chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria, Vomiting
Clinical narrative: I had the ZOSTAVAX injection at a pharmacy. In a few hours, I got a terrific headache that lasted until 8/7/2009. The right top of my head felt extremely sore and I felt a lump was there. I should have called the doctor but it was evening and night. I found it hard to concentrate the next morning. The right arm of the injection -- but not the same area -- became very swollen and had a raised hard lump which was very red. that lasted about 3 days after starting BENEDRYL. I itched at that area mainly but also itched all over my body. The next day I then began to break out with hives on the palms of my hands. The pharmacist told me to take BENEDRYL which I did. I was getting better and then had diarrhea and threw up and was very ill. It is now 8/8/2009 and I feel that I am much better. I don't know if there is permanent damage. I don't know if I was bleeding on the right side of my head -- I don't know what was causing all of these problems by taking the vaccine. I need to know what to tell my doctor that I was allergic to that was in the vaccine. The next morning. I noticed I couldn't think of my multiplication tables when doing math, which I never had problems before. I hope there is no permanent damage and would like some possible explanations. This was about 20 years ago. I've never smoked. I'm on oxygen. I'm not a drinker. I'm 65 and not pregnant. No liver or kidney problems that I know of....
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: I received the ZOSTAVAX on April 18, 2008. Two months ago, I started feeling a burning sensation in the skin on the left side of my back. It progressed around to the front with needle- like stabbings into my side and left breast. It didn't go away, so I saw my internist who, after my describing my pain, prescribed NEURONTIN. It has helped greatly -after 2 weeks-. Is it possible I had the shingles without the rash?
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: About 24 hours after DTaP + IPU given in left arm, it became swollen, red, hot, indurated approximately 13 x 13 cm.  No fever.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Abdominal pain upper, Headache
Clinical narrative: pt had headace and stomache slef resolving after 24 hours
Age: 13.0
Sex: F
Vaccine: DTP, HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received 4 immunizations on 8/7/98.  Mother called after hours nurse on 8/8 to report her daughter had developed a reaction on her right leg. At the site of the injection was an egg sized swelling that was red and warm to the touch.  Pt. used Ibuprophen and ice to the site
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Fever to Tmax of 103, soft tissue swelling, erythema, and warmth of overlying skin at site of vaccine administration.  +Fatigue.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever to Tmax of 103, soft tissue swelling, erythema, and warmth of overlying skin at site of vaccine administration.  +Fatigue.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Activities of daily living impaired, Body temperature increased, Cellulitis, Dizziness, Feeling abnormal
Clinical narrative: Pt described feeling lousy, muscle aches, and temp of 102.3 10 days post vaccination.  On day 11, presented to immunization clinic with temp of 100.6.  Around site and approximately 4 inches medially was red, swollen, and hot to the touch.  Pt had episode of lightheadness and almost fainted when having smallpox dressing changed.  Was taken to the Urgent Care clinic where they cultured the site and put her on Keflex 500 mg tid x 10 days because of a concern of cellulitis.  Pt missed 24 hrs of work as a result of illness/fever.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia, Presyncope
Clinical narrative: Pt described feeling lousy, muscle aches, and temp of 102.3 10 days post vaccination.  On day 11, presented to immunization clinic with temp of 100.6.  Around site and approximately 4 inches medially was red, swollen, and hot to the touch.  Pt had episode of lightheadness and almost fainted when having smallpox dressing changed.  Was taken to the Urgent Care clinic where they cultured the site and put her on Keflex 500 mg tid x 10 days because of a concern of cellulitis.  Pt missed 24 hrs of work as a result of illness/fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Swelling
Clinical narrative: reddish rash and swelling, similar to a hive, silver-dollar sized...appeared at least within 48 hrs of immunization
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, cool compress.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness & swelling of arm. Cool compress
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Skin warm
Clinical narrative: Developed a 4x4 in erythematous, warm area with vesicles noted centrally no fever.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: 1st dose of HEP A gave pt. "severe stomach cramps and diarrhea".  Symptoms lasted 2 days per mother.  2nd dose gave patient the same stomach cramps without the diarrhea.
Age: 1.3
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Accidental overdose
Clinical narrative: PCV 7 #4 vaccine given @ 12 months, and PCV7 #5 given @ 15 month of age.  (Accidental extra PCV7 administration).
Age: 62.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Diarrhoea, Headache, Heart rate increased, Myalgia, Oedema peripheral
Clinical narrative: High fever, accelerated heart rate, muscle aches over whole body, swelling under arm, vomiting, headache, some diarrhea. Felt better after 3 1/2 days.
