chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Pain, Pruritus
Clinical narrative: A non-serious spontaneous report of lips itching, chills and aching has been received from a consumer concerning a 42 year-old female, subsequent to receiving FLUMIST. The patient's medical history includes an allergy to raw eggs, increased food sensitivity issues than in prior years. The patient carries an EPIPEN on her person and she reports she received FLUMIST last year and had no problems. Her concomitant medications include FLOVENT, SYNTHROID, PAXIL, CRESTOR and montelukast. She received FLUMIST nasally on 25-Aug-2010 for flu vaccination. On 25-Aug-2010, she received FLUMIST at her daughter's pediatrician office. She complained of her lips itching at the pediatrican's office, they did not treat her but sent her to a walk-in clinic for treatment. At the walk-in clinic she was treated with an unknown antihistamine that made her very drowsy. She states she also took a dose of diphenhydramine that did not relieve the itching. On 26-Aug-2010, the patient experienced chills and aching. The patient went to her allergist who told her to take fexofenadine. She took the ALLEGRA around the clock for two days and she states it worked well. Her allergist also suggested in the future that she take flu injections. After taking fexofenadine the itching of her lips resolved, the chills and aching both resolved within 24 hours. Patient stated her lips itched over the weekend after eating pineapple.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash generalised
Clinical narrative: A spontaneous, non-serious report of "bumps on her abdomen and interior thighs" has been received from a nurse concerning a six-year-old female patient subsequent to FLUMIST administration. Medical history included anemia and allergy to amoxicillin. The subject received H1N1 nasal vaccine last season on 23-Oct-2009 and a second dose in Nov-2009. Concomitant medications were not reported. On 27-Sep-2010, the patient received FLUMIST. One hour after receiving FLUMIST, the patient had quarter size bumps on her abdomen and interior thighs. The patient returned to the clinic and was examined by her physician, three hours after receiving FLUMIST. Treatment included diphenhydramine. On the morning of 28-Sep-2010, the patient was "completely well". The patient's mother called the office on a later date and reported that the patient continued to develop a more generalized rash for five evenings after the vaccination. Treatment with diphenhydramine continued. On 02-Oct-2010, the rash resolved. On 02-Oct-2010, the rash was resolved.
Age: 0.67
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to a child under two years-old was received from a health care professional concerning an eight-month-old female. On 24-Sep-2010 the patient received FLUMIST and was under the approved two-year-old age limit. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Follow up obtained on 02-Nov-2010, the reporting registered nurse states that she has been in contact with the family and they have not reported any problems.
Age: 1.59
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST was administered to a 19-month-old child was received from a health professional concerning a 19-month-old female. Neither the patient's past medical history nor the concomitant medications were reported. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to a pregnant female was received from a health professional concerning a 27-year-old female. The patient did not have any significant medical history. The patient's obstetrical history included gravida four and para three and her estimated date of delivery was 08-Aug-2011. The patient was not taking any concomitant medications. The patient was three weeks pregnant at the time of vaccination. The patient received FLUMIST on 01-Nov-2010. The patient was seen on 22-Mar-2011 and she was "doing fine". There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable and the event was considered resolved. The reporter was asked to inform when the pregnancy has ended. Additional information was received on 23-Mar-2011 and incorporated in the narrative: patient's obstetrical history, estimated date of delivery and concomitant medication information.
