chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Emp was given flu vaccine at work on 12-13-06.  Emp went home and started with headache and a stiff neck.  sxs worsened on 12-14-06 with a temperature spiking to 102 degrees.  Stiff neck was increasing worse.   Employee was taken to Hospital on 12-14-06 by his wife.  Emplyee was given Cat scan of head and neck, blood work and spinal tap.  It was reported to employee by the ER doctor that he did not have menigitis.  Employee was given Motrin, valium and darvocet for pain. Employee was discharged from the ER to home after 8 hours.  Employee wife called work clinic on 12-18-06, advising that employee was feeling better each day after he received treatment on 12-14-06 at the ER.   Employee off work due to Christmas vacation but will report to work as usual on 1-2-2007.  The health services department has requested that employee report to medical upon reutrn to work from vacation to have evaluation and follow up by the plant physician.  Employee agreed to do this
Age: 42.0
Sex: M
Vaccine: HEPAB
Symptoms: Headache, Neck pain
Clinical narrative: severe disabling neck pain and headache
Age: 22.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: HIV infection
Clinical narrative: A Refugee came to this county on 12/7/06.  Client is HIV postive. Was given variclla vaccine on 12/12/06. She had already received a varicella on 7/17/06 without any incident. Client is being carefully watched for any adverse reactions.  Also gave Td. SPU1704AA LA  IM  1 previous dose  Box 13- At this time, client has had no adverse reactions
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Pain, Rash erythematous
Clinical narrative: REDNESS/RAISED WARMTH 5 CM X 4 CM OF R ARM PAIN WITH MOVEMENT OF ARM. TX: COOL COMPRESSES AND CONTINUE AMOXIL PRESCRIBED ON 12/12/06 FOR OME
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: 24 hours post MMR (given 11/13/2006) started having explosive diarrhea 3-4 times a day with a sporadic high fever of 101-102degrees. This is still happening on a daily basis. All lab work has proven normal blood counts.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Crying, Rash erythematous, Rash papular, Rash pruritic, Skin ulcer
Clinical narrative: Developed pruritic erythematous papular rash over lower extremities within 24 hr of administration. Rash progressed to involve most of body, including face, over the next week.  Ongoing at the time of this report despite diphenhydramine.  Popliteal fossae lesions weeped after several days then cleared.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Joint range of motion decreased, Muscle twitching, Neck pain
Clinical narrative: The day following the vaccine, I experienced a low grade fever (100.0), achiness down the arm of the injection, achiness in neck and other arm.  I had pain at the site of the injection, and couldn't lift my arm more than 30 degrees.  I also got a headache.  I had to lie down for most of the day following the vaccine.  All of those symptoms were gone by the next morning.  In the next 2 days, I had pain in the muscle that was vaccinated accompanied by muscle twitching.  It is now 6 days post-vaccination, and my muscle is very hard, like a knot, but not painful unless I rub it.  It hurts slightly to raise my arm, but doesn't affect my normal activity.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: The day following the vaccine, I experienced a low grade fever (100.0), achiness down the arm of the injection, achiness in neck and other arm.  I had pain at the site of the injection, and couldn't lift my arm more than 30 degrees.  I also got a headache.  I had to lie down for most of the day following the vaccine.  All of those symptoms were gone by the next morning.  In the next 2 days, I had pain in the muscle that was vaccinated accompanied by muscle twitching.  It is now 6 days post-vaccination, and my muscle is very hard, like a knot, but not painful unless I rub it.  It hurts slightly to raise my arm, but doesn't affect my normal activity.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Patient felt dizzy after dTaP, Varicella, and HPV administration.  She had a syncopal episode lasting seconds, immediately recoverd with stable vital signs.  To note patient has a past medical history significant for syncope and did not take her atenolo that morning.  She was sent to the ER for fluids and further monitoring.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Return 2 1/2 hours after recieving Vaccine c/o itching-slight rash to neck-chest and arms.  Denied SOB, difficulty breathing.  AXOX3 Benadryl 50 mg PO given.  Applied Caldryl lotion to areas.  Advised to call PCP from Clinic which she did.  F/U visit at 2PM.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Eye discharge, Headache, Oral pain
Clinical narrative: onset of cough, runny eyes, headache, inside of mouth hurt, difficulty breathing, ache all over. Went to ED at 4:30pm felt reaction to vaccination. Patient took Benadryl at home after the ED visit.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: onset of cough, runny eyes, headache, inside of mouth hurt, difficulty breathing, ache all over. Went to ED at 4:30pm felt reaction to vaccination. Patient took Benadryl at home after the ED visit.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Swelling
Clinical narrative: Had some swelling evening of 11/29/06, put ice on left arm. Has had increased pain in left arm since injection given.  No warmth or swelling in left arm at present.  Is unable to sleep because of severe pain in left arm when lying down.  Arm is painful when she lifts left arm.  Is taking Tylenol.  Saw physician on 12/8/06 - no treatment given.  Has not had a reaction to influenza vaccine in the past.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: had Adacel on Thurs (5 days ago). Noted redness spreading on arm on Sunday. Arm has been achy since shot. Swelling also noted. Warmth on upper arm as well. 8x10 area of erythema on left arm. Will be treated with Keflex 500 mg three times daily for 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid - "redness and swelling of the left shoulder, down to about the mid-upper arm"   No fever.  Happy, playful, eating and drinking normally.   Mother applied ice pack
Age: 0.12
Sex: F
Vaccine: RVX
