chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site mass, White blood cell count increased
Clinical narrative: Pt Received vaccinations and 1 week later noted erythema and lumps at the site then about 1 month after vaccination abcesses with pus drainage was noted at the immunization sites.  No fever noted.  Pt otherwise well.  11/2/07 Received medical records from pcp which are only ER records of 10/18/07 & reveal patient experienced induration & ecchymosis at bilateral thigh vax sites, left greater than right.  D/C home on oral antibiotics & pcp f/u. FINAL DX: Cellulitis of thighs & local immunization reaction.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: v Patient had redness and itching at vaccination site
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Erythema, Nausea, Oedema peripheral, Pain
Clinical narrative: Swelling upper left arm, erythema, extreme soreness- 3 hrs. post injection. Shortness of breath and nausea.
Age: 0.8
Sex: M
Vaccine: FLU3
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Patient developed rash approximately 1 hour after administration of the flu shot. Rash itchy, welps. Resolved after benadryl administration at the emergency department at Hospital.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Developed redness and swelling to right upper thigh 24 hours after shots.  Seen at Hospital ER 10/7/07 and placed on Keflex and Bendadryl for cellulitis.  Had follow up visit with primary doctor 10/9/2007-almost back to normal.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Injection site infection, Joint range of motion decreased, Malaise
Clinical narrative: Superficial infection Left deltoid within 2-3 days and lasting 4-5 days.  Generalized malais, joint tenderness, body aches, ad weakness since vaccination.  Right shoulder severe pain, mild warmth and decreased range of motion from 10/16/07 and continued through this reporting date.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Skin warm
Clinical narrative: Superficial infection Left deltoid within 2-3 days and lasting 4-5 days.  Generalized malais, joint tenderness, body aches, ad weakness since vaccination.  Right shoulder severe pain, mild warmth and decreased range of motion from 10/16/07 and continued through this reporting date.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Dehydration, Diarrhoea, Headache, Malaise, Vomiting
Clinical narrative: ABOUT 2:30 A.M.WOKE UP WITH A ON AND OFF AGAIN HEADACHE THAT STARTED ABOVE MY RIGHT EYE AND TRAVELED TO MY RIGHT EAR. I GOT UP AND HAD SOME WATER BUT THE HEADACHE KEPT GETTING WORSE. GOT UP AGAIN ABOUT 3:30 AND TOOK TWO ASPIRIN, ABOUT 4:00 A.M. GOT UP AND HAD DIARRHEA, WENT BACK TO BED ABOUT 4:30 GOT BACK UP AND VOMITED ALL THE WATER AND ASPIRIN UP.  THE HEADACHE GOT A LITTLE BETTER BUT ALL DAY IT WAS THERE AND I FELT DEHYDRATED AND JUST SICK.  COULDN`T DRINK ANYTHING OR EAT. I SLEPT ALL DAY, ABOUT 6;00 P.M. I STARTED TO FEEL A LITTLE BETTER. I DON`T THINK I`LL GET ANOTHER FLU SHOT NEXT YEAR, I HAVE NEVER HAD A HEADACHE LIKE THAT BEFORE
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain, Abdominal pain upper, Feeling abnormal, Headache, Myalgia
Clinical narrative: Injection at 9 am . By 2pm experienced stomach/intestinal cramps, headache and leg muscle pain.  Saturday morning got up at 7 am with severe stomach/intestinal cramps, headache and leg muscle pain.  Took ibuprofin and vicodin to relieve symptoms. Felt bad all day. Sunday morning woke up at 4 am with same symptoms. Same ibuprofin/vicodin pain relief. Felt bad all day. Moday morning woke up midnite, 2am, 4am with severe headache. At 2am had severe abdominal pain. Same ibuprofin/vicodin pain relief. Still hurt at 4pm Monday.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diet refusal, Somnolence
Clinical narrative: Less than twelve hours after vaccination, mother noticed patient refusing feed, very drowsy.   There was no fever or edema of the vaccinated sites.  He got vaccinated with Pediarix, ActHib, Prevnar, Rotateq around noon, got one feeding right after that, and refused subsequent feeds until the next morning.  Per mother, she was not able to wake him up at night for feed; his arms and legs were limp.  Patient was seen by me the next day in the morning.  He was sleeping, but woke up for exam, alert and able to breast feed, though not with strong suck.  Exam was within normal limit.  Sites of vaccination had no edema or erythema.  Patient was sent home for observation.  When I talked to his mother over the phone in the afternoon, she said that patient is back to his baseline, feeding well, active, playful.  When I checked back with his mother over the phone on day 3 after vaccination, he remained well.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Autism, Developmental delay
