chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Computerised tomogram normal, Convulsion, Drooling, Dyskinesia, Electroencephalogram abnormal
Clinical narrative: Focal seizures (staring, drooling, generalized jerking) for > 15 min. the morning after receiving MMR, VARIVAX, DTAP, IPV. Transferred to PICU.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Intensive care, Staring
Clinical narrative: Focal seizures (staring, drooling, generalized jerking) for > 15 min. the morning after receiving MMR, VARIVAX, DTAP, IPV. Transferred to PICU.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Rash erythematous, Rash generalised, Rash papular
Clinical narrative: Child received PENTACEL (Lot #3555AA, exp 10-17-11, Sanofi) and PREVNAR (#D94434, exp. 4/12, Wyeth) on 3-15-10. On 3-19-10 child present with a fine erythematous papular rash from head to feet. Child given RX for BENADRYL & ORAPRED on 3-19-10.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Crying, Dizziness, Feeling cold, Tremor
Clinical narrative: Lips trembling, feeling cold with obvious chills, observed kept warm, started feeling dizzy, started crying no difficulty breathing.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Oedema peripheral
Clinical narrative: Large localized swelling from shoulder to elbow.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: The patient sent an e-mail and stated a few days after my flu shot on 10/15/09 I began to have an inflamed area around the shot. There was some swelling but not that painful. It was a red ring with a yellow ring in the center. Went to the doctor and said that the needles may have moved & bruised it but that there was a small CA was there row and I am being treated for that.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: MMR shot given with VAR + HA-on 3/17/10 came to office on 3/9 for 4cm + 8 3/4cm red, hard mass to right thigh. Not warm to touch, no fever.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Flushing, Rash
Clinical narrative: Developed rash on face within one hour of vaccination. Faded to flushed face by second hour. Taken home by father.  Did not see doctor. Returned to school 12/15/2009 No symptoms.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Injection site cellulitis, Injection site reaction, Injection site warmth
Clinical narrative: Patient developed local site reaction during the evening of 3/18. Was seen in office at 4:00 on 3/19. 7x5 cm erythematous cellulitis, warm to touch, soft.
Age: 34.0
Sex: F
Vaccine: HEP, MMR, TD, TDAP
Symptoms: Oropharyngeal pain, Pruritus, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Severe Rash covering whole left arm with fever, sore throat, congestion, runny nose, itching at rash site, site has now began to slough off dead skin. Rash resembled a mild chemical burn.
Age: 34.0
Sex: F
Vaccine: HEP, MMR, TD, TDAP
Symptoms: Skin exfoliation
Clinical narrative: Severe Rash covering whole left arm with fever, sore throat, congestion, runny nose, itching at rash site, site has now began to slough off dead skin. Rash resembled a mild chemical burn.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: pt felt dizzy and weak and nauseous
Age: 4.0
Sex: F
Vaccine: FLUX(H1N1), UNK, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: R arm swelling with induration, erythema, warmth, tenderness and vesicles
Age: 4.0
Sex: F
Vaccine: FLUX(H1N1), UNK, VARCEL
Symptoms: Injection site warmth
Clinical narrative: R arm swelling with induration, erythema, warmth, tenderness and vesicles
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dysphonia, Dyspnoea, Epstein-Barr virus test negative, Full blood count normal
Clinical narrative: 45 min after H1N1 injection given, difficulty breathing, hoarse vocie, only able to whisper, thingling in knees, fingers and toes.  feels faint, but does not pass out.  feet feel cold.  symptoms resolved with dose of benadryl and predinsone.  reoccur once daily on Friday, Saturday, Monday and Tuesday.  gets better after takes one dose of benadryl.  taking 5 day course of prednisone.  no other reaction to any other IZ or meds. seen twice in ED (Friday and Saturday) once in pedi clinic on 3/15/10. every day the symptoms are shorter.  lasted 1 1/2hr Friday, by Tuesday on lasting 1/2 hour.  hoarseness and whispery voice goes away with dose of Benadryl.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Paraesthesia, Parvovirus B19 test negative, Peripheral coldness, Streptococcus test negative
Clinical narrative: 45 min after H1N1 injection given, difficulty breathing, hoarse vocie, only able to whisper, thingling in knees, fingers and toes.  feels faint, but does not pass out.  feet feel cold.  symptoms resolved with dose of benadryl and predinsone.  reoccur once daily on Friday, Saturday, Monday and Tuesday.  gets better after takes one dose of benadryl.  taking 5 day course of prednisone.  no other reaction to any other IZ or meds. seen twice in ED (Friday and Saturday) once in pedi clinic on 3/15/10. every day the symptoms are shorter.  lasted 1 1/2hr Friday, by Tuesday on lasting 1/2 hour.  hoarseness and whispery voice goes away with dose of Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness on left deltoid 3 3/4 in wide and 4 1/2 in long, warm to touch.  Parent states it hurts her.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Felt hot and diaphoric, felt faint amd nauseous.  Did not faint.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: REDNESS ON THE SITE OF THE VACCINATION WAS NOTED 2CM BY 3 CM, NO SWELLINGS, NO FEVER, AND NO INDENTATION NOTED. INSTRUCTED PATIENT'S PARENT TO APPLY ICE PACK AND ADMINISTER TYLENOL 320MG IN CASE OF ANY FEVER.
