chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: TYP
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Myalgia, Nasal congestion, Oral mucosal erythema
Clinical narrative: Requested consult for evaluation of diffuse myalgia, arthralgia and URI like symptoms following receipt of several influenza and anthrax vaccinations. He received his Influenza vaccinations on 3/2/2003, 12/30/2004, 11/26/2007, H1N1 on 2/19/2010, and FLUMIST on 10/16/2010. Approximately 5-8 hours following each of these vaccinations (with and without other vaccines administered) he complained of feeling diffuse body aches, headaches, and nasal congestion that would last 3-4 days. Headaches and nasal congestion were worse with 2010 FLUMIST. He self-treated with TYLENOL, ADVIL and/or OTC cold medications and advised he was treated for UTI in 2010. He remembers being out of work 3 days each time. He received his Anthrax vaccinations 6/27/2007, 8/24/2007, and 3/1/2008 with sequential worsening of diffuse myalgia and arthralgia to knees/hands, nasal congestion, fatigue and frontal headaches. He recalls onset of symptoms was about 1-2 hours post vaccination (each vac.). He remembers duration of all symptoms in 2007 was 2-3 days and 5-7 days in 2008 before fully resolving. He treated with MOTRIN and increased fluid intake. However, a review of available medical records documented an exam on 7/14/2007 for complaints of a sore throat, cough, bilateral ear pressure, and congestion beginning 6/29/2007 unrelieved with OTC medications (onset 2 days after AVA vac#1 versus above recall of 1-2 hours post vaccination). His exam noted enlarged erythematous swollen tonsils with exudate, mucoid nasal discharge, and expiratory wheezing that cleared with cough. He was diagnosed with bronchitis and treated with Z-PAK, albuterol inhaler, ENTEX PSE, and TYLENOL. There were no throat cultures obtained. He reported full recovery over next few weeks. On 4/7/2008, while deployed, he was examined for complaints of 2 week history of headaches, stuffed ears, sore throat, cough, sinus & chest congestion (symptom onset at 3/23/08 or 22 days after AVA vac #3). His exam was unremarkable with some clear nasal discharge and erythema cobblestone appearance to oral cavity. He was diagnosed and treated for sinusitis and URI with full recovery. Agency form on 8/15/2008 was marked yes for complaints of painful joints, back pain, heartburn and increased irritability. X-rays in Sept-Oct 2009 showed degenerative disc disease to L5-S1 and mild vacuum phenomena with spurring L5; and, DDD to C5-6 and C6-7 with straightening of cervical curvature. As of 2011 his diagnoses include hypertension, hypercholesterolemia, glucose intolerance, and he sees a chiropractor for episodic cervical, thoracic and lumbar spine somatic dysfunction (pain). He is currently preparing for a June 2011 deployment, is in smoking cessation program, voices no restrictions in daily activities, or an increase in seasonal URI like events pre-post vaccinations.
Age: 41.0
Sex: M
Vaccine: TYP
Symptoms: Oropharyngeal pain, Pain, Respiratory disorder, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Requested consult for evaluation of diffuse myalgia, arthralgia and URI like symptoms following receipt of several influenza and anthrax vaccinations. He received his Influenza vaccinations on 3/2/2003, 12/30/2004, 11/26/2007, H1N1 on 2/19/2010, and FLUMIST on 10/16/2010. Approximately 5-8 hours following each of these vaccinations (with and without other vaccines administered) he complained of feeling diffuse body aches, headaches, and nasal congestion that would last 3-4 days. Headaches and nasal congestion were worse with 2010 FLUMIST. He self-treated with TYLENOL, ADVIL and/or OTC cold medications and advised he was treated for UTI in 2010. He remembers being out of work 3 days each time. He received his Anthrax vaccinations 6/27/2007, 8/24/2007, and 3/1/2008 with sequential worsening of diffuse myalgia and arthralgia to knees/hands, nasal congestion, fatigue and frontal headaches. He recalls onset of symptoms was about 1-2 hours post vaccination (each vac.). He remembers duration of all symptoms in 2007 was 2-3 days and 5-7 days in 2008 before fully resolving. He treated with MOTRIN and increased fluid intake. However, a review of available medical records documented an exam on 7/14/2007 for complaints of a sore throat, cough, bilateral ear pressure, and congestion beginning 6/29/2007 unrelieved with OTC medications (onset 2 days after AVA vac#1 versus above recall of 1-2 hours post vaccination). His exam noted enlarged erythematous swollen tonsils with exudate, mucoid nasal discharge, and expiratory wheezing that cleared with cough. He was diagnosed with bronchitis and treated with Z-PAK, albuterol inhaler, ENTEX PSE, and TYLENOL. There were no throat cultures obtained. He reported full recovery over next few weeks. On 4/7/2008, while deployed, he was examined for complaints of 2 week history of headaches, stuffed ears, sore throat, cough, sinus & chest congestion (symptom onset at 3/23/08 or 22 days after AVA vac #3). His exam was unremarkable with some clear nasal discharge and erythema cobblestone appearance to oral cavity. He was diagnosed and treated for sinusitis and URI with full recovery. Agency form on 8/15/2008 was marked yes for complaints of painful joints, back pain, heartburn and increased irritability. X-rays in Sept-Oct 2009 showed degenerative disc disease to L5-S1 and mild vacuum phenomena with spurring L5; and, DDD to C5-6 and C6-7 with straightening of cervical curvature. As of 2011 his diagnoses include hypertension, hypercholesterolemia, glucose intolerance, and he sees a chiropractor for episodic cervical, thoracic and lumbar spine somatic dysfunction (pain). He is currently preparing for a June 2011 deployment, is in smoking cessation program, voices no restrictions in daily activities, or an increase in seasonal URI like events pre-post vaccinations.
