chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report was received from a health care professional on 13 January 2012. A female patient (age and date of birth not reported) had received an injection of FLUZONE HIGH-DOSE, sanofi pasteur Inc. (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient developed numbness and tingling in the extremities. The patient has had ongoing complaints for the past several months. The patient saw a neurologist and the doctor told her that was the side effects were a result of the FLUZONE HIGH-DOSE. Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient had intense itching at injection site - left deltoid, approximately 6 hours after injection. Went to bed, and woke up with pain, redness, warmth and swelling from injection site to elbow. Advised to apply ice to area and call if no improvement.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Malaise
Clinical narrative: Patient described redness of arm appearing off and on red ring where vaccine given, feeling sick off and on - on inspection 1 large bruise just above her elbow and diffuse redness. No red ring. Called drug co to report & risk management.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Neuralgia, Sensory disturbance
Clinical narrative: Injection site reaction - redness/pain/soreness but no rash. On 1/18/12 (approximately 2 days after shot) got shingles rash on mid-right back & along with increased nerve sensation/pain. Initiated antiviral therapy on 1/19/12 for shingles.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Deafness
Clinical narrative: Hearing loss.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Confusional state, Dysphonia, Headache, Injection site erythema, Injection site pain
Clinical narrative: Initially - day after vaccine administered had local site reaction (swollen, red, painful). 4 days after developed headache, mental confusion, fever, and was hoarse w/o congestion, sinus symptoms, wheezing or rash. No SOB.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Local reaction, Pyrexia
Clinical narrative: Initially - day after vaccine administered had local site reaction (swollen, red, painful). 4 days after developed headache, mental confusion, fever, and was hoarse w/o congestion, sinus symptoms, wheezing or rash. No SOB.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Cardiac stress test normal, Chest X-ray normal, Chest pain, Electrocardiogram ambulatory normal
Clinical narrative: Chest pains for approximately 3 hours. EKGs, chest x-ray, Holter monitor, bloodwork, stress test - negative.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram normal
Clinical narrative: Chest pains for approximately 3 hours. EKGs, chest x-ray, Holter monitor, bloodwork, stress test - negative.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP, FLU3, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Pt. was given 3 vaccines: MENVEO, TDAP, FLU shot on 1-5-12 and came back next day with cellulitis left deltoid area, redness right deltoid area. Pt. was prescribed KEFLEX 500mg 1 tab every 12 hr x 10 d and an appt. was scheduled for 1-20-12 for follow up.
Age: 0.74
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Cough, Crying, Decreased appetite, Feeling hot, Irritability
Clinical narrative: Pt. received PENTACEL, Hep B (Pediatric), PCV13 on 1/18/12 - Mom called morning of 1/19/12 stating he started running "fever" (unknown how high as Mom never measured this) "he felt warm". She said he awoke at night fussy and usually sleeps all night. He awoke in AM crying, fussy with congestion and nasal cong. and coughing - con't "fever" and fussy, only take few drinks of formula - referred to her doctor.
Age: 0.74
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Nasal congestion, Poor quality sleep, Pyrexia, Respiratory tract congestion
Clinical narrative: Pt. received PENTACEL, Hep B (Pediatric), PCV13 on 1/18/12 - Mom called morning of 1/19/12 stating he started running "fever" (unknown how high as Mom never measured this) "he felt warm". She said he awoke at night fussy and usually sleeps all night. He awoke in AM crying, fussy with congestion and nasal cong. and coughing - con't "fever" and fussy, only take few drinks of formula - referred to her doctor.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypotonia, Infantile spitting up
Clinical narrative: 3 days after immunization, the baby vomited formula after feeding and lay limp for 5 minutes as per mother.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Impaired driving ability, Mobility decreased, Musculoskeletal pain, X-ray
Clinical narrative: Rec. shot 9/14 AM - 7 PM pain in shoulder. 9/15 AM could not raise arm. Leaving for 2 week vacation 9/15 AM. 9/16 AM Called Doctor, he said go to ER - ER took x-ray's, pills, ice and sling. He directed me to orthopedic surgeon. 9/19 Dr. took x-rays, shot, sling and ice. Pain for 10 days (Could not raise arm, no driving, exercise vaccination shot .
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Left arm localized urticaria, erythematous 5"x4" swollen area.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Eye pain, Headache, Pain, Pain of skin
Clinical narrative: Severe headache and body ache and chills on 1/19/12.  I took Tylenol and went to bed at 8pm.  I woke up today 1/20/11 with severe body aches, chills, but no headache.  I feel like I have the flu but I do not have a temperature or respiratory symptoms.  I am aching all over.  Even my eyes hurt and my skin on my head/scalp is painful.
