chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Chest X-ray normal, Condition aggravated, Cough, Malaise, Pertussis identification test
Clinical narrative: Information has been received from a physician concerning a 9 week old male who on 16-JUL-2008 was seen at clinic for cough and while there was vaccinated with ROTATEQ, HIBTITER, PREVNAR and PEDIARIX. After the vaccines administered, baby became very ill with coughing spasms, which has been seen almost everyday in hospital or clinic period. The patient was hospitalized on 20-JUL-2008 to rule out pertussis. The reporter considered the event to be life-threatening. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Respiratory syncytial virus test negative
Clinical narrative: Information has been received from a physician concerning a 9 week old male who on 16-JUL-2008 was seen at clinic for cough and while there was vaccinated with ROTATEQ, HIBTITER, PREVNAR and PEDIARIX. After the vaccines administered, baby became very ill with coughing spasms, which has been seen almost everyday in hospital or clinic period. The patient was hospitalized on 20-JUL-2008 to rule out pertussis. The reporter considered the event to be life-threatening. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Biopsy site unspecified normal, Caesarean section, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL concerning a 26 year old female with a history of polycystic ovaries, irregular periods, absence of menstruation (August 2007), Papanicolaou smear abnormal (low grade 2007) and biopsy (July 2007, showed no dysplasia) who on 07-NOV-2007 was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 658282/0929U) and on 04-FEB-2008 was vaccinated intramuscularly with a second dose of GARDASIL (Lot # 659653/1448U). There was no concomitant medication. The physician reported that the patient received 2 doses of the vaccine and is pregnant. The patient had a negative pregnancy test on 02-FEB-2008. On 05-FEB-2008 she had a positive qualitative HCG test (LMP 26-DEC-2007). The patient was seen in the office for unspecified medical attention. The patient was given a slip on 25-FEB-2008 to have routine OB panel. On 25-FEB-2008 the ultrasound showed the fetus to be 7 weeks and 6 days. No product quality complaint was involved. Outcome unknown. Follow-up information has been received from the physician on 10-NOV-2008. It was reported that this was the patient's first pregnancy. Medication taken during pregnancy included duet DHA prenatal vitamin, daily and Fe supplement, daily, for 9 months of pregnancy. Prenatal testing included MSAFP for Down's syndrome, screen negative, on 24-APR-2008. Subsequently, a healthy female infant was delivered at 38.5 weeks from LMP by cesarean section due to compound presentation on 26-SEP-2008. Birth weight was 7 pound 12 ounce, length 21.5 inch. The cesarean section was recommended due to non-vertex presentation. The infant was normal and with no congenital anomalies; there were no complications during pregnancy. The patient's concurrent medical condition included obesity. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Ultrasound scan
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL concerning a 26 year old female with a history of polycystic ovaries, irregular periods, absence of menstruation (August 2007), Papanicolaou smear abnormal (low grade 2007) and biopsy (July 2007, showed no dysplasia) who on 07-NOV-2007 was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 658282/0929U) and on 04-FEB-2008 was vaccinated intramuscularly with a second dose of GARDASIL (Lot # 659653/1448U). There was no concomitant medication. The physician reported that the patient received 2 doses of the vaccine and is pregnant. The patient had a negative pregnancy test on 02-FEB-2008. On 05-FEB-2008 she had a positive qualitative HCG test (LMP 26-DEC-2007). The patient was seen in the office for unspecified medical attention. The patient was given a slip on 25-FEB-2008 to have routine OB panel. On 25-FEB-2008 the ultrasound showed the fetus to be 7 weeks and 6 days. No product quality complaint was involved. Outcome unknown. Follow-up information has been received from the physician on 10-NOV-2008. It was reported that this was the patient's first pregnancy. Medication taken during pregnancy included duet DHA prenatal vitamin, daily and Fe supplement, daily, for 9 months of pregnancy. Prenatal testing included MSAFP for Down's syndrome, screen negative, on 24-APR-2008. Subsequently, a healthy female infant was delivered at 38.5 weeks from LMP by cesarean section due to compound presentation on 26-SEP-2008. Birth weight was 7 pound 12 ounce, length 21.5 inch. The cesarean section was recommended due to non-vertex presentation. The infant was normal and with no congenital anomalies; there were no complications during pregnancy. The patient's concurrent medical condition included obesity. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a dental hygienist concerning a female patient ("one of their office employee's daughters), whose first dose of GARDASIL was well-tolerated. On an unspecified date she was vaccinated a second dose of GARDASIL (lot number, route and injection site not reported). Sometime after the vaccination, she had developed severe abdominal pain. It was stated that the patient was hospitalized for severe abdominal pain (duration unknown). The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a female who was pregnant and vaccinated with the third dose of GARDASIL, IM, 0.5ml.  