chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Nuclear magnetic resonance imaging brain normal, Radioallergosorbent test positive
Clinical narrative: On 6/16/00 the pt received HepB #1 and the Meningococcal Vaccination in preparation for college entrance. On 7/17/00 the pt suffered a seizure and has been exempt to further Hep B vaccinations and influenza vaccinations since. Past medical history reviewed with patient. The pt reports and the medical records indicated that on 7/17/00 the pt woke with a headache. She took ADVIL without relief. She then took a nap. Her mother noted the pt to be confused with some involuntary movements of her face when she awoke. She decided to take her to the hospital. On the way, the pt had a generalized tonic-clonic seizure without tongue biting or urinary incontinence which lasted for 45 seconds. In the ER she was awake but confused and disoriented. She was afebrile. The pt had no history of headaches, head injury, febrile illness, history of alcohol or drug abuse or FH of seizure disorder. According to the medical record the pt had a CT of the brain which was negative; an MRI of the brain which was negative and an EEG which showed a mild degree of dysrhythmia with a mild degree of intermittent generalized slowing. She was treated with anticonvulsants for 18 months and was tapered without further seizures. The pt has had "stress induced" migraine headaches since that time which she treats with rest with relief of her symptoms. The pt had a Td on 12/1/08 without adverse event. Per the patient she had a Hepatitis B titer drawn 1/07 for employment as a contractor which was negative. 2/10/09-records received for DOS 7/17/-7/18/00-DC DX: Generalized seizure possibly due to comples partial seizure, etiology could not be detected. Woke disoriented and nonfocusing then noncommunicative staring. Generalized seizure and completely unresponsive. Postictal upon arrival  to ED.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal discharge, Vaginitis bacterial
Clinical narrative: I took GARDASIL shot series, It didn't cause major problems, but when I took the second shot around the above date I noticed a change in my vaginal discharge.  The shot caused me to get bacterial vaginosis.  I had it for nine months till I figured out there was a problem because a month before hand I took myself off birth control and I thought my body was just going through changes.  I talked to my doctor and he told me it wasn't the GARDASIL shot, so I took the third shot in the series.  It immediately caused the bacterial vaginosis yet again.  It's not that it's serious, but every woman should know that this is a possible side effect and may be they should prepare themselves.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Back pain, Depression, Headache, Nausea
Clinical narrative: Daughter had second shot of GARDASIL and is having bad headaches, pain in the abdomen, nausea, night sweats, depression, lower back pain.  Her first shot she vomited once, but no other side effects.  2/12/09 Office note received from PCP dated 12/17/08 for 16 yr WCC. Normal exam. Assessment:  Well Adolescent.  Possible pregnancy (due to LMP 2 months ago-normally irregular) Pt not seen for OV since 12/17/08.  Only in for vax 2/3/09. No further info available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Night sweats, Vomiting
Clinical narrative: Daughter had second shot of GARDASIL and is having bad headaches, pain in the abdomen, nausea, night sweats, depression, lower back pain.  Her first shot she vomited once, but no other side effects.  2/12/09 Office note received from PCP dated 12/17/08 for 16 yr WCC. Normal exam. Assessment:  Well Adolescent.  Possible pregnancy (due to LMP 2 months ago-normally irregular) Pt not seen for OV since 12/17/08.  Only in for vax 2/3/09. No further info available.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, fever (>100 degrees), chills-onset 8 hrs. After administration of FLUZONE. Lasted over night, until next A.M. Took Tylenol po.
Age: 22.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Oedema peripheral
Clinical narrative: Right arm swollen, red, and hot to touch around area where VARICELLA was administered.  Pt states pain has worsened.  Advised pt to go to doctor to have checked.  Went to physician at Medical center and was prescribed KEFLEX for cellulitis.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, HPV4, VARCEL
Symptoms: Rash, Wrong drug administered
Clinical narrative: Evening of vaccination developed rash on trunk.  Parent thought possible hives.  Advised BENADRYL po dose.  No other symptoms.  Rash resolved in 24 hours.  Inadvertently received GARDASIL dose.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: States hives on both arms & trunk day after injection - resolving with use of OTC catesine cream
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Erythema, Fatigue, Induration, Pain in extremity
Clinical narrative: Dec. 22, 2008, family medicine--Got shingles vaccine around 2:00pm in my upper right arm; given by medical assistant II.  She had taken my temperature, which was 98 (normal for me).  Saw P.A. before I got the shot, but she was not in the room when it was given.  I was handed the a vaccine information statement after the shot was given.  I took on TYLENOL 500 mg capsule preventatively.  Within 1-1/2 hours, my right little toe, which had been broken in Aug. 2005, spontaneously began to hurt.  I had not bumped it, nor was I wearing tight shoes (I was wearing mules with lots of toe room), so that was odd, as it has bothered me before.  I had no arm pain that nite.  Dec. 23, 2003, When I took the bandaid off my arm in the morning, it was not red.  At noon (22 hours after getting the vaccine), I felt pain in my thigh bones--the same pain as when I was on Neupogen in 1997 during chemotherapy, but not as severe.  I was also very tired.  My temperature was 98.8, which is fever for me.  I called clinic and relayed was what going on;  the message came back that doctor was with a patient but said I should take TYLENOL and put a cool (not ice) compress on my arm it it hurt (I did both).  The arm had red blotches and was a bit itchy.  Blisters looked like they were trying to form, but didn't.  Slept all day;  by 8:00p.m. I felt much better.  Dec. 24, 2008, No fever, some bone pain in thighs.  Arm redness was 2 inches in diameter (I measured) and itchy & painful.  Dec. 25, 2008, Pain was down in bones;  arm redness down to 1/2 of Dec. 24 but still sore.  Pain lingered in my thigh bones until mid January.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash macular
