chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting, White blood cell count decreased
Clinical narrative: This case involves a fatal event and was considered medically important for the events of vomiting and fever.  Additional information was received that provided patient demographics, medical history, additional lot numbers, event details leading to a change in the verbatim for the code of bacterial culture positive, the additional code of streptococcal meningitis and additional laboratory results.  Information regarding PREVNAR 13 was received from a healthcare professional regarding a 5-month-old male patient who experienced a positive bacterial culture, fever and vomiting, streptococcal meningitis and died due to an overwhelming sepsis from Group A Streptococcus pyogenes.  The patient received the first dose on 26-Apr-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and a second dose of ROTATEQ (Merck).  On 18-May-2010 the patient experienced fever and vomiting and was evaluated in the emergency room.  On 18-May-2010, a blood culture (initially reported as "a very early culture) was performed that revealed gram positive cocci in pairs and chains possibly of Streptococcal pneumoniae origin (bacterial test positive), later however the blood culture confirmed the pathogen as Group A Streptococcus pyogenes.  On the same day, a CSF culture was positive for Streptococcus pyogenes Group A.  On 19-May-2010 the patient died due overwhelming sepsis from Group A Streptococcus pyogenes.  The cause of death was reported as streptococcal sepsis.  An autopsy was not performed.  No additional information was available at the time of this report.  Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information.  As a consequence of the migration, the follow-up report may indicate in the appropriate field that it is an initial report.  Follow-up (23FEB2011): New information received from the healthcare professional as part of VAERS annual follow-up, indicated the patient died on 21MAY2010, (originally reported as 19May2010) and updated the causes of death as sepsis and meningitis due to streptococcus pyogenes Group A. (previously, meningitis was not considered a cause of death).  Follow-up attempts completed.  No further information is expected.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 56.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Joint range of motion decreased, Swelling
Clinical narrative: Within 2 hours redness & swelling, reaching a 4 inch wide band around total circumference of arm 24 hours later. Incredible pain lasting 3 days. Range of motion limited, difficult to lift arm. Area of injection hard to touch.
Age: 56.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site induration, Joint range of motion decreased, Mobility decreased, Pain
Clinical narrative: Within 2 hours redness & swelling, reaching a 4 inch wide band around total circumference of arm 24 hours later. Incredible pain lasting 3 days. Range of motion limited, difficult to lift arm. Area of injection hard to touch.
Age: 56.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: Within 2 hours redness & swelling, reaching a 4 inch wide band around total circumference of arm 24 hours later. Incredible pain lasting 3 days. Range of motion limited, difficult to lift arm. Area of injection hard to touch.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her 36 month old child who on an unspecified date was vaccinated with 0.5 ml MMR II (lot # not reported).  On an unspecified date the patient experienced autism.  It was unspecified if the patient sought medical attention.  At the time of reporting, the patient's outcome was unknown.  Upon internal review, autism was considered to be another important medical event.  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Feeling hot, Monoplegia, Movement disorder, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 66 year old male with Barrett's disease, hypercholesterolemia, diet controlled type 2 diabetes mellitus and drug allergy to PERCOCET and PERCODAN who on 10-JAN-2011 was vaccinated intramuscularly with his second dose of 0.5 ml PNEUMOVAX 23 (lot # 665925/0932Z) on left arm. Concomitant therapy included LIPITOR, PRILOSEC, KADIAN and aspirin. On 11-JAN-2011 the patient woke up "in the middle of the night" with severe pain in his left arm, the patient reported to the physician that he also felt like all of his joints "were on fire" and that he felt warm all over. He couldn't get up, and had great difficulty moving at that same time. This lasted about 5-6 minutes. In the morning of 11-JAN-2011 the patient was experiencing aching in his left arm, but was feeling better than he did last night. The physician reported that this patient had previously had a dose of PNEUMOVAX 23 (dose, indication, lot # not reported) some time in 1993. The TYLENOL was given as a treatment for adverse events. There was no laboratory diagnostic study performed. The patient sought a medical attention by a phone call. At the time of reporting, the patient was recovering. Follow-up information was received from the physician concerning a 66 year old white male patient with type 2 diabetes mellitus, peripheral vascular disorder and increased lipids who on 3:00 pm 10-JAN-2011 was vaccinated intramuscularly with his second dose of 0.5 ml PNEUMOVAX 23 (lot # 665925/0932Z) on deltoid in left arm. On 11-JAN-2011 the patient experienced pain in his left arm, injection site was ok and no pain, both legs and arms paralyzed for 5-6 minutes, then joints felt like they were on fire. Upon internal review, both legs and arms paralyzed for 5-6 minutes was determined to be an other important medical event. The patient recovered on 11-JAN-2011. No further information is available.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Rigors; fever to 104; Swelling at the Tdap vaccine site on R arm with redness, pain and warmth.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Vaccination site warmth
