chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU3
Symptoms: Uterine dilation and curettage
Clinical narrative: Initial report received on 25 February 2010 from the Centers for Disease Control (CDC), who had received the original report from a patient's mother-in-law, who is a Sanofi Pasteur employee. Follow-up information was received on 02 March 2010 from the facility where he vaccine was administered. A 32-year-old female patient had received a 0.5 mL intramuscular left deltoid injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP001AA, expiration date 09 March 2011) on 11 October 2009. The patient was approximately 1 month pregnant at the time. The patient subsequently received a 0.5 mL intramuscular right deltoid injection of FLUZONE (lot number UT3251AA, expiration date 30 June 2010) on 14 November 2009. The patient was approximately 2 months pregnant at that time. The date of the patient's last menstrual period was not reported. The patient's expected date of delivery was 12 June 2010. The patient had a doctor visit 33 days after receiving the FLUZONE, which was also 67 days after receiving the Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, and the fetal heart beat was not heard. A "D&E" (dilation and evacuation) was performed the following day for intrauterine fetal death (known as miscarriage). Medical and obstetrical history was not provided. The patient had not received any other vaccinations within 4 weeks prior to 11 October 2009. At the time of this report, the patient had recovered. Additional information has been requested. Follow-up information received on 16 April 2010 from an employee of the manufacturer who received the information from the patient. The patient had received FLUZONE vaccination the last 3 years (including the dose received on 14 November 2009) with no adverse events reported for the 2 prior FLUZONE vaccinations. The patient's obstetrical history includes 2 prior pregnancies that resulted in C-sections. She takes no concomitant medications, had no medical complications, and does not smoke. The date of the patient's last menstrual period was on 27 August 2009. Per the patient, she had no symptoms prior to the fetal death and all physical examinations up to that point were "great." An ultrasound in November 2009 showed the baby's heart pulsating and the baby was moving around. At 16 weeks gestation, no fetal heartbeat was noted by the OBGYN physician and the patient underwent a D&C. The patient was subsequently seen in the emergency room on 30 January 2010 for another D&C to remove more retained placental tissue. Follow-up care was required and the patient was seen by a specialist who performed another D&C for retained placental tissue not removed during prior D&C procedures. The patient had her last visit with her physician on 16 April 2010 and was recovered at that time. Documents held by sender: None.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Clinical evidence of Herpes like eruption maculopapular clustered vesicular rash left axilla.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash maculo-papular, Rash vesicular
Clinical narrative: Clinical evidence of Herpes like eruption maculopapular clustered vesicular rash left axilla.
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: 24 hours after receiving H1N1 LAIV developed rash which began under eyes and spread behind ears and then to chest. Rash looks like sunburn with pinpoint bumps.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: VARICELLA and KINRIX administered 5:30 pm on 3-31-10. 4-1-10 redness, 4-2-10 AM arm still red, by PM temp. Child taken to same day care clinic, arm still red, swollen.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Impaired work ability, Pyrexia, Urticaria
Clinical narrative: Shot given 04/21/10 and on 04/22/10 pt said called out of work - due to fever (told to take APAP, which controlled fever, on 4/22/10 he said he DC'd APAP and fever increase 102 degrees, he was told cont. APAP. On 04/24/10 had trouble breathing and went to urgent care and on 04/25 he had hives and went to ER. ER told him DC Lamotrigine.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest pain, Chills, Dry eye, Eye pruritus, Fatigue
Clinical narrative: headache immediately after vaccination lasting approx. 15 minutes; sore throat upon awakening in AM, fatigue during the day after vaccination, low grade fever and chills; excessive post nasal drip, runny nose in following days up to the present, excessive phlegm/mucus, chest ache, excessive fatigue, dry red itchy eyes, muscle aches; worsening sore throat; chest ache, sleeplessness, exhaustion, low-grade fever and chills at present 4/27/2010 2:44 AM...
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Immediate post-injection reaction, Increased upper airway secretion, Insomnia, Myalgia
Clinical narrative: headache immediately after vaccination lasting approx. 15 minutes; sore throat upon awakening in AM, fatigue during the day after vaccination, low grade fever and chills; excessive post nasal drip, runny nose in following days up to the present, excessive phlegm/mucus, chest ache, excessive fatigue, dry red itchy eyes, muscle aches; worsening sore throat; chest ache, sleeplessness, exhaustion, low-grade fever and chills at present 4/27/2010 2:44 AM...
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Postnasal drip, Pyrexia, Rhinorrhoea
Clinical narrative: headache immediately after vaccination lasting approx. 15 minutes; sore throat upon awakening in AM, fatigue during the day after vaccination, low grade fever and chills; excessive post nasal drip, runny nose in following days up to the present, excessive phlegm/mucus, chest ache, excessive fatigue, dry red itchy eyes, muscle aches; worsening sore throat; chest ache, sleeplessness, exhaustion, low-grade fever and chills at present 4/27/2010 2:44 AM...
