chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular, Rash pustular, Viral infection
Clinical narrative: Information regarding smallpox vaccine, dried calf lymph type injection was received from a published literature article. Autoinoculation vaccinia. In light of the anthrax attacks in 2001 and the threat of further bioterrorism, this article discusses the issues of smallpox vaccination within the current dermatologic environment, presenting the case of a 19 year old male pt who developed autoinoculation vaccinia. Four to five days post-immunization, the pt developed a "major reaction" at the site of vaccination. A few days later, he noticed the onset of a painful, erythematous, edematous eruption on his upper thighs and scrotum. Small papules develped into umbilicated pustules. The pt admitted to scratching the vaccination site. After he was seen during the second week of his illness, he was admitted to the hospital. Viral culture results were positive for vaccinia. Tzanck smear was negative for multinucleated giant cells, and no Guarnieri bodies were seen. He was treated with compresses, and the eruption resolved in two days without scarring. The authors concluded that "smallpox vaccination complications were relatively common when it was a routine inoculation in the 1950s and 1960s. The most common complication, occurring at a rate of 1 in 1000 vaccinations, was accidental inoculation. Accidental inoculation can be due to either autoinoculation, as in the case presented, or to contact with a vaccinated person, often a sibling or a close contact." The common and occasionally severe complications must be taken into account when shaping our national strategy.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Infection, Muscle spasms, Paraesthesia
Clinical narrative: Sinus infection on 12/24/04- I subsequently began having back pain with tingling in arms (hands) and feet. The tingling is new in my legs- have had spasm, burning and joint pain throughout my hands/feet/back and other parts of my body- have never had these symptoms till I received flu shot.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Skin burning sensation
Clinical narrative: Sinus infection on 12/24/04- I subsequently began having back pain with tingling in arms (hands) and feet. The tingling is new in my legs- have had spasm, burning and joint pain throughout my hands/feet/back and other parts of my body- have never had these symptoms till I received flu shot.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Client complained of waking up with a rash on her left hip, thigh and left arm on 10-21-03. Client went in to see her private doctor on 10-23-03. She was instructed to get over the counter Benadryl and return in two weeks if rash didn't resolve. Client continues to have rash. Client plans to follow up.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Migraine, Pain
Clinical narrative: Client states after getting the influenza vaccine he drove to the pet supplies store to pick up some pet food. Client states he started getting migrane headaches and then he blacked out and when he awakened he was on the floor. Two individuals helped him up on his feet but his right arm and left hand war hurting. Public health nurse advised client to go to the nearest ER or follow-up with his physician. Follow-up call was made. Client has an appointment with his physician on 10/30/03. 11/18/03 spoke with Mrs. states her husband did follow-up with his physician. From the physicians evaluation, Mrs. said the doctor states Mr. is a diabetic and did not eat for 8 hours that day. In result of him fainting he has a broken hand. Mrs. also states he has a history of having migranes.
Age: 53.0
Sex: F
Vaccine: FLU3, IPV, PPV, TYP
Symptoms: Fatigue, Injection site induration, Malaise, Type III immune complex mediated reaction
Clinical narrative: Suspect "arthus reaction," seems to be at site of Pneumovax. Had intense local soft tissue induration as well as profound malaise, fatigue, constitutional symptoms.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Movement disorder, Pyrexia
Clinical narrative: Glt flu vac 24 hrs later temp 103 pt have of 100 due thrombocytopenia (bone marrow pl). As I said in my email my mom had fever off and on for over one year. She is 92 and has a very high platelet count. We were told that the fever was most likely due to her underlying bone marrow condition. When she had her flu shot (only the 3rd in her life). She became very ill, higher fever than ever (shot Thursday pm-sick the night to Sunday night). Couldn't ear or drink on her own. On Monday morning she not only was better but was better than she had been in many months the fever never came back until 2 mo later just for 2 days. But this time related to Tylenol toxicity. She is fine now.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site pain, Pain
Clinical narrative: Pt with pain at injection site since injection, never resolved, has exacerbations of pain last approx. one week at a time. Hurts with some movement and lay on it. 2/20/04 first visit-given course Cerebrex 200mg x 14 days denied redness at site, swelling, fever. Denies numbness, weakness, electric like sensations.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Two day post Pediarix lot #21918D2 in the LVL with intense 9cm diameter redness, warmth and swelling. Also received Hib #2, PCV 7 and flu.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Myalgia, Palpitations, Skin nodule, Tenderness
Clinical narrative: Immediately following hep B inj. pt states felt "hardness" at inj site radiating to chest area. C/O breast pressure continues to complaint of chest muscle pain, and chest tenderness to touch. C/O palpitations on night following the injection. C/O axillary nodules. B/P 118/76 HR 82 regular.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Started on back, wrists and arm and stomach; Sat. started to clear but same on inner thighs, hives, under arms; Sunday on face under eyes and cheeks today on face and arms. They are in clusters welts. They itch no fever and they come and go. Pt has had these before when fever arises. First when fever reduces. This is 2nd time that they have started this long school i shaving her see dermatologist tomorrow.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Constipation, Irritability, Pyrexia
Clinical narrative: 02/16/04 fever 104 axillar-lasted until 2/17/04, irritable, constipated. Mom stated child better on 2/18/04 and had BM. No more fever since 2/17/04.