Clinical narrative: Rigors; fever to 104; Swelling at the Tdap vaccine site on R arm with redness, pain and warmth.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Bed rest, Erythema, Headache, Oedema peripheral, Pain
Clinical narrative: Information has been received from a 61 year old male registered pharmacist who in October 2009, was vaccinated with the first and only  0.5ml dose of PNEUMOVAX 23 (lot number not provided). The patient reported that as far as he got the PNEUMOVAX 23, he had a headache and felt achy for 3 days. He also experienced a high fever and his whole arm was red and swollen, for 3 days as well. The patient did not seek medical attention. It was unspecified if he got any treatment for the adverse event. No lab diagnostics studies were performed. The patient reported he recovered as of 3 days after got the vaccine. The registered pharmacist considered it was a significant disability due to the fact that he was on bed rest for 3 days as a result of his symptoms. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a 61 year old male registered pharmacist who in October 2009, was vaccinated with the first and only  0.5ml dose of PNEUMOVAX 23 (lot number not provided). The patient reported that as far as he got the PNEUMOVAX 23, he had a headache and felt achy for 3 days. He also experienced a high fever and his whole arm was red and swollen, for 3 days as well. The patient did not seek medical attention. It was unspecified if he got any treatment for the adverse event. No lab diagnostics studies were performed. The patient reported he recovered as of 3 days after got the vaccine. The registered pharmacist considered it was a significant disability due to the fact that he was on bed rest for 3 days as a result of his symptoms. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Oedema peripheral, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Information has been received from a certified medical assistant concerning a 70 year old female patient with hypertension, hyperlipidemia and pre-existing heart conditions and no drug reactions or allergies who on 21-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 666639/0564Z, expire date 09-OCT-2011), 0.5 ml, intramuscularly. There was no concomitant medication. Certified medical assistant stated that after the patient was administered PNEUMOVAX 23 on 21-FEB-2011, the patient's right arm became swollen and hot to the touch. The patient complained of pain radiating to her right hand and stated that it was also itchy. The patient also complained of chest pain which certified medical assistant reporting stated that the chest pain was completely unrelated to this event. The nurse practitioner provided the patient with antihistamines of unknown origin. There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Right arm became swollen, hot to the touch, pain radiating to her right hand, itchy and chest pain were considered to be disabling "for a few days" by the certified medical assistant. This is one of two reports received from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a physician concerning a 29 year old female, for the Pregnancy Registry for GARDASIL, who on approximately 03-NOV-2009, "between week 4 and 5 of the patient's pregnancy", was vaccinated with a dose of GARDASIL (Lot No. not reported). It was reported that on 15-JUL-2010, 40 weeks from LMP, the patient delivered a female baby with 7 pounds and 1 ounces of weight, apgar score 8/9. Additional information has been received from the patient. She stated that her baby was doing well, but the pediatrician was following the baby's hemangioma on her neck (from birth), and an MRI of the fontanel was scheduled for next week. The mother's experience was captured in WAES# 0912USA01998. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Apgar score normal, Drug exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 29 year old female, for the Pregnancy Registry for GARDASIL, who on approximately 03-NOV-2009, "between week 4 and 5 of the patient's pregnancy", was vaccinated with a dose of GARDASIL (Lot No. not reported). It was reported that on 15-JUL-2010, 40 weeks from LMP, the patient delivered a female baby with 7 pounds and 1 ounces of weight, apgar score 8/9. Additional information has been received from the patient. She stated that her baby was doing well, but the pediatrician was following the baby's hemangioma on her neck (from birth), and an MRI of the fontanel was scheduled for next week. The mother's experience was captured in WAES# 0912USA01998. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Electroconvulsive therapy, Guillain-Barre syndrome, Lumbar puncture normal
Clinical narrative: Guillain Barre Syndrome. 15 days hospital. Recovery incomplete.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve conduction studies normal, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Guillain Barre Syndrome. 15 days hospital. Recovery incomplete.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Loss of consciousness, Simple partial seizures, Staring, Unresponsive to stimuli
Clinical narrative: Pt would be engaged in play or conversation and would spontaneously "phase out" with a vacant, still stare off into space. He was unresponsive to his name for first 2-3 call outs lasting - 1/2-3/4-1 min in duration. He had never had this behavior before and continued for about 2 mos. When he would "come back" he had no awareness of "phasing out". Seemed like a seizure. Sevl practitioners have indic that it seems like Jacksonian seizures.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Convulsion, Staring, Unresponsive to stimuli
