chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Pyelonephritis, Pyrexia, Urinary tract infection
Clinical narrative: Went to medical center on 5/14/06 reportedly with c/o nausea, fever, dysuria, headache, (in ER). Also had dysuria with fever. Was placed on antibiotic Cipro and Pyridium and dismissed. On 5/16/06 was admitted to Hospital without much improvement and continued fever, lab work obtained. Pt to be discharged on 5/18/06. 06/01/06-8 page ED report received for services provided on 5/14/06-seen for c/o sharp bladder pain, N/V-DC DX pylonephritis. Initial temp 100. Medicated in ED with Tylenol, Toradol, Cipro and Motrin. Urine culture positive for E.coli. DC RX Cipro and Motrin. Patient was also seen at Hospital on 5/16/06. 9 page medical record to include H&P and DC summary received from Hospital. DC summary did not include a DX. Dates fo service 5/16-5/17/06. Admitting DX acute UTI with recurrent fever. Admitted with c/o nausea, mild left flank pain, dysuria and fever, 3 day HX treatment with antibiotics with no resolution of fever but UTI symptoms had resolved.  Urine difficult to assess secondary to color staining with Pyridium. Stated symptoms began "not long after vaccinations".  Hospital course included RX with Levauin antibiotic therapy, aggressive hydration. On second day of hospital stay she had no recurrence of fever.
Sex: U
Vaccine: MMR
Symptoms: Paralysis
Clinical narrative: Information has been received from a pharmacist who was told by a physician about a patient who was vaccianted with a dose of rubella virus vaccine live and mumps virus vaccine live and then was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Subsequently, following the dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live the patient experienced temporary paralysis. It was not reported if medical attention was sought. No outcome was reported. No product quality complaint was involved. Follow up information was obtained on 5/25/2006 indication that the pharmacist had no additional information regarding this case and could not provide physician information. Up internal review, temporary paralysis was determined to be an other important medical event (OMIC). Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Convulsion, Encephalopathy, Epilepsy, Laboratory test abnormal
Clinical narrative: Child with hx of epilepsy well controlled on topramax had reoccurrence of seizures on 5/17 am. Increasing in frequency through evening progressing to status epilepticus late on 5/17 that needed IV Cerebyx for control. 06/07/2006-received 1 page office notes and 6 page medical record from hospital to include consultation report and lab results.  Consult of 5/17/2006 documented 12 year old with history of seizures, history of migraine headache until recently after pertussis immunization and her usual menstrual cycle time that she had breakthrough seizure. She had 3 seizures possibly due to encephalopathy after pertussis immunization. During exam did not have any focal neurological signs. Treated with Cerebyx.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Status epilepticus
Clinical narrative: Child with hx of epilepsy well controlled on topramax had reoccurrence of seizures on 5/17 am. Increasing in frequency through evening progressing to status epilepticus late on 5/17 that needed IV Cerebyx for control. 06/07/2006-received 1 page office notes and 6 page medical record from hospital to include consultation report and lab results.  Consult of 5/17/2006 documented 12 year old with history of seizures, history of migraine headache until recently after pertussis immunization and her usual menstrual cycle time that she had breakthrough seizure. She had 3 seizures possibly due to encephalopathy after pertussis immunization. During exam did not have any focal neurological signs. Treated with Cerebyx.
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, MEN, TYP
Symptoms: Asthma, Depression, Dyspepsia, Fatigue, Gastritis
Clinical narrative: Fatigue during exercise, after meals, during and after sleep. This random effect started a few months post deployment. Sleep disorders and digestion disorders were also seen. Acid reflux, allergies, cold and flu-like symptoms, asthma, blood pressure high, depression, gastritis, insomnia, numbness and tingling fingers, sinusitis,  10/16/06 Records reviewed.  Records received are for 2006 only.  MSW screening positive for depression 5/06.  6/06 PCP note indicates patient has HTN, upper back pain, insomnia, anxiety & reddish skin rash in elbows with mild scaling for a few months.
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, MEN, TYP
Symptoms: Gastrooesophageal reflux disease, Hypersensitivity, Hypertension, Hypoaesthesia, Influenza like illness
Clinical narrative: Fatigue during exercise, after meals, during and after sleep. This random effect started a few months post deployment. Sleep disorders and digestion disorders were also seen. Acid reflux, allergies, cold and flu-like symptoms, asthma, blood pressure high, depression, gastritis, insomnia, numbness and tingling fingers, sinusitis,  10/16/06 Records reviewed.  Records received are for 2006 only.  MSW screening positive for depression 5/06.  6/06 PCP note indicates patient has HTN, upper back pain, insomnia, anxiety & reddish skin rash in elbows with mild scaling for a few months.
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, MEN, TYP
Symptoms: Insomnia, Paraesthesia, Pharyngitis, Rhinitis, Sinusitis
Clinical narrative: Fatigue during exercise, after meals, during and after sleep. This random effect started a few months post deployment. Sleep disorders and digestion disorders were also seen. Acid reflux, allergies, cold and flu-like symptoms, asthma, blood pressure high, depression, gastritis, insomnia, numbness and tingling fingers, sinusitis,  10/16/06 Records reviewed.  Records received are for 2006 only.  MSW screening positive for depression 5/06.  6/06 PCP note indicates patient has HTN, upper back pain, insomnia, anxiety & reddish skin rash in elbows with mild scaling for a few months.