Age: 32.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Erythema, Rash papular, Skin ulcer
Clinical narrative: Onset pink papular scattered lesions 2/4/04. Progression of rash-centralized lumbar/ abd/ thigh macular localized rash. C/O itching. Hx with Zyrtec  d/c Atarax po.
Age: 32.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Headache, Pain, Rash maculo-papular
Clinical narrative: Onset pink papular scattered lesions 2/4/04. Progression of rash-centralized lumbar/ abd/ thigh macular localized rash. C/O itching. Hx with Zyrtec  d/c Atarax po.
Age: 8.0
Sex: F
Vaccine: HIBV
Symptoms: Drug ineffective, Injection site oedema, Injection site pain, Laboratory test abnormal, Pyrexia
Clinical narrative: Child had Hib #1 11/30/95 #2 3/6/96 #3 4/23/96 #4 3/21/01 #5 1/27/97. Labs done 1/27/04 showed negative Haemophilus B-pt has localized swelling 2 1/2" x 1 1/2" tender with fever 24h after 101 injection with given 2/18/04. Diltaret .5ml. Fm hx: mother had difficulty with MMR-getting immunity. Hx: asthma, steroids medications inhalers.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Convulsion
Clinical narrative: Mother states pt experienced a seizure at 10:30pm 5/21/03. He is presently on Lamictal for a seizure disorder. Was taken to hospital ER. She does not remember physician's name. Observed x 3-4 hrs. OK this am.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: L upper deltoid area increase swelling/ redness (8.5 x 10cm) mild tenderness received DTaP and varicella on 2/20/04 c/o discomfort x increase sx post vaccination.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Local redness, tenderness L deltoid.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 2-3" area of erythema with swelling to R thigh-probably DTaP site.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Local reaction to Pneumovax swelling, pain and increased warmth. Medrol dose pak given-ice.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Redness, warmth and swollen area as well as itching.
Age: 1.25
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Temp 103.7. Generalized rash, 7 days after MMR, Varicella IPV given- Could not get temp to go down with Tylenol/Motrin alternation.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Abasia, Aphasia, Dizziness, Vertigo
Clinical narrative: Waited in lobby "after sometime we left and as soon as we left she got real dizzy couldn't walk or talk" Child was taken to ER and was told child has vertigo and happens to 1 of 10 kids vaccinated. Child was monitored in ER then released home.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Elevated temperature (febrile 102-101).
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Left deltoid with large erythematous 1/2-2/3 arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Left deltoid with large erythematous 1/2-2/3 arm
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Left deltoid with large erythematous 1/2- 2/3 arm.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, High-pitched crying, Irritability, Muscle twitching, Pyrexia
Clinical narrative: Since approximately 9 pm of the same day received vaccines infant developed fussiness, high pitch crying, staring spells, twitching of lower extremities, fever of 98.7 and vomiting.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Staring, Vomiting
Clinical narrative: Since approximately 9 pm of the same day received vaccines infant developed fussiness, high pitch crying, staring spells, twitching of lower extremities, fever of 98.7 and vomiting.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Swelling, erythema left deltoid within 48 hours after receiving vaccine, followed by cellulitis 72 hours after administration.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Injection site oedema, Pallor
Clinical narrative: Mom called stated baby is very pale and is screaming for about an hour. Injection sites is little swollen no redness. Had shots in arm-called in afternoon. Notified VAERS and CDC. To continue to watch and give Tylenol every hour. Called on 2/17/04 and mom states baby is fine now.