Symptoms: Haematochezia
Clinical narrative: 7days after rotavirus, had bloody, mucousy stools.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Vomiting
Clinical narrative: Beginning 4 hours after Fluzone and Hepititis A vaccines began to vomit and continued for the next 4 hours. Approximately 12 hours later started to vomit again and continued for another 3 hours. No fever, no rash. Home symptomatic treatment given at first and then Phenergan 12.5mg q 4-6 hours prn. No further complaints of vomiting.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: developed redness warmth and knot at injection site 12/7/06, treated with warm compress and tylenol,treated 12/09/06 at walk in center for cellulitis with oral and injectable antibiotics,followed up 12/13/06 at PCP, arm swelling decreased.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Abdominal pain lower, Gastrointestinal disorder, Laboratory test abnormal, Vomiting
Clinical narrative: Shot was given on Nov 28th Tues within 2 hours pt vomiting and abd pain. then worsened to not being able to lay supine. Wed Nov 29th tried to wait SX out but went to student health where Dr asked her to go to hospital for CBC and ABD CT scan. As 0.02% appendicitis from Gardasil. She then proceeded to have appendectomy. This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a health professional concerning a 20 year old female patient who on 28-NOV-2006 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 653978/0955F). On 28-NOV-2006 from three hours after vaccination the patient developed right-sided abdominal cramping, inability to sleep and "appendicitis symptoms." On 29-NOV-2006 the patient returned to the health center with and was referred to the emergency room for a CT scan and abdominal ultrasound. She was being referred to a specialist to rule out appendicitis. The patient was admitted to the hospital until at least the 01-DEC-2006 (reported as 31-NOV-2006) for an appendectomy. It was unknown if the appendicitis was due to the vaccination. At the time of this report, the outcome of appendicitis was unknown and the patient did not recover from her inability to sleep. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Insomnia
Clinical narrative: Shot was given on Nov 28th Tues within 2 hours pt vomiting and abd pain. then worsened to not being able to lay supine. Wed Nov 29th tried to wait SX out but went to student health where Dr asked her to go to hospital for CBC and ABD CT scan. As 0.02% appendicitis from Gardasil. She then proceeded to have appendectomy. This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a health professional concerning a 20 year old female patient who on 28-NOV-2006 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 653978/0955F). On 28-NOV-2006 from three hours after vaccination the patient developed right-sided abdominal cramping, inability to sleep and "appendicitis symptoms." On 29-NOV-2006 the patient returned to the health center with and was referred to the emergency room for a CT scan and abdominal ultrasound. She was being referred to a specialist to rule out appendicitis. The patient was admitted to the hospital until at least the 01-DEC-2006 (reported as 31-NOV-2006) for an appendectomy. It was unknown if the appendicitis was due to the vaccination. At the time of this report, the outcome of appendicitis was unknown and the patient did not recover from her inability to sleep. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Abdominal pain, Appendicectomy, Appendicitis, Computerised tomogram
Clinical narrative: Shot was given on Nov 28th Tues within 2 hours pt vomiting and abd pain. then worsened to not being able to lay supine. Wed Nov 29th tried to wait SX out but went to student health where Dr asked her to go to hospital for CBC and ABD CT scan. As 0.02% appendicitis from Gardasil. She then proceeded to have appendectomy. This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a health professional concerning a 20 year old female patient who on 28-NOV-2006 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 653978/0955F). On 28-NOV-2006 from three hours after vaccination the patient developed right-sided abdominal cramping, inability to sleep and "appendicitis symptoms." On 29-NOV-2006 the patient returned to the health center with and was referred to the emergency room for a CT scan and abdominal ultrasound. She was being referred to a specialist to rule out appendicitis. The patient was admitted to the hospital until at least the 01-DEC-2006 (reported as 31-NOV-2006) for an appendectomy. It was unknown if the appendicitis was due to the vaccination. At the time of this report, the outcome of appendicitis was unknown and the patient did not recover from her inability to sleep. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Full blood count, Insomnia, Ultrasound abdomen, Vomiting
Clinical narrative: Shot was given on Nov 28th Tues within 2 hours pt vomiting and abd pain. then worsened to not being able to lay supine. Wed Nov 29th tried to wait SX out but went to student health where Dr asked her to go to hospital for CBC and ABD CT scan. As 0.02% appendicitis from Gardasil. She then proceeded to have appendectomy. This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a health professional concerning a 20 year old female patient who on 28-NOV-2006 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 653978/0955F). On 28-NOV-2006 from three hours after vaccination the patient developed right-sided abdominal cramping, inability to sleep and "appendicitis symptoms." On 29-NOV-2006 the patient returned to the health center with and was referred to the emergency room for a CT scan and abdominal ultrasound. She was being referred to a specialist to rule out appendicitis. The patient was admitted to the hospital until at least the 01-DEC-2006 (reported as 31-NOV-2006) for an appendectomy. It was unknown if the appendicitis was due to the vaccination. At the time of this report, the outcome of appendicitis was unknown and the patient did not recover from her inability to sleep. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme 2 degrees, trunk area; front and back. Resolved within 72 hours using Prednisone 20 mg, 3 tabs, times 5 days, then 2 tabs for 5 days. Route:  Scarification (block 13, no choice).
