chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Breast pain, Lymph node pain, Musculoskeletal pain, Pain
Clinical narrative: Rose thorn injury developed nodule in right 4th finger (R) hand that was a month & 1/2 before going to ER for tetanus shot, within 2 weeks of vaccination began having bilateral pain, more focused in (L) breast. L breast had an fined needle aspiration biopsy 5 years prior. There were multiple cysts in the left breast....There had been pain in the left breast following FNA-Fined Needle Aspiration, finally subsided completely until receiving the ADACEL within 2 weeks began having bilateral pain and that continued since. So I was given Intraconazole on 10/16/2010- I took 3 doses then stopped. In addition to the breast pain which is at the sites of the cyst the breast. There has also been an exacerbation of the supra clavicular lymph node pain extending to the left shoulder - bilateral pain, primarily on the left side. There is no fever, taking no hormones, post-menopausal. At this time there is no diagnose that suggest a cause other than the administration of the ADACEL which was the DTAP with the exception of the needle track pain from the FNA 5 years prior the breast had been asymptomatic until the administration of the ADACEL.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling at the site, fever to 101
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Laboratory test, Pyrexia
Clinical narrative: Patient developed a fever of 103 and taken to the emergency room for evaluation.  Triaged and evaluated by a physician then sent home.  No labs done.
Age: 1.02
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Herpes zoster, Polymerase chain reaction, Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient developed localized rash on 5/10/10 on right shoulder that spread to rest of her arm. Rash was itchy, but not painful. She developed > 500 maculopapular vesicular lesions. Physician diagnosed her with herpes zoster. Patient had no history of varicella or herpes zoster.
Age: 1.02
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Varicella virus test positive
Clinical narrative: Patient developed localized rash on 5/10/10 on right shoulder that spread to rest of her arm. Rash was itchy, but not painful. She developed > 500 maculopapular vesicular lesions. Physician diagnosed her with herpes zoster. Patient had no history of varicella or herpes zoster.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Hives over entire body
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site irritation, Injection site swelling, Mass, Pruritus
Clinical narrative: Injection site irritation/swelling. Itching. Hard lump formation.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness on both legs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Febrile convulsion, Nuclear magnetic resonance imaging brain normal, X-ray limb normal
Clinical narrative: Febrile seizure.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Abdomen scan normal, Antinuclear antibody increased, Arthralgia, Arthropathy, Blood catecholamines normal
Clinical narrative: A review of the medical records and interview noted that on 15 Aug 09 she received AVA #1, Hep B #1, and Typhoid. Other than slight arm pain, she denied any problems. Then on 23 Sep 09, she received AVA and Hep B #2 and passed her medical exam. Her BP at that time was 132/90, consistent with her prior 3 yr average of 132/88. Per review, on 20 Oct 09, during her well woman exam, her BP was noted to be elevated at 164/121 with a repeat reading of 155/102. On 23 Oct during f/u for BP she reported bil great toe pain in the area between her toes. An x-ray detected no abnormalities. There were many subsequent visits for BP management without mention of toe pain. She was deployed in late Nov 09, returned in Jan 10, and reported that her feet continued to bother her. She was treated for plantar fascitis. Mar 10 increasing foot pain, given NSAIDS and a MRI was ordered, completed in Apr and noted mild disc protrusion, facet arthropathy with no neuroforaminal or central canal stenosis. In May 10 evaluated by neuro for bilateral foot pain and paresthesia with an EMG indicating a mild neuropathic process with an unclear etiology. In Jul she had a normal MRI of the brain, an elevated ANA with pos SS-A-Ab, and was evaluated by podiatry, where tarsal tunnel syndrome was ruled out. A follow up visit in Aug reported the onset of multiple joint and muscle pain that involves her neck, shoulders, hips and feet. Rheumatology dx her as having inflammatory polyarthritis, to rule out psoriatic arthritis. On 07 Dec she was evaluated by rheumatology and met the classification for fibromyalgia with no identifiable rheumatologic conditions to cause her HTN and neuropathy. She was evaluated by allergy on 08 Dec and there was no evidence of an IgE mediated event, and other than a temporal relationship to the vaccines, a causal relationship could not be identified. She was referred to internal medicine for HTN evaluation who stated that there is no current explanation for this new onset of significant HTN. She had a normal echocardiogram, U/S of abd, VMA, catecholamines. Metanephrine, GTT, but had a slightly elevated B12, and plasma rennin, and slightly low urine free cortisol. She is currently pending a renal evaluation and will follow-up with internal med. She was evaluated by neurology and was assessed as having Pedal pain and numbness. Her recent nerve conduction study suggested the presence of a mild, length-dependent, sensorimotor polyneuropathy. Extensive work-up to date revealed no symptomatic etiology for a peripheral neuropathy.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Blood fibrinogen increased, Blood pressure increased, Cortisol free urine decreased, Echocardiogram normal, Electromyogram abnormal