Age: 4.67
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Type III immune complex mediated reaction
Clinical narrative: Left arm Arthus-like reaction. Is expected to recover.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Eyelid oedema, Swelling face, Urticaria
Clinical narrative: Given vaccines around 3 pm at 4 pm presented to office with severe hives- lip/eye swelling- persistent cough no wheeze no stridor- give Epinephrine 1 :1000 0.16 ml Sa x l Benadryl 15 mg/5ml 1 1/2 tsp. orally- 45 mins later for improvement given Orapred 15 mg/5 ml 1 tsp. orally -sent to ER for monitoring.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blister, Diarrhoea, Oral intake reduced, Pyrexia, Rash
Clinical narrative: 2/13/04 Watery stools. 2/15/04 Blisters started on face. 2/16/04 Blisters covered entire face ears temp 100.8. 2/17/04 still rash face and head-stopped eating 101.3. 2/18- temp 102. 2/19 101.8. 2/20/04 temp 103. 2/20/04 took to Dr-throat culture for strep-Neg. CBC tested for wheat, rye, rice, soy, milk allergy. Stomach x-ray and stool samples watery stool since 2/13/04.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Face oedema
Clinical narrative: Approximately 14 hr after pt received vaccine she awoke with difficulty breathing and swelling to face and lips. Symptoms subsided throughout the day, although swelling to face and lips continued until late afternoon. Pt notified by phone MD office. Instruct to take OTC Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Discomfort, Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Mother reports one day post immunization LA very swollen into shoulder and chest. Child c/o discomfort. Then is redness, area is hot and hcild has trouble moving LA. No fever or SOB. No previous problems with vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Immunizations done 2/11/04. Mother noted erythemic ring around injection site on 2/18/04. Not sure if it was present soon post injection because child dresses himself. The area is 7.5cm widely erythemic ring with 1cm induration center at injection site. Non-tender to pt. No warmth. No exudate. Pt has not had fever, has been well otherwise. 7.5cm erythemic ring was noted on the L lateral thigh.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Injection site erythema, Injection site oedema, Injection site pain, Oedema peripheral
Clinical narrative: L upper arm swelling, redness, pain extending from injection site. Entire arm swelled from site to finger tips. Numbness in hands and fingers. Currently recovering.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Dermatitis bullous, Infection, Nasal congestion, Nasopharyngitis
Clinical narrative: Seen in office 2/22/04 with rash which was diagnosed by Dr as atypical varicella. Had 10 lesions scattered on torso and neck pink papules to pustules. Pt seen two times prior to this on 2/15/04 and 2/17/04 with nasal congestion and cough. Temp 99. Put on amoxicillin on 2/17/04 for nasopharyngitis/ bacterial rhinitis.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash papular, Rash pustular, Rhinitis
Clinical narrative: Seen in office 2/22/04 with rash which was diagnosed by Dr as atypical varicella. Had 10 lesions scattered on torso and neck pink papules to pustules. Pt seen two times prior to this on 2/15/04 and 2/17/04 with nasal congestion and cough. Temp 99. Put on amoxicillin on 2/17/04 for nasopharyngitis/ bacterial rhinitis.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hep B vaccine. The second vaccine in the 1st series was given. Within 30 minutes pt developed one hive to the R cheek and one hive to the L thigh with redness and itchiness. Offered Benadryl which pt refused and monitored x 1 hr.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus
Clinical narrative: Rec. immunizations 2/17/04 mom came to clinic 2/19/04 at approximately 4pm for nurse to check L deltoid. RN checked arm L, found to be warm and red, area approx. size of an orange. Child states red area itches. Mom reports onset 2/19/04, no problems previously. Tx: ice packs, use Tylenol for pain and soreness. Benadryl prn for itching and see MD if not resolved.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site rash, Pruritus
Clinical narrative: Rash, itching, swelling, pain. All symptoms traveled down right arm from injection site in upper tricep and stopped mid-forearm. Injection given 2/6/04. Seen in ER on 2/9/04 8th shot. Reaction similar after 7th shot on 11/22/02.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Convulsion
Clinical narrative: She had several seizure few hours after shot. Admitted at hospital.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rash
Clinical narrative: Rash.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site nodule
Clinical narrative: 2 1/2 x 1 1/2 cm non tender nodule under skin of left ant thigh began same day. No fever; getting smaller.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Pt develop red and hot 13cm x 8cm area on L upper arm.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: 2/21/04-rash started. Resolved with Benadryl post 8-10 hrs. 2/22/04 fever x 1 day.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Rash
Clinical narrative: Rash starting in Lt leg then spreading over entire body.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Difficulty in walking, Oedema peripheral, Pain
Clinical narrative: Leg sore, not wanting to walk or stand day of shot and following day; on exam-slight pain and slight swelling.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Contracted chickenpox as documented by pediatrician. Under physician's care from 1/25/04-2/1/04. Illness began 1/23/04.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Oedema peripheral
Clinical narrative: Swollen left arm and warm. Treatment Tylenol Advil.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Infection transmission via personal contact
Clinical narrative: Pt with suspect accidental transmission of vaccinia from close contact.
Sex: M
Vaccine: DTP, HEP, HIBV, PNC
Symptoms: Insomnia, Stomach discomfort
Clinical narrative: Information was received from a consumer regarding a 6 month old male patient who received Dimetapp Infant Drops Decongestant therapy and experienced difficulty sleeping and upset stomach. Relevant medical history was not provided. Indication for Dimetapp Infant Drops Decongestant was nasal congestion. Therapy began on 9/26/03 and was permanently discontinued on 9/28/03. Dose regimen was 1.2 mL 2 times per day (oral). Additional suspect medication included Prevnar, DPT, Hepatitis B vaccine and Hib-Titer Vaccine. Concomitant medications were not reported. The patient experienced difficulty sleeping and upset stomach on 9/26/03.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Urticaria
Clinical narrative: A mother reported that her 18-month-old daughter received an initial dose of Hib-Titer (haemophilus B conjugate vaccine) vaccine "14 months ago", at the age of 4 months. Post-immunization, the child developed hives. The mother stated that the incident was reported, possibly to the CDC. No further information was available at the date of this report.