Clinical narrative: Dec. 22, 2008, family medicine--Got shingles vaccine around 2:00pm in my upper right arm; given by medical assistant II.  She had taken my temperature, which was 98 (normal for me).  Saw P.A. before I got the shot, but she was not in the room when it was given.  I was handed the a vaccine information statement after the shot was given.  I took on TYLENOL 500 mg capsule preventatively.  Within 1-1/2 hours, my right little toe, which had been broken in Aug. 2005, spontaneously began to hurt.  I had not bumped it, nor was I wearing tight shoes (I was wearing mules with lots of toe room), so that was odd, as it has bothered me before.  I had no arm pain that nite.  Dec. 23, 2003, When I took the bandaid off my arm in the morning, it was not red.  At noon (22 hours after getting the vaccine), I felt pain in my thigh bones--the same pain as when I was on Neupogen in 1997 during chemotherapy, but not as severe.  I was also very tired.  My temperature was 98.8, which is fever for me.  I called clinic and relayed was what going on;  the message came back that doctor was with a patient but said I should take TYLENOL and put a cool (not ice) compress on my arm it it hurt (I did both).  The arm had red blotches and was a bit itchy.  Blisters looked like they were trying to form, but didn't.  Slept all day;  by 8:00p.m. I felt much better.  Dec. 24, 2008, No fever, some bone pain in thighs.  Arm redness was 2 inches in diameter (I measured) and itchy & painful.  Dec. 25, 2008, Pain was down in bones;  arm redness down to 1/2 of Dec. 24 but still sore.  Pain lingered in my thigh bones until mid January.
Age: 1.1
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Condition aggravated, Pyrexia, Rash erythematous
Clinical narrative: Morn after imm. child had fever 101, rash very red and much more prominent than usual.  No vom or diarrhea.  Took to doctors office at 11 AM.  Doctor called and reported reaction was to one of the vaccines.  Benadryl and Tylenol prn.  2/4 called mom to check on child and she is much better.  Still has dry skin and rash as before imm. with derm.  Will make appt.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient had complained of pain in her R arm with pain radiating from shoulder to hand the morning of 1/28/09.  This pain is still present > 1 week after vaccination.  Mother gave IBUPROFEN which helps but not completely.  Mother will call pediatrics Dept @ the end of 2 wks.  if pain has not resolved.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain in extremity
Clinical narrative: Daughter complained of pain in her entire R arm the afternoon of 1/28/09, approx 2 days after vaccination.  No radiating pain-just persistant pain in her entire arm.  Sibling was vaccinated with same vaccines @ same time also has R arm pain.  IBUPROFEN is somewhat helpful.  Mom will call MD by 2 wks post vaccination if pain persists.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Wrong technique in drug usage process
Clinical narrative: I took patient to receive the 3rd shot of GARDASIL. The person who administered the shot squeezed patient's arm and stuck the needle in her arm and the needle almost went out her arm the other part of her skin. Like she was sewing a piece of fabric.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever of 101 degrees F > Broke out in Hives > Pt. called into H. Dept 9/23 c/o of these symptoms did not seek medical care- Never returned phone calls from many messages left by doctors office- Eventually phone disconnected
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain.
Age: 5.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Varicella
Clinical narrative: Chicken pox
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Feeling hot, Limb discomfort, Musculoskeletal discomfort, Nausea
Clinical narrative: pt reported dog bite in am and needed booster td was given tdap approx 10 am in rt delt im.pt states about noon his rt upper arm and rt shoulder started to ache. the next day he had fever-said felt hot and nausea vomiting and diarrhes started. today 2/9/9 he still has diarrhea. rt arm not red or swollen but has pain and complains of increased pain when raising arm. advised to sign up for same day appointment at our clinic to be evaluated by one of our providers.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: pt reported dog bite in am and needed booster td was given tdap approx 10 am in rt delt im.pt states about noon his rt upper arm and rt shoulder started to ache. the next day he had fever-said felt hot and nausea vomiting and diarrhes started. today 2/9/9 he still has diarrhea. rt arm not red or swollen but has pain and complains of increased pain when raising arm. advised to sign up for same day appointment at our clinic to be evaluated by one of our providers.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Pruritus, Urticaria
Clinical narrative: Pruritus as soon as injection given then later that day large reddened area looked like a hive about the size of baseball which lasted several days.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose decreased, Convulsion, Loss of consciousness, Pain
Clinical narrative: Shot given Monday, February 2, 2009. Per patient: Tuesday night I could barely move. Sore all over, kinda like a flu ache but much worse. Wednesday night 911 was called.  Blood sugar had dropped low enough that I was unconscious. I bit my tongue and started seizures.  The paramedics that responsed said that this was something kinda common they had seen with the Tdap shot and diabetics. I thought I had taken too much insulin, but because the paramedics said there was some correlation between the shot and my BSL I decided to let you know.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Varicella
Clinical narrative: BREAKTHROUGH CHICKENPOX FEBRUARY 2009.  RECEIVED VARIVAX 8/1/2003 AND PROQUAD 8/18/2006.