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain in extremity, Swelling, Tenderness
Clinical narrative: Silver dollar - sized red swollen tender area and arm aches. Treatment cool compresses for 20 min QID and MOTRIN or ALEVE for the discomfort.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Body temperature increased, Cough, Dizziness, Headache, Heart rate increased
Clinical narrative: Light headed and dizziness 3 hours after vaccination and lasted a couple hours.  Breathing and heart beating like had just got back from a run the remainder of that day.  Skin tender to the touch (especially in the lower back and legs) started a few hours after the vaccination and is almost gone today 04/28/10.  Had severe headaches the night of the vaccination and the day after vaccination.  Dry cough with a lot of pressure in my head started morning of 04/28/10.  Started a temp of 101.3 the night of the vaccination and temp ot 101.0 the next day.  Having cramps just below the ribcage the day after the vaccination.  Had night sweats the 2nd night after the vaccination.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Muscle spasms, Night sweats, Pain of skin, Respiratory rate increased
Clinical narrative: Light headed and dizziness 3 hours after vaccination and lasted a couple hours.  Breathing and heart beating like had just got back from a run the remainder of that day.  Skin tender to the touch (especially in the lower back and legs) started a few hours after the vaccination and is almost gone today 04/28/10.  Had severe headaches the night of the vaccination and the day after vaccination.  Dry cough with a lot of pressure in my head started morning of 04/28/10.  Started a temp of 101.3 the night of the vaccination and temp ot 101.0 the next day.  Having cramps just below the ribcage the day after the vaccination.  Had night sweats the 2nd night after the vaccination.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Body temperature normal, Nausea, Pruritus, Rash, Swelling face
Clinical narrative: Rash, hives, itching, facial swelling, severe nausea, T 98.4.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Rash, hives, itching, facial swelling, severe nausea, T 98.4.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthritis, Injection site pain, Pain, Paraesthesia, Rotator cuff syndrome
Clinical narrative: 12/03/2009 noted tingling across right upper arm after H1N1 flu vaccination given in right deltoid muscle. Tingling traveled up into right neck and shoulder blade (aching). Reported to doctor, who felt there was arthritis causing an impingement syndrome. 4/28/2010 reported to hospital. Still has right upper arm pain "7"/10 scale.
Age: 0.41
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal discomfort, Abdominal pain upper, Decreased appetite, Dyspepsia, Irritability
Clinical narrative: Child became extremely fussy, stomach was tensing up (believed to be stomach cramps), upset stomach (lots of indigestion could be heard), appetite slightly depressed.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at the injection site with redness that goes down his forearm.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Blood culture positive, Pyrexia
Clinical narrative: Patient had previously received all routine vaccines, including a prevnar 7 on 06/03/09, 08/04/09, and 10/02/09.  She had sudden onset high fever, and presented to emergency room.  Blood culture was positive for S. Pneumonia, serotype currently unknown.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Contusion, Epistaxis, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Bloody nose that wouldn't stop, bruising, petechiae.  Diagnosis of ITP.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever-got as high as 102.2, lots of chils, achy body, very sore arm where shot was given, headache.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest X-ray, Cough, Dyspnoea, Electrocardiogram, Feeling abnormal
Clinical narrative: Feeling lousy, some cough and shortness of breath, and possible spread to left nipple.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Laboratory test
Clinical narrative: Feeling lousy, some cough and shortness of breath, and possible spread to left nipple.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Breast discharge, Carditis, Chest X-ray, Cough, Dyspnoea
Clinical narrative: Feeling lousy, some cough and shortness of breath, and possible spread to left nipple.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Electrocardiogram, Feeling abnormal, Laboratory test
Clinical narrative: Feeling lousy, some cough and shortness of breath, and possible spread to left nipple.
Age: 26.0
Sex: M
Vaccine: FLU(H1N1), PPV
Symptoms: Erythema
Clinical narrative: H1N1 and Pneumovax given L.arm deltoid approx. 3pm on 4/26/2010.  Client states noticed small area of redness in l. armpit area at 6pm on 4/27/2010.  On 4/28/12010 area approx. 2" in diameter in same area. Denies itching, welts or swelling.  Denies redness or swelling at injection site.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pain in left arm and swelling per ED record (patient presented to ED, two days after administration).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid oedema, Pruritus, Rash papular
Clinical narrative: Large Red, slightly raised bumps on both elbows with mild pruritis.  Slightly puffy under eyes.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Increased warmth, redness, pain in axilla.