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, MEN, TYP
Symptoms: Sleep disorder
Clinical narrative: Fatigue during exercise, after meals, during and after sleep. This random effect started a few months post deployment. Sleep disorders and digestion disorders were also seen. Acid reflux, allergies, cold and flu-like symptoms, asthma, blood pressure high, depression, gastritis, insomnia, numbness and tingling fingers, sinusitis,  10/16/06 Records reviewed.  Records received are for 2006 only.  MSW screening positive for depression 5/06.  6/06 PCP note indicates patient has HTN, upper back pain, insomnia, anxiety & reddish skin rash in elbows with mild scaling for a few months.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Hypokinesia, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Cellulitis of left leg from hip to knee. Painful ambulation and significant swelling, redness, heat and pain. Admitted for IV antibiotics and improved.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Cellulitis of left leg from hip to knee. Painful ambulation and significant swelling, redness, heat and pain. Admitted for IV antibiotics and improved.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis of left arm extending 3/4 of the distance to elbow. Failed oral antibiotics with worsening cellulitis. Required IV antibiotics and hospitalization.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: 5/9/06, at approx. 08:00 AM awaken with red whelp R deltoid approx. 1 hr later, R deltoid became swollen, red and warm to touch. C/o pain in neck. Mother states she called the doctor and he instructed her to get lot number of vaccine from health dept with no further directions.
Age: 70.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Medication error
Clinical narrative: 70 year old client received Tdap recommended maximum age is 64 Adacel.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Pruritus, Skin burning sensation, Sunburn
Clinical narrative: Pt received TDAP on 4/18/06. Received phone call from mother of pt on 4/20/06. States pt started complaining 4/19/06 at 21:00 PM of a burning, stinging, quick shooting pains under R shoulder blade and going down his back. Pt had worked in flower garden digging up hard clay and moving dirt with wheel barrows and had gotten sunburned after receiving TDAP. States back itched but hurt worse when he scratched it. Pain relieved some with a cold shower. Advised mom to take child to MD and report receiving TDAP and events that took place afterwards also.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Administered Tdap to a 77 year old male client is above recommended age for vaccination. Client was called with in 24 hours after incident. Client reported no adverse reaction to vaccine, except soreness at injection site.  Patient did not have adverse event.  TDAP mis-administered 77 yr old client.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site infection, Pyrexia
Clinical narrative: Observed severe local reaction on left arm below injection site with induration, redness, and fever down to just above antecubital area. Referred to Dr 3/31/06 client was given antibiotic and told by MD site was infected.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: 1st ever flu shot given 12/16/03 then ITP diagnosed 1/2/04 had noticed easy bruising for about 3-4 wks around the time flu shot given.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia oral, Pruritus
Clinical narrative: Perioral numbness (paresthesias) nasal itching intranasal.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature decreased, Chills, Pyrexia, Tremor
Clinical narrative: Developed onset of chills, shaking unable to stop although no seizure activity, taken to ER body temp felt to be below normal 97 felt reaction to immun had fever to 101 in the morning, no other sx fine 24 hours later.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Cyst, Dry skin, Infection, Pruritus, Skin burning sensation
Clinical narrative: Skin cysts developed, skin itchy, skin eczema, itching, dry and flaky skin. Skin hives, spontaneous burning sensation on the skin, infection with rash, skin discoloration.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Skin cysts developed, skin itchy, skin eczema, itching, dry and flaky skin. Skin hives, spontaneous burning sensation on the skin, infection with rash, skin discoloration.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Necrosis, Skin disorder, Skin nodule
Clinical narrative: Localized dimpling in skin of thigh with associated 2cm or so subcutaneous nodule, 2 weeks after vaccine administration. Possible early fat necrosis, will observe.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Lethargy, Pyrexia, Screaming
Clinical narrative: 4 hours after immunizations given, inconsolable crying, screaming, alternating with periods of lethargy for the next 30 hours. Fever to 103 began about 8 hours after the shots were given. Tylenol given every 4 hours. Fever did not resolve until 24 hours later.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Vaccine positive rechallenge
Clinical narrative: 4 hours after immunizations given, inconsolable crying, screaming, alternating with periods of lethargy for the next 30 hours. Fever to 103 began about 8 hours after the shots were given. Tylenol given every 4 hours. Fever did not resolve until 24 hours later.
Age: 0.68
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration and erythema upper part of leg 2.1cm X 4cm and lower part of thigh, .5cm X 1cm.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Chills, Influenza like illness, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: 05/20/06 injection site sore next am, in pm relates became achy and sore with temp 100 deg with warmth, swelling and knot at injection site took Tylenol. 5/21/06 felt worse with temp 101 chills, flu-like symptoms and warmth arm and sore. Had 4x4 swelling at left deltoid muscle, warmth to touch, small knot at injection site.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Injection site warmth, Malaise, Pain, Pyrexia
Clinical narrative: 05/20/06 injection site sore next am, in pm relates became achy and sore with temp 100 deg with warmth, swelling and knot at injection site took Tylenol. 5/21/06 felt worse with temp 101 chills, flu-like symptoms and warmth arm and sore. Had 4x4 swelling at left deltoid muscle, warmth to touch, small knot at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 5-6cm erythematous patch left anterior thigh.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness to left deltoid.