Clinical narrative: Pt would be engaged in play or conversation and would spontaneously "phase out" with a vacant, still stare off into space. He was unresponsive to his name for first 2-3 call outs lasting - 1/2-3/4-1 min in duration. He had never had this behavior before and continued for about 2 mos. When he would "come back" he had no awareness of "phasing out". Seemed like a seizure. Sevl practitioners have indic that it seems like Jacksonian seizures.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: States 2/9/11 noticed redness with small amt. swelling states size of 50 cents piece with some tenderness. States applied cold compress to site right arm. 2/10/11 states noticed more swelling and redness had increased to fist size but no tenderness, states applied cold compress at 11:00am. At 11:00pm states redness had made a circle around Rt arm. Took TYLENOL in am. 2-11-11 on exam at HD there is extensive redness and induration with edema at injection site and warm to touch no tenderness BP 110/70 P 72 R-20 Temp 98.4 degrees - referred to MD. 2-16-11 client never called health dept. to say if went to see MD. Contacted client's mother who stated client had gone to see Dr. and received a cortisone shot. When Dr. office was contacted to verify visit, MD's office stated client had not been seen by them since 6-2010.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Hot/red 7 x 7 cm patch on upper (L) thigh - not tender, no treatment needed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Approximately 36 hrs after injection pt. took off bandaid and noted red, sore area at site of injection. Presented to our clinic where shot was given on day 2 - area appears red, rough 45 mm circular diameter. Spoke to pt by phone 2-25 - no change in red area or size, slight itching, slight headache. No treatment to area.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: As soon as the needle was put in I felt pain. He had to push very hard to get it to go in. The first few days the arm was sore then it started to get where daily I had pain. It will wake me at night. The are things I can't do without sharp pain. The doctor said it could take 6 months to go away. I'm in the 6th month and its not going away.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Pain, Pain of skin
Clinical narrative: Pt developed painful rash in left lower abdomen. Wrapping around to lower back w/ throbbing pain. Burning. Numbness - treated with VALTREX x 500mg & NEURONTIN 250mg.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. seen on 2/10/11 and 2/28/11 and received vaccines both times.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: My upper left arm started to hurt almost immediately after the shot. About 1 1/2-2 hrs after I literally couldn't move my arm without severe pain. I had to use a sling the rest of the day & even at night. I couldn't sleep on it.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Patient received her vaccination on 2/2/11 said shortly thereafter in the car shoulder started to hurt - called me 2 days later say still sore & hard to move - documented when called again about 13 days later said she should contact Dr. again - gave cortisone inj.
Age: 14.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: On 2-21-11 AM. VARIVAX #2 administered (L) arm SQ and Hepatitis A #2 in (L) deltoid. At VARIVAX site area of red, painful lump noticed at noon on 2-22-11. Evening of 2-22-11 increased redness around lump. On 2-23-11, size of lump decreased, and size of surrounding redness increased. Positive itching.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Chicken pox illness (varicella infection) with fever, headache and rash with at least 100 lesions
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Aphonia, Cough, Dizziness, Dizziness postural, Dysphonia
Clinical narrative: Began Saturday, 2/26/2011. Woke up nauseous with funny feeling in head and not feeling good. Then she thought she might be hungry or cold. She ate and put on her robe but the illness got worse. Felt hot and cold, achy, tired. Feeling more lightheaded. Got worse with laying down the rest of the day.  On Sunday, coughing very bad and through up from that. Started having dizziness on standing up. Still had really bad body aches, hot and cold. Constant headache. Noticed right ear hurt a little on and off. Lost her voice that day.   As of 2/28/2011, had blurred vision in addition. Slept all day. Ear pain continued.    On 3/1/2011, voice worse, hoarse, still having hot and cold feelings, scratchy irritated throat.  Photophobic and sensitive to motion.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Ear pain, Fatigue, Feeling abnormal, Feeling of body temperature change, Headache
Clinical narrative: Began Saturday, 2/26/2011. Woke up nauseous with funny feeling in head and not feeling good. Then she thought she might be hungry or cold. She ate and put on her robe but the illness got worse. Felt hot and cold, achy, tired. Feeling more lightheaded. Got worse with laying down the rest of the day.  On Sunday, coughing very bad and through up from that. Started having dizziness on standing up. Still had really bad body aches, hot and cold. Constant headache. Noticed right ear hurt a little on and off. Lost her voice that day.   As of 2/28/2011, had blurred vision in addition. Slept all day. Ear pain continued.    On 3/1/2011, voice worse, hoarse, still having hot and cold feelings, scratchy irritated throat.  Photophobic and sensitive to motion.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersomnia, Influenza A virus test positive, Nausea, Pain, Photophobia
Clinical narrative: Began Saturday, 2/26/2011. Woke up nauseous with funny feeling in head and not feeling good. Then she thought she might be hungry or cold. She ate and put on her robe but the illness got worse. Felt hot and cold, achy, tired. Feeling more lightheaded. Got worse with laying down the rest of the day.  On Sunday, coughing very bad and through up from that. Started having dizziness on standing up. Still had really bad body aches, hot and cold. Constant headache. Noticed right ear hurt a little on and off. Lost her voice that day.   As of 2/28/2011, had blurred vision in addition. Slept all day. Ear pain continued.    On 3/1/2011, voice worse, hoarse, still having hot and cold feelings, scratchy irritated throat.  Photophobic and sensitive to motion.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Polymerase chain reaction, Throat irritation, Vertigo, Vision blurred, Vomiting