Age: 41.0
Sex: M
Vaccine: TYP
Symptoms: Sinus congestion, Sinusitis, Spinal X-ray abnormal, Tonsillar hypertrophy, Upper respiratory tract infection
Clinical narrative: Requested consult for evaluation of diffuse myalgia, arthralgia and URI like symptoms following receipt of several influenza and anthrax vaccinations. He received his Influenza vaccinations on 3/2/2003, 12/30/2004, 11/26/2007, H1N1 on 2/19/2010, and FLUMIST on 10/16/2010. Approximately 5-8 hours following each of these vaccinations (with and without other vaccines administered) he complained of feeling diffuse body aches, headaches, and nasal congestion that would last 3-4 days. Headaches and nasal congestion were worse with 2010 FLUMIST. He self-treated with TYLENOL, ADVIL and/or OTC cold medications and advised he was treated for UTI in 2010. He remembers being out of work 3 days each time. He received his Anthrax vaccinations 6/27/2007, 8/24/2007, and 3/1/2008 with sequential worsening of diffuse myalgia and arthralgia to knees/hands, nasal congestion, fatigue and frontal headaches. He recalls onset of symptoms was about 1-2 hours post vaccination (each vac.). He remembers duration of all symptoms in 2007 was 2-3 days and 5-7 days in 2008 before fully resolving. He treated with MOTRIN and increased fluid intake. However, a review of available medical records documented an exam on 7/14/2007 for complaints of a sore throat, cough, bilateral ear pressure, and congestion beginning 6/29/2007 unrelieved with OTC medications (onset 2 days after AVA vac#1 versus above recall of 1-2 hours post vaccination). His exam noted enlarged erythematous swollen tonsils with exudate, mucoid nasal discharge, and expiratory wheezing that cleared with cough. He was diagnosed with bronchitis and treated with Z-PAK, albuterol inhaler, ENTEX PSE, and TYLENOL. There were no throat cultures obtained. He reported full recovery over next few weeks. On 4/7/2008, while deployed, he was examined for complaints of 2 week history of headaches, stuffed ears, sore throat, cough, sinus & chest congestion (symptom onset at 3/23/08 or 22 days after AVA vac #3). His exam was unremarkable with some clear nasal discharge and erythema cobblestone appearance to oral cavity. He was diagnosed and treated for sinusitis and URI with full recovery. Agency form on 8/15/2008 was marked yes for complaints of painful joints, back pain, heartburn and increased irritability. X-rays in Sept-Oct 2009 showed degenerative disc disease to L5-S1 and mild vacuum phenomena with spurring L5; and, DDD to C5-6 and C6-7 with straightening of cervical curvature. As of 2011 his diagnoses include hypertension, hypercholesterolemia, glucose intolerance, and he sees a chiropractor for episodic cervical, thoracic and lumbar spine somatic dysfunction (pain). He is currently preparing for a June 2011 deployment, is in smoking cessation program, voices no restrictions in daily activities, or an increase in seasonal URI like events pre-post vaccinations.
Age: 41.0
Sex: M
Vaccine: TYP
Symptoms: Urinary tract infection, Wheezing
Clinical narrative: Requested consult for evaluation of diffuse myalgia, arthralgia and URI like symptoms following receipt of several influenza and anthrax vaccinations. He received his Influenza vaccinations on 3/2/2003, 12/30/2004, 11/26/2007, H1N1 on 2/19/2010, and FLUMIST on 10/16/2010. Approximately 5-8 hours following each of these vaccinations (with and without other vaccines administered) he complained of feeling diffuse body aches, headaches, and nasal congestion that would last 3-4 days. Headaches and nasal congestion were worse with 2010 FLUMIST. He self-treated with TYLENOL, ADVIL and/or OTC cold medications and advised he was treated for UTI in 2010. He remembers being out of work 3 days each time. He received his Anthrax vaccinations 6/27/2007, 8/24/2007, and 3/1/2008 with sequential worsening of diffuse myalgia and arthralgia to knees/hands, nasal congestion, fatigue and frontal headaches. He recalls onset of symptoms was about 1-2 hours post vaccination (each vac.). He remembers duration of all symptoms in 2007 was 2-3 days and 5-7 days in 2008 before fully resolving. He treated with MOTRIN and increased fluid intake. However, a review of available medical records documented an exam on 7/14/2007 for complaints of a sore throat, cough, bilateral ear pressure, and congestion beginning 6/29/2007 unrelieved with OTC medications (onset 2 days after AVA vac#1 versus above recall of 1-2 hours post vaccination). His exam noted enlarged erythematous swollen tonsils with exudate, mucoid nasal discharge, and expiratory wheezing that cleared with cough. He was diagnosed with bronchitis and treated with Z-PAK, albuterol inhaler, ENTEX PSE, and TYLENOL. There were no throat cultures obtained. He reported full recovery over next few weeks. On 4/7/2008, while deployed, he was examined for complaints of 2 week history of headaches, stuffed ears, sore throat, cough, sinus & chest congestion (symptom onset at 3/23/08 or 22 days after AVA vac #3). His exam was unremarkable with some clear nasal discharge and erythema cobblestone appearance to oral cavity. He was diagnosed and treated for sinusitis and URI with full recovery. Agency form on 8/15/2008 was marked yes for complaints of painful joints, back pain, heartburn and increased irritability. X-rays in Sept-Oct 2009 showed degenerative disc disease to L5-S1 and mild vacuum phenomena with spurring L5; and, DDD to C5-6 and C6-7 with straightening of cervical curvature. As of 2011 his diagnoses include hypertension, hypercholesterolemia, glucose intolerance, and he sees a chiropractor for episodic cervical, thoracic and lumbar spine somatic dysfunction (pain). He is currently preparing for a June 2011 deployment, is in smoking cessation program, voices no restrictions in daily activities, or an increase in seasonal URI like events pre-post vaccinations.
