chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a physician refers to a 56 years old female patient. On an unspecified date, the patient was vaccinated (assuming subcutaneous) with a 0.65 ml dose of ZOSTAVAX (lot# not reported). Physician informed that a female patient was hospitalized for experiencing "cellulitis at the injection site." The patient was still at the hospital to date but the patient duration was unspecified by the reporter. Cellulitis at the injection site was considered as disability and an other important medical event by the reporter. The outcome of cellulitis at the injection site was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pyrexia
Clinical narrative: Erythema of right arm. Fever of 48 hrs duration.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Rash erythematous
Clinical narrative: Pt has a rash red dots for 3 days and is going away. Did not see an MD or ER. Encourage to see MD to identify allergy.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Constipation, Cough, Crying, Death, Decreased appetite
Clinical narrative: Cough, fussiness, fever, persistent crying, lack of appetite, cough, constipation, death.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Cough, fussiness, fever, persistent crying, lack of appetite, cough, constipation, death.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Red streaks down arm, swelling, causing hospitalization. No other information was given.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Discomfort, Grip strength decreased, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: On 8/27/12 pt called & reported on Fri, 8/24 he developed pain in (B) arches of feet/calves/hamstrings that got worse on 8/25 & 8/26. On 8/27, pt reported feet, calves, hamstrings pains pretty much gone but now with pain on top of (B) forearms with stiffness, On 8/28 at approximately 1:30 pm pt called to report inside of (B) forearms with pain & weakness, states can't grip, stated could not pull up socks or zipper this AM. Also now with discomfort in (B) Biceps & front on neck. Instructed to go to ER/Immediate care. On 8/29 I called pt. Pt reports, seen by MD in urgent care on 8/28 who referred him to hospital ER to see neurologist. Pt states told symptoms are 'Atypical' & to continues to monitor - if worse to return to ER if no resolution --> FU with PMD. Pt as of 8/29 states still with (B) arm pain, weakness with grip.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pain in extremity
Clinical narrative: On 8/27/12 pt called & reported on Fri, 8/24 he developed pain in (B) arches of feet/calves/hamstrings that got worse on 8/25 & 8/26. On 8/27, pt reported feet, calves, hamstrings pains pretty much gone but now with pain on top of (B) forearms with stiffness, On 8/28 at approximately 1:30 pm pt called to report inside of (B) forearms with pain & weakness, states can't grip, stated could not pull up socks or zipper this AM. Also now with discomfort in (B) Biceps & front on neck. Instructed to go to ER/Immediate care. On 8/29 I called pt. Pt reports, seen by MD in urgent care on 8/28 who referred him to hospital ER to see neurologist. Pt states told symptoms are 'Atypical' & to continues to monitor - if worse to return to ER if no resolution --> FU with PMD. Pt as of 8/29 states still with (B) arm pain, weakness with grip.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Oedema peripheral
Clinical narrative: 6 1/2 x 6 cm area of redness on (L) thigh, swelling of thigh - 14 cm circumference on (R), 15.5 cm circumference on (L).
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Dizziness, Dyspnoea, Erythema, Palpitations
Clinical narrative: Pt. seen at urgent care 8-30-12 with redness, palpitations, lightheaded, fever, cough, SOB, rash, swelling 1 day after vaccines. Racing heart.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: Pt. seen at urgent care 8-30-12 with redness, palpitations, lightheaded, fever, cough, SOB, rash, swelling 1 day after vaccines. Racing heart.
Age: 62.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Erythema, urticaria at injection site. No systemic symptoms, (L) deltoid.
Age: 53.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Generalized itching with hives that developed. 8 hours after vaccine administration per client. Client took a few spaced doses of BENADRYL with relief from symptoms. No itching or hives noted 48 hours after admin. When client seen for follow-up of something else.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling of the (L) deltoid warmth, no erythema or cellulitis.
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Balance disorder, Headache, Hypoaesthesia, Nausea
Clinical narrative: Vertigo, nausea, weakness, headache, & numbness & tingling in lower extremities, poor balance.