Subsequently the patient had a miscarriage.  This occurred some time ago and the reporter does not have patient information at this time.  The patient sought unspecified medical attention.  Upon internal review, miscarriage was determined to be an other important medical event.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: On 11-12-2008 after a field trip from school L deltoid- red, swollen, warm to touch a area estimated 9cm by 9cm.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Itching with rash on face and neck, not observed by this reporter. I was notified by phone after leaving patient's worksite (where administered).  I recommended ER visit.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Contusion, Injection site erythema, Injection site haematoma, Lymphadenopathy, Swelling
Clinical narrative: Left deltoid, erythematous raised patch below site. Contusion above site. Large amt swelling into upper forearm. Lymphadenopathy, axilla and tonsillar.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Ataxia, Blood test normal, Body temperature increased, CSF culture negative, Computerised tomogram normal
Clinical narrative: Two hours after vaccine, temp increased 106 deg. 10/14-10/17/08 vomiting, rash 10/16/08 developed ataxia -> admitted to hosp. CSF within normal limits.  12/18/08-records received for DOS 10/17/08-C/O fever since vaccinations. Tonsillar exudates noted. Assessment:tonsillopharyngitis.  Tonsillar exudates noted. Assessment:tonsillopharyngitis. krk 2/17/09-records received for DOS 10/21-10/23/08-DC DX Acute gastroenteritis. Presented with ataxia, fever over last few days and vomiting. Developed fever day of immunization at which time pharyngitis was diagnosed. Developed rash while on antibiotic azthromycin. Ataxia began on 10/21/08-in ED left acute otits media. poor oral intake. Diarrhea began on 10/22/08. No ataxia or fever while hospitalized.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Culture urine negative, Full blood count normal, Rash, Vomiting
Clinical narrative: Two hours after vaccine, temp increased 106 deg. 10/14-10/17/08 vomiting, rash 10/16/08 developed ataxia -> admitted to hosp. CSF within normal limits.  12/18/08-records received for DOS 10/17/08-C/O fever since vaccinations. Tonsillar exudates noted. Assessment:tonsillopharyngitis.  Tonsillar exudates noted. Assessment:tonsillopharyngitis. krk 2/17/09-records received for DOS 10/21-10/23/08-DC DX Acute gastroenteritis. Presented with ataxia, fever over last few days and vomiting. Developed fever day of immunization at which time pharyngitis was diagnosed. Developed rash while on antibiotic azthromycin. Ataxia began on 10/21/08-in ED left acute otits media. poor oral intake. Diarrhea began on 10/22/08. No ataxia or fever while hospitalized.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Sinusitis, Wheezing
Clinical narrative: Patient received the Influenza vaccine on 10/3/08. Reported that about 2 or 3 days later, developed cough and sinusitis. Symptoms resolved in slightly over 1 week. Symptom: wheeze.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Patient given 1st GARDASIL injection. 3 hours later patient developed pruritic rash on back and torso.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Patient complains of tongue and throat swelling.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral, No reaction on previous exposure to drug
Clinical narrative: Patient received influenza vaccine on 10/1/08. 15 minutes after the injection, patient reported her lip went numb and her jaw went numb. Vitals were checked and were WNL. Symptoms resolved. No other vaccines in past month and never had a reaction to the influenza vaccine.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Previously healthy 53 y/o received influenza vaccine at work around Nov. 5, 2008.  This individual has no medical problems and takes no meds.  Manufacturer was Novartis, Lot number 88637.  10 days later, the patient developed Shingles - Herpes Zoster - involving the C8 dermatome on the left arm/hand.  The Zoster appears to be mild in intensity.  Placed on Valtrex 1 gm tid x 7 days on 11/16/2008.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Erythema, Injection site anaesthesia, Lymphadenitis, Oedema
Clinical narrative: Edema, Erythema, warm to touch, tenderness to palp. Numbness at injection site, pain to upper right arm and back. In conjunction with Lymphadenitis.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Skin warm, Tenderness
Clinical narrative: Edema, Erythema, warm to touch, tenderness to palp. Numbness at injection site, pain to upper right arm and back. In conjunction with Lymphadenitis.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: Exacerbation of rebif side effects- specifically chills.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Pt had swelling, erythema and induration fo (R) upper arm, from mid deltoid approx 24 hrs after immunization. Had reduced some when seen by provider approx 36 hrs after immun. Verified Rxn to pt- suggested cool compresses and dose of Benadryl 25mg PO ( in addition to Allegra BID that pt normally takes). Lungs clear bilaterally, heart RRR, neuro intact. No musculoskeletal weakness. Pt will RTC if not improving.  Pt had previous sinusitis.   tx with Biaxin x 10 days- finished 10/31/08.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Rash papular
Clinical narrative: Red bumps on both arms and on head.