Age: 43.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: 1/18/12 body aches and fatigue.  I took Advil and went to bed early.  On 1/19/12 I experienced severe body aches, fatigue, and fever or 100.0.  I took more Advil and worked all day.  After work, I went home and went to bed around 10pm.  On 1/20/12 I feel much better with just a little achiness but no fever.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Pain, Pain in extremity
Clinical narrative: Throbbing/painful arm, fatigue, felt cold, body physically shaking "felt out of it". Pt. went to ER and was told to take Benadryl/ibuprofen every 6 hours.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Throbbing/painful arm, fatigue, felt cold, body physically shaking "felt out of it". Pt. went to ER and was told to take Benadryl/ibuprofen every 6 hours.
Age: 1.05
Sex: M
Vaccine: MMR
Symptoms: Blood culture negative, Febrile convulsion, Full blood count normal, Metabolic function test normal
Clinical narrative: Febrile seizure, lasted about 10 seconds, no treatment needed, labwork done was normal.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pyrexia, Rash erythematous, Rash macular, Urticaria
Clinical narrative: Slight fever (100) Blotchy red welted rash over upper body.
Age: 12.0
Sex: M
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Acne, Cellulitis, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Client developed a large red bump on back or right arm where varicella vaccine had been given, and also small raised bumps 3 on the left arm, one on forehead, 1 in groin, 1 on nose. On Jan 17 client developed more raised pimples and the left arm at the injection site became painful and more swollen.  Parent took to Urgent Care, client diagnosed with Chickenpox and cellulitis of the left arm.  Placed on Keflex 500mg TID.  Client did not have fever or any other problems.
Age: 12.0
Sex: M
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Rash, Rash erythematous, Varicella post vaccine
Clinical narrative: Client developed a large red bump on back or right arm where varicella vaccine had been given, and also small raised bumps 3 on the left arm, one on forehead, 1 in groin, 1 on nose. On Jan 17 client developed more raised pimples and the left arm at the injection site became painful and more swollen.  Parent took to Urgent Care, client diagnosed with Chickenpox and cellulitis of the left arm.  Placed on Keflex 500mg TID.  Client did not have fever or any other problems.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Bacterial test negative, Borrelia test negative, CSF protein increased, CSF test normal, Computerised tomogram normal
Clinical narrative: Guillain-Barre Syndrome.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Cytomegalovirus test negative, Enterovirus test negative, Guillain-Barre syndrome, HIV test negative, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Guillain-Barre Syndrome.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal cord abnormal, Treponema test negative
Clinical narrative: Guillain-Barre Syndrome.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Eye swelling, Injection site discolouration, Oedema peripheral, Rash macular, Tremor
Clinical narrative: Patient began tremoring around 10:30 AM. The area around his eyes, nose, and forehead also were red and splotchy. Area around his eyes were puffy. Sites where shots were given WNL @ 11:00 AM- no redness or swelling. They saw the doctor around 2:00 PM. By this time, patient's left arm was beginning to swell according to mother. PCP prescribed oral and topical Benadryl. Mother states by that night, the left arm had a purplish tint around where the shot was given and had become more swollen. As of 1-20-12 at 12:00 PM, mother says patient getting better, arm almost back to normal.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Feeding disorder of infancy or early childhood, Lethargy, Somnolence
Clinical narrative: Infant received 2mo immunizations 1/18/12 at 115pm at health department, later in day lethargic. Mom unable to wake infant, calls Dr nurse sends to ER at 5pm. ER examines child and sends home with normal exam. Mom calls 1100am 1/19/12 same s/s. Infant ate only 2oz formula since 12 1/18/12. Sent infant back to ER for exam and evaluation.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Injection site urticaria, Pyrexia, Urticaria
Clinical narrative: Hives starting on thighs and spreading to trunk and back and extremities, fever, diarrhea.
Age: 1.34
Sex: F
Vaccine: DT, DTAP, HIBV, TD
Symptoms: Abdominal pain upper, Chills, Crying, Diarrhoea, Dizziness
Clinical narrative: Fussiness, dizziness, crying, having chills (goosebumps on her limbs), turning red, vomiting after tried to feed her, curled up because of stomach pain, diarrhea.
Age: 1.34
Sex: F
Vaccine: DT, DTAP, HIBV, TD
Symptoms: Erythema, Irritability, Piloerection, Vomiting
Clinical narrative: Fussiness, dizziness, crying, having chills (goosebumps on her limbs), turning red, vomiting after tried to feed her, curled up because of stomach pain, diarrhea.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness, Colonoscopy, Eye pruritus, Nuclear magnetic resonance imaging abnormal, Ocular hyperaemia
Clinical narrative: 4 hours after flu vaccine, blurry vision, itchiness, red eyes. Progressed and worsened over 3 weeks. 1/3/12-had colonoscopy. 1/17/12-hospitalized for complete blindness. MRI showed optic neuritis. Treated with steroids with.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Optic neuritis, Vision blurred
Clinical narrative: 4 hours after flu vaccine, blurry vision, itchiness, red eyes. Progressed and worsened over 3 weeks. 1/3/12-had colonoscopy. 1/17/12-hospitalized for complete blindness. MRI showed optic neuritis. Treated with steroids with.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Bed sharing, Cardiac arrest, Death, Dyspnoea
Clinical narrative: Jan 20 2011 5 pm Call from hosp/med ctr. Mother accompanied infant to ER. Resp difficulty infant had cardiac arrest. Expired. Infant had been sleeping in parent bed with his father.