Clinical narrative: Began Saturday, 2/26/2011. Woke up nauseous with funny feeling in head and not feeling good. Then she thought she might be hungry or cold. She ate and put on her robe but the illness got worse. Felt hot and cold, achy, tired. Feeling more lightheaded. Got worse with laying down the rest of the day.  On Sunday, coughing very bad and through up from that. Started having dizziness on standing up. Still had really bad body aches, hot and cold. Constant headache. Noticed right ear hurt a little on and off. Lost her voice that day.   As of 2/28/2011, had blurred vision in addition. Slept all day. Ear pain continued.    On 3/1/2011, voice worse, hoarse, still having hot and cold feelings, scratchy irritated throat.  Photophobic and sensitive to motion.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Bipolar I disorder, Depression, Dizziness, Fatigue
Clinical narrative: I received a series of 3 anthrax vaccinations at unknown dates during this time period.  On the first and third administrations, I briefly lost consciousness within 5 minutes of receiving the vaccine.  I also felt nauseous for the rest of the day and weak for about two days.  On the second administration, I remained reclined after receiving the vaccination and did not pass out.  However, I did feel nauseous the remainder of the day and weak for about two days.  During the time after receiving the vaccines, I felt generally weaker and had unexplained pains and dizziness.  My physical fitness test scores dropped markedly even though I was doing the same amount of exercise and conditioning.  Over the course of the last decade, I have sought treatment for chronic fatigue on several occasions.  All lab tests, such as thyroid tests, came out normal.  Within a few months receiving the vaccine, I suffered a hypomanic episode followed a few months later my a moderate depressive episode.  These episodes intensified and became more frequent in the next ten years.  Eventually I had a full manic episode with psychotic features, and was diagnosed with Bipolar I disorder.  I have been treated with individual psychotherapy, bupropion, Abilify, Seroquel, divalproex, Prozac, Lexapro, Celexa and Zoloft.  None of my relatives has been diagnosed with or shown symptoms of bipolar disorder, and I did not suffer any mood events or psychological problems prior to receiving the vaccine.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Hypomania, Laboratory test normal, Loss of consciousness, Mania, Nausea
Clinical narrative: I received a series of 3 anthrax vaccinations at unknown dates during this time period.  On the first and third administrations, I briefly lost consciousness within 5 minutes of receiving the vaccine.  I also felt nauseous for the rest of the day and weak for about two days.  On the second administration, I remained reclined after receiving the vaccination and did not pass out.  However, I did feel nauseous the remainder of the day and weak for about two days.  During the time after receiving the vaccines, I felt generally weaker and had unexplained pains and dizziness.  My physical fitness test scores dropped markedly even though I was doing the same amount of exercise and conditioning.  Over the course of the last decade, I have sought treatment for chronic fatigue on several occasions.  All lab tests, such as thyroid tests, came out normal.  Within a few months receiving the vaccine, I suffered a hypomanic episode followed a few months later my a moderate depressive episode.  These episodes intensified and became more frequent in the next ten years.  Eventually I had a full manic episode with psychotic features, and was diagnosed with Bipolar I disorder.  I have been treated with individual psychotherapy, bupropion, Abilify, Seroquel, divalproex, Prozac, Lexapro, Celexa and Zoloft.  None of my relatives has been diagnosed with or shown symptoms of bipolar disorder, and I did not suffer any mood events or psychological problems prior to receiving the vaccine.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Thyroid function test normal
Clinical narrative: I received a series of 3 anthrax vaccinations at unknown dates during this time period.  On the first and third administrations, I briefly lost consciousness within 5 minutes of receiving the vaccine.  I also felt nauseous for the rest of the day and weak for about two days.  On the second administration, I remained reclined after receiving the vaccination and did not pass out.  However, I did feel nauseous the remainder of the day and weak for about two days.  During the time after receiving the vaccines, I felt generally weaker and had unexplained pains and dizziness.  My physical fitness test scores dropped markedly even though I was doing the same amount of exercise and conditioning.  Over the course of the last decade, I have sought treatment for chronic fatigue on several occasions.  All lab tests, such as thyroid tests, came out normal.  Within a few months receiving the vaccine, I suffered a hypomanic episode followed a few months later my a moderate depressive episode.  These episodes intensified and became more frequent in the next ten years.  Eventually I had a full manic episode with psychotic features, and was diagnosed with Bipolar I disorder.  I have been treated with individual psychotherapy, bupropion, Abilify, Seroquel, divalproex, Prozac, Lexapro, Celexa and Zoloft.  None of my relatives has been diagnosed with or shown symptoms of bipolar disorder, and I did not suffer any mood events or psychological problems prior to receiving the vaccine.
