chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Sensory disturbance, Speech disorder
Clinical narrative: The pt received seasonal influenza IM right arm on 12/1/09 and H1N1 mist on 12/8/09 without immediate adverse reaction. The pt was healthy at the time of the vaccinations. On 12/20/09 the pt awoke and noted right lower facial weakness (drooping and the sensation of being stretched) and difficulty speaking which lasted several seconds. She reported having similar episodes each day, increasing in frequency (2-4 episodes/day) and continuing to last a few seconds. Beginning 12/23/09 the pt also noted right arm weakness and numbness associated with the facial symptoms. On 12/30/09 she noted that the episodes increased to about 6/7 per day and lasted 45-60 seconds. She was evaluated by a neurosurgeon who is a family friend. She was treated with anti-inflammatory medication and vitamin B complex IM (without improvement in the pt's symptoms). On 1/11/10 the pt experienced about 22 episodes of right sided facial weakness and right arm weakness. Additionally, the pt experienced facial pain (10/10). The pt was seen in the ER. Evaluation included a CT of the head and MRI of the brain (see below). The pt was evaluated by neurology on 1/12/10 and had a normal PE except for 1+ DTRs UE. EEG and LP performed (see below). IV SOLU-MEDROL 1gm qd for 3 days initiated without impact on the pt's symptoms. Per neurology on 1/21/10: "The MRI is more suggestive of MS than ADEM/post vaccinial encephalomyelitis considering the involvement of the corpus callosum as well as the presence of other nonenhancing lesions and overall mild symptomatology. The lack of possible presenting symptom of the underlying demyelinating disorder." Rebif initiated on 1/25/10. Pt had resolution of facial and arm symptoms within 2 weeks. Symptoms: disturbance of skin sensation, symptom, facial weakness, disturbance, speech NEC, paralysis, transient, limb.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Fever x 4 day. Enlarge L axillary lymph node joint muscle and aches.
Age: 23.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Lymphadenopathy, Rash maculo-papular, Rash pruritic, Skin lesion
Clinical narrative: 23 y/o male, w/ 2 day h/o widespread rash w/ pruritus on anterior & posterior trunk b/l arms. Received SPV & AVA # 1 3/7/2010. Medical exam 3/17/2010: 2-> 10mm macules, papules on anterior & posterior trunk, b/l arms. Typical SPV site until 3/15 when following PT, site became increasing red, hot & highly pruritic associated with palpable lymph node left axilla. No respiratory difficulties, other systemic symptoms or fever. As of 3/29/2010 SM reported lesions cleared no itching or systemic symptoms, & SPV site still healing.
Age: 23.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Skin warm
Clinical narrative: 23 y/o male, w/ 2 day h/o widespread rash w/ pruritus on anterior & posterior trunk b/l arms. Received SPV & AVA # 1 3/7/2010. Medical exam 3/17/2010: 2-> 10mm macules, papules on anterior & posterior trunk, b/l arms. Typical SPV site until 3/15 when following PT, site became increasing red, hot & highly pruritic associated with palpable lymph node left axilla. No respiratory difficulties, other systemic symptoms or fever. As of 3/29/2010 SM reported lesions cleared no itching or systemic symptoms, & SPV site still healing.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling
Clinical narrative: Patient woke up morning of 3/25/10 and lower lip is swollen. No other c/o or s/s. FNC to 1) come to MCHD 2) See PCP or 3) Go to ER today for evaluation. Pt called clinic on 4-1-10 & told me she went to ER 3/25 & was told swollen lip due to spider bite.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: Mother calls clinic at 12:50pm 3/25/10 to report patient had large red reaction around the site of injection to the extent of covering the back upper arm the day following the injection. Redness also accompanied by a lump felt under the skin around injection site. By Wednesday 3/24, there became pain and a lump on the "inside, front of her left upper arm". Redness has resolved since Tuesday, but both arms are painful to touch.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Cough, Diarrhoea, Dizziness
Clinical narrative: Pain burning itching severe, pain body aches, fever, nausea & diarrhea, stuffy nose/congestion/cough. Started immediately. Skin out break on spine & across back, general malaise, weakness, dizziness. New outbreak of shingles or chickenpox on 4/7/10 being treated by Dr. with ACYCLOVIR and pain.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Malaise, Nasal congestion, Nausea
Clinical narrative: Pain burning itching severe, pain body aches, fever, nausea & diarrhea, stuffy nose/congestion/cough. Started immediately. Skin out break on spine & across back, general malaise, weakness, dizziness. New outbreak of shingles or chickenpox on 4/7/10 being treated by Dr. with ACYCLOVIR and pain.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Respiratory tract congestion, Skin disorder
Clinical narrative: Pain burning itching severe, pain body aches, fever, nausea & diarrhea, stuffy nose/congestion/cough. Started immediately. Skin out break on spine & across back, general malaise, weakness, dizziness. New outbreak of shingles or chickenpox on 4/7/10 being treated by Dr. with ACYCLOVIR and pain.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Pain burning itching severe, pain body aches, fever, nausea & diarrhea, stuffy nose/congestion/cough. Started immediately. Skin out break on spine & across back, general malaise, weakness, dizziness. New outbreak of shingles or chickenpox on 4/7/10 being treated by Dr. with ACYCLOVIR and pain.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Diarrhoea, Screaming, Vomiting
Clinical narrative: 3/20/10 screaming uncontrollably. 3/23/10 vomiting began. 3/24/10 watery stools.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), HPV4, TDAP, VARCEL
Symptoms: Syncope, Tremor
Clinical narrative: 15 minutes after vaccines patient walked 1 block to school. During this week she tells me she fainted 2X. Patient went to her teacher who told her to go home but call 911 or clinic if any trouble breathing. Teacher told this nurse patient was shaky. I called patient at home X3. Call if symptoms reoccur or elevation of symptoms. "I feel fine". Reviewed v/s again over the phone. She has them with her. Guardian is with her & says she is good. Will call 911 if symptoms reoccur.
