chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.88
Sex: M
Vaccine: HIBV
Symptoms: Urticaria, Vaccination site rash
Clinical narrative: Rash started on right thigh under and around vaccine site. Within hours developed into full blown hives covering entire body, extremities, neck and face.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck mass, Pyrexia, Ultrasound scan
Clinical narrative: Patient did not report any injection site reactions after getting vaccine, but 4 days post immunization she noticed a very large lump at the bottom of her neck near her shoulders.  She saw two physicians and had an ultrasound of the area done.  Physician informed her it was probably due to the recent vaccine she was given.  She also noted a lowgrade (99) fever four days post vaccine at the same time she noticed the large lump.  Vaccine was given sub-Q in the back of her left arm.  No redness or other reactions were noted after vaccine was administered aside from the lump on her neck.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Arm burning/redness at injection site. Diagnosed with cellulitis. MD gave him Keflex. Cellulitis looked about 8-10 inches in diameter from picture.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Nausea, Paraesthesia, Pruritus
Clinical narrative: Tingling it tips of fingers both hands feeling like I was sick to my stomach achy --itching stiffness in fingers.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness, soreness, swelling and itching which last for 1 week.  Applied 1% hydrocortisone topically and ice packs.
Age: 1.04
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Contusion, Decreased eye contact, Eczema, Injection site erythema, Injection site inflammation
Clinical narrative: Quarter sized inflammation and redness at injection site (1-15-2016).  Redness and eczema, at current date of 2-20-2016 there is a bruise colored scar. I have noticed personality changes and regression since the injections. (Lack of eye contact, no longer responds to name, lost vocabulary (no longer says mama, dada, or hi), seems listless, etc.)
Age: 1.04
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Listless, Personality change, Regressive behaviour, Scar, Unresponsive to stimuli
Clinical narrative: Quarter sized inflammation and redness at injection site (1-15-2016).  Redness and eczema, at current date of 2-20-2016 there is a bruise colored scar. I have noticed personality changes and regression since the injections. (Lack of eye contact, no longer responds to name, lost vocabulary (no longer says mama, dada, or hi), seems listless, etc.)
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Swelling at site of injection, and surrounding area, redness, bruise, discoloration of skin.  Treated with ice pack. One month later, skin is still discolored.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chills, Cough, Dyspnoea, Headache
Clinical narrative: Started with running nose, hard to get breath, next day 2/18/2016, bad, bad, bad, head ache, back hurt, legs hurt, legs very sensitive on top, sore throat, depth cough, chills, high fever 102 plus went to Urgent Care, said look bad.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hyperaesthesia, Influenza virus test negative, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Started with running nose, hard to get breath, next day 2/18/2016, bad, bad, bad, head ache, back hurt, legs hurt, legs very sensitive on top, sore throat, depth cough, chills, high fever 102 plus went to Urgent Care, said look bad.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rhinorrhoea
Clinical narrative: Started with running nose, hard to get breath, next day 2/18/2016, bad, bad, bad, head ache, back hurt, legs hurt, legs very sensitive on top, sore throat, depth cough, chills, high fever 102 plus went to Urgent Care, said look bad.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Dry skin, Eczema, Skin infection
Clinical narrative: The baby had dry skin, it turned to eczema the next day after vaccination and worsened over the next week. Some if it got infected. Using topical steroids on eczema, neosporin on the infected area. Cerave and Aveeno eczema for the dry skin.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: My physician strongly recommended I get the Gardasil vaccine even though I have been married for 6 years and completely monogamous. She also knew I was trying to get pregnant. One week after I got the vaccine I found out I was pregnant and one week after that I miscarried. I already have had a successful pregnant so there was no reason for my miscarriage. I strongly feel that it was related to the vaccine. I did go on to have another successful pregnancy 5 months after the vaccine.
