chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles vaccine last week. Got shingles this week.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Rash
Clinical narrative: Rash to head and neck 2 hours after vaccines which lasted about an hour, then went away.  Father of baby said 2 small red dots appeared again same night then went away quickly.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyskinesia, Dysphagia, Face oedema
Clinical narrative: Phone call from mom- stated when child woke up this AM-  She was experiencing some facial edema, difficulty opening her mouth, + difficulty swallowing-  Referred to E Room.  Spoke with mom.  Seen in E Room. No treatment.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Dysphagia, Dyspnoea, Malaise, Neck pain
Clinical narrative: About 1 1/4 hrs post pneumonia vaccine started having some problems with swallowing & felt bad.  During that night had problems swallowing, breathing & some pain in right arm & into her neck.  Next morning (12/23/08) realized tongue swollen - Went to ER & was given BENADRYL & something to help with breathing: Was told was allergic to something in vaccine.  Pt ok now.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Swollen tongue
Clinical narrative: About 1 1/4 hrs post pneumonia vaccine started having some problems with swallowing & felt bad.  During that night had problems swallowing, breathing & some pain in right arm & into her neck.  Next morning (12/23/08) realized tongue swollen - Went to ER & was given BENADRYL & something to help with breathing: Was told was allergic to something in vaccine.  Pt ok now.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Computerised tomogram, Confusional state, Dizziness, Electrocardiogram, Laboratory test
Clinical narrative: Dr from mother, reports client had episode of dizziness and blacked out at school. Ambulance took him to hospital. Reports he had mental confusion not knowing who she (mother) was at first. Was discharged same day (yesterday 02/25/09) - couldn't find anything wrong. Mother remembered this am that he had #2 Hep B vaccine 02/13/09. Also he had dizziness last week.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Loss of consciousness
Clinical narrative: Dr from mother, reports client had episode of dizziness and blacked out at school. Ambulance took him to hospital. Reports he had mental confusion not knowing who she (mother) was at first. Was discharged same day (yesterday 02/25/09) - couldn't find anything wrong. Mother remembered this am that he had #2 Hep B vaccine 02/13/09. Also he had dizziness last week.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Incorrect storage of drug
Clinical narrative: This case was reported by a physician and described the occurrence of incorrect storage of drug in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). There were no concurrent medications. On an unspecified date the subject received unspecified dose of PEDIARIX (unknown). The physician stated that the PEDIARIX vaccination was stored at below recommended temperatures and was then administered to the infant. The physician had no further details of the event because she did not have the subject's chart with her at the time of reporting. The physician reported that the subject was going to be re-vaccinated. The physician considered the event was clinically significant (or requiring intervention).
Age: 7.0
Sex: M
Vaccine: FLUX, HEPA, VARCEL, FLUX, HEPA, VARCEL
Symptoms: Body temperature decreased, Eosinophil percentage increased, Eosinophilic cellulitis, Erythema, Pain
Clinical narrative: This case was reported in a literature article and described the occurrence of WELL's syndrome in a 7-year-old male subject who was vaccinated with Hepatitis A (manufacturer unspecified), Varicella and Influenza. The boy presented with a 4-week history of rash and peripheral eosinophilia. He had received the three vaccines (dosages not stated) between 7 and 9 days before developing the rash that initially appeared on the sole of his left foot as a single, raised, pruritic lesion. It subsequently got larger and resembled cellulitis. The boy received oral antibiotics with no effect. The rash progressed to his face and extremities over several days and was pruritic and painful. Lesions varied in appearance and were up to 15cm in diameter; some lesions were flat and target-lesion-like and others were bright red, raised and urticarial. He had low grade fevers as the rash waxed and waned. Laboratory investigations revealed he had an increased WBC count of 23.7 x 109/L, with 59% eosinophils. Lesion biopsy showed eosinophilic cellulitis/WELL's syndrome. His symptoms and peripheral eosinophilia resolved without treatment within 8 weeks of diagnosis and he was asymptomatic at last follow-up. Author stated that the presented case brings to attention a less recognized condition of peripheral eosinophilia and rash that may be associated with immunizations.
