chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a license practical nurse (L.P.N) concerning a patient of unknown age and gender. It was reported that on 16-JUL-2013 the patient was vaccinated with an expired ZOSTAVAX (lot #0242AE, ex. date 01-APR-2013). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Assessment: post immunization, shortly after developed hives on face, small bumps on trunk. Encounter attached. No respiratory symptoms. Tx: 10 ml of Prednisolone 15/5mg adminsitered, 10 ml of BENADRYL 12.5/5ml administered.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Injection site discolouration, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Mom brings patient in because of a feared reaction to his vaccines (PENTACEL) given earlier today --8hrs ago. He received his vaccine around 10am then he slept much of afternoon. Awakened at 3pm w/fever up to 101.3 and his entire left leg, not including foot, appearing swollen w/ red w/ purple splotches. Mom applied a cool washcloth and leg sx resolved after 30min. Upon awakening, he was also "crying for a long time as if in pain". Gave TYLENOL at 3 w/ fever and crying eventually resolving "maybe after an hour or 2". Has seemed fine since then. Mom notes that he had this same problem when he received his 2 mo shots at an outside clinic. Mom had discussed this w/ Dr, whom they are established w/ now. They agreed to split his 4 mo vaccines, receiving his Pneumococcal and Rotavirus vaccine on 6/24. He had no reaction at all following these.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia
Clinical narrative: Mom brings patient in because of a feared reaction to his vaccines (PENTACEL) given earlier today --8hrs ago. He received his vaccine around 10am then he slept much of afternoon. Awakened at 3pm w/fever up to 101.3 and his entire left leg, not including foot, appearing swollen w/ red w/ purple splotches. Mom applied a cool washcloth and leg sx resolved after 30min. Upon awakening, he was also "crying for a long time as if in pain". Gave TYLENOL at 3 w/ fever and crying eventually resolving "maybe after an hour or 2". Has seemed fine since then. Mom notes that he had this same problem when he received his 2 mo shots at an outside clinic. Mom had discussed this w/ Dr, whom they are established w/ now. They agreed to split his 4 mo vaccines, receiving his Pneumococcal and Rotavirus vaccine on 6/24. He had no reaction at all following these.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Differential white blood cell count normal, Febrile convulsion, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Day after vaccines developed 104 degree fever and had a febrile seizure.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Thyroid function test
Clinical narrative: Day after vaccines developed 104 degree fever and had a febrile seizure.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 24 year old female patient. There was reported none pertinent medical history, drug reaction or allergy. On 08-JUL-2013 the patient was vaccinated with the third dose of GARDASIL (lot # H021608, exp. date 13-AUG-2015) 0.5 ml, intramuscular for routine vaccination. Concomitant medications included "birth control". On 08-JUL-2013, "about ten hours" after receiving the dose of GARDASIL, the patient developed a headache as well as tenderness and swelling at the injection site. Physician reported that the patient was instructed to apply an ice pack to the injection site and take TYLENOL for the headache. No lab diagnostics studies were performed. On 09-JUL-2013, the patient went to the physician's office. The outcome of headache, swelling at the injection site and tenderness at the injection site was reported as recovering/resolving. The relationship between GARDASIL and the events was not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Local warmth-induration-erythema and swell at injection site suspicious for cellulitis. Tx with antibiotics.
Age: 1.01
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (R) lateral thigh with 2 cm x 3 cm erythema and warm area.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Redness/swelling at injection site, 101 degree F fever, achiness, fatigue.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram head, Confusional state, Dysarthria, Fall, Injected limb mobility decreased
Clinical narrative: Slurred speech, confusion, fall, inability to use (L) arm.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test
Clinical narrative: Slurred speech, confusion, fall, inability to use (L) arm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood culture, Erythema, Infection, Lymphadenopathy, Oedema peripheral
Clinical narrative: Whole upper arm swelling, pain, redness at time of E.R. admin. Doctor found lymph node was swollen. Put on IV Abx ROCEPHIN in hospital for two days. Oral KEFLEX after. Massive swelling, pain, infection within 48 hours after inj.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Whole upper arm swelling, pain, redness at time of E.R. admin. Doctor found lymph node was swollen. Put on IV Abx ROCEPHIN in hospital for two days. Oral KEFLEX after. Massive swelling, pain, infection within 48 hours after inj.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient was given Rotarix oral immunization via the IM route.
