chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cough, Hyperhidrosis
Clinical narrative: Initial report received from a health care professional on 27 October 2010. A 62-year-old male patient received on 27 October 2010 at 10:00 AM a left arm intramuscular injection of FLUZONE, lot number U3620CB. The patient has an allergy to codeine, penicillin, trazadone, and carbanenems. The patient had no illness at the time of vaccination. The patient's medical history and concomitant medications were not reported. On 27 October 2010 at 4:15 PM, the patient developed sweating and a cough. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 10 December 2010 who reported that the event diagnosis was anaphylactic reaction and atypical chest pain "most likely pulmonary in origin". Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The patient reported receiving the vaccine at 10 o'clock in the morning and "around 2:00 pm" broke out in a cold sweat, red blotches, wheezing with shortness of breath, he felt clammy, lightheaded and had a nonproductive cough. He was evaluated in the emergency room on 27 October 2010 and was hospitalized overnight (discharged on 28 October 2010). The patient's physical exam revealed a blood pressure of 125/83, pulse 69, respiratory rate 22 and oxygen saturation was 99% on oxygen at two liters. His reflexes were 2+/4. A 2/6 systolic heart murmur was noted. His lungs were clear but wheezing was noted on the right "greater than left base". Treatments included BENADRYL 100 milligrams, IV SOLU-MEDROL 125 milligrams, LOVENOX, PEPCID, Morphine and oxygen. The patient had a chest x-ray which revealed no infiltrates or cardiomegally. Cardiac enzymes were negative. An electrocardiogram was reviewed and no significant changes were noted. Concomitant medications include: LOVAZA one gram twice a day, PLAVIX 75 milligrams daily, Omeprazole 20 milligrams, LIPITOR 40 milligrams daily, LEXAPRO 20 milligrams daily and TOPROL XL 50 milligrams. The patient has a past medical history of coronary artery disease, stent placement in April of 2010, hypercholesterolemia, depression, peripheral vascular disease, nicotine abuse, gastroesophageal reflux disease, a questionable 3.2 centimeter aneurysm, chronic back pain and cluster headaches. The patient was also noted to have allergies to "contrast", bee stings and shellfish. He has a past surgical history of coronary angioplasty with stent placement, vasectomy, six epidural injections in 2010, lumbar laminectomy, multiple back surgeries x 2, and a right knee arthroscopy in 2009. It was reported the patient was "fine" and was stable at discharge. However his outcome was not reported. Documents held by sender: None.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Cardiac enzymes normal, Cardiac murmur, Chest X-ray normal, Cold sweat
Clinical narrative: Initial report received from a health care professional on 27 October 2010. A 62-year-old male patient received on 27 October 2010 at 10:00 AM a left arm intramuscular injection of FLUZONE, lot number U3620CB. The patient has an allergy to codeine, penicillin, trazadone, and carbanenems. The patient had no illness at the time of vaccination. The patient's medical history and concomitant medications were not reported. On 27 October 2010 at 4:15 PM, the patient developed sweating and a cough. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 10 December 2010 who reported that the event diagnosis was anaphylactic reaction and atypical chest pain "most likely pulmonary in origin". Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The patient reported receiving the vaccine at 10 o'clock in the morning and "around 2:00 pm" broke out in a cold sweat, red blotches, wheezing with shortness of breath, he felt clammy, lightheaded and had a nonproductive cough. He was evaluated in the emergency room on 27 October 2010 and was hospitalized overnight (discharged on 28 October 2010). The patient's physical exam revealed a blood pressure of 125/83, pulse 69, respiratory rate 22 and oxygen saturation was 99% on oxygen at two liters. His reflexes were 2+/4. A 2/6 systolic heart murmur was noted. His lungs were clear but wheezing was noted on the right "greater than left base". Treatments included BENADRYL 100 milligrams, IV SOLU-MEDROL 125 milligrams, LOVENOX, PEPCID, Morphine and oxygen. The patient had a chest x-ray which revealed no infiltrates or cardiomegally. Cardiac enzymes were negative. An electrocardiogram was reviewed and no significant changes were noted. Concomitant medications include: LOVAZA one gram twice a day, PLAVIX 75 milligrams daily, Omeprazole 20 milligrams, LIPITOR 40 milligrams daily, LEXAPRO 20 milligrams daily and TOPROL XL 50 milligrams. The patient has a past medical history of coronary artery disease, stent placement in April of 2010, hypercholesterolemia, depression, peripheral vascular disease, nicotine abuse, gastroesophageal reflux disease, a questionable 3.2 centimeter aneurysm, chronic back pain and cluster headaches. The patient was also noted to have allergies to "contrast", bee stings and shellfish. He has a past surgical history of coronary angioplasty with stent placement, vasectomy, six epidural injections in 2010, lumbar laminectomy, multiple back surgeries x 2, and a right knee arthroscopy in 2009. It was reported the patient was "fine" and was stable at discharge. However his outcome was not reported. Documents held by sender: None.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cough, Dizziness, Dyspnoea, Electrocardiogram normal, Hyperhidrosis