Age: 7.0
Sex: M
Vaccine: FLUX, HEPA, VARCEL, FLUX, HEPA, VARCEL
Symptoms: Pyrexia, Rash, Rash pruritic, Urticaria, White blood cell count increased
Clinical narrative: This case was reported in a literature article and described the occurrence of WELL's syndrome in a 7-year-old male subject who was vaccinated with Hepatitis A (manufacturer unspecified), Varicella and Influenza. The boy presented with a 4-week history of rash and peripheral eosinophilia. He had received the three vaccines (dosages not stated) between 7 and 9 days before developing the rash that initially appeared on the sole of his left foot as a single, raised, pruritic lesion. It subsequently got larger and resembled cellulitis. The boy received oral antibiotics with no effect. The rash progressed to his face and extremities over several days and was pruritic and painful. Lesions varied in appearance and were up to 15cm in diameter; some lesions were flat and target-lesion-like and others were bright red, raised and urticarial. He had low grade fevers as the rash waxed and waned. Laboratory investigations revealed he had an increased WBC count of 23.7 x 109/L, with 59% eosinophils. Lesion biopsy showed eosinophilic cellulitis/WELL's syndrome. His symptoms and peripheral eosinophilia resolved without treatment within 8 weeks of diagnosis and he was asymptomatic at last follow-up. Author stated that the presented case brings to attention a less recognized condition of peripheral eosinophilia and rash that may be associated with immunizations.
Age: 7.0
Sex: M
Vaccine: FLUX, HEPA, VARCEL, FLUX, HEPA, VARCEL
Symptoms: Biopsy skin, Eosinophil count increased, Eosinophilic cellulitis, Erythema, Pain
Clinical narrative: This case was reported in a literature article and described the occurrence of WELL's syndrome in a 7-year-old male subject who was vaccinated with Hepatitis A (manufacturer unspecified), Varicella and Influenza. The boy presented with a 4-week history of rash and peripheral eosinophilia. He had received the three vaccines (dosages not stated) between 7 and 9 days before developing the rash that initially appeared on the sole of his left foot as a single, raised, pruritic lesion. It subsequently got larger and resembled cellulitis. The boy received oral antibiotics with no effect. The rash progressed to his face and extremities over several days and was pruritic and painful. Lesions varied in appearance and were up to 15cm in diameter; some lesions were flat and target-lesion-like and others were bright red, raised and urticarial. He had low grade fevers as the rash waxed and waned. Laboratory investigations revealed he had an increased WBC count of 23.7 x 109/L, with 59% eosinophils. Lesion biopsy showed eosinophilic cellulitis/WELL's syndrome. His symptoms and peripheral eosinophilia resolved without treatment within 8 weeks of diagnosis and he was asymptomatic at last follow-up. Author stated that the presented case brings to attention a less recognized condition of peripheral eosinophilia and rash that may be associated with immunizations.
Age: 67.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt received TDAP instead of rec. TD. No reactions reported. Pt contacted of error. Rec. ACIP recommendation.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Nausea, Pyrexia, Urinary retention
Clinical narrative: Soon after administer-  flushed cheeks- then went home, nausea, urine retention and fever 102-103- condition persisted + Pt. went to ER-fu evaluation next day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L Thigh with swelling / Erythema.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Pain, Rash papular, Serum sickness, Type II hypersensitivity
Clinical narrative: Member has small bump on chest, back, and head / some painful to touch. Member was seen by Dr and she stated it was Type II hypersensitivity - serum sickness.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Pain, Rash, Serum sickness, Type II hypersensitivity
Clinical narrative: Member has small bump on chest, back, and head / some painful to touch. Member was seen by Dr and she stated it was Type II hypersensitivity - serum sickness.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: 2 days post vaccination, pt presented with 7cm area of redness on (L) deltoid with warmth/redness.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Fever for 2 days.  Red spots on face and body.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: -pain, erythema, swelling surrounding injection site. Rx:  antihistamine, steroid, antibiotic.