Age: 30.0
Sex: M
Vaccine: FLU(H1N1), PPV, TDAP
Symptoms: Oedema peripheral, Pain
Clinical narrative: C/o pain and mild swelling of upper right arm. Provider massaged and did ROM to arm. Warm, moist heat applied. No redness or hives.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature normal, Headache, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Redness approx 4x4" (L) deltoid area, raised and felt warm. Headache got worse and visual disturbance increased. T-98, B/P - 144/88. Seen by Dr.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Visual impairment
Clinical narrative: Redness approx 4x4" (L) deltoid area, raised and felt warm. Headache got worse and visual disturbance increased. T-98, B/P - 144/88. Seen by Dr.
Age: 10.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Blister, Pyrexia, Rash pruritic
Clinical narrative: Presented 4-19-10 at office c/o itchy rash. Open vesicles on face and extremities. Had fever over weekend.
Age: 49.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Blood creatine phosphokinase normal, C-reactive protein increased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Almost right after shot, pain in left arm/shoulder, progressive to whole left side.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Cough, Decreased appetite, Dizziness, Injected limb mobility decreased
Clinical narrative: Afternoon of 2/9/10 felt light headed - had to pull over off highway, "fell asleep" for 15-20 min.  Then drove rest of way to cabin - utterly incapacitated for two days, no appetite, slept around the clock, arm (L) useless, unable to lift arm for 7 days, much pain.  Lungs seem sensitive chronic cough.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Somnolence, X-ray
Clinical narrative: Afternoon of 2/9/10 felt light headed - had to pull over off highway, "fell asleep" for 15-20 min.  Then drove rest of way to cabin - utterly incapacitated for two days, no appetite, slept around the clock, arm (L) useless, unable to lift arm for 7 days, much pain.  Lungs seem sensitive chronic cough.
Age: 73.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: Received vaccine 12-15-09 - 2 wks later, had severe pain and stiffness in neck, shoulders, arms and down into hands. Swelling in hands - now in care of 2 doctors and on prednisone and other meds.
Age: 73.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rheumatoid arthritis
Clinical narrative: Received vaccine 12-15-09 - 2 wks later, had severe pain and stiffness in neck, shoulders, arms and down into hands. Swelling in hands - now in care of 2 doctors and on prednisone and other meds.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Arthropathy, Injected limb mobility decreased, Joint fluid drainage
Clinical narrative: Information has been received from a registered nurse concerning a 45 year old female with asthma, rhinitis allergic, chronic sinusitis, food allergy, sulfonamide allergy and KEFLEX allergies who on 07-APR-2010 at 2-3 PM was vaccinated with a dose of PNEUMOVAX 23 (lot # 662270/1135Y, IM) into her left deltoid. Concomitant therapy included ADVAIR, RHINOCORT AQUA, PROVNETIL HFA and EPIPEN. On 08-APR-2010 at 4 AM, the patient awoke with joint problems. She couldn't move her left arm. The patient went to the hospital and was admitted for 2-3 days. The hospital removed fluid from the left shoulder and also gave vancomycin. On 11-APR-2010, the office called the patient and discovered that she had better mobility in her left shoulder. At the time of reporting, the patient was recovering. Joint problems and couldn't move her left arm were considered to be disabling and other important medical events. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: FLU(H1N1), HEPA, HPV4, MEN, TDAP, VARCEL
Symptoms: Cough, Dyspnoea, Erythema, Eye swelling, Oxygen saturation decreased
Clinical narrative: Difficulty Breathing, low oxygen saturation, cough, eye swelling, facial redness.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Body temperature increased, Condition aggravated, Febrile convulsion
Clinical narrative: Initial report was received 21 April 2010 from a health care professional. An 18-month-old male patient had received an intramuscular right thigh injection of PENTACEL, lot number C3533AA and an intramuscular left thigh injection of HAVRIX (manufacturer GlaxoSmithKline), lot number AHADB359 on 21 April 2010, and an unspecified amount of time later that same day, the patient's temperature went up to 104 degrees and he experienced a febrile seizure which lasted five to ten minutes. It was reported that the patient had a temperature prior to vaccination; however this was not reported to the physician. The patient had no known illnesses or pre-existing medical conditions at the time of vaccination, and he had not been taking any concomitant medications. According to the reporter, the patient recovered.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Blood immunoglobulin E normal, Chills, Constipation, Diarrhoea
Clinical narrative: Dizziness, fatigue, nausea, muscle aches, stuffy/runny nose, chest congestion, yellow and green mucous, headaches, chills, sweats, diarrhea followed my stomach pain and constipation, stiff lower back with tingling sensation, concentration and vision problems, etc.  I was advised by Army staff that it is impossible to have a bad reaction to the flu vaccine other than immediate anaphylaxis.  Was given mucinex and discharged.  Explained previous complications with same symptoms shortly after flu vaccines, and was told that it was still impossible.  Medical staff would not report ANY complications with the flu vaccine.  And they attempted to administer the H1N1 vaccine while I was still dangerously sick from the seasonal.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Disturbance in attention, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Dizziness, fatigue, nausea, muscle aches, stuffy/runny nose, chest congestion, yellow and green mucous, headaches, chills, sweats, diarrhea followed my stomach pain and constipation, stiff lower back with tingling sensation, concentration and vision problems, etc.  I was advised by Army staff that it is impossible to have a bad reaction to the flu vaccine other than immediate anaphylaxis.  Was given mucinex and discharged.  Explained previous complications with same symptoms shortly after flu vaccines, and was told that it was still impossible.  Medical staff would not report ANY complications with the flu vaccine.  And they attempted to administer the H1N1 vaccine while I was still dangerously sick from the seasonal.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Myalgia, Nasal congestion, Nausea, Paraesthesia