Age: 1.53
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, & swelling at site of injection - cool compresses.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: No adverse reaction as of 3/25/10 (ZOSTAVAX given instead of Varicella).
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Soft tissue swelling and erythema at site of injection which tracked down into elbow. Not suggestive of cellulitis. Appeared to be non absorbed medium causing localized reaction.
Age: 2.4
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: VARIVAX given in RA while patient lying down, due to past issues with imms and fainting. As patient stood up he got dizzy and nauseated and vomited within 5 minutes of administration.
Age: 22.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Morning after vaccination developed itchy papular rash across chest.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Computerised tomogram normal, Gait disturbance, Henoch-Schonlein purpura, Joint swelling
Clinical narrative: 1/11/10 Abd pain doctor appt. order CT scan. Findings normal. 1/19/10 spots all over lower extremities, knee and foot swelled up could not walk. Went to ER -diagnosed with HSP. X-rays, labs and transferred to hospital. Stayed overnight discharged in AM 1/20/10. No known cause.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Laboratory test, Oedema peripheral, Skin discolouration, Urine analysis, X-ray
Clinical narrative: 1/11/10 Abd pain doctor appt. order CT scan. Findings normal. 1/19/10 spots all over lower extremities, knee and foot swelled up could not walk. Went to ER -diagnosed with HSP. X-rays, labs and transferred to hospital. Stayed overnight discharged in AM 1/20/10. No known cause.
Age: 50.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Back pain, Musculoskeletal discomfort, Musculoskeletal stiffness, Pain, Sleep disorder
Clinical narrative: Lower back discomfort (mainly central, lower back) began within a couple hours of my receiving the vaccine. The discomfort slowly intensified throughout the day. By evening there was stiffness and at times along with the steady discomfort, there would be sharp, stabbing pains experienced upon certain movements. Awoke in the middle of the night with severe stiffness, pain and discomfort. That morning (day after the vaccine), I made a doctor's appointment. My regular physician was booked for the day so I took an appointment with my wife's physician. Dr. gave me Skelaxin 800mg to take as needed along with ibuprofen and use of a heating pad. She told me to contact my physician if symptoms do not get better after a few days. Sometimes it would appear the medication(s) and/or heating pad helped somewhat but only for a very short time, maybe an hour or two at the most. I have since tried various over-the-counter pain relievers such as Tylenol, Advil and Aleve with little success. Nights and mornings are the most difficult with this ongoing condition, even with the heating pad. Last evening (3/39/2010) however, without taking any medications, I was elated to be experiencing much reduced pain, stiffness and general discomfort between the hours of 5:00 PM and 8:00 PM. So much so that I was confident I was entering the final stages of whatever was ailing me. Sadly, this was short-lived, as it all steadily came back through the remainder of the evening. I awoke last night once again in fairly severe pain and stiffness. I got some relief by using a reclining chair with a rolled blanket for lumbar support. I slept a little more like this but when I awoke, I was again in pain and stiffness. I have made a second appointment with a doctor for this evening. Please respond to this writing via email so that I may send updates to you.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Hypoacusis, Induration, Malaise
Clinical narrative: 3/17/10 Quarter size on left arm hot, freezing at night, couldn't get warm. 3/19 spot 2x2 red/hot, itching still cold. 3/19 spot 4x4 red/hot, itching 3/20 still 4x4 & hot. Thought I was coming down with a odd don't feel good. 3/21 spot still there but fading & cold gone. 3/22 spot down to quarter size. 3/23 spot quarter size. Redness finally fading. Redness from day one all around the site, hard & red.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular, Skin warm, Swelling
Clinical narrative: 3/17/10 Quarter size on left arm hot, freezing at night, couldn't get warm. 3/19 spot 2x2 red/hot, itching still cold. 3/19 spot 4x4 red/hot, itching 3/20 still 4x4 & hot. Thought I was coming down with a odd don't feel good. 3/21 spot still there but fading & cold gone. 3/22 spot down to quarter size. 3/23 spot quarter size. Redness finally fading. Redness from day one all around the site, hard & red.
