chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Visual impairment
Clinical narrative: The day after vaccine 4/6/2012, patient was more hyper, less attentive, less affect, less eye contact, and some strange facial expressions. Low temp of 99. All within normal side effects for vaccine assuming they were temporary and self limiting; no concern at this point of reaction. Upon waking, patient was lethargic, irritable, flushed. Temperature reading at 8:00 was 103. Patient had never experienced a fever higher than 102 in his life, or lethargy, despite having several viruses in his young life. Patient was taken to doctor this day, thought to be virus, however the next morning awoke perfectly well. This is when the immune activation is thought to have begun. On 4/29/2012 mild leg pain and fatigue; extremely unusual for patient. This is when the Encephalopathy is thought to have begun.  4/30/2012 Awoke at 5:30 screaming, afraid, nightsweat. Irritable, flushed, lethargic. Similar to previous event with 103.5 fever this time. This time however, he looked, felt, acted, seriously ill. Was unable to eat, would not drink, scared, skin hurt. This is when suspected Encephalomyelitis began. On the way to the doctor's office, his pupils were as large as his iris, shivering, aching knees, leg muscles, breathing was labored. Dr. that he saw observed that he was very ill and did bloodwork for mono, EBV, strep. All turned out to be negative. He woke up "well" the next morning. Another episode on 5/2/2012 in which he had headache, small bumpy rash on his ears, arms, and legs, completely lethargic, diarrhea. This is the day that the neurological symptoms became more noticable. For the next 7-10 days, patient loss cognitive abilities, memory loss, muscle pain, sensory sensations, nightmares / possible febrile seizures, hearing, vision changes, urination accidents, loss of coordination, unable to pronounce words, unable to follow directions, unable to express himself the way that he had always been able to so well.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash generalised
Clinical narrative: Bumps on back, chest, armpits and knees.
Age: 0.94
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Lethargy
Clinical narrative: 102.9 temp with lethargy.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Pruritus, Rash maculo-papular, Skin warm
Clinical narrative: Twenty minutes after the shot (on 1/23) patient noticed a maculopapular rash on both arms, very hot to the touch with very mild pruritus. Later that night she experienced chills. The next day (1/24) she was light-headed and the rash was still hot to the touch. Today (1/25), she noticed it spread to her legs but no pruritus or heat in this location. The rash on her arms today (1/25) is not as hot to the touch, but still warm. She has applied OTC hydrocortisone cream to her arms twice on 1/24.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Nuclear magnetic resonance imaging
Clinical narrative: Numbness in right leg.
Age: 31.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Headache, nausea, fever one day after taking 1st dose.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache, Pyrexia, Vomiting
Clinical narrative: High temp, headache, vomiting, dizziness x 2 days much improved now.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Feeling hot, Injection site bruising, Swelling
Clinical narrative: Swelling, erythema, warmth of deltoid muscle. Bruising at site.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to an unknown number of patients of unknown age and genders who were vaccinated with, 0.5 ml PNEUMOVAX23 (Lot not reported) between 16-DEC-2012 to 20-DEC-2012 that had been improperly stored. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Action item of PNEUMOVAX23 and outcome of the event was unknown. Event was not related to PNEUMOVAX23. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chest X-ray abnormal, Cough, Pneumonia
Clinical narrative: Coughing on 1/23 pm started.  Temp 103 started on 1/24. Came to ED, chest x ray showed pneumonia.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cough, Fatigue, Increased upper airway secretion
Clinical narrative: Pt. received flu vacc. on 12/8/12. Developed chills, weakness & tiredness. Now (1/23/13) c/o coughing up white mucous, nasal discharge & still feels weak/tired.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza virus test negative, Rhinorrhoea
Clinical narrative: Pt. received flu vacc. on 12/8/12. Developed chills, weakness & tiredness. Now (1/23/13) c/o coughing up white mucous, nasal discharge & still feels weak/tired.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Fatigue, Malaise, Nausea
Clinical narrative: Family from another area new to city, mom is a nurse reported client experienced nausea, fatigue, malaise several days after immunizations.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning to an 18 years old patient of unknown gender who recently received two concomitant doses of RECOMBIVAX HB (dose, route and lot number not reported) at one time, when he or she should only had received one. It was unknown where in the series of dosing the patient was supposed to be. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome of the event was unknown. The event was not related to RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella virus test negative, Viral test negative
Clinical narrative: This spontaneous report was received from a health care student refers to a patient (age and gender unknown). On unknown dates, the patient received 2 doses of live (Merck) VARIVAX. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient had negative VZV antibody titers for varicella zoster virus. Laboratory titer of varicella was performed. The outcome of negative titers for varicella zoster virus was unknown. Negative titers for varicella zoster virus was unknown related to live (Merck) VARIVAX. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Administered flu vaccine then administered GARDASIL vaccine #1, client had episode of syncope & vomiting 15-20 min. felt fine walked out.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, TDAP, VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Family from another area, new to city, mom is a nurse, called several days after immunization to report: client experienced high fever, brownish rash on various parts of body.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fungal infection, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm of ZOSTAVAX injection swelled around area and extended approx 5 inches diameter. Site was warm and "itchy". Pt also reported a yeast infection 1 day after injection.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Pt. developed red, warm, itchy rash on both lower extremities. No fever or any other systemic symptoms. Rash is still present.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Left deltoid still aches and produces shooting pain on exercise during archery and during left handed mouse movements.