Age: 39.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: No adverse event
Clinical narrative: Suspected spread of smallpox due to drying self with towel that may have had possible contact with vaccination area. 2/10/09 Per reporter-pt was not seen at any medical office or hosp. Reaction turned out to be possible mosquito bites.
Age: 19.0
Sex: F
Vaccine: ANTH, TYP, YF
Symptoms: Confusional state, Dizziness, Electrocardiogram, Nausea, Vision blurred
Clinical narrative: Pt recieved yellow fever vaccination 05 Feb09. After recieving the injection, pt experienced dizziness, confusion, nausea, and blurred vision x 4 days.  Pt is still experiencing symptoms but they are starting to resolve.  4/7/09 MR received for ER visit 2/7/09 with dx: Nausea w/o vomiting, lightheadedness. Pt initially presented 2/6/09 with c/o dizziness, nausea and syncopal episode with fall.  Returned to ER next day with continued lightheadedness, nausea, H/A and intermittent blurry vision. W/u (-) and d/c. Returned for f/u 2/9/09 with visual disturbance improved but still with balance issues. PE WNL. DX: Blurry vision.  Adverse Effects of Vaccines, most likely YF.  Sx resolved by 2/17/09.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Mom Called in and states that child has chicken pox despite receiving the vaccine on 05/24/2002
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: After Zoster vaccination, varicella-zoster virus-like rash and symptoms.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Musculoskeletal pain, Paralysis, Similar reaction on previous exposure to drug
Clinical narrative: Pt experienced shoulder girdle pain for 3 days followd by arm weakness and serratus muscle paralysis which has not resolved as of today. Pt had a similar symptoms after influenza shot in 2007 but only involved pain in the shoulder not weakness like this year.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody increased, Areflexia, Asthenia, Back pain, Blood product transfusion
Clinical narrative: 12/3/08 pt started with "strangled cough" and body aches. 12/12/2008 Had severe vomiting and diarrhea- extremely weak and barely could walk-no stool cultures done. Pt prescribed anti-nausea and anti-diarrheal med. 12/17/2008 Pt achy, tired, and cough returned. 12/21-12/22/2008 Couldn't walk up steps describes legs feeling like jelly. 12/23/08 extreme pain in back and all extremities, but pain only at night. 12/24/2008 Burning electrical pain continued but only at pm. 12/26/08 pt to emergency room-no reflexes present in lower extremities. Admitted to ICU. Seen by neurologist and diagnosed with Guillain Barre Syndrome. Pt had lumbar puncture, MRI, nerve conduction tests. Given IVIG for total of 5 days. 2/6/09 Pt still has residual weakness and compacted feeling in hands.  2/11/09 Received hospital medical records of 12/26-12/31/2009. FINAL DX: Guillain Barre syndrome; cervical spinal stenosis Records reveal patient had stomach flu approx 2 wks prior to admit w/N/V/D that resolved after 3 days.  Developed weakness/numbness of limbs, difficulty walking, & pain in her back x 3 days prior to admit.  Neuro consult done.  Areflexia & loss of sensation of legs.  LP done.  Tx w/IVIG x 5 day w/improvement.  D/C to home w/outpatient PT.  2/16/09 Received CSF results.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia burgdorferi serology negative, Burning sensation, CSF cell count normal, CSF protein increased, CSF white blood cell count
Clinical narrative: 12/3/08 pt started with "strangled cough" and body aches. 12/12/2008 Had severe vomiting and diarrhea- extremely weak and barely could walk-no stool cultures done. Pt prescribed anti-nausea and anti-diarrheal med. 12/17/2008 Pt achy, tired, and cough returned. 12/21-12/22/2008 Couldn't walk up steps describes legs feeling like jelly. 12/23/08 extreme pain in back and all extremities, but pain only at night. 12/24/2008 Burning electrical pain continued but only at pm. 12/26/08 pt to emergency room-no reflexes present in lower extremities. Admitted to ICU. Seen by neurologist and diagnosed with Guillain Barre Syndrome. Pt had lumbar puncture, MRI, nerve conduction tests. Given IVIG for total of 5 days. 2/6/09 Pt still has residual weakness and compacted feeling in hands.  2/11/09 Received hospital medical records of 12/26-12/31/2009. FINAL DX: Guillain Barre syndrome; cervical spinal stenosis Records reveal patient had stomach flu approx 2 wks prior to admit w/N/V/D that resolved after 3 days.  Developed weakness/numbness of limbs, difficulty walking, & pain in her back x 3 days prior to admit.  Neuro consult done.  Areflexia & loss of sensation of legs.  LP done.  Tx w/IVIG x 5 day w/improvement.  D/C to home w/outpatient PT.  2/16/09 Received CSF results.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Electrophoresis protein, Fatigue, Gait disturbance