Age: 62.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: High fever, accelerated heart rate, muscle aches over whole body, swelling under arm, vomiting, headache, some diarrhea. Felt better after 3 1/2 days.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Blood glucose normal, Dizziness, Eye movement disorder, Immediate post-injection reaction, Nausea
Clinical narrative: Patient became very dizzy, nauseous immediately after vaccines given, eyes fluttering back. Her syncope lasted >15 min; EMS called transported to ER. She was fasting & she had blood drawn prior to vaccines.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Patient became very dizzy, nauseous immediately after vaccines given, eyes fluttering back. Her syncope lasted >15 min; EMS called transported to ER. She was fasting & she had blood drawn prior to vaccines.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt mother called health center on 8-11-09 stating child had reaction to immunization. Red with swelling per provider informed pt mother to apply ice to area to decrease swelling and return to clinic if worse.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction- erythema, warmth and swelling 3cm induration, non tender to palpation and not pruritic.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site pruritus, Injection site vesicles, Scab, Varicella, Varicella post vaccine
Clinical narrative: Varicella vaccine given in left arm and Hep A given in left deltoid IM on 6/15/09. Presented 5 days later with itchy bumps/ vesicles starting on arms, then legs. Most scabbing in different days of healing. Physician who saw child at that time diagnosed varicella secondary to the recent vaccination.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt given immunization and within five minutes had localized swelling and redness. Had provider examine pt ordered Ice to arm applied x20 minutes. No further redness or swelling noted.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain, redness right upper arm.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Throat irritation, Urticaria
Clinical narrative: urticaria, throat scratchiness
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Biopsy bone marrow, Blood test, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Blood work was done as a routine physical one year after vaccine was distributed and the patients blood platelet count was at a low of 90 (normal range 140-400) Primary physician suggested that patient see a hemotologist, over the last year 2008-2009 patient has undergone routine bloodwork 01-09, 03-09, 05-09, and platelet count was still low, then Hemotologist had patient do a bone marrow biopsy to see if maybe her marrow wasnt producing enough platelets, biopsy showed that marrow was producing a healthy count of platelets, so after much blood work and evaluation, patient now has an auto-immune disease called ITP where her immune system is killing off her platelets leaving her with a low range of platelets, prior to the vaccination blood work shows normal range of platelet counts.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: No reaction on previous exposure to drug, Rash
Clinical narrative: Patient received third dose of series for RabAvert vaccine due to rabies exposure.  Patient had no reactions to first two doses.  On third dose, patient developed rash that was self-limiting.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Culture, Skin lesion
Clinical narrative: Hundres of lesions on body
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Received the following vaccinations today (at approximately 1545)including Tdap, MCV4, HepA, Varivax and HPV. The patient stood up from exam table about 4 minutes after the last shot (HPV), then fainted, fell to ground and experienced LOC for few seconds. After 15 minutes further observation, the patient was fine and left for home.
Age: 72.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 08/13/2009 Caregiver noted a red area on R arm when doing morning cares this am. Presented to HD with reddened area with irregualr borders between R deltoid and elbow. Red area is firm and warm. No redness on deltoid area. Afebrile. Referred to MD for evaluation. Pt saw NP on 8-13-2009 and was given Cephalexin 500mg tid x 10 days and to return to NP on 8-15-2009
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Pt was given Smallpox vaccine and Anthrax vaccine. Pt did not know that she was pregnat at time of vaccine
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Depressed level of consciousness, Disturbance in social behaviour, Hypotonia, Immunisation reaction, Neurological symptom
Clinical narrative: 2 days after 1-09 4 month shots of DTaP (with Hib/IPV/Prevnar/Rotateq) had about 48 hours of neurologic symptoms (namely poorly responsive, no social smile, maybe a little hypotonic in muscles) but without fever, rash, or other sequelae.  Presumed due to pertussis vaccine we are suspecting.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Myalgia, Oedema peripheral, Poor quality sleep
Clinical narrative: Swollen Arm, Muscle Aches, 100 F Temperature, restless sleep.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Both legs swollen & red.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Both arms swollen & red.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Screaming
Clinical narrative: Mom called office child screaming (uncontrollable) High pitched cry.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site swelling, Local reaction
Clinical narrative: 8/12/09 - Swelling of left arm where shot was given:  local inflammatory reaction to DTAP #4, r/ ocelliclitis.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Loss of consciousness, Muscle rigidity
Clinical narrative: Loc for a few seconds body stiffened face flushed.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives on right arm, right leg and abdomen. 2 days after vaccine given, given BENADRYL by mother, hives confirmed by their specialist. Not seen by DR at this time. Mother enc to watch for more adverse reactions and etc if needed.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Pt felt lightheaded and was pale.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, Raised, Warm, Size -->1.5 in diameter
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Local reaction: swelling, redness, warm to touch; 5 cm in diameter - left arm.