Age: 69.0
Sex: F
Vaccine: TYP, YF
Symptoms: Fatigue, Insomnia, Malaise, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: On 1/14 felt tired and achy, but had had a good nights sleep.  On 1/15 felt more tired and achy.  On 1/16 more achy and tired than before.  On 1/17 felt worse and patient had a fever 101.  She took aspirin and then the fever rose.  She then took another dose of aspirin.  Did not feel better.  Still achy and feverish.  Fever broke during the night.  On 1/18 felt better in the morning, but felt sick again in the afternoon and starting having a sore throat.  Took Advil and Vitamin C.  Fever was 99.6.  Unable to sleep that night.  On 1/20 fever was 100.  Took more Vitamin C and Advil.  Not able to sleep well.  Fever subsided.  Still tired, but achy feeling is gone.  Now has upper respiratory symptoms "head cold" like and sore throat better.
Age: 69.0
Sex: F
Vaccine: TYP, YF
Symptoms: Pain, Pyrexia
Clinical narrative: On 1/14 felt tired and achy, but had had a good nights sleep.  On 1/15 felt more tired and achy.  On 1/16 more achy and tired than before.  On 1/17 felt worse and patient had a fever 101.  She took aspirin and then the fever rose.  She then took another dose of aspirin.  Did not feel better.  Still achy and feverish.  Fever broke during the night.  On 1/18 felt better in the morning, but felt sick again in the afternoon and starting having a sore throat.  Took Advil and Vitamin C.  Fever was 99.6.  Unable to sleep that night.  On 1/20 fever was 100.  Took more Vitamin C and Advil.  Not able to sleep well.  Fever subsided.  Still tired, but achy feeling is gone.  Now has upper respiratory symptoms "head cold" like and sore throat better.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash erythematous
Clinical narrative: Red spots around chest area and back.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Speech disorder, VIIth nerve paralysis
Clinical narrative: Patient called to report facial numbness and drooping on left side and trouble speaking.  Was advised to call 911 to go to nearest ER.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Inflammation, Injection site pain, Local reaction, X-ray normal
Clinical narrative: PT STATES LOCALIZED PAIN AT INJECTION SITE AT TIME OF ADMINISTRATION. WHEN DISCOMFORT DID NOT RESOLVE IN 6 WEEKS, SHE REPORTED TO EMPLOYEE HEALTH ON 12/21/11.  DIAGNOSIS-PROLONGED INFLAMMATORY LOCAL REACTION TO FLU INJECTION WITHOUT ANY BRACHIAL PLEXUS INVOLVEMENT.  X-RAY = NO FOREIGN BODY, NO CALCIFICATION. NAPROSYN GIVEN WITH RELIEF.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Headache, Hyperaesthesia, Injection site erythema, Lymphadenopathy
Clinical narrative: Swelling in arm and in lymph nodes across neck area on right side of torso, soreness under arm area on day one. Day two fever 101.5 x 12 hours followed by bright red area on arm at shot sight 3"x3", day three fever 99.5 and arm redness spreading to inside of arm near armpit, extremely sensitive to touch. Headache and sleepy most of two days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia, Somnolence
Clinical narrative: Swelling in arm and in lymph nodes across neck area on right side of torso, soreness under arm area on day one. Day two fever 101.5 x 12 hours followed by bright red area on arm at shot sight 3"x3", day three fever 99.5 and arm redness spreading to inside of arm near armpit, extremely sensitive to touch. Headache and sleepy most of two days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Urticaria
Clinical narrative: 2X2IN WHELP WITH BURNING SENSATION.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site warmth, Pain
Clinical narrative: First the site had looked like a dark bruise, then the next day 01/10/2012, the site had started a small circle of redness that was warm to the touch and hurt when using the arm. The red area continued to grow each day the the pain of the site when the arm was used continued. Pt. thought it would go away but today it is an oval area about the width of a quarter's diameter and about twice as long over the lower tricept area on the Left arm. Pt was seen today with this report, 01/20/2012 @ 4:00 PM.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Lumbar puncture abnormal, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: Progressive lower extremity weakness and numbness with urinary retention.  Proven diagnosis of T6-7 transverse myelitis.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pleocytosis, Spinal cord disorder, Urinary retention
Clinical narrative: Progressive lower extremity weakness and numbness with urinary retention.  Proven diagnosis of T6-7 transverse myelitis.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Balance disorder, Gait disturbance, Hypoaesthesia, Musculoskeletal stiffness, Sensation of heaviness
Clinical narrative: Progressive lower extremity weakness and numbness with urinary retention.  Proven diagnosis of T6-7 transverse myelitis.