Age: 23.0
Sex: F
Vaccine: HPVX, TDAP
Symptoms: Chest pain, Fatigue, Pain, Pyrexia, Syncope
Clinical narrative: Chest pain, fever, fatigue, faint, body aches.
Age: 0.32
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: HIVES TO FOREHEAD AND SEVERE TO BOTH COMPLETE LOWER EXTREMITIES. NO TREATMENT GIVEN.  GRANDMOTHER ADVISED TO TAKE BABY TO URGENT CARE FOR FOLLOW-UP WHEN THEY RETURNED TO CLINIC ON 01/22/2013.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Severe onset of hives all over back, chest, and trunk.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Child was resting in chair for 3 different immunizations, was not afraid or anxious.  Requested to watch RN immunize one at a time instead of one in each arm at the same time.  Child sat for a couple of minutes, then stood to get a sucker in our draw.  She then placed her hand on her stomach and became very pale.  Child was assisted to the chair right next to her then laid down by 2 RN assist on the floor with her legs elevated.  Child was very pale during this fainting episode.  Cool wash cloth was placed on her forehead and fan in room placed facing towards child.  Encouraged child to breathe in her nose and out her mouth very slowly.  Child laid on the floor for 10 minutes then slowly sat up for 10 minutes then stood with RN.  Child stated she was very hungry.  Water and a graham cracker was provided.  Mother denied any history or fainting or diabetes.  Mother and sister were present during this event.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Dyskinesia, Lip swelling, Nausea, Paraesthesia
Clinical narrative: Patient indicated she had involuntary facial muscle movement on left side, tingling in the facial area, some swelling of lips/tongue. Slight nausea and a tin taste in mouth. Blurry vision.  She did contact her physician by phone.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Vision blurred
Clinical narrative: Patient indicated she had involuntary facial muscle movement on left side, tingling in the facial area, some swelling of lips/tongue. Slight nausea and a tin taste in mouth. Blurry vision.  She did contact her physician by phone.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, HPV4
Symptoms: Amnesia, Fall, Gaze palsy, Muscle twitching, Pallor
Clinical narrative: PALLOR, MUSCLE TWITCHING, SHAKING ALL OVER BODY, FALLING BACKWARD MOTION. EYES ROLLING UPWARD. LOSS OF MEMORY OF INCIDENT WHEN QUESTIONED AFTER IT HAPPENED.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, HPV4
Symptoms: Tremor
Clinical narrative: PALLOR, MUSCLE TWITCHING, SHAKING ALL OVER BODY, FALLING BACKWARD MOTION. EYES ROLLING UPWARD. LOSS OF MEMORY OF INCIDENT WHEN QUESTIONED AFTER IT HAPPENED.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, HPV4
Symptoms: Fall, Gaze palsy, Muscle twitching, Pallor, Tremor
Clinical narrative: PALLOR, MUSCLE TWITCHING, SHAKING ALL OVER BODY, FALLING BACKWARD MOTION. EYES ROLLING UPWARD. LOSS OF MEMORY OF INCIDENT WHEN QUESTIONED AFTER IT HAPPENED.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Dysphonia, Urticaria
Clinical narrative: Hives and hoarseness. Took 25 mg Benadryl po.