Clinical narrative: After the Dtap, Hepatitis B, IPV shots and Flu Shots, patient was diagnosed with a development delay which after evaluations was further defined/diagnosed as autism; before the vaccines; she appeared to be a normal healthy infant.  11/9/07 Received vax records from pcp.  No flu shot until 10/2006.  Medical records reveal patient w/colic; neonatal SDH; left lazy eye; otitis media; GERD.  States patient has multiple food allergies, multiple bouts of OM, PE tubes & Fifths disease.  Autism not mentioned in their chart until 2/15/07.  11/26/07 Reviewed vax record from prior pediatrics office which indicates vaccinations for 1/3/2003 of DTaP, Hib, HBV & PCV given elsewhere by unknown clinic.  No additional medical records available. 1/15/08 Reviewed medical records provided by parent.  Office note of 7/14/2006 states dx of pervasive developmental delay.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Anosmia, Laboratory test abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: A serious report of anosmia has been received from a physician concerning a nine-year-old female. No relevant medical or drug history information has been reported for this patient. The patient received the initial dose of FluMist on an unknown date in 2005 and continued to receive FluMist on unknown dates in 2006 and 2007. On an unknown date in the summer of 2005, the patient began complaining of not being able to smell anything. Reporter was not sure whether this occurred before or after receiving the initial dose of FluMist. The patient continued to complain of not being able to smell, but continued to receive FluMist in 2006 and 2007. A neurologist was consulted and a MRI was performed in Sep 2007 with normal results. A smell test was also performed in Sep 2007 and the results were abnormal. In Oct 2007, the patient's primary care provider called the sponsor's medical information department to ask if anyone had lost the ability to smell after receiving FluMist. While obtaining follow up information, the primary care physician stated "the smell test indicated that the child could not smell anything" and that she "was not sure when a child recognizes the sense of smell or the absence of the sense and was not sure whether the loss of smell could be a result of a virus or was present at birth". The primary care physician would not release the contact information for the neurologist. The event has not resolved and is considered to be a permanent disability by the primary care provider. No additional information information is available. The primary care physician was unsure whether the patient would continue to receive FluMist. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a causality assessment for the adverse events reported.
Age: 49.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Unevaluable event
Clinical narrative: Hep B vaccine given in (R) hip.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: Flu vaccine was given at the clinic. Patient states approximately 5 hours after getting the flu shot his eyes got very red, itchy and swollen. The patient did notify the clinic where the injection was given and the doctor's office.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: Flu vaccine was given at the clinic. Pt states approx 5 hours after getting the flu shot her eyes got very red, itchy and swollen. Pt notified the clinic where injection was given and the doctor's office.
Age: 5.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Received vaccines: Hep A #1, Varicella #2, Influenza at 5 year check and within 12 hours developed fever to 102.3 despite Tylenol and had febrile seizure (1st febrile seizure). Was evaluated in ER and released. Seizure believed to be <5 minutes in length.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Injection site erythema
Clinical narrative: erythema at site of injection-Right arm. Treated with Benadryl
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Pharyngeal oedema, Sinus congestion
Clinical narrative: 4 hours after vaccine, pt c/o throat swelling, trouble swallowing, dyspnea, sudden head congestion - took Ibuprofen and came back to doctor 10-18-07.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Pruritus
Clinical narrative: Rash and redness around site and down arm stopping at elbow with itching - started 3 days after injection, lasted approx 14 days.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Dizziness, Feeling of body temperature change, Headache
Clinical narrative: Vaccine 10:30 a.m. on 10/17/07 "Could hardly wake up" on morning on 10/18/07. "It was like I took a sleeping pill, and I had a strange headache." felt hot and cold. (Did not take temperature.) "Dizzy" on 10/19/07 and stayed home from work. 10/22 at work and feels fine.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Induration, Lymphadenopathy, Nausea, Pain
Clinical narrative: Adacel vaccine 10-17-07 (L) deltoid. On 10-18-07 in the afternoon, pt began to experience body ache, fever, nausea and diarrhea, and dry heaves - ibuprofen and Pepto Bismol 2 doses and rest. Called off work - scheduled day on Friday 10-19-07. Later in day 10-19-07 -  shoulder and clavicle areas became tender to palpitation with swollen lymph nodes palpable under clavicle area; (L) deltoid area firm and tender x days; symptoms gradually resolving.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Retching, Tenderness
Clinical narrative: Adacel vaccine 10-17-07 (L) deltoid. On 10-18-07 in the afternoon, pt began to experience body ache, fever, nausea and diarrhea, and dry heaves - ibuprofen and Pepto Bismol 2 doses and rest. Called off work - scheduled day on Friday 10-19-07. Later in day 10-19-07 -  shoulder and clavicle areas became tender to palpitation with swollen lymph nodes palpable under clavicle area; (L) deltoid area firm and tender x days; symptoms gradually resolving.