Age: 0.73
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site dryness, Injection site erythema, Injection site induration, Injection site reaction, Injection site ulcer
Clinical narrative: Per client- redness, dry skin sore, hard as a knot developed at injection site 12/30.2010.   3/1/2011  purulent drainage came from injection site.  Client has and is under the care of a licensed independent practioner, this has required multiple visits from primary care provider, and is a financial burden.
Age: 0.73
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Laboratory test, Purulent discharge
Clinical narrative: Per client- redness, dry skin sore, hard as a knot developed at injection site 12/30.2010.   3/1/2011  purulent drainage came from injection site.  Client has and is under the care of a licensed independent practioner, this has required multiple visits from primary care provider, and is a financial burden.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Headache, Nausea, Pain
Clinical narrative: Achy, nauseous, headache, hoarseness a few hours after vaccine.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Activities of daily living impaired, Dizziness, Guillain-Barre syndrome, Loss of control of legs, Paraesthesia
Clinical narrative: tingling in toes, and legs... slight dizziness at times  heaviness and later the next week feeling as if his brain cannot tell his legs what to do.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Sensation of heaviness
Clinical narrative: tingling in toes, and legs... slight dizziness at times  heaviness and later the next week feeling as if his brain cannot tell his legs what to do.
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Facial paresis, VIIth nerve paralysis
Clinical narrative: Received vaccines on 12/20/10. Day after noticed left side of face at eyebrow and mouth droopy - noted in mirror smile asymmetrical. Did not see M.D. The weakness on left side of face resolved in 3 days.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Haematochezia, Haemorrhage
Clinical narrative: Mom called 3/2/11, small streaks of blood in diaper 3 separate episodes during same day. No other apparent symptoms/distress, febrile. Mom monitoring 3/2-3/3/11. Spoke to mother, follow-up 3-3-11. She saw a miniscule amount of blood in stool otherwise fine mom will monitor/call if sees any symptoms.
Age: 0.47
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Screaming, Sleep disorder
Clinical narrative: After 4mon & 6mon. sets of shots he developed constant waking & screaming every hour. Lasting for about 2 months.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever 104 started around 12 pm.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Blood pressure orthostatic, Dizziness
Clinical narrative: Patient felt dizzy after HPV injection, symptoms lasted about 30 minutes.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Nasopharyngitis, Nausea, Pain, Urticaria
Clinical narrative: Client awoke with hives.  Client had been having cold symptoms since 02/25/2011 including nausea and aches.  She had started taking Tylenol, chor-tabs and Mucinex.  She also took Advil on 02/27/2011 PM.  Hives were disappearing by time of report/telephone conversation in the afternoon.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PPV
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Pain in extremity, Weight bearing difficulty
Clinical narrative: Shots given in right lateral thigh.  Pt had severe pain and swelling in right leg within 1.5 hours of receiving vaccine.  Over next 24 hrs, swelling resolved.  Pt seen for f/u at about 24hrs and still had significant pain in BOTH upper thighs and hips with refusal to bear weight.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Paralysis
Clinical narrative: paralysis of lower extremities witnessed by mother and unresponsive lasted about 4 minutes total. mother took him to emergency room, but by the time she arrived he was well and back to normal self. active and playful
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Urticaria all over entire body daily. tx with Zyrtec daily. However when tapering off Zyrtec x7 days, urticaria remains.
Age: 1.07
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella
Clinical narrative: On 02-25-2011 pt broke out with chickenpox rash.