Age: 37.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Hyperhidrosis, Hyperventilation, Hypotension, Posturing, Syncope
Clinical narrative: Rec'd vaccines listed, syncope, awoke so pale, dyphoretic, posturing, hyperventilating, hypotensive (70/50), given Benadryl 50mg IM-recovered with BP 114/70, alert, able to sit up, walk-sent via ambulance to ER. F/u with ER diagnosis vagal response-discharged home.
Age: 37.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Syncope vasovagal
Clinical narrative: Rec'd vaccines listed, syncope, awoke so pale, dyphoretic, posturing, hyperventilating, hypotensive (70/50), given Benadryl 50mg IM-recovered with BP 114/70, alert, able to sit up, walk-sent via ambulance to ER. F/u with ER diagnosis vagal response-discharged home.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Injection site erythema, Injection site mass, Injection site pain, Joint range of motion decreased
Clinical narrative: Shot #1- mayalgia in hip joints lasted 24 hours  Shot #2- dime size knot at injection site.  Opposite arm injections site soreness returned.  Mild mayalgia in both knees which lasted 14 days.  Shot #3- dime size knot at injection site.  Red blotchy rash around injection site for 3days.  Severe pain in left knee when standing up or sitting down(6 hours)subsiding to mayalgia in both knees for 30 days.  This mayalgia manifested joint pain which required the legs to be stretched out every 15 minutes.  In other words I could not leave my legs bent at 90 degrees for more than 15 minutes without feeling the need to pop the joint.  After appoximately 30 days this subsided.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Rash, Rash macular
Clinical narrative: Shot #1- mayalgia in hip joints lasted 24 hours  Shot #2- dime size knot at injection site.  Opposite arm injections site soreness returned.  Mild mayalgia in both knees which lasted 14 days.  Shot #3- dime size knot at injection site.  Red blotchy rash around injection site for 3days.  Severe pain in left knee when standing up or sitting down(6 hours)subsiding to mayalgia in both knees for 30 days.  This mayalgia manifested joint pain which required the legs to be stretched out every 15 minutes.  In other words I could not leave my legs bent at 90 degrees for more than 15 minutes without feeling the need to pop the joint.  After appoximately 30 days this subsided.
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Rash maculo-papular
Clinical narrative: macular papular truncal rash
Age: 29.0
Sex: M
Vaccine: ANTH, RUB
Symptoms: Rash maculo-papular
Clinical narrative: macular papular truncal rash
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash maculo-papular
Clinical narrative: macular papular truncal rash
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Had 2 "spots" the size of a "half-dollar", on upper chest (per mom report on phone), per phone call to mother next am (02/27/04 @ 8:05am)  Pt is fine, no further  problems during evening or night
Age: 1.5
Sex: M
Vaccine: DT, IPV
Symptoms: Anorexia, Lethargy, Pyrexia, Vomiting
Clinical narrative: Received immunization on Friday. No appetite Friday night/lethargic. No appetite Saturday AM but good disposition.  By Noon, severe lethargy, no appetite and vomiting.  Repeat Saturday exactly on Sunday with vomiting and addition of fever. Treated with Acetominophen and Ibuprofin.  Reported to doctor on Monday morning.  No major concerns by parent or office/doctor.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site abscess, Joint range of motion decreased, Pain
Clinical narrative: LEFT ARM PAIN, LIMITED RANGE OF MOTION, "BLACKISH" FLUIDS FROM SITE DUE TO  DRAINING VACCINE SITE
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Asthenia, Discomfort, Libido decreased, Myalgia
Clinical narrative: Anxiety, musculoskeletal pain, disconfort, weakeness and erectile dysfunction and decline in libido. Situation getting worse. Immunization record sent in by pt indicates that the date of 12/7/02 in Box 10 was for his first Anthrax vaccination. It was noted in the comment section of the NRFU that the pt stated on the follow up questionnaire that he was not seen in the ER and was not hospitalized for this event. However, on his web report he checked hospitalization in Box 8. Body aches, low energy, anxiety, low libido. Conditions have remained pretty much the same.
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Sexual dysfunction
Clinical narrative: Anxiety, musculoskeletal pain, disconfort, weakeness and erectile dysfunction and decline in libido. Situation getting worse. Immunization record sent in by pt indicates that the date of 12/7/02 in Box 10 was for his first Anthrax vaccination. It was noted in the comment section of the NRFU that the pt stated on the follow up questionnaire that he was not seen in the ER and was not hospitalized for this event. However, on his web report he checked hospitalization in Box 8. Body aches, low energy, anxiety, low libido. Conditions have remained pretty much the same.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Fatigue, Mouth ulceration, Nausea, Swelling face
Clinical narrative: Case description: This 16-year old female patient got vaccinated with Vivotif on 08 JAN 2003 at 6 am. Three hours later the patient experienced nausea and extreme fatigue as well as lip swelling and bumps on mouth upon awakening the next morning. The patient recovered completely.