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Paraesthesia, Vertigo
Clinical narrative: Vertigo, nausea, weakness, headache, & numbness & tingling in lower extremities, poor balance.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Muscular weakness, Pain in extremity
Clinical narrative: Radiating pain built for days in left arm following vaccine administration. Pt is debilitated cannot exercise, open car door, difficulty dressing. Pt complains of weakness & pain from elbow to shoulder, not specific at administration site. Recommend neurologist as has no GP.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint pain, Injection site reaction, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain/stiffness neck/shoulder of vaccinated arm - progressively got worse. Saw MD 1 week later - MD gave Tramadol - not f/u yet.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed 2x1 cm area of redness & swelling at injection site.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysphagia, Feeling abnormal, Influenza like illness, Nausea
Clinical narrative: By 1700 "feels really bad" c/o sore throat, difficulty swallowing, flu like symptoms, body aches, chills and nausea. Taken to ED and given Epinephrine sq, benadry and ibuprofen.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: By 1700 "feels really bad" c/o sore throat, difficulty swallowing, flu like symptoms, body aches, chills and nausea. Taken to ED and given Epinephrine sq, benadry and ibuprofen.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Arm circumference 4 cm larger than other arm & redness & swelling & soreness.
Age: 1.26
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Rash generalised, Swollen tongue
Clinical narrative: Rash all over lower body, swelling tongue.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Biopsy skin, Blood pressure systolic decreased, Exfoliative rash, Hypotension, Rash erythematous
Clinical narrative: Patient began to develop rash about 36 hours after vaccine administration. Ten days later (9/1/12) she was admitted to our hospital with a generalized, erythematous rash which started in her extremities and spread to her trunk. Upon admission, the rash was desquamating in character and she was also hypotensive with SBP in the 70s. Patient was using OTC antihistamines which helped. In the hospital she received diphenhydramine 50 mg IV q8H PRN and triamcinolone cream applied to all rash areas. Patient was dicharged on 9/6/12.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Rash generalised
Clinical narrative: Patient began to develop rash about 36 hours after vaccine administration. Ten days later (9/1/12) she was admitted to our hospital with a generalized, erythematous rash which started in her extremities and spread to her trunk. Upon admission, the rash was desquamating in character and she was also hypotensive with SBP in the 70s. Patient was using OTC antihistamines which helped. In the hospital she received diphenhydramine 50 mg IV q8H PRN and triamcinolone cream applied to all rash areas. Patient was dicharged on 9/6/12.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Lymphadenopathy, Neck pain, Pain, Pyrexia
Clinical narrative: Fever, HA, neck pain, body aches. Fever broke Tuesday 9/4/12. Rash started on chest & back Wed. night 9/5/12. Glands are also swollen.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Fever, HA, neck pain, body aches. Fever broke Tuesday 9/4/12. Rash started on chest & back Wed. night 9/5/12. Glands are also swollen.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Right arm redness, swelling, itching, "welting"; treated with ibuprofen and Benadryl, looking a little better per mom on 09/06/2012.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Arthralgia, Chest X-ray, Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever, joint pain.
Age: 1.61
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 0.5ml of influenza vaccine given instead of 0.25ml.
Age: 43.0
Sex: F
Vaccine: ANTH, MEN
Symptoms: Abdominal pain, Back pain, Confusional state, Dyspnoea, Headache
Clinical narrative: Itching, rash on left chin, headache, backache, abdominal pain, difficulty breathing, rapid heart beat, difficulty sleeping, confusion, nightmares, eye sesitivity to light.
Age: 43.0
Sex: F
Vaccine: ANTH, MEN
Symptoms: Heart rate increased, Insomnia, Nightmare, Photophobia, Pruritus
Clinical narrative: Itching, rash on left chin, headache, backache, abdominal pain, difficulty breathing, rapid heart beat, difficulty sleeping, confusion, nightmares, eye sesitivity to light.
Age: 43.0
Sex: F
Vaccine: ANTH, MEN
Symptoms: Rash
Clinical narrative: Itching, rash on left chin, headache, backache, abdominal pain, difficulty breathing, rapid heart beat, difficulty sleeping, confusion, nightmares, eye sesitivity to light.
Age: 32.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient was seen in ED on 8/23/12 for a laceration.  Tetanus/Diphtheria vaccine was administered.  On 8/30/12, patient returned to ED complaining of redness with some swelling to the injection site.  Ceftriaxone 1 gm IM x1 and Atarax 25 mg PO x1 were given.  Patient was discharged home and was told to follow-up in 2 days in ED.  As of 9/6/12, patient has not returned to ED.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Discomfort, Dizziness, Nausea, Retching
Clinical narrative: Extreme dizziness and nausea near vomiting gagging. Dizziness still persisting as of 09/06/2012 but milder but very uncomfortable. Taking Promethazine 25 mg for stomach problems.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Vertigo
Clinical narrative: Extreme dizziness and nausea near vomiting gagging. Dizziness still persisting as of 09/06/2012 but milder but very uncomfortable. Taking Promethazine 25 mg for stomach problems.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Discomfort, Dizziness, Nausea, Retching
Clinical narrative: Extreme Vertigo.  Sought Medical treatment and was prescribed Meclizine.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Vertigo
Clinical narrative: Extreme Vertigo.  Sought Medical treatment and was prescribed Meclizine.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Muscle spasms
Clinical narrative: Patient given HPV4 1st dose and MCV4 #2 within 10 minutes of receiving vaccines patient started with severe cramping rt calf muscle. Physician consulted immediately while still in medical group.