Age: 1.26
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site induration
Clinical narrative: Firm, hard knot at injection site R upper leg.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Inflammation, Injection site oedema, Pain, Similar reaction on previous exposure to drug
Clinical narrative: 24 y/o male ADSM is referred by Research Nurse for inclusion in the Anthrax study.  SM reports increased erythema, swelling, and pain after each of his previous Anthrax vaccines.  The inflammatory response has decreased with each subsequent Anthrax vaccination.  Symptoms: Edema @ injection site 30-50mm, Edema @ injection site > 120 mm beyond elbow.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: 24 y/o male ADSM is referred by Research Nurse for inclusion in the Anthrax study.  SM reports increased erythema, swelling, and pain after each of his previous Anthrax vaccines.  The inflammatory response has decreased with each subsequent Anthrax vaccination.  Symptoms: Edema @ injection site 30-50mm, Edema @ injection site > 120 mm beyond elbow.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Pharyngeal oedema, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Pt called at 10:20 to Immunization clinic and stated she had broken out in hives and  her throat was swelling up, pt was then instructed to call 112 (ambulance)and go to the ER. Pt Appeared in Clinic 10 minutes later and was rushed to treatment room. Pt had hives all over body and was barely able to speak, pt stated that throat was itchy and closing up. Pt was seen by porvider and administered 02, epi, IV, bendryl and solumedrol and transported to ER.
Age: 64.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt given varicella vaccine in error, should have been given zostavax.  No adverse reaction noted.  Zostavax will be given in 4 weeks, due to it being a live vaccine.
Age: 17.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, vomitting, headache, pain, 100.3 fever, pain at injection site
Age: 17.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Vomiting
Clinical narrative: Nausea, vomitting, headache, pain, 100.3 fever, pain at injection site
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Local reaction
Clinical narrative: Local reaction. 40mm X 26mm area of erythema and itching at site. No systemic symptoms. Similar to previous reaction to MMR on 6/2/08.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Rash pruritic
Clinical narrative: Patient complained of a itchy, painful rash begining the day after the injection was recieved
Age: 40.0
Sex: U
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Received Tdap vaccine. Approx. 18 hours later, felt a combination of chills, fever, body aches which lasted approximately 2 full days.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Approximately one hr. after receiving vaccinations c/o itching to left cheek then progressing to right cheek, chin and ankles.  Red raised "pimple-like" rash.  Progressively subsided after approx. five days.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Approximately three hours following vaccination c/o itching on neck, cheeks and chest areas.  Also reports accompanied by red,raised rash.  Symptoms progressively improved and subsided after approximately five days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Induration, Rash pruritic, Rash vesicular, Scab
Clinical narrative: Pt developed a rash, resembling chicken pox, on both arms and both legs, starting the night after she received the vaccines.  Still evident 5 days later.  Not getting worse now, since had bath, benadryl, hydrocortisone cream, and calamine lotion.  Very itchy.  Hard bumps, now some with scabs.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Premature menopause
Clinical narrative: She has not had a period after receiving her third vaccine.  It's been ten months since she had a period.4/2/09-records received for DOS 3/17/09-office visit 25 pound weight gain since 8/08-last period 8 months ago.