Age: 1.48
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Electroencephalogram, Laboratory test, Staring, Tonic clonic movements
Clinical narrative: Foster parent reported she observed the baby staring and then had tonic/clonic movements of extremities lasting a few seconds. She is unsure of exact length of time lapse. 911 was called and child was taken to E.R.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Pt reports that her entire L) arm had severe muscle aching.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness to site (Right tricep area), itchyness, hot to touch. Next day, worse with a raised area where subcutaneous injection given and a large area of flat redness surrounding it. RN measured it on 01/25/2013 as 25 mm x 20 mm raised area and the surrounding redness as 70 mm wide by 48 mm long.  Client took Benadryl x1 for itching on this a.m.  Instructed client to continue Benadryl PRN, try ice to area, seek medical attention if condition worsens, and return on Monday 01/28/2013 for nurse to evaluate. Client agreeable to instructions.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Inappropriate schedule of drug administration, Neuropathy peripheral
Clinical narrative: Patient received Tdap vaccine while she was ins the hopsital in August. She came to the pharmacy in October for a flu vaccine and reported that she had a newborn.  Pharmacist recommended that if she had a young child at home she should get a Tdap booster for pertussis prevention.  Patient did not recall having received a TDaP vaccine in the hospital.  She got the TDaP vaccine. States that she now has neuropathy due to receiving the vaccine a second time.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Gait disturbance, Laboratory test normal
Clinical narrative: 1/2/13 Received Adacel, Tdap vaccine that morning, went home and slept about 4 hours. 1/5/13 patient woke up feeling like every joint was hurting. 1/9/13 patient began having difficulty walking from painful joints. 1/11/13 patient went to Dr, he prescribed Prednisone, and it made patient feel better. 1/16/13 took last dose of Prednisone and by that evening his pain had returned to his joints. 1/21/13 patient went back to Dr where he drew lab for Arthritis, which was negative, and told patient that something in the Tdap vaccine connected with something in the patients body and has attacked all his joints. 1/23/13 patients wife called to report this incident and ask for direction.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Communication disorder, Gaze palsy, Muscle rigidity
Clinical narrative: Administered the vaccine and 1-2 minutes later the patient's eyes rolled in the back of his head and he became very stiff and couldn't communicate. It lasted for about 45 seconds then the patient came back and was talking.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral
Clinical narrative: Vaccine was given by myself. Pt reported to nurses that tongue was tingling.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Muscular weakness, Neck pain
Clinical narrative: Weakness in right arm from elbow to shoulder up to neck.  Hand became numb.  Neck pain with turning head.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Neck pain
Clinical narrative: Achiness on both sides of his neck, into his shoulders and where the clavicles meet in his chest (at the base of the neck).  Limited range of motion in both arms, cannot lift very high.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Persistant injection site pain -- patient recieved Fluzone HD on 11-5-12 reports to me on 1-25-13 that her arm still hurts where the injection was givin, at times she feels like it is swollen.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Chills, Cyanosis, Dysphemia
Clinical narrative: Eating at local restaurant on 1/12/13; suddenly noticed development of lower lip numbness, heaviness, and lips felt droopy.  Developed intense body chills/ shivering.  Developed global body weakness; fingers turned blue. Given Clarinex at home-breathing was tightening. Taken to local ER for evaluation.  Unable to walk on own power. Follow-up appts: 1-16-2013 w/pediatrician, 1/21/13 w/neurologist.  Reported persistent symptoms of global body weakness, easy fatigability, widespread muscle achiness, intermittent speech stuttering for 1-2days. Not able to feel hands/feet at initial onset 1-12-2013. Patient states she feels her symptoms are decreasing, although she is not yet back to baseline.  Neurologist assessment: Possible patient has very mild Guillain-Barre-like syndrome post flu vaccination.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Eating at local restaurant on 1/12/13; suddenly noticed development of lower lip numbness, heaviness, and lips felt droopy.  Developed intense body chills/ shivering.  Developed global body weakness; fingers turned blue. Given Clarinex at home-breathing was tightening. Taken to local ER for evaluation.  Unable to walk on own power. Follow-up appts: 1-16-2013 w/pediatrician, 1/21/13 w/neurologist.  Reported persistent symptoms of global body weakness, easy fatigability, widespread muscle achiness, intermittent speech stuttering for 1-2days. Not able to feel hands/feet at initial onset 1-12-2013. Patient states she feels her symptoms are decreasing, although she is not yet back to baseline.  Neurologist assessment: Possible patient has very mild Guillain-Barre-like syndrome post flu vaccination.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza virus test negative, Lip disorder, Myalgia
Clinical narrative: Eating at local restaurant on 1/12/13; suddenly noticed development of lower lip numbness, heaviness, and lips felt droopy.  Developed intense body chills/ shivering.  Developed global body weakness; fingers turned blue. Given Clarinex at home-breathing was tightening. Taken to local ER for evaluation.  Unable to walk on own power. Follow-up appts: 1-16-2013 w/pediatrician, 1/21/13 w/neurologist.  Reported persistent symptoms of global body weakness, easy fatigability, widespread muscle achiness, intermittent speech stuttering for 1-2days. Not able to feel hands/feet at initial onset 1-12-2013. Patient states she feels her symptoms are decreasing, although she is not yet back to baseline.  Neurologist assessment: Possible patient has very mild Guillain-Barre-like syndrome post flu vaccination.