Age: 51.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Arthralgia, Biopsy skin abnormal, Blood test, Henoch-Schonlein purpura
Clinical narrative: 1. cold 8-6-2012 2. Rash on buttocks first 8-12 3. rash on legs 8/16 4. lower leg biopsy 8/29. Diagnosis HSP (Henoch Scholein Purpura)  5. stomach and joint pain came and went. 6. Following are notes from company nurse. "Employee called to advise that he is being treated for HSP.  States that he received Typhim on 7/24, two weeks later got a cold (Aug. 5 or 6), was traveling and on 8/13 got rash on legs.  Advises that he had original rash on buttocks (unsure of date).  Was taking Malarone on 8/13 and advised to stop.  States that last week Aug 27, saw PCP and was on Z Pak and biopsy done of leg rash, Tuesday saw Dermatologist and Wed (8/29) saw Allergist who diagnosed HSP.  States that he is having joint pain now.  Had bloodwork completed on Renal Functions which he states were normal."
Age: 51.0
Sex: M
Vaccine: TYP
Symptoms: Nasopharyngitis, Rash, Renal function test normal, Urine analysis
Clinical narrative: 1. cold 8-6-2012 2. Rash on buttocks first 8-12 3. rash on legs 8/16 4. lower leg biopsy 8/29. Diagnosis HSP (Henoch Scholein Purpura)  5. stomach and joint pain came and went. 6. Following are notes from company nurse. "Employee called to advise that he is being treated for HSP.  States that he received Typhim on 7/24, two weeks later got a cold (Aug. 5 or 6), was traveling and on 8/13 got rash on legs.  Advises that he had original rash on buttocks (unsure of date).  Was taking Malarone on 8/13 and advised to stop.  States that last week Aug 27, saw PCP and was on Z Pak and biopsy done of leg rash, Tuesday saw Dermatologist and Wed (8/29) saw Allergist who diagnosed HSP.  States that he is having joint pain now.  Had bloodwork completed on Renal Functions which he states were normal."
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: About an hour after administering MMR, she broke out in hives. Hydrocortisone cream, hydrocortisone by mouth.  Sent home with Epi Pen.
Age: 41.0
Sex: M
Vaccine: TD
Symptoms: Confusional state, Fatigue, Headache, Pain
Clinical narrative: Headache, confusion, bodyaches, fatigue.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Local reaction, Nuclear magnetic resonance imaging, Pain
Clinical narrative: After the initial, expected, local reaction healed, the same local pain returned a couple of weeks later.  At first the pain was intermittent, aching pain at the injection site.  Eventually the pain became almost continuous.  It felt as if I was constantly receiving the injection.  Within approximately 12 weeks, my shoulder was frozen.  I went to see my PCP on 1/11/13, had an MRI on 1/23/13, and seen by an orthopedic surgeon on 1/27/13.  I underwent 2 months of physical therapy to regain the range of motion in my arm.  I am no longer receiving PT but, still do not have complete ROM that I had before the flu intrademal injection.  The constant pain at the injection site seems to be resolved but the shoulder still is not back to normal.  I still have to continue using the exercises I learned from the physical therapists to keep my shoulder flexible.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis, X-ray
Clinical narrative: After the initial, expected, local reaction healed, the same local pain returned a couple of weeks later.  At first the pain was intermittent, aching pain at the injection site.  Eventually the pain became almost continuous.  It felt as if I was constantly receiving the injection.  Within approximately 12 weeks, my shoulder was frozen.  I went to see my PCP on 1/11/13, had an MRI on 1/23/13, and seen by an orthopedic surgeon on 1/27/13.  I underwent 2 months of physical therapy to regain the range of motion in my arm.  I am no longer receiving PT but, still do not have complete ROM that I had before the flu intrademal injection.  The constant pain at the injection site seems to be resolved but the shoulder still is not back to normal.  I still have to continue using the exercises I learned from the physical therapists to keep my shoulder flexible.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Dyspnoea exertional, Epistaxis, Erythema
Clinical narrative: The next morning I woke up with significant pain at the injections site. There was also a half dollar size knot in the arm and significant erythema. There was swelling as well diffuse upper arm. To this day there is knot in deltoid muscle. Still continue to have joint pain and continued myalgias. Have been having neck, lower back pain. Had nosebleeds on 7/13 and 7/14. Strep throat on 7/15 with no known contact. Have been dyspenic with exertion as well. Have also been having significant headaches that are not my typical migraines.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Myalgia, Neck pain, Nodule
Clinical narrative: The next morning I woke up with significant pain at the injections site. There was also a half dollar size knot in the arm and significant erythema. There was swelling as well diffuse upper arm. To this day there is knot in deltoid muscle. Still continue to have joint pain and continued myalgias. Have been having neck, lower back pain. Had nosebleeds on 7/13 and 7/14. Strep throat on 7/15 with no known contact. Have been dyspenic with exertion as well. Have also been having significant headaches that are not my typical migraines.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pharyngitis streptococcal
Clinical narrative: The next morning I woke up with significant pain at the injections site. There was also a half dollar size knot in the arm and significant erythema. There was swelling as well diffuse upper arm. To this day there is knot in deltoid muscle. Still continue to have joint pain and continued myalgias. Have been having neck, lower back pain. Had nosebleeds on 7/13 and 7/14. Strep throat on 7/15 with no known contact. Have been dyspenic with exertion as well. Have also been having significant headaches that are not my typical migraines.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itchy, sx began 2-3 hours after receiving immunization.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Rash pustular
Clinical narrative: Significant swelling & erythema of L arm (site of injection) w/ pustular rash development.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP, HPV4, MNQ, TDAP
Symptoms: Local swelling, Ultrasound scan
Clinical narrative: Significant swelling & erythema of L arm (site of injection) w/ pustular rash development.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Throat irritation
Clinical narrative: Patient developed itching on upper body, face, and throat few days later.