Age: 5.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a five-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 02-Jan-2011. On 12-Jan-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Adverse drug reaction, Biopsy site unspecified normal, Blood aluminium increased, Laboratory test, Lymphadenitis
Clinical narrative: Rash, vomiting, fever, chills, skin eruption, enlarged lymph nodes neck to groin, enlarged liver and spleen, weight loss 35 lbs., yeast infection, extreme fatigue, migraines, Jaw and neck and throat pain. High white cell count, uric acid and LDH.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Rash, Recurring skin boils
Clinical narrative: Rash, vomiting, fever, chills, skin eruption, enlarged lymph nodes neck to groin, enlarged liver and spleen, weight loss 35 lbs., yeast infection, extreme fatigue, migraines, Jaw and neck and throat pain. High white cell count, uric acid and LDH.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy, Biopsy bone marrow, Blood lactate dehydrogenase increased, Blood test, Blood uric acid increased
Clinical narrative: Rash, vomiting, fever, chills, skin eruption, enlarged lymph nodes neck to groin, enlarged liver and spleen, weight loss 35 lbs., yeast infection, extreme fatigue, migraines, Jaw and neck and throat pain. High white cell count, uric acid and LDH.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bone scan, Chills, Computerised tomogram, Fatigue, Fungal infection
Clinical narrative: Rash, vomiting, fever, chills, skin eruption, enlarged lymph nodes neck to groin, enlarged liver and spleen, weight loss 35 lbs., yeast infection, extreme fatigue, migraines, Jaw and neck and throat pain. High white cell count, uric acid and LDH.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hepatomegaly, Lumbar puncture, Lymphadenopathy, Migraine, Neck pain
Clinical narrative: Rash, vomiting, fever, chills, skin eruption, enlarged lymph nodes neck to groin, enlarged liver and spleen, weight loss 35 lbs., yeast infection, extreme fatigue, migraines, Jaw and neck and throat pain. High white cell count, uric acid and LDH.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Oropharyngeal pain, Pain in jaw, Pyrexia, Rash
Clinical narrative: Rash, vomiting, fever, chills, skin eruption, enlarged lymph nodes neck to groin, enlarged liver and spleen, weight loss 35 lbs., yeast infection, extreme fatigue, migraines, Jaw and neck and throat pain. High white cell count, uric acid and LDH.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Splenomegaly, Vomiting, Weight decreased, White blood cell count increased, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Rash, vomiting, fever, chills, skin eruption, enlarged lymph nodes neck to groin, enlarged liver and spleen, weight loss 35 lbs., yeast infection, extreme fatigue, migraines, Jaw and neck and throat pain. High white cell count, uric acid and LDH.
Age: 0.21
Sex: M
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Crying, Cyanosis, Decreased eye contact, Pyrexia, Screaming
Clinical narrative: He had a moderate reaction right after Immunization. High pitch non-stop crying, for about 8 hours or more ... He was purple from screaming!!! Fever for about 3 days. Lost eye contact for about 30 days.... He has a twin brother who was not vaccinated at this moment yet. We could see a big difference socially.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Laboratory test, Rash generalised, Rash maculo-papular
Clinical narrative: Generalized maculopapular rash over complete body.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal growth restriction, Laboratory test abnormal
Clinical narrative: Initial report was received on 03 August 2011 from a consumer who is also the patient. A 31 year-old first trimester pregnant female patient with a history of nocturnal seizures and an allergy to sulfa medications, had received 22 December 2010 a left arm injection of FLUZONE (lot number and route not reported). On 03 January 2011, the patient experienced a miscarriage. She stated that five days prior to miscarriage she had a "test" that showed no fetal growth. The patient's reported that her expected due date had been August of 2011. The patient had no illness at the time of vaccination. Concomitant medications included multi-vitamins, folic acid and KEPPRA. No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a registered nurse concerning an 8 weeks old male patient who on an unspecified date was vaccinated with his first dose of ROTATEQ (dose, route and lot# not reported). The nurse reported that on an unspecified date, the mother of the child informed her that after her son received the ROTATEQ, he was diagnosed with intussusception and was hospitalized. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: PNC
Symptoms: Antibody test abnormal
Clinical narrative: This is a spontaneous report from a contactable health professional (other HCP) who reported that an 11-year-old child received a third dose of PREVNAR on an unspecified date for an unspecified indication. The patient had previously received a first and second dose of PREVNAR also on an unspecified dates. Titers were 50% of what they should be for streptococcus pneumoniae. The physician was considering administering the patient a single dose of PREVNAR 13.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Immunizations 8/11/11, 8/13/11 RT leg - thigh to knee swollen 2x normal with heat & redness. Temp 101.5, pain. ED visit treated with BENADRYL q 4 hours. Resolving today 8/15/11.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose, Chest X-ray, Chest pain, Computerised tomogram, Confusional state