Sex: F
Vaccine: UNK, FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching, wheal. No induration. No SOB, no tongue swelling. Advised Diphenhydramine 25mg now & q 6 hours prn.
Sex: F
Vaccine: UNK, FLU3
Symptoms: Injection site urticaria
Clinical narrative: Itching, wheal. No induration. No SOB, no tongue swelling. Advised Diphenhydramine 25mg now & q 6 hours prn.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: Administered 0.5 ml of Flu vaccine to a 2 yrs old instead of a 0.25 ml dose. No reaction seen while in clinic.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Headache, Rash
Clinical narrative: Pt stated she had chest tightness Friday night (1-18-13) and a headache and now today she has a rash on her torso (1-20-13) rash cleared on 1-21-13.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Fatigue, Nausea, Pain in extremity, Vomiting
Clinical narrative: HPV vaccine ((L) deltoid) administered as well as influenza vaccine ((R) deltoid) on 1/21/13. Reported (L) arm soreness and generalized fatigue within hours of administration. Positive vomiting episodes 1/22/13 am, positive nausea. Mother recalls vomiting episode after HPV dose #1.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness & slight swelling on right arm. Using cool packs, ADVIL/TYLENOL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Rash macular, Rash papular
Clinical narrative: Vaccines given on the 21st January. Patient returned 3 days later with erythematous macular rash on the vaccine site with smaller scattered blanching erythematous papules on the trunk oral pred, hydroxyzine and KEFLEX prescribed. Pending follow up visit.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Acute hepatic failure, Alanine aminotransferase increased, Aspartate aminotransferase increased, Autoimmune hepatitis, Biopsy liver abnormal
Clinical narrative: Acute liver failure. Patient treated with steroids for autoimmune finding on liver biopsy.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Blood bilirubin increased
Clinical narrative: Acute liver failure. Patient treated with steroids for autoimmune finding on liver biopsy.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Malaise, Myalgia, Pyrexia
Clinical narrative: Reported by patients wife to me by phone on 1/21/13. Spiked fever of 103 F. Described condition as "asthenia" to me. Muscle aches and pain. Felt deathly ill. Couldn't get up. Pulse of 140. Symptoms lasted for 15 hours. Fever subsided gradually over this time. After 2 days patient was back to normal.
Age: 0.7
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Compulsive lip biting, Depressed level of consciousness, Electroencephalogram, Hypersomnia, Slow response to stimuli
Clinical narrative: Decreased level on consciousness starting shortly after vaccine administration with excessive sleep and difficulty being roused and then subsequently an hour of decreased responsiveness with a period of several minutes of rhythmic lip biting concerning for seizure activity.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, hot, painful and firm spot on leg, approximately 2 inches in diameter, at site of injection. Child received four injections, two in each leg, not sure which injection caused reaction. Received DTap booster, MMR booster, IPV, and Varicella.
Age: 1.2
Sex: F
Vaccine: MMR
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: This spontaneous report as received from a physician refers to a 14 months old female patient. The patient was vaccinated with a dose of M-M-R II (Lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The physician reported that on an unspecified date "about 10 days" after vaccination, the patient developed idiopathic thrombocytopenic purpura. The patient was taken to the emergency room and admitted to the hospital. It was unknown how long the patient was hospitalized. The outcome of idiopathic thrombocytopenic purpura was reported as recovered/resolved. The relatedness for idiopathic thrombocytopenic purpura was unknown for M-M-R II. Additional information is not expected.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Drug administration error, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 09-JAN-2013 the patient was vaccinated with a dose of VARIVAX (merck) (reported lot number H01172; expiry date 12-JUN-2014; route unknown) and a dose of PROQUAD (Merck) (reported lot number H01563; route unknown). No concomitant medications were reported. The patient received both PROQUAD (Merck) and VARIVAX (merck) on the same day inadvertently. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender with no pertinent medical history and drug allergies reported, who in 2008, was vaccinated with dose 1 ZOSTAVAX (lot #, dose and route not provided). On 22-JAN-2013, the patient was vaccinated subcutaneously with dose 2 ZOSTAVAX (lot # and dose not provided). No other co-suspects were reported. No concomitant medications were reported. The medical assistant stated that patient was recently diagnosed with cancer but the reporter was not sure what type of cancer the patient has. The outcome of cancer was unknown. The relatedness for cancer was unknown for ZOSTAVAX. Additional information has been requested.