Clinical narrative: Dizziness, fatigue, nausea, muscle aches, stuffy/runny nose, chest congestion, yellow and green mucous, headaches, chills, sweats, diarrhea followed my stomach pain and constipation, stiff lower back with tingling sensation, concentration and vision problems, etc.  I was advised by Army staff that it is impossible to have a bad reaction to the flu vaccine other than immediate anaphylaxis.  Was given mucinex and discharged.  Explained previous complications with same symptoms shortly after flu vaccines, and was told that it was still impossible.  Medical staff would not report ANY complications with the flu vaccine.  And they attempted to administer the H1N1 vaccine while I was still dangerously sick from the seasonal.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Respiratory tract congestion, Rhinorrhoea, Skin test, Sputum discoloured, Visual impairment
Clinical narrative: Dizziness, fatigue, nausea, muscle aches, stuffy/runny nose, chest congestion, yellow and green mucous, headaches, chills, sweats, diarrhea followed my stomach pain and constipation, stiff lower back with tingling sensation, concentration and vision problems, etc.  I was advised by Army staff that it is impossible to have a bad reaction to the flu vaccine other than immediate anaphylaxis.  Was given mucinex and discharged.  Explained previous complications with same symptoms shortly after flu vaccines, and was told that it was still impossible.  Medical staff would not report ANY complications with the flu vaccine.  And they attempted to administer the H1N1 vaccine while I was still dangerously sick from the seasonal.
Age: 59.0
Sex: M
Vaccine: TDAP, YF
Symptoms: Chills, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Started feeling not too well last evening, then this morning woke up and had headache, chills, achiness and low-grade fever.  100F Temp.  Took Ibuprofen and is resting.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blepharospasm, Convulsion, Feeling cold, Incorrect route of drug administration
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 21-JUL-2009, 22-OCT-2009 in the left arm and on 10-MAR-2010 (lot # 661530/1575X) was vaccinated with the first, second and third 0.5 ml doses respectively of GARDASIL. On 21-JUL-2009, the patient was vaccinated with the second dose of VARIVAX (Merck) and on 22-OCT-2009 a dose of intranasal FLUMIST "in different arm". It was reported that the patient experienced injection site pain and fever up to 101 degrees after getting the third dose of GARDASIL on 10-MAR-2010. On 31-MAR-2010, the patient experienced tiredness, pain in her knee, complaint of fainting, 30 seconds of eye twitching, her body felt cold and ringing in her ears. On 18-APR-2010, the patient experienced 45 seconds of blurred vision to black out, eyes twitching, seizures and ongoing severe fatigue. The physician suspected that it could be Narcolepsy. The patient sought unspecified medical attention. At the time of the report the adverse events reported as not improved and the patient's present status was reported as unspecified. Upon internal review seizures were determined to be other important medical event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Loss of consciousness, Narcolepsy, Pyrexia, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 21-JUL-2009, 22-OCT-2009 in the left arm and on 10-MAR-2010 (lot # 661530/1575X) was vaccinated with the first, second and third 0.5 ml doses respectively of GARDASIL. On 21-JUL-2009, the patient was vaccinated with the second dose of VARIVAX (Merck) and on 22-OCT-2009 a dose of intranasal FLUMIST "in different arm". It was reported that the patient experienced injection site pain and fever up to 101 degrees after getting the third dose of GARDASIL on 10-MAR-2010. On 31-MAR-2010, the patient experienced tiredness, pain in her knee, complaint of fainting, 30 seconds of eye twitching, her body felt cold and ringing in her ears. On 18-APR-2010, the patient experienced 45 seconds of blurred vision to black out, eyes twitching, seizures and ongoing severe fatigue. The physician suspected that it could be Narcolepsy. The patient sought unspecified medical attention. At the time of the report the adverse events reported as not improved and the patient's present status was reported as unspecified. Upon internal review seizures were determined to be other important medical event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 21-JUL-2009, 22-OCT-2009 in the left arm and on 10-MAR-2010 (lot # 661530/1575X) was vaccinated with the first, second and third 0.5 ml doses respectively of GARDASIL. On 21-JUL-2009, the patient was vaccinated with the second dose of VARIVAX (Merck) and on 22-OCT-2009 a dose of intranasal FLUMIST "in different arm". It was reported that the patient experienced injection site pain and fever up to 101 degrees after getting the third dose of GARDASIL on 10-MAR-2010. On 31-MAR-2010, the patient experienced tiredness, pain in her knee, complaint of fainting, 30 seconds of eye twitching, her body felt cold and ringing in her ears. On 18-APR-2010, the patient experienced 45 seconds of blurred vision to black out, eyes twitching, seizures and ongoing severe fatigue. The physician suspected that it could be Narcolepsy. The patient sought unspecified medical attention. At the time of the report the adverse events reported as not improved and the patient's present status was reported as unspecified. Upon internal review seizures were determined to be other important medical event. Additional information has been requested.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Diarrhoea, Faeces discoloured, Upper respiratory tract congestion, Vomiting
Clinical narrative: Mom reported to me on 4-28-10 that her son had vomiting 4 days after receiving ROTATEQ and PENTACEL vaccines (vaccines given on 4-21-10). Has had slightly loose stool, yellow and frothy in last few days, some congestion but otherwise well. Was not seen.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Client noticed tenderness under (L) arm by armpit. Approx quarter size lump upon palpation. Client called Dr - Mon. - appt. Tues 4/27/10. Client to have diagnostic mammogram Fri - 4/30/10. Also was started on AUGMENTIN 875 mg BID x 10 days.