Age: 28.0
Sex: F
Vaccine: ANTH, FLUN3, TDAP
Symptoms: Erythema, Feeling hot, Induration, Urticaria
Clinical narrative: Large redden area behind left triceps. With welping radiating on inner portion of arm. Arm redness 3 1/2in x 4in hard warm to touch. VS=97.5- 117/80-82-18
Age: 6.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain
Clinical narrative: (L) upper arm swelling, warmth and redness from above elbow to arm pit. Started at 24hrs after vaccine and progressed. We are seeing pt as 36 hrs after vaccine admin. Has full range of motion, normal strength, just slight ache pain. Recommended Ibuprofen on second day of symptoms.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Generalized raised red rash began approx 24hrs after vaccination. Personal physician administrated steroid injections.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Fatigue, Headache, Injection site dryness, Oedema peripheral
Clinical narrative: Patient begin to feel tired, achey and had a headache, described her left arm as showing angry red band around her arm. Days later the injection site became flaky at the injection site. Arm swelling size of baseball
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Skin exfoliation
Clinical narrative: Patient begin to feel tired, achey and had a headache, described her left arm as showing angry red band around her arm. Days later the injection site became flaky at the injection site. Arm swelling size of baseball
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine "burned" upon administration. Following morning (L) deltoid area was itchy, red, hot and swollen and continued this way x3-4 days. Then became itchy & red x2-3 days. Then resolved.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Aphthous stomatitis, Oedema mouth
Clinical narrative: Received FLUZONE (L) deltoid 11/06/08 @ 4PM. Over a period of 2 hours felt "vaccine move from upper arm to shoulder to cheek." Following morning cheek swollen and mouth full of canker sores. Saw MD 11/7/08. Advised not to have FLUZONE again.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Eye pruritus, Eye swelling, Lip swelling, Rash
Clinical narrative: 5 1/2 hrs after injection c/o  itchy eyes; took BENADRYL .25 mg. Following morning woke with eyes swollen shut. Called MD who advised to take 50 mg BENADRYL @ 9A-1P-6P. AT 6 pm, lips began to swell + burn.  Developed rash on face + groin. Went to ER + treated with IV BENADRYL + Steroids. 3 days following vaccine, but (L) eye + cheek still rashy + slightly swollen. NB: Recalls during an environmental site test on 11/13. Friend/calleague has similar symptoms.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Chills, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: 10/31/08 Received FLUVIRUS on 11/11/08 noticed bilateral lower extremity muscle pain. 11/12/08 additional muscle pain in upper left extremities. 11/13/08 felt feverish, chills, muscle pain continue. 11/14/08 no fever/chills but had significant muscle pain in arms and legs, called PMD, Doctor instructed to discontinue PRAVASTATIN 40mg and take 2 ALEVE every 12 hrs. 11/15/08 muscle pain decreased with ALEVE but developed severe weakness hands/finger. Seen by PMD 11/16/08.
Age: 9.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Pruritus at injection site (received vaccine @ 10 am).  Developed  @ 5pm 11/18/08.  Swelling, induration.- Swelling 6 cm x 3 cm noted.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Ear infection, Pyrexia, Rash, Stomach discomfort
Clinical narrative: Patient received flu shot 9:30 AM.  States within hours had rash, upset stomach, fever.  Patient called hospital, spoke with someone on phone - patient seeing doctor, taking Amoxicillin for ear infection.  No fever - patient seen at hospital 11/18/08 2:10 pm.  Patient will follow up with primary MD if symptoms reoccur or if she does not continue to improve.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Body temperature increased, Irritability, Vomiting projectile
Clinical narrative: 24 hrs after imms given. Pt. developed a temp of 100.3. 2 episodes of 'projectile vomiting' + crankiness. Foster mom took him to ER for eval.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperaesthesia, Hyperreflexia, Injected limb mobility decreased, Pain in extremity, Sensory disturbance
Clinical narrative: Received vaccine in (L) arm. Could not lift arm subsequently. Reports deep pain & hyperesthesias. Shoulder exam normal. Neuro exam hyperreflexic & increased/hyper sensory exam.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy, Pregnancy test positive
Clinical narrative: Pt. got pregnant 2 mos. after 2nd GARDASIL injection.  Last inj. 11/30/07 / LMP 1/1/08 - preg. mid Jan. 2008
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash macular, Rash pruritic, Urticaria