Age: 60.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Parotid gland enlargement, Swelling face
Clinical narrative: Upon arising next morning after immunization.  Noted swelling of both parotid glands & (slightly) face.  Confirmed on physical examination today.  No other abnormal physical findings other than swelling RIF. RMF.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abscess limb, Computerised tomogram, Computerised tomogram abnormal, Crying, Erythema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female with allergy to codeine and a history of Lyme disease and chronic ear infection as a baby who on 14-MAY-2008 was vaccinated with her first 0.5 ml IM dose of GARDASIL (lot # 659964/1978U), her second 0.5 ml IM dose of GARDASIL (Lot# 659054/0315Y) on 20-MAY-2009 and her third 0.5 ml IM dose of GARDASIL (Lot# 665266/1378Y) on 10-MAR-2010. The patient did not receive any concomitant vaccination on 10-MAR-2010. There was no concomitant medication. On 15-MAR-2010 the patient developed soreness/discomfort at the injection site on the left arm, she was crying in pain which was getting worse, and developed erythema that "comes and goes". The patient was seen by the physician on two occasions, once in the morning (AM) and again in the afternoon (PM). She was started on AUGMENTIN. The patient went to the emergency room (ER) and was not admitted to the hospital. On 16-MAR-2010 the patient was seen by the physician in the morning (AM). She was seen in the emergency room for increasing pain. She had "lots of swelling" in her left arm. Her right arm circumference was 11 inches but the left arm was 12.75 inches. A CT scan of the arm was performed which revealed a possible abscess forming which was later confirmed. Therapy with AUGMENTIN was discontinued and the patient was started on KEFLEX and BACTRIM. The patient returned to the doctor's office in the afternoon. The pain was worse and swelling the same. She was admitted to the hospital for pain control and possible incision and drainage of site. The patient was hospitalized for three days. On 18-MAR-2010 the patient had an incision and drainage of the abscess which was 9.8 cm x 3 cm x 5 cm, with 2 ounces of fluid removed. On 19-MAR-2010 the patient was discharged from the hospital. On 23-MAR-2010 the patient was seen by the physician for a follow-up physician's visit. She also had a follow-up visit with the Pediatric surgeon. The patient did not have another scheduled follow-up appointment with the physician. At the time of the report, the patient was recovering. It was also reported that the physician was concerned about similar adverse events related to the lot of the last dose of GARDASIL. The L.P.N. requested a lot check for lot# 665266/1378Y. The reporter considered possible abscess which was later confirmed, left arm was sore at injection site, crying in pain, increasing pain, erythema that comes and goes and swelling in her left arm to be other important medical events. A lot check has been initiated. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incisional drainage, Injection site discomfort, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female with allergy to codeine and a history of Lyme disease and chronic ear infection as a baby who on 14-MAY-2008 was vaccinated with her first 0.5 ml IM dose of GARDASIL (lot # 659964/1978U), her second 0.5 ml IM dose of GARDASIL (Lot# 659054/0315Y) on 20-MAY-2009 and her third 0.5 ml IM dose of GARDASIL (Lot# 665266/1378Y) on 10-MAR-2010. The patient did not receive any concomitant vaccination on 10-MAR-2010. There was no concomitant medication. On 15-MAR-2010 the patient developed soreness/discomfort at the injection site on the left arm, she was crying in pain which was getting worse, and developed erythema that "comes and goes". The patient was seen by the physician on two occasions, once in the morning (AM) and again in the afternoon (PM). She was started on AUGMENTIN. The patient went to the emergency room (ER) and was not admitted to the hospital. On 16-MAR-2010 the patient was seen by the physician in the morning (AM). She was seen in the emergency room for increasing pain. She had "lots of swelling" in her left arm. Her right arm circumference was 11 inches but the left arm was 12.75 inches. A CT scan of the arm was performed which revealed a possible abscess forming which was later confirmed. Therapy with AUGMENTIN was discontinued and the patient was started on KEFLEX and BACTRIM. The patient returned to the doctor's office in the afternoon. The pain was worse and swelling the same. She was admitted to the hospital for pain control and possible incision and drainage of site. The patient was hospitalized for three days. On 18-MAR-2010 the patient had an incision and drainage of the abscess which was 9.8 cm x 3 cm x 5 cm, with 2 ounces of fluid removed. On 19-MAR-2010 the patient was discharged from the hospital. On 23-MAR-2010 the patient was seen by the physician for a follow-up physician's visit. She also had a follow-up visit with the Pediatric surgeon. The patient did not have another scheduled follow-up appointment with the physician. At the time of the report, the patient was recovering. It was also reported that the physician was concerned about similar adverse events related to the lot of the last dose of GARDASIL. The L.P.N. requested a lot check for lot# 665266/1378Y. The reporter considered possible abscess which was later confirmed, left arm was sore at injection site, crying in pain, increasing pain, erythema that comes and goes and swelling in her left arm to be other important medical events. A lot check has been initiated. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Clinical narrative: Hive-like rash spreading arms/legs -> torso, started around 24 hours after vaccine. No other known exposures. Tx; BENADRYL ->hydroxyzine, prednisone
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Flushing, Immediate post-injection reaction, Palpitations
Clinical narrative: Right after injection, felt flushed & heart racing. BENADRYL given 25mg.