Clinical narrative: 12/3/08 pt started with "strangled cough" and body aches. 12/12/2008 Had severe vomiting and diarrhea- extremely weak and barely could walk-no stool cultures done. Pt prescribed anti-nausea and anti-diarrheal med. 12/17/2008 Pt achy, tired, and cough returned. 12/21-12/22/2008 Couldn't walk up steps describes legs feeling like jelly. 12/23/08 extreme pain in back and all extremities, but pain only at night. 12/24/2008 Burning electrical pain continued but only at pm. 12/26/08 pt to emergency room-no reflexes present in lower extremities. Admitted to ICU. Seen by neurologist and diagnosed with Guillain Barre Syndrome. Pt had lumbar puncture, MRI, nerve conduction tests. Given IVIG for total of 5 days. 2/6/09 Pt still has residual weakness and compacted feeling in hands.  2/11/09 Received hospital medical records of 12/26-12/31/2009. FINAL DX: Guillain Barre syndrome; cervical spinal stenosis Records reveal patient had stomach flu approx 2 wks prior to admit w/N/V/D that resolved after 3 days.  Developed weakness/numbness of limbs, difficulty walking, & pain in her back x 3 days prior to admit.  Neuro consult done.  Areflexia & loss of sensation of legs.  LP done.  Tx w/IVIG x 5 day w/improvement.  D/C to home w/outpatient PT.  2/16/09 Received CSF results.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Intensive care, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: 12/3/08 pt started with "strangled cough" and body aches. 12/12/2008 Had severe vomiting and diarrhea- extremely weak and barely could walk-no stool cultures done. Pt prescribed anti-nausea and anti-diarrheal med. 12/17/2008 Pt achy, tired, and cough returned. 12/21-12/22/2008 Couldn't walk up steps describes legs feeling like jelly. 12/23/08 extreme pain in back and all extremities, but pain only at night. 12/24/2008 Burning electrical pain continued but only at pm. 12/26/08 pt to emergency room-no reflexes present in lower extremities. Admitted to ICU. Seen by neurologist and diagnosed with Guillain Barre Syndrome. Pt had lumbar puncture, MRI, nerve conduction tests. Given IVIG for total of 5 days. 2/6/09 Pt still has residual weakness and compacted feeling in hands.  2/11/09 Received hospital medical records of 12/26-12/31/2009. FINAL DX: Guillain Barre syndrome; cervical spinal stenosis Records reveal patient had stomach flu approx 2 wks prior to admit w/N/V/D that resolved after 3 days.  Developed weakness/numbness of limbs, difficulty walking, & pain in her back x 3 days prior to admit.  Neuro consult done.  Areflexia & loss of sensation of legs.  LP done.  Tx w/IVIG x 5 day w/improvement.  D/C to home w/outpatient PT.  2/16/09 Received CSF results.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Protein urine present, Syphilis test negative, Vomiting
Clinical narrative: 12/3/08 pt started with "strangled cough" and body aches. 12/12/2008 Had severe vomiting and diarrhea- extremely weak and barely could walk-no stool cultures done. Pt prescribed anti-nausea and anti-diarrheal med. 12/17/2008 Pt achy, tired, and cough returned. 12/21-12/22/2008 Couldn't walk up steps describes legs feeling like jelly. 12/23/08 extreme pain in back and all extremities, but pain only at night. 12/24/2008 Burning electrical pain continued but only at pm. 12/26/08 pt to emergency room-no reflexes present in lower extremities. Admitted to ICU. Seen by neurologist and diagnosed with Guillain Barre Syndrome. Pt had lumbar puncture, MRI, nerve conduction tests. Given IVIG for total of 5 days. 2/6/09 Pt still has residual weakness and compacted feeling in hands.  2/11/09 Received hospital medical records of 12/26-12/31/2009. FINAL DX: Guillain Barre syndrome; cervical spinal stenosis Records reveal patient had stomach flu approx 2 wks prior to admit w/N/V/D that resolved after 3 days.  Developed weakness/numbness of limbs, difficulty walking, & pain in her back x 3 days prior to admit.  Neuro consult done.  Areflexia & loss of sensation of legs.  LP done.  Tx w/IVIG x 5 day w/improvement.  D/C to home w/outpatient PT.  2/16/09 Received CSF results.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HEP, PNC
Symptoms: Cyanosis, Irritability, Oedema peripheral, Pyrexia, Swelling face
Clinical narrative: Diffuse upper and lower extremity swelling and erythema when extemities are warm. Cyanosis of the swollen extremities when they are cool. Also facial swelling. Also, acting very cranky. Possible slight fever, but none now.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Hives over entire body that itches.  Zyrtec 1/2 tsp q12hrs. given to treat symptoms as needed to help with itching.