Age: 1.03
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Rash consisting of small red marks all over her body and more noticeable on her face. More marks developed through 1/20/2012. Called her primary care physician and was told nothing to worry about.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Immediate burning pain down left arm when injected. Pain continues to radiate to hand. The pain is constant with no relief from over the counter meds, heat or cold compresses.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Erythema at site of injection right deltoid approximately 2 cm in diameter.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Oedema peripheral, Tenderness, Urticaria
Clinical narrative: Pt. arm started with swollen, red, welt the size of a quarter. Overnight it grew 4 times in size, red and hard and tender. Pt. treated with BENADRYL and Prednisolone.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Arthralgia, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, muscle and joint pain, nausea.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: On 11/23/11 patient woke up with red rash on right arm with faint rash on left arm. Seen by physician 11/23/11 AM: temp 97.3 oral, no allergies prior to this; hives right upper arm diffusely erythematous up to the top of the shoulder to mid-forearm. There is a raised ring area injection. Left arm has 2 faint areas of erythema, no other signs/symptoms of any other illness, treatment continue TYLENOL & loratadine.
Age: 0.35
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Convulsion, Muscle twitching, Tremor
Clinical narrative: Rec'd shots in the am = DTaP, HIB, Hep B. Home - took a  nap - upon waking mom noted baby shaking - called my office advised to CI now = upon arrival noted to be having seizure = eyes, mouth, arms & legs twitching lasted approximately 10 mins.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Condition aggravated, Crohn's disease, Diarrhoea, Eating disorder
Clinical narrative: We had received the first dose of the cervical cancer vaccine a few months before the second dose on 10/10/2011.  My daughter complained that the first dose was very painful and caused tingling in her feet and hands.  She said she could actually feel the medication run through her and burn as it went through.  We began to see some issues with her ability to eat and diarrhea after the first dose.  Our life completely changed right after the second dose on October 10th.  Her ability to eat worsened and her diarrhea did not go away.  After many tests she has now been diagnosed with an immune disorder that she never had before the vaccine and we do not have any family history of, Crohns.  She still has cramps to this day in her feet and hands.  I will never let anyone I know take this vaccine it has destroyed my daughters life at a very young age.  I am confused as to why this vaccine is being pushed so hard.  Every time I went to doctors it was peddled to me as being very safe.  I now know this vaccine is very unsafe and it was not given enough time in trials with children my daughters age.  It is time to prevent this from happening to anymore children.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Immune system disorder, Injection site pain, Laboratory test, Muscle spasms, Paraesthesia
Clinical narrative: We had received the first dose of the cervical cancer vaccine a few months before the second dose on 10/10/2011.  My daughter complained that the first dose was very painful and caused tingling in her feet and hands.  She said she could actually feel the medication run through her and burn as it went through.  We began to see some issues with her ability to eat and diarrhea after the first dose.  Our life completely changed right after the second dose on October 10th.  Her ability to eat worsened and her diarrhea did not go away.  After many tests she has now been diagnosed with an immune disorder that she never had before the vaccine and we do not have any family history of, Crohns.  She still has cramps to this day in her feet and hands.  I will never let anyone I know take this vaccine it has destroyed my daughters life at a very young age.  I am confused as to why this vaccine is being pushed so hard.  Every time I went to doctors it was peddled to me as being very safe.  I now know this vaccine is very unsafe and it was not given enough time in trials with children my daughters age.  It is time to prevent this from happening to anymore children.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Paresthesia (pringling, itching feeling) all over body, comes and goes.  Tingling and numbness in right hand.
Age: 0.38
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RIGHT UPPER LEG WAS RED AND SWOLLEN AT INJECTION SITE.
Age: 42.0
Sex: F
Vaccine: MER
Symptoms: Blepharospasm, Oropharyngeal pain, Rash erythematous, Rash pruritic
Clinical narrative: Have red bumps on chest, stomach, back, shoulders. Have a few red bumps on arms, legs, face. Bumps itch and are still present. Had sore throat, left eye began twitching and is still twitching. Not doing this previously, just had eye exam beginning of December. Not exactly sure of vaccine dates or beginning of symptoms.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Crying, Immediate post-injection reaction, Sinusitis, Sjogren's syndrome
Clinical narrative: Immediately developed a bad deep sinus infection, uncontrollable crying, and eventually Sjogrens syndrome has developed.
Age: 0.63
Sex: M
Vaccine: PPV
Symptoms: Balance disorder, Clumsiness, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Irritability, low grade fever of 100.1, redness at injection site, tenderness at injection site, injection site is hot when palpated, injection site is very firm and nodular. Patient was very clumsy, seemed to be off balance on 01/21/2012. Also on this date, very drowsy but slept well the night before.