Age: 37.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Nausea, Rash, Vomiting
Clinical narrative: Case description: This 37 year old female took a VIVOTIF BERNA capsule on Jan 01, 2003 at 7.30 am. One hour later, at 08.30 am she became nauseated and vomited 3 to 4 hours later. The same day she experienced abdominal cramps and a loose stool. she continued to feel ill the next day and also developed rash on both cheeks. The patient recovered completely. The reporter assessed this case as non serious.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Pain, Pyrexia
Clinical narrative: Case description: This 24 year old female developed approximately 17 hours after the intake of Vivotif capsule (Typhoid Vaccine Live Oral Ty21a; Lot No.: 3000097) on FEB 02, 2003 fever with body ache, abdominal pain and diarrhea. The symptoms persisted for 5-6 days and then resolved under treatment with Septra (sulfametoxazole, trimenthoprime) DS bid for 10 days. The patient needed a doctor visit, but was not hospitalized.
Age: 21.0
Sex: U
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Myocarditis
Clinical narrative: This is a 1 year follow-up on this service member who developed myopericarditis 8 days after receipt of the smallpox vaccine (administered 2/27/03)  Patient continues to have chest pain.  He states that he has not gone a day without chest pain since March 2003.  It remains a daily constant chest pain with a severity rating of 3/10.  The pain is localized to mainly his left chest at approximately the 4th & 5th intercostal spaces about 1 inch from sternum.  It occasionally radiates down and laterally with no radiation to neck or arm.  Last week, he noted increased episodes of severe chest pain that occurred approximately 3 times a day almost every day last week.  He rates it as a 7-8/10 and states that it was almost bad enough to send him to the ER.  He experienced both at rest and with walking.  Associated symptoms included dyspnea at rest and with exertion.  He denies any diaphoresis, pedal edema, or cough.  The pain lasted 30-45 minutes and then resolved on its own.  He does not take any medication for the pain.  Occasionally, he finds that lying down with his feet elevated will help the pain.  The pain worsens with deep inspiration.  He reports chronic shortness of breath with exertion, particularly with climbing stairs.  He was residing on the fourth floor and after climbing the stairs to the second floor, he had to stop and rest.  He reports that he did not receive any additional diagnostic testing. He was referred to a pain specialist and diagnosed with "Thoracal Pain Syndrome after Epicarditis and Myocarditis."  Vioxx was prescribed bid for one week without benefit.  The specialist wanted to perform steroid injections, which the patient declined.  He also underwent a mental health evaluation.  Doctor stated that the patient does not appear to have a psychiatric diagnosis causing the pain.  He will be medically discharged on 29 March 2004 as he was determined to be physically unfit for duty.
Age: 34.0
Sex: M
Vaccine: HEPAB, IPV, TD, TYP
Symptoms: Diarrhoea
Clinical narrative: Diarrhea (Diarrhea, Diarrhea NOS). Case description: This 34-year old male developed diarrhea one day after intake of the first Vivotif (typhoid vaccine live oral Ty21a, Batch no. 3000091) capsule on 17 JUN 2003. He complained of eight watery stools on 18 JUN 2003. On 20 JUN 2003 he devloped 5 watery stools after the intake of the second capsule. The third and fourth capsule he tolerated without any problems.
Age: 51.0
Sex: U
Vaccine: SMALL
Symptoms: Injection site reaction, Injection site vesicles
Clinical narrative: About Aug. 26,2003 developed blister at site of smallpox vaccine (received vaccine 3/6/03). Blister was fluid filled, drained and now scab at site.
Age: 8.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Asthenia, Difficulty in walking, Fatigue, Hypersensitivity
Clinical narrative: This 8 year old girl was vaccinated with Vivotif on 7/22/03 and 7/24/03. One day after the intake of the second dose she experienced weakness, fatigue and pain in arms and legs. At the time of the onset of the symptoms she was at the airport with her mother on the way overseas to move for three years. The mother called the physician who prescribed the vaccine and was told that this reaction would be over when they left the plane. One week later, the symptoms were still present and they visited a western health service department. An allergic reaction was diagnosed and medication with an antihistamine and paracetamol was prescribed. Another week later the patient additionally experienced serious abdominal pain, strong enough to wake her up in the night and lasting for 10 days. The consulted physician interpreted the abdominal pain as a consequence of the paracetamol therapy. Then the patient developed further symptoms such as respiratory and eye infections. They visited the clinic. Antibiotic treatment for the eye and respiratory infections was started. Since the hospital staff was not aware of the seriousness of the symptoms they looked for other treatment possibilities. The strength in the patient's arms was close to normal, no more pain, but hips and legs were still very weak and painful, so she hardly could not walk. The patient then visited the joint venture hospital on 9/18/03 and was admitted on 9/19/03. Blood tests, urine tests, stools tests, brain CT scan and chest x-ray were normal, only the spinal fluid was a little high. On 9/26/03, the patient had cranial and full spinal MRI and additional blood tests performed at the hospital. The tests were normal. An EMG performed on 10/11/03 was positive for mild chronic polyradiculoneuropathy. At the time of reporting the patient is still hospitalized. This case was received by email from the patient's mother, who had access to the relevant medical records.
