General weakness and extremely tired-sleeping a lot
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: Abdominal pain upper, Headache, Hyperacusis, Injection site irritation, Mental impairment
Clinical narrative: Child woke up in the morning with a mild headache; but 230PM child was running a 101.4 fever and was called to remove her from school. She also had site irritation.  By 5PM, child had temporary cloudy thinking.  By 6PM,s he had a migraine caliber headache with sensitivity to light and sound and still had a 101.4-101.8 fever.  Patient was given one dose of Tylenol and fever and headache did not return.  By 620PM, patient was throwing up and complaining of severe stomach pain.  Vomiting continued until approximately 10PM, until child went to sleep.  During her sleep, child moaned complaining of leg pain in both legs (assuming that part is unrelated to vaccine).  Woke up the next morning with very mild stomach pain only.
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: Migraine, Moaning, Pain in extremity, Photophobia, Pyrexia
Clinical narrative: Child woke up in the morning with a mild headache; but 230PM child was running a 101.4 fever and was called to remove her from school. She also had site irritation.  By 5PM, child had temporary cloudy thinking.  By 6PM,s he had a migraine caliber headache with sensitivity to light and sound and still had a 101.4-101.8 fever.  Patient was given one dose of Tylenol and fever and headache did not return.  By 620PM, patient was throwing up and complaining of severe stomach pain.  Vomiting continued until approximately 10PM, until child went to sleep.  During her sleep, child moaned complaining of leg pain in both legs (assuming that part is unrelated to vaccine).  Woke up the next morning with very mild stomach pain only.
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: Vomiting
Clinical narrative: Child woke up in the morning with a mild headache; but 230PM child was running a 101.4 fever and was called to remove her from school. She also had site irritation.  By 5PM, child had temporary cloudy thinking.  By 6PM,s he had a migraine caliber headache with sensitivity to light and sound and still had a 101.4-101.8 fever.  Patient was given one dose of Tylenol and fever and headache did not return.  By 620PM, patient was throwing up and complaining of severe stomach pain.  Vomiting continued until approximately 10PM, until child went to sleep.  During her sleep, child moaned complaining of leg pain in both legs (assuming that part is unrelated to vaccine).  Woke up the next morning with very mild stomach pain only.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Sore upper arm at injection site for months
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Left upper arm -blanching faint pink macular rash 10x 11 cm extending to medial arm
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient requested second shingrix vaccine at dropoff. After administering, patient stated she meant pneumonia 23 vaccine so she was administered a third dose of shingrix. Last shingrix dose was 9/2019/
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema of eyelid, Swelling of eyelid
Clinical narrative: Patient developed redness and swelling beneath each eye.  Saw prescriber at Urgent Care.  Prescribed methylprednisolone 4mg dosepak and epinephrine 0.3mg autoinjector.  Unsure if patient was given steroid injection at Urgent Care
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Daughter called to say her fathers arm above elbow was hurting, red and swollen
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Per patient she has a very red and painful arm.  Like a band around the arm several inches wide.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Arm swelling, chills, fever, aches and headache.  On 11/11/2020, the shot area raised up and became red... approximately 1.5 inch diameter. This was my second shot.  My first shot I experienced a large swelling at the shot site, but nothing else.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Arm swelling, chills, fever, aches and headache.  On 11/11/2020, the shot area raised up and became red... approximately 1.5 inch diameter. This was my second shot.  My first shot I experienced a large swelling at the shot site, but nothing else.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Intense pain and slight swelling at injection site. Overall body aches and joint pain. Fatigue. Intensification of shoulder pain from previous injury.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Intense pain and slight swelling at injection site. Overall body aches and joint pain. Fatigue. Intensification of shoulder pain from previous injury.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Malaise, Pyrexia
Clinical narrative: Within 12 hours of injection I experienced: mild fever, chills, and malaise.  Self-treated with Advil, which eliminated the symptoms.  Also, soreness at the injection site for 5 days.