Age: 89.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: Received pneumonia shot in (L) arm. Hurt on & off severely for several days then kept hurting off & on less severely until last week when it began to hurt even without movement much more severe - saw Orthopedist, did X-ray but could see nothing - advised her to see regular MD.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, FLU3, MMR, PNC13
Symptoms: Blood test, Body temperature increased, Febrile convulsion, Gaze palsy, Tremor
Clinical narrative: TYLENOL given before bed at 8:30pm. Awoke & emesised, 2:30A. Ibuprofen given 3AM, awoke & emesis 6AM. Bath to clean emesis. Shaking. TYLENOL given 6:45A. 11A became unresponsive eyes rolled back, shaking all limbs. Seizure lasted 5-10 mins EMS called. Transported to hospital. Temp 101 degrees diagnosed with "febrile seizure".
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, FLU3, MMR, PNC13
Symptoms: Unresponsive to stimuli, Urine analysis, Vomiting, X-ray
Clinical narrative: TYLENOL given before bed at 8:30pm. Awoke & emesised, 2:30A. Ibuprofen given 3AM, awoke & emesis 6AM. Bath to clean emesis. Shaking. TYLENOL given 6:45A. 11A became unresponsive eyes rolled back, shaking all limbs. Seizure lasted 5-10 mins EMS called. Transported to hospital. Temp 101 degrees diagnosed with "febrile seizure".
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Hives, itchiness on entire body that night. Mother gave BENADRYL.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Rash, Skin oedema
Clinical narrative: Lip swelling - at first later - ant neck skin rash & edematous skin in area.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: (L) arm swelling, redness at heat at site of MMR - first noted early AM on 2/17/11... size of golf ball. By afternoon entire (L) upper arm was swollen, red, hot & tight. Saw Dr. 2/17 received rx for cellulitis. Improved by pm of 1/18/11.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling, Injection site mass, Lymphadenopathy, Muscle spasms, Pain
Clinical narrative: Puffy eyes, swollen glands in throat, lump where inject was. Body has spasm on right side and sharp pains.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting, fever (102.4).
Age: 38.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt called on 2/21/11 to report onset of fever, this is 2 days after his vaccine, also stated the injection site was red & swollen: advised to apply ice to injection site, take ibuprofen or TYLENOL for fever (alternating every 8 & 6 hours, respectively); unable to reach pt for follow up phone call after 3 attempts.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cold sweat, Convulsion, Fall, Gaze palsy, Head injury
Clinical narrative: About 1 to 3 min. after administration of vaccines chills seizured. Her eyes rolled back and skin was cold and clammy. Child feel and hit her head. Used ammonia inhalant and she was awake and responsive when ambulance to her to hospital.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Myalgia
Clinical narrative: Achiness in trunk muscles blisters under right breast.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site mass, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Large red, raised lump on (R) leg. Increased in size since yesterday. Hot to the touch & streaking up leg.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Influenza like illness, Pain, Respiratory tract congestion, Tenderness
Clinical narrative: (1) localized pain & tenderness, mild swelling at vaccine site (R) shoulder (2) headache, flu like symptoms, congestion 1 day after inject.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Vaccination site swelling
Clinical narrative: (1) localized pain & tenderness, mild swelling at vaccine site (R) shoulder (2) headache, flu like symptoms, congestion 1 day after inject.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash developed on bilateral legs & arms 1 day after receiving TDAP vaccine & PPD. Treated on 24 Feb 2011 with prednisone. The patient is a 42 year old male. 1. c/o skin rash on legs, arms, lower abdomen x 4 days, started on Sat 19 Feb. Not on any medications, but he received PPD and TDAP on Fri 18 Feb. Using OTC lotion for sx's. No shortness of breath/wheezing/facial swelling. States had similar rash in 3/2010 but was localized to left leg at that time, was treated with steroid cream.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Erythema, Pain, Pruritus
Clinical narrative: Pt received vaccine 2/18. 2/21 returned to office with redness, soreness, systemic itching. Dx with allergy to TDAP. Pt advised to take CLARITIN 10mg q day until resolved.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Chest X-ray normal, Dyspnoea, Full blood count, Metabolic function test, Swollen tongue
Clinical narrative: 1/2 hr after vaccination, patient went to ER at hospital for swollen tongue and difficulty in breathing. Admitted for IV BENADRYL and SOLUMEDROL.
