chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Influenza like illness, Intensive care, Laryngoscopy, Liver function test
Clinical narrative: (IV immunoglobulin given). Diagnosis post-vaccination viral syndrome R/O Guillain Barre syndrome. Flu-like symptoms & neck pain; headaches; loss of ability to support myself & loss of ability to walk: loss of ability to protect airway - visited emergency dept at hospital 2-11-13, then hospitalized at hospital 2-14-13 to 2-21-13. Required intensive unit care, monitoring multiple systems, IV meds, lab, MRI of head.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Metabolic function test, Neck pain, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: (IV immunoglobulin given). Diagnosis post-vaccination viral syndrome R/O Guillain Barre syndrome. Flu-like symptoms & neck pain; headaches; loss of ability to support myself & loss of ability to walk: loss of ability to protect airway - visited emergency dept at hospital 2-11-13, then hospitalized at hospital 2-14-13 to 2-21-13. Required intensive unit care, monitoring multiple systems, IV meds, lab, MRI of head.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Obstructive airways disorder, Viral infection
Clinical narrative: (IV immunoglobulin given). Diagnosis post-vaccination viral syndrome R/O Guillain Barre syndrome. Flu-like symptoms & neck pain; headaches; loss of ability to support myself & loss of ability to walk: loss of ability to protect airway - visited emergency dept at hospital 2-11-13, then hospitalized at hospital 2-14-13 to 2-21-13. Required intensive unit care, monitoring multiple systems, IV meds, lab, MRI of head.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site inflammation, Malaise, Pyrexia, Swelling
Clinical narrative: Patient experienced swelling, malaise, fever, inflammation. Swelling and inflammation spread out from site of injection. MD treated with BENADRYL, AMOX, as well as MEDROL.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Hypersensitivity, Hypoaesthesia, Hypoaesthesia oral, Increased upper airway secretion
Clinical narrative: I began itching in random places all over my body at approximately 3:00pm, My skin was splotchy but no raised rash, by 3:30PM my bottom lip went completely numb and I noticed I felt like I had phlegm in my throat and was having trouble clearing. By 5:00PM the itching had became worse and my face began to itch and tingle, by 5:30pm the whole left side of my face was numb as well as my top lip. By 5:45PM my tongue was tingling and itching and when I looked at it, it was doubled in size and the back of my throat began to itch and I felt I was having difficulty breathing. I realized the itching was not normal like I had thought, when I noticed my face, tongue, and throat. I took 2 Benadryl immediately. I continued taking Benadryl every time I felt the reaction coming back as the pharmacist had instructed. I did this around the clock Friday evening and Saturday until around 9:00PM. When I realized the reaction time was getting closer together and the dose of Benadryl I had taken was no longer seeming to stop the reaction. The pharmacist had recommended going to the hospital if the last statement began happening and they would have to give me something to stop it. I went to the ER, arriving around 9:45PM and was given 60mgs of Prednisone orally shortly after. I was sent home with a prednisone prescription for 10mg tablet taper 5, 4, 3, 2, 1 to start on Sunday April 7th, 2013. The diagnoses was allergic reaction.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Paraesthesia, Paraesthesia oral, Pruritus generalised, Rash macular, Swollen tongue
Clinical narrative: I began itching in random places all over my body at approximately 3:00pm, My skin was splotchy but no raised rash, by 3:30PM my bottom lip went completely numb and I noticed I felt like I had phlegm in my throat and was having trouble clearing. By 5:00PM the itching had became worse and my face began to itch and tingle, by 5:30pm the whole left side of my face was numb as well as my top lip. By 5:45PM my tongue was tingling and itching and when I looked at it, it was doubled in size and the back of my throat began to itch and I felt I was having difficulty breathing. I realized the itching was not normal like I had thought, when I noticed my face, tongue, and throat. I took 2 Benadryl immediately. I continued taking Benadryl every time I felt the reaction coming back as the pharmacist had instructed. I did this around the clock Friday evening and Saturday until around 9:00PM. When I realized the reaction time was getting closer together and the dose of Benadryl I had taken was no longer seeming to stop the reaction. The pharmacist had recommended going to the hospital if the last statement began happening and they would have to give me something to stop it. I went to the ER, arriving around 9:45PM and was given 60mgs of Prednisone orally shortly after. I was sent home with a prednisone prescription for 10mg tablet taper 5, 4, 3, 2, 1 to start on Sunday April 7th, 2013. The diagnoses was allergic reaction.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Throat irritation