Age: 50.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Armpit tenderness; lump to injection site with redness, swelling, and warmth.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Patient reports she had localized pain and swell on date of administration. Patient reports that she woke up on the morning of 9/4/12 with upper arm with raised pink area (14 1/2 cm x 9 1/2 cm) given 1 gm ROCEPHIN IM and BACTRIM. Vital signs 98.8, 183/87 P 71 RR 18.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Viral rash
Clinical narrative: Mother reported in office visit on 8/27/12 that child had a rash on her left leg x 1 week that was not improving. Viral exanthema vs vaccine rash.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Hypoaesthesia, Pain
Clinical narrative: Felt arm numb, pain shooting through tissue probably following nerve pathway. Redness gone only lasted for a couple of days but numbness continues and it is spreading. Today numbness down to elbow and gradually spreading to pectoral muscles. Today a bit of shortness of breath.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, achy body, chills, shortness of breath.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Full blood count normal, Laboratory test normal, Macule, Rash erythematous, Skin irritation
Clinical narrative: The pt received Tdap and HPV (GARDASIL) #1 in her right upper arm at 1400 on 7/23/12. At the time the pt was in her normal state of good health. When the pt removed her uniform at 1700 she noted a red, flat, non-pruritic "rash" on her shoulders. She denied difficulty swallowing, difficulty breathing, swelling, pruritus, nausea, vomiting, abdominal pain or diarrhea. The pt presented to her PCM on 7/24/12 at 0915. The rash consisted of 5 marks/lesions on her right shoulder and 4 lesions/marks on her left shoulder. It was suggested that a tryptase level be drawn which was nml. When the pt presented to the clinic she had 4: 2-4mm long x 1-2mm wide linear red non-raised marks on the top of the left shoulder lateral to her bra strap. Additionally, she has 2: 10mm long x 1-2mm wide linear red non-raised marks; 2: 3-4 mm macules (red) and one 5mm V shaped red non-raised red mark on the top of the right shoulder. She denied use of any new shampoos, hair products, laundry detergent, soaps, body creams/lotions. The pt did report that she wore a new shirt (unlaundered) with a tank top and bra underneath on 7/23/12. She did not note that the shirt was irritating. She denied scratching her shoulders. The "marks" began to fade on 7/25/12 and gradually resolved by 7/30/12.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Skin lesion, Tryptase
Clinical narrative: The pt received Tdap and HPV (GARDASIL) #1 in her right upper arm at 1400 on 7/23/12. At the time the pt was in her normal state of good health. When the pt removed her uniform at 1700 she noted a red, flat, non-pruritic "rash" on her shoulders. She denied difficulty swallowing, difficulty breathing, swelling, pruritus, nausea, vomiting, abdominal pain or diarrhea. The pt presented to her PCM on 7/24/12 at 0915. The rash consisted of 5 marks/lesions on her right shoulder and 4 lesions/marks on her left shoulder. It was suggested that a tryptase level be drawn which was nml. When the pt presented to the clinic she had 4: 2-4mm long x 1-2mm wide linear red non-raised marks on the top of the left shoulder lateral to her bra strap. Additionally, she has 2: 10mm long x 1-2mm wide linear red non-raised marks; 2: 3-4 mm macules (red) and one 5mm V shaped red non-raised red mark on the top of the right shoulder. She denied use of any new shampoos, hair products, laundry detergent, soaps, body creams/lotions. The pt did report that she wore a new shirt (unlaundered) with a tank top and bra underneath on 7/23/12. She did not note that the shirt was irritating. She denied scratching her shoulders. The "marks" began to fade on 7/25/12 and gradually resolved by 7/30/12.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Mom reports that patients Rt. arm swelled locally to about the size of a half-dollar and broke out in a hive-looking rash at the injection site, with redness and hard area encircling arm. Mom reports that within 24 hours the swelling increased all the way around the arm and was warm to touch. Mom gave BENADRYL and TYLENOL x 2 days, swelling decreased and rash almost gone now.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Mom reports that patients Rt. arm swelled locally to about the size of a half-dollar and broke out in a hive-looking rash at the injection site, with redness and hard area encircling arm. Mom reports that within 24 hours the swelling increased all the way around the arm and was warm to touch. Mom gave BENADRYL and TYLENOL x 2 days, swelling decreased and rash almost gone now.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Inflammation, Injection site warmth, Local reaction