Age: 44.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Arthralgia, Asthenia, Blood test normal, Condition aggravated, Fatigue
Clinical narrative: Individual reports his symptoms began approximately one week following his BIOTHRAX #2 and Yellow Fever immunization and have persisted unchanged. He reports bilateral hand stiffness, bilateral shoulder pain, increase in pain in right shoulder (has a history of right shoulder pain), joint pain, fatigue, decrease in strength generalized, decrease in grip strength and persistent burning at both right and left arm injection sites. He reports he had an evaluation by his personal physician and blood laboratory testing is planned. Follow up received on 24MAY10-Slowly improving, noticing most improvement in lessening of fatigue symptoms. He reports his doctor said his blood work was "great". Follow-up received on 24JUN10-Continues to experience decreased grip strength. X-ray of both hands reported as "normal". His other symptoms are improving; his general strength is much better. He no longer experiences burning at injection sites.
Age: 44.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Grip strength decreased, Injection site pain, Musculoskeletal stiffness, X-ray limb normal
Clinical narrative: Individual reports his symptoms began approximately one week following his BIOTHRAX #2 and Yellow Fever immunization and have persisted unchanged. He reports bilateral hand stiffness, bilateral shoulder pain, increase in pain in right shoulder (has a history of right shoulder pain), joint pain, fatigue, decrease in strength generalized, decrease in grip strength and persistent burning at both right and left arm injection sites. He reports he had an evaluation by his personal physician and blood laboratory testing is planned. Follow up received on 24MAY10-Slowly improving, noticing most improvement in lessening of fatigue symptoms. He reports his doctor said his blood work was "great". Follow-up received on 24JUN10-Continues to experience decreased grip strength. X-ray of both hands reported as "normal". His other symptoms are improving; his general strength is much better. He no longer experiences burning at injection sites.
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Insomnia, Restless legs syndrome, Restlessness
Clinical narrative: He reports he was unable to sleep the evening of immunization. Symptoms include fatigued, restless, legs restless. All complaints resolved as of 21 July 2010.
Age: 65.0
Sex: M
Vaccine: ANTH
Symptoms: No adverse event
Clinical narrative: During the shipping of vaccine to immunization clinic on 20 JUL 2010 temperature was recorded at 1.3 degrees C for 6 hrs 5 min. Vaccine was administered to individual on 26 July 2010. Clinic reports no adverse event noted.
Age: 23.0
Sex: M
Vaccine: ANTH, HEPAB
Symptoms: No adverse event
Clinical narrative: During the shipping of vaccine to immunization clinic on 20JUL2010 temperature was recorded at 1.3 degrees C for 6hrs 5 min. Vaccine was administered to individual on 20Jul2010. Clinic reports no adverse event noted.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Contusion, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Subject states she noted a hard lump with warmth, swelling, redness, itching and induration at the injection site. There is bruising directly over the injection site. She has treated her symptoms with oral BENADRYL and topical hydrocortisone cream with improvement of all symptoms.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Subject states she noted a hard lump with warmth, swelling, redness, itching and induration at the injection site. There is bruising directly over the injection site. She has treated her symptoms with oral BENADRYL and topical hydrocortisone cream with improvement of all symptoms.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Full blood count abnormal, Immediate post-injection reaction, Neutrophil percentage increased, White blood cell count increased
Clinical narrative: Felt faint immediately after immunization. On the next day the subject had physical exam (reported to be normal) and CBC was drawn. Results of CBC, per reporter, WBC 15 with 80% neutrophils. Subject denied illness, infection or significant history.
Age: 54.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injected limb mobility decreased, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: On 05NOV2010, a 54 year-old male, was vaccinated with BIOTHRAX by subcutaneous route to an unknown arm. On 06NOV2010, the subject experienced swelling, pain, limited mobility of the injection site arm, and stated he was "feeling ill". At the time of the report, the events had not resolved. Additional information was received on 02DEC2010 which revealed the subject recovered well, and without lasting effects.
Age: 26.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: On 05NOV2010, a 26 year old male, was vaccinated with BIOTHRAX by subcutaneous route to an unknown arm. It was noted prior to vaccination, that the subject had flu-like symptoms and a canker sore. On 06NOV2010, the subject experienced "severe" swelling, pain, limited mobility of the injection site arm and a fever. At the time of report, the events had not resolved. Additional information was received on 02DEC2010 which revealed the subject recovered well, and without lasting effects.
Age: 26.0
Sex: M
Vaccine: ANTH, FLU3, TYP
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: On 05NOV2010, a 26 year old male, was vaccinated with BIOTHRAX by subcutaneous route to an unknown arm. On 06Nov2010, the subject complained of swelling of the arm at the injection site. On 07Nov2010 the subject complained of pain with limited mobility of the injection site arm. 08NOV2010, he was seen by a medical provider and subsequently diagnosed with cellulitis. He was treated with an unspecified antibiotic and told to return in 24 hours if there was no improvement. At the time of report, the outcome was unknown. Additional information was received on 02DEC2010 which revealed the subject recovered well, and without lasting effects.