Clinical narrative: A review of the medical records and interview noted that on 15 Aug 09 she received AVA #1, Hep B #1, and Typhoid. Other than slight arm pain, she denied any problems. Then on 23 Sep 09, she received AVA and Hep B #2 and passed her medical exam. Her BP at that time was 132/90, consistent with her prior 3 yr average of 132/88. Per review, on 20 Oct 09, during her well woman exam, her BP was noted to be elevated at 164/121 with a repeat reading of 155/102. On 23 Oct during f/u for BP she reported bil great toe pain in the area between her toes. An x-ray detected no abnormalities. There were many subsequent visits for BP management without mention of toe pain. She was deployed in late Nov 09, returned in Jan 10, and reported that her feet continued to bother her. She was treated for plantar fascitis. Mar 10 increasing foot pain, given NSAIDS and a MRI was ordered, completed in Apr and noted mild disc protrusion, facet arthropathy with no neuroforaminal or central canal stenosis. In May 10 evaluated by neuro for bilateral foot pain and paresthesia with an EMG indicating a mild neuropathic process with an unclear etiology. In Jul she had a normal MRI of the brain, an elevated ANA with pos SS-A-Ab, and was evaluated by podiatry, where tarsal tunnel syndrome was ruled out. A follow up visit in Aug reported the onset of multiple joint and muscle pain that involves her neck, shoulders, hips and feet. Rheumatology dx her as having inflammatory polyarthritis, to rule out psoriatic arthritis. On 07 Dec she was evaluated by rheumatology and met the classification for fibromyalgia with no identifiable rheumatologic conditions to cause her HTN and neuropathy. She was evaluated by allergy on 08 Dec and there was no evidence of an IgE mediated event, and other than a temporal relationship to the vaccines, a causal relationship could not be identified. She was referred to internal medicine for HTN evaluation who stated that there is no current explanation for this new onset of significant HTN. She had a normal echocardiogram, U/S of abd, VMA, catecholamines. Metanephrine, GTT, but had a slightly elevated B12, and plasma rennin, and slightly low urine free cortisol. She is currently pending a renal evaluation and will follow-up with internal med. She was evaluated by neurology and was assessed as having Pedal pain and numbness. Her recent nerve conduction study suggested the presence of a mild, length-dependent, sensorimotor polyneuropathy. Extensive work-up to date revealed no symptomatic etiology for a peripheral neuropathy.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Fibromyalgia, Glucose tolerance test normal, Hypoaesthesia, Intervertebral disc protrusion, Metanephrine urine normal
Clinical narrative: A review of the medical records and interview noted that on 15 Aug 09 she received AVA #1, Hep B #1, and Typhoid. Other than slight arm pain, she denied any problems. Then on 23 Sep 09, she received AVA and Hep B #2 and passed her medical exam. Her BP at that time was 132/90, consistent with her prior 3 yr average of 132/88. Per review, on 20 Oct 09, during her well woman exam, her BP was noted to be elevated at 164/121 with a repeat reading of 155/102. On 23 Oct during f/u for BP she reported bil great toe pain in the area between her toes. An x-ray detected no abnormalities. There were many subsequent visits for BP management without mention of toe pain. She was deployed in late Nov 09, returned in Jan 10, and reported that her feet continued to bother her. She was treated for plantar fascitis. Mar 10 increasing foot pain, given NSAIDS and a MRI was ordered, completed in Apr and noted mild disc protrusion, facet arthropathy with no neuroforaminal or central canal stenosis. In May 10 evaluated by neuro for bilateral foot pain and paresthesia with an EMG indicating a mild neuropathic process with an unclear etiology. In Jul she had a normal MRI of the brain, an elevated ANA with pos SS-A-Ab, and was evaluated by podiatry, where tarsal tunnel syndrome was ruled out. A follow up visit in Aug reported the onset of multiple joint and muscle pain that involves her neck, shoulders, hips and feet. Rheumatology dx her as having inflammatory polyarthritis, to rule out psoriatic arthritis. On 07 Dec she was evaluated by rheumatology and met the classification for fibromyalgia with no identifiable rheumatologic conditions to cause her HTN and neuropathy. She was evaluated by allergy on 08 Dec and there was no evidence of an IgE mediated event, and other than a temporal relationship to the vaccines, a causal relationship could not be identified. She was referred to internal medicine for HTN evaluation who stated that there is no current explanation for this new onset of significant HTN. She had a normal echocardiogram, U/S of abd, VMA, catecholamines. Metanephrine, GTT, but had a slightly elevated B12, and plasma rennin, and slightly low urine free cortisol. She is currently pending a renal evaluation and will follow-up with internal med. She was evaluated by neurology and was assessed as having Pedal pain and numbness. Her recent nerve conduction study suggested the presence of a mild, length-dependent, sensorimotor polyneuropathy. Extensive work-up to date revealed no symptomatic etiology for a peripheral neuropathy.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Pain in extremity