Age: 0.63
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Irritability, Pyrexia, Somnolence
Clinical narrative: Irritability, low grade fever of 100.1, redness at injection site, tenderness at injection site, injection site is hot when palpated, injection site is very firm and nodular. Patient was very clumsy, seemed to be off balance on 01/21/2012. Also on this date, very drowsy but slept well the night before.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Pt. claims his arm is still sore months after getting his flu shot. On 1-16-2012 he said he went to the doctor and he had a torn rotator cuff. I called his primary care Doctor's office to inform them per person at doctor's office. He was in the office week before his flu shot for muscle pain in his arm. She thinks this may be the reason for the sore arm. The shot was given in deltoid no where near his rotator cuff.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injected limb mobility decreased, Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: Enlargement, redness, stiffness, pain, moderately limits activity at the injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt returned to pharmacy 3 days after the vac. was administered displaying red-raised warm to touch area around inj. site. The area was spreading toward elbow about 2". Pt called her PCP and he prescribed BACTRIM DS.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Pain, Pruritus, Swelling
Clinical narrative: Itchiness, swelling, hard, very sore.
Age: 29.0
Sex: M
Vaccine: HEPAB, SMALL, TD, TYP, YF
Symptoms: Adverse reaction, Headache, Hypertension, Nervousness, Nightmare
Clinical narrative: Nightmares, head aches, Central/obstructive sleep apnea, hypertension, Systemic Lupus Erythematosus, nervousness, etc.
Age: 29.0
Sex: M
Vaccine: HEPAB, SMALL, TD, TYP, YF
Symptoms: Sleep apnoea syndrome, Systemic lupus erythematosus
Clinical narrative: Nightmares, head aches, Central/obstructive sleep apnea, hypertension, Systemic Lupus Erythematosus, nervousness, etc.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Myalgia, Pain, X-ray abnormal
Clinical narrative: Received flu shot at lunch time and it was administered very high in my left arm rather than in the muscle as I was accustomed to. By 8:00 PM  any movement of my arm became very painful. At times I used my right arm to pick up my left arm because the act of moving it on its own was too painful.  After about two weeks with no improvement, I consulted my doctor.  He prescribed prednisone and I did get relief while I was on it, but then returned to extreme pain in the deltoid muscle with movement.  After Thanksgiving he suggested another treatment of prednisone and again I did get some relief.  Although, I have been able to accomplish more movement with the arm, I am still experiencing pain with movement in the deltoid muscle.  I am currently seeing an orthopaedic doctor and getting physical therapy.  However, the pain in the deltoid muscle when I move the arm continues.
Age: 18.0
Sex: M
Vaccine: TTOX
Symptoms: Pruritus, Urticaria
Clinical narrative: DONOR BECAME ITCHY AND BROKE OUT IN HIVES.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Discomfort, Injected limb mobility decreased, Joint range of motion decreased, Pain
Clinical narrative: Unable to lift affected arm high enough to get a bowl out the cabinets, since this date my range of motion in that arm has decreased with daily activities..ie dressing, cleaning, etc...experience pain & discomfort. Hurts to sleep on this arm as well, currently prescribed muscle relaxers and pain meds.
Age: 1.3
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMR
Symptoms: Rash
Clinical narrative: Rash.
Age: 58.0
Sex: U
Vaccine: TDAP
Symptoms: Chest discomfort, Chills, Cough, Dyspnoea, Oropharyngeal pain
Clinical narrative: Hives - face area - night after shot Chills - day after. Sore throat, chest congestion - coughing. SOB - chest discomfort - ER adm. 1/17/12. Albuterol inh. IV fluids.
Age: 58.0
Sex: U
Vaccine: TDAP
Symptoms: Respiratory tract congestion, Urticaria
Clinical narrative: Hives - face area - night after shot Chills - day after. Sore throat, chest congestion - coughing. SOB - chest discomfort - ER adm. 1/17/12. Albuterol inh. IV fluids.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Intussusception, Irritability, Surgery, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week old male patient who on 16-SEP-2011, was vaccinated with a first dose of ROTATEQ, 2 ml, orally (lot number 669826/0256AA) for the treatment of rotavirus. Concomitant therapy included PENTACEL, ENGERIX-B and PREVNAR 13. The patient who had received a dose of ROTATEQ experienced vomiting, was fussy and had bloody stools. The patient was taken to the hospital (name and address unknown) and diagnosed with intussusception. The patient was admitted on 21-SEP-2011, had surgery and was released on 23-SEP-2011. On 16-SEP-2011, the therapy with ROTATEQ was discontinued. An unspecified laboratory work was performed. On an unspecified date, the patient recovered. Therapy with ROTATEQ was not reintroduced. Intussusception was considered to be immediately life-threatening and other important medical event. A lot check has been initiated. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Autopsy, Death
Clinical narrative: This case was obtained from a non-scientific website on 14 January 2012 via a company representative. A seven year-old female (date of birth not reported) who was "fit and healthy" had received an INFLUENZA VACCINE (manufacturer, route, site and date of administration not reported) and four days later died. Autopsy results were pending and cause of death was not reported. No further information was available at the time of the report. The patient's outcome was fatal. Documents held by sender: none.