Age: 50.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: On 05NOV2010, a 50 year old male, was vaccinated with BIOTHRAX by subcutaneous route to an unknown arm. On 06Nov2010, the subject complained of swelling, pain and limited mobility of the injection site arm. It was noted that on 05NOV2010, the patient had also received a Typhoid vaccination intramuscularly on the same arm as the BIOTHRAX vaccination. At the time of report, the events had not resolved. Additional information was received on 02DEC2010 which revealed the subject recovered well, and without lasting effects.
Age: 2.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Erythema, Injection site swelling, Joint swelling, Pruritus, Rash
Clinical narrative: Marked erythematous papular large rash, large urticaria Type 1, with severe pruritus and edema. Beginning shortly post a course of amoxicillin & receiving PREVNAR. Treatment IV diphenhydramine and IV methylprednisolone. Then changed to hydroxyzine and ranitidine. Discharge medications ORAPRED 1mg/kg 1 dose BID for 3 days then 1mg/kg 1 dose for 3 days. Epi Jr., hydroxyzine & ranitidine.
Age: 2.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Oedema, Pruritus, Rash papular, Urticaria
Clinical narrative: Marked erythematous papular large rash, large urticaria Type 1, with severe pruritus and edema. Beginning shortly post a course of amoxicillin & receiving PREVNAR. Treatment IV diphenhydramine and IV methylprednisolone. Then changed to hydroxyzine and ranitidine. Discharge medications ORAPRED 1mg/kg 1 dose BID for 3 days then 1mg/kg 1 dose for 3 days. Epi Jr., hydroxyzine & ranitidine.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Influenza, Oropharyngeal pain
Clinical narrative: PATIENT REFERS THE DAY AFTER RECEIVING THE FLU SHOT HE BEGAN FEELING TIRED, WITH SORE THROAT AND SIGNS AND SYMPTOMS OF THE FLU.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Injection area of right deltoid with a 13cm area with edema, induration and warm to the touch.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Injection site discolouration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At site of injection - large slightly raised pink area 25mm x 25mm - warm to touch c/o of pain in shoulder & upper arm. Tx - ice pk and ibuprofen 400mg q 3- 4 hours for pain & inflammation.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site redness and warmth 2-3 inches in diameter.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient has a 10cm red circular raised area on right thigh - cellulitis of right leg - placed on BACTRIM antibiotics.
Age: 38.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dizziness, Dysgeusia, Nausea, Vaccine positive rechallenge
Clinical narrative: Slight dizziness, nausea and metallic taste in mouth. This has happened all 3 times I recieved the vaccine. I was bothered the most by the metal taste, which increased the nausea. Lasts about 2 days.  Is it normal?
Age: 38.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Abdominal pain upper, Dizziness, Dysgeusia, Hypoaesthesia oral, Nausea
Clinical narrative: Slight dizziness, nausea and metallic taste in mouth. This has happened all 3 times I recieved the vaccine. I was bothered the most by the metal taste, which increased the nausea. Lasts about 2 days.  Is it normal?
Age: 24.0
Sex: M
Vaccine: DTAP, HPV4, MMR, TYP
Symptoms: Feeling cold, Hot flush, Influenza like illness, Nausea
Clinical narrative: Patients reported hot/cold flashes, nausea, flu-like symptoms all throughout the night and has remained the same until following morning. After being notified, immediately instructed patient to be seen at Health Clinic for possible reaction to HPV vaccination. Pending doctor visit. Unknown outcome as of 25FEB2011, 10:30AM.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Blood test normal, Fatigue, Flushing, Headache
Clinical narrative: sore injection site, swelling, achy, fevers, nausea, tiredness, headaches, flushed. rubbing site, moving arm. fluids, rest. not able to work at job for a week.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: sore injection site, swelling, achy, fevers, nausea, tiredness, headaches, flushed. rubbing site, moving arm. fluids, rest. not able to work at job for a week.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: sore injection site, swelling, achy, fevers, nausea, tiredness, headaches, flushed. rubbing site, moving arm. fluids, rest. not able to work at job for a week.
Age: 32.0
Sex: M
Vaccine: ANTH, FLUN3, HEP, TYP
Symptoms: Blood creatine phosphokinase MB normal, Blood creatine phosphokinase normal, Blood magnesium normal, C-reactive protein normal, Catheterisation cardiac normal
Clinical narrative: Patient is 32 y/o who received FLUMIST on Jan 18 and AVA#1, HepB, and Typhoid vaccinations on Jan 25th. Patient presented to ER with substernal chest pain/pressure radiating to left arm on 11 Feb. Pain lasted 45-60 minutes only. Pos fam hx for MI - GF had MI at age 30.
Age: 32.0
Sex: M
Vaccine: ANTH, FLUN3, HEP, TYP
Symptoms: Chest discomfort, Chest pain, Computerised tomogram normal, Computerised tomogram thorax normal, Echocardiogram normal
Clinical narrative: Patient is 32 y/o who received FLUMIST on Jan 18 and AVA#1, HepB, and Typhoid vaccinations on Jan 25th. Patient presented to ER with substernal chest pain/pressure radiating to left arm on 11 Feb. Pain lasted 45-60 minutes only. Pos fam hx for MI - GF had MI at age 30.