Clinical narrative: Initial report received from a health care professional on 27 October 2010. A 62-year-old male patient received on 27 October 2010 at 10:00 AM a left arm intramuscular injection of FLUZONE, lot number U3620CB. The patient has an allergy to codeine, penicillin, trazadone, and carbanenems. The patient had no illness at the time of vaccination. The patient's medical history and concomitant medications were not reported. On 27 October 2010 at 4:15 PM, the patient developed sweating and a cough. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 10 December 2010 who reported that the event diagnosis was anaphylactic reaction and atypical chest pain "most likely pulmonary in origin". Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The patient reported receiving the vaccine at 10 o'clock in the morning and "around 2:00 pm" broke out in a cold sweat, red blotches, wheezing with shortness of breath, he felt clammy, lightheaded and had a nonproductive cough. He was evaluated in the emergency room on 27 October 2010 and was hospitalized overnight (discharged on 28 October 2010). The patient's physical exam revealed a blood pressure of 125/83, pulse 69, respiratory rate 22 and oxygen saturation was 99% on oxygen at two liters. His reflexes were 2+/4. A 2/6 systolic heart murmur was noted. His lungs were clear but wheezing was noted on the right "greater than left base". Treatments included BENADRYL 100 milligrams, IV SOLU-MEDROL 125 milligrams, LOVENOX, PEPCID, Morphine and oxygen. The patient had a chest x-ray which revealed no infiltrates or cardiomegally. Cardiac enzymes were negative. An electrocardiogram was reviewed and no significant changes were noted. Concomitant medications include: LOVAZA one gram twice a day, PLAVIX 75 milligrams daily, Omeprazole 20 milligrams, LIPITOR 40 milligrams daily, LEXAPRO 20 milligrams daily and TOPROL XL 50 milligrams. The patient has a past medical history of coronary artery disease, stent placement in April of 2010, hypercholesterolemia, depression, peripheral vascular disease, nicotine abuse, gastroesophageal reflux disease, a questionable 3.2 centimeter aneurysm, chronic back pain and cluster headaches. The patient was also noted to have allergies to "contrast", bee stings and shellfish. He has a past surgical history of coronary angioplasty with stent placement, vasectomy, six epidural injections in 2010, lumbar laminectomy, multiple back surgeries x 2, and a right knee arthroscopy in 2009. It was reported the patient was "fine" and was stable at discharge. However his outcome was not reported. Documents held by sender: None.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Non-cardiac chest pain, Rash macular, Wheezing
Clinical narrative: Initial report received from a health care professional on 27 October 2010. A 62-year-old male patient received on 27 October 2010 at 10:00 AM a left arm intramuscular injection of FLUZONE, lot number U3620CB. The patient has an allergy to codeine, penicillin, trazadone, and carbanenems. The patient had no illness at the time of vaccination. The patient's medical history and concomitant medications were not reported. On 27 October 2010 at 4:15 PM, the patient developed sweating and a cough. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 10 December 2010 who reported that the event diagnosis was anaphylactic reaction and atypical chest pain "most likely pulmonary in origin". Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The patient reported receiving the vaccine at 10 o'clock in the morning and "around 2:00 pm" broke out in a cold sweat, red blotches, wheezing with shortness of breath, he felt clammy, lightheaded and had a nonproductive cough. He was evaluated in the emergency room on 27 October 2010 and was hospitalized overnight (discharged on 28 October 2010). The patient's physical exam revealed a blood pressure of 125/83, pulse 69, respiratory rate 22 and oxygen saturation was 99% on oxygen at two liters. His reflexes were 2+/4. A 2/6 systolic heart murmur was noted. His lungs were clear but wheezing was noted on the right "greater than left base". Treatments included BENADRYL 100 milligrams, IV SOLU-MEDROL 125 milligrams, LOVENOX, PEPCID, Morphine and oxygen. The patient had a chest x-ray which revealed no infiltrates or cardiomegally. Cardiac enzymes were negative. An electrocardiogram was reviewed and no significant changes were noted. Concomitant medications include: LOVAZA one gram twice a day, PLAVIX 75 milligrams daily, Omeprazole 20 milligrams, LIPITOR 40 milligrams daily, LEXAPRO 20 milligrams daily and TOPROL XL 50 milligrams. The patient has a past medical history of coronary artery disease, stent placement in April of 2010, hypercholesterolemia, depression, peripheral vascular disease, nicotine abuse, gastroesophageal reflux disease, a questionable 3.2 centimeter aneurysm, chronic back pain and cluster headaches. The patient was also noted to have allergies to "contrast", bee stings and shellfish. He has a past surgical history of coronary angioplasty with stent placement, vasectomy, six epidural injections in 2010, lumbar laminectomy, multiple back surgeries x 2, and a right knee arthroscopy in 2009. It was reported the patient was "fine" and was stable at discharge. However his outcome was not reported. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Back pain, Breast pain, Chest pain, Herpes zoster
Clinical narrative: November 9, 2010 received a flu shot at her cardiologist office. Three days later on the 12th started experience pain on left side of back and chest. Went to cardiologist on 11/19 due to the chest pain nothing seen. Pain worse on 11/21 went to emergency room and diagnosed with shingles given ADVIL. On 12/1/2010 went to another provider and was given additional pain medication. Symptoms are now improving but rash has not resolved.