Age: 4.0
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Infection, Inflammation, Injection site vesicles
Clinical narrative: Patient contracted cellulitis in his left leg, after receiving 3 vaccinations in that leg.  He had to be treated at the ER 38 hours after receiving the vaccines.  He was diagnosed with severe acute cellulitis.  During the 38 hours previous to treatment, he had been spiraling into a worse health condition, the infection in his left leg started with a small blister, evolving into a small red and hot mass.  Within 24 hours after vaccination, the infection had spread to about 5-6 inches in diameter, hotness, and redness, including swelling were present.  Patient ran a fever of 104 F.  By day 2, after his vaccintion, his whole upper thigh on his left leg was entirely inflamed, including his left knee.  We took him to the ER immediately.  He was given two different antibiotics, 7 doses daily; an antihistamine, 2 times daily; and pain relievers around the clock.  His upper thigh on his left leg was nearly 3 times the size of his right leg.  He also had a blister at the sight of injection.  His leg was hot and severely inflamed.  Patient also ran a severe fever.  We called our insurance nurse hotline, and were instructed to take him into ER.  He was treated by foreign health care system for the infection.  He is to be on both antibiotics for at least one week.  He is showing improvements.  Patient did receive 1 other vaccination in his right leg, but had no negative affects thus far.  Only vaccinations given in left leg had caused the problem.
Age: 4.0
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HEPA, VARCEL
Symptoms: Mass, Pyrexia, Swelling
Clinical narrative: Patient contracted cellulitis in his left leg, after receiving 3 vaccinations in that leg.  He had to be treated at the ER 38 hours after receiving the vaccines.  He was diagnosed with severe acute cellulitis.  During the 38 hours previous to treatment, he had been spiraling into a worse health condition, the infection in his left leg started with a small blister, evolving into a small red and hot mass.  Within 24 hours after vaccination, the infection had spread to about 5-6 inches in diameter, hotness, and redness, including swelling were present.  Patient ran a fever of 104 F.  By day 2, after his vaccintion, his whole upper thigh on his left leg was entirely inflamed, including his left knee.  We took him to the ER immediately.  He was given two different antibiotics, 7 doses daily; an antihistamine, 2 times daily; and pain relievers around the clock.  His upper thigh on his left leg was nearly 3 times the size of his right leg.  He also had a blister at the sight of injection.  His leg was hot and severely inflamed.  Patient also ran a severe fever.  We called our insurance nurse hotline, and were instructed to take him into ER.  He was treated by foreign health care system for the infection.  He is to be on both antibiotics for at least one week.  He is showing improvements.  Patient did receive 1 other vaccination in his right leg, but had no negative affects thus far.  Only vaccinations given in left leg had caused the problem.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blood 25-hydroxycholecalciferol, Blood thyroid stimulating hormone, Chest X-ray normal, Computerised tomogram normal
Clinical narrative: Persistent headaches and numbness in left arm, fingers, chest and leg starting after HPV #1(7/8/08), which were annoying but tolerable. Now experiencing persistent intolerable painful tingling and numbness with headaches over past 2 weeks after receiving HPV#2 (1/22/09). These symptoms are interfering with her ability to sleep and participate in college activities.  2/11/09 MR received for ER visit 2/7/09 with DX: Left Arm/Leg Pain. Numbness. Pt presented with 6 month hx of intermittent, worsening numbness and tingling which began in the chest and L arm, now involving bilateral upper and lower extremities.  Happening now several times/day and lasting hours at a time. Currently with chest and arm pain. Sleeping more. HPV vax in July 2008 and January 2009.  PE WNL. W/U (-). D/C.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Headache, Hypoaesthesia, Metabolic function test, Paraesthesia
Clinical narrative: Persistent headaches and numbness in left arm, fingers, chest and leg starting after HPV #1(7/8/08), which were annoying but tolerable. Now experiencing persistent intolerable painful tingling and numbness with headaches over past 2 weeks after receiving HPV#2 (1/22/09). These symptoms are interfering with her ability to sleep and participate in college activities.  2/11/09 MR received for ER visit 2/7/09 with DX: Left Arm/Leg Pain. Numbness. Pt presented with 6 month hx of intermittent, worsening numbness and tingling which began in the chest and L arm, now involving bilateral upper and lower extremities.  Happening now several times/day and lasting hours at a time. Currently with chest and arm pain. Sleeping more. HPV vax in July 2008 and January 2009.  PE WNL. W/U (-). D/C.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Sleep disorder
Clinical narrative: Persistent headaches and numbness in left arm, fingers, chest and leg starting after HPV #1(7/8/08), which were annoying but tolerable. Now experiencing persistent intolerable painful tingling and numbness with headaches over past 2 weeks after receiving HPV#2 (1/22/09). These symptoms are interfering with her ability to sleep and participate in college activities.  2/11/09 MR received for ER visit 2/7/09 with DX: Left Arm/Leg Pain. Numbness. Pt presented with 6 month hx of intermittent, worsening numbness and tingling which began in the chest and L arm, now involving bilateral upper and lower extremities.  Happening now several times/day and lasting hours at a time. Currently with chest and arm pain. Sleeping more. HPV vax in July 2008 and January 2009.  PE WNL. W/U (-). D/C.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC, RV1