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Convulsion, Pneumonia, Respiratory arrest
Clinical narrative: 5-8-06 Grandmother reports, child had continuous seizure on 5/5/06, required visit to ER, due to respiratory arrest. Diagnosed with pneumonia and released home to mothers care. 5/9/06 phone call, to mom, child is on antibiotics for pneumonia doing well.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Swelling size of soft ball, redness some, site warm and very sore to touch pt states hurts when moves.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Mother states pt had immunizations on 4/17/06 about 14:00 PM. States pt ran low temperature on 4/18/06. States she gave him Advil (children's Tylenol) on 4/18/06. States he did not have anymore fever until 4/23/06. States has had fever off and on since 4/23/06. Voices no other complaints. Referred mother to child's pediatrician for evaluation of fever.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: 2 1/2 x 3" lump in arm warm and Swollen left arm.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Left upper thigh red, swollen and warm to touch x 1 day Tx cool compress, Benadryl, et monitor.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Mother called on 5/22/06 reporting fevers 6-4 days after shot given on 5/15/06. How has fine red rash to chest, back, neck. Otherwise doing well and fevers have now broken.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity, Pruritus
Clinical narrative: Itching around site for 2-3 hours, after 5/10/05 injection never reported until came for hep B #3 on 5/23/06 Hep B #3 not given by general HD.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site warmth, Pyrexia
Clinical narrative: Fever, redness, warmth right deltoid measuring 7cm.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Decreased appetite, Pyrexia, Somnolence
Clinical narrative: 4 hours after immunizations, fever 104.1, decreased appetite, crying inconsolably, waking dozily.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia, Vomiting
Clinical narrative: T0104 evening 5/18/06, vomited x 1 evening 5/18/06. Injection site with large surrounding erythema 3cm, warm to touch, no fluctuance.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Pyrexia
Clinical narrative: Induration, fever, erythema.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Pyrexia
Clinical narrative: Left arm red, hard, swollen, low grade fever 100.
Age: 0.56
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Nasal congestion, Pyrexia
Clinical narrative: 05/23/06 fever 103.8 - 103 starting last night Motrin given 5/22/06, Tylenol 5/23/06, 5/24/06 office call T 101.7 with Tylenol and Motrin throat erythema, RTC negative, nasal congestion.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site reaction
Clinical narrative: Pt was given DTaP in LD IM on 5/22/2006 and IPV SQ in left arm on 5/22/2006. Seen by nurse 5/24/06 at 11:25. Left deltoid red and swollen area measures 8cm x 9cm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis of left arm from shoulder to 2" above elbow. Was given oral antibiotics instructed to call next day and return if not improving.
Age: 1.35
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Haematoma, Injection site mass, Injection site pain, Injection site swelling, Muscle atrophy
Clinical narrative: VACCINES ADMINISTERED ON 4/24/06.  MOTHER REPORTS HE SOON DEVELOPED A LARGE SWELLING IN THE RIGHT UPPER ANTERIOR THIGH AT THE INJECTION SITE.  DESCRIBED AS GOLF BALL SIZE WITH SOME PAIN AND TENDERNESS AND AN ASSOC. LIMP OF THE RIGHT LEG. PARENTS THOUGHT THIS WAS PROBABLY A HEMATOMA SECONDARY TO VACCINATION.  NEVERTHELESS, THERE WAS NO FEVER AT THE TIME, NO RASH, OR OTHER SYMPTOMS OF NOTE.  SLOW RESOLUTION OF THE SWELLING IN THE RIGHT ANTERIOR THIGH WITH FINAL RESOLUTION.  AT THIS POINT HE WAS NOTED TO HAVE A WELL-CIRCUMSCRIBED DEPRESSED ARE OF APPROXIMATELY 5 CM IN DIAMETER AT THE INJECTION SITE.  THIS HAD A SLIGHTLY BLUISH-PINK DISCOLORATION.  ASCENDING FROM THIS LESION WAS A LINEAR DEPRESSION EXTENDING TO THE PUBIC SYMPHYSIS SUGGESTIVE OF MUSCULAR ATROPHY.  LESIONS ARE NON-TENDER AND GAIN IS NORMAL.  NO OTHER SYMPTOMS OF NOTE. OF NOTE OLDER BROTHER ALLEGEDLY DEVELOPED SIMILAR LESION FOLLOWING AN INJECTION (NOT VACCINATION).
Age: 1.35
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Skin discolouration, Tenderness
Clinical narrative: VACCINES ADMINISTERED ON 4/24/06.  MOTHER REPORTS HE SOON DEVELOPED A LARGE SWELLING IN THE RIGHT UPPER ANTERIOR THIGH AT THE INJECTION SITE.  DESCRIBED AS GOLF BALL SIZE WITH SOME PAIN AND TENDERNESS AND AN ASSOC. LIMP OF THE RIGHT LEG. PARENTS THOUGHT THIS WAS PROBABLY A HEMATOMA SECONDARY TO VACCINATION.  NEVERTHELESS, THERE WAS NO FEVER AT THE TIME, NO RASH, OR OTHER SYMPTOMS OF NOTE.  SLOW RESOLUTION OF THE SWELLING IN THE RIGHT ANTERIOR THIGH WITH FINAL RESOLUTION.  AT THIS POINT HE WAS NOTED TO HAVE A WELL-CIRCUMSCRIBED DEPRESSED ARE OF APPROXIMATELY 5 CM IN DIAMETER AT THE INJECTION SITE.  THIS HAD A SLIGHTLY BLUISH-PINK DISCOLORATION.  ASCENDING FROM THIS LESION WAS A LINEAR DEPRESSION EXTENDING TO THE PUBIC SYMPHYSIS SUGGESTIVE OF MUSCULAR ATROPHY.  LESIONS ARE NON-TENDER AND GAIN IS NORMAL.  NO OTHER SYMPTOMS OF NOTE. OF NOTE OLDER BROTHER ALLEGEDLY DEVELOPED SIMILAR LESION FOLLOWING AN INJECTION (NOT VACCINATION).