Age: 1.0
Sex: F
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash vesicular
Clinical narrative: Right thigh where vaccine was administered was reddened, swollen and had a rash with raised vesicles similar to chickenpox.  Symptoms started 7 days after vaccine administration.  Within 11 days the rash was on back chest and both legs. Rash on back, chest and other areas of legs did not progress to vesicles.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Pyrexia
Clinical narrative: Patient recieved vaccines on 3/17/09 around 1600 Mom reports that infant woke up in the middle of the night with 102.5 fever.  Patient did recieve amoxicillin as of 3/6/09 for OM but had to stop treatment after 5 days due to rash.  Dr. has advised mom to give tylenol to control fever and if fever continues follow up in office on 3/19/09 for further evaluation and treatment.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash papular, Skin warm
Clinical narrative: Bilateral arms red, raised rash.  Warm to touch.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Dizziness, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Pt awoke at 7AM on 3/12/2009 with fever of 101, pain and redness at the administration site, pain all over including jaw, joints and muscles.  Pt also complained of nausea and dizziness.  Pt went to the hospital at 1:50 PM that afternoon.  Pt was given Ibuprofen 600 mg to be taken every 6 hours and prochlorperazine for nausea. Pt was instructed by physician at the hospital not to have a tetanus containing vaccine again.  Pt's symptoms lasted until 3/16/2009.  Pt came to clinic today to report the above symptoms.  He reports that his arm is still sore and aches today.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain in jaw, Pyrexia
Clinical narrative: Pt awoke at 7AM on 3/12/2009 with fever of 101, pain and redness at the administration site, pain all over including jaw, joints and muscles.  Pt also complained of nausea and dizziness.  Pt went to the hospital at 1:50 PM that afternoon.  Pt was given Ibuprofen 600 mg to be taken every 6 hours and prochlorperazine for nausea. Pt was instructed by physician at the hospital not to have a tetanus containing vaccine again.  Pt's symptoms lasted until 3/16/2009.  Pt came to clinic today to report the above symptoms.  He reports that his arm is still sore and aches today.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site infection, Injection site inflammation, Injection site swelling
Clinical narrative: Patient presented day after vaccination with redness and swelling to site of shot administration on right thigh (MMR injection site)  Dr. prescribed Zyrtec 1/2 tsp bid and Ceftin 250/5 1/2 tsp bid for 7 days for inflammation and possible infection.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Diet refusal, Eye swelling, Injection site urticaria, Pyrexia
Clinical narrative: Approximately 1 week after shot was given, my son developed a large hive at the injection site, a measles like rash, a high fever 102.5, refusal to eat, diahrrea, puffy eyes, etc.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: Approximately 1 week after shot was given, my son developed a large hive at the injection site, a measles like rash, a high fever 102.5, refusal to eat, diahrrea, puffy eyes, etc.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: syncopal episode condition and vitals monitored
Age: 0.83
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: pt returned to clinic 2 days after vaccine given with red raised wheal around injection site.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: PT RETURNED TO CLINIC WITH RAised red wheal measuring 9cm by 7cm .  Area was warm to touch .
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3, HPV4, MEN, TD
Symptoms: Abdominal pain, Asthma, Biopsy skin, Computerised tomogram, Lethargy
Clinical narrative: Fever, severe abdominal pain; muscle aches, lethargic, has asthma now, also developed skin indentions (tissue break down up underneath the skin) indentions are circular in size, starting around the injection site and has spread throughout entire body; specialist have never seen anything like it; referred for further testing; indentions are not going away but permanently scarring my child, also experiencing vertigo. 3/23/09-records received for DOS 11/10/08-presented with C/O lesions to trunk and extremities- 3/30/09-records received-ED visit 11/2/08-C/O abdominal pain, DX: ruptured ovarian cyst.  Follow-up: (hospitalization, moody, headaches, sweating, vomiting, has developed a rash (skin indentions); attended a wide dermatologist meeting; commented it looks almost like a "pox"; they've never seen; also referred me; visual looks like an indentation someone might receive from a polio shot; please help; she has over seventy now and spreading.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3, HPV4, MEN, TD
Symptoms: Myalgia, Pyrexia, Scar, Skin disorder, Ultrasound abdomen