Age: 20.0
Sex: M
Vaccine: PNC13
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: Patient saw blood run down his arm from vaccination and immediately felt faint. I helped to a chair, got him a cool, wet cloth and O.J. because he had nothing to eat that day also. Pt was very clammy and sweaty, but after juice and sitting for 15 mins., recovered and was alert, called pt 3 hrs later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Pain
Clinical narrative: Patient received ZOSTAVAX 2/18/16 on 2/20/16 comes in to pharmacy complaining of left sided pain similar to previous shingles pain in the past. Pain is located on belly radiates from mid-back to belly button. WO red marks discoloration. Injection site looked fine no redness. Recommended urgent care since weekend.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Ear pain, Injection site erythema, Pain in extremity
Clinical narrative: Redness at site of injection. Aching/pain in arm up to ear.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician assistant refers to a female patient of unknown age. The medical history, concurrent conditions and concomitant medications were none. On 08-FEB-2016, the patient was vaccinated with VARIVAX (Merck) lot # L016127, expiry date 06-MAY-2017, 0.5 ml, subcutaneous. The patient's LMP was 29-NOV-2015 and EDD of 04-SEP-2016. The patient had an unspecified pregnancy test performed on 15-FEB-2016 which came back positive. The patient sought medical attention. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain in shoulder/upper arm limiting movement and disrupting activities.  Followed up with doctor on 2/18 when pain didn't subside and was diagnosed with tendonitis from the shot being administered in the wrong location on my shoulder.  It has now been nine days and I am still in intense pain.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Tendonitis
Clinical narrative: Severe pain in shoulder/upper arm limiting movement and disrupting activities.  Followed up with doctor on 2/18 when pain didn't subside and was diagnosed with tendonitis from the shot being administered in the wrong location on my shoulder.  It has now been nine days and I am still in intense pain.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Skin ulcer
Clinical narrative: Sores on head, numbness on right side of face/neck, with sensation of burning when touched.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Musculoskeletal pain, Pain in extremity, X-ray limb
Clinical narrative: Not sure of exact time. Continuing pain in shoulder/arm, along with flu-like symptoms (which I never had before). Pain has continued since November.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site mass, Skin warm
Clinical narrative: Patient came to pharmacy on Friday after receiving Zostavax on Wednesday and showed her arm which was red and warm to touch. I spoke to patient on Saturday and Sunday and redness has subsided but has a lump at injection site. Patient feels fine.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: PATIENT REPORTS NUMBNESS DOWN HER RIGHT ARM AND TINGLING IN HER RIGHT HAND AND FINGERS. SHE ALSO REPORTS PAIN IN HER RIGHT FOREARM AND SHOULDER.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling of the arm below the injection about the size of a small grapefruit, tender to the touch and painful.
Age: 56.0
Sex: M
Vaccine: DTAP
Symptoms: Asthma, Breath sounds abnormal, Chest X-ray, Cough
Clinical narrative: Asthma like. Rattle in breath and unproductive cough.  Zyrtec controlled the symptoms.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: PT'S ARM HAS BEEN SORE, ON AND OFF, SINCE HE RECIEVED HIS VACCINE.  AS THE WEATHER HAS GOTTEN COLDER, THE SITE IS SORE MORE OFTEN.  STRETCHING CAUSES SORENESS.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Autoimmune disorder, Psoriasis
Clinical narrative: Psoriasis, Autoimmune Disease; psoriasis scales appeared first on elbow then on center of forehead, within 6 months it had spread to cover over 90% of entire skin surface.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Her arm was swollen and raised at the site of injection (deltoid) and there was also a bruise the size of a small marble. The swelling was more significant than her previous vaccinations of the same vaccine. It was sore the day of the injection but noticed the large raised area the next morning. She was evaluated by a provider and no treatment was needed but patient was instructed to report back if swelling/pain did not resolve.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt could not move right arm (vaccinated arm) the day after vaccination. She still has pain in right deltoid & trouble lifting right arm.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Flank pain, Musculoskeletal pain, Musculoskeletal stiffness, Sleep disorder, Vertigo
Clinical narrative: Began with stiff neck, progressed to sore shoulders front and back by Thurs. AM. Unable to sleep pain was so severe. Vertigo and severe pain 02/18- 2/19/2016. Stabbing pain migrated to right, then left sides. Stabbing pain on left side through 02/21/2016.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Joint injury, Joint range of motion decreased, Juvenile idiopathic arthritis
Clinical narrative: Juvenile rheumatoid arthritis as diagnosed by a doctor. Extreme joint pain, restricted movement in joints, permanent joint damage.
Age: 57.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Sore bicep and elbow.