Clinical narrative: Large local inflammatory reaction in right deltoid. Warm to touch.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood culture, Culture urine, Full blood count, Unevaluable event
Clinical narrative: New onset ? febrile seizure as diagnosed by children hospital.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Histiocytosis haematophagic, Leukopenia, Platelet count decreased, Pyrexia, Serum ferritin increased
Clinical narrative: Pt developed hemophagocytic lymphohistiocytosis with high fever, leucopenia, thrombocytopenia. Now in hospital. Sx first noted: approximately 8.27. Vaccine 8.14.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Thrombocytopenia, White blood cell count decreased
Clinical narrative: Pt developed hemophagocytic lymphohistiocytosis with high fever, leucopenia, thrombocytopenia. Now in hospital. Sx first noted: approximately 8.27. Vaccine 8.14.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Localized redness induration 8-10 cm.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Culture throat negative, Irritability, Rash scarlatiniform, Streptococcus test negative
Clinical narrative: 8/29 Developed rash & irritability. 8/30 Seen in office. Scarlatiniform appearance but not raised. 9/6 Resolving rash - not gone yet.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Back pain, Feeling cold, Myalgia, Myelitis transverse, Pain in extremity
Clinical narrative: Received Hepatitis A and GARDASIL vaccines on 08/03/12. 13 days later developed painful legs (muscle and skin), perineal pain, lower back pain, abnormal cold sensation, no URI no fever. Diagnosed with transverse myelitis by specialist.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pain of skin, Perineal pain
Clinical narrative: Received Hepatitis A and GARDASIL vaccines on 08/03/12. 13 days later developed painful legs (muscle and skin), perineal pain, lower back pain, abnormal cold sensation, no URI no fever. Diagnosed with transverse myelitis by specialist.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: Mother called to state child is very sick after flu vaccine and was called from school.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: REDNESS/RASH AND SWELLING AT INJECTION SITE - STILL SWOLLEN 5 DAYS POST VACCINATION.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Blistering rash on bilateral legs, abd, and back - mild.  No documented fever, no SOB, no other symptoms.  Recommended to do OTC anti-histamines for itching.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: ONSET FEVER OF 103-RECTAL THAT PM. THE NEXT DAY TEMP WAS 102-RECTAL. NO THER SYPTOMS.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye pruritus, Myalgia, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Red, itchy eyes with yellow pus, sore throat, sore muscles, cough. Got antibiotic eyedrops
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Purulent discharge
Clinical narrative: Red, itchy eyes with yellow pus, sore throat, sore muscles, cough. Got antibiotic eyedrops
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Axillary pain, Fatigue, Injection site pain, Lymph node pain
Clinical narrative: Unusual fatigue; went to bed early. Woke up next morning, my entire R armpit was painfully sore. I took 2 Arthritis Strength Tylenol around 6:00 AM, some relief, but by 10:30 AM, it was painful again. Entire site of injection painful and in glands under armpit, it is 2:30 PM.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: C-reactive protein increased, Coronary artery dilatation, Differential white blood cell count, Echocardiogram abnormal, Haematocrit decreased
Clinical narrative: Pt presented to hospital with high fevers and was later found to have atypical Kawasaki's Disease given echo findings of L coronary artery dilatation.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haemoglobin decreased, Kawasaki's disease, Laboratory test, Platelet count increased, Pyrexia
Clinical narrative: Pt presented to hospital with high fevers and was later found to have atypical Kawasaki's Disease given echo findings of L coronary artery dilatation.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: White blood cell count normal
Clinical narrative: Pt presented to hospital with high fevers and was later found to have atypical Kawasaki's Disease given echo findings of L coronary artery dilatation.
Age: 1.17
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Child developed a rash on trunk 3-5 days after receiving vaccinations that spread to legs and arms and face along with a low grade temp. The rash looks like measles in appearance. They have taken him to his personal physician 2 times and to ER once. He has been treated with oral steroids and Benadryl.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Gaze palsy, Immediate post-injection reaction, Loss of consciousness, Muscle twitching
Clinical narrative: Immediately after receiving Gardasil, Patient's eyes rolled back, her whole body started twitching and she passed out.  Lasted 15 seconds.