Age: 1.99
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Rash
Clinical narrative: Mother reports child spent 3 hrs with father on 3/24/2010.  Upon return home, child had rash to back of neck and right arm.  Child left with father at 6 PM on 3/24 & returned at 9 PM.  No rash when he left, but rash upon his return.  Dr. notified.  Child received HEPA, DTP, & HIB on 3/23/10.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, VARCEL
Symptoms: Apnoeic attack, Chest X-ray normal, Computerised tomogram normal, Cyanosis, Electroencephalogram normal
Clinical narrative: 0n 3/25/10 Patient had immuns at approx. 0930 with lyncosce. Had sx lasting approximately 11/2 min prior to 12:46pm. Witnessed by mother. Had + LOL, suffering and arching, eyes rolled up, apneic with perioral cyanosis. EMS called and taken to ER. SAT labs, CXR, CT, EEG WNL. Admitted; 3/26/10. Dx Prob. Viral Syndrome with ass. febrile sx masked by Tylenol.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Gaze palsy, Laboratory test normal, Loss of consciousness, Opisthotonus
Clinical narrative: 0n 3/25/10 Patient had immuns at approx. 0930 with lyncosce. Had sx lasting approximately 11/2 min prior to 12:46pm. Witnessed by mother. Had + LOL, suffering and arching, eyes rolled up, apneic with perioral cyanosis. EMS called and taken to ER. SAT labs, CXR, CT, EEG WNL. Admitted; 3/26/10. Dx Prob. Viral Syndrome with ass. febrile sx masked by Tylenol.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, VARCEL
Symptoms: Syncope, Viral infection
Clinical narrative: 0n 3/25/10 Patient had immuns at approx. 0930 with lyncosce. Had sx lasting approximately 11/2 min prior to 12:46pm. Witnessed by mother. Had + LOL, suffering and arching, eyes rolled up, apneic with perioral cyanosis. EMS called and taken to ER. SAT labs, CXR, CT, EEG WNL. Admitted; 3/26/10. Dx Prob. Viral Syndrome with ass. febrile sx masked by Tylenol.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, VARCEL
Symptoms: Computerised tomogram, Condition aggravated, Convulsion, Herpes virus infection, Stomatitis
Clinical narrative: 0n 3/25/10 Patient had immuns at approx. 0930 with lyncosce. Had sx lasting approximately 11/2 min prior to 12:46pm. Witnessed by mother. Had + LOL, suffering and arching, eyes rolled up, apneic with perioral cyanosis. EMS called and taken to ER. SAT labs, CXR, CT, EEG WNL. Admitted; 3/26/10. Dx Prob. Viral Syndrome with ass. febrile sx masked by Tylenol.
Age: 47.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Acute respiratory distress syndrome, Altered state of consciousness, Chest X-ray abnormal, Computerised tomogram normal, Endotracheal intubation
Clinical narrative: Hx of diabetes, hypertension, and chronic renal failure with baseline cr of 1.7-2.1 that because quadriplegic secondary to acute demyelinating encephalomyelitis with onset of H1N1 vaccine in November of 2009. He was initially admitted to hospital on November 6th 2009 with flulike syndrome. Discharged and currently residing in a long term care facility.
Age: 47.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Influenza like illness, Pneumonia, Quadriplegia
Clinical narrative: Hx of diabetes, hypertension, and chronic renal failure with baseline cr of 1.7-2.1 that because quadriplegic secondary to acute demyelinating encephalomyelitis with onset of H1N1 vaccine in November of 2009. He was initially admitted to hospital on November 6th 2009 with flulike syndrome. Discharged and currently residing in a long term care facility.
Age: 63.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Respiratory depression
Clinical narrative: H1N1 vaccine was a one-time dose. Symptoms: Symptoms: 1. RespDepression, 2. DYSPNEA (1/16/10@08-00).
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash all over body with fever
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood culture, Decreased appetite, Full blood count, Injection site mass, Laboratory test
Clinical narrative: Mom noted a lump on leg where shots were given. Also noted lymphadenopathy bilateral groins. Decrease appetite.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Lymphadenopathy, Respiratory syncytial virus test, Urine analysis
Clinical narrative: Mom noted a lump on leg where shots were given. Also noted lymphadenopathy bilateral groins. Decrease appetite.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Condition aggravated, Lip swelling, Urticaria
Clinical narrative: HIVES, SWELLING OF LIPS, PT WAS GIVEN BENADRYL AND A NEBULIZER BREATHING TX AND TAKEN TO ER
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Eye pruritus, Eyelid oedema
Clinical narrative: Several hours after administration of H1N1 vaccine, pt developed itching in eyes, then swelling of eyelids. No rash or other symptoms.