Age: 57.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sore bicep and elbow.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dysstasia, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: 10/04 unstable walking. 10/05 went to family doctor as walking. 10/06 taken to ER not able to stand and was admitted to hospital. 10/07 diagnosed with GBS and transferred to another hospital.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient had severe swelling and pain in upper right arm.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Myalgia in (L) deltoid m. > 2 wks.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Warm, red, itchy area local to injection site, advised to watch carefully, take BENADRYL. I will call pt to follow up tomorrow.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: ZOSTAVAX vaccine was given around 11:45 am to this pt. About 2-5 minutes later, I noticed that pt's skin was pale. I asked pt if he was ok. Pt told me that he was sweating and I also noticed that his face and body were dripping of water. He also told me that he felt hot. I started to call 911 while waiting for 911 I checked his BP.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, X-ray
Clinical narrative: This spontaneous report was received from a physician regarding an 11 year old male patient. The reporter stated that the patient had "a history of chronic sinus infections, chronic upper respiratory infections, and a history of immune insufficiency, IGG "sub-class" and low immunoglobulin." On 30-JAN-2016, the patient went to pharmacy and was vaccinated with PNEUMOVAX 23 (dose, lot#/expiration unspecified) in the left deltoid. No concomitant medications were reported. Later that day on 30-JAN-2016, the patient's mother called to report that the patient was experiencing pain in the left deltoid and swelling and redness at the injection site. Medical attention was sought. The reporter told the patient's mother to give the patient acetaminophen/ibuprofen by mouth (manufacturer and dose unspecified) and cold compresses at the left deltoid injection site. On 01-FEB-2016, the mother brought the patient to the office and the patient's left deltoid area was red, warm and painful to touch, reported as the "size of a softball". The reporter prescribed antihistamines and corticosteroids (unspecified manufacturer and dose) and prescribed an x-ray of the left shoulder to "rule out infection". In approximately 2016, x-ray was performed and the results of the x-ray were pending, not provided at the time of the call. No Product Quality Complaint (PQC) was reported. The outcome of the events were unknown. Causality assessment was not provided. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Abasia
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (lot # L029631, expiration date: 14-AUG-2017, route and dose were unknown) that were improperly stored. No adverse effects were reported. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with M-M-R II (lot # L026550, expiration date: 16-JUL-2017, route and dose were unknown) that were improperly stored (55 Fahrenheit for 1 month). No adverse effects were reported. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 6 month old patient of unknown gender. The patient's concurrent and historical conditions were not reported. On 23-DEC-2014, the patient was vaccinated with the first dose of PEDVAXHIB at the age of 2 months. On 03-MAR-2015, the patient was vaccinated with the second dose of PEDVAXHIB at the age of 4 months. On 07-MAY-2015, the patient was vaccinated with the third dose of PEDVAXHIB at the age of 6 months (Inappropriate schedule of vaccine administered). Dose, route, lot # and expiration date for all were unknown. No adverse effects were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a pharmacist referring to a 68 years old female patient. The patient had no drug reactions/allergies. On 12-FEB-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L011533, expiration 03-JUL-2016, 0.65 ml) subcutaneously. Concomitant medication included unspecified blood pressure medicine. In February 2016, the patient developed red and hardened area around injection site after receiving ZOSTAVAX. No treatment was given for the events. The patient did not seek for medical attention. The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Syncope
Clinical narrative: Patient became pale and fainted.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Anger, Asthenia, Biopsy site unspecified abnormal, Burning sensation
Clinical narrative: Started with hives, gradually changing to rash and spreading over large areas of body. Itching and burning, skin very hot, felt cold, chills, very nervous and shaky. Got worse at night, couldn't sleep, took BENADRYL, didn't help. Lasted all of June, July and half of Aug. I would like to add a little more information concerning my adverse event. It started almost 2 wks. after the vaccination with hives and rash. The hives would turn into rash after a short while. Intense itching and burning was constant, BENADRYL was no help. It seemed to be getting out of control, also used CORTIZONE cream which was very little help. Had to go to Emergency twice in June, but continued on. Couldn't see Allergist for 3 wks. She was puzzled by it, sent me to a Dermatologist for biopsy. The whole time this was going on, the rash covered at least 50% of my body and got worse at night. I lost a lot of sleep. Also affected my nerves, shaky and pain in my abdomen and upper chest, sort of a ringing and humming in my ears. Was so depressed and upset. A good friend helped me thru all of this (2 1/2 mos) or I don't know how I could have stood this alone. I couldn't drive or do much of anything. A nerve med I took, (from the doctor) made me so dizzy I was afraid of falling. There were days, I could hardly stand my clothes against my body, also days of extreme weakness and chills. After getting to see Dr. and getting a biopsy I was put on Prednisone almost all of August. Immediately got better, rash and hives left. Have had (2) events since in Oct and Dec. Took Prednisone both times so, will be seeing Dr. from now on. I am concerned that maybe this is not over. I don't like to be taking the Prednisone so much, but it is only thing that helps. I will add, about the rash, after a few days it begins to turn purple and dark, like a bruise and gets some painful with it. I hope this information is helpful to your program.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Capillaritis, Chest pain, Chills, Contusion, Depressed mood