Clinical narrative: Headache, neck stiffness, fever, confusion, visual changes, change of mental status, jaw pain, chest pain.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Mental status changes, Metabolic function test, Musculoskeletal stiffness, Pain in jaw
Clinical narrative: Headache, neck stiffness, fever, confusion, visual changes, change of mental status, jaw pain, chest pain.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Urine analysis, Visual impairment
Clinical narrative: Headache, neck stiffness, fever, confusion, visual changes, change of mental status, jaw pain, chest pain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: (L) upper arm with redness, swelling, some induration on lateral aspect with TTP. Tx: O.V.; BENADRYL 2 tsp po every 6 hrs x 48 hrs, then PRN. Return if s/s worsen or fever develops.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Rash 2" x 1.5" on R upper arm, feverish area
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Patient said he had a fever and a runny nose for 3 days.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Excrutiating pain in right arm (where I received the shot) about 2 hours after shot. Over the next hour or two a gradually increasing weakness in that arm. Within a few hours I lost complete use of my right arm. I could only move it by lifting it with my left arm. The weakness went on for several days. Eventually I could use my right arm again. But I don't know that it's the same as it was before. It feels weaker two months later.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Dysphemia, Tic
Clinical narrative: Started with tics of sounding out "s" and "t" sounds at the end of words, progressing to stutterting at the end of words (eg. "Mommy, y, my, my...", "Right there, there, there...") by the next afternoon.  Still stuttering and having the "s" and "t" tics now, regularly throughout the day.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: HSV C4 distribution on Left starting 4 days after receiving Zostavax vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient reported rash at injection site
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and pain of L shoulder where Hep A and Menactra administered.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Balance disorder, Blister, Diarrhoea, Fatigue
Clinical narrative: Reaction at injection site; lump, hot, red, itchy. A day later diarrhea began for 2 days; also nausea. Took PEPTO BISMOL. Then fatigued, unsteady, started to develop insect bites on trunk of body. Ithced terribly. Only had a couple 2-3 that later blistered, oozed and scaled over. Next day a few more appeared. Could not sleep because of itchiness. They are not along nerves or nerve roots like if shingles. This morning checked packet insert and symptoms similar to what is noted which is chicken pox. Counted 30 spots located on back, chest, midriff, both arms to elbows only, on neck but not on face nor on lower extremities. Pt doesn't know if she ever had chicken pox in childhood.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth, Nausea
Clinical narrative: Reaction at injection site; lump, hot, red, itchy. A day later diarrhea began for 2 days; also nausea. Took PEPTO BISMOL. Then fatigued, unsteady, started to develop insect bites on trunk of body. Ithced terribly. Only had a couple 2-3 that later blistered, oozed and scaled over. Next day a few more appeared. Could not sleep because of itchiness. They are not along nerves or nerve roots like if shingles. This morning checked packet insert and symptoms similar to what is noted which is chicken pox. Counted 30 spots located on back, chest, midriff, both arms to elbows only, on neck but not on face nor on lower extremities. Pt doesn't know if she ever had chicken pox in childhood.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Scab, Sleep disorder, Wound secretion
Clinical narrative: Reaction at injection site; lump, hot, red, itchy. A day later diarrhea began for 2 days; also nausea. Took PEPTO BISMOL. Then fatigued, unsteady, started to develop insect bites on trunk of body. Ithced terribly. Only had a couple 2-3 that later blistered, oozed and scaled over. Next day a few more appeared. Could not sleep because of itchiness. They are not along nerves or nerve roots like if shingles. This morning checked packet insert and symptoms similar to what is noted which is chicken pox. Counted 30 spots located on back, chest, midriff, both arms to elbows only, on neck but not on face nor on lower extremities. Pt doesn't know if she ever had chicken pox in childhood.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Order given for Hepatitis A # 1 dose Merck & Co 0627AA.
Age: 12.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt needed Hepatitis A - # 1 dose Merck & Co 0627AA. Given instead Hepatitis B - pediatric = adolescent use manufacturer GSK AHBVB972DA 7-6-13.