Age: 62.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: No adverse s/s given Menactra instead of Menomune discovered because charges not covered no problems
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Contusion, Erythema, Injection site swelling, Injection site vesicles, Oedema peripheral
Clinical narrative: Patient received vaccines, as noted below, on 10/16/07. Mother called office nurse and reported that patient's (R) arm was red and swollen (10-17-07). Mother called office nurse on 10/22/07 and reported patient's arm, (R), swelled to approx. softball size around site of injection. Additionally, blisters formed around injection site, since initial phone call on 10-17-07. Today, 10-22-07, swelling gone, blisters gone, and there is slight bruising only.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Feeling hot, Rash
Clinical narrative: Rash arms and legs, feels hot, feels weird. Benadryl 25mg PO given. Rash persisted - sent to private physician.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Lethargy, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient fainted, diaphoretic, pale, lethargic following commands A & O x c. Gave fluids PO, had pt put his head between knees. HR 70s-80s. Reg rate unsuccessful getting BP reading d/t small of arm. Pt continued to pass out then had came to. 911 was called and they found vitals were stable and encouraged pt rest at home.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactoid reaction, Cough, Eye pruritus, Pharyngeal oedema, Swollen tongue
Clinical narrative: Patient received flu vaccination at 4:00 pm. Around 6:30 pm she experienced dry cough, itchy throat and eyes; this became progressively worse; her tong and throat started swelling up. Family called "911", patient taken to hospital. Condition stabilized in the E.R., by 10 pm. Pt discharged home by 11 pm. Pt seen by private MD for follow-up on 10/18. Recovery complete.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Patient received flu vaccination at 4:00 pm. Around 6:30 pm she experienced dry cough, itchy throat and eyes; this became progressively worse; her tong and throat started swelling up. Family called "911", patient taken to hospital. Condition stabilized in the E.R., by 10 pm. Pt discharged home by 11 pm. Pt seen by private MD for follow-up on 10/18. Recovery complete.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Convulsion
Clinical narrative: Seizure, used Amonia pt. recovered.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Head discomfort, Syncope
Clinical narrative: Pt received Gardasil vaccine 2nd within 10 minutes complained of dizziness, heaviness in her head 2nd then had syncope episode. Pt came to with one minute. Lying down had a blood pressure of 100/62 and remained dizzy for next 1/2 hour. Pt recovered within 45 minutes.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain in extremity, Pyrexia, Tremor
Clinical narrative: fever shakes sore arm-RED area by injection site Resolved in about 7 days per client on 10/22/07
Age: 20.0
Sex: M
Vaccine: FLU3, MEN, PPV
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: That evening, patient's arm started to swell around injection site and was red and warm to touch. Patient "felt bad" and had fever and chills. Patient went to an emergent care clinic where he was treated with antibiotics prophylactically to rule out infection. The site of reaction was on the right arm. Patient was also seen by primary care provider and believed to be AE to pneumonia vaccine.
Age: 20.0
Sex: M
Vaccine: FLU3, MEN, PPV
Symptoms: Pyrexia
Clinical narrative: That evening, patient's arm started to swell around injection site and was red and warm to touch. Patient "felt bad" and had fever and chills. Patient went to an emergent care clinic where he was treated with antibiotics prophylactically to rule out infection. The site of reaction was on the right arm. Patient was also seen by primary care provider and believed to be AE to pneumonia vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: Patient came in for sports PE. After examination done, PPD and HPV #1 were ordered and placed. Pt observed for 15 minutes. However, while checking out with Mom, patient had syncope < 5 secs (witnessed by Mom and front office). Patient stabilized, O2 sat (100%) and EKG (WNL) ordered.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Left arm swollen stopping at elbow with pain; treated with Ibuprofen 600 mg x qd and Vicodin
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site pruritus, Injection site vesicles, Scab
Clinical narrative: Severe pain at injection site, vesicles, pruritus starting date of injection, vesicles appeared day after. When seen 6 days after, continues with severe pain at injection site, pruritus vesicles open/scabbed. Rx Benadryl, hydrocodone.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Pt developed a fever of 103.7 two days after vaccine administered, this was her 3rd dosage.
Age: 18.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Flushing, Hot flush, Pruritus
Clinical narrative: Whole body reaction - flushed skin, hot flashes - pruritis - tried with Zyrtec.
Age: 56.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Unevaluable event
Clinical narrative: None as of date of infection.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Inflammation
Clinical narrative: Inflammatory reaction to vaccine on the (L) arm.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Oedema peripheral
Clinical narrative: Arm swollen after Varicella vaccine. Arm has blister on it.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Hypersensitivity, Rash, Rash macular
Clinical narrative: One week after receiving the Varivax vaccine, she developed a rash consisting of pink macules of varying size some ring like. Rash was on trunk, face and were portions of arms and legs. There was little if any pruritus. There were no systemic symptoms (no fever or joint pain). Rash was felt to be a hypersensitivity reaction possibly to the Varivax vaccine. She received some Benadryl. Phone f/u 3 days later indicated the rash was almost gone. There were no vesicles.