Clinical narrative: A review of the medical records and interview noted that on 15 Aug 09 she received AVA #1, Hep B #1, and Typhoid. Other than slight arm pain, she denied any problems. Then on 23 Sep 09, she received AVA and Hep B #2 and passed her medical exam. Her BP at that time was 132/90, consistent with her prior 3 yr average of 132/88. Per review, on 20 Oct 09, during her well woman exam, her BP was noted to be elevated at 164/121 with a repeat reading of 155/102. On 23 Oct during f/u for BP she reported bil great toe pain in the area between her toes. An x-ray detected no abnormalities. There were many subsequent visits for BP management without mention of toe pain. She was deployed in late Nov 09, returned in Jan 10, and reported that her feet continued to bother her. She was treated for plantar fascitis. Mar 10 increasing foot pain, given NSAIDS and a MRI was ordered, completed in Apr and noted mild disc protrusion, facet arthropathy with no neuroforaminal or central canal stenosis. In May 10 evaluated by neuro for bilateral foot pain and paresthesia with an EMG indicating a mild neuropathic process with an unclear etiology. In Jul she had a normal MRI of the brain, an elevated ANA with pos SS-A-Ab, and was evaluated by podiatry, where tarsal tunnel syndrome was ruled out. A follow up visit in Aug reported the onset of multiple joint and muscle pain that involves her neck, shoulders, hips and feet. Rheumatology dx her as having inflammatory polyarthritis, to rule out psoriatic arthritis. On 07 Dec she was evaluated by rheumatology and met the classification for fibromyalgia with no identifiable rheumatologic conditions to cause her HTN and neuropathy. She was evaluated by allergy on 08 Dec and there was no evidence of an IgE mediated event, and other than a temporal relationship to the vaccines, a causal relationship could not be identified. She was referred to internal medicine for HTN evaluation who stated that there is no current explanation for this new onset of significant HTN. She had a normal echocardiogram, U/S of abd, VMA, catecholamines. Metanephrine, GTT, but had a slightly elevated B12, and plasma rennin, and slightly low urine free cortisol. She is currently pending a renal evaluation and will follow-up with internal med. She was evaluated by neurology and was assessed as having Pedal pain and numbness. Her recent nerve conduction study suggested the presence of a mild, length-dependent, sensorimotor polyneuropathy. Extensive work-up to date revealed no symptomatic etiology for a peripheral neuropathy.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Plantar fasciitis, Polyarthritis, Polyneuropathy, Sensorimotor disorder
Clinical narrative: A review of the medical records and interview noted that on 15 Aug 09 she received AVA #1, Hep B #1, and Typhoid. Other than slight arm pain, she denied any problems. Then on 23 Sep 09, she received AVA and Hep B #2 and passed her medical exam. Her BP at that time was 132/90, consistent with her prior 3 yr average of 132/88. Per review, on 20 Oct 09, during her well woman exam, her BP was noted to be elevated at 164/121 with a repeat reading of 155/102. On 23 Oct during f/u for BP she reported bil great toe pain in the area between her toes. An x-ray detected no abnormalities. There were many subsequent visits for BP management without mention of toe pain. She was deployed in late Nov 09, returned in Jan 10, and reported that her feet continued to bother her. She was treated for plantar fascitis. Mar 10 increasing foot pain, given NSAIDS and a MRI was ordered, completed in Apr and noted mild disc protrusion, facet arthropathy with no neuroforaminal or central canal stenosis. In May 10 evaluated by neuro for bilateral foot pain and paresthesia with an EMG indicating a mild neuropathic process with an unclear etiology. In Jul she had a normal MRI of the brain, an elevated ANA with pos SS-A-Ab, and was evaluated by podiatry, where tarsal tunnel syndrome was ruled out. A follow up visit in Aug reported the onset of multiple joint and muscle pain that involves her neck, shoulders, hips and feet. Rheumatology dx her as having inflammatory polyarthritis, to rule out psoriatic arthritis. On 07 Dec she was evaluated by rheumatology and met the classification for fibromyalgia with no identifiable rheumatologic conditions to cause her HTN and neuropathy. She was evaluated by allergy on 08 Dec and there was no evidence of an IgE mediated event, and other than a temporal relationship to the vaccines, a causal relationship could not be identified. She was referred to internal medicine for HTN evaluation who stated that there is no current explanation for this new onset of significant HTN. She had a normal echocardiogram, U/S of abd, VMA, catecholamines. Metanephrine, GTT, but had a slightly elevated B12, and plasma rennin, and slightly low urine free cortisol. She is currently pending a renal evaluation and will follow-up with internal med. She was evaluated by neurology and was assessed as having Pedal pain and numbness. Her recent nerve conduction study suggested the presence of a mild, length-dependent, sensorimotor polyneuropathy. Extensive work-up to date revealed no symptomatic etiology for a peripheral neuropathy.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Vanillyl mandelic acid urine, Vitamin B12 increased, X-ray normal