Clinical narrative: Fever, severe abdominal pain; muscle aches, lethargic, has asthma now, also developed skin indentions (tissue break down up underneath the skin) indentions are circular in size, starting around the injection site and has spread throughout entire body; specialist have never seen anything like it; referred for further testing; indentions are not going away but permanently scarring my child, also experiencing vertigo. 3/23/09-records received for DOS 11/10/08-presented with C/O lesions to trunk and extremities- 3/30/09-records received-ED visit 11/2/08-C/O abdominal pain, DX: ruptured ovarian cyst.  Follow-up: (hospitalization, moody, headaches, sweating, vomiting, has developed a rash (skin indentions); attended a wide dermatologist meeting; commented it looks almost like a "pox"; they've never seen; also referred me; visual looks like an indentation someone might receive from a polio shot; please help; she has over seventy now and spreading.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3, HPV4, MEN, TD
Symptoms: Vertigo
Clinical narrative: Fever, severe abdominal pain; muscle aches, lethargic, has asthma now, also developed skin indentions (tissue break down up underneath the skin) indentions are circular in size, starting around the injection site and has spread throughout entire body; specialist have never seen anything like it; referred for further testing; indentions are not going away but permanently scarring my child, also experiencing vertigo. 3/23/09-records received for DOS 11/10/08-presented with C/O lesions to trunk and extremities- 3/30/09-records received-ED visit 11/2/08-C/O abdominal pain, DX: ruptured ovarian cyst.  Follow-up: (hospitalization, moody, headaches, sweating, vomiting, has developed a rash (skin indentions); attended a wide dermatologist meeting; commented it looks almost like a "pox"; they've never seen; also referred me; visual looks like an indentation someone might receive from a polio shot; please help; she has over seventy now and spreading.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3, HPV4, MEN, TD
Symptoms: Abdominal pain, Asthma, Biopsy skin, Computerised tomogram, Hyperhidrosis
Clinical narrative: Fever, severe abdominal pain; muscle aches, lethargic, has asthma now, also developed skin indentions (tissue break down up underneath the skin) indentions are circular in size, starting around the injection site and has spread throughout entire body; specialist have never seen anything like it; referred for further testing; indentions are not going away but permanently scarring my child, also experiencing vertigo. 3/23/09-records received for DOS 11/10/08-presented with C/O lesions to trunk and extremities- 3/30/09-records received-ED visit 11/2/08-C/O abdominal pain, DX: ruptured ovarian cyst.  Follow-up: (hospitalization, moody, headaches, sweating, vomiting, has developed a rash (skin indentions); attended a wide dermatologist meeting; commented it looks almost like a "pox"; they've never seen; also referred me; visual looks like an indentation someone might receive from a polio shot; please help; she has over seventy now and spreading.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3, HPV4, MEN, TD
Symptoms: Lethargy, Myalgia, Ovarian cyst ruptured, Pyrexia, Scar
Clinical narrative: Fever, severe abdominal pain; muscle aches, lethargic, has asthma now, also developed skin indentions (tissue break down up underneath the skin) indentions are circular in size, starting around the injection site and has spread throughout entire body; specialist have never seen anything like it; referred for further testing; indentions are not going away but permanently scarring my child, also experiencing vertigo. 3/23/09-records received for DOS 11/10/08-presented with C/O lesions to trunk and extremities- 3/30/09-records received-ED visit 11/2/08-C/O abdominal pain, DX: ruptured ovarian cyst.  Follow-up: (hospitalization, moody, headaches, sweating, vomiting, has developed a rash (skin indentions); attended a wide dermatologist meeting; commented it looks almost like a "pox"; they've never seen; also referred me; visual looks like an indentation someone might receive from a polio shot; please help; she has over seventy now and spreading.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3, HPV4, MEN, TD
Symptoms: Skin disorder, Skin lesion, Vertigo
Clinical narrative: Fever, severe abdominal pain; muscle aches, lethargic, has asthma now, also developed skin indentions (tissue break down up underneath the skin) indentions are circular in size, starting around the injection site and has spread throughout entire body; specialist have never seen anything like it; referred for further testing; indentions are not going away but permanently scarring my child, also experiencing vertigo. 3/23/09-records received for DOS 11/10/08-presented with C/O lesions to trunk and extremities- 3/30/09-records received-ED visit 11/2/08-C/O abdominal pain, DX: ruptured ovarian cyst.  Follow-up: (hospitalization, moody, headaches, sweating, vomiting, has developed a rash (skin indentions); attended a wide dermatologist meeting; commented it looks almost like a "pox"; they've never seen; also referred me; visual looks like an indentation someone might receive from a polio shot; please help; she has over seventy now and spreading.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: Baby died 4 days after vaccines were given, death is under investigation cause of death is still unknown 6/15/09 Autopsy report also states patient had fever since receiving vaccinations.  6/15/09 Autopsy report states COD as unknown./Had been given Tylenol & put down for nap.  Found face down between pillow & mesh of playpen.  Attempted resuscitation but patient with rigor & unsuccessful.  Noted to have dried blood around nose.  Skeletal survey, drug & metabolic testing all WNL./