Clinical narrative: I began itching in random places all over my body at approximately 3:00pm, My skin was splotchy but no raised rash, by 3:30PM my bottom lip went completely numb and I noticed I felt like I had phlegm in my throat and was having trouble clearing. By 5:00PM the itching had became worse and my face began to itch and tingle, by 5:30pm the whole left side of my face was numb as well as my top lip. By 5:45PM my tongue was tingling and itching and when I looked at it, it was doubled in size and the back of my throat began to itch and I felt I was having difficulty breathing. I realized the itching was not normal like I had thought, when I noticed my face, tongue, and throat. I took 2 Benadryl immediately. I continued taking Benadryl every time I felt the reaction coming back as the pharmacist had instructed. I did this around the clock Friday evening and Saturday until around 9:00PM. When I realized the reaction time was getting closer together and the dose of Benadryl I had taken was no longer seeming to stop the reaction. The pharmacist had recommended going to the hospital if the last statement began happening and they would have to give me something to stop it. I went to the ER, arriving around 9:45PM and was given 60mgs of Prednisone orally shortly after. I was sent home with a prednisone prescription for 10mg tablet taper 5, 4, 3, 2, 1 to start on Sunday April 7th, 2013. The diagnoses was allergic reaction.
Age: 38.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Insomnia, Muscle spasms
Clinical narrative: Muscle spasms, twitching. Large lump at injection site, redness, painful. Unable to sleep, due to muscle spasms. Mild fever.
Age: 38.0
Sex: M
Vaccine: DTAP
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: Muscle spasms, twitching. Large lump at injection site, redness, painful. Unable to sleep, due to muscle spasms. Mild fever.
Age: 19.0
Sex: M
Vaccine: HEPAB
Symptoms: Chromaturia, Cough, Epstein-Barr virus infection, Epstein-Barr virus test positive, Fatigue
Clinical narrative: fever, extreme aches, extreme fatigue, dark gold/orange urine, pain in upper body when coughing or other movements- diagnosed with Epstein Barr on 4/4/2013. Going back to test liver today - 4/8/13.
Age: 19.0
Sex: M
Vaccine: HEPAB
Symptoms: Pain, Pyrexia
Clinical narrative: fever, extreme aches, extreme fatigue, dark gold/orange urine, pain in upper body when coughing or other movements- diagnosed with Epstein Barr on 4/4/2013. Going back to test liver today - 4/8/13.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-02-28.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2013-02-28.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Differential white blood cell count normal, Full blood count normal, HIV test negative, Laboratory test normal, Papule
Clinical narrative: Patient reported onset "rash"  on legs which spread to buttocks and arms.  Not painful and not itchy.  Seen 4/5/13- showed phone photos of diffuse confluent purplish-red rash.  PE showed remained non-blanching 3-4 mm dark red palpable papules on legs and arms.  No rash on palms or soles or mucuos membranes.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Red blood cell sedimentation rate normal, Treponema test, Urine analysis normal
Clinical narrative: Patient reported onset "rash"  on legs which spread to buttocks and arms.  Not painful and not itchy.  Seen 4/5/13- showed phone photos of diffuse confluent purplish-red rash.  PE showed remained non-blanching 3-4 mm dark red palpable papules on legs and arms.  No rash on palms or soles or mucuos membranes.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paralysis
Clinical narrative: I was absolutely fine & healthy prior to the early A.M. of Nov. 10, 2012. I suffered enormous pain, and paralysis and have endured major medical treatments and huge medical bills due to this illness from the flu shot.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Mental impairment, Sensory loss, VIIth nerve paralysis, Vision blurred
Clinical narrative: Facial drooping & numbness, was diagnosed with Bells Palsy at hosp. Went to neurologist a couple days later he admitted me to overlook. By then lost feeling in my feet, legs, arms, hands and had trouble understanding & focusing.
Age: 23.0
Sex: M
Vaccine: FLU3, HEPA, IPV, MNQ, TDAP, TYP, YF
Symptoms: Urticaria
Clinical narrative: A week after patient received vaccinations he broke out into hives on his arms, chest, and neck. Patient did not go to the doctor. He started taking BENADYL. His hives are healing. He contacted office on 04/05/13 pt advised to contact primary care physician immediately.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient had a red itchy area around the injection site.