Clinical narrative: Pt. given VARIVAX 11-15-08. Per pt., on 11-17-08, 8A pt. developed pruritic rash with red, blotchy spots over shoulder-neck area. Pt. was seen by Dr. 11-18-08. Slight blotchy erythema on cheeks other wise most hives have resolved (PRN BENADRYL/hydrocortisone cream)
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Patient reports he received flu vaccination at his place of business at 2:15 pm on Monday,  11/03/2008. The same evening at 8:00 pm his arm developed a "softball size hive" which he described as being "raised, red, swollen, hard, itching, and warm to touch" at site of administration (LD). Hr reports that when he woke up the following morning at 7:00 am on Tuesday, ll/4 his arm was "normal." On Tuesday evening (11/4) at 9:00  pm he developed a "tennis ball." sized "hive" on his mid back area that progressively spread to his entire back and a large area of both thighs. He denied any SOB or airway obstruction. He took 2 OTC Benedryl tablets at 3:00 am and states when he awoke the following morning on Wednesday, 11/5 at 7:00 am the "hives" had resolved. He had carpel tunnel surgery on Thursday, Nov 6 on his R wrist and reports no episode of hives on the day of surgery, but on the same evening (Thursday) he again developed  a hive on his outer left thigh which he described as golf ball in size, raised, warm and itchy. He again took 2 OTC Benedryl tablets. On Friday, Nov. 7 at 7 am he reports having hives on both buttocks and thighs which progressively spread to both of his entire thighs and to back of both knees. By 12:15 on Friday, Nov. 7 the hives had resolved.I checked back with him on Wednesday, Nov. 12 and he reports no further problems since Friday, Nov. 7. He reports he has received the flu vaccine annually for the last 10 years without adverse effects.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reports he received flu vaccination at his place of business at 2:15 pm on Monday,  11/03/2008. The same evening at 8:00 pm his arm developed a "softball size hive" which he described as being "raised, red, swollen, hard, itching, and warm to touch" at site of administration (LD). Hr reports that when he woke up the following morning at 7:00 am on Tuesday, ll/4 his arm was "normal." On Tuesday evening (11/4) at 9:00  pm he developed a "tennis ball." sized "hive" on his mid back area that progressively spread to his entire back and a large area of both thighs. He denied any SOB or airway obstruction. He took 2 OTC Benedryl tablets at 3:00 am and states when he awoke the following morning on Wednesday, 11/5 at 7:00 am the "hives" had resolved. He had carpel tunnel surgery on Thursday, Nov 6 on his R wrist and reports no episode of hives on the day of surgery, but on the same evening (Thursday) he again developed  a hive on his outer left thigh which he described as golf ball in size, raised, warm and itchy. He again took 2 OTC Benedryl tablets. On Friday, Nov. 7 at 7 am he reports having hives on both buttocks and thighs which progressively spread to both of his entire thighs and to back of both knees. By 12:15 on Friday, Nov. 7 the hives had resolved.I checked back with him on Wednesday, Nov. 12 and he reports no further problems since Friday, Nov. 7. He reports he has received the flu vaccine annually for the last 10 years without adverse effects.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: Was contacted by employee's mother who said employee had had a "migraine" headache for one week post influenza vaccination. Employee does not have a history of migraines.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Her physician called to report that her flu shot resulted in the inability to move her entire arm, but the condition is improving.  Her arm was very sore and tender and the doctor thought maybe the injection had been given too high on her arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Neuritis, Pain, Paraesthesia
Clinical narrative: Erythema and tenderness at injection site for 4 days. On the 4th day  a neuritis tingling and pain were noted proximal to the injection site.  On the 6th day eruption of a vesicular rash occurred. Currently this has descended, in a milder form, to the wrist area.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Erythema and tenderness at injection site for 4 days. On the 4th day  a neuritis tingling and pain were noted proximal to the injection site.  On the 6th day eruption of a vesicular rash occurred. Currently this has descended, in a milder form, to the wrist area.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient received influenza vaccine 10/24/08.  Patient called 11/12/08 stating he has been experiencing numbness and tingling in left arm and arm since receiving the vaccine. Spoke with physician who instucted patient to be seen at student health. Patient reports he will go 11/14/08 at noon. Message was left for patient on Fri 11/14 in the afternoon, Sat 11/15 and Monday 11/16.  As of Wed 11/17 patient has not called back to notify us of outcome.