Age: 33.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Erythema, Pain
Clinical narrative: Pain - injection administered (L) arm SC. Erythema approximately 20 cm. Encouraged to apply warm compress & TYLENOL for pain if needed.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site red, warm to touch two days post injection.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: (R) upper arm edema, warm to the touch, minimal erythema.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Here for 12 mo WCC, rec'd VARIVAX & Hep A vaccine in (R) thigh approx 5 min after administration noted 1 hive adjacent to VARIVAX insertion site, no resp s/sx. BENADRYL po given observed 30 min in office. Discg home.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dysphagia, Erythema, Limb discomfort, Lymphadenopathy, Oedema peripheral
Clinical narrative: Bilateral arm discomfort swelling erythema lymphadenopathy - neck: difficulty swallowing.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid with redness and swelling for one day. Vaccine given 8/3/11. Seen by provider 8/5/11.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Induration, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Significant redness, induration, warmth. Left upper arm tense and tender - 7x5 inches.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Skin warm
Clinical narrative: Significant redness, induration, warmth. Left upper arm tense and tender - 7x5 inches.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: (L) shoulder cellulitis.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Joint effusion
Clinical narrative: Pain - edema - (R) elbow. Started 7-22-11.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Gaze palsy, Laboratory test, Lethargy, Nuclear magnetic resonance imaging brain, Staring
Clinical narrative: Mom states changing diaper when childs eyes rolled back into her head and she stared shaking. Then child was very lethargic and just blankly staring. Was admitted to Hospital.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Tremor
Clinical narrative: Mom states changing diaper when childs eyes rolled back into her head and she stared shaking. Then child was very lethargic and just blankly staring. Was admitted to Hospital.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dyspnoea, Headache, Pyrexia
Clinical narrative: Headache, fever 102, chills, trouble breathing
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Subcutaneous area of left upper arm was erythemic 30 mm across by 25 mm high, slightly raised and itchy.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Vesicular rash at site of injection
Age: 41.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Back pain, Chills, Feeling cold, Feeling hot, Hyperhidrosis
Clinical narrative: Extreme tenderness at injection site, all over body aches, especially concentrated in the back, hot sweaty followed by cold/chills.
Age: 41.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Injection site pain, Pain
Clinical narrative: Extreme tenderness at injection site, all over body aches, especially concentrated in the back, hot sweaty followed by cold/chills.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client presented in office w/ grandmother 08/5/11 and stated since she woke up on 8/3, she had a reddened, warm swollen area around site that Varivax was given and its gotten increasingly bigger. Area = 2X3 in. Instructed client to seek care if worsens, recommended APAP/ibuprofen.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Ataxia, Back pain, CSF culture, Computerised tomogram head
Clinical narrative: Generalized weakness, tremors, paresthesia, ataxia, involuntary movement, back and head pain, urinary incontinence, hypersensitive, sensory problems, incoordination. Preliminary diagnostic (Guillain Barre), second (encephalomyelitis), finally myelopathy. The treatment included hospitalization and rehabilitation program.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Coordination abnormal, Dyskinesia, Electrocardiogram, Electroencephalogram, Electromyogram
Clinical narrative: Generalized weakness, tremors, paresthesia, ataxia, involuntary movement, back and head pain, urinary incontinence, hypersensitive, sensory problems, incoordination. Preliminary diagnostic (Guillain Barre), second (encephalomyelitis), finally myelopathy. The treatment included hospitalization and rehabilitation program.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electrophoresis protein, Encephalomyelitis, Guillain-Barre syndrome, Headache, Herpes simplex serology
Clinical narrative: Generalized weakness, tremors, paresthesia, ataxia, involuntary movement, back and head pain, urinary incontinence, hypersensitive, sensory problems, incoordination. Preliminary diagnostic (Guillain Barre), second (encephalomyelitis), finally myelopathy. The treatment included hospitalization and rehabilitation program.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersensitivity, Laboratory test, Myelopathy, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: Generalized weakness, tremors, paresthesia, ataxia, involuntary movement, back and head pain, urinary incontinence, hypersensitive, sensory problems, incoordination. Preliminary diagnostic (Guillain Barre), second (encephalomyelitis), finally myelopathy. The treatment included hospitalization and rehabilitation program.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Sensory disturbance, Tremor, Urinary incontinence
Clinical narrative: Generalized weakness, tremors, paresthesia, ataxia, involuntary movement, back and head pain, urinary incontinence, hypersensitive, sensory problems, incoordination. Preliminary diagnostic (Guillain Barre), second (encephalomyelitis), finally myelopathy. The treatment included hospitalization and rehabilitation program.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Back pain, Coordination abnormal, Dyskinesia, Headache
Clinical narrative: Generalized weakness, tremors, paresthesia, ataxia, involuntary movement, back and head pain, urinary incontinence, hypersensitive, sensory problems, incoordination. Preliminary diagnostic (Guillain Barre), second (encephalomyelitis), finally myelopathy. The treatment included hospitalization and rehabilitation program.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test abnormal, Myopathy, Sensory disturbance, Tremor, Urinary incontinence
Clinical narrative: Generalized weakness, tremors, paresthesia, ataxia, involuntary movement, back and head pain, urinary incontinence, hypersensitive, sensory problems, incoordination. Preliminary diagnostic (Guillain Barre), second (encephalomyelitis), finally myelopathy. The treatment included hospitalization and rehabilitation program.