Age: 1.2
Sex: M
Vaccine: HEPA, HIBV, MMR, MMRV
Symptoms: Pyrexia, Rash erythematous, Varicella post vaccine
Clinical narrative: Varicella - low grade temp and red spots, treated with Zovirax ointment.
Age: 1.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC, VARCEL
Symptoms: Anorexia, Crying, Diet refusal, Dyspnoea, Lip swelling
Clinical narrative: 8/12 3:40 PM- vomited - (crying since receiving vaccines). 3:45 PM- redness around mouth. 3:50 PM- breathing S.O.B. 4:40 PM- lips swollen. 7:15 PM- vomited11:30 PM- Vomited. 2:30 AM- Vomited. Mother gave BENADRYL. 8/13/09 morning - Swelling gone; lips hot red. No S.O.B. -No appetite. 2:30 PM -still refuses bottle/food taking a nap.
Age: 1.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC, VARCEL
Symptoms: Stomatitis, Vomiting
Clinical narrative: 8/12 3:40 PM- vomited - (crying since receiving vaccines). 3:45 PM- redness around mouth. 3:50 PM- breathing S.O.B. 4:40 PM- lips swollen. 7:15 PM- vomited11:30 PM- Vomited. 2:30 AM- Vomited. Mother gave BENADRYL. 8/13/09 morning - Swelling gone; lips hot red. No S.O.B. -No appetite. 2:30 PM -still refuses bottle/food taking a nap.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 1.89
Sex: M
Vaccine: DTAP, MMR
Symptoms: Gait disturbance, Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Child received immunization 1 on 8-11-09 & mother reports on 8-12-09 in AM (L) thigh became red & inflamed a injection site. Child would not move leg very much throughout the day. This noon child was seen here in clinic - child was walking with difficulty & was with c/o. Mother states he feels better but leg remains red & warm area of redness 3 1/2 cm.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Muscle swelling
Clinical narrative: R shoulder (trapezius muscle) enlargement.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4, MNQ, TDAP
Symptoms: Fall, Head injury, Immediate post-injection reaction, Syncope
Clinical narrative: Immediately following HPV injection, pt. experienced syncope. Pt. was seated, fell to the to the right side, and struck the right side of her head on the floor. An ammonia capsule was provided for pt. inhalation. Pt. awakened after app. 60 seconds. Carefully moved to sitting position. Ice applied to Rt. head. Pt. alert and oriented. No visible injuries.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abscess drainage, Culture wound positive, Injection site abscess, Injection site haematoma, Injection site mass
Clinical narrative: Parent brought pt into clinic on 7/24/09 (9 days after vaccines were administered) c/o bruise and lump on R upper leg down to back of knee. Dr and nurse (myself) observed. Pt's father came in on 8/9/09 without child and reported pt had abscess on R thigh opened and drained at hospital ER; Dr is consulting with hospital-ID for ? potential relation to vaccines?
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Streptococcal identification test positive
Clinical narrative: Parent brought pt into clinic on 7/24/09 (9 days after vaccines were administered) c/o bruise and lump on R upper leg down to back of knee. Dr and nurse (myself) observed. Pt's father came in on 8/9/09 without child and reported pt had abscess on R thigh opened and drained at hospital ER; Dr is consulting with hospital-ID for ? potential relation to vaccines?
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Both legs swollen & red.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash
Clinical narrative: Patient came in with ~24 hr history of rash, starting at L abd, then increased and spread central to extremities. Pt : multiple vesicles (>200), primarily on torso.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Blisters around injection site swelling onset day after injection.
Age: 1.8
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Erythema, Skin nodule
Clinical narrative: 08/12/09 Pt returned with reddened nodes all over the body. Seen at ER. Please. see accompanying ER records. Per Dad, Pt is getting better nodes are going away.
Age: 1.5
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Erythema multiforme, Full blood count abnormal, Metabolic function test, Otitis media acute, Petechiae
Clinical narrative: Diagnosed with R OM 7/22/09, put on Amoxicillin. Had Hib and Hep A boosters 8/3/09. Developed red rash, hives 8/5/09, progressed to petechiae and purpura by 8/6/09-Seen in our office dx'd with Erythema multiforme. Seen by allergist 8/7/09 - had blood drawn, given ATARAX, ZURTEC. TYLENOL. Had f/u appt 8/11/09 - rash had resolved. Dx'd with Amoxicillin allergy.