Age: 1.35
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Gait disturbance, Injection site mass, Injection site oedema, Injection site pain, Skin discolouration
Clinical narrative: VACCINES ADMINISTERED ON 4/24/06.  MOTHER REPORTS HE SOON DEVELOPED A LARGE SWELLING IN THE RIGHT UPPER ANTERIOR THIGH AT THE INJECTION SITE.  DESCRIBED AS GOLF BALL SIZE WITH SOME PAIN AND TENDERNESS AND AN ASSOC. LIMP OF THE RIGHT LEG. PARENTS THOUGHT THIS WAS PROBABLY A HEMATOMA SECONDARY TO VACCINATION.  NEVERTHELESS, THERE WAS NO FEVER AT THE TIME, NO RASH, OR OTHER SYMPTOMS OF NOTE.  SLOW RESOLUTION OF THE SWELLING IN THE RIGHT ANTERIOR THIGH WITH FINAL RESOLUTION.  AT THIS POINT HE WAS NOTED TO HAVE A WELL-CIRCUMSCRIBED DEPRESSED ARE OF APPROXIMATELY 5 CM IN DIAMETER AT THE INJECTION SITE.  THIS HAD A SLIGHTLY BLUISH-PINK DISCOLORATION.  ASCENDING FROM THIS LESION WAS A LINEAR DEPRESSION EXTENDING TO THE PUBIC SYMPHYSIS SUGGESTIVE OF MUSCULAR ATROPHY.  LESIONS ARE NON-TENDER AND GAIN IS NORMAL.  NO OTHER SYMPTOMS OF NOTE. OF NOTE OLDER BROTHER ALLEGEDLY DEVELOPED SIMILAR LESION FOLLOWING AN INJECTION (NOT VACCINATION).
Age: 1.35
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Tenderness
Clinical narrative: VACCINES ADMINISTERED ON 4/24/06.  MOTHER REPORTS HE SOON DEVELOPED A LARGE SWELLING IN THE RIGHT UPPER ANTERIOR THIGH AT THE INJECTION SITE.  DESCRIBED AS GOLF BALL SIZE WITH SOME PAIN AND TENDERNESS AND AN ASSOC. LIMP OF THE RIGHT LEG. PARENTS THOUGHT THIS WAS PROBABLY A HEMATOMA SECONDARY TO VACCINATION.  NEVERTHELESS, THERE WAS NO FEVER AT THE TIME, NO RASH, OR OTHER SYMPTOMS OF NOTE.  SLOW RESOLUTION OF THE SWELLING IN THE RIGHT ANTERIOR THIGH WITH FINAL RESOLUTION.  AT THIS POINT HE WAS NOTED TO HAVE A WELL-CIRCUMSCRIBED DEPRESSED ARE OF APPROXIMATELY 5 CM IN DIAMETER AT THE INJECTION SITE.  THIS HAD A SLIGHTLY BLUISH-PINK DISCOLORATION.  ASCENDING FROM THIS LESION WAS A LINEAR DEPRESSION EXTENDING TO THE PUBIC SYMPHYSIS SUGGESTIVE OF MUSCULAR ATROPHY.  LESIONS ARE NON-TENDER AND GAIN IS NORMAL.  NO OTHER SYMPTOMS OF NOTE. OF NOTE OLDER BROTHER ALLEGEDLY DEVELOPED SIMILAR LESION FOLLOWING AN INJECTION (NOT VACCINATION).
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Irritability, Pharyngitis, Pyrexia
Clinical narrative: FEVER /FUSSY /INCONSOLABLE CRYING FEVER IN OFFICE 101 RECTALLY.   DX: FEVER /PHARYNGITIS/PERTUSSIS REACTION.
Age: 0.08
Sex: F
Vaccine: DTP, OPV
Symptoms: Erythema, High-pitched crying, Pyrexia, Swelling
Clinical narrative: Swelling, high pitch screaming, redness, fever of 101.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Headache, Lymphadenopathy, Rash
Clinical narrative: 5/22/06 Had swollen glands- neck and front of ears went to MD. Had blood tests(?) and put on antibiotics.  5/24/06 rash all over body. MD took him off antibiotics and told him all his blood work was OK. He had headaches and some dizziness."no fever or sore throat".