Age: 46.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chills, Decreased appetite, Diarrhoea, Differential white blood cell count normal, Fatigue
Clinical narrative: 8/6/11-fatigue 8/7/11-body aches, chills, nausea 8/9/11-laryngitis, sore throat, loose BM's, chills 8/12/11-throat pressure & pain, general achiness, chills, nausea 8/15/11-sore throat, lack of appetite, fatigue
Age: 46.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Full blood count normal, Laryngitis, Liver function test normal, Metabolic function test, Metabolic function test normal
Clinical narrative: 8/6/11-fatigue 8/7/11-body aches, chills, nausea 8/9/11-laryngitis, sore throat, loose BM's, chills 8/12/11-throat pressure & pain, general achiness, chills, nausea 8/15/11-sore throat, lack of appetite, fatigue
Age: 46.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Nausea, Oropharyngeal pain, Pain, Sensation of pressure, Streptococcus test
Clinical narrative: 8/6/11-fatigue 8/7/11-body aches, chills, nausea 8/9/11-laryngitis, sore throat, loose BM's, chills 8/12/11-throat pressure & pain, general achiness, chills, nausea 8/15/11-sore throat, lack of appetite, fatigue
Age: 46.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Streptococcus test negative
Clinical narrative: 8/6/11-fatigue 8/7/11-body aches, chills, nausea 8/9/11-laryngitis, sore throat, loose BM's, chills 8/12/11-throat pressure & pain, general achiness, chills, nausea 8/15/11-sore throat, lack of appetite, fatigue
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Nausea, Rash, Swelling
Clinical narrative: STARTED AT ABOUT 8:30 PM ON 8-6-11. STATES SHE HAS RASH ON STOMACH/ENTIRE BACK = BOTH ARMS. NO REDNESS = SL. SWELLING.  NO FEVER NAUSEATED FOR ABOUT 1 HOUR.  (AT SITE RIGHT ARM) - STATES THIS AM RASH IS JUST ABOUT GONE - DENIES ANY OTHER PROBLEMS
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Fall, Loss of consciousness, Swelling face, Tremor
Clinical narrative: After recieving vaccines, client stood up, lost consciousness, fell to the floor, shook for 2-3 seconds while on his stomach. He began to roll over, assisted by nurses at this time. Client attempted to sit up. Nurses encouraged him to remain lying on floor. Ice applied to knot forming on his right forehead. He remained under 1st aid protocols until exiting the building, ambulatory, with his mother. Nurse talked to Mother at 1:00 pm. Client was wnl, per Mom.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Lip swelling, Paraesthesia, Urticaria
Clinical narrative: THE DAY AFTER CLIENT RECIEVED INJECTION SHE BROKE OUT IN HIVES ALL OVER HER BODY - LASTED 3 WEEKS. NEXT DAY HER LIPS BECAME SWOLLEN. THE DAY AFTER THAT HER HANDS AND FEET STARTED TINGLING AND FELT NUMB. CLIENT WAS SEEN AT AN URGENT CARE ER - GIVEN STEROIDS AND CLARITIN. ALL SYMPTOMS HAVE RESOLVED.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Skin warm
Clinical narrative: Redness, swelling and pain in right deltoid.  2 days after vaccines had mild fever.  Three days post vaccines was seen for PPD reading in Primary Care Clinic. Redness measured 3.5 x 3.5 inches, was slightly warm, and redness was beginning to fade.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Nodule
Clinical narrative: Two large knots developed on the child's Left arm.  The site was swollen, sore, hard and hot to touch.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Petit mal epilepsy, Syncope
Clinical narrative: Syncope, Petit Mal Seizure
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: On 8/10/2011 the patient's mother called reporting that the child was c/o a red sore RA. Also, had fever.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Culture throat negative, Dysphagia, Pharyngeal oedema, Pharyngitis, Streptococcus test negative
Clinical narrative: Patient started complaining that it was hard to swallow and that her throat was swollen.  She was given an allergy medication and it didn't seem to help. At one point she feared her throat would swell shut. She was taken to Urgent Care and diagnosed with Acute Pharyngitis and prescribed 10 MG Prednisone  1/day for 3 days. After 3 days of Prednisone she was still trying to clear her throat and complaining about her throat still bothering her.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Throat irritation
Clinical narrative: Patient started complaining that it was hard to swallow and that her throat was swollen.  She was given an allergy medication and it didn't seem to help. At one point she feared her throat would swell shut. She was taken to Urgent Care and diagnosed with Acute Pharyngitis and prescribed 10 MG Prednisone  1/day for 3 days. After 3 days of Prednisone she was still trying to clear her throat and complaining about her throat still bothering her.