Age: 0.71
Sex: M
Vaccine: PNC
Symptoms: Vasculitis
Clinical narrative: Information regarding Prevnar was received from a healthcare professional via a regulatory authority regarding an 8 month old male patient who experienced vasculitis. The patient received the first dose on 21 Nov 2006. The patient experienced vasculitis starting 22 Nov 2006. he was hospitalized. On 29 Nov 2006 the event was abating.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Cyanosis, Respiratory disorder, Vomiting
Clinical narrative: Multiple episodes of pausing with breathing with perioral cyanosis. 1 episode of vomiting.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Abnormal behaviour, Agitation, Anger, Confusional state, Mental impairment
Clinical narrative: Behavior changes: 1. Confusion -lasted all evening see below. A. Loss of time as related to events 5pm. B. Frustration 6pm. C. Anger 6:30pm.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Complained of off and on pain in left arm since he received a flu shot on 12/6/06.
Age: 1.54
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, MMRV, PNC
Symptoms: Hyperhidrosis, Hypotonia, Pallor
Clinical narrative: At noon at home, started to hold right arm tight to her body, then held arm tight to her head. Held by mother, child's head was limp, then child fell asleep. Mom woke child after 15 minutes, difficult to awaken and child was sweating and pale. Took to ER-recovered and went home. Symptoms developed again 2 hours later and child returned to ER for CT scan, sedation and blood workup. Mom reports client afebrile during this time.  ER doctor told parents "Textbook signs of MMR reaction."
Age: 1.56
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Erythema, Irritability, Muscular weakness, Pyrexia, Vomiting
Clinical narrative: Patient developed 103.3 fever day after immunization. Refused liquids. Did not want to put weight on Left leg. Does have 1.5cm x 1.8cm redness at injection site of left lower thigh. Did throw up Tylenol. Irritable.
Age: 0.38
Sex: F
Vaccine: DTP, HIBV, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Hives patient given Benadryl.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, pain, swelling below injection site.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Muscular weakness, Pain
Clinical narrative: Pain started in right arm (shoulder) and moved down to fingers-pain was not relieved by Motrin. Pain decreased that night. Now has constant pain and decreased mobility of arm. Also muscle weakness due to pain.
Age: 1.54
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever up to 103F about 4 hours after receiving the vaccine followed by a febrile seizure.  1/9/07 Received medical records from hospital which reveal patient was seen in ER on 12/14/06 afternoon after receiving flu vax in am.  Patient had awakened from nap with rash & parent found him seizing.  Temp 103.6 in ER.  Patient noted to be post ictal in ER. Final DX: febrile seizure s/p flu vaccine; mild bronchiolitis.
Age: 1.54
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever up to 103F about 4 hours after receiving the vaccine followed by a febrile seizure.  1/9/07 Received medical records from hospital which reveal patient was seen in ER on 12/14/06 afternoon after receiving flu vax in am.  Patient had awakened from nap with rash & parent found him seizing.  Temp 103.6 in ER.  Patient noted to be post ictal in ER. Final DX: febrile seizure s/p flu vaccine; mild bronchiolitis.
Age: 14.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Medication error
Clinical narrative: 2nd MCV4 was given. First dose 7/19/06.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Pain
Clinical narrative: Patient received injection following work related injury. Now has severe deep muscle aching all through left back and left arm, elbow, wrist. No visible swelling, no infection. Persistant aching and pain through arm.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Hypokinesia, Myasthenic syndrome
Clinical narrative: Guillian-Barre syndrome, loss of sensation in extremities and motor movement coordination 10 days after influenza vaccination.  Treated with IVIG 24 gm x 1 then 42 gm x 4 doses.  12/29/06 Received partial medical records from hospital with note that d/c summary not available at this time.  Admitted on 12/13/06.  H&P indicates patient with increased back pain, numbness of hands & feet, facial numbness, headaches & frequent falls prior to admit.  Consults by neurosurg, neuro.  Admit Dx: carpal tunnel syndrome, polyneuropathy possible Guillain Barre Syndrome  2/2/07 Received additional records from hospital which reveal patient experienced lower extremity weakness & falls from 12/13-12/21/06.  Also had weak cough & poor swallowing but did not require ventilator.  Day before d/c, developed fever & CXR showed LLL infiltrate.  Started IV antibiotics & was to continue oral antibiotics upon transfer to rehab facility. FINAL DX: Demyelinating polyneuropathy, c/w Guillain Barre Syndrome; HTN; poorly controlled diabetes; chronic pain; & pneumonia.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hot flush
Clinical narrative: Face felt hot, appeared reddened.  Diphenhydramine 25 mg given at Employee Health Center.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Recieved Varivax vaccine on 12/18/06 and developed rash on 12/19/06 at night. Reported on 12/20/06 and diagnosied by MD with chicken pox.