Sex: U
Vaccine: IPV, MMR
Symptoms: Rash
Clinical narrative: Rash.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Woke up the following day with red ring around injection site.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diet refusal, Emotional distress, Insomnia, Irritability, Pyrexia
Clinical narrative: High fever 103 for 2 days, irritable for 4 days, difficult to console, he refused his bottle, sleep max 1-2 hours at one time for 4 days.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local injection site reaction no systemic symptoms. Tx w/ antihistamine & NSAID.
Age: 0.85
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Screaming
Clinical narrative: Pt screamed uncontrollably for many hrs on day shots were given.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Erythema, Skin exfoliation, Swelling face
Clinical narrative: Low grade temp.; face swollen and red; face peeling.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Computerised tomogram head, Computerised tomogram normal, Convulsion
Clinical narrative: Generalized seizure within 24 hrs.
Age: 16.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: (R) upper arm w/ warm, erythematous area about 4 cm diam, mild induration.
Age: 31.0
Sex: F
Vaccine: MEN
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: Patient started breaking out with it with redness and swelling. Received meningitis injection. No systemic symptoms. ER sheets attached.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthropod bite, Erythema, Induration, Injection site pain, Pruritus
Clinical narrative: "On 2-28-11 at 4p-noticed mosquito like bite to arm that got bigger & bigger, was itchy & bright red". Nurse observed a scarcely noted 15mm induration with redness extending to 31mm, mildly warm area. Pt. c/o tenderness to site.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm
Clinical narrative: "On 2-28-11 at 4p-noticed mosquito like bite to arm that got bigger & bigger, was itchy & bright red". Nurse observed a scarcely noted 15mm induration with redness extending to 31mm, mildly warm area. Pt. c/o tenderness to site.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Mechanical urticaria, Nodule, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Primary Care Physician contacts Call Center on 06DEC10 re 34 y/o male patient with an onset of itchy red welts, appearing initially on patient's upper arms 1-2 months after the SM's receipt of Anthrax #4 (25APR07) and AVA # 5 (14MAY07). SM also received his 2nd Smallpox Vaccine on 26APR07 and Typhoid ViCPS on 20JUN07. SM continued to have recurrent, intermittent bouts of "red bumps" not associated with any known food or environmental trigger and no h/o atopy. Pt was dx'd with "chronic papular urticaria" (20JUL09) by Dermatologist. Pt. also exhibited marked dermatographism one exam. The Dermatologist, felt the etiology was consistent with "a hypersensitivity to some kind of trigger, difficult to pinpoint". Rx'd with TEMOVATE 0.05% topical TEMOVATE cream BID and po Loratadine, which was changed to daily ZYRTEC 10mg po qd at subsequent visit. Patient continued with chronic bouts of "itchy red bumps" on upper arms, spreading to thighs, back and buttocks and lasting minutes to hours. SM received AVA # 6 on 12NOV10 in preparation for upcoming 2011 deployment abroad and expressed concern for his recurrent itchy red bumps to his PCP, who referred the SM for a second opinion to a Civilian Allergist in Nov of 2010. When the SM saw the Allergist, the red bumps were not present, but he showed the Allergist photos he had taken. The Allergist felt the photos of the bumps did not appear allergic in nature, but like nodules and suggested they may be related to receipt of the Anthrax and Smallpox vaccines. The patient's second SPV was 26APR07 and AVA # 6 & Typhoid ViCPS were on 12NOV10. The patient has had ongoing, intermittent bouts of the red itchy bumps since MAY/JUN 2007. They are a "nuisance" but do not affect his ability to perform his work or cause any sx of anaphylaxis- no breathing or swallowing difficulties, no facial or periorbital edema. No shellfish, Latex allergies.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria papular
Clinical narrative: Primary Care Physician contacts Call Center on 06DEC10 re 34 y/o male patient with an onset of itchy red welts, appearing initially on patient's upper arms 1-2 months after the SM's receipt of Anthrax #4 (25APR07) and AVA # 5 (14MAY07). SM also received his 2nd Smallpox Vaccine on 26APR07 and Typhoid ViCPS on 20JUN07. SM continued to have recurrent, intermittent bouts of "red bumps" not associated with any known food or environmental trigger and no h/o atopy. Pt was dx'd with "chronic papular urticaria" (20JUL09) by Dermatologist. Pt. also exhibited marked dermatographism one exam. The Dermatologist, felt the etiology was consistent with "a hypersensitivity to some kind of trigger, difficult to pinpoint". Rx'd with TEMOVATE 0.05% topical TEMOVATE cream BID and po Loratadine, which was changed to daily ZYRTEC 10mg po qd at subsequent visit. Patient continued with chronic bouts of "itchy red bumps" on upper arms, spreading to thighs, back and buttocks and lasting minutes to hours. SM received AVA # 6 on 12NOV10 in preparation for upcoming 2011 deployment abroad and expressed concern for his recurrent itchy red bumps to his PCP, who referred the SM for a second opinion to a Civilian Allergist in Nov of 2010. When the SM saw the Allergist, the red bumps were not present, but he showed the Allergist photos he had taken. The Allergist felt the photos of the bumps did not appear allergic in nature, but like nodules and suggested they may be related to receipt of the Anthrax and Smallpox vaccines. The patient's second SPV was 26APR07 and AVA # 6 & Typhoid ViCPS were on 12NOV10. The patient has had ongoing, intermittent bouts of the red itchy bumps since MAY/JUN 2007. They are a "nuisance" but do not affect his ability to perform his work or cause any sx of anaphylaxis- no breathing or swallowing difficulties, no facial or periorbital edema. No shellfish, Latex allergies.