Age: 7.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Death, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: This case was obtained from a non-scientific website on 14 January 2012 via a company representative. A seven year-old female (date of birth not reported) who was "fit and healthy" had received an INFLUENZA VACCINE (manufacturer, route, site and date of administration not reported) and four days later died. Autopsy results were pending and cause of death was not reported. No further information was available at the time of the report. The patient's outcome was fatal. Documents held by sender: none.
Age: 1.05
Sex: F
Vaccine: FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Papule
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old female patient with no pre-existing allergies, birth defects or medical conditions who on 22-DEC-2011, was vaccinated SQ in the right leg with the first dose of both VARIVAX (Merck) (Lot# 665973/0158AA) and MMR II (Lot# 671255/1002AA). The same day, on 22-DEC-2011, the patient was vaccinated IM in the left leg with the first dose of FLUZONE (manufactured by Sanofi) (Lot# U418BA). 10 days prior vaccination, on 12-DEC-2011, the patient finished therapy with ZITHROMAX for otitis. At the time of vaccination, on 22-DEC-2011, the patient had nasal congestion and fluid in ears. On 04-JAN-2012, the patient developed papular area on shoulders, spread to arms, legs, head, chest and back, vesicles on right eyelid, red papule on lower eyelid and cellulitis secondary to papule. The patient required medical/surgical intervention and received KEFLEX, 250/5 - 1 teaspoon, twice a day, orally for the treatment of cellulitis. In January 2012, the patient recovered. All the events were considered by the reporter to be important medical events. No further information is available.
Age: 1.05
Sex: F
Vaccine: FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Blister, Cellulitis, Erythema of eyelid, Papule, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old female patient with no pre-existing allergies, birth defects or medical conditions who on 22-DEC-2011, was vaccinated SQ in the right leg with the first dose of both VARIVAX (Merck) (Lot# 665973/0158AA) and MMR II (Lot# 671255/1002AA). The same day, on 22-DEC-2011, the patient was vaccinated IM in the left leg with the first dose of FLUZONE (manufactured by Sanofi) (Lot# U418BA). 10 days prior vaccination, on 12-DEC-2011, the patient finished therapy with ZITHROMAX for otitis. At the time of vaccination, on 22-DEC-2011, the patient had nasal congestion and fluid in ears. On 04-JAN-2012, the patient developed papular area on shoulders, spread to arms, legs, head, chest and back, vesicles on right eyelid, red papule on lower eyelid and cellulitis secondary to papule. The patient required medical/surgical intervention and received KEFLEX, 250/5 - 1 teaspoon, twice a day, orally for the treatment of cellulitis. In January 2012, the patient recovered. All the events were considered by the reporter to be important medical events. No further information is available.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: CSF test, Computerised tomogram head, Cranial nerve disorder, Dyskinesia, Facial nerve disorder
Clinical narrative: Patient reports onset of headache on 3 January, progressing to peak onset within 24 hours, then diminishing to intermittent and episodic over the next 72 hours.  Patient reports onset of left sided facial numbness on 5 January in the morning, progressing throughout the day.  Pt reports by the evening of 5 January he was unable to hold his lips closed while using mouthwash and experiencing dribbling on himself.  He presented to the clinic the following morning with c/o right sided headache and left sided facial numbness and weakness.  He was transferred to the Hospital and admitted for evaluation and treatment.  He was found to have left sided facial numbness and right sided facial weakness affecting the facial nerve.  He underwent at least two head CT's, had consultation with neurology and was treated with IV steroids x 7 days and then switched to po steroids for an additional 4 days.  He participated in speech therapy exercises for facial weakness.  His final diagnosis was peripheral lesion of facial nerve right, differential diagnosis:  multiple neuritis, secondary facial palsy after vaccination.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Facial paresis, Full blood count, Headache, Hypoaesthesia, Lumbar puncture