Age: 27.0
Sex: M
Vaccine: TTOX
Symptoms: Hypoaesthesia, Muscle twitching, Pain in extremity, Similar reaction on previous exposure to drug
Clinical narrative: Donor stated he had pain and numbness in (L) arm that lasted 1 week. Donor also stated he had muscle twitching in his jaw. Donor stated he has had all of these symptoms previously from tetanus.  Donor stated he developed pain & numbenss in left arm with twitching jaw muscles lasting 1 week.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Lethargy, Pyrexia
Clinical narrative: 1st 48 hours - high fever - lethargic - ultra sensitive to loud sounds. Behavior deteriorated thru week at school that was "bizarre" for child including hitting and fighting.
Age: 44.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site erythema
Clinical narrative: Patient presented with erythema at injection site two days after receiving injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU(H1N1), MMR
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient received vaccine below on 3/17 (KINRIX and V2V). 3/17 Developed erythema, rash severe at left deltoid, is for positive pruritus. No papus.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Arthralgia, Asthenia, Headache, Hypersomnia
Clinical narrative: 03/11/ pm- behavior changes, swelling of face & neck, head & joint pain, high temperature, weakness, can't stop sleeping. I called Dr's office, they told me this was normal & use pain medication & Benadryl.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Local swelling, Pyrexia, Swelling face
Clinical narrative: 03/11/ pm- behavior changes, swelling of face & neck, head & joint pain, high temperature, weakness, can't stop sleeping. I called Dr's office, they told me this was normal & use pain medication & Benadryl.
Age: 0.36
Sex: F
Vaccine: DTAPH, RVX
Symptoms: Infantile spitting up, Vomiting projectile
Clinical narrative: Projectile vomiting and/or excessive spit up (pouring out of mouth and nose)
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Convulsion, Febrile convulsion, Pyrexia, Unresponsive to stimuli
Clinical narrative: On 12/29, child had a fever induced seizure while sleeping (fever of 105).  6 weeks later, child had another seizure while awake and playing.  When paramedics arrived, fever was 102, blood sugar was 140.  Took child 1.25 hours to become responsive after seizure.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site warmth, Rash macular
Clinical narrative: Since it is normal for a vaccine site to be warm, red and sore I didn't pay any attention to it. After a few weeks I noticed that my left arm (where I got the H1N1 vaccine) was still sore, hot and red and was not getting any better. The right arm where I got the seasonal flu vaccine was fine. When I was able to, I went to the occupational health office at work the end of December (I think 12/28). I was given 650mg of Motrin to take 3x a day. It didn't help. I went back a week later and was started on a Medrol pack 1/9/10. All the symptoms went away, but a few days after stopping the Medrol they all came back. I took a picture to show the blotchy red on 1/19. I was started on a second Medrol pack 1/23. A CBC was drawn and I was told the results were all normal. The redness went away but then I got an upper respiratory infection. Now the soreness and warmth are always there but the redness only periodically appears. On 3/19/10 I noticed my arm was getting increasingly more painful and red I took a picture. In the morning my arm felt even worse than the day before so I looked at it and the redness had spread an was more blotchy. I took another picture. The entire deltoid is very sore and painful and is several degrees warmer than my other arm. The best way I can describe it is like a cross between a bad sunburn, wicked bruise, and a badly sprained ankle.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Upper respiratory tract infection
Clinical narrative: Since it is normal for a vaccine site to be warm, red and sore I didn't pay any attention to it. After a few weeks I noticed that my left arm (where I got the H1N1 vaccine) was still sore, hot and red and was not getting any better. The right arm where I got the seasonal flu vaccine was fine. When I was able to, I went to the occupational health office at work the end of December (I think 12/28). I was given 650mg of Motrin to take 3x a day. It didn't help. I went back a week later and was started on a Medrol pack 1/9/10. All the symptoms went away, but a few days after stopping the Medrol they all came back. I took a picture to show the blotchy red on 1/19. I was started on a second Medrol pack 1/23. A CBC was drawn and I was told the results were all normal. The redness went away but then I got an upper respiratory infection. Now the soreness and warmth are always there but the redness only periodically appears. On 3/19/10 I noticed my arm was getting increasingly more painful and red I took a picture. In the morning my arm felt even worse than the day before so I looked at it and the redness had spread an was more blotchy. I took another picture. The entire deltoid is very sore and painful and is several degrees warmer than my other arm. The best way I can describe it is like a cross between a bad sunburn, wicked bruise, and a badly sprained ankle.