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypokinesia, Joint stiffness, Pain
Clinical narrative: Pt states the day after receiving the Influenza & Pneumococcal vaciines his Rt shoulder started to hurt with stiffness & the pain/stiffness started to progress down into his hips & knees.  He has difficulty opening his Lt hand when he wakes up in the morning.  He states he has a little arthritis in the Lt shoulder & "spurs" here & there" but his physician is not able to find the cause of the joint problems.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Pyrexia
Clinical narrative: Patient developed fever and chills after receiving vaccinations. Area of injection developed a red erythema area. Patient admitted to hospital for suspicion of cellulitis and started on intravenous antibiotics.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Face oedema, Pruritus, Urticaria
Clinical narrative: Patient initially noted itching on back of thighs, then on face around mouth.  She went to the ER for hives and was given IV medication -- Benadryl, maybe something else.  Went home with Prednisone 60 mg QD x3, Benadryl 50 mg Q4 hours, Cemedtine 300 mg TID.  Returned to the ER yesterday 5/29 for chest pain.  This resolved after sittingin the cool environment of the waiting room.  Symptoms have improved, but she still needs Benadryl Q4 hours, and wakes with worsened hives.  Presents today (3 days post ER visit) with persistent hives, swelling around the mouth.  No respiratory or cardiac sx.   Heat increases sx.  No PMH hives or known food allergies.  No history of skin allergies or eczema.  PMH sulfa allergy.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Irritability, Pyrexia, Sleep disorder
Clinical narrative: Developed a fever mid-day May 27th.  By 3pm on May 28th the fever reached 107degF, at which point I called her physician's office and administered Children's Tylenol (tylenol).  Her fever stayed at 102degF while on tylenol, but ramped up again around 8pm to 104degF.  I gave her one more dose of tylenol before she went to sleep.  She awoke the next morning with a temperature of 101degF, which persisted throughout the day, ramping up again toward the evening to 102degF.  She awoke Tuesday morning May 30th with a normal temperature of 97.8degF.  Throughout the fever, her sleep had been fitful.  In addition, she experienced irritability within 24 hours of receiving the vaccine, which persisted until the morning of May 30th.  My daughter had the same reaction within a week after receiving her first set of immunizations on February 25, 2006.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness, Oedema peripheral
Clinical narrative: Patient had multiple joint pains and stiffness with some swelling in the hands to the point that she was unable to continue with usual life for a week.  Steroids helped a lot with the symptoms.  MMR was required by nursing school since her rubella titer was low.
Age: 29.0
Sex: M
Vaccine: FLUN3
Symptoms: Alopecia, Alopecia areata
Clinical narrative: ONE PATCH OF HAIR LOSS APPEARED WITHIN 30 DAYS OF VACCINE ADMINISTRATION AND CONTINUED TO INCREASE OVER THE NEXT COUPLE OF MONTHS. BY TODAY OVER 50 PERCENT OF HEAD AND FACIAL HAIR HAS FALLEN OFF.  VARIOUS STEROID TREATMENT HAVE BEEN ADMINISTERED WITHOUT ANY IMPROVEMENT.
Age: 41.0
Sex: M
Vaccine: JEV
Symptoms: Chills, Hyperhidrosis, Pharyngolaryngeal pain, Pyrexia, Stomach discomfort
Clinical narrative: Sore throat, Feverish, Sweating, Chills, Upset Stomach.
Age: 1.3
Sex: M
Vaccine: HEP, HIBV, PNC, VARCEL
Symptoms: Chest X-ray abnormal, Convulsion, Cough, Dehydration, Gastritis
Clinical narrative: Seizure 3-4 days after his one year old immunizations. 4 more seizure episodes after that. Last one 1 year ago. 06/01/06-10 pages of office notes received from dates of service range from 8/20/02 through 8/24/05-note for 4/22/04 documents intractable N/V and moderate dehydration, with subsequent admission to hospital, a note of 8/24/05 documented febrile seizure history x2 and 1 afebrile seizure-last seizure 8 months prior to 8/24/05 visit. Referral for Neuro consult to MD.  06/06/06-6 page ED reports for dates of service 11/06/03 (date of vaccine), 11/07/03(8pages),11/08/03 (6 pages) and 11/25/03 (6 pages) received from Hospital. Notes document temp of 104.9 on 11/06/03 with c/o fever and vomiting and cough. RX with Rocephin 600 mg, Tylenol and Phenergan. DX of otitis media, viral gastritis with secondary diagnosis of s/p vaccine. ED note of 11/07/03 documents mother stated had apparent siezure and vomiting, temp of 103.1 and RX with Rocephin 600mg. DC instructions return on 11/08/03 for additional Rocephin. DC DX Fever, Febrile seizure and secondary diagnosis of otitis media. ED report 11/08/03 documents temp of 100.4 RX with Rocephin 400 mg IV. DC DX febrile seizure. ED report 11/25/03 documents temp of 98.8 with c/o fever times 2 days and seizures from fever. DC DX Right otitis media. DC instructions included f/u with family practice physician. Notes from Clinic document that the next visit occurred on 02/26/04 for well baby visit.