Age: 8.0
Sex: F
Vaccine: TYP
Symptoms: Infection, Laboratory test abnormal, Neuropathy, Pain
Clinical narrative: This 8 year old girl was vaccinated with Vivotif on 7/22/03 and 7/24/03. One day after the intake of the second dose she experienced weakness, fatigue and pain in arms and legs. At the time of the onset of the symptoms she was at the airport with her mother on the way overseas to move for three years. The mother called the physician who prescribed the vaccine and was told that this reaction would be over when they left the plane. One week later, the symptoms were still present and they visited a western health service department. An allergic reaction was diagnosed and medication with an antihistamine and paracetamol was prescribed. Another week later the patient additionally experienced serious abdominal pain, strong enough to wake her up in the night and lasting for 10 days. The consulted physician interpreted the abdominal pain as a consequence of the paracetamol therapy. Then the patient developed further symptoms such as respiratory and eye infections. They visited the clinic. Antibiotic treatment for the eye and respiratory infections was started. Since the hospital staff was not aware of the seriousness of the symptoms they looked for other treatment possibilities. The strength in the patient's arms was close to normal, no more pain, but hips and legs were still very weak and painful, so she hardly could not walk. The patient then visited the joint venture hospital on 9/18/03 and was admitted on 9/19/03. Blood tests, urine tests, stools tests, brain CT scan and chest x-ray were normal, only the spinal fluid was a little high. On 9/26/03, the patient had cranial and full spinal MRI and additional blood tests performed at the hospital. The tests were normal. An EMG performed on 10/11/03 was positive for mild chronic polyradiculoneuropathy. At the time of reporting the patient is still hospitalized. This case was received by email from the patient's mother, who had access to the relevant medical records.
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Found dead in crib 2 days after shot.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Sudden infant death syndrome
Clinical narrative: Information was received concerning a 38 month old female who was involved in a research clinical trial and who on 11/28/00 was vaccinated with a dose of Hepatitis B virus vaccine. Concomitant therapy that day included a dose of poliovirus vaccine inactivated. (It was not specified whether the pt received an injectable or oral form of the vaccine.) On 12/1/00, three days post vaccination, the patient died of unexpected sudden death. The association between hepatitis B virus vaccine and the unexpected sudden death was not provided. The original reporting source was not provided. Additional information received from a business partner indicated that poliovirus vaccine inactivated was no longer considered as part of the study. The original reporting source was not provided.  No further information was provided. Follow up on 05/19/04 states: "Follow up information indicated that an autopsy was performed on 12/02/00 and revealed pulmonary edema, congestion, and visceral organ congestion. There were no congenital anomalies. The investigator reported the cause of death as "SIDS", however the coroner reported the cause of death as "unexpected sudden death in a two-month old infant". No further information was anticipated. The case is considered closed. The original reporting source was not provided. No further information was provided."
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Unevaluable event
Clinical narrative: Information was received concerning a 38 month old female who was involved in a research clinical trial and who on 11/28/00 was vaccinated with a dose of Hepatitis B virus vaccine. Concomitant therapy that day included a dose of poliovirus vaccine inactivated. (It was not specified whether the pt received an injectable or oral form of the vaccine.) On 12/1/00, three days post vaccination, the patient died of unexpected sudden death. The association between hepatitis B virus vaccine and the unexpected sudden death was not provided. The original reporting source was not provided. Additional information received from a business partner indicated that poliovirus vaccine inactivated was no longer considered as part of the study. The original reporting source was not provided.  No further information was provided. Follow up on 05/19/04 states: "Follow up information indicated that an autopsy was performed on 12/02/00 and revealed pulmonary edema, congestion, and visceral organ congestion. There were no congenital anomalies. The investigator reported the cause of death as "SIDS", however the coroner reported the cause of death as "unexpected sudden death in a two-month old infant". No further information was anticipated. The case is considered closed. The original reporting source was not provided. No further information was provided."
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: Information was received concerning a 38 month old female who was involved in a research clinical trial and who on 11/28/00 was vaccinated with a dose of Hepatitis B virus vaccine. Concomitant therapy that day included a dose of poliovirus vaccine inactivated. (It was not specified whether the pt received an injectable or oral form of the vaccine.) On 12/1/00, three days post vaccination, the patient died of unexpected sudden death. The association between hepatitis B virus vaccine and the unexpected sudden death was not provided. The original reporting source was not provided. Additional information received from a business partner indicated that poliovirus vaccine inactivated was no longer considered as part of the study. The original reporting source was not provided.  No further information was provided. Follow up on 05/19/04 states: "Follow up information indicated that an autopsy was performed on 12/02/00 and revealed pulmonary edema, congestion, and visceral organ congestion. There were no congenital anomalies. The investigator reported the cause of death as "SIDS", however the coroner reported the cause of death as "unexpected sudden death in a two-month old infant". No further information was anticipated. The case is considered closed. The original reporting source was not provided. No further information was provided."