Age: 52.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea and Mild Diarrhea contuning now today over 10 days later. Treated Diarrhea with Pepto Bismol daily 8 doses which has helped the Diarrhea but not the Nausea which I rate on a 10 scale as a 5.
Age: 18.0
Sex: F
Vaccine: FLUX(H1N1), HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site irritation
Clinical narrative: Had area of induration and irritation at site of Varicella Vaccination that is improving.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Pt reports back of tongue and throat feel swollen. Pt with no IV access. Pt given Diphenhydramine 25 mg po x 1. Symptoms relieved by 12 NOON.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: No reaction on previous exposure to drug, Pharyngeal oedema, Swollen tongue
Clinical narrative: Pt reports back of tongue and throat feel swollen. Pt with no IV access. Pt given Diphenhydramine 25 mg po x 1. Symptoms relieved by 12 NOON.
Age: 62.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Blood test, Diarrhoea, Dizziness, Hypoaesthesia, Muscular weakness
Clinical narrative: Severe diarrhea, dizziness, nausea, general weakness.  Leg weakness, numbness, tingling. Went to ER, Administered IV fluids and medications. Went to Primary Physician on Jan 26, 2010 for Annual Physical Checkup (blood test, pap smear) and told her about the ER visit. Went out of the country for a scheduled vacation (Jan 29-Mar 5, 2010) Went to Hospital while on vacation on Feb 13, 2010 - due to persistent leg weakness, numbness, tingling. Had MRI and nerve analysis. Given GABAPENTIN (30) for neuropathy for one month. Advised to see a neurologist when back home. Made an apptment with Dr. on March 23, 2010. Currently waiting for apptment/visit.
Age: 62.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Nausea, Nerve conduction studies, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Severe diarrhea, dizziness, nausea, general weakness.  Leg weakness, numbness, tingling. Went to ER, Administered IV fluids and medications. Went to Primary Physician on Jan 26, 2010 for Annual Physical Checkup (blood test, pap smear) and told her about the ER visit. Went out of the country for a scheduled vacation (Jan 29-Mar 5, 2010) Went to Hospital while on vacation on Feb 13, 2010 - due to persistent leg weakness, numbness, tingling. Had MRI and nerve analysis. Given GABAPENTIN (30) for neuropathy for one month. Advised to see a neurologist when back home. Made an apptment with Dr. on March 23, 2010. Currently waiting for apptment/visit.
Age: 0.18
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mass, Swelling
Clinical narrative: Redness and swelling-large lump.
Age: 36.0
Sex: F
Vaccine: DT, HEPA, IPV, TYP, YF
Symptoms: Rash erythematous, Swelling
Clinical narrative: Small bug-bite size red mark. Size of rash has grown to half dollar-size by 03/20/2010.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Myalgia, Skin warm
Clinical narrative: After injection significant amount of pain at injection site in upper shoulder throughout first day and night.  Woke me up multiple times during that first night, even after taking ibuprofen.  Pain again throughout the day on Thursday, taking ibuprofen. Noticed during the evening that the pain migrated from the shoulder muscle into the bicep muscle.  About 9pm when changing clothes Thursday evening caught site of left arm.  Bicep area red and inflamed, with swelling in shoulder and upper arm, as compared to right arm.  Red areas very hot to the touch.  Had taken Zyrtec already both the day of the injection and on Thursday, due to allergies.  Called the 24 hour nurse line associated with my health insurance to ask what to do.  The nurse recommended I seek medical treatment within one hour.  As I write this on Saturday evening, 3/20, about 9:45pm, the reaction has subsided somewhat, but there is still some swelling and redness in my upper arm.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Inflammation and redness at injection site spread to just above elbow and to the inside of bicep and top of deltoid. Visited ER, they recommended Benadryl.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Red swollen large bump on leg that faded in color but is still present, large and very hard one week later.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging spinal cord abnormal, Paraesthesia
Clinical narrative: Seasonal flu shot FLUZONE 2009 on Oct 6th. 2 weeks later woke up with tingly feeling in both legs-like they were "asleep" but no weakness, pain or loss of feeling. Within a week the numbness spread from the chest down to the feet. after 3 weeks, saw doctor and a neurologist. MRI at 4 weeks showed inflammation in the spinal cord. Tingling now felt in fingers.  Hospitalized for Spinal tap and treated with heavy dose of steroids IV. All other test results were negative.  After 4 months all symptoms were gone.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Spinal cord disorder
Clinical narrative: Seasonal flu shot FLUZONE 2009 on Oct 6th. 2 weeks later woke up with tingly feeling in both legs-like they were "asleep" but no weakness, pain or loss of feeling. Within a week the numbness spread from the chest down to the feet. after 3 weeks, saw doctor and a neurologist. MRI at 4 weeks showed inflammation in the spinal cord. Tingling now felt in fingers.  Hospitalized for Spinal tap and treated with heavy dose of steroids IV. All other test results were negative.  After 4 months all symptoms were gone.