Age: 51.0
Sex: F
Vaccine: TTOX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe stabbing pain in shoulder 11 days following injection.  I use my arms all the time while riding my horse, but now I can't raise the arm very far from my body.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: At the injection sight located on the back of the upper L arm, there is a red lump the size of a small lime. It is tender, itchy & burns.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Pt. called complaining of redness, discomfort, swelling and itching at injection site on right arm where Varicella vaccine had been given. Initially treated on 5/23 with Loratadine and ice topically, but then on 5/24 due to increased area of redness and new onset pain and itching, she treated with Cephalexin 500mg BID x7 days with resolution of symptoms.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 2 SISTERS WERE IN FOR THEIR WELL CHILD EXAMS AND VACCINES. THEY BOTH REQUIRED THE TDAP AND MCV VACCINES. WERE SEEN IN THE SAME EXAM ROOM TOGETHER. A MEDICAL ASSISTANT DREW UP THE 2 TDAPS AND MCV INJECTIONS AND BROUGHT THEM ALL TO THE ROOM AT THE SAME TIME. SHE THEN GROUPED THEM SEPERATELY ON THE COUNTER AS VACCINE TYPE INSTEAD OF PT. I CAME IN THE ROOM TO ASSIST. WE WERE GOING TO GIVE THE VACCINES SIMULTANEOUSLY TO MINIMIZE DISCOMFORT TO THE PT. THE MEDICAL ASSISTANT TOOK A VACCINE AND I THEN TOOK THE REMAINING VACCINE FROM THE GROUP WHICH WAS MARKED "RIGHT" IN MARKER ON THE NEEDLE COVER. WE PROCEEDED TO GIVE THE VACCINE, ME TO THE RIGHT DELYOID AND HER TO THE LEFT AND I IMMEDIATELY SAW THAT WE EACH HAD GIVEN THE TDAP B/C OF THE PRE DRAWN SYRINGE. I IMMEDIATELY REPORTED TO THE PROVIDER. PT WAS EXAMINED. I ADMINISTERED THE MCV IN THE RIGHT DELTOID AND PT WAS RELEASED WITH NO ADVERSE SYMPTOMS.
Age: 90.0
Sex: F
Vaccine: TDAP
Symptoms: Cerebrovascular accident, Diplopia, Fall, Headache, Hemiparesis
Clinical narrative: Patient states she woke up to go to bathroom @ about 4am and fell down, her right side gave out on her, she was having a very bad headache and then was having difficutly using right arm and leg.  She was taken to hospital and currenly in hospital.  She is told she had a stroke.  Today she is saying she is now having double vision, which is new.  She is planning on going Rehab.
Age: 90.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Mobility decreased, Scan
Clinical narrative: Patient states she woke up to go to bathroom @ about 4am and fell down, her right side gave out on her, she was having a very bad headache and then was having difficutly using right arm and leg.  She was taken to hospital and currenly in hospital.  She is told she had a stroke.  Today she is saying she is now having double vision, which is new.  She is planning on going Rehab.
Age: 1.03
Sex: F
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Herpes zoster, Laboratory test abnormal, Polymerase chain reaction
Clinical narrative: Herpes zoster in a 1-dose varicella vaccine recipient.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Ache and tenderness at point of insertion.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: 8 x 8 centimeter local reaction to right arm. Mother took child to emergency room for redness and swelling of right arm.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Screaming
Clinical narrative: Swelling and redness at injection site down past the knee; uncharacteristic screaming for 10 minutes before cold compress applied.