Age: 1.05
Sex: F
Vaccine: HIBV, MMR, PNC, TYP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Hard knot, redness, swelling, warmth to right upper thigh.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Agitation, Autism, Condition aggravated, Gaze palsy
Clinical narrative: Increased and intense stimming (exessive hand flapping, body cringing/tightening) and vocal stimming followed by long periods of staring in space with episodes of eyes rolling towards back of head, increased aggitation and excessive head sweating. Not typical behavior for child.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Hyperhidrosis, Staring
Clinical narrative: Increased and intense stimming (exessive hand flapping, body cringing/tightening) and vocal stimming followed by long periods of staring in space with episodes of eyes rolling towards back of head, increased aggitation and excessive head sweating. Not typical behavior for child.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Slight swelling reddened area oval 2 1/2" x 3 approx. Within 12 hours no itch swelling & redness diminishing after 48 hours gone in 96 hours.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient returned to pharmacy 24 hours after injection.  She woke up the morning after and noticed she had a rash on her arms, legs and chest.  I intstructed her to take Benadryl and contact her primary care doctor.  She was not having any trouble breathing, just was itching due to rash.
Age: 18.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, itching, burning covering 4 inches around site.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Injection was administered on August 30/ 2012. On September 1/ 2012 2 days after injection, patient developed intermittent  urticaria  with severe itching covered almost body area. Last episode of flaring was reported on September 5th. No anaphylactic reaction reported
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Dizziness, Feeling hot, Immediate post-injection reaction, Vomiting
Clinical narrative: Patient received 4 vaccines: Tdap, MCV, Flu shot and HPV. Immediately after (while still sitting in chair), patient complained of being "hot" and feeling "faint". I told pt to stay seated and called for another nurse the the next room to grab a Coke. I got cool compresses to put on pt's back of neck, and to wipe face. Pt vomited into the trash can. Told pt to slowly sip the Coke. After about 15 minutes of sitting, the patient felt much better. Pt left our office with her mother. The mother came back into the office after about 3 minutes and said that her daughter was feeling faint again. Daughter was sitting in the hot car, wearing a flannel long sleeve shirt. It was about 98 degrees outside. Pt told me that she felt hot again and like she was going to faint. Another nurse went to get a cold compress for the pt. Once applied, pt felt better. I told the mom that we should bring the pt in the office for about 10 minutes to make sure she's alright. Pt said again that she felt better and mom said she thinks she will be ok. HR was 60 beats/ minute. I instructed the pt to stay cool for the rest of the day, don't do anything strenuous, and if felt faint again to lie down. I told the mom to monitor pt for rest of today, and contact dr if there are any more issues. My office number was on the shot record. I told mom she could call me if she had any more questions.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itchiness at site. Swollen area is 2 cm x 3 cm.
Age: 0.52
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash pruritic, Scab
Clinical narrative: Complains of rash x 2 days. Started as a few spots on face and has been progressive. Now all over trunk, extremities, face. Minimally pruritic. New spots continue to emerge and old spots are filling with fluid/crusting. Has low grade fever first day of illness. He has been in daycare in the past month. Also received 12 month IZs (including varicella) 10 days ago. 10 days post vaccine administration, patient developed rash. Minimally pruritic. New spots continue to emerge and old spots are filling with fluid/crusting. Has low grade fever first day of illness.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Fall, Head injury, Headache, Loss of consciousness, Seizure like phenomena
Clinical narrative: My daughter passed out, falling backwards and fell to the floor; she hit her head on the wall in the office and left a large hole in the wall where her head had impact; she appeared to have seizure like movements in her upper body; it lasted 20-30 seconds; at this time she is complaining of a head ache.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Vertigo
Clinical narrative: Severe vertigo. Saw primary care MD and was referred to ENT. ENT placed her on prednisone for immunosupressant action.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of upper left thigh.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13
Symptoms: Crying, Lymphadenopathy, Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: Patient presents with complaint(s) of fever 102-103 fevers, rash all over, lymph node in groin the size of a pea x 3 days. 102.4 fever in office. Onset three days ago. No real rhinorrhea-other than when crying. Had an appointment for well visit but was fine. MMR given in left leg at that time. Now with enlarged lymph node left femoral/inguinal-no inflammation-non-tender. Vomits with Ibuprofen-no Acetaminophen yet today 9/6/12. Plan: Treat to cover strep in light of pharyngitis. Strongly suspect sequelae to MMR vaccination - does not follow course of events or characteristics of rash of roseola. Monitor closely in light of high fever. Coun/Edu: Discussed viral exanthem vs. sequelae of MMR vaccine-handout re: MMR vaccination with possible rash/fever within 7-12 days of vaccination. Discussed cover for strep in light of pharyngitis and recent increase in strep pharyngitis seen. Symptomatic treatment and usual course discussed. Reviewed fever and pain control with tylenol. Instructed to call or return for: --Symptoms not improved in 2 days, --Worsening symptoms, --New, unexplained symptoms develop.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: Patient presents with complaint(s) of fever 102-103 fevers, rash all over, lymph node in groin the size of a pea x 3 days. 102.4 fever in office. Onset three days ago. No real rhinorrhea-other than when crying. Had an appointment for well visit but was fine. MMR given in left leg at that time. Now with enlarged lymph node left femoral/inguinal-no inflammation-non-tender. Vomits with Ibuprofen-no Acetaminophen yet today 9/6/12. Plan: Treat to cover strep in light of pharyngitis. Strongly suspect sequelae to MMR vaccination - does not follow course of events or characteristics of rash of roseola. Monitor closely in light of high fever. Coun/Edu: Discussed viral exanthem vs. sequelae of MMR vaccine-handout re: MMR vaccination with possible rash/fever within 7-12 days of vaccination. Discussed cover for strep in light of pharyngitis and recent increase in strep pharyngitis seen. Symptomatic treatment and usual course discussed. Reviewed fever and pain control with tylenol. Instructed to call or return for: --Symptoms not improved in 2 days, --Worsening symptoms, --New, unexplained symptoms develop.