Clinical narrative: Started with hives, gradually changing to rash and spreading over large areas of body. Itching and burning, skin very hot, felt cold, chills, very nervous and shaky. Got worse at night, couldn't sleep, took BENADRYL, didn't help. Lasted all of June, July and half of Aug. I would like to add a little more information concerning my adverse event. It started almost 2 wks. after the vaccination with hives and rash. The hives would turn into rash after a short while. Intense itching and burning was constant, BENADRYL was no help. It seemed to be getting out of control, also used CORTIZONE cream which was very little help. Had to go to Emergency twice in June, but continued on. Couldn't see Allergist for 3 wks. She was puzzled by it, sent me to a Dermatologist for biopsy. The whole time this was going on, the rash covered at least 50% of my body and got worse at night. I lost a lot of sleep. Also affected my nerves, shaky and pain in my abdomen and upper chest, sort of a ringing and humming in my ears. Was so depressed and upset. A good friend helped me thru all of this (2 1/2 mos) or I don't know how I could have stood this alone. I couldn't drive or do much of anything. A nerve med I took, (from the doctor) made me so dizzy I was afraid of falling. There were days, I could hardly stand my clothes against my body, also days of extreme weakness and chills. After getting to see Dr. and getting a biopsy I was put on Prednisone almost all of August. Immediately got better, rash and hives left. Have had (2) events since in Oct and Dec. Took Prednisone both times so, will be seeing Dr. from now on. I am concerned that maybe this is not over. I don't like to be taking the Prednisone so much, but it is only thing that helps. I will add, about the rash, after a few days it begins to turn purple and dark, like a bruise and gets some painful with it. I hope this information is helpful to your program.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Feeling cold, Inflammation, Insomnia, Nervousness, Pain
Clinical narrative: Started with hives, gradually changing to rash and spreading over large areas of body. Itching and burning, skin very hot, felt cold, chills, very nervous and shaky. Got worse at night, couldn't sleep, took BENADRYL, didn't help. Lasted all of June, July and half of Aug. I would like to add a little more information concerning my adverse event. It started almost 2 wks. after the vaccination with hives and rash. The hives would turn into rash after a short while. Intense itching and burning was constant, BENADRYL was no help. It seemed to be getting out of control, also used CORTIZONE cream which was very little help. Had to go to Emergency twice in June, but continued on. Couldn't see Allergist for 3 wks. She was puzzled by it, sent me to a Dermatologist for biopsy. The whole time this was going on, the rash covered at least 50% of my body and got worse at night. I lost a lot of sleep. Also affected my nerves, shaky and pain in my abdomen and upper chest, sort of a ringing and humming in my ears. Was so depressed and upset. A good friend helped me thru all of this (2 1/2 mos) or I don't know how I could have stood this alone. I couldn't drive or do much of anything. A nerve med I took, (from the doctor) made me so dizzy I was afraid of falling. There were days, I could hardly stand my clothes against my body, also days of extreme weakness and chills. After getting to see Dr. and getting a biopsy I was put on Prednisone almost all of August. Immediately got better, rash and hives left. Have had (2) events since in Oct and Dec. Took Prednisone both times so, will be seeing Dr. from now on. I am concerned that maybe this is not over. I don't like to be taking the Prednisone so much, but it is only thing that helps. I will add, about the rash, after a few days it begins to turn purple and dark, like a bruise and gets some painful with it. I hope this information is helpful to your program.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Purpura, Rash, Skin discolouration, Skin warm
Clinical narrative: Started with hives, gradually changing to rash and spreading over large areas of body. Itching and burning, skin very hot, felt cold, chills, very nervous and shaky. Got worse at night, couldn't sleep, took BENADRYL, didn't help. Lasted all of June, July and half of Aug. I would like to add a little more information concerning my adverse event. It started almost 2 wks. after the vaccination with hives and rash. The hives would turn into rash after a short while. Intense itching and burning was constant, BENADRYL was no help. It seemed to be getting out of control, also used CORTIZONE cream which was very little help. Had to go to Emergency twice in June, but continued on. Couldn't see Allergist for 3 wks. She was puzzled by it, sent me to a Dermatologist for biopsy. The whole time this was going on, the rash covered at least 50% of my body and got worse at night. I lost a lot of sleep. Also affected my nerves, shaky and pain in my abdomen and upper chest, sort of a ringing and humming in my ears. Was so depressed and upset. A good friend helped me thru all of this (2 1/2 mos) or I don't know how I could have stood this alone. I couldn't drive or do much of anything. A nerve med I took, (from the doctor) made me so dizzy I was afraid of falling. There were days, I could hardly stand my clothes against my body, also days of extreme weakness and chills. After getting to see Dr. and getting a biopsy I was put on Prednisone almost all of August. Immediately got better, rash and hives left. Have had (2) events since in Oct and Dec. Took Prednisone both times so, will be seeing Dr. from now on. I am concerned that maybe this is not over. I don't like to be taking the Prednisone so much, but it is only thing that helps. I will add, about the rash, after a few days it begins to turn purple and dark, like a bruise and gets some painful with it. I hope this information is helpful to your program.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Tinnitus, Tremor, Urticaria, Vasculitis