Age: 18.0
Sex: F
Vaccine: HEPA, MEN, TDAP
Symptoms: Full blood count normal, Petechiae, Pruritus, Rash macular, Skin burning sensation
Clinical narrative: At 7pm, 4/22, she developed macular exanthema left lower and lateral leg from below knee to the ankle. Petechiae present, itching and burning. Gave script for triamcinolone 0.1% cream 80 mg apply BID.
Age: 66.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Rash, Similar reaction on previous exposure to drug
Clinical narrative: 3-4 hours after taking the 3rd oral typhoid vaccine dose patient experienced itching and a rash around her neck. Rash and itching improved.  Patient took final dose 4 of oral typhoid vaccine on 4.26.10 and within 1 hour had same rash with worse symptoms.
Age: 47.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Injection site pain
Clinical narrative: Dull nagging ache to the left deltoid, the area where the vaccine was administered. It still continues.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Febrile convulsion
Clinical narrative: MMR, VARICELLA and HEP A @ 12 months - 8 days later - patient had febrile seizure. DTAP #4 and HEP A @ 18 months - 8 days later patient had seizure - without fever.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count normal, Metabolic function test
Clinical narrative: MMR, VARICELLA and HEP A @ 12 months - 8 days later - patient had febrile seizure. DTAP #4 and HEP A @ 18 months - 8 days later patient had seizure - without fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Skin warm, Swelling
Clinical narrative: On left thigh at site of KINRIX - Mom noticed some localized redness on 4/15/10 but on 4/16/10 it became much larger and hotter to touch. 14x20 cm area of raised well documented erythema. We called to check on pt on 4/19/10. Mom states leg is better - swelling decrease, leg no longer hard.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Rash papular
Clinical narrative: Began with rash on 4/27/10, has > 30 papules on body, given script for acyclovir and mom to do BENADRYL also.
Age: 1.56
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Localized erythema and swelling of right thigh. Treated with abx and BENADRYL.
Age: 1.11
Sex: M
Vaccine: HEP, HEPA, HIBV, IPV, MMR, VARCEL
Symptoms: Blood culture, Chest X-ray, Diarrhoea, Full blood count, Pyrexia
Clinical narrative: Fever, rash, diarrhea.
Age: 1.11
Sex: M
Vaccine: HEP, HEPA, HIBV, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Fever, rash, diarrhea.
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Blood glucose increased, Disorientation, Dyspnoea, Electrocardiogram normal
Clinical narrative: Within 30 minutes after TDAP administration experienced disorientation, weakness generalized, shortness of breath, tingling of arms. No localized reaction.
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Within 30 minutes after TDAP administration experienced disorientation, weakness generalized, shortness of breath, tingling of arms. No localized reaction.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: (4-26-10) pt presents with 2 day h/o rash. 2 wks prior had 1 year shots. 4 days ago had fever.
Age: 38.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: VARIVAX given right arm sq on 4-26-10 also had HEP B in left deltoid & PPD on RFA intradermal. Seen in office today to check PPD - site with no RXN but pt. has area > 5cm of redness and warm to touch at VARIVAX inj. site.
Age: 45.0
Sex: F
Vaccine: DTP
Symptoms: Culture urine positive, Decreased appetite, Gastrointestinal disorder, Headache, Kidney infection
Clinical narrative: Severe anorexia, kidney infections, head aches, red eyes.