Sex: U
Vaccine: PPV
Symptoms: Meningitis pneumococcal
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23. No dosage information, route of administration or lot number was reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced pneumococcal meningitis (considered as medically significant per manufacturer). It was unknown if the patient received any treatment for the adverse event. The outcome of pneumococcal meningitis was unknown. The reporter did not provide a causality statement. It was added that the reporter was not sure if the patient received PNEUMOVAX23 in the past. No further information was provided. Follow up information has been received. On 02-APR-2013 a phone call was placed to the pharmacist, he had heard about this patient from an infectious disease specialist who was asking his opinion on pneumococcal vaccines. He was not sure if the patient actually received the PNEUMOVAX23. The health care professional contacted during telephone follow/up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, recovery status, healthcare provider name and contact information. Additional information has been requested. This is a corrected report. Date learned was changed from 13-MAR-2013 to 12-MAR-2013. Therefore a new case was created (MARRS 1304USA002643) and MARRS (1303USA007284) is being deleted from our files in PNEUMOVAX 23.
Age: 0.22
Sex: F
Vaccine: BCG
Symptoms: Incorrect route of drug administration, Injection site erythema, Scab, Vaccination site induration, Vaccination site pain
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 04-JAN-2013, the patient was vaccinated with BCG. No lot number or expiration date was reported. No concomitant medications were reported. The physician stated that the patient received BCG via the intradermal route. There were no known adverse effect. Follow up information received from the physician regarding the 5 month old male patient. Contact details of vaccine administrator and patient were updated. The patient had no pre existing allergies. BCG (lot# 4511121-A) given intradermally instead of percutaneous. On 04-JAN-2013, the vaccination site became red and indurated and painful (medically significant-as events required medical intervention). The patient was seen by infectious disease doctor and was started on rifampin and isoniazid to prevent any adverse reactions. The patient did not have laboratory tests performed. Area was drained on its own and is now scabbed and healing. Medication was given for 6 weeks. Prophylactic anti T.B medicines to prevent abscess or lymph node enlargement. No surgical problems or other complications. Illness at time of vaccination was none. Twin sibling was also vaccinated with the same vaccine. This is 1 of 2 reports from the same source. Additional information has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Respiratory arrest
Clinical narrative: Initial report was received on 27 March 2013 from another manufacturer national service center (manufacturer report number 2013081062), who received the report from a health care professional. A female patient had received tetanus toxoid (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, stopped breathing. The patient's outcome was not reported. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Noticed slight redness to injection site from day 1 but increased to pain, redness, swelling with itching to upper arm by day 3; short lasting relief with ice packs and topical cortisone cream.
Age: 51.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Fatigue, Headache, Local reaction, Pain in extremity
Clinical narrative: Initially local reaction - redness, then tiredness, headache, sore arm, wheezing, denies fever.
Age: 51.0
Sex: F
Vaccine: YF
Symptoms: Wheezing
Clinical narrative: Initially local reaction - redness, then tiredness, headache, sore arm, wheezing, denies fever.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Incorrect dose administered
Clinical narrative: Pt was mistakenly given 1.5 mL of typhoid VICPs and anthrax vaccines, instead of 0.5 mL.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site irritation, Wrong drug administered
Clinical narrative: I WAS TO BE ADMINISTERED TB TEST & WAS GIVEN TDAP VACCINE INSTEAD, SUBCUTANEOUSLY IN MY FOREARM.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pain in lateral shoulder, progressing to inability to abduct arm past 40 degrees. No local reaction noted. No swelling or bruising. No pain at time of injection. Has been worsening since. Now all rom is limited. Did not respond to steroids orally. Has been referred for PT.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is red, raised and warm to touch x 3-4 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash vesicular
Clinical narrative: Large swollen painful red area, at site of injection, accompanied by shingles-like lesion.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Foetal disorder
Clinical narrative: Baby stopped growing at 6 weeks 5 days and miscarried at 10 weeks 6 days.