Age: 1.68
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site urticaria, Rash, Urticaria
Clinical narrative: Developed urticarial lesions of face later around the injection site, given Benadryl IM and after 5-10 minutes, rash started fading. Given Rx for Benadryl and Prednisolone and told to take to emergency if gets worse.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood creatine phosphokinase normal, Chest pain, Computerised tomogram head normal, Drug screen positive, Electrocardiogram normal
Clinical narrative: Severe midsternal chest pain, arching of back, throat pain, hyperventilation with dilation of pupils and period of unresponsiveness lasting 30-60 seconds, and recurring every 10-15 minutes for approximately 6 hours.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Electroencephalogram normal, Full blood count normal, Hyperventilation, Liver function test normal, Metabolic function test normal
Clinical narrative: Severe midsternal chest pain, arching of back, throat pain, hyperventilation with dilation of pupils and period of unresponsiveness lasting 30-60 seconds, and recurring every 10-15 minutes for approximately 6 hours.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Mydriasis, Opisthotonus, Oropharyngeal pain, Unresponsive to stimuli
Clinical narrative: Severe midsternal chest pain, arching of back, throat pain, hyperventilation with dilation of pupils and period of unresponsiveness lasting 30-60 seconds, and recurring every 10-15 minutes for approximately 6 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Vaccination site cellulitis
Clinical narrative: Mom stated that patient complained of thigh pain later that day after vaccine was given but she didn't look at the area until the next morning, 07/18/13 and noted that the area was swollen, red and warm to the touch. Patient did not have a fever. Mom brought child in later that day, 07/18/13 for evaluation. On exam patient noted to have cellulitis at the vaccine site. Patient was started on appropriate antibiotic. Mom was told to call for worsening symptoms.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Anaemia, Blood albumin decreased, C-reactive protein increased, Conjunctivitis, Haemoglobin decreased
Clinical narrative: Fever, mild respiratory symptoms, sent to ED for septic workup, admitted and ultimately diagnosed with incomplete Kawasaki's disease.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypoalbuminaemia, Immunoglobulin therapy, Kawasaki's disease, Oral disorder, Platelet count increased
Clinical narrative: Fever, mild respiratory symptoms, sent to ED for septic workup, admitted and ultimately diagnosed with incomplete Kawasaki's disease.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Pyuria, Rash, Respiratory disorder, Thrombocytosis
Clinical narrative: Fever, mild respiratory symptoms, sent to ED for septic workup, admitted and ultimately diagnosed with incomplete Kawasaki's disease.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash macular
Clinical narrative: Began developing diffuse red blotches throughout, including face, arms, legs and trunk. No difficulty breathing or respiratory distress. Went to ER, given Benadryl and hydrocortisone ointment.
Age: 1.26
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Cough, Croup infectious, Diarrhoea, Lacrimation increased, Rash generalised
Clinical narrative: Hive looking rash appeared on torso, by the next day it had spread from head to toe, including his cheeks, hands, feet, and bottom areas. He also began throwing up (2x day), had 4 diarrheas each day for 5 days straight, and has a croupy sounding coughing (water eyes and nose). Just plain miserable! He has had this for 8 days and it's just getting worse.
Age: 1.26
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Rhinorrhoea, Urticaria, Vomiting
Clinical narrative: Hive looking rash appeared on torso, by the next day it had spread from head to toe, including his cheeks, hands, feet, and bottom areas. He also began throwing up (2x day), had 4 diarrheas each day for 5 days straight, and has a croupy sounding coughing (water eyes and nose). Just plain miserable! He has had this for 8 days and it's just getting worse.
Age: 23.0
Sex: M
Vaccine: HEPAB
Symptoms: Back pain, Computerised tomogram, Fall, Gait disturbance, Lumbar puncture
Clinical narrative: Pins and needles sensation. Fell twice. Couldn't feel legs or feet or hands. Terrible lower back pain. Inability to walk up stairs.
Age: 23.0
Sex: M
Vaccine: HEPAB
Symptoms: Nerve conduction studies, Neurological examination, Paraesthesia, Sensory loss
Clinical narrative: Pins and needles sensation. Fell twice. Couldn't feel legs or feet or hands. Terrible lower back pain. Inability to walk up stairs.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (gender unknown) either 6 months or 9 months of age. On an unknown date the patient was vaccinated with a dose of ROTATEQ (dose and lot # not reported). On an unknown date the patient developed intussusception and was hospitalized. The outcome of intussusception was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient received all kindergarten boosters on 7/16/13 and that evening began with "low grade" fever which progressed to 102.7 within 24 hrs of vaccination. Also with (L) arm pain.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Movement disorder, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Arm pain - intense for 10 days - shoulder locked up could not lift arm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Local swelling, Pruritus
Clinical narrative: Redness, burning, itching, swelling at local site.
Age: 63.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Myalgia, Pyrexia, Tenderness
Clinical narrative: Fever, redness, muscle ache and tenderness.