Age: 39.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site pain, Wrong drug administered
Clinical narrative: Administered by: MA  Symptoms: Inappropriate drug administration; wrong vaccine given to 40 yr. old woman. Injected arm sore for 2days. Injection site sore for four days.  40 yr. old woman was given injectable Merck Gardasil vaccine instead of injectable Merck Varivax vaccine.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Injection site pain, Joint injection, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Upper arm pain began shortly after seasonal flu shot. Initially concentrated at site of shot, which broadened to upper arm and shoulder area with decreasing range of motion and intensifying pain with movement. Dr. indicated he had never seen such a reaction to a seasonal flu shot and ordered an X-Ray, which showed no abnormality. He referred me to orthopedic shoulder specialist, who gave me a cortisone shot in the shoulder and ordered an MRI. The MRI showed a bruised and inflamed bursa and rotator cuff and he felt I had a frozen shoulder. Dr. also recommended physical therapy, and after 9 PT sessions, and also 6 chiropractic therapy sessions I have had little improvement.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Periarthritis, X-ray normal
Clinical narrative: Upper arm pain began shortly after seasonal flu shot. Initially concentrated at site of shot, which broadened to upper arm and shoulder area with decreasing range of motion and intensifying pain with movement. Dr. indicated he had never seen such a reaction to a seasonal flu shot and ordered an X-Ray, which showed no abnormality. He referred me to orthopedic shoulder specialist, who gave me a cortisone shot in the shoulder and ordered an MRI. The MRI showed a bruised and inflamed bursa and rotator cuff and he felt I had a frozen shoulder. Dr. also recommended physical therapy, and after 9 PT sessions, and also 6 chiropractic therapy sessions I have had little improvement.
Age: 2.0
Sex: M
Vaccine: FLUX(H1N1), HEPA
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: Projectile vomiting (6+ times) Low grade fever
Age: 43.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Hypoaesthesia, Mobility decreased, Muscular weakness
Clinical narrative: L ARM NUMBNESS, WEAKNESS, UNABLE TO LIFT L HAND ABOVE HEAD
Age: 23.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness, Lightheadedness, Nausea, Vomiting.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: Numbness, pain and tingling in radiating from the injection site to the tips of my fingers (left arm & hand). The pain, numbness & tingling have become unbearable & I will have to seek medical treatment.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Numbness, pain and tingling in radiating from the injection site to the tips of my fingers (left arm & hand). The pain, numbness & tingling have become unbearable & I will have to seek medical treatment.
Age: 21.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Aortic rupture, Chest pain, Death
Clinical narrative: He recieved the H1N1 vaccine around 9:00 am. At he at 12:00 Complaining of chest pain. No Diagnosis, then released from hospital. He Died at midnight (12:00 am) from a ruptured aorta.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left upper arm. Rx given for KEFLEX and BENADRYL. No improvement after 28 hours with antibiotics per mother. Instructed parent to take child to ER.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching around injection site.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Autopsy, Cardiomegaly, Death, Ventricular arrhythmia
Clinical narrative: Information has been received from a consumer through an article on the internet concerning an 18 year old female who on an unspecified date was vaccinated with the dose of GARDASIL. On an unspecified date the patient died. The autopsy was performed and it was revealed that there was biventricular cardiomegaly, transmural replacement of myocytes by fibro-fatty tissue in the right ventricular wall and also diffuse variable myocyte hypertrophy. The arrhythmogenic right ventricular dysplasia (ARVD) was reported as a possible diagnosis. It was stated that because of the extensive tissue degeneration that had occurred prior to autopsy, some of these diagnostic findings could not be definitely identified. The cause of death was unspecified. This is one of several cases from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Abortion induced, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Information has been received from a health worker concerning a 20 year old female patient who on 06-JUL-2009 was vaccinated with a 0.5ml dose of MMR II (rHA, lot # 660008/1375X). There was no concomitant medication. The patient became pregnant after receiving the vaccination. Pregnancy test had been done. Unspecified medical attention had been sought. Follow up information has been received from a clinic which reported that the patient had elective therapeutic abortion (TAB) in the first trimester. Upon internal review, elective therapeutic abortion (TAB) was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a consumer via internet newspaper concerning her daughter, who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently the patient was suffering for seizures, a problem her parents were convinced was a result of GARDASIL "shots". It was stated that the Centers for Disease Control stand behind the vaccine, as a safe way to prevent cases of cervical cancer that health officials insist will otherwise kill thousands of women. At the time of the report the patient's outcome was unknown. It was unknown if the patient sought medical attention. Upon internal review seizures was considered to be an other important medical event. This is one of several reports from the same source. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HEP, HEP, VARCEL
Symptoms: Injection site erythema, Injection site macule, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Left upper arm at inj site (subQ) 7.5 cm x 7 cm erythematous, warm, tender macular rash no d/c, rash x 1 day, observe, no NSAIDS or ASA, ice to arm.