Age: 66.0
Sex: M
Vaccine: DT, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: patient had heat induration and erythema to right deltoid area and low grade 99.4 oral temp.  Complained of pain in upper right arm restricting movement.  Given oral antibiotic Levofloxacin 500 mg daily for 7 days with resolution when seen one week later.  (Levo chosen for compliance of daily only administration in this patient.)
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Coma
Clinical narrative: bABY FOUND UNRESPONSIBE ABOUT 11 P.M BY FATHER. dAD CALLED THE MOTHER OF CHILD WHO IS AN ICU NURSE. SHE CALLED AN AMBULANCE. DAD BEGAN CPR. THE CHILD WAS TAKEN TO HOSPITAL AND THEN FLOWN TO MC. THE CHILD LIVED ABOUT 12 HOURS OFF LIFE SUPPORT.  12/21/06 Received medical records from initial hospital which reveals patient arrived at ER in full arrest, had been intubated by EMS in the field & CPR was in progress.  Patient had been down approx 20-25 min prior to arrival to ER.  During code in ER given multi doses of atropine & epi with no response.  Developed V tach & was cardioverted multi times.  Finally stabilized after Lido begun & ET tube replacement.  Had to be transported to tertiary hospital via ambulance instead of helicopter due to bad weather in the area.  8/17/07 Received Death Certificate from state epidemiologist office which states COD as necrotizing bacterial pneumonia.  2/11/08 Reviewed autopsy report which states COD as necrotizing bacterial pneumonia.   Brain revealed slightly thickened & mildly inflamed leptomeninges & early signs of hypoxic-ischemic encephalopathy.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Synovitis
Clinical narrative: Hip synovitis right more than left. Unable to bear weight for 48 hours 12/21/06 Received medical records from hospital which reveal patient admitted 12/13-12/14/06 following 2 days of right hip pain with weight bearing & also had some pain left hip.  Pain kept patient awake at night.  No illness or trauma.  Flu vax 3 days prior to symptoms.  Exam revealed right hip with pain when flexed at 90 degrees, pain with extrenal rotation beyond 60 degrees and pain increased when hip internally rotated.  No pain when flexed or at rest.  Treated w/anti inflammatory & pain meds overnight & was able to walk next day.  D/C to home to be f/u as outpatient. Final Dx: Synovitis of hip/ss
Age: 0.2
Sex: F
Vaccine: DTAP, FLU3, HEP, HIBV, IPV, PNC
Symptoms: Respiratory disorder
Clinical narrative: I was giving 2 month immunizations  & for unknown reasons, encluded the flu immunization. I not sure  how this happened.  No excuse.  There were no problems  noted because of the immunization on f/u visit other than the continued raspy breathing.  Patient was referred to a pediatrician for the breathing problem.
Age: 20.0
Sex: F
Vaccine: HIBV, PPV, TDAP, HIBV, PPV, TDAP
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial information received from another manufacturer (reference number 0607USA04170) on 08 December 2006. The information was reported to the other manufacturer by a health care professional. A 20 year old female patient received a second dose of Pneumovax 23 ,lot number 651356/0089F, administered subcutaneously in the right arm, a second dose of ActHib, lot number UE785AA administered intramuscularly in the left arm, and a dose of Adacel, lot number C2384AA, administered intramuscularly in the right arm on 17 July 2006. There was no illness at the time of vaccination. Two days later, on 19 July 2006, the patient presented to the physicians office with an injection site reaction (exact site unspecified) with right arm pain, approximately 3 inch swelling and redness at the injection site. This was also described as reddened, swollen arm. This was also described as very pronounced local reaction at administration site. Site red, hot touch, painful. The physician ordered a prednisone dose pack and recommended ice to the area. On 20 July 2006 the patient presented for a follow up visit. There was no improvement or worsening of symptoms, Erythema was noted. The swelling at the injection site had increased to approximately 5 inches. The reporting nurse stated that the patient's arm looked bad. The patient's experience was also described as an exaggerated response. It was noted that the patient, as a result of the experience, had missed work. The patient was previously vaccinated with Pneumococcal 23 polysaccharide vaccine on 16 March 2005. The patient was to follow up, however the patient never came back after that. There were no relevant diagnostic test or laboratory data. It was unk if the patient recovered. It was noted that the patient had no adverse experiences following prior vaccinations. The reporter considered the patient's experience to be disabling and to be other medical events (OMIC). Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HIBV, PPV, TDAP, HIBV, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial information received from another manufacturer (reference number 0607USA04170) on 08 December 2006. The information was reported to the other manufacturer by a health care professional. A 20 year old female patient received a second dose of Pneumovax 23 ,lot number 651356/0089F, administered subcutaneously in the right arm, a second dose of ActHib, lot number UE785AA administered intramuscularly in the left arm, and a dose of Adacel, lot number C2384AA, administered intramuscularly in the right arm on 17 July 2006. There was no illness at the time of vaccination. Two days later, on 19 July 2006, the patient presented to the physicians office with an injection site reaction (exact site unspecified) with right arm pain, approximately 3 inch swelling and redness at the injection site. This was also described as reddened, swollen arm. This was also described as very pronounced local reaction at administration site. Site red, hot touch, painful. The physician ordered a prednisone dose pack and recommended ice to the area. On 20 July 2006 the patient presented for a follow up visit. There was no improvement or worsening of symptoms, Erythema was noted. The swelling at the injection site had increased to approximately 5 inches. The reporting nurse stated that the patient's arm looked bad. The patient's experience was also described as an exaggerated response. It was noted that the patient, as a result of the experience, had missed work. The patient was previously vaccinated with Pneumococcal 23 polysaccharide vaccine on 16 March 2005. The patient was to follow up, however the patient never came back after that. There were no relevant diagnostic test or laboratory data. It was unk if the patient recovered. It was noted that the patient had no adverse experiences following prior vaccinations. The reporter considered the patient's experience to be disabling and to be other medical events (OMIC). Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HIBV, PPV, TDAP, HIBV, PPV, TDAP
Symptoms: Injection site warmth, Medication error, Oedema
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial information received from another manufacturer (reference number 0607USA04170) on 08 December 2006. The information was reported to the other manufacturer by a health care professional. A 20 year old female patient received a second dose of Pneumovax 23 ,lot number 651356/0089F, administered subcutaneously in the right arm, a second dose of ActHib, lot number UE785AA administered intramuscularly in the left arm, and a dose of Adacel, lot number C2384AA, administered intramuscularly in the right arm on 17 July 2006. There was no illness at the time of vaccination. Two days later, on 19 July 2006, the patient presented to the physicians office with an injection site reaction (exact site unspecified) with right arm pain, approximately 3 inch swelling and redness at the injection site. This was also described as reddened, swollen arm. This was also described as very pronounced local reaction at administration site. Site red, hot touch, painful. The physician ordered a prednisone dose pack and recommended ice to the area. On 20 July 2006 the patient presented for a follow up visit. There was no improvement or worsening of symptoms, Erythema was noted. The swelling at the injection site had increased to approximately 5 inches. The reporting nurse stated that the patient's arm looked bad. The patient's experience was also described as an exaggerated response. It was noted that the patient, as a result of the experience, had missed work. The patient was previously vaccinated with Pneumococcal 23 polysaccharide vaccine on 16 March 2005. The patient was to follow up, however the patient never came back after that. There were no relevant diagnostic test or laboratory data. It was unk if the patient recovered. It was noted that the patient had no adverse experiences following prior vaccinations. The reporter considered the patient's experience to be disabling and to be other medical events (OMIC). Additional information is not expected.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Malaise, Platelet count decreased
Clinical narrative: Extreme aching within minutes of shot. Fatigue, nausea, and dehydration starting 11/4. Extreme weakness, weight loss, nausea observed on 11/6. On 11/7 had temperature of 103, had lost 11 pounds since physical on 10/31/06, high creatin level, too weak to tie shoes, eyes very red, other symptoms of infection. Admitted to emergency room about 20:00 11/7. Condition deteriorated to death. Cause of death listed as sepsis with pneumonia and acute renal failure.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Renal failure, Respiratory failure, White blood cell count increased
Clinical narrative: Extreme aching within minutes of shot. Fatigue, nausea, and dehydration starting 11/4. Extreme weakness, weight loss, nausea observed on 11/6. On 11/7 had temperature of 103, had lost 11 pounds since physical on 10/31/06, high creatin level, too weak to tie shoes, eyes very red, other symptoms of infection. Admitted to emergency room about 20:00 11/7. Condition deteriorated to death. Cause of death listed as sepsis with pneumonia and acute renal failure.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood creatinine increased, Dehydration, Fatigue, Infection
Clinical narrative: Extreme aching within minutes of shot. Fatigue, nausea, and dehydration starting 11/4. Extreme weakness, weight loss, nausea observed on 11/6. On 11/7 had temperature of 103, had lost 11 pounds since physical on 10/31/06, high creatin level, too weak to tie shoes, eyes very red, other symptoms of infection. Admitted to emergency room about 20:00 11/7. Condition deteriorated to death. Cause of death listed as sepsis with pneumonia and acute renal failure.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nausea, Ocular hyperaemia, Pain, Pneumonia, Pyrexia