Age: 65.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Back pain, Chest pain, Herpes zoster, Pain, Rash
Clinical narrative: November 9, 2010 received a flu shot at her cardiologist office. Three days later on the 12th started experience pain on left side of back and chest. Went to cardiologist on 11/19 due to the chest pain nothing seen. Pain worse on 11/21 went to emergency room and diagnosed with shingles given ADVIL. On 12/1/2010 went to another provider and was given additional pain medication. Symptoms are now improving but rash has not resolved.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Achy legs, nausea and vomiting - threw up through the night.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Tender 2" red spot at site of injection cold compress - TYLENOL.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash, legs, arms, front of shins, 1st H1N1 vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pruritus
Clinical narrative: Began to notice neck itching and flushing of face. Seen for care at 10:50 am. B/P 130/80, pulse 68 resp 16. Observed.  Took own Benadryl. Talked with patient next day took a total of 2 Bendaryl. Feeling fine on 10/14/10.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Skin discolouration, Skin exfoliation, Skin irritation, Skin mass
Clinical narrative: The reaction I'm reporting may have been from the pain ease that was administered at the injection site with the flu vaccine.  That  product is by Gebauer's Pain ease and is a topical anesthetic spray. My arm had a big black spot that turned into a sore and begin to peel.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pruritus, Pyrexia, Skin lesion
Clinical narrative: Began with fever and feeling "achy". First lesions appeared on chest, then spread to back, arms, face, and around ears. Doctor instructed patient to take baking soda baths and over the counter Benadryl as needed for itching.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting about 5 hours after receiving the vaccine
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial flutter, Chills, Hyperhidrosis, Malaise, Productive cough
Clinical narrative: "2 Days after flu shot developed severe congestion in chest. For 2 weeks experienced malaise, chills, sweats and congestion grew worse. After 2 weeks acute symptoms disappeared but severe coughing remained with production of white mucous. 4th week saw doctor and lungs were clearing but was found to have an atrial flutter.  Being treated for that.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: "2 Days after flu shot developed severe congestion in chest. For 2 weeks experienced malaise, chills, sweats and congestion grew worse. After 2 weeks acute symptoms disappeared but severe coughing remained with production of white mucous. 4th week saw doctor and lungs were clearing but was found to have an atrial flutter.  Being treated for that.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: PAINFUL ARM X3 MONTHS
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration
Clinical narrative: patient has red oval area with a hard spot in the middle of it
Age: 0.77
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pyrexia, Rash, Upper respiratory tract infection, Vomiting
Clinical narrative: This information was reported here 11/24/10 during a routine visit. I am delayed in filling this out and did not make a note if this was the mother or another relative reporting. Said 10/30/10 had rash; saw Dr. 11/3 for rash/vomiting/fever - few days later went to E.R. for diarrhea and rash. Rash stayed until 11/15 or 11/16, no medication given except TYLENOL/MOTRIN. Was not hospitalized. No diagnosis. Rash disappeared stated one Dr. "said it was the shot; one Dr. said URI, and one did not know".
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient received immunization on 11/4/2010 and called back to complain about pain at injection site immobility issues on 12/10/2010. Patient stated she received a "cortisone" shot from her doctor on that date for treatment.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Body temperature increased, Diarrhoea, Headache, Malaise
Clinical narrative: Received influenza injectable vax 11-16-10 reports feeling achy, h/a, malaise, weak, felt like wheezing" evening of vax. diarrhea Temp 96.5 11-17-10 - sent to see occ med dr.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Wheezing
Clinical narrative: Received influenza injectable vax 11-16-10 reports feeling achy, h/a, malaise, weak, felt like wheezing" evening of vax. diarrhea Temp 96.5 11-17-10 - sent to see occ med dr.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HIBV, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt was given PENTACEL and PEDVAX at the same visit. No adverse reactions.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus, Throat irritation
Clinical narrative: Started 30-40 min after vaccine. Itching on left side of body & tingling in throat. Took 2 BENADRYL, 2 puff of albuterol and was fine. Total duration about 90 min.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Musculoskeletal pain, Nuclear magnetic resonance imaging, Ultrasound scan, X-ray
Clinical narrative: Severe shoulder pain & temporary weakness. Pain has persisted x >60 days and continues.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: As shot being injected, immediate swelling approximately 1 inch laterally. 1 cm welt with surrounding erythema. Welt & redness increased for first 15 min, then started to fade. No respiration sx.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Injection site discomfort, Muscular weakness, Pain in extremity
Clinical narrative: Patient described typical injection site discomfort for approximately 3 days post injection. Roughly 1 week after initial resolution of injection site discomfort, pain returned to the middle arm & shoulder joint. Pain has continued for about 3 wks now & numbness & weakness are also occasionally present. Patient reported to pharmacy 12/7/10.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Electrocardiogram, Unevaluable event
Clinical narrative: None stated.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe arm pain starting 12 hrs after injection. Unable to abduct shoulder. No tenderness or swelling.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Fatigue, Laboratory test normal
Clinical narrative: Fatigue, stomach ache - stayed home 3 days - MD called - resulting in labs ordered. All labs WNL.