Clinical narrative: A review of the medical records and interview noted that on 15 Aug 09 she received AVA #1, Hep B #1, and Typhoid. Other than slight arm pain, she denied any problems. Then on 23 Sep 09, she received AVA and Hep B #2 and passed her medical exam. Her BP at that time was 132/90, consistent with her prior 3 yr average of 132/88. Per review, on 20 Oct 09, during her well woman exam, her BP was noted to be elevated at 164/121 with a repeat reading of 155/102. On 23 Oct during f/u for BP she reported bil great toe pain in the area between her toes. An x-ray detected no abnormalities. There were many subsequent visits for BP management without mention of toe pain. She was deployed in late Nov 09, returned in Jan 10, and reported that her feet continued to bother her. She was treated for plantar fascitis. Mar 10 increasing foot pain, given NSAIDS and a MRI was ordered, completed in Apr and noted mild disc protrusion, facet arthropathy with no neuroforaminal or central canal stenosis. In May 10 evaluated by neuro for bilateral foot pain and paresthesia with an EMG indicating a mild neuropathic process with an unclear etiology. In Jul she had a normal MRI of the brain, an elevated ANA with pos SS-A-Ab, and was evaluated by podiatry, where tarsal tunnel syndrome was ruled out. A follow up visit in Aug reported the onset of multiple joint and muscle pain that involves her neck, shoulders, hips and feet. Rheumatology dx her as having inflammatory polyarthritis, to rule out psoriatic arthritis. On 07 Dec she was evaluated by rheumatology and met the classification for fibromyalgia with no identifiable rheumatologic conditions to cause her HTN and neuropathy. She was evaluated by allergy on 08 Dec and there was no evidence of an IgE mediated event, and other than a temporal relationship to the vaccines, a causal relationship could not be identified. She was referred to internal medicine for HTN evaluation who stated that there is no current explanation for this new onset of significant HTN. She had a normal echocardiogram, U/S of abd, VMA, catecholamines. Metanephrine, GTT, but had a slightly elevated B12, and plasma rennin, and slightly low urine free cortisol. She is currently pending a renal evaluation and will follow-up with internal med. She was evaluated by neurology and was assessed as having Pedal pain and numbness. Her recent nerve conduction study suggested the presence of a mild, length-dependent, sensorimotor polyneuropathy. Extensive work-up to date revealed no symptomatic etiology for a peripheral neuropathy.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Dyspnoea, Erythema, Pyrexia, Vomiting
Clinical narrative: VOMITING, FEVER RED AREA MOM STATED CHILD "BREATHING FUNNY. PLACED ON ORAPRED AND BENADRYL.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Body temperature increased, Febrile convulsion, Full blood count, Fungal test, Metabolic function test
Clinical narrative: Febrile seizure after vaccines. T 104.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, FLU3, HEPA, MNQ, TDAP
Symptoms: Dyspnoea, Pruritus, Wheezing
Clinical narrative: SUDDEN ONSET OF DYSPNEA PRURITUS FACE WHEEZING BILATERAL
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Left upper arm red, swollen, hot to touch.  Area red is approximately 2 1/2 by 3 1/2 inches.  No fever.  C/O soreness in left arm.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Psychomotor hyperactivity, Rash pustular, Vision blurred
Clinical narrative: Arm was itchy and little pustules developed on both arms.  No rash on chest or trunk.  Mom states he is acting "hyperactive" and complained that one eye was "fuzzy".
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: C/O redness to left deltoid after Tdap vaccine. Slight redness noted and warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMRV, PNC13
Symptoms: Abdominal pain upper, Malaise, Presyncope
Clinical narrative: 5 minutes after receiving vaccines (Pentacel, PCV-13, MMR-V, Influenza), patient stood up and put coat on, then reported that she didnt feel well and lied down on the ground. No LOC. C/o belly pain. BP 60/30 (pre-vaccine 92/56); improved over 30 minutes with juice and rest. Attributed to vasovagal response.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal discomfort, Arthralgia, Influenza like illness, Pyrexia, Rash
Clinical narrative: Rash, fever, achy joints, upset stomach, flu-like symptoms
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Headache, Hypoaesthesia, Paraesthesia, Sensation of pressure
Clinical narrative: 1 hour after administration, she felt tingling and numbess up her left sife of neck to ear. Then she felt pressure/pain behind her left ear and left teeth and left side of tongue felt numb. She went to the ED and they said she was having an allergic reaction to the vaccine, however it wasn't severe.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Toothache
Clinical narrative: 1 hour after administration, she felt tingling and numbess up her left sife of neck to ear. Then she felt pressure/pain behind her left ear and left teeth and left side of tongue felt numb. She went to the ED and they said she was having an allergic reaction to the vaccine, however it wasn't severe.
Age: 30.0
Sex: F
Vaccine: FLUX, HEPA, TYP
Symptoms: Fatigue, Pain, Pruritus, Rash
Clinical narrative: rash, stinging pain, itching, extreme fatigue for over one month
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Arthralgia, Blood test, Lymphadenopathy
Clinical narrative: severe stomach ache, gland swelling, joint pain after receiving Gardasil vaccine
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Musculoskeletal pain, Pyrexia, Vaccination site pain
Clinical narrative: Severe pain in shoulder at vaccination site, mild pain in joints, Fever; required 2000mg of Tylenol daily.