Clinical narrative: Patient reports onset of headache on 3 January, progressing to peak onset within 24 hours, then diminishing to intermittent and episodic over the next 72 hours.  Patient reports onset of left sided facial numbness on 5 January in the morning, progressing throughout the day.  Pt reports by the evening of 5 January he was unable to hold his lips closed while using mouthwash and experiencing dribbling on himself.  He presented to the clinic the following morning with c/o right sided headache and left sided facial numbness and weakness.  He was transferred to the Hospital and admitted for evaluation and treatment.  He was found to have left sided facial numbness and right sided facial weakness affecting the facial nerve.  He underwent at least two head CT's, had consultation with neurology and was treated with IV steroids x 7 days and then switched to po steroids for an additional 4 days.  He participated in speech therapy exercises for facial weakness.  His final diagnosis was peripheral lesion of facial nerve right, differential diagnosis:  multiple neuritis, secondary facial palsy after vaccination.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Metabolic function test, Neuritis, VIIth nerve paralysis
Clinical narrative: Patient reports onset of headache on 3 January, progressing to peak onset within 24 hours, then diminishing to intermittent and episodic over the next 72 hours.  Patient reports onset of left sided facial numbness on 5 January in the morning, progressing throughout the day.  Pt reports by the evening of 5 January he was unable to hold his lips closed while using mouthwash and experiencing dribbling on himself.  He presented to the clinic the following morning with c/o right sided headache and left sided facial numbness and weakness.  He was transferred to the Hospital and admitted for evaluation and treatment.  He was found to have left sided facial numbness and right sided facial weakness affecting the facial nerve.  He underwent at least two head CT's, had consultation with neurology and was treated with IV steroids x 7 days and then switched to po steroids for an additional 4 days.  He participated in speech therapy exercises for facial weakness.  His final diagnosis was peripheral lesion of facial nerve right, differential diagnosis:  multiple neuritis, secondary facial palsy after vaccination.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Dysphagia, Lactation disorder, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Rash from day 10 (itchy). Swollen glands, lymph nodes, sore throat and difficulty swallowing. Fever. Severe joint pain. Adverse effect on milk supply (I am breast feeding). This vaccine should not be taken while breastfeeding.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Rash from day 10 (itchy). Swollen glands, lymph nodes, sore throat and difficulty swallowing. Fever. Severe joint pain. Adverse effect on milk supply (I am breast feeding). This vaccine should not be taken while breastfeeding.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Chest X-ray abnormal, Intussusception, Nausea, Ultrasound scan abnormal, Vomiting
Clinical narrative: Nausea and vomiting brought patient to the ED.  X-ray and ultrasound showed evidence of intussusception.  Patient transferred to another hospital for treatment.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Patient developed a site reaction at the injection site on the left upper arm.  Induration, warmth, redness and itching.  She also developed a hive type rash on the bilateral inner thighs that was highly pruritic.  Patient was advised to use ice on the arm.  To take Claritin in the am x 7 days, Zyrtec in pm x 7 days and Benadryl needed per package instructions.  Advised patient to not finish the series of vaccinations.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 1 day after administration of vaccine, patient called pharmacy and told RPh on duty her site of injection was very painful, red and swollen down to (L) elbow. Patient is a retired nurse and suspected cellulitis; a phone call was made to patient 7 days later and symptoms did subside after applying warm compresses. No other medical intervention was necessary.
Age: 29.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash & redness at the site of injection.
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash & redness at the site of injection.
Age: 0.8
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Infection transmission via personal contact
Clinical narrative: My mother who is also my babysitter for my 9 month old daughter received the shingles vaccination on or about 12/1/2012. She is 58 years old. She is in constant contact with my daughter at least 4-5 days a week and is a very loving grandmother which means lots of cuddles and kisses. On 12/28/2011-12/29/2011 we noticed our daughter becoming fussy, slight fever, runny nose, not sleeping as well. Thought it's teething or a cold. On 12/31/2011 we noticed 3 small bumps on her neck area. Between 1/1 and 1/2/2012 more bumps followed on her forehead. By the night of 1/2/2012 the older bumps were becoming fluid filled and new ones had spread throughout body. On 1/3/2012 we took her to the pediatrician who confirmed what I expected. It was chicken pox. My daughter is not in daycare, we do not attend large gatherings, she does not get passed around to many people due to stranger anxiety. The doctor told us this is the first case she has seen of chicken pox in a very long time. She even asked if anyone close had the shingles or the vaccine. I was unaware at the time my mom had this vaccine on the above date, and my dad -also close to my child- had the vaccine just 2 weeks before my mother.