Age: 20.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Blister, Erythema, Induration, Viral test
Clinical narrative: 8 inch erythematous indurated area started 2 days after vaccine.  Centrally increased induration and vesicles. Tx acyclovir, Prednisone, BENADRYL.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Rash on shoulders & chest 10 hours after vaccination. BENADRYL was taken and rash - hives gone the following day.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: 4.5 mo male infant in study had hematochezia reported to study PI on 11/30/2010 by study report card submission. Mother had not called during AE. Patient had some reported blood in stool, 2 - 4 episodes per day, from 10/23/10 - 10/27/10. Mother had changed patient's formula prior to this. The Primary doctor changed the patient to Prosoybee formula -10/22/10-, a soy based formula, and the blood in the stools stopped by 10/27/10. This appeared to be unrelated to vaccine dose #2 administration from 10/1/10. This AE resolved completely by 10/27/10 and did not recur. This AE appeared to be related to the formula change. This serves and first and final report.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Neck pain
Clinical narrative: Swelling and pain in neck. Back right side.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Arm is still hurting at injection site. Patient was given pain meds by doctor and will be having an MRI.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Urticaria
Clinical narrative: Hives, angioedema H1N1 given 11/17. Symptoms began and recurred through 11/19-12/02 - given IV SOLU-MEDROL x 2 prednisone taper, antihistamines.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Pt. received shot in (L) arm. States within an hr it started to hurt. States her (L) shoulder ached constantly for 2 wks. States she still can't lift (L) arm up over her head. C/o (L) arm going to sleep at times.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt. states received injection in (L) arm. Pt. states arm hurt at time of injection. C/o limited ROM.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pt. states received injection in (L) arm. States since then she's had a dull pain in her (L) shoulder.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Autism, Psychiatric evaluation
Clinical narrative: Autism
Age: 0.1
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Had IZ's 6pm 12/6 next afternoon 12/7 started getting swollen arms. No fever red, warm to touch (B) deltoids (R) 3 1/2" x 3"; 3 1/2" x 2" (L) treatment BENADRYL Elixir compresses.
Age: 4.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Diarrhoea, Faeces discoloured, Injection site rash, Rash pruritic
Clinical narrative: One day after receiving immunization in left thigh, mom noted rash around injection site. Rash also noted on right upper outer arm and shoulder (no injection administered warm). Patient complained of itching of rash: two days later noted 3 loose very dark stools. No abdominal pain.
Age: 1.1
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever and rash x 2 days vomit x 1.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Patient received vaccine on 12/9/10 and noticed pain and significant swelling in arm on 12/11/10 referred to MD/Urgent care.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Back pain, Injection site pain, Nausea, Vision blurred
Clinical narrative: After receiving vaccine pt complained of blurred/black vision nausea 12/10/10 pt mother called to say pt experiencing back pain and site of injection pain.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Immunization given 12/7/2010, mother noticed 12/9/10 hard raised red area on (L) deltoid - size of tennis ball. Patient did not c/o pain unless laying on (L) side. 12/13/10 no signs of redness or hardness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Body temperature, Cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 12/8/10 patient received vaccines, arm was tender and low grade temp (per mother report) 12/9/10 pts mother called and spoke with nurse: swollen, warm to touch at site, low grade temp. Will manage with ice to area, control with TYLENOL/ADVIL. 12/10/10 saw MD, given abx for 10d for cellulitis.
Age: 0.38
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site papule, Injection site pruritus, Injection site rash
Clinical narrative: One day after vaccines given, child developed itching hives on both thighs surrounding injection sites. Also noted temperature elevation for one reading. Given BENADRYL which reduced itching and redness of area. Papular rash around sites persisted. Prescribed ORAPRED and hydrocortisone cream for 5 day course.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: One day after vaccines given, child developed itching hives on both thighs surrounding injection sites. Also noted temperature elevation for one reading. Given BENADRYL which reduced itching and redness of area. Papular rash around sites persisted. Prescribed ORAPRED and hydrocortisone cream for 5 day course.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Hyperaesthesia, Local reaction, Myalgia
Clinical narrative: Localized reaction, chills, skin sensitivity, nausea, joint & muscle pain.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Rubella antibody negative
Clinical narrative: Localized reaction, chills, skin sensitivity, nausea, joint & muscle pain.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Swelling, Tenderness
Clinical narrative: Client received TDAP in left deltoid. Arm is tender to touch and swollen to the size of a small golf ball. Instructed client to alternate cool & warm compresses and take MOTRIN PRN for pain & swelling.