Age: 45.0
Sex: F
Vaccine: DTP
Symptoms: Ocular hyperaemia
Clinical narrative: Severe anorexia, kidney infections, head aches, red eyes.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Abdominal pain, Bowel movement irregularity, Food allergy, Irritability
Clinical narrative: Extreme fussiness with appearance of severe abdominal pain.  No bowel movement for 7 days following vaccine, with pattern persisting for a month. There was question of infant having an ileus.  To date, infant is exhibiting signs of significant food allergies, in a family where food allergies are not prevalent.
Age: 1.05
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: As per mom right thigh became itchy, red and warm to touch.  No pain per pt.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Diarrhoea, Haematochezia, Rotavirus infection
Clinical narrative: Diarrhea, blood in stool, Rotavirus
Age: 0.32
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Apnoeic attack
Clinical narrative: Infant had 1 apneic event approx 24 - 36 hours after being vaccinated.  Parents report calling EMS and pt was breathing by the time EMS arrived.  Parents state child was transported to hospital and were discharged home from the ER.  No treatment or medications given.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Bone pain, Headache, Injected limb mobility decreased
Clinical narrative: Date: 01/13/2010 10:48 AM  Pt. got the  H1N1 VACC.; though on December 10, 2009 she got the Pneumonia shot. She says she is still having pain where the shot was administered: "My L shoulder joint was hot @ the time of the shot. Experiencing pain to joint-collar bone and up into lower L side of skull. Pain is continual, weakness and loss of arm function for several days. She still cannot use arm much or sleep on her L side. Collar bone is still sensitive as is L base of skull. She is rubbing w/Flexall @ times, also taking Advil = pain is still there some what through the Advil."  ( Told Pt to wait in room while I would speak w/the midlevel that is working Today). Per  P.A.- Told Pt it is common for some people to have pain for one month or a little bit after a month. Pt was told to use warm compresses, ice, and to take Tylenol. Told Pt to call office if pain gets severe or won't go away. 06:39 PM: That same evening I called pt to offered an appt to be seeing though she wanted to keep the tips and if pain did not go away she will schedule an appt.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Sleep disorder
Clinical narrative: Date: 01/13/2010 10:48 AM  Pt. got the  H1N1 VACC.; though on December 10, 2009 she got the Pneumonia shot. She says she is still having pain where the shot was administered: "My L shoulder joint was hot @ the time of the shot. Experiencing pain to joint-collar bone and up into lower L side of skull. Pain is continual, weakness and loss of arm function for several days. She still cannot use arm much or sleep on her L side. Collar bone is still sensitive as is L base of skull. She is rubbing w/Flexall @ times, also taking Advil = pain is still there some what through the Advil."  ( Told Pt to wait in room while I would speak w/the midlevel that is working Today). Per  P.A.- Told Pt it is common for some people to have pain for one month or a little bit after a month. Pt was told to use warm compresses, ice, and to take Tylenol. Told Pt to call office if pain gets severe or won't go away. 06:39 PM: That same evening I called pt to offered an appt to be seeing though she wanted to keep the tips and if pain did not go away she will schedule an appt.
Age: 52.0
Sex: F
Vaccine: HEPAB, TTOX
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: No treatment given. Feels sharp pain in deltoid of left side when rotation/reaching cannot sleep o0n left deltoid. Is woken up from sleep by mild throbbing in deltoid left. (Injection site). Pain scale 2-3- No other apparent problems.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: As per mom notice a swelling on (L) deltoid yesterday even. The swelling has decreased from yesterday to today. Mom apply. child on ZYRTEC & SINGULAIR today swollen 52 in x 5 cm redness mom said is better then before.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash papular
Clinical narrative: Patient received hepatitis A, HIB, MMR, PCV and varicella on 4/20/10. Shortly after she received her IZ's she started getting some red bumps to her buttocks, sides and lower back that were small with white dots at the head. Pt started scratching.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness on injection site getting bigger and wider, swollen and firm to touch, today, is day 3, warm, mist compress, ZYRTEC 5 mg every day.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Incorrect dose administered, Vomiting
Clinical narrative: I gave the patient several drops of ROTATEQ and he vomited within several seconds of swallowing. I repeated this 2 more times with the same results.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Abscess sterile, Erythema, Swelling
Clinical narrative: Uncomfortable size of tennis ball - big and red.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Full blood count, Headache, Metabolic function test, Musculoskeletal stiffness
Clinical narrative: Occipital neuritis - Pain in back of head, stiff neck. Time line was about 1 wk after being vaccinated. Treatment: Steroids, pain med, trigger point injection.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Neuritis, Nuclear magnetic resonance imaging, Red blood cell sedimentation rate
Clinical narrative: Occipital neuritis - Pain in back of head, stiff neck. Time line was about 1 wk after being vaccinated. Treatment: Steroids, pain med, trigger point injection.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthropod sting, Erythema, Hypoaesthesia, Immediate post-injection reaction, Muscle spasms
Clinical narrative: C/o immediate numbness, swelling that PM warm to touch after warm salt soaks afebrile - no local erythema - No red streaking - ER Dx: Muscle spasm (L) arm.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: C/o immediate numbness, swelling that PM warm to touch after warm salt soaks afebrile - no local erythema - No red streaking - ER Dx: Muscle spasm (L) arm.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: RUA --> GARDASIL - Site IM given area of swelling and redness and mild itching 2cm x 2cm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Pt waiting in waiting room after vaccine. Approx 15 minutes after vaccine, pt developed a rash on face & back. Dr. re-evaluated pt & ordered PO ADVIL 200mg & PO BENADRYL. -ADVIL given here & mom instructed to get BENADRYL. Rash was fading on back when he left our office. No problems breathing.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Balance disorder, Headache, Hyperhidrosis
Clinical narrative: See attached
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: See attached
Age: 11.0
Sex: F
Vaccine: FLU(H1N1), VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching x 1d ( red area measured 2 1/2 "x2) alternate ibuprofen/TYLENOL, warm packs, BENADRYL cream by day, BENADRYL po @ night.