Age: 1.13
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion, Laboratory test normal
Clinical narrative: febrile seizure took to pediatricians office and then to hospital
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood culture, CSF culture, Computerised tomogram head, Culture urine, Dyskinesia
Clinical narrative: Transferred from hosp. to ER 02-03-11 with 2 day history of fever (100.9) jerky abnormal movements and vomiting. Diagnosis pending.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Electroencephalogram, Pyrexia, Vomiting
Clinical narrative: Transferred from hosp. to ER 02-03-11 with 2 day history of fever (100.9) jerky abnormal movements and vomiting. Diagnosis pending.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nausea, Neurological examination, Pain in extremity, Paraesthesia
Clinical narrative: Arms ached later same day - next day had numbness/paresthesias hands. 1/30/11 developed aching then numbness plantar (R) foot and distal (L) stump. Fingertip numbness persisted 3 days. Foot still feels numb with weight bearing. Also developed nausea/vomiting day after vaccine -> today.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Arms ached later same day - next day had numbness/paresthesias hands. 1/30/11 developed aching then numbness plantar (R) foot and distal (L) stump. Fingertip numbness persisted 3 days. Foot still feels numb with weight bearing. Also developed nausea/vomiting day after vaccine -> today.
Age: 31.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Abdominal pain, Arthralgia, Dysphagia, Eye irritation, Sneezing
Clinical narrative: 12/27/10 at 4:00PM - at work. Eye burning, red, swollen difficulty swallowing - pain abdomen top of hips after sneezing. Tried eye drops - no relief - to ER at Hospital Emergency Room treated - BENADRYL IM. Symptoms resolved after 3 hours. BENADRYL PO 3 hrs after IM.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Eye irritation, Eye swelling, Ocular hyperaemia
Clinical narrative: 12/27/10 at home - red eyes, burning & slight swelling. No treatment. Symptoms resolved.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 101 degrees. Rash on stomach, chest, in elbows & knee joints. Sx onset 1-29-11.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, VARCEL
Symptoms: Drug exposure during pregnancy, Pregnancy test
Clinical narrative: Pt came to clinic 1 m prior to pregnancy test.
Age: 8.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Large, firm, erythematous reaction to (R) deltoid inj site.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site joint swelling, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial consumer (patient) report received on 28 Jan 2011: This patient had a previous vaccination history with flu shots which were well tolerated. She was vaccinated with FLUVIRIN 2010/2011 (batch number: 111812P1) too high in her arm, intramuscularly on 04 Oct 2010. Following evening she experienced pain in her arm near the injection site. After 1-2 weeks, she experienced difficulty using her arm and could not move it well. The patient was in physical therapy since then and she lost 23 degrees of movement. An MRI done on unknown date revealed swelling in the shoulder joint and it was reported that the swelling was most likely due to injection. She stated that the vaccine administered was from a recalled lot. The outcome was reported as condition improving but not fully resolved. The events were also reported to Vaccine Adverse Event Reporting System (VAERS).
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial consumer (patient) report received on 28 Jan 2011: This patient had a previous vaccination history with flu shots which were well tolerated. She was vaccinated with FLUVIRIN 2010/2011 (batch number: 111812P1) too high in her arm, intramuscularly on 04 Oct 2010. Following evening she experienced pain in her arm near the injection site. After 1-2 weeks, she experienced difficulty using her arm and could not move it well. The patient was in physical therapy since then and she lost 23 degrees of movement. An MRI done on unknown date revealed swelling in the shoulder joint and it was reported that the swelling was most likely due to injection. She stated that the vaccine administered was from a recalled lot. The outcome was reported as condition improving but not fully resolved. The events were also reported to Vaccine Adverse Event Reporting System (VAERS).
Age: 24.0
Sex: F
Vaccine: RAB, TDAP, TYP
Symptoms: Blister, Dyspnoea, Erythema, Formication, Hypersensitivity
Clinical narrative: 24 y/o F reported onset of skin changes approximately 12 hours post-vaccine receipt on 30 Dec 2010. She has a history of skin changes between her fingers and on her hands (small blisters and peeling skin), so when she noted similar changes on her hands the evening of vaccine receipt, she did not think much of it. The next morning when she awoke, she reports increased lesions on her hands, forearms, and new lesions noted on her feet (both blister-like and some "red dots"). She described a "splotchy" rash on her arms too - nonraised, pink, and pruritic. She denies facial angioedema, cardiovascular, respiratory, GI or other systemic symptoms. She denies fever/chills, headache, fatigue or generalized body aches, but did report "typical" arm soreness following immunizations. The following morning, 1 Jan 2011, when she awoke, the pruritic macular rash was noted from mid-thigh to her feet and on her forearms up to her elbows. It was pruritic and areas were becoming sore from scratching during the night. She also said her fingers and hands were swollen, but denies redness or swelling of joints. She had not self-treated until afternoon of 1/1/2011 when she took a couple of BENADRYL without significant change in symptoms. On the afternoon of 1/1/2011, after climbing a flight of stairs, she reported feeling winded, and her friend urged her to seek evaluation. Patient went to ER where she  was treated for an allergic reaction. She received Epinephrine and BENADRYL IM and received a dose of oral Prednisone. She continued to c/o itching and skin crawling. An IV was initiated and she was given additional medications intravenously; she is not sure what she received, but thinks there were 3 separate medications. The itching improved, but the splotchy rash continued. She was released and instructed to take OTC ZANTAC and was prescribed an oral Prednisone 10 mg taper (4tabs x 2 days, 3 tabs x 2 days, 2 tabs x 2 days, & 1 tab x 2 days), as well as another medication (not sure of name , but it was a pink and yellow capsule). Notes from visit not visible, but discharge instructions noted prescriptions for Prednisone and VISTARIL. Reports rash and pruritus continued to improve over the weekend and for the most part, was gone by Monday, 1/3/2011, when she was seen at clinic. She was prescribed Cetirizine 10 mg daily, but patient did not take as symptoms were almost gone. SM felt well on 30 Dec. prior to vaccine receipt. Denied new medications. Patient denied other known exposures. No allergies to medications, food, latex or insect stings. Denies previous adverse events following receipt of vaccines prior to December 2010.