Age: 1.3
Sex: M
Vaccine: HEP, HIBV, PNC, VARCEL
Symptoms: Nausea, Otitis media, Pyrexia, Vomiting
Clinical narrative: Seizure 3-4 days after his one year old immunizations. 4 more seizure episodes after that. Last one 1 year ago. 06/01/06-10 pages of office notes received from dates of service range from 8/20/02 through 8/24/05-note for 4/22/04 documents intractable N/V and moderate dehydration, with subsequent admission to hospital, a note of 8/24/05 documented febrile seizure history x2 and 1 afebrile seizure-last seizure 8 months prior to 8/24/05 visit. Referral for Neuro consult to MD.  06/06/06-6 page ED reports for dates of service 11/06/03 (date of vaccine), 11/07/03(8pages),11/08/03 (6 pages) and 11/25/03 (6 pages) received from Hospital. Notes document temp of 104.9 on 11/06/03 with c/o fever and vomiting and cough. RX with Rocephin 600 mg, Tylenol and Phenergan. DX of otitis media, viral gastritis with secondary diagnosis of s/p vaccine. ED note of 11/07/03 documents mother stated had apparent siezure and vomiting, temp of 103.1 and RX with Rocephin 600mg. DC instructions return on 11/08/03 for additional Rocephin. DC DX Fever, Febrile seizure and secondary diagnosis of otitis media. ED report 11/08/03 documents temp of 100.4 RX with Rocephin 400 mg IV. DC DX febrile seizure. ED report 11/25/03 documents temp of 98.8 with c/o fever times 2 days and seizures from fever. DC DX Right otitis media. DC instructions included f/u with family practice physician. Notes from Clinic document that the next visit occurred on 02/26/04 for well baby visit.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Lt upper arm swollen, red and warm to touch from elbow to shoulder. Saw Dr; has cellulitis and was treated with antibiotic on5/18/06. 5/23/06, phone call to clinic, much better.
Age: 0.79
Sex: M
Vaccine: HIBV, IPV, PNC
Symptoms: Rash papular, Urticaria
Clinical narrative: He developed papular urticaria diffusely of extremities, trunk, back and palms.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Injection site hypersensitivity, Injection site pain, Neck pain, Parotid gland enlargement
Clinical narrative: 5/15/06 c/o fatigue, neck and shoulder pain, 5/20/06 pain at injection site, slight redness at site, continues shoulder pain and neck pain, 5/21/06 swelling left parotid, tender to both sides of neck into ears, fatigue, shoulder pain.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Shoulder pain, Tenderness
Clinical narrative: 5/15/06 c/o fatigue, neck and shoulder pain, 5/20/06 pain at injection site, slight redness at site, continues shoulder pain and neck pain, 5/21/06 swelling left parotid, tender to both sides of neck into ears, fatigue, shoulder pain.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Tremor
Clinical narrative: Tremors. Tremor arms and legs ///. No staring spells. No distress, (-) EEG.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Dizziness, Pruritus, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 9 yr old female pt with a history of fever of 101 degrees F on 26Mar05 or 27Mar05 who on 29Mar05 was vaccinated with a dose of hep A virus vaccine inactivated (lot645995/0675P). On 29Mar05 within 2 1/2 to 3 hrs the pt developed an itch all over, good size welts on her chest, back, sides, and hips. She was also light headed and had slight diarrhea. She was treated with diphenhydramine hydrochloride (Benadryl) and was recovering at the time of the report. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Alanine aminotransferase increased
Clinical narrative: Information has been received from a registered nurse concerning a 53 year old female who in February 2005 and March 2003 was vaccinated with a first and second dose of hepatitis A virus vaccine inactivated, respectively (manufacturer unknown). Concomitant therapy included a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). It was noted that the patient has been donating platelets for many years. She has given many times thus her blood is tested each time she donates. On 13-MAY-2005, her alanine aminotransferase (ALT) was very high. It was noted that the patient had no other symptoms. The patient was contacted and reported that she had received the vaccines. It was noted that she had donated many times since receiving the vaccines but this was the first indication of any abnormal results. It was also noted that the patient had no paper work identifying the manufacturer or any other pertinent information. Therefore, the reporter was not sure of the vaccine manufacturer, it is possible but not definite. No medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. No further information is available.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning her son who on 18-MAY-2005 was vaccinated with a dose of hepatitis A virus vaccine inactivated. On 19-MAY-2005, she reported that her son had since developed hives all over his entire body and has a low fever. He is being treated with over the counter diphenhydramine hydrochloride (BENADRYL). Unspecified medical attention was sought. At the time of this report, her son was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Laboratory test abnormal