Age: 8.0
Sex: F
Vaccine: FLU(H1N1), VARCEL
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: She has redness, swelling and bruising around the area of injection posterior (L) arm. No surface lesions or drainage patient was very tense & had to be held down for the shot.
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Activities of daily living impaired, Bipolar disorder, Brain injury, Convulsion
Clinical narrative: Information has been received from a consumer via TV, concerning on an unspecified age consumer's daughter who from 2007 to 2008 was vaccinated with a series of GARDASIL (route and lot number not reported). The mother was claiming her daughter suffered from seizures and got brain damage after getting the vaccination. It was reported that has been sick for the past three years with uncontrollable vomiting and seizures that left her brain damaged. The mother reported that shortly after, the patient reportedly went from being a happy, honor-roll student to a completely different person. The mother said that the doctor told her that her daughter's condition was behavioral, not medical. "They had put her on psych meds, thinking she was bi-polar or something like that.", but the mother was convinced that the injections were to blame. According to the mother, her daughter needed constant care. She said the refrigerator was locked because she has urges to eat constantly. It was reported that her daughter was narcoleptic during the middle of the day, could not sleep at night and was in constant pain. The patient said she wanted to go back to school but she could not. At the time of the report the outcome of the patient was unknown. Can not go back to school and she needed constant care were considered to be disabling. Upon internal review, seizures and brain injury damage were determined to be an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Increased appetite, Insomnia, Malaise, Narcolepsy, Pain
Clinical narrative: Information has been received from a consumer via TV, concerning on an unspecified age consumer's daughter who from 2007 to 2008 was vaccinated with a series of GARDASIL (route and lot number not reported). The mother was claiming her daughter suffered from seizures and got brain damage after getting the vaccination. It was reported that has been sick for the past three years with uncontrollable vomiting and seizures that left her brain damaged. The mother reported that shortly after, the patient reportedly went from being a happy, honor-roll student to a completely different person. The mother said that the doctor told her that her daughter's condition was behavioral, not medical. "They had put her on psych meds, thinking she was bi-polar or something like that.", but the mother was convinced that the injections were to blame. According to the mother, her daughter needed constant care. She said the refrigerator was locked because she has urges to eat constantly. It was reported that her daughter was narcoleptic during the middle of the day, could not sleep at night and was in constant pain. The patient said she wanted to go back to school but she could not. At the time of the report the outcome of the patient was unknown. Can not go back to school and she needed constant care were considered to be disabling. Upon internal review, seizures and brain injury damage were determined to be an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer via TV, concerning on an unspecified age consumer's daughter who from 2007 to 2008 was vaccinated with a series of GARDASIL (route and lot number not reported). The mother was claiming her daughter suffered from seizures and got brain damage after getting the vaccination. It was reported that has been sick for the past three years with uncontrollable vomiting and seizures that left her brain damaged. The mother reported that shortly after, the patient reportedly went from being a happy, honor-roll student to a completely different person. The mother said that the doctor told her that her daughter's condition was behavioral, not medical. "They had put her on psych meds, thinking she was bi-polar or something like that.", but the mother was convinced that the injections were to blame. According to the mother, her daughter needed constant care. She said the refrigerator was locked because she has urges to eat constantly. It was reported that her daughter was narcoleptic during the middle of the day, could not sleep at night and was in constant pain. The patient said she wanted to go back to school but she could not. At the time of the report the outcome of the patient was unknown. Can not go back to school and she needed constant care were considered to be disabling. Upon internal review, seizures and brain injury damage were determined to be an other important medical event. No further information is available.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Autopsy, Death, Loss of consciousness, Respiratory arrest, Resuscitation
Clinical narrative: Initial case was received on 20 April 2010 from an attorney and additional information was provided via the VAERS Database. On 12 August 2009 at 11:39 a.m. an infant had a four -month check-up and was found to be well. At 12:00 p.m. on 12 August 2009, the 4 month old male patient received a left leg injection of PENTACEL (lot number C3301AA), a right leg injection of PREVNAR (lot number D39015, manufacturer Wyeth) and an oral dose of ROTATEQ (lot number 1695X, manufacturer Merck). The following morning on 13 August 2009 at 8:00 a.m. (20 hours later), he was found unconscious and not breathing by his parents. The patient was sleeping with his parent at the time. Cardiopulmonary resuscitation was initiated. Emergency medical services were called and found the infant in full code. He was transported to the hospital where he was "essentially dead on arrival." The patient's history from hospital records and cardiology consultation, with service dates 01 April 2009 to 13 August 2009, indicated the patient was "premature-36 weeks", and had history of jaundice, benign pulmonary flow murmur, tiny collateral vessel originating from descending thoracic aorta, seborrheic dermatitis, plagiocephaly, decreased upper body strength and circumcision. Records also noted fussy, gas, vomiting and diarrhea on unspecified dates. There were no concomitant medications. A postmortem skeletal survey showed no evidence of acute or healing fractures. An autopsy report (date performed not provided) listed the cause of death and manner of death as undetermined. Additional information abstracted: Pathological diagnosis-well baby by clinical history. Overlay cannot be excluded. Documents held by sender: Immunization record, VAERS report.