Clinical narrative: Started with hives, gradually changing to rash and spreading over large areas of body. Itching and burning, skin very hot, felt cold, chills, very nervous and shaky. Got worse at night, couldn't sleep, took BENADRYL, didn't help. Lasted all of June, July and half of Aug. I would like to add a little more information concerning my adverse event. It started almost 2 wks. after the vaccination with hives and rash. The hives would turn into rash after a short while. Intense itching and burning was constant, BENADRYL was no help. It seemed to be getting out of control, also used CORTIZONE cream which was very little help. Had to go to Emergency twice in June, but continued on. Couldn't see Allergist for 3 wks. She was puzzled by it, sent me to a Dermatologist for biopsy. The whole time this was going on, the rash covered at least 50% of my body and got worse at night. I lost a lot of sleep. Also affected my nerves, shaky and pain in my abdomen and upper chest, sort of a ringing and humming in my ears. Was so depressed and upset. A good friend helped me thru all of this (2 1/2 mos) or I don't know how I could have stood this alone. I couldn't drive or do much of anything. A nerve med I took, (from the doctor) made me so dizzy I was afraid of falling. There were days, I could hardly stand my clothes against my body, also days of extreme weakness and chills. After getting to see Dr. and getting a biopsy I was put on Prednisone almost all of August. Immediately got better, rash and hives left. Have had (2) events since in Oct and Dec. Took Prednisone both times so, will be seeing Dr. from now on. I am concerned that maybe this is not over. I don't like to be taking the Prednisone so much, but it is only thing that helps. I will add, about the rash, after a few days it begins to turn purple and dark, like a bruise and gets some painful with it. I hope this information is helpful to your program.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Atrial fibrillation, Cerebrovascular accident, Dysstasia, Intensive care
Clinical narrative: Initial unsolicited report received from a consumer on 10 February 2016. This case linked with 2016SA027286 (same reporter).This case involves 85-year-old male patient who was vaccinated with a dose of Fluzone HD (batch number, expiry date, dose, dose in series, were not reported) intramuscularly in left deltoid on 16 October 2015. Illness at time of vaccination reported as unknown and Pre-existing physician diagnosed allergies, birth defects, medical conditions reported as amioderone and quinolones. Concomitant medications were not reported. The patient required ER/doctor visit. On 17 October 2016, four hours after the vaccination, the patient experienced symptoms of atrial fibrillation and extreme weakness collapsed on the couch and could not get up. He felt lethargic and could not move and then got up and went to bed. On 18 October 2015, 02 days (the next day), following the vaccination, the patient had Afib and taken to the hospital for overnight observation. On 04 January 2016, the patient was again hospitalized with Afib and 2 Strokes for 10 days in intensive care. The patient's laboratory data was not reported. The patient treated with medication.The outcome of event was not reported. List of documents held by sender: none. Sender's Comments: Atrial fibrillation, stroke, muscular weakness, mobility decreased is unlisted with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE whereas lethargy and weakness is listed. Time to onset after vaccination is compatible. Further information on patient's medical history and concomitant medications, etc. are needed to fully assess the case. Based on the information available, the role of vaccine cannot be assessed.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Lethargy, Mobility decreased, Syncope
Clinical narrative: Initial unsolicited report received from a consumer on 10 February 2016. This case linked with 2016SA027286 (same reporter).This case involves 85-year-old male patient who was vaccinated with a dose of Fluzone HD (batch number, expiry date, dose, dose in series, were not reported) intramuscularly in left deltoid on 16 October 2015. Illness at time of vaccination reported as unknown and Pre-existing physician diagnosed allergies, birth defects, medical conditions reported as amioderone and quinolones. Concomitant medications were not reported. The patient required ER/doctor visit. On 17 October 2016, four hours after the vaccination, the patient experienced symptoms of atrial fibrillation and extreme weakness collapsed on the couch and could not get up. He felt lethargic and could not move and then got up and went to bed. On 18 October 2015, 02 days (the next day), following the vaccination, the patient had Afib and taken to the hospital for overnight observation. On 04 January 2016, the patient was again hospitalized with Afib and 2 Strokes for 10 days in intensive care. The patient's laboratory data was not reported. The patient treated with medication.The outcome of event was not reported. List of documents held by sender: none. Sender's Comments: Atrial fibrillation, stroke, muscular weakness, mobility decreased is unlisted with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE whereas lethargy and weakness is listed. Time to onset after vaccination is compatible. Further information on patient's medical history and concomitant medications, etc. are needed to fully assess the case. Based on the information available, the role of vaccine cannot be assessed.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2016US008213 is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604692) on 18 Jan 2016. This report refers to a 65 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1518001) intramuscularly into left arm on 21 Oct 2015. On 25 Oct 2015 the patient experienced cellulitis at injection site. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "vaccination site cellulitis" was upgraded based on the NVS-IMS list. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1518001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from quality assurance department (QA reference nr. 1011343) on 25 Jan 2016: Updated QA reference number only. Follow-up information received from quality assurance department on 19 Feb 2016: Updated batch review report.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Angina pectoris, Echocardiogram, Electrocardiogram normal, Troponin