Age: 0.55
Sex: M
Vaccine: FLU3, HEP
Symptoms: Abdominal pain, Haematochezia, Intussusception, Ultrasound abdomen
Clinical narrative: Abdominal pain/bloody stool. Intussusception - reduced successfully.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Had Ims = noon 12/6/10 (L) deltoid about 10 pm noted red, warm arm to touch, next day 12/7 swollen. Fever 12/7 only low grade <100. Treatment BENADRYL, ice, warm pk KEFLEX.
Age: 1.08
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site nodule
Clinical narrative: Mom noticed a bump under her skin about 10 days after VARIVAX was given at the site of administration.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram, Laboratory test, Syncope, X-ray
Clinical narrative: Syncope about 6pm on day vaccine was given.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: After administering final vaccine (GARDASIL) the pt. passed out, ammonia inhalant was used to help regain consciousness. The pt. continued to sit for awhile until feeling better.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Full blood count, Injection site erythema, Laboratory test, Urticaria
Clinical narrative: Pt had either a cellulitis in the left arm or a possible allergic reaction to the pneumonia vaccine. She had a line of redness & a red welt that was 4" below injection site.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever (101.4), chills, & body aches, despite Tylenol and ibuprofen. Lasting until late pm 12/16 (16-18 hour duration).
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Flu shot given 12/15/2010 at 10:30 AM, 12/16/2010 12:00 PM rash started.  Maxed 12/17/2010 and 12/18/2010 rash was the same.  Used steroid/antihistamine oral medication 12/17/2010 at night with no effect. Was in to see Dr. 12/18/2010.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Device malfunction, Dizziness, Loss of consciousness
Clinical narrative: The first shot I gave the patient, the needle mal-functioned and the vaccine came out of the top of the needle. After completing the 2nd shot, I went to draw up another injection for her husband when he called me back over to the patient. He seemed to think that she blacked out for a second or two cause she stated that she didn't hear him call me back over. She was coherent and able to communicate with me as soon as I got there. She said she was a little clammy, light-headed and felt a little dizzy. I gave her some water to drink and a cold wash cloth on her head. She remained seated for at least 20-30 minutes as I proceeded to administer her husband his vaccine. She seemed to recover pretty quickly, and was surprised because something like this has never happened to her before. She said she was a little thirsty before I even gave her the shot, but not sure if that had any bearing. The couple left after 30 minutes or so and stated they both were fine. I called her before I left work to check on her, but there was no answer so I left a message.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain, Skin irritation
Clinical narrative: Irritation on opposite arm than injection. Increased in discomfort and pain over next 4 days. Patient when to ER on Sunday 12/19/10 and was told she had Active Shingles outbreak. Given Acyclovir to treat.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Loss of consciousness, Lumbar puncture, Muscular weakness, Myelitis transverse
Clinical narrative: Loss of consciousness, followed by fever, and inability to urinate and leg weakness that persists to this day. Diagnosis is transverse myelitis.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Urinary retention
Clinical narrative: Loss of consciousness, followed by fever, and inability to urinate and leg weakness that persists to this day. Diagnosis is transverse myelitis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: PT. DEVELOPED CELLULITIS ON BACK SIDE OF RIGHT UPPER ARM
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Fall
Clinical narrative: Was talking with patient, became quiet and just fell to the side of the exam table, at that point I caught her and laid her back. Only lasted about one minute. When she woke, she said that she thought that she fell asleep. She has done this previously with blood draws and injections. BP 110/60, pulse 46. After resting about 15 minutes BP was 110/70 and pulse 74. States she feels fine to leave the office.
Age: 71.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Diarrhoea, Pain, Pyrexia, Tremor
Clinical narrative: Soreness, body aches & pains, fever, vomit, diarrhea, chills & uncontrollable shivers/shakes.  In it's 5th day and slowly recovering/feel slightly better.
Age: 71.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Vomiting
Clinical narrative: Soreness, body aches & pains, fever, vomit, diarrhea, chills & uncontrollable shivers/shakes.  In it's 5th day and slowly recovering/feel slightly better.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever to 104, persisted for 24 hours, vomiting x 3, fine spotty rash on both legs
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Blindness, Death, Headache, Intensive care, Pyrexia
Clinical narrative: On 12/6/10, developed fever & headache.  Treated with Advil until 12/9/10; went to PMD; patient vomiting, 12/10/10, vision loss, adm. to E.R.  12/11/10, transferred to PICU.  Expired 12/16/10.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: On 12/6/10, developed fever & headache.  Treated with Advil until 12/9/10; went to PMD; patient vomiting, 12/10/10, vision loss, adm. to E.R.  12/11/10, transferred to PICU.  Expired 12/16/10.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site swelling
Clinical narrative: Patient reported to her doctor due to swelling and redness at injection site in arm. Her doctor prescribed an antibiotic (patient unsure of name) at this time as he felt there was infection present.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome after receiving Tdap, influenza vaccine and Pneumovax.