Age: 25.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Client states that (L) upper arm vaccination site became progressively more painful, was hard hot to the touch, red and slightly swollen by the time she went to hospital ER for tx. Client received prescription for KEFLEX 500 mg. 1 tab 4x daily which she had not began as of 10:00 am on 3-30-10. No fever noted by clients went to ER 3-29-10 at approx 8:00 pm.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site discolouration, Injection site pruritus, Rash papular, Rash pruritic, Skin lesion
Clinical narrative: discoloration and itching at his SPV site.  Oct 08 he was seen for a pruritic erythmatous papule on rt upper chest that occurred post biopsy.  He was diagnosed as having a hypertropic scar.  He reported that he was treated by derm 7 months ago and it helped with the discoloration but it continues to itch.  Description of lesion, red, raised, smooth, within confines of his scar with itching.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, No reaction on previous exposure to drug, Pruritus, Rash
Clinical narrative: C/o that after vaccination of GARDASIL #3, developed a "rash of bumps" over left deltoid area. States it was itchy at onset. 3/22/10 No SOB, extension of rash or itching when seen 3/25. Presents with localized 4x4 inch of tiny bumps over L deltoid No redness. No other sites of eruption over body. No problems with 1st two GARDASIL.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Within 15 minutes of shot my arm felt like it had been burned by an iron. The burning pain was extreme, unlike any other shot and lasted for about 15 hours. Then the soreness - rather typical for a shot -  settled in. The doctor refused to suggest any manner of relief -  could ice or pain meds or antihistamine relieved this? The hand out did not include any relevant information. This vaccine only available in this area at this drugstore -  more information and concern for patient needed in this situation.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: No known adverse events know at this time. *Newborn was given Season Flu A/B instead of HEPATITIS B vaccine.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received PNEUMOVAX in the clinic as per protocol and returned to clinic with swelling and pain left upper arm. NO rash, itching or dyspnea. No wheeze. Swelling of left deltoid at injection site with tenderness and mild warmth. No bruising or bleeding.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Decreased eye contact, Diarrhoea, Enzyme abnormality, Eye disorder, Hepatitis B antibody abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of mitochondrial dysfunction in a male subject of unspecified age who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included jaundice. There was no concurrent medications. On 24 May 2006 the subject received unspecified dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced mitochondrial dysfunction, immunological reaction, "eye contact", "speech problems", diarrhea, "skin issues" and "greater than 100 titer levels of hepatitis B". It was found upon testing, that the subject had greater than 100 titer levels of hepatitis B. The subject had a severe immune reaction and mitochondrial dysfunction. The mother of the subject inquired how to treat the enormous titer levels. The subject currently is 4-years old. This case was assessed as medically serious by GSK. The subject was treated with TYLENOL. At the time of reporting the mitochondrial dysfunction and immunological reaction were unresolved; eye disorder, speaking problem, diarrhea and skin problem were unspecified.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Hepatitis viral test, Hypersensitivity, Plasma cell disorder, Skin disorder, Speech disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of mitochondrial dysfunction in a male subject of unspecified age who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included jaundice. There was no concurrent medications. On 24 May 2006 the subject received unspecified dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced mitochondrial dysfunction, immunological reaction, "eye contact", "speech problems", diarrhea, "skin issues" and "greater than 100 titer levels of hepatitis B". It was found upon testing, that the subject had greater than 100 titer levels of hepatitis B. The subject had a severe immune reaction and mitochondrial dysfunction. The mother of the subject inquired how to treat the enormous titer levels. The subject currently is 4-years old. This case was assessed as medically serious by GSK. The subject was treated with TYLENOL. At the time of reporting the mitochondrial dysfunction and immunological reaction were unresolved; eye disorder, speaking problem, diarrhea and skin problem were unspecified.
Age: 53.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood test, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: Pain in hands, wrists, arms. Tingling in fingers, feet. Pain in palm of left hand - for 1 week - woke in night. After 1 month. Got a little better, but now tingling in hands still a problem, pain in hands and R -  wrist still happening, feet tingling is better. All started 1 week after vaccine given.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Rea vaccine 3/22/10 in afternoon. Afternoon of 3/23 pain and limited motion of left arm began. 3/30/10-Pain and limited movement of left arm continues-Reports can move arm and left to side but unable to lift arm toward front without pain. Hurts worse in am. Has subsided slightly past few days.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm, Urticaria
Clinical narrative: 80 mm wheal to left deltoid, warm to redness, painful and swelling.
Age: 1.14
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomited X 1 after nap.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC
Symptoms: Wrong drug administered
Clinical narrative: Infant seen for 2 month well check and vaccines were ordered. Hepatitis A was inadvertently ordered and administered along with PENTACEL and PREVENAR.
Age: 1.02
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Rash morbilliform, Skin warm
Clinical narrative: 8 days after MMR, VZV, pt started tacticle temp x 24 hrs. Nex tday, broke out in morbilliform rash (small, raised blister bump with papule over scalp, face, thigh and torso). No other lesion subsequent.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dermatitis atopic
Clinical narrative: Atopic Dermatitis. Treatment Triamcinalone.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Myalgia
Clinical narrative: Waves of muscle pain, significant rash and soreness at site of injection and redness.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea, Visual impairment
Clinical narrative: My nose just started running clear liquid. I can't keep up with it. I use toilet paper now because Tissues won't cover it. My vision has been affected. It is harder to see things like I use to since the flu shot. Finally my blood appears thinner I bruise easier now. I told my doctor and he did nothing.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Neuralgia
Clinical narrative: Localized erythema and tenderness at site of vaccination onset 12/12/2009. On 12/12/29 patient complained of nerve pain on the outside of her right thigh to the knee.