Age: 27.0
Sex: F
Vaccine: HEP, HEP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Rash macular
Clinical narrative: Left upper arm at inj site (subQ) 7.5 cm x 7 cm erythematous, warm, tender macular rash no d/c, rash x 1 day, observe, no NSAIDS or ASA, ice to arm.
Age: 27.0
Sex: F
Vaccine: HEP, HEP, VARCEL
Symptoms: Viral titre
Clinical narrative: Left upper arm at inj site (subQ) 7.5 cm x 7 cm erythematous, warm, tender macular rash no d/c, rash x 1 day, observe, no NSAIDS or ASA, ice to arm.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Intussusception
Clinical narrative: intussusception
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: MOM REPORTS INJECTION SITE IRRITATION, RED, TENDER, ITCHING
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Localized Erythema/Edema at Varivax vaccination site.
Age: 5.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Chest discomfort, Dysphagia
Clinical narrative: CHILD C/O HAVING HARD TIME SWALLOWING AND FEELING CRACKLY IN HER CHEST. ABLE TO EAT LUNCH.  SAT 100%, NO DISTRESS AT TIME RETURNED TO OFFICE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Arm swelling and erythema to "twice its diameter" (per ED notes) without fever and only with minimal pain, resolved with NSAID administration.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RED, SLIGHTLY SWOLLEN AREA ON R ARM SUBCUTANEOUS AREA. KEFLEX 500 MG BID X 10 DAYS.
Age: 15.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Symptoms, signs, 2 weeks, no treatments
Age: 1.59
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Weight bearing difficulty
Clinical narrative: Child was not bearing weight on legs post immunization. Mother gave MOTRIN, child was able to bear weight, treatment: q 6 - 8 hours MORTIN PRN. Complete recovery by 2 days.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV4, TDAP
Symptoms: Convulsion, Dizziness
Clinical narrative: Pt was ready to go and mom was signing some papers and pt fell forward. I caught her lowered her to ground and she had a small 10 sec seizure. Mom said she has hx of them. Pt woke and asked what happened. Pt was checked by doctor and left. Follow up with pt 3/22/10. Pt doing fine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 13 x 9 cm area of mild erythema and swelling on left upper arm - circular.
Age: 4.0
Sex: U
Vaccine: DTAPIPVHIB, HEP, MMR, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: L thigh redness, warmth and edematous area of about 1 x 1.5 inch. Started on 3/18/ 2010 in the evening according to mother. Child seen at the clinic today @ ice, TYLENOL q 4 hours as order by PCP.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Asthenia, Cyanosis, Eye disorder, Fall, Headache
Clinical narrative: Less than 5 minutes after receiving vaccines patient passed out on the bed, fell down from the bed to floor and became unconscious, stiff, fingers and hand turned outward, face turned white and blue, eyes rolled back, tongue was sticking out and she became completely soaked in urine. I (parent) screamed and called for help. Head was stuck under wooden board found at the bottom of examining table and her head had to be pulled out. About 5 minutes later came around, put hands on head, seemed unaware of what had occurred. Blood pressure was taken after that. She was observed and sent home. For next 2 days had headache and body was weak and sore.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pain, Skin discolouration, Tongue disorder
Clinical narrative: Less than 5 minutes after receiving vaccines patient passed out on the bed, fell down from the bed to floor and became unconscious, stiff, fingers and hand turned outward, face turned white and blue, eyes rolled back, tongue was sticking out and she became completely soaked in urine. I (parent) screamed and called for help. Head was stuck under wooden board found at the bottom of examining table and her head had to be pulled out. About 5 minutes later came around, put hands on head, seemed unaware of what had occurred. Blood pressure was taken after that. She was observed and sent home. For next 2 days had headache and body was weak and sore.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Urinary incontinence
Clinical narrative: Less than 5 minutes after receiving vaccines patient passed out on the bed, fell down from the bed to floor and became unconscious, stiff, fingers and hand turned outward, face turned white and blue, eyes rolled back, tongue was sticking out and she became completely soaked in urine. I (parent) screamed and called for help. Head was stuck under wooden board found at the bottom of examining table and her head had to be pulled out. About 5 minutes later came around, put hands on head, seemed unaware of what had occurred. Blood pressure was taken after that. She was observed and sent home. For next 2 days had headache and body was weak and sore.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TD, HPV4, MNQ, TDAP
Symptoms: Syncope, Tonic convulsion
Clinical narrative: Less than 5 minutes after receiving vaccines patient passed out on the bed, fell down from the bed to floor and became unconscious, stiff, fingers and hand turned outward, face turned white and blue, eyes rolled back, tongue was sticking out and she became completely soaked in urine. I (parent) screamed and called for help. Head was stuck under wooden board found at the bottom of examining table and her head had to be pulled out. About 5 minutes later came around, put hands on head, seemed unaware of what had occurred. Blood pressure was taken after that. She was observed and sent home. For next 2 days had headache and body was weak and sore.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Crying, Screaming
Clinical narrative: INCONSOLABLE SCREAMING, CRYING
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Blood test, Feeling cold, Feeling hot, Hypoaesthesia, Lumbar puncture