Age: 40.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Biopsy skin, Varicella post vaccine
Clinical narrative: Developed Varicella disease 14 days after receiving Varivax # 1 injection
Age: 20.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Injection site vesicles
Clinical narrative: 11/13 - 1 cm diameter blister @ vaccine site. No erythema
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Malaise
Clinical narrative: Employee had extreme fatigue, malaise for one week after receiving annual influenza vaccine. Also reported left arm where vaccine was given was so sore that she was unable to sleep on that side.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Throat irritation
Clinical narrative: At about 3 pm the day of vaccination, patient began to cough in response to a tickling sensation in throat.  The cough got progressively worse ove the enxt 2 hours in response to what felt like a "river" of drainage.  Patient took Nyquil Cough to sleep & felt better the next am.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: 2-3 hrs after flulaval injection, client broke out in itchy, red rash with welts abdomen and back. Speads to face. MD called. Benadrl 50 mg IM given/LD. Symptoms worsening.To ER, private car driven by school nurse. No throat or breathing difficulties. DC'd home at 6 PM. Rash cleared by AM Sat 10/11/08.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Rash erythematous, Rash papular
Clinical narrative: CLIENT BROKE OUT IN SMALL RED PAPULES ALL OVER BODY, FIRST NOTED IN EARLY AM HOURS OF 11-06-2008.  CLIENT HAD ALSO RUN LOW-GRADE TEMPERATURE THROUGHOUT NIGHT.  IMMIS WERE GIVEN ON 11-05-2008.  MOM GAVE BENADRYL EVERY 6 HOURS, STARTING ON 11-06-2008 UNTIL 11-07-2008.  STATES RASH RESOLVING BY 11-07-2008 AM.  CLIENT WAS ALSO RX PREDNISONE 5MG-5ML 2CC BID FOR 7 DAYS.  UNSURE HOW LONG MOM GAVE THE MEDICINES.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Back pain, Induration, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Eztreme swelling of deltoid, hard, hot to tough. Deep pain over entire deltoid and generalized pain throughout arm, shoulder, neck, and upper back. Hives across base of deltoid, rash across chest.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral, Pain in extremity, Rash, Skin warm, Urticaria
Clinical narrative: Eztreme swelling of deltoid, hard, hot to tough. Deep pain over entire deltoid and generalized pain throughout arm, shoulder, neck, and upper back. Hives across base of deltoid, rash across chest.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema multiforme, Myalgia, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Generalized body rash, diagnosed on 11/17 by dermatologist as erythema multiforme. Rash appeared on back approximately 24 hours after vaccination and spread to entire body, persisting as of this writing (11/19). Rash is flat and itchy. Also experienced low grade fever and muscle aches that began overnight and  subsided within 24 hours of vaccination.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Rash papular, Vaccine positive rechallenge
Clinical narrative: Patches of papules covering symmetric areas of both lateral thighs, with onset several hours after vaccination, and persistent at exam 1 week later.  Patient had similar but less widespread papules after 2 month vaccines.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Pt. stated left upper arm became red, swollen, painful and hot a few hours after Pneumonia vaccine given.  Also, had chills, body aches and fever of 100.2 that evening.  On 11/11, she felt slightly better, but arm still swollen, red and painful, but no fever, chills or body aches. Follow up phone call on 11/17, husband stated that she was completely recovered.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Pt. stated left upper arm became red, swollen, painful and hot a few hours after Pneumonia vaccine given.  Also, had chills, body aches and fever of 100.2 that evening.  On 11/11, she felt slightly better, but arm still swollen, red and painful, but no fever, chills or body aches. Follow up phone call on 11/17, husband stated that she was completely recovered.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Amenorrhoea, Back pain, Dizziness, Fatigue
Clinical narrative: Severe Migraines,Dizziness,Blacked out vision, Fatigue, Body aches,Neck pain, Back pain, abdominal pain, Rash on scalp, hand and foot tingling/falling asleep. No menstrual cycle. Foggy thinking.  7/01/09 H&P dated 12/18/08 received with dx:  Fibromyalgia.  Possible reaction to Gardasil vaccine.  Pt reports after HPV#1 (0688F) on 6/16/08 pt had worsening intensity and frequency of migraine H/A. After HPV#2 (0072X) on 9/2/08 pt had worsening of migraines and now extreme fatigue, abdominal pain, lower pelvic pain, back pain-lower, hand and foot paresthesias, pain all over, sensation of heaviness, forgetfulness and disturbed sleep. TX with antidepressants. PE (+) for 16/18 tender points in neck, elbow, knees and back.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Migraine, Neck pain, Nuclear magnetic resonance imaging brain normal, Pain