Symptoms: Abnormal faeces, Constipation, Faeces discoloured, Infrequent bowel movements, Irritability
Clinical narrative: Patient presented to clinic with mother (MOC) to receive 4 month vaccinations.  During the screening process MOC stated that infant became extremely irritable and became constipated  following receipt of vaccinations on 12/17/08.  MOC stated that infant did not have bowel movement for 5 five days post-vaccination.  Infant taken to urgent care center for assessment; no treatment provided.  Infant is breastfed.  Explained to MOC that breastfed infants can go for several days without having a bowel movement.  This is not reason for concern unless the infant appears to be uncomfortable.  MOC went on to state that when infant did have a bowel movement it was "black and tar-like".  MOC also stated that the stool had a very foul smell.  Current stool pattern has returned to normal and infant no longer appears to be in distress.  On 02/5/09 RN made determination to proceed with administering HIB dose #2 and PCV dose #2; withheld Rotarix dose #2 due to concerns regarding potential adverse reaction to Rotarix vaccination.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC, RV1
Symptoms: Melaena
Clinical narrative: Patient presented to clinic with mother (MOC) to receive 4 month vaccinations.  During the screening process MOC stated that infant became extremely irritable and became constipated  following receipt of vaccinations on 12/17/08.  MOC stated that infant did not have bowel movement for 5 five days post-vaccination.  Infant taken to urgent care center for assessment; no treatment provided.  Infant is breastfed.  Explained to MOC that breastfed infants can go for several days without having a bowel movement.  This is not reason for concern unless the infant appears to be uncomfortable.  MOC went on to state that when infant did have a bowel movement it was "black and tar-like".  MOC also stated that the stool had a very foul smell.  Current stool pattern has returned to normal and infant no longer appears to be in distress.  On 02/5/09 RN made determination to proceed with administering HIB dose #2 and PCV dose #2; withheld Rotarix dose #2 due to concerns regarding potential adverse reaction to Rotarix vaccination.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Anorexia, Irritability, Lethargy, Listless, Pyrexia
Clinical narrative: 103 Fever (48 hours later)  Low-grade fever after treatment with Tylenol/Ibuprofen lasting at least 5 days, Mild Rash, Lethargy, Listlessness, Fussiness, loss of appetite
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: 103 Fever (48 hours later)  Low-grade fever after treatment with Tylenol/Ibuprofen lasting at least 5 days, Mild Rash, Lethargy, Listlessness, Fussiness, loss of appetite
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: An itchy, slightly swollen red rash (approx. 1.5 inches in diameter) was noticed on my upper arm at the site of the vaccination about 24 hours after being administered.  I applied topical 1% hydrocortisone cream 3 or 4 times a day to reduce the itching.  The rash gradually disappeared after 6 days.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site rash, Injection site urticaria, Pyrexia
Clinical narrative: hives/raised rash at injection site, fever
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Redness, swollen, & rash around vaccine area notice on 2/6/09 taking bath, on 2/7/09 & 2/8/09.  The rash went away redness swollen 7cm x 6cm on 2/9/09
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Beginning 1/10/2009, red bumps appeared on back of hands + face -  total E2Y changed to  - 5 pustules resolved after one week
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Pneumonia, Pyrexia, Rash
Clinical narrative: Client was noted to have Red spots first on arms, trunk and then legs. Rash lasted 5-6 client was taken to ER with 104. fever, client TX for pneumonia.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Rash, Swelling face
Clinical narrative: Facial Swelling, rash prescribed Orapred and given Benadryl at ER
Age: 2.0
Sex: F
Vaccine: DTAP, FLUN3, HEPA, IPV
Symptoms: Febrile convulsion, Full blood count normal, Laboratory test normal, Lethargy, Pyrexia
Clinical narrative: Vaccine on 25-09  2-6-09 fever (elevated to 104.7 rectally - ER notes) lethargy > febrile seizure
Age: 2.0
Sex: F
Vaccine: DTAP, FLUN3, HEPA, IPV
Symptoms: Scan brain
Clinical narrative: Vaccine on 25-09  2-6-09 fever (elevated to 104.7 rectally - ER notes) lethargy > febrile seizure
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives on face, neck, groin area, back, and torso.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Full blood count, Metabolic function test, Oedema, Tenderness
Clinical narrative: On 2/3/09 student came in with c/o R hand reddness at the nails.  Started with 2-4 fingers then extended to 4th + 5th fingers, slight edema, mild tenderness of affected joint & complaints that hand feels heavy.  Student denies itching.  Full ROM of hand.  Student say symptoms began 5 days after receiving #2 Hep B vaccine.  Pt reported on 2/3/09 and advised to take BENADRYL.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Chills, Pyrexia, Streptococcal identification test negative
Clinical narrative: Fever + Chills 5 hours after vaccine, lasted 4 days.