Clinical narrative: Initial unsolicited case received from Consumer on 09-Feb-2016. This case involves a 27-years old male patient was vaccinated with a dose of ACAM2000 (lot number was unknown by reporter, manufacturer: Sanofi Pasteur Biologics Co) in the left deltoid via an "unknown route" and a dose of Anthrax, lot number was unknown by reporter, manufacturer: other) in right deltoid via unknown route on 03-Feb-2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination was denied by the reporter. Concomitant medications were not reported. On 08-Feb-2016, five days post vaccination; patient experienced sharp chest pains and was evaluated and treated. Patient required doctor visit. Patient was admitted for 24 hours observation and was discharged on 09-Feb-2016. Laboratory investigations included complete blood count (CBC) was normal, electrocardiogram (EKG x2 normal). Troponin levels 0.019-0.033. Patient sched for echocardiogram were performed and corrective treatments included Albuterol nebulizer, Toradol 30mg, Diazapam 1mg and ASA (Acetylsalicylic Acid) 160mg. Case was considered as serious due to hospitalization. The outcome of the events was reported as unknown. List of documents held by sender: none. Sender's Comments: Chest pain is listed with SMALLPOX. Time to onset of 5 days is compatible with the role of the vaccine. EKG and troponin level results were normal. Further information on patient's medical history, concomitant medications, etc. will be needed for complete assessment. Based on the information available, a role of the vaccine cannot be ruled out.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Palpitations
Clinical narrative: Initial unsolicited case received from Consumer on 09-Feb-2016. This case involves a 27-years old male patient was vaccinated with a dose of ACAM2000 (lot number was unknown by reporter, manufacturer: Sanofi Pasteur Biologics Co) in the left deltoid via an "unknown route" and a dose of Anthrax, lot number was unknown by reporter, manufacturer: other) in right deltoid via unknown route on 03-Feb-2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination was denied by the reporter. Concomitant medications were not reported. On 08-Feb-2016, five days post vaccination; patient experienced sharp chest pains and was evaluated and treated. Patient required doctor visit. Patient was admitted for 24 hours observation and was discharged on 09-Feb-2016. Laboratory investigations included complete blood count (CBC) was normal, electrocardiogram (EKG x2 normal). Troponin levels 0.019-0.033. Patient sched for echocardiogram were performed and corrective treatments included Albuterol nebulizer, Toradol 30mg, Diazapam 1mg and ASA (Acetylsalicylic Acid) 160mg. Case was considered as serious due to hospitalization. The outcome of the events was reported as unknown. List of documents held by sender: none. Sender's Comments: Chest pain is listed with SMALLPOX. Time to onset of 5 days is compatible with the role of the vaccine. EKG and troponin level results were normal. Further information on patient's medical history, concomitant medications, etc. will be needed for complete assessment. Based on the information available, a role of the vaccine cannot be ruled out.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Echocardiogram, Electrocardiogram normal, Full blood count normal, Troponin normal
Clinical narrative: Initial unsolicited case received from Consumer on 09-Feb-2016. This case involves a 27-years old male patient was vaccinated with a dose of ACAM2000 (lot number was unknown by reporter, manufacturer: Sanofi Pasteur Biologics Co) in the left deltoid via an "unknown route" and a dose of Anthrax, lot number was unknown by reporter, manufacturer: other) in right deltoid via unknown route on 03-Feb-2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination was denied by the reporter. Concomitant medications were not reported. On 08-Feb-2016, five days post vaccination; patient experienced sharp chest pains and was evaluated and treated. Patient required doctor visit. Patient was admitted for 24 hours observation and was discharged on 09-Feb-2016. Laboratory investigations included complete blood count (CBC) was normal, electrocardiogram (EKG x2 normal). Troponin levels 0.019-0.033. Patient sched for echocardiogram were performed and corrective treatments included Albuterol nebulizer, Toradol 30mg, Diazapam 1mg and ASA (Acetylsalicylic Acid) 160mg. Case was considered as serious due to hospitalization. The outcome of the events was reported as unknown. List of documents held by sender: none. Sender's Comments: Chest pain is listed with SMALLPOX. Time to onset of 5 days is compatible with the role of the vaccine. EKG and troponin level results were normal. Further information on patient's medical history, concomitant medications, etc. will be needed for complete assessment. Based on the information available, a role of the vaccine cannot be ruled out.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Soreness at injection site that runs down to my elbow.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site that runs down to my elbow.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Chills, Feeling cold, Pain in extremity, Pyrexia
Clinical narrative: Nausea, dizziness, fatigue and anorexia, temperature elevation to 100.4 (progressed to 101.1 during the afternoon in spite of acetaminophen). Temperature back to normal by 8:00 am 02/20/2016. Injection site erythema and swelling increased by 02/20/2016, to encompass most of left deltoid, still present as of 12:00 PM 02/22/2016. Rash over face, scalp, chest, neck and back noted 7:00 AM 02/21/2016 with some itching (already on cetirizine for allergies), still present, but fading.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Body temperature increased, Decreased appetite, Dizziness, Fatigue, Injection site erythema