Age: 92.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Petechiae, Pruritus
Clinical narrative: Itching, Peticiae rash under the skin - back, shoulders, upper arms, and upper legs, arms & shoulders became red. Self treatment with CALAHIST liquid
Age: 1.42
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Firmness at site of administration. Left thigh with very mild swelling and redness. Redness moved a little past original mark. Was seen at another hospital on day one and prescribed Keflex.
Age: 70.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased, Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Throw-up, Feaver (101.7), Diarrhea, Nausea. Taken Pepto-Bismol
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: redness in arm and hot to the touch
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Condition aggravated, Diarrhoea, Insomnia, Irritability, Pyrexia
Clinical narrative: It began as the typical drowsiness and fussiness after shots. This lasted 2 days, then he started getting low fevers of 99.8 or so, trouble falling and staying asleep, and was extremely fussy, to the point of being inconsolable. He had a couple episodes of vomiting and diarrhea. Total time lasted about 10 days, although, he has been more fussy and hasn't slept as well ever since. Also, his reflux that previously existed has become much worse and he is on medication for it now (Zantac).  During his vaccine reaction, we called the doctor's office several times to talk to the advice nurse. They told us the vaccine reaction should only last a couple of days, and so when he became more and more inconsolable we took him into ER, not knowing what was wrong. They told us it was probably a vaccine reaction. Later in the week we took him to the doctor's office as he was still not recovering. He finally got better after 10 days. Again, he still does not seem quite as happy of a baby since then, his stomach seems more touchy and his reflux is worse.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Somnolence, Vomiting
Clinical narrative: It began as the typical drowsiness and fussiness after shots. This lasted 2 days, then he started getting low fevers of 99.8 or so, trouble falling and staying asleep, and was extremely fussy, to the point of being inconsolable. He had a couple episodes of vomiting and diarrhea. Total time lasted about 10 days, although, he has been more fussy and hasn't slept as well ever since. Also, his reflux that previously existed has become much worse and he is on medication for it now (Zantac).  During his vaccine reaction, we called the doctor's office several times to talk to the advice nurse. They told us the vaccine reaction should only last a couple of days, and so when he became more and more inconsolable we took him into ER, not knowing what was wrong. They told us it was probably a vaccine reaction. Later in the week we took him to the doctor's office as he was still not recovering. He finally got better after 10 days. Again, he still does not seem quite as happy of a baby since then, his stomach seems more touchy and his reflux is worse.
Age: 0.69
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash which had also appeared after last immunizations.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Asthenia, Chest X-ray, Constipation, Culture urine
Clinical narrative: High Fever, constipation, weak and listless, stomach ache, painful body all over, unable to hold her head up, no appetite, spitting up, could not sit by herself or walk without falling, very sleepy all the time, dehydrated.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Dehydration, Differential white blood cell count, Gait disturbance, Listless
Clinical narrative: High Fever, constipation, weak and listless, stomach ache, painful body all over, unable to hold her head up, no appetite, spitting up, could not sit by herself or walk without falling, very sleepy all the time, dehydrated.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Pain, Platelet count increased, Pyrexia, Somnolence, Urine analysis
Clinical narrative: High Fever, constipation, weak and listless, stomach ache, painful body all over, unable to hold her head up, no appetite, spitting up, could not sit by herself or walk without falling, very sleepy all the time, dehydrated.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: High Fever, constipation, weak and listless, stomach ache, painful body all over, unable to hold her head up, no appetite, spitting up, could not sit by herself or walk without falling, very sleepy all the time, dehydrated.
Sex: U
Vaccine: FLU(H1N1), FLU3
Symptoms: Abdominal pain
Clinical narrative: Initial report received on 16 March 2010 for the above-mentioned trial. This report was received from a phase II trial with investigational product MONOVALENT FLU A/H1N1 PRESERVATIVE or FLUZONE SV 2009-2010 or PLACEBO for which sanofi pasteur is not the sponsor. SAE Term: Hospitalization for Abdominal Pain. Onset Date: 22 January 2010. Causality: Not Provided. Serious Criteria: Hospitalization/Prolonged Hospitalization. Documents held by sender: None.
Sex: U
Vaccine: FLU(H1N1), FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Initial report received on 17 March 2010 from a trial. This report was received from a phase II trial with investigational product MONOVALENT FLU A/H1N1 PRESERVATIVE or FLUZONE SV 2009-2010 or PLACEBO for which sanofi pasteur is not the sponsor. SAE Term: Hospitalized for Numbness in Right Leg. Onset Date: 19 February 2010. Causality: Not reported. Seriousness Criteria: Hospitalization/Prolonged Hospitalization. Documents held by sender: None.