Age: 1.5
Sex: M
Vaccine: FLU3, HEP
Symptoms: Agitation, Decreased appetite, Emotional disorder, Irritability, Skin warm
Clinical narrative: FUSSY, CLINGING, AGITATED AND WARM TO TOUCH, DECREASED EATING AND FEEDINGS.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pain and stinging at time of injection. Now with painful ROM and abduction of the arm.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Erythema, Fatigue, Headache, Mass
Clinical narrative: Experienced feverish chills, headache, fatigue.  Symptoms in area where vaccine administered (left upper arm): redness, rash (from armpit to part of elbow), swelling, hot to touch.  Also experienced severe pain on arm. Lasted several days.  Minor pain in area of arm where vaccine received persists, when touched.  Muscle also has a lump on it.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Pyrexia, Rash, Skin warm, Swelling
Clinical narrative: Experienced feverish chills, headache, fatigue.  Symptoms in area where vaccine administered (left upper arm): redness, rash (from armpit to part of elbow), swelling, hot to touch.  Also experienced severe pain on arm. Lasted several days.  Minor pain in area of arm where vaccine received persists, when touched.  Muscle also has a lump on it.
Age: 28.0
Sex: F
Vaccine: FLUN3, TDAP, FLUN3, TDAP
Symptoms: Dysphagia, Erythema, Hypersensitivity, Obstructive airways disorder, Pruritus
Clinical narrative: 30 minutes after getting Flumist and TDAP on 12/16 developed redness on soles of feet, palms of hands very itchy, rash on UE, thighs, felt constricted airway, difficulty swallowing, but still able to breathe, better now. Still very itchy arms and legs, taking Benadryl for children with not much help. Pt not allergic to eggs. No fevers. No URI sx. No prior rxns to IZs.
Age: 28.0
Sex: F
Vaccine: FLUN3, TDAP, FLUN3, TDAP
Symptoms: Rash
Clinical narrative: 30 minutes after getting Flumist and TDAP on 12/16 developed redness on soles of feet, palms of hands very itchy, rash on UE, thighs, felt constricted airway, difficulty swallowing, but still able to breathe, better now. Still very itchy arms and legs, taking Benadryl for children with not much help. Pt not allergic to eggs. No fevers. No URI sx. No prior rxns to IZs.
Age: 28.0
Sex: F
Vaccine: FLUN3, TDAP, FLUN3, TDAP
Symptoms: Dysphagia, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: 30 minutes after getting Flumist and TDAP on 12/16 developed redness on soles of feet, palms of hands very itchy, rash on UE, thighs, felt constricted airway, difficulty swallowing, but still able to breathe, better now. Still very itchy arms and legs, taking Benadryl for children with not much help. Pt not allergic to eggs. No fevers. No URI sx. No prior rxns to IZs.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Cough, Injection site cellulitis, Injection site pain, Pain in extremity
Clinical narrative: First symptom was pain at the injections site. A few hours later I developed a dry cough, then a fever of 102.3, chills, arm pain became severe (couldn't touch the entire upper arm). Injection site then developed cellulitis.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: First symptom was pain at the injections site. A few hours later I developed a dry cough, then a fever of 102.3, chills, arm pain became severe (couldn't touch the entire upper arm). Injection site then developed cellulitis.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Pneumonia, Sputum test
Clinical narrative: I have had pneumonia for three months, since I received the pneumonia vaccine.  I have take two courses of Cipro and 3 courses of Levaquin and I'm still stick.  I was in the ER yesterday all day!
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Rash, Wheezing
Clinical narrative: After received flu vaccination, patient developed reddened eyes, wheeze, rash to extremities about with a few minutes of injection. Pt was given EPI-PEN jr., XOPENEX via HHN, tarist syrup & prednisone. Pt observed for 25 hours & D/C stable.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Swelling, Tenderness
Clinical narrative: Tenderness, significant swelling and pain over deltoid. Unable to elevate arm. 16 days after injection.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Borrelia test negative, Chest X-ray, Computerised tomogram, Hypoaesthesia facial, Laboratory test normal
Clinical narrative: 12/10/10 - pt. experienced difficulty with vision in (R) eye and numbness in (R) side of face. 12/11/10 - E.D. visit; diagnosed with Bell's Palsy - Rx: Prednisone x 7 days and antiviral meds, Lyme test - neg., CT scan, bloodwork - neg.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis, Visual impairment
Clinical narrative: 12/10/10 - pt. experienced difficulty with vision in (R) eye and numbness in (R) side of face. 12/11/10 - E.D. visit; diagnosed with Bell's Palsy - Rx: Prednisone x 7 days and antiviral meds, Lyme test - neg., CT scan, bloodwork - neg.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV, MMRV
Symptoms: Bordetella test, Culture, Unevaluable event
Clinical narrative: Had DTAP 9/27/07 - pos pertussis 9/13/10.