Age: 1.5
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Platelet count, Purpura, Rash erythematous, Urticaria
Clinical narrative: Diagnosed with R OM 7/22/09, put on Amoxicillin. Had Hib and Hep A boosters 8/3/09. Developed red rash, hives 8/5/09, progressed to petechiae and purpura by 8/6/09-Seen in our office dx'd with Erythema multiforme. Seen by allergist 8/7/09 - had blood drawn, given ATARAX, ZURTEC. TYLENOL. Had f/u appt 8/11/09 - rash had resolved. Dx'd with Amoxicillin allergy.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood culture negative, Cough, Headache, Pain, Pyrexia
Clinical narrative: A serious labeled spontaneous report of fever, headache and non-serious body aches, cough and vomiting has been received from a nurse for a nine-year-old male. The events occurred one day after the patient received FLUMIST. The patient is a normal, healthy boy with no history of allergies and he is not taking any concomitant medications. The patient received FLUMIST on 25-Oct-2008 nasally for influenza prophylaxis. The day after receiving FLUMIST he experienced fever, cough, headache, vomiting and body aches. On 27-Oct-2008, he visited the clinic and had a high temp of 102.9, he was treated with acetaminophen and ibuprofen. On 28-Oct-2008, he did not improve and was hospitalized due to the high fever and headache. His WBC was elevated to 24,000 and a blood culture was negative. He was treated with intravenous fluids. After treatment, the events resolved and the patient was discharged in good condition on 29-Oct-2008.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: A serious labeled spontaneous report of fever, headache and non-serious body aches, cough and vomiting has been received from a nurse for a nine-year-old male. The events occurred one day after the patient received FLUMIST. The patient is a normal, healthy boy with no history of allergies and he is not taking any concomitant medications. The patient received FLUMIST on 25-Oct-2008 nasally for influenza prophylaxis. The day after receiving FLUMIST he experienced fever, cough, headache, vomiting and body aches. On 27-Oct-2008, he visited the clinic and had a high temp of 102.9, he was treated with acetaminophen and ibuprofen. On 28-Oct-2008, he did not improve and was hospitalized due to the high fever and headache. His WBC was elevated to 24,000 and a blood culture was negative. He was treated with intravenous fluids. After treatment, the events resolved and the patient was discharged in good condition on 29-Oct-2008.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Malaise, Nasal congestion, Sneezing
Clinical narrative: A non-serious spontaneous report of stuffy nose, headache, sneezing, and malaise has been received from a consumer, concerning a 14-year-old female subsequent to FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on 08-AUG-2008.  The day after receiving FLUMIST, the patient developed stuffy nose, headache, sneezing, and malaise.  At the time of the report, the patient was feeling better.  The outcome has not been reported.
Age: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Asthma
Clinical narrative: A non-serious spontaneous report of accidental exposure while administering drug and asthma attack has been received from a nurse concerning a 31-year-old female, subsequent to administering FLUMIST to patients in a physician's office.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient administered FLUMIST to two patients in a physicians office.  Immediately after administering FLUMIST to the two patients, the patient (a health care worker) experienced an asthma attack.  The patient self-administered a nebulizer treatment and experienced relief.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A non-serious spontaneous report of NOSE BLEED was received from a physician concerning a seven-year-old male subsequent to FLUMIST.  The patient's medical history has not been reported.  The patient "was also taking SINGULAIR".  The patient received FLUMIST vaccine on 12-Aug-2008.  On 17-Aug-2008, the patient started having nose bleeds which continued over four days.  The patient's parent indicated that there was a total of ten nose bleeding episodes during that period of time.  The outcome of the event is unknown.
Sex: U
Vaccine: FLUN3
Symptoms: Chills, Headache, Hyperhidrosis, Nasal discomfort, Nausea
Clinical narrative: A non-serious spontaneous report of shaking, nasal passage irritation, sweating, chills, headache, and nausea has been received from a consumer concerning a patient of unknown age subsequent to FLUMIST.  The patient's past medical history includes mild anemia.  The patient received FLUMIST on 22-Aug-2008 at 0920.  The patient experienced shaking, chills, sweating (enough to create six inch by three inch large pit stain under her arms), headache (that lasted all day), nasal passage irritation, and intermittent nausea on the same day that FLUMIST was received.  The outcome was not reported.