Age: 12.0
Sex: M
Vaccine: JEV, RAB
Symptoms: Pityriasis rosea, Pruritus, Rash erythematous, Rash papular, Urticaria
Clinical narrative: 9/6/07, 6:00 PM - 2 hours after injections parents called doctor reporting that the patient had hives. Benadryl 25 mg. was given to patient with no relief. At 7:00 PM parents brought patient to see doctor who noted 'erythematous papular rash and urticaria.' Benadryl 50 mg. IM given. 9/7/07 Rash worsens. Pt visits doctor again and was given Benadryl 25 mg. q 4 - 6 hours. 9/18 and 9/20/07 Pt. returned to clinic and saw another doctor who described rash as 'persistent papular erythematous rash and pruritus rash with general itchiness despite Benadryl notable on trunk and thighs.' 9/27/07 Pt saw doctor again who noted 'pruritis rash probable pityriasis rosea.' Dermatologist consulted who concurred with pityriasis rosea diagnosis and prescribed Atarax 25 mg instead of Benadryl along with Flutazone (Flutivate E) topical cream. Pt's mother reported that rash resolved within 2 days of stopping the Benadryl.
Age: 1.8
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Contusion, Erythema
Clinical narrative: (R) thigh bruising and mild erythema. Treating with Augmentin 400mg 3/4 tsp BID.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Headache
Clinical narrative: Onset of symptoms started after receiving Hep B #2, weak, headache, sensitivity to light sweaty, chills, diarrhea, stomach cramps Treated in the ER 10/10/07 and 10/14/07
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Photophobia, White blood cell count increased
Clinical narrative: Onset of symptoms started after receiving Hep B #2, weak, headache, sensitivity to light sweaty, chills, diarrhea, stomach cramps Treated in the ER 10/10/07 and 10/14/07
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms, ache, sweaty, chills, headaches, sensitivity to light, itchy rash. Symptoms started 10/8/07. Treated in the ER 10/10/07 and 10/14/07.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Photophobia, Rash, White blood cell count decreased
Clinical narrative: Flu-like symptoms, ache, sweaty, chills, headaches, sensitivity to light, itchy rash. Symptoms started 10/8/07. Treated in the ER 10/10/07 and 10/14/07.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash vesicular
Clinical narrative: Itching, redness, vesicular rash - not responding to Keflex.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling
Clinical narrative: Child came back to facility for lead testing of child, and at the time of the visit the mother showed the (R) thigh where DTaP #5 was given on 10/12/07, was swollen.
Age: 27.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone decreased, Blood thyroid stimulating hormone increased, Hyperthyroidism, Thyroid function test abnormal
Clinical narrative: Description: SM received 3 doses AVA May-June 2004: also several other vaccines (HepB, Influenza, MMR, Smallpox, & Meningocccal) from Mar-Nov 2004; beginning Oct-Nov 2004, he had unexplained weight loss 42 pounds; SM was subsequently diagnosed with hyperthyroidism March 2005 Symptom: Weight loss, unexpected Start: 10/01/2004 End: 03/01/2005 Comment: unexplained weight loss 42 pounds over 3 month period
Age: 27.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Ultrasound scan normal, Weight decreased
Clinical narrative: Description: SM received 3 doses AVA May-June 2004: also several other vaccines (HepB, Influenza, MMR, Smallpox, & Meningocccal) from Mar-Nov 2004; beginning Oct-Nov 2004, he had unexplained weight loss 42 pounds; SM was subsequently diagnosed with hyperthyroidism March 2005 Symptom: Weight loss, unexpected Start: 10/01/2004 End: 03/01/2005 Comment: unexplained weight loss 42 pounds over 3 month period
Age: 60.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: tdap order, DTaP given
Age: 40.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap ordered, DTaP given
Age: 52.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Tdap ordered, DTaP given
Age: 2.0
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Swelling and heat in (L) thigh, mild s/s 24 hours after injection. Worse by 48 hours. Swelling was 20cm x 8cm, warm, slightly tender to touch. Was walking well. No fever.
Age: 62.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap ordered; DTaP given
Age: 39.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap ordered, DTaP given.
Age: 47.0
Sex: M
Vaccine: DTAP
Symptoms: Hypertension, Inappropriate schedule of drug administration
Clinical narrative: no adverse event Tdap ordered, DTaP given.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythematous 4 1/2 x 5" swelling at (L) area
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema, swelling of immunization site.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized swelling, redness and itching at injection site.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 2 wk s/p vaccines, pt developed red nontender patch at injection site. 2 days later, pt had induration and tenderness and was treated with Clindamycin (pending would culture) for cellulitis.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized swelling, redness and itching at injection site.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pain, itching, hard and warm to touch, red (large area of redness) at injection site.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash face and trunk c/w chicken pox mild form about 8 days post vaccine.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: 1-2 days with "redness (R) thigh". Pt got MMR vaccine (R) thigh on 10/15/07. No fever pas per Mom "warm".
Age: 58.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Asthenia, Dysphonia, Dyspnoea, Headache, Influenza like illness
Clinical narrative: 10/4/07 Hepatitis and Pneumococcal vaccines given. Evening time at same day I started development like a high fever, difficulty breathing, hoarseness, weakness symptoms like flu 10/5/07 getting worse. 10/6/07 I lost my voice, a lot green mucus. Heavy headache, etc.