Age: 44.0
Sex: F
Vaccine: MEN, YF
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Urticaria
Clinical narrative: Two vaccines given in right arm, swollen and red half dollar size welts on deltoid and back of right arm.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Rash
Clinical narrative: Red blister rash, wrist to elbow, right arm, vaccine was administered to upper arm, left arm.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Malaise, Myalgia
Clinical narrative: Local erythema and induration, maliase/ myalgia lasting 24 hours.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Photophobia
Clinical narrative: Extreme sensitivity to light.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Injection site mass, Injection site warmth, Pruritus
Clinical narrative: Felt hard lump where vaccine was given.  The area was also warm to the touch.  Outside the very red, hard area, was a lighter red area, which seemed to be getting larger.  Some itching.  First used Benadryl.  Then Dr told me to take 20 mg Prednisone for 3 days.  However, when I told my husband he said that was the wrong thing to do, that prednisone can interfere with vaccine.  So, I had already taken it for 2 days, then stopped.  Eventually it got better.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dehydration, Intussusception, Rectal haemorrhage, Surgery, Ultrasound abdomen abnormal
Clinical narrative: Vomiting, dehydration, rectal bleeding.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting, dehydration, rectal bleeding.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Asthenia, Chills, Decreased appetite, Dizziness
Clinical narrative: Mild headache, dizziness, tiredness, feeling of vomiting, but next day it got worse with high fever 103.3 F, loss of appetite, on Thu I couldn't go to work, chills, body ache, really bad headaches, feeling weak, the area was red and swollen.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Headache, Local swelling, Nausea
Clinical narrative: Mild headache, dizziness, tiredness, feeling of vomiting, but next day it got worse with high fever 103.3 F, loss of appetite, on Thu I couldn't go to work, chills, body ache, really bad headaches, feeling weak, the area was red and swollen.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Mild headache, dizziness, tiredness, feeling of vomiting, but next day it got worse with high fever 103.3 F, loss of appetite, on Thu I couldn't go to work, chills, body ache, really bad headaches, feeling weak, the area was red and swollen.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, RVX, UNK
Symptoms: Crying, Erythema, Injection site warmth, Pain, Swelling
Clinical narrative: Extreme pain, crying, red streaks with in 3 mins of the red streaks he had swelling and very red and hot leg. From hip to knee.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: SWELLING REDNESS, TENDER.  RED GOES DOWN ARM TO ELBOW. 2 days after shot, went to dr, said to put ice on arm and take Advil for pain if not better in 10 days go see your dr and you can not get another shot.
Age: 44.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe brachial pain.  Burning pain, tingling, swelling, numbness in injection arm.  Very limited arm range of motion in shoulder.
Age: 44.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Swelling
Clinical narrative: Severe brachial pain.  Burning pain, tingling, swelling, numbness in injection arm.  Very limited arm range of motion in shoulder.
Age: 44.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Expired drug administered, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Severe brachial pain.  Burning pain, tingling, swelling, numbness in injection arm.  Very limited arm range of motion in shoulder.
Age: 44.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Severe brachial pain.  Burning pain, tingling, swelling, numbness in injection arm.  Very limited arm range of motion in shoulder.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a physician refers to 4 patients of unknown age and gender. On 01-APR-2013 the patients were vaccinated with GARDASIL (lot# H021608, expiration date 13-AUG-2015, route not reported). The physician noted that GARDASIL was shipped on 27-MAR-2013 and did not arrive at the office until 01-APR-2013 and the GARDASIL was in the shipper the entire time. The physician's office could not determine the exact temperature the GARDASIL was exposed to while in the shipment from 27-MAr-2013 to 01-APR-2013. No patient contact details available. No further information was available. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Approximately on an unknown date in 2013 the patients were vaccinated with VAQTA (lot#, expiration date and route not reported) that was improperly stored approximately on an unknown date in March 2013 (reported as over the last month). No adverse effects reported. The medical assistant was unable to confirm the exact number or identities of the patients at the time of this report. No further information provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Approximately an unknown date in 2013 the patients were vaccinated with GARDASIL (lot#, expiration date and route not reported) that was improperly store approximately on an unknown date in March 2013 (reported as over the last month). No adverse effects reported. The medical assistant was unable to confirm the exact number or identities of the patients at the time of this report. No further information provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Asperger's disorder, Blood test
Clinical narrative: Information has been received from an approximately 21 year old female consumer with no concomitant medications, no pertinent medical history and no drug reactions/allergies. The consumer reported in 2001, she received three doses of Hepatitis B vaccine (Recombinant) (lot number, expiration date and specific dates, route and site of administration not reported). The consumer reported in 2009, she was diagnosed with Asperger's syndrome. She has seen her health care provider and had unspecified blood work done. The consumer reported she has been institutionalized several times (no dates reported) for different time periods. The consumer reported the combination of being on "drugs" (no additional information provided regarding the type of drugs) and her Asperger's syndrome were the reasons she was hospitalized. At the time of the report, she was "feuding" with the people in the house where she lived. No further information provided. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEPAB, IPV, MMR