Age: 1.18
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Varicella
Clinical narrative: Mom states child had full body rash - took her to hospital - MD said it was chickenpox.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Pruritus
Clinical narrative: Vaccine administered 1/23/13. Client calls 1/25/13 to report local redness, "1/2 dollar" sized around site where Zoster administered. States mild itching, no pain. States slight lightheadedness/dizziness day of 1/24/13. Instructed client to make appointment with primary care provider.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: X-ray limb normal
Clinical narrative: Possible ejection of needle into muscle. Patient X-ray done at ER revealing no injury.
Age: 1.09
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMRV
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Patient immediately developed rash around her eyes and on her forehead. 2 mls of BENADRYL.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: ZOSTAVAX SQ (R) arm 1-23-13 120pm shortly after administering she developed itching, redness and slight swelling at injection site. 10 min later- swelling went down pt was better when she left office.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Blood glucose, Disorientation, Dizziness, Drug screen, Electroencephalogram
Clinical narrative: Almost immediate c/o dizziness, followed by uncontrolled laughter, inappropriate & disoriented (sometimes) conversation. Mild HA. VS normal, neuro exam normal except mental status. Episode lasted approximately 1 1/4 hrs; pt said he was "coming down", took a brief nap, then was fine.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Headache, Inappropriate affect, Mental status changes, Neurological examination abnormal, Speech disorder
Clinical narrative: Almost immediate c/o dizziness, followed by uncontrolled laughter, inappropriate & disoriented (sometimes) conversation. Mild HA. VS normal, neuro exam normal except mental status. Episode lasted approximately 1 1/4 hrs; pt said he was "coming down", took a brief nap, then was fine.
Age: 31.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Blood pressure increased, Cellulitis, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Severe headache, body aches, N, stiff neck; swollen, red, hot tender vax site; increased BP (156/106). Developed cellulitis by day 3-4.
Age: 31.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Severe headache, body aches, N, stiff neck; swollen, red, hot tender vax site; increased BP (156/106). Developed cellulitis by day 3-4.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching, redness induration onset 1/24/13 (R) bicep 20 cm (R) shoulder 22.5 cm (L) bicep 17 cm (L) shoulder 19 cm erythema upper (R) arm - mostly around VARIVAX site.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient was given the MENACTRA vaccine, he then passed out about 2 minutes after getting the injection.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Upper arm red and warm, swollen. Full ROM and not complaining much.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Cyanosis, Fall, Respiratory arrest
Clinical narrative: Pt. given immunizations and did fine with mom on side. Pt. in rm. for about 10-15 min. Was at front desk & apparently slipped to ground with mom at side. I was with a pt. in back office, so R.N. went out to assist. Pt. was on ground, lips were blue states nurse & B/P was 138/110 pulse 140 at 3:05 PM. O2 100% via pulse oximeter BP 110/98. Ambulance called. Staff Dr. saw pt. immediately. Nurse states he stopped breathing, gave a couple of compressions and immediately came around. Ambulance arrived & mom wanted child to go to hospital. Taken to hospital.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abscess, Injection site pain, Injection site swelling
Clinical narrative: Patient said he noticed swelling at injection site the night he received it. He woke up the next day with pain & more swelling and felt very sick to his stomach. Took BENADRYL & ADVIL with no relief. We advised him to see a doctor - who told him an abscess had developed.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Presyncope
Clinical narrative: Vasovagal episode after immunization.