Sex: M
Vaccine: LYME
Symptoms: Arthropod bite, Back pain, Blister, Borrelia test, Borrelia test positive
Clinical narrative: This case was reported by a consumer and described the occurrence of positive for Lyme disease in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hypothyroidism (for 16 years) and incomplete right bundle branch block. Concurrent medications included SYNTHROID. On an unspecified date in 1999 the subject received 1st dose, 2nd dose and 3rd dose of LYMERIX (unknown). On 24 July 2012, 13 years after vaccination with LYMERIX, the subject experienced bug bite, slow healing, blister. On unspecified dates the subject experienced headache, exhausted feeling, low grade headaches. On 03 August 2012 the subject felt as if going to pass out. On unspecified dates the subject also experienced chest pain, neck pain, shoulder pain, upper back pain, headache-pressure around head, dizziness, pressure headache and vaccination failure. In 1999 the subject took the LYMERIX vaccine (three doses over a year). Since 24 July 2012 the subject had bug bite on point of elbow that turned into pea sized red blister (the subject thought it was West Nile) there was no bullseye. It took five weeks to heal. The subject had to take afternoon naps due to headache and feeling exhausted in the first week. Four days of constant low grade headache before travel and then in ER on 03 August 2012 due to feeling of passing out while driving. Then three weeks of chest, neck, shoulder, upper back pain with high pressure headache mostly top and front like sinus back also back of head, has gotten better. The subject reported having seen "heart doctor (ok with continued incomplete right bundle branch block (IRBBB) and heart rate of 40-45 like last year), have seen endocrinologist and waiting results". Relevant test results included ELISA: Positive Lyme and Western blot Lyme: reactive IgM bands 23 and 39, non reactive IgG. The subject started treatment on 05 August 2012 doxycycline 100 mg, twice daily for 21 days. At the time of reporting the bug bite, slow healing, blister and low grade headaches resolved. The chest pain, neck pain, shoulder pain, upper back pain, headache-pressure around head had improved. The outcome of Lyme disease, headache, exhausted feeling, felt as if going to pass out, dizziness, and pressure headache were not specified. This case was assessed as medically serious by GSK.
Sex: M
Vaccine: LYME
Symptoms: Chest pain, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: This case was reported by a consumer and described the occurrence of positive for Lyme disease in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hypothyroidism (for 16 years) and incomplete right bundle branch block. Concurrent medications included SYNTHROID. On an unspecified date in 1999 the subject received 1st dose, 2nd dose and 3rd dose of LYMERIX (unknown). On 24 July 2012, 13 years after vaccination with LYMERIX, the subject experienced bug bite, slow healing, blister. On unspecified dates the subject experienced headache, exhausted feeling, low grade headaches. On 03 August 2012 the subject felt as if going to pass out. On unspecified dates the subject also experienced chest pain, neck pain, shoulder pain, upper back pain, headache-pressure around head, dizziness, pressure headache and vaccination failure. In 1999 the subject took the LYMERIX vaccine (three doses over a year). Since 24 July 2012 the subject had bug bite on point of elbow that turned into pea sized red blister (the subject thought it was West Nile) there was no bullseye. It took five weeks to heal. The subject had to take afternoon naps due to headache and feeling exhausted in the first week. Four days of constant low grade headache before travel and then in ER on 03 August 2012 due to feeling of passing out while driving. Then three weeks of chest, neck, shoulder, upper back pain with high pressure headache mostly top and front like sinus back also back of head, has gotten better. The subject reported having seen "heart doctor (ok with continued incomplete right bundle branch block (IRBBB) and heart rate of 40-45 like last year), have seen endocrinologist and waiting results". Relevant test results included ELISA: Positive Lyme and Western blot Lyme: reactive IgM bands 23 and 39, non reactive IgG. The subject started treatment on 05 August 2012 doxycycline 100 mg, twice daily for 21 days. At the time of reporting the bug bite, slow healing, blister and low grade headaches resolved. The chest pain, neck pain, shoulder pain, upper back pain, headache-pressure around head had improved. The outcome of Lyme disease, headache, exhausted feeling, felt as if going to pass out, dizziness, and pressure headache were not specified. This case was assessed as medically serious by GSK.