Age: 34.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Asthenia, Dyspnoea, Fatigue, Visual impairment
Clinical narrative: Patient states he is having vision problems, feels weak and tired. I told him it was unlikely to be from the vaccines since they were given 16 days ago, however he is insistent he believes it is due specifically to the Havrix injection. He asked if he should go to the ER, I told him if he is having trouble breathing he should, he states he is having some difficulty breathing but did not mention that until I said it. I advised him if he is having trouble breathing to the point that he cannot, or just feels bad enough that he feels he should go, that he should.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: about 8.5 hours after getting the shot, I started an all over not well feeling.  Within an hour I had a fever and was shivering.  That lasted all night.  During the night I got a horrible headache which is still affecting me at the time of this writing.  I have been very fatigued and slept for 3 hours in the afternoon.  When I woke up I felt somewhat better but now a few hours later the headache, body aches and shivering has returned.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: about 8.5 hours after getting the shot, I started an all over not well feeling.  Within an hour I had a fever and was shivering.  That lasted all night.  During the night I got a horrible headache which is still affecting me at the time of this writing.  I have been very fatigued and slept for 3 hours in the afternoon.  When I woke up I felt somewhat better but now a few hours later the headache, body aches and shivering has returned.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphemia
Clinical narrative: acute onset of stuttering   ***as my office did not administer the vaccine, I do not know the exact type and manufacturer of the flu vaccine
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test abnormal, Dehydration, Fall, Fatigue
Clinical narrative: Extreme flu like symptoms lasting 2 weeks. Woke up arms bent at elbow for awhile I has no control to use my arms, walking pushing grocery cart on sidewalk my legs involuntary began to run had no control sidewalk had ice I fell only way I stopped sprained left arm went to hospital 2 days later my arm got worse I had a NP look at me told her about the vaccine she had no interest. Called pharmacy was told all people react to vacines differently, Almost on a mid afternoon basis I get extremely tired lay down sleep for around 2 hours wake up feeling sick body aches headache joint pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Ligament sprain, Loss of control of legs, Malaise
Clinical narrative: Extreme flu like symptoms lasting 2 weeks. Woke up arms bent at elbow for awhile I has no control to use my arms, walking pushing grocery cart on sidewalk my legs involuntary began to run had no control sidewalk had ice I fell only way I stopped sprained left arm went to hospital 2 days later my arm got worse I had a NP look at me told her about the vaccine she had no interest. Called pharmacy was told all people react to vacines differently, Almost on a mid afternoon basis I get extremely tired lay down sleep for around 2 hours wake up feeling sick body aches headache joint pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle contractions involuntary, Pain
Clinical narrative: Extreme flu like symptoms lasting 2 weeks. Woke up arms bent at elbow for awhile I has no control to use my arms, walking pushing grocery cart on sidewalk my legs involuntary began to run had no control sidewalk had ice I fell only way I stopped sprained left arm went to hospital 2 days later my arm got worse I had a NP look at me told her about the vaccine she had no interest. Called pharmacy was told all people react to vacines differently, Almost on a mid afternoon basis I get extremely tired lay down sleep for around 2 hours wake up feeling sick body aches headache joint pain.
Age: 72.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Fatigue, Heart rate increased, Pain in extremity, Pyrexia
Clinical narrative: sore arm , increase heart rate, feverish ,fatigue was prescribed triamcinolone ointment but couldn't confirm if it was for the arm (unable to reach patient via phone, i wasn't present when the patient reported the side affects)
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Blepharospasm, Choking, Cough, Pyrexia, Rhinorrhoea
Clinical narrative: shots on 12/30/19, ER visit on 01/03/2020 due to coughing to the point of choking and snotty, 01/05/2020 started having seizures with high fever rushed by ems to hospital. Also since seizures has had a on and off again eye twitch mainly right eye.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Seizure
Clinical narrative: shots on 12/30/19, ER visit on 01/03/2020 due to coughing to the point of choking and snotty, 01/05/2020 started having seizures with high fever rushed by ems to hospital. Also since seizures has had a on and off again eye twitch mainly right eye.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Skin plaque
Clinical narrative: no big problems that I noticed until saturday. then suddenly Very serious rash all over the body. Big plaques. Small balls. Big balls. Lines. Very red. Very itchy.Started to itch and became not supportable within two hours on Saturday late afternoon, I was at a movie and at the end I tried to go eat but instead I went directly to urgent care. I do not know if I wrote the correct type of vaccine, it was Recombinant Zoster (Shingles) Vaccine, RZV, the new shingles, first dose. The doctor told me NOT to get the second dose.  A few years ago I took the old shingles vaccine and had no problem, so i was surprised this was had such terrible effect.