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm reddened area where received PREVNAR 13 vacc. 3cm in diameter, mildly warm, non-tender, not supprative in thigh surrounding injection site. No fever; no signs of infection; rec. cool compresses/MOTRIN.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site extravasation, Scratch
Clinical narrative: Child frightened, screaming. Mother holding child as directed. Attempted to comfort child & advised to be as still as possible. As paramedic administered KINRIX (L) arm child jerked causing some vaccine to be lost & also a small (1/4) superficial scratch on arm. Explained to mother both IPV & DTAP were 4th & 5th respectively vaccines received by child & no action needed other than to monitor site. Mother indicated understanding.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site abscess
Clinical narrative: Abscess at the injection site developed about 4-5 days after injection.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: Right thigh became inflamed 6cm x 7cm area. Noted around 11:30. BENADRYL & TYLENOL given at 11:45AM, warm compresses at 11:50AM vital signs stable. 12:15pm - decreased in size 4cm x 6cm. 2/25/11 called patient - no answer 2/28 - patient reports no redness or swelling.
Age: 2.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Injection site pain, Weight bearing difficulty
Clinical narrative: Pain Rt leg, will not weight bear x 1d.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: 11:30 am none stated.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperaesthesia, Injection site mass, Pain, Pain in extremity
Clinical narrative: Patient was vaccinated on 2-4-11 on 3-3-11 AM - patient complain soreness on left arm and discomfort when moving arm. Also sensitive when putting shirt with sleeve on. She has some soreness & aching for a few days after vaccination but it is more severe now. There is a lump at injection site.
Age: 1.06
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Differential white blood cell count normal, Full blood count normal, Platelet count normal, Pyrexia
Clinical narrative: This 13-month old female was given her 12 months vaccines on 2/19/11. She developed a fever on Sunday 2/20/11, of 103 degrees. She was taken to ER for persistent fever of 101 degrees.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Arthralgia, Balance disorder, Mydriasis, Nausea
Clinical narrative: Initial report was received from a health care professional on 11 February 2011. A 14 year-old female with allergies to penicillin and CECLOR had received an intramuscular right deltoid injection of MENACTRA, lot number U3098AA in the AM on 09 February 2011 and that PM, experienced generalized body aches and pains, stomach pain, nausea, joint pain, dilated eyes and was reported to be off balance. The patient was evaluated by her primary care physician. Treatments were not reported. The patient did not have any concomitant medications. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Pain
Clinical narrative: Initial report was received from a health care professional on 11 February 2011. A 14 year-old female with allergies to penicillin and CECLOR had received an intramuscular right deltoid injection of MENACTRA, lot number U3098AA in the AM on 09 February 2011 and that PM, experienced generalized body aches and pains, stomach pain, nausea, joint pain, dilated eyes and was reported to be off balance. The patient was evaluated by her primary care physician. Treatments were not reported. The patient did not have any concomitant medications. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU3, HEPA, MNQ
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial report received from a health care professional on 15 February 2011. A 21-year-old male patient on 10 February 2011 at 4:30 PM received a right arm subcutaneous injection (dose 1) of MENACTRA, lot number U3473AA, a left arm intramuscular injection of HAVRIX, GSK lot number AHAVB443AB, and a right arm influenza vaccine lot number 111796P1. The patient had no medical history and had an allergy to sulfa drugs. The patient took no concomitant medications, had no illness at the time of vaccination and no other vaccinations within 4 weeks. On 12 February 2011 at 12:00 PM he experienced symptoms of a 4 inch area of redness, warmth and soreness at the injection site with body aches and headache. He required a doctor visit and the patient was treated with BENADRYL. The outcome was reported as unknown. Documents held by sender: None.