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 58 year old female social worker with hypertension and penicillin allergy who on 15-SEP-2004 was vaccinated with a first dose of hepatitis A virus vaccine inactivated (Lot # unknown). On 20-MAR-2005, the patient was vaccinated IM in the right deltoid with a second dose of hepatitis A virus vaccine inactivated (Lot # unknown). Subsequently, on 07-JUN-2005, a titer was drawn and did not show seroconversion (hepatitis A IgM antibody was negative). The nurse reported a "possible vaccine failure". The nurse also noted that the patient had a history of non-conversion with series # 1 of hepatitis B vaccine (WAES0605USA00044). After completing a second series, the patient's titer was positive for hepatitis B antibody. The nurse reported that a repeat of the hepatitis A vaccine was administered on 28-JUN-2005. It was also reported that the patient had nor symptoms. There was no product quality complaint involved. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Syncope, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with unknown medical history who on 10-JUN-2005 was vaccinated with a 1 mL first dose of hepatitis A virus vaccine inactivated (Lot# 648526/0859P) (reported as the pediatric formulation). Concomitant therapy was reported as "other medications exact names unknown". On 10-JUN-2005, about 2 hours after receiving the vaccination, the patient developed hives, shortness of breath and a feeling that she was going to pass out. The patient sought unspecified medical attention. The symptoms resolved spontaneously the same day. There was no product quality complaint involved. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Hyperhidrosis, Medication error
Clinical narrative: Information has been received from a pharmacist concerning a healthy 35 year old black female with no history of drug reactions or allergies who on 23-JUN-2005 was vaccinated with a first dose of hepatitis A virus vaccine inactivated (lot # 648722/1125P). Suspect vaccination at the same time included a 0.5 mg second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 650044/0004R) which was given using two pediatric doses. It was noted that the patient received their first dose of hepatitis B virus vaccine rHBsAg (yeast) in September 2004. Other concomitant medication included ethinyl estradiol (+) norgestimate (ORTHO TRI CYCLEN). It was also noted that the patient also had no reactions to prior vaccine doses. Subsequently, 45 minutes later, the patient started vomiting and sweating. She was admitted to the emergency intensive care unit for an anaphylactic reaction and was given ephedrine and intravenous fluids. She was discharged the next day. Subsequently, the patient recovered from anaphylactic reaction. A product quality complaint was not involved. Follow-up information was received from the pharmacist who reported that the patient developed difficulty breathing and nausea and dizziness about ten minutes after being vaccinated with hepatitis A virus vaccine inactivated and hepatitis B virus vaccine rHBsAg (yeast). The patient had two episodes of emesis and went to the emergency room for evaluation. The patient was noted to have stridor and received methylprednisolone sodium succinate (SOLU-MEDROL) (125 mg IV), epinephrine (0.5 mg SC), diphenhydramine hydrochloride (BENADRYL) (50 mg IV), and cimetidine (300 mg IVBP). The patient was hospitalized for one day and recovered on 24-JUN-2005.   Anaphylactic reaction was considered to be immediately life threatening and an other important medical event (OMIC) by the reporter.   No further information is expected.  The records of testing prior to release of both lots in question (#1125P and #0004R) have been rechecked and found to be satisfactory. The lots met the requirements of the Center and were released by the regulatory agency.
Age: 35.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Nausea, Stridor, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a healthy 35 year old black female with no history of drug reactions or allergies who on 23-JUN-2005 was vaccinated with a first dose of hepatitis A virus vaccine inactivated (lot # 648722/1125P). Suspect vaccination at the same time included a 0.5 mg second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 650044/0004R) which was given using two pediatric doses. It was noted that the patient received their first dose of hepatitis B virus vaccine rHBsAg (yeast) in September 2004. Other concomitant medication included ethinyl estradiol (+) norgestimate (ORTHO TRI CYCLEN). It was also noted that the patient also had no reactions to prior vaccine doses. Subsequently, 45 minutes later, the patient started vomiting and sweating. She was admitted to the emergency intensive care unit for an anaphylactic reaction and was given ephedrine and intravenous fluids. She was discharged the next day. Subsequently, the patient recovered from anaphylactic reaction. A product quality complaint was not involved. Follow-up information was received from the pharmacist who reported that the patient developed difficulty breathing and nausea and dizziness about ten minutes after being vaccinated with hepatitis A virus vaccine inactivated and hepatitis B virus vaccine rHBsAg (yeast). The patient had two episodes of emesis and went to the emergency room for evaluation. The patient was noted to have stridor and received methylprednisolone sodium succinate (SOLU-MEDROL) (125 mg IV), epinephrine (0.5 mg SC), diphenhydramine hydrochloride (BENADRYL) (50 mg IV), and cimetidine (300 mg IVBP). The patient was hospitalized for one day and recovered on 24-JUN-2005.   Anaphylactic reaction was considered to be immediately life threatening and an other important medical event (OMIC) by the reporter.   No further information is expected.  The records of testing prior to release of both lots in question (#1125P and #0004R) have been rechecked and found to be satisfactory. The lots met the requirements of the Center and were released by the regulatory agency.