Age: 32.0
Sex: M
Vaccine: ANTH, FLUN3, HEP, TYP
Symptoms: Electrocardiogram normal, Full blood count normal, Laboratory test normal, Lipids normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient is 32 y/o who received FLUMIST on Jan 18 and AVA#1, HepB, and Typhoid vaccinations on Jan 25th. Patient presented to ER with substernal chest pain/pressure radiating to left arm on 11 Feb. Pain lasted 45-60 minutes only. Pos fam hx for MI - GF had MI at age 30.
Age: 32.0
Sex: M
Vaccine: ANTH, FLUN3, HEP, TYP
Symptoms: Troponin I increased, Troponin T, Urine analysis normal
Clinical narrative: Patient is 32 y/o who received FLUMIST on Jan 18 and AVA#1, HepB, and Typhoid vaccinations on Jan 25th. Patient presented to ER with substernal chest pain/pressure radiating to left arm on 11 Feb. Pain lasted 45-60 minutes only. Pos fam hx for MI - GF had MI at age 30.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever x 5 days after vaccines - 2 days Tm 104 then about 3 days 102 - resolved before day 6. (Apparently as infant Mom with a similar hx requiring ?IVF/adm).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: One day after vaccination, patient had a localized reaction about one inch below injection site. The site was red, slightly raised and tender to the touch.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Developed cellulitis at injection site 2.5 days after immunization seen by MD in 2-18 started on Cephalexin 500mg.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Dyskinesia, Muscle spasms, Musculoskeletal stiffness, Nasopharyngitis, Neck pain
Clinical narrative: Developed cold-like symptoms approximately 2 days after vaccine. Shortly thereafter, I began to experience neck pain & stiffness. Then I began having spasms and involuntary movement of neck. Subsequently diagnosed with cervical dystonia.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging, Torticollis
Clinical narrative: Developed cold-like symptoms approximately 2 days after vaccine. Shortly thereafter, I began to experience neck pain & stiffness. Then I began having spasms and involuntary movement of neck. Subsequently diagnosed with cervical dystonia.
Age: 26.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Asthenia, Blood creatine phosphokinase MB increased, Blood test, Chest discomfort, Chest pain
Clinical narrative: Patient received Anthrax #1 and typhoid vaccines on 10 Jan and smallpox vaccine on 11 Jan'11. On 12 Jan (1 day post vaccine) he reports he developed a rapid heart rate, cold sweats in night and felt like he was being punched in the chest. He described the pain in the middle of the chest as a sharp pressure. He also had SOB, no energy, and that it was worse when lying down and thus interfered with sleep but improved if he was up and moving around. The pain was continuous and he couldn't keep up in PT during the following week. He states he didn't worry about it since had been briefed that these sxs might occur after receiving the SPV. He also states he 'got sick that week' after receiving the vaccines with a fever and runny nose. He sought medical tx on 18 Jan where he had an EKG performed and blood work. EKG was apparently normal (no copy available) and troponins negative, but CKMB positive at 30 (0-5 ng/mL). (Repeat on eval at medical center on 15 Feb was normal). The pain was constant and still is present continuously (one month later) with intermittent twinges of sharper pain, although he states overall the intensity is lessening. He states he can press in on the right side of the bone in middle of the chest next to his ribs and feel pain. He reports he had no viral illnesses in the weeks prior to receipt of the vaccine.
Age: 26.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Cold sweat, Dyspnoea, Echocardiogram, Electrocardiogram normal, Heart rate increased
Clinical narrative: Patient received Anthrax #1 and typhoid vaccines on 10 Jan and smallpox vaccine on 11 Jan'11. On 12 Jan (1 day post vaccine) he reports he developed a rapid heart rate, cold sweats in night and felt like he was being punched in the chest. He described the pain in the middle of the chest as a sharp pressure. He also had SOB, no energy, and that it was worse when lying down and thus interfered with sleep but improved if he was up and moving around. The pain was continuous and he couldn't keep up in PT during the following week. He states he didn't worry about it since had been briefed that these sxs might occur after receiving the SPV. He also states he 'got sick that week' after receiving the vaccines with a fever and runny nose. He sought medical tx on 18 Jan where he had an EKG performed and blood work. EKG was apparently normal (no copy available) and troponins negative, but CKMB positive at 30 (0-5 ng/mL). (Repeat on eval at medical center on 15 Feb was normal). The pain was constant and still is present continuously (one month later) with intermittent twinges of sharper pain, although he states overall the intensity is lessening. He states he can press in on the right side of the bone in middle of the chest next to his ribs and feel pain. He reports he had no viral illnesses in the weeks prior to receipt of the vaccine.