Age: 66.0
Sex: M
Vaccine: HEPAB
Symptoms: Arthritis bacterial, Injection site pain, Intensive care, Shoulder operation, Staphylococcal infection
Clinical narrative: per patient, on 12/29/2019 he developed left shoulder pain went to the "hospital medical center", and was prescribed Ibuprofen 800 mg and generic Norco 5/325 mg on 12/31/19. On 01/02/20 patient got "Adacel ( lot: c5609aa)" vaccine  on his right deltoid. Per patients wife, patient developed severe shoulder pain on left side and admitted to ICU on 01/03/20. Per patient family, attending clinicians said he developed "Septic arthritis" and Staphylococcal infection. Patient went for left shoulder surgery on 01/10/20.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema of eyelid, Eye contusion, Eye irritation, Eye pruritus, Ocular hyperaemia
Clinical narrative: Went to Urgent Care 12-24-2019 Doctor Put me on Prednisone 10mg 12-24-2019 also the pharmacist told me to take Benadryl and Alg Pill, which I did and Ibuprofen. I did what she said, went to doctor next day I think it was. It was a lady pharmist, the next day they tried to help. 01-09-20 upper eyelid and corner of eye still red and burns like I thing its getting Better though Friday itched really bad But I tried not to touch, I put anti Bio cream on and then that didn't work so I put a hydrocortisone cream on and it help some. Went to Bed got up Saturday morning all the way around my neck and up my neck in my hair a lot more. Didn't know what to do call number on this paper no in on weekdays, called medical center (closed Pill for nose drainage generic alergan, then Took a shower, By time I was done, I was getting some relief, But felt dryed up but I didn't hurt. A friend, said to make a paste of Baking Soda Its 1:00PM eating my oatmeal, Took my morning pills Was my check up, doctor or eye doctor said gets any worse call my reg doctor, which I did go to clinic next day P.S. Just wanted you to know all, its still around left eye, can't ware make-up and its 01-09-20 Hurt to put any then around it (bump)
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: Went to Urgent Care 12-24-2019 Doctor Put me on Prednisone 10mg 12-24-2019 also the pharmacist told me to take Benadryl and Alg Pill, which I did and Ibuprofen. I did what she said, went to doctor next day I think it was. It was a lady pharmist, the next day they tried to help. 01-09-20 upper eyelid and corner of eye still red and burns like I thing its getting Better though Friday itched really bad But I tried not to touch, I put anti Bio cream on and then that didn't work so I put a hydrocortisone cream on and it help some. Went to Bed got up Saturday morning all the way around my neck and up my neck in my hair a lot more. Didn't know what to do call number on this paper no in on weekdays, called medical center (closed Pill for nose drainage generic alergan, then Took a shower, By time I was done, I was getting some relief, But felt dryed up but I didn't hurt. A friend, said to make a paste of Baking Soda Its 1:00PM eating my oatmeal, Took my morning pills Was my check up, doctor or eye doctor said gets any worse call my reg doctor, which I did go to clinic next day P.S. Just wanted you to know all, its still around left eye, can't ware make-up and its 01-09-20 Hurt to put any then around it (bump)
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Peripheral swelling
Clinical narrative: Patient called on 1/9/20 to let us know that his left arm had swollen to twice the normal size the following the vaccination. He had laid down to nap and slept with his left arm up on his left side and noticed it swollen. He was also dizzy and light headed. He took Tylenol that evening and visited 1/9/20 and we have an appointment with the office on 1/10/20. Per lady - patient prescribed Medrol Dosepak and Benadryl 25mg. Patient also reports had parasites on skin for 3 years.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Asthenia, Injection site pain, Pain, Pyrexia, Sciatica
Clinical narrative: Fever 101.0 degrees, body ache, decrease energy, sciatica, sore at injection site. Never had a reaction to  the Influenzas Vaccine. Will see HCP in the am if signs and symptoms worsen.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Soreness at injection site, mild headache, fever, & shivering
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Lichenoid keratosis, Pruritus, Rash, Rash erythematous
Clinical narrative: Small red/orange dots over both lower legs and tops of feet progressed from12/16/2019 through 1/6/2020 with increased itching. Dermatologist seen on 12/30/2019.   Triamcinolone Acetonide Cream was prescribed and a biopsy was taken.  Biopsy results on 1/9/2020 suggested  "purpuric lichenoid dermatitis".    Starting on 1/6/2019 the "rash" began to fade and the itching lessened.  The rash and itching have continued to lessen, but have not completely resolved.  On 7/23/2019 after the first dose of Shingrix , a similar rash appeared that was restricted to the tops of feet.  It cleared within 10-14 days without medical attention.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: From the shoulder to the elbow, sharp pain. Does not burn. Throbs upon pronation. Has been treating with Aleve, but has not alleviated much pain. Applying heat may help some. Pain increases with different arm position. Pain occurs upon trying to lift arm. Pain recedes when arm is loose.