Age: 24.0
Sex: F
Vaccine: RAB, TDAP, TYP
Symptoms: Oedema peripheral, Pain, Pain in extremity, Pruritus, Rash macular
Clinical narrative: 24 y/o F reported onset of skin changes approximately 12 hours post-vaccine receipt on 30 Dec 2010. She has a history of skin changes between her fingers and on her hands (small blisters and peeling skin), so when she noted similar changes on her hands the evening of vaccine receipt, she did not think much of it. The next morning when she awoke, she reports increased lesions on her hands, forearms, and new lesions noted on her feet (both blister-like and some "red dots"). She described a "splotchy" rash on her arms too - nonraised, pink, and pruritic. She denies facial angioedema, cardiovascular, respiratory, GI or other systemic symptoms. She denies fever/chills, headache, fatigue or generalized body aches, but did report "typical" arm soreness following immunizations. The following morning, 1 Jan 2011, when she awoke, the pruritic macular rash was noted from mid-thigh to her feet and on her forearms up to her elbows. It was pruritic and areas were becoming sore from scratching during the night. She also said her fingers and hands were swollen, but denies redness or swelling of joints. She had not self-treated until afternoon of 1/1/2011 when she took a couple of BENADRYL without significant change in symptoms. On the afternoon of 1/1/2011, after climbing a flight of stairs, she reported feeling winded, and her friend urged her to seek evaluation. Patient went to ER where she  was treated for an allergic reaction. She received Epinephrine and BENADRYL IM and received a dose of oral Prednisone. She continued to c/o itching and skin crawling. An IV was initiated and she was given additional medications intravenously; she is not sure what she received, but thinks there were 3 separate medications. The itching improved, but the splotchy rash continued. She was released and instructed to take OTC ZANTAC and was prescribed an oral Prednisone 10 mg taper (4tabs x 2 days, 3 tabs x 2 days, 2 tabs x 2 days, & 1 tab x 2 days), as well as another medication (not sure of name , but it was a pink and yellow capsule). Notes from visit not visible, but discharge instructions noted prescriptions for Prednisone and VISTARIL. Reports rash and pruritus continued to improve over the weekend and for the most part, was gone by Monday, 1/3/2011, when she was seen at clinic. She was prescribed Cetirizine 10 mg daily, but patient did not take as symptoms were almost gone. SM felt well on 30 Dec. prior to vaccine receipt. Denied new medications. Patient denied other known exposures. No allergies to medications, food, latex or insect stings. Denies previous adverse events following receipt of vaccines prior to December 2010.
Age: 24.0
Sex: F
Vaccine: RAB, TDAP, TYP
Symptoms: Rash pruritic, Skin discolouration, Skin lesion
Clinical narrative: 24 y/o F reported onset of skin changes approximately 12 hours post-vaccine receipt on 30 Dec 2010. She has a history of skin changes between her fingers and on her hands (small blisters and peeling skin), so when she noted similar changes on her hands the evening of vaccine receipt, she did not think much of it. The next morning when she awoke, she reports increased lesions on her hands, forearms, and new lesions noted on her feet (both blister-like and some "red dots"). She described a "splotchy" rash on her arms too - nonraised, pink, and pruritic. She denies facial angioedema, cardiovascular, respiratory, GI or other systemic symptoms. She denies fever/chills, headache, fatigue or generalized body aches, but did report "typical" arm soreness following immunizations. The following morning, 1 Jan 2011, when she awoke, the pruritic macular rash was noted from mid-thigh to her feet and on her forearms up to her elbows. It was pruritic and areas were becoming sore from scratching during the night. She also said her fingers and hands were swollen, but denies redness or swelling of joints. She had not self-treated until afternoon of 1/1/2011 when she took a couple of BENADRYL without significant change in symptoms. On the afternoon of 1/1/2011, after climbing a flight of stairs, she reported feeling winded, and her friend urged her to seek evaluation. Patient went to ER where she  was treated for an allergic reaction. She received Epinephrine and BENADRYL IM and received a dose of oral Prednisone. She continued to c/o itching and skin crawling. An IV was initiated and she was given additional medications intravenously; she is not sure what she received, but thinks there were 3 separate medications. The itching improved, but the splotchy rash continued. She was released and instructed to take OTC ZANTAC and was prescribed an oral Prednisone 10 mg taper (4tabs x 2 days, 3 tabs x 2 days, 2 tabs x 2 days, & 1 tab x 2 days), as well as another medication (not sure of name , but it was a pink and yellow capsule). Notes from visit not visible, but discharge instructions noted prescriptions for Prednisone and VISTARIL. Reports rash and pruritus continued to improve over the weekend and for the most part, was gone by Monday, 1/3/2011, when she was seen at clinic. She was prescribed Cetirizine 10 mg daily, but patient did not take as symptoms were almost gone. SM felt well on 30 Dec. prior to vaccine receipt. Denied new medications. Patient denied other known exposures. No allergies to medications, food, latex or insect stings. Denies previous adverse events following receipt of vaccines prior to December 2010.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling at the inject site, it is approximately the size of a golf ball. Very Sore, had some burning sensations the first night. It is still swollen and sore.