Age: 26.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Night sweats, Pyrexia, Rhinorrhoea, Sleep disorder, Troponin
Clinical narrative: Patient received Anthrax #1 and typhoid vaccines on 10 Jan and smallpox vaccine on 11 Jan'11. On 12 Jan (1 day post vaccine) he reports he developed a rapid heart rate, cold sweats in night and felt like he was being punched in the chest. He described the pain in the middle of the chest as a sharp pressure. He also had SOB, no energy, and that it was worse when lying down and thus interfered with sleep but improved if he was up and moving around. The pain was continuous and he couldn't keep up in PT during the following week. He states he didn't worry about it since had been briefed that these sxs might occur after receiving the SPV. He also states he 'got sick that week' after receiving the vaccines with a fever and runny nose. He sought medical tx on 18 Jan where he had an EKG performed and blood work. EKG was apparently normal (no copy available) and troponins negative, but CKMB positive at 30 (0-5 ng/mL). (Repeat on eval at medical center on 15 Feb was normal). The pain was constant and still is present continuously (one month later) with intermittent twinges of sharper pain, although he states overall the intensity is lessening. He states he can press in on the right side of the bone in middle of the chest next to his ribs and feel pain. He reports he had no viral illnesses in the weeks prior to receipt of the vaccine.
Age: 26.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Asthenia, Blood creatine phosphokinase MB increased, Chest discomfort, Chest pain, Cold sweat
Clinical narrative: Patient received Anthrax #1 and typhoid vaccines on 10 Jan and smallpox vaccine on 11 Jan'11. On 12 Jan (1 day post vaccine) he reports he developed a rapid heart rate, cold sweats in night and felt like he was being punched in the chest. He described the pain in the middle of the chest as a sharp pressure. He also had SOB, no energy, and that it was worse when lying down and thus interfered with sleep but improved if he was up and moving around. The pain was continuous and he couldn't keep up in PT during the following week. He states he didn't worry about it since had been briefed that these sxs might occur after receiving the SPV. He also states he 'got sick that week' after receiving the vaccines with a fever and runny nose. He sought medical tx on 18 Jan where he had an EKG performed and blood work. EKG was apparently normal (no copy available) and troponins negative, but CKMB positive at 30 (0-5 ng/mL). (Repeat on eval at medical center on 15 Feb was normal). The pain was constant and still is present continuously (one month later) with intermittent twinges of sharper pain, although he states overall the intensity is lessening. He states he can press in on the right side of the bone in middle of the chest next to his ribs and feel pain. He reports he had no viral illnesses in the weeks prior to receipt of the vaccine.
Age: 26.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram normal, Heart rate increased, Night sweats
Clinical narrative: Patient received Anthrax #1 and typhoid vaccines on 10 Jan and smallpox vaccine on 11 Jan'11. On 12 Jan (1 day post vaccine) he reports he developed a rapid heart rate, cold sweats in night and felt like he was being punched in the chest. He described the pain in the middle of the chest as a sharp pressure. He also had SOB, no energy, and that it was worse when lying down and thus interfered with sleep but improved if he was up and moving around. The pain was continuous and he couldn't keep up in PT during the following week. He states he didn't worry about it since had been briefed that these sxs might occur after receiving the SPV. He also states he 'got sick that week' after receiving the vaccines with a fever and runny nose. He sought medical tx on 18 Jan where he had an EKG performed and blood work. EKG was apparently normal (no copy available) and troponins negative, but CKMB positive at 30 (0-5 ng/mL). (Repeat on eval at medical center on 15 Feb was normal). The pain was constant and still is present continuously (one month later) with intermittent twinges of sharper pain, although he states overall the intensity is lessening. He states he can press in on the right side of the bone in middle of the chest next to his ribs and feel pain. He reports he had no viral illnesses in the weeks prior to receipt of the vaccine.
Age: 26.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TYP
Symptoms: Pyrexia, Rhinorrhoea, Sleep disorder, Troponin normal
Clinical narrative: Patient received Anthrax #1 and typhoid vaccines on 10 Jan and smallpox vaccine on 11 Jan'11. On 12 Jan (1 day post vaccine) he reports he developed a rapid heart rate, cold sweats in night and felt like he was being punched in the chest. He described the pain in the middle of the chest as a sharp pressure. He also had SOB, no energy, and that it was worse when lying down and thus interfered with sleep but improved if he was up and moving around. The pain was continuous and he couldn't keep up in PT during the following week. He states he didn't worry about it since had been briefed that these sxs might occur after receiving the SPV. He also states he 'got sick that week' after receiving the vaccines with a fever and runny nose. He sought medical tx on 18 Jan where he had an EKG performed and blood work. EKG was apparently normal (no copy available) and troponins negative, but CKMB positive at 30 (0-5 ng/mL). (Repeat on eval at medical center on 15 Feb was normal). The pain was constant and still is present continuously (one month later) with intermittent twinges of sharper pain, although he states overall the intensity is lessening. He states he can press in on the right side of the bone in middle of the chest next to his ribs and feel pain. He reports he had no viral illnesses in the weeks prior to receipt of the vaccine.
Age: 58.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Full blood count normal, Musculoskeletal stiffness, Pain
Clinical narrative: Pt reports stiffness in (R) arm approximately 2 days after inj. this by day 5 progressed to excruciating, throbbing pain. No redness or swelling of site was noticed. No fever. Took OTC meds without relief. Seen MD 1-11-11 & received KENALOG & DECADRON inj. Also given tramadol & Prednisone dose pack.