Age: 44.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash papular
Clinical narrative: large raised rash around injection site, hot to touch and slightly painful; took xyzal
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Dyskinesia, Injection site haemorrhage, Loss of consciousness, Syncope
Clinical narrative: Shot was given, injection site bled a small amount (but did not need more than 1 cotton ball), dizziness began about 1-2 minutes post-injection, patients head dropped and she passed out. She was immediately guided to the ground to lie down, she was tense and had few small jerks. Syncope did not last longer than 30 seconds, she was given a water and pharmacy intern sat with her for 10 minutes until she no longer felt dizzy and lightheaded.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Tension
Clinical narrative: Shot was given, injection site bled a small amount (but did not need more than 1 cotton ball), dizziness began about 1-2 minutes post-injection, patients head dropped and she passed out. She was immediately guided to the ground to lie down, she was tense and had few small jerks. Syncope did not last longer than 30 seconds, she was given a water and pharmacy intern sat with her for 10 minutes until she no longer felt dizzy and lightheaded.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 61 years old and received the high dose influenza vaccine incorrectly.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Mild shingles outbreak that resolved on own quickly.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Pt initially tolerated administration and did not complain of vision changes, dizziness, nausea. Pt discharged from exam room ambulating independently with her Mother. Made it out of the clinic space and into the building foyer when syncopal episode began. Pt did not fall per report from Mother. Pt  transported back to clinic space, vital signs checked, PCP came to bedside. Juice provided and patient discharged without incident.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Rash
Clinical narrative: PATIENT HAD RASH AT THE SITE THAT LATER DEVELOPED INTO RASH OVER THE BODY
Sex: M
Vaccine: HEP
Symptoms: Blister, Pyrexia, Rash, Urticaria
Clinical narrative: Symptoms: Welts, Blisters, and Rash. Slight fever. Time Course: Months to reverse skin issues.  Unsure of any other symptoms that could still have happened.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Nausea, Pain in extremity, Rash
Clinical narrative: the day following the vaccine, pt was nauseous and headache. patient states that starting the 29th, she had a rash that spread down her entire body and she went to the ER. Since the vaccine her arm has remained sore
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Coordination abnormal, Gait disturbance, Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: Acute ischemic stroke vertigo, trouble walking, loss of balance & coordination, vomiting
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo, Vomiting
Clinical narrative: Acute ischemic stroke vertigo, trouble walking, loss of balance & coordination, vomiting
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Skin irritation, Urticaria
Clinical narrative: Left arm started getting irritated and then the irritation moved to her chest, breaking out in hives hours after the vaccination. Later on, the hives traveled towards her abdomen, forearms, and neck being itchy and irritable. She took a Benadryl approximately 6:00 pm and hives decreased slowly over time after taking medication.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Patient got vaccine on 1/9/20; on 1/12/20, they called, saying that on 1/11/20, they started getting a red, swollen and slightly tender arm. They said that it was getting larger today. I recommended that patient use OTC pain meds and/or ice pack for symptoms, and to let us know if it doesn't start going down by tomorrow.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Electrocardiogram, Hypoaesthesia, Magnetic resonance imaging, Musculoskeletal stiffness
Clinical narrative: Stiffness, numbness arms leg, vertigo  servere  nerve pain
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Neuralgia, Pain, Quality of life decreased, Tinnitus, Vertigo
Clinical narrative: Stiffness, numbness arms leg, vertigo  servere  nerve pain
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Sore arm, headache.  Worst side effect and most disabling was dizziness that lasted approximately 2 weeks.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling, Malaise
Clinical narrative: pt reported pain and discomfort at injection site, since 9/15/2019. she has been feeling sick ever since, also presenting with small bump
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Dyspepsia, Exposure during pregnancy