Clinical narrative: Severe Migraines,Dizziness,Blacked out vision, Fatigue, Body aches,Neck pain, Back pain, abdominal pain, Rash on scalp, hand and foot tingling/falling asleep. No menstrual cycle. Foggy thinking.  7/01/09 H&P dated 12/18/08 received with dx:  Fibromyalgia.  Possible reaction to Gardasil vaccine.  Pt reports after HPV#1 (0688F) on 6/16/08 pt had worsening intensity and frequency of migraine H/A. After HPV#2 (0072X) on 9/2/08 pt had worsening of migraines and now extreme fatigue, abdominal pain, lower pelvic pain, back pain-lower, hand and foot paresthesias, pain all over, sensation of heaviness, forgetfulness and disturbed sleep. TX with antidepressants. PE (+) for 16/18 tender points in neck, elbow, knees and back.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Somnolence, Thinking abnormal, Thyroid function test normal
Clinical narrative: Severe Migraines,Dizziness,Blacked out vision, Fatigue, Body aches,Neck pain, Back pain, abdominal pain, Rash on scalp, hand and foot tingling/falling asleep. No menstrual cycle. Foggy thinking.  7/01/09 H&P dated 12/18/08 received with dx:  Fibromyalgia.  Possible reaction to Gardasil vaccine.  Pt reports after HPV#1 (0688F) on 6/16/08 pt had worsening intensity and frequency of migraine H/A. After HPV#2 (0072X) on 9/2/08 pt had worsening of migraines and now extreme fatigue, abdominal pain, lower pelvic pain, back pain-lower, hand and foot paresthesias, pain all over, sensation of heaviness, forgetfulness and disturbed sleep. TX with antidepressants. PE (+) for 16/18 tender points in neck, elbow, knees and back.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Given Flu shot 11/12/2008.  Next day a rash appeared on left upper thigh.  Rash spread over the next few days and now is on lower abdomen, legs and arms.  Rash is fine, red, raised and very itchy.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's arm at the site of the injection is swollen and red from the top of his shoulder to his elbow.  Patient got the shot on 11/17/08 at 3:15pm.  He tested positive for strep that same day at 8:00am.  He took his first dose of amoxicillin at 9:30am.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: ADMINISTERED ADULT ONLY ON FLU
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: The same day as receiving an influenza injection, the patient started with fever, cough and body aches that lasted 1 week.  She did not complain of runny nose or sore throat.  All symptoms resolved without medical treatment.  Patient was concerned that there was a live componant to the vaccine and was reassured by myself.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cold sweat, Dyspnoea, Flushing, Nausea, Pallor
Clinical narrative: Was called to room where client was found to be  clammy, flushed, then turned white as a sheet, had n/v, shortness of breath, and difficulty breathing with in 10 to 15 minutes of the time the injections were given. Advised to call 911. Flu and pneumonia immunizations were given at the same time.  Epinephrine 1:1000 0.50 ml given IM and Benadryl 50mg (1.0ml) given IM. 12/19/08-records received-presented to Ed with C/O nausea and vomiting on 11/13/08. C/O pain in subxiphoid area of stomach, crampy. DX:adverse reaction to flu shot. Acute nausea and vomiting.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Was called to room where client was found to be  clammy, flushed, then turned white as a sheet, had n/v, shortness of breath, and difficulty breathing with in 10 to 15 minutes of the time the injections were given. Advised to call 911. Flu and pneumonia immunizations were given at the same time.  Epinephrine 1:1000 0.50 ml given IM and Benadryl 50mg (1.0ml) given IM. 12/19/08-records received-presented to Ed with C/O nausea and vomiting on 11/13/08. C/O pain in subxiphoid area of stomach, crampy. DX:adverse reaction to flu shot. Acute nausea and vomiting.
Age: 7.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Patient received VZV immunization on 10/21/08.  On 11/17/08 small papules began to appear over legs, arms, and trunk.  Fever onset on 11/18/08 at home (97.8 temperature here today). Patient has 50 or less scattered lesions.  (Mom states that years ago, two siblings both developed rash after receiving VZV immunization #1, children now age 9 and 12).
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Discomfort, Erythema, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Received Pneumovax 10 AM 11/18/08.  Complained of some immediate discomfort.  Noted some minor warmth and erythema at the injection site the morning of 11/19/08 which worsened over the day and by the time of evaluation at 5 PM had fairly extensive erythema over the right deltoid and a large, oval area of erythema and warmth over the triceps region.  Low grade fever of 100.2 (temporal) noted but no other systemic symptoms or signs.  Given Solumedrol 125 mg IM and Rocephin 1 gm IM and given prescriptions for Prednisone 20 mg 3 tabs daily x 3 days and Keflex 500 mg 1 tab qid x 7 days to start 11/20/08.