Clinical narrative: Extreme aching within minutes of shot. Fatigue, nausea, and dehydration starting 11/4. Extreme weakness, weight loss, nausea observed on 11/6. On 11/7 had temperature of 103, had lost 11 pounds since physical on 10/31/06, high creatin level, too weak to tie shoes, eyes very red, other symptoms of infection. Admitted to emergency room about 20:00 11/7. Condition deteriorated to death. Cause of death listed as sepsis with pneumonia and acute renal failure.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Renal failure acute, Sepsis, Weight decreased
Clinical narrative: Extreme aching within minutes of shot. Fatigue, nausea, and dehydration starting 11/4. Extreme weakness, weight loss, nausea observed on 11/6. On 11/7 had temperature of 103, had lost 11 pounds since physical on 10/31/06, high creatin level, too weak to tie shoes, eyes very red, other symptoms of infection. Admitted to emergency room about 20:00 11/7. Condition deteriorated to death. Cause of death listed as sepsis with pneumonia and acute renal failure.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Decreased appetite, Pyrexia
Clinical narrative: Day after immunization child presented with fever up to 102.8, inconsolable crying, decreased appetite.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Feeling hot, Hyperaemia, Pyrexia
Clinical narrative: heat, high temperature, hyperemia in the right ear and under the right cheek, neck and chest
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Irritability, Urticaria
Clinical narrative: Generalized wheals shortly after administration of vaccine. Irritability. Treatment Benadryl IM, SoluMedrol IM 01/18/07-records received and reviewed, generalized wheals, treated with Benadryl and SoluMedrol IM
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: Approximately 15 hours after vaccine administered reported feeling sick-very tired generalized body aches. Left work, took Tylenol by mouth and slept all day 12/19/06 and night. Awoke 12/20/06-felt better feels like she is getting a cold though.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Infection
Clinical narrative: Began feeling raised area in perineum evening of 12/18/06. Diagnosed by OB/GYN office with Shingles on 12/11/06. Prescribed Valtrex 1 gm TID for 7 days.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Injection site swelling, Rash
Clinical narrative: Red, raised rash on left thigh for 2 weeks.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Lymphadenitis
Clinical narrative: Urticartial skin reaction at injection site, lymphadenitis in left axilla beginning  < 48 hours after injection treatment supportive care.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: 2nd Flu shot this season (due to recall vaccine on 10/20/06) same arm right upper arm, red, swollen, warm to touch (whole upper arm).
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: Vaccines given on 12-13-06, patient returned to clinic 12-15-06. Complain of reddened areas on arms, 2 on right arm, one on left arm. Approximate size 1 to 10 mm. Child states they are "itching". I told father take child to MD immediately. I am an RN, no MD at this site.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abdominal pain, Agitation, Crying, Dermatitis bullous, Pyrexia
Clinical narrative: Pox after immunizations, infant developed fever up to 102 degrees, and  inconsolable crying and abdominal pain. Blood cultures and urine cultures done fever resolved in 2 days. Abdominal pain continues.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Decreased appetite, Pyrexia, Screaming
Clinical narrative: Day after immunizations, child developed fever, decreased appetite, inconsolable crying, fever resolved that day. Crying continued for three days.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Injection site swelling, Irritability, Pyrexia
Clinical narrative: One day after immunizations child developed irritability - swelling at injection shot. Fever up to 102 degrees.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Joint range of motion decreased, Pain, Swelling
Clinical narrative: Never stopped hurting from time of shot. Swollen, red, hard upper arm closer to elbow. Sent to MD. Hurt left arm to lift.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Ached and felt like getting sick with something then arm swollen and red. But not hard, hurts to lift arm. Says not as bad as his wife's. Returned to MD.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Joint range of motion decreased, Neck pain, Shoulder pain
Clinical narrative: Right shoulder joint ache continuous but notices more in arm a.m. and p.m. Client received her flu shot on 11/14/2006 at approximately 1:30 pm in her right deltoid of FluLaval manufactured was reported, Lot#2F600311, expiration date 7/07. Saw her again on 11/22/06 while I was giving flu shots to her co-workers. She states her right shoulder joint started aching the next day, 11/15 and has ached ever since. General ache in joint and around back of neck with increased awareness of aching in the morning and evening. She is right handed. Hurts to raise arm above shoulder height. Shoveled snow yesterday with increase pain afterwards. Approximately ten years ago she received a cortisone injection to the right shoulder for rotator cuff with good results from injection, no problems with shoulder since that time. Treatment since 11/15 has been Ibuprofen 600 mg at 5 and 10 pm (States it makes her tired so she can not take it during the day) and Aspirin-cream at bedtime. Suggested ice/heat, rest of shoulder, and above medications. No swelling, redness or any abnormal findings on exam. Will follow up in a few days. 11/28/2006 consulted with MD about above situation then called client. "No improvement with shoulder". MD visited with her via phone then prescription for Prednisone 40-40-20-20 20mg every day for 5 days ordered and called into pharmacy. 