Clinical narrative: Nausea, dizziness, fatigue and anorexia, temperature elevation to 100.4 (progressed to 101.1 during the afternoon in spite of acetaminophen). Temperature back to normal by 8:00 am 02/20/2016. Injection site erythema and swelling increased by 02/20/2016, to encompass most of left deltoid, still present as of 12:00 PM 02/22/2016. Rash over face, scalp, chest, neck and back noted 7:00 AM 02/21/2016 with some itching (already on cetirizine for allergies), still present, but fading.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Nausea, Pruritus, Rash
Clinical narrative: Nausea, dizziness, fatigue and anorexia, temperature elevation to 100.4 (progressed to 101.1 during the afternoon in spite of acetaminophen). Temperature back to normal by 8:00 am 02/20/2016. Injection site erythema and swelling increased by 02/20/2016, to encompass most of left deltoid, still present as of 12:00 PM 02/22/2016. Rash over face, scalp, chest, neck and back noted 7:00 AM 02/21/2016 with some itching (already on cetirizine for allergies), still present, but fading.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in upper arm and limited range of motion; currently performing self-prescribed exercises but still experiencing pain.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain in upper arm and limited range of motion; currently performing self-prescribed exercises but still experiencing pain.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Intensive care, Sudden infant death syndrome
Clinical narrative: Pt was preemie triplet in ICU at med ctr. Given vaccines 2/11/16. Discharge 2/15/16. Seen 2/16/16. Died of SIDS 2/19/16.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Immediate post-injection reaction, Urticaria, Vomiting
Clinical narrative: Patient immediately vomited upon administration of rotavirus live oral vaccine, then developed hives on face, chest, abdomen, back, and legs. The hives resolved within 10 minutes of administration without any medical intervention.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Left arm pain, pain with moving left shoulder. Immediate onset after vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Noticed in area that vaccine was given that multiple red whelps in a circle developed.  C/o mild soreness, no pruritis.  The area started small but by the next day site reaction was a little larger than golf ball size.  Reports this morning that looks more like one whelp and still red in color.  No fever.
Age: 17.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm with flu vaccine started as big red warm, swollen reaction. Right arm with Menactra started small and then next day became large swollen reaction. Pt returned to clinic day 3 post vaccine with 3" well demarcated red raised, itchy warm and tender on both site. Ice, Benadryl and return if no improvement.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rheumatoid factor increased
Clinical narrative: Initial unsolicited report received from a healthcare professional on 4 February 2016. This case involves a 61 years old female patient who was vaccinated with a dose of Adacel, (batch number, expiry date, dose and dose number were not reported) via unspecified route in arm and also received Zostavax (Manufacturer: Merck, batch number, expiry date, dose and dose number were not reported) via unspecified route in arm both on an unspecified date (either late September or early October). Patient had medical history of allergies to Sulfa, possibly latex and minor arthritis and concomitant medications were not reported. On an unspecified date one month post vaccination, the patient had blood work done and slight increase in RA factor and experiencing swelling, redness, pain of all fingers of both hands. Patient also stated that he had appointment with rheumatologist but appointment could not be scheduled until March, 2016. It was reported that patient had doctor visit. Lab data and corrective treatments were not reported. At the time of this report, the outcomes of the events were not recovered. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: TYP, YF
Symptoms: Neck pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Initial unsolicited report received from a physician on 09 February 2016. This case involves a 58-year-old female patient who was vaccinated with a dose of YELLOW FEVER VACCINE (batch number: UI080AA) (expiry date, dose, dose in series, route of administration were not reported) in left deltoid; with first dose of Vivotif via oral route (batch number, manufacturer: Pax Vax, expiry date, dose, dose in series, and site of administration were not reported) on 08 February 2016. Illness at time of vaccination, any other vaccinations within 4 weeks of vaccinations reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as NKA, HX Diabetes Oral. Concomitant medications were not reported. On 08 February 2016, same day after Yellow fever vaccine and within about 01 hour after taking Typhim pill, the patient developed neck pain and pain down her left leg. On an unknown date, the patient was unable to bear weight on her left leg due to the pain. She was on the way to the emergency room at Hospital. He was awaiting a call from the Emergency room. The patient required ER/doctor visit. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from the event. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: On 02/20/2016 child noticed a rash on chest, back, and thighs. Rash is not raised or itch per mother and no fever or other symptoms reported. Mother administered Benadryl. As of 02/22/2016 rash has not resolved.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised, Rash pruritic, Skin warm
Clinical narrative: Patient returned to clinic with hot itchy rash over entire body. The patient did not have any wheezing, cough or shortness of breath.  Pt was given 25 mg of diphenhydramine intramuscularly and monitored for 30 minutes. Patient was released after monitoring and has had no further complications.