Age: 58.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Pneumonia, Pyrexia, Rhinorrhoea
Clinical narrative: 10/4/07 Hepatitis and Pneumococcal vaccines given. Evening time at same day I started development like a high fever, difficulty breathing, hoarseness, weakness symptoms like flu 10/5/07 getting worse. 10/6/07 I lost my voice, a lot green mucus. Heavy headache, etc.
Age: 48.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Culture negative, Herpes zoster, Inappropriate schedule of drug administration, Rash
Clinical narrative: Vaccine - zoster given 10/5/07 no ordered and requested by patient she was here for annual physical and flu vaccine too. 10/11 came back in with rash looking like shingles
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Computerised tomogram, Convulsion, Dysarthria, Dyskinesia
Clinical narrative: 1.Flu-like symptoms (fever, chills, headache) 4-5 hours after receipt of first dose AVA on 1/24/2003 (left arm). The headache persisted into the following day. 2. On the third day after the vaccine 1/27/2003, he had an episode of slurred speech, and sensation of being in a 'black cloud', followed by a witnessed seizure (jerking of extremities, tongue biting and loss of bladder control), unrelated to the seizure. 3.Two weeks after receipt of AVA, intense numbness and tingling of his left index, middle, ring and little fingers. Now diminished but constant He is right-hand dominant. 4.Recurrent nonfocal moderate to severe headaches, 2/month, onset Feb 2003, associated with flashing lights and floating dots in both visual fields, photo/phonophobia, and nausea. Symptom: Flu-like symptoms< 96 hours Start: 01/24/2003 End: 01/25/2003 Symptom: Dysarthria Start: 01/27/2003 End: 01/27/2003 Symptom: Seizure disorder Start: 01/27/2003 End: 01/27/2003 Comment: Tonic/Clonic Symptom: Paresthesia Start: 02/07/2003 Comment: Persistent - left index, middle, ring, little fingers Symptom: Headache, general Start: 02/01/2003 Comment: often with migraine features
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Electroencephalogram, Headache, Hypoaesthesia, Influenza like illness, Laboratory test
Clinical narrative: 1.Flu-like symptoms (fever, chills, headache) 4-5 hours after receipt of first dose AVA on 1/24/2003 (left arm). The headache persisted into the following day. 2. On the third day after the vaccine 1/27/2003, he had an episode of slurred speech, and sensation of being in a 'black cloud', followed by a witnessed seizure (jerking of extremities, tongue biting and loss of bladder control), unrelated to the seizure. 3.Two weeks after receipt of AVA, intense numbness and tingling of his left index, middle, ring and little fingers. Now diminished but constant He is right-hand dominant. 4.Recurrent nonfocal moderate to severe headaches, 2/month, onset Feb 2003, associated with flashing lights and floating dots in both visual fields, photo/phonophobia, and nausea. Symptom: Flu-like symptoms< 96 hours Start: 01/24/2003 End: 01/25/2003 Symptom: Dysarthria Start: 01/27/2003 End: 01/27/2003 Symptom: Seizure disorder Start: 01/27/2003 End: 01/27/2003 Comment: Tonic/Clonic Symptom: Paresthesia Start: 02/07/2003 Comment: Persistent - left index, middle, ring, little fingers Symptom: Headache, general Start: 02/01/2003 Comment: often with migraine features
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging brain, Paraesthesia, Pyrexia, Tongue biting
Clinical narrative: 1.Flu-like symptoms (fever, chills, headache) 4-5 hours after receipt of first dose AVA on 1/24/2003 (left arm). The headache persisted into the following day. 2. On the third day after the vaccine 1/27/2003, he had an episode of slurred speech, and sensation of being in a 'black cloud', followed by a witnessed seizure (jerking of extremities, tongue biting and loss of bladder control), unrelated to the seizure. 3.Two weeks after receipt of AVA, intense numbness and tingling of his left index, middle, ring and little fingers. Now diminished but constant He is right-hand dominant. 4.Recurrent nonfocal moderate to severe headaches, 2/month, onset Feb 2003, associated with flashing lights and floating dots in both visual fields, photo/phonophobia, and nausea. Symptom: Flu-like symptoms< 96 hours Start: 01/24/2003 End: 01/25/2003 Symptom: Dysarthria Start: 01/27/2003 End: 01/27/2003 Symptom: Seizure disorder Start: 01/27/2003 End: 01/27/2003 Comment: Tonic/Clonic Symptom: Paresthesia Start: 02/07/2003 Comment: Persistent - left index, middle, ring, little fingers Symptom: Headache, general Start: 02/01/2003 Comment: often with migraine features
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Urinary incontinence, Vitreous floaters
Clinical narrative: 1.Flu-like symptoms (fever, chills, headache) 4-5 hours after receipt of first dose AVA on 1/24/2003 (left arm). The headache persisted into the following day. 2. On the third day after the vaccine 1/27/2003, he had an episode of slurred speech, and sensation of being in a 'black cloud', followed by a witnessed seizure (jerking of extremities, tongue biting and loss of bladder control), unrelated to the seizure. 3.Two weeks after receipt of AVA, intense numbness and tingling of his left index, middle, ring and little fingers. Now diminished but constant He is right-hand dominant. 4.Recurrent nonfocal moderate to severe headaches, 2/month, onset Feb 2003, associated with flashing lights and floating dots in both visual fields, photo/phonophobia, and nausea. Symptom: Flu-like symptoms< 96 hours Start: 01/24/2003 End: 01/25/2003 Symptom: Dysarthria Start: 01/27/2003 End: 01/27/2003 Symptom: Seizure disorder Start: 01/27/2003 End: 01/27/2003 Comment: Tonic/Clonic Symptom: Paresthesia Start: 02/07/2003 Comment: Persistent - left index, middle, ring, little fingers Symptom: Headache, general Start: 02/01/2003 Comment: often with migraine features