Age: 23.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient, 23 year old female, was accidentally given ZOSTAVAX instead of being given Varicella vaccine. Pt has not had any reaction that we know of.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Inappropriate schedule of drug administration, Pregnancy test negative
Clinical narrative: This spontaneous report was received from a physician concerning a 14 years old female patient. The patient was vaccinated with the first 0.5 ml dose of GARDASIL (lot not reported) on 22-OCT-2012. The patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot not reported) on 28-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient's last menstrual cycle was on September 2012 and it had not come back. Physician reported that the patient had a negative pregnancy test. She still had not had cycle. The outcome of the event was not recovered/not resolved. The relatedness for the event was unknown for GARDASIL. 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 physician refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (lot number unspecified) in June 2012. Route was not reported. On 15-JAN-2013 she would receive her 2nd dose of GARDASIL (lot number unspecified). Route was not reported. No adverse effect was reported. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 38 days old patient. The patient was vaccinated with the first dose of PEDVAXIB (Lot # not reported) on 09-JAN-2013 "too soon". No symptoms were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients of unknown age. The patients were vaccinated with 0.5 ml doses of GARDASIL (Lot # not reported) IM at 0, 2 and 6 months intervals. No other co-suspects were reported. No concomitant medications were reported. The physician reported that there had been 3 instances where patients have passed out after receiving GARDASIL. The outcome of passed out was unknown. The relatedness for passed out was unknown for GARDASIL. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Muscle soreness & pain for weeks after vaccine administration.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Musculoskeletal pain
Clinical narrative: Muscle soreness & pain for weeks after vaccine administration.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Blood test, Confusional state, Encephalopathy, Haematemesis
Clinical narrative: Mental confusion, vomiting blood, no memory, visual problems. Diagnosed with encephalopathy, then bone infection flared and had amputation of right lower leg.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Leg amputation, Nuclear magnetic resonance imaging brain, Osteomyelitis, Visual impairment
Clinical narrative: Mental confusion, vomiting blood, no memory, visual problems. Diagnosed with encephalopathy, then bone infection flared and had amputation of right lower leg.
Age: 65.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Chills, headache, sore all over, both arms very sore.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Diarrhea at 10pm.
Age: 19.0
Sex: M
Vaccine: ANTH, MMRV, TD, TYP
Symptoms: Chills, Hyperventilation, Laboratory test, Loss of consciousness, Tremor
Clinical narrative: Sarted as hyperventilating cold chills, and than Ibegan to shake and tremor, and than I lost consciousness.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on legs above calfs, on thighs, lower abdomen, chest, back, neck, ears, head, shoulders, arms above elbows.
Age: 1.48
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction occurred.
Age: 31.0
Sex: M
Vaccine: TYP
Symptoms: Gaze palsy, Loss of consciousness, Muscle twitching
Clinical narrative: 15 seconds after receiving Typhoid VI vaccine, the patient started twitching and his eyes rolled into the back of his head for several moments. He was lowered to the floor with the assistance of the patient's wife, and regained consciousness 10 seconds later. Patient was provided with a cold pack and juice, but no medications. Patient walked out of clinic under own power after regaining consciousness with wife's care. No additional injuries to patient were observed or reported.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Contusion, Tenderness
Clinical narrative: BOTH ARMPITS LOOK VERY BRUISED AND THE ARM WHERE HE GOT THE SHOT IS MORE BRUISED LOOKING THAN THE OTHER AND BOTH ARE TENDER TO THE TOUCH.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Anxiety, Fatigue, Feeling abnormal, Headache
Clinical narrative: Sudden stomach abdominal pain.  Several dr visits, specialist appointment, endoscopy done. No one could find any reason.   After 2nd vaccine 8/7/2012. Brain fog, tingling in extremities, headaches.   After 3rd vaccine 12/27/2012. All symptoms immediately worsened. Also sinus issues, more severe head pain, vision issues worsened, and anxiety and panic attacks. Also chronic fatigue from first vaccine worsening over the months.  Appointment with neurologist brain MRI all normal.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Nuclear magnetic resonance imaging brain normal, Panic attack, Paraesthesia, Sinus headache, Visual impairment
Clinical narrative: Sudden stomach abdominal pain.  Several dr visits, specialist appointment, endoscopy done. No one could find any reason.   After 2nd vaccine 8/7/2012. Brain fog, tingling in extremities, headaches.   After 3rd vaccine 12/27/2012. All symptoms immediately worsened. Also sinus issues, more severe head pain, vision issues worsened, and anxiety and panic attacks. Also chronic fatigue from first vaccine worsening over the months.  Appointment with neurologist brain MRI all normal.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling/warmth at site, developed into redness up arm and then into facial area.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever that lasted 24 hours. High temp. was 102 F. One dose of children's ibuprofen.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Headache
Clinical narrative: Persistent. Severe headache.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Lymphadenopathy, Swelling
Clinical narrative: First, extremely swollen lymph nodes in armpit. Visible swelling. Later, pain the shoulder joint for 2-4 days. Sudden onset of pain.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Fatigue, Headache