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: left deltoid swollen and reddness noted approx. 3 inches over deltoid area. pt told to applt cold comperss and to give tylenol or motrin according to weight  handout given about imm. aftercare told to return to clinic as needed pt with out fever able to move arm without distress
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Dehydration, Endotracheal intubation, Influenza, Influenza serology positive, Pyrexia
Clinical narrative: A serious, spontaneous report of status epilepticus, dehydration and fever was received from a physician, concerning a 36-month-old male subsequent to FLUMIST.  The patient's past medical history includes neuromuscular disorder, cerebral palsy, seizure and microcephaly.  Concomitant medications included anti-epileptic medication.  A week prior to vaccination the patient had a runny nose and congestion.  The patient received FLUMIST on 15-Oct-2008 for vaccination.  On 17-Oct-2008, the patient presented with a fever of 38.1 degrees Celsius.  On 18-Oct-2008 the patient was admitted to the hospital with dehydration and status epilepticus and was intubated.  During routine surveillance of sick children, CDC analysis of samples from this patient revealed Influenza type B, which proved to be FLUMIST type B.  The reporter stated that the events would be reported to VAERS.  The patient recovered on an unknown date.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Status epilepticus
Clinical narrative: A serious, spontaneous report of status epilepticus, dehydration and fever was received from a physician, concerning a 36-month-old male subsequent to FLUMIST.  The patient's past medical history includes neuromuscular disorder, cerebral palsy, seizure and microcephaly.  Concomitant medications included anti-epileptic medication.  A week prior to vaccination the patient had a runny nose and congestion.  The patient received FLUMIST on 15-Oct-2008 for vaccination.  On 17-Oct-2008, the patient presented with a fever of 38.1 degrees Celsius.  On 18-Oct-2008 the patient was admitted to the hospital with dehydration and status epilepticus and was intubated.  During routine surveillance of sick children, CDC analysis of samples from this patient revealed Influenza type B, which proved to be FLUMIST type B.  The reporter stated that the events would be reported to VAERS.  The patient recovered on an unknown date.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Pharyngeal oedema, Rash
Clinical narrative: Client reported of experiencing heavy chest, rashes swelling throat 1 1/2 hour after vaccination, went to E.R and received BENADRYL/Epinephrine. Released at about 8 PM. Completely resolved. 3/24/09-records received for ED visit 3/16/09-impression:allergic reaction, minor, suspect secondary to injections. Presented to ED with C/O feeling tired and lightheaded one hour after receiving vaccines. Felt chest heaviness, voice feels slightly hoarse, itchy all over and face if tingly.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Body temperature increased, Erythema, Pain, Swelling
Clinical narrative: swelling, redness, pain, increased temp 101 degrees
Age: 1.3
Sex: F
Vaccine: DTAP, HEP, MMR, PNC
Symptoms: Body temperature increased, Convulsion, Pyrexia
Clinical narrative: Had Hep B # 3, DTaP # 4, PCV # 4 and MMR # 1 on 12/4/08. At 8pm that night, pt had seizure with 104.2 temp. Went to medical center ER. TX with TYLENOL/MOTRIN, sent home. At 6am 12/5/08 had another seizure at home mom took her to ER. DX with seizure, sent home, per mom.
Age: 53.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Asthenia, Chest X-ray normal, Cough, Dizziness, Full blood count normal
Clinical narrative: Started with cough 1900 15MAR09, progressed to headache, nausea, sore throat, tachycardia, fever (103 degrees F), muscle ache, general weakness and dizziness on standing. Also, wheezing.
Age: 53.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Metabolic function test normal, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Started with cough 1900 15MAR09, progressed to headache, nausea, sore throat, tachycardia, fever (103 degrees F), muscle ache, general weakness and dizziness on standing. Also, wheezing.
Age: 53.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Pyrexia, Tachycardia, Wheezing
Clinical narrative: Started with cough 1900 15MAR09, progressed to headache, nausea, sore throat, tachycardia, fever (103 degrees F), muscle ache, general weakness and dizziness on standing. Also, wheezing.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: Like usual after vax, jogged for 3 1/2 hours with 2-3lb weights. At 2p had lunch and became nauseous, dizzy and weak so went to sleep. Woke up at 6pm and only ate some dinner because felt physically exhausted and woke up by noon next day. Problems resolved, no recurrence since then. No pain at site of injection or scratchy throat.