Age: 19.0
Sex: M
Vaccine: HEPAB, YF
Symptoms: Asthenia, Syncope, Visual impairment
Clinical narrative: Received yellow fever vaccination in left arm over August Unit Training Assembly.  Patient did not experience any problems until approx 1 hour later.  He ate lunch returned to work and felt a generalized weakness in his body, he denies any ringing in the ears but states that he did see stars.  Patient was sent to the MC and given fluids (PO) and no further treatment was provided and symptoms did not recur.  He was released back to full duty and considered worldwide ready and able to perform assigned tasks.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Arthritis, Asthenia, Fatigue, Immune system disorder
Clinical narrative: Two days after getting shot, I started developing join pain all over my body.  In my elbows, knees, hands, shoulders, feet.  I called my doctor 2 weeks later, and another doctor on duty prescribed Ibuprofen 600 mg for the pain.  I requested an appointment with my rheumatologist, since I suffer from Scleroderma and Reynaud's Disease.  On October 31, 2008 the rheumatologist prescribed Prednisone for inflammation and pain in my joints.  Condition has not improved.  It is getting worse, pain has not gone away, hands are swollen and puffy.  It is getting so difficult to do daily activities, since I am very weak and fatigue.  I believe Dr. should not have ordered to get the shot in the first place, since my immune system was compromised already.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain
Clinical narrative: Two days after getting shot, I started developing join pain all over my body.  In my elbows, knees, hands, shoulders, feet.  I called my doctor 2 weeks later, and another doctor on duty prescribed Ibuprofen 600 mg for the pain.  I requested an appointment with my rheumatologist, since I suffer from Scleroderma and Reynaud's Disease.  On October 31, 2008 the rheumatologist prescribed Prednisone for inflammation and pain in my joints.  Condition has not improved.  It is getting worse, pain has not gone away, hands are swollen and puffy.  It is getting so difficult to do daily activities, since I am very weak and fatigue.  I believe Dr. should not have ordered to get the shot in the first place, since my immune system was compromised already.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood test normal, Drug screen negative, Electroencephalogram normal, Full blood count normal, Metabolic function test
Clinical narrative: One week after the flumist, she began to have simple movements of mouth and fingers -- aka tics.  Eventually hospitalized to evaluate as tics became more complex involving arms/legs.  MRI, EEG, blood tests all normal.  Followed by neurology and undergoing workup.  Also had recent stress and fungal infection at the same time.  Previous history of hospitalization due to dehydration and cramping after flu-like virus. 12/10/08-records received for DOS 11/9/08- DC DX: Complex Tics. Vaginal yeast infection. Presented with recent onset of abnormal facial, shoulder, hand and feet movements. C/O itching of genital area. Observed complex movements involving hands and feet and some lip smacking.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging normal, Streptococcal identification test negative, Stress, Tic
Clinical narrative: One week after the flumist, she began to have simple movements of mouth and fingers -- aka tics.  Eventually hospitalized to evaluate as tics became more complex involving arms/legs.  MRI, EEG, blood tests all normal.  Followed by neurology and undergoing workup.  Also had recent stress and fungal infection at the same time.  Previous history of hospitalization due to dehydration and cramping after flu-like virus. 12/10/08-records received for DOS 11/9/08- DC DX: Complex Tics. Vaginal yeast infection. Presented with recent onset of abnormal facial, shoulder, hand and feet movements. C/O itching of genital area. Observed complex movements involving hands and feet and some lip smacking.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: 6 by 6.5 cm erythmatic patch to left thigh
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Pain in extremity
Clinical narrative: mild soreness at injection site that resolved within 1-2 days of vaccination. approximately 2 weeks later, noticed pain/soreness in right upper arm. thought may have pulled muscle with exercise. continued to be sore with right arm abduction and deep palpation. noticed right deltoid weakness on 11/15/08 when tried to do bench press and push ups. didn't notice weakness in deltoid muscles prior. weakness slowly improving but not completely resolved.
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Acoustic stimulation tests normal, Activities of daily living impaired, Arthralgia, Autoimmune disorder, Back pain
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, fatigue, pain, swollen joint, walking difficulty, decrease hand grasp, back pain, sinus problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information in the form of medical records was received on 22 September 2008. Medical history noted by the subject included recurring flu, asthma, frequent pneumonia, anaphylactic shock to penicillin and vomiting with codeine. Also mentioned was a small lump in the left breast (cyst-date no specified). An x-ray of the right hip and pelvis due to chronic pain performed on 07 February 2005 was unremarkable. An x-ray of the right knee performed on the same date showed narrowing of the medial compartment of the knee joint and was otherwise unremarkable. It was documented that the subject uses NASOCORT for sinus problems. In the course of review of medical records, it was noted that the subject was at some point diagnosed with reflux and was given PRILOSEC as treatment. This was not indicated as an adverse event at this time. The PRILOSEC seemed to improve the subjects symptoms. Also in the course of review, it was noted that the subjects hearing was tested on 26 February 2008 and found to be at normal thresholds. An exam dated 11 February 2008 for nasal problems noted hearing loss, chronic otitis externa, allergic rhinitis and rhinitis medicamentosa, but did not indicate these specifically as events or related symptoms to claimed events. Follow up information was received on 07 November 2008 via an interview between lawyers and the subject. The subject received the first and second doses of LYMERIX on 16 May 2001 and 13 June 2001. In May 2001, she developed joint pain. In June 2001, she developed fatigue and flu-like symptoms. In 2001 she experienced forgetfulness and hot flashes. In 2005 she developed bursitis, dyslexia, and mononucleosis. In 2006/2007, she was diagnosed with plantar fasciitis. On unspecified dates she experienced depression and weight gain. Treatment included glucosamine chondroitin, ALEVE, cortisone, clonazepam, and CELEXA. Dyslexia was assessed by GSK to be medically significant. With the exception of flu-like symptoms and mononucleosis, the events were unresolved at the time of reporting.