Age: 53.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Myalgia, Palpitations, Pyrexia, Urticaria
Clinical narrative: Initial report received from a health care professional on 15 February 2011. A 53-year-old male patient with a history of melanoma received on 09 February 2011 at 09:05 AM an intramuscular left deltoid injection of MENACTRA, lot number U2754AA. The patient's concomitant medication was ezetimibe and VYTORIN 1/2 pill daily (OD). The patient had no other vaccinations within 4 weeks of the MENACTRA. On 10 February 2011, the patient developed a headache which lasted for 12 hours, fever which lasted for 3 days, racing heart rate which lasted for 6-8 hours and muscle aches which lasted for 3 days. On 11 February 2011, the patient developed nausea which lasted for one day and hives which lasted for 2 days. The patient was treated with ibuprofen and a 24 hour pain reliever. The patient received no prescriptions. The outcome was reported as recovered. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Allergy test positive, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a pediatric female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (unknown). An unspecified time after vaccination with HAVRIX, the subject experienced hives after she left the pediatrician's office. The subject was in first grade. At the time of reporting the outcome of the event was unspecified. There was no additional information at the time of reporting. Follow-up received from the healthcare professional on 31 August 2010: The subject received a skin allergy test at the reporters office and the results were positive. Follow-up received from a physician on 05 October 2010: The subject was 5-years-old. Concurrent medical conditions included eczema, allergic rhinitis, allergy to soy and allergy to peanuts. Concurrent medications included TOPICORT GEL. Previous and/or concurrent vaccinations included (non-GSK) FLUZONE given on 30 December. On 31 December 2008, the subject received 1st dose of HAVRIX (0.5 ml, intramuscular, right thigh). On 31 December 2008, 1 hour and 45 minutes after vaccination with HAVRIX, the subject experienced urticaria and hives. The diagnosis was reported as urticaria. The physician considered the events were clinically significant (or requiring intervention). The events resolved on 01 January 2009. The vaccination series with HAVRIX was discontinued.
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Balance disorder, Bladder catheterisation, Cerebral ventricle dilatation, Computerised tomogram abnormal, Computerised tomogram head
Clinical narrative: Client called 2/16/11 inquiring about possibility Hep B vaccine caused his "transverse myelitis" he experienced in fall. He admits began in Sept. loss of balance, progressed to loss of bowel and bladder control. Paraplegic hospitalized 10/13/10. Home 12-16-10. Remains in physical therapy. Continues to need self cath, bowel assistance, admits walking is "coming back, using walker.
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Cytomegalovirus test negative, Encephalitis, Epstein-Barr virus test negative, Faecal incontinence, Fall
Clinical narrative: Client called 2/16/11 inquiring about possibility Hep B vaccine caused his "transverse myelitis" he experienced in fall. He admits began in Sept. loss of balance, progressed to loss of bowel and bladder control. Paraplegic hospitalized 10/13/10. Home 12-16-10. Remains in physical therapy. Continues to need self cath, bowel assistance, admits walking is "coming back, using walker.
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Herpes simplex serology negative, Mycobacterium tuberculosis complex test negative, Myelitis, Myelitis transverse, Paraplegia
Clinical narrative: Client called 2/16/11 inquiring about possibility Hep B vaccine caused his "transverse myelitis" he experienced in fall. He admits began in Sept. loss of balance, progressed to loss of bowel and bladder control. Paraplegic hospitalized 10/13/10. Home 12-16-10. Remains in physical therapy. Continues to need self cath, bowel assistance, admits walking is "coming back, using walker.
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Treponema test negative, Urinary incontinence, Walking aid user, West Nile virus test negative, White blood cell count increased
Clinical narrative: Client called 2/16/11 inquiring about possibility Hep B vaccine caused his "transverse myelitis" he experienced in fall. He admits began in Sept. loss of balance, progressed to loss of bowel and bladder control. Paraplegic hospitalized 10/13/10. Home 12-16-10. Remains in physical therapy. Continues to need self cath, bowel assistance, admits walking is "coming back, using walker.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Secondary transmission, Vaccine virus shedding, Vomiting
Clinical narrative: Information has been received from a consumer who thinks she transmitted shingles to her sister on an unspecified date.  On 31-JAN-2011 the reporter was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) (WAES# 1102USA02514).  On 10-FEB-2011 the reporter's sister broke out in shingles on her forehead and face; she had been throwing up and had bad headaches and was hospitalized.  At the time of the report the patient's outcome was unknown.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Patient had 4 cm area at vaccination site of redness, warmth, firm to touch.  No evidence of discomfort.