Age: 32.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: 3/19/09 T/C to reporter who states patient experienced redness & pain at anthrax site right arm & had limited mobility w/right arm, using left arm to lift right.  Seen in clinic yesterday & improving slowly.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythematous induration area at the injection site on (R) thigh. Treated with BENEDRYL/ KEFLEX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local redness and swelling 13 x 10 cm on the L thigh. Noted approximately 30 minutes after Imms. Given BENADRYL and warm compresses. Resolved after 6 days.
Age: 40.0
Sex: U
Vaccine: ANTH, FLU3, HEP, MNQ, TYP
Symptoms: Antinuclear antibody positive, Biopsy endometrium normal, Blood fibrinogen, Blood thyroid stimulating hormone normal, Coagulation test normal
Clinical narrative: Incidental diagnosis of thrombocytopenia during routine physical.  Menorrhagia (excessive menstrual bleeding) Start: 11/15/2004
Age: 40.0
Sex: U
Vaccine: ANTH, FLU3, HEP, MNQ, TYP
Symptoms: Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Fibrin D dimer normal, Haematocrit, Haemoglobin
Clinical narrative: Incidental diagnosis of thrombocytopenia during routine physical.  Menorrhagia (excessive menstrual bleeding) Start: 11/15/2004
Age: 40.0
Sex: U
Vaccine: ANTH, FLU3, HEP, MNQ, TYP
Symptoms: Mammogram normal, Menorrhagia, Metabolic function test, Ultrasound pelvis, Ultrasound scan abnormal
Clinical narrative: Incidental diagnosis of thrombocytopenia during routine physical.  Menorrhagia (excessive menstrual bleeding) Start: 11/15/2004
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Dizziness and LOC x 30 sec, about 10 min after vaccination.
Age: 0.62
Sex: M
Vaccine: HIBV, PNC, TDAP
Symptoms: Wrong drug administered
Clinical narrative: On 5/28/08, Pt was 7mo old and received a Tdap instead of DTaP. No known injury.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Asthenia, Cold sweat, Dizziness, Pallor, Paraesthesia
Clinical narrative: Pt had a c/o feeling as though she were going to pass out as she was checking out with secretaries.  Secretary called M.A. and they assisted Pt to sitting in chair.  MA got me to check Pt.  Pt stated she felt like she was going to pass out, had blurry vision, tingling to hands and ringing in her ears.  BP 92/54, R 18, P 78 weak, Pt stated she felt clammy, Pt too weak to transfer to w/c -> exam room at that time.  Color slightly pale.  BP 96/60, P62.  After sitting up 10" BP 98/62, P62, R-15 10" later BP 98/62 P60.  Standing BP98/60 P60 R-15 color improved, clammy feeling gone, Pt stated she thinks it was made worse by becoming frightened by Sx's.  Pt released to home once WNL- baseline.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Pulse pressure decreased, Tinnitus, Vision blurred
Clinical narrative: Pt had a c/o feeling as though she were going to pass out as she was checking out with secretaries.  Secretary called M.A. and they assisted Pt to sitting in chair.  MA got me to check Pt.  Pt stated she felt like she was going to pass out, had blurry vision, tingling to hands and ringing in her ears.  BP 92/54, R 18, P 78 weak, Pt stated she felt clammy, Pt too weak to transfer to w/c -> exam room at that time.  Color slightly pale.  BP 96/60, P62.  After sitting up 10" BP 98/62, P62, R-15 10" later BP 98/62 P60.  Standing BP98/60 P60 R-15 color improved, clammy feeling gone, Pt stated she thinks it was made worse by becoming frightened by Sx's.  Pt released to home once WNL- baseline.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Back pain, Blood culture negative, Chest X-ray abnormal, Cough, Influenza serology negative
Clinical narrative: A serious, study report of right lower lobe pneumonia was received from an investigator, concerning a four-year-old female subject number 1-08-02946 enrolled in a study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject had a history of fever and cough for approximately five days prior to hospitalization but was otherwise a healthy patient. She was not taking any concomitant medications. The subject received FLUMIST on 10-Oct-2008. The subject was admitted to the hospital on 18-Nov-2008. On admission, her chest X-ray was consistent with right lower lobe pneumonia. WBC was 13,300 with 63% neutrophils. A blood culture was sterile. She had an uncomplicated hospital course and was discharged on cefdinir twice a day to complete a ten-day course. The subject was seen again on 22-Nov-2008 in the emergency room (ER) for subjective fever and back pain. Physical examination was unremarkable and the subject was not in respiratory distress. Repeat chest x-ray was without significant change. Her rapid flu test was negative. She was sent home on ibuprofen for pain. The subject's final diagnosis was right lower lobe pneumonia. The subject was discharged from the hospital on 19-Nov-2009, but the outcome of the event was not reported. The investigator assessed the event as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Lobar pneumonia, Neutrophil percentage increased, Pyrexia, White blood cell count increased