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Bursitis, Cognitive disorder, Decreased activity, Depression, Differential white blood cell count normal
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, fatigue, pain, swollen joint, walking difficulty, decrease hand grasp, back pain, sinus problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information in the form of medical records was received on 22 September 2008. Medical history noted by the subject included recurring flu, asthma, frequent pneumonia, anaphylactic shock to penicillin and vomiting with codeine. Also mentioned was a small lump in the left breast (cyst-date no specified). An x-ray of the right hip and pelvis due to chronic pain performed on 07 February 2005 was unremarkable. An x-ray of the right knee performed on the same date showed narrowing of the medial compartment of the knee joint and was otherwise unremarkable. It was documented that the subject uses NASOCORT for sinus problems. In the course of review of medical records, it was noted that the subject was at some point diagnosed with reflux and was given PRILOSEC as treatment. This was not indicated as an adverse event at this time. The PRILOSEC seemed to improve the subjects symptoms. Also in the course of review, it was noted that the subjects hearing was tested on 26 February 2008 and found to be at normal thresholds. An exam dated 11 February 2008 for nasal problems noted hearing loss, chronic otitis externa, allergic rhinitis and rhinitis medicamentosa, but did not indicate these specifically as events or related symptoms to claimed events. Follow up information was received on 07 November 2008 via an interview between lawyers and the subject. The subject received the first and second doses of LYMERIX on 16 May 2001 and 13 June 2001. In May 2001, she developed joint pain. In June 2001, she developed fatigue and flu-like symptoms. In 2001 she experienced forgetfulness and hot flashes. In 2005 she developed bursitis, dyslexia, and mononucleosis. In 2006/2007, she was diagnosed with plantar fasciitis. On unspecified dates she experienced depression and weight gain. Treatment included glucosamine chondroitin, ALEVE, cortisone, clonazepam, and CELEXA. Dyslexia was assessed by GSK to be medically significant. With the exception of flu-like symptoms and mononucleosis, the events were unresolved at the time of reporting.
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Dyslexia, Fatigue, Full blood count normal, Gait disturbance, Grip strength decreased
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, fatigue, pain, swollen joint, walking difficulty, decrease hand grasp, back pain, sinus problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information in the form of medical records was received on 22 September 2008. Medical history noted by the subject included recurring flu, asthma, frequent pneumonia, anaphylactic shock to penicillin and vomiting with codeine. Also mentioned was a small lump in the left breast (cyst-date no specified). An x-ray of the right hip and pelvis due to chronic pain performed on 07 February 2005 was unremarkable. An x-ray of the right knee performed on the same date showed narrowing of the medial compartment of the knee joint and was otherwise unremarkable. It was documented that the subject uses NASOCORT for sinus problems. In the course of review of medical records, it was noted that the subject was at some point diagnosed with reflux and was given PRILOSEC as treatment. This was not indicated as an adverse event at this time. The PRILOSEC seemed to improve the subjects symptoms. Also in the course of review, it was noted that the subjects hearing was tested on 26 February 2008 and found to be at normal thresholds. An exam dated 11 February 2008 for nasal problems noted hearing loss, chronic otitis externa, allergic rhinitis and rhinitis medicamentosa, but did not indicate these specifically as events or related symptoms to claimed events. Follow up information was received on 07 November 2008 via an interview between lawyers and the subject. The subject received the first and second doses of LYMERIX on 16 May 2001 and 13 June 2001. In May 2001, she developed joint pain. In June 2001, she developed fatigue and flu-like symptoms. In 2001 she experienced forgetfulness and hot flashes. In 2005 she developed bursitis, dyslexia, and mononucleosis. In 2006/2007, she was diagnosed with plantar fasciitis. On unspecified dates she experienced depression and weight gain. Treatment included glucosamine chondroitin, ALEVE, cortisone, clonazepam, and CELEXA. Dyslexia was assessed by GSK to be medically significant. With the exception of flu-like symptoms and mononucleosis, the events were unresolved at the time of reporting.