Clinical narrative: 3 seizures: 1/12 excessively tired, 1/13 woke up with 2 cuts on tongue so we suspect seizure over night, 1/13 headache in morning, seizure at about 11:00 in school followed by another seizure in emergency room at about 1:00.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Tongue injury
Clinical narrative: 3 seizures: 1/12 excessively tired, 1/13 woke up with 2 cuts on tongue so we suspect seizure over night, 1/13 headache in morning, seizure at about 11:00 in school followed by another seizure in emergency room at about 1:00.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Anaemia, Blood culture negative, Bradycardia, C-reactive protein normal, Chest X-ray normal
Clinical narrative: 9 hours after receiving routine 2 month immunizations (DTaP, Hib, rotavirus, inactivated polio) this pt became first drowsy then lethargic and pale. Pt was brought to ER were he had episodes of bradycardia with desaturations. Events continued hourly for 24 hours and lethargy slowly finished over the next 48 hours.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Culture urine negative, Full blood count normal, Haemoglobin decreased, Lethargy, Lumbar puncture normal
Clinical narrative: 9 hours after receiving routine 2 month immunizations (DTaP, Hib, rotavirus, inactivated polio) this pt became first drowsy then lethargic and pale. Pt was brought to ER were he had episodes of bradycardia with desaturations. Events continued hourly for 24 hours and lethargy slowly finished over the next 48 hours.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Oxygen saturation decreased, Pallor, Somnolence, Urine analysis normal
Clinical narrative: 9 hours after receiving routine 2 month immunizations (DTaP, Hib, rotavirus, inactivated polio) this pt became first drowsy then lethargic and pale. Pt was brought to ER were he had episodes of bradycardia with desaturations. Events continued hourly for 24 hours and lethargy slowly finished over the next 48 hours.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling hot, Vision blurred
Clinical narrative: Pt came with her parents and younger sister to receive flu shots at 7:10 pm on 1/18/13. At 7:15 pm her mom stated the pt had a reaction and was asked to call 911 first. The pt was complaining that she had blurry vision and felt hot and weak. Wet towel and ice pack were provided. No rash or edema was seen at injection site. Paramedic came in 5 minutes and checked pt's blood pressure & oxygen level. Pt refused to go to hospital. Pt went home with her parents afterward.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Pharyngeal oedema
Clinical narrative: Throat swelling later in evening. Went to ER & they treated with BENADRYL, PEPCID & prednisone.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse refers to an approximately 74-year-old male patient (the physician) with no pertinent drug reactions/allergies. Current condition included prone to asthma. On 03-JAN-2013 patient was vaccinated with dose 2, 0.5 millilitre (ml) PNEUMOVAX23 (lot#1850AA, expiration date 28-JUL2013) intramuscularly (IM). The patient was vaccinated with dose 1 PNEUMOVAX23 (lot#, expiration date and route not reported) approximately on an unknown date in 2002 (reported as more than 10 years ago). No concomitant medications were reported. On 03-JAN-2013 patient's left arm became red, swollen and hard at the injection site and appeared to be cellulitis. He had limited mobility of his left arm due to the swelling. No laboratory diagnostic tests were performed. Treatment was not rendered for the events. Patient sought medical attention for the events. The reported events did not resolve at the time of this report. This is one of the reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report was received from a registered nurse refers to 2 patients of unknown age and gender. On an unknown date in 2012 (reported as last year) the patients were vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date and route not reported). They received PNEUMOVAX23 with different lot numbers. Patients experienced redness, swelling and hard at the injection site which appeared to be a cellulitis (similar local reactions). Outcome of the reported events were unknown. This is one of the reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 03-JAN-2013 the patient was vaccinated with an expired dose of live, oral ROTATEQ (lot # 1236AA, expiration date 15-OCT-2012). No concomitant medications were reported. No adverse effect reported. No further information is available. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Incorrect route of drug administration, Oral herpes
Clinical narrative: This spontaneous report as received from a 61 year old male patient with none of concomitant medication, pertinent medical history and drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (product circular #9989115) on 14-JAN-2013. The patient was informed by the HCP that it was administered intramuscularly, not subcutaneously. He also stated that he had developed a cold sore at the corner of his mouth since the vaccine. The patient talked to the nurse. There was not lab diagnostics study performed. No treatment was given for the AE. The outcome of cold sore at the corner of his mouth was not recovered/not resolved. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Injection site erythema, Injection site mass, Mobility decreased, Nausea
Clinical narrative: Nausea, dizziness, arm pain & pins & needles.  Cannot lift arm.  Red, egg-shaped lump around injection site.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Nausea, dizziness, arm pain & pins & needles.  Cannot lift arm.  Red, egg-shaped lump around injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: The shingles vaccine injection site was firm and felt like a penny-sized lump. The arm was red, swollen, itchy, and very warm to the touch. I called the doctor's office on 1/20/13 and the nurse said to take Benadryl and Tylenol; if not better, make appt. for 1/20/13. I saw physician on 1/20 and she prescribed cephalexin 500 mg. She advised I make additional appt. for 1/22 or 1/23. I saw Dr. U (same office) on 1/23. My arm was still red and itchy, but no longer warm or swollen. Dr. told me to discontinue cephalexin prescription. Dr. could not find any reason for my adverse reaction.