12/4/06 at 3:10 pm follow up call to client. States "it still aches, the medication didn't make a difference". Last dose taken Friday, December 1st. Phone consult with MD after visiting with client with return call to her at 3:30 pm. Recommended to follow up with her doctor, if shoulder doesn't improve. I will follow up with a form for the client in the near future.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, PNC
Symptoms: Cellulitis, Pyrexia, Swelling
Clinical narrative: Cellulitis and swelling. Mild fever
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Laboratory test abnormal, Myocarditis, Pericarditis
Clinical narrative: Chest pain; pericarditis sx: EKG with Diffuse ST elevation; Elevated TnI - 9 Pericarditis/myocarditis 01/12/07-records received and reviewed: DX:Myocarditis and Pericarditis
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood creatine phosphokinase increased, Cardiomegaly, Chest pain, Electrocardiogram ST segment elevation, Insomnia
Clinical narrative: Chest pain; pericarditis sx: EKG with Diffuse ST elevation; Elevated TnI - 9 Pericarditis/myocarditis 01/12/07-records received and reviewed: DX:Myocarditis and Pericarditis
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Laboratory test abnormal, Pain, Pericarditis
Clinical narrative: Chest pain; pericarditis sx: EKG with Diffuse ST elevation; Elevated TnI - 9 Pericarditis/myocarditis 01/12/07-records received and reviewed: DX:Myocarditis and Pericarditis
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Neoplasm malignant
Clinical narrative: Guillian-Barre Syndrome Information received from the annual follow up states patient last visit was 8/17/07, diagnosed with hepatic cancer.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase increased, Chest X-ray normal, Guillain-Barre syndrome, Respiratory disorder, White blood cell count increased
Clinical narrative: Hospitalized 12-15-06 with a diagnosis of Guillain Barre - On a ventilator with Respiratory Complications.  1/22/07 Received medical records from hospital which reveal patient admitted 12/15/06-1/12/07 for dizziness, ascending numbness & tingling of his hands & feet for a couple of days.  Had been seen in outlying hospital ER & released 3 days prior to admit w/o diagnosis.   Patient stated he had viral infection for a few days & felt lousy.  Patient also stated he received his first & only flu vax on 11/30/06.  On admission, CPK/MB were very elevated.  Neuro, cardio, pulmo, nephro, ENT & GI consults were obtained.  Was areflexia throughout & had stocking/glove distribution paresthesia.Patient developed respiratory distress.  Treated w/plasmaphoresis & IVIG. Patient was trached & had G tube placement.  Developed MRSA URI, UTI & sepsis.  Patient was transferred to Special Care Unit upon d/c from ICU on 1/12/07. FINAL DX: Axonal Guillian Barre Syndrome. Per information received from annual follow up,  full social security disability was granted in June 2007. Was seen in Outpatient theapy and discharged 7-26-07. Was hospitalized in May with a DVT. Has pain in his feet-fells they are "asleep" all the time. Walks with a cane. Is indepent in self care (struggles with his shoes and socks). He can't sit, stand or walk for very long.
Age: 6.0
Sex: M
Vaccine: DTAP, FLUN3, IPV
Symptoms: Erythema, Pyrexia
Clinical narrative: 6 X 9 area or erythema on right upper extremity, 100.8 temperature orally.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives after given HPV.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Numbness, burning sensation at injection site down B/L arms within hours after vaccine, next day down right lower extremity.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Decreased appetite, Headache, Migraine, Nausea
Clinical narrative: Approximately 20 hours after flu shot given, developed migraine headache, pain back and legs, nausea, no vomiting, decrease appetite - treated with Tylenol, rest and heating pad. Did not seek medical attention. Symptoms lasted approximately 36 hours, still does not feel better.
Age: 15.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Dizziness for 2 days, then resolved independently. Did not inform us until she presented for her next immunization 4 weeks later.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Otitis media, Pyrexia, Tremor
Clinical narrative: Patient had episodes of shaking of the entire body 1 day after immunization. Per mom he had a fever. On my exam he was afebrile and had a right otitis media.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Application site reaction, Erythema, Feeling hot, Tenderness
Clinical narrative: Local large reaction: elbow to upper shoulder red, warm, tender
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Wrong drug administered
Clinical narrative: A vaccine was given, not ordered by the doctor. Hep A was given at 6 months by mistake.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling; erythema at injection site.