Age: 1.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: After 10 days fever and runny nose. 12 days-rash-head, belly, arms and legs. Itching. Improvement at 15 days.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Immediate post-injection reaction, Lethargy
Clinical narrative: Chills, lethargic 10 minutes after the infection chills immediately after injection.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: 24-30 hours after vaccine pt broke out in hives all over hands and face on and off x 3 days. Given Benadryl with relief.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: During administration the patient had a vasovagal response. She was sitting on an exam table was brought to a recombant position and recovered within a few minutes.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Musculoskeletal pain, Pain
Clinical narrative: Pt contacted clinic on 2/6/09 (injection given on 02/4/09) stating after third HPV injection she experienced mild swelling @ site with moderate pain and bilateral shoulder , elbow, and wrist join pain (no recent trauma noted), throbbing in (R) side down to fingers, cannot sleep on (R)Side.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Pt contacted clinic on 2/6/09 (injection given on 02/4/09) stating after third HPV injection she experienced mild swelling @ site with moderate pain and bilateral shoulder , elbow, and wrist join pain (no recent trauma noted), throbbing in (R) side down to fingers, cannot sleep on (R)Side.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient states she had a S/E of right arm pain from upper arm down her arm which lasted 5 days, It was hard for her to lift her right arm over her shoulder. This started at night on 1-15-08 and was worse in the arm 1-16-08, she also had dizziness X2 days. Ice and Tylenol helped the arm pain.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Decreased appetite, Dizziness, Erythema, Injection site mass
Clinical narrative: Tdap 1/30/09- Rx scarred immediately - dizziness, 1/31/09 Temp 103 redness- swelling and warmth. Decreased appetite. Dizziness relieved by antivent. No Temp 2/2/09 Lump still growing 12 x 10 cm. Very warm. Redness up to shoulder
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Tdap 1/30/09- Rx scarred immediately - dizziness, 1/31/09 Temp 103 redness- swelling and warmth. Decreased appetite. Dizziness relieved by antivent. No Temp 2/2/09 Lump still growing 12 x 10 cm. Very warm. Redness up to shoulder
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Chest X-ray normal, Headache, Pain in extremity, Tenderness
Clinical narrative: Pt presented to ER c/o arm soreness radiating to head. Increased soreness over WE. Pt noted mobile firm module (L) elest @ collar bone. MD's note - "No erythema or heat pr swelling of (L) shoulder or deltoid. Normal ROM of hand & elbow. Painful to motion of shoulder. Tender Lt trapezius esp upper mid position" Prescribed with MOTRIN, BACLOFEN, BACTRIM DS.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Oedema, Pyrexia
Clinical narrative: Pt presented to office with erythema & ederma @ below the sight of the injection, pt also developed fevers for 2 days post injection- treatment was BENADRYL & TYLENOL/IBUPROFEN & ice to site.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Excessive swelling at injection site.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Activities of daily living impaired, Aggression, Anorexia
Clinical narrative: Information has been received from a gynecologist, concerning a 21 year old female patient with history of pollinosis who was vaccinated with a third dose GARDASIL (Lot number 0277U, Batch number NG00020, injection route and site not reported) On 13-MAR-2008. On 28-MAR-2008, the patient developed gastrointestinal cramps with postprandial diarrhea for, the first time. She recurrently complained of abdominal cramps with diarrhoea. After one of these episodes, in September 2008, she went to the emergency room. Clinical examination, lab tests and abdominal sonography were without pathologies. Suspected diagnosis was enteritis. During months she had a weight loss of 5 kg of weight. Within a few months p.v. the patient also experienced generalized itching and an eczema on the right hand. The patient additionally complained of impaired memory, amnesic aphasia, concentration impairment, bad mood, aggression, listlessness, arthralgia, headache, pain and numbness in the whole left arm (from shoulder to fingertips) so that temporarily driving a car was not possible. Also, the patient experienced intermenstrual bleeding, sleeping disorder because of pain in legs, dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with lymphadenopathy followed by ear pain and reduced hearing. In June 2008, the patient consulted a pneumologist because of frequent dyspnoea and unusual cough. Diagnosis of allergic bronchial asthma was diagnosed for the first time (long time history of pollinosis). Treatment with beclometasone and salbutamole inhalatives was started. The outcome was not reported. Upon internal review report considered medically significant. Other business partner numbers included: E2009-00384. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Arthralgia, Asthenia, Asthma, Cough
Clinical narrative: Information has been received from a gynecologist, concerning a 21 year old female patient with history of pollinosis who was vaccinated with a third dose GARDASIL (Lot number 0277U, Batch number NG00020, injection route and site not reported) On 13-MAR-2008. On 28-MAR-2008, the patient developed gastrointestinal cramps with postprandial diarrhea for, the first time. She recurrently complained of abdominal cramps with diarrhoea. After one of these episodes, in September 2008, she went to the emergency room. Clinical examination, lab tests and abdominal sonography were without pathologies. Suspected diagnosis was enteritis. During months she had a weight loss of 5 kg of weight. Within a few months p.v. the patient also experienced generalized itching and an eczema on the right hand. The patient additionally complained of impaired memory, amnesic aphasia, concentration impairment, bad mood, aggression, listlessness, arthralgia, headache, pain and numbness in the whole left arm (from shoulder to fingertips) so that temporarily driving a car was not possible. Also, the patient experienced intermenstrual bleeding, sleeping disorder because of pain in legs, dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with lymphadenopathy followed by ear pain and reduced hearing. In June 2008, the patient consulted a pneumologist because of frequent dyspnoea and unusual cough. Diagnosis of allergic bronchial asthma was diagnosed for the first time (long time history of pollinosis). Treatment with beclometasone and salbutamole inhalatives was started. The outcome was not reported. Upon internal review report considered medically significant. Other business partner numbers included: E2009-00384. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Disturbance in attention, Dizziness, Dyspnoea, Ear pain