Clinical narrative: A serious, study report of right lower lobe pneumonia was received from an investigator, concerning a four-year-old female subject number 1-08-02946 enrolled in a study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject had a history of fever and cough for approximately five days prior to hospitalization but was otherwise a healthy patient. She was not taking any concomitant medications. The subject received FLUMIST on 10-Oct-2008. The subject was admitted to the hospital on 18-Nov-2008. On admission, her chest X-ray was consistent with right lower lobe pneumonia. WBC was 13,300 with 63% neutrophils. A blood culture was sterile. She had an uncomplicated hospital course and was discharged on cefdinir twice a day to complete a ten-day course. The subject was seen again on 22-Nov-2008 in the emergency room (ER) for subjective fever and back pain. Physical examination was unremarkable and the subject was not in respiratory distress. Repeat chest x-ray was without significant change. Her rapid flu test was negative. She was sent home on ibuprofen for pain. The subject's final diagnosis was right lower lobe pneumonia. The subject was discharged from the hospital on 19-Nov-2009, but the outcome of the event was not reported. The investigator assessed the event as not related to FLUMIST.
Age: 2.8
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 34-month-old female who received FLUMIST.  Neither the patient's medical history nor concomitant medications were reported.   The patient received FLUMIST on 19-Feb-2009, which expired on 12-Feb-2009.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Medication error
Clinical narrative: A non-serious, spontaneous report of gave expired FLUMIST in a 33-month-old female patient was received from a nurse practitioner. On 11-Feb-2009, the patient received expired FLUMIST.  The office called the parent and explained that the child may no be fully protected;  however, the parents decided no to return to the office for re-dosing.  On 12 Mar 2009, the nurse practitioner confirmed that no adverse event occurred. There was no adverse event associated with this medication error;  therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with agency post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 12 Mar 2009 and the following information was added to the narrative: no adverse event occurred.  This is in follow-up to report(s) previously submitted on 02/11/09. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMRV
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of gave expired FLUMIST in a four-year-old male patient was received from a nurse practitioner. The patient's medical history included constipation and ear infections. Concomitant medications included: taking MIRALAX one daily for constipation; coadministration of three other vaccines with FLUMIST (DTAP, POLIO, MMR/Chicken Pox). On 11-Feb-2009, the patient received expired FLUMIST. The office called the parent and explained that the child may not be fully protected; however, the parents decided not to return to the office for re-dosing. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. This is in follow-up to report(s) previously submitted on 02/11/09. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 04/09/2009: Product Complaint Investigation results. 03/12/09 On 12 Mar 2009, the nurse practitioner confirmed that no adverse event occurred. Additional information received on 12-Mar-2009 and added to the narrative. No adverse event occurred.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a Registered Nurse concerning a child.  FLUMIST was administered on 24-Jan-2009 and the dose had expired on 18-Dec-2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of th eflu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009; product complaint investigation results.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a four-year-old male.  The patient's medical history included no history of asthma.  Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a four-year-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-JAN-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a 36-month-old male.  The patient's medical history included no history of asthma.  No concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicted population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Follow-up information received on 31-Mar-2009 included Product Complaint Investigation results.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a four-year-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. This is in follow-up to report(s) previously submitted on 02/05/09. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 and incorporated into the narrative: product complaint investigation results.