Sex: U
Vaccine: FLUN3
Symptoms: Tremor
Clinical narrative: A non-serious spontaneous report of shaking, nasal passage irritation, sweating, chills, headache, and nausea has been received from a consumer concerning a patient of unknown age subsequent to FLUMIST.  The patient's past medical history includes mild anemia.  The patient received FLUMIST on 22-Aug-2008 at 0920.  The patient experienced shaking, chills, sweating (enough to create six inch by three inch large pit stain under her arms), headache (that lasted all day), nasal passage irritation, and intermittent nausea on the same day that FLUMIST was received.  The outcome was not reported.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash generalised
Clinical narrative: A non-serious spontaneous report of GENERLIZED RASH as been received from a nurse concerning a 13-year-old male subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported. The patient received FLUMIST vaccine on 21-Aug-2008. Two and a half hours after receiving FLUMIST vaccine, the patient developed rash described as covering the entire body except the hands and soles of the feet. The rash was aggravated by heat and is relieved by BENADRYL. At the time of the report, the event has not resolved and the rash was reported to be "still waxing and waning".
Age: 42.0
Sex: M
Vaccine: FLUN3
Symptoms: Back pain, Chills, Cough, Fatigue, Headache
Clinical narrative: A non-serious spontaneous report of shaking, fever, muscular chest and back pain, chills, headache, cough and fatigue has been received from a consumer (male, in his late 30's), who happens to be a physician, subsequent to FLUMIST.  The patient stated that he already had a cold prior to FLUMIST administration.  No concomitant medications have been reported for this patient.  The patient received FLUMIST on 02-Sep-2008 at 2pm.  This was the patient's first dose of FLUMIST.  By 6pm on the same date, the patient started experiencing symptoms of muscular chest and back pain, fever, fatigue, shaking, chills and headache.  By 12 midnight on the same date, the symptoms continued and were reportedly worse.  The patient also had a cough by this time.  The symptoms continued through the day of 03-Sep-2008 and started resolving by the evening.  The outcome of the events is resolved.  The patient has fully recovered on 04-Sep-2008.  The reporter was unsure of the relationship of the adverse events to FLUMIST therapy.  Additional information was obtained on 23-Sep-2008 and incorporated into the narrative:  data and time of FLUMIST administration, event description, information that patient had a cold the same time as the occurrence of adverse events, and adverse events onset and cessation dates.
Age: 42.0
Sex: M
Vaccine: FLUN3
Symptoms: Myalgia, Non-cardiac chest pain, Pyrexia, Tremor
Clinical narrative: A non-serious spontaneous report of shaking, fever, muscular chest and back pain, chills, headache, cough and fatigue has been received from a consumer (male, in his late 30's), who happens to be a physician, subsequent to FLUMIST.  The patient stated that he already had a cold prior to FLUMIST administration.  No concomitant medications have been reported for this patient.  The patient received FLUMIST on 02-Sep-2008 at 2pm.  This was the patient's first dose of FLUMIST.  By 6pm on the same date, the patient started experiencing symptoms of muscular chest and back pain, fever, fatigue, shaking, chills and headache.  By 12 midnight on the same date, the symptoms continued and were reportedly worse.  The patient also had a cough by this time.  The symptoms continued through the day of 03-Sep-2008 and started resolving by the evening.  The outcome of the events is resolved.  The patient has fully recovered on 04-Sep-2008.  The reporter was unsure of the relationship of the adverse events to FLUMIST therapy.  Additional information was obtained on 23-Sep-2008 and incorporated into the narrative:  data and time of FLUMIST administration, event description, information that patient had a cold the same time as the occurrence of adverse events, and adverse events onset and cessation dates.
Age: 52.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of FLUMIST inadvertently given to a 52-year old male was received from a pharmacist.  The patient's medical history was not reported.  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.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Decreased appetite, Dehydration, Diarrhoea, Gastroenteritis
Clinical narrative: A non-serious spontaneous report of viral syndrome, flu symptoms, gastroenteritis, myalgias, and neck pain has been received from a nurse in a physician's assistant office and the patient, a 27-year-old female. Concomitant medications included lamotrigine, buspirone hydrochloride, venlafaxine, and duloxetine hydrochloride.  The patient had an allergy to aspirin. The patient received FLUMIST, intranasal administration for flu immunization on 19-AUG-2008. The patient had never received FLUMIST before. Since receiving FLUMIST, the patient was having viral syndrome that started to improve. On 26-Aug-2008, the patient thought she may have had gastroenteritis or food poisoning. She developed severe diarrhea. The patient also reported her experience as flu symptoms described as headache, fever, chills, sever aches, and dehydration. She had no abdominal pain, nausea or vomiting, just decreased appetite. She had no blood or mucous in her stools. On 27-Aug-2008, the patient experienced myalgias and neck pain (reported by the patient as a neck strain that stretched from the back of the lower neck over the head and to the eyes). The patient saw her physician's assistant on 28-Aug-2008 and was diagnosed with gastroenteritis with viral syndrome, currently improving. The patient reported her diagnosis as "a virus that attacks the neck muscles." The PA recommended pushing plenty of fluids and gastrointestinal rest. The patient recovered from the events of Viral syndrome, gastroenteritis, flu symptoms, myalgias, and neck pain. The PA's nurse did not feel the patient's illness was secondary to FLUMIST.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Influenza, Myalgia, Neck pain, Pain