Age: 73.0
Sex: F
Vaccine: HEP, TD, TYP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt. reported redness & itching (L) upper arm at deltoid area beginning 1/30/11 or 1/31/11 then dissipating at this area & moving down arm 2/1/11 to (L) upper inner arm area. No fever. Pt. applied cortisone cream 2/1/11 & 2/2/11 to relieve itching. Area red, warm to touch, approximately 3" x 3" area with irregular borders (L) upper arm below deltoid 2/2/11 at office visit. Rx given for KEFLEX 500mg TID x 5 days. Going out of country for 2 wks at time report written.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: PNC
Symptoms: Asthma, Bacterial infection, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative of an unknown age and gender patient.  It was reported that "the patient received all 4 doses of PREVNAR back in 1997-dx with pneumonia with hospitalizations for one month because of the bacterial infections".  The patient was treated with IV penicillin.  It was also reported that the patient "now has Asthma and if the patient needs the booster for PCV 23."  The outcome of the event is unknown.  No other relevant medical history or test results were provided.  This report is lacking information critical for an independent medical assessment.  Clinical evaluation is postponed after receipt of additional information.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.
Age: 1.96
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Convulsion, Gaze palsy, Myoclonic epilepsy, Pyrexia, Viral infection
Clinical narrative: Initial report was received on 21 February 2011 from a health care professional.  A two year-old male patient who had no illness at the time of vaccination and no reported past medical history had received on 07 February 2011 a second dose intramuscular injection of FLUZONE, lot number U3794CB (site of administration not reported) and HAVRIX, GSK lot number AHAVB462BA (route and site of administration not reported).  On 10 February 2011 the child developed a fever and was diagnosed with a viral illness.  The reporter then stated that over the weekend the patient had seizure activity and his eyes rolled back in his head.  He was taken to the ER (emergency room) where he was diagnosed with myoclonic seizures.  Treatments included Keppra.  No further information was provided at the time of the report.  The patient's outcome was unknown.  Documents held by sender: none.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Intensive care, Organ failure, Renal failure, Staphylococcal infection
Clinical narrative: Initial report received from a consumer on 22 February 2011. A 73-year-old male patient received on 06 November 2010 an injection (route and site unknown) of FLUZONE, lot number U3703AA. The patient had no illness at the time of vaccination and had no other vaccinations within 4 weeks of the FLUZONE. The patient had no known allergies and his medical history was not reported. The patient's concomitant medications included a blood pressure medication, SYNTHROID, baby Aspirin and multivitamin. On 19 January 2011, the patient was diagnosed with a staph infection of the blood with an elevated temperature, the start of kidney failure and other organ failure. The patient was admitted on an unknown date to the intensive care unit (ICU) and was treated with intravenous (IV) antibiotics. The patient continues to have the infection and was going to be hospitalized starting "today" for IV antibiotic. The outcome was reported as not recovered. Documents held by sender: None.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Staphylococcal sepsis
Clinical narrative: Initial report received from a consumer on 22 February 2011. A 73-year-old male patient received on 06 November 2010 an injection (route and site unknown) of FLUZONE, lot number U3703AA. The patient had no illness at the time of vaccination and had no other vaccinations within 4 weeks of the FLUZONE. The patient had no known allergies and his medical history was not reported. The patient's concomitant medications included a blood pressure medication, SYNTHROID, baby Aspirin and multivitamin. On 19 January 2011, the patient was diagnosed with a staph infection of the blood with an elevated temperature, the start of kidney failure and other organ failure. The patient was admitted on an unknown date to the intensive care unit (ICU) and was treated with intravenous (IV) antibiotics. The patient continues to have the infection and was going to be hospitalized starting "today" for IV antibiotic. The outcome was reported as not recovered. Documents held by sender: None.
Sex: F
Vaccine: HPV4
Symptoms: Cerebrovascular accident
Clinical narrative: Information has been received from a physician via telephone call about a conversation he heard concerning a teenage female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # not reported). On an unspecified date the patient had a stroke. At the time of the report, the patient's outcome was unknown. Upon internal review strokes were considered to be an other important medical event. It was unknown if the patient sought medical attention. This is one of several reports received from the same source.
Age: 6.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warmth, erythema and tenderness at site of injection, spreading to ~5cm diameter
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Pain of skin
Clinical narrative: Pt received vaccine on 9/2/10 and came in 12/10 reporting that shoulder/arm still ached and hurt to quite a degree. Advised pt that the needle may have hit a nerve and it is possible, but to follow-up if this pain keeps persisting.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling & redness of inner side Rt upper arm.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Erythema, Pain, Secretion discharge, Skin warm
Clinical narrative: Given shot on 2/16/11, on 2/18/11 had area approx. 6cm x 5cm of redness appear. On 2/20/11 blisters started forming area is painful to touch, weeping, and red today. Has had pain and warmth in area since 2/18/11.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Lymphadenopathy, Malaise, Pain, Pyrexia
Clinical narrative: Given TDAP on 2-16-11, didn't feel well on 2-17-11 - had headache and fever 102 degrees on 2-18-11. Body aches, swollen glands in neck fever and headache went to ER.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Rash, Urticaria
Clinical narrative: 101.0 fever - caregiver reports rash (hive like on trunk of body) about 2 hours after immunizations. Mild erythema and induration (app skin) at each of the injection sites for the immunizations temp 99.4 degrees.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Called by county to report that above patient is being treated for poss. Guillain-Barre syndrome at hospital. Pt history of INFLUENZA given 1/4/11.