Age: 38.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test abnormal, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Softball size, bright red, raised, and itching around injection site. Started 7/18/13. States is bigger this morning 7/19/13 than yesterday.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersomnia, Mydriasis
Clinical narrative: Pupils dilated, slept all day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pain, Pruritus, Rash
Clinical narrative: Local reactions started 18 hrs after injection. Started with a rash, soreness, warm to touch and redness grew larger. She has mild pruritus. 7 1/2 cm x 11 cm area.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Local reactions started 18 hrs after injection. Started with a rash, soreness, warm to touch and redness grew larger. She has mild pruritus. 7 1/2 cm x 11 cm area.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Antibody test, Antinuclear antibody, Blood creatine phosphokinase, Blood immunoglobulin G, C-reactive protein
Clinical narrative: Hematuria with gross hematuria with onset a few hours after administration - no other symptoms. Grossly improved after 48 hours.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Complement factor C3, Complement factor C4, Culture urine, Full blood count, Haematuria
Clinical narrative: Hematuria with gross hematuria with onset a few hours after administration - no other symptoms. Grossly improved after 48 hours.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Laboratory test, Red blood cell sedimentation rate, Urine analysis
Clinical narrative: Hematuria with gross hematuria with onset a few hours after administration - no other symptoms. Grossly improved after 48 hours.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Blood test normal, Haematuria, Ultrasound scan normal
Clinical narrative: Hematuria with gross hematuria with onset a few hours after administration - no other symptoms. Grossly improved after 48 hours.
Age: 71.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Diagnosis of shingles rash on 7/15/13, treated with Valtrex (mid thoracic torso).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain, Back pain, Cyanosis, Faecal incontinence, Feeling cold
Clinical narrative: Immediately after immunizations given, pt began c/o ABD pain and back pain. Went to bathroom then began vomiting repetitively and has stool incontinence. C/O lips and hands "hurting". Lips slightly swollen, cold, hands purplish.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Lip pain, Lip swelling, Pain in extremity, Vomiting
Clinical narrative: Immediately after immunizations given, pt began c/o ABD pain and back pain. Went to bathroom then began vomiting repetitively and has stool incontinence. C/O lips and hands "hurting". Lips slightly swollen, cold, hands purplish.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 3 cm reaction at (L) deltoid - erythema, no pruritus, mild tenderness - no muscle tenderness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Pt rec Zostavax Wed 6/19/13. On Monday 6/24/13 pt noticed a 2 inch swollen area at the injection site. It disappeared 2 days later. Spoke with pt. 7/19/13 and pt has felt fine and not experienced any other adverse reactions since.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a 12 month old patient of unknown gender. The nurse reported that a patient received both PROQUAD (Merck) (lot number was not reported) 0.5 ml, subcutaneous, and VARIVAX (Merck) (lot number was not reported) 0.5 nl, subcutaneous, on 09-JUL-2013. Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified amount of patients. The patients were vaccinated with VARIVAX (Merck) lot # H007704, expiry date 30-MAR-2014, doses and routes not reported on: 05-OCT-2012 (2 doses), 17-OCT-2012 (1 dose), 26-OCT-2012 (2 doses), 16-NOV-2012 (1 dose), 20-NOV-2012 (1 dose), 30-NOV-2012 (1 dose), 12-DEC-2012 (1 dose), 29-APR-2013 (1 dose), 02-MAY-2013 (1 dose), 09-MAY-2013 (1 dose), 15-MAY-2013 (1 dose), 20-MAY-2013 (1 dose) 24-MAY-2013 (1 dose), 31-MAY-2013 (1 dose), 13-JUN-2013 (1 dose) and 14-JUN-2013 (1 dose). The vaccine was reported to be improperly stored (exposed to a temperature of -2.5C for a total time of 650.5 hours) since 06-SEP-2012. No patient specific information was provided for any administered doses. The administered doses were not specified as first dose or second dose of VARIVAX (Merck). It was not specified whether any one patient might have received both series from the affected VARIVAX (Merck) doses. No adverse effect reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Injection site erythema, Injection site warmth, Swelling