Clinical narrative: A non-serious spontaneous report of viral syndrome, flu symptoms, gastroenteritis, myalgias, and neck pain has been received from a nurse in a physician's assistant office and the patient, a 27-year-old female. Concomitant medications included lamotrigine, buspirone hydrochloride, venlafaxine, and duloxetine hydrochloride.  The patient had an allergy to aspirin. The patient received FLUMIST, intranasal administration for flu immunization on 19-AUG-2008. The patient had never received FLUMIST before. Since receiving FLUMIST, the patient was having viral syndrome that started to improve. On 26-Aug-2008, the patient thought she may have had gastroenteritis or food poisoning. She developed severe diarrhea. The patient also reported her experience as flu symptoms described as headache, fever, chills, sever aches, and dehydration. She had no abdominal pain, nausea or vomiting, just decreased appetite. She had no blood or mucous in her stools. On 27-Aug-2008, the patient experienced myalgias and neck pain (reported by the patient as a neck strain that stretched from the back of the lower neck over the head and to the eyes). The patient saw her physician's assistant on 28-Aug-2008 and was diagnosed with gastroenteritis with viral syndrome, currently improving. The patient reported her diagnosis as "a virus that attacks the neck muscles." The PA recommended pushing plenty of fluids and gastrointestinal rest. The patient recovered from the events of Viral syndrome, gastroenteritis, flu symptoms, myalgias, and neck pain. The PA's nurse did not feel the patient's illness was secondary to FLUMIST.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Viral infection
Clinical narrative: A non-serious spontaneous report of viral syndrome, flu symptoms, gastroenteritis, myalgias, and neck pain has been received from a nurse in a physician's assistant office and the patient, a 27-year-old female. Concomitant medications included lamotrigine, buspirone hydrochloride, venlafaxine, and duloxetine hydrochloride.  The patient had an allergy to aspirin. The patient received FLUMIST, intranasal administration for flu immunization on 19-AUG-2008. The patient had never received FLUMIST before. Since receiving FLUMIST, the patient was having viral syndrome that started to improve. On 26-Aug-2008, the patient thought she may have had gastroenteritis or food poisoning. She developed severe diarrhea. The patient also reported her experience as flu symptoms described as headache, fever, chills, sever aches, and dehydration. She had no abdominal pain, nausea or vomiting, just decreased appetite. She had no blood or mucous in her stools. On 27-Aug-2008, the patient experienced myalgias and neck pain (reported by the patient as a neck strain that stretched from the back of the lower neck over the head and to the eyes). The patient saw her physician's assistant on 28-Aug-2008 and was diagnosed with gastroenteritis with viral syndrome, currently improving. The patient reported her diagnosis as "a virus that attacks the neck muscles." The PA recommended pushing plenty of fluids and gastrointestinal rest. The patient recovered from the events of Viral syndrome, gastroenteritis, flu symptoms, myalgias, and neck pain. The PA's nurse did not feel the patient's illness was secondary to FLUMIST.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST inadvertently administered was received from a registered nurse concerning a seven-year-old male. Neither medical history nor concomitant medications were provided. The patient received his first dose of FLUMIST on 11-Sep-2008. The FLUMIST had expired on 03-Apr-2008. The reporter stated that FLUMIST was given by one of the nurses helping out the clinic on 11-Sep-2008 and not by the nurse in-charge of immunizations. The incident regarding the expired FLUMIST was noted when the immunization record was being updated. As of 24-Sep-2008, there was no adverse event reported; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Mar-2009: Product Complaint Investigative results. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthma, Cough, Hypersomnia, Pneumonia, Pyrexia
Clinical narrative: A non-serious spontaneous report of pneumonia, sleeping a lot, fever, asthma and coughing was received from a mother concerning a six year-old female subsequent to FLUMIST. Medical history included asthma. No concomitant medications were reported for this patient. The patient received FLUMIST in the last week of August 2008. The patient developed a high fever (104 degrees Fahrenheit) 12 hours after receiving FLUMIST. The patient was taken to the emergency room and treated for pneumonia and an asthma attack. The patient was not hospitalized. Subsequently in September 2008, the patient had symptoms of coughing and sleeping a lot. The outcome of the adverse events was not reported. Additional dosing with FLUMIST was not reported. No causality assessment was reported.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Medication error
Clinical narrative: A Non - serious spontaneous report of administered two doses of vaccine in two day period has been received from a nurse concerning a 5-year old female patient.  No medical or medication history were reported for this patient.  The patient received FLUMIST intranasally in one office on 27AUG2008 and received another dose at a different office by the same physician on 29Aug2008.  The patient received FLUMIST for flu prevention.  The office were reportedly not computerized and the second office did not have the patient's chart.  The physician's office confirmed that there were no adverse events associated with this medication error; therefore, treatment and reporter/ sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was obtained on 19Sep2008 and incorporated into the narrative:  confirmation from the physician's office that no adverse events occurred from the medication error.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Cough, Rhonchi, Sick relative
Clinical narrative: A non-serious spontaneous case of inadvertent administration of FLUMIST to an asthmatic and cough has been received from a nurse in a 12-year-old male, subsequent to receiving FLUMIST.  The reporting nurse stated the patient was inadvertently administered FLUMIST.  The patient returned to see the physician on 15-Sep-2008 for a cough; at that time there was no wheezing, some rhonchi and other family members had upper respiratory symptoms.  The patient was treated with PREDNISONE and ZITHROMYCIN.  The patient was rechecked on 17-Sep-2008 at which time his lungs were clear and the cough had resolved.  All events resolved.