Age: 3.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Approximatley 7-8 hours after getting the shots the child began itching with hives and no fever.  During the day the itching goes away, but comes back at night. Mother took child to the family doctor on Friday (48 hrs later) and was told the MMR did this. Mother giving medicine from doctor to help with the itching.  Child is slowly fetting better.  On 2/1/11 child still had hives over the entire body, but they were getting better.
Age: 1.06
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Hypophagia, Lethargy, Swelling face
Clinical narrative: 3 hours after vaccine axillary temp was 100.6, 10 hours later 101.0, 12 hours later temp was 104.0. Mother gave Tylenol and sponge bath q 30 mins till temp was 101.  Child was lethargic and face looked swollen to the mother. The fever was 101.0 off and on the next day. Child not eating or drinking as much. Third day she still has temp. 100.6 with out Tylenol. Sixth day she is getting better; eating, drinking, and playing.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Oropharyngeal pain, Streptococcus test, Streptococcus test negative
Clinical narrative: Patient alleges after receiving vaccine she began to feel fatigue and joint pain, sore throat this continued until approximately 12/16/2011.  She saw her PCP 11/10, 3 times in December and was told it was viral and no treatment was given.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Viral infection
Clinical narrative: Patient alleges after receiving vaccine she began to feel fatigue and joint pain, sore throat this continued until approximately 12/16/2011.  She saw her PCP 11/10, 3 times in December and was told it was viral and no treatment was given.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Lacrimation increased, Nervousness, Pharyngeal oedema, Throat irritation
Clinical narrative: Felt very shaky, eyes were burning and runny, throat raw and felt swollen. Later took Benadryl and it relieved symptoms.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure before pregnancy
Clinical narrative: Information has been received from a consumer for GARDASIL a Pregnancy Registry product, who in approximately August 2010, was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot# not reported) and in approximately November 2010, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot# not reported). The consumer stated that she became pregnant around September 2010. LMP (last menstrual period) was approximately in September 2010. EDD (estimated date of delivery) was on 08-JUN-2011 and then she experienced a miscarriage around December 2010. She also stated that she felt fine. Therapy with GARDASIL was discontinued. At the time of the report, the consumer recovered. The consumer did not seek medical attention. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Acrochordon, Apgar score normal, Congenital naevus, Drug exposure during pregnancy, Haemoglobin decreased
Clinical narrative: Information has been received from a nurse concerning a 21- year-old female patient with a medical history of papanicolaou smear abnormal who on 01-APR-2009 was vaccinated with GARDASIL (Lot # 661954/1496X).  There were no concomitant medications.  The patient had recently become pregnant.  She found out she was pregnant on 01-JUN-2009.  This information was previously reported in WAES 0906USA00715.  Follow up information was received from the licensed practical nurse, via medical record reported that on 13-JAN-2010 the 22 year old female patient delivered a normal female infant without any congenital anomaly.  The abnormal lab data for the mother is Chlamydia positive.  The lab data for the baby is apgar score 9 for 1', 9 for 5', birth weight 3391 gms, length 52.1 cm, OFC 33.17 cm, Hgb 12.9/37.2 to 11.8/39.0, skin exam showed mongoliem on buttracks, head fontanets exam showed molding, eyes showed b/c kk, chest lungs exam showed small left nipple skin tag, GU exam showed large labra, spine/back exam showed closed sacral dimple.  The baby was vaccinated with a dose of hepatitis vaccine on 13-JAN-2010 and was discharged on 14-JAN-2010, discharged weight was 3222 gms.  Upon internal review, mongoliem on buttrack was considered to be a congenital anomaly.  The mother's information was captured in WAES 0906USA00715.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Oedema peripheral, Pruritus, Rash, Throat irritation, Urticaria
Clinical narrative: Urticaria on bil arms, legs, assoc with itching to include throat itching. Got worse on 20 Nov, the rash was even worse with some feet swelling and hand swelling, BENADRYL was helping control rash. On 22 Nov finally started to improve and resolved over couple days. No peeling or skin scarring. No clear arthralgia/arthritis. No fevers.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Appendicitis, Endotracheal intubation complication, Extubation, Laparoscopic surgery
Clinical narrative: Our son (13) began to complain of stomach pains the evening of Feb. 2, 2011.  He had a very difficult night the night of 2/1-2/2/11.  On Wed., Feb. 2, he was diagnosed with acute appendicitis at 4pm and had surgery at 9pm at Hospital.  The surgery was laporoscopic and successful.  The appendix had not ruptured.  However, when his breathing tube was removed (late Wed. night, Feb. 2, 2011), his larynx spasmed, collapsed, blocked the airway, causing pressure to build up and fluid to be pushed into his lungs.  He was released from the hospital on Friday, Feb. 4, 2011 and is now recovering at home.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Laryngospasm, Obstructive airways disorder, Pulmonary arterial pressure, Pulmonary oedema
Clinical narrative: Our son (13) began to complain of stomach pains the evening of Feb. 2, 2011.  He had a very difficult night the night of 2/1-2/2/11.  On Wed., Feb. 2, he was diagnosed with acute appendicitis at 4pm and had surgery at 9pm at Hospital.  The surgery was laporoscopic and successful.  The appendix had not ruptured.  However, when his breathing tube was removed (late Wed. night, Feb. 2, 2011), his larynx spasmed, collapsed, blocked the airway, causing pressure to build up and fluid to be pushed into his lungs.  He was released from the hospital on Friday, Feb. 4, 2011 and is now recovering at home.