Sex: M
Vaccine: LYME
Symptoms: Immunology test, Immunology test abnormal, Impaired healing, Lyme disease, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer and described the occurrence of positive for Lyme disease in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hypothyroidism (for 16 years) and incomplete right bundle branch block. Concurrent medications included SYNTHROID. On an unspecified date in 1999 the subject received 1st dose, 2nd dose and 3rd dose of LYMERIX (unknown). On 24 July 2012, 13 years after vaccination with LYMERIX, the subject experienced bug bite, slow healing, blister. On unspecified dates the subject experienced headache, exhausted feeling, low grade headaches. On 03 August 2012 the subject felt as if going to pass out. On unspecified dates the subject also experienced chest pain, neck pain, shoulder pain, upper back pain, headache-pressure around head, dizziness, pressure headache and vaccination failure. In 1999 the subject took the LYMERIX vaccine (three doses over a year). Since 24 July 2012 the subject had bug bite on point of elbow that turned into pea sized red blister (the subject thought it was West Nile) there was no bullseye. It took five weeks to heal. The subject had to take afternoon naps due to headache and feeling exhausted in the first week. Four days of constant low grade headache before travel and then in ER on 03 August 2012 due to feeling of passing out while driving. Then three weeks of chest, neck, shoulder, upper back pain with high pressure headache mostly top and front like sinus back also back of head, has gotten better. The subject reported having seen "heart doctor (ok with continued incomplete right bundle branch block (IRBBB) and heart rate of 40-45 like last year), have seen endocrinologist and waiting results". Relevant test results included ELISA: Positive Lyme and Western blot Lyme: reactive IgM bands 23 and 39, non reactive IgG. The subject started treatment on 05 August 2012 doxycycline 100 mg, twice daily for 21 days. At the time of reporting the bug bite, slow healing, blister and low grade headaches resolved. The chest pain, neck pain, shoulder pain, upper back pain, headache-pressure around head had improved. The outcome of Lyme disease, headache, exhausted feeling, felt as if going to pass out, dizziness, and pressure headache were not specified. This case was assessed as medically serious by GSK.
Sex: M
Vaccine: LYME
Symptoms: Neck pain, Sinus headache, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of positive for Lyme disease in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hypothyroidism (for 16 years) and incomplete right bundle branch block. Concurrent medications included SYNTHROID. On an unspecified date in 1999 the subject received 1st dose, 2nd dose and 3rd dose of LYMERIX (unknown). On 24 July 2012, 13 years after vaccination with LYMERIX, the subject experienced bug bite, slow healing, blister. On unspecified dates the subject experienced headache, exhausted feeling, low grade headaches. On 03 August 2012 the subject felt as if going to pass out. On unspecified dates the subject also experienced chest pain, neck pain, shoulder pain, upper back pain, headache-pressure around head, dizziness, pressure headache and vaccination failure. In 1999 the subject took the LYMERIX vaccine (three doses over a year). Since 24 July 2012 the subject had bug bite on point of elbow that turned into pea sized red blister (the subject thought it was West Nile) there was no bullseye. It took five weeks to heal. The subject had to take afternoon naps due to headache and feeling exhausted in the first week. Four days of constant low grade headache before travel and then in ER on 03 August 2012 due to feeling of passing out while driving. Then three weeks of chest, neck, shoulder, upper back pain with high pressure headache mostly top and front like sinus back also back of head, has gotten better. The subject reported having seen "heart doctor (ok with continued incomplete right bundle branch block (IRBBB) and heart rate of 40-45 like last year), have seen endocrinologist and waiting results". Relevant test results included ELISA: Positive Lyme and Western blot Lyme: reactive IgM bands 23 and 39, non reactive IgG. The subject started treatment on 05 August 2012 doxycycline 100 mg, twice daily for 21 days. At the time of reporting the bug bite, slow healing, blister and low grade headaches resolved. The chest pain, neck pain, shoulder pain, upper back pain, headache-pressure around head had improved. The outcome of Lyme disease, headache, exhausted feeling, felt as if going to pass out, dizziness, and pressure headache were not specified. This case was assessed as medically serious by GSK.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Plasmapheresis
Clinical narrative: This spontaneous report as received from a physician via field representative concerning a 17 years old female patient with unspecified pertinent medical history and unspecified drug reaction/allergies. The physician stated that "a niece of one of her nurses" on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and indication were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unspecified date, the patient developed seizures (medically significant) and the only thing they could contributed it to was the administration of GARDASIL. A plasmapheresis was the treatment given for seizures. Diagnostic tests performed were not reported. The patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Allergy test positive, Blood test normal, Dyspnoea, Emotional distress, Erythema