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Diarrhoea, Haematochezia, Pain, Pyrexia, Renal failure acute
Clinical narrative: Information has been received from a pharmacist and a nephrologist concerning a 13 year old female patient with bilateral cystic kidney disease who in March 2007, was vaccinated with a first dose of Gardasil. In Spring of 2007, about a week after receiving her injection the patient developed febrile illness with nausea and weakness and was hospitalized. Her laboratory work up revealed renal failure with serum creatinine of 9 and dialysis was instituted. In October 2007, serum creatinine was 3, without dialysis. The reporter indicated that the patient's adverse event renal failure was disabling, life threatening and an other medical event (OME). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Renal failure
Clinical narrative: Information has been received from a pharmacist and a nephrologist concerning a 13 year old female patient with bilateral cystic kidney disease who in March 2007, was vaccinated with a first dose of Gardasil. In Spring of 2007, about a week after receiving her injection the patient developed febrile illness with nausea and weakness and was hospitalized. Her laboratory work up revealed renal failure with serum creatinine of 9 and dialysis was instituted. In October 2007, serum creatinine was 3, without dialysis. The reporter indicated that the patient's adverse event renal failure was disabling, life threatening and an other medical event (OME). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Blood creatinine increased, Dialysis, Nausea, Pyrexia
Clinical narrative: Information has been received from a pharmacist and a nephrologist concerning a 13 year old female patient with bilateral cystic kidney disease who in March 2007, was vaccinated with a first dose of Gardasil. In Spring of 2007, about a week after receiving her injection the patient developed febrile illness with nausea and weakness and was hospitalized. Her laboratory work up revealed renal failure with serum creatinine of 9 and dialysis was instituted. In October 2007, serum creatinine was 3, without dialysis. The reporter indicated that the patient's adverse event renal failure was disabling, life threatening and an other medical event (OME). Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Encephalitis
Clinical narrative: First admitted May 2007 with inability to swallow, clear mucous - during hospitalization, resp distress, ventilated, transferred to further neuro work up - no definitive diagnosis - Home in July recovering until 2 weeks prior to readmit 8-18-07. Slowly couldn't swallow, ventilated and trach and "Pen" tube - upper, lower extremities strong and intact - neurologist. Sequela of immunization in form of local encephalopathy.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Dysphagia, Electrocardiogram, Encephalopathy, Laboratory test
Clinical narrative: First admitted May 2007 with inability to swallow, clear mucous - during hospitalization, resp distress, ventilated, transferred to further neuro work up - no definitive diagnosis - Home in July recovering until 2 weeks prior to readmit 8-18-07. Slowly couldn't swallow, ventilated and trach and "Pen" tube - upper, lower extremities strong and intact - neurologist. Sequela of immunization in form of local encephalopathy.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mechanical ventilation, Nuclear magnetic resonance imaging, Respiratory distress, Tracheostomy, X-ray
Clinical narrative: First admitted May 2007 with inability to swallow, clear mucous - during hospitalization, resp distress, ventilated, transferred to further neuro work up - no definitive diagnosis - Home in July recovering until 2 weeks prior to readmit 8-18-07. Slowly couldn't swallow, ventilated and trach and "Pen" tube - upper, lower extremities strong and intact - neurologist. Sequela of immunization in form of local encephalopathy.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Clinical narrative: Information has been received through the Merck pregnancy registry and from a mother of a 17 year old female patient who on 25-APR-2007 was vaccinated IM with a second 0.5ml dose of Gardasil (date unknown of first injection). On 25-APR-2007, the patient discovered she was pregnant. (date of LMP = 27-MAr-2007). Follow up information stated that on approximately 13-MAY-2007, the patient had a spontaneous abortion. She was approximately 7 weeks from her LMP. It was unknown if the products of conception were examined or if the fetus was normal. At the time of this report, the patient's outcome was unknown. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received through the Merck pregnancy registry and from a mother of a 17 year old female patient who on 25-APR-2007 was vaccinated IM with a second 0.5ml dose of Gardasil (date unknown of first injection). On 25-APR-2007, the patient discovered she was pregnant. (date of LMP = 27-MAr-2007). Follow up information stated that on approximately 13-MAY-2007, the patient had a spontaneous abortion. She was approximately 7 weeks from her LMP. It was unknown if the products of conception were examined or if the fetus was normal. At the time of this report, the patient's outcome was unknown. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Blood thyroid stimulating hormone normal, Diarrhoea, Full blood count normal, Nausea