Clinical narrative: I am pregnant, due February 19th. No other complications before or after this event. For two days after receiving this injection, I felt strong chest pains. At my routine ObGyn appointment on the 30th, the midwife figured the pains were caused by heartburn and said to monitor them. I have never felt heartburn that felt the same way other than after the vaccine, and it has not returned once it subsided.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dyspnoea, Pyrexia, Vomiting
Clinical narrative: Patient  reports getting short of air, weak, having a fever, and vomiting within 2 days of getting vaccine.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Fatigue, Generalised tonic-clonic seizure, Headache, Hypersomnia, Nausea
Clinical narrative: Pt was very tired after getting vaccine. Husband reported no fever. Pt slept most of day on 1/8/2020 1/9/2020 & 1/10/2020. On the evening of 1/10/2020 pt had 3 grand mal seizures. Pt also had a bad headache & nausea on 1/10/2020.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Post -Herpetic Neuralgia; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 12-APR-2010 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions (for prophylaxis). Subsequent to inoculation, the patient was treated for postherpetic neuralgia.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Periarthritis, Product administered at inappropriate site
Clinical narrative: Injection given in upper left arm, "too high up" per patient. Area swollen, red, tender. Patient not able to lift arm above 90 degrees. As of today's date, still can't lift arm over head. Patient states felt pain immediately after shot given.
Age: 51.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection given in upper left arm, "too high up" per patient. Area swollen, red, tender. Patient not able to lift arm above 90 degrees. As of today's date, still can't lift arm over head. Patient states felt pain immediately after shot given.
Age: 51.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Product administered at inappropriate site
Clinical narrative: Injection given in upper left arm, "too high up" per patient. Area swollen, red, tender. Patient not able to lift arm above 90 degrees. As of today's date, still can't lift arm over head. Patient states felt pain immediately after shot given.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: the patient was inadvertently administered an expired dose of MMRII; This spontaneous report was received from office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies  were unknown. Concomitant medications included sterile diluent .    On 28-DEC-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# N032749, expiration date: 20-NOV-2019; dose and route were unknown) for prophylaxis (expired product administered).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: Nurse reports that patient did not experience any symptoms.; patient was administered a dose of improperly stored VARIVAX that was reconstituted with Merck DILUENT that did not experience a temperature excursion.; Nurse reports route of administration to be "intramuscular" rather than subcutaneous.; This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. Information on pertinent medical history and drug reactions/allergies was not reported.   On 07-MAY-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), intramuscularly (strength, dose, and vaccination scheme were not reported) (lot # R002057, expiration date: 22-JAN-2022), administered for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).   The vaccine underwent a temperature excursion of 15-degree Fahrenheit (° F) to 46° F (18.3 F) for a period of 1 hour and 15 minutes. The vaccine previously underwent a temperature excursion of 15° F to 46° F (34.5 F) for a period of 2 hours and 33 minutes. The excursion was called by a digital data logger. The nurse reported that the patient did not experience any symptoms (no adverse event).   This was one of three cases from the same reporter.; Sender's Comments:  US-009507513-2001USA000143: US-009507513-2001USA000179:
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no symptoms; patient who received 3 doses of GARDASIL 9 in 2017 received an additional dose of GARDASIL 9 on 1/2/2019; This spontaneous report was received from a nurse and refers to a 19-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates in 2017, the patient was vaccinated with 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis. On 02-JAN-2019, the patient was vaccinated with additional dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly, (lot # 1621929, expiration date 06-DEC-2021) (strength and dose was not reported) for prophylaxis. It was confirmed that the administration of the GARDASIL 9 was not the result of product confusion. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 20-FEB-2018 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions (for prophylaxis). Subsequent to inoculation, the patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Additional information has been requested.