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Sudden infant death syndrome
Clinical narrative: It was reported that a two month old female pt received Poliomyelitis vaccine inactivated, site and route of administration not reported on 11/28/00. It was not specified whether the pt received an injectable or oral form of the vaccine. Three days post-immunization, the pt unexpectedly died. No other info was provided.  Corrective report on 02Mar04 from additional information received on 02Mar2004 from internal email correspondence, it was reported that this case is no longer internally classified as a study case, but is considered a spontaneous report. The events occurred during a clinical trial. No new medical information was provided. From additional information received on 18/Mar/2004 from an internal email correspondence, the manufacturer identification number was provided (WAES0402USA01439). On 28/Nov/2000 the patient was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). On 01/Dec/200, the patient died of an unexpected death. The association between the hepatitis B virus vaccine rHBsAg (yeast) and the unexpected sudden death was not provided. No other information was given.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Unevaluable event
Clinical narrative: It was reported that a two month old female pt received Poliomyelitis vaccine inactivated, site and route of administration not reported on 11/28/00. It was not specified whether the pt received an injectable or oral form of the vaccine. Three days post-immunization, the pt unexpectedly died. No other info was provided.  Corrective report on 02Mar04 from additional information received on 02Mar2004 from internal email correspondence, it was reported that this case is no longer internally classified as a study case, but is considered a spontaneous report. The events occurred during a clinical trial. No new medical information was provided. From additional information received on 18/Mar/2004 from an internal email correspondence, the manufacturer identification number was provided (WAES0402USA01439). On 28/Nov/2000 the patient was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). On 01/Dec/200, the patient died of an unexpected death. The association between the hepatitis B virus vaccine rHBsAg (yeast) and the unexpected sudden death was not provided. No other information was given.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: It was reported that a two month old female pt received Poliomyelitis vaccine inactivated, site and route of administration not reported on 11/28/00. It was not specified whether the pt received an injectable or oral form of the vaccine. Three days post-immunization, the pt unexpectedly died. No other info was provided.  Corrective report on 02Mar04 from additional information received on 02Mar2004 from internal email correspondence, it was reported that this case is no longer internally classified as a study case, but is considered a spontaneous report. The events occurred during a clinical trial. No new medical information was provided. From additional information received on 18/Mar/2004 from an internal email correspondence, the manufacturer identification number was provided (WAES0402USA01439). On 28/Nov/2000 the patient was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). On 01/Dec/200, the patient died of an unexpected death. The association between the hepatitis B virus vaccine rHBsAg (yeast) and the unexpected sudden death was not provided. No other information was given.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a company representative concerning an 18 month old female who was vaccinated with a dose of VARIVAX. The company representative reported she read in the newspaper that in July 2003, the patient developed an adverse reaction to the immunization (not further specified). As a result of the adverse reaction, the patient has had numerous surgeries. At the time of this report, the outcome was unknown. Upon internal review, adverse reaction requiring numerous surgeries was considered to be an other important medical event (OMIC). Follow up on 03/22/04 states: "Follow up information was received from a newspaper article and registered nurse. The RN reported that she spoke with the pt's grandmother who indicated that her granddaughter had been vaccinated with a dose of varicella virus vaccine live in July 2003.  One day after being vaccinated the pt became ill with temperature and vomiting. Subsequently, the pt underwent a bowel resection and temporary colostomy. It was noted in the newspaper article that the pt was recovering from several surgeries. It was also noted that the pt's physician related the pt's events to vaccination with varicella virus vaccine live. Upon internal review, bowel disorder requiring a bowel resection and temporary colostomy was considered to be an other important medical event. Additional information has been requested."