Clinical narrative: I had my yearly flu shot at a pharmacy on September 22, 2009. Within approximately one week I began to have strange sensations that I had never experienced before. These were mainly in the lower torso. My first experience was thinking I had stepped in water and gotten my foot wet, only to see that it was not wet at all. I would experience hot spots, wet and or cold sensations and tingling sensations. I had many of these but they were brief in duration. In late November my toes began to go numb. I first dismissed as maybe my shoes being too tight. At this point the numbness spread into my legs and I could feel it moving upward into my stomach area. I began to feel like I had a tight corsett like feeling in my stomach area. The numbness then began in my hands, and my back muscles became very week. I began to have spasm if I stood for any time. I got a list of neurologists that my insurance company recommended and called through until I found a doctor that could see me right away. The Dr evaluated me. He ordered an MRI of my spine and brain. He did a spinal tap and many blood tests. His diagnosis was that I have post inoculation transverse myelitis.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Muscle spasms, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging brain, Paraesthesia
Clinical narrative: I had my yearly flu shot at a pharmacy on September 22, 2009. Within approximately one week I began to have strange sensations that I had never experienced before. These were mainly in the lower torso. My first experience was thinking I had stepped in water and gotten my foot wet, only to see that it was not wet at all. I would experience hot spots, wet and or cold sensations and tingling sensations. I had many of these but they were brief in duration. In late November my toes began to go numb. I first dismissed as maybe my shoes being too tight. At this point the numbness spread into my legs and I could feel it moving upward into my stomach area. I began to feel like I had a tight corsett like feeling in my stomach area. The numbness then began in my hands, and my back muscles became very week. I began to have spasm if I stood for any time. I got a list of neurologists that my insurance company recommended and called through until I found a doctor that could see me right away. The Dr evaluated me. He ordered an MRI of my spine and brain. He did a spinal tap and many blood tests. His diagnosis was that I have post inoculation transverse myelitis.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Sensory disturbance
Clinical narrative: I had my yearly flu shot at a pharmacy on September 22, 2009. Within approximately one week I began to have strange sensations that I had never experienced before. These were mainly in the lower torso. My first experience was thinking I had stepped in water and gotten my foot wet, only to see that it was not wet at all. I would experience hot spots, wet and or cold sensations and tingling sensations. I had many of these but they were brief in duration. In late November my toes began to go numb. I first dismissed as maybe my shoes being too tight. At this point the numbness spread into my legs and I could feel it moving upward into my stomach area. I began to feel like I had a tight corsett like feeling in my stomach area. The numbness then began in my hands, and my back muscles became very week. I began to have spasm if I stood for any time. I got a list of neurologists that my insurance company recommended and called through until I found a doctor that could see me right away. The Dr evaluated me. He ordered an MRI of my spine and brain. He did a spinal tap and many blood tests. His diagnosis was that I have post inoculation transverse myelitis.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Biopsy muscle abnormal, CSF test abnormal, Dermatomyositis, Dysphagia, Dysphonia
Clinical narrative: I had my yearly flu shot at a pharmacy on September 22, 2009. Within approximately one week I began to have strange sensations that I had never experienced before. These were mainly in the lower torso. My first experience was thinking I had stepped in water and gotten my foot wet, only to see that it was not wet at all. I would experience hot spots, wet and or cold sensations and tingling sensations. I had many of these but they were brief in duration. In late November my toes began to go numb. I first dismissed as maybe my shoes being too tight. At this point the numbness spread into my legs and I could feel it moving upward into my stomach area. I began to feel like I had a tight corsett like feeling in my stomach area. The numbness then began in my hands, and my back muscles became very week. I began to have spasm if I stood for any time. I got a list of neurologists that my insurance company recommended and called through until I found a doctor that could see me right away. The Dr evaluated me. He ordered an MRI of my spine and brain. He did a spinal tap and many blood tests. His diagnosis was that I have post inoculation transverse myelitis.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Guillain-Barre syndrome, Haematocrit normal, Haemoglobin normal, Immunoglobulin therapy, Muscular weakness
Clinical narrative: I had my yearly flu shot at a pharmacy on September 22, 2009. Within approximately one week I began to have strange sensations that I had never experienced before. These were mainly in the lower torso. My first experience was thinking I had stepped in water and gotten my foot wet, only to see that it was not wet at all. I would experience hot spots, wet and or cold sensations and tingling sensations. I had many of these but they were brief in duration. In late November my toes began to go numb. I first dismissed as maybe my shoes being too tight. At this point the numbness spread into my legs and I could feel it moving upward into my stomach area. I began to feel like I had a tight corsett like feeling in my stomach area. The numbness then began in my hands, and my back muscles became very week. I began to have spasm if I stood for any time. I got a list of neurologists that my insurance company recommended and called through until I found a doctor that could see me right away. The Dr evaluated me. He ordered an MRI of my spine and brain. He did a spinal tap and many blood tests. His diagnosis was that I have post inoculation transverse myelitis.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Myopathy, Myositis, Pain in extremity, Platelet count normal, Rash