Sex: U
Vaccine: FLU(H1N1), FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received on 17 March 2010 from a local health authority for the above-mentioned trial. This reported was received from a phase II trial with investigational product MONOVALENT FLU A/H1N1 PRESERVATIVE or FLUZONE SV 2009-2010 or PLACEBO for which sanofi pasteur is not the sponsor.
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Pyrexia
Clinical narrative: Headache, trawicat fever of approximately 102.
Sex: U
Vaccine: HPV4
Symptoms: Myelitis transverse, Quadriplegia
Clinical narrative: Information has been received from a company representative who overheard a physician mention information concerning a patient who on an unknown date was vaccinated with a dose of GARDASIL (route, dose and lot number not provided). On an unknown date, the patient experienced "transverse mellitus" after getting GARDASIL which resulted in quadriplegia. The patient's outcome was unknown at the time of reporting. Upon internal review, myelitis transverse and quadriplegia were considered to be an other important medical event. This is one of two reports from the same source. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1)
Symptoms: Dyspnoea, Heart rate increased, Pallor, Wheezing
Clinical narrative: Patient was given H1N1 nasal mist by RN at school. 10 minutes later complained of shortness of breath, audible wheezing and dizziness. Appeared pale. RN administered 1 epi pen preloaded at 0.015mg epi 1:100 and called EMS. Patient then complained of " tongue feeling too big " and Mom on scene states patient's voice sounds deeper than normal. Patient then tolerates IV and benadryl administration. Patient transferred to Hospital ED and treated with tylenol, solu-medrol, zantac, proventil, orapred, benadryl, focalin XR and catapres.
Age: 8.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1)
Symptoms: Dizziness, Dysphonia, Dyspnoea, Pallor, Swollen tongue
Clinical narrative: Patient was given H1N1 nasal mist by RN at school. 10 minutes later complained of shortness of breath, audible wheezing and dizziness. Appeared pale. RN administered 1 epi pen preloaded at 0.015mg epi 1:100 and called EMS. Patient then complained of " tongue feeling too big " and Mom on scene states patient's voice sounds deeper than normal. Patient then tolerates IV and benadryl administration. Patient transferred to Hospital ED and treated with tylenol, solu-medrol, zantac, proventil, orapred, benadryl, focalin XR and catapres.
Age: 8.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1)
Symptoms: Wheezing
Clinical narrative: Patient was given H1N1 nasal mist by RN at school. 10 minutes later complained of shortness of breath, audible wheezing and dizziness. Appeared pale. RN administered 1 epi pen preloaded at 0.015mg epi 1:100 and called EMS. Patient then complained of " tongue feeling too big " and Mom on scene states patient's voice sounds deeper than normal. Patient then tolerates IV and benadryl administration. Patient transferred to Hospital ED and treated with tylenol, solu-medrol, zantac, proventil, orapred, benadryl, focalin XR and catapres.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTP, HEPA, HPV4, MNQ, TDAP
Symptoms: Autoimmune disorder, Blood test, Bone scan, Hypoaesthesia, Juvenile arthritis
Clinical narrative: Information has been received from a register nurse concerning a 12 year old female with no pertinent medical history and no known drug allergies who on 09-JUL-2009 was vaccinated IM into right deltoid with a first 0.5ml dose of GARDASIL (lot# 661953/1130X). Concomitant therapy included ADACEL, DTaP, MENACTRA, and HAVRIX. At the end of July 2009 or beginning of August 2008, the patient experienced numbness of the fingers and toes. Shortly after, the patient was diagnosed with juvenile rheumatoid arthritis sometime before school started. The patient was seeing an unspecified specialist through an office visit. At the time of the report, the patient had not recovered. Juvenile rheumatoid arthritis was considered to be disabling by the reporter because of affecting eye sight and mobility. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTP, HEPA, HPV4, MNQ, TDAP
Symptoms: Sensory loss, X-ray
Clinical narrative: Information has been received from a register nurse concerning a 12 year old female with no pertinent medical history and no known drug allergies who on 09-JUL-2009 was vaccinated IM into right deltoid with a first 0.5ml dose of GARDASIL (lot# 661953/1130X). Concomitant therapy included ADACEL, DTaP, MENACTRA, and HAVRIX. At the end of July 2009 or beginning of August 2008, the patient experienced numbness of the fingers and toes. Shortly after, the patient was diagnosed with juvenile rheumatoid arthritis sometime before school started. The patient was seeing an unspecified specialist through an office visit. At the time of the report, the patient had not recovered. Juvenile rheumatoid arthritis was considered to be disabling by the reporter because of affecting eye sight and mobility. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, DTP, HEPA, HPV4, MNQ, TDAP
Symptoms: Hypoaesthesia, Juvenile arthritis, Mobility decreased, Sight disability
Clinical narrative: Information has been received from a register nurse concerning a 12 year old female with no pertinent medical history and no known drug allergies who on 09-JUL-2009 was vaccinated IM into right deltoid with a first 0.5ml dose of GARDASIL (lot# 661953/1130X). Concomitant therapy included ADACEL, DTaP, MENACTRA, and HAVRIX. At the end of July 2009 or beginning of August 2008, the patient experienced numbness of the fingers and toes. Shortly after, the patient was diagnosed with juvenile rheumatoid arthritis sometime before school started. The patient was seeing an unspecified specialist through an office visit. At the time of the report, the patient had not recovered. Juvenile rheumatoid arthritis was considered to be disabling by the reporter because of affecting eye sight and mobility. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood alkaline phosphatase increased, Cholangitis, Gamma-glutamyltransferase increased, Hepatobiliary scan, Jaundice
Clinical narrative: Fever, jaundice > admitted to hospital diagnosed with cholangitis of unknown cause treated with antibiotic IV x 14 days & recovered well all symptoms started within first 24hrs after vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever, jaundice > admitted to hospital diagnosed with cholangitis of unknown cause treated with antibiotic IV x 14 days & recovered well all symptoms started within first 24hrs after vaccine.