Symptoms: Blood test, Measles antibody positive, Pain, Pyrexia, Rash generalised
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 44 year old male patient with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with single dose of each of the monovalent vaccines for Measles, Mumps, and Rubella when he was a child. On 11-MAR-2013, the patient was vaccinated with 0.5 milliliter (ml) of M-M-R II (lot number and expiry date reported as H012571 and 29-JUN-2014 (also reported as 29-JUL-2014) respectively), subcutaneously. Concomitant therapies included TWINRIX and poliovirus vaccine inactivated (unspecified). Both were administered on 11-MAR-2013. On 19-MAR-2013, the patient experienced achiness and fever (103.0 Fahrenheit). On 23-MAR-2013 the patient experienced full body rash. The patient sought medical attention (office visit). On 23-MAR-2013, blood tests were performed and Measles (Rubeola) IgG antibody level was found to be 1.31, Rubella IgG antibody level was found to be 39 and rubella IgM antibody level was found to be negative. On an unknown date in 2013, the patient had recovered. The relatedness for all the events was unknown for M-M-R II. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEPAB, IPV, MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 44 year old male patient with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with single dose of each of the monovalent vaccines for Measles, Mumps, and Rubella when he was a child. On 11-MAR-2013, the patient was vaccinated with 0.5 milliliter (ml) of M-M-R II (lot number and expiry date reported as H012571 and 29-JUN-2014 (also reported as 29-JUL-2014) respectively), subcutaneously. Concomitant therapies included TWINRIX and poliovirus vaccine inactivated (unspecified). Both were administered on 11-MAR-2013. On 19-MAR-2013, the patient experienced achiness and fever (103.0 Fahrenheit). On 23-MAR-2013 the patient experienced full body rash. The patient sought medical attention (office visit). On 23-MAR-2013, blood tests were performed and Measles (Rubeola) IgG antibody level was found to be 1.31, Rubella IgG antibody level was found to be 39 and rubella IgM antibody level was found to be negative. On an unknown date in 2013, the patient had recovered. The relatedness for all the events was unknown for M-M-R II. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash erythematous, Urticaria
Clinical narrative: This spontaneous report as received from a 63 year old female patient. The patient did not have drug reactions/allergies. The patient had mild shingles prior to receiving the vaccine. On 11-DEC-2012 the patient was vaccinated with ZOSTAVAX (dose, route and lot # were unknown). The patient received a flu shot (manufacturer unknown) on the same day. The patient had Various other medications including TOPROL and SYNTHROID. The patient reported that after receiving the ZOSTAVAX vaccine she developed a red rash 1-2 days later and the rash had little red dots, and sometimes appeared in hives in the same location that her prior shingles outbreak had occurred. The outcome of event was unknown. Treatment was given: SINGULAIR, ZYRTEC, ZANTAC and Cortisone cream. Other lab work was taken for other conditions. The patient had sought unspecified medical attention. 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 medical assistant refers to a female patient of unknown age. The patient was vaccinated with her three doses series of GARDASIL intramuscularly on 20-NOV-2008, 22-MAY-2009 and 31-JUL-2009. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported). ZOSTAVAX was exposed to temperature up to 24F for 67 days (1608 hours) and it was determined not viable. Improperly stored ZOSTAVAX had been administered to the patient. No adverse effects reported. This is one of several reports received from the same source (same reporter link:same reporter link: 1303USA011844 and 1304USA002220). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 07-DEC-2012, the patient was vaccinated with (route not provided) GARDASIL (lotnumber and expiry date not provided). On 07-DEC-2012, the patient received the first dose of GARDASIL on 12/07/2012 that expired on 10/18/2012. The patient is not experiencing any known symptoms. The outcome of received the first dose of GARDASIL on 12/07/2012 that expired on 10/18/2012 and the patient is not experiencing any known symptoms is unknown. The reporter considered received the first dose of GARDASIL on 12/07/2012 that on 10/18/2012 and the patient is not experiencing any known symptoms to be not related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and unknown age. On an unknown date (reported as 8-10 years ago) the patient was vaccinated with ZOSTAVAX, 65 ml, subcutaneous. Medical history and concomitant medication was not reported. On an unknown date the patient experienced mild rash lower on the arm than the injection site. The outcome of mild rash lower on the arm than the injection site is unknown. No causality was reported. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEPAB, IPV, MMR
Symptoms: Blood test, Body temperature increased, Feeling abnormal, Measles, Rash generalised
Clinical narrative: Pt received booster MMR for travel on 3/11/13. Started feeling bad on 3/19/13, to doctor on 3/20/13 and 3/22/13. Broke out in full body rash on 3/23/13. Max temp 103. Bld test done to prove measles by doctor.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Joint injury
Clinical narrative: Shoulder injury on the left side due to vaccine administration, due to injection of influenza vaccine into the subacromial bursa. [Vaccine over penetration].