Clinical narrative: I had my yearly flu shot at a pharmacy on September 22, 2009. Within approximately one week I began to have strange sensations that I had never experienced before. These were mainly in the lower torso. My first experience was thinking I had stepped in water and gotten my foot wet, only to see that it was not wet at all. I would experience hot spots, wet and or cold sensations and tingling sensations. I had many of these but they were brief in duration. In late November my toes began to go numb. I first dismissed as maybe my shoes being too tight. At this point the numbness spread into my legs and I could feel it moving upward into my stomach area. I began to feel like I had a tight corsett like feeling in my stomach area. The numbness then began in my hands, and my back muscles became very week. I began to have spasm if I stood for any time. I got a list of neurologists that my insurance company recommended and called through until I found a doctor that could see me right away. The Dr evaluated me. He ordered an MRI of my spine and brain. He did a spinal tap and many blood tests. His diagnosis was that I have post inoculation transverse myelitis.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Red blood cell sedimentation rate normal, White blood cell count normal
Clinical narrative: I had my yearly flu shot at a pharmacy on September 22, 2009. Within approximately one week I began to have strange sensations that I had never experienced before. These were mainly in the lower torso. My first experience was thinking I had stepped in water and gotten my foot wet, only to see that it was not wet at all. I would experience hot spots, wet and or cold sensations and tingling sensations. I had many of these but they were brief in duration. In late November my toes began to go numb. I first dismissed as maybe my shoes being too tight. At this point the numbness spread into my legs and I could feel it moving upward into my stomach area. I began to feel like I had a tight corsett like feeling in my stomach area. The numbness then began in my hands, and my back muscles became very week. I began to have spasm if I stood for any time. I got a list of neurologists that my insurance company recommended and called through until I found a doctor that could see me right away. The Dr evaluated me. He ordered an MRI of my spine and brain. He did a spinal tap and many blood tests. His diagnosis was that I have post inoculation transverse myelitis.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, TDAP, VARCEL
Symptoms: Injection site reaction
Clinical narrative: 5cm local reaction at site of Tdap in (L) arm. Give BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Induration
Clinical narrative: L ant thigh red, indurated area 6 in x 3 in.
Age: 28.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Heart rate decreased
Clinical narrative: Patient report dizzy, clammy feeling. BP 99/60 pulse 58. Patient rested until feeling better and at 1:45 ate sandwich and drank tea. By 2:10 felt recovered with BP 99/61 and pulse 73. 20 hour follow up OK.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site rash, Rash
Clinical narrative: rash initially at site which spread to other parts of body
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Electroencephalogram normal, Insomnia, Personality change, Sleep terror
Clinical narrative: Insomnia, persistent Night terrors Personality change with rages, which resolved over approx. 2 month period
Age: 12.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cold sweat, Loss of consciousness, Pallor
Clinical narrative: Approximately 10 minutes after vaccination given, client became clammy, pale and lost consciousness briefly. Client placed in chair, feet elevated, and ammonia satts given. Client awoke. Paramedics called and came and assessed client. Client left with family.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Feeling hot, Pruritus, Rash, Rash erythematous
Clinical narrative: 2nd shot - approx 12hrs after shot given - white bumps L arm between elbow - wrist, intense itching stopped within hour. 3rd shot 12 later red rash, felt hot, intense itching lasted maximum 1 hour. Little red bumps.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pt stated today that (L) deltoid is painful and swollen.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Nausea, Paraesthesia, Urticaria
Clinical narrative: Initial report was received on 16 March 2010 from another manufacturer, with document number WAES 1003USA00893. The initial reporter to this manufacturer was a healthcare professional. Verbatim from the report: "Information has been received from a physician and licensed practical nurse. Information concerning a 14 year old female with attention deficit disorder and allergic to Penicillin who on 25-Feb-2009 was IM vaccinated with a first dose of GARDASIL vaccinated on 25-Feb-2010 with a dose of GARDASIL (Lot no. 662529/1317Y) given in left upper thigh; a dose of VAQTA (Lot no. 666201/1538Y) given in right upper thigh; a dose of MENACTRA (Lot # 430800AA) given in left lower thigh and a dose of ADACEL (Lot # C3352AA) given in right lower thigh. Concomitant medication included ADDERALL." "It was reported that the patient called the physician's office at the afternoon, the patient experienced hives, nausea and dizziness and also complaint of tingling in both legs. Patient had taken 12.5 mg. of BENADRYL twice before going to the emergency room. The patient was seen at approximately 23:00PM the same day and symptoms were gone. Patient received a dose of SOLU MEDROL IV and ZANTAC prior to being discharged from emergency room. At the time of the report the patient was recovered." "Upon internal review, hives, nausea, dizziness and tingling in both legs were considered to be other important medical events." "No further information is available." Of note, MENACTRA lot number 43080AA (also reported as 430800AA) is not a valid sanofi pasteur lot number. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Dyspnoea, Throat tightness