Age: 13.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Condition aggravated, Convulsion, Dyskinesia, Loss of consciousness
Clinical narrative: Patient had a slight seizure (passed out and had jerking movements of arms) that lasted approximately 10 seconds.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Monoplegia, Muscular weakness, Ulnar nerve injury
Clinical narrative: Partially paralyzed left hand, weakness in left hand (same day) Numbness in feet from instep forward
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Pain, Pyrexia, Rash, Screaming
Clinical narrative: Fever, lethargy, rash, complaining of pain all over, screaming out at night and whenever wakes up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: After MMR and Kinrix given in left arm, experienced left arm swelling from shoulder to elbow.  Mom questions if "relates to bug bite."  Mom gave 2 doses of Benadryl and it resolved within 24 hours.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea & vomiting x 1
Age: 1.07
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood culture, Computerised tomogram head, Condition aggravated, Convulsion, Culture
Clinical narrative: Increased seizure activity, emesis, diarrhea.
Age: 1.07
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Culture urine, Diarrhoea, Electroencephalogram, Nuclear magnetic resonance imaging brain, Viral test
Clinical narrative: Increased seizure activity, emesis, diarrhea.
Age: 1.07
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Increased seizure activity, emesis, diarrhea.
Age: 0.33
Sex: M
Vaccine: DTAP, RVX
Symptoms: Convulsion, Crying, Feeding disorder neonatal, Injection site erythema, Irritability
Clinical narrative: Vaccine given on the afternoon of the 27th. No symptoms initial day other than a little fussy and redness at injection site. The following day, infant was fussy, feverish (nothing over 103*), lethargic, and not breastfeeding as much as normal (I had to pump). Continued for the entire day and into the next. Third day, he began having convulsions/seizures. They lasted anywhere from 10-20 secs., sporadically but in clusters of 2-3 at a time, spread out over a 5-10 minute window. He would stiffen from head to toe and convulse. Sometimes he would cry immediately after, other times he did not. This went on for two more days, slowly dwindling down, before the seizures suddenly stopped.   I called the nurse line, panicked, but was told his reaction was normal and not related to vaccine. He had never shaken like this before. And otherwise was a very healthy baby.
Age: 0.33
Sex: M
Vaccine: DTAP, RVX
Symptoms: Lethargy, Musculoskeletal stiffness, Pyrexia, Tremor
Clinical narrative: Vaccine given on the afternoon of the 27th. No symptoms initial day other than a little fussy and redness at injection site. The following day, infant was fussy, feverish (nothing over 103*), lethargic, and not breastfeeding as much as normal (I had to pump). Continued for the entire day and into the next. Third day, he began having convulsions/seizures. They lasted anywhere from 10-20 secs., sporadically but in clusters of 2-3 at a time, spread out over a 5-10 minute window. He would stiffen from head to toe and convulse. Sometimes he would cry immediately after, other times he did not. This went on for two more days, slowly dwindling down, before the seizures suddenly stopped.   I called the nurse line, panicked, but was told his reaction was normal and not related to vaccine. He had never shaken like this before. And otherwise was a very healthy baby.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Nausea, Pallor
Clinical narrative: Pt felt nauseated, went to bathroom, then woke up and found herself on floor. Mother came to pharmacy to inform me. Pt looked pale upon waking.
Age: 5.0
Sex: U
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (L) upper lateral arm with 4 x 8cm erythema and induration.
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Chills, Headache, Injection site rash, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient with headache 5/10, fever up to 102.5, rash to injection site, chills but felt warm, neck stiffness but movable.
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Skin warm
Clinical narrative: Patient with headache 5/10, fever up to 102.5, rash to injection site, chills but felt warm, neck stiffness but movable.
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Chills, Erythema, Headache, Injection site rash, Musculoskeletal stiffness
Clinical narrative: Patient with headache 5/10, fever up to 102.5, rash to injection site, chills but felt warm, neck stiffness but movable.