Age: 21.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Full blood count normal, Laboratory test normal, Liver function test normal, Oral mucosal exfoliation, Rash
Clinical narrative: Rash appeared about 1.5 hr following vaccine administration. Pt received Benadryl by aid station, given Epipen to take home with him. 3 days after vaccination, presented to the ED with sloughing of oral mucosa and ulceration on tongue. Admitted for evaluation for possible Stevens-Johnson Syndrome, not found. Pt was discharged in stable condition after 1 day.
Age: 21.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Tongue ulceration
Clinical narrative: Rash appeared about 1.5 hr following vaccine administration. Pt received Benadryl by aid station, given Epipen to take home with him. 3 days after vaccination, presented to the ED with sloughing of oral mucosa and ulceration on tongue. Admitted for evaluation for possible Stevens-Johnson Syndrome, not found. Pt was discharged in stable condition after 1 day.
Age: 21.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Glossodynia, Rash, Tongue ulceration
Clinical narrative: Rash appeared about 1.5 hr following vaccine administration. Pt received Benadryl by aid station, given Epipen to take home with him. 3 days after vaccination, presented to the ED with sloughing of oral mucosa and ulceration on tongue. Admitted for evaluation for possible Stevens-Johnson Syndrome, not found. Pt was discharged in stable condition after 1 day.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Extreme arm pain....ongoing for four weeks following the injection.  Treated with steroids and alleviated for one week.  Upon completion of the steroids, the arm pain in the injected arm returned.
Age: 1.11
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Bumps under his arm and belly with a fever.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Oedema peripheral, Oropharyngeal pain, Pain, Swelling
Clinical narrative: Pt c/o of swelling and pain of 7/10. Upper body aches, sore throat, and swollen hands and feet. Denies fever, breathing problems, and itching.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: 01/23 arm pain became unbearable, large bruise formed at injection site. 01/24 woke up feeling out of sorts with a nasty headache, arm pain was severe, redness around site size of half cup measure and site was hot to the touch, by afternoon a low grade fever (99.4) began; fever went to 101.1 on 01/24, felt chills alternating with sweating, severe joint pain, restless sleep. 01/25 woke up in a sweat, same symptoms as the day before, site was hot, red and very sensitive to the touch; fever, spiked to 102.2, chills, sweating, severe joint pain, nasty headache, fever broke around 2:00 PM, joint pain and chills eased. Site was red and hot and very sensitive to the touch from shoulder halfway to elbow. 01/26 site still red, hot and very sensitive to the touch; called pharmacist and began taking Zyrtec in afternoon, site somewhat less sensitive and a bit less red by bedtime. 01/27 site about 50% less sensitive than original pain, but still sensitive. Redness and heat has subsided to now being from shoulder to about 4" below shoulder - covering entire front of right arm. 01/28 will call my primary care physician. Note: Shot was recommended by my pulmonologist.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: 01/23 arm pain became unbearable, large bruise formed at injection site. 01/24 woke up feeling out of sorts with a nasty headache, arm pain was severe, redness around site size of half cup measure and site was hot to the touch, by afternoon a low grade fever (99.4) began; fever went to 101.1 on 01/24, felt chills alternating with sweating, severe joint pain, restless sleep. 01/25 woke up in a sweat, same symptoms as the day before, site was hot, red and very sensitive to the touch; fever, spiked to 102.2, chills, sweating, severe joint pain, nasty headache, fever broke around 2:00 PM, joint pain and chills eased. Site was red and hot and very sensitive to the touch from shoulder halfway to elbow. 01/26 site still red, hot and very sensitive to the touch; called pharmacist and began taking Zyrtec in afternoon, site somewhat less sensitive and a bit less red by bedtime. 01/27 site about 50% less sensitive than original pain, but still sensitive. Redness and heat has subsided to now being from shoulder to about 4" below shoulder - covering entire front of right arm. 01/28 will call my primary care physician. Note: Shot was recommended by my pulmonologist.