Age: 0.03
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Medication error
Clinical narrative: Information has been received from a mother concerning her 11 day old son with no past medical history and no drug allergies who on 05-MAY-2005 was "accidentally" vaccinated with hepatitis A virus vaccine inactivated. There was no concomitant medication. Subsequently the patient developed redness of the skin. There were no relevant diagnostic laboratory tests. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning her daughter who was vaccinated with hepatitis A virus vaccine live inactivated (0.5 ml). Subsequently the patient experienced reaction the next day on her neck and face. The reaction resolved in a few days. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEPA, IPV, TYP
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a 25 year old female consumer with no medical history or allergies, who in approximately February 2005 "six months ago", was vaccinated with a dose of hepatitis A virus vaccine inactivated (lot# 648459/0856P). Concomitant therapy included typhoid vaccine (unspecified), poliovirus vaccine and Chloroquine. After receiving hepatitis A virus vaccine inactivated, the consumer only had one period. It was noted that she did not have one for four months so she began taking birth control pills to see if that would help. She reported that she had one period then, so she stopped taking the pills, and she has had none since. Unspecified medical attention was sought. Laboratory diagnostic tests included blood work. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 3 year old female patient with no reported medical history who on 01-AUG-2005 was vaccinated with a dose of hepatitis A virus vaccine inactivated (Lot# 649453/0132R). There was no concomitant medication. The patient developed a severe local reaction after receiving a hepatitis A virus vaccine inactivated. The child developed a fever and vomiting within the first 24 hours following the vaccination. Then her arm turned red and was warm to the touch. The child was seen in the office in on 04-AUG-2005 and her father called because the swelling got worse during the past few hours. The reported indicated that it may be cellulitis and that the child had an appointment for 05-AUG-2005. At the time of this report, the patient had not recovered. There was no product quality complaint involved.  Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Swelling, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 3 year old female patient with no reported medical history who on 01-AUG-2005 was vaccinated with a dose of hepatitis A virus vaccine inactivated (Lot# 649453/0132R). There was no concomitant medication. The patient developed a severe local reaction after receiving a hepatitis A virus vaccine inactivated. The child developed a fever and vomiting within the first 24 hours following the vaccination. Then her arm turned red and was warm to the touch. The child was seen in the office in on 04-AUG-2005 and her father called because the swelling got worse during the past few hours. The reported indicated that it may be cellulitis and that the child had an appointment for 05-AUG-2005. At the time of this report, the patient had not recovered. There was no product quality complaint involved.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a nurse practitioner concerning a child (gender not specified) who in approximately August 2005 ("recently") was vaccinated with a dose of hepatitis A virus vaccine inactivated (Lot# unknown). It was reported that the patient developed a severe reaction after receiving a hepatitis A virus vaccine inactivated. The reporter indicated that it was not her patient; she had no details to provide. The patient sought unspecified medical attention. The patient status was unknown at the time of the report. There was no product quality complaint involved. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: HEPA
Symptoms: Computerised tomogram normal, Injection site erythema
Clinical narrative: Injection site erythema; wrong drug administered. Information has been received from a certified medical assistant and a physician concerning an 8 week old female with no previous medical history who on 22-AUG-2005 was vaccinated intramuscularly one time with a first 0.5ml dose of hepatitis A virus vaccine inactivated (lot# 649456/0400R) instead of scheduled dose of 'PediVax" (therapy unspecified). There was no illness at the time of vaccination. On the same day post vaccination 22-AUG-2005, the patient developed a mild 3-4cm area of erythema at the injection site. Unspecified medical attention was sought and the patient was treated with cephalexin (KEFLEX) and was reported as recovered on the same day. No laboratory or diagnostic tests were performed. No product quality complain was involved.  Additional information is no expected. 02/11/2010 Follow-up information received from a medical assistant stated that hte patient was diagnosed with torticolis on 25-SEP-2005. A computerized tomography scar of the neck and head were within normal limits. The patient began physical therapy from12-OCT-2005 to 12-JAN-2006. No additional symptoms or treatment were mentioned. Unspecified medical attention was sought. No product quality complaint was involved.
Sex: M
Vaccine: HEPA
Symptoms: Contusion, Injection site haemorrhage, Injection site mass, Medication error
Clinical narrative: Injection site haemorrhage; injection site mass; incorrect route of drug administration. Information has been received from a registered nurse (RN) concerning an adult male who on approximately 12-AUG-2005 was vaccinated SC with a dose of hepatitis A virus vaccine inactivated. There was no concomitant therapy. The RN reported that on approximately 26-AUG-2005, the patient's vaccination site became bruised with a lump. Unspecified medical attention was sought but treatment was not required. At the time of this report, the patient had not recovered.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Pyrexia
Clinical narrative: Pyrexia; headache Information has been received from a consumer concerning her 14 year old daughter who on approximately August 2004 and on 30-AUG-2005 was vaccinated with a first and second dose of hepatitis A virus vaccine inactivated, respectively. Illness at the time of vaccination included a viral infection. On 30-AUG-2005 in the evening, she developed a fewer up to 102.1 F and had a headache associated with the fever. It was noted that she continued to have a fever 36 hours later. It was noted that there were no other symptoms. At the time of this report, she had not recovered. Additional information is not expected.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Lethargy, Malaise, Medication error, Photophobia, Rash
Clinical narrative: Photophobia; incorrect dose administered; Lethargy: Rash; Malaise Information has been received from a registered nurse concerning a 19 year old male with anxiety who on an unspecified date was vaccinated IM with a first 0.5ml dose of hepatitis A virus vaccine inactivated and on 30-AUG-2005 at 14:00 was vaccinated IM with a second dose of hepatitis A virus vaccine inactivated (lot #649454/0202R). It was noted that the pediatric formulation was used for both doses. There was no illness at the time of vaccination. It was reported that "recently" (2005), after the vaccination, the patient developed a rash and became lethargic and photophobic. Unspecified medical attention was sought and the patient subsequently recovered. A product quality complaint was not involved. Follow-up information was received from the registered nurse and physician. The nurse reported that on 30-AUG-2005 at midnight, the patient was awakened from sleep with a headache, photophobia, a rash and generalized malaise. The patient was awake for about on half hour. This was reported by the mother on the phone on 31-AUG-2005. The patient slept through the night and was still asleep at the time of the call. It was requested that the mother awaken the patient and evaluate the condition. There was no return phone call. The physician reported that the patient awoke with a headache, malaise, photophobia and a rash. The patient did not report to a medical provider for evaluation. No diagnostic laboratory tests were performed. The patient recovered on 31-AUG-2005. No further information is expected.