Age: 1.89
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Bordetella test, Culture, Pertussis
Clinical narrative: Swelling, induration, probable cellulitis. Antibiotics.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Dysphonia
Clinical narrative: Client stated that 1 week after she received the nasal mist vaccine on 11/10/2010 she had chills with no fever and developed hoarseness. No sore throat. For the past month she has had hoarseness off and on.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Bordetella test positive, Pertussis
Clinical narrative: 10/28/10 pos pertussis.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash erythematous, Tenderness
Clinical narrative: VARIVAX administered on 11-30-10. On 12-7-10 a rash consisting of 4 red raised spots covering the size of a quarter appeared. Tender to touch, not itchy, no vesicles. No treatment. Foster mother will monitor. 12-20-10 Foster mother reports no other symptoms.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Basophil count normal, Basophil percentage, C-reactive protein increased, Eosinophil count normal
Clinical narrative: SM develops HA, malaise, arthralgias, myalgias, fatigue after AVA and recurs with each successive vaccine.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Eosinophil percentage, Fatigue, Haematocrit normal, Haemoglobin normal, Headache
Clinical narrative: SM develops HA, malaise, arthralgias, myalgias, fatigue after AVA and recurs with each successive vaccine.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Laboratory test normal, Lymphocyte count normal, Lymphocyte percentage, Malaise, Mean cell haemoglobin concentration increased
Clinical narrative: SM develops HA, malaise, arthralgias, myalgias, fatigue after AVA and recurs with each successive vaccine.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count normal, Monocyte percentage
Clinical narrative: SM develops HA, malaise, arthralgias, myalgias, fatigue after AVA and recurs with each successive vaccine.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Neutrophil count normal, Neutrophil percentage, Platelet count normal, Red blood cell count normal
Clinical narrative: SM develops HA, malaise, arthralgias, myalgias, fatigue after AVA and recurs with each successive vaccine.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Red blood cell sedimentation rate increased, Red cell distribution width normal, Rheumatoid factor positive, White blood cell count normal
Clinical narrative: SM develops HA, malaise, arthralgias, myalgias, fatigue after AVA and recurs with each successive vaccine.
Sex: U
Vaccine: PPV
Symptoms: Cold sweat, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt given pneumo vaccine to left deltoid on 12-7-10. Pt came into office on 12-9-10 c/o pain, swelling to injection site, also with fever and cold sweats.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt given pneumo vaccine to left deltoid on 12-6-10, seen in office on 12-7-10, c/o fever, swelling & redness to injection site.
Age: 1.43
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Joint swelling, Weight bearing difficulty
Clinical narrative: Swelling left knee, slight erythema, pain. Began evening 12/7/10. Does not want to flex (L) knee, favors when walking. Came to office 12/9/10 without sx. Placed on oral KEFLEX.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Bordetella infection, Bordetella test positive
Clinical narrative: 12/3/10 (+) Bordetella - had ADACEL (TDAP) 7/17/08.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Tremor
Clinical narrative: No s/s reaction at clinic post injection - stayed 15 min. (This was HPV vaccine #2) with #1 having no s/s of side effects, rec. a triage message at 10:18 from parent, stating pt. is lying down R/T "spinning" dizziness - spoke with phy., & called mom, dizziness did not subside pt. was sent to ER with dizziness & "weak, shaky legs" approx 1300. (? reaction to immunization).
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Pertussis
Clinical narrative: 12/8/10 culture bordetella + positive pertussis.
Age: 21.0
Sex: M
Vaccine: ANTH, FLU3, SMALL
Symptoms: Rash, Vaccinia virus infection, Viral infection
Clinical narrative: Smallpox immunization given 12/5/10. Came to clinic c/o raised sores on left shoulder and going down his back. Instructed to see a provider on 12/17/10. Provider given diagnosis of "mild viral illness called vaccinia". No additional treatment given. As of 12/20, sores have decreased in number, no problems noted.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Scratch, Swelling
Clinical narrative: Start scratching the next day. Small raise red areas on the arm, back of arms, back of ankles, elbows, knees top of foot. Went to family Dr. received 2 steroid injections.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Inappropriate schedule of drug administration
Clinical narrative: I got TDAP vaccine even tho doctor was aware I had had TD vaccination in 2007. By day after this latest vaccination (Sat, 18 Dec '10) felt very tired after good night's sleep. Fever and chills began at 1pm, continued over next 10 hours, along with dizziness & lack of appetite. Still felt tired & dizzy (no fever, tho) on Sun, 12/19/10. No warning from doctor or nurse re side effects.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: I got TDAP vaccine even tho doctor was aware I had had TD vaccination in 2007. By day after this latest vaccination (Sat, 18 Dec '10) felt very tired after good night's sleep. Fever and chills began at 1pm, continued over next 10 hours, along with dizziness & lack of appetite. Still felt tired & dizzy (no fever, tho) on Sun, 12/19/10. No warning from doctor or nurse re side effects.