Age: 20.0
Sex: M
Vaccine: FLUN3
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Patient went home after work and took a nap; awoke around 8PM with the following symptoms: Headache (24 hrs); Diarrhea (18 hrs); Vomiting (18 hrs); Nausea (6 hrs).  Reported to Medical at 11AM following day. Afebrile (98.3) with symptoms subsiding a little.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Rash, Urticaria
Clinical narrative: Patient recieved DTAP, Hep A, and Prevnar vaccines on 12/13/06 was seen on 12/19/2006 for a body rash.  Provider unsure if rash resulted from immunizations or antibiotic.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Injection site pain
Clinical narrative: Client reports pain in left upper arm which started 12/15/2006 after she received a vaccination in that area.  The pain has continued for 1 week.  Client reports she has pain whenever she lifts her left arm.  No redness/swelling noted per this nurse upon visual exam.  Client has been taking Tylenol 325mg/tab, 2 tablets, about every 6 hours since the pain started on 12/15.
Age: 0.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Patient has a very large locallzed reaction at injection site.  Left arm over the tricep area is a >10cm area that is red raised and hot with a 3-4cm center that has an orange peal appearance. not fluctuant, no discharge or toxic striae.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Joint aches especially in knees, slight headache, fatigue
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site (left upper arm)reaction area measured 5.5 inches by 9.25 inches. No shortness of breath, no difficulties in swallowing, no fever or other irritations. Treatment: Warm soakes, Ibuprofen or Tylenol, Medral 4mgn tid today, 4mgm bid tomorrow, 4mgm  1 on day 3. Call or return to office immediately if other symptoms or redness or swelling worsens otherwise return to office on 12-26-06 for follow up.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Pain
Clinical narrative: Approx 1-2 weeks after injection, developed bursitis in Left shoulder.  At time of injection pt had no pain, swelling, bruising or reddness.  Pain continues at this time.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pruritus, Urticaria
Clinical narrative: Pt received flu shot 10am, called agency @2:10 pm. Stated had hives and itching.Hx ofBee sting allergy.went to see pt,hives on arms,upper chest,face and was diaphoretic,given 0.3cc epiSC,patient works in factory,worked with walnut wood for the first time day before,stated she had same S+S yesterday while working. Employer is now aware of the "walnut" issue.The rescue squad was called initially, at arrival 5 mins after epi dose her BP136/78, P 98.She refused  tx to Emerg Rm, Advised to take Benadryl when she  got home.She appeared stable when I left.   Pt received flu shot at her work site,given by a RN
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Arthritis, Arthropathy, Bone disorder, Injection site erythema
Clinical narrative: Concerned about left hip pain 6 months following initial AVA vac in 1998 with progressive worsening with each vac x 6 until total hip replacement in 10/2006 due to severe osteoarthritis.  He reported he remembers vaccine site redness, a sore arm and burning at the vaccine site, but no other adverse events.  In the summer of 1998 he began to experience intermittent left hip pain without radiating pain or paresthesia. He advised the ships corpsman who advised him he may have tendonitis and to take oral Motrin. He denies any trauma, injury, straining or illness at the time while aboard ship. His job was a sonar tech.  He described this discomfort as a continuous dull ache 2/10 pain scale to the hip alone that lasted from 1-4 days.  His discomfort would reoccur approximately every 6 months without cause, each time being advised by corpsmen-medical it was probably just a strain. He did not associate worsening pain with subsequent AVA vaccinations but did note his discomfort did worsen over the following 2-4 years both in frequency, intensity and duration.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Concerned about left hip pain 6 months following initial AVA vac in 1998 with progressive worsening with each vac x 6 until total hip replacement in 10/2006 due to severe osteoarthritis.  He reported he remembers vaccine site redness, a sore arm and burning at the vaccine site, but no other adverse events.  In the summer of 1998 he began to experience intermittent left hip pain without radiating pain or paresthesia. He advised the ships corpsman who advised him he may have tendonitis and to take oral Motrin. He denies any trauma, injury, straining or illness at the time while aboard ship. His job was a sonar tech.  He described this discomfort as a continuous dull ache 2/10 pain scale to the hip alone that lasted from 1-4 days.  His discomfort would reoccur approximately every 6 months without cause, each time being advised by corpsmen-medical it was probably just a strain. He did not associate worsening pain with subsequent AVA vaccinations but did note his discomfort did worsen over the following 2-4 years both in frequency, intensity and duration.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Insomnia, Shoulder pain
Clinical narrative: Patient has complained of pain of left shoulder and deltoid. Since injection. Started after injection and has persisted to the point that patient has difficulty sleeping. Orthopedics evaluation, xray and MRI all negative. No functional deficit, normal exam.
Age: 23.0
Sex: F
Vaccine: YF
Symptoms: Feeling hot, Injection site erythema, Pyrexia
Clinical narrative: Recieved immunization on 12/18.  Contacted on 12/19 with redness at site of injection approx. the size of a quarter site warm to touch at this time. Contacted on 12/21 with increase in redness to the size of a clenched fist and pt. c/o fever, unknown temp due to pt. not owning a thermometer.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Headache, Pain
Clinical narrative: Within 16 hrs experienced severe lower back pain, lasted couple days, still experience intermitant light headaches, intermitant upset stomach, intermitant pain in side, (prior to flu shot had no symptoms),  have not sought medical help.