Clinical narrative: Pt received Gardasil then 2-3 hours later started vomiting, diarrhea, and severe abdominal pain x 3 days. Pt used Phenergan without success, used Zofran and Lomotil with some relief.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: Pt received Gardasil then 2-3 hours later started vomiting, diarrhea, and severe abdominal pain x 3 days. Pt used Phenergan without success, used Zofran and Lomotil with some relief.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: Pt received Gardasil then 2-3 hours later started vomiting, diarrhea, and severe abdominal pain x 3 days. Pt used Phenergan without success, used Zofran and Lomotil with some relief.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asperger's disorder, Erythema, Herpes zoster, Rash vesicular
Clinical narrative: Mom reports that vaccine was direct cause for case of shingles that she reports lasted for two months in length. Pt seen 08.19.07 with clusters of bumps on left side of body that were reported to be one week old.  Pt treated with Famvir 500 mg tabs.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Herpes zoster
Clinical narrative: Mom reports that vaccine was direct cause for case of shingles that she reports lasted for two months in length. Pt seen 08.19.07 with clusters of bumps on left side of body that were reported to be one week old.  Pt treated with Famvir 500 mg tabs.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Body temperature increased, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Hive like rash all over, fever to 101.8 with headaches, myalgias, marked pain and swelling at injection site (L) arm with erythema and warmth.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling, Lethargy, Rash
Clinical narrative: Hive like rash all over, fever to 101.8 with headaches, myalgias, marked pain and swelling at injection site (L) arm with erythema and warmth.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Headache, Injection site pain, Injection site swelling, Laboratory test normal
Clinical narrative: Hive like rash all over, fever to 101.8 with headaches, myalgias, marked pain and swelling at injection site (L) arm with erythema and warmth.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Myalgia, Pyrexia, Rash, Red blood cell sedimentation rate increased, Skin warm
Clinical narrative: Hive like rash all over, fever to 101.8 with headaches, myalgias, marked pain and swelling at injection site (L) arm with erythema and warmth.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Urticaria, White blood cell count increased
Clinical narrative: Hive like rash all over, fever to 101.8 with headaches, myalgias, marked pain and swelling at injection site (L) arm with erythema and warmth.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Began itching within 10 minutes. Flu and pneumonia shots given in same arm. Red that evening. Next morning very swollen. By second morning a swollen red area 6 1/2" x 3" raised, red and very swollen. Dr. said reaction had to be treated like a staph infection. Dr. gave decadron and antibiotic for 10 days. When medication gone, still slightly red, itchy, and sore after 16 days
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Induration
Clinical narrative: 12 x 18 cm erythema and iduration left arm extending below elbow (LR6)
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Agoraphobia, Anxiety, Chest X-ray normal, Chest pain, Depression
Clinical narrative: Initial information received from another manufacturer (reference number WAES0710USA01964) on 15 October 2007. The following information is reported verbatim from the other manufacturer's report: "Information has been received on request from the FDA under the Freedom of Information Act regarding a 15 year old female with no known drug or food allergies and a history of symptoms of depression and anxiety with suicidal ideation (SI) on and off who on 05-Sep-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (lot #656371/0181U). Concomitant vaccination on 05-Sep-2007 included an intramuscular injection into the right arm with a first dose of MENACTRA (Lot #U2394BA). On 05-Sep-2007 the patient experienced chest pain, shortness of breath, headache, dizziness, nausea and fever. The patient was given SOLU-MEDROL and BENADRYL intravenously and 2 liters of oxygen nasal cannula with a possible diagnosis of an allergic reaction to MENACTRA, dyspepsia and tachycardia. Diagnostic impression revealed major depressive disorder (MDD), agoraphobia and generalized anxiety. A chest x-ray was within normal limits (WNL). At the time of the report the patient's outcome was unknown. The original reporting source was not provided." "The reporter felt that agoraphobia, chest pain, dizziness, dyspepsia, dyspnoea, generalized anxiety disorder, headache, hypersensitivity, major depression, nausea, pyrexia and tachycardia to be serious events due to hospitalization." "Additional information is not available."