Age: 34.0
Sex: M
Vaccine: FLUN3
Symptoms: Eye swelling, Rash, Rash papular, Throat tightness
Clinical narrative: During the night of vaccination noticed swelling of his eyes and an irritated like rash on his arms. Non itching. Reported that his throat felt tight. With IM vaccination in Oct 08 he reported a heart rash like bumps on both arms. With IM vaccination in Oct 09 he was just recovering from pneumonia and he noticed little red non irritating bumps on injection arm only. Bumps lasted a couple of days.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Headache, Nausea, Paraesthesia, Skin tightness
Clinical narrative: Reported shortness of breath one day post vaccination with AVA # 2. Noted that his arm felt tight with tingling for one week and that his nodes felt tender. Noticed occasional headaches AVA # 4, increase in headaches after # 5. He would get 2-3 headaches per week, associated with nausea, and would last approx. 24 hrs. Headaches eventually cleared but returned after deployment. Also reported that approx 1 wk after #5, he wife said he stopped breathing while he was sleeping and she had to pound on him to wake him up. Symptom: Headache(784.0).
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Sleep apnoea syndrome
Clinical narrative: Reported shortness of breath one day post vaccination with AVA # 2. Noted that his arm felt tight with tingling for one week and that his nodes felt tender. Noticed occasional headaches AVA # 4, increase in headaches after # 5. He would get 2-3 headaches per week, associated with nausea, and would last approx. 24 hrs. Headaches eventually cleared but returned after deployment. Also reported that approx 1 wk after #5, he wife said he stopped breathing while he was sleeping and she had to pound on him to wake him up. Symptom: Headache(784.0).
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Culture negative, Erythema, Folliculitis, Pruritus, Rash papular
Clinical narrative: Patient 54 years old who is requesting an exemption from AVA re-vaccination, due to h/o chronic, intermittent pruritus/non-specific dermatitis vaccination, s/p receipt of AVA's (#1- 05-Nov-99; #2- 16-Nov-99l #3- 22Feb-2000). Denies any difficulty breathing, swallowing, wheezing, angioedema or urticaria immediately following receipt of AVA vaccinations. Two to three weeks after receipt of AVA #2 / AVA #3, upon deployment, the SM began to experience intense itching around his lower abdomen, extending to suprapubic area, base of genitalia, inner aspect of thighs, calves & underneath forearms, bilaterally. The itching which was intense during the day, but intolerable at night "it would itch till driving me crazy - felt like something was crawling under my skin. Denies dx of scabies or STD's or h/o high risk sexual behavior. The SM would unconsciously scratch affected areas at night, while sleeping, without relief of pruritus. Given OTC hydrocortisone cream by medic and military docs rx'd with topical triamcinalone & antifungals, po antibiotics & Allegra for relief of relief of itching. SM would experience recurrent episodes of similar symptoms, but stopped seeking medical care, as nothing was helping. Per AHLTA medical record review, SM's sx worsened considerably in August 2007, upon return from deployment. In Nov of 2007, SM was seen by dermatology x 3 (27-Nov-07, 14-Dec-07, 17-Dec-07) with documentation of "elongated excoriated patterns and inflamed papules with white cloudy fluid over lower abdomen & sparsely scattered on chest/shoulders. "Rx'd for FOLLICULITIS with KEFLEX 250  mg, 2 caps po gid x 10 days & ATARAX 10 mg po ghs, with excellent response. However, several days later, after participating in filed exercise competitions, the SM noticed new red, tender papules on his thigh and scrotal area. Culture of drainage from papules + for MRSA / Rx'd with Septra DS po BID # 14 (17-Dec-07). F/U nasal swab neg for MRSA. SM's Pruritic outbreaks not only associated with periods of deployment in warm, tropical climates. Most recent episodes of intense pruritus of abdomen and things was Dec 2009, while at Fort Bragg, but SM did not consult with a provider. Some relief with home remedies (olive oil and water spray). Never has seen Allergist. No skin testing. SM is scared that another dose of AVA will make his sx flare during his deployment leaving 02-Apr-10.