Clinical narrative: 12:35 P - was in class, returned to clinic stating she felt dizzy. BP 124/70, P100, R 28. 12:40 Taken to nurses office, lying on cot. BP 124/70, P 100, R 28. Complains of difficulty breathing and "throat tightening". 911 called. Epi 1:1000 0.5 ml given IM and 50 mg BENADRYL PO. 12:45 Squad arrived - transported to hospital. Call to mother 3-17/10: states child returned to school.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood pressure decreased, Dizziness, Loss of consciousness, Pallor
Clinical narrative: 120 when returning to class, school nurse observed patient appearing dizzy, call to RN for assistance, at which time patient was pearly, placed on floor. Briefly lost consciousness. BP 80/50, legs up 911 called. 123 Awake and responsive BP 90/50 P64 R 12 - 128 Awake and responsive BP 104/64 P 72 R 12. Squad arrived. Father arrived; transported child home.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Headache, Muscle spasms, Oropharyngeal pain, Somnolence
Clinical narrative: After 1 3/4 hours 1. headache, 2. thirsty, 3. throat pain, 4. cramping of legs, 4. generalized weakness, 5. weakness of arms seen by doctor evaluated: drinking fluids well, drowsy, BP 94/64, HR 64\mm, RR 18 to 20/min. No diaphoresis, no voice change (cercious/no SOB/ No chest pain. Negative pulses, no pain circulatory gen. normal after treatment.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Thirst
Clinical narrative: After 1 3/4 hours 1. headache, 2. thirsty, 3. throat pain, 4. cramping of legs, 4. generalized weakness, 5. weakness of arms seen by doctor evaluated: drinking fluids well, drowsy, BP 94/64, HR 64\mm, RR 18 to 20/min. No diaphoresis, no voice change (cercious/no SOB/ No chest pain. Negative pulses, no pain circulatory gen. normal after treatment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh swollen-discolored and slightly warm to touch. -Rx: Cetirizine 3/4 tsp BID with cool compresses.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: On 3/11/10 pt. received 3 vaccines that were not needed. She had already had them. The PHOA failed to print out the immunization screen from PTB MIS, so the nurse did not know she had already had them. Called and spoke with house parent - no side effects noted, no problems.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash maculo-papular
Clinical narrative: Received HPV 3-12-10 @ 1600 L delt. Noted macular papular rash after noon 3-15-10 on L delt. Pt instructed by PAC to take ZYRTEC 10 mg once daily.
Age: 1.02
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Rash, fever
Sex: M
Vaccine: HEP
Symptoms: Death, Epistaxis
Clinical narrative: Information has been received from an administrator concerning her nephew who on 22-JAN-2010 was vaccinated with a dose of RECOMBIVAX HB (lot# not reported). On 31-JAN-2010 the patient died. At the time of death, in approximately 31-JAN-2010 the patient had a bloody nose. The cause of death was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Body temperature normal, Cellulitis, Chills, Erythema
Clinical narrative: Information has been received from a nurse practitioner concerning a 66 year old female with egg allergy, sulfonamide allergy and doxycycline allergy and a history of right kidney removing who on 06-FEB-2009 was vaccinated subcutaneously into left arm with a 0.65 ml dose of ZOSTAVAX (Merck) (expiration date 01-MAR-2009, lot# 658863/1414U). There was no other vaccine administered. On 09-FEB-2009 the patient went to her primary health care provider with complaints of fever, chills, low back pain on left and right side. While at the provider's office it was found that the patient had a no shingles rash, 3 by 1 inch erythematous patch, induration, inferior to the left deltoid. The patient was diagnosed with cellulitis and was treated with KEFLEX. At the time of the report, the patient had recovered. Follow up information received from a nurse practitioner via medical records indicated that the patient was a female business owner with no acute illness, who on 06-FEB-2009 was vaccinated with a first dose of ZOSTAVAX (Merck) into her left arm. Concomitant therapy included LEVOXYL, PRILOSEC, simvastatin (manufacturer unknown), lisinopril (manufacturer unknown) and aspirin. The patient came to the physician's office on 09-FEB-2009 and reported that she had chills and some right and left lower back pain since 07-FEB-2009. Her left arm had been sore as well. The patient had presented with fever and back pain. On 09-FEB-2009 the patient was diagnosed with cellulitis by her primary physician; her blood pressure was 118/70 and also presented with a fever ( temperature was 99, units not reported), patient's urine was clear; she had a 3 inch by 1 inch patch of erythema and induration just inferior to the vaccination site on the left deltoid. No shingles rash. The back had no CVA tenderness. The physician's assessment was cellulitis left arm status post-injection; the patient was prescribed KEFLEX 500 mg TID x 5 days, ADVIL or ALEVE as directed. The reporter considered cellulitis, low back pain, chills and fever to be other important medical events. No further information is available.