Age: 3.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Mother noticed the area (right thigh) where shot was given appeared as a red 3cm induration with irregular borders - Dr. recommended warm compresses to area and call if no improvement.
Age: 56.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Ear pain, Headache, Hyperhidrosis
Clinical narrative: Took oral Typhoid dose #2 on 12/14/10 at 10pm. On 12/15/10 developed headache. By 5pm developed earache, neck ache, sore throat. Uvula swelling. On 12/16/10 took Typhoid dose #3. On 12/17/10 in a.m developed nausea, vomiting, abdominal cramping, diarrhea, diaphoresis. Went to ER.
Age: 56.0
Sex: F
Vaccine: TYP
Symptoms: Liver function test abnormal, Nausea, Neck pain, Oropharyngeal pain, Swelling
Clinical narrative: Took oral Typhoid dose #2 on 12/14/10 at 10pm. On 12/15/10 developed headache. By 5pm developed earache, neck ache, sore throat. Uvula swelling. On 12/16/10 took Typhoid dose #3. On 12/17/10 in a.m developed nausea, vomiting, abdominal cramping, diarrhea, diaphoresis. Went to ER.
Age: 56.0
Sex: F
Vaccine: TYP
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Took oral Typhoid dose #2 on 12/14/10 at 10pm. On 12/15/10 developed headache. By 5pm developed earache, neck ache, sore throat. Uvula swelling. On 12/16/10 took Typhoid dose #3. On 12/17/10 in a.m developed nausea, vomiting, abdominal cramping, diarrhea, diaphoresis. Went to ER.
Age: 51.0
Sex: F
Vaccine: YF
Symptoms: Hypoaesthesia
Clinical narrative: 12/15/10 soon after shot given had numbness right side of head. On 12/19/10 last two fingers of right hand became numb.
Age: 13.0
Sex: M
Vaccine: IPV, MNQ, TDAP, VARCEL
Symptoms: Chest pain, Cough, Nasal congestion, Urticaria, Wheezing
Clinical narrative: Pt developed chest pain, stuffy nose, sl cough & hives approx. 30 min after receiving TDAP, MCV4, IPV, and varicella immunizations. 36 mg BENADRYL given IM per standing MD orders. Wheezing noted upon administrating BENADRYL. 5 minutes after receiving BENADRYL pt no longer c/o itching or chest pain. No further wheezing noted.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt developed hives approximately 1hr after receiving her vaccine. Hives present to both arms. No difficulty breathing. Breath sounds CTA (B). Slight itching noted. 25 mg Benadryl po given per RN (school nurse) & parent notified.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a 25 year old female with no known drug reactions/allergies and with a history of caesarean section for first pregnancy who in approximately September 2009, "about six months ago" was vaccinated with the first dose of GARDASIL. Concomitant therapy included SUBOXONE. The patient reported that she received the third dose of GARDASIL the same day she had a positive pregnancy test. The patient reported to be about 1 month pregnant. The last menstrual period was estimated happened in January 2010 and the estimated delivery date is 08-OCT-2010. The patient sought medical attention visiting the physician. Follow up information has been received from a physician from a pregnancy questionnaire who reported that the patient had an elective termination of pregnancy on 19-APR-2010, 11 weeks from last menstrual period. It was unknown if the products of conception were examined. It was unknown if the fetus was normal. The patient's last menstrual period was on 01-JAN-2010. Upon internal review elective termination was considered to be an other important medical event. No further information is available.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Arrhythmia, Bacterial infection, Cardiac enzymes, Cardiac monitoring, Condition aggravated
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old male patient with Stevens-Johnson syndrome and no drug reaction/allergies, who on approximately on 17-NOV-2010 was vaccinated with a first dose of GARDASIL (Lot # not reported) (4 days ago, reported date as 08-DEC-2010). The nurse reported that on 04-DEC-2010 about three weeks after vaccination, the patient had a flare up of Stevens-Johnson syndrome. The patient had a fever, high white cell count, blisters on his mouth, lips and genitals and was diagnosed with a bacterial infection. He also had cardiac arrhythmias and required a cardiac monitor and evaluation of his cardiac enzymes. He was hospitalized on 05-DEC-2010 and released on 07-DEC-2010. He was prescribed with antibiotics and steroids for 6 months. At the time of the report, the patient was  recovering. Flare up of Stevens-Johnson syndrome, cardiac arrhythmia and bacterial infection were considered to be immediately life-threatening by the reporter. Upon internal review flare up of Stevens-Johnson syndrome and hospitalization were considered to be an other important medical events. Additional information has been requested.