Age: 7.0
Sex: F
Vaccine: FLU3, HEP, IPV, MMR, TD
Symptoms: Incorrect dose administered
Clinical narrative: Grandparents brought child in for vaccinations with permission slip from mother to receive required shots for school. The next day an aunt of child called to say 1 week prior child had received same shots - she had taken child to doctor 1 week ago.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Swelling of (L) arm more than typically expected also was hot to touch.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a Nurse for the pregnancy registry for GARDASIL, concerning an approximately 15 year old female patient who on unspecified day was vaccinated with the third dose of GARDASIL (Lot #, dose and route not reported). The nurse reported that after the patient received the vaccine, she immediately reported to the nurse that she may be pregnant. The nurse stated that they were awaiting confirmation of the pregnancy. At the time of the report the outcome of the patient was unknown. Follow-up information has been received from a nurse reporting that the patient had an abortion on 23-DEC-2011. Upon internal review, abortion was considered to be an other important medical event. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Patient complained about the numbness of the hand.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Autonomic neuropathy, Biopsy muscle abnormal, Cardiac output decreased, Electrocardiogram normal, Fibromyalgia
Clinical narrative: Information has been received from an approximately 24 (currently 50) year old female physician with Lyme disease and severe latex allergy (developed approximately in 1985), who in 1985, was vaccinated with a dose of RECOMBIVAX HB (lot number, dose and route not reported). Concomitant medication included unspecified antibiotics for Lyme disease. Physician stated that she received RECOMBIVAX HB while in her surgical rotation, and she had since suffered from "myocytis" and an autonomic nervous disorder. She reported that shortly after receipt of RECOMBIVAX HB (in 1985), she started "passing out" in during her surgical rotation in medical school. She reported that she consulted a cardiologist and neurologist at the time and the results of the tests did not show any cardiac arrhythmias or any specific neurological disorder. Muscle biopsy revealed a non-specific inflammatory process and her laboratory tests had demonstrated a consistent elevation in her muscle enzymes and no evidence of an autoimmune disorder. She reported that at the age of 31 (in 1992), she developed fibromyalgia and due to ongoing muscle pain, she underwent a muscle biopsy 10 years ago (in January 2002), which revealed a non-specific inflammatory process. Presently (in January 2012), she reported that 15 minutes after moderate exercise her cardiac output decreased, and she "nearly lost consciousness as a result". She did not want her physician to be contacted because these events had been ongoing "for years". The patient sought medical attention by physician examination. Performed lab studies included: electrocardiogram, muscle enzymes and autoimmune profile. The patient's outcome was not recovered at the time of report. Therapy with RECOMBIVAX HB was not reintroduced. The patient's adverse events were considered to be disabling by the reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Immunology test normal, Loss of consciousness, Muscle enzyme increased, Myalgia, Myositis
Clinical narrative: Information has been received from an approximately 24 (currently 50) year old female physician with Lyme disease and severe latex allergy (developed approximately in 1985), who in 1985, was vaccinated with a dose of RECOMBIVAX HB (lot number, dose and route not reported). Concomitant medication included unspecified antibiotics for Lyme disease. Physician stated that she received RECOMBIVAX HB while in her surgical rotation, and she had since suffered from "myocytis" and an autonomic nervous disorder. She reported that shortly after receipt of RECOMBIVAX HB (in 1985), she started "passing out" in during her surgical rotation in medical school. She reported that she consulted a cardiologist and neurologist at the time and the results of the tests did not show any cardiac arrhythmias or any specific neurological disorder. Muscle biopsy revealed a non-specific inflammatory process and her laboratory tests had demonstrated a consistent elevation in her muscle enzymes and no evidence of an autoimmune disorder. She reported that at the age of 31 (in 1992), she developed fibromyalgia and due to ongoing muscle pain, she underwent a muscle biopsy 10 years ago (in January 2002), which revealed a non-specific inflammatory process. Presently (in January 2012), she reported that 15 minutes after moderate exercise her cardiac output decreased, and she "nearly lost consciousness as a result". She did not want her physician to be contacted because these events had been ongoing "for years". The patient sought medical attention by physician examination. Performed lab studies included: electrocardiogram, muscle enzymes and autoimmune profile. The patient's outcome was not recovered at the time of report. Therapy with RECOMBIVAX HB was not reintroduced. The patient's adverse events were considered to be disabling by the reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Neurological examination normal, Presyncope
Clinical narrative: Information has been received from an approximately 24 (currently 50) year old female physician with Lyme disease and severe latex allergy (developed approximately in 1985), who in 1985, was vaccinated with a dose of RECOMBIVAX HB (lot number, dose and route not reported). Concomitant medication included unspecified antibiotics for Lyme disease. Physician stated that she received RECOMBIVAX HB while in her surgical rotation, and she had since suffered from "myocytis" and an autonomic nervous disorder. She reported that shortly after receipt of RECOMBIVAX HB (in 1985), she started "passing out" in during her surgical rotation in medical school. She reported that she consulted a cardiologist and neurologist at the time and the results of the tests did not show any cardiac arrhythmias or any specific neurological disorder. Muscle biopsy revealed a non-specific inflammatory process and her laboratory tests had demonstrated a consistent elevation in her muscle enzymes and no evidence of an autoimmune disorder. She reported that at the age of 31 (in 1992), she developed fibromyalgia and due to ongoing muscle pain, she underwent a muscle biopsy 10 years ago (in January 2002), which revealed a non-specific inflammatory process. Presently (in January 2012), she reported that 15 minutes after moderate exercise her cardiac output decreased, and she "nearly lost consciousness as a result". She did not want her physician to be contacted because these events had been ongoing "for years". The patient sought medical attention by physician examination. Performed lab studies included: electrocardiogram, muscle enzymes and autoimmune profile. The patient's outcome was not recovered at the time of report. Therapy with RECOMBIVAX HB was not reintroduced. The patient's adverse events were considered to be disabling by the reporter. Additional information has been requested.