Clinical narrative: Skin 6 x 9 1/2 cm mild erythematous warm area (L) arm around site of injection. Left axilla no lymph nodes palpated but axilla entire area increased tissue area swollen, nontender. Axilla swelling, erythema resolved by 7/15/13.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old male patient. The patient's medical history included kidney removed, three weeks ago in approximately 07-JUN-2013. There were no drug reactions or allergies reported. On 26-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose unspecified) (lot # J001009, exp. date 24-APR-2014) subcutaneous in the right arm. Concomitant therapies included VIAGRA. Pharmacist reported that after ZOSTAVAX administration, on 27-JUN-2013, patient experienced redness, itching, and swelling at the injection site. On 28-JUN-2013, the patient went to the pharmacy to seek advice from pharmacist. Pharmacist recommended the patient take BENADRYL. The outcome of redness, swelling, and itching at the injection site was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. No lab diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site discharge, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date after the patient was vaccinated with GARDASIL (dose, lot number and route were not reported) for vaccination, a small amount of GARDASIL trickled out of the patients arm following withdrawal of the needle used to administer the GARDASIL vaccine. Concomitant medications were not reported. No adverse event was reported. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Dizziness, Fatigue, Immediate post-injection reaction, Skin test
Clinical narrative: This spontaneous report was received from a physician regarding a 14 year old female patient with no pertinent medical history reported. On 16-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies or concomitant medications were reported. The physician stated that the patient immediately felt dizzy, faint, tired and then fell "asleep". However, the patient was arousal, vitals were all stable. Blood glucose (finger prick) also done, incase the patient had not eaten yet today. It was 90 (units not reported). The physician gave the patient smelling salts and patient sat up. One hour after the dose and subsequent symptoms, the patient did go home. At 3:00pm the physician called the mother and the mother reported the patient was still "in and out of it" in terms of sleepiness. The outcome for the above mentioned events was unknown at the time of the report. The physician did not assess the relatedness between GARDASIL and the above mentioned events. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Somnolence, Syncope
Clinical narrative: This spontaneous report was received from a physician regarding a 14 year old female patient with no pertinent medical history reported. On 16-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies or concomitant medications were reported. The physician stated that the patient immediately felt dizzy, faint, tired and then fell "asleep". However, the patient was arousal, vitals were all stable. Blood glucose (finger prick) also done, incase the patient had not eaten yet today. It was 90 (units not reported). The physician gave the patient smelling salts and patient sat up. One hour after the dose and subsequent symptoms, the patient did go home. At 3:00pm the physician called the mother and the mother reported the patient was still "in and out of it" in terms of sleepiness. The outcome for the above mentioned events was unknown at the time of the report. The physician did not assess the relatedness between GARDASIL and the above mentioned events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A), refers to a female patient of unknown age. It was reported that on 07-DEC-2012 the patient received her first dose of GARDASIL (lot # not reported) (0.5 ml, intramuscular route), on 29-JAN-2013 received the second dose of GARDASIL (lot # not reported) (0.5 ml, intramuscular route) and on 29-MAR-2013 received the third dose of GARDASIL (lot # not reported) (0.5 ml. intramuscular route). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MNQ, PPV, MEN, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Fever, headache, rash at site, sore/ tender to the touch arm at injection site area.
Age: 21.0
Sex: F
Vaccine: MNQ, PPV, MEN, PPV
Symptoms: Headache, Hypersensitivity, Infection, Injection site pain, Injection site rash
Clinical narrative: Fever, headache, rash at site, sore/ tender to the touch arm at injection site area.
Age: 21.0
Sex: F
Vaccine: MNQ, PPV, MEN, PPV
Symptoms: Pyrexia
Clinical narrative: Fever, headache, rash at site, sore/ tender to the touch arm at injection site area.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site induration, Injection site swelling
Clinical narrative: Fever 101 (normal temp less than 97) , chills, headache, slight nausea. Hard swollen 2" x 4" hot area around injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Malaise, Nausea, Pyrexia
Clinical narrative: Fever 101 (normal temp less than 97) , chills, headache, slight nausea. Hard swollen 2" x 4" hot area around injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia, Rash
Clinical narrative: Fever 101 (normal temp less than 97) , chills, headache, slight nausea. Hard swollen 2" x 4" hot area around injection site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Inj. site warm to palp. and with some redness, 4 cm in width edematous area starting at deltoid and down arm 6 cm. "started 7/18".
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Cold sweat, Lacrimation increased, Palpitations, Tremor
Clinical narrative: Heart racing cold sweats trembling eyes watering.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site swelling, Pain, Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: Entire Lft Arm swelled. Fever, Aches. Vomiting.
Age: 0.41
Sex: F
Vaccine: HIBV, RV5
Symptoms: Clostridium test negative, Culture negative, Haematochezia, Rotavirus test negative
Clinical narrative: Bloody stools 24 hours after vaccine, otherwise well. Resolved with removal of milk protein. Stool studios (culture, cdiff, Rotazyme) all negative. Symptoms resolved.