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Abortion
Clinical narrative: Information has been received from a nurse practitioner concerning a 40 year old white female with a history of 6 previous pregnancies with 1 live birth who on 9/25/01 was vaccinated with MMR (lot 635920/0826K). The nurse reported that the patient had just tested positive for pregnancy. The date of the patient's last menstrual period was 9/18/01. The patient's estimated date of delivery was determine to be 6/25/02. The nurse indicated that the patient was not likely to carry out the pregnancy. Additional information has been received from the nurse. Three of the patient's previous pregnancies ended in miscarriage in the first trimester and 2 were elective terminations. The outcome of her most recent pregnancy was an elective termination 8 weeks from last menstrual period. The nurse reported that the patient was counseled on termination of pregnancy, and all factors including risks from vaccination, Down's Syndrome, patient's age, financial situation, college, and being a single mother were considered important in choosing to terminate the pregnancy. No additional information is expected.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Anorexia, Arthralgia, Chills, Diarrhoea, Dizziness
Clinical narrative: Monday evening 11/10/03. Influenza and Pneumo 23 was given around 1700 shots were given. 1730 noted dizziness at home. 2000 went to bed-both arms sore, left worse than right. Absolute fatigue, headache, sinus feeling pressure. Took Tylenol/ Ibuprofen, tried another medication for relief. Had a rough nite, up six times to get relief of pain, aches in knees in the nite. Tuesday 11/12/03. Kind of lifted. Left arm still sore, shoulder joint to knuckles stiff couldn't use it, muscles felt sore and site hot. Right arm minimal soreness. Felt miserable, no appetite. Sinus headache went to a migraine in the afternoon. 6pm went to be shivering under 3 quilts, vomited, diarrhea started. Taking a lot of Ibuprofen. Wednesday 11/13/03. Headache gone. Couldn't bend elbow today. Slept in the afternoon and went to work, was a little better that she could go to work. Got real hot couldn't drive. Felt like "I had run a marathon." Went to the doctor for another reason, doctor noted fast heart rate. Thursday 11/14/03. Morning arm now bends. Stomach upset, not wanting to eat. Sinus headache, more diarrhea and noted stools dark. Nosebleed and dizziness at intervals. pt called our agency at this time. Pt was encouraged to seek medical evaluation and report the above. She refused. Friday 11/15/03. No breakfast, no appetite, nervous stomach, denies headache and migraine, can move fingers, knee aches and elbow aches gone. 11/20/03 shoulder to elbow stiff. 11/30/03 stiff and aches.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Epistaxis, Fatigue, Headache, Heart rate increased, Joint stiffness
Clinical narrative: Monday evening 11/10/03. Influenza and Pneumo 23 was given around 1700 shots were given. 1730 noted dizziness at home. 2000 went to bed-both arms sore, left worse than right. Absolute fatigue, headache, sinus feeling pressure. Took Tylenol/ Ibuprofen, tried another medication for relief. Had a rough nite, up six times to get relief of pain, aches in knees in the nite. Tuesday 11/12/03. Kind of lifted. Left arm still sore, shoulder joint to knuckles stiff couldn't use it, muscles felt sore and site hot. Right arm minimal soreness. Felt miserable, no appetite. Sinus headache went to a migraine in the afternoon. 6pm went to be shivering under 3 quilts, vomited, diarrhea started. Taking a lot of Ibuprofen. Wednesday 11/13/03. Headache gone. Couldn't bend elbow today. Slept in the afternoon and went to work, was a little better that she could go to work. Got real hot couldn't drive. Felt like "I had run a marathon." Went to the doctor for another reason, doctor noted fast heart rate. Thursday 11/14/03. Morning arm now bends. Stomach upset, not wanting to eat. Sinus headache, more diarrhea and noted stools dark. Nosebleed and dizziness at intervals. pt called our agency at this time. Pt was encouraged to seek medical evaluation and report the above. She refused. Friday 11/15/03. No breakfast, no appetite, nervous stomach, denies headache and migraine, can move fingers, knee aches and elbow aches gone. 11/20/03 shoulder to elbow stiff. 11/30/03 stiff and aches.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Migraine, Pain, Sensation of pressure, Sinus headache, Sleep disorder
Clinical narrative: Monday evening 11/10/03. Influenza and Pneumo 23 was given around 1700 shots were given. 1730 noted dizziness at home. 2000 went to bed-both arms sore, left worse than right. Absolute fatigue, headache, sinus feeling pressure. Took Tylenol/ Ibuprofen, tried another medication for relief. Had a rough nite, up six times to get relief of pain, aches in knees in the nite. Tuesday 11/12/03. Kind of lifted. Left arm still sore, shoulder joint to knuckles stiff couldn't use it, muscles felt sore and site hot. Right arm minimal soreness. Felt miserable, no appetite. Sinus headache went to a migraine in the afternoon. 6pm went to be shivering under 3 quilts, vomited, diarrhea started. Taking a lot of Ibuprofen. Wednesday 11/13/03. Headache gone. Couldn't bend elbow today. Slept in the afternoon and went to work, was a little better that she could go to work. Got real hot couldn't drive. Felt like "I had run a marathon." Went to the doctor for another reason, doctor noted fast heart rate. Thursday 11/14/03. Morning arm now bends. Stomach upset, not wanting to eat. Sinus headache, more diarrhea and noted stools dark. Nosebleed and dizziness at intervals. pt called our agency at this time. Pt was encouraged to seek medical evaluation and report the above. She refused. Friday 11/15/03. No breakfast, no appetite, nervous stomach, denies headache and migraine, can move fingers, knee aches and elbow aches gone. 11/20/03 shoulder to elbow stiff. 11/30/03 stiff and aches.