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: A non-serous spontaneous report of headache, nausea, vomiting, and diarrhea has been received from a consumer concerning a 40-year old male subsequent to FLUMIST. No medical or medication history was provided for this patient. The patient received FLUMIST on 13-Sep-2008. The patient started having slight symptoms on 15-Sep and 16-Sep-2008. The patient was reportedly "bending over" by 17-Sep-2008. The patient was not seen by a physician for treatment. The patient did not receive treatment for the adverse events but had lots of rest. The patient recovered from the adverse events on 17-Sep-2008. The reporter assessed the relationship of the adverse events to FLUMIST as "not sure", but we think so."
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: A non-serious spontaneous report of headache, nausea, vomiting, and diarrhea has been received from a consumer concerning a five-year old male subsequent to FLUMIST.  No medical or medication history was provided for this patient.  The patient received FLUMIST on 13-Sep-2008.  The patient's symptoms started on 13-Sep-2008.  The symptoms were reportedly worse on 14-Sep-2008 and better on 15-Sep-2008.  The patient was not seen by a physician for treatment.  The patient did not receive treatment for the adverse events but had lots of rest.  The patient recovered from the adverse events on 15-Sep-2008.  The reporter assessed the relationship of the adverse events of headache, nausea and vomiting to FLUMIST as "not sure, but we think so."
Age: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Oral mucosal eruption, Rash generalised, Urticaria
Clinical narrative: A non-serious spontaneous report of rash and whelps was received from an office manager of a doctor's clinic concerning a 31-year-old female health care worker after receiving FLUMIST.  The patient has no known allergies to food including eggs or other medication.  She is not taking any concomitant medications.  The patient received FLUMIST intranasally on 17-Sep-2008.  Upon awakening on 19-Sep-2008, the patient noted rash and whelps over her entire body and inside her mouth.  On the same day, she consulted with her health care provider.  She was given an unknown steroid injection in the clinic and prescribed unknown steroid to be taken orally.  The patient's rash and whelps resolved on 21-Sep-2008.
Age: 5.0
Sex: F
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Rash pruritic, Swelling face, Urticaria
Clinical narrative: A non-serious spontaneous report of swelling under left eye, flat red itchy rash, and hives has been received from a nurse and a physician concerning a five-year-old female subsequent to FLUMIST. Medical history included Down's syndrome, trigonocephaly, hypothyroidism, and alopecia. The patient had no known allergies. On 19-Sep-2008, the patient received FLUMIST for flu immunization. The patient also received DTaP, IPV, MMR, and VARICELLA vaccines on the same day. About 40-45 minutes after receiving FLUMIST on 19-Sep-2008, the patient developed swelling under the left eye (1/4 size of an egg) and a flat red itchy rash that disseminated throughout her body. She developed hives on the back of her neck, one on her trunk, and one behind her left ear. The patient's mother brought her back to the physician's office. She had no difficulty breathing and no distress. The patient was treated with oral diphenhydramine in the office 40 minutes after the events started and the swelling and rash improved. The hives disappeared within a few hours and the patient had no other problems. The physician spoke to the patient's mother who indicated the patient "has been fine" since the events. The nurse indicated the physician thought the events were caused by FLUMIST because it was the only vaccine the patient had never had before. Additional information was received from the physician on 30-Sep-2008 and incorporated into the above narrative which included the outcome of the events.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Wheezing
Clinical narrative: A non-serious spontaneous report of wheezing was received from a physician concerning an 11-year-old male subsequent to FLUMIST. The patient has no history of asthma, wheezing, or allergies. No concomitant medications were reported. The patient received FLUMIST on 24-Sep-2008. Fifteen minutes after receiving FLUMIST, the patient started wheezing. The symptoms required treatment with nebulized albuterol. The wheezing improved but still ongoing as of 24-Sep-2008.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis, Immediate post-injection reaction
Clinical narrative: A non-serious spontaneous report of nose bleed was received by an employee in a pediatric office, concerning a five-year old female subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported. The patient received FLUMIST on an unreported date. Immediately after FLUMIST administration, the patient developed nose bleed in one nostril. The bleeding was easily controlled and stopped before the patient left the pediatrician's office.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Eyelid oedema, No reaction on previous exposure to drug