Age: 1.02
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: fever of 102, not responding to Tylenol
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Headache, Injection site swelling, Malaise
Clinical narrative: fever, swelling at administration site, H/A, myalgia, arthragia, malaise, chills, nausea, decreased limb mobility
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia, Nausea, Pyrexia
Clinical narrative: fever, swelling at administration site, H/A, myalgia, arthragia, malaise, chills, nausea, decreased limb mobility
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Cough, Dyspnoea, Pyrexia, Vomiting
Clinical narrative: Mother called said baby woke up and vomited and had shortness of breath. I advised mother to call her physican and take baby to emergency room. She said baby had a mild fever and cough before vaccines. She did not know what baby's temp was now. She could not find thermometer. I again advised her if baby is SOB she need to go to ER and to call her doctor.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Agitation, Crying, Dizziness, Feeling abnormal, Hyperventilation
Clinical narrative: Approximately 1.5 hours after influenza vaccine was administered Pt inquired about the adverse reactions of the flu vaccine and said she felt dizzy and her left arm was numb and tingling. Arm without redness or swelling upon assessment. Pt alert, no signs of distress. BP was 110/70. Instructed patient that if she was feeling dizzy she needed to call someone to pick her up and drive her to her MD because dizziness was the only symptom that could remotely be associated with adverse reaction to the influenza vaccine and that something else could be going on with her that needed medical attention. She also had her 15 month old daughter with her.  After this was suggested she stated she would sit for awhile and see if she got better. RN asked her again to contact someone to come drive her home even if she felt better.  Pt then started crying, hyperventilating and saying she felt funny.  BP 122/80, pulse 72 and regular. Continued to cry and hyperventilate and would not calm down. Client was texting on her phone repeatedly to a family member to come and get her.  EMS activated due to pts increased aggitation and inability to calm down.  Pt transported to local ER by EMS.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Approximately 1.5 hours after influenza vaccine was administered Pt inquired about the adverse reactions of the flu vaccine and said she felt dizzy and her left arm was numb and tingling. Arm without redness or swelling upon assessment. Pt alert, no signs of distress. BP was 110/70. Instructed patient that if she was feeling dizzy she needed to call someone to pick her up and drive her to her MD because dizziness was the only symptom that could remotely be associated with adverse reaction to the influenza vaccine and that something else could be going on with her that needed medical attention. She also had her 15 month old daughter with her.  After this was suggested she stated she would sit for awhile and see if she got better. RN asked her again to contact someone to come drive her home even if she felt better.  Pt then started crying, hyperventilating and saying she felt funny.  BP 122/80, pulse 72 and regular. Continued to cry and hyperventilate and would not calm down. Client was texting on her phone repeatedly to a family member to come and get her.  EMS activated due to pts increased aggitation and inability to calm down.  Pt transported to local ER by EMS.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, PER, RVX
Symptoms: Abdominal discomfort, Abdominal pain, Crying, Diarrhoea, Diet refusal
Clinical narrative: My son was given the rotavirus vaccine at his 8 week check up.  It is unclear how much of it he even swallowed, as he spit out large amounts and the nurse had a difficult time getting him to take it.  He was crying quite a bit during the administration resisting it.  About 30 min. after the dose he nursed just fine and then fell asleep for several hours. He awoke screaming in pain...certainly not just your typical "I'm hungry,  tired, or want to be held cry".  My baby is typically a very mellow baby, so this was especially concerning to us.  Patient screamed for several hours...he would not nurse or take his pacifier.  He stopped for approximately 3-4 min increments about every hour and then the screaming started again.  His fists were tightly clenched and his toes flexed as he cried.  His belly was very, very tight and I could tell that he was having a lot of abdominal pain.  After approx 3 hours of crying I placed him in a very warm bath and massaged his belly.  This seemed to calm him down a little and he had a small bowel movement, which seemed to relax his tight belly as well.   He ate after that as well.  For the rest of the evening, the screamed continued but did become less in duration and frequency.  Through the night, he would scream about 10 min and then have an enormous bowel movement.....intense diarrhea.  The diarrhea was gone by late the next morning and the screaming and stomach pain stopped as well.   Ironically, my now three year old daughter demonstrated the EXACT same reaction after and course of events after her 8 week dose.  For this reason, we decided NOT to give her the 4 and 6 month doses.