Age: 1.51
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Child broke out in hives after 12month and 18month vaccines approximately 4-5 days after vaccine administration.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None.
Age: 53.0
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Anxiety, Cardiac monitoring, Electrocardiogram normal, Heart rate increased, Palmar erythema
Clinical narrative: Pt states last year had a bad reaction to flu vaccine where her pulse went high and they made her lay down. Pre vaccine vitals, BP 120/84 R arm, P 76 R 20 at 1004. 1023 pt states she is feeling palpitations, P 116, R24 BP 143/99, R 26,  HA pain 7-8 out of 10, palms are red, pt is very anxious.  Denies itching, SOB. 1028 Benadryl 50 mg IM given in R arm (lot 6008296 exp 7/31/16), BP 150/106 P 126 R 22. 1033 - pt taken to ED and registered, reported off to Triage RN.  Will complete UAIR when pt done at the ED.
Age: 53.0
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Palpitations
Clinical narrative: Pt states last year had a bad reaction to flu vaccine where her pulse went high and they made her lay down. Pre vaccine vitals, BP 120/84 R arm, P 76 R 20 at 1004. 1023 pt states she is feeling palpitations, P 116, R24 BP 143/99, R 26,  HA pain 7-8 out of 10, palms are red, pt is very anxious.  Denies itching, SOB. 1028 Benadryl 50 mg IM given in R arm (lot 6008296 exp 7/31/16), BP 150/106 P 126 R 22. 1033 - pt taken to ED and registered, reported off to Triage RN.  Will complete UAIR when pt done at the ED.
Age: 53.0
Sex: F
Vaccine: FLUR3, FLUX
Symptoms: Contusion, Heart rate increased, Nausea
Clinical narrative: Pt states last year had a bad reaction to flu vaccine where her pulse went high and they made her lay down. Pre vaccine vitals, BP 120/84 R arm, P 76 R 20 at 1004. 1023 pt states she is feeling palpitations, P 116, R24 BP 143/99, R 26,  HA pain 7-8 out of 10, palms are red, pt is very anxious.  Denies itching, SOB. 1028 Benadryl 50 mg IM given in R arm (lot 6008296 exp 7/31/16), BP 150/106 P 126 R 22. 1033 - pt taken to ED and registered, reported off to Triage RN.  Will complete UAIR when pt done at the ED.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Skin warm
Clinical narrative: Initial unsolicited report received from a non-health care professional via other company (Pfizer, reference number 2016066192) on 09-Feb-2016. This case involves a 72-year-old male patient who was vaccinated with a dose of FLUZONE (batch number, expiry date and site of administration were not reported) in left arm on an unspecified date. Medical history was not reported. Concomitant medications were Diltiazem, atorvastatin for the indication high cholesterol 40 mg tablet. Other conditions reported as hypertension, high cholesterol, osteopenia and fall with cracked ribs. On an unspecified date of Sep-2015, following the vaccination patient experienced big red rash the size of her hand, itching and really hot arm. Laboratory investigation and corrective treatment were not reported. On an unspecified date of Sep-2015, the outcome of event was recovered. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rhinorrhoea, Throat irritation, Urticaria
Clinical narrative: Shot given in Right upper arm. Bilateral urticaria and prurtus of arms developing after injection. Rhinorrhea. Itchy throat. No dyspnea or wheezing.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, soreness and swelling.