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Oedema peripheral, Pain, Pyrexia
Clinical narrative: Patient with headache 5/10, fever up to 102.5, rash to injection site, chills but felt warm, neck stiffness but movable.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fall, Pallor, Syncope
Clinical narrative: After pt receiving the vaccine fainted from exam table and has (?) convulsion x few seconds was complete pale pt fell forward.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site joint pain, Injection site joint swelling, Injection site pain, Joint swelling
Clinical narrative: Extreme swelling and joint pain in all joints of arm shot was given, shoulder, elbow, wrist, knuckles. Continued joint pain to date of filing form.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, X-ray
Clinical narrative: Extreme swelling and joint pain in all joints of arm shot was given, shoulder, elbow, wrist, knuckles. Continued joint pain to date of filing form.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Urticaria around site of injection, neck, chest. Soon after home from office approx. 1 hour from time of injection.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: A 3cm hive appeared near injection site. BENADRYL 18.75mg solution given. Site decreased to 1cm with less itch. Pt. remained in office for observation for approx. 30 mins.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at injection site. Pt called 8-4-2011 at 3:49 pm. Advised ice pack 3-4 times per day, BENADRYL cream & BENADRYL 25mg oral.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Tenderness
Clinical narrative: Tdap given approx. 4:30pm on 8-8-11. Pt came in office on 8-9-11 with c/o red dt, edema, warm to touch, & pain. Saw PA. Line drawn around red area. Pt. returned to office AM 8-10-11, red area enlarged, edema but less tenderness & warmth. Tx with KEFLEX 250mg 1 Tid x 7d, & Prednisone. 8-15-11 pt states she is doing fine.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site mass
Clinical narrative: 1 day after ADACEL pt. experienced all over joint pain, a large lump at injection site and redness. She is feeling much better today but arm is still red at injection site.
Age: 9.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Reddened, tender to touch area 80 x 80 cm - raised area in center 30 cm at longest.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Speech disorder, Tongue spasm, Trismus
Clinical narrative: Within minutes of vaccination, pt c/o jaw tingling and "spasm-like feeling of tongue and jaw". Pt talked w/lisp but no evident swelling of tongue/face. Pt received IV BENADRYL given within 3 minutes and Prednisone 40mg PO 20 minutes later. Pt discharged within 1 hour.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Viral test
Clinical narrative: Pt reported she noticed a blister on 8-14-11 and it popped today (8/15/11). Denies itching, pain or fever. No HA, nausea, dizziness. Tx - BACTROBAN and dressing applied.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: (R) arm injection site area red and swollen, hot to touch. Whealed a little bit. All around the redness is 10 1/2 cm and the middle is 3 1/2 cm with it being raised.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Patient stated a few hours after injection a welt formed on her arm at site. It's warm to the touch and itching. Recommended topical Hydrocortisone and oral BENADRYL.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Dizziness, Erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt. felt dizzy a few minutes after ADACEL (Tdap) given. Pt. then complained of stomach pain. Pt. given water and was sitting with head down for about 10 minutes. Pt. then reported feeling better but had pain & itching in right deltoid. Arm appeared red. Gave pt. ice pack, APAP 1000mg and Diphenhydramine 25mg. Pt did not report any problems with breathing or swallowing. Pt remained seated and in pharmacy for 30 minutes after shot given. Pt appeared better and mom took son home. The next day, the mom informed me that pt. got worse after leaving pharmacy and she took son to ER per MD recommendation. She reported son had high fevers and shaking. Per mom, pt. given IV fluids in hospital and was given Rx for Prednisone and BENADRYL at ER. Son is better per mom.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Tremor
Clinical narrative: Pt. felt dizzy a few minutes after ADACEL (Tdap) given. Pt. then complained of stomach pain. Pt. given water and was sitting with head down for about 10 minutes. Pt. then reported feeling better but had pain & itching in right deltoid. Arm appeared red. Gave pt. ice pack, APAP 1000mg and Diphenhydramine 25mg. Pt did not report any problems with breathing or swallowing. Pt remained seated and in pharmacy for 30 minutes after shot given. Pt appeared better and mom took son home. The next day, the mom informed me that pt. got worse after leaving pharmacy and she took son to ER per MD recommendation. She reported son had high fevers and shaking. Per mom, pt. given IV fluids in hospital and was given Rx for Prednisone and BENADRYL at ER. Son is better per mom.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Gait disturbance, Injected limb mobility decreased, Pyrexia
Clinical narrative: Fever 103, problems walking or could not lift her legs. Had never had vaccines before 8-11-11. On 8/12/2011 she was ambulating well with a mild limp.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Parotitis
Clinical narrative: Patient presented with right parotitis 3 days after MMR vaccine. No treatment - but excluded from daycare.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm/deltoid 5x6 cm area swelling/redness/increased warmth. No streaking/ no fever. Rx'd with KEFLEX.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation, Musculoskeletal pain, Pain
Clinical narrative: Pt went to E.R. due to pain/inflammation of shoulder & body pains. Headache, chills. Patient received Rx for Antibiotic in ER.