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Dyspepsia, Dyspnoea, Headache, Hypersensitivity
Clinical narrative: Initial information received from another manufacturer (reference number WAES0710USA01964) on 15 October 2007. The following information is reported verbatim from the other manufacturer's report: "Information has been received on request from the FDA under the Freedom of Information Act regarding a 15 year old female with no known drug or food allergies and a history of symptoms of depression and anxiety with suicidal ideation (SI) on and off who on 05-Sep-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (lot #656371/0181U). Concomitant vaccination on 05-Sep-2007 included an intramuscular injection into the right arm with a first dose of MENACTRA (Lot #U2394BA). On 05-Sep-2007 the patient experienced chest pain, shortness of breath, headache, dizziness, nausea and fever. The patient was given SOLU-MEDROL and BENADRYL intravenously and 2 liters of oxygen nasal cannula with a possible diagnosis of an allergic reaction to MENACTRA, dyspepsia and tachycardia. Diagnostic impression revealed major depressive disorder (MDD), agoraphobia and generalized anxiety. A chest x-ray was within normal limits (WNL). At the time of the report the patient's outcome was unknown. The original reporting source was not provided." "The reporter felt that agoraphobia, chest pain, dizziness, dyspepsia, dyspnoea, generalized anxiety disorder, headache, hypersensitivity, major depression, nausea, pyrexia and tachycardia to be serious events due to hospitalization." "Additional information is not available."
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nausea, Pyrexia, Tachycardia
Clinical narrative: Initial information received from another manufacturer (reference number WAES0710USA01964) on 15 October 2007. The following information is reported verbatim from the other manufacturer's report: "Information has been received on request from the FDA under the Freedom of Information Act regarding a 15 year old female with no known drug or food allergies and a history of symptoms of depression and anxiety with suicidal ideation (SI) on and off who on 05-Sep-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (lot #656371/0181U). Concomitant vaccination on 05-Sep-2007 included an intramuscular injection into the right arm with a first dose of MENACTRA (Lot #U2394BA). On 05-Sep-2007 the patient experienced chest pain, shortness of breath, headache, dizziness, nausea and fever. The patient was given SOLU-MEDROL and BENADRYL intravenously and 2 liters of oxygen nasal cannula with a possible diagnosis of an allergic reaction to MENACTRA, dyspepsia and tachycardia. Diagnostic impression revealed major depressive disorder (MDD), agoraphobia and generalized anxiety. A chest x-ray was within normal limits (WNL). At the time of the report the patient's outcome was unknown. The original reporting source was not provided." "The reporter felt that agoraphobia, chest pain, dizziness, dyspepsia, dyspnoea, generalized anxiety disorder, headache, hypersensitivity, major depression, nausea, pyrexia and tachycardia to be serious events due to hospitalization." "Additional information is not available."
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Glossodynia, Swollen tongue
Clinical narrative: Initial report received on 12 October 2007 from a health care professional. A 60-year-old female patient, who had recently stepped on a nail, had received a right gluteal, intramuscular injection of Decavac, lot number U1820GA, on 08 October 2007. The next day, the patient developed a swollen tongue and soreness under the left side of her tongue. She experienced no shortness of breath or wheezing, and her speech was clear. The following day, she was examined in an emergency room and treated with intravenous Benadryl and "intravenous" epinephrine. The patient also took oral Benadryl daily. Per the reporter, the soreness and some swelling persists. At the time of this report, the patient had not recovered.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Malaise, Night sweats, Pertussis, Wheezing
Clinical narrative: Initial information received on 15 October 2007 from a health care professional. A 55-year-old male patient, with no illness at the time of vaccination, had received a left arm, intramuscular injection of Adacel, lot number C2769AA, on 06 August 2007. Three weeks post-vaccination, the patient experienced general malaise, coughing, night sweats, and wheezing. He was examined by his personal physician twice and referred to a pulmonary specialist. Per the reporter, the patient had possible whooping cough per the pulmonary consult. Relevant diagnostic testing was reported as "none done." At the time of this report, the patient had not recovered.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Face injury, Surgery, Syncope, Tooth injury
Clinical narrative: Information has been received from a nurse concerning her 12 year old daughter who on 08-AUG-2007 was vaccinated intramuscularly with the 1st dose of Gardasil (Lot# 658488/0930U). Concomitant therapies included an unspecified varicella and hepatitis A vaccinations. The patient's mother stated that after the vaccinations the girl was "feeling fine" and went into the bathroom, fainted and hit her face on the tile floor. The mother reported that the patient was rushed into emergency oral surgery. She reported that the patient has undergone root canal and now has braces. It was reported that the patient does not have a history of fainting after injections. Follow up information received from the patient's physicians office stated that the patient was "not hospitalized, just visited the oral surgeon to have her teeth re implanted". It was reported that the events were not disabling. It was reported that the patient was fine, got up to go the bathroom and fainted in the bathroom. At the time of the report the patient had recovered from the events. Upon internal medical review the oral trauma was felt to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Blood glucose, Full blood count, Lethargy, Liver function test, Vomiting
Clinical narrative: Hospitalization - 3 hrs after immunization. Vomiting, lethargy. After 24 hrs - pt back to normal.  11/06/2007 MR received for o/n observation 10/16/2007 for c/o Lethargy and vomiting. Several hours after Hep A vax child developed redness and swelling of the R cheek.  Activity level was decreased and pt slept during the day which is unusual for her.  Later she appeared listless and pale.  Taken to PCP office where she vomited several times. Admitted to hospital for observation.  PE (+) for pallor.