Age: 65.0
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Injection site pain, Injection site reaction, Joint range of motion decreased, Pain, Sleep disorder
Clinical narrative: Pt. states 3 days after she received H1N1 vaccine - her arm started to ache. She noticed a bruised arm in that area sometime after injection. She has intermittent pain when using that arm and when she sleeps. She hasn't taken any medication for the pain. She has seen her family doctor 2 times for this since injection. Pt states pain wakes her at night nd has interfered with her ROM. But that her Doctor has told her to wait and see if it resolves itself. He has instructed her to use heat. She says the pain is still just a severe and so she came to our office today to file a complaint. She did allow that the pain isn't continuous. Looking at her shoulders/deltoid, there doesn't appear to be any swelling or bruising.
Age: 65.0
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Contusion, Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Pt. states 3 days after she received H1N1 vaccine - her arm started to ache. She noticed a bruised arm in that area sometime after injection. She has intermittent pain when using that arm and when she sleeps. She hasn't taken any medication for the pain. She has seen her family doctor 2 times for this since injection. Pt states pain wakes her at night nd has interfered with her ROM. But that her Doctor has told her to wait and see if it resolves itself. He has instructed her to use heat. She says the pain is still just a severe and so she came to our office today to file a complaint. She did allow that the pain isn't continuous. Looking at her shoulders/deltoid, there doesn't appear to be any swelling or bruising.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Glossodynia, Nausea, Rash
Clinical narrative: On 4/1/10 a 67 year old female with history of chronic eczema and asthma but no other significant medical problems requested and received ZOSTAVAX Two days later she developed typical shingles on her left buttock with a few satellite lesions on her heel and abdomen. The rash was quite painful and pruritic. It progressed for about 10 days but by 3 weeks she was asymptomatic and the rash had largely resolved. By the data in the package insert this should be a rare coincidence, but of course that's difficult for the patient to believe.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash pruritic, Skin lesion
Clinical narrative: On 4/1/10 a 67 year old female with history of chronic eczema and asthma but no other significant medical problems requested and received ZOSTAVAX Two days later she developed typical shingles on her left buttock with a few satellite lesions on her heel and abdomen. The rash was quite painful and pruritic. It progressed for about 10 days but by 3 weeks she was asymptomatic and the rash had largely resolved. By the data in the package insert this should be a rare coincidence, but of course that's difficult for the patient to believe.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1, RV1
Symptoms: Intussusception
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccines (manufacturer unspecified). On an unspecified date the subject received 1st dose of ROTARIX (oral). Two months after vaccination with ROTARIX, the subject presented to his physician with intussusception. The subject was hospitalised. At the time of reporting the event was resolved. The physician considered the event was possibly related to vaccination with ROTARIX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL, DTAPIPV, MMR, PNC13
Symptoms: Blister, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: VARICELLA VACCINE 4/16/2010 THEN DEVELOPED FEVER AND RASH STARTED 4/21/2010 CROPS OF RED BUMPS, FLUID FILLED VESICLES, PRURITIC.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL, DTAPIPV, MMR, PNC13
Symptoms: Blister, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: VARICELLA VACCINE 4/16/2010 THEN DEVELOPED FEVER AND RASH STARTED 4/21/2010 CROPS OF RED BUMPS, FLUID FILLED VESICLES, PRURITIC.
Age: 1.56
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 24 hour after vaccine given - patient with swelling / redness to whole left thigh. Advised ice/observe.