Age: 1.09
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Blood glucose increased, Febrile convulsion, Postictal state, Pyrexia, Viral upper respiratory tract infection
Clinical narrative: Seen in ER 7/19/13 for febrile seizure x2 postictal in ER. ER diagnosis; fever, febrile seizure, viral - upper resp. infection. Seen in office 7/20/13: afebrile, alert.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blood test, Neuropathy peripheral, Paraesthesia
Clinical narrative: Got tingling in finger, back and neck. Neuropathy in the toes got worse. Pain in her back. Her Dr doesn't think the vaccine caused this but is still running blood tests.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Headache, Lip swelling, Lymphadenopathy
Clinical narrative: Body aches, joint aches, mild headache, no fever no rash, upper lip swollen with papules on upper lip, tired, shotty cervical nodes, no seizures, no neck pain.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Papule
Clinical narrative: Body aches, joint aches, mild headache, no fever no rash, upper lip swollen with papules on upper lip, tired, shotty cervical nodes, no seizures, no neck pain.
Age: 1.14
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Diet refusal, Hypophagia
Clinical narrative: Refused to eat the rest of the day, barely ate for 3 days following MMR vaccine. Appetite was severely decreased for 2 months following. Was seen by a different doctor, was put on Nexium for the following 2 months before appetite began to return to pre- vaccine normal.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site vesicles
Clinical narrative: Three fluid filled blisters appeared at the injection site.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Patient experienced a rash and a warm feeling at the site of the injection.
Age: 1.3
Sex: F
Vaccine: DTAP, PPV
Symptoms: Blood test normal, Convulsion, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Days 2 & 3: extreme redness and swelling on injection site, fussiness. Day 5: tiredness, fussiness, lethargic, 105 fever, seizure.
Age: 1.3
Sex: F
Vaccine: DTAP, PPV
Symptoms: Irritability, Lethargy, Pyrexia, Urine analysis normal
Clinical narrative: Days 2 & 3: extreme redness and swelling on injection site, fussiness. Day 5: tiredness, fussiness, lethargic, 105 fever, seizure.
Age: 0.42
Sex: M
Vaccine: DPP
Symptoms: Abasia, Constipation, Crying, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: Severe pain/crying constipation stiffness in leg by 7=21 unable to walk and swelling in left leg.
Age: 0.42
Sex: M
Vaccine: DPP
Symptoms: Pain
Clinical narrative: Severe pain/crying constipation stiffness in leg by 7=21 unable to walk and swelling in left leg.
Age: 1.24
Sex: F
Vaccine: VARCEL
Symptoms: Choking, Pyrexia, Vomiting
Clinical narrative: Daughter got the chicken pox vaccine, a week after the vaccine she got a fever of 104.5, and also vomited so violently she choked on her vomit, fever was very hard to get down, had to take her to the ER.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site vesicles, Local swelling, Pain, Pruritus
Clinical narrative: Pt received shot Thurs 7/18. Pt said initially it was painful. Friday left arm was red and swollen and itchy. Saturday area was blistering. Pt was using hydrocortisone to help the itch-recommended an antihistamine instead. Area is about 6 in long and 4 in wide and at the injection site 1/2 dollar area with blisters.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Chest X-ray normal, Chills, Dyspnoea, Feeling abnormal
Clinical narrative: Awoke AM following vaccine with myalgia and subjective fever and chills and shortness of breath. Went to work felt poor. Returned to clinic evaluated by me. Normal CXR and UA. Reported same symptoms above and back pain. Mild HTN/tachycardia improved by end of encounter. Gave Decadron 10 mg and Prednisone. F/U 24 hours.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Hypertension, Myalgia, Pyrexia, Tachycardia, Urine analysis normal
Clinical narrative: Awoke AM following vaccine with myalgia and subjective fever and chills and shortness of breath. Went to work felt poor. Returned to clinic evaluated by me. Normal CXR and UA. Reported same symptoms above and back pain. Mild HTN/tachycardia improved by end of encounter. Gave Decadron 10 mg and Prednisone. F/U 24 hours.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Patient presented to the emergency room with complaints of difficulty swallowing and "throat closing" after receiving vaccine earlier in the day.  No difficulty breathing noted from ED record. Received dose of diphenhydramine, albuterol and sq epinephine.  Differential diagnosis included anxiety/stress related event.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Hot flush, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from 59 year old female patient with high blood pressure, chronic Lyme disease, antibiotic allergy and steroids allergy referring to herself. On 07-FEB-2013 the patient was vaccinated with ZOSTAVAX (dose, indication and route of administration were not reported). Concomitant medications included: LASIX (dose, indication were not reported), NORVASC (dose, indication were not reported), potassium chloride (manufacturer unknown) (dose, indication were not reported). On 11-FEB-2103 the patient developed  "lots of bumps on her cheeks neck and upper body and what seemed like a mild sunburn" after she received ZOSTAVAX. Patient reported the symptoms after approximately one week (on an approximately 18-FEB-2013). Patient reported that she had experienced a recurring problem or her face (more on the left cheek) and often her