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Angiogram abnormal, Angiogram retina, Choroiditis, Eye inflammation, Fundoscopy abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of multifocal choroiditis of eye in a 33-year-old male subject who was vaccinated with Typhoid vaccine (manufacturer unspecified), yellow fever vaccine (non-GSK) and hepatitis A vaccine inactivated for travel. Historic vaccination included 1st dose of hepatitis A vaccine inactivated (manufacturer unspecified, unknown route and injection site) given 12 years prior. The subject had no history of autoimmune disease or recent viral illness and had no family history of autoimmune disease. Before vaccination, the subject was healthy. On an unspecified date, the subject received 1st dose of typhoid vaccine (unknown route and injection site, batch number not provided), 1st dose of yellow fever vaccine (unknown route and injection site, batch number not provided) and 2nd dose of hepatitis A vaccine (unknown route and injection site, batch number not provided). 3 weeks after vaccination with hepatitis A vaccine, typhoid vaccine and yellow fever vaccine, the subject experienced intermittent floaters and flashing lights in right eye. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1+ anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. The patient was diagnosed as having acute multifocal choroiditis and was observed. This case was assessed as medically serious by GSK. After 2 weeks, the subject continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the non-progressive examination findings and given the excellent visual acuity, it was decided to continue close observation. After 8 weeks, the subject's symptoms had self-resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. Although this case did not prove causation and the relationship remained presumptive, it did suggest that some vaccinations could act as a trigger for immunologic initiation that could subsequently lead to the development of non-infectious uveitis.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Intraocular pressure test normal, Photopsia, Pupillary light reflex tests normal, Retinal depigmentation, Slit-lamp tests abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of multifocal choroiditis of eye in a 33-year-old male subject who was vaccinated with Typhoid vaccine (manufacturer unspecified), yellow fever vaccine (non-GSK) and hepatitis A vaccine inactivated for travel. Historic vaccination included 1st dose of hepatitis A vaccine inactivated (manufacturer unspecified, unknown route and injection site) given 12 years prior. The subject had no history of autoimmune disease or recent viral illness and had no family history of autoimmune disease. Before vaccination, the subject was healthy. On an unspecified date, the subject received 1st dose of typhoid vaccine (unknown route and injection site, batch number not provided), 1st dose of yellow fever vaccine (unknown route and injection site, batch number not provided) and 2nd dose of hepatitis A vaccine (unknown route and injection site, batch number not provided). 3 weeks after vaccination with hepatitis A vaccine, typhoid vaccine and yellow fever vaccine, the subject experienced intermittent floaters and flashing lights in right eye. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1+ anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. The patient was diagnosed as having acute multifocal choroiditis and was observed. This case was assessed as medically serious by GSK. After 2 weeks, the subject continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the non-progressive examination findings and given the excellent visual acuity, it was decided to continue close observation. After 8 weeks, the subject's symptoms had self-resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. Although this case did not prove causation and the relationship remained presumptive, it did suggest that some vaccinations could act as a trigger for immunologic initiation that could subsequently lead to the development of non-infectious uveitis.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Visual acuity tests normal, Visual field tests normal, Vitreous floaters
Clinical narrative: This case was reported in a literature article and described the occurrence of multifocal choroiditis of eye in a 33-year-old male subject who was vaccinated with Typhoid vaccine (manufacturer unspecified), yellow fever vaccine (non-GSK) and hepatitis A vaccine inactivated for travel. Historic vaccination included 1st dose of hepatitis A vaccine inactivated (manufacturer unspecified, unknown route and injection site) given 12 years prior. The subject had no history of autoimmune disease or recent viral illness and had no family history of autoimmune disease. Before vaccination, the subject was healthy. On an unspecified date, the subject received 1st dose of typhoid vaccine (unknown route and injection site, batch number not provided), 1st dose of yellow fever vaccine (unknown route and injection site, batch number not provided) and 2nd dose of hepatitis A vaccine (unknown route and injection site, batch number not provided). 3 weeks after vaccination with hepatitis A vaccine, typhoid vaccine and yellow fever vaccine, the subject experienced intermittent floaters and flashing lights in right eye. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1+ anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. The patient was diagnosed as having acute multifocal choroiditis and was observed. This case was assessed as medically serious by GSK. After 2 weeks, the subject continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the non-progressive examination findings and given the excellent visual acuity, it was decided to continue close observation. After 8 weeks, the subject's symptoms had self-resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. Although this case did not prove causation and the relationship remained presumptive, it did suggest that some vaccinations could act as a trigger for immunologic initiation that could subsequently lead to the development of non-infectious uveitis.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Angiogram abnormal, Angiogram retina abnormal, Choroiditis, Fundoscopy abnormal, Inflammation
Clinical narrative: This case was reported in a literature article and described the occurrence of multifocal choroiditis of eye in a 33-year-old male subject who was vaccinated with Typhoid vaccine (manufacturer unspecified), yellow fever vaccine (non-GSK) and hepatitis A vaccine inactivated for travel. Historic vaccination included 1st dose of hepatitis A vaccine inactivated (manufacturer unspecified, unknown route and injection site) given 12 years prior. The subject had no history of autoimmune disease or recent viral illness and had no family history of autoimmune disease. Before vaccination, the subject was healthy. On an unspecified date, the subject received 1st dose of typhoid vaccine (unknown route and injection site, batch number not provided), 1st dose of yellow fever vaccine (unknown route and injection site, batch number not provided) and 2nd dose of hepatitis A vaccine (unknown route and injection site, batch number not provided). 3 weeks after vaccination with hepatitis A vaccine, typhoid vaccine and yellow fever vaccine, the subject experienced intermittent floaters and flashing lights in right eye. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1+ anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. The patient was diagnosed as having acute multifocal choroiditis and was observed. This case was assessed as medically serious by GSK. After 2 weeks, the subject continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the non-progressive examination findings and given the excellent visual acuity, it was decided to continue close observation. After 8 weeks, the subject's symptoms had self-resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. Although this case did not prove causation and the relationship remained presumptive, it did suggest that some vaccinations could act as a trigger for immunologic initiation that could subsequently lead to the development of non-infectious uveitis.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Angiogram abnormal, Angiogram retina, Choroiditis, Eye inflammation, Fundoscopy abnormal
Clinical narrative: Initial report was retrieved from the scientific literature on 25 March 2013. The following is verbatim from the report: "A previously health 33-year-old male was referred to our retina service for sudden onset of intermittent floaters and flashing lights in his right eye which developed 3 weeks following inactivated hepatitis A, yellow fever, and typhoid vaccinations. These vaccines were given prophylactically in preparation for a 2-week trip at [a clinic]. The patient had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1+ anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. There was no history of autoimmune disease or recent viral illness. There was no family history of autoimmune disease. The patient was diagnosed as having acute multifocal choroiditis and observed. After 2 weeks, the patient continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the nonprogressive examination findings and given the excellent visual acuity, it was decided to continue close observation. At 8 weeks, the patient's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy." Outcome was recovered. Documents held by sender: None.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Intraocular pressure test normal, Photopsia, Pupillary light reflex tests normal, Retinal depigmentation, Slit-lamp tests abnormal
Clinical narrative: Initial report was retrieved from the scientific literature on 25 March 2013. The following is verbatim from the report: "A previously health 33-year-old male was referred to our retina service for sudden onset of intermittent floaters and flashing lights in his right eye which developed 3 weeks following inactivated hepatitis A, yellow fever, and typhoid vaccinations. These vaccines were given prophylactically in preparation for a 2-week trip at [a clinic]. The patient had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1+ anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. There was no history of autoimmune disease or recent viral illness. There was no family history of autoimmune disease. The patient was diagnosed as having acute multifocal choroiditis and observed. After 2 weeks, the patient continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the nonprogressive examination findings and given the excellent visual acuity, it was decided to continue close observation. At 8 weeks, the patient's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy." Outcome was recovered. Documents held by sender: None.