Clinical narrative: A non-serious spontaneous report of swelling of right lower eyelid was received from a father concerning his 5-year-old male child subsequent to FLUMIST. The patient has no egg or milk protein allergy nor asthma. Concomitant medications were not reported for this patient. The patient had previously received 3 doses of flu vaccine with no reported adverse events. The patient received FLUMIST by nasal administration for the first time on 23-Sep-2008. On 24-Sep-2008, a reaction occurred under the patient's eye described as swelling of the right lower eyelid. As of 03-Oct-2008, the clinic where the patient received FLUMIST has not received any communication regarding the adverse event nor was the patient brought in for follow-up consultation. The right lower eyelid was still swollen as of 26-Sep-2008.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: No adverse event
Clinical narrative: A non-serious report of administration of FLUMIST to a nine-year-old male on daily ASPIRIN was received from a consumer. The patient's medical history was not provided. His only concomitant medication is daily ASPIRIN taken orally. The patient received FLUMIST via nasal administration for the first time on 26-Sep-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event in considered resolved.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Feeling of body temperature change, Headache, Laboratory test, Nausea
Clinical narrative: A non-serious, spontaneous report of aching, hot then cold, headache, nausea, sinus infection and stomachache was received from a consumer concerning a eight-year old female patient, subsequent to FLUMIST.  Consumer indicated there is no medical history and no concomitant medications.  The patient received FLUMIST on Wednesday, 24-Sep-2008.  Approximately two hours after dosing the patient experienced aching and headache.  The following morning the patient was seen in the doctors office and diagnosed with a sinus infection.  Later the same day the symptoms were reported as worse and the patient was prescribed CODEINE/acetaminophen, which barely took the headaches and aching away.  On Friday, 26-Sep-2008 the patient cried for hours and experienced stomachache, nausea and reported feeling hot then cold.  The patient was taken to the emergency room and the physician diagnosed her with having adverse side effects from FLUMIST and prescribed HYDROCODONE/acetaminophen just numbed the pain but did not make it go away.  The patient was taken back to the emergency room at a different hospital and blood work and a contrast MRI of the head to the abdomen were collected.  All results were normal and he said it must be some adverse reaction to FLUMIST.  The consumer stated she does not think the patient has a sinus infection.  Events of aching, hot then cold, headache, nausea and stomach ache are ongoing as of 03-Oct-2008.  The outcome of the event of sinus infection is unknown.  The reporter assessed the events as possibly related to FLUMIST. Required follow-up attempts have been performed, requested information unable to be obtained.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Sinusitis
Clinical narrative: A non-serious, spontaneous report of aching, hot then cold, headache, nausea, sinus infection and stomachache was received from a consumer concerning a eight-year old female patient, subsequent to FLUMIST.  Consumer indicated there is no medical history and no concomitant medications.  The patient received FLUMIST on Wednesday, 24-Sep-2008.  Approximately two hours after dosing the patient experienced aching and headache.  The following morning the patient was seen in the doctors office and diagnosed with a sinus infection.  Later the same day the symptoms were reported as worse and the patient was prescribed CODEINE/acetaminophen, which barely took the headaches and aching away.  On Friday, 26-Sep-2008 the patient cried for hours and experienced stomachache, nausea and reported feeling hot then cold.  The patient was taken to the emergency room and the physician diagnosed her with having adverse side effects from FLUMIST and prescribed HYDROCODONE/acetaminophen just numbed the pain but did not make it go away.  The patient was taken back to the emergency room at a different hospital and blood work and a contrast MRI of the head to the abdomen were collected.  All results were normal and he said it must be some adverse reaction to FLUMIST.  The consumer stated she does not think the patient has a sinus infection.  Events of aching, hot then cold, headache, nausea and stomach ache are ongoing as of 03-Oct-2008.  The outcome of the event of sinus infection is unknown.  The reporter assessed the events as possibly related to FLUMIST. Required follow-up attempts have been performed, requested information unable to be obtained.