Age: 1.71
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Agitation, Blood count normal, Computerised tomogram head, Computerised tomogram normal, Drug screen negative
Clinical narrative: On 8/4/11 in the middle of the night, he developed altered mental status with hyperactivity and agitation. He was seen at hospital where he was admitted and treated. His symptoms slowly resolved and was discharged on 8/7/11 when he had returned to his baseline.
Age: 1.71
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Full blood count normal, Liver function test normal, Lumbar puncture normal, Mental status changes, Nuclear magnetic resonance imaging brain normal
Clinical narrative: On 8/4/11 in the middle of the night, he developed altered mental status with hyperactivity and agitation. He was seen at hospital where he was admitted and treated. His symptoms slowly resolved and was discharged on 8/7/11 when he had returned to his baseline.
Age: 1.71
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Psychomotor hyperactivity, Renal function test normal, Urine analysis normal
Clinical narrative: On 8/4/11 in the middle of the night, he developed altered mental status with hyperactivity and agitation. He was seen at hospital where he was admitted and treated. His symptoms slowly resolved and was discharged on 8/7/11 when he had returned to his baseline.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Nasopharyngitis
Clinical narrative: A non-serious spontaneous report of cold has been received from a consumer concerning her daughter, a 36-month-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 60 months of age. Patient has no medical history or concomitant medications. The patient received FLUMIST in 2009. The reporter stated that she and her daughter developed cold after receiving FLUMIST. The patient was not hospitalized. The outcome of the event was resolved. Additional information received on 11-MAY-2011 and incorporated into case, modification of event term from flu to cold, outcome, concomitant medications, and medical history.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Influenza, Influenza A virus test positive, Nasal congestion, Pyrexia
Clinical narrative: A non-serious spontaneous report of diagnosed with influenza with symptoms of cough, nasal congestion and fever has been received from a health professional concerning a four-year-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient's medical history includes gestation age of 35 weeks and allergy to lavender soap. The patient's sibling had influenza following FLUMIST vaccination. No concomitant medications were reported. The patient received 0.2 ml FLUMIST on 26-Oct-2010 nasally for protection against influenza. The patient came to the doctor's office on 08-Feb-2011 with complaints of cough, nasal congestion and fever that the patient had during two days. A rapid flu test was done at the office which was positive. A sample was also sent to state lab and it was positive for type A. The patient was prescribed oseltamivir. The outcome of the event was resolved.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a 14-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza, Influenza A virus test positive, Influenza B virus test positive, Polymerase chain reaction, Vaccine breakthrough infection
Clinical narrative: A non-serious spontaneous report of breakthrough influenza has been received from a non-healthcare professional concerning seven children, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. The patients received FLUMIST for the 2010/2011 season. The Department of Health reported seven cases of breakthrough influenza following vaccination with FLUMIST. Six of the infections were type H3N2 and one was type B. All the patient's received treatment but no patients were hospitalized. The outcome of the event was not reported.
Age: 1.19
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST to 2 kids under 2 years-old was received from a registered nurse concerning a 14-month-old female. Neither medical history nor concomitant medication was reported for this patient. On 14-NOV-2010, the patient received FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 24-Mar-2011 and incorporated into the narrative: no late occurring adverse event was reported.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Influenza, Influenza B virus test positive, Pyrexia, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of a patient testing positive for flu B manifested with fever, cough and chest congestion has been received from a health professional concerning a four-year-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 20-Sep-2010. The child received FLUMIST and 56 days later tested positive for flu B. The reporter said that the patient came in the office on 15-Nov-2010 with fever, cough and chest congestion. The patient was tested positive for that day. The reporter stated that she thought the patient was "ok" since they had not heard anything further from the child's mother. The outcome of event remains unknown. Additional information was received on 28-Dec-2010 and was added to the narrative: Symptoms of Flu were reported.