Clinical narrative: This spontaneous report as received from a 25 years old female patient with allergy to CIPRO and none pertinent medical history. On 24-MAY-2012, the patient was vaccinated subcutaneously with a second 0.5 ml dose of MMR II, lot number 669517/0037AA exp date 01-FEB-2013. No other co-suspects were reported. Concomitant medications included: hormonal contraceptives (unspecified). The patient reported that she received the second dose and on 02-JUN-2012, she experienced swelling under the chin and under the tongue (medically significant, upon internal review). The consumer was still experiencing swelling under the chin and under the tongue and at the time of the report, back of the tongue 3 times a day. The patient experienced this at anytime, whether she was when she first got up in the morning or exercising or eating. The attacks last from 45 minutes to one hour. She was having constricted breathing (medically significant, upon internal review). At the time of report, the patient had food allergies (medically significant, upon internal review), panic attacks (medically significant, upon internal review), her hands and feet were swollen (medically significant, upon internal review), and she got red (medically significant, upon internal review), her vagina swollen (medically significant, upon internal review) and got a yeast infection (medically significant, upon internal review). She had seen 4 different physicians and an allergist. She stated that at the time of report, she was "allergic to all things" (medically significant, upon internal review) and what she was experiencing was causing distress every day (medically significant, upon internal review) and she was a 2nd year graduate student and this was interfering with her life. The patient carried an epinephrine (medically significant, upon internal review) at the time of report, but had not need to use it yet. Prednisone (manufacturer unknown), CLARITIN, PEPCID and BENADRYL was given as treatment for the events. Food allergy test was performed and showed that the patient was allergic to almost everything, some food given were eggs, nuts, melon, mustard, tomatoes, peas, beans, everything in the legume family. Blood test was also performed and was normal. Ultrasound of throat taken showed slightly enlarged but normal. At the time of report, the patient had not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Food allergy, Fungal infection, Multiple allergies, Oedema peripheral, Panic attack
Clinical narrative: This spontaneous report as received from a 25 years old female patient with allergy to CIPRO and none pertinent medical history. On 24-MAY-2012, the patient was vaccinated subcutaneously with a second 0.5 ml dose of MMR II, lot number 669517/0037AA exp date 01-FEB-2013. No other co-suspects were reported. Concomitant medications included: hormonal contraceptives (unspecified). The patient reported that she received the second dose and on 02-JUN-2012, she experienced swelling under the chin and under the tongue (medically significant, upon internal review). The consumer was still experiencing swelling under the chin and under the tongue and at the time of the report, back of the tongue 3 times a day. The patient experienced this at anytime, whether she was when she first got up in the morning or exercising or eating. The attacks last from 45 minutes to one hour. She was having constricted breathing (medically significant, upon internal review). At the time of report, the patient had food allergies (medically significant, upon internal review), panic attacks (medically significant, upon internal review), her hands and feet were swollen (medically significant, upon internal review), and she got red (medically significant, upon internal review), her vagina swollen (medically significant, upon internal review) and got a yeast infection (medically significant, upon internal review). She had seen 4 different physicians and an allergist. She stated that at the time of report, she was "allergic to all things" (medically significant, upon internal review) and what she was experiencing was causing distress every day (medically significant, upon internal review) and she was a 2nd year graduate student and this was interfering with her life. The patient carried an epinephrine (medically significant, upon internal review) at the time of report, but had not need to use it yet. Prednisone (manufacturer unknown), CLARITIN, PEPCID and BENADRYL was given as treatment for the events. Food allergy test was performed and showed that the patient was allergic to almost everything, some food given were eggs, nuts, melon, mustard, tomatoes, peas, beans, everything in the legume family. Blood test was also performed and was normal. Ultrasound of throat taken showed slightly enlarged but normal. At the time of report, the patient had not recovered. Additional information has been requested.