Clinical narrative: Information has been received from a gynecologist, concerning a 21 year old female patient with history of pollinosis who was vaccinated with a third dose GARDASIL (Lot number 0277U, Batch number NG00020, injection route and site not reported) On 13-MAR-2008. On 28-MAR-2008, the patient developed gastrointestinal cramps with postprandial diarrhea for, the first time. She recurrently complained of abdominal cramps with diarrhoea. After one of these episodes, in September 2008, she went to the emergency room. Clinical examination, lab tests and abdominal sonography were without pathologies. Suspected diagnosis was enteritis. During months she had a weight loss of 5 kg of weight. Within a few months p.v. the patient also experienced generalized itching and an eczema on the right hand. The patient additionally complained of impaired memory, amnesic aphasia, concentration impairment, bad mood, aggression, listlessness, arthralgia, headache, pain and numbness in the whole left arm (from shoulder to fingertips) so that temporarily driving a car was not possible. Also, the patient experienced intermenstrual bleeding, sleeping disorder because of pain in legs, dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with lymphadenopathy followed by ear pain and reduced hearing. In June 2008, the patient consulted a pneumologist because of frequent dyspnoea and unusual cough. Diagnosis of allergic bronchial asthma was diagnosed for the first time (long time history of pollinosis). Treatment with beclometasone and salbutamole inhalatives was started. The outcome was not reported. Upon internal review report considered medically significant. Other business partner numbers included: E2009-00384. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Eczema, Enteritis, Gastrointestinal pain, Headache, Hypoacusis
Clinical narrative: Information has been received from a gynecologist, concerning a 21 year old female patient with history of pollinosis who was vaccinated with a third dose GARDASIL (Lot number 0277U, Batch number NG00020, injection route and site not reported) On 13-MAR-2008. On 28-MAR-2008, the patient developed gastrointestinal cramps with postprandial diarrhea for, the first time. She recurrently complained of abdominal cramps with diarrhoea. After one of these episodes, in September 2008, she went to the emergency room. Clinical examination, lab tests and abdominal sonography were without pathologies. Suspected diagnosis was enteritis. During months she had a weight loss of 5 kg of weight. Within a few months p.v. the patient also experienced generalized itching and an eczema on the right hand. The patient additionally complained of impaired memory, amnesic aphasia, concentration impairment, bad mood, aggression, listlessness, arthralgia, headache, pain and numbness in the whole left arm (from shoulder to fingertips) so that temporarily driving a car was not possible. Also, the patient experienced intermenstrual bleeding, sleeping disorder because of pain in legs, dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with lymphadenopathy followed by ear pain and reduced hearing. In June 2008, the patient consulted a pneumologist because of frequent dyspnoea and unusual cough. Diagnosis of allergic bronchial asthma was diagnosed for the first time (long time history of pollinosis). Treatment with beclometasone and salbutamole inhalatives was started. The outcome was not reported. Upon internal review report considered medically significant. Other business partner numbers included: E2009-00384. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Impaired driving ability, Laboratory test normal, Listless, Lymphadenopathy
Clinical narrative: Information has been received from a gynecologist, concerning a 21 year old female patient with history of pollinosis who was vaccinated with a third dose GARDASIL (Lot number 0277U, Batch number NG00020, injection route and site not reported) On 13-MAR-2008. On 28-MAR-2008, the patient developed gastrointestinal cramps with postprandial diarrhea for, the first time. She recurrently complained of abdominal cramps with diarrhoea. After one of these episodes, in September 2008, she went to the emergency room. Clinical examination, lab tests and abdominal sonography were without pathologies. Suspected diagnosis was enteritis. During months she had a weight loss of 5 kg of weight. Within a few months p.v. the patient also experienced generalized itching and an eczema on the right hand. The patient additionally complained of impaired memory, amnesic aphasia, concentration impairment, bad mood, aggression, listlessness, arthralgia, headache, pain and numbness in the whole left arm (from shoulder to fingertips) so that temporarily driving a car was not possible. Also, the patient experienced intermenstrual bleeding, sleeping disorder because of pain in legs, dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with lymphadenopathy followed by ear pain and reduced hearing. In June 2008, the patient consulted a pneumologist because of frequent dyspnoea and unusual cough. Diagnosis of allergic bronchial asthma was diagnosed for the first time (long time history of pollinosis). Treatment with beclometasone and salbutamole inhalatives was started. The outcome was not reported. Upon internal review report considered medically significant. Other business partner numbers included: E2009-00384. Additional information has been requested.