scalp, where she "got bumps that look like mild chicken pox, felt like a mild sunburn" (in 2013, exact date unspecified). Patient repotted she experienced the recurring problem, approximately every three weeks (in 2013, exact date unspecified) and it was preceded by hot flash at least one day ahead. Patient reported her face and scalp, become oily and she had "gained weight" (in 2013, exact date unspecified). Patient sought medical attention via telephone call and seeing nurse practitioner in office after the first episode. No lab diagnostics were performed. No treatment was given for adverse event. The outcome of hot flash, she has "gained weight", event described as "recurring problem on her face (more on the left cheek) and often her scalp, where she "got bumps that look like mild chicken pox, felt like a mild sunburn" and face and scalp, become oily was not reported. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash vesicular, Scab, Skin warm
Clinical narrative: This spontaneous report as received from 59 year old female patient with high blood pressure, chronic Lyme disease, antibiotic allergy and steroids allergy referring to herself. On 07-FEB-2013 the patient was vaccinated with ZOSTAVAX (dose, indication and route of administration were not reported). Concomitant medications included: LASIX (dose, indication were not reported), NORVASC (dose, indication were not reported), potassium chloride (manufacturer unknown) (dose, indication were not reported). On 11-FEB-2103 the patient developed  "lots of bumps on her cheeks neck and upper body and what seemed like a mild sunburn" after she received ZOSTAVAX. Patient reported the symptoms after approximately one week (on an approximately 18-FEB-2013). Patient reported that she had experienced a recurring problem or her face (more on the left cheek) and often her scalp, where she "got bumps that look like mild chicken pox, felt like a mild sunburn" (in 2013, exact date unspecified). Patient repotted she experienced the recurring problem, approximately every three weeks (in 2013, exact date unspecified) and it was preceded by hot flash at least one day ahead. Patient reported her face and scalp, become oily and she had "gained weight" (in 2013, exact date unspecified). Patient sought medical attention via telephone call and seeing nurse practitioner in office after the first episode. No lab diagnostics were performed. No treatment was given for adverse event. The outcome of hot flash, she has "gained weight", event described as "recurring problem on her face (more on the left cheek) and often her scalp, where she "got bumps that look like mild chicken pox, felt like a mild sunburn" and face and scalp, become oily was not reported. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hot flush, Rash erythematous, Rash vesicular, Seborrhoea, Weight increased
Clinical narrative: This spontaneous report as received from 59 year old female patient with high blood pressure, chronic Lyme disease, antibiotic allergy and steroids allergy referring to herself. On 07-FEB-2013 the patient was vaccinated with ZOSTAVAX (dose, indication and route of administration were not reported). Concomitant medications included: LASIX (dose, indication were not reported), NORVASC (dose, indication were not reported), potassium chloride (manufacturer unknown) (dose, indication were not reported). On 11-FEB-2103 the patient developed  "lots of bumps on her cheeks neck and upper body and what seemed like a mild sunburn" after she received ZOSTAVAX. Patient reported the symptoms after approximately one week (on an approximately 18-FEB-2013). Patient reported that she had experienced a recurring problem or her face (more on the left cheek) and often her scalp, where she "got bumps that look like mild chicken pox, felt like a mild sunburn" (in 2013, exact date unspecified). Patient repotted she experienced the recurring problem, approximately every three weeks (in 2013, exact date unspecified) and it was preceded by hot flash at least one day ahead. Patient reported her face and scalp, become oily and she had "gained weight" (in 2013, exact date unspecified). Patient sought medical attention via telephone call and seeing nurse practitioner in office after the first episode. No lab diagnostics were performed. No treatment was given for adverse event. The outcome of hot flash, she has "gained weight", event described as "recurring problem on her face (more on the left cheek) and often her scalp, where she "got bumps that look like mild chicken pox, felt like a mild sunburn" and face and scalp, become oily was not reported. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: YF, YF
Symptoms: Myalgia
Clinical narrative: Initial report was received on 12 July 2013 from a health care professional and a consumer who is also the patient. A 52 year-old male patient with no reported past medical history had received on 09 May 2013, an intramuscular injection of YF VAX, lot number UH598AA (site not reported) and within 24 hours on 10 May 2013 experienced index finger numbness, intermittent pain of the arm, chest and scapula to the neck. The patient also has tingling and numbness down arm into the fingers, general weakness and muscle aches. According to the patient, the index finger numbness had resolved and his strength had returned. The patient reported that all symptoms had resolved until he resumed his usual workout routine and the next day the symptoms returned but not as severe. The patient was evaluated in the ER